THOUSAND
OAKS, Calif., April 27,
2022 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today
announced financial results for the first quarter of 2022. Key
results include:
- Total revenues increased 6% to $6.2
billion in comparison to the first quarter of 2021,
resulting from 2% growth in global product sales and increased
Other Revenue from our COVID-19 manufacturing collaboration.
-
- Volumes grew double-digits for a number of products including
Repatha® (evolocumab), Prolia® (denosumab)
and EVENITY® (romosozumab-aqqg).
- GAAP earnings per share (EPS) decreased 5% to $2.68 driven by a decrease in other (expense)
income, net, partially offset by increased revenues and lower
weighted-average shares outstanding. The decrease in other
(expense) income, net, was primarily driven by net losses
recognized on our strategic equity investments in the current year
compared with net gains recognized in the prior year.
-
- GAAP operating income increased 17% to $2.5 billion, and GAAP operating margin increased
5.5 percentage points to 43.6%.
- Non-GAAP EPS increased 15% to $4.25, driven by increased revenues and lower
weighted-average shares outstanding.
-
- Non-GAAP operating income increased 10% to $3.1 billion, and non-GAAP operating margin
increased 3.6 percentage points to 54.8%.
- The Company generated $2.0
billion of free cash flow for the first quarter versus
$1.9 billion in the first quarter of
2021.
- 2022 total revenues guidance reaffirmed at $25.4-$26.5
billion; EPS guidance revised to $12.53-$13.58 on a
GAAP basis, and reaffirmed at $17.00-$18.00 on a
non-GAAP basis.
- Amgen will vigorously contest the adjustments and penalties
proposed by the Internal Revenue Service (IRS) for the 2010-15
period as discussed in more detail on pages 7-8 of this release.
Amgen is confident in its position in the dispute, and in the level
of reserves the Company has established.
"We achieved strong, volume-driven growth
in the quarter, while launching two very promising first-in-class
medicines," said Robert A. Bradway,
chairman and chief executive officer. "We are also advancing a
robust pipeline with data for several mid-to-late stage candidates
expected during the year."
$Millions, except EPS,
dividends paid per share and
percentages
|
|
Q1
'22
|
|
Q1
'21
|
|
YOY Δ
|
Total
Revenues
|
|
$
6,238
|
|
$
5,901
|
|
6%
|
GAAP Operating
Income
|
|
$
2,500
|
|
$
2,129
|
|
17%
|
GAAP Net
Income
|
|
$
1,476
|
|
$
1,646
|
|
(10%)
|
GAAP EPS
|
|
$
2.68
|
|
$
2.83
|
|
(5%)
|
Non-GAAP Operating
Income
|
|
$
3,140
|
|
$
2,864
|
|
10%
|
Non-GAAP Net
Income
|
|
$
2,343
|
|
$
2,150
|
|
9%
|
Non-GAAP EPS
|
|
$
4.25
|
|
$
3.70
|
|
15%
|
Dividends Paid Per
Share
|
|
$
1.94
|
|
$
1.76
|
|
10%
|
References in this release to "non-GAAP" measures, measures
presented "on a non-GAAP basis" 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 2% for the first quarter of 2022
versus the first quarter of 2021. Unit volumes grew 9%, offset by
7% lower net selling price and 2% negative impact from foreign
exchange, and sales in the first quarter benefited 2% ($110 million) from year-over-year favorable
changes to estimated sales deductions. Consistent with prior years,
Enbrel® (etanercept) and Otezla®
(apremilast) followed the pattern of lower Q1 sales relative to the
remainder of the year due to the impact of benefit plan changes,
insurance reverifications and increased co-pay expenses as U.S.
patients work through deductibles.
COVID-19 continued to affect our business around the world in
the first quarter. In March and April, we have seen the impact of
the pandemic recede in the U.S., which has led to improved demand
patterns and allowed us to engage in increased field-facing
activities.
General Medicine
- Prolia sales increased 12% year-over-year for the first
quarter, driven by 10% volume growth and higher net selling
price.
- EVENITY sales increased 59% year-over-year to a record
$170 million for the first quarter,
driven by strong volume growth across our markets. U.S. sales grew
93% year-over-year, driven by 79% volume growth.
- Repatha sales increased 15% year-over-year for the first
quarter, driven by 49% volume growth partially offset by lower net
selling price. Sales grew 19% in the U.S., driven by 41% volume
growth partially offset by lower net selling prices resulting from
higher rebates to support and expand access for patients. Sales
grew 12% outside the U.S., with 57% volume growth partially offset
by lower net selling price primarily driven by the inclusion of
Repatha on China's National
Reimbursement Drug List as of January 1,
2022. Repatha remains the global proprotein convertase
subtilisin/kexin type 9 (PCSK9) segment leader, with over 1 million
patients treated since launch.
- Aimovig® (erenumab-aooe) sales increased 53%
year-over-year for the first quarter, driven by favorable changes
to estimated sales deductions and higher net selling price,
partially offset by a 4% decline in volume.
Inflammation
- TEZSPIRE™ (tezepelumab-ekko) generated sales of
$7 million for the first quarter.
TEZSPIRE has been well received by prescribers, with initial
adoption by both allergists and pulmonologists. Healthcare
providers have welcomed the product's novel approach to treating
the approximately 2.5 million worldwide patients with severe asthma
who are uncontrolled or biologic eligible, without any phenotypic
and biomarker limitation.
- Otezla® (apremilast) sales decreased 5%
year-over-year for the first quarter, primarily driven by lower net
selling price and lower inventory levels, partially offset by 7%
volume growth. In the U.S., we saw strengthening of the market,
with Otezla remaining the market share leader among patients who
are new to systemic agents for psoriasis. U.S. sales were impacted
in the first quarter as both wholesalers and specialty pharmacies
reduced inventory levels. Otezla sales in the U.S. were also
impacted by price declines in the first quarter, driven primarily
by enhancements to our co-pay and patient assistance programs to
support new patients starting treatment as well as additional
rebates to improve the quality of coverage. Going forward, we
expect continued strong volume growth and lower year-over-year
price erosion for the remaining quarters of 2022.
- Enbrel® (etanercept) sales decreased 7%
year-over-year for the first quarter, driven by declines in net
selling price and inventory levels. Year-over-year volume remained
flat in the first quarter, supported by Enbrel's long track record
of efficacy and safety.
- AMGEVITA™ (adalimumab) sales increased 2% year-over-year
for the first quarter, driven by 16% volume growth, partially
offset by foreign exchange impact and lower net selling price
resulting from increased competition. AMGEVITA continues to be the
most prescribed adalimumab biosimilar in Europe.
Hematology-Oncology
- LUMAKRAS®/LUMYKRAS™ (sotorasib) generated
$62 million of sales for the first
quarter, representing 38% quarter-over-quarter growth. In the U.S.,
LUMAKRAS has been prescribed to approximately 2,500 patients by
over 1,500 physicians in both academic and community settings.
