Amgen Reports Second Quarter 2020 Financial Results
THOUSAND OAKS, Calif., July 28, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial results for the second quarter of 2020.
Key results include:
-- Despite the impact of the COVID-19 pandemic, total revenues increased 6%
to $6.2 billion in comparison to the second quarter of 2019, driven by
higher unit demand, offset partially by lower net selling prices.
-- Product sales increased 6% globally, driven by 13% volume growth
across a number of our newer products, including Otezla(®
)(apremilast), MVASI(® )(bevacizumab-awwb), KANJINTI(®)
(trastuzumab-anns), EVENITY(®) (romosozumab-aqqg) and Repatha(®)
(evolocumab), offset partially by declines in select products from
the impact of COVID-19 and biosimilar and generic competition.
-- GAAP earnings per share (EPS) decreased 15% to $3.05 driven primarily by
the amortization of costs associated with our November 2019 acquisition
of Otezla, offset partially by increased revenues. Of note, this is the
first period to include our share of BeiGene's net loss under the equity
method of accounting.
-- GAAP operating income decreased 13% to $2.3 billion and GAAP
operating margin decreased 8.7 percentage points to 39.3%, driven
primarily by the amortization of intangible assets from our Otezla
acquisition.
-- Non-GAAP EPS increased 7% to $4.25 driven by increased revenues and
fewer weighted-average shares outstanding while also taking into account
our share of BeiGene's net loss for the previous quarter as noted above.
-- Non-GAAP operating income increased 9% to $3.2 billion and non-GAAP
operating margin increased 1.7 percentage points to 55.0%.
-- The Company generated $2.7 billion of free cash flow in the second
quarter versus $1.3 billion in the second quarter of 2019, an increase
driven primarily by the timing of tax payments.
-- 2020 total revenues guidance reaffirmed at $25.0-$25.6 billion; EPS
guidance revised to $10.73-$11.43 on a GAAP basis and revised to
$15.10-$15.75 on a non-GAAP basis.
"As our strong results demonstrate, we continue to reliably supply patients as we navigate the COVID-19 pandemic," said Robert A. Bradway, chairman and chief executive officer. "We look forward to several significant pipeline updates in the second half of the year."
$Millions, except EPS, dividends paid per share and percentages Q2'20 Q2'19 YOY
Total Revenues $
6,206 $
5,871 6%
GAAP Operating Income $
2,323 $
2,678 (13%)
GAAP Net Income $
1,803 $
2,179 (17%)
GAAP EPS $
3.05 $
3.57 (15%)
Non-GAAP Operating Income $
3,247 $
2,973 9%
Non-GAAP Net Income $
2,518 $
2,423 4%
Non-GAAP EPS $
4.25 $
3.97 7%
Dividends Paid Per Share $
1.60 $
1.45 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
-- Notwithstanding the effects of the pandemic, total product sales
increased 6% for the second quarter of 2020 versus the second quarter of
2019 driven by 13% volume growth.
-- COVID-19 impacts: The pandemic interrupted many physician-patient
interactions, which led to delays in diagnosis and treatment with
varying degrees of impact across our portfolio. Sales of negatively
affected products fell most early in the second quarter with sales
beginning to recover in the latter weeks of the quarter. As the quarter
progressed, our teams increasingly responded to customer needs via
remote interactions and also identified innovative solutions to support
the delivery of patient care. Our medicines were reliably supplied to
patients throughout the quarter.
-- Prolia(®) (denosumab) sales decreased 6% year-over-year driven by lower
unit demand as a result of fewer office visits by osteoporosis patients,
a population that is generally older and more vulnerable to COVID-19.
Our historical pattern of higher sales in the second quarter was
accordingly disrupted, resulting in relatively flat quarter-over-quarter
sales. During the month of April, 60% fewer patients in the U.S. were
diagnosed with osteoporosis compared to a pre-COVID-19 baseline. In
response to the concerns of patients and providers, we worked to
identify alternate sites for Prolia administration and have since seen
improved sales with many patients returning for therapy as well as
increased new patient diagnoses.
-- EVENITY generated $101 million of sales in the second quarter of 2020.
