Edwards Lifesciences
2020 Annual Report
Edwards Lifesciences is the global leader of patient-focused medical innovations
for structural heart disease and critical care monitoring. Driven by a passion for patients,
the company is dedicated to improving and enhancing lives through partnerships with
clinicians and stakeholders across the global healthcare landscape.
To Our Shareholders
In mid-December 2020, for the first time ever, Edwards Lifesciences hosted its annual investor
conference as a virtual event. Rather than standing in a room with several hundred people
discussing Edwards’ strategy for long-term growth, I was joined by only a handful of colleagues.
Separated by plexiglass partitions, socially distanced and fresh off COVID testing for all, this
experience underscored what made 2020 so unprecedented.
There is no doubt that the ongoing pandemic resulted in one of the most challenging years
in recent history – for our global community, clinicians, partners, our employees and especially
our patients.
As we look to 2021 and
beyond, I am more excited
than ever before about the
work happening at Edwards
and, more importantly, what
we envision for the future
of patient care.
Tremendous progress has been made on vaccines and other therapeutic advancements from
medical technology innovators and I find myself hopeful and optimistic about 2021 and beyond.
Remarkable Patient-Focused Team
As a member of the critical healthcare infrastructure,
Edwards and our employees never stopped during
the pandemic. In fact, our employees have been more
patient focused than ever before in their relentless
pursuit to deliver life-saving technologies. A recent
survey of our global employees found that 94 percent
of them consider what’s important to patients when
making decisions. We saw this in action as extraordinary
efforts across our company ensured that the patients we
serve received the help they needed throughout 2020.
Our employees kept the last sentence of our Credo
as their North Star: “Helping patients is our life’s work,
and life is now.”
Navigating through the challenges brought by the
pandemic, our Board of Directors also advanced their
commitment and focus on their service to Edwards.
We added Ramona Sequeira and Paul LaViolette to our
Board, and Martha Marsh assumed the role of lead
independent director. Bringing such highly respected,
diverse and talented leaders to our Board provides us
with valuable insights, along with unique and varying
perspectives on our strategy.
We understand the strength of community and
diversity, and I’m proud of the inclusive culture that
we’ve built at Edwards where all employees can grow,
thrive and belong.
Edwards Lifesciences I 2020 Annual Report
1
Though we believe we exhibit strength in this area,
we continue to listen and evolve, focusing on
sustainable systemic improvement. We’ve expanded
our performance metrics to further that commitment
as well as made significant contributions to support
organizations addressing needs and racial disparities
in healthcare.
Our strategy for giving back has always focused on
helping underserved patients, and supporting the
communities where we live and work across the globe
is central to our company culture and values. In 2020,
the Edwards Lifesciences Foundation celebrated an
extraordinary milestone for Every Heartbeat Matters,
our signature philanthropic initiative, of impacting
more than 1.7 million underserved people – exceeding
our goal. We are well on our way to reaching our new
bold goal to improve the lives of 2.5 million more un-
derserved structural heart and critical care patients by
2025. I’m pleased to share that with an increase in our
in-kind and financial support through the Foundation
and the tripling of our employees’ donations with our
matching gift program, 2020 was our biggest year of
giving ever – doubling our charitable support to nearly
$20 million. This is a remarkable and humbling
commitment by everyone at Edwards, and we are
so grateful to our outstanding partners for their
dedicated efforts.
There have been countless stories told this year at
Edwards about the way our employees have positively
impacted the lives of others. One story that stuck with
me is that of a surgical patient from Singapore who
shared with us how his Edwards valve has a “multiplier
effect of positivity,” bringing a better life not just to him,
but also to others around the world. This is a bright
reminder of the importance of our work, and the
critical need of our current and future therapies.
Innovative Strategic Focus
Despite the pandemic, our commitment to our
patient-focused innovation strategy remained
unwavering. We continued to safely, but aggressively,
pursue breakthrough therapies for the millions of
patients with structural heart diseases and critical
illnesses. And, while many other medtech companies
have diversified, we continued to be focused, as we
know there are still many structural heart disease and
critically ill patients who need life-saving treatment.
With this focus, we are able to bring our decades
of expertise, clinical knowledge, resources and
understanding of the patient journey to developing
and advancing potential solutions. We are focused on
bold innovations and continuing with our rich pipeline
of future therapies. These innovations that “change the
practice of medicine” are supported by rigorous clinical
trials and best-in-class outcomes. While some evidence
collection was slowed due to the pandemic, we and the
clinical community are enthusiastic about continuing
our trials and generating robust evidence.
Our citizenship and sustainability efforts are aligned
to our aspirations and integrated into our overall
strategic planning process. This past year, we were
honored to have been recognized once again for our
efforts in these areas by the Dow Jones Sustainability
Indices, America’s Most JUST Companies and the
World’s Most Ethical Companies by the Ethisphere
Institute, among others.
Transforming Patient Care
Putting patients first has never been more important,
and I am proud of the steadfast work we maintained
throughout the year.
We’ve continued to invest in developing solutions that
extend lives, improve quality of life and bring value to
the healthcare system. Our consistent and significant
R&D investments allowed us to fuel this progress.
To support our innovation and growth, we continued
investing in our people, technology pipeline, robust
evidence and our infrastructure. During a year when
many companies furloughed or reduced employees
because of COVID, we prioritized protecting jobs
and were able to grow our team to nearly 15,000
employees worldwide.
Helping patients and developing innovations for structural heart disease and critical care monitoring remains our strategic focus.
2
Edwards Lifesciences I 2020 Annual Report As I write this letter, construction is continuing on our
headquarters and research expansion in Irvine. We have
also continued to grow our international footprint,
with our facility in Costa Rica coming online
midyear, and significant progress on new
facilities in Limerick, Ireland, and Caesarea,
Israel. These important additions to our
global supply chain and R&D capabilities
will further diversify our network and our
ability to serve patients around the world.
w
o
l
F
h
a
s
C
Long-Term
Shareholder
Returns
Sales G
r
o
w
t
h
P r o fi t a bility
We celebrated some exciting milestones
this year that directly impact patients. More than
100,000 TAVR patients were treated with SAPIEN valves
worldwide in 2020. We were also very encouraged
to receive approval for the SAPIEN 3 valve in China,
distinguishing Edwards as the first global company to
introduce TAVR to China. In Surgical Structural Heart,
we launched our KONECT aortic valved conduit and our
INSPIRIS valve became the leading aortic surgical valve
worldwide. We’ve seen early positive clinical evidence
across the TMTT platform, physician feedback is
encouraging, and patient outcomes have been
distinguished. In Critical Care, we met the increased
demand for core pressure monitoring products due
to the pandemic and we are proud that we were able
to help over one million COVID patients globally with
our monitoring technology. We began shifting focus
to Smart Recovery, which helps patients in the hospital
recover more quickly and go home sooner.
Strong Global Performance
Though COVID significantly impacted our financial
performance, I’m pleased that we were able to
match our impressive 2019 sales. This consistency
demonstrates patients’ need for the work that we do.
2020 adjusted sales grew one percent to $4.4 billion
and adjusted earnings per share were in line with the
prior year.
We also executed a 3-for-1 stock split, increasing
the number of common shares, and repurchased
$615 million of stock.
Looking to the Future
In 2021, we anticipate returning to strong
double-digit revenue growth as patients still
require life-saving treatments for structural
heart disease, even during a pandemic. And while
we recognize the uncertainty of when the pandemic
will subside, we remain confident in our continued
investment in our patient-focused innovation strategy,
which will position us to emerge even more prepared
to embrace the future.
As we look to 2021 and beyond, I am more excited
than ever before about the work happening at
Edwards and, more importantly, what we envision
for the future of patient care. I continue to believe
we are poised for long-term success, built on a track
record of credibility and trust. Our innovation and
cultural imperative to put patients first is driving
strong long-term organic sales growth and exceptional
shareholder returns. As I stand with our employees
worldwide and the global community, we are filled
with gratitude and hope for the future. Thank you
for your continued support of our quest to deliver
innovations to even more patients around the world.
Michael A. Mussallem
Chairman & Chief Executive Officer
This Annual Report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934. We intend the forward-looking statements contained in this report to be covered by the safe harbor provisions of such Acts. Statements
other than statements of historical fact in this report or referred to or incorporated by reference into this report are “forward-looking statements” for purposes
of these sections. These statements include, among other things, the statements made by the Company’s executives, the Company’s future financial and
strategic goals for 2021 and beyond as well as its expectations for the results of research and development and clinical evidence, the timing and impact of new
product introductions, expected patient benefits of new products, and opportunities for growth and stockholder value, and any statements of assumptions
underlying any of the foregoing. These statements can sometimes be identified by the use of the forward-looking words, such as “may,” “believe,” “will,” “expect,”
“project,” “estimate,” “should,” “anticipate,” “plan,” “goal,” “continue,” “seek,” “pro forma,” “forecast,” “intend,” “guidance,” “optimistic,” “aspire,” “confident,”
other forms of these words, or similar words or expressions or the negative thereof. Statements of past performance, efforts, or results about which inferences
or assumptions may be made can also be forward-looking statements and are not indicative of future performance or results; these statements can be identified
by the use of words such as “preliminary,” “initial,” “diligence,” “industry- leading,” “compliant,” “indications,” or “early feedback” or other forms of these words
or similar words or expressions or the negative thereof. Investors are cautioned not to unduly rely on such forward-looking statements. These forward-looking
statements are subject to substantial risks and uncertainties that could cause our results or future business, financial condition, results of operations, or
performance to differ materially from our historical results or experiences or those expressed or implied in any forward-looking statements contained in this
report. See “Risk Factors” in Part I, Item 1A in the Form 10-K attached hereto for a discussion of these risks, as such risks and uncertainties may be amended,
supplemented or superseded from time to time by our subsequent reports on Forms 10-Q and 8-K that we file with the Securities and Exchange Commission.
These forward-looking statements speak only as of the date on which they are made and we do not undertake any obligation to update any forward-looking
statement to reflect events or circumstances after the date of the statement. If we do update or correct one or more of these statements, investors and others
should not conclude that we will make additional updates or corrections. “Adjusted” or “underlying” amounts are non-GAAP. Refer to “Non-GAAP Financial
Information” starting on page 11 as well as our IR website under “Historical financial information” for the most directly comparable GAAP financial measure.
3
Edwards Lifesciences I 2020 Annual Report
Even in the midst of a global pandemic,
some things never stopped.
Despite unprecedented challenges throughout 2020, we continued our mission to transform
patient lives with breakthrough technologies and remained steadfast in our commitment to
behaving as a trusted partner through distinguished quality and integrity.
Transcatheter Aortic Valve Replacement
Bob
“Because of TAVR, I can keep going and do the
things that I really want to do, such as sharing
with others in my community.”
In his neighborhood, Bob is known as a good-hearted person
always looking to help others. Last year, amid the global
pandemic, he was unexpectedly diagnosed with severe aortic
stenosis. Even though he was quickly identified as a TAVR
candidate, Bob’s procedure was postponed due to COVID
protocols. While waiting for treatment, he and his wife kept
their spirits high by recognizing a local need and created a
community garden to help their neighbors. Ultimately,
Bob received treatment with an Edwards SAPIEN 3 valve
and was then able to be back home with his family.
Transcatheter Mitral & Tricuspid Therapies
Larry
“I had shortness of breath just while walking.
The more I talk about my participation in the
PASCAL clinical trial, the more choked up I get –
this research was extremely meaningful to me.”
A couple of years ago, Larry experienced a significant decline
in his health. He started coughing, feeling dizzy and losing
balance and was soon diagnosed with mitral regurgitation.
Due to his complicated anatomy, Larry’s doctor recommended
enrolling in the ongoing PASCAL clinical trial. He was identified
as a candidate and shortly after, was treated with the PASCAL
valve repair system as part of the clinical research. Today,
Larry is grateful to have been a part of groundbreaking medical
research and is encouraged by spending by more time
with his son.
4
Edwards Lifesciences I 2020 Annual Report
Patient care never stopped.
Case support never stopped.
Our team never stopped.
Innovation never stopped.
Daniel
“INSPIRIS RESILIA valve is the valve that is going to
let me get back to my high-performance lifestyle.”
Even though he was younger than the conventional heart patient,
one day Daniel started feeling out of breath and was becoming
pale. Soon after, he was diagnosed with a severely damaged aortic
valve in need of replacement. Being an energetic individual, Daniel
spent months researching the best technology that would allow
him to return to his active lifestyle, and he decided upon the
Edwards INSPIRIS RESILIA valve. Daniel is a supercar designer
by trade, however he spent much of last year helping develop
ventilators needed by hospitals impacted by the pandemic. After
the procedure to replace his damaged valve, Daniel is back to
doing all the things he is used to doing, including mountain biking
and go-karting, and he even hopes to do some car racing soon.
Surgical Structural Heart
Critical Care
Phil
“A week later, I was on a driving range.
A month after that, I was walking eighteen holes.”
Several years ago, Phil, a retired U.S. Navy Air Controller,
was diagnosed with early-stage lung cancer. His cancer was
considered operable but required intense surgery. During
Phil’s procedure, his anesthesiologist relied on Edwards’ FloTrac
and ForeSight sensors to continuously monitor blood flow and
oxygen levels in his heart and brain. The use of advanced
hemodynamic monitoring helps clinicians stay ahead of critical
moments during surgery. Phil’s surgical procedure was a
success, and he is now back at the golf course cancer-free.
5
Edwards Lifesciences I 2020 Annual Report Transcatheter Aortic Valve Replacement
Edwards leads the world in the development of new therapies designed for the
nonsurgical replacement of heart valves. The proven SAPIEN 3 System is commercially
available in over 75 countries and is now an approved treatment option for patients
at low risk to surgery in Europe, the U.S. and other countries around the world based
on the superiority of outcomes demonstrated in the PARTNER 3 trial.
Edwards SAPIEN 3
Ultra transcatheter
heart valve
The Edwards SAPIEN 3 Ultra transcatheter heart
valve system is built upon the proven SAPIEN platform
featuring a ~40 percent taller*, textured outer skirt to
further reduce paravalvular leak.
Its short frame height is designed
to facilitate coronary access, factoring
in the future needs of patients in the
treatment of severe symptomatic
aortic stenosis.
* Compared to the Edwards SAPIEN 3 valve.
Edwards SAPIEN 3
Ultra transcatheter heart
valve and delivery system
Long-Term
Growth Drivers
Therapy expansion
Increasing awareness
Technological advances
The Edwards Pulmonic platform combines the
SAPIEN 3 valve and the Alterra adaptive prestent
to expand transcatheter therapy for congenital
heart disease patients.
100,000+
Patients treated
globally in 2020
Alterra Adaptive
Prestent and SAPIEN 3
transcatheter heart valve
Strong evidence indicates that TAVR is a proven therapy
with excellent outcomes. It offers efficient use of hospital
resources and can benefit many more patients whose
structural heart disease is deadly and undertreated today.
Larry Wood
Corporate Vice President,
Transcatheter Aortic
Valve Replacement
Transcatheter Mitral & Tricuspid Therapies
Edwards’ focused investment in structural heart initiatives has resulted in
the development of multiple breakthrough therapies for patients suffering
from mitral and tricuspid diseases.
Edwards SAPIEN M3*
mitral valve replacement
Edwards EVOQUE*
tricuspid valve replacement
Our SAPIEN M3 valve and Edwards EVOQUE valve
are transcatheter valve replacement systems.
The SAPIEN M3 valve is designed to treat patients
with mitral valve disease, while the EVOQUE valve is
designed to expand treatment options for both
mitral and tricuspid patients.
The PASCAL transcatheter valve repair system
is designed to treat mitral and tricuspid valve
regurgitation with differentiated innovation enabling
treatment of a broader patient population. High
touch procedural and imaging support enables
optimal outcomes for these patients.
Edwards PASCAL**
valve repair system
Edwards PASCAL Ace**
valve repair system
Edwards Cardioband**
reconstruction system
The Cardioband reconstruction system
is designed to provide individualized
annular reduction with real-time
confirmation of results, leaving options
open for future intervention if required.
Long-Term
Growth Drivers
Differentiated portfolio
Clinical evidence
Real world outcomes
~2,000
Patients treated
globally in 2020
TMTT is committed to a consistent cadence of
differentiated innovations, coupled with world-class
clinical evidence to drive leadership and provide optimal
therapies for mitral and tricuspid patients.
Bernard Zovighian
Corporate Vice President,
Transcatheter Mitral &
Tricuspid Therapies
*Investigational devices. Limited to investigational use only.
**CE Mark in EU. Investigational device and not available for sale in the U.S.
Surgical Structural Heart
As a leading manufacturer of tissue heart valves and repair therapies, Edwards offers
leading innovations to treat a patient’s diseased heart valves. We are committed
to being the partner of choice for cardiac surgeons and helping transform patients’
lives by advancing surgical structural heart innovations.
INSPIRIS
RESILIA aortic valve
HARPOON*
beating heart mitral
valve repair system
KONECT
RESILIA
aortic valved conduit
The INSPIRIS RESILIA aortic valve is
right for today, and ready for tomorrow. This valve
features RESILIA tissue, a bovine pericardial tissue
with advanced anti-calcification properties and
proprietary VFit technology, which is designed for
potential future valve-in-valve procedures.
The HARPOON system transforms surgery
for many patients with degenerative mitral
regurgitation. This novel therapy standardizes
mitral repair with an echo-guided, beating-heart
procedure.
KONECT RESILIA aortic valved conduit is the second
offering in Edwards Lifesciences’ class of resilient
RESILIA tissue valves. This ready-to-implant aortic
valved conduit helps patients maintain their active
lifestyles and reduces the complexity of bio-Bentall
procedures.
Long-Term
Growth Drivers
Surgeon partnerships
Premium innovations
Emerging regions
~500,000
Patients treated
globally in 2020
As we look to the future, we believe our innovations will
continue to drive balanced growth within our surgical
structural heart portfolio by lowering our relative contribution
from SAVR, increasing growth contribution from mitral, and
finally, providing solutions for unmet needs in surgical
structural heart for surgeons and their patients.
Daveen Chopra
Corporate Vice President,
Surgical Structural Heart
*CE Mark in EU. Investigational device and not available for sale in the U.S.
Critical Care
Edwards is the leader in hemodynamic monitoring solutions
including monitoring platforms, predictive software and sensors
ranging from invasive to noninvasive, all of which play an important
role in enhancing patient recovery.
Long-Term
Growth Drivers
Smart technologies
HemoSphere growth
Portfolio expansion
~15,500,000
Patients helped globally
in 2020
(includes 1M+ COVID patients)
HemoSphere advanced
monitoring platform
with HPI software
Acumen IQ
sensor
Acumen IQ
finger cuff
ForeSight
Elite tissue
oximetry
sensor
Acumen Hypotension Prediction Index
(HPI) software is a first-of-its-kind predictive
software developed with machine learning.
It detects the likelihood of a patient trending
towards a hypotensive event before the
event occurs. This software is available on
the HemoSphere monitoring platform, which
is the latest monitor from Edwards and is
compatible with our portfolio of Smart
Recovery sensors and catheters.
Our latest Smart Recovery solutions, such as
Acumen IQ sensor and Acumen IQ finger cuff,
work with our predictive software to provide
clinicians decision support and help them
stay a step ahead of their patient’s rapidly
evolving status. With the addition of our
noninvasive ForeSight Elite tissue oximetry
sensor to HemoSphere monitor, Edwards
became the first to offer clinicians the ability
to monitor the brain and the heart from
one screen.
We are grateful that our products have been able
to monitor and help over one million patients during
the pandemic and we are so proud to have been a part
of the stories where patients were able to leave the
isolation of the ICU and get home to their families.
Katie M. Szyman
Corporate Vice President,
Critical Care
2020 Financial Highlights
Adjusted
Net Sales
Adjusted Earnings
Per Share
Research and
Development
Adjusted Free
Cash Flow
S
P
E
t
p
e
c
x
e
,
s
n
o
i
l
l
i
m
n
I
(
) 2020 I $4,386
2019 I $4,348
2018 I $3,813
2017 I $3,434
2016 I $2,962
$1.86
$1.86
$1.57
$1.27
$0.97
$761
$753
$622
$553
$442
$734
$1,067
$786
$695
$527
“Adjusted net sales”, “adjusted earnings per share” and “adjusted free cash flow” are all non-GAAP numbers.
Refer to pages 11 and 12 for reconciliations to the most directly comparable GAAP financial measure.
2020 Sales by Geographic Region
2020 Sales by Product Line
n United States
n Europe
n Japan
n Rest of World
57%
22%
11%
10%
17%
65%
17%
1%
n TAVR
n Surgical
n Critical Care
n TMTT
Edwards Sales ($ in billions)
$4.3
$4.4
$3.4
$3.7
$3.0
$1.4
$1.7
$1.9
$2.0
$2.3
$2.5
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
Strong sales growth, healthy profitability and robust cash
flow are financial objectives that help us guide our internal
decisions and yield long-term shareholder returns.
Scott Ullem
Corporate Vice President,
Chief Financial Officer
Non-GAAP Financial Information
To supplement the consolidated financial results prepared in
accordance with Generally Accepted Accounting Principles
(“GAAP”), the Company uses non-GAAP historical financial
measures. Management makes adjustments to the GAAP
measures for items (both charges and gains) that (a) do not
reflect the core operational activities of the Company, (b) are
commonly adjusted within the Company’s industry to enhance
comparability of the Company’s financial results with those of
its peer group, or (c) are inconsistent in amount or frequency
between periods (albeit such items are monitored and controlled
with equal diligence relative to core operations). The Company
uses the term “adjusted sales” or “underlying growth rate” when
referring to non-GAAP sales information, which excludes foreign
exchange fluctuations, the conversion to a consignment
inventory system for surgical structural heart (“Surgical”),
sales return reserves associated with transcatheter aortic valve
replacement (“TAVR”) product upgrades, the positive impact
of TAVR stocking sales in Germany and the negative impact of
de-stocking, and includes the prior year sales results of a business
acquired as if the acquisition had occurred at the beginning of
the earliest period presented. The Company uses the terms
“adjusted” to also exclude intellectual property litigation
income and expenses, amortization of intangible assets, fair
value adjustments to contingent consideration liabilities arising
from acquisitions, gains from significant investments, the
positive impact of TAVR stocking sales in Germany and the
negative impact of de-stocking, realignment expenses, the
conversion to a consignment inventory for Surgical, sales
return reserves and related costs associated with TAVR product
upgrades, charitable contributions to the Edwards Lifesciences
Foundation, significant pension curtailment gains, significant
charges associated with TAVR inventory write offs, impairment of
long-lived assets, the purchase of intellectual property, and the
impact from implementation of tax law changes and settlements.
Management uses non-GAAP financial measures internally for
strategic decision making, forecasting future results, and evaluating
current performance. These non-GAAP financial measures are
used in addition to, and in conjunction with, results presented in
accordance with GAAP and reflect an additional way of viewing
aspects of the Company’s operations by investors that, when
viewed with its GAAP results, provide a more complete under-
standing of factors and trends affecting the Company’s business
and facilitate comparability to historical periods.
Non-GAAP financial measures are not prepared in accordance
with GAAP; therefore, the information is not necessarily
comparable to other companies and should be considered
as a supplement to, and not as a substitute for, or superior to,
the corresponding measures calculated in accordance with
GAAP. A reconciliation of non-GAAP historical financial
measures to the most comparable GAAP measure is provided
in the tables below.
Fluctuations in exchange rates impact the comparative results
and sales growth rates of the Company’s underlying business.
Management believes that excluding the impact of foreign
exchange rate fluctuations from its sales growth provides
investors a more useful comparison to historical financial results.
Guidance for sales and sales growth rates is provided on an
“underlying basis,” and projections for diluted earnings per
share, net income and growth, gross profit margin, taxes, and
free cash flow are also provided on a non-GAAP basis as adjusted
for the items identified above due to the inherent difficulty in
forecasting such items without unreasonable effort. The
Company is not able to provide a reconciliation of the non-GAAP
guidance to comparable GAAP measures due to the unknown
effect, timing, and potential significance of special charges or
gains, and management’s inability to forecast charges associated
with future transactions and initiatives.
Management considers free cash flow to be a liquidity measure
which provides useful information to management and investors
about the amount of cash generated by business operations,
after deducting payments for capital expenditures, which can
then be used for strategic opportunities or other business
purposes including, among others, investing in the Company’s
business, making strategic acquisitions, strengthening the
balance sheet, and repurchasing stock.
Adjusted Net Sales
Twelve months ended December 31 (in millions)
GAAP Net Sales
Impact of Surgical consignment
Impact of Germany stocking
Impact of sales return reserve
2020
2019
2018
2017
2016
$4,386.3
–
–
–
$4,348.0
–
–
–
$3,722.8
82.5
8.0
–
$3,435.3
–
(1.4)
–
$2,963.7
–
–
(1.7)
Adjusted Net Sales
$4,386.3
$4,348.0
$3,813.3
$3,433.9
$2,962.0
Note: Numbers may not calculate due to rounding.
11
Edwards Lifesciences I 2020 Annual Report
Reconciliation of GAAP to Adjusted Net Income
Twelve months ended December 31 (in millions, except per share data)
GAAP Net Income
Non-GAAP adjustments:
Litigation settlement
Intellectual property litigation expenses, net
Change in fair value of contingent consideration liabilities, net
Amortization of intangible assets
TAVR inventory write off
Surgical consignment conversion
TAVR Germany stocking sales
Impairment of long-lived assets
Pension curtailment gain
Charitable fund contribution
Investment gain
Realignment expenses
Purchased in-process research and development
TAVR sales returns reserve and related costs
Impact from U.S. tax legislation
Tax audit settlements
2020
2019
2018
2017
2016
$823.4
$1,046.9
$722.2
$583.6
$569.5
305.1
28.5
12.3
4.6
–
–
–
–
–
–
–
–
–
–
–
–
–
25.2
(7.1)
4.0
55.2
–
–
40.6
–
–
–
–
18.1
–
–
–
137.5
26.4
(8.0)
2.4
–
54.7
4.7
109.3
(6.3)
–
–
–
–
–
(2.5)
(36.1)
(70.3)
24.5
(9.8)
5.3
–
–
(0.4)
19.5
–
15.6
(6.5)
9.1
–
–
262.0
(12.9)
–
20.8
1.1
5.1
–
–
–
–
–
–
–
–
34.5
0.1
–
–
Adjusted Net Income
$1,173.9
$1,182.9
$1,004.3
$819.7
$631.1
Reconciliation of GAAP to Adjusted Diluted Earnings Per Share
GAAP Diluted Earnings Per Share
$1.30
$1.64
$1.13
$0.90
$0.87
Non-GAAP adjustments:
Litigation settlement
Intellectual property litigation expenses, net
Change in fair value of contingent consideration liabilities
Amortization of intellectual property
TAVR inventory write off
Surgical consignment conversion
TAVR Germany stocking sales
Impairment of long-lived assets
Pension curtailment gain
Charitable fund contribution
Investment gain
Realignment expenses
Purchased in-process research and development
Impact from U.S. tax legislation
Tax audit settlements
Adjusted Diluted Earnings Per Share
Adjusted Free Cash Flow
Twelve months ended December 31 (in millions)
Net cash provided by operating activities
Capital expenditures
Litigation settlements
Tax audit settlement
Repatriation tax payments
Deposit of cash in escrow
Adjusted Free Cash Flow
Adjusted Net Sales Growth
Twelve months ended December 31
GAAP Net Sales Growth Rate
Impact of Surgical consignment
Impact of Germany stocking
Impact of sales return reserve
Impact of CASMED acquisition
Impact of foreign exchange
Adjusted Net Sales Growth Rate
Note: Numbers may not calculate due to rounding.
12
0.48
0.05
0.02
0.01
–
–
–
–
–
–
–
–
–
–
–
-
0.04
(0.01)
0.01
0.09
–
–
0.06
–
–
–
–
0.03
–
–
0.21
0.04
(0.01)
–
–
0.09
0.01
0.17
(0.01)
–
–
–
–
–
(0.06)
(0.11)
0.04
(0.01)
0.01
–
–
–
0.03
–
0.02
(0.01)
0.02
–
0.40
(0.02)
–
0.03
–
0.01
–
–
–
–
–
–
–
–
0.06
–
–
$1.86
$1.86
$1.57
$1.27
$0.97
2020
2019
2018
2017
2016
$1,054.3
(407.0)
86.4
–
–
–
$1,182.9
(254.4)
138.3
–
–
–
$926.7
(238.7)
–
56.7
41.0
–
$1,000.8
(168.1)
(112.5)
–
–
(25.0)
$703.2
(176.1)
–
–
–
–
$733.7
$1,066.8
$785.7
$695.2
$527.1
2020
2019
2018
2017
2016
0.9%
0.0%
0.0%
0.0%
0.0%
(0.3%)
0.6%
16.8%
(2.5%)
(0.3%)
0.0%
(0.5%)
1.8%
15.3%
8.4%
2.4%
0.3%
0.0%
0.0%
(1.1%)
10.0%
15.9%
0.0%
0.0%
0.0%
0.0%
(0.2%)
15.7%
18.8%
0.0%
0.0%
(0.1%)
0.0%
(0.2%)
18.5%
Edwards Lifesciences I 2020 Annual Report
Our Credo
At Edwards Lifesciences, we are dedicated to providing
innovative solutions for people fighting cardiovascular disease.
Through our actions, we will become trusted partners with customers,
colleagues and patients creating a community unified in its mission to
improve the quality of life around the world. Our results will benefit
customers, patients, employees and shareholders.
We will celebrate our successes, thrive on discovery and continually
expand our boundaries. We will act boldly, decisively and with
determination on behalf of people fighting cardiovascular disease.
1
Edwards Lifesciences I 2020 Annual Report UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(Mark One)
È ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934
‘ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
For the Fiscal Year Ended December 31, 2020
OR
EXCHANGE ACT OF 1934
For the Transition Period From
to
Commission File Number 1-15525
EDWARDS LIFESCIENCES CORPORATION
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of
incorporation or organization)
36-4316614
(I.R.S. Employer
Identification No.)
One Edwards Way Irvine California 92614
(Address of Principal Executive Offices) (Zip Code)
(949) 250-2500
Registrant’s telephone number, including area code
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Common Stock, par value $1.00 per share
Trading Symbols(s)
EW
Name of each exchange on which
registered:
New York Stock Exchange
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined by Rule 405 of the Securities Act. Yes È No ‘
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Exchange
Act. Yes ‘ No È
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities
Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and
(2) has been subject to such filing requirements for the past 90 days. Yes È No ‘
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant
to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was
required to submit such files). Yes È No ‘
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,”
and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer È
Non-accelerated filer ‘
Accelerated filer
Smaller reporting company ‘
Emerging growth company ‘
‘
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for
complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ‘
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of
its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public
accounting firm that prepared or issued its audit report È.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ‘ No È
The aggregate market value of the registrant’s common stock held by non-affiliates as of June 30, 2020 (the last trading day of the
registrant’s most recently completed second quarter): $42,640,586,293 based on the closing price of the registrant’s common stock on the
New York Stock Exchange. This calculation does not reflect a determination that persons are affiliates for any other purpose.
The number of shares outstanding of the registrant’s common stock, $1.00 par value, as of January 31, 2021, was 624,518,873.
Documents Incorporated by Reference
Portions of the registrant’s proxy statement for the 2021 Annual Meeting of Stockholders (to be filed within 120 days of December 31,
2020) are incorporated by reference into Part III, as indicated herein.
EDWARDS LIFESCIENCES CORPORATION
Form 10-K Annual Report—2020
Table of Contents
PART I
Item 1.
Business . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 1A. Risk Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 1B. Unresolved Staff Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Properties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 2.
Legal Proceedings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 3.
Item 4.
Mine Safety Disclosures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART II
Item 5.
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of
Equity Securities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Selected Financial Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 6.
Item 7.
Management’s Discussion and Analysis of Financial Condition and Results of Operations . . . .
Item 7A. Quantitative and Qualitative Disclosures About Market Risk . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Financial Statements and Supplementary Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 8.
Item 9.
Changes in and Disagreements With Accountants on Accounting and Financial Disclosure . . . .
Item 9A. Controls and Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 9B. Other Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART III
Item 10. Directors, Executive Officers and Corporate Governance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Executive Compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 11.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder
Item 12.
Item 13.
Item 14.
PART IV
Item 15.
Item 16.
Matters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Certain Relationships and Related Transactions, and Director Independence . . . . . . . . . . . . . . .
Principal Accounting Fees and Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Exhibits and Financial Statement Schedules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Form 10-K Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Signatures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1
12
20
21
21
21
22
24
24
40
43
103
103
103
104
104
104
104
104
105
107
108
PART I
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933
and Section 21E of the Securities Exchange Act of 1934. We intend the forward-looking statements contained in
this report to be covered by the safe harbor provisions of such Acts. Some statements other than statements of
historical fact in this report or referred to or incorporated by reference into this report are “forward-looking
statements” for purposes of these sections. These statements include, among other things, the expected impact of
COVID-19 on our business, any predictions, opinions, expectations, plans, strategies, objectives and any
statements of assumptions underlying any of the foregoing relating to the company’s current and future business
and operations, including, but not limited to, financial matters, development activities, clinical trials and
regulatory matters, manufacturing and supply operations, and product sales and demand. These statements can
sometimes be identified by the use of the forward-looking words such as “may,” “believe,” “will,” “expect,”
“project,” “estimate,” “should,” “anticipate,” “plan,” “goal,” “continue,” “seek,” “pro forma,” “forecast,”
“intend,” “guidance,” “optimistic,” “aspire,” “confident,” other forms of these words or similar words or
expressions or the negative thereof. Statements of past performance, efforts, or results about which inferences or
assumptions may be made can also be forward- looking statements and are not indicative of future performance
or results; these statements can be identified by the use of words such as “preliminary,” “initial,” diligence,”
“industry-leading,” “compliant,” “indications,” or “early feedback” or other forms of these words or similar
words or expressions or the negative thereof. These forward-looking statements are subject to substantial risks
and uncertainties that could cause our results or future business, financial condition, results of operations or
performance to differ materially from our historical results or experiences or those expressed or implied in any
forward- looking statements contained in this report. These risks and uncertainties include, but are not limited
to: uncertainties regarding the severity and duration of the COVID-19 pandemic and its impact on our business
and the economy generally, clinical trial or commercial results or new product approvals and therapy adoption;
inability or failure to comply with regulations; unpredictability of product launches; competitive dynamics;
changes to reimbursement for the company’s products; the company’s success in developing new products and
avoiding manufacturing and quality issues; the impact of currency exchange rates; the timing or results of
research and development and clinical trials; unanticipated actions by the U.S. Food and Drug Administration
and other regulatory agencies; unexpected litigation impacts or expenses; and other risks detailed under
“Risk Factors” in Part I, Item 1A below, as such risks and uncertainties may be amended, supplemented or
superseded from time to time by our subsequent reports on Forms 10-Q and 8-K we file with the Securities and
Exchange Commission. These forward-looking statements speak only as of the date on which they are made and
we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances
after the date of the statement. If we do update or correct one or more of these statements, investors and others
should not conclude that we will make additional updates or corrections.
Unless otherwise indicated or otherwise required by the context, the terms “we,” “our,” “it,” “its,” “Company,”
“Edwards,” and “Edwards Lifesciences” refer to Edwards Lifesciences Corporation and its subsidiaries.
Item 1.
Business
Overview
Edwards Lifesciences Corporation is the global leader in patient-focused medical innovations for structural
heart disease and critical care monitoring. Driven by a passion to help patients, we partner with the world’s
leading clinicians and researchers and invest in research and development to transform care for those impacted
by structural heart disease or who require hemodynamic monitoring during surgery or in intensive care. Edwards
Lifesciences has been a leader in these areas for over six decades. Since our founder, Lowell Edwards, first
dreamed of using engineering to address diseases of the human heart, we have steadily built a company on the
premise of imagining, building, and realizing a better future for patients.
1
A pioneer in the development of heart valve therapies, we are the world’s leading manufacturer of heart
valve systems and repair products used to replace or repair a patient’s diseased or defective heart valve. Our
innovative work in heart valves encompasses both surgical and transcatheter therapies for heart valve
replacement and repair. In addition, our robust pipeline of future technologies is focused on the less invasive
repair or replacement of the mitral and tricuspid valves of the heart, which are more complex and more
challenging to treat than the aortic valve that is currently the focus of many of our commercially approved valve
technologies. We are also a global leader in hemodynamic and noninvasive brain and tissue oxygenation
monitoring systems used to measure a patient’s cardiovascular function in the hospital setting.
Cardiovascular disease is the number-one cause of death in the world, and is the top disease in terms of
health care spending in nearly every country. Cardiovascular disease is progressive in that it tends to worsen over
time and often affects the structure of an individual’s heart.
Patients undergoing treatment for cardiovascular disease can be treated with a number of our medical
technologies, which are designed to address individual patient needs with respect to disease process,
comorbidities, and health status. For example, an individual with a heart valve disorder may have a faulty valve
that is affecting the function of his or her heart or blood flow throughout his or her body. A clinician may elect to
remove the valve and replace it with one of our bioprosthetic surgical tissue heart valves or surgically re-shape
and repair the faulty valve with an Edwards Lifesciences annuloplasty ring. Alternatively, a clinician may
implant an Edwards Lifesciences transcatheter valve or repair system via a catheter-based approach that does not
require traditional open-heart surgery and can be done while the heart continues to beat. Patients in the hospital
setting, including high-risk patients in the operating room or intensive care unit, are candidates for having their
cardiac function or fluid levels monitored by our Critical Care products through multiple monitoring options,
including noninvasive and minimally invasive technologies. These technologies enable proactive clinical
decisions while also providing the opportunity for improving diagnoses and developing individualized
therapeutic management plans for patients.
Corporate Background
Edwards Lifesciences Corporation was incorporated in Delaware on September 10, 1999.
Our principal executive offices are located at One Edwards Way, Irvine, California 92614. The telephone
number at that address is (949) 250-2500. We make available, free of charge on our website located at
www.edwards.com, our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form
8-K, and any amendments to those reports, as soon as reasonably practicable after filing such reports with the
Securities and Exchange Commission (“SEC”). The contents of our website are not incorporated by reference
into this report.
Edwards Lifesciences’ Product and Technology Offerings
The following discussion summarizes the main areas of products and technologies we offer to treat
advanced cardiovascular disease. Our products and technologies are categorized into four main areas:
Transcatheter Aortic Valve Replacement, Transcatheter Mitral and Tricuspid Therapies, Surgical Structural
Heart, and Critical Care. For more information on net sales from these four main areas, see “Net Sales by
Product Group” in Part II, Item 7 “Management’s Discussion and Analysis of Financial Condition and Results of
Operations.”
Transcatheter Aortic Valve Replacement
We are the global leader in transcatheter heart valve replacement technologies designed for the minimally
invasive replacement of heart valves. The Edwards SAPIEN family of valves, including Edwards SAPIEN XT,
the Edwards SAPIEN 3, and the Edwards SAPIEN 3 Ultra transcatheter aortic heart valves, and their respective
2
delivery systems, are used to treat heart valve disease using catheter-based approaches for patients who have
severe symptomatic aortic stenosis and certain patients with congenital heart disease. Delivered while the heart is
beating, these valves can enable patients to experience a better quality of life sooner than patients receiving
traditional surgical therapies. We began offering our transcatheter heart valves to patients commercially in
Europe in 2007, in the United States in 2011, and in Japan in 2013. Supported by extensive customer training and
service, and a growing body of compelling clinical evidence, our SAPIEN family of transcatheter aortic heart
valves are the most widely prescribed transcatheter heart valves in the world.