Outside the U.S., LUMYKRAS has now been approved in nearly 40
countries around the world, with recent reimbursement approvals in
the United Kingdom and
Japan.
- KYPROLIS® (carfilzomib) sales increased 14%
year-over-year for the first quarter, driven by 13% volume
growth.
- XGEVA® (denosumab) sales increased 7%
year-over-year for the first quarter, driven by favorable changes
to estimated sales deductions and higher net selling price,
partially offset by a 2% decline in volume growth.
- Vectibix® (panitumumab) sales increased 5%
year-over-year for the first quarter, driven by volume growth in
ex-US markets. Vectibix remains the EGFR (epidermal growth factor
receptor) inhibitor of choice across all lines of therapy.
- Nplate® (romiplostim) sales increased 17%
year-over-year for the first quarter, driven by 7% volume growth
and favorable changes to estimated sales deductions.
- BLINCYTO® (blinatumomab) sales increased 29%
year-over-year for the first quarter, driven by volume growth.
- MVASI® sales decreased 17% year-over-year for
the first quarter, primarily driven by lower net selling price that
was partially offset by 13% volume growth. In the U.S., MVASI
continues to hold leading volume share with 49% of the bevacizumab
segment in the quarter. For the full-year, we expect continued net
selling price erosion and volume declines driven by increased
competition and Average Selling Price (ASP) erosion.
- KANJINTI® (trastuzumab-anns) sales decreased
40% year-over-year for the first quarter, primarily driven by
declines in net selling price and volume. In the U.S., KANJINTI
continues to hold leading volume share with 39% of the trastuzumab
segment in the quarter. Going forward, we expect continued net
selling price deterioration and volume declines driven by increased
competition and ASP erosion.
Established Products
- Total sales of our established products, which include
Neulasta® (pegfilgrastim), NEUPOGEN®
(filgrastim), EPOGEN® (epoetin alfa),
Aranesp® (darbepotein alfa),
Parsabiv® (etelcalcetide), and
Sensipar®/Mimpara™ (cinacalcet), decreased 12%
year-over-year for the first quarter, primarily driven by lower net
selling price and volume declines. In the aggregate, we expect the
year-over-year net price and volume erosion for this portfolio of
products to continue.
Product Sales Detail by Product and Geographic Region
$Millions, except
percentages
|
|
Q1
'22
|
|
Q1
'21
|
|
YOY Δ
|
|
|
US
|
|
ROW
|
|
TOTAL
|
|
TOTAL
|
|
TOTAL
|
Prolia®
|
|
$
582
|
|
$
270
|
|
$
852
|
|
$
758
|
|
12%
|
EVENITY®
|
|
110
|
|
60
|
|
170
|
|
107
|
|
59%
|
Repatha®
|
|
165
|
|
164
|
|
329
|
|
286
|
|
15%
|
Aimovig®
|
|
98
|
|
3
|
|
101
|
|
66
|
|
53%
|
TEZSPIRE™
|
|
7
|
|
—
|
|
7
|
|
—
|
|
*
|
Otezla®
|
|
350
|
|
101
|
|
451
|
|
476
|
|
(5%)
|
Enbrel®
|
|
843
|
|
19
|
|
862
|
|
924
|
|
(7%)
|
AMGEVITA™
|
|
—
|
|
108
|
|
108
|
|
106
|
|
2%
|
LUMAKRAS®/LUMYKRAS™
|
|
48
|
|
14
|
|
62
|
|
—
|
|
*
|
KYPROLIS®
|
|
196
|
|
91
|
|
287
|
|
251
|
|
14%
|
XGEVA®
|
|
368
|
|
134
|
|
502
|
|
468
|
|
7%
|
Vectibix®
|
|
85
|
|
116
|
|
201
|
|
191
|
|
5%
|
Nplate®
|
|
156
|
|
110
|
|
266
|
|
227
|
|
17%
|
BLINCYTO®
|
|
79
|
|
59
|
|
138
|
|
107
|
|
29%
|
MVASI®
|
|
168
|
|
76
|
|
244
|
|
294
|
|
(17%)
|
KANJINTI®
|
|
80
|
|
16
|
|
96
|
|
161
|
|
(40%)
|
Neulasta®
|
|
304
|
|
44
|
|
348
|
|
482
|
|
(28%)
|
NEUPOGEN®
|
|
23
|
|
15
|
|
38
|
|
34
|
|
12%
|
EPOGEN®
|
|
120
|
|
—
|
|
120
|
|
125
|
|
(4%)
|
Aranesp®
|
|
137
|
|
221
|
|
358
|
|
355
|
|
1%
|
Parsabiv®
|
|
57
|
|
29
|
|
86
|
|
79
|
|
9%
|
Sensipar®/Mimpara™
|
|
4
|
|
16
|
|
20
|
|
23
|
|
(13%)
|
Other
products**
|
|
57
|
|
28
|
|
85
|
|
72
|
|
18%
|
Total product
sales
|
|
$ 4,037
|
|
$ 1,694
|
|
$ 5,731
|
|
$ 5,592
|
|
2%
|
|
|
|
|
|
|
|
|
|
|
|
* Change in excess of
100%
|
|
|
|
|
|
|
|
|
|
|
** Other products
includes Corlanor®, GENSENTA, IMLYGIC®,
AVSOLA®, Bergamo, and RIABNI™
|
Operating Expense, Operating Margin and Tax Rate
Analysis
On a GAAP basis:
- Total Operating Expenses decreased 1%. Cost of
Sales margin increased 0.6 percentage points primarily driven
by manufacturing cost, including COVID-19 antibody manufacturing,
and increased royalties and profit share, partially offset by lower
amortization expenses from acquisition-related assets. Research
& Development (R&D) expenses decreased 1%. The first
quarter of 2021 included $53 million
related to the Rodeo Therapeutics acquisition. Selling, General
& Administrative (SG&A) expenses decreased 2%.
- Operating Margin as a percentage of product sales
increased 5.5 percentage points to 43.6%.
- Tax Rate increased 0.5 percentage points primarily
driven by current year net unfavorable items compared to last year
partially offset by changes in earnings mix.
On a non-GAAP basis:
- Total Operating Expenses increased 2%. Cost of
Sales margin increased 1.1 percentage points primarily driven
by manufacturing cost, including COVID-19 antibody manufacturing,
and increased royalties and profit share. R&D expenses
decreased 1%. The first quarter of 2021 included $53 million related to the Rodeo Therapeutics
acquisition. SG&A expenses decreased 1%.
- Operating Margin as a percentage of product sales
increased 3.6 percentage points to 54.8%.
- Tax Rate increased 0.5 percentage points primarily
driven by current year net unfavorable items compared to last year
partially offset by changes in earnings mix.