Although COVID-19 impacted new patient starts in the U.S. this quarter,
we saw a continuous increase in new prescribers. We remain focused on
increasing the number of patients and ensuring they receive their full
12 months of therapy. While patient uptake remains strong, we anticipate
a slowdown in reported sales in the third quarter as the first half of
2020 benefited from larger shipments to Astellas, our partner in Japan,
to ensure they had appropriate inventory.
-- Repatha sales increased 32% year-over-year driven by 69% volume growth,
offset partially by lower net selling price. Sales declined 13%
quarter-over-quarter driven by unfavorable changes to estimated sales
deductions. Although new-to-brand prescriptions (NBRx) in the U.S. for
the proprotein convertase subtilisin/kexin type 9 (PCSK9) segment were
negatively impacted by COVID-19, Repatha maintained share leadership
among new patients, exiting the quarter with approximately 80% share.
Repatha's year-over-year net selling price declined as a result of
additional contracting to improve Medicare Part D patient access and
patient affordability. We expect net selling price to be relatively
stable for the remainder of the year.
-- Aimovig(® )(erenumab-aooe) sales increased 18% year-over-year driven by
45% volume growth, offset partially by lower net selling price as a
result of additional contracting to expand patient access. Aimovig
remains the segment leader within the preventative calcitonin
gene-related peptide (CGRP) class with 48% share of total prescriptions
(TRx) in the quarter. Although NBRx for the total CGRP segment were
negatively impacted by COVID-19, Aimovig regained NBRx share leadership
exiting the quarter with 41% share. We continue to see improvement in
our conversion from free to paid prescriptions and expect net selling
price to be relatively stable for the remainder of the year.
-- Parsabiv(® )(etelcalcetide) sales increased 11% year-over-year driven
by higher unit demand, offset partially by lower net selling price. As
expected, on July 6, 2020, the Centers for Medicare & Medicaid Services
(CMS) proposed a methodology to modify the end-stage renal disease
(ESRD) Prospective Payment System (PPS) base rate to include
calcimimetics in the ESRD PPS bundled payment in 2021. This proposal is
subject to a public comment period and the Final Rule is expected in
November 2020.
-- Otezla was acquired in November 2019 and generated $561 million of sales
in the second quarter of 2020, reflecting 14% growth year-over-year
driven primarily by volume. U.S. Otezla TRx growth remained strong in
the quarter. Although NBRx volumes were negatively impacted by COVID-19
early in the quarter, trends have improved since then. From a
competitive standpoint, Otezla's NBRx share of the psoriasis segment
grew slightly in the quarter. Otezla provides a convenient oral option
with an established safety profile and does not require lab monitoring,
making it an attractive option during this COVID-19 period and for
physicians practicing telemedicine.
-- Enbrel(®) (etanercept) sales decreased 9% year-over-year driven by
lower unit demand. Consistent with prior periods, Enbrel continued to
lose share and the effects of such share loss were compounded by lower
growth of the rheumatology segment due to COVID-19. Consistent with
other agents within the class, Enbrel experienced a decline in new
patients. Of note, earlier this month, the U.S. Court of Appeals for the
Federal Circuit affirmed the judgment of the New Jersey District Court
upholding the validity of the two patents that describe and claim Enbrel
and methods for making it.
-- AMGEVITA((TM)) (adalimumab) generated $62 million of sales in the second
quarter of 2020 and is the most prescribed adalimumab biosimilar in
Europe for the fourth consecutive quarter. AMGEVITA sales declined 28%
quarter-over-quarter driven by lower net selling prices and reductions
in customer inventories following COVID-19-related stocking in the first
quarter.
-- KYPROLIS(®) (carfilzomib) sales decreased 5% year-over-year driven by
lower unit demand. This decline was driven by reduced multiple myeloma
patient visits to providers due to COVID-19.
-- XGEVA(®) (denosumab) sales decreased 13% year-over-year driven by lower
unit demand. This decline was driven by the impact of COVID-19,
including a decrease in patient visits and recently revised treatment
recommendations from the National Comprehensive Cancer Network (NCCN) in
response to COVID-19 to prioritize primary cancer treatments over bone
targeting agents.
