Amgen Reports Fourth Quarter And Full Year 2020 Financial Results
THOUSAND OAKS, Calif., Feb. 2, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial results for the fourth quarter and full year 2020 versus comparable periods in 2019. Key results include:
-- For the fourth quarter, total revenues increased 7% to $6.6 billion in
comparison to the fourth quarter of 2019, driven by higher volume
growth, partially offset by lower net selling prices.
-- Product sales increased 8% globally, driven by 13% volume growth
across the portfolio, including Otezla(® )(apremilast), MVASI(®
)(bevacizumab-awwb), KANJINTI(®) (trastuzumab-anns), and Repatha(®
)(evolocumab), partially offset by declines in mature products that
resulted from biosimilar and generic competition.
-- For the full year, total revenues increased 9% to $25.4 billion driven
by higher volume growth, partially offset by lower net selling prices
and the effects of the COVID-19 pandemic.
-- GAAP earnings per share (EPS) decreased 3% to $2.76 in the fourth
quarter and 4% to $12.31 for the full year primarily driven by the
amortization of costs associated with our November 2019 acquisition of
Otezla, partially offset by an increase in revenues.
-- For the fourth quarter, GAAP operating income decreased 2% to $2.0
billion and GAAP operating margin decreased 3.1 percentage points to
31.7%, primarily driven by the amortization of intangible assets
from our Otezla acquisition. For the full year, GAAP operating
income decreased 6% to $9.1 billion and GAAP operating margin
decreased 5.9 percentage points to 37.7%.
-- Non-GAAP EPS increased 5% in the fourth quarter to $3.81, and 12% to
$16.60 for the full year, driven by increased revenues, partially offset
by increased operating expenses.
-- For the fourth quarter, non-GAAP operating income increased 4% to
$2.7 billion and non-GAAP operating margin decreased 1.5 percentage
points to 43.1%. For the full year, non-GAAP operating income
increased 11% to $12.3 billion and non-GAAP operating margin
increased 0.7 percentage points to 50.9%.
-- The Company generated $9.9 billion of free cash flow for the full year
versus $8.5 billion in 2019.
-- 2021 total revenues guidance of $25.8-$26.6 billion; EPS guidance of
$12.12-$13.17 on a GAAP basis and $16.00-$17.00 on a non-GAAP basis.
"In a year marked by the disruption of COVID-19, we served patients around the world without interruption, advanced our pipeline and delivered strong financial performance, all while keeping our employees safe," said Robert A. Bradway, chairman and chief executive officer. "As we move into 2021, we look forward to commercializing our pipeline successes."
$Millions, except EPS, dividends paid per share and percentages Q4 '20 Q4 '19 YOY FY'20 FY'19 YOY
Total Revenues $
6,634 $
6,197 7% $
25,424 $
23,362 9%
GAAP Operating Income $
2,008 $
2,048 (2%) $
9,139 $
9,674 (6%)
GAAP Net Income $
1,615 $
1,703 (5%) $
7,264 $
7,842 (7%)
GAAP EPS $
2.76 $
2.85 (3%) $
12.31 $
12.88 (4%)
Non-GAAP Operating Income $
2,728 $
2,621 4% $
12,334 $
11,157 11%
Non-GAAP Net Income $
2,229 $
2,174 3% $
9,795 $
9,028 8%
Non-GAAP EPS $
3.81 $
3.64 5% $
16.60 $
14.82 12%
Dividends Paid Per Share $
1.60 $
1.45 10% $
6.40 $
5.80 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.
Product Sales Performance
Total product sales increased 8% for the fourth quarter of 2020 versus the fourth quarter of 2019 driven by 13% volume growth, partially offset by lower net selling price. Product sales increased 9% for the full year driven by 15% volume growth, partially offset by lower net selling price. Full-year product sales in the U.S. grew 9%. Full-year product sales outside the U.S. grew 10%, with revenues in the Asia-Pacific region exceeding $1 billion for the first time.
COVID-19 update: During the fourth quarter, physician-patient interactions continued to rebound but remained below pre-COVID-19 levels on a portfolio basis. We expect continued COVID-19 impact and quarter-to-quarter variability throughout 2021, with recovery in the latter part of the year contingent upon the speed and effectiveness of the global vaccination rollout. Recall, Q1 2020 also benefited from ~$100 million in inventory stocking across the portfolio related to COVID-19, which we do not expect to repeat in Q1 2021.
Results for individual products are as follows:
-- Prolia(®) (denosumab) sales were flat year-over-year for the fourth
quarter, and increased 3% for the full year. Given the impact of the
pandemic in the second quarter of 2020 and the 6-month dosing regimen of
Prolia, the number of repeat patients in the fourth quarter was lower
than historical trends. We saw a sustained positive trend in new
patients starting treatment, as osteoporosis diagnosis levels in the
U.S. reached ~80% of pre-COVID-19 levels in the fourth quarter, and we
remain confident in the continued recovery and growth of Prolia. With
approximately 9 million osteoporotic fractures each year globally, our
efforts remain focused on ensuring that post-menopausal women receive
appropriate screening, diagnosis and treatment.