$Millions, except
percentages
|
|
GAAP
|
|
Non-GAAP
|
|
|
Q1 '22
|
|
Q1 '21
|
|
YOY Δ
|
|
Q1 '22
|
|
Q1 '21
|
|
YOY Δ
|
Cost of
Sales
|
|
$ 1,561
|
|
$ 1,490
|
|
5%
|
|
$
951
|
|
$
867
|
|
10%
|
%
of product sales
|
|
27.2%
|
|
26.6%
|
|
0.6 pts
|
|
16.6%
|
|
15.5%
|
|
1.1 pts
|
Research &
Development
|
|
$
959
|
|
$
967
|
|
(1%)
|
|
$
934
|
|
$
944
|
|
(1%)
|
%
of product sales
|
|
16.7%
|
|
17.3%
|
|
(0.6) pts
|
|
16.3%
|
|
16.9%
|
|
(0.6) pts
|
Selling, General &
Administrative
|
|
$ 1,228
|
|
$ 1,254
|
|
(2%)
|
|
$ 1,213
|
|
$ 1,226
|
|
(1%)
|
%
of product sales
|
|
21.4%
|
|
22.4%
|
|
(1.0) pts
|
|
21.2%
|
|
21.9%
|
|
(0.7) pts
|
Other
|
|
$ (10)
|
|
$ 61
|
|
(116%)
|
|
$ —
|
|
$ —
|
|
NM
|
Total Operating Expenses
|
|
$
3,738
|
|
$
3,772
|
|
(1%)
|
|
$
3,098
|
|
$
3,037
|
|
2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
Margin
|
|
|
|
|
|
|
|
|
|
|
|
|
operating income as % of product sales
|
|
43.6%
|
|
38.1%
|
|
5.5 pts
|
|
54.8%
|
|
51.2%
|
|
3.6 pts
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax Rate
|
|
11.9%
|
|
11.4%
|
|
0.5 pts
|
|
14.1%
|
|
13.6%
|
|
0.5 pts
|
|
|
|
|
|
|
|
|
|
|
|
|
|
pts: percentage
points
|
|
|
|
|
|
|
|
|
|
|
|
|
NM: not
meaningful
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flow and Balance Sheet
- The Company generated $2.0
billion of free cash flow in the first quarter of 2022
versus $1.9 billion in the first
quarter of 2021.
- The Company's first quarter 2022 dividend of $1.94 per share was declared on December 3,
2021, and was paid on March 8, 2022, to all stockholders of
record as of February 15, 2022, representing a 10% increase
from 2021.
- On February 24, 2022, the Company
entered into Accelerated Stock Repurchase (ASR) agreements to
repurchase an aggregate of up to $6
billion of the Company's common stock with an initial 23.3
million shares received and retired. The final number of shares to
be repurchased by the Company under the ASR will be based on the
daily volume-weighted average stock price of the Company's common
stock, subject to the terms of the ASR agreements. In total, the
Company repurchased 24.6 million shares of common stock at a total
cost of $6.3 billion during the first
quarter of 2022, including shares received under the ASR
agreements.
- Cash and investments totaled $6.5
billion and debt outstanding totaled $36.9 billion as of March
31, 2022.
$Billions, except
shares
|
|
Q1 '22
|
|
Q1 '21
|
|
YOY Δ
|
Operating Cash
Flow
|
|
$ 2.2
|
|
$ 2.1
|
|
$ 0.1
|
Capital
Expenditures
|
|
$ 0.2
|
|
$ 0.2
|
|
$ 0.0
|
Free Cash
Flow
|
|
$ 2.0
|
|
$ 1.9
|
|
$ 0.0
|
Dividends
Paid
|
|
$ 1.1
|
|
$ 1.0
|
|
$ 0.1
|
Share
Repurchases
|
|
$ 6.3
|
|
$ 0.9
|
|
$ 5.4
|
Average Diluted Shares
(millions)
|
|
551
|
|
581
|
|
(30)
|
|
|
|
|
|
|
|
Note: Numbers may not add due to rounding
|
|
|
|
|
|
|
|
$Billions
|
|
3/31/22
|
|
12/31/21
|
|
YTD Δ
|
Cash and
Investments
|
|
$ 6.5
|
|
$ 8.0
|
|
$
(1.5)
|
Debt
Outstanding
|
|
$ 36.9
|
|
$ 33.3
|
|
$ 3.5
|
|
|
|
|
|
|
|
Note: Numbers may not add due to rounding
|
|
|
|
|
|
|
2022 Guidance
For the full year 2022, the Company now expects:
- Total revenues in the range of $25.4 billion to $26.5
billion.
- On a GAAP basis, EPS in the range of $12.53 to $13.58
and a tax rate in the range of 10.5% to 12.0%.
- On a non-GAAP basis, EPS in the range of $17.00 to $18.00
and a tax rate in the range of 13.5% to 14.5%.
- Capital expenditures to be approximately $950 million.
- Share repurchases in the range of $6.0 billion to $7.0
billion.
U.S. Tax Petition
On April 18, 2022, Amgen received
a notice of deficiency from the IRS for the 2013-2015 period
proposing adjustments primarily related to the allocation of
profits between certain of the Company's entities in the United States and the U.S. territory of
Puerto Rico similar to those
previously proposed by the IRS for the 2010-2012 period. This
notice seeks to increase Amgen's U.S. taxable income for the
2013-2015 period by an amount that would result in additional
federal tax of approximately $5.1
billion, plus interest. In addition, the notice proposes
penalties of approximately $2
billion.
Amgen firmly believes that the adjustments proposed by the IRS
for the 2010-2015 period and the penalties proposed by the IRS for
the 2013-2015 period are without merit:
- Puerto Rico is the site of the
Company's flagship manufacturing complex responsible for the
majority of Amgen's global manufacturing. Amgen has had a
substantial manufacturing presence in Puerto Rico for 30 years, and the Company's
Puerto Rico subsidiary produces
sophisticated biologic medicines for millions of patients around
the world. The many valuable contributions of the Company's
Puerto Rico subsidiary include the
effort and expertise of its 2,400 highly skilled staff members, the
nearly $4 billion in capital
investments it has made on the Island, the valuable assets it
possesses, and the significant risks it has assumed in connection
with its business. It is through these investments that Amgen has
been able to meet the needs of every patient, every
time.
- Amgen's allocation of profit between its U.S. and Puerto Rico entities appropriately recognizes
the key contributions made by the Company's Puerto Rico subsidiary. The IRS position fails
to adequately account for the importance of these value drivers.
The proposed adjustments would result in Amgen's Puerto Rico subsidiary earning little or no
profit from its operations despite the value of and risk associated
with its contributions.
- The IRS audited Amgen at length for many years on the
allocation of profit between the U.S. and Puerto Rico. These audits were resolved
through agreements with the IRS, resulting in no financial
statement detriment to the Company. Refer to Footnote 5, Income
Taxes, in Amgen's 2007 and 2008 Form 10-K filings, and Footnote 4,
Income Taxes, in Amgen's 2012 and 2013 Form 10-K filings.