-- Vectibix(®) (panitumumab) sales were relatively flat year-over-year.
-- Nplate(®) (romiplostim) sales decreased 4% year-over-year driven by
unfavorable changes to estimated sales deductions. Volume growth slowed
primarily as a result of fewer physician office visits due to COVID-19,
and a loss of new patient starts to oral alternatives.
-- BLINCYTO(®) (blinatumomab) sales increased 19% year-over-year driven by
higher unit demand as we continue to see broader adoption in the
community hospital setting.
-- MVASI generated $172 million of sales in the second quarter of 2020,
with a 39% exit share of the bevacizumab segment in the U.S. Going
forward, we expect increased competition in the U.S. given the launch of
a competing biosimilar earlier this year.
-- KANJINTI generated $123 million of sales in the second quarter of 2020,
with a 32% exit share of the trastuzumab segment in the U.S. The
trastuzumab market has become increasingly competitive with the launches
of four additional biosimilar products in the U.S. earlier this year.
-- Neulasta(®) (pegfilgrastim) sales decreased 28% year-over-year driven
by the impact of biosimilar competition on net selling price and unit
demand. Unit volumes for the overall long-acting granulocyte
colony-stimulating factors (G-CSFs) segment grew, supported by the NCCN
guidelines, recently revised in response to COVID-19 recommending
increased use of long-acting G-CSFs in intermediate risk febrile
neutropenia cancer patients. Within the long-acting G-CSF segment,
Neulasta Onpro(®) continues to be the preferred choice for physicians
and patients and share increased to 58% this quarter. Onpro provides a
unique value proposition during the pandemic as it allows patients to
receive their G-CSF treatment without having to return to their doctor's
office or other site of care for administration.
-- NEUPOGEN(®) (filgrastim) sales decreased 35% year-over-year driven by
the impact of competition on unit demand and unfavorable changes to
estimated sales deductions.
-- EPOGEN(®) (epoetin alfa) sales decreased 28% year-over-year driven by
lower unit demand and lower net selling price from our existing
contractual commitment with DaVita.
-- Aranesp(®) (darbepoetin alfa) sales decreased 11% year-over-year driven
by lower net selling price and the impact of competition on unit demand.
-- Sensipar/Mimpara(® )(cinacalcet) sales decreased 34% year-over-year
driven by the impact of generic competition on unit demand. Supplemental
patent protection certificates for cinacalcet have now expired in major
European markets and generic launches have begun. We expect ex-U.S.
sales to continue to decline in the second half of 2020.
Product Sales Detail by Product and Geographic Region
$Millions, except percentages
Q2'20 Q2'19 YOY
US ROW TOTAL TOTAL TOTAL
Prolia(R) $
441 $
218 $
659 $
698 (6%)
EVENITY(R) 40 61 101 28
*
Repatha(R) 115 85 200 152 32%
Aimovig(R) 98 98 83 18%
Parsabiv(R) 160 26 186 168 11%
Otezla(R) 464 97 561
*
Enbrel(R) 1,213 33 1,246 1,363 (9%)
AMGEVITA(TM) 62 62 52 19%
KYPROLIS(R) 167 86 253 267 (5%)
XGEVA(R) 318 117 435 499 (13%)
Vectibix(R) 79 116 195 196 (1%)
Nplate(R) 107 86 193 201 (4%)
BLINCYTO(R) 56 37 93 78 19%
KANJINTI(R) 101 22 123 30
*
MVASI(R) 149 23 172
*
Neulasta(R) 520 73 593 824 (28%)
NEUPOGEN(R) 28 21 49 75 (35%)
EPOGEN(R) 161 161 223 (28%)
Aranesp(R) 156 231 387 436 (11%)
Sensipar(R)/Mimpara(R) 32 49 81 122 (34%)
Other** 23 37 60 79 (24%)
Total product sales $
4,428 $
1,480 $
5,908 $
5,574 6%
* Change in excess of 100%
** Other includes GENSENTA, IMLYGIC(R), Corlanor(R) and Bergamo
---
Operating Expense, Operating Margin and Tax Rate Analysis
On a GAAP basis:
-- Total Operating Expenses increased 22% primarily driven by
Otezla-related expenses, including the amortization of intangible
assets, offset partially by the reduction in certain expenses as a
result of COVID-19. Cost of Sales margin increased 7 percentage points
driven by amortization expense related to the Otezla acquisition and the
benefit of Hurricane Maria insurance proceeds in 2019, offset partially
by lower manufacturing costs. Research & Development (R&D) expenses
increased 4% driven by higher spend in support of our late-stage
development programs, primarily AMG 510 (sotorasib) and our biosimilar
programs, along with Otezla, offset partially by recoveries from our
collaboration with BeiGene. Selling, General & Administrative (SG&A)
expenses increased 3% primarily due to Otezla commercial and
acquisition-related expenses, offset partially by COVID-19-related
deceleration of certain expenses. Other expenses increased due to a
legal settlement.