Sales of our transcatheter aortic valve replacement products represented 65%, 63%, and 61% of our net
sales in 2020, 2019, and 2018, respectively.
Transcatheter Mitral and Tricuspid Therapies
We are making significant investments in the development of transcatheter heart valve repair and
replacement technologies designed to treat mitral and tricuspid valve diseases. While many of these technologies
are in early development and clinical phases, the PASCAL transcatheter valve repair system and the Cardioband
systems for mitral and tricuspid valve repair are commercially available in Europe. The PASCAL system provides
a differentiated, minimally-invasive therapy to address the needs of patients with mitral or tricuspid regurgitation
through leaflet approximation, while the Cardioband system enables clinicians to restore a patient’s mitral or
tricuspid valve to a more functional state by reducing the annulus and lowering regurgitation. In addition to
transcatheter repair, we believe transcatheter replacement is key to unlocking the full mitral and tricuspid
opportunity, given the complex and diverse patient population. Our two-platform strategy positions us for
leadership in the mid-to-long term. SAPIEN M3 is based on the proven SAPIEN valve, paired with a novel
docking system. We are also continuing to advance our EVOQUE platform for both mitral and tricuspid
replacement. Both SAPIEN M3 and EVOQUE transfemoral delivery systems are sub 30-French, which has
benefits for femoral puncture and septal crossing, contributing to ease of use, and patient safety.
Surgical Structural Heart
The core of our surgical tissue heart valve product line is the Carpentier-Edwards PERIMOUNT pericardial
valve platform, including the line of PERIMOUNT Magna Ease pericardial valves for aortic and mitral surgical
valve replacement. With more long-term clinical publications on durability and performance than any other
surgical valve, PERIMOUNT valves are the most widely implanted surgical tissue heart valves in the world. Our
latest innovation, the INSPIRIS RESILIA aortic valve, is built on our PERIMOUNT platform and offers RESILIA
tissue and VFit technology. INSPIRIS is now the leading aortic surgical valve in the world. In addition to our
replacement valves, we are the worldwide leader in surgical heart valve repair therapies. In 2020, we launched
the HARPOON Beating Heart Mitral Valve Repair System, which can help transform care for many patients with
degenerative mitral regurgitation. We are also a global leader in cardiac cannula devices and offer a variety of
procedure-enabling innovations that advance minimally invasive surgery. We believe the demand for surgical
structural heart therapies is growing worldwide and that our innovation strategy will continue to extend our
leadership and patient impact.
Sales of our surgical tissue heart valve products represented 16%, 17%, and 18% of our net sales in 2020,
2019, and 2018, respectively.
Critical Care
We are a world leader in hemodynamic monitoring systems used to measure a patient’s heart function and
fluid status in surgical and intensive care settings. Hemodynamic monitoring plays an important role in
enhancing surgical recovery. Edwards’ complete hemodynamic portfolio helps clinicians make proactive clinical
decisions that can improve patient outcomes, and includes the minimally invasive FloTrac system, the
noninvasive ClearSight system, and ForeSight, the noninvasive tissue oximetry system. We also support clinical
3
needs with our well-established Swan-Ganz line of pulmonary artery catheters, arterial pressure monitoring
products, and Edwards Oximetry Central Venous Catheters. In conjunction with our sensors, our HemoSphere
monitoring platforms display valuable physiological information in an easy to understand and actionable manner.
Amplifying our sensor and monitoring platform portfolio is the addition of our first predictive algorithm, Acumen
Hypotension Prediction Index, which alerts clinicians in advance of a patient developing low blood pressure.
Sales of our core hemodynamic products represented 9%, 9%, and 10% of our net sales in 2020, 2019, and
2018, respectively.
Competition
The medical technology industry is highly competitive. We compete with many companies, including
divisions of companies much larger than us and smaller companies that compete in specific product lines or
certain geographies. Furthermore, new product development and technological change characterize the areas in
which we compete. Our present or future products could be rendered obsolete or uneconomical as a result of
technological advances by one or more of our present or future competitors or by other therapies, including drug
therapies. We must continue to develop and commercialize new products and technologies to remain competitive
in the cardiovascular medical technology industry. We believe that we are competitive primarily because we
deliver superior clinical outcomes that are supported by extensive data, and innovative features that enhance
patient benefit, product performance, and reliability; these superior clinical outcomes are in part due to the level
of customer and clinical support we provide.
The cardiovascular segment of the medical technology industry is dynamic and subject to significant change
due to cost-of-care considerations, regulatory reform, industry and customer consolidation, and evolving patient
needs. The ability to provide products and technologies that demonstrate value and improve clinical outcomes is
becoming increasingly important for medical technology manufacturers.
We believe that we are a leading global competitor in each of our product lines. In Transcatheter Aortic
Valve Replacement, our primary competitors include Medtronic PLC and Abbott Laboratories (“Abbott”). In
Transcatheter Mitral and Tricuspid Therapies, our primary competitor is Abbott, and there are a considerable
number of large and small companies with development efforts in these fields. In Surgical Structural Heart, our
primary competitors include Medtronic PLC, Abbott, and CryoLife. In Critical Care, we compete primarily with
a variety of companies in specific product lines including ICU Medical, Inc., PULSION Medical Systems SE, a
subsidiary of Getinge AB, Cheetah Medical, Inc., a subsidiary of Baxter International, and LiDCO Group PLC,
now part of Masimo.
Sales and Marketing
Our portfolio includes some of the most recognizable cardiovascular device product brands in treating
structural heart disease today. We have a number of product lines that require sales and marketing strategies
tailored to deliver high-quality, cost-effective products and technologies to customers worldwide. Because of the
diverse global needs of the population that we serve, our distribution system consists of several direct sales forces
as well as independent distributors. We are not dependent on any single customer and no single customer
accounted for 10% or more of our net sales in 2020.
To ensure optimal outcomes for patients, we conduct educational symposia and best practices training for
our physician, hospital executive, service line leadership, nursing, and clinical-based customers. We rely
extensively on our sales and field clinical specialist personnel who work closely with our customers in hospitals.
Field clinical specialists routinely attend procedures where Edwards’ products are being used in order to provide
guidance on the use of our devices, thereby enabling physicians and staff to reach expert proficiency and deliver
positive patient outcomes. Our customers include physicians, nurses, and other clinical personnel, but can also
include decision makers such as service line leaders, material managers, biomedical staff, hospital administrators
4
and executives, purchasing managers, and ministries of health. Also, for certain of our product lines and where
appropriate, our corporate sales team actively pursues approval of Edwards Lifesciences as a qualified supplier
for hospital group purchasing organizations (“GPOs”) that negotiate contracts with suppliers of medical products.
Additionally, we have contracts with a number of United States and European national and regional buying
groups, including healthcare systems and Integrated Delivery Networks. Where we choose to market our
products is also influenced by the existence of, or potential for, adequate reimbursement to hospitals and other
providers by national healthcare systems.
United States. In the United States, we sell substantially all of our products through our direct sales forces.
In 2020, 57% of our net sales were derived from sales to customers in the United States.
International. In 2020, 43% of our net sales were derived internationally through our direct sales forces and
independent distributors. Of the total international sales, 52% were in Europe, 25% were in Japan, and 23% were
in Rest of World. We sell our products in approximately 100 countries, and our major international markets
include Canada, China, France, Germany, Italy, Japan, and the United Kingdom. A majority of the sales and
marketing approach outside the United States is direct sales, although it varies depending on each country’s size
and state of development.
Raw Materials and Manufacturing
We operate manufacturing facilities in various geographies around the world. We manufacture our
Transcatheter Aortic Valve Replacement, Transcatheter Mitral and Tricuspid technologies, and Structural
Surgical Heart products primarily in the United States (California and Utah), Singapore, Costa Rica, and Ireland.
We manufacture our Critical Care products primarily in our facilities located in Puerto Rico and the Dominican
Republic.
We use a diverse and broad range of raw and organic materials in the design, development, and manufacture
of our products. We manufacture our non-implantable products from fabricated raw materials including resins,
chemicals, electronics, and metals. Most of our replacement heart valves are manufactured from natural tissues
harvested from animal tissue, as well as fabricated materials. We purchase certain materials and components
used in manufacturing our products from external suppliers. In addition, we purchase certain supplies from single
sources for reasons of sole source availability or constraints resulting from regulatory requirements.
We work with our suppliers to mitigate risk and seek continuity of supply while maintaining quality and
reliability. Alternative supplier options are generally considered, identified, and approved for materials deemed
critical to our products, although we do not typically pursue immediate regulatory qualification of alternative
sources due to the strength of our existing supplier relationships and the time and expense associated with the
regulatory validation process.
We comply with all current global guidelines regarding risks for products incorporating animal tissue
intended to be implanted in humans. We follow rigorous sourcing and manufacturing procedures intended to
safeguard humans from potential risks associated with diseases such as bovine spongiform encephalopathy
(“BSE”). We obtain bovine tissue used in our pericardial tissue valve products only from sources within the
United States and Australia, where strong control measures and surveillance programs exist. In addition, bovine
tissue used in our pericardial tissue valve products is from tissue types considered by global health and regulatory
organizations to have shown no risk of infectibility. Our manufacturing and sterilization processes are designed
to render tissue biologically safe from all known infectious agents and viruses.
Quality Assurance
We are committed to providing to our patients quality products and have implemented modern quality
systems and concepts throughout the organization. The quality system starts with the initial design concept, risk
5
management, and product specification, and continues through the design of the product, packaging and labeling,
and the manufacturing, sales, support, and servicing of the product. The quality system is intended to design
quality into the products and utilizes continuous improvement concepts, including Lean/Six Sigma principles,
throughout the product lifecycle.
Our operations are frequently inspected by the many regulators that oversee medical device manufacturing,
including the United States Food and Drug Administration (“FDA”), European Notified Bodies, and other
regulatory entities. The medical technology industry is highly regulated and our facilities and operations are
designed to comply with all applicable quality systems standards, including the International Organization for
Standardization (“ISO”) 13485. These standards require, among other items, quality system controls that are
applied to product design, component material, suppliers, and manufacturing operations. These regulatory
approvals and ISO certifications can be obtained only after a successful audit of a company’s quality system has
been conducted by regulatory or independent outside auditors. Periodic reexamination by an independent outside
auditor is required to maintain these certifications.
Environmental, Health, and Safety
We are committed to providing a safe and healthy workplace and complying with all relevant regulations
and medical technology industry standards. Through our corporate and site level Environmental, Health, and
Safety functions, we establish and monitor programs to reduce pollution, prevent injuries, and maintain
compliance with applicable regulations. In order to measure performance, we monitor and report on a number of
metrics, including regulated and non-regulated waste disposal, energy usage, water consumption, air toxic
emissions, and injuries from our production activities. Each of our manufacturing sites is evaluated regularly
with respect to a broad range of Environmental, Health, and Safety criteria.
Research and Development
In 2020, we made significant investments in research and development as we worked to develop therapies
that we believe have the potential to change the practice of medicine. Research and development spending
increased 1% year over year to 17% of 2020 sales. This increase was primarily the result of significant
investments in our transcatheter structural heart programs, including an increase in clinical research for our
mitral and tricuspid therapies business. We are engaged in ongoing research and development to deliver
clinically advanced new products, to enhance the effectiveness, ease of use, safety, and reliability of our current
leading products, and to expand the applications of our products as appropriate. We focus on opportunities within
specific areas of structural heart disease and critical care monitoring.
A considerable portion of our research and development investment includes clinical trials and the
collection of evidence that provide data for use in regulatory submissions, and required post-market approval
studies involving applications of our products. Our investment in clinical studies also includes outcomes and
cost-effectiveness data for payers, clinicians, and healthcare systems.
In Transcatheter Aortic Valve Replacement, we are developing new products to further improve and
streamline transcatheter aortic heart valve replacement procedures, and developing pulmonic platforms to expand
therapies for congenital heart disease patients.
In Transcatheter Mitral and Tricuspid Therapies, we are making significant investments in innovation and
clinical evidence to develop technologies designed to treat mitral and tricuspid valve diseases. In addition to our
internally developed programs, we have made investments in several companies that are independently
developing minimally-invasive technologies to treat structural heart diseases.
Our Surgical Structural Heart development programs include innovative platforms for patients who are best
treated surgically, specifically active patients and patients with more complex combined procedures.
6
In our Critical Care product line, we are pursuing the development of a variety of decision support solutions
for our clinicians. This includes next-generation noninvasive and minimally-invasive hemodynamic monitoring
systems, and a next-generation monitor platform. We are also developing a decision support software suite with
advanced algorithms for proactive hemodynamic management, including a semi-closed loop system for
standardized management of patient fluid levels. Lastly, we are developing a connectivity platform that will offer
clinicians additional clinical support, remote monitoring capability, analytics, and insights for their patients’
hemodynamic status.
Our research and development activities are conducted primarily in facilities located in the United States
and Israel. Our experienced research and development staff are focused on product design and development,
quality, clinical research, and regulatory compliance. To pursue primary research efforts, we have developed
alliances with several leading research institutions and universities, and also work with leading clinicians around
the world in conducting scientific studies on our existing and developing products.
Proprietary Technology
Patents, trademarks, and other proprietary rights are important to the success of our business. We also rely
upon trade secrets, know-how, continuing innovations, licensing opportunities, and non-disclosure agreements to
develop and maintain our competitive position.
We own or have rights to a substantial number of patents and have patent applications pending both in the
U.S. and in foreign countries. We continue to innovate and file new patent applications to protect the full range
of our products and technologies.
Additionally, we are a party to numerous license agreements with various third parties pursuant to which we
have obtained, for varying terms, the exclusive or non-exclusive rights to certain patents held by such third
parties in consideration for cross-licensing rights and/or royalty payments. We have also licensed certain patent
rights to others.
We undertake reasonable measures to protect our patent rights, including monitoring the products of our
competitors for possible infringement of our owned and licensed patents. Litigation has been necessary to
enforce certain patent rights held by us, and we plan to continue to defend and prosecute our rights with respect
to such patents.
Moreover, we own certain U.S. registered trademarks used in our business. Many of our trademarks have
also been registered for use in certain foreign countries where registration is available and where we have
determined it is commercially advantageous to do so.
Government Regulation and Other Matters
Our products and facilities are subject to regulation by numerous government agencies, including the U.S.
FDA, European Union Member States competent authorities, and the Japanese Pharmaceuticals and Medical
Devices Agency, to confirm compliance with the various laws and regulations governing the development,
testing, manufacturing, labeling, marketing, and distribution of our products. We are also governed by federal,
state, local, and international laws of general applicability, such as those regulating employee health and safety,
and the protection of the environment. Overall, the amount and scope of domestic and foreign laws and
regulations applicable to our business has increased over time. Compliance with these regulations has not had a
material effect on our capital expenditures, earnings, or competitive position to date, but new regulations or
amendments to existing regulations to make them more stringent could have such an effect in the future. We
cannot estimate the expenses we may incur to comply with potential new laws or changes to existing laws, or the
other potential effects these laws may have on our business.
7
United States Regulation. In the United States, the FDA has responsibility for regulating medical devices.
The FDA regulates design, development, testing, clinical studies, manufacturing, labeling, promotion, and record
keeping for medical devices, and reporting of adverse events, recalls, or other field actions by manufacturers and
users to identify potential problems with marketed medical devices. Many of the devices that we develop and
market are in a category for which the FDA has implemented stringent clinical investigation and pre-market
clearance or approval requirements. The process of obtaining FDA clearance or approval to market a product is
resource intensive, lengthy, and costly. FDA review may involve substantial delays that adversely affect the
marketing and sale of our products. A number of our products are pending regulatory clearance or approval to
begin commercial sales in various markets. Ultimately, the FDA may not authorize the commercial release of a
medical device if it determines the device is not safe and effective or does not meet other regulatory standards.
Additionally, even if a product is cleared or approved, the FDA may impose restrictions or require testing and
surveillance programs to monitor the effects of these products once commercialized.
The FDA has the authority to halt the distribution of certain medical devices, detain or seize adulterated or
misbranded medical devices, order the repair, replacement, or refund of the costs of such devices, or preclude the
importation of devices that are or appear violative. The FDA also conducts inspections to determine compliance
with the quality system regulations concerning the manufacturing and design of devices and current medical
device reporting regulations, recall regulations, clinical testing regulations, and other requirements. The FDA
may withdraw product clearances or approvals due to failure to comply with regulatory standards, or the
occurrence of unforeseen problems following initial approval, and require notification of health professionals and
others with regard to medical devices that present unreasonable risks of substantial harm to the public health.
Additionally, the failure to comply with FDA or comparable regulatory standards or the discovery of previously
unknown product problems could result in fines, delays, suspensions or withdrawals of regulatory clearances or
approvals, seizures, injunctions, recalls, refunds, civil money penalties, or criminal prosecution. Our compliance
with applicable regulatory requirements is subject to continual review. Moreover, the FDA and several other
United States agencies administer controls over the export of medical devices from the United States and the
import of medical devices into the United States, which could also subject us to sanctions for noncompliance.
We are also subject to additional laws and regulations that govern our business operations, products, and
technologies, including:
•
•
•
•
•
•
federal, state, and foreign anti-kickback laws and regulations, which generally prohibit payments to
anyone, including physicians as an inducement to purchase or recommend a product;
the Stark law, which prohibits physicians from referring Medicare or Medicaid patients to a provider
that bills these programs for the provision of certain designated health services if the physician (or a
member of the physician’s immediate family) has a financial relationship with that provider;
federal and state laws and regulations that protect the confidentiality of certain patient health
information, including patient records, and restrict the use and disclosure of such information, in
particular, the Health Insurance Portability and Accountability Act of 1996;
the Physician Payments Sunshine Act, which requires public disclosure of the financial relationships of
United States physicians and teaching hospitals with applicable manufacturers, including medical
device, pharmaceutical, and biologics companies;
the False Claims Act, which prohibits the submission of false or otherwise improper claims for
payment to a federally funded health care program, and health care fraud statutes that prohibit false
statements and improper claims to any third-party payor; and
the United States Foreign Corrupt Practices Act, which can be used to prosecute United States
companies for arrangements with foreign government officials or other parties, or for not keeping
accurate financial records or maintaining adequate internal controls to prevent and detect arrangements
with foreign government officials or other parties.
8
Failure to comply with these laws and regulations could result in criminal liability, significant fines or
penalties, negative publicity, and substantial costs and expenses associated with investigation and enforcement
activities. To assist in our compliance efforts, we work to adhere to many codes of ethics and conduct regarding
our business activities in the United States and other countries in which we operate. In addition, we have in place
a dedicated team to improve our internal business compliance programs and policies.
International Regulation. Internationally, the regulation of medical devices is complex. In Europe, our
products are subject to extensive regulatory requirements. The regulatory regime in the European Union for
medical devices became mandatory in June 1998. It requires that medical devices may only be placed on the
market if they do not compromise safety and health when properly installed, maintained, and used in accordance
with their intended purpose. National laws conforming to the European Union’s legislation regulate our products
under the medical devices regulatory system. Although the more variable national requirements under which
medical devices were formerly regulated have been substantially replaced by the European Union Medical
Devices Directive, individual nations can still impose unique requirements that may require supplemental
submissions. The European Union medical device laws require manufacturers to declare that their products
conform to the essential regulatory requirements after which the products may be placed on the market bearing
the CE Mark. Manufacturers’ quality systems for products in all but the lowest risk classification are also subject
to certification and audit by an independent notified body. In Europe, particular emphasis is being placed on
more sophisticated and faster procedures for the reporting of adverse events to the competent authorities.
In May 2017, the European Union (the “EU”) implemented a new regulatory scheme for medical devices
under the Medical Device Regulation (“MDR”). The MDR becomes fully effective in 2021 and will bring
significant new requirements for many medical devices, including enhanced requirements for clinical evidence
and documentation, increased focus on device identification and traceability, new definitions and registration of
economic operators throughout the distribution chain, and additional post-market surveillance and vigilance.
Compliance with the MDR requires re-certification of many of our products to the enhanced standards, and has
resulted in and will continue to result in substantial additional expense. In addition, in the EU, we import some of
our devices through our offices in Switzerland. Switzerland is not a member state of the EU, but is linked to the
EU through bilateral treaties; therefore, the free movement of goods, including medical devices, between the EU
and Switzerland after implementation of the MDR requires a revised Mutual Recognition Agreement (“MRA”),
which continues to be under negotiation for the MDR. If an MRA covering the MDR is not put in place, then
non-EU manufacturers may be required to make significant changes, including replacement of Swiss economic
operators with operators based in EU Member States, and changes will need to be made to our device labeling
and/or packaging to satisfy MDR requirements. If these measures are unable to be taken, it may no longer be
possible to place such devices on the EU market.
In Japan, pre-market approval and clinical studies are required as is governmental pricing approval for
medical devices. Clinical studies are subject to a stringent Japanese “Good Clinical Practices” standard. Approval
time frames from the Japanese Ministry of Health, Labour and Welfare vary from simple notifications to review
periods of one or more years, depending on the complexity and risk level of the device. In addition, importation
of medical devices into Japan is subject to the “Good Import Practices” regulations. As with any highly regulated
market, significant changes in the regulatory environment could adversely affect future sales.
In many of the other foreign countries in which we market our products, we may be subject to regulations
affecting, among other things:
•
•
•
•
•
product standards and specifications;
packaging requirements;
labeling requirements;
product collection and disposal requirements;
quality system requirements;
9
•
•
•
•
import restrictions;
tariffs;
duties; and
tax requirements.
Many of the regulations applicable to our devices and products in these countries are similar to those of the
FDA. In some regions, the level of government regulation of medical devices is increasing, which can lengthen
time to market and increase registration and approval costs. In many countries, the national health or social
security organizations require our products to be qualified before they can be marketed and considered eligible
for reimbursement.
Health Care Initiatives. Government and private sector initiatives to limit the growth of health care costs,
including price regulation and competitive pricing, coverage and payment policies, comparative effectiveness
reviews, technology assessments, increasing evidentiary demands, and managed-care arrangements, are
continuing in many countries where we do business, including the United States, Europe, and Japan. As a result
of these changes, the marketplace has placed increased emphasis on the delivery of more cost-effective medical
therapies. For example, government programs, private health care insurance, and managed-care plans have
attempted to control costs by restricting coverage and limiting the level of reimbursement for procedures or
treatments, and some third-party payors require their pre-approval before new or innovative devices or therapies
are utilized by patients. These various initiatives have created increased price sensitivity over medical products
generally and may impact demand for our products and technologies.
The delivery of our products is subject to regulation by the United States Department of Health and Human
Services (“HHS”) and comparable state and foreign agencies responsible for reimbursement and regulation of
health care items and services. Foreign governments also impose regulations in connection with their health care
reimbursement programs and the delivery of health care items and services. Reimbursement schedules regulate
the amount the United States government will reimburse hospitals and doctors for the inpatient care of persons
covered by Medicare. HHS’ Centers for Medicare & Medicaid Services (“CMS”) may also review whether and/
or under what circumstances a procedure or technology is reimbursable for Medicare beneficiaries. Changes in
current coverage and reimbursement levels could have an adverse effect on market demand and our pricing
flexibility. The CMS National Coverage Determination for Transcatheter Aortic Valve Replacement was issued
in June 2019. The modernized requirements and more streamlined patient evaluation process are meaningful
enhancements that may help ensure equitable access for more patients suffering from severe aortic stenosis.
Health care cost containment efforts have also prompted domestic hospitals and other customers of medical
device manufacturers to consolidate into larger purchasing groups to enhance purchasing power. The medical
technology industry has also experienced some consolidation, partly in order to offer a broader range of products
to large purchasers. As a result, transactions with customers are larger, more complex, and tend to involve more
long-term contracts than in the past. These larger customers, due to their enhanced purchasing power, may have a
material impact on product pricing.
These laws or any future legislation, including deficit reduction legislation, could impact medical procedure
volumes, reimbursement for our products, and demand for our products or the prices at which we sell our
products.
Seasonality
Our quarterly net sales are influenced by many factors, including new product introductions, acquisitions,
regulatory approvals, patient and physician holiday schedules, and other factors. Net sales in the third quarter are
typically lower than other quarters of the year due to the seasonality of the United States and European markets,
where summer vacation schedules normally result in fewer medical procedures.
10
Human Capital Management Strategy
Human Capital Management (“HCM”) Governance
Attracting, developing, and retaining talent is fundamental to our success. The primary goals of our talent
management strategy are to attract and maintain a motivated, professional workforce and to ensure alignment on
our patient-focused innovation strategy.
Our Board of Directors has oversight over human capital management with time dedicated at each regularly
scheduled meeting to discuss talent management, including, among other things, talent strategy, diversity,
succession planning, employee development, employee health, safety, and welfare, results of employee surveys,
and compensation. The Board of Directors also approves Key Operating Drivers, which are strategic milestones
that include financial objectives and are tracked using a point system across our entire organization, that focus
the Company and management toward short, medium, and long-term goals that align with our talent management
strategy. In addition, the Chief Executive Officer (“CEO”) has talent management related performance goals tied
to his compensation; these Performance Management Objectives are tracked and, then, reported to and evaluated
by our Board of Directors.
Our HCM governance includes a global talent development review (“TDR”) process as well as an HCM
dashboard. The purpose of our TDR process is to align our business strategy with talent strategies, assess talent
against future organizational needs, evaluate critical talent populations, and enhance the strength of our
succession planning. Our HCM dashboard is generated quarterly and provides insights on key metrics related to
areas such as attraction and growth rates, retention trends, diversity, and employee sentiment.
Culture
Investing in our workforce means our employees can stay focused on our patient-focused innovation
strategy and the development of life-saving therapies for the patients we serve. We are committed to maintaining
a culture where we celebrate diversity, ensure that employees’ voices are heard, and promote good health and
safety. We strive to offer competitive employee benefits packages and are committed to fair and equitable pay
practices. We track compensation patterns in all geographies where we operate, and we regularly look for ways
to ensure fair and equitable pay.
We are committed to fostering an environment where all employees can grow and thrive. A diverse
workforce results in a broader range of perspectives, helping drive our commitment to innovation.
We believe in empowering our employees and providing avenues that enable their voices to be heard. We
conduct a multilingual global employee survey, called myVoice, to pulse our employees and gain their feedback
in a confidential manner. We gain insights on various topics including patient focus, diversity, inclusion and
belonging, quality, innovation, and engagement. Speak-Up is a resource available to all employees to bring forth
compliance related concerns. In addition, during each quarterly townhall meeting, our CEO has an “Ask Mike”
section in which he answers questions that have been submitted to him by employees. Answers to questions that
are not covered in the townhall meeting are posted online internally.
We understand that good health leads to better performance. Edwards offers a competitive employee
benefits package that includes, among other things, health and welfare insurance, health savings accounts, family
support services, and a variety of site-specific programs. We regularly evaluate our benefits package to make
modifications that are aligned with the competitive landscape, legislative changes, and the unique needs of our
population. We also provide robust wellness programs that address prevention, nutrition, mental health, physical
activity, education, financial fitness, and community service.
Talent Development
In addition to our robust TDR process and tuition reimbursement programs, we provide a variety of
leadership, technical, and professional development programs around the globe.
11
Headcount and Labor Representation
As of December 31, 2020, we had approximately 14,900 employees worldwide, the majority of whom were
located in the United States, Singapore, and the Dominican Republic. None of our North American employees
are represented by a labor union. In various countries outside of North America, we interact with trade unions
and work councils that represent employees.
Additional details regarding diversity, talent development, compensation, and employee health and safety
can be found in our Sustainability Report posted on our website at www.edwards.com under “About Us —
Corporate Responsibility.”
References to our website in this Annual Report on Form 10-K are provided for convenience only and the
content on our website does not constitute a part of this Report.
Item 1A. Risk Factors
Our business and assets are subject to varying degrees of risk and uncertainty. An investor should carefully
consider the risks described below, as well as other information contained in this Annual Report on Form 10-K
and in our other filings with the SEC. Additional risks not presently known to us or that we currently deem
immaterial may also adversely affect our business. If any of these events or circumstances occurs, our business,
financial condition, results of operations, or prospects could be materially harmed. In that case, the value of our
securities could decline and an investor could lose part or all of his or her investment. In addition, forward-
looking statements within the meaning of the federal securities laws that are contained in this Annual Report on
Form 10-K or in our other filings or statements may be subject to the risks described below as well as other risks
and uncertainties. Please read the cautionary notice regarding forward-looking statements in Part I above.
Business and Operating Risks
We are subject to risks associated with public health threats and epidemics, including the novel coronavirus
(“COVID-19”).
We are subject to risks associated with public health threats and epidemics, including the global health
concerns relating to the COVID-19 pandemic. The global pandemic has adversely impacted and is likely to
further adversely impact nearly all aspects of our business and markets, including our workforce and operations
and the operations of our customers, suppliers, and business partners. In particular, we may experience material
financial or operational impacts, including:
•
•
Significant volatility or reductions in demand for our products;
Impacts and delays to clinical trials, our pipeline milestones, or regulatory clearances and approvals; or
• The inability to meet our customers’ needs or other obligations due to disruptions to our operations or
the operations of our third-party partners, suppliers, contractors, logistics partners, or customers
including disruptions to production, development, manufacturing, administrative, and supply
operations and arrangements.
The extent to which the COVID-19 global pandemic and measures taken in response thereto impact our
business, results of operations, and financial condition will depend on future developments, which are highly
uncertain and are difficult to predict. These developments include, but are not limited to, the duration and spread
of the outbreak (including new variants of COVID-19), its severity, the actions to contain the virus or address its
impact, the timing, distribution, and efficacy of vaccines and other treatments, U.S. and foreign government
actions to respond to the reduction in global economic activity, and how quickly and to what extent normal
economic and operating conditions can resume.
12
Failure to successfully innovate and develop new and differentiated products in a timely manner and
effectively market these products could have a material effect on our prospects.
Our continued growth and success depend on our ability to innovate and develop new and differentiated
products in a timely manner and effectively market these products. Without the timely innovation and
development of products, our products could be rendered obsolete or less competitive by changing customer
preferences or because of the introduction of a competitor’s newer technologies. Innovating products requires the
devotion of significant financial and other resources to research and development activities; however, there is no
certainty that the products we are currently developing will complete the development process, or that we will
obtain the regulatory or other approvals required to market such products in a timely manner or at all. Even if we
timely innovate and develop products, our ability to market them could be constrained by a number of different
factors, including barriers in patients’ treatment pathway (including disease awareness, detection, and diagnosis),
the need for regulatory clearance, restrictions imposed on approved indications, and uncertainty over third-party
reimbursement. Failure in any of these areas could have a material effect on our prospects.
Unsuccessful clinical trials or procedures relating to products could have a material adverse effect on our
prospects.
The regulatory approval process for new products and new indications for existing products requires
extensive clinical trials and procedures, including early clinical feasibility and regulatory studies. Unfavorable or
inconsistent clinical data from current or future clinical trials or procedures conducted by us, our competitors, or
third parties, or perceptions regarding this clinical data, could adversely affect our ability to obtain necessary
approvals and the market’s view of our future prospects. Such clinical trials and procedures are inherently
uncertain and there can be no assurance that these trials or procedures will be enrolled or completed in a timely
or cost-effective manner or result in a commercially viable product or indication; failure to do so could have a
material adverse effect on our prospects. Clinical trials or procedures may experience significant setbacks even
after earlier trials have shown promising results. Further, preliminary results from clinical trials or procedures
may be contradicted by subsequent analyses. In addition, results from our clinical trials or procedures may not be
supported by actual long-term studies or clinical experience. If preliminary clinical results are later contradicted,
or if initial results cannot be supported by actual long-term studies or clinical experience, our business could be
adversely affected. Clinical trials or procedures may be delayed, suspended, or terminated by us, the FDA, or
other regulatory authorities at any time if it is believed that the trial participants face unacceptable health risks or
any other reasons.
We operate in highly competitive markets, and if we do not compete effectively, our business will be harmed.
We face substantial competition and compete with companies of all sizes on the basis of cost-effectiveness,
technological innovations, product performance, brand name recognition, breadth of product offerings, real or
perceived product advantages, pricing and availability and rate of reimbursement. In addition, given the trend
toward value-based healthcare, if we are not able to continue to demonstrate the full value of our differentiated
products to healthcare providers and payors, our competitive position could be adversely affected. See
“Competition” under “Business” in Part I, Item 1 included herein.
If we identify underperforming operations or products or if there are unforeseen operating difficulties and
expenditures in connection with business acquisitions or strategic alliances, we may be required, from time to
time, to recognize charges, which could be substantial and which could adversely affect our results of
operations.
We actively manage a portfolio of research and development products, and we regularly explore potential
acquisitions of complementary businesses, technologies, services, or products, as well as potential strategic
alliances. From time to time, we identify operations and products that are underperforming, do not fit with our
longer-term business strategy or there may be unforeseen operating difficulties and significant expenditures
13
during the integration of an acquired business, technology, service, or product into our existing operations. We
may seek to dispose of these underperforming operations or products, and we may also seek to dispose of other
operations or products for strategic or other business reasons. If we cannot dispose of an operation or product on
acceptable terms, we may voluntarily cease operations related to that product. In addition, we may be required to
take charges or write-downs in connection with acquisitions and divestitures. In particular, acquisitions of
businesses engaged in the development of new products may give rise to developed technology and/or in-process
research and development assets. To the extent that the value of these assets decline, we may be required to write
down the value of the assets. Also, in connection with certain asset acquisitions, we may be required to take an
immediate charge related to acquired in-process research and development assets. Any of these events could
result in charges, which could be substantial and which could adversely affect our results of operations.
The success of many of our products depends upon certain key physicians.
We maintain working relationships with physicians upon whom we rely to provide considerable knowledge
and experience. These physicians may assist us as researchers, marketing consultants, product trainers and
consultants, inventors, and as public speakers. If new laws, regulations, or other developments limit our ability to
appropriately engage these professionals or to continue to receive their advice and input, the development,
marketing, and successful use of our products could suffer, which could have a material adverse effect on our
business, financial condition, and results of operations.
If we or one of our suppliers or logistics partners encounters manufacturing, logistics, or quality problems,
our business could be materially adversely affected.
The manufacture and sterilization of many of our products is highly complex due in part to rigorous
regulatory requirements. Quality is extremely important due to the serious and costly consequences of a product
failure. Problems can arise for a number of reasons, including disruption of facility utilities, equipment
malfunction, failure to follow protocols and procedures, raw material problems, software problems, or human
error. Disruptions can occur at any time, including during production line transfers and expansions. Disruptions
can also occur if our manufacturing and warehousing facilities are damaged by earthquakes, hurricanes,
volcanoes, fires, and other natural disasters or catastrophic circumstances. As we expand into new markets and
scale new products for commercial production, we may face unanticipated delays or surges in demand which
could strain our production capacity and lead to other types of disruption. If any of these manufacturing,
logistics, or quality problems arise or if we or one of our suppliers or logistics partner otherwise fail to meet
internal quality standards or those of the FDA or other applicable regulatory body, our reputation could be
damaged, we could become subject to a safety alert or a recall, we could incur product liability and other costs,
product approvals and production could be delayed, and our business could otherwise be materially adversely
affected.
We rely on third parties in the design, manufacture, and sterilization of our products. Any failure by or loss of
a vendor could result in delays and increased costs, which may adversely affect our business.
We rely on third parties for a broad range of raw and organic materials and other items in the design,
manufacture, and sterilization of our products, and we purchase certain supplies and services from single sources
for reasons of quality assurance, cost-effectiveness, availability, constraints resulting from regulatory
requirements, and other reasons. We may experience supply interruptions due to a variety of factors, including:
• General economic conditions that could adversely affect the financial viability of our vendors;
• Vendors’ election to no longer service medical technology companies due to the burdens of applicable
quality requirements and regulations;
• The limitation or ban of certain materials used in the manufacture of our products; and
• Delays or shortages due to trade or regulatory embargoes.
14
A change or addition to our vendors could require significant effort due to the rigorous regulations and
requirements of the FDA and other regulatory authorities; it could be difficult to establish additional or
replacement sources on a timely basis, which could have a material adverse effect on our business.
Failure to protect our information technology infrastructure against cyber-based attacks, network security
breaches, service interruptions, or data corruption could materially disrupt our operations and adversely affect
our business and operating results.
The operation of our business depends on our information technology systems. We rely on our information
technology systems to, among other things, effectively manage sales and marketing data, accounting and
financial functions, inventory management, product development tasks, clinical data, customer service and
technical support functions. Our information technology systems are vulnerable to damage or interruption from
earthquakes, fires, floods and other natural disasters, terrorist attacks, power losses, computer system or data
network failures, security breaches, data corruption, and cyber-based attacks. Cyber-based attacks can include,
but are not limited to, computer viruses, computer denial-of-service attacks, phishing attacks, ransomware
attacks, worms, and other malicious software programs or other attacks, covert introduction of malware to
computers and networks, impersonation of authorized users, and efforts to discover and exploit any design flaws,
bugs, security vulnerabilities, or security weaknesses, as well as intentional or unintentional acts by employees or
other insiders with access privileges, intentional acts of vandalism by third parties and sabotage. In addition,
federal, state, and international laws and regulations, such as the General Data Protection Regulation adopted by
the European Union and the California Consumer Privacy Act, can expose us to enforcement actions and
investigations by regulatory authorities, and potentially result in regulatory penalties and significant legal
liability, if our information technology security efforts fail. In addition, a variety of our software systems are
cloud-based data management applications, hosted by third-party service providers whose security and
information technology systems are subject to similar risks.
The failure of either our or our service providers’ information technology could disrupt our operations or
result in decreased sales, result in liability claims or regulatory penalties, or lead to increased overhead costs,
product shortages, loss or misuse of proprietary or confidential information, intellectual property, or sensitive or
personal information, all of which could have a material adverse effect on our reputation, business, financial
condition, and operating results.
Our business and results of operations may be adversely affected if we are unable to recruit and retain
qualified management and other personnel.
Our continued success depends, in large part, on our ability to hire and retain qualified people or otherwise
have access to such qualified people globally and if we are unable to do so, our business and operations may be
impaired or disrupted. See “Human Capital Management Strategy” under “Business” in Part I, Item 1 included
herein. Competition for highly qualified people is intense, and there is no assurance that we will be successful in
attracting or retaining replacements to fill vacant positions, successors to fill retirements or employees moving to
new positions, or other highly qualified personnel.
Market and Other External Risks
Because we operate globally, our business is subject to a variety of risks associated with international sales
and operations.
Our extensive global operations and business activity as well as the fact that many of our manufacturing
facilities and suppliers are outside of the United States are accompanied by certain financial, economic, political,
and other risks, including those listed below.
Domestic and Global Economic Conditions. We cannot predict to what extent general domestic and global
economic conditions may negatively impact our business. These include, but are not limited to, credit and capital
15
markets, interest rates, tax law, including tax rate and policy changes, factors affecting global economic stability,
the political environment relating to health care, and the potential implications of the U.K. “Brexit” or the
withdrawal from the European Union of other member countries. These and other conditions could also
adversely affect our customers, payers, vendors and other stakeholders and may impact their ability or decision to
purchase our products or make payments on a timely basis.