Further, the amount of the adjustments proposed by the IRS for
the 2010-2015 period overstates by billions of dollars the
magnitude of the dispute:
- Amgen believes, based upon the positions advanced by the IRS,
that the IRS adjustments for the 2010-2015 period are overstated by
approximately $2 billion due to the
IRS failure to account for certain income and expenses. Amgen has
reported its income and expenses in a consistent manner for many
years and the IRS has appropriately accounted for the Company's
income and expenses in all prior audits.
- Any additional tax that could be imposed for the 2010-2015
period would be reduced by up to approximately $3.1 billion of repatriation tax previously
accrued with respect to the Company's Puerto Rico earnings.
- Amgen previously made advance tax deposits to the IRS totaling
$1.1 billion for the 2010-2015
period. These deposits would further reduce any additional cash tax
that could be imposed.
In addition, Amgen believes the IRS assertion of approximately
$2 billion in penalties for the
2013-2015 period is wholly unwarranted. Amgen has applied a
consistent transfer pricing methodology since 2002, has documented
that transfer pricing methodology as required under relevant tax
regulations, and has extensively discussed that methodology with
the IRS across multiple tax audits over multiple years. The IRS has
never previously proposed transfer pricing penalties.
Amgen believes that the Company has appropriate tax reserves.
The Company filed a petition in the U.S. Tax Court in July 2021 to contest the adjustments previously
proposed for the 2010-2012 period and plans to file another
petition in the U.S. Tax Court to contest the adjustments proposed
in the notice for the 2013-2015 period. Amgen will seek
consolidation of the two periods into one case in Tax Court. The
dispute is expected to take several years to resolve.
The IRS is currently auditing the 2016-2018 period. Amgen
expects the audit to continue for several years, and it is possible
the 2010-2015 dispute will be resolved before the conclusion of the
2016-2018 audit and administrative appeals process. Any transfer
pricing adjustments the IRS may propose for this period will be
lessened by the change in tax rates resulting from the 2017 tax
reform law, which reduced the difference between the tax rates
applicable in the U.S. and Puerto
Rico by approximately two thirds beginning in
2018.
First Quarter Product and Pipeline Update
The Company provided the following updates on selected product
and pipeline programs:
Inflammation
TEZSPIRE
- In February, data were presented at the American Academy of
Allergy, Asthma, and Immunology Annual meeting that demonstrated
reductions in the annualized asthma exacerbation rate across
biomarker subgroups of patients with severe asthma and consistent
efficacy throughout the year, regardless of season.
- The WAYFINDER Phase 3b study,
designed to demonstrate a reduction in oral corticosteroid use in
adult participants with severe asthma on long-term oral
corticosteroid therapy, was initiated.
- The PASSAGE Phase 4 real-world effectiveness study was
initiated in adult and adolescent participants with severe asthma,
including underrepresented populations such as Black Americans,
smokers and patients with asthma-chronic obstructive pulmonary
disease overlap.
- A Phase 3 study continues to enroll patients with chronic
rhinosinusitis with nasal polyps.
- Planning is underway for a Phase 3 study in patients with
eosinophilic esophagitis.
- A Phase 2b study continues to
enroll patients with chronic spontaneous urticaria.
- A Phase 2 study continues to enroll patients with chronic
obstructive pulmonary disease.
Otezla
- In March, data were presented at the American Academy of
Dermatology Association meeting. Among others, the Company
presented new results from both the ADVANCE and PROMINENT Phase 3
studies reinforcing the efficacy of Otezla in patients with mild to
moderate plaque psoriasis, and results from the Phase 2 Japanese
trial (PPP-001) in palmoplantar pustulosis (PPP). Results from
PPP-001 indicated that Otezla was associated with statistically
significant improvements in the primary endpoint and all secondary
endpoints vs. placebo.
- In March, a Phase 3 study for the treatment of Japanese
patients with PPP was initiated.
Rocatinlimab (AMG 451 / KHK4083)
- Phase 3 planning continues for rocatinlimab, an anti-OX40
monoclonal antibody being investigated in patients with
heterogeneous moderate to severe atopic dermatitis.
- Rocatinlimab binds activated pathogenic T-cells expressing
OX40. Through its unique mechanism of action, rocatinlimab inhibits
and prevents the expansion of activated pathogenic T-cells, and
reduces their number.
- Initiation of the comprehensive ROCKET Phase 3 program is
anticipated in mid-2022.
Rozibafusp alfa (AMG 570)
- A Phase 2b study of rozibafusp
alfa, an antibody-peptide conjugate that simultaneously blocks
inducible T-cell costimulatory ligand (ICOSL) and B-cell activating
factor (BAFF) activity, continues to enroll patients with systemic
lupus erythematosus (SLE).
Efavaleukin alfa (AMG 592)
- A Phase 2b study of efavaleukin
alfa, an interleukin-2 (IL-2) mutein Fc fusion protein, continues
to enroll patients with SLE while a Phase 2 study continues to
enroll patients with ulcerative colitis.
Ordesekimab (AMG 714 / PRV-015)
- A Phase 2b study of AMG 714, a
monoclonal antibody that binds interleukin-15 (IL-15), continues to
enroll patients with nonresponsive celiac disease.
Oncology
LUMAKRAS/LUMYKRAS
- LUMAKRAS/LUMYKRAS is now approved in nearly 40 countries for
the treatment of adults with advanced non-small cell lung cancer
(NSCLC) with KRAS G12C mutation and who have progressed after at
least one prior line of systemic therapy. Regulatory reviews
continue in other jurisdictions.
- In April, data were presented at the American Association for
Cancer Research annual meeting on the long-term outcomes from a
two-year analysis of the CodeBreak 100 trial in patients with KRAS
G12C-mutated advanced NSCLC. These data showed that 32.5% of
patients were still alive at two years and that prolonged tumor
response was also observed with a 40.7% objective response rate by
central review. There were no new safety signals reported over the
course of this 2-year follow-up analysis.
- In February, data were presented at the American Society of
Clinical Oncology plenary series demonstrating a centrally
confirmed objective response rate of 21% and disease control rate
of 84% in 38 patients with heavily pre-treated advanced pancreatic
cancer. The Company continues to explore the benefit of LUMAKRAS in
this setting.
- Initial data from cohorts exploring LUMAKRAS in combination
with the anti-programmed cell death 1 protein (PD-1) antibody
pembrolizumab in patients with KRAS G12C-mutated NSCLC were
submitted to a medical congress taking place in the late
summer.
- Initial data from cohorts exploring LUMAKRAS in combination
with the Src homology-2 domain-containing protein tyrosine
phosphatase-2 (SHP2) inhibitor
RMC-4630 from Revolution Medicines in patients with KRAS
G12C-mutated NSCLC were submitted to a medical congress taking
place in the late summer.
- 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 Q3-2022.