-- Operating Margin decreased 8.7 percentage points to 39.3% driven
primarily by the amortization of intangible assets from our Otezla
acquisition.
-- Tax Rate decreased 3.8 percentage points due primarily to net favorable
items in the quarter, amortization related to the Otezla acquisition and
changes in jurisdictional mix of earnings.
On a non-GAAP basis:
-- Total Operating Expenses increased 2% driven by Otezla-related expenses,
offset partially by the reduction in certain expenses as a result of
COVID-19. Cost of Sales margin decreased 0.4 percentage points driven
primarily by lower manufacturing costs, offset partially by an increase
in royalties and the benefit of Hurricane Maria insurance proceeds in
2019. R&D expenses increased 3% driven by higher spend in support of our
late-stage development programs, primarily AMG 510 (sotorasib) and our
biosimilar programs, along with Otezla, offset partially by recoveries
from our collaboration with BeiGene. SG&A expenses increased 1% due
primarily to Otezla commercial related expenses, offset partially by
COVID-19-related deceleration of certain expenses.
-- Operating Margin increased 1.7 percentage points to 55.0%.
-- Tax Rate decreased 1.6 percentage points due primarily to net favorable
items in the quarter.
$Millions, except percentages
GAAP
Non-GAAP
Q2'20 Q2'19 YOY Q2'20 Q2'19 YOY
Cost of Sales $
1,488 $
1,012 47% $
758 $
736 3%
% of product sales 25.2 18.2
7 pts 12.8 13.2
% % % %
(0.4) pts
Research & Development $
964 $
924 4% $
936 $
906 3%
% of product sales 16.3 16.6
(0.3) pts 15.8 16.3
% % % %
(0.5) pts
Selling, General & Administrative $
1,295 $
1,260 3% $
1,265 $
1,256 1%
% of product sales 21.9 22.6
(0.7) pts 21.4 22.5
% % % %
(1.1) pts
Other $
136 $
(3)
*
$
$ -%
Total Operating Expenses $
3,883 $
3,193 22% $
2,959 $
2,898 2%
Operating Margin
operating income as % of product sales 39.3 48.0
(8.7) pts 55.0 53.3
% % % %
1.7 pts
Tax Rate 11.2 15.0 (3.8) pts 13.7 15.3
% % % % (1.6) pts
* Change in excess of 100%
pts: percentage points
---
Cash Flow and Balance Sheet
-- The Company generated $2.7 billion of free cash flow in the second
quarter of 2020 versus $1.3 billion in the second quarter of 2019,
driven primarily by the timing of tax payments.
-- The Company's second quarter 2020 dividend of $1.60 per share was
declared on March 4, 2020, and was paid on June 8, 2020, to all
stockholders of record as of May 18, 2020, representing a 10% increase
from 2019.
-- During the second quarter, the Company repurchased 2.6 million shares of
common stock at a total cost of $591 million. At the end of the second
quarter, the Company had $4.9 billion remaining under its stock
repurchase authorization.
-- Cash and investments totaled $11.4 billion as of June 30, 2020, a
decrease of $10.3 billion from the quarter ended June 30, 2019. This
decrease was primarily due to the Otezla and BeiGene transactions, as
well as cash returned to shareholders in the form of share repurchases
and dividends, offset partially by free cash flow generated during the
period and net proceeds from debt issuances.