Health Care Legislation and Other Regulations. We are subject to various federal and foreign laws that
govern our domestic and international business practices. For example, in the U.S., the Affordable Care Act, the
Medicare Access and CHIP Reauthorization Act of 2015, and the 21st Century Cures Act, or any future
legislation, including deficit reduction legislation, could impact medical procedure volumes, reimbursement for
our products, and demand for our products or the prices at which we sell our products. In addition, a Mutual
Recognition Agreement still under negotiation for the Medical Device Regulation can result in a lack of free
movement of medical devices between the European Union and Switzerland, can impact our access in the
European Union and can, ultimately, have a material effect on our business, financial condition, and results of
operations. For more information about these laws as they relate to our business, see the section entitled “Health
Care Legislation” and “Government Regulation and Other Matters” in Part I, Item 1, “Business.”
In addition, the United States Foreign Corrupt Practices Act, the United Kingdom Bribery Act, and similar
laws in other jurisdictions contain prohibitions against bribery and other illegal payments, and make it an offense
to fail to have procedures in place that prevent such payments. Penalties resulting from any violation of these
laws could adversely affect us and our business.
Taxes. We are subject to income taxes in the United States as well as other jurisdictions.
• Provision for Income Taxes. Our provision for income taxes and our underlying effective tax rate could
fluctuate due to changes in the mix of earnings and losses in countries with differing statutory tax rates.
Our income tax provision could also be impacted by changes in excess tax benefits of stock-based
compensation, federal and state tax credits, non-deductible expenses, changes in the valuation of
deferred tax assets and liabilities and our ability to utilize them, the applicability and creditability of
withholding taxes, and effects from acquisitions.
•
•
•
Tax Reform. Our provision for income taxes could be materially impacted by changes in accounting
principles or evolving tax laws, including, but not limited to, global corporate tax reform and base-
erosion and tax transparency efforts. For example, many countries are aligning their international tax
rules with the Organisation for Economic Co-operation and Development’s Base Erosion and Profit
Shifting recommendations and action plans that aim to standardize and modernize international
corporate tax policy, including changes to cross-border taxes, transfer pricing documentation rules,
nexus-based tax practices, and taxation of digital activities.
Tax Audits. We are subject to ongoing tax audits in the various jurisdictions in which we operate. Tax
authorities may disagree with certain positions we have taken and assess additional taxes. Although we
regularly assess the likely outcomes of the audits and record reserves for potential tax payments, the
calculation of tax liabilities involves the application of complex tax laws, and our estimates could be
different than the amounts for which we are ultimately liable.
Tax Incentives. We benefit from various global tax incentives extended to encourage investment or
employment. Several foreign jurisdictions have granted us tax incentives which require renewal at
various times in the future. If our incentives are not renewed or we cannot or do not wish to satisfy all
or part of the tax incentive conditions, we may lose the tax incentives and could be required to refund
tax incentives previously realized. As a result, our provision for income taxes could be higher than it
would have been had we maintained the benefits of the tax incentives.
16
Other economic, political, and social risks. Our future results could be harmed by a variety of other factors
associated with doing business internationally such as those enumerated in these risk factors as well as the
following:
•
•
•
•
trade protection measures, quotas, embargoes, import or export requirements, and duties, tariffs, or
surcharges;
cultural or other local factors affecting financial terms with customers;
differing labor regulations; and
currency exchange rate fluctuations; that is, decreases in the value of the United States dollar to the
Euro or the Japanese yen, as well as other currencies, have the effect of increasing our reported
revenues even when the volume of international sales has remained constant. Increases in the value of
the United States dollar relative to the Euro or the Japanese yen, as well as other currencies, have the
opposite effect. Significant increases or decreases in the value of the United States dollar could have a
material adverse effect on our revenues, cost of sales, or results of operations.
If government and other third-party payors decline to reimburse our customers for our products or impose
other cost containment measures to reduce reimbursement levels, our ability to profitably sell our products
will be harmed.
We sell our products and technologies to hospitals and other health care providers, nearly all of which
receive reimbursement for the health care services provided to patients from third-party payors, such as
government programs (both domestic and international), private insurance plans, and managed care programs.
The ability of customers to obtain appropriate reimbursement for their products from private and governmental
third-party payors is critical to our success. The availability of reimbursement affects which products customers
purchase and the prices they are willing to pay. Reimbursement varies from country to country and can
significantly impact acceptance of new products.
Government and other third-party payors are increasingly attempting to contain health care costs by limiting
both coverage and the level of reimbursement for medical products and services. Reimbursement levels may be
decreased in the future. Additionally, future legislation, regulation, or reimbursement policies of third-party
payors may otherwise adversely affect the demand for and price levels of our products. The introduction of cost
containment incentives, combined with closer scrutiny of health care expenditures by both private health insurers
and employers, has resulted in increased discounts and contractual adjustments to hospital charges for services
performed. Hospitals or physicians may respond to such cost- containment pressures by substituting lower cost
products or other therapies.
Third-party payors may deny reimbursement if they determine that a device used in a procedure was not
used in accordance with cost-effective treatment methods as determined by such third-party payors or was used
for an unapproved indication. Third-party payors may also deny reimbursement for experimental procedures and
devices. We believe that many of our existing products are cost-effective, even though the one-time cost may be
significant, because they are intended to improve quality of life and reduce overall health care costs over a long
period of time. We cannot be certain that these third-party payors will recognize these cost savings and quality of
life benefits instead of merely focusing on the lower initial costs associated with competing therapies. If our
products are not considered cost-effective by third-party payors, our customers may not be reimbursed for them,
resulting in lower sales of our products.
Continued consolidation in the health care industry could have an adverse effect on our sales and results of
operations.
The health care industry has been consolidating, and organizations such as GPOs, independent delivery
networks, and large single accounts, such as the United States Veterans Administration, continue to consolidate
17
purchasing decisions for many of our health care provider customers. As a result, transactions with customers are
larger and more complex, and tend to involve more long-term contracts. The purchasing power of these larger
customers has increased, and may continue to increase, causing downward pressure on product pricing. If we are
not one of the providers selected by one of these organizations, we may be precluded from making sales to its
members or participants. Even if we are one of the selected providers, we may be at a disadvantage relative to
other selected providers that are able to offer volume discounts based on purchases of a broader range of medical
equipment and supplies. Further, we may be required to commit to pricing that has a material adverse effect on
our revenues, profit margins, business, financial condition, and results of operations. We expect that market
demand, governmental regulation, third-party reimbursement policies, and societal pressures will continue to
drive consolidation and increase pricing pressure.
Legal, Compliance, and Regulatory Risks
Our inability to protect our intellectual property or failure to maintain the confidentiality and integrity of data
or other sensitive company information, by cyber-attack or other event, could have a material adverse effect
on our business.
Our success and competitive position are dependent in part upon our ability to protect our proprietary
intellectual property through a combination of patents and trade secrets. We cannot guarantee that the protective
steps we take are adequate to protect these rights:
•
Patents issued to or licensed by us in the past or in the future may be challenged and held invalid.
• As our patents expire, we may be unsuccessful in extending their protection through patent term
extensions.
• Confidentiality agreements with certain employees, consultants, and other third parties intended to
protect, in part, trade secrets and other proprietary information could be breached, and we may not have
adequate remedies.
• Others could independently develop substantially equivalent proprietary information or gain access to
our trade secrets or proprietary information, design around our technology, or develop competing
technologies.
• Our intellectual property, other proprietary technology, and other sensitive company information is
dependent on sophisticated information technology systems and is potentially vulnerable to cyber-
attacks, loss, theft, damage, destruction from system malfunction, computer viruses, loss of data
privacy, or misappropriation or misuse of it by those with permitted access, and other events.
• We may not detect infringement.
•
Intellectual property protection may also be unavailable or limited in some foreign countries.
We spend significant resources to protect and enforce our intellectual property rights, sometimes resulting in
expensive and time-consuming litigation that is complex and may ultimately be unsuccessful. Our inability to
protect our intellectual property could have a material adverse effect on our business or prospects.
Third parties may claim we are infringing their intellectual property, and we could suffer significant litigation
or licensing expenses or be prevented from selling products.
During recent years, we and our competitors have been involved in substantial litigation regarding patent
and other intellectual property rights which is typically costly and time-consuming. We may be forced to defend
against claims and legal actions alleging infringement of the intellectual property rights of others, and, if our
defense is unsuccessful, Edwards could have significant liabilities to third parties or face injunctions that bar the
sale of our products, or could require us to seek licenses from third parties. Such licenses may not be available on
commercially reasonable terms, may prevent us from manufacturing, selling, or using certain products, or may be
non-exclusive, which could provide our competitors access to the same technologies.
18
In addition, third parties could also obtain patents that may require us to either redesign products, negotiate
licenses from such third parties, which may be costly, unavailable or require us to exit a particular product
offering.
We and our customers are subject to rigorous governmental regulations and we may incur significant
expenses to comply with these regulations and develop products that are compatible with these regulations. In
addition, failure to comply with these regulations could subject us to substantial sanctions which could
adversely affect our business, results of operations, and financial condition.
The medical technologies we create, study, manufacture and market globally are subject to rigorous
regulation and scrutiny by the FDA and various other federal, state, and foreign governmental authorities.
Government regulation applies to nearly all aspects of our products’ lifecycles, including testing, clinical study,
manufacturing, transporting, sourcing, safety, labeling, storing, packaging, recordkeeping, reporting, advertising,
promoting, distributing, marketing, and importing or exporting of medical devices and products. In general,
unless an exemption applies, a medical device or product must receive regulatory approval or clearance before it
can be marketed or sold. Modifications to existing products or the marketing of new uses for existing products
also may require regulatory approvals, approval supplements, or clearances. If we are unable to obtain these
required approvals, we may be required to cease manufacturing and sale, or recall or restrict the use of such
modified device, pay fines, or take other action until such time as appropriate clearance or approval is obtained.
Regulatory agencies may refuse to grant approval or clearance, or review and disagree with our
interpretation of approvals or clearances, or with our decision that regulatory approval is not required or has been
maintained. Regulatory submissions may require the provision of additional data and may be time consuming
and costly, and their outcome is uncertain. Regulatory agencies may also change policies, adopt additional
regulations, or revise existing regulations, each of which could prevent or delay approval or clearance of devices,
or could impact our ability to market a previously cleared, approved, or unregulated device. Our failure to
comply with these regulatory requirements of the FDA or other applicable regulatory requirements in the United
States or elsewhere might subject us to administratively or judicially imposed sanctions. These sanctions include,
among others, warning letters, fines, civil penalties, criminal penalties, injunctions, debarment, product seizure or
detention, product recalls and total or partial suspension of production, sale and/or promotion. Any of the
foregoing actions could result in decreased sales including as a result of negative publicity and product liability
claims, and could have a material adverse effect on our financial condition, results of operations, and prospects.
In addition to the sanctions for noncompliance described above, commencement of an enforcement proceeding,
inspection, or investigation could divert substantial management attention from the operation of our business and
have an adverse effect on our business, results of operations, and financial condition.
Also, we are subject to various United States and international laws pertaining to health care pricing, anti-
corruption, and fraud and abuse, including prohibitions on kickbacks and the submission of false claims laws and
restrictions on relationships with physicians and other referral sources. These laws are broad in scope and are
subject to evolving interpretation, which could require us to incur substantial costs to monitor compliance. If we
are found not to be in compliance, we may be required to alter our practices or have sanctions imposed against us
and our officers and employees, including substantial fines, imprisonment, and exclusion from participation in
governmental health care programs.
We may incur losses from product liability or other claims that could adversely affect our operating results.
Our business exposes us to potential product liability risks that are inherent in the design, manufacture, and
marketing of medical technologies. Our products are often used in surgical and intensive care settings with
seriously ill patients. In addition, many of the devices we manufacture and sell are designed to be implanted in
the human body for long periods of time. Component failures, manufacturing and assembly flaws, design defects,
software defects, medical procedure errors, or inadequate disclosure of product-related risks or information could
result in an unsafe condition, injury to, or death of, patients. Such problems could result in product liability,
19
medical malpractice or other lawsuits and claims, safety alerts, or product recalls in the future. We establish
reserves and may incur charges in excess of those reserves. Although we maintain product liability and other
insurance with coverages we believe are adequate, product liability or other claims may exceed insurance
coverage limits, fines, and penalties. In addition, regulatory sanctions may not be covered by insurance, or
insurance may not continue to be available or available on commercially reasonable terms. These litigation
matters and regulatory actions, recalls or other actions, regardless of outcome, could have a material adverse
effect on our business, reputation, and ability to attract and retain customers.
Use of our products in unapproved circumstances could expose us to liabilities.
The marketing approval from the FDA and other regulators of certain of our products are, or are expected to
be, limited to specific indications. We are prohibited from marketing or promoting any unapproved use of our
products. Physicians, however, can use these products in ways or circumstances other than those strictly within
the scope of the regulatory approval. Although the product training we provide to physicians and other health
care professionals is conducted in compliance with applicable laws, and therefore, is mainly limited to approved
uses or for clinical trials, no assurance can be given that claims might not be asserted against us if our products
are used in ways or for procedures that are not approved.
Our operations are subject to environmental, health, and safety regulations that could result in substantial
costs.
Our operations are subject to environmental, health, and safety laws, and regulations concerning, among
other things, the generation, handling, transportation, and disposal of hazardous substances or wastes, the cleanup
of hazardous substance releases, and emissions or discharges into the air or water. We have incurred and may
incur in the future expenditures in connection with environmental, health and safety laws, and regulations. New
laws and regulations, violations of these laws or regulations, stricter enforcement of existing requirements, or the
discovery of previously unknown contamination could require us to incur costs or could become the basis for
new or increased liabilities that could be material.
We are subject to risks arising from concerns and/or regulatory actions relating to animal borne illnesses,
including “mad cow disease.”
Certain of our products, including pericardial tissue valves, are manufactured using bovine tissue. Concerns
relating to the potential transmission of animal borne illnesses, including BSE, commonly known as “mad cow
disease,” from cows to humans may result in reduced acceptance of products containing bovine materials.
Certain medical device regulatory agencies have considered whether to continue to permit the sale of medical
devices that incorporate bovine material. We obtain bovine tissue only from closely controlled sources within the
United States and Australia. The bovine tissue used in our pericardial tissue valves is from tissue types
considered by global health and regulatory organizations to have shown no risk of infectibility for the suspected
BSE infectious agent. We have not experienced any significant adverse impact on our sales as a result of
concerns regarding BSE, but no assurance can be given that such an impact may not occur in the future.
Item 1B. Unresolved Staff Comments
None.
20
Item 2.
Properties
The locations and uses of our major properties are as follows:
North America
Irvine, California
Draper, Utah
Haina, Dominican Republic
Añasco, Puerto Rico
Central America
Cartago, Costa Rica
Europe
Nyon, Switzerland
Prague, Czech Republic
Shannon, Limerick, Ireland
Asia
Singapore
Tokyo, Japan
Shanghai, China
Caesarea, Israel
Or Yehuda, Israel
(1) Owned property.
(2) Leased property.
(1)
Corporate Headquarters, Research and Development, Regulatory
and Clinical Affairs, Manufacturing, Marketing, Administration
(1),(2) Manufacturing, Administration
(1),(2) Manufacturing
(2) Manufacturing
(1),(2) Manufacturing
(1)
(2)
Administration, Marketing
Administration
(1),(2) Manufacturing (under construction)
(1),(2) Manufacturing, Distribution, Administration
(2)
(2)
(2)
(2)
Administration, Marketing, Distribution
Administration, Marketing
Research and Development
Research and Development
The Dominican Republic lease expires in 2022; the Puerto Rico property has two leases that expire in 2023;
the Costa Rica lease expires in 2021; the Prague, Czech Republic lease expires in 2026; the Shannon, Ireland
lease expires in 2024; the Tokyo, Japan lease expires in 2021; the Shanghai, China lease expires in 2021;
Singapore has one land lease that expires in 2036 and one that expires in 2041; Caesarea, Israel has one lease that
expires in 2021 and one that expires in 2030; and the Or Yehuda, Israel lease expires in 2023. We believe our
properties have been well maintained, are in good operating condition, and are adequate for current needs. We do
not anticipate difficulty in renewing existing leases as they expire or in finding alternative facilities.
Item 3.
Legal Proceedings
For a description of our material pending legal proceedings, please see Note 18 to the “Consolidated
Financial Statements” of this Annual Report on Form 10-K, which is incorporated by reference.
Item 4. Mine Safety Disclosures
Not applicable.
21
PART II
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of
Equity Securities
Market Information
Our common stock is traded on the New York Stock Exchange (the “NYSE”) under the symbol “EW.”
Number of Stockholders
On January 31, 2021, there were 8,876 stockholders of record of our common stock.
Dividends
We have never paid any cash dividends on our capital stock and have no current plans to pay any cash
dividends. Our current policy is to retain any future earnings for use in our business.
Issuer Purchases of Equity Securities
On May 8, 2019, the Board of Directors approved a stock repurchase program authorizing us to purchase on
the open market, including pursuant to a Rule 10b5-1 plan and in privately negotiated transactions, up to
$1.0 billion of our common stock. The repurchase program does not have an expiration date. We did not
purchase any of our common stock during the fourth quarter of 2020 and, as of December 31, 2020, we had
remaining authority to purchase $625.0 million of common stock.
22
Performance Graph
The following graph compares the performance of our common stock with that of the S&P 500 Index and
the S&P 500 Health Care Equipment Index. The cumulative total return listed below assumes an initial
investment of $100 at the market close on December 31, 2015 and reinvestment of dividends. Stockholder
returns over the indicated period should not be considered indicative of future stockholder returns.
COMPARISON OF 5-YEAR CUMULATIVE TOTAL RETURN
500
400
300
200
100
s
r
a
l
l
o
D
0
12/31/2015
12/31/2016
12/31/2017
12/31/2018
12/31/2019
12/31/2020
Edwards Lifesciences
S&P 500
S&P 500 Health Care Equipment
Edwards Lifesciences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
S&P 500 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
S&P 500 Health Care Equipment . . . . . . . . . . . . . . . . . . . .
$118.64
111.96
106.48
$142.71
136.40
139.38
$193.94
130.42
162.02
$295.38
171.49
209.52
$346.53
203.04
246.47
Total Cumulative Return
2016
2017
2018
2019
2020
23
Item 6.
Selected Financial Data
OPERATING RESULTS . . Net sales . . . . . . . . . . . .
Gross profit . . . . . . . . . .
Operating income (a) . .
. . . . . . .
Net income (a)
Net income per common
share (a) (c):
INFORMATION . . . . . . .
COMMON STOCK
As of or for the Years Ended December 31,
2020
2019
2018
2017
2016
$4,386.3
3,305.7
897.6
823.4
(in millions, except per share data)
$3,435.3
$3,722.8
$4,348.0
2,560.0
2,783.4
3,233.6
1,089.4
748.2
1,146.8
583.6
722.2
1,046.9
$2,963.7
2,166.3
751.2
569.5
Basic . . . . . . . . . . . . .
Diluted . . . . . . . . . . .
Cash dividends declared
per common share . . . . .
$
$
1.32
1.30
$
1.68
1.64
$
1.15
1.13
0.92
0.90
$
0.89
0.87
—
—
—
—
—
BALANCE SHEET
DATA . . . . . . . . . . . . . . . . Total assets . . . . . . . . . .
Long-term debt (b) . . . .
$7,237.1
595.0
$6,488.1
594.4
$5,323.7
593.8
$5,666.4
438.4
$4,518.5
822.3
(a) The above results for 2020 include a $367.9 million pre-tax charge ($305.1 million, net of tax) related to a
litigation settlement. The above results for 2019 include special charges of $64.6 million ($58.7 million, net
of tax), primarily the impairment of certain assets and the acquisition of early-stage intellectual property.
The above results for 2018 include special charges of $109.1 million ($103.0 million, net of tax), primarily
the impairment of intangible assets and a $180.0 million ($137.5 million, net of tax) charge related to a
litigation settlement. The above results for 2017 include a $112.5 million ($70.3 million, net of tax) gain for
a litigation payment received in 2017 and a $262.0 million tax expense related to the implementation of U.S.
tax law changes. See Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and
Results of Operations” and Note 3, Note 4, and Note 17 to the “Consolidated Financial Statements” for
additional information.
In October 2013, we issued $600.0 million of 2.875% fixed-rate unsecured senior notes due October 15,
2018 (the “2013 Notes”). At December 31, 2017, the 2013 Notes were classified as short-term obligations as
these obligations were due within one year. These 2013 Notes were paid in October 2018. In June 2018, we
issued $600.0 million of 4.3% fixed-rate unsecured senior notes due June 15, 2028, which were classified as
long-term obligations as of December 31, 2020, 2019 and 2018. Amounts outstanding under our Five-Year
Credit Agreement (“Credit Agreement”) have been classified as long-term obligations in accordance with
the terms of the Credit Agreement.
(b)
(c) The per share amounts for the prior periods presented have been retroactively adjusted to reflect the
three-for-one stock split effected in the second quarter of 2020.
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis presents the factors that had a material effect on our results of
operations during the two years ended December 31, 2020. Also discussed is our financial position as of
December 31, 2020. You should read this discussion in conjunction with the historical consolidated financial
statements and related notes included elsewhere in this Form 10-K. For a discussion related to the results of
operations for 2019 compared to 2018 and a discussion related to our consolidated cash flows for 2019 compared
to 2018, refer to Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of
Operations” in our 2019 Annual Report on Form 10–K filed with the Securities and Exchange Commission on
February 14, 2020.
24
Overview
We are the global leader in patient-focused medical innovations for structural heart disease, as well as
critical care and surgical monitoring. Driven by a passion to help patients, we partner with the world’s leading
clinicians and researchers and invest in research and development to transform care for those impacted by
structural heart disease or who require hemodynamic monitoring during surgery or in intensive care. We conduct
operations worldwide and are managed in the following geographical regions: United States, Europe, Japan, and
Rest of World. Our products are categorized into the following main areas: Transcatheter Aortic Valve
Replacement (“TAVR”), Transcatheter Mitral and Tricuspid Therapies (“TMTT”), Surgical Structural Heart
(“Surgical”), and Critical Care.
On May 7, 2020, our Board of Directors declared a three-for-one stock split of our outstanding shares of
common stock effected in the form of a stock dividend, distributed on May 29, 2020 to stockholders of record on
May 18, 2020. We distributed two newly issued shares of common stock to holders of record of each share of
common stock to effect the stock split. All applicable share and per-share amounts in this “Management’s
Discussion and Analysis of Financial Condition and Results of Operations” have been retroactively adjusted to
give effect to this stock split.
Financial Highlights and COVID-19
s
n
o
i
l
l
i
m
n
i
$
5,000
4,500
4,000
3,500
3,000
2,500
2,000
1,500
1,000
500
2019
2020
Net Sales
Gross profit
Diluted Earnings per Share
1.64
1.30
e
r
a
h
s
r
e
p
$
2.0
1.8
1.6
1.4
1.2
1.0
0.8
0.6
0.4
0.2
0.0
Net Income
2019
2020
In March 2020, the World Health Organization categorized the Coronavirus disease 2019 (“COVID-19”) as
a pandemic. COVID-19 continues to spread throughout the United States and other countries across the world,
and the duration and severity of its effects are currently unknown. The global pandemic has adversely impacted
and is likely to further adversely impact nearly all aspects of our business and markets, including our workforce
and the operations of our customers, suppliers, and business partners. Our priority has been to support our
clinician partners, protect the well-being of our employees, and maintain continuous access to our life-saving
technologies while offering front-line in-hospital support. Our manufacturing operations have continued to
respond to impacts related to COVID-19, and we have been able to supply our technologies around the world.
Across the organization, we are proactively managing inventory, assessing alternative logistics options, and
closely monitoring the supply of components.
TAVR and Surgical procedure volumes varied greatly since the middle of March 2020 by geography, and
even by hospital, as patients and their physicians analyzed the trade-off between aortic stenosis and their concern
25
for COVID-19. In the last few weeks of the first quarter of 2020, procedure volumes related to our TAVR and
Surgical products dropped significantly. Beginning in the second quarter of 2020, procedure volumes improved.
In the second quarter of 2020, we also started to progressively resume patient enrollment in all clinical trials that
were voluntarily paused or slowed at the end of the first quarter of 2020. While we saw improvements to
pre-COVID levels when we resumed enrollment, procedure volumes and enrollment in our clinical trials have
since been negatively impacted due to a resurgence of COVID-19 in late 2020. Even though health systems
adapted to the challenge, the resurgence of COVID-19 late in 2020 continued to impact these patients who need
care. In Critical Care, there was greater demand in Europe and the United States for our pressure monitoring
products, but demand for other Critical Care products began to decrease at the end of the first quarter of 2020 due
to COVID-19, and that trend continued through the fourth quarter of 2020.
Despite the challenges associated with COVID-19, our net sales for 2020 were $4.4 billion, representing an
increase of $38.3 million over 2019, driven by sales growth of our TAVR products.
Our gross profit increase in 2020 was driven by a charge of $73.1 million recorded in 2019, primarily
comprised of the write off of inventory related to strategic decisions regarding our TAVR portfolio, including the
decision to discontinue our CENTERA program.
The decrease in our diluted earnings per share in 2020 was driven by an after-tax charge of $305.1 million
to settle certain patent litigation related to transcatheter mitral and tricuspid repair products.
Healthcare Environment, Opportunities, and Challenges
The medical technology industry is highly competitive and continues to evolve. Our success is measured
both by the development of innovative products and the value we bring to our stakeholders. We are committed to
developing new technologies and providing innovative patient care, and we are committed to defending our
intellectual property in support of those developments. While some evidence collection was slowed due to the
COVID-19 pandemic, we and the clinical community are committed to continuing our trials and generating
robust evidence. In 2020, we invested 17.3% of our net sales in research and development. The following is a
summary of important developments during 2020:
•
in response to the urgent COVID-19 response around the globe, we temporarily paused new
enrollments in our active pivotal clinical trials of transcatheter mitral and tricuspid therapies, which
began resuming in the second quarter of 2020;
• we received CE Mark for the Edwards PASCAL transcatheter valve repair system for the treatment of
European patients with tricuspid regurgitation;
• we received Chinese regulatory approval for the Edwards SAPIEN 3 transcatheter heart valve for the
treatment of severe, symptomatic aortic stenosis patients at high risk for or unable to undergo open-
heart surgery;
• we reached an agreement with Abbott to settle all outstanding patent disputes between the companies
in cases related to transcatheter mitral and tricuspid repair products;
• we received FDA approval for the KONECT RESILIA aortic valved conduit, the first ready-to-implant
solution for bio-Bentall procedures, a complex surgery that involves replacement of a patient’s aortic
valve, aortic root, and the ascending aorta.
• we treated our first patient in the RESTORE clinical trial, which will evaluate the safety and
effectiveness of the investigational HARPOON Beating Heart Mitral Valve Repair System in the
United States and Canada.
We are dedicated to generating robust clinical, economic, and quality of life evidence increasingly expected
by patients, clinicians, and payors in the current healthcare environment, with the goal of encouraging the
adoption of innovative new medical therapies that demonstrate superior outcomes.
26
Results of Operations
Net Sales by Major Regions
(dollars in millions)
Years Ended December 31,
Change
2020
2019
$
%
United States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$2,516.8
$2,532.7
$(15.9)
(0.6)%
Europe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Japan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Rest of World . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
973.6
460.1
435.8
941.2
444.7
429.4
International
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1,869.5
1,815.3
32.4
15.4
6.4
54.2
Total net sales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$4,386.3
$4,348.0
$ 38.3
3.4%
3.5%
1.5%
3.0%
0.9%
International net sales include the impact of foreign currency exchange rate fluctuations. The impact of
foreign currency exchange rate fluctuations on net sales is not necessarily indicative of the impact on net income
due to the corresponding effect of foreign currency exchange rate fluctuations on international manufacturing and
operating costs, and our hedging activities. For more information, see “Quantitative and Qualitative Disclosures
About Market Risk.”
Net Sales by Product Group
(dollars in millions)
Transcatheter Aortic Valve Replacement . . . . . . . . . . . . . . . . . . . . . . .
Transcatheter Mitral and Tricuspid Therapies . . . . . . . . . . . . . . . . . . .
Surgical Heart Valve Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Critical Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$2,857.3
41.8
761.8
725.4
$2,737.9
28.2
841.7
740.2
$119.4
13.6
(79.9)
(14.8)
4.4%
48.5%
(9.5)%
(2.0)%
Total net sales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$4,386.3
$4,348.0
$ 38.3
0.9%
Years Ended December 31,
Change
2020
2019
$
%
27
Transcatheter Aortic Valve Replacement
For the years ended December 31, 2020 and 2019:
$2,737.9
$2,857.3
)
s
n
o
i
l
l
i
M
(
$
3,500
3,000
2,500
2,000
1,500
1,000
500
0
2019
2020
The increase in net sales of TAVR products was due primarily to higher sales of the Edwards SAPIEN 3
Ultra System following its regulatory approval in the United States (December 2018) and in Europe (November
2018). The adoption of the Edwards SAPIEN 3 Ultra System continued to be very positive in 2020. However, our
sales in 2020 were negatively impacted by the COVID-19 pandemic, and these challenges have continued in
early 2021. Our procedure volumes dropped significantly beginning in March 2020 due to COVID-19, and began
to steadily improve beginning in May 2020. In the first quarter of 2020, to ensure the safety of our employees
and clinician partners from the threat of COVID-19, we decided to pause proctoring at centers that were not
already trained on the Edwards SAPIEN 3 Ultra System. In the second quarter of 2020, we resumed proctoring.
Transcatheter Mitral and Tricuspid Therapies
For the years ended December 31, 2020 and 2019:
)
s
n
o
i
l
l
i
M
(
$
50
40
30
20
10
0
$41.8
$28.2
2019
2020
28
The increase in net sales of TMTT products was due primarily to sales in Europe of the Edwards PASCAL
transcatheter valve repair system, which received CE Mark in February 2019. Our sales in 2020 were negatively
impacted by the COVID-19 pandemic. Our procedure volumes for PASCAL dropped significantly in March 2020
due to COVID-19, and began to improve beginning in May 2020.
At the end of March 2020, we temporarily paused new enrollments in our active pivotal clinical trials of
transcatheter mitral and tricuspid therapies in response to the COVID-19 response around the globe. In the
second quarter of 2020, we began resuming enrollments. However, due to a resurgence of COVID-19 in late
2020, we are experiencing a negative impact to clinical trial enrollment. In May 2020, we received CE Mark for
the PASCAL Ace implant system for mitral and tricuspid repair.
Surgical Structural Heart
For the years ended December 31, 2020 and 2019:
$841.7
$761.8
)
s
n
o
i
l
l
i
M
(
$
1,000
800
600
400
200
0
2019
2020
The decrease in net sales of Surgical products was due primarily to decreased sales of aortic tissue valves,
primarily in the United States and Europe, due to the impact of COVID-19. The ongoing adoption of TAVR also
contributed to the decrease in United States surgical aortic valve sales. These decreases were partially offset by
increased sales of the INSPIRIS RESILIA aortic valve and the KONECT aortic valved conduit, primarily in the
United States. Increased and improved management of intensive care unit capacity, as well as prioritization of
heart surgery in many hospitals, contributed to rebounding procedure volumes late in the second quarter of 2020.
In the fourth quarter of 2020, hospitals experienced an influx of COVID-19 patients, limiting surgical valve
procedures.
In Europe, our HARPOON Beating Heart Mitral Valve Repair System became available commercially at the
end of 2019, and the first commercial case was successfully completed in Europe in the second quarter of 2020.
In addition, we received FDA approval in April 2020 to begin our U.S. pivotal investigational device exemption
study. HARPOON offers the potential for earlier treatment of degenerative mitral valve disease, with faster
recovery and more consistent outcomes for surgical patients.
29
Critical Care
For the years ended December 31, 2020 and 2019:
$740.2
$725.4
)
s
n
o
i
l
l
i
M
(
$
1,000
800
600
400
200
0
2019
2020
The decrease in net sales of Critical Care products was driven by a decline in sales of our enhanced surgical
recovery products, primarily in the United States, as many surgical procedures were delayed due to COVID-19
beginning in March 2020. We also experienced a decline in orders of our HemoSphere advanced monitoring
platform in the United States as hospitals limited their capital spending due to COVID-19.
These decreases in net sales were partially offset by increased demand for our pressure monitoring products,
primarily in Europe and the United States, as COVID-19 hospitalizations increased. In addition, our sales in 2020
and 2019 included $22.6 million and $16.8 million, respectively, related to CAS Medical Systems, Inc.
(“CASMED”), which we acquired on April 18, 2019. CASMED is a medical technology company dedicated to
non-invasive monitoring of tissue oxygenation in the brain.
Gross Profit
s
n
o
i
l
l
i
m
n
i
$
3,750
3,000
2,250
1,500
750
0
For the years ended December 31, 2020 and 2019:
$3,233.6
$3,305.7
74.4%
75.4%
2019
2020
Gross profit
Percent of net sales
85
80
75
70
e
g
a
t
n
e
c
r
e
P
Our gross profit was higher as a percentage of net sales in 2020 compared to 2019. In 2019, our gross profit
was reduced by $73.1 million due to the decision to discontinue our CENTERA program, resulting in a 1.7
30
percentage point increase in 2020 compared to 2019. This increase was partially offset by a) a 1.0 percentage
point decrease in 2020 due to the impact of foreign currency exchange rate fluctuations, net of hedging, and
b) incremental costs associated with COVID-19.
Selling, General, and Administrative (“SG&A”) Expenses
For the years ended December 31, 2020 and 2019:
s
n
o
i
l
l
i
m
n
i
$
1,500
1,200
900
600
300
0
$1,242.2
$1,228.4
28.6%
28.0%
e
g
a
t
n
e
c
r
e
P
40
35
30
25
20
2019
2020
SG&A
Percent of net sales
The decrease in SG&A expenses in 2020 compared to 2019 was due primarily to a) decreased sales,
marketing and travel- related expense associated with COVID-19 and b) lower performance-based compensation,
partially offset by increased sales and marketing expenses related to transcatheter structural heart field personnel,
primarily in the United States.
Research and Development (“R&D”) Expenses
For the years ended December 31, 2020 and 2019:
s
n
o
i
l
l
i
m
n
i
$
900
600
300
0
$752.7
17.3%
$760.7
17.3%
30
25
20
15
10
e
g
a
t
n
e
c
r
e
P
2019
2020
R&D
Percent of net sales
The increase in R&D expenses in 2020 compared to 2019 was due primarily to a) investments in our
transcatheter mitral and tricuspid therapies and our aortic valve replacement programs and b) costs associated
with discontinuing our SUTRAFIX program. These increases were partially offset by a) decreased spending on
transcatheter aortic valve clinical trials and b) decreased performance-based compensation.
31
Intellectual Property Litigation Expenses, net
We incurred intellectual property litigation expenses, including settlements and external legal costs, of
$405.4 million and $33.4 million during 2020 and 2019, respectively. On July 12, 2020, we reached an
agreement with Abbott Laboratories and its direct and indirect subsidiaries (“Abbott”) to, among other things,
settle all outstanding patent disputes between the companies (the “Settlement Agreement”) in cases related to
transcatheter mitral and tricuspid repair products. See Note 18 to the “Consolidated Financial Statements” for
additional information. The Settlement Agreement resulted in us recording an estimated $367.9 million pre-tax
charge and related liability in June 2020 related to past damages. In addition, we will incur royalty expenses
through May 2024 totaling an estimated $100 million. We made a one-time $100.0 million payment to Abbott in
July 2020, and will make quarterly payments in future years.
Change in Fair Value of Contingent Consideration Liabilities, net
The change in fair value of contingent consideration liabilities resulted in expense of $13.6 million in 2020
and income of $6.1 million in 2019. The expense in 2020 was primarily driven by the accretion of interest due to
the passage of time and adjustments to discount rates, partially offset by changes in the projected probability and
timing of milestone achievements, and the projected timing of cash inflows. The income in 2019 was due
primarily to longer product development timelines, which reduced the probability of milestone achievements,
partially offset by the accretion of interest due to the passage of time and discount rate adjustments.
Special Charges (Gain), net
For information on special charges and gains, see Note 4 to the “Consolidated Financial Statements.”
Interest Expense
Interest expense was $15.8 million and $20.7 million in 2020 and 2019, respectively. The decrease in
interest expense resulted primarily from higher capitalized interest due to facilities construction.
Interest Income
Interest income was $23.4 million and $32.2 million in 2020 and 2019, respectively. The decrease in interest
income resulted primarily from lower average interest rates, partially offset by a higher average investment
balance.
Other Income, net
(in millions)
Years Ended December 31,
Foreign exchange gains, net . . . . . . . . . . . . . . . . . . . . . . .
Gain on investments . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Non-service cost components of net periodic pension
benefit cost . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2020
$(12.3)
(0.6)
0.4
1.0
Total other income, net
. . . . . . . . . . . . . . . . . . . . . .
$(11.5)
2019
$(5.9)
(0.5)
0.2
(2.0)
$(8.2)
The net foreign exchange gains relate to the foreign currency fluctuations in our global trade and
intercompany receivable and payable balances, offset by the gains and losses on derivative instruments intended
as an economic hedge of those exposures.
32
The gain on investments represents our net share of gains and losses in investments accounted for under the
equity method, and realized gains and losses on investments in equity securities.
The non-service cost components of net periodic pension benefit cost includes the costs of our defined
benefit plans that are not attributed to services rendered by eligible employees during the year, such as interest
costs, expected return on plan assets, and amortization of actuarial gains or losses.
Provision for Income Taxes
Provision for income taxes . . . . . . . . . . . . . . . . . . . . . . . . .
Effective tax rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Years Ended December 31,
Change
2020
93.3
10.2%
2019
$
%
119.6
10.3%
(26.3)
(22.0)%
Our effective income tax rate in 2020 and 2019 was 10.2% and 10.3%, respectively. Our effective tax rate
for 2020 decreased slightly in comparison to 2019 primarily due to the tax benefit from the Settlement
Agreement with Abbott (see Notes 3 and 18 to the “Consolidated Financial Statements”), partially offset by the
increase in the U.S. tax on global intangible low-taxed income and the decrease in the tax benefit from employee
share-based compensation.
In 2020, the difference between our 10.2% effective tax rate and the Federal statutory rate of 21% was
primarily due to a) foreign earnings taxed at lower rates, b) Federal and California research and development
credits, and c) the tax benefit from employee share-based compensation.
As of December 31, 2020, we have $145.1 million of California research expenditure tax credits that we
expect to use in future periods. The credits may be carried forward indefinitely. Based upon anticipated future
taxable income, we expect that it is more likely than not that all California research expenditure tax credits will
be utilized, although the utilization of the full benefit is expected to occur over a number of years and into the
distant future.
As of December 31, 2020, gross uncertain tax positions were $281.8 million. We estimate that these
liabilities would be reduced by $95.1 million from offsetting tax benefits associated with the correlative effects
of potential transfer pricing adjustments, state income taxes, and timing adjustments. The net amount of
$186.7 million, if not required, would favorably affect our effective tax rate.