- Top-line results from a study comparing the 960 mg/day dose of
LUMAKRAS with a lower dose of 240 mg/day in patients with KRAS
G12C-mutated advanced NSCLC are expected in Q4-2022.
- A Phase 2 study in first-line patients with KRAS G12C-mutated
NSCLC whose tumors express serine/threonine kinase 11 (STK11)
mutations and/or less than 1% programmed death-ligand 1 continues
to enroll.
- A Phase 3 study of LUMAKRAS in combination with Vectibix in
third-line KRAS G12C-mutated colorectal cancer is enrolling
patients.
Bemarituzumab
- A Phase 3 study (FORTITUDE-101) of bemarituzumab, a fibroblast
growth factor receptor 2b (FGFR2b)
targeting monoclonal antibody plus chemotherapy, versus placebo
plus chemotherapy in first-line gastric cancer with FGFR2b
overexpression continues to enroll patients.
- A Phase 1b/3 study
(FORTITUDE-102) of bemarituzumab plus chemotherapy and nivolumab
versus chemotherapy and nivolumab in first-line gastric cancer with
FGFR2b overexpression continues to enroll patients.
- A Phase 1b study (FORTITUDE-103)
of bemarituzumab plus oral chemotherapy regimens in first-line
gastric cancer with FGFR2b overexpression was initiated.
- A Phase 1b study (FORTITUDE-201)
of bemarituzumab monotherapy and in combination with docetaxel is
enrolling patients with squamous NSCLC with FGFR2b
overexpression.
- Planning is underway for a signal-seeking basket study in other
solid tumors.
Tarlatamab (AMG 757)
- DeLLphi-301, a potentially registrational Phase 2 study of
tarlatamab, an HLE BiTE molecule targeting delta-like ligand 3
(DLL3), for the treatment of relapsed/refractory small cell lung
cancer (SCLC) after two or more prior lines of treatment continues
to enroll patients.
- A Phase 1b study of tarlatamab in
combination with AMG 404 continues to enroll patients with
second-line or later SCLC.
- DeLLphi-303, a Phase 1b study,
testing tarlatamab in combination with standard of care in
first-line SCLC, is on track to start enrolling patients this
quarter.
- Updated exploration and first expansion Phase 1 data of
tarlatamab in patients with relapsed/refractory SCLC were submitted
to a medical congress taking place in late summer.
- A Phase 1b study of tarlatamab
continues to enroll patients with de novo or treatment emergent
neuroendocrine prostate cancer.
Acapatamab (AMG 160)
- Data continue to mature in a dose-expansion cohort of
acapatamab, a half-life extended (HLE) BiTE molecule targeting
prostate-specific membrane antigen (PSMA) for the treatment of
patients with metastatic castrate-resistant prostate cancer
(mCRPC). Decision-enabling data are expected in H1 2022.
- A master protocol evaluating combinations with acapatamab
continues to enroll patients with earlier-line mCRPC.
AMG 340
- A Phase 1 dose-escalation study of AMG 340, a lower T-cell
affinity BiTE molecule targeting PSMA, is enrolling patients with
mCRPC.
AMG 509
- A Phase 1 dose-escalation study of AMG 509, a bi-specific
molecule targeting six-transmembrane epithelial antigen of prostate
1 (STEAP1) continues to enroll patients with mCRPC.
AMG 193
- A Phase 1/1b/2 study of AMG 193,
a novel small-molecule methylthioadenosine (MTA) cooperative
protein arginine methyltransferase 5 (PRMT5) molecular glue,
continues to enroll patients with advanced methylthioadenosine
phosphorylase (MTAP)-null solid tumors.
AMG 330
- Development of AMG 330, a BiTE molecule targeting CD33, being
investigated for the treatment of acute myeloid leukemia (AML) has
been discontinued based on the overall benefit:risk profile
observed and the Company's on-going efforts to prioritize programs
with the greatest potential benefit to AML patients. These
on-going programs include AMG 176, a small-molecule inhibitor of
myeloid cell leukemia 1 (MCL-1) and AMG 427, an HLE BiTE molecule
targeting anti-fms-like tyrosine kinase 3 (FLT3).
General Medicine
Repatha
- In April, the Company announced results from two Repatha open
label extension (OLE) studies (FOURIER-OLE) designed to assess the
long-term safety and tolerability of Repatha in more than 6,600
high-risk adults with clinically evident atherosclerotic
cardiovascular disease.
- In the OLE studies, patients received Repatha for approximately
5 years, with some patients receiving Repatha for up to 8.5 years
in aggregate across the FOURIER and OLE studies.
- No new long-term safety findings were observed.
- Medically significant and sustained reduction in low-density
lipoprotein cholesterol (LDL-C) levels were observed, with more
than 85 percent of patients achieving an LDL-C level of <40
mg/dL during the OLE period.
- The results of these studies will be presented at an upcoming
medical congress later this year.
Olpasiran (AMG 890)
- Top-line results from a Phase 2 study of olpasiran, a
lipoprotein(a) (Lp(a)) small interfering RNA molecule, in subjects
with elevated Lp(a), are expected in H1 2022. Presentation of
results is expected at a medical congress in H2 2022.
AMG 133
- A Phase 1 study of AMG 133, a multispecific that inhibits the
gastric inhibitory polypeptide receptor (GIPR) and activates the
glucagon-like peptide 1 (GLP-1) receptor, continues to enroll
patients in the multidose portion of the study.
Biosimilars
- In April, the Company announced preliminary results from a
Phase 3 study evaluating the efficacy and safety of ABP 654
compared to STELARA® (ustekinumab) in adult patients
with moderate to severe plaque psoriasis. The study met the primary
efficacy endpoint, demonstrating no clinically meaningful
differences between ABP 654 and STELARA.
- A Phase 3 study to support an interchangeability designation in
the U.S. for ABP 654 is ongoing.
- Phase 3 studies of ABP 938, an investigational biosimilar to
EYLEA® (aflibercept), and ABP 959, an investigational
biosimilar to SOLIRIS® (eculizumab), are on track, with
data expected in 2022.
- A Phase 3 study to support an interchangeability designation in
the U.S. for AMJEVITA™ (adalimumab-atto) is enrolling
patients.
Environmental, Social & Governance Report Released
Today
Amgen today released its latest Environmental, Social &
Governance (ESG) report at amgen.com/responsibility, providing a
comprehensive overview of the many ways the Company is building a
better, healthier world. The report tracks the Company's
progress across four categories:
- Healthy People: Focusing on removing barriers that limit
equitable access to healthcare so that people can live their
healthiest lives. In 2021, for example, the Amgen Safety Net
Foundation1 provided $2.2
billion2 of the Company's medicines, at no cost,
to uninsured or underinsured patients in the U.S.
- Healthy Society: Working toward a more just society for our
employees and the people we serve. In 2021, no-cost science
education programs funded by the Amgen Foundation1
reached more than 27 million students and educators globally,
helping to level the scientific playing field.