-- EVENITY(® )(romosozumab-aqqg) sales increased 6% year-over-year for the
fourth quarter and increased 85% for the full year, driven by volume
growth. We expect the second half 2020 inventory drawdown in Japan from
our partner Astellas to be largely complete. We expect strong volume
growth for Evenity to continue in 2021.
-- Repatha sales increased 27% year-over-year for the fourth quarter, and
increased 34% for the full year, driven by 49% and 67% volume growth,
respectively. These volume gains in 2020 were partially offset by price
declines resulting from contracting to improve Medicare Part D patient
access and patient affordability. With comprehensive payer coverage now
secured in the U.S., we expect net selling price to remain relatively
stable in 2021. Repatha remains the global proprotein convertase
subtilisin/kexin type 9 (PCSK9) segment leader, and we remain confident
in our ability to grow Repatha given the millions of high-risk
cardiovascular patients worldwide.
-- Aimovig(® )(erenumab-aooe)* sales increased 6% year-over-year for the
fourth quarter, and increased 24% for the full year, driven by volume
growth, partially offset by lower net selling price. Aimovig remains the
leader within the preventive calcitonin gene-related peptide (CGRP)
segment, with 46% average share of total prescriptions (TRx), and 38%
average share of new-to-brand prescriptions (NBRx) in the fourth
quarter. The impact of the COVID-19 pandemic has dampened new patient
starts for this segment. However, with strong payer access as well as
recent positive efficacy and safety data versus topiramate, Aimovig is
well positioned for long-term growth in the preventive segment, which
impacts more than 4 million individuals in the U.S.
-- Parsabiv(® )(etelcalcetide) sales decreased 4% year-over-year for the
fourth quarter, and increased 14% for the full year. Parsabiv sales
benefited in the quarter from an end customer inventory build ahead of
the inclusion of calcimimetics in the end-stage renal disease (ESRD)
bundled payment system. With Parsabiv's inclusion in the bundle, we
expect sales to decline by approximately 40-50% in 2021 as U.S. dialysis
centers update their treatment protocols to shift utilization from
Parsabiv to generic oral calcimimetics. Additionally, we expect sales in
Q1 2021 to be impacted as customers draw down the approximately $40
million in inventory built in the second half of 2020.
-- Otezla* generated $617 million of sales in the fourth quarter of 2020,
and $2.2 billion for the full year. Full-year U.S. Otezla TRx increased
13% year-over-year, and NBRx volumes continued to recover from the
effects of COVID-19. Looking forward, we see growth opportunities with
continued geographic expansion and the planned U.S. submission of the
mild-to-moderate psoriasis indication.
-- Enbrel(®) (etanercept)* sales decreased 5% year-over-year for the
fourth quarter, and decreased 4% for the full year, driven by volume
declines. In addition, the full year decrease was driven by lower net
selling price, partially offset by favorable changes to estimated sales
deductions. Enbrel share declined modestly in the fourth quarter, and
that loss was compounded by lower growth of the rheumatology segment due
to COVID-19. Enbrel benefited from ~$115M in favorable changes to
estimated sales deductions in Q1 2020 which will unfavorably impact the
year-over-year comparison in Q1 2021.
-- AMGEVITA((TM)) (adalimumab) increased 45% year-over-year for the fourth
quarter, and increased 54% for the full year driven by volume growth,
partially offset by lower net selling price. AMGEVITA continues to be
the most prescribed adalimumab biosimilar in Europe. We expect volume
trends to continue into 2021 as we launch into additional markets across
the world.
-- KYPROLIS(®) (carfilzomib) sales increased 2% year-over-year for the
fourth quarter, and increased 2% for the full year. Uptake of KYPROLIS
in combination with DARZALEX(®) (daratumumab) plus dexamethasone (DKd)
in the U.S. has been encouraging as reflected in new patient share, and
we expect this momentum to continue into 2021 with additional global
regulatory approvals of the DKd combination.
-- XGEVA(®) (denosumab) sales increased 3% year-over-year for the fourth
quarter driven by volume growth. The full year decline of 2% was driven
by the impacts of the COVID-19 pandemic, including a decrease in patient
visits and revised treatment recommendations to prioritize primary
cancer treatments over bone-targeting agents. In 2021, we expect volume
growth to continue.
-- Vectibix(®) (panitumumab) sales increased 21% year-over-year for the
fourth quarter, and increased 9% for the full year, driven by volume
growth. In the fourth quarter, volume growth benefited from the timing
of shipments to Takeda, our partner in Japan.
-- Nplate(®) (romiplostim) sales increased 8% year-over-year for the
fourth quarter, benefited by favorable changes in inventory and volume
growth, and increased 7% for the full year, driven by volume growth.
-- BLINCYTO(®) (blinatumomab) sales increased 29% year-over-year for the
fourth quarter, and increased 21% for the full year, driven by volume
growth as we continued to see broader adoption in the community hospital
setting.
-- MVASI generated $280 million of sales in the fourth quarter of 2020, and
$798 million of sales for the full year. In the U.S., MVASI became the
leader of the bevacizumab segment in the fourth quarter with an average
share of 48%. Sales increased 21% quarter-over-quarter driven by 25%
volume growth, partially offset by a decline in net selling price.