We strive to resolve open matters with each tax authority at the examination level and could reach
agreement with a tax authority at any time. While we have accrued for matters we believe are more likely than
not to require settlement, the final outcome with a tax authority may result in a tax liability that is more or less
than that reflected in the consolidated financial statements. Furthermore, we may later decide to challenge any
assessments, if made, and may exercise our right to appeal. The uncertain tax positions are reviewed quarterly
and adjusted as events occur that affect potential liabilities for additional taxes, such as lapsing of applicable
statutes of limitations, proposed assessments by tax authorities, negotiations between tax authorities,
identification of new issues, and issuance of new legislation, regulations, or case law. We believe that adequate
amounts of tax and related penalty and interest have been provided in income tax expense for any adjustments
that may result from our uncertain tax positions.
At December 31, 2020, all material state, local, and foreign income tax matters have been concluded for
years through 2015. While not material, we continue to address matters in Wisconsin and India for years from
2010.
During 2018, we executed an Advance Pricing Agreement (“APA”) between the United States and
Switzerland governments for tax years 2009 through 2020 covering various, but not all, transfer pricing matters.
33
The unagreed transfer pricing matters, namely Surgical Structural Heart and Transcatheter Aortic Valve
Replacement intercompany royalty transactions, then reverted to Internal Revenue Service (“IRS”) Examination
for further consideration as part of the respective years’ regular tax audit. In addition, we signed agreements
during 2018 with the IRS to settle open tax years 2009 through 2014, including all transfer pricing matters for
those years and the tax treatment of a portion of a litigation settlement payment received in 2014.
The IRS began its examination of the 2015 and 2016 tax years during the fourth quarter of 2018 and later
added the 2017 tax year to this audit cycle during the first quarter of 2019. The IRS audit field work for the 2015
through 2017 tax years was substantially completed during the fourth quarter of 2020, except for transfer pricing
matters.
As a result, certain intercompany transactions covering tax years 2015 through 2020 that were not resolved
under the APA program remain subject to IRS examination, and those transactions and related tax positions
remain uncertain as of December 31, 2020. The IRS has signaled that it may be preparing proposed audit
adjustments related to these intercompany transactions for the 2015 through 2017 tax years which, if issued,
could be provided to us during 2021. We have considered this information in our evaluation of our reserves for
uncertain tax positions.
These unresolved transfer pricing matters, net of any correlative repatriation tax adjustment, may be
significant to our consolidated financial statements. Based on the information currently available and numerous
possible outcomes, we cannot reasonably estimate what, if any, changes to our existing uncertain tax positions
may occur in the next 12 months and, therefore, have continued to record the gross uncertain tax positions as a
long-term liability.
We intend to file to renew the APA between the United States and Switzerland for the years 2021 and
forward. In addition, we executed other APAs as follows: during 2017, an APA between the United States and
Japan covering tax years 2015 through 2019; and during 2018, APAs between Japan and Singapore and between
Switzerland and Japan covering tax years 2015 through 2019. We have filed to renew these APAs related to
Japan for the years 2020 and forward. The execution of some or all of these APAs depends on a number of
variables outside of our control.
We have received tax incentives in certain non-U.S. tax jurisdictions, the primary benefit for which will
expire in 2029. The tax reductions as compared to the local statutory rates were $189.2 million ($0.30 per diluted
share) and $157.6 million ($0.25 per diluted share) for the years ended December 31, 2020 and 2019,
respectively.
Liquidity and Capital Resources
Our sources of cash liquidity include cash and cash equivalents, short-term investments, amounts available
under credit facilities, and cash from operations. We believe that these sources are sufficient to fund the current
requirements of working capital, capital expenditures, and other financial commitments for the next twelve
months from the financial statement issuance date. However, we periodically consider various financing
alternatives and may, from time to time, seek to take advantage of favorable interest rate environments or other
market conditions.
The Tax Cuts and Jobs Act of 2017 (the “2017 Act”), which was signed into law on December 22, 2017,
included extensive changes to the international tax regime. The 2017 Act required a deemed repatriation of post-
1986 undistributed foreign earnings and profits. The one-time transition tax liability, as adjusted, is payable in
five remaining annual installments, as outlined in the contractual obligations table below. As of December 31,
2020, we had a remaining tax obligation of $238.7 million related to the deemed repatriation. See Note 17 to the
“Consolidated Financial Statements” for additional information about the one-time transition tax.
34
As of December 31, 2020, cash and cash equivalents and short-term investments held in the United States
and outside the United States were $618.8 million and $783.8 million, respectively. During 2020, we repatriated
cash of $600.0 million. We assert that $1.1 billion of our foreign earnings continue to be permanently reinvested
and our intent is to repatriate $599.8 million of our foreign earnings as of December 31, 2020.
On July 12, 2020, we reached the Settlement Agreement with Abbott to settle all outstanding patent disputes
between the companies in cases related to transcatheter mitral and tricuspid repair products. The Settlement
Agreement resulted in us recording an estimated $367.9 million pretax charge in June 2020 related to past
damages. In addition, we will incur royalty expenses through May 2024 totaling an estimated $100 million. We
made a one-time $100.0 million payment to Abbott in July 2020, and will make quarterly payments in future
years. For further information, see Notes 3 and 18 to the “Consolidated Financial Statements.”
On April 18, 2019, we acquired CASMED for an aggregate cash purchase price of $2.45 per share of
common stock, or $100.8 million. For more information, see Note 8 to the “Consolidated Financial Statements.”
Certain of our business acquisitions involve contingent consideration arrangements. Payment of additional
consideration in the future may be required, contingent upon the acquired company reaching certain performance
milestones, such as attaining specified revenue levels or obtaining regulatory approvals. For further information,
see Note 8 to the “Consolidated Financial Statements.”
We have a Five-Year Credit Agreement (“the Credit Agreement”) which matures on April 28, 2023. The
Credit Agreement provides up to an aggregate of $750.0 million in borrowings in multiple currencies. Subject to
certain terms and conditions, we may increase the amount available under the Credit Agreement by up to an
additional $250.0 million in the aggregate. As of December 31, 2020, there were no borrowings outstanding
under the Credit Agreement. The Credit Agreement is unsecured and contains various financial and other
covenants, including a maximum leverage ratio, as defined in the Credit Agreement. The Company was in
compliance with all covenants at December 31, 2020.
In June 2018, we issued $600.0 million of 4.3% fixed-rate unsecured senior notes (the “2018 Notes”) due
June 15, 2028. We may redeem the 2018 Notes, in whole or in part, at any time and from time to time at
specified redemption prices. As of December 31, 2020, we have not elected to redeem any of the 2018 Notes. As
of December 31, 2020, the total carrying value of our 2018 Notes was $595.0 million. For further information on
our debt, see Note 10 to the “Consolidated Financial Statements.”
From time to time, we repurchase shares of our common stock under share repurchase programs authorized
by the Board of Directors. We consider several factors in determining when to execute share repurchases,
including, among other things, expected dilution from stock plans, cash capacity, and the market price of our
common stock. During 2020, under the Board authorized repurchase programs, we repurchased a total of
3.0 million shares at an aggregate cost of $614.7 million, and as of December 31, 2020, we had remaining
authority to purchase $625.0 million of our common stock. For further information, see Note 14 to the
“Consolidated Financial Statements.” In February 2021, we entered into an accelerated share repurchase
agreement to repurchase $250.0 million of our common stock. For further information, see Note 22 to the
“Consolidated Financial Statements.”
35
Consolidated Cash Flows—For the twelve months ended December 31, 2020 and 2019
Operating Cash Flows
Investing Cash Flows
Financing Cash Flows
)
s
n
o
i
l
l
i
M
(
$
1,200
900
600
300
0
)
s
n
o
i
l
l
i
M
(
$
0
-200
-400
-600
-800
2019
2020
2019
2020
)
s
n
o
i
l
l
i
M
(
$
0
-200
-400
-600
2019
2020
Net cash flows provided by operating activities of $1.1 billion for 2020 decreased $128.6 million from
2019 due primarily to lower operating profits in 2020 and a payment of $100.0 million for a litigation settlement,
partially offset by a payment of $180.0 million in 2019 for a litigation settlement.
Net cash used in investing activities of $531.1 million in 2020 consisted primarily of capital expenditures
of $407.0 million and net purchases of investments of $87.6 million.
Net cash used in investing activities of $595.8 million in 2019 consisted primarily of a) capital expenditures
of $254.4 million, b) net purchases of investments of $174.9 million, c) a $100.2 million net cash payment
associated with the acquisition of CASMED, d) a $35.0 million payment for an option to acquire a company, and
e) a $24.0 million payment to acquire certain early-stage transcatheter intellectual property and associated
clinical and regulatory experience.
We currently anticipate making capital expenditures of approximately $350 million in 2021 as we continue
to invest in our operations.
Net cash used in financing activities of $486.9 million in 2020 consisted primarily of purchases of treasury
stock of $625.4 million, partially offset by proceeds from stock plans of $140.5 million.
Net cash used in financing activities of $115.6 million in 2019 consisted primarily of purchases of treasury
stock of $263.3 million, partially offset by proceeds from stock plans of $160.5 million.
Contractual Obligations
A summary of all of our contractual obligations and commercial commitments as of December 31, 2020 is
as follows (in millions):
Contractual Obligations
Payments Due by Period
Total
Year 1
Years
2-3
Years
4-5
After 5
Years
Debt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 600.0 $ — $ — $ — $600.0
28.1
Operating leases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
48.5
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Interest on debt
—
Transition tax on unremitted foreign earnings and profits (a)
. . . . .
—
Litigation settlement obligation (minimum payments) . . . . . . . . . . .
—
Pension obligations (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.8
Purchase and other commitments (c) . . . . . . . . . . . . . . . . . . . . . . . .
35.1
40.5
72.2
100.0
—
9.7
14.9
39.4
141.4
100.0
—
1.5
108.1
148.9
238.7
250.0
2.5
26.7
30.0
20.5
25.1
50.0
2.5
13.7
Total contractual cash obligations (d), (e) . . . . . . . . . . . . . . . . . . . . . $1,374.9 $141.8 $257.5 $297.2 $678.4
36
(a) As of December 31, 2020, we had recorded $238.7 million of income tax liabilities related to the one-time
transition tax that resulted from the enactment of the 2017 Act. The transition tax is due in eight annual
installments, with the first annual installment paid in 2018, the second annual installment paid in 2019 and
the third annual installment paid in 2020. The remaining installment amounts will be equal to 8% of the
total liability, payable in fiscal years 2021 through 2022, 15% in fiscal year 2023, 20% in fiscal year 2024,
and 25% in fiscal year 2025. See Note 17 to the “Consolidated Financial Statements” for additional
information about the one-time transition tax.
(b) The amount included in “Less Than 1 Year” reflects anticipated contributions to our various pension plans.
Anticipated contributions beyond one year are not determinable. The total accrued benefit liability for our
pension plans recognized as of December 31, 2020 was $52.9 million. This amount is impacted by, among
other items, pension expense funding levels, changes in plan demographics and assumptions, and
investment returns on plan assets. Therefore, we are unable to make a reasonably reliable estimate of the
amount and period in which the liability might be paid, and did not include this amount in the contractual
obligations table. See Note 13 to the “Consolidated Financial Statements” for further information.
(c) Purchase and other commitments consists primarily of open purchase orders for the acquisition of goods and
services in the normal course of business. We have excluded open purchase orders with a remaining term of
less than one year. For certain purchase and other commitments, such as commitments to fund equity
method or other investments, the timing of the payment is not certain. In these cases, the maturity dates in
the table reflect our best estimates.
(d) As of December 31, 2020, the gross liability for uncertain tax positions, including interest, was
$301.2 million and relates primarily to transfer pricing matters. During 2018, we executed an APA between
the United States and Switzerland governments for tax years 2009 through 2020 covering various but not all
transfer pricing matters. As a result, certain intercompany transactions covering tax years 2015 through
2020 that were not resolved under the APA program remain subject to IRS examination, and those
transactions and related tax positions remain uncertain as of the balance sheet date. These unresolved
transfer pricing matters may be significant to our consolidated financial statements, and the final outcome of
the negotiations is uncertain. Management believes that adequate amounts of tax and related penalty and
interest have been provided in income tax expense for any adjustments that may result for our uncertain tax
positions. We are unable to make a reasonably reliable estimate of the amount and period in which the
liability might be paid, and did not include this amount in the contractual obligations table.
(e) We acquire assets still in development, enter into research and development arrangements, acquire
businesses, and sponsor certain clinical trials that often require milestone, royalty, or other future payments
to third-parties, contingent upon the occurrence of certain future events. In situations where we have no
ability to influence the achievement of the milestone or otherwise avoid the payment, we have included
those payments in the table above. However, we have excluded from the table contingent milestone
payments and other contingent liabilities for which we cannot reasonably predict future payments or for
which we can avoid making payment by unilaterally deciding to stop development of a product or cease
progress of a clinical trial. We estimate that these contingent payments could be up to $810.0 million if all
milestones or other contingent obligations are met. This amount includes certain milestone-based contingent
obligations that may be paid through a combination of cash and issuance of common stock, and certain
sales-based royalties in excess of minimum payment thresholds related to litigation settlements.
Critical Accounting Policies and Estimates
Our results of operations and financial position are determined based upon the application of our accounting
policies, as discussed in the notes to the “Consolidated Financial Statements.” Certain of our accounting policies
represent a selection among acceptable alternatives under GAAP. In evaluating our transactions, management
assesses all relevant GAAP and chooses the accounting policy that most accurately reflects the nature of the
transactions.
The application of accounting policies requires the use of judgment and estimates. These matters that are
subject to judgments and estimation are inherently uncertain, and different amounts could be reported using
37
different assumptions and estimates. Management uses its best estimates and judgments in determining the
appropriate amount to reflect in the consolidated financial statements, using historical experience and all
available information. We also use outside experts where appropriate. We apply estimation methodologies
consistently from year to year.
We believe the following are the critical accounting policies which could have the most significant effect on
our reported results and require subjective or complex judgments by management.
Revenue Recognition
When we recognize revenue from the sale of our products, the amount of consideration we ultimately
receive varies depending upon the return terms, sales rebates, discounts, and other incentives that we may offer,
which are accounted for as variable consideration when estimating the amount of revenue to recognize. The
estimate of variable consideration requires significant judgment. We include estimated amounts in the transaction
price to the extent it is probable that a significant reversal of cumulative revenue recognized will not occur when
the uncertainty associated with the variable consideration is resolved. The estimates of variable consideration and
determination of whether to include estimated amounts in the transaction price are based largely upon an
assessment of historical payment experience, historical relationship to revenues, estimated customer inventory
levels, and current contract sales terms with direct and indirect customers. Product returns are typically not
significant because returns are generally not allowed unless the product is damaged at time of receipt. If the
historical data and inventory estimates used to calculate the variable consideration do not approximate future
activity, our financial position, results of operations, and cash flows could be impacted.
In addition, in limited circumstances, we may allow customers to return previously purchased products,
such as for next-generation product offerings. For these transactions, we defer recognition of revenue on the sale
of the earlier generation product based upon an estimate of the amount of product to be returned when the next-
generation products are shipped to the customer. Uncertain timing of next-generation product approvals,
variability in product launch strategies, product recalls, and variation in product utilization all affect the estimates
related to sales returns and could cause actual returns to differ from these estimates.
Our sales adjustment related to distributor rebates given to our United States distributors represents the
difference between our sales price to the distributor and the negotiated price to be paid by the end-customer. We
validate the distributor rebate accrual quarterly through either a review of the inventory reports obtained from our
distributors or an estimate of the distributor’s inventory. This distributor inventory information is used to verify
the estimated liability for future distributor rebate claims based on historical rebates and contract rates. We
periodically monitor current pricing trends and distributor inventory levels to ensure the credit for future
distributor rebates is fairly stated.
Excess and Obsolete Inventory
The valuation of our inventory requires us to estimate excess, obsolete, and expired inventory. We base our
provisions for excess, obsolete, and expired inventory on our estimates of forecasted net sales. A significant
change in the timing or level of demand for our products as compared to forecasted amounts may result in
recording additional allowances for excess, obsolete, and expired inventory in the future. In addition, our
industry is characterized by rapid product development and frequent new product introductions. Uncertain timing
of next-generation product approvals, variability in product launch strategies, product recalls, increasing levels of
consigned inventory, and variation in product utilization all affect our estimates related to excess, obsolete, and
expired inventory.
Intangible Assets and Long-lived Assets
We acquire intangible assets in connection with business combinations and asset purchases. The acquired
intangible assets are recorded at fair value, which is determined based on a discounted cash flow analysis. The
38
determination of fair value requires significant estimates, including, but not limited to, the amount and timing of
projected future cash flows, the discount rate used to discount those cash flows, the assessment of the asset’s life
cycle, including the timing and expected costs to complete in-process projects, and the consideration of legal,
technical, regulatory, economic, and competitive risks.
In-process research and development assets acquired in business combinations is reviewed for impairment
annually, or whenever an event occurs or circumstances change that would indicate the carrying amount may be
impaired. Additionally, management reviews the carrying amounts of other intangible and long-lived assets
whenever events or circumstances indicate that the carrying amounts of an asset may not be recoverable. The
impairment reviews require significant estimates about fair value, including estimation of future cash flows,
selection of an appropriate discount rate, and estimates of long-term growth rates.
Contingent Consideration
We record contingent consideration resulting from a business combination at its fair value on the acquisition
date. We determine the fair value of the contingent consideration based primarily on the following factors:
•
•
•
•
discount rates used to present value the projected cash flows;
the probability of success of clinical events and regulatory approvals, and/or meeting commercial
milestones;
projected payment dates; and
volatility of future revenue.
On a quarterly basis, we revalue these obligations and record changes in their fair value as an adjustment to
earnings. Changes to contingent consideration obligations can result from adjustments to discount rates, accretion
of the discount rates due to the passage of time, changes in our estimates of the likelihood or timing of achieving
development or commercial milestones, changes in the probability of certain clinical events, or changes in the
assumed probability associated with regulatory approval.
The assumptions related to determining the value of contingent consideration include a significant amount
of judgment, and any changes in the underlying estimates could have a material impact on the amount of
contingent consideration expense recorded in any given period.
Income Taxes
The determination of our provision for income taxes requires significant judgment, the use of estimates, and
the interpretation and application of complex tax laws. Realization of certain deferred tax assets, primarily tax
credits, net operating loss and other carryforwards, is dependent upon generating sufficient taxable income in the
appropriate jurisdiction prior to the expiration of the carryforward periods. Failure to achieve forecasted taxable
income in the applicable taxing jurisdictions could affect the ultimate realization of deferred tax assets and could
result in an increase in our effective tax rate on future earnings.
We have made an accounting policy election to recognize the U.S. tax effects of global intangible low-taxed
income as a component of income tax expense in the period the tax arises.
We are subject to income taxes in the United States and numerous foreign jurisdictions. Our income tax
returns are periodically audited by domestic and foreign tax authorities. These audits include questions regarding
our tax filing positions, including the timing and amount of deductions and the allocation of income amongst
various tax jurisdictions. We evaluate our tax positions and establish liabilities in accordance with the applicable
accounting guidance on uncertainty in income taxes. Significant judgment is required in evaluating our uncertain
tax positions, including estimating the ultimate resolution to intercompany pricing controversies between
39
countries when there are numerous possible outcomes. We review these tax uncertainties quarterly and adjust the
liability as events occur that affect potential liabilities for additional taxes, such as the progress of tax audits,
lapsing of applicable statutes of limitations, negotiations between tax authorities, identification of new issues,
and issuance of new legislation, regulations, or case law.
For additional details on our income taxes, see Note 2 and Note 17 to the “Consolidated Financial
Statements.”
Stock-based Compensation
We measure and recognize compensation expense for all stock-based awards based on estimated fair values.
Stock-based awards consist of stock options, service-based restricted stock units, market-based restricted stock
units, performance-based restricted stock units, and employee stock purchase subscriptions. The fair value of
each option award and employee stock purchase subscription is estimated on the date of grant using the Black-
Scholes option valuation model. The fair value of market-based restricted stock units is determined using a
Monte Carlo simulation model, which uses multiple input variables to determine the probability of satisfying the
market condition requirements. The Black-Scholes and Monte Carlo models require various highly judgmental
assumptions, including stock price volatility, risk-free interest rate, and expected option term. For performance-
based restricted stock units, expense is recognized if and when we conclude that it is probable that the
performance condition will be achieved, which requires judgment. Stock-based compensation expense is
recorded net of estimated forfeitures. Judgment is required in estimating the stock awards that will ultimately be
forfeited. If actual results differ significantly from these estimates, stock-based compensation expense and our
results of operations would be impacted.
Legal Contingencies
We are or may be a party to, or may otherwise be responsible for, pending or threatened lawsuits including
those related to products and services currently or formerly manufactured or performed, as applicable, by us,
workplace and employment matters, matters involving real estate, our operations or health care regulations, or
governmental investigations. We accrue for loss contingencies to the extent that we conclude that it is probable
that a loss will be incurred and the amount of the loss can be reasonably estimated. These matters raise difficult
and complex factual and legal issues and are subject to many uncertainties, including, but not limited to, the facts
and circumstances of each particular case or claim, the jurisdiction in which each suit is brought, and differences
in applicable law. As such, significant judgment is required in determining our legal accruals. We describe our
legal proceedings in Note 18 to the “Consolidated Financial Statements.”
New Accounting Standards
Information regarding new accounting standards is included in Note 2 to the “Consolidated Financial
Statements.”
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
Our business and financial results are affected by fluctuations in world financial markets, including changes
in currency exchange rates and interest rates. We manage these risks through a combination of normal operating
and financing activities and derivative financial instruments. We do not use derivative financial instruments for
trading or speculative purposes.
Interest Rate Risk
Our exposure to market risk for changes in interest rates relates primarily to our investment portfolio and
our long-term debt. Our investment strategy is focused on preserving capital and supporting our liquidity
40
requirements, while earning a reasonable market return. We invest in a variety of debt securities, primarily time
deposits, commercial paper, U.S. and foreign government and agency securities, asset-backed securities,
corporate debt securities, and municipal debt securities. The market value of our investments may decline if
current market interest rates rise. As of December 31, 2020, we had $985.9 million of investments in debt
securities which had an average remaining term to maturity of approximately 1.56 years. Taking into
consideration the average maturity of our debt securities, a hypothetical 0.5% to 1.0% absolute increase in
interest rates at December 31, 2020 would have resulted in a $7.8 million to $15.6 million decrease in the fair
value of these investments. Such a decrease would only result in a realized loss if we choose or are forced to sell
the investments before the scheduled maturity, which we currently do not anticipate.
For more information related to investments, see Note 7 to the “Consolidated Financial Statements.”
We are also exposed to interest rate risk on our debt obligations. As of December 31, 2020, we had
$600.0 million of Notes outstanding that carry a fixed rate, and also had available a $750.0 million Credit
Agreement that carries a variable interest rate based on the London interbank offered rate (“LIBOR”). As of
December 31, 2020, there were no borrowings outstanding under the Credit Agreement. Based on our
December 31, 2020 variable debt levels, a hypothetical 1.0% absolute increase in floating market interest rates
would not have impacted our interest expense since we had no variable debt outstanding during the year. As of
December 31, 2020, a hypothetical 1.0% absolute increase in market interest rates would decrease the fair value
of the fixed-rate debt by approximately $43.2 million. This hypothetical change in interest rates would not impact
the interest expense on the fixed-rate debt.
For more information related to outstanding debt obligations, see Note 10 to the “Consolidated Financial
Statements.”
Currency Risk
We are exposed to foreign currency risks that arise from normal business operations. These risks include the
translation of local currency balances and results of our non-United States subsidiaries into United States dollars,
currency gains and losses related to intercompany and third-party transactions denominated in currencies other
than a subsidiary’s functional currency, and currency gains and losses associated with intercompany loans. Our
principal currency exposures relate to the Euro and the Japanese yen. Our objective is to minimize the volatility
of our exposure to these risks through a combination of normal operating and financing activities and the use of
derivative financial instruments in the form of foreign currency forward exchange contracts and cross currency
swap contracts. The total notional amount of our derivative financial instruments entered into for foreign
currency management purposes at December 31, 2020 was $1.8 billion. A hypothetical 10% increase/decrease in
the value of the United States dollar against all hedged currencies would increase/decrease the fair value of these
derivative contracts by $141.5 million. Any gains or losses on the fair value of derivative contracts would
generally be offset by gains and losses on the underlying transactions, so the net impact would not be significant
to our financial condition or results of operations.
For more information related to outstanding foreign exchange contracts, see Note 2 and Note 12 to the
“Consolidated Financial Statements.”
Credit Risk
Derivative financial instruments involve credit risk in the event the financial institution counterparty should
default. It is our policy to execute such instruments with major financial institutions that we believe to be
creditworthy. At December 31, 2020, all derivative financial instruments were with bank counterparties assigned
investment grade ratings by national rating agencies. We further diversify our derivative financial instruments
among counterparties to minimize exposure to any one of these entities. We have not experienced a counterparty
default and do not anticipate any non-performance by our current derivative counterparties.
41
Concentrations of Risk
We invest excess cash in a variety of debt securities, and diversify the investments between financial
institutions. Our investment policy limits the amount of credit exposure to any one issuer.
In the normal course of business, we provide credit to customers in the health care industry, perform credit
evaluations of these customers, and maintain allowances for potential credit losses, which have historically been
adequate compared to actual losses. In 2020, we had no customers that represented 10% or more of our total net
sales or accounts receivable, net.
Investment Risk
We are exposed to investment risks related to changes in the underlying financial condition and credit
capacity of certain of our investments. As of December 31, 2020, we had $985.9 million of investments in debt
securities of various companies, of which $766.5 million were long-term. In addition, we had $35.1 million of
investments in equity instruments of public and private companies. Should these companies experience a decline
in financial performance, financial condition or credit capacity, or fail to meet certain development milestones,
including as a result of the impact from COVID-19 on their business or operations or otherwise, a decline in the
investments’ value may occur, resulting in unrealized or realized losses.
42
Item 8.
Financial Statements and Supplementary Data
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2020
Report of Independent Registered Public Accounting Firm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
44
Financial Statements:
Consolidated Balance Sheets as of December 31, 2020 and 2019 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
For the Years Ended December 31, 2020, 2019, and 2018:
Consolidated Statements of Operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Consolidated Statements of Comprehensive Income . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Consolidated Statements of Cash Flows
Consolidated Statements of Stockholders’ Equity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Notes to Consolidated Financial Statements
47
48
49
50
51
52
All other schedules are omitted as they are not applicable or the required information is furnished in the
Consolidated Financial Statements or notes thereto.
43
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Stockholders of Edwards Lifesciences Corporation
Opinions on the Financial Statements and Internal Control over Financial Reporting
We have audited the accompanying consolidated balance sheets of Edwards Lifesciences Corporation and its
subsidiaries (the “Company”) as of December 31, 2020 and 2019, and the related consolidated statements of
operations, of comprehensive income, of stockholders’ equity and of cash flows for each of the three years in the
period ended December 31, 2020, including the related notes (collectively referred to as the “consolidated
financial statements”). We also have audited the Company’s internal control over financial reporting as of
December 31, 2020, based on criteria established in Internal Control—Integrated Framework (2013) issued by
the Committee of Sponsoring Organizations of the Treadway Commission (COSO).
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the
financial position of the Company as of December 31, 2020 and 2019, and the results of its operations and its
cash flows for each of the three years in the period ended December 31, 2020 in conformity with accounting
principles generally accepted in the United States of America. Also in our opinion, the Company maintained, in
all material respects, effective internal control over financial reporting as of December 31, 2020, based on criteria
established in Internal Control—Integrated Framework (2013) issued by the COSO.
Change in Accounting Principle
As discussed in Note 2 to the consolidated financial statements, the Company changed the manner in which it
accounts for leases in 2019.
Basis for Opinions
The Company’s management is responsible for these consolidated financial statements, for maintaining effective
internal control over financial reporting, and for its assessment of the effectiveness of internal control over
financial reporting, included in Management’s Report on Internal Control Over Financial Reporting appearing
under Item 9A. Our responsibility is to express opinions on the Company’s consolidated financial statements and
on the Company’s internal control over financial reporting based on our audits. We are a public accounting firm
registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to
be independent with respect to the Company in accordance with the U.S. federal securities laws and the
applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan
and perform the audits to obtain reasonable assurance about whether the consolidated financial statements are
free of material misstatement, whether due to error or fraud, and whether effective internal control over financial
reporting was maintained in all material respects.
Our audits of the consolidated financial statements included performing procedures to assess the risks of material
misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures
that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts
and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting
principles used and significant estimates made by management, as well as evaluating the overall presentation of
the consolidated financial statements. Our audit of internal control over financial reporting included obtaining an
understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and
testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our
audits also included performing such other procedures as we considered necessary in the circumstances. We
believe that our audits provide a reasonable basis for our opinions.
44
Definition and Limitations of Internal Control over Financial Reporting
A company’s internal control over financial reporting is a process designed to provide reasonable assurance
regarding the reliability of financial reporting and the preparation of financial statements for external purposes in
accordance with generally accepted accounting principles. A company’s internal control over financial reporting
includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail,
accurately and fairly reflect the transactions and dispositions of the assets of the company; (ii) provide reasonable
assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance
with generally accepted accounting principles, and that receipts and expenditures of the company are being made
only in accordance with authorizations of management and directors of the company; and (iii) provide reasonable
assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the
company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect
misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that
controls may become inadequate because of changes in conditions, or that the degree of compliance with the
policies or procedures may deteriorate.
Critical Audit Matters
The critical audit matters communicated below are matters arising from the current period audit of the
consolidated financial statements that were communicated or required to be communicated to the audit
committee and that (i) relate to accounts or disclosures that are material to the consolidated financial statements
and (ii) involved our especially challenging, subjective, or complex judgments. The communication of critical
audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole,
and we are not, by communicating the critical audit matters below, providing separate opinions on the critical
audit matters or on the accounts or disclosures to which they relate.
Uncertain Tax Positions Related to Intercompany Transfer Pricing
As described in Notes 2 and 17 to the consolidated financial statements, the Company had a gross uncertain tax
position liability balance of $281.8 million as of December 31, 2020, primarily related to transfer pricing. The
Company is subject to income taxes in the United States and numerous foreign jurisdictions. As disclosed by
management, the Company’s income tax returns in these jurisdictions are periodically audited by domestic and
foreign tax authorities. These audits include questions regarding the Company’s tax filing positions, including the
timing and amount of deductions and the allocation of income amongst various tax jurisdictions. Significant
judgment is required by management in evaluating uncertain tax positions, including estimating the ultimate
resolution to intercompany pricing controversies between countries when there are numerous possible outcomes.
The principal considerations for our determination that performing procedures relating to uncertain tax positions
related to intercompany transfer pricing is a critical audit matter are the significant judgment by management
when determining uncertain tax positions related to intercompany transfer pricing, including a high degree of
estimation uncertainty in evaluating whether certain tax filing positions taken by management will be upheld by
the related local tax authority. This in turn led to a high degree of auditor judgment, effort, and subjectivity in
performing procedures to evaluate the accurate measurement of uncertain tax positions related to intercompany
transfer pricing. Also, the evaluation of audit evidence available to support the tax liabilities for uncertain tax
positions related to intercompany transfer pricing is complex and required significant auditor judgment as the
nature of the evidence is highly subjective and the audit effort involved the use of professionals with specialized
skill and knowledge.
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming
our overall opinion on the consolidated financial statements. These procedures included testing the effectiveness
45
of controls relating to recognition of the liability for uncertain tax positions related to intercompany transfer
pricing and controls over measurement of the liability. These procedures also included, among others, (i) testing
the information used in the calculation of the liability for uncertain tax positions, including U.S. federal filing
positions and the related final tax returns; (ii) testing the calculation of the liability for uncertain tax positions
related to intercompany transfer pricing, by jurisdiction, including management’s assessment of the technical
merits of tax positions and estimates of the amount of tax benefit expected to be sustained; (iii) testing of
management’s assessment of possible outcomes of uncertain tax positions related to intercompany transfer
pricing; and (iv) evaluating the status and results of income tax audits with the relevant tax authorities.
Professionals with specialized skill and knowledge were used to assist in the evaluation of the completeness and
measurement of the Company’s uncertain tax positions related to intercompany transfer pricing, including
evaluating the reasonableness of management’s assessment of whether tax positions are more-likely-than-not to
be sustained and the amount of potential benefit to be realized, and the application of relevant tax laws.
Fair Value of Contingent Consideration Liabilities
As described in Note 11 to the consolidated financial statements, certain of the Company’s acquisitions involve
contingent consideration arrangements. As of December 31, 2020, the Company had a contingent consideration
liability of $186.1 million. As disclosed by management, payment of additional consideration is contingent upon
the acquired company reaching certain performance milestones, such as attaining specified revenue levels or
obtaining regulatory approvals. These contingent consideration liabilities are measured by management at
estimated fair value using either a probability weighted discounted cash flow analysis or a Monte Carlo
simulation model, both of which consider significant unobservable inputs. These inputs include (1) the discount
rate used to present value the projected cash flows, (2) the probability of milestone achievement, (3) the
projected payment dates, and (4) the volatility of future revenue.
The principal considerations for our determination that performing procedures relating to the fair value of
contingent consideration liabilities is a critical audit matter are the significant judgment by management when
estimating the fair value of these contingent consideration liabilities, including a high degree of estimation
uncertainty in evaluating the discount rate, the probability of milestone achievement, the projected payment
dates, and the volatility of future revenue. This in turn led to a high degree of auditor judgment, effort, and
subjectivity in performing procedures to evaluate the fair value of contingent consideration liabilities. Also, the
evaluation of audit evidence available to support the fair value of the contingent consideration liabilities is
complex and resulted in significant auditor judgment as the nature of the evidence is highly subjective and the
audit effort involved the use of professionals with specialized skill and knowledge.
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming
our overall opinion on the consolidated financial statements. These procedures included testing the effectiveness
of controls relating to management’s process for estimating the fair value of contingent consideration liabilities,
including controls over the determination of the significant unobservable inputs selected by management. These
procedures also included, among others, (i) testing management’s process for estimating the fair value of
contingent consideration liabilities and (ii) testing management’s probability weighted discounted cash flow
analysis or a Monte Carlo simulation used to estimate the fair value of the contingent consideration liabilities.
Testing management’s process included evaluating the appropriateness of the valuation methods used and the
reasonableness of the significant assumptions related to the discount rate, the probability of milestone
achievement, the projected payment dates, and the volatility of future revenue. Evaluating the reasonableness of
the probability of milestone achievement and projected payment date of each milestone involved consideration of
information obtained from the Company’s product engineers, clinical trial data, and third-party industry data.
The discount rate was evaluated by considering the cost of capital of comparable businesses and other industry
factors. Professionals with specialized skill and knowledge were used to assist in the evaluation of certain
significant assumptions, including the discount rate and volatility of future revenue.
/s/ PricewaterhouseCoopers LLP
Irvine, California
February 12, 2021
We have served as the Company’s auditor since 1999
46
EDWARDS LIFESCIENCES CORPORATION
CONSOLIDATED BALANCE SHEETS
(in millions, except par value)
December 31,
2020
2019
Current assets
ASSETS
Cash and cash equivalents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Short-term investments (Note 7)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accounts receivable, net of allowances of $9.6 and $8.7, respectively . . . . . . . . . . . .
Other receivables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inventories (Note 5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Prepaid expenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other current assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total current assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Long-term investments (Note 7)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Property, plant, and equipment, net (Note 5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operating lease right-of-use assets (Note 6)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Goodwill (Note 9) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other intangible assets, net (Note 9)
Deferred income taxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 1,183.2
219.4
514.6
88.2
802.3
75.1
208.2
3,091.0
801.6
1,395.2
94.2
1,173.2
331.4
230.9
119.6
$ 7,237.1
$ 1,179.1
337.8
543.6
55.5
640.9
59.1
168.0
2,984.0
585.5
1,060.3
80.1
1,167.7
336.5
172.2
101.8
$ 6,488.1
Current liabilities
LIABILITIES AND STOCKHOLDERS’ EQUITY
Accounts payable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accrued and other liabilities (Note 5)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operating lease liabilities (Note 6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total current liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Long-term debt (Note 10) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Contingent consideration liabilities (Notes 8 and 11) . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Taxes payable (Note 17) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operating lease liabilities (Note 6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Uncertain tax positions (Note 17) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Litigation settlement accrual (Notes 3 and 18) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other long-term liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Commitments and contingencies (Notes 6, 10 and 18)
$
$
196.5
670.2
27.2
893.9
595.0
186.1
215.3
72.7
214.4
233.0
252.4
180.4
696.5
25.5
902.4
594.4
172.5
236.6
58.9
171.7
—
203.3
Stockholders’ equity (Note 14)
Preferred stock, $0.01 par value, authorized 50.0 shares, no shares outstanding . . . .
Common stock, $1.00 par value, 1,050.0 shares authorized, 636.4 and 218.1 shares
issued, and 624.3 and 209.1 shares outstanding, respectively . . . . . . . . . . . . . . . . .
Additional paid-in capital . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Retained earnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accumulated other comprehensive loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Treasury stock, at cost, 12.1 and 9.0 shares, respectively . . . . . . . . . . . . . . . . . . . . . .
Total stockholders’ equity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total liabilities and stockholders’ equity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
—
—
636.4
1,438.1
4,565.0
(161.1)
(1,904.1)
4,574.3
$ 7,237.1
218.1
1,623.3
3,741.6
(156.0)
(1,278.7)
4,148.3
$ 6,488.1
The accompanying notes are an integral part of these consolidated financial statements.
47
EDWARDS LIFESCIENCES CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
(in millions, except per share information)
Years Ended December 31,
2020
2019
2018
Net sales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cost of sales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$4,386.3
1,080.6
$4,348.0
1,114.4
$3,722.8
939.4
Gross profit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Selling, general, and administrative expenses . . . . . . . . . . . . . . . . . . . . . . . .
Research and development expenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Intellectual property litigation expenses, net (Note 3) . . . . . . . . . . . . . . . . .
Change in fair value of contingent consideration liabilities . . . . . . . . . . . . .
Special charges (Note 4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3,305.7
1,228.4
760.7
405.4
13.6
—
Operating income . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Interest expense . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Interest income . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Special gain (Note 4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other income, net (Note 16) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Income before provision for income taxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Provision for income taxes (Note 17) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
897.6
15.8
(23.4)
—
(11.5)
916.7
93.3
3,233.6
1,242.2
752.7
33.4
(6.1)
64.6
1,146.8
20.7
(32.2)
—
(8.2)
1,166.5
119.6
2,783.4
1,088.5
622.2
214.0
(5.7)
116.2
748.2
29.9
(32.0)
(7.1)
(4.0)
761.4
39.2
Net income . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 823.4
$1,046.9
$ 722.2
Share information (Note 2):
Earnings per share:
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Basic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Diluted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Weighted-average number of common shares outstanding:
$
$
1.32
1.30
$
$
1.68
1.64
$
$
1.15
1.13
Basic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Diluted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
622.6
631.9
624.8
636.7
627.6
640.9
The accompanying notes are an integral part of these consolidated financial statements.