- Healthy Planet: Prioritizing sustainability and aiming to
minimize our environmental impact. Amgen continued its
progress in 2021 toward the goal of achieving carbon neutrality in
our operations by 20273.
- Healthy Amgen: Holding ourselves to high standards in the
Company's operations – working to ensure that our actions and
culture reflect Amgen values. In 2021, and again in 2022,
Amgen added an ESG goal to our annual incentive plans to focus our
entire Company on activities supporting achievement of our 2027
environment sustainability targets and to strengthen and improve
the Company's diversity, inclusion, and belonging
efforts.
1 Amgen Safety Net Foundation and The Amgen
Foundation, Inc. are separate legal entities entirely funded by
Amgen.
2 Valued at Wholesale
Acquisition Cost.
3 Carbon neutrality
goal refers to Scope 1 and 2 emissions.
TEZSPIRE is being developed in collaboration with
AstraZeneca.
Rocatinlimab, formerly AMG 451 / KHK4083 is
being developed in collaboration with Kyowa
Kirin.
Ordesekimab formerly AMG 714 and also known as
PRV-015 is being developed in collaboration with Provention
Bio.
AMG 509 is being developed in collaboration with
Xencor.
STELARA is a registered trademark of Janssen
Pharmaceutica NV.
EYLEA is a registered trademark of
Regeneron Pharmaceuticals, Inc.
SOLIRIS is a registered
trademark of Alexion Pharmaceuticals, Inc.
Non-GAAP Financial Measures
In this news release,
management has presented its operating results for the first
quarters of 2022 and 2021, in accordance with U.S. Generally
Accepted Accounting Principles (GAAP) and on a non-GAAP basis. In
addition, management has presented its full year 2022 EPS and tax
guidance in accordance with GAAP and on a non-GAAP basis. These
non-GAAP financial measures are computed by excluding certain items
related to acquisitions, 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 first quarters of 2022 and 2021. 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.
The Company uses the non-GAAP financial measures set forth in
the news release in connection with its own budgeting and financial
planning internally to evaluate the performance of the business,
including to allocate resources and to evaluate results relative to
incentive compensation targets. The non-GAAP financial measures are
in addition to, not a substitute for, or superior to, measures of
financial performance prepared in accordance with GAAP.
About Amgen
Amgen is committed to unlocking the potential of biology for
patients suffering from serious illnesses by discovering,
developing, manufacturing and delivering innovative human
therapeutics. This approach begins by using tools like advanced
human genetics to unravel the complexities of disease and
understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages
its expertise to strive for solutions that improve health outcomes
and dramatically improve people's lives. A biotechnology pioneer
since 1980, Amgen has grown to be one of the world's leading
independent biotechnology companies, has reached millions of
patients around the world and is developing a pipeline of medicines
with breakaway potential.
Amgen is one of the 30 companies that comprise the Dow Jones
Industrial Average and is also part of the Nasdaq-100 index. In
2021, Amgen was named one of the 25 World's Best Workplaces™ by
Fortune and Great Place to Work™ and one of the 100 most
sustainable companies in the world by Barron's.
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., Kyowa-Kirin Co., Ltd., Generate
Biomedicines, Inc., Arrakis Therapeutics, Inc., Plexium, Inc., or
any collaboration to manufacture therapeutic antibodies against
COVID-19), the performance of Otezla® (apremilast)
(including anticipated Otezla sales growth and the timing of
non-GAAP EPS accretion), the Five Prime Therapeutics, Inc.
acquisition, or the Teneobio, Inc. acquisition, as well as
estimates of revenues, operating margins, capital expenditures,
cash, other financial metrics, expected legal, arbitration,
political, regulatory or clinical results or practices, customer
and prescriber patterns or practices, reimbursement activities and
outcomes, effects of pandemics or other widespread health problems
such as the ongoing COVID-19 pandemic on our business, outcomes,
progress, and other such estimates and results. Forward-looking
statements involve significant risks and uncertainties, including
those discussed below and more fully described in the Securities
and Exchange Commission reports filed by Amgen, including our most
recent annual report on Form 10-K and any subsequent periodic
reports on Form 10-Q and current reports on Form 8-K. Unless
otherwise noted, Amgen is providing this information as of the date
of this news release and does not undertake any obligation to
update any forward-looking statements contained in this document as
a result of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual
results may differ materially from those we project. Our results
may be affected by our ability to successfully market both new and
existing products domestically and internationally, clinical and
regulatory developments involving current and future products,
sales growth of recently launched products, competition from other
products including biosimilars, difficulties or delays in
manufacturing our products and global economic conditions. In
addition, sales of our products are affected by pricing pressure,
political and public scrutiny and reimbursement policies imposed by
third-party payers, including governments, private insurance plans
and managed care providers and may be affected by regulatory,
clinical and guideline developments and domestic and international
trends toward managed care and healthcare cost containment.
Furthermore, our research, testing, pricing, marketing and other
operations are subject to extensive regulation by domestic and
foreign government regulatory authorities. We or others could
identify safety, side effects or manufacturing problems with our
products, including our devices, after they are on the market. Our
business may be impacted by government investigations, litigation
and product liability claims. In addition, our business may be
impacted by the adoption of new tax legislation or exposure to
additional tax liabilities. If we fail to meet the compliance
obligations in the corporate integrity agreement between us and the
U.S. government, we could become subject to significant sanctions.
Further, while we routinely obtain patents for our products and
technology, the protection offered by our patents and patent
applications may be challenged, invalidated or circumvented by our
competitors, or we may fail to prevail in present and future
intellectual property litigation. We perform a substantial amount
of our commercial manufacturing activities at a few key facilities,
including in Puerto Rico, and also
depend on third parties for a portion of our manufacturing
activities, and limits on supply may constrain sales of certain of
our current products and product candidate development. An outbreak
of disease or similar public health threat, such as COVID-19, and
the public and governmental effort to mitigate against the spread
of such disease, could have a significant adverse effect on the
supply of materials for our manufacturing activities, the
distribution of our products, the commercialization of our product
candidates, and our clinical trial operations, and any such events
may have a material adverse effect on our product development,
product sales, business and results of operations. We rely on
collaborations with third parties for the development of some of
our product candidates and for the commercialization and sales of
some of our commercial products. In addition, we compete with other
companies with respect to many of our marketed products as well as
for the discovery and development of new products. Discovery or
identification of new product candidates or development of new
indications for existing products cannot be guaranteed and movement
from concept to product is uncertain; consequently, there can be no
guarantee that any particular product candidate or development of a
new indication for an existing product will be successful and
become a commercial product. Further, some raw materials, medical
devices and component parts for our products are supplied by sole
third-party suppliers. Certain of our distributors, customers and
payers have substantial purchasing leverage in their dealings with
us. The discovery of significant problems with a product similar to
one of our products that implicate an entire class of products
could have a material adverse effect on sales of the affected
products and on our business and results of operations. Our efforts
to collaborate with or acquire other companies, products or
technology, and to integrate the operations of companies or to
support the products or technology we have acquired, may not be
successful. A breakdown, cyberattack or information security breach
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
Jessica Akopyan, 805-440-5721
(media)
Arvind Sood, 805-447-1060
(investors)
Amgen
Inc.