Heading into 2021, we expect MVASI to be launched across multiple new
markets and expect worldwide volume growth, partially offset by a
decline in net selling price due to increased competition.
-- KANJINTI generated $158 million of sales in the fourth quarter of 2020,
and $567 million for the full year, with a 41% average share of the
trastuzumab segment in the U.S for the fourth quarter. Sales declined
quarter-over-quarter as volume gains were offset by price declines and
unfavorable changes to estimated sales deductions. Given the number of
competitors in the trastuzumab segment, we expect the fourth quarter
sequential sales trend to continue in 2021.
-- Neulasta(®) (pegfilgrastim) sales decreased 19% year-over-year for the
fourth quarter, and decreased 29% for the full year, driven by declines
in net selling price and volumes due to increased biosimilar
competition. Within the long-acting granulocyte colony-stimulating
factor (G-CSF) segment, Neulasta Onpro(®) continues to be the preferred
choice for physicians and patients with volume share of 54% in the
quarter. The most recent published Average Selling Price for Neulasta in
the U.S. showed a decline of 28% year-over-year. In 2021, we expect the
pricing and volume dynamics to continue as biosimilar competition
increases.
-- NEUPOGEN(®) (filgrastim) sales decreased 26% year-over-year for the
fourth quarter, and decreased 15% for the full year, driven by volume
decline due to competition.
-- EPOGEN(®) (epoetin alfa) sales decreased 37% year-over-year for the
fourth quarter, and decreased 31% for the full year, driven by volume
declines, as well as lower net selling price resulting from our existing
contractual commitment with DaVita. We expect these volume and pricing
trends to continue in 2021.
-- Aranesp(®) (darbepoetin alfa) sales decreased 12% year-over-year for
the fourth quarter, and decreased 9% for the full year, driven by lower
net selling price and volume declines due to competition.
-- Sensipar/Mimpara(® )(cinacalcet) sales decreased 58% year-over-year for
the fourth quarter, and decreased 48% for the full year, driven by
declines in volume due to generic competition.
* We expect Aimovig, Otezla and Enbrel to follow the historic pattern of lower Q1 sales relative to subsequent quarters due to the impact of benefit plan changes, insurance reverification and increased co-pay expenses as U.S. patients work through deductibles.
Product Sales Detail by Product and Geographic Region
$Millions, except percentages
Q4 '20 Q4 '19 YOY
US ROW TOTAL TOTAL TOTAL
Prolia(R) $
489 $
260 $
749 $
752 -%
EVENITY(R) 60 30 90 85 6%
Repatha(R) 128 125 253 200 27%
Aimovig(R) 104 104 98 6%
Parsabiv(R) 143 29 172 179 (4%)
Otezla(R) 510 107 617 178
*
Enbrel(R) 1,236 36 1,272 1,346 (5%)
AMGEVITA(TM) 103 103 71 45%
KYPROLIS(R) 183 89 272 266 2%
XGEVA(R) 369 133 502 489 3%
Vectibix(R) 93 128 221 182 21%
Nplate(R) 133 94 227 210 8%
BLINCYTO(R) 64 39 103 80 29%
MVASI(R) 214 66 280 84
*
KANJINTI(R) 129 29 158 103 53%
Neulasta(R) 463 73 536 665 (19%)
NEUPOGEN(R) 27 19 46 62 (26%)
EPOGEN(R) 133 133 210 (37%)
Aranesp(R) 140 235 375 427 (12%)
Sensipar(R)/Mimpara(R) 11 34 45 107 (58%)
Other** 31 45 76 87 (13%)
Total product sales $
4,660 $
1,674 $
6,334 $
5,881 8%
* Change in excess of 100%
** Other includes GENSENTA, IMLYGIC(R), Corlanor(R), Bergamo and AVSOLA(R)
---
$Millions, except percentages
FY'20 FY'19 YOY
US ROW TOTAL TOTAL TOTAL
Prolia(R) $
1,830 $
933 $
2,763 $
2,672 3%
EVENITY(R) 191 159 350 189 85%
Repatha(R) 459 428 887 661 34%
Aimovig(R) 378 378 306 24%
Parsabiv(R) 605 111 716 630 14%
Otezla(R) 1,790 405 2,195 178
*
Enbrel(R) 4,855 141 4,996 5,226 (4%)
AMGEVITA(TM) 331 331 215 54%
KYPROLIS(R) 710 355 1,065 1,044 2%
XGEVA(R) 1,405 494 1,899 1,935 (2%)
Vectibix(R) 342 469 811 744 9%
Nplate(R) 485 365 850 795 7%
BLINCYTO(R) 231 148 379 312 21%
MVASI(R) 656 142 798 127
*
KANJINTI(R) 475 92 567 226
*
Neulasta(R) 2,001 292 2,293 3,221 (29%)
NEUPOGEN(R) 144 81 225 264 (15%)
EPOGEN(R) 598 598 867 (31%)
Aranesp(R) 629 939 1,568 1,729 (9%)
Sensipar(R)/Mimpara(R) 92 196 288 551 (48%)
Other** 109 174 283 312 (9%)
Total product sales $
17,985 $
6,255 $
24,240 $
22,204 9%
* Change in excess of 100%
** Other includes GENSENTA, IMLYGIC(R), Corlanor(R), Bergamo and AVSOLA(R)
---
Operating Expense, Operating Margin and Tax Rate Analysis
On a GAAP basis:
-- Total Operating Expenses increased 11% in the fourth quarter and 19% for
the full year. Cost of Sales margin increased 3.9 percentage points in
the fourth quarter primarily driven by the amortization of intangible
assets acquired in the Otezla acquisition, product mix, profit share and
royalties. For the full year, Cost of Sales margin increased 5.8
percentage points, primarily driven by the amortization of intangible
assets acquired in the Otezla acquisition, royalties, and profit share,
partially offset by lower manufacturing costs. Research & Development
(R&D) expenses decreased 6% in the fourth quarter driven by lower spend
in research and early pipeline, which includes recoveries from our
collaboration with BeiGene. For the full year, R&D expenses increased 2%
driven by higher spend in support of our late-stage development
programs, primarily sotorasib, our biosimilars and Otezla, partially
offset by recoveries from our collaboration with BeiGene, and lower
spend in certain oncology programs included in research and early
pipeline. Selling, General & Administrative (SG&A) expenses increased
17% in the fourth quarter and 11% for the full year primarily due to
investments in marketed product support, including Otezla, and product
launches. The full-year increase was partially offset by a reduction in
certain expenses due to the impact of COVID-19.