48
EDWARDS LIFESCIENCES CORPORATION
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(in millions)
Years Ended December 31,
2020
2019
2018
Net income . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$823.4
$1,046.9
$722.2
Other comprehensive (loss) income, net of tax (Note 15):
Foreign currency translation adjustments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Unrealized (loss) gain on hedges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Unrealized pension costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Unrealized gain (loss) on available-for-sale investments . . . . . . . . . . . . . . . . . .
Reclassification of net realized investment loss to earnings . . . . . . . . . . . . . . . .
Other comprehensive (loss) income, net of tax . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
32.4
(40.2)
(4.2)
6.6
0.3
(5.1)
(11.2)
(11.1)
(1.9)
6.3
0.4
(17.5)
(38.6)
40.4
0.6
(3.3)
2.9
2.0
Comprehensive income . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$818.3
$1,029.4
$724.2
The accompanying notes are an integral part of these consolidated financial statements.
49
EDWARDS LIFESCIENCES CORPORATION
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in millions)
Years Ended December 31,
2020
2019
2018
Cash flows from operating activities
Net income . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 823.4 $1,046.9 $
Adjustments to reconcile net income to cash provided by operating activities:
Depreciation and amortization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Non-cash operating lease cost . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Stock-based compensation (Notes 2 and 14) . . . . . . . . . . . . . . . . . . . . . . . . . .
Inventory write off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Impairment charges (Note 4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Change in fair value of contingent consideration liabilities, net (Note 11) . . .
Deferred income taxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Purchased in-process research and development . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other
107.2
28.2
92.6
—
—
13.6
(49.4)
—
(3.5)
89.3
25.3
81.3
73.1
40.6
(6.1)
12.1
24.0
(2.8)
Changes in operating assets and liabilities:
Accounts and other receivables, net
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inventories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Prepaid expenses and other current assets . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accounts payable and accrued liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Litigation settlement accrual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Income taxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other
Net cash provided by operating activities . . . . . . . . . . . . . . . . . . . . . . . .
41.9
(120.6)
(28.5)
(84.5)
270.5
(52.9)
16.3
1,054.3
(88.0)
(105.4)
(6.8)
116.5
(180.0)
43.2
19.7
1,182.9
Cash flows from investing activities
Capital expenditures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Purchases of held-to-maturity investments (Note 7) . . . . . . . . . . . . . . . . . . . . . . . .
Proceeds from sales and maturities of held-to-maturity investments (Note 7) . . . .
Purchases of available-for-sale investments (Note 7) . . . . . . . . . . . . . . . . . . . . . . .
Proceeds from sales and maturities of available-for-sale investments (Note 7) . . .
Acquisition (Notes 8 and 9) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Payment for acquisition option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Issuances of notes receivable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Investments in intangible assets and in-process research and development . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other
Net cash (used in) provided by investing activities . . . . . . . . . . . . . . . . .
Cash flows from financing activities
Proceeds from issuance of debt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Payments on debt and finance lease obligations . . . . . . . . . . . . . . . . . . . . . . . . . . .
Purchases of treasury stock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Proceeds from stock plans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Payment of contingent consideration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other
Net cash used in financing activities . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Effect of currency exchange rate changes on cash, cash equivalents, and restricted
cash . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net increase (decrease) in cash, cash equivalents, and restricted cash . .
Cash, cash equivalents, and restricted cash at beginning of year . . . . . . . . . . . . . . . . . .
(407.0)
(162.0)
212.2
(689.7)
564.8
—
(10.0)
(27.0)
(0.3)
(12.1)
(531.1)
16.2
(17.0)
(625.4)
140.5
—
(1.2)
(486.9)
(20.5)
15.8
1,184.4
(254.4)
(130.2)
50.0
(437.9)
359.9
(100.2)
(35.0)
(12.9)
(24.0)
(11.1)
(595.8)
18.9
(28.9)
(263.3)
160.5
—
(2.8)
(115.6)
(3.0)
468.5
715.9
Cash, cash equivalents, and restricted cash at end of year
. . . . . . . . . . . . . . . . . . . . . . . $1,200.2 $1,184.4 $
722.2
77.4
—
71.0
—
118.8
(5.7)
(27.3)
—
13.0
(28.7)
(65.7)
15.6
12.5
180.0
(157.8)
1.4
926.7
(238.7)
(210.0)
578.1
(249.3)
223.2
—
—
(0.6)
(3.0)
(23.0)
76.7
688.0
(1,125.3)
(795.5)
147.0
(15.1)
(0.3)
(1,101.2)
(6.5)
(104.3)
820.2
715.9
The accompanying notes are an integral part of these consolidated financial statements.
50
EDWARDS LIFESCIENCES CORPORATION
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(in millions)
Common Stock Treasury Stock
Shares
Par
Value Shares Amount
Additional
Paid-in
Capital
Retained
Earnings
Accumulated
Other
Comprehensive
Loss
Total
Stockholders’
Equity
BALANCE AT DECEMBER 31, 2017 . . . . 212.0 $212.0
Impact to retained earnings from adoption of
ASU 2016-16 and ASU 2018-02 . . . . . . . .
BALANCE AT JANUARY 1, 2018 . . . . . . . 212.0 212.0
Net income . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other comprehensive income, net of tax . . . . .
Common stock issued under equity plans . . . .
Stock-based compensation expense . . . . . . . .
Shares issued in payment for contingent
3.2
3.2
consideration liabilities . . . . . . . . . . . . . . . .
Purchases of treasury stock . . . . . . . . . . . . . . .
BALANCE AT DECEMBER 31, 2018 . . . . 215.2 215.2
Net income . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other comprehensive loss, net of tax . . . . . . .
Common stock issued under equity plans . . . .
Stock-based compensation expense . . . . . . . .
Purchases of treasury stock . . . . . . . . . . . . . . .
2.9
2.9
BALANCE AT DECEMBER 31, 2019 . . . . 218.1 218.1
Net income . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other comprehensive loss, net of tax . . . . . . .
Common stock issued under equity plans . . . .
Stock-based compensation expense . . . . . . . .
Purchases of treasury stock . . . . . . . . . . . . . . .
Stock issued to effect stock split . . . . . . . . . . . 413.8 413.8
4.5
4.5
2.3 $ (252.1) $1,166.9 $1,962.1
$(132.7)
$2,956.2
10.4
2.3
(252.1) 1,166.9 1,972.5
722.2
143.8
71.0
2.7
32.2
(795.5)
(1,015.4) 1,384.4 2,694.7
1,046.9
157.6
81.3
—
(263.3)
(1,278.7) 1,623.3 3,741.6
823.4
(0.3)
5.5
7.5
1.5
9.0
3.1
(625.4)
136.0
92.6
(413.8)
(7.8)
(140.5)
2.0
(138.5)
(17.5)
(156.0)
(5.1)
2.6
2,958.8
722.2
2.0
147.0
71.0
34.9
(795.5)
3,140.4
1,046.9
(17.5)
160.5
81.3
(263.3)
4,148.3
823.4
(5.1)
140.5
92.6
(625.4)
—
BALANCE AT DECEMBER 31, 2020 . . . . 636.4 $636.4 12.1 $(1,904.1) $1,438.1 $4,565.0
$(161.1)
$4,574.3
The accompanying notes are an integral part of these consolidated financial statements.
51
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. DESCRIPTION OF BUSINESS
Edwards Lifesciences Corporation (“Edwards Lifesciences” or the “Company”) conducts operations
worldwide and is managed in the following geographical regions: United States, Europe, Japan, and Rest of
World. Edwards Lifesciences is focused on technologies that treat structural heart disease and critically ill
patients. The products and technologies provided by Edwards Lifesciences are categorized into the following
main areas: Transcatheter Aortic Valve Replacement, Transcatheter Mitral and Tricuspid Therapies, Surgical
Structural Heart, and Critical Care.
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Principles of Consolidation
The accompanying consolidated financial statements include the accounts of Edwards Lifesciences and its
majority-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation.
The Company reviews its investments in other entities to determine whether the Company is the primary
beneficiary of a variable interest entity (“VIE”). The Company would be the primary beneficiary of the VIE, and
would be required to consolidate the VIE, if it has the power to direct the significant activities of the entity and
the obligation to absorb losses or receive benefits from the entity that may be significant to the VIE. Based on the
Company’s analysis, it determined it is not the primary beneficiary of any VIEs; however, future events may
require VIEs to be consolidated if the Company becomes the primary beneficiary.
Certain reclassifications of previously reported amounts have been made to conform to classifications used
in the current year.
Stock Split
On May 7, 2020, the Company’s Board of Directors declared a three-for-one stock split of its outstanding
shares of common stock effected in the form of a stock dividend, distributed on May 29, 2020 to stockholders of
record on May 18, 2020. The Company distributed two newly issued shares of common stock to holders of
record of each share of common stock to effect the stock split. All applicable share and per-share amounts in the
consolidated financial statements and the notes to consolidated financial statements have been retroactively
adjusted to reflect this stock split. The consolidated balance sheet as of December 31, 2019 and the consolidated
statements of stockholders’ equity for the twelve months ended December 31, 2019 have not been retroactively
adjusted to reflect the stock split.
Use of Estimates
The consolidated financial statements of Edwards Lifesciences have been prepared in accordance with
generally accepted accounting principles in the United States of America (“GAAP”) which have been applied
consistently in all material respects. The preparation of financial statements in conformity with GAAP requires
management to make estimates and assumptions that affect the amounts reported in the financial statements.
Actual results could differ from those estimates. In particular, the novel Coronavirus (“COVID-19”) pandemic
has adversely impacted and is likely to further adversely impact nearly all aspects of our business and markets,
including our workforce and the operations of our customers, suppliers, and business partners. The full extent to
which the pandemic will directly or indirectly impact the Company’s business, results of operations and financial
condition, including sales, expenses, manufacturing, clinical trials, research and development costs, reserves and
allowances, fair value measurements, asset impairment charges, contingent consideration obligations, and the
effectiveness of the Company’s hedging instruments, will depend on future developments that are highly
52
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)
uncertain and difficult to predict. These developments include, but are not limited to, the duration and spread of
the outbreak (including new variants of COVID-19), its severity, the actions to contain the virus or address its
impact, the timing, distribution, and efficacy of vaccines and other treatments, U.S. and foreign government
actions to respond to the reduction in global economic activity, and how quickly and to what extent normal
economic and operating conditions can resume.
Foreign Currency Translation
When the local currency of the Company’s foreign entities is the functional currency, all assets and
liabilities are translated into United States dollars at the rate of exchange in effect at the balance sheet date.
Income and expense items are translated at the weighted-average exchange rate prevailing during the period. The
effects of foreign currency translation adjustments for these entities are deferred and reported in stockholders’
equity as a component of “Accumulated Other Comprehensive Loss.” The effects of foreign currency transactions
denominated in a currency other than an entity’s functional currency are included in “Other Income, net.”
Revenue Recognition
Revenue is recognized when control of the promised goods or services is transferred to the customer in an
amount that reflects the consideration to which the Company expects to be entitled in exchange for those
products or services.
The Company generates nearly all of its revenue from direct product sales and sales of products under
consignment arrangements. Revenue from direct product sales is recognized at a point in time when the
performance obligation is satisfied upon delivery of the product. Revenue from sales of consigned inventory is
recognized at a point in time when the performance obligation is satisfied once the product has been implanted or
used by the customer. The Company periodically reviews consignment inventories to confirm the accuracy of
customer reporting. The Company also generates a small portion of its revenue from service contracts, and
recognizes revenue from service contracts ratably over the term of the contracts. Sales taxes and other similar
taxes that the Company collects concurrent with revenue-producing activities are excluded from revenue. The
Company does not typically have any significant unusual payment terms beyond 90 days in its contracts with
customers. In addition, the Company receives royalty payments for the licensing of certain intellectual property
and recognizes the royalty when the subsequent sale of product using the intellectual property occurs.
The amount of consideration the Company ultimately receives varies depending upon the return terms, sales
rebates, discounts, and other incentives that the Company may offer, which are accounted for as variable
consideration when estimating the amount of revenue to recognize. The Company includes estimated amounts in
the transaction price to the extent it is probable that a significant reversal of cumulative revenue recognized will
not occur when the uncertainty associated with the variable consideration is resolved. The estimates of variable
consideration and determination of whether to include estimated amounts in the transaction price are based
largely upon an assessment of historical payment experience, historical relationship to revenues, estimated
customer inventory levels, and current contract sales terms with direct and indirect customers.
The Company’s sales adjustment related to distributor rebates given to the Company’s United States
distributors represents the difference between the Company’s sales price to the distributor and the negotiated
price to be paid by the end-customer. This distributor rebate is recorded as a reduction to sales and a reduction to
the distributor’s accounts receivable at the time of sale to a distributor. The Company periodically monitors
current pricing trends and distributor inventory levels to ensure the credit for future distributor rebates is fairly
stated.
53
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)
The Company offers volume rebates to certain group purchasing organizations (“GPOs”) and customers
based upon targeted sales levels. Volume rebates offered to GPOs are recorded as a reduction to sales and an
obligation to the GPOs, as the Company expects to pay in cash. Volume rebates offered to customers are
recorded as a reduction to sales and either accounts receivable if the Company expects a net payment from the
customer, or as an obligation to the customer if the Company expects to pay in cash. The provision for volume
rebates is estimated based upon customers’ contracted rebate programs, projected sales levels, and historical
experience of rebates paid. The Company periodically monitors its customer rebate programs to ensure that the
allowance and liability for accrued rebates is fairly stated.
Product returns are typically not significant because returns are generally not allowed unless the product is
damaged at time of receipt. In limited circumstances, the Company may allow customers to return previously
purchased products, such as for next-generation product offerings. For these transactions, the Company defers
recognition of revenue on the sale of the earlier generation product based upon an estimate of the amount of
product to be returned when the next-generation products are shipped to the customer.
The Company sells separately priced service contracts, which range from 12 to 36 months, to owners of its
hemodynamic monitors. The Company invoices the customer the total amount of consideration at the inception
of the contract and recognizes revenue ratably over the term of the contract. As of December 31, 2020 and
December 31, 2019, $6.3 million and $8.4 million, respectively, of deferred revenue associated with outstanding
service contracts was recorded in “Accrued and Other Liabilities” and “Other Long-term Liabilities.” During
2020, the Company recognized as revenue $6.3 million that was included in the balance of deferred revenue as of
December 31, 2019, and during 2019, the Company recognized as revenue $5.5 million that was included in the
balance of deferred revenue as of December 31, 2018.
A limited number of the Company’s contracts with customers contain multiple performance obligations. For
these contracts, the transaction price is allocated to each performance obligation based on its relative standalone
selling price charged to other customers.
The Company applies the optional exemption of not disclosing the amount of the transaction price allocated
to unsatisfied performance obligations for contracts with an original expected duration of one year or less.
Shipping and Handling Costs
Shipping costs, which are costs incurred to physically move product from the Company’s premises or third
party distribution centers, including storage, to the customer’s premises, are included in “Selling, General, and
Administrative Expenses.” Handling costs, which are costs incurred to store at the Company’s premises, move,
and prepare products for shipment, are included in “Cost of Sales.” For the years ended December 31, 2020,
2019, and 2018, shipping costs of $74.0 million, $71.5 million, and $70.6 million, respectively, were included in
“Selling, General, and Administrative Expenses.”
Cash Equivalents
The Company considers highly liquid investments with original maturities of three months or less to be cash
equivalents. These investments are valued at cost, which approximates fair value.
Investments
The Company invests its excess cash in debt securities, including time deposits, commercial paper, U.S.
government and agency securities, asset-backed securities, corporate debt securities, and municipal debt
54
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)
securities. Investments with maturities of one year or less are classified as short-term, and investments with
maturities greater than one year are classified as long-term. Investments that the Company has the ability and
intent to hold until maturity are classified as held-to-maturity and carried at amortized cost. Investments in debt
securities that are classified as available-for-sale are carried at fair value with unrealized gains and losses
included in “Accumulated Other Comprehensive Loss.” The Company determines the appropriate classification
of its investments in debt securities at the time of purchase and reevaluates such designation at each balance sheet
date.
The Company also has long-term equity investments in companies that are in various stages of
development. These investments are reported at fair value or under the equity method of accounting, as
appropriate. Equity investments that do not have readily determinable fair values are recorded at cost minus
impairment, if any, plus or minus changes resulting from observable price changes in orderly transactions for the
identical or similar investment of the same issuer. The Company accounts for investments in limited partnerships
and limited liability corporations, whereby the Company owns a minimum of 5% of the investee’s outstanding
voting stock, under the equity method of accounting. These investments are recorded at the amount of the
Company’s investment and adjusted each period for the Company’s share of the investee’s income or loss, and
dividends paid.
Realized gains and losses on investments that are sold are determined using the specific identification
method, or the first-in, first-out method, depending on the investment type, and recorded to “Other Income, net.”
Income relating to investments in debt securities is recorded to “Interest Income.”
Equity investments without readily determinable fair value are considered impaired when there is an
indication that the fair value of the Company’s interest is less than the carrying amount. Equity method
investments are considered impaired when there is an indication of an other-than-temporary decline in value
below the carrying amount. Impairments of equity investments are recorded in “Other Income, net.”
Debt securities in an unrealized loss position are written down to fair value through “Other Income, net” if
the Company intends to sell the security or it is more likely than not that the Company will be required to sell the
security before recovery of its amortized cost basis. For debt securities in an unrealized loss position that do not
meet the aforementioned criteria, the Company assesses whether the decline in fair value has resulted from credit
losses or other factors. In making this assessment, the Company considers the extent to which fair value is less
than amortized cost, changes to the rating of the security by a rating agency, and any adverse conditions
specifically related to the security, among other factors. When a credit loss exists, the Company compares the
present value of cash flows expected to be collected from the debt security to the amortized cost basis of the
security to determine the allowance amount that should be recorded, if any. For available-to-sale debt securities,
any additional impairment not recorded through an allowance for credit losses is recognized in “Accumulated
Other Comprehensive Loss.”
Accounts Receivable
The majority of the Company’s accounts receivable arise from direct product sales and sales of products
under consignment arrangements, and have payment terms that generally require payment within 30 to 90 days.
The Company does not adjust its receivables for the effects of a significant financing component at contract
exception if collection of the receivable is expected within one year or less from the time of sale. In countries
where the Company has experienced a pattern of payments extending beyond the stated terms and collection of
the receivable is expected beyond one year from the time of sale, the Company assesses whether the customer
55
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)
has a significant financing component and discounts the receivable and reduces the related revenues over the
period of time that the Company estimates those amounts will be paid using the country’s market- based
borrowing rate for such period.
The Company provides reserves against accounts receivable for estimated losses that may result from a
customer’s inability to pay based on customer-specific analysis and general matters such as current assessments
of past due balances, economic conditions and forecasts, and historical credit loss activity. Amounts determined
to be uncollectible are charged or written-off against the reserve.
Inventories
Inventories are stated at the lower of cost (first-in, first-out method) or net realizable value. Market value for
raw materials is based on replacement costs, and for other inventory classifications is based on net realizable
value.
A write-down for excess or slow moving inventory is recorded for inventory which is obsolete, damaged,
nearing its expiration date (generally triggered at six months prior to expiration), or slow moving (generally
defined as quantities in excess of a two-year supply).
The Company allocates to inventory general and administrative costs that are related to the production
process. These costs include insurance, manufacturing accounting personnel, human resources personnel, and
information technology. During the years ended December 31, 2020, 2019, and 2018, the Company allocated
$63.1 million, $56.6 million, and $45.0 million, respectively, of general and administrative costs to inventory.
General and administrative costs included in inventory at December 31, 2020 and 2019 were $30.7 million and
$22.8 million, respectively.
At December 31, 2020 and 2019, $130.0 million and $117.8 million, respectively, of the Company’s
finished goods inventories were held on consignment.
Property, Plant, and Equipment
Property, plant, and equipment are recorded at cost. Depreciation is principally calculated for financial
reporting purposes on the straight-line method over the estimated useful lives of the related assets, which range
from 10 to 40 years for buildings and improvements, from 3 to 15 years for machinery and equipment, and from
3 to 5 years for software. Leasehold improvements are amortized over the life of the related facility leases or the
asset, whichever is shorter. Straight-line and accelerated methods of depreciation are used for income tax
purposes. Construction in progress is not depreciated until the asset is ready for its intended use.
Depreciation expense for property, plant, and equipment was $101.8 million, $84.7 million, and
$74.9 million for the years ended December 31, 2020, 2019, and 2018, respectively.
Leases
On January 1, 2019, the Company adopted an amendment to the guidance on leases using a modified
retrospective transition approach. The Company determines whether a contract is, or contains, a lease at
inception. Right-of-use assets represent the Company’s right to use an underlying asset during the lease term, and
lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Right-of-use
56
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)
assets and lease liabilities are recognized at lease commencement based upon the estimated present value of
unpaid lease payments over the lease term. The Company uses its incremental borrowing rate based on the
information available at lease commencement in determining the present value of unpaid lease payments. The
Company’s incremental borrowing rate is determined based on the estimated rate of interest for collateralized
borrowing over a similar term as the associated lease. Right-of-use assets also include any lease payments made
at or before lease commencement and any initial direct costs incurred, and exclude any lease incentives received.
The Company determines the lease term as the noncancellable period of the lease, and may include options
to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Leases
with a term of 12 months or less are not recognized on the balance sheet. Certain of the Company’s leases
include variable lease payments that are based on costs incurred or actual usage, or adjusted periodically based
on an index or a rate. The Company’s leases do not contain any residual value guarantees.
The Company accounts for the lease and non-lease components as a single lease component for all of its
leases except vehicle leases, for which the lease and non-lease components are accounted for separately.
Operating leases are included in “Operating Lease Right-of-Use Assets” and “Operating Lease Liabilities”
on the Company’s consolidated balance sheets. See Note 6 for further information.
Impairment of Goodwill and Long-lived Assets
Goodwill is reviewed for impairment annually in the fourth quarter of each fiscal year, or whenever an event
occurs or circumstances change that would indicate that the carrying amount may be impaired. Goodwill is tested
for impairment at the reporting unit level by first performing a qualitative assessment to determine whether it is
more likely than not that the fair value of the reporting unit is less than its carrying value. If the reporting unit
does not pass the qualitative assessment, then the Company performs a quantitative impairment test. The
Company determined, after performing a qualitative review of each reporting unit, that it is more likely than not
that the fair value of each of its reporting units substantially exceeds the respective carrying amounts.
Accordingly, in 2020, 2019, and 2018, the Company did not record any impairment loss.
Indefinite-lived intangible assets relate to in-process research and development acquired in business
combinations. The estimated fair values of in-process research and development projects acquired in a business
combination which have not reached technological feasibility are capitalized and accounted for as indefinite-
lived intangible assets subject to impairment testing until completion or abandonment of the projects. Upon
successful completion of the project, the capitalized amount is amortized over its estimated useful life. If the
project is abandoned, all remaining capitalized amounts are written off immediately. Indefinite-lived intangible
assets are reviewed for impairment annually in the fourth quarter of each fiscal year, or whenever an event occurs
or circumstances change that would indicate the carrying amount may be impaired. An impairment loss is
recognized when the asset’s carrying value exceeds its fair value. In-process research and development projects
acquired in an asset acquisition are expensed unless the project has an alternative future use.
Management reviews the carrying amounts of other finite-lived intangible assets and long-lived tangible
assets whenever events or circumstances indicate that the carrying amounts of an asset may not be recoverable.
Impairment indicators include, among other conditions, cash flow deficits, historic or anticipated declines in
revenue or operating profit, and adverse legal or regulatory developments. If it is determined that such indicators
are present and the review indicates that the assets will not be fully recoverable, based on undiscounted estimated
cash flows over the remaining amortization periods, their carrying values are reduced to estimated fair market
57
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)
value. Estimated fair market value is determined primarily using the anticipated cash flows discounted at a rate
commensurate with the risk involved. For the purposes of identifying and measuring impairment, long-lived
assets are grouped with other assets and liabilities at the lowest level for which identifiable cash flows are largely
independent of the cash flows of other assets and liabilities.
In 2020, the Company did not record any impairment loss related to its in-process research and development
assets. In 2019, the Company recorded a $40.6 million charge related to the impairment of certain in-process
research and development assets. In 2018, the Company recorded a $116.2 million charge related to the
impairment of certain developed technology and in-process research and development assets. See Note 4 for
further information.
Income Taxes
The Company is subject to income taxes in the United States and numerous foreign jurisdictions. Significant
judgment is required in evaluating the Company’s uncertain tax positions and determining its provision for
income taxes. The Company recognizes the financial statement benefit of a tax position only after determining
that a position would more likely than not be sustained based upon its technical merit if challenged by the
relevant taxing authority and taken by management to the court of last resort. For tax positions meeting the more-
likely-than-not threshold, the amount recognized in the consolidated financial statements is the largest benefit
that has a greater than 50% likelihood of being realized upon settlement with the relevant tax authority. The
Company recognizes interest and penalties related to income tax matters in income tax expense. The Company
has made an accounting policy election to recognize the U.S. tax effects of global intangible low-taxed income as
a component of income tax expense in the period the tax arises.
Deferred tax assets and liabilities are recognized for the expected future tax consequences of events that
have been recognized in the Company’s financial statements or tax returns. The Company evaluates quarterly the
realizability of its deferred tax assets by assessing its valuation allowance and adjusting the amount, if necessary.
The factors used to assess the likelihood of realization are both historical experience and the Company’s forecast
of future taxable income and available tax planning strategies that could be implemented to realize the net
deferred tax assets. Failure to achieve forecasted taxable income in the applicable taxing jurisdictions could
affect the ultimate realization of deferred tax assets and could result in an increase in the Company’s effective tax
rate on future earnings.
Research and Development Costs
Research and development costs are charged to expense when incurred.
Earnings per Share
Basic earnings per share is computed by dividing net income by the weighted-average common shares
outstanding during a period. Diluted earnings per share is computed based on the weighted-average common
shares outstanding plus the effect of dilutive potential common shares outstanding during the period calculated
using the treasury stock method. Dilutive potential common shares include employee equity share options,
nonvested shares, and similar equity instruments granted by the Company. Potential common share equivalents
have been excluded where their inclusion would be anti-dilutive.
58
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)
The table below presents the computation of basic and diluted earnings per share (in millions, except for per
share information):
Basic:
Years Ended December 31,
2020
2019
2018
Net income . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$823.4
$1,046.9
$722.2
Weighted-average shares outstanding . . . . . . . . . . . . . .
622.6
624.8
627.6
Basic earnings per share . . . . . . . . . . . . . . . . . . . . . . . .
$ 1.32
$
1.68
$ 1.15
Diluted:
Net income . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$823.4
$1,046.9
$722.2
Weighted-average shares outstanding . . . . . . . . . . . . . .
Dilutive effect of stock plans . . . . . . . . . . . . . . . . . . . .
Dilutive weighted-average shares outstanding . . . . . . .
622.6
9.3
631.9
624.8
11.9
636.7
627.6
13.3
640.9
Diluted earnings per share . . . . . . . . . . . . . . . . . . . . . . .
$ 1.30
$
1.64
$ 1.13
Stock options, restricted stock units, and market-based restricted stock units to purchase approximately
2.0 million, 1.5 million, and 3.2 million shares were outstanding for the years ended December 31, 2020, 2019,
and 2018, respectively, but were not included in the computation of diluted earnings per share because the effect
would have been anti-dilutive.
Stock-based Compensation
The Company measures and recognizes compensation expense for all stock-based awards based on
estimated fair values. Stock-based awards consist of stock options, restricted stock units (service-based, market-
based, and performance-based), and employee stock purchase subscriptions. Stock-based compensation expense
is measured at the grant date based on the fair value of the award and is recognized as expense over the requisite
service period (vesting period) on a straight-line basis. For performance-based restricted stock units, the
Company recognizes stock-based compensation expense if and when the Company concludes that it is probable
that the performance condition will be achieved, net of estimated forfeitures. The Company reassesses the
probability of vesting at each quarter end and adjusts the stock-based compensation expense based on its
probability assessment. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent
periods if actual forfeitures differ from those estimates. Upon exercise of stock options or vesting of restricted
stock units, the Company issues common stock.
59
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)
Total stock-based compensation expense was as follows (in millions):
Years Ended December 31,
2020
2019
2018
Cost of sales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Selling, general, and administrative expenses . . . . . . . . . . . . . .
Research and development expenses . . . . . . . . . . . . . . . . . . . . .
$ 17.2
56.6
18.8
$ 14.7
51.2
15.4
$ 11.4
46.3
13.3
Total stock-based compensation expense . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Income tax benefit
92.6
(15.4)
81.3
(14.8)
71.0
(13.4)
Total stock-based compensation expense, net of tax . . . . .
$ 77.2
$ 66.5
$ 57.6
Upon a participant’s retirement, all unvested stock options and performance-based restricted stock units are
immediately forfeited. In addition, upon retirement, a participant will immediately vest in 25% of service-based
restricted stock units for each full year of employment with the Company measured from the grant date. All
remaining unvested service-based restricted stock units are immediately forfeited. For market-based restricted
stock units, upon retirement and in certain other specified cases, a participant will receive a pro-rated portion of
the shares that would ultimately be issued based on attainment of the performance goals as determined on the
vesting date. The pro-rated portion is based on the participant’s whole months of service with the Company
during the performance period prior to the date of termination.
Derivatives
The Company uses derivative financial instruments to manage interest rate and foreign currency risks. It is
the Company’s policy not to enter into derivative financial instruments for speculative purposes.
Derivative financial instruments involve credit risk in the event the counterparty should default. It is the
Company’s policy to execute such instruments with global financial institutions that the Company believes to be
creditworthy. The Company diversifies its derivative financial instruments among counterparties to minimize
exposure to any one of these entities. The Company also uses International Swap Dealers Association master-
netting agreements. The master-netting agreements provide for the net settlement of all contracts through a single
payment in a single currency in the event of default, as defined by the agreements.
The Company uses foreign currency forward exchange contracts, cross currency swap contracts, and foreign
currency denominated debt to manage its exposure to changes in currency exchange rates from (1) future cash
flows associated with intercompany transactions and certain local currency expenses expected to occur within the
next 13 months (designated as cash flow hedges), (2) its net investment in certain foreign subsidiaries
(designated as net investment hedges) and (3) foreign currency denominated assets or liabilities (designated as
fair value hedges). The Company also uses foreign currency forward exchange contracts that are not designated
as hedging instruments to offset the transaction gains and losses associated with certain assets and liabilities
denominated in currencies other than their functional currencies resulting principally from intercompany and
local currency transactions.
All derivative financial instruments are recognized at fair value in the consolidated balance sheets. For each
derivative instrument that is designated as a fair value hedge, the gain or loss on the derivative included in the
assessment of hedge effectiveness is recognized immediately to earnings, and offsets the loss or gain on the
underlying hedged item. The Company reports in “Accumulated Other Comprehensive Loss” the gain or loss on
60
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)
derivative financial instruments that are designated, and that qualify, as cash flow hedges. The Company
reclassifies these gains and losses into earnings in the same line item and in the same period in which the
underlying hedged transactions affect earnings. Changes in the fair value of net investment hedges are reported in
“Accumulated Other Comprehensive Loss” as a part of the cumulative translation adjustment and would be
reclassified into earnings if the underlying net investment is sold or substantially liquidated. The portion of the
change in fair value related to components excluded from the hedge effectiveness assessment are amortized into
earnings over the life of the derivative. The gains and losses on derivative financial instruments for which the
Company does not elect hedge accounting treatment are recognized in the consolidated statements of operations
in each period based upon the change in the fair value of the derivative financial instrument. Cash flows from net
investment hedges are reported as investing activities in the consolidated statements of cash flows, and cash
flows from all other derivative financial instruments are reported as operating activities.
Recently Adopted Accounting Standards
In August 2018, the Financial Accounting Standards Board (“FASB”) issued an amendment to the
accounting guidance on cloud computing service arrangements. The guidance aligns the requirements for
capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the
requirements for capitalizing implementation costs incurred to develop or obtain internal-use software. The
guidance also requires an entity to expense the capitalized implementation costs of a hosting arrangement that is
a service contract over the term of the hosting arrangement. The guidance was effective for fiscal years beginning
after December 15, 2019, and interim periods within those fiscal years. The adoption of this guidance on January
1, 2020 did not have a material impact on the Company’s consolidated financial statements.
In August 2018, the FASB issued an amendment to the accounting guidance on fair value measurements.
The guidance modifies the disclosure requirements on fair value measurements, including the removal of
disclosures of the amount of and reasons for transfers between Level 1 and Level 2 of the fair value hierarchy,
the policy for timing of transfers between levels, and the valuation processes for Level 3 fair value
measurements. The guidance also adds certain disclosure requirements related to Level 3 fair value
measurements. The guidance was effective for fiscal years, and interim periods within those fiscal years,
beginning after December 15, 2019. The adoption of this guidance on January 1, 2020 did not have a material
impact on the Company’s consolidated financial statements.
In June 2016, the FASB issued an amendment to the guidance on the measurement of credit losses on
financial instruments. The amendment updates the guidance for measuring and recording credit losses on
financial assets measured at amortized cost by replacing the “incurred loss” model with an “expected loss”
model. Accordingly, these financial assets will be presented at the net amount expected to be collected. The
amendment also requires that credit losses related to available-for-sale debt securities be recorded as an
allowance through net income rather than reducing the carrying amount under the current, other-than-temporary-
impairment model. The guidance was effective for fiscal years beginning after December 15, 2019, including
interim periods within those fiscal years. The adoption of this guidance on January 1, 2020 did not have a
material impact on the Company’s consolidated financial statements.
3. INTELLECTUAL PROPERTY LITIGATION EXPENSES, NET
The Company incurred intellectual property litigation expenses, including settlements and external legal
costs, of $405.4 million, $33.4 million and $214.0 million during 2020, 2019 and 2018, respectively.
61
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
3. INTELLECTUAL PROPERTY LITIGATION EXPENSES, NET (Continued)
On July 12, 2020, the Company reached an agreement with Abbott Laboratories and its direct and indirect
subsidiaries (“Abbott”) to, among other things, settle all outstanding patent disputes between the companies (the
“Settlement Agreement”) in cases related to transcatheter mitral and tricuspid repair products. See Note 18 for
additional information. The Settlement Agreement resulted in the Company recording an estimated
$367.9 million pre-tax charge and related liability in June 2020 related to past damages. In addition, the
Company will incur royalty expenses through May 2024 totaling an estimated $100 million. The Company made
a one-time $100.0 million payment to Abbott in July 2020, and will make quarterly payments in future years.
In January 2019, the Company reached an agreement with Boston Scientific Corporation (“Boston
Scientific”) to settle all outstanding patent disputes for a one-time payment to Boston Scientific of
$180.0 million, which was included as an expense in 2018. The settlement covered alleged past damages and no
further royalties will be owed by either party.
4. SPECIAL CHARGES (GAIN)
Impairment of Long-lived Assets
In December 2019, the Company recorded a charge of $40.6 million related to the impairment of certain
in-process research and development assets, and in December 2018, the Company recorded a charge of
$116.2 million related to the impairment of certain developed technology and in-process research and
development assets. These assets were acquired as part of the acquisition of Valtech Cardio Ltd. (“Valtech”). The
Company measured the amount of the impairments by calculating the amount by which the carrying values
exceeded the estimated fair values, which were based on projected discounted future net cash flows. Based on
market and clinical trial developments at the time of the impairments, the Company re-evaluated the clinical
development plans for the technologies acquired from Valtech, which resulted in a reduction to the projected
near-term discounted future net cash flows related to the acquired mitral technology for the 2018 charge, and
related to the acquired mitral and tricuspid technology for the 2019 charge. The impairments were recorded to the
Company’s Rest of World segment.
Acquisition of Intellectual Property
In March 2019, the Company recorded a $24.0 million charge related to the acquisition of early-stage
transcatheter intellectual property and associated clinical and regulatory experience.
Pension Gain
In March 2018, the Company recorded a $7.1 million gain related to the curtailment of its defined benefit
plan in Switzerland resulting from the closure of its manufacturing plant.
62
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
5. OTHER CONSOLIDATED FINANCIAL STATEMENT DETAILS
Composition of Certain Financial Statement Captions
Components of selected captions in the consolidated balance sheets are as follows:
As of December 31,
2020
2019
(in millions)
Inventories
Raw materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Work in process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Finished products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 136.7
140.0
525.6
$ 118.0
121.7
401.2
$ 802.3
$ 640.9
Property, plant, and equipment, net
Land . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Buildings and leasehold improvements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Machinery and equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Equipment with customers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Construction in progress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$
97.6
881.5
564.9
42.2
94.2
313.3
$
98.0
619.8
466.3
35.6
87.9
265.0
Accumulated depreciation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1,993.7
(598.5)
1,572.6
(512.3)
$1,395.2
$1,060.3
Accrued and other liabilities
Employee compensation and withholdings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accrued rebates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Property, payroll, and other taxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Research and development accruals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Litigation settlement (Notes 3 and 18) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Litigation and insurance reserves (Note 18) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Taxes payable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fair value of derivatives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accrued marketing expenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accrued professional services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accrued realignment reserves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accrued relocation related costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other accrued liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 236.7
67.2
49.7
52.3
37.5
23.3
18.6
39.3
14.3
7.6
14.5
21.0
88.2
$ 295.8
67.1
51.4
51.4
—
20.0
52.9
6.4
17.5
10.1
16.7
17.4
89.8
$ 670.2
$ 696.5
In 2019, the Company recorded a $73.1 million charge to “Cost of Sales,” primarily comprised of the write
off of inventory related to strategic decisions regarding its transcatheter aortic valve portfolio, including the
decision to discontinue its CENTERA program.
63
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
5. OTHER CONSOLIDATED FINANCIAL STATEMENT DETAILS (Continued)
Supplemental Cash Flow Information
(in millions)
Years Ended December 31,
2020
2019
2018
Cash paid during the year for:
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Interest
Income taxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Amounts included in the measurement of lease liabilities:
$ 19.9
$197.9
$19.9
$61.5
$ 30.1
$223.7
Operating cash flows from operating leases . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 29.7
$28.6
$ —
Non-cash investing and financing transactions:
Fair value of shares issued in payment for contingent consideration liabilities . . .
Right-of-use assets obtained in exchange for new lease liabilities . . . . . . . . . . . . .
Capital expenditures accruals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ — $ — $ 34.3
$49.6
$ 39.7
$50.8
$ 80.4
$ —
$ 18.7
Cash, Cash Equivalents, and Restricted Cash
(in millions)
Years Ended December 31,
2020
2019
2018
Cash and cash equivalents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Restricted cash included in other current assets . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Restricted cash included in other assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$1,183.2
16.6
0.4
$1,179.1
1.6
3.7
$714.1
1.5
0.3
Total cash, cash equivalents, and restricted cash . . . . . . . . . . . . . . . . . . . . . . .
$1,200.2
$1,184.4
$715.9
Amounts included in restricted cash primarily represent funds placed in escrow related to litigation and real
estate purchases, and funds restricted for construction.
6. LEASES
The Company leases certain office space, manufacturing facilities, land, apartments, warehouses, vehicles,
and equipment with remaining lease terms ranging from less than 1 year to 20 years, some of which include
options to extend or terminate the leases.