-- Additionally, the Company issued $4 billion of long-term debt in May for
general corporate purposes, including enhancing our working capital
position, given favorable market conditions. Debt outstanding at the end
of the quarter totaled $34.2 billion with a weighted-average interest
rate of 3.5% and an average maturity of 14 years.
$Billions, except shares Q2'20 Q2'19 YOY
Operating Cash Flow $
2.8 $
1.4 $
1.4
Capital Expenditures 0.2 0.1 0.0
Free Cash Flow 2.7 1.3 1.4
Dividends Paid 0.9 0.9 0.0
Share Repurchases 0.6 2.3 (1.8)
Average Diluted Shares (millions) 592 610 (18)
Cash and Investments 11.4 21.8 (10.3)
Debt Outstanding 34.2 30.6 3.6
Stockholders' Equity 10.7 10.8 (0.1)
Note: Numbers may not add due to rounding
---
2020 Guidance
For the full year 2020, the Company now expects:
-- Total revenues in the range of $25.0 billion to $25.6 billion, unchanged
from previous guidance.
-- On a GAAP basis, EPS in the range of $10.73 to $11.43 and a tax rate in
the range of 10.5% to 11.5%.
-- Previously, the Company expected GAAP EPS in the range of $10.65 to
$11.45 and a tax rate in the range of 10.5% to 11.5%.
-- On a non-GAAP basis, EPS in the range of $15.10 to $15.75 and a tax rate
in the range of 13.5% to 14.5%.
-- Previously, the Company expected non-GAAP EPS in the range of $14.85
to $15.60 and a tax rate in the range of 13.5% to 14.5%.
-- Capital expenditures to be approximately $600 million.
-- Quarterly dividend maintained at $1.60 per share.
-- Share repurchases will be executed opportunistically resulting in an
amount at the lower end of our previous guidance of $3 billion to $5
billion.
Second Quarter Product and Pipeline Update
The Company provided the following updates on selected product and pipeline programs:
AMG 510 (sotorasib)
-- The Company continues to expect initial data from a potentially pivotal
Phase 2 monotherapy study in patients with advanced non-small cell lung
cancer (NSCLC) in H2 2020.
-- The Phase 3 CodeBreaK 200 study comparing sotorasib to docetaxel is
enrolling patients with advanced NSCLC.
-- 6 Phase 1 combination cohorts are enrolling patients.
Bispecific Programs
-- The Company expects initial data from Phase 1 dose escalation studies of
the following half-life extended BiTE(®) constructs in H2 2020:
-- AMG 160 targeting PSMA (prostate specific membrane antigen) for
prostate cancer
-- AMG 701 targeting BCMA (B-cell maturation antigen) for multiple
myeloma
-- AMG 757 targeting DLL3 (delta-like ligand 3) for small cell lung
cancer
-- Phase 1 development of AMG 424, a CD38-CD3 XmAb(®) antibody has been
stopped, with rights reverting to Xencor.
Otezla
-- In May, the Phase 3 ADVANCE study in patients with mild to moderate
psoriasis met its primary endpoint and all secondary endpoints at week
16.
-- Otezla is being investigated as a potential immunomodulatory treatment
in patients hospitalized with SARS-CoV-2 infections in multiple COVID-19
platform trials.
Tezepelumab
-- The Company continues to expect data from the Phase 3 NAVIGATOR study in
patients with severe uncontrolled asthma in late 2020.
-- A Phase 2 atopic dermatitis study was stopped based on efficacy data
that did not support continuation of the study. No new safety findings
were observed and there is no impact to the ongoing studies in chronic
obstructive pulmonary disease and asthma.
AMG 592
-- Phase 1b/2 clinical studies in systemic lupus erythematosus and chronic
graft versus host disease are enrolling patients.
-- A Phase 1b study in rheumatoid arthritis (RA) was stopped due to
insufficient benefit-risk for the use with standard of care therapy in
active RA patients.
Omecamtiv mecarbil
-- The Company continues to expect data from the Phase 3 GALACTIC-HF study
in Q4 2020.
-- In May, the U.S. Food and Drug Administration granted Fast Track
designation for omecamtiv mecarbil for the treatment of chronic heart
failure with reduced ejection fraction.