-- Operating Margin decreased 3.1 percentage points in the fourth quarter
to 31.7% primarily driven by the amortization of intangible assets from
our Otezla acquisition, and decreased 5.9 percentage points for the full
year to 37.7%.
-- Tax Rate decreased 0.1 percentage points in the fourth quarter and 3.5
percentage points for the full year. The full year tax rate decrease is
primarily driven by audit settlements, adjustments to prior year tax
liabilities and lower interest expense on tax accruals.
On a non-GAAP basis:
-- Total Operating Expenses increased 9% in the fourth quarter and 7% for
the full year. Cost of Sales margin increased 1.7 percentage points in
the fourth quarter primarily due to product mix, profit share, and
royalties. For the full year, Cost of Sales margin increased 0.1
percentage points primarily driven by royalties, profit share and
product mix, offset by lower manufacturing costs. R&D expenses decreased
8% in the fourth quarter driven by lower spend in research and early
pipeline, which includes recoveries from our collaboration with BeiGene.
For the full year, R&D expenses increased 1% driven by the higher spend
in support of our late-stage development programs, primarily sotorasib,
our biosimilars and Otezla, partially offset by recoveries from our
collaboration with BeiGene, and lower spend in certain oncology programs
included in research and early pipeline. SG&A expenses increased 17% in
the fourth quarter and 10% for the full year, primarily due to
investments in marketed product support, including Otezla, and product
launches. The full-year increase was partially offset by a reduction in
certain expenses due to the impact of COVID-19.
-- Operating Margin decreased 1.5 percentage points to 43.1% in the fourth
quarter, and increased 0.7 percentage points to 50.9% for the full year.
-- Tax Rate increased 0.5 percentage points in the fourth quarter and
decreased 1.2 percentage points for the full year. The fourth quarter
tax rate increase is primarily driven by changes in foreign loss
utilization, partially offset by lower interest expense on tax accruals.
The full year tax rate decrease is primarily driven by adjustments to
prior year tax liabilities and lower interest expense on tax accruals.
$Millions, except percentages
GAAP
Non-GAAP
Q4 '20 Q4 '19 YOY Q4 '20 Q4 '19 YOY
Cost of Sales $
1,597 $
1,253 27% $
959 $
790 21%
% of product sales 25.2% 21.3%
3.9 pts 15.1% 13.4%
1.7 pts
Research & Development $
1,229 $
1,312 (6%) $
1,185 $
1,285 (8%)
% of product sales 19.4% 22.3%
(2.9) pts 18.7% 21.9%
(3.2) pts
Selling, General & Administrative $
1,773 $
1,513 17% $
1,762 $
1,501 17%
% of product sales 28.0% 25.7%
2.3 pts 27.8% 25.5%
2.3 pts
Other $
27 $
71 (62%)
$
$ -%
Total Operating Expenses $
4,626 $
4,149 11% $
3,906 $
3,576 9%
Operating Margin
operating income as % of product sales 31.7% 34.8%
(3.1) pts 43.1% 44.6%
(1.5) pts
Tax Rate 14.0% 14.1% (0.1) pts 15.4% 14.9% 0.5 pts
pts: percentage points
---
$Millions, except percentages
GAAP
Non-GAAP
FY'20 FY'19 YOY FY'20 FY'19 YOY
Cost of Sales $
6,159 $
4,356 41% $
3,362 $
3,065 10%
% of product sales 25.4% 19.6%
5.8 pts 13.9% 13.8%
0.1 pts
Research & Development $
4,207 $
4,116 2% $
4,085 $
4,027 1%
% of product sales 17.4% 18.5%
(1.1) pts 16.9% 18.1%
(1.2) pts
Selling, General & Administrative $
5,730 $
5,150 11% $
5,643 $
5,113 10%
% of product sales 23.6% 23.2%
0.4 pts 23.3% 23.0%
0.3 pts
Other $
189 $
66
*
$
$ -%
Total Operating Expenses $
16,285 $
13,688 19% $
13,090 $
12,205 7%
Operating Margin
operating income as % of product sales 37.7% 43.6%
(5.9) pts 50.9% 50.2%
0.7 pts
Tax Rate 10.7% 14.2% (3.5) pts 13.8% 15.0% (1.2) pts
* Change in excess of 100%
pts: percentage points
---
Cash Flow and Balance Sheet
-- The Company generated $2.0 billion of free cash flow in the fourth
quarter of 2020 versus $2.3 billion in the fourth quarter of 2019. The
Company generated $9.9 billion of free cash flow for the full year 2020
versus $8.5 billion in 2019.