Operating lease costs for the years ended December 31, 2020, 2019, and 2018 were $30.5 million,
$27.9 million, and $27.0 million, respectively. Short-term and variable lease costs were not material for the years
ended December 31, 2020 and 2019.
64
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
6. LEASES (Continued)
Supplemental balance sheet information related to operating leases was as follows (in millions, except lease
term and discount rate):
Operating lease right-of-use assets . . . . . . . . . . . . . . . . . . . .
Operating lease liabilities, current portion . . . . . . . . . . . . . .
Operating lease liabilities, long-term portion . . . . . . . . . . . .
Total operating lease liabilities . . . . . . . . . . . . . . . . . . .
As of December 31,
2020
$94.2
$27.2
72.7
$99.9
2019
$80.1
$25.5
58.9
$84.4
Maturities of operating lease liabilities at December 31, 2020 were as follows (in millions):
2021 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2022 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2023 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2024 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2025 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Thereafter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 30.0
20.7
14.4
8.8
6.1
28.1
Total lease payments . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . .
Less: imputed interest
108.1
(8.2)
Total lease liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 99.9
The following table provides information on the lease terms and discount rates:
Weighted-average remaining lease term (in years) . . . . .
Weighted-average discount rate . . . . . . . . . . . . . . . . . . . .
Years Ended December 31,
2020
6.6
2.7 %
2019
5.3
2.8 %
As of December 31, 2020, the Company had no additional operating lease commitments for office space
that have not yet commenced.
65
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
7. INVESTMENTS
Debt Securities
Investments in debt securities at the end of each period were as follows (in millions):
Held-to-maturity
December 31, 2020
December 31, 2019
Amortized
Cost
Gross
Unrealized
Gains
Gross
Unrealized
Losses
Fair
Value
Amortized
Cost
Gross
Unrealized
Gains
Gross
Unrealized
Losses
Fair
Value
Bank time deposits . . . . . . . .
$ 50.0
$ —
$—
$ 50.0
$100.2
$—
$ — $100.2
Available-for-sale
Bank time deposits . . . . . . . .
Commercial paper . . . . . . . .
U.S. government and agency
securities . . . . . . . . . . . . .
Foreign government
bonds . . . . . . . . . . . . . . . .
Asset-backed securities . . . .
Corporate debt securities . . .
Municipal securities . . . . . . .
$ 24.1
—
$ —
—
$—
—
$ 24.1
—
$ 13.1
34.3
$—
—
$ — $ 13.1
34.3
—
147.0
—
149.6
600.8
2.8
2.2
—
1.9
7.5
—
—
—
—
—
—
149.2
113.2
—
151.5
608.3
2.8
1.7
141.2
487.0
—
0.6
—
0.6
2.3
—
—
113.8
—
(0.1)
(0.1)
—
1.7
141.7
489.2
—
$924.3
$11.6
$—
$935.9
$790.5
$ 3.5
$(0.2)
$793.8
The cost and fair value of investments in debt securities, by contractual maturity, as of December 31, 2020
were as follows:
Due in 1 year or less . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Due after 1 year through 5 years . . . . . . . . . . . . . . . . . . . .
Instruments not due at a single maturity date . . . . . . . . . .
Held-to-Maturity
Available-for-Sale
Amortized
Cost
Fair
Value
Amortized
Cost
Fair
Value
$50.0
—
—
$50.0
(in millions)
$50.0
—
—
$50.0
$168.4
578.2
177.7
$924.3
$169.4
586.5
180.0
$935.9
Actual maturities may differ from the contractual maturities due to call or prepayment rights.
66
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
7. INVESTMENTS (Continued)
There were no investments that were in an unrealized loss position as of December 31, 2020. The following
table presents gross unrealized losses and fair values for those investments that were in an unrealized loss
position as of December 31, 2019, aggregated by investment category and the length of time that individual
securities have been in a continuous loss position (in millions):
Asset-backed securities . . . . . . . . . . . . . . . . . . . . . .
Corporate debt securities . . . . . . . . . . . . . . . . . . . . .
Less than 12 Months
December 31, 2019
12 Months or
Greater
Fair
Value
$ 73.4
81.4
$154.8
Gross
Unrealized
Losses
Fair
Value
Gross
Unrealized
Losses
$(0.1)
$—
(0.1) —
$(0.2)
$—
$—
—
$—
Total
Gross
Unrealized
Losses
$(0.1)
(0.1)
$(0.2)
Fair
Value
$ 73.4
81.4
$154.8
Investments in Unconsolidated Affiliates
The Company has a number of equity investments in privately and publicly held companies. Investments in
these unconsolidated affiliates are recorded in “Long-term Investments” on the consolidated balance sheets, and
are as follows:
December 31,
2020
2019
(in millions)
Equity method investments
Carrying value of equity method investments . . . . . . . . . . .
$ 5.7
$ 6.2
Equity securities
Carrying value of non-marketable equity securities . . . . . . .
29.4
23.1
Total investments in unconsolidated affiliates . . . . . . . . . . . . .
$35.1
$29.3
Non-marketable equity securities consist of investments in privately held companies without readily
determinable fair values, and are reported at cost minus impairment, if any, plus or minus changes resulting from
observable price changes in orderly transactions for the identical or similar investment of the same issuer. The
Company recorded an upward adjustment of $1.8 million based on observable price changes and a downward
adjustment of $0.7 million due to an impairment during 2020, and an upward adjustment of $0.3 million based on
observable price changes during 2019. As of December 31, 2020 and 2019, the Company had recorded
accumulated upward adjustments of $3.8 million and $2.0 million, respectively, based on observable price
changes, and accumulated downward adjustments of $2.6 million and $1.9 million, respectively, due to
impairment and observable price changes.
During 2020, 2019, and 2018, the gross realized gains or losses from sales of available-for-sale investments
were not material.
8. ACQUISITIONS
CAS Medical Systems, Inc.
On February 11, 2019, the Company entered into an agreement and plan of merger to acquire all the
outstanding shares of CAS Medical Systems, Inc. (“CASMED”) for an aggregate cash purchase price of $2.45
67
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
8. ACQUISITIONS (Continued)
per share of common stock, or an equity value of approximately $100 million. The transaction closed on
April 18, 2019, and the cash purchase price was $100.8 million. Acquisition-related costs of $2.0 million were
recorded in “Selling, General, and Administrative Expenses” during the year ended December 31, 2019.
CASMED is a medical technology company dedicated to noninvasive monitoring of tissue oxygenation in
the brain. The Company integrated the acquired technology platform into its hemodynamic monitoring platform.
The acquisition was accounted for as a business combination. Tangible and intangible assets acquired were
recorded based on their estimated fair values at the acquisition date. The excess of the purchase price over the
fair value of net assets acquired was recorded to goodwill. The following table summarizes the fair values of the
assets acquired and liabilities assumed (in millions):
Current assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Property and equipment, net . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Goodwill . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Developed technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Customer relationships . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deferred tax assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Liabilities assumed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total purchase price . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Less: cash acquired . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$
6.1
1.3
64.4
35.9
8.8
2.2
(17.9)
100.8
(0.6)
Total purchase price, net of cash acquired . . . . . . . . . . . . .
$100.2
Goodwill includes expected synergies and other benefits the Company believes will result from the
acquisition. Goodwill was assigned to the Company’s United States segment and is not deductible for tax
purposes. Developed technology assets are being amortized over a weighted-average useful life of 14 years.
Customer relationships assets are being amortized over a weighted-average useful life of 10 years.
The results of operations for CASMED have been included in the accompanying consolidated financial
statements from the date of acquisition. Pro forma results have not been presented as the results of CASMED are
not material in relation to the consolidated financial statements of Edwards Lifesciences.
Harpoon Medical, Inc.
On December 1, 2017, the Company acquired all the outstanding shares of Harpoon Medical, Inc. for an
aggregate cash purchase price of $119.5 million, which includes $16.0 million paid previously for a cost method
investment and an exclusive option to acquire Harpoon Medical, Inc., and is net of $8.0 million received from the
sale of the Company’s previous ownership interest. In addition, the Company agreed to pay up to an additional
$150.0 million in pre-specified milestone-driven payments over the next 10 years. The Company recognized in
“Contingent Consideration Liabilities” a $59.7 million liability for the estimated fair value of the contingent
milestone payments. The fair value of the contingent milestone payments are remeasured each quarter, with
changes in the fair value recognized within operating expenses on the consolidated statements of operations. For
further information on the fair value of the contingent milestone payments, see Note 11.
In-process research and development assets acquired as part of this transaction were capitalized at fair value,
which was determined using the income approach. This approach determines fair value based on cash flow
projections which are discounted to present value using a risk-adjusted rate of return. Completion of successful
68
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
8. ACQUISITIONS (Continued)
design developments, bench testing, pre-clinical studies and human clinical studies are required prior to selling
any product. The risks and uncertainties associated with completing development within a reasonable period of
time include those related to the design, development, and manufacturability of the product, the success of
pre-clinical and clinical studies, and the timing of regulatory approvals. The valuation assumed $41.4 million of
additional research and development expenditures would be incurred prior to the date of product introduction. In
the valuation, net cash inflows were modeled to commence in Europe in 2018, and in the United States and Japan
in 2022. The Company does not currently anticipate significant changes to forecasted research and development
expenditures, and net cash inflows commenced in Europe in 2020 and are now expected to commence in the
United States and Japan in 2023. Upon completion of development, the underlying in-process research and
development asset will be amortized over its estimated useful life.
Valtech Cardio Ltd.
On November 26, 2016, the Company entered into an agreement and plan of merger to acquire Valtech
Cardio Ltd. (“Valtech”) for approximately $340.0 million, subject to certain adjustments, with the potential for
up to an additional $350.0 million in pre-specified milestone-driven payments over the next 10.0 years. The
transaction closed on January 23, 2017, and the consideration paid included the issuance of approximately
2.8 million shares of the Company’s common stock (fair value of $266.5 million) and cash of $86.2 million. The
Company recognized in “Contingent Consideration Liabilities” a $162.9 million liability for the estimated fair
value of the contingent milestone payments. For further information on the fair value of the contingent milestone
payments, see Note 11.
Prior to the close of the transaction, Valtech spun off its early-stage transseptal mitral valve replacement
technology program. Concurrent with the closing, the Company entered into an agreement for an exclusive
option to acquire that program and its associated intellectual property for approximately $200.0 million, subject
to certain adjustments, plus an additional $50.0 million if a certain European regulatory approval is obtained
within 10 years of the acquisition closing date. The option expired in January 2020.
In-process research and development assets acquired as part of this transaction were capitalized at fair value,
which was determined using the income approach. This approach determines fair value based on cash flow
projections which are discounted to present value using a risk-adjusted rate of return. The valuation assumed
$87.3 million of additional research and development expenditures would be incurred prior to the date of product
introduction and that net cash inflows would commence in 2019. In December 2018, the Company recorded a
$116.2 million impairment charge related to Valtech’s intangible assets, and in December 2019, the Company
recorded a $40.6 million impairment charge to write off the remaining in-process research and development
assets. For further information, see Note 4.
CardiAQ Valve Technologies, Inc.
On July 3, 2015, the Company entered into an agreement and plan of merger to acquire CardiAQ Valve
Technologies, Inc. (“CardiAQ”) for an aggregate cash purchase price of $350.0 million, subject to certain
adjustments. The transaction closed on August 26, 2015, and the cash purchase price after the adjustments was
$348.0 million. In addition, the Company agreed to pay an additional $50.0 million if a certain European
regulatory approval is obtained within 48 months of the acquisition closing date. The Company recognized in
“Contingent Consideration Liabilities” a $30.3 million liability for the estimated fair value of this contingent
milestone payment. The Company estimated this milestone would not be achieved and reversed the liability in
2018. For further information on the fair value of the contingent milestone payment, see Note 11.
69
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
8. ACQUISITIONS (Continued)
In-process research and development assets acquired as part of this acquisition were capitalized at fair value,
which was determined using the income approach. This approach determines fair value based on cash flow
projections which are discounted to present value using a risk-adjusted rate of return. Completion of successful
design developments, bench testing, pre-clinical studies and human clinical studies are required prior to selling
any product. The risks and uncertainties associated with completing development within a reasonable period of
time include those related to the design, development, and manufacturability of the product, the success of
pre-clinical and clinical studies, and the timing of regulatory approvals. The valuation assumed $97.7 million of
additional research and development expenditures would be incurred prior to the date of product introduction and
that net cash inflows would commence in late 2018. As a result of certain design enhancements to increase the
product’s commercial life and applicability to a broader group of patients, the Company has incurred incremental
research and development expenditures; however, the Company expects an increase in the net cash inflows,
commencing in 2023. Upon completion of development, the underlying research and development intangible
asset will be amortized over its estimated useful life.
9. GOODWILL AND OTHER INTANGIBLE ASSETS
Goodwill and in-process research and development assets resulting from purchase business combinations
are not subject to amortization. Other acquired intangible assets with finite lives are amortized over their
expected useful lives on a straight- line basis, or if reliably determinable, based on the pattern in which the
economic benefit of the asset is expected to be used. The Company expenses costs incurred to renew or extend
the term of acquired intangible assets.
In April 2019, the Company acquired CASMED. This transaction resulted in an increase to goodwill of
$64.4 million and developed technology of $35.9 million. For further information, see Note 8.
The changes in the carrying amount of goodwill, by segment, during the years ended December 31, 2020
and 2019 were as follows:
United
States
Europe
Rest of
World
Total
(in millions)
Goodwill at December 31, 2018 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Goodwill acquired during the year . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Currency translation adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$709.3
$64.2
64.4 —
—
(1.4)
$338.7
—
(7.5)
$1,112.2
64.4
(8.9)
Goodwill at December 31, 2019 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Currency translation adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
773.7
—
62.8
5.5
331.2
—
1,167.7
5.5
Goodwill at December 31, 2020 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$773.7
$68.3
$331.2
$1,173.2
70
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
9. GOODWILL AND OTHER INTANGIBLE ASSETS (Continued)
Other intangible assets consist of the following (in millions):
Finite-lived intangible assets
Patents . . . . . . . . . . . . . . . . . .
Developed technology . . . . .
Other . . . . . . . . . . . . . . . . . . .
Indefinite-lived intangible assets
In-process research and
development . . . . . . . . . . .
December 31,
Weighted-
Average
Useful Life
(in years)
2020
2019
Cost
Accumulated
Amortization
Net
Carrying
Value
Cost
Accumulated
Amortization
Net
Carrying
Value
7.4
13.1
10.0
12.6
$186.1
155.2
12.6
353.9
$(183.6)
(51.0)
(6.0)
$
2.5
104.2
6.6
$185.7
153.5
12.3
$(182.1)
(46.6)
(4.4)
$
3.6
106.9
7.9
(240.6)
113.3
351.5
(233.1)
118.4
218.1
—
218.1
218.1
—
218.1
$572.0
$(240.6)
$331.4
$569.6
$(233.1)
$336.5
Amortization expense related to other intangible assets for the years ended December 31, 2020, 2019, and
2018 was $5.4 million, $4.6 million, and $2.5 million, respectively. Estimated amortization expense for each of
the years ending December 31 is as follows (in millions):
2021 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2022 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2023 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2024 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2025 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 5.2
7.6
10.1
12.2
14.8
10. DEBT AND CREDIT FACILITIES
In June 2018, the Company issued $600.0 million of fixed-rate unsecured senior notes (the “Notes”) due
June 15, 2028. Interest is payable semi-annually in arrears, with payments due in June and December of each
year. The Company may redeem the Notes, in whole or in part, at any time and from time to time at specified
redemption prices. In addition, upon the occurrence of certain change of control triggering events, the Company
may be required to repurchase all or a portion of the Notes at a price equal to 101% of their principal amount,
plus accrued and unpaid interest. The Notes also include covenants that limit the Company’s ability to incur
secured indebtedness, enter into sale and leaseback transactions, and consolidate, merge, or transfer all or
substantially all of its assets.
71
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
10. DEBT AND CREDIT FACILITIES (Continued)
The following is a summary of the Notes as of December 31, 2020 and 2019:
Fixed-rate 4.300% 2018 Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Unamortized discount . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Unamortized debt issuance costs . . . . . . . . . . . . . . . . . . . . . . . . . . . .
December 31,
2020
2019
Amount
(in millions)
$600.0
(1.1)
(3.9)
Effective
Interest
Rate
Amount
(in millions)
4.329% $600.0
(1.2)
(4.4)
Effective
Interest
Rate
4.329%
Total carrying amount
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$595.0
$594.4
As of December 31, 2020 and 2019, the fair value of the Notes was $711.2 million and $667.6 million,
respectively, based on observable market prices in less active markets and categorized as Level 2 (Note 11). The
debt issuance costs, as well as the discount, are being amortized to interest expense over the term of the notes.
The Company has a Five-Year Credit Agreement (“the Credit Agreement”) which matures on April 28,
2023. The Credit Agreement provides up to an aggregate of $750.0 million in borrowings in multiple currencies.
The Company may increase the amount available under the Credit Agreement, subject to agreement of the
lenders, by up to an additional $250.0 million in the aggregate. Borrowings generally bear interest at the London
interbank offered rate (“LIBOR”), or a comparable or successor rate, plus a spread ranging from 0.9% to 1.3%,
depending on the leverage ratio, as defined in the Credit Agreement. The Company also pays a facility fee
ranging from 0.1% to 0.2%, depending on the leverage ratio, on the entire credit commitment available, whether
drawn or not. The facility fee is expensed as incurred. During 2020, the spread over LIBOR was 0.9% and the
facility fee was 0.1%. Issuance costs of $2.4 million are being amortized to interest expense over the term of the
Credit Agreement. As of December 31, 2020 and 2019, there were no borrowings outstanding under the Credit
Agreement. Amounts outstanding under the Credit Agreement, if any from time to time, are classified as long-
term obligations in accordance with the terms of the Credit Agreement. The Credit Agreement is unsecured and
contains various financial and other covenants, including a maximum leverage ratio, as defined in the Credit
Agreement. The Company was in compliance with all covenants at December 31, 2020.
The weighted-average interest rate under all debt obligations was 3.5% and 3.4% at December 31, 2020 and
2019, respectively.
11. FAIR VALUE MEASUREMENTS
The consolidated financial statements include financial instruments for which the fair market value of such
instruments may differ from amounts reflected on a historical cost basis. Financial instruments of the Company
consist of cash deposits, accounts and other receivables, investments, accounts payable, certain accrued
liabilities, and borrowings under a revolving credit agreement. The carrying value of these financial instruments
generally approximates fair value due to their short-term nature. Financial instruments also include notes
payable. See Note 10 for further information on the fair value of the notes payable.
Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an
orderly transaction between market participants. The Company prioritizes the inputs used to determine fair
values in one of the following three categories:
Level 1—Quoted market prices in active markets for identical assets or liabilities.
72
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
11. FAIR VALUE MEASUREMENTS (Continued)
Level 2—Inputs, other than quoted prices in active markets, that are observable, either directly or indirectly.
Level 3—Unobservable inputs that are not corroborated by market data.
In certain cases, the inputs used to measure fair value may fall into different levels of the fair value
hierarchy. In such cases, the level in the fair value hierarchy within which the fair value measurement in its
entirety falls has been determined based on the lowest level input that is significant to the fair value measurement
in its entirety.
73
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
11. FAIR VALUE MEASUREMENTS (Continued)
Assets and Liabilities Measured at Fair Value on a Recurring Basis
The following table summarizes the Company’s financial instruments which are measured at fair value on a
recurring basis as of December 31, 2020 and 2019 (in millions):
December 31, 2020
Assets
Cash equivalents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Available-for-sale investments:
Bank time deposits . . . . . . . . . . . . . . . . . . . . . . . .
Corporate debt securities . . . . . . . . . . . . . . . . . . .
Asset-backed securities . . . . . . . . . . . . . . . . . . . .
U.S. government and agency securities . . . . . . . .
Municipal securities . . . . . . . . . . . . . . . . . . . . . . .
Investments held for deferred compensation plans . . .
Derivatives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Level 1
Level 2
Level 3
Total
$ 16.2
$ —
$ —
$
16.2
—
—
—
56.9
—
111.2
—
24.1
608.3
151.5
92.2
2.8
—
8.1
—
—
—
—
—
—
—
24.1
608.3
151.5
149.1
2.8
111.2
8.1
$184.3
$887.0
$ —
$1,071.3
Liabilities
Derivatives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deferred compensation plans . . . . . . . . . . . . . . . . . . . .
Contingent consideration liabilities . . . . . . . . . . . . . . .
$ —
111.6
—
$ 39.3
—
—
$ —
—
186.1
$
39.3
111.6
186.1
$111.6
$ 39.3
$186.1
$ 337.0
December 31, 2019
Assets
Cash equivalents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Available-for-sale investments:
Bank time deposits . . . . . . . . . . . . . . . . . . . . . . . .
Corporate debt securities . . . . . . . . . . . . . . . . . . .
Asset-backed securities . . . . . . . . . . . . . . . . . . . .
U.S. government and agency securities . . . . . . . .
Foreign government bonds . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . .
Commercial paper
Investments held for deferred compensation plans . . .
Derivatives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$
0.7
$ 31.7
$ —
$
32.4
—
—
—
76.1
—
—
88.9
—
13.1
489.2
141.7
37.7
1.7
34.3
—
30.7
—
—
—
—
—
—
—
—
13.1
489.2
141.7
113.8
1.7
34.3
88.9
30.7
$165.7
$780.1
$ —
$ 945.8
Liabilities
Derivatives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deferred compensation plans . . . . . . . . . . . . . . . . . . . .
Contingent consideration liabilities . . . . . . . . . . . . . . .
$ —
88.7
—
$
6.4
—
—
$ —
—
172.5
$
6.4
88.7
172.5
$ 88.7
$
6.4
$172.5
$ 267.6
74
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
11. FAIR VALUE MEASUREMENTS (Continued)
The following table summarizes the changes in fair value of the contingent consideration obligation for the
years ended December 31, 2020 and 2019 (in millions):
Fair value, beginning of year . . . . . . . . . . . . . . . . . . . . . . . . . . .
Changes in fair value . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$172.5
13.6
$178.6
(6.1)
Fair value, end of year . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$186.1
$172.5
December 31,
2020
2019
The changes in 2020 in fair value of the contingent consideration obligation were primarily driven by the
accretion of interest due to the passage of time and adjustments to discount rates, partially offset by a
$12.7 million reduction to the liability due to changes in the projected probability and timing of milestone
achievements, and the projected timing of cash inflows. During 2019, the contingent consideration liability was
reduced by $24.1 million due to delays in product development, which reduced the probability of milestone
achievement. This reduction was partially offset by changes in the fair value of the liabilities associated primarily
with adjustments to discount rates and accretion of interest due to the passage of time.
Cash Equivalents and Available-for-sale Investments
The Company estimates the fair values of its money market funds based on quoted prices in active markets
for identical assets. The Company estimates the fair values of its time deposits, commercial paper, U.S. and
foreign government and agency securities, municipal securities, asset-backed securities, and corporate debt
securities by taking into consideration valuations obtained from third-party pricing services. The pricing services
use industry standard valuation models, including both income and market-based approaches, for which all
significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported
trades and broker-dealer quotes on the same or similar securities, benchmark yields, credit spreads, prepayment
and default projections based on historical data, and other observable inputs. The Company independently
reviews and validates the pricing received from the third-party pricing service by comparing the prices to prices
reported by a secondary pricing source. The Company’s validation procedures have not resulted in an adjustment
to the pricing received from the pricing service.
Deferred Compensation Plans
The Company holds investments in trading securities related to its deferred compensation plans. The
investments are in a variety of stock, bond, and money market mutual funds. The fair values of these investments
and the corresponding liabilities are based on quoted market prices.
Derivative Instruments
The Company uses derivative financial instruments in the form of foreign currency forward exchange
contracts and cross currency swap contracts to manage foreign currency exposures. All derivatives contracts are
recognized on the balance sheet at their fair value. The fair value of foreign currency derivative financial
instruments and the cross currency swap contracts was estimated based on quoted market foreign exchange rates,
cross currency swap basis rates, and market discount rates. Judgment was employed in interpreting market data
to develop estimates of fair value; accordingly, the estimates presented herein are not necessarily indicative of
the amounts that the Company could realize in a current market exchange. The use of different market
assumptions or valuation methodologies could have a material effect on the estimated fair value amounts.
75
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
11. FAIR VALUE MEASUREMENTS (Continued)
Contingent Consideration Liabilities
Certain of the Company’s acquisitions involve contingent consideration arrangements. Payment of
additional consideration is contingent upon the acquired company reaching certain performance milestones, such
as attaining specified revenue levels or obtaining regulatory approvals. These contingent consideration liabilities
are measured at estimated fair value using either a probability weighted discounted cash flow analysis or a Monte
Carlo simulation model, both of which consider significant unobservable inputs. These inputs include (1) the
discount rate used to present value the projected cash flows (ranging from 0.08% to 8.53%; weighted average of
3.1%), (2) the probability of milestone achievement (ranging from 0.4% to 99.7%; weighted average of 70.7%),
(3) the projected payment dates (ranging from 2023 to 2027; weighted average of 2026), and (4) the volatility of
future revenue (ranging from 37.0% to 40.0%; weighted average of 38.8%). The weighted average of each of the
above inputs was determined based on the relative fair value of each obligation. The use of different assumptions
could have a material effect on the estimated fair value amounts.
12. DERIVATIVE INSTRUMENTS AND HEDGING ACTIVITIES
The Company uses derivative financial instruments to manage its currency exchange rate risk and its
interest rate risk as summarized below. Notional amounts are stated in United States dollar equivalents at spot
exchange rates at the respective dates. The Company does not enter into these arrangements for trading or
speculation purposes.
Notional Amount
December 31,
2020
December 31,
2019
(in millions)
Foreign currency forward exchange contracts . . . . . .
Cross currency swap contracts . . . . . . . . . . . . . . . . . .
$1,525.5
300.0
$1,336.5
300.0
The following table presents the location and fair value amounts of derivative instruments reported in the
consolidated balance sheets (in millions):
Balance Sheet Location
Fair Value
December 31,
2020
December 31,
2019
Derivatives designated as hedging instruments
Assets
Foreign currency contracts . . . . . . . . . . . . . . . . . . Other current assets
Foreign currency contracts . . . . . . . . . . . . . . . . . . Other assets
Cross currency swap contracts . . . . . . . . . . . . . . . Other assets
$ 7.3
$—
$0.8
Liabilities
Foreign currency contracts . . . . . . . . . . . . . . . . . . Accrued and other liabilities
$39.3
$14.2
$3.2
$13.3
$ 6.4
76
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
12. DERIVATIVE INSTRUMENTS AND HEDGING ACTIVITIES (Continued)
The following table presents the effect of master-netting agreements and rights of offset on the consolidated
balance sheets (in millions):
Gross Amounts
Not Offset in the
Consolidated
Balance Sheet
December 31, 2020
Derivative Assets
Foreign currency contracts . . . . . . . . .
Cross currency swap contracts . . . . . .
Derivative Liabilities
Foreign currency contracts . . . . . . . . .
December 31, 2019
Derivative Assets
Foreign currency contracts . . . . . . . . .
Cross currency swap contracts . . . . . .
Derivative Liabilities
Foreign currency contracts . . . . . . . . .
Gross Amounts
Offset in the
Consolidated
Balance Sheet
Net Amounts
Presented in the
Consolidated
Balance Sheet
Gross
Amounts
Financial
Instruments
Cash
Collateral
Received
Net
Amount
$ 7.3
$ 0.8
$39.3
$17.4
$13.3
$ 6.4
$—
$—
$—
$—
$—
$—
$ 7.3
$ 0.8
$39.3
$17.4
$13.3
$ 6.4
$(6.1)
$—
$(6.1)
$(5.7)
$—
$(5.7)
$—
$—
$—
$—
$—
$—
$ 1.2
$ 0.8
$33.2
$11.7
$13.3
$ 0.7
The following tables present the effect of derivative and non-derivative hedging instruments on the
consolidated statements of operations and consolidated statements of comprehensive income:
Amount of Gain or (Loss)
Recognized in OCI on
Derivative (Effective Portion)
2020
2019
(in millions)
Location of Gain or (Loss)
Reclassified from
Accumulated OCI into
Income
Amount of Gain or (Loss)
Reclassified from
Accumulated OCI
into Income
2020
2019
(in millions)
Cash flow hedges
Foreign currency contracts . . .
$(33.7)
$23.5
Cost of sales
Selling, general, and
administrative expenses
$18.4
$ 2.2
$40.9
$ 1.9
Amount of Gain or (Loss)
Recognized in OCI on
Derivative (Effective Portion)
2020
2019
(in millions)
Location of Gain or (Loss)
Reclassified from
Accumulated OCI into
Income
Amount of Gain or (Loss)
Recognized in Income on
Derivative (Amount
Excluded from
Effectiveness Testing)
2020
2019
(in millions)
Net investment hedges
Cross currency swap
contracts . . . . . . . . . . . . . . .
$(12.6)
$12.5
Interest expense
$6.4
$6.6
77
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
12. DERIVATIVE INSTRUMENTS AND HEDGING ACTIVITIES (Continued)
The cross currency swaps have an expiration date of June 15, 2028. At maturity of the cross currency swap
contracts, the Company will deliver the notional amount of €257.2 million and will receive $300.0 million from
the counterparties. The Company will receive semi-annual interest payments from the counterparties based on a
fixed interest rate until maturity of the agreements.
Location of Gain or
(Loss) Recognized in
Income on Derivative
Fair value hedges
Foreign currency contracts . . . . . . Other income, net
Location of Gain or
(Loss) Recognized in
Income on Derivative
Amount of Gain or
(Loss) Recognized in
Income on Derivative
2020
2019
2018
(in millions)
$(1.4)
$1.4
$0.5
Amount of Gain or
(Loss) Recognized in
Income on Derivative
2020
2019
2018
(in millions)
Derivatives not designated as
hedging instruments
Foreign currency contracts . . . . . . Other income, net
$(15.1)
$0.3
$9.7
The following table presents the effect of fair value and cash flow hedge accounting on the consolidated
statements of operations:
Location and Amount of Gain or (Loss)
Recognized in Income on Fair Value
and Cash Flow Hedging Relationships
Twelve Months Ended December 31, 2020
Selling,
general, and
administrative
expenses
Other
Income,
net
Cost of
sales
Total amounts of income and expense line items shown in the consolidated
statements of operations in which the effects of fair value or cash flow
hedges are recorded . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$(1,080.6)
$(1,228.4)
$11.5
The effects of fair value and cash flow hedging:
Gain (loss) on fair value hedging relationships:
Foreign currency contracts:
Hedged items . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Derivatives designated as hedging instruments . . . . . . . . . . .
Amount excluded from effectiveness testing recognized in
earnings based on an amortization approach . . . . . . . . . . .
—
—
—
—
—
—
4.8
(4.8)
3.4
Gain (loss) on cash flow hedging relationships:
Foreign currency contracts:
Amount of gain (loss) reclassified from accumulated OCI
into income . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
18.4
2.2
—
78
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
12. DERIVATIVE INSTRUMENTS AND HEDGING ACTIVITIES (Continued)
Location and Amount of Gain or (Loss)
Recognized in Income on Fair Value
and Cash Flow Hedging Relationships
Twelve Months Ended December 31, 2019
Selling,
general, and
administrative
expenses
Other
Income,
net
Cost of
sales
Total amounts of income and expense line items shown in the consolidated
statements of operations in which the effects of fair value or cash flow
hedges are recorded . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$(1,114.4)
$(1,242.2)
$ 8.2
The effects of fair value and cash flow hedging:
Gain (loss) on fair value hedging relationships:
Foreign currency contracts:
Hedged items . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Derivatives designated as hedging instruments . . . . . . . . . . .
Amount excluded from effectiveness testing recognized in
earnings based on an amortization approach . . . . . . . . . . .
—
—
—
—
—
—
2.9
(2.9)
4.3
Gain (loss) on cash flow hedging relationships:
Foreign currency contracts:
Amount of gain (loss) reclassified from accumulated OCI
into income . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
40.9
1.9
—
The Company expects that during 2021 it will reclassify to earnings a $7.0 million loss currently recorded in
“Accumulated Other Comprehensive Loss.” For the years ended December 31, 2020, 2019, and 2018, the
Company did not record any gains or losses due to hedge ineffectiveness.
79
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
13. EMPLOYEE BENEFIT PLANS
Defined Benefit Plans
Edwards Lifesciences maintains defined benefit pension plans in Japan and certain European countries. In
2018, the Company curtailed its defined benefit plan in Horw, Switzerland (see Note 4).
Years Ended
December 31,
2020
2019
(in millions)
Change in projected benefit obligation:
Beginning of year . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Service cost . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Interest cost . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Participant contributions . . . . . . . . . . . . . . . . . . . . . . . . .
Actuarial loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Benefits paid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Plan amendment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . .
Currency exchange rate changes and other
$ 105.2
6.3
0.5
1.5
2.9
(0.6)
—
10.4
$ 97.4
5.2
0.9
1.3
8.2
(4.2)
(4.6)
1.0
End of year . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 126.2
$ 105.2
Change in fair value of plan assets:
Beginning of year . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Actual return on plan assets . . . . . . . . . . . . . . . . . . . . . .
Employer contributions . . . . . . . . . . . . . . . . . . . . . . . . .
Participant contributions . . . . . . . . . . . . . . . . . . . . . . . . .
Benefits paid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . .
Currency exchange rate changes and other
$ 63.2
0.4
2.8
1.5
(0.6)
6.0
$ 60.4
2.0
2.6
1.3
(4.2)
1.1
End of year . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 73.3
$ 63.2
Funded Status
Projected benefit obligation . . . . . . . . . . . . . . . . . . . . . .
Plan assets at fair value . . . . . . . . . . . . . . . . . . . . . . . . . .
$(126.2)
73.3
$(105.2)
63.2
Underfunded status . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ (52.9)
$ (42.0)
Net amounts recognized on the consolidated balance sheet:
Other long-term liabilities . . . . . . . . . . . . . . . . . . . . . . .
$ 52.9
$ 42.0
Accumulated other comprehensive loss, net of tax:
Net actuarial loss . . . . . . . . . . . . . . . . . . . . . . . . . .
Net prior service cost
. . . . . . . . . . . . . . . . . . . . . . .
Deferred income tax benefit . . . . . . . . . . . . . . . . . .
$ (30.8)
6.6
4.6
$ (26.3)
6.7
4.2
Total
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ (19.6)
$ (15.4)
The accumulated benefit obligation (“ABO”) for all defined benefit pension plans was $120.9 million and
$101.1 million as of December 31, 2020 and 2019, respectively. The projected benefit obligation and ABO were
in excess of plan assets for all pension plans as of December 31, 2020 and 2019.
80
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
13. EMPLOYEE BENEFIT PLANS (Continued)
The components of net periodic pension benefit cost (credit) are as follows (in millions):
Years Ended
December 31,
2020
2019
2018
Service cost, net . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Interest cost
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Expected return on plan assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Settlements and curtailment gain . . . . . . . . . . . . . . . . . . . . . . . . . . .
Amortization of actuarial loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Amortization of prior service credit . . . . . . . . . . . . . . . . . . . . . . . . .
$ 6.3
0.5
(1.0)
—
1.6
(0.7)
$ 5.2
0.9
(1.4)
—
0.9
(0.2)
Net periodic pension benefit cost (credit) . . . . . . . . . . . . . . . . . . . .
$ 6.7
$ 5.4
$ 6.0
0.8
(1.3)
(7.4)
0.8
(0.1)
$(1.2)
Expected long-term returns for each of the plans’ strategic asset classes were developed through
consultation with investment advisors. Several factors were considered, including a survey of investment
managers’ expectations, current market data, minimum guaranteed returns in certain insurance contracts, and
historical market returns over long periods. Using policy target allocation percentages and the asset class
expected returns, a weighted-average expected return was calculated.
To select the discount rates for the defined benefit pension plans, the Company uses a modeling process that
involves matching the expected duration of its benefit plans to a yield curve constructed from a portfolio of
AA-rated fixed-income debt instruments, or their equivalent. For each country, the Company uses the implied
yield of this hypothetical portfolio at the appropriate duration as a discount rate benchmark.
The weighted-average assumptions used to determine the benefit obligations are as follows:
Discount rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Rate of compensation increase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cash balance interest crediting rate . . . . . . . . . . . . . . . . . . . . . . . . . .
Social securities increase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Pension increase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
December 31,
2020
2019
0.3% 0.5%
2.6% 2.7%
2.5% 2.6%
1.6% 1.6%
1.8% 1.8%
The weighted-average assumptions used to determine the net periodic pension benefit cost are as follows:
Discount rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Expected return on plan assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Rate of compensation increase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cash balance interest crediting rate . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Social securities increase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Pension increase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Years ended
December 31,
2020
2019
2018
0.5% 0.9% 0.9%
1.5% 2.3% 2.3%
2.7% 2.8% 2.6%
1.5% 1.5% 1.5%
1.6% 1.8% 1.5%
1.8% 1.8% 1.8%
81
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
13. EMPLOYEE BENEFIT PLANS (Continued)
Plan Assets
The Company’s investment strategy for plan assets is to seek a competitive rate of return relative to an
appropriate level of risk and to earn performance rates of return in accordance with the benchmarks adopted for
each asset class. Risk management practices include diversification across asset classes and investment styles,
and periodic rebalancing toward asset allocation targets.
The Administrative and Investment Committee decides on the defined benefit plan provider in each location
and that provider decides the target allocation for the Company’s defined benefit plan at that location. The target
asset allocation selected reflects a risk/return profile the Company feels is appropriate relative to the plans’
liability structure and return goals. In certain plans, asset allocations may be governed by local requirements.
Target weighted-average asset allocations at December 31, 2020, by asset category, are as follows:
Equity securities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Debt securities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Real estate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
25.3%
47.5%
7.7%
19.5%
Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
100.0%
82
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
13. EMPLOYEE BENEFIT PLANS (Continued)
The fair values of the Company’s defined benefit plan assets at December 31, 2020 and 2019, by asset
category, are as follows (in millions):
December 31, 2020
Level 1
Level 2
Level 3
Total
Asset Category
Cash . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Equity securities:
United States equities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
International equities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Debt securities:
United States government bonds . . . . . . . . . . . . . . . . . . . . .
International government bonds . . . . . . . . . . . . . . . . . . . . . .
Real estate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Mortgages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Insurance contracts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 3.0
$—
$—
$ 3.0
3.3
16.1
7.4
26.0
—
—
—
—
—
—
—
5.6
3.1
—
—
—
—
—
—
—
1.0
3.3
16.1
7.4
26.0
5.6
3.1
1.0
Total plan assets measured at fair value . . . . . . . . . . . .
$55.8
$ 8.7
$ 1.0
$65.5
Alternative investments measured at net asset value (a) . . . . . . .
Total plan assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.8
$73.3
December 31, 2019
Level 1
Level 2
Level 3
Total
Asset Category
Cash . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Equity securities:
United States equities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
International equities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Debt securities:
United States government bonds . . . . . . . . . . . . . . . . . . . . .
International government bonds . . . . . . . . . . . . . . . . . . . . . .