AMG 890
-- A Phase 2 study in patients with cardiovascular disease has commenced
for AMG 890, a small interfering RNA molecule that lowers
lipoprotein(a).
COVID-19 Therapeutics
-- The Company is pursuing the development of therapeutic antibodies that
may be complementary with antibodies directed against the receptor
binding domain of the SARS-CoV-2 spike protein. In addition, the Company
has the option to review and potentially pursue antibody candidates
identified by Adaptive Biotechnologies.
Tezepelumab is being developed in collaboration with AstraZeneca
Omecamtiv mecarbil is being developed under a collaboration between Amgen and Cytokinetics, with funding and strategic support from Servier
Non-GAAP Financial Measures
In this news release, management has presented its operating results for the second quarters 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 2020 EPS and tax rate guidance in accordance with GAAP and on a non-GAAP basis. These non-GAAP financial measures are computed by excluding certain items related to acquisitions, restructuring and certain other items from the related GAAP financial measures. Reconciliations for these non-GAAP financial measures to the most directly comparable GAAP financial measures are included in the news release. Management has also presented Free Cash Flow (FCF), which is a non-GAAP financial measure, for the second quarters of 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.
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 Adaptive Biotechnologies (including statements regarding such collaboration's, or our own, ability to discover and develop fully-human neutralizing antibodies targeting SARS-CoV-2 to potentially prevent or treat COVID-19), BeiGene, Ltd., 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. 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 Six months ended
June 30,
June 30,
2020 2019 2020 2019
Revenues:
Product sales $
5,908 $
5,574 $
11,802 $
10,860
Other revenues 298 297 565 568
Total revenues 6,206 5,871 12,367 11,428
Operating expenses:
Cost of sales 1,488 1,012 3,001 2,067
Research and
development 964 924 1,916 1,803
Selling, general and
administrative 1,295 1,260 2,611 2,414
Other 136 (3) 161 (6)
Total operating
expenses 3,883 3,193 7,689 6,278
Operating income 2,323 2,678 4,678 5,150
Interest expense, net 296 332 642 675
Interest and other
income, net 3 218 14 403
Income before income
taxes 2,030 2,564 4,050 4,878
Provision for income
taxes 227 385 422 707
Net income $
1,803 $
2,179 $
3,628 $
4,171
Earnings per share:
Basic $
3.07 $
3.59 $
6.16 $
6.78
Diluted $
3.05 $
3.57 $
6.12 $
6.75
Weighted-average shares used in
calculation of earnings per share:
Basic 588 607 589 615
Diluted 592 610 593 618
Amgen Inc.
Consolidated Balance Sheets - GAAP
(In millions)
June 30, December 31,
2020 2019
(Unaudited)
Assets
Current assets:
Cash, cash equivalents and marketable securities $
11,421 $
8,911
Trade receivables, net 5,366 4,057
Inventories 3,840 3,584
Other current assets 2,268 1,888
Total current assets 22,895 18,440
Property, plant and equipment, net 4,843 4,928
Intangible assets, net 17,948 19,413
Goodwill 14,678 14,703
Other assets 4,647 2,223
Total assets $
65,011 $
59,707
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable and accrued liabilities $
10,432 $
9,882
Current portion of long-term debt 91 2,953
Total current liabilities 10,523 12,835
Long-term debt 34,133 26,950
Long-term deferred tax liabilities 259 606
Long-term tax liabilities 7,556 8,037
Other noncurrent liabilities 1,881 1,606
Total stockholders' equity 10,659 9,673
Total liabilities and stockholders' equity $
65,011 $
59,707
Shares outstanding 586 591
Amgen Inc.