Consolidated
Statements of Income - GAAP
(In millions, except
per-share data)
(Unaudited)
|
|
|
Three months ended
March 31,
|
|
2022
|
|
2021
|
Revenues:
|
|
|
|
Product sales
|
$
5,731
|
|
$
5,592
|
Other revenues
|
507
|
|
309
|
Total revenues
|
6,238
|
|
5,901
|
|
|
|
|
Operating
expenses:
|
|
|
|
Cost of sales
|
1,561
|
|
1,490
|
Research and development
|
959
|
|
967
|
Selling, general and administrative
|
1,228
|
|
1,254
|
Other
|
(10)
|
|
61
|
Total operating
expenses
|
3,738
|
|
3,772
|
|
|
|
|
Operating
income
|
2,500
|
|
2,129
|
|
|
|
|
Other income
(expense):
|
|
|
|
Interest expense, net
|
(295)
|
|
(285)
|
Other (expense) income, net
|
(530)
|
|
13
|
|
|
|
|
Income before income
taxes
|
1,675
|
|
1,857
|
|
|
|
|
Provision for income
taxes
|
199
|
|
211
|
|
|
|
|
Net income
|
$
1,476
|
|
$
1,646
|
|
|
|
|
Earnings per
share:
|
|
|
|
Basic
|
$ 2.69
|
|
$ 2.85
|
Diluted
|
$ 2.68
|
|
$ 2.83
|
|
|
|
|
Weighted-average shares
used in calculation of earnings per share:
|
|
|
|
Basic
|
548
|
|
577
|
Diluted
|
551
|
|
581
|
Amgen
Inc.
Consolidated Balance
Sheets - GAAP
(In
millions)
|
|
|
March 31,
|
|
December 31,
|
|
2022
|
|
2021
|
|
(Unaudited)
|
|
|
Assets
|
Current
assets:
|
|
|
|
Cash, cash equivalents and marketable securities
|
$
6,544
|
|
$
8,037
|
Trade receivables, net
|
5,077
|
|
4,895
|
Inventories
|
4,411
|
|
4,086
|
Other current assets
|
2,488
|
|
2,367
|
Total current assets
|
18,520
|
|
19,385
|
|
|
|
|
Property, plant and
equipment, net
|
5,142
|
|
5,184
|
Intangible assets,
net
|
14,567
|
|
15,182
|
Goodwill
|
14,897
|
|
14,890
|
Other noncurrent
assets
|
6,070
|
|
6,524
|
Total assets
|
$
59,196
|
|
$
61,165
|
|
|
|
|
Liabilities and Stockholders'
Equity
|
Current
liabilities:
|
|
|
|
Accounts payable and accrued liabilities
|
$
12,042
|
|
$
12,097
|
Current portion of long-term debt
|
844
|
|
87
|
Total current
liabilities
|
12,886
|
|
12,184
|
|
|
|
|
Long-term
debt
|
36,010
|
|
33,222
|
Long-term tax
liabilities
|
6,652
|
|
6,594
|
Other noncurrent
liabilities
|
2,732
|
|
2,465
|
Total stockholders'
equity
|
916
|
|
6,700
|
Total liabilities and
stockholders' equity
|
$
59,196
|
|
$
61,165
|
|
|
|
|
Shares
outstanding
|
534
|
|
558
|
Amgen
Inc.
GAAP to Non-GAAP
Reconciliations
(Dollars in
millions)
(Unaudited)
|
|
|
Three months ended
March 31,
|
|
2022
|
|
2021
|
GAAP cost of sales
|
$
1,561
|
|
$
1,490
|
Adjustments to cost of
sales:
|
|
|
|
Acquisition-related expenses
(a)
|
(610)
|
|
(623)
|
Total adjustments to cost of
sales
|
(610)
|
|
(623)
|
Non-GAAP cost of sales
|
$
951
|
|
$
867
|
|
|
|
|
GAAP cost of sales as a percentage of product
sales
|
27.2%
|
|
26.6%
|
Acquisition-related expenses
(a)
|
(10.6)
|
|
(11.1)
|
Non-GAAP cost of sales as a percentage of product
sales
|
16.6%
|
|
15.5%
|
|
|
|
|
GAAP research and development
expenses
|
$
959
|
|
$
967
|
Adjustments to research and
development expenses:
|
|
|
|
Acquisition-related expenses
(a)
|
(25)
|
|
(23)
|
Total adjustments to research and
development expenses
|
(25)
|
|
(23)
|
Non-GAAP research and development
expenses
|
$
934
|
|
$
944
|
|
|
|
|
GAAP research and development expenses as a
percentage of product sales
|
16.7%
|
|
17.3%
|
Acquisition-related expenses
(a)
|
(0.4)
|
|
(0.4)
|
Non-GAAP research and development expenses as a
percentage of product sales
|
16.3%
|
|
16.9%
|
|
|
|
|
GAAP selling, general and administrative
expenses
|
$
1,228
|
|
$
1,254
|
Adjustments to selling, general
and administrative expenses:
|
|
|
|
Acquisition-related expenses
(a)
|
(15)
|
|
(12)
|
Other
|
—
|
|
(16)
|
Total adjustments to selling, general
and administrative expenses
|
(15)
|
|
(28)
|
Non-GAAP selling, general and administrative
expenses
|
$
1,213
|
|
$
1,226
|
|
|
|
|
GAAP selling, general and administrative expenses as
a percentage of product sales
|
21.4%
|
|
22.4%
|
Acquisition-related expenses
(a)
|
(0.2)
|
|
(0.2)
|
Other
|
0.0
|
|
(0.3)
|
Non-GAAP selling, general and administrative expenses
as a percentage of product sales
|
21.2%
|
|
21.9%
|
|
|
|
|
GAAP operating expenses
|
$
3,738
|
|
$
3,772
|
Adjustments to operating
expenses:
|
|
|
|
Adjustments to cost of
sales
|
(610)
|
|
(623)
|
Adjustments to research and
development expenses
|
(25)
|
|
(23)
|
Adjustments to selling, general
and administrative expenses
|
(15)
|
|
(28)
|
Certain charges pursuant to our
cost savings initiatives
|
(2)
|
|
(52)
|
Certain other expenses
(b)
|
12
|
|
(9)
|
Total adjustments to operating
expenses
|
(640)
|
|
(735)
|
Non-GAAP operating expenses
|
$
3,098
|
|
$
3,037
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
March 31,
|
|
2022
|
|
2021
|
GAAP operating income
|
$
2,500
|
|
$
2,129
|
Adjustments to operating expenses
|
640
|
|
735
|
Non-GAAP operating income
|
$
3,140
|
|
$
2,864
|
|
|
|
|
GAAP operating income as a percentage of product
sales
|
43.6%
|
|
38.1%
|
Adjustments to cost of sales
|
10.6
|
|
11.1
|
Adjustments to research and development expenses
|
0.4
|
|
0.4
|
Adjustments to selling, general and administrative
expenses
|
0.2
|
|
0.5
|
Certain charges pursuant to our cost savings
initiatives
|
0.1
|
|
0.9
|