-- The Company's fourth quarter 2020 dividend of $1.60 per share was
declared on October 21, 2020, and was paid on December 8, 2020, to all
stockholders of record as of November 16, 2020, representing a 10%
increase from 2019.
-- During the fourth quarter of 2020, the Company repurchased 5.3 million
shares of common stock at a total cost of $1.2 billion. For the full
year, the Company repurchased 15.2 million shares of common stock at a
total cost of $3.5 billion. At the end of the fourth quarter, the
Company had $3.0 billion remaining under its stock repurchase
authorization.
-- Cash and investments totaled $10.6 billion and debt outstanding totaled
$33.0 billion at the end of Q4 2020.
$Billions, except shares Q4 '20 Q4 '19 YOY FY'20 FY'19 YOY
Operating Cash Flow $
2.2 $
2.5 $
(0.4) $
10.5 $
9.2 $
1.3
Capital Expenditures 0.2 0.2 0.0 0.6 0.6 0.0
Free Cash Flow 2.0 2.3 (0.3) 9.9 8.5 1.4
Dividends Paid 0.9 0.9 0.1 3.8 3.5 0.2
Share Repurchases 1.2 1.1 0.1 3.5 7.6 (4.1)
Average Diluted Shares (millions) 585 598 (13) 590 609 (19)
Note: Numbers may not add due to rounding
---
12/31/20 12/31/19 YOY
Cash and Investments 10.6 8.9 1.7
Debt Outstanding 33.0 29.9 3.1
---
2021 Guidance
For the full year 2021, the Company expects:
-- Total revenues in the range of $25.8 billion to $26.6 billion.
-- On a GAAP basis, EPS in the range of $12.12 to $13.17 and a tax rate in
the range of 11.0% to 12.5%.
-- On a non-GAAP basis, EPS((1)) in the range of $16.00 to $17.00 and a tax
rate in the range of 13.0% to 14.0%.
-- Capital expenditures to be approximately $900 million.
-- Quarterly dividend increased to $1.76 per share.
-- Share repurchases in the range of $3.0B to $4.0B subject to our Board's
authorization.
((1)) 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 interest and other income pursuant to an update to our non-GAAP policy. This policy update does not apply to our strategic investment in BeiGene, which is included in our non-GAAP results, and is accounted for under the equity method of accounting. Please note that this updated non-GAAP policy will become the basis for our comparisons going forward in 2021 and is reflected in our 2021 guidance. For convenience, we are providing additional information in the attached reconciliations to show the effects of the application of the new policy as if it had been adopted at the beginning of 2020.
Fourth Quarter Product and Pipeline Update
The Company provided the following updates on selected product and pipeline programs:
Sotorasib
-- Regulatory submissions have been completed in the U.S., EU, Canada,
Australia, Brazil and the United Kingdom for the treatment of patients
with KRAS G12C-mutated locally advanced or metastatic non-small cell
lung cancer (NSCLC), following at least one prior systemic therapy.
-- Sotorasib has received Breakthrough Therapy Designation in the U.S. and
China and is being reviewed under the Real-Time Oncology Review pilot
program in the U.S.
-- The positive results of the registrational Phase 2 monotherapy study in
patients with KRAS G12C-mutated advanced NSCLC were presented at the
World Conference on Lung Cancer in January 2021. Sotorasib demonstrated
a confirmed objective response rate of 37.1%, including 3 complete
responses, a median duration of response of 10 months and median
progression-free survival of 6.8 months. Sotorasib had a favorable
benefit-risk profile with most treatment-related adverse events
mild-to-moderate and no treatment-related deaths. In exploratory
analyses, encouraging tumor response to sotorasib was observed across a
range of biomarker subgroups, including patients with negative or low
programmed death-ligand 1 (PD-L1) expression levels and those with
serine threonine kinase 11 (STK11) mutation.
-- Data from the Phase 2 monotherapy study in advanced colorectal cancer
patients are expected in H1 2021.
-- A Phase 2 monotherapy study is expected to initiate in H1 2021 for
previously untreated NSCLC patients with the highest unmet need,
including STK11 mutations, as determined by biomarker analyses.
-- Ten Phase 1b combination cohorts with sotorasib are enrolling patients
with some initial data expected in H1 2021. The safety hurdle has been
cleared for the 960mg sotorasib dose in combination with a
mitrogen-activated protein kinase kinase (MEK) inhibitor and an
expansion cohort has been enrolled to assess efficacy. A triplet cohort
combining sotorasib, a MEK inhibitor and an epidermal growth factor
receptor (EGFR) antibody has also been initiated.