Real estate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Mortgages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Insurance contracts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 3.8
$—
$—
$ 3.8
3.0
11.2
8.2
22.3
—
—
—
—
—
—
—
4.4
2.3
—
—
—
—
—
—
—
0.9
3.0
11.2
8.2
22.3
4.4
2.3
0.9
Total plan assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$48.5
$ 6.7
$ 0.9
$56.1
Alternative investments measured at net asset value (a) . . . . . . .
Total plan assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.1
$63.2
(a) Certain investments that were measured at net asset value per share have not been classified in the fair value
hierarchy. The fair value amounts presented in this table are intended to permit reconciliation of the fair
value hierarchy to the total plan assets.
83
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
13. EMPLOYEE BENEFIT PLANS (Continued)
The following table summarizes the changes in fair value of the Company’s defined benefit plan assets that
have been classified as Level 3 for the years ended December 31, 2020 and 2019 (in millions):
Balance at December 31, 2018 . . . . . . . . . . . . . . . . . . . . . . . .
Purchases, sales and settlements . . . . . . . . . . . . . . . . . . .
Balance at December 31, 2019 . . . . . . . . . . . . . . . . . . . . . . . .
Currency exchange rate impact . . . . . . . . . . . . . . . . . . . .
Insurance
Contracts
$ 1.0
(0.1)
0.9
0.1
Balance at December 31, 2020 . . . . . . . . . . . . . . . . . . . . . . . .
$ 1.0
Equity and debt securities are valued at fair value based on quoted market prices reported on the active
markets on which the individual securities are traded. Real estate investments are valued by discounting to
present value the cash flows expected to be generated by the specific properties. Investments in mortgages are
valued at cost, which is deemed to approximate its fair value. The insurance contracts are valued at the cash
surrender value of the contracts, which is deemed to approximate its fair value. Alternative investments include
hedge funds, private equity funds and other miscellaneous investments, and are valued using the net asset value
provided by the fund administrator as a practical expedient. The net asset value is based on the fair value of the
underlying assets owned by the fund divided by the number of shares outstanding.
The following benefit payments, which reflect expected future service, as appropriate, at December 31,
2020, are expected to be paid (in millions):
2021 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2022 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2023 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2024 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2025 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2024-2026 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 4.6
4.9
6.7
5.6
5.3
36.7
As of December 31, 2020, expected employer contributions for 2021 are $2.5 million.
Defined Contribution Plans
The Company’s employees in the United States and Puerto Rico are eligible to participate in a qualified
defined contribution plan. In the United States, participants may contribute up to 25% of their eligible
compensation (subject to tax code limitation) to the plan. Edwards Lifesciences matches the first 4% of the
participant’s annual eligible compensation contributed to the plan on a dollar-for-dollar basis. Edwards
Lifesciences matches the next 2% of the participant’s annual eligible compensation to the plan on a 50% basis. In
Puerto Rico, participants may contribute up to 25% of their annual compensation (subject to tax code limitation)
to the plan. Edwards Lifesciences matches the first 4% of participant’s annual eligible compensation contributed
to the plan on a 50% basis. The Company also provides a 2% profit sharing contribution calculated on eligible
earnings for each employee. Matching contributions relating to Edwards Lifesciences employees were
$36.6 million, $31.4 million, and $26.6 million in 2020, 2019, and 2018, respectively.
The Company also has nonqualified deferred compensation plans for a select group of employees. The plans
provide eligible participants the opportunity to defer eligible compensation to future dates specified by the
84
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
13. EMPLOYEE BENEFIT PLANS (Continued)
participant with a return based on investment alternatives selected by the participant. The amount accrued under
these nonqualified plans was $111.6 million and $88.7 million at December 31, 2020 and 2019, respectively.
14. COMMON STOCK
Treasury Stock
In May 2019, the Board of Directors approved a stock repurchase program authorizing the Company to
purchase up to $1.0 billion of the Company’s common stock. The repurchase program does not have an
expiration date. Stock repurchased under the program may be used to offset obligations under the Company’s
employee stock-based benefit programs and stock- based business acquisitions, and will reduce the total shares
outstanding.
During 2020, 2019, and 2018, the Company repurchased 3.1 million, 1.5 million, and 5.5 million shares,
respectively, at an aggregate cost of $625.4 million, $263.3 million, and $795.5 million, respectively, including
shares purchased under the accelerated share repurchase (“ASR”) agreements described below and shares
acquired to satisfy tax withholding obligations in connection with the vesting of restricted stock units issued to
employees. The timing and size of any future stock repurchases are subject to a variety of factors, including
expected dilution from stock plans, cash capacity, and the market price of the Company’s common stock.
Accelerated Share Repurchase
During 2019 and 2018, the Company entered into ASR agreements providing for the repurchase of the
Company’s common stock based on the volume-weighted average price (“VWAP”) of the Company’s common
stock during the term of the agreements, less a discount. The following table summarizes the terms of the ASR
agreements (dollars and shares in millions, except per share data):
Initial Delivery
Final Settlement
Agreement Date
Amount
Paid
Shares
Received
Price per
Share (a)
Value of
Shares as %
of Contract
Value
Settlement
Date
Total
Shares
Received
Average
Price
per Share (a)
April 2018 . . . . . . . . . . . . .
October 2018 . . . . . . . . . . .
May 2019 . . . . . . . . . . . . . .
May 2019 . . . . . . . . . . . . . .
$400.0
$250.0
$150.0
$100.0
2.5
1.4
0.7
0.5
$127.36
$139.22
$178.66
$170.02
July 2018
November 2018
80%
80%
80% May 2019
June 2019
80%
2.8
1.7
0.8
0.6
$142.37
$150.54
$178.42
$178.46
(a) The three-for-one stock split distributed on May 29, 2020 excluded treasury shares. The shares and per share
prices in the table are reflected at the pre-split amounts and prices at the time of the transaction.
The ASR agreements were accounted for as two separate transactions: (1) the value of the initial delivery of
shares was recorded as shares of common stock acquired in a treasury stock transaction on the acquisition date
and (2) the remaining amount of the purchase price paid was recorded as a forward contract indexed to the
Company’s own common stock and was recorded in “Additional Paid-in Capital” on the consolidated balance
sheets. The initial delivery of shares resulted in an immediate reduction of the outstanding shares used to
calculate the weighted-average common shares outstanding for basic and diluted earnings per share. The
Company determined that the forward contract indexed to the Company’s common stock met all the applicable
criteria for equity classification and, therefore, was not accounted for as a derivative instrument.
85
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
14. COMMON STOCK (Continued)
Employee and Director Stock Plans
The Edwards Lifesciences Corporation Long-term Stock Incentive Compensation Program (the “Program”)
provides for the grant of incentive and non-qualified stock options, restricted stock, and restricted stock units for
eligible employees of the Company. Under the Program, these grants are awarded at a price equal to the fair
market value at the date of grant based upon the closing price on that date. Options to purchase shares of the
Company’s common stock granted under the Program generally vest over predetermined periods of between
three to four years and expire seven years after the date of grant. Service-based restricted stock units of the
Company’s common stock granted under the Program generally vest over predetermined periods ranging from
three to four years after the date of grant. Market-based restricted stock units of the Company’s common stock
granted under the Program vest over three years based on a combination of certain service and market conditions.
The actual number of shares issued will be determined based on the Company’s total stockholder return relative
to a selected industry peer group. Performance-based restricted stock units vest based on a combination of certain
service conditions and upon achievement of specified milestones. Under the Program, the number of shares of
common stock available for issuance under the Program was 327.6 million shares. No more than 33.6 million
shares reserved for issuance may be granted in the form of restricted stock or restricted stock units.
The Company also maintains the Nonemployee Directors Stock Incentive Compensation Program (the
“Nonemployee Directors Program”). Under the Nonemployee Directors Program, annually each nonemployee
director may receive up to 120,000 stock options or 48,000 restricted stock units of the Company’s common
stock, or a combination thereof, provided that in no event may the total value of the combined annual award
exceed $0.2 million. These grants generally vest over one year from the date of grant. Under the Nonemployee
Directors Program, an aggregate of 8.4 million shares of the Company’s common stock has been authorized for
issuance.
The Company has an employee stock purchase plan for United States employees and a plan for international
employees (collectively “ESPP”). Under the ESPP, eligible employees may purchase shares of the Company’s
common stock at 85% of the lower of the fair market value of Edwards Lifesciences common stock on the
effective date of subscription or the date of purchase. Under the ESPP, employees can authorize the Company to
withhold up to 12% (15% effective January 1, 2021) of their compensation for common stock purchases, subject
to certain limitations. The ESPP is available to all active employees of the Company paid from the United States
payroll and to eligible employees of the Company outside the United States, to the extent permitted by local law.
The ESPP for United States employees is qualified under Section 423 of the Internal Revenue Code. The number
of shares of common stock authorized for issuance under the ESPP was 45.9 million shares.
The fair value of each option award and employee stock purchase subscription is estimated on the date of
grant using the Black-Scholes option valuation model that uses the assumptions noted in the following tables.
The risk-free interest rate is estimated using the U.S. Treasury yield curve and is based on the expected term of
the award. Expected volatility is estimated based on a blend of the weighted-average of the historical volatility of
Edwards Lifesciences’ stock and the implied volatility from traded options on Edwards Lifesciences’ stock. The
expected term of awards granted is estimated from the vesting period of the award, as well as historical exercise
behavior, and represents the period of time that awards granted are expected to be outstanding. The Company
uses historical data to estimate forfeitures and has estimated an annual forfeiture rate of 6.4%.
86
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
14. COMMON STOCK (Continued)
The Black-Scholes option pricing model was used with the following weighted-average assumptions for
options granted during the following periods:
Option Awards
Average risk-free interest rate . . . . . . . . . . . . . . . . . . . . . . . . .
Expected dividend yield . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Expected volatility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Expected life (years) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fair value, per share . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
0.3%
2.3%
2.9%
None
None
None
33%
5.0
$21.70
30%
5.1
$18.17
29%
5.0
$14.17
2020
2019
2018
The Black-Scholes option pricing model was used with the following weighted-average assumptions for
ESPP subscriptions granted during the following periods:
ESPP
Average risk-free interest rate . . . . . . . . . . . . . . . . . . . . . . . . .
Expected dividend yield . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Expected volatility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Expected life (years) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fair value, per share . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.3%
2.4%
1.7%
None
None
None
33%
0.6
$16.61
27%
0.6
$16.43
31%
0.6
$12.18
2020
2019
2018
The fair value of market-based restricted stock units was determined using a Monte Carlo simulation model,
which uses multiple input variables to determine the probability of satisfying the market condition requirements.
The weighted-average assumptions used to determine the fair value of the market-based restricted stock units
during the years ended December 31, 2020, 2019, and 2018 included a risk-free interest rate of 0.2%, 2.2%, and
2.7%, respectively, and an expected volatility rate of 32.7%, 29.4%, and 29.7%, respectively.
Stock option activity during the year ended December 31, 2020 under the Program and the Nonemployee
Directors Program was as follows (in millions, except years and per-share amounts):
Outstanding as of December 31, 2019 . . . . . . . . . . . .
Options granted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Options exercised . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Options forfeited . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Outstanding as of December 31, 2020 . . . . . . . . . . . .
Shares
17.1
1.8
(4.3)
(0.3)
14.3
Exercisable as of December 31, 2020 . . . . . . . . . . . . .
9.5
Vested and expected to vest as of December 31,
Weighted-
Average
Exercise
Price
$32.19
73.02
18.16
49.74
41.27
32.32
Weighted-
Average
Remaining
Contractual
Term
Aggregate
Intrinsic
Value
3.4 years
$712.5
2.5 years
558.1
2020 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
13.6
40.37
3.3 years
690.4
87
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
14. COMMON STOCK (Continued)
The following table summarizes nonvested restricted stock unit activity during the year ended December 31,
2020 under the Program and the Nonemployee Directors Program (in millions, except per-share amounts):
Nonvested as of December 31, 2019 . . . . . . . . . . . . . . . . . .
Granted (a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Vested . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Forfeited . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Nonvested as of December 31, 2020 . . . . . . . . . . . . . . . . . .
Weighted-
Average
Grant-Date
Fair Value
$46.89
71.31
40.03
49.90
57.59
Shares
2.7
0.9
(0.9)
(0.1)
2.6
(a) The shares granted includes 0.1 million shares of market-based restricted stock units granted during 2020,
which represents the target number of shares to be issued, and 0.1 million shares related to a previous year’s
grant of market-based restricted stock units since the payout percentage achieved at the end of the
performance period was in excess of target. As described above, the actual number of shares ultimately
issued is determined based on the Company’s total stockholder return relative to a selected industry peer
group.
The intrinsic value of stock options exercised and restricted stock units vested during the years ended
December 31, 2020, 2019, and 2018 were $323.5 million, $382.1 million, and $281.1 million, respectively. The
intrinsic value of stock options is calculated as the amount by which the market price of the Company’s common
stock exceeds the exercise price of the option. During the years ended December 31, 2020, 2019, and 2018, the
Company received cash from exercises of stock options of $79.2 million, $110.4 million, and $103.7 million,
respectively, and tax benefits from exercises of stock options and vesting of restricted stock units of
$72.1 million, $85.1 million, and $62.5 million, respectively. The total grant-date fair value of stock options
vested during the years ended December 31, 2020, 2019, and 2018 were $34.0 million, $31.2 million, and
$29.0 million, respectively.
As of December 31, 2020, the total remaining unrecognized compensation expense related to nonvested
stock options, restricted stock units, and employee stock purchase subscriptions amounted to $140.9 million,
which will be amortized over the weighted-average remaining requisite service period of 30 months.
88
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
15. ACCUMULATED OTHER COMPREHENSIVE LOSS
Presented below is a summary of activity for each component of “Accumulated Other Comprehensive Loss”
for the years ended December 31, 2020, 2019, and 2018.
December 31, 2017 . . . . . . . . . . . . . . . . . .
Impact from adoption of ASU 2016-16
and ASU 2018-02 . . . . . . . . . . . . . . .
January 1, 2018 . . . . . . . . . . . . . . . . . . . . .
Other comprehensive (loss) income
before reclassifications . . . . . . . . . . .
Amounts reclassified from accumulated
other comprehensive loss . . . . . . . . .
Deferred income tax expense . . . . . . . .
December 31, 2018 . . . . . . . . . . . . . . . . . .
Other comprehensive (loss) income
before reclassifications . . . . . . . . . . .
Amounts reclassified from accumulated
other comprehensive loss . . . . . . . . .
Deferred income tax (expense)
benefit
. . . . . . . . . . . . . . . . . . . . . . . .
December 31, 2019 . . . . . . . . . . . . . . . . . .
Other comprehensive income (loss)
before reclassifications . . . . . . . . . . .
Amounts reclassified from accumulated
other comprehensive loss . . . . . . . . .
Deferred income tax benefit
Foreign
Currency
Translation
Adjustments
Unrealized
(Loss) Gain on
Hedges
$(100.1)
$(13.9)
(4.9)
(105.0)
(2.9)
(16.8)
(36.7)
35.1
—
(1.9)
(143.6)
(1.5)
(6.6)
(3.1)
(154.8)
19.1
(13.8)
23.6
27.9
(44.2)
5.2
12.5
35.7
(34.8)
(6.4)
(19.2)
(expense) . . . . . . . . . . . . . . . . . . . . . .
3.1
13.8
December 31, 2020 . . . . . . . . . . . . . . . . . .
$(122.4)
$(27.7)
Unrealized
(Loss) Gain on
Available-for-
sale
Investments
(in millions)
$(4.6)
Total
Accumulated
Other
Comprehensive
Loss
Unrealized
Pension
Costs (a)
$(14.1)
$(132.7)
—
(4.6)
(3.1)
2.9
(0.2)
(5.0)
7.9
0.4
(1.6)
1.7
8.0
0.3
(1.4)
$ 8.6
—
(14.1)
(7.8)
(140.5)
7.6
2.9
(6.7)
(0.3)
(13.5)
15.3
(16.2)
(138.5)
(3.2)
31.1
0.7
0.6
(49.7)
1.1
(15.4)
(156.0)
(5.5)
3.4
0.9
0.4
(24.4)
15.9
$(19.6)
$(161.1)
89
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
15. ACCUMULATED OTHER COMPREHENSIVE LOSS (Continued)
(a) For the years ended December 31, 2020, 2019, and 2018, the change in unrealized pension costs consisted
of the following (in millions):
Pre-Tax
Amount
Tax (Expense)
Benefit
Net of
Tax
Amount
2020
Prior service credit arising during period . . . . . . . . . . . .
. . . . . . . . . . . . . . . .
Amortization of prior service credit
Net prior service cost arising during period . . . . . . . . . .
Net actuarial loss arising during period . . . . . . . . . . . . .
$ 0.6
(0.7)
(0.1)
(4.5)
Unrealized pension costs, net
. . . . . . . . . . . . . . . . . . . . .
$(4.6)
2019
Prior service credit arising during period . . . . . . . . . . . .
. . . . . . . . . . . . . . . .
Amortization of prior service credit
Net prior service credit arising during period . . . . . . . . .
Net actuarial loss arising during period . . . . . . . . . . . . .
$ 4.6
(0.2)
4.4
(6.9)
Unrealized pension costs, net
. . . . . . . . . . . . . . . . . . . . .
$(2.5)
2018
Prior service credit arising during period . . . . . . . . . . . .
. . . . . . . . . . . . . . . .
Amortization of prior service credit
Net prior service credit arising during period . . . . . . . . .
Net actuarial loss arising during period . . . . . . . . . . . . .
$ 3.3
(0.1)
3.2
(2.3)
Unrealized pension credits, net . . . . . . . . . . . . . . . . . . . .
$ 0.9
$(0.2)
0.1
(0.1)
0.5
$ 0.4
$(0.6)
0.1
(0.5)
1.1
$ 0.6
$(0.9)
—
(0.9)
0.6
$(0.3)
$ 0.4
(0.6)
(0.2)
(4.0)
$(4.2)
$ 4.0
(0.1)
3.9
(5.8)
$(1.9)
$ 2.4
(0.1)
2.3
(1.7)
$ 0.6
90
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
15. ACCUMULATED OTHER COMPREHENSIVE LOSS (Continued)
The following table provides information about amounts reclassified from “Accumulated Other
Comprehensive Loss” (in millions):
Details about Accumulated Other Comprehensive Loss
Components
Foreign currency translation adjustments . . . . . . . . . .
Years Ended
December 31,
2020
2019
Affected Line on Consolidated
Statements of Operations
$ 6.4
(1.6)
$ 6.6 Other income, net
(1.6) Provision for income taxes
$ 4.8
$ 5.0 Net of tax
(Loss) gain on hedges . . . . . . . . . . . . . . . . . . . . . . . . .
$18.4
$ 40.9 Cost of sales
Selling, general, and administrative
expenses
1.9
1.4 Other income, net
44.2 Total before tax
(11.0) Provision for income taxes
2.2
(1.4)
19.2
(5.0)
$14.2
$ 33.2 Net of tax
(Loss) gain on available-for-sale investments . . . . . . .
$ (0.3) $ (0.4) Other income, net
(0.6)
(0.3) Provision for income taxes
$ (0.9) $ (0.7) Net of tax
Amortization of pension adjustments . . . . . . . . . . . . .
$ (0.9) $ (0.7) Other income, net
0.2
0.1 Provision for income taxes
$ (0.7) $ (0.6) Net of tax
16. OTHER INCOME, NET
Foreign exchange gains, net . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Gain on investments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Non-service cost components of net periodic pension benefit
cost (credit) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Years Ended December 31,
2020
2019
2018
$(12.3)
(0.6)
(in millions)
$(5.9)
(0.5)
$(6.7)
1.7
0.4
1.0
0.2
(2.0)
(0.1)
1.1
Total other income, net
. . . . . . . . . . . . . . . . . . . . . . . . . . .
$(11.5)
$(8.2)
$(4.0)
91
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
17. INCOME TAXES
The Company’s income before provision for income taxes was generated from United States and
international operations as follows (in millions):
United States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
International, including Puerto Rico . . . . . . . . . . . . . . . . . . .
$151.3
765.4
$ 383.4
783.1
$266.1
495.3
$916.7
$1,166.5
$761.4
Years Ended December 31,
2020
2019
2018
The provision for income taxes consists of the following (in millions):
Years Ended December 31,
2020
2019
2018
Current
United States:
Federal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
State and local . . . . . . . . . . . . . . . . . . . . . . . . . . . .
International, including Puerto Rico . . . . . . . . . . . . . . .
$ 23.4
48.2
73.9
$ 31.3
48.7
29.1
Current income tax expense . . . . . . . . . . . . . . . . .
$145.5
$109.1
Deferred
United States:
Federal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
State and local . . . . . . . . . . . . . . . . . . . . . . . . . . . .
International, including Puerto Rico . . . . . . . . . . . . . . .
$ 11.0
(32.9)
(30.3)
$ 28.3
(18.3)
0.5
Deferred income tax (benefit) expense . . . . . . . . .
(52.2)
10.5
$
$
10.9
13.6
35.9
60.4
$(16.1)
(22.4)
17.3
(21.2)
Total income tax provision . . . . . . . . . . . . . . . . . . . . . . . . .
$ 93.3
$119.6
$
39.2
92
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
17. INCOME TAXES (Continued)
The components of deferred tax assets and liabilities are as follows (in millions):
Deferred tax assets
Compensation and benefits . . . . . . . . . . . . . . . . . . . . . . .
Benefits from uncertain tax positions . . . . . . . . . . . . . . .
Net tax credit carryforwards . . . . . . . . . . . . . . . . . . . . . .
Net operating loss carryforwards . . . . . . . . . . . . . . . . . .
Accrued liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inventories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cash flow and net investment hedges . . . . . . . . . . . . . .
State income taxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Investments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Lease liability obligations . . . . . . . . . . . . . . . . . . . . . . . .
Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
December 31,
2020
2019
$ 88.6
27.0
125.5
64.1
105.0
16.3
3.3
0.5
1.8
7.7
3.6
$ 90.1
22.5
108.4
57.6
41.3
12.9
—
0.5
1.5
18.4
3.4
Total deferred tax assets . . . . . . . . . . . . . . . . . . . . . . . . .
443.4
356.6
Deferred tax liabilities
Property, plant, and equipment . . . . . . . . . . . . . . . . . . . .
Cash flow and net investment hedges . . . . . . . . . . . . . .
Deferred tax on foreign earnings . . . . . . . . . . . . . . . . . .
Right-of-use assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other intangible assets . . . . . . . . . . . . . . . . . . . . . . . . . .
Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(53.4)
—
(29.2)
(7.0)
(76.3)
(3.1)
(22.6)
(6.8)
(35.3)
(17.5)
(71.0)
(2.2)
Total deferred tax liabilities . . . . . . . . . . . . . . . . . . . . . .
(169.0)
(155.4)
Valuation allowance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(71.6)
(65.8)
Net deferred tax assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 202.8
$ 135.4
During 2020, net deferred tax assets increased $67.4 million, including items that were recorded to
stockholders’ equity and which did not impact the Company’s income tax provision.
The valuation allowance of $71.6 million as of December 31, 2020 reduces certain deferred tax assets to
amounts that are more likely than not to be realized. This allowance primarily relates to the net operating loss
carryforwards of certain non- United States subsidiaries and certain non-United States credit carryforwards.
93
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
17. INCOME TAXES (Continued)
Net operating loss and capital loss carryforwards and the related carryforward periods at December 31, 2020
are summarized as follows (in millions):
Carryforward
Amount
Tax Benefit
Amount
Valuation
Allowance
Net Tax
Benefit
Carryforward
Period Ends
United States federal net operating losses . . . . . . .
United States federal net operating losses . . . . . . .
United States state net operating losses . . . . . . . . .
United States state net operating losses . . . . . . . . .
Non-United States net operating losses . . . . . . . . .
Non-United States net operating losses . . . . . . . . .
United States capital losses . . . . . . . . . . . . . . . . . . .
Total
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 26.6
11.3
33.5
1.0
18.2
295.1
34.1
$419.8
$ 5.6
2.4
2.1
0.1
4.7
49.2
0.2
$64.3
$ —
—
(2.1)
(0.1)
(3.6)
(39.9)
(0.2)
$(45.9)
$ 5.6
2.4
—
—
1.1
9.3
—
$18.4
2030-2037
Indefinite
2026-2039
Indefinite
2020-2027
Indefinite
2024
Certain tax attributes are subject to an annual limitation as a result of the acquisitions of Harpoon Medical,
Inc. and CASMED (see Note 8), which constitute a change of ownership as defined under Internal Revenue Code
Section 382.
The gross tax credit carryforwards and the related carryforward periods at December 31, 2020 are
summarized as follows (in millions):
California research expenditure tax credits . . . .
Federal research expenditure tax credits . . . . . .
. . . . . . . . . . . . . . .
Puerto Rico purchases credit
Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 145.1
1.5
23.4
$ 170.0
Carryforward
Amount
Valuation
Allowance
Net Tax
Benefit
$145.1
1.5
—
Carryforward
Period Ends
Indefinite
2026-2039
Indefinite
$ —
—
(23.4)
$ (23.4)
$146.6
The Company has $145.1 million of California research expenditure tax credits it expects to use in future
periods. The credits may be carried forward indefinitely. Based upon anticipated future taxable income, the
Company expects that it is more likely than not that all California research expenditure tax credits will be
utilized, although the utilization of the full benefit is expected to occur over a number of years and into the
distant future. Accordingly, no valuation allowance has been provided. The Company has $23.4 million of Puerto
Rico purchases credit. Throughout its history and into the future, the Puerto Rico operations generate, or are
expected to generate, credits each year in excess of its ability to utilize credits in those years. As a result, even
though the credits have an indefinite life, the Company continues to record a valuation allowance on the credit
carryforwards.
On December 22, 2017, Public Law 115-97, commonly referred to as the Tax Cuts and Jobs Act (the “2017
Act”), was signed into law. The 2017 Act a) reduced the U.S. federal corporate tax rate from 35 percent to
21 percent for tax years beginning after December 31, 2017, b) required companies to pay a one-time mandatory
deemed repatriation tax on the cumulative earnings of certain foreign subsidiaries that were previously tax
deferred, and c) created new taxes on certain foreign earnings in future years.
On December 22, 2017, Staff Accounting Bulletin No. 118 (“SAB 118”) was issued to address the
application of generally accepted accounting principles in the United States of America in situations when a
94
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
17. INCOME TAXES (Continued)
registrant does not have the necessary information available, prepared, or analyzed (including computations) in
reasonable detail to complete the accounting for certain income tax effects of the 2017 Act. In accordance with
SAB 118, as of December 31, 2017, the Company had estimated provisional amounts for a) $3.3 million of tax
benefits in connection with the remeasurement of certain tax assets and liabilities, b) $297.4 million of net tax
expense in connection with the one-time mandatory deemed repatriation tax on cumulative earnings of certain
foreign subsidiaries, and c) $32.3 million of tax benefits associated with a tax reform related restructuring. In
accordance with SAB 118, during 2018 the Company adjusted the provisional amounts as described below.
As a result of Internal Revenue Service (“IRS”) guidance issued subsequent to the 2017 Act, the
$32.3 million of tax benefits associated with the tax reform related restructuring mentioned above were reversed
in 2018. In addition, during 2018, the Company recorded a $12.8 million reduction in the repatriation tax and an
additional benefit of $3.7 million in connection with the remeasurement of deferred tax assets. In accordance
with SAB 118, the Company completed its accounting for the 2017 Act during the fourth quarter of 2018. In
addition, the Company elected to pay the repatriation tax in installments over eight years.
The Company asserts that $1.1 billion of its foreign earnings continue to be indefinitely reinvested and it
intends to repatriate $599.8 million of its foreign earnings as of December 31, 2020. The estimated net tax
liability on the indefinitely reinvested earnings if repatriated is $21.1 million.
The Company has received tax incentives in certain non-U.S. tax jurisdictions, the primary benefit for which
will expire in 2029. The tax reductions as compared to the local statutory rates were $189.2 million ($0.30 per
diluted share), $157.6 million ($0.25 per diluted share), and $144.9 million ($0.23 per diluted share) for the years
ended December 31, 2020, 2019, and 2018, respectively.
A reconciliation of the United States federal statutory income tax rate to the Company’s effective income
tax rate is as follows (in millions):
Income tax expense at U.S. federal statutory rate . . . . . . . . . .
Foreign income taxed at different rates . . . . . . . . . . . . . . . . . .
State and local taxes, net of federal tax benefit . . . . . . . . . . . .
Tax credits, federal and state . . . . . . . . . . . . . . . . . . . . . . . . . .
Build (release) of reserve for prior years’ uncertain tax
positions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
U.S. tax on foreign earnings, net of credits . . . . . . . . . . . . . . .
Tax on global intangible low-taxed income . . . . . . . . . . . . . . .
Foreign-derived intangible income deduction . . . . . . . . . . . . .
U.S. federal deductible employee share-based
compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Nondeductible employee share-based compensation . . . . . . . .
Impact related to 2017 U.S. Tax Reform . . . . . . . . . . . . . . . . .
Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Years Ended December 31,
2020
2019
2018
$192.5
(80.5)
5.0
(43.1)
$245.0
(75.0)
11.9
(42.9)
$159.9
(16.2)
6.8
(36.7)
4.2
1.5
49.2
(2.6)
(48.3)
4.2
—
11.2
5.0
(2.9)
32.0
(7.2)
(57.6)
3.2
2.8
5.3
(35.5)
(12.2)
—
(6.6)
(41.8)
2.8
15.8
2.9
Income tax provision . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 93.3
$119.6
$ 39.2
The Company’s effective tax rate for 2020 decreased slightly in comparison to 2019 primarily due to the tax
benefit from the Settlement Agreement with Abbott (see Notes 3 and 18), partially offset by the increase in the
95
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
17. INCOME TAXES (Continued)
U.S. tax on global intangible low-taxed income and the decrease in the tax benefit from employee share-based
compensation. The Company’s effective tax rate for 2019 increased in comparison to 2018 primarily because of
the increase in the U.S. tax on global intangible low-taxed income and the tax benefit in 2018 from audit
settlements.
Uncertain Tax Positions
As of December 31, 2020 and 2019, the gross uncertain tax positions were $281.8 million and
$203.1 million, respectively. The Company estimates that these liabilities would be reduced by $95.1 million and
$50.1 million, respectively, from offsetting tax benefits associated with the correlative effects of potential
transfer pricing adjustments, state income taxes, and timing adjustments. The net amounts of $186.7 million and
$153.0 million, respectively, if not required, would favorably affect the Company’s effective tax rate.
A reconciliation of the beginning and ending amount of uncertain tax positions, excluding interest,
penalties, and foreign exchange, is as follows (in millions):
December 31,
2020
2019
2018
Uncertain gross tax positions, January 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Current year tax positions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Increase in prior year tax positions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Decrease in prior year tax positions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Settlements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Lapse of statutes of limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$150.7
55.4
0.8
(3.8)
$203.1
86.4
6.0
(10.0)
(3.7) —
—
—
$225.6
37.8
13.9
(78.8)
(46.5)
(1.3)
Uncertain gross tax positions, December 31 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$281.8
$203.1
$150.7
The table above summarizes the gross amounts of uncertain tax positions without regard to reduction in tax
liabilities or additions to deferred tax assets and liabilities if such uncertain tax positions were settled.
The Company recognizes interest and penalties, if any, related to uncertain tax positions in the provision for
income taxes. As of December 31, 2020, the Company had accrued $14.3 million (net of $5.1 million tax benefit)
of interest related to uncertain tax positions, and as of December 31, 2019, the Company had accrued
$9.3 million (net of $3.5 million tax benefit) of interest related to uncertain tax positions. During 2020, 2019, and
2018, the Company recognized interest expense (benefit), net of tax benefit, of $5.0 million, $4.7 million, and
$(2.8) million, respectively, in “Provision for Income Taxes” on the consolidated statements of operations.
The Company strives to resolve open matters with each tax authority at the examination level and could
reach agreement with a tax authority at any time. While the Company has accrued for matters it believes are
more likely than not to require settlement, the final outcome with a tax authority may result in a tax liability that
is more or less than that reflected in the consolidated financial statements. Furthermore, the Company may later
decide to challenge any assessments, if made, and may exercise its right to appeal. The uncertain tax positions
are reviewed quarterly and adjusted as events occur that affect potential liabilities for additional taxes, such as
lapsing of applicable statutes of limitations, proposed assessments by tax authorities, negotiations between tax
authorities, identification of new issues, and issuance of new legislation, regulations, or case law. Management
believes that adequate amounts of tax and related penalty and interest have been provided in income tax expense
for any adjustments that may result from these uncertain tax positions.
96
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
17. INCOME TAXES (Continued)
At December 31, 2020, all material state, local, and foreign income tax matters have been concluded for
years through 2015. While not material, the Company continues to address matters in Wisconsin and India for
years from 2010.
During 2018, the Company executed an Advance Pricing Agreement (“APA”) between the United States
and Switzerland governments for tax years 2009 through 2020 covering various, but not all, transfer pricing
matters. The unagreed transfer pricing matters, namely Surgical Structural Heart and Transcatheter Aortic Valve
Replacement intercompany royalty transactions, then reverted to IRS Examination for further consideration as
part of the respective years’ regular tax audit. In addition, the Company signed agreements during 2018 with the
IRS to settle open tax years 2009 through 2014, including all transfer pricing matters for those years and the tax
treatment of a portion of a litigation settlement payment received in 2014.
The IRS began its examination of the 2015 and 2016 tax years during the fourth quarter of 2018 and later
added the 2017 tax year to this audit cycle during the first quarter of 2019. The IRS audit field work for the 2015-
2017 tax years was substantially completed during the fourth quarter of 2020, except for transfer pricing matters.
As a result, certain intercompany transactions covering tax years 2015 through 2020 that were not resolved
under the APA program remain subject to IRS examination, and those transactions and related tax positions
remain uncertain as of December 31, 2020. The IRS has signaled that it may be preparing proposed audit
adjustments related to these intercompany transactions for the 2015-2017 tax years which, if issued, could be
provided to the Company during 2021. The Company has considered this information in its evaluation of its
uncertain tax positions.
These unresolved transfer pricing matters, net of any correlative repatriation tax adjustment, may be
significant to the Company’s consolidated financial statements. Based on the information currently available and
numerous possible outcomes, the Company cannot reasonably estimate what, if any, changes to its existing
uncertain tax positions may occur in the next 12 months and, therefore, has continued to record the gross
uncertain tax positions as a long-term liability.
The Company intends to file to renew the APA between the United States and Switzerland for the years
2021 and forward. In addition, the Company executed other APAs as follows: during 2017, an APA between the
United States and Japan covering tax years 2015 through 2019; and during 2018, APAs between Japan and
Singapore and between Switzerland and Japan covering tax years 2015 through 2019. The Company has filed to
renew these APAs related to Japan for the years 2020 and forward. The execution of some or all of these APAs
depends on a number of variables outside of the Company’s control.
18. LEGAL PROCEEDINGS
In January 2019, Abbott filed lawsuits against Edwards Lifesciences and its direct and indirect subsidiaries
(“Edwards”) in the Federal District Court in the District of Delaware, in the United Kingdom, Germany,
Switzerland and Italy, and, in February 2020, in Ireland, alleging patent infringement involving Edwards’
PASCAL heart valve repair system (collectively, the “PASCAL litigation”). In February 2019, Edwards filed a
lawsuit against Abbott in the Federal District Court in the Central District of California alleging patent
infringement involving Abbott’s MITRACLIP device (with the PASCAL litigation, the “Abbott Matters”). On
July 12, 2020, Edwards entered into the Settlement Agreement with Abbott to, among other things, settle all
patent litigation between the parties related to alleged patent infringement involving Edwards’ PASCAL heart
valve repair system and Abbott’s MITRACLIP device. Pursuant to the Settlement Agreement, all of the Abbott
97
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
18. LEGAL PROCEEDINGS (Continued)
Matters and related appeals in courts worldwide were dismissed. The Settlement Agreement resulted in the
Company recording an estimated $367.9 million pre-tax net charge in June 2020 related to past damages. See
Note 3 for additional information.
In addition, the Company is or may be a party to, or may otherwise be responsible for, pending or threatened
lawsuits including those related to products and services currently or formerly manufactured or performed, as
applicable, by the Company, workplace and employment matters, matters involving real estate, Company
operations or health care regulations, or governmental investigations (the “Other Lawsuits”). The Other Lawsuits
raise difficult and complex factual and legal issues and are subject to many uncertainties, including, but not
limited to, the facts and circumstances of each particular case or claim, the jurisdiction in which each suit is
brought, and differences in applicable law. Management does not believe that any loss relating to the Other
Lawsuits would have a material adverse effect on the Company’s overall financial condition, results of
operations or cash flows. However, the resolution of one or more of the Other Lawsuits in any reporting period,
could have a material adverse impact on the Company’s financial results for that period. The Company is not
able to estimate the amount or range of any loss for legal contingencies related to the Other Lawsuits for which
there is no reserve or additional loss for matters already reserved.
The Company is subject to various environmental laws and regulations both within and outside of the
United States. The Company’s operations, like those of other medical device companies, involve the use of
substances regulated under environmental laws, primarily in manufacturing and sterilization processes. While it
is difficult to quantify the potential impact of continuing compliance with environmental protection laws,
management believes that such compliance will not have a material impact on the Company’s financial results.
The Company’s threshold of disclosing material environmental legal proceedings involving a governmental
authority where potential monetary exposure is involved is $1 million.
19. SEGMENT INFORMATION
The Company conducts operations worldwide and is managed in the following geographical regions: United
States, Europe, Japan, and Rest of World. All regions sell products that are used to treat advanced cardiovascular
disease.
The Company’s geographic segments are reported based on the financial information provided to the Chief
Operating Decision Maker (the Chief Executive Officer). The Company evaluates the performance of its
geographic segments based on net sales and operating income. The accounting policies of the segments are
substantially the same as those described in Note 2. Segment net sales and segment operating income are based
on internally derived standard foreign exchange rates, which may differ from year to year, and do not include
inter-segment profits. Because of the interdependence of the reportable segments, the operating profit as
presented may not be representative of the geographical distribution that would occur if the segments were not
interdependent. Net sales by geographic area are based on the location of the customer.
Certain items are maintained at the corporate level and are not allocated to the segments. The non-allocated
items include net interest expense, global marketing expenses, corporate research and development expenses,
manufacturing variances, corporate headquarters costs, special gains and charges, stock-based compensation,
foreign currency hedging activities, certain litigation costs, changes in the fair value of contingent consideration
liabilities, and most of the Company’s amortization expense. Although most of the Company’s depreciation
expense is included in segment operating income, due to the Company’s methodology for cost build-up, it is
impractical to determine the amount of depreciation expense included in each segment, and, therefore, a portion
98
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
19. SEGMENT INFORMATION (Continued)
is maintained at the corporate level. The Company neither discretely allocates assets to its operating segments,
nor evaluates the operating segments using discrete asset information.
The table below presents information about Edwards Lifesciences’ reportable segments (in millions):
Years Ended December 31,
2020
2019
2018
Segment Net Sales
United States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Europe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Japan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Rest of World . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$2,516.8
945.2
448.6
451.5
$2,532.7
926.1
441.4
433.3
$2,055.2
826.4
398.4
396.0
Total segment net sales . . . . . . . . . . . . . . . . . . . . . .