Certain other expenses (b)
|
(0.1)
|
|
0.2
|
Non-GAAP operating income as a percentage of product
sales
|
54.8%
|
|
51.2%
|
|
|
|
|
GAAP other income (expense),
net
|
$
(530)
|
|
$
13
|
Adjustments to other income
(expense), net:
|
|
|
|
Equity method investment basis difference
amortization
|
47
|
|
42
|
Net
gains from equity investments
|
365
|
|
(145)
|
Total adjustments to other income
(expense), net
|
412
|
|
(103)
|
Non-GAAP other income (expense),
net
|
$
(118)
|
|
$
(90)
|
|
|
|
|
GAAP income before income taxes
|
$
1,675
|
|
$
1,857
|
Adjustments to income before
income taxes:
|
|
|
|
Adjustments to operating expenses
|
640
|
|
735
|
Adjustments to other income, net
|
412
|
|
(103)
|
Total adjustments to income before
income taxes
|
1,052
|
|
632
|
Non-GAAP income before income
taxes
|
$
2,727
|
|
$
2,489
|
|
|
|
|
GAAP provision for income taxes
|
$
199
|
|
$
211
|
Adjustments to provision for
income taxes:
|
|
|
|
Income tax effect of the above
adjustments (c)
|
189
|
|
131
|
Other income tax adjustments
(d)
|
(4)
|
|
(3)
|
Total adjustments to provision for
income taxes
|
185
|
|
128
|
Non-GAAP provision for income
taxes
|
$
384
|
|
$
339
|
|
|
|
|
GAAP tax as a percentage of income before
taxes
|
11.9%
|
|
11.4%
|
Adjustments to provision for
income taxes:
|
|
|
|
Income tax effect of the above
adjustments (c)
|
2.3
|
|
2.3
|
Other income tax adjustments
(d)
|
(0.1)
|
|
(0.1)
|
Total adjustments to provision for
income taxes
|
2.2
|
|
2.2
|
Non-GAAP tax as a percentage of income before
taxes
|
14.1%
|
|
13.6%
|
|
|
|
|
GAAP net income
|
$
1,476
|
|
$
1,646
|
Adjustments to net
income:
|
|
|
|
Adjustments to income before
income taxes, net of the income tax effect
|
863
|
|
501
|
Other income tax adjustments
(d)
|
4
|
|
3
|
Total adjustments to net
income
|
867
|
|
504
|
Non-GAAP net income
|
$
2,343
|
|
$
2,150
|
|
|
|
|
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, 2022
|
|
Three months ended
March 31, 2021
|
|
GAAP
|
|
Non-GAAP
|
|
GAAP
|
|
Non-GAAP
|
Net income
|
$
1,476
|
|
$
2,343
|
|
$
1,646
|
|
$
2,150
|
|
|
|
|
|
|
|
|
Weighted-average shares for diluted EPS
|
551
|
|
551
|
|
581
|
|
581
|
|
|
|
|
|
|
|
|
Diluted EPS
|
$
2.68
|
|
$
4.25
|
|
$
2.83
|
|
$
3.70
|
|
|
|
|
|
|
|
|
(a)
|
The adjustments related
primarily to noncash amortization of intangible assets from
business acquisitions.
|
|
|
(b)
|
For the three months
ended March 31, 2022, the adjustments related primarily to an
in-process research and development asset adjustment.
|
|
|
(c)
|
The tax effect of the
adjustments between our GAAP and non-GAAP results takes into
account the tax treatment and related tax rate(s) that apply to
each adjustment in the applicable tax jurisdiction(s). Generally,
this results in a tax impact at the U.S. marginal tax rate for
certain adjustments, including the majority of amortization of
intangible assets, whereas the tax impact of other adjustments,
including restructuring initiatives, depends on whether the amounts
are deductible in the respective tax jurisdictions and the
applicable tax rate(s) in those jurisdictions. Due to these
factors, the effective tax rate for the adjustments to our GAAP
income before income taxes, for the three months ended March 31,
2022, was 18.0%, compared to 20.7% for the corresponding period of
the prior year.
|
|
|
(d)
|
The adjustments related
to certain acquisition items, prior period and other items excluded
from GAAP earnings.
|
Amgen
Inc.
Reconciliations of
Cash Flows
(In
millions)
(Unaudited)
|
|
|
Three months ended
March 31,
|
|
2022
|
|
2021
|
Net cash provided by
operating activities
|
$
2,164
|
|
$
2,104
|
Net cash used in
investing activities
|
(111)
|
|
(319)
|
Net cash used in
financing activities
|
(3,514)
|
|
(1,939)
|
Decrease in cash and
cash equivalents
|
(1,461)
|
|
(154)
|
Cash and cash
equivalents at beginning of period
|
7,989
|
|
6,266
|
Cash and cash
equivalents at end of period
|
$
6,528
|
|
$
6,112
|
|
|
|
|
|
|
|
Three months ended
March 31,
|
|
2022
|
|
2021
|
Net cash provided by
operating activities
|
$
2,164
|
|
$
2,104
|
Capital
expenditures
|
(190)
|
|
(166)
|
Free cash
flow
|
$
1,974
|
|
$
1,938
|
Amgen
Inc.
Reconciliation of
GAAP EPS Guidance to Non-GAAP
EPS Guidance for the
Year Ending December 31, 2022
(Unaudited)
|
|
GAAP diluted EPS guidance
|
|
$ 12.53
|
—
|
$ 13.58
|
Known adjustments to arrive at non-GAAP*:
|
|
|
|
|
Acquisition-related expenses (a)
|
|
3.89
|
—
|
3.94
|
Net
(gains)/losses from equity investments
|
|
|
0.53
|
|
Non-GAAP diluted EPS guidance
|
|
$ 17.00
|
—
|
$ 18.00
|
|
* The known adjustments
are presented net of their related tax impact, which amount to
approximately $1.19 per share.
|
|
(a) The adjustments
relate primarily to noncash amortization of intangible assets
acquired in business acquisitions.
|
|
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, 2022
(Unaudited)
|
|
GAAP tax rate
guidance
|
|
10.5%
|
—
|
12.0%
|
Tax
rate of known adjustments discussed above
|
|
2.5%
|
—
|
3.0%
|
Non-GAAP tax rate
guidance
|
|
13.5%
|
—
|
14.5%
|
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SOURCE Amgen