Tezepelumab
-- Data from the pivotal Phase 3 NAVIGATOR study will be presented at the
American Academy of Allergy Asthma and Immunology Virtual Annual Meeting
in February.
-- Regulatory submissions in the U.S. and EU are expected in H1 2021.
Otezla
-- The Company expects to submit a supplemental New Drug Application to the
FDA in Q1 2021 for the treatment of adults with mild-to-moderate plaque
psoriasis.
Oncology / Hematology Pipeline
-- In December, the European Commission approved an expanded indication for
the use of BLINCYTO in patients with Philadelphia chromosome positive
B-precursor ALL that have failed treatment with at least two tyrosine
kinase inhibitors and have no alternative treatment options.
-- Dose escalation data for AMG 757, a half-life extended BiTE molecule
targeting delta-like ligand 3 (DLL3) for relapsed or refractory small
cell lung cancer, were presented at the Society for Immunotherapy of
Cancer 35th Annual Meeting in October 2020 and the World Conference on
Lung Cancer in January 2021, and the Company expects to enter AMG 757
into expansion cohorts over the next several months.
-- Dose escalation data for AMG 701 (pavurutamab), a half-life extended
BiTE molecule targeting B-cell maturation antigen (BCMA) for relapsed or
refractory multiple myeloma, were presented at the American Society of
Hematology Annual Meeting in December. Enrollment in the Phase 1 study
has been paused while we discuss protocol modifications to optimize
safety monitoring and mitigation with the FDA. Currently enrolled
patients who are demonstrating benefit may continue to receive
investigational product and the Company expects to resume patient
enrollment in H1 2021.
-- Clinical development of AMG 673, a half-life extended BiTE molecule
targeting CD33, is paused while we gather further information on the
CD33 program through progression of AMG 330.
-- Clinical development of AMG 596, a BiTE molecule targeting EGFR variant
III for glioblastoma, has been stopped as we prioritize our portfolio.
-- Phase 1 development of the oral MCL-1 inhibitor AMG 397 was paused with
focus shifting to the intravenous MCL-1 inhibitor AMG 176, currently in
Phase 1 for the treatment of hematologic malignancies.
Nplate
-- In December, the European Commission approved an expanded indication for
use in adult patients who have had immune thrombocytopenia for 12 months
or less and who have had an insufficient response to corticosteroids or
immunoglobulins.
-- The FDA has approved Nplate for the treatment of Hematopoietic Syndrome
of Acute Radiation Syndrome.*
IMLYGIC
-- A Phase 3 study evaluating IMLYGIC in combination with pembrolizumab
(KEYTRUDA(®)) versus pembrolizumab alone for treatment of unresectable
stage IIIB to IVM1c melanoma was stopped for futility after an interim
analysis by the Data Monitoring Committee. No new safety signals were
observed.
Aimovig
-- In November, Novartis announced positive results from a head-to-head
trial where Aimovig demonstrated superiority vs. topiramate in achieving
at least a 50% reduction from baseline in monthly migraine days. Aimovig
also demonstrated a significantly lower rate of discontinuation due to
AEs vs. topiramate.
Repatha
-- In November, a supplemental Biologics License application was submitted
to the FDA for the treatment of pediatric patients with heterozygous
familial hypercholesterolemia.
ABP 959 (biosimilar SOLIRIS(®))
-- A Phase 3 study evaluating the efficacy and safety of ABP 959 compared
with Soliris (eculizumab) in adults with paroxysmal nocturnal
hemoglobinuria has completed enrollment.
* Funding and execution of the pivotal study was provided by the National Institute of Allergy and Infectious Diseases (NIAID) and the Priority Review regulatory submission was conducted in partnership with the Biomedical Advanced Research and Development Authority (BARDA).
KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc.
Tezepelumab is being developed in collaboration with AstraZeneca
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 fourth quarters and full years of 2020 and 2019, 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 fourth quarters and full years of 2020 and 2019. 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.
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 interest and other income. 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.
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, or the Otezla acquisition (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), 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 Hawkins, 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 Twelve months ended
December 31, December 31,
---
2020 2019 2020 2019
---
Revenues:
Product sales $
6,334 $
5,881 $
24,240 $
22,204
Other revenues 300 316 1,184 1,158
Total revenues 6,634 6,197 25,424 23,362
Operating expenses:
Cost of sales 1,597 1,253 6,159 4,356
Research and development 1,229 1,312 4,207 4,116
Selling, general and administrative 1,773 1,513 5,730 5,150
Other 27 71 189 66
Total operating expenses 4,626 4,149 16,285 13,688
Operating income 2,008 2,048 9,139 9,674
Interest expense, net 318 301 1,262 1,289
Interest and other income, net 187 236 256 753
Income before income taxes 1,877 1,983 8,133 9,138
Provision for income taxes 262 280 869 1,296
Net income $
1,615 $
1,703 $
7,264 $
7,842
Earnings per share:
Basic $
2.78 $
2.87 $
12.40 $
12.96
Diluted $
2.76 $
2.85 $
12.31 $
12.88
Weighted-average shares used in calculation of earnings per share:
Basic 581 593 586 605
Diluted 585 598 590 609
Amgen Inc.