$4,362.1
$4,333.5
$3,676.0
Segment Operating Income
United States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Europe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Japan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Rest of World . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$1,727.3
479.3
286.4
150.1
$1,742.3
472.0
272.3
127.9
$1,368.1
394.8
237.0
115.6
Total segment operating income . . . . . . . . . . . . . . .
$2,643.1
$2,614.5
$2,115.5
The table below presents reconciliations of segment net sales to consolidated net sales and segment
operating income to consolidated income before provision for income taxes (“pre-tax income”) (in millions):
Years Ended December 31,
2020
2019
2018
Net Sales Reconciliation
Segment net sales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 4,362.1 $ 4,333.5 $ 3,676.0
46.8
Foreign currency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
14.5
24.2
Consolidated net sales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 4,386.3 $ 4,348.0 $ 3,722.8
Pre-tax Income Reconciliation
Segment operating income . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 2,643.1 $ 2,614.5 $ 2,115.5
Unallocated amounts:
Corporate items . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Special charges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Intellectual property litigation expenses, net . . . . . . . . .
Change in fair value of contingent consideration
liabilities, net
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Foreign currency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Consolidated operating income . . . . . . . . . . . . . . . . . . . . . . .
Non-operating income . . . . . . . . . . . . . . . . . . . . . . . . . .
(1,358.0)
—
(405.4)
(1,439.7)
(64.6)
(33.4)
(1,058.1)
(116.2)
(214.0)
(13.6)
31.5
897.6
19.1
6.1
63.9
1,146.8
19.7
5.7
15.3
748.2
13.2
Consolidated pre-tax income . . . . . . . . . . . . . . . . . . . . . . . . . $
916.7 $ 1,166.5 $
761.4
99
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
19. SEGMENT INFORMATION (Continued)
Enterprise-Wide Information
Enterprise-wide information is based on actual foreign exchange rates used in the Company’s consolidated
financial statements.
Net Sales by Geographic Area
As of or for the Years Ended
December 31,
2020
2019
2018
(in millions)
United States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $2,516.8 $2,532.7 $2,055.3
885.1
Europe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
396.8
Japan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
385.6
Rest of World . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
941.2
444.7
429.4
973.6
460.1
435.8
Net Sales by Major Product Area
$4,386.3 $4,348.0 $3,722.8
Transcatheter Aortic Valve Replacement
Transcatheter Mitral and Tricuspid Therapies . . . . . . . . . . . . . . . . . . . . . . . . . .
Surgical Structural Heart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Critical Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . $2,857.3 $2,737.9 $2,283.8
2.9
761.6
674.5
41.8
761.8
725.4
28.2
841.7
740.2
Long-lived Tangible Assets by Geographic Area
$4,386.3 $4,348.0 $3,722.8
United States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $1,084.3 $ 849.1 $ 642.1
36.6
Europe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.7
Japan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
214.4
Rest of World . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
192.7
20.4
311.0
101.5
21.7
269.4
$1,608.4 $1,241.7 $ 899.8
100
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
20. QUARTERLY FINANCIAL RESULTS AND MARKET FOR THE COMPANY’S STOCK
(UNAUDITED)
Years Ended December 31,
2020
First
Quarter
Second
Quarter
Third
Quarter
Fourth
Quarter
Total
Year
(in millions, except per share data)
2019
Net sales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Gross profit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net income (loss) (a) . . . . . . . . . . . . . . . . . . . . . . . . .
Earnings (loss) per common share (a):
$1,128.7
863.6
310.6
$ 925.0
686.8
(121.9)
$1,140.9
859.9
325.2
$1,191.7
895.4
309.5
$4,386.3
3,305.7
823.4
Basic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Diluted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
0.50
0.49
(0.20)
(0.20)
0.52
0.52
0.50
0.49
1.32
1.30
Market price:
High . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Low . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 81.90
51.51
$ 78.43
56.44
$ 87.79
66.87
$ 92.08
70.92
$ 92.08
51.51
Net sales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Gross profit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net income (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Earnings per common share (b):
$ 993.0
761.2
249.7
$1,086.9
782.9
242.3
$1,094.0
801.6
274.7
$1,174.1
887.9
280.2
$4,348.0
3,233.6
1,046.9
Basic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Diluted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
0.40
0.39
0.39
0.38
0.44
0.43
0.45
0.44
1.68
1.64
Market price:
High . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Low . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 65.95
46.95
$ 65.00
55.23
$ 76.06
61.00
$ 82.55
71.08
$ 82.55
46.95
(a) The second quarter of 2020 includes a $367.9 million charge related to a litigation settlement.
(b) The first quarter of 2019 includes a $24.0 million charge related to the acquisition of early-stage
transcatheter intellectual property and associated clinical and regulatory experience. The second and third
quarters of 2019 include a $46.2 million and $26.9 million charge, respectively, related to the write off of
inventory. The fourth quarter of 2019 includes a $40.6 million charge related to the impairment of certain
in-process research and development assets.
101
EDWARDS LIFESCIENCES CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
21. VALUATION AND QUALIFYING ACCOUNTS
Additions
Balance at
Beginning
of Period
Charged to
Costs and
Expenses
Charged to
Other
Accounts
(in millions)
Deductions
Balance at
End of
Period
Year ended December 31, 2020
Allowance for doubtful accounts (a)
. . . . . . . . . .
Tax valuation allowance (b) . . . . . . . . . . . . . . . . .
Year ended December 31, 2019
Allowance for doubtful accounts (a)
. . . . . . . . . .
Tax valuation allowance (b) . . . . . . . . . . . . . . . . .
Year ended December 31, 2018
. . . . . . . . . .
Allowance for doubtful accounts (a)
Tax valuation allowance (b) . . . . . . . . . . . . . . . . .
$14.7
64.0
$13.6
44.9
$13.7
41.6
$ 3.1
6.3
$ 4.7
18.9
$ 2.2
7.1
$—
0.6
$ 0.2
0.2
$ 1.0
(1.8)
$(1.4)
(1.1)
$(3.8)
—
$(3.3)
(2.0)
$16.4
69.8
$14.7
64.0
$13.6
44.9
(a) The deductions related to allowances for doubtful accounts represent accounts receivable which are written
off.
(b) The tax valuation allowances are provided for other-than-temporary impairments and unrealized losses
related to certain investments that may not be recognized due to the uncertainty of the ready marketability of
certain impaired investments, and net operating loss and credit carryforwards that may not be recognized
due to insufficient taxable income.
22. SUBSEQUENT EVENT
In February 2021, Edwards entered into an ASR agreement to repurchase $250.0 million of the Company’s
common stock based on the volume-weighted average price (“VWAP”) of the Company’s common stock during
the term of the agreements, less a discount. Upon entering into the agreement, Edwards received an initial
delivery of 2.4 million shares, representing approximately 80% of the shares to be repurchased. At the
termination of the ASR, Edwards may receive additional shares or may be required to pay additional cash or
shares (at the Company’s election). The final settlement is based on the VWAP over the term of the agreement,
less a discount. The ASR agreement has a scheduled termination date of March 18, 2021.
102
Item 9.
Changes in and Disagreements With Accountants on Accounting and Financial Disclosure
None.
Item 9A. Controls and Procedures
Evaluation of Disclosure Controls and Procedures. The Company’s management, including the Chief
Executive Officer and Chief Financial Officer, performed an evaluation of the effectiveness of the design and
operation of the Company’s disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e)
under the Securities Exchange Act of 1934, as amended) as of December 31, 2020.
Based on their evaluation, the Chief Executive Officer and Chief Financial Officer have concluded as of
December 31, 2020 that the Company’s disclosure controls and procedures are designed at a reasonable
assurance level and are effective in providing reasonable assurance that the information required to be disclosed
by the Company in the reports it files or submits under the Securities Exchange Act of 1934, as amended, is
recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms,
and that such information is accumulated and communicated to the Company’s management, including the Chief
Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required
disclosure.
Management’s Report on Internal Control Over Financial Reporting. The Company’s management,
including the Chief Executive Officer and Chief Financial Officer, is responsible for establishing and
maintaining adequate internal control over financial reporting, as such term is defined in Rules 13a-15(f) and
15d-15(f) under the Securities Exchange Act of 1934, as amended. Under the supervision and with the
participation of the Company’s management, including the Chief Executive Officer and Chief Financial Officer,
the Company conducted an evaluation of the effectiveness of its internal control over financial reporting based on
the framework in Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring
Organizations of the Treadway Commission (COSO). Based on that evaluation, the Company’s management
concluded that its internal control over financial reporting was effective as of December 31, 2020. The
effectiveness of the Company’s internal control over financial reporting as of December 31, 2020 has been
audited by PricewaterhouseCoopers LLP, the independent registered public accounting firm that audited the
financial statements included in this Annual Report on Form 10-K, as stated in their report which appears herein.
Changes in Internal Control Over Financial Reporting. There have been no changes in the Company’s
internal control over financial reporting that occurred during the Company’s fourth fiscal quarter of 2020 that
have materially affected, or are reasonably likely to materially affect, the Company’s internal control over
financial reporting. We have not experienced any material impact to our internal control over financial reporting
despite the fact that many of our employees are working remotely due to the COVID-19 pandemic. We are
continually monitoring and assessing the potential impact of COVID-19 on our internal controls to minimize the
impact on their design and operating effectiveness.
Item 9B. Other Information
None.
103
PART III
Item 10. Directors, Executive Officers and Corporate Governance
Certain information required by this Item will be set forth under the headings “Board of Directors Matters—
Proposal 1 - Election of Directors—Board of Director Nominees,” “Board of Directors Matters—Corporate
Governance Policies and Practices,” and “Executive Compensation and Other Information—Executive Officers”
in the definitive proxy statement to be filed in connection with the Company’s 2021 Annual Meeting of
Stockholders (the “Proxy Statement”) (which Proxy Statement will be filed with the SEC within 120 days of
December 31, 2020). The information required by this Item to be contained in the Proxy Statement is
incorporated herein by reference. The Company has adopted a code of ethics that applies to all directors and
employees, including the Company’s principal executive officer, principal financial officer, and principal
accounting officer, or persons performing similar functions. The code of ethics (business practice standards) is
posted on the Company’s website, which is found at www.edwards.com under “Investors—Corporate
governance—Corporate responsibility—Global Integrity Program.” To the extent required by applicable rules of
the SEC and the New York Stock Exchange, the Company intends to disclose on its website any amendments to,
or waivers from, any provision of its code of ethics that apply to the Company’s directors and executive officers,
including the principal executive officer, principal financial officer or controller or persons performing similar
functions.
Item 11. Executive Compensation
The information contained under the heading “Executive Compensation and Other Information” in the
Proxy Statement is incorporated herein by reference.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder
Matters
The information contained under the headings “Security Ownership of Certain Beneficial Owners and
Management” and “Equity Compensation Plan Information” in the Proxy Statement is incorporated herein by
reference.
Item 13. Certain Relationships and Related Transactions, and Director Independence
The information contained under the heading “Other Matters and Business—Related Persons Transactions”
and under the heading “Corporate Governance Policies and Practices—Director Independence” in the Proxy
Statement is incorporated herein by reference.
Item 14. Principal Accounting Fees and Services
The information contained under the headings “Audit Matters—Fees Paid to Principal Accountants” and
“Audit Matters—Pre-Approval of Services” in the Proxy Statement is incorporated herein by reference.
104
Item 15. Exhibits and Financial Statement Schedules
(a) The following documents are filed as part of this report:
PART IV
1. Consolidated Financial Statements. See “Index to Consolidated Financial Statements” in Part II, Item 8
herein.
2. Financial Statement Schedules. Other schedules are not applicable and have not been included herein.
3. Exhibits.
Exhibit No.
Description
3.1
3.2
3.3
4.1
+4.2
4.3
4.4
4.5
4.6
10.1
Amended and Restated Certificate of Incorporation of Edwards Lifesciences Corporation, dated
May 16, 2013 (incorporated by reference to Exhibit 3.1 in Edwards Lifesciences’ report on Form
8-K filed on May 17, 2013)
Certificate of Amendment of Amended and Restated Certificate of Incorporation of Edwards
Lifesciences Corporation, dated May 7, 2020 (incorporated by reference to Exhibit 3.1 in
Edwards Lifesciences’ report on Form 8-K filed on May 8, 2020)
Bylaws of Edwards Lifesciences Corporation, as amended and restated as of February 25, 2016
(incorporated by reference to Exhibit 3.1 in Edwards Lifesciences’ report on Form 8-K filed on
March 2, 2016)
Specimen form of certificate representing Edwards Lifesciences Corporation common stock
(incorporated by reference to Exhibit 4.1 in Edwards Lifesciences’ Registration Statement on
Form 10 (File No. 001-15525) filed on March 15, 2000)
Description of Edwards Lifesciences Corporation’s Capital Stock
Indenture, dated as of September 6, 2013, between Edwards Lifesciences Corporation and Wells
Fargo Bank, National Association, as trustee (incorporated by reference to Exhibit 4.5 in
Edwards Lifesciences’ Registration Statement on Form S-3 (File No. 333-191022) filed on
September 6, 2013) (the “Indenture”)
First Supplemental Indenture, dated as of October 3, 2013, to the Indenture (incorporated by
reference to Exhibit 4.1 in Edwards Lifesciences’ report on Form 8-K filed on October 3, 2013)
Second Supplemental Indenture, dated as of June 15, 2018, to the Indenture (incorporated by
reference to Exhibit 4.2 in Edwards Lifesciences’ report on Form 8-K filed on June 15, 2018)
(“Second Supplemental Indenture”)
Form of Global Note for the 4.300% Senior Notes due 2028 (incorporated by reference to
Exhibit A in the Second Supplemental Indenture filed as Exhibit 4.2 in Edwards Lifesciences’
report on Form 8-K filed on June 15, 2018)
Five-Year Credit Agreement, dated as of April 30, 2018, among Edwards Lifesciences
Corporation and certain of its subsidiaries, as Borrowers, the lenders signatory thereto, Bank of
America, N.A., as Administrative Agent, JPMorgan Chase Bank, N.A., as Syndication Agent,
and Morgan Stanley MUFG Loan Partners, LLC, Deutsche Bank Securities Inc., HSBC Bank
USA, National Association, and Wells Fargo Bank, National Association, as Co-Documentation
Agents (incorporated by reference to Exhibit 10.1 in Edwards Lifesciences’ report on Form 8-K
filed on April 30, 2018)
#10.2
Settlement Agreement, dated May 19, 2014, between Edwards Lifesciences Corporation and
Medtronic, Inc. (incorporated by reference to Exhibit 10.2 in Edwards Lifesciences’ report on
Form 10-Q for the quarterly period ended June 30, 2014)
105
Exhibit No.
*10.3
*10.4
*10.5
*10.6
*10.7
*10.8
*10.9
*10.10
*10.11
*10.12
*10.13
*10.14
*10.15
Description
Edwards Lifesciences Corporation Form of Employment Agreement (incorporated by reference
to Exhibit 10.8 in Edwards Lifesciences’ report on Form 10-Q for the quarterly period ended
March 31, 2003)
Edwards Lifesciences Corporation Amended and Restated Employment Agreement for Michael
A. Mussallem, dated March 30, 2009 (incorporated by reference to Exhibit 10.2 in Edwards
Lifesciences’ report on Form 10-Q for the quarterly period ended March 31, 2009)
Edwards Lifesciences Corporation Amended and Restated Chief Executive Officer
Change-in-Control Severance Agreement, dated October 9, 2012 (incorporated by reference to
Exhibit 10.1 in Edwards Lifesciences’ report on Form 10-Q for the quarterly period ended
September 30, 2012)
Edwards Lifesciences Corporation Form of Change-in-Control Severance Agreement
(incorporated by reference to Exhibit 10.2 in Edwards Lifesciences’ report on Form 10-Q for the
quarterly period ended September 30, 2012)
Edwards Lifesciences Corporation 2018 Edwards Incentive Plan (incorporated by reference to
Exhibit 10.7 in Edwards Lifesciences’ report on Form 10-K for the fiscal year ended
December 31, 2018)
Edwards Lifesciences Corporation Long-Term Stock Incentive Compensation Program, as
amended and restated as of May 7, 2020 (incorporated by reference to Exhibit 10.1 in Edwards
Lifesciences’ report on Form 10-Q for the quarterly period ended June 30, 2020)
Edwards Lifesciences Corporation Form of Participant Stock Option Statement and related
Long-Term Stock Program Global Nonqualified Stock Option Award Agreement for awards
granted prior to May 2015 (incorporated by reference to Exhibit 10.1 in Edwards Lifesciences’
report on Form 10-Q for the quarterly period ended March 31, 2011)
Edwards Lifesciences Corporation Form of Participant Restricted Stock Unit Statement and
related Long-Term Stock Program Global Restricted Stock Unit Award Agreement for awards
granted prior to May 2015 (incorporated by reference to Exhibit 10.2 in Edwards Lifesciences’
report on Form 10-Q for the quarterly period ended March 31, 2011)
Edwards Lifesciences Corporation Form of Long-Term Stock Incentive Compensation Program
Global Nonqualified Stock Option Award Agreement for awards granted beginning May 2015
(incorporated by reference to Exhibit 10.3 in Edwards Lifesciences’ report on Form 10-Q for the
quarterly period ended June 30, 2015)
Edwards Lifesciences Corporation Form of Long-Term Stock Incentive Compensation Program
Global Restricted Stock Unit Award Agreement for awards granted beginning May 2015
(incorporated by reference to Exhibit 10.4 in Edwards Lifesciences’ report on Form 10-Q for the
quarterly period ended June 30, 2015)
Edwards Lifesciences Corporation Form of Performance-Based Restricted Stock Unit Award
Statement and related Long-Term Stock Program Global Performance-Based Restricted Stock
Unit Award Agreement for awards granted beginning May 2015 (incorporated by reference to
Exhibit 10.5 in Edwards Lifesciences’ report on Form 10-Q for the quarterly period ended
June 30, 2015)
Edwards Lifesciences Corporation Nonemployee Directors Stock Incentive Program, as
amended and restated as of February 25, 2016 (incorporated by reference to Exhibit 10.1 in
Edwards Lifesciences’ report on Form 10-Q for the quarterly period ended March 31, 2016)
Edwards Lifesciences Corporation 2020 Nonemployee Directors Stock Incentive Program
(incorporated by reference to Appendix B in Edwards Lifesciences’ Definitive Proxy Statement
filed on March 25, 2020)
106
Exhibit No.
+*10.16
+*10.17
+*10.18
*10.19
*10.20
*10.21
21.1
23
31.1
31.2
+32
Description
Edwards Lifesciences Corporation Form of Participant Stock Option Statement and related
Nonemployee Directors Stock Incentive Program Nonqualified Stock Option Award Agreement
Edwards Lifesciences Corporation Form of Nonemployee Directors Stock Incentive Program
Restricted Stock Units Agreement
Edwards Lifesciences Corporation Form of Nonemployee Directors Stock Incentive Program
Restricted Stock Agreement
Edwards Lifesciences Corporation Executive Deferred Compensation Plan, as amended and
restated effective as of November 9, 2011 (incorporated by reference to Exhibit 10.7 in Edwards
Lifesciences’ report on Form 10-K for the fiscal year ended December 31, 2011)
Edwards Lifesciences Corporation Officer Perquisite Program Guidelines, as of February 20,
2013 (incorporated by reference to Exhibit 10.25 in Edwards Lifesciences’ report on Form 10-K
for the fiscal year ended December 31, 2012)
Edwards Lifesciences Corporation Form of Indemnification Agreement (incorporated by
reference to Exhibit 10.20 in Edwards Lifesciences’ report on Form 10-K for the fiscal year
ended December 31, 2011)
Subsidiaries of Edwards Lifesciences Corporation
Consent of Independent Registered Public Accounting Firm
Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002
101.INS
XBRL Instance Document - the instance document does not appear in the Interactive Data File
because its XBRL tags are embedded within the Inline XBRL document
101.SCH
XBRL Taxonomy Extension Schema Document
101.CAL
XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF
XBRL Taxonomy Extension Definition Linkbase Document
101.LAB
XBRL Taxonomy Extension Label Linkbase Document
101.PRE
XBRL Taxonomy Extension Presentation Linkbase Document
104
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
# Pursuant to a request for confidential treatment, confidential portions of this exhibit have been redacted and
have been filed separately with the Securities and Exchange Commission
* Represents management contract or compensatory plan
+ Furnished herewith
Item 16. Form 10-K Summary
None.
107
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant
has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
SIGNATURES
February 12, 2021
EDWARDS LIFESCIENCES CORPORATION
By:
/s/ MICHAEL A. MUSSALLEM
Michael A. Mussallem
Chairman of the Board and
Chief Executive Officer
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by
the following persons on behalf of the registrant and in the capacities and on the dates indicated.
Signature
Title
Date
/s/ MICHAEL A. MUSSALLEM
Chairman of the Board and Chief
February 12, 2021
Michael A. Mussallem
Executive Officer
(Principal Executive Officer)
/s/ SCOTT B. ULLEM
Corporate Vice President, Chief
February 12, 2021
Scott B. Ullem
Financial Officer
(Principal Financial Officer)
/s/ ROBERT W.A. SELLERS
Vice President, Corporate
February 12, 2021
Robert W.A. Sellers
Controller
(Principal Accounting Officer)
/s/ KIERAN T. GALLAHUE
Director
February 12, 2021
Kieran T. Gallahue
/s/ LESLIE S. HEISZ
Leslie S. Heisz
Director
February 12, 2021
/s/ PAUL A. LAVIOLETTE
Director
February 12, 2021
Paul A. LaViolette
/s/ WILLIAM J. LINK, PH.D.
Director
February 12, 2021
William J. Link, Ph.D.
/s/ STEVEN R. LORANGER
Director
February 12, 2021
Steven R. Loranger
/s/ MARTHA H. MARSH
Director
February 12, 2021
Martha H. Marsh
/s/ RAMONA SEQUEIRA
Director
February 12, 2021
Ramona Sequeira
/s/ NICHOLAS J. VALERIANI
Director
February 12, 2021
Nicholas J. Valeriani
108
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We hereby consent to the incorporation by reference in the Registration Statements on Form S-8 (Nos.
333-33054, 333-33056, 333-40434, 333-52334, 333-52346, 333-60670, 333-98219, 333-105961, 333-127260,
333-150810, 333-154242, 333-168462, 333-183106, 333-192229, 333-195853, 333-204180, 333-211333, and
333-217909) and Form S-3 (No. 333-232866) of Edwards Lifesciences Corporation of our report dated
February 12, 2021 relating to the financial statements and the effectiveness of internal control over financial
reporting, which appears in this Form 10-K.
Exhibit 23
/s/ PricewaterhouseCoopers LLP
Irvine, California
February 12, 2021
EDWARDS LIFESCIENCES CORPORATION
CERTIFICATIONS PURSUANT TO
SECTION 302 OF
THE SARBANES-OXLEY ACT OF 2002
CERTIFICATION
Exhibit 31.1
I, Michael A. Mussallem, certify that:
1.
I have reviewed this annual report on Form 10-K of Edwards Lifesciences Corporation;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state
a material fact necessary to make the statements made, in light of the circumstances under which such
statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report,
fairly present in all material respects the financial condition, results of operations and cash flows of the
registrant as of, and for, the periods presented in this report;
4.
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure
controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control
over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and
have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to
be designed under our supervision, to ensure that material information relating to the registrant,
including its consolidated subsidiaries, is made known to us by others within those entities, particularly
during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial
reporting to be designed under our supervision, to provide reasonable assurance regarding the
reliability of financial reporting and the preparation of financial statements for external purposes in
accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this
report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end
of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that
occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the
case of an annual report) that has materially affected, or is reasonably likely to materially affect, the
registrant’s internal control over financial reporting; and
5.
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of
internal control over financial reporting, to the registrant’s auditors and the audit committee of the
registrant’s board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over
financial reporting which are reasonably likely to adversely affect the registrant’s ability to record,
process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a
significant role in the registrant’s internal control over financial reporting.
By:
/S/ MICHAEL A. MUSSALLEM
Michael A. Mussallem
Chairman of the Board and
Chief Executive Officer
February 12, 2021
EDWARDS LIFESCIENCES CORPORATION
CERTIFICATIONS PURSUANT TO
SECTION 302 OF
THE SARBANES-OXLEY ACT OF 2002
CERTIFICATION
Exhibit 31.2
I, Scott B. Ullem, certify that:
1.
I have reviewed this annual report on Form 10-K of Edwards Lifesciences Corporation;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state
a material fact necessary to make the statements made, in light of the circumstances under which such
statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report,
fairly present in all material respects the financial condition, results of operations and cash flows of the
registrant as of, and for, the periods presented in this report;
4.
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure
controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control
over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and
have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to
be designed under our supervision, to ensure that material information relating to the registrant,
including its consolidated subsidiaries, is made known to us by others within those entities, particularly
during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial
reporting to be designed under our supervision, to provide reasonable assurance regarding the
reliability of financial reporting and the preparation of financial statements for external purposes in
accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this
report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end
of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that
occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the
case of an annual report) that has materially affected, or is reasonably likely to materially affect, the
registrant’s internal control over financial reporting; and
5.
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of
internal control over financial reporting, to the registrant’s auditors and the audit committee of the
registrant’s board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over
financial reporting which are reasonably likely to adversely affect the registrant’s ability to record,
process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a
significant role in the registrant’s internal control over financial reporting.
By:
/s/ SCOTT B. ULLEM
Scott B. Ullem
Corporate Vice President,
Chief Financial Officer
February 12, 2021
EDWARDS LIFESCIENCES CORPORATION
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
Exhibit 32
In connection with the Annual Report of Edwards Lifesciences Corporation (the “Company”) on Form 10-K
for the year ended December 31, 2020 as filed with the Securities and Exchange Commission on the date hereof
(the “Report”), we, Michael A. Mussallem, Chairman of the Board and Chief Executive Officer of the Company,
and Scott B. Ullem, Corporate Vice President, Chief Financial Officer, certify, pursuant to 18 U.S.C. 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
(1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange
Act of 1934; and
(2) The information contained in the Report fairly presents, in all material respects, the financial condition
and results of operations of the Company.
February 12, 2021
February 12, 2021
/s/ MICHAEL A. MUSSALLEM
Michael A. Mussallem
Chairman of the Board and Chief Executive Officer
/s/ SCOTT B. ULLEM
Scott B. Ullem
Corporate Vice President,
Chief Financial Officer
Intended for Investor audience only. Patients and caregivers
should talk to their physician about any of the procedures or
devices discussed herein. For patient-focused information,
please see www.newheartvalve.com or www.edwards.com.
CAUTION: Federal (United States) law restricts these devices to
sale by or on the order of a physician. See instructions for use
for the important safety information, including indications,
contraindications, warnings, precautions, and adverse events.
Edwards devices placed on the European market meeting the
essential requirements referred to in Article 3 of the Medical
Device Directive 93/42/EEC bear the CE marking of conformity.
Important Safety Information:
INSPIRIS RESILIA Aortic Valve
Indications: For use in replacement of native or prosthetic aortic
heart valves.
Contraindications: There are no known contraindications with
the use of the INSPIRIS RESILIA aortic valve.
Complications and Side Effects: Thromboembolism, valve
thrombosis, hemorrhage, hemolysis, regurgitation, endocarditis,
structural valve deterioration, nonstructural dysfunction, stenosis,
arrhythmia, transient ischemic attack/stroke, congestive heart
failure, myocardial infarction, any of which could lead to
reoperation, explanation, permanent disability, and death.
Warnings: DO NOT ADJUST THE VALVE DIAMETER BY EXPANDING
THE BAND PRIOR TO/OR DURING IMPLANTATION OF THE
SURGICAL VALVE. The expandable band is not designed to allow
for compression or expansion during implantation of the surgical
valve. This will cause damage to the valve and may result in aortic
incompetence. DO NOT PERFORM STAND-ALONE BALLOON
AORTIC VALVULOPLASTY PROCEDURES ON THIS VALVE FOR
THE SIZES 19 – 25mm as this may expand the valve causing
aortic incompetence, coronary embolism or annular rupture.
Valve-in-Valve sizing in the INSPIRIS valve has only been tested
with specific Edwards transcatheter heart valves. Use of other
transcatheter valves may result in embolization of transcatheter
devices anchored within or result in annular rupture.
Important Safety Information:
KONECT RESILIA Aortic Valved Conduit
Indications: For use in replacement of native or prosthetic
aortic heart valves and the associated repair or replacement
of a damaged or diseased ascending aorta.
Contraindications: There are no known contraindications with
the use of the KONECT RESILIA aortic valved conduit.
Complications and Side Effects: Thromboembolism, valve
thrombosis, hemorrhage, hemolysis, regurgitation, endocarditis,
structural valve deterioration, nonstructural dysfunction, stenosis,
arrhythmia, transient ischemic attack/stroke, congestive heart
failure, myocardial infarction, any of which could lead to
reoperation, explantation, permanent disability, and death.
Adverse events potentially associated with the use of polyester
vascular grafts include hemorrhage, thrombosis, graft infection,
embolism, aneurysm, pseudoaneurysm, seroma, occlusion
(anastomotic intimal hyperplasia), immunological reaction to
collagen (shown to be a weak immunogen; infrequent, mild,
localized and self-limiting), intimal peel formation, and conduit
dilatation.
Important Safety Information:
Edwards SAPIEN 3 and Edwards SAPIEN 3
Ultra Transcatheter Heart Valve system
Indications: The Edwards SAPIEN 3 and SAPIEN 3 Ultra
Transcatheter Heart Valve system is indicated for relief of aortic
stenosis in patients with symptomatic heart disease due to
severe native calcific aortic stenosis who are judged by a Heart
Team, including a cardiac surgeon, to be appropriate for the
transcatheter heart valve replacement therapy.
The Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart
Valve system is indicated for patients with symptomatic heart
disease due to failing (stenosed, insufficient, or combined) of a
surgical or transcatheter bioprosthetic aortic valve or surgical
bioprosthetic mitral valve who are judged by a heart team,
including a cardiac surgeon, to be at high or greater risk for
open surgical therapy (i.e., predicted risk of surgical mortality
≥ 8% at 30 days, based on the Society of Thoracic Surgeons (STS)
risk score and other clinical co-morbidities unmeasured by the
STS risk calculator).
Contraindications (Who should not use): The Edwards
SAPIEN 3 Transcatheter Heart Valve System and Edwards
SAPIEN 3 Ultra Transcatheter Heart Valve System should not
be used in patients who:
• Cannot tolerate medications that thin the blood or prevent
blood clots from forming.
• Have an active infection in the heart or elsewhere.
Warnings:
• There may be an increased risk of stroke in transcatheter
aortic valve replacement procedures, compared to other
standard treatments for aortic stenosis in the high or greater
risk population.
• If an incorrect valve size for your anatomy is used, it may lead
to heart injury, valve leakage, movement, or dislodgement.
• Patients should talk to their doctor if they have significant
heart disease, a mitral valve device or are sensitive to cobalt,
nickel, chromium, molybdenum, titanium, manganese, silicon,
and/or polymeric materials.
• The Edwards SAPIEN 3 Ultra and SAPIEN 3 valves may not last
as long in younger patients, or patients with a disease that
results in more calcium in their blood.
• During the procedure, your doctors should monitor the
dye used in the body; if used in excess it could lead to kidney
damage. X-ray guidance used during the procedure may
cause injury to the skin, which may be painful, damaging,
and long-lasting.
• Patient’s creatinine level should be measured prior to the
procedure.
• Patients who have already had a valve replaced should be
carefully assessed by their physician prior to receiving a new
valve to ensure proper placement of the new valve.
• Injury can occur if the delivery system is not used properly.
• Transcatheter heart valve patients should talk to their
physicians about the potential need for medications that
thin the blood or prevent blood clots from forming.
Edwards Lifesciences I 2020 Annual Report
Precautions:
The long-term durability of the Edwards SAPIEN 3 Ultra and
SAPIEN 3 transcatheter heart valves are not known at this time.
Regular medical follow-up is recommended to evaluate how
well a patient’s heart valve is performing. Limited clinical data are
available for transcatheter aortic valve replacement in patients
who are born with an aortic heart valve that has only two leaflets
and who are determined to be at low risk for open heart surgery.
Long-term durability of the valve has not been established.
The safety and effectiveness of the transcatheter heart valves
are also not known for patients who have:
• An aortic heart valve that is not calcified, contains only one
leaflet, has leaflets with large pieces of calcium that may block
the vessels that supply blood to the heart or in which the main
problem is that the valve leaks.
• Previous prosthetic ring in any position.
• Previous atrial septal occlude.
• A heart that does not pump well, has thickening of the heart
muscle, with or without blockage, unusual ultrasound images
of the heart that could represent irregularities such as a blood
clot, a diseased mitral valve that is calcified or leaking, or Gorlin
syndrome, a condition that affects many areas of the body and
increases the risk of developing various cancers and tumors.
• Low white, red or platelet blood cell counts, or history of
bleeding because the blood does not clot properly.
• Diseased, abnormal or irregularly shaped vessels leading to
the heart. Vessels which are heavily diseased or too small for
associated delivery devices, or a large amount of calcification
at the point of entry.
• Allergies to blood-thinning medications or dye injected during
the procedure.
• For a valve-in-valve procedure, there is a risk of leakage if the
previously implanted tissue valve is not securely in place or
if it is damaged. There is also the possibility that a partially
detached valve leaflet from the previously implanted valve
could block a blood vessel.
• Additional pre-procedure imaging will be completed to
evaluate proper sizing.
Potential risks associated with the procedure include:
• Death, stroke, paralysis (loss of muscle function), permanent
disability, or severe bleeding.
• Risks to the heart, including heart attack or heart failure, a heart
that does not pump well, irregular heartbeat that may result in
a need for a permanent pacemaker, chest pain, heart murmur,
false aneurysm, recurring aortic stenosis (narrowing), too much
fluid around the heart, injury to the structure of the heart.
• Risks to your lungs or breathing, including difficulty breathing,
fainting, buildup of fluid in or around the lungs, weakness or
inability to exercise.
• Risks involving bleeding or your blood supply, including
formation of a blood clot, high or low blood pressure, limited
blood supply, a decrease in red blood cells, or abnormal lab
values, bleeding in the abdominal cavity, collection of blood
under the skin.
• Additional risks, including life-threatening infection,
dislodgement of calcified material, air embolism (air bubbles
in the blood vessels), poor kidney function or failure, nerve
injury, fever, allergic reaction to anesthesia or dye, reoperation,
pain, infection or bleeding at incision sites, or swelling.
Additional potential risks specifically associated with the
use of the heart valves include:
• Valve movement after deployment, blockage or disruption
of blood flow through the heart, need for additional heart
surgery and possible removal of the Edwards SAPIEN 3 Ultra
and SAPIEN 3 valves, a blood clot that requires treatment,
damage to the valve (e.g., wear, breakage, recurring aortic
stenosis), nonstructural valve dysfunction (e.g., leakage,
inappropriate sizing or positioning, blockage, excess tissue
in growth, blood cell damage, etc.) or mechanical failure
of the delivery system and/or accessories.
CAUTION: Federal (United States) law restricts these devices
to sale by or on the order of a physician.
Edwards EVOQUE Tricuspid Valve Replacement System /
Edwards Cardioband System / PASCAL System /
HARPOON Beating Heart Mitral Valve Repair System
CAUTION: Investigational devices. Limited by Federal
(United States) law to investigational use. These devices are
not available for marketing or commercial sale in the United
States. The PASCAL system and Harpoon Beating Heart Mitral
Valve Repair System bear the CE marking of conformity.
The Edwards SAPIEN 3 transcatheter heart valve
and Edwards Alterra
CAUTION: Investigational devices. The Edwards SAPIEN 3
transcatheter heart valve and Edwards Alterra adaptive
prestent are investigational devices when used in patients
with a dysfunctional right ventricular outflow tract/pulmonary
valve (RVOT/PV) who are indicated for treatment of pulmonary
regurgitation (PR). Limited by Federal (USA) law to
investigational use only.
Edwards SAPIEN M3 System
CAUTION: Investigational devices. The Edwards SAPIEN M3
System consists of investigational devices, limited by Federal
(United States) law to investigational use. These devices are not
available for marketing or commercial sale in the United States.
Edwards Lifesciences I 2020 Annual Report
Corporate Information
Corporate Headquarters
Edwards Lifesciences Corporation
One Edwards Way, Irvine, California 92614
1-800-4-A-HEART or (949) 250-2500
Board of Directors
Michael A. Mussallem
Chairman & Chief Executive Officer,
Edwards Lifesciences Corporation
Annual Meeting
The virtual Annual Meeting of Stockholders
will be held on May 4, 2021 at 10:00 a.m.
(Pacific).
Stock Symbol
Edwards Lifesciences’ stock is traded
on The New York Stock Exchange
(NYSE) under the symbol EW.
Information on the Internet
Edwards Lifesciences’ “Investor Relations”
section of our web site – ir.edwards.com –
provides access to a wide range of information
including our press releases, SEC filings and
other company information.
Investor Information
Members of the investing public should
contact Investor Relations at (949) 250-2806
or investor_relations@edwards.com.
Corporate Public Relations
Members of the news media should call
(949) 250-5070.
Transfer Agent
Correspondence about shares, stock certificates
and account information may be directed to:
Computershare Investor Services
P.O. Box 30170
College Station, TX 77842-3170
(800) 446-2617
(781) 575-3120/outside U.S.
computershare.com/investor
Independent Registered Public
Accounting Firm
PricewaterhouseCoopers LLP
Orange County, CA
Edwards Lifesciences is an affirmative
action, equal opportunity employer.
Kieran T. Gallahue
Former Chairman &
Chief Executive Officer,
CareFusion Corporation
Leslie S. Heisz
Former Managing Director,
Lazard Frères & Co.
Paul A. LaViolette
Managing Partner &
Chief Operating Officer,
SV Health Investors LLC
William J. Link, Ph.D.
Managing Director & Co-Founder,
Versant Ventures
Executive Management
Michael A. Mussallem
Chairman & Chief Executive Officer
Donald E. Bobo, Jr.
Corporate Vice President,
Strategy & Corporate Development
Todd J. Brinton, M.D., F.A.C.C.
Corporate Vice President,
Advanced Technology
Chief Scientific Officer
Daveen Chopra
Corporate Vice President,
Surgical Structural Heart
Dirksen J. Lehman
Corporate Vice President,
Public Affairs
Jean-Luc Lemercier
Corporate Vice President,
EMEA, Canada and Latin America
Christine Z. McCauley
Corporate Vice President,
Human Resources
Joseph Nuzzolese
Corporate Vice President,
Global Supply Chain
Steven R. Loranger
Former Chairman, President
& Chief Executive Officer,
ITT Corporation
Martha H. Marsh
Former President &
Chief Executive Officer,
Stanford Hospital & Clinics
Ramona Sequeira
President of the U.S. Business
Unit and Global Portfolio
Commercialization, Takeda
Pharmaceutical USA, Inc.
Nicholas J. Valeriani
Former Chief Executive Officer,
Gary and Mary West Health Institute
Arnold A. Pinkston
Corporate Vice President,
General Counsel
Gary I. Sorsher
Vice President,
Quality & Regulatory