GAAP to Non-GAAP Reconciliations
(Dollars in millions)
(Unaudited)
Three months ended Six months ended
June 30,
June 30,
2020 2019 2020 2019
GAAP cost of sales $
1,488 $
1,012 $
3,001 $
2,067
Adjustments to cost of sales:
Acquisition-related expenses
(a) (730) (276) (1,472) (552)
Total adjustments to cost of
sales (730) (276) (1,472) (552)
Non-GAAP cost of sales $
758 $
736 $
1,529 $
1,515
GAAP cost of sales as a 25.2 18.2 25.4 19.0
percentage of product sales % % % %
Acquisition-related expenses
(a) -12.4 -5.0 -12.4 -5.0
Non-GAAP cost of sales as a 12.8 13.2 13.0 14.0
percentage of product sales % % % %
GAAP research and development
expenses $
964 $
924 $
1,916 $
1,803
Adjustments to research and development expenses:
Acquisition-related expenses
(a) (28) (18) (53) (38)
Total adjustments to research
and development expenses (28) (18) (53) (38)
Non-GAAP research and
development expenses $
936 $
906 $
1,863 $
1,765
GAAP research and development
expenses as a percentage of % % % %
product sales 16.3 16.6 16.2 16.6
Acquisition-related expenses
(a) -0.5 -0.3 -0.4 -0.3
Non-GAAP research and
development expenses as a % % % %
percentage of product sales 15.8 16.3 15.8 16.3
GAAP selling, general and
administrative expenses $
1,295 $
1,260 $
2,611 $
2,414
Adjustments to selling, general and
administrative expenses:
Acquisition-related expenses
(a) (30) (5) (59) (9)
Certain net charges pursuant to
our restructuring initiatives - 1
Total adjustments to selling,
general and administrative
expenses (30) (4) (59) (9)
Non-GAAP selling, general and
administrative expenses $
1,265 $
1,256 $
2,552 $
2,405
GAAP selling, general and
administrative expenses as a % % % %
percentage of product sales 21.9 22.6 22.1 22.2
Acquisition-related expenses
(a) -0.5 -0.1 -0.5 -0.1
Certain net charges pursuant to
our restructuring initiatives 0.0 0.0 0.0 0.0
Non-GAAP selling, general and
administrative expenses as a % % % %
percentage of product sales 21.4 22.5 21.6 22.1
GAAP operating expenses $
3,883 $
3,193 $
7,689 $
6,278
Adjustments to operating expenses:
Adjustments to cost of sales (730) (276) (1,472) (552)
Adjustments to research and
development expenses (28) (18) (53) (38)
Adjustments to selling, general
and administrative expenses (30) (4) (59) (9)
Certain net charges pursuant to
our restructuring initiatives 2 1 4 2
Certain other expenses (b) (138) 2 (165) 4
Total adjustments to operating
expenses (924) (295) (1,745) (593)
Non-GAAP operating expenses $
2,959 $
2,898 $
5,944 $
5,685
GAAP operating income $
2,323 $
2,678 $
4,678 $
5,150
Adjustments to operating
expenses 924 295 1,745 593
Non-GAAP operating income $
3,247 $
2,973 $
6,423 $
5,743
Three months ended Six months ended
June 30,
June 30,
2020 2019 2020 2019
GAAP operating income as a 39.3 48.0 39.6 47.4
percentage of product sales % % % %
Adjustments to cost of sales 12.4 5.0 12.5 5.0
Adjustments to research and
development expenses 0.5 0.3 0.4 0.3
Adjustments to selling, general
and administrative expenses 0.5 0.1 0.5 0.1
Certain net charges pursuant to
our restructuring initiatives 0.0 0.0 0.0 0.0
Certain other expenses (b) 2.3 -0.1 1.4 0.1
Non-GAAP operating income as a 55.0 53.3 54.4 52.9
percentage of product sales % % % %
GAAP interest and other income,
net $
3 $
218 $
14 $
403
Adjustments to interest and
other income, net (c) (36) (36)
Non-GAAP interest and other
income, net $
(33) $
218 $
(22) $
403
GAAP income before income taxes $
2,030 $
2,564 $
4,050 $
4,878
Adjustments to operating
expenses 924 295 1,745 593
Adjustments to other income (36) (36)
Non-GAAP income before income
taxes $
2,918 $
2,859 $
5,759 $
5,471
GAAP provision for income taxes $
227 $
385 $
422 $
707
Adjustments to provision for income taxes:
Income tax effect of the above
adjustments (d) 164 70 335 138