Consolidated Balance Sheets - GAAP
(In millions)
December 31, December 31,
---
2020 2019
---
(Unaudited)
Assets
Current assets:
Cash,
cash
equivalents
and
marketable
securities $
10,647 $
8,911
Trade
receivables,
net 4,525 4,057
Inventories 3,893 3,584
Other
current
assets 2,079 1,888
Total
current
assets 21,144 18,440
Property,
plant
and
equipment,
net 4,889 4,928
Intangible
assets,
net 16,587 19,413
Goodwill 14,689 14,703
Other
assets 5,639 2,223
Total
assets $
62,948 $
59,707
Liabilities and Stockholders' Equity
Current
liabilities:
Accounts
payable
and
accrued
liabilities $
11,562 $
9,882
Current
portion
of
long-
term
debt 91 2,953
Total
current
liabilities 11,653 12,835
Long-
term
debt 32,895 26,950
Long-
term
tax
liabilities 6,968 8,037
Other
noncurrent
liabilities 2,023 2,212
Total
stockholders'
equity 9,409 9,673
Total
liabilities
and
stockholders'
equity $
62,948 $
59,707
Shares
outstanding 578 591
Amgen Inc.
GAAP to Non-GAAP Reconciliations
(Dollars in millions)
(Unaudited)
Three months ended Twelve months ended
December 31,
December 31,
2020 2019 2020 2019
---
GAAP cost of sales $
1,597 $
1,253 $
6,159 $
4,356
Adjustments to cost of sales:
Acquisition-related expenses (a) (638) (463) (2,797) (1,291)
Non-GAAP cost of sales $
959 $
790 $
3,362 $
3,065
GAAP cost of sales as a percentage of product sales 25.2 21.3 25.4 19.6
% % % %
Acquisition-related expenses (a) -10.1 -7.9 -11.5 -5.8
Non-GAAP cost of sales as a percentage of product sales 15.1 13.4 13.9 13.8
% % % %
===
GAAP research and development expenses $
1,229 $
1,312 $
4,207 $
4,116
Adjustments to research and development expenses:
Acquisition-related expenses (a) (43) (25) (120) (87)
Certain net charges pursuant to our restructuring initiatives (1) (2) (2) (2)
Total adjustments to research and development expenses (44) (27) (122) (89)
Non-GAAP research and development expenses $
1,185 $
1,285 $
4,085 $
4,027
GAAP research and development expenses as a percentage of product sales 19.4 22.3 17.4 18.5
% % % %
Acquisition-related expenses (a) -0.7 -0.4 -0.5 -0.4
Certain net charges pursuant to our restructuring initiatives 0.0 0.0 0.0 0.0
Non-GAAP research and development expenses as a percentage of product sales 18.7 21.9 16.9 18.1
% % % %
===
GAAP selling, general and administrative expenses $
1,773 $
1,513 $
5,730 $
5,150
Adjustments to selling, general and administrative expenses:
Acquisition-related expenses (a) (11) (12) (85) (38)
Certain net charges pursuant to our restructuring initiatives - 1
Other - (2)
Total adjustments to selling, general and administrative expenses (11) (12) (87) (37)
Non-GAAP selling, general and administrative expenses $
1,762 $
1,501 $
5,643 $
5,113
GAAP selling, general and administrative expenses as a percentage of product sales 28.0 25.7 23.6 23.2
% % % %
Acquisition-related expenses (a) -0.2 -0.2 -0.3 -0.2
Certain net charges pursuant to our restructuring initiatives 0.0 0.0 0.0 0.0
Other 0.0 0.0 0.0 0.0
Non-GAAP selling, general and administrative expenses as a percentage of product sales 27.8 25.5 23.3 23.0
% % % %
===
GAAP operating expenses $
4,626 $
4,149 $
16,285 $
13,688
Adjustments to operating expenses:
Adjustments to cost of sales (638) (463) (2,797) (1,291)
Adjustments to research and development expenses (44) (27) (122) (89)
Adjustments to selling, general and administrative expenses (11) (12) (87) (37)
Certain net charges pursuant to our restructuring initiatives 1 (46) 5 (44)
Certain other expenses (b) (28) (25) (194) (22)
Total adjustments to operating expenses (720) (573) (3,195) (1,483)
Non-GAAP operating expenses $
3,906 $
3,576 $
13,090 $
12,205
GAAP operating income $
2,008 $
2,048 $
9,139 $
9,674
Adjustments to operating expenses 720 573 3,195 1,483
Non-GAAP operating income $
2,728 $
2,621 $
12,334 $
11,157
Three months ended Twelve months ended
December 31,
December 31,
---
2020 2019 2020 2019
---
GAAP operating income as a percentage of product sales 31.7 34.8 37.7 43.6
% % % %
Adjustments to cost of sales 10.1 7.9 11.5 5.8
Adjustments to research and development expenses 0.7 0.4 0.5 0.4
Adjustments to selling, general and administrative expenses 0.2 0.2 0.4 0.2
Certain net charges pursuant to our restructuring initiatives 0.0 0.8 0.0 0.2
Certain other expenses (b) 0.4 0.5 0.8 0.0
Non-GAAP operating income as a percentage of product sales 43.1 44.6 50.9 50.2
% % % %
===
GAAP interest and other income, net $
187 $
236 $
256 $
753
Adjustments to interest and other income, net (c) 37 37
Non-GAAP interest and other income, net $
224 $
236 $
293 $
753
GAAP income before income taxes $
1,877 $
1,983 $
8,133 $
9,138