Other income tax adjustments (e) 9 (19) 8 (27)
Total adjustments to provision
for income taxes 173 51 343 111
Non-GAAP provision for income
taxes $
400 $
436 $
765 $
818
GAAP tax as a percentage of 11.2 15.0 10.4 14.5
income before taxes % % % %
Adjustments to provision for income taxes:
Income tax effect of the above
adjustments (d) 2.2 0.9 2.7 1.0
Other income tax adjustments (e) 0.3 -0.6 0.2 -0.5
Total adjustments to provision
for income taxes 2.5 0.3 2.9 0.5
Non-GAAP tax as a percentage of 13.7 15.3 13.3 15.0
income before taxes % % % %
GAAP net income $
1,803 $
2,179 $
3,628 $
4,171
Adjustments to net income:
Adjustments to income before
income taxes, net of the income
tax effect 724 225 1,374 455
Other income tax adjustments (e) (9) 19 (8) 27
Total adjustments to net income 715 244 1,366 482
Non-GAAP net income $
2,518 $
2,423 $
4,994 $
4,653
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
June 30, 2020
June 30, 2019
GAAP Non-GAAP GAAP Non-GAAP
Net income $
1,803 $
2,518 $
2,179 $
2,423
Weighted-average shares for
diluted EPS 592 592 610 610
Diluted EPS $
3.05 $
4.25 $
3.57 $
3.97
Six months ended Six months ended
June 30, 2020
June 30, 2019
GAAP Non-GAAP GAAP Non-GAAP
Net income $
3,628 $
4,994 $
4,171 $
4,653
Weighted-average shares for
diluted EPS 593 593 618 618
Diluted EPS $
6.12 $
8.42 $
6.75 $
7.53
(a) The adjustments related primarily
to noncash amortization of
intangible assets from business
acquisitions.
(b) For the three months ended June 30,
2020 the adjustment related
primarily to legal settlement
expenses. For the six months ended
June 30, 2020 the adjustment
related primarily to legal
settlement expenses and an
impairment charge associated with
an in-process research and
development asset.
(c) For the six months ended June 30,
2020 the adjustment related
primarily to a gain from legal
judgment proceeds offset partially
by amortization of the basis
difference from our BeiGene equity
method investment.
(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 six months ended
June 30, 2020, were 18.5% and
19.6%, compared with 23.7% and
23.3% 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 Six months ended
June 30,
June 30,
2020 2019 2020 2019
Net cash provided
by operating
activities $
2,842 $
1,414 $
4,976 $
3,259
Net cash (used
in) provided by
investing
activities (2,159) 2,745 (2,389) 6,300
Net cash provided
by (used in)
financing
activities 775 (5,992) 521 (10,979)
Increase
(decrease) in
cash and cash
equivalents 1,458 (1,833) 3,108 (1,420)
Cash and cash
equivalents at
beginning of
period 7,687 7,358 6,037 6,945
Cash and cash
equivalents at
end of period $
9,145 $
5,525 $
9,145 $
5,525
Three months ended Six months ended
June 30,
June 30,
2020 2019 2020 2019
Net cash provided
by operating
activities $
2,842 $
1,414 $
4,976 $
3,259
Capital
expenditures (158) (144) (300) (260)
Free cash flow $
2,684 $
1,270 $
4,676 $
2,999
Amgen Inc.
Reconciliation of GAAP EPS Guidance to Non-GAAP
EPS Guidance for the Year Ending December 31, 2020
(Unaudited)
GAAP diluted EPS guidance $
10.73 $
11.43
Known adjustments to arrive at non-GAAP*:
Acquisition-related expenses (a) 4.24 4.29
Net legal proceedings 0.08
Non-GAAP diluted EPS guidance $
15.10 $
15.75
* The known adjustments are
presented net of their related tax
impact, which amount to
approximately $1.07 -$1.08 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 and changes in the fair
value or our contingent
consideration.
Reconciliation of GAAP Tax Rate Guidance to Non-GAAP
Tax Rate Guidance for the Year Ending December 31, 2020
(Unaudited)
GAAP tax rate guidance 10.5 11.5
% %
Tax rate of known adjustments discussed above 3.0%
Non-GAAP diluted EPS guidance 13.5 14.5
% %
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SOURCE Amgen