Adjustments to operating expenses 720 573 3,195 1,483
Adjustments to interest and other income, net 37 37
Non-GAAP income before income taxes $
2,634 $
2,556 $
11,365 $
10,621
GAAP provision for income taxes $
262 $
280 $
869 $
1,296
Adjustments to provision for income taxes:
Income tax effect of the above adjustments (d) 139 99 634 329
Other income tax adjustments (e) 4 3 67 (32)
Total adjustments to provision for income taxes 143 102 701 297
Non-GAAP provision for income taxes $
405 $
382 $
1,570 $
1,593
GAAP tax as a percentage of income before taxes 14.0 14.1 10.7 14.2
% % % %
Adjustments to provision for income taxes:
Income tax effect of the above adjustments (d) 1.3 0.7 2.5 1.1
Other income tax adjustments (e) 0.1 0.1 0.6 -0.3
Total adjustments to provision for income taxes 1.4 0.8 3.1 0.8
Non-GAAP tax as a percentage of income before taxes 15.4 14.9 13.8 15.0
% % % %
===
GAAP net income $
1,615 $
1,703 $
7,264 $
7,842
Adjustments to net income:
Adjustments to income before income taxes, net of the income tax effect 618 474 2,598 1,154
Other income tax adjustments (e) (4) (3) (67) 32
Total adjustments to net income 614 471 2,531 1,186
Non-GAAP net income $
2,229 $
2,174 $
9,795 $
9,028
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 Three months ended
December 31, 2020 December 31, 2019
---
GAAP Non-GAAP GAAP Non-GAAP
---
Net income $
1,615 $
2,229 $
1,703 $
2,174
Weighted-
average shares
for diluted EPS 585 585 598 598
Diluted EPS $
2.76 $
3.81 $
2.85 $
3.64
Year ended Year ended
December 31, 2020 December 31, 2019
---
GAAP Non-GAAP GAAP Non-GAAP
---
Net income $
7,264 $
9,795 $
7,842 $
9,028
Weighted-
average shares
for diluted EPS 590 590 609 609
Diluted EPS $
12.31 $
16.60 $
12.88 $
14.82
(a) The adjustments related primarily
to noncash amortization of
intangible assets from business
acquisitions.
(b) For the three and twelve months
ended December 31, 2020, the
adjustments related primarily to
legal matters. For the three and
twelve months ended December 31,
2019, the adjustments related
primarily to an impairment charge
associated with a nonkey in-
process research and development
asset.
(c) For the three and twelve months
ended December 31, 2020, the
adjustments related to the
amortization of the basis
difference from our BeiGene equity
method investment. For the twelve
months ended December 31, 2020,
the adjustment was partially
offset by a gain from legal
judgment proceeds.
(d) 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 rates
for the adjustments to our GAAP
income before income taxes, for
the three and twelve months ended
December 31, 2020, were 18.4% and
19.6%, compared with 17.3% and
22.2% for the corresponding
periods of the prior year.
(e) The adjustments related to certain
acquisition items and prior period
items excluded from GAAP earnings.
Amgen Inc.
Reconciliations of Cash Flows
(In millions)
(Unaudited)
Three months ended Twelve months ended
December 31, December 31,
---
2020 2019 2020 2019
---
Net cash provided by operating activities $
2,153 $
2,514 $
10,497 $
9,150
Net cash (used in) provided by investing activities (1,384) (5,963) (5,401) 5,709
Net cash used in financing activities (3,590) (1,929) (4,867) (15,767)
(Decrease) increase in cash and cash equivalents (2,821) (5,378) 229 (908)
Cash and cash equivalents at beginning of period 9,087 11,415 6,037 6,945
Cash and cash equivalents at end of period $
6,266 $
6,037 $
6,266 $
6,037
Three months ended Twelve months ended
December 31, December 31,
---
2020 2019 2020 2019
---
Net cash provided by operating activities $
2,153 $
2,514 $
10,497 $
9,150
Capital expenditures (173) (188) (608) (618)
Free cash flow $
1,980 $
2,326 $
9,889 $
8,532
Amgen Inc.
Reconciliation of GAAP EPS Guidance to Non-GAAP
EPS Guidance for the Year Ending December 31, 2021
(Unaudited)
GAAP diluted EPS guidance $12.12 $13.17
Known adjustments to arrive
at non-GAAP*:
Acquisition-related expenses
(a) 3.77 3.82
Restructuring costs 0.06
Non-GAAP diluted EPS
guidance $16.00 $17.00
* The known adjustments are
presented net of their related tax
impact, which amount to
approximately $0.99 -$1.00 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 the fair
value of our contingent
consideration 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, 2021
(Unaudited)
GAAP tax rate guidance 11.0% 12.5%
Tax rate of known adjustments
discussed above 1.5% 2.0%
Non-GAAP tax rate guidance 13.0% 14.0%
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 Interest and 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 will become the basis for our comparisons going forward 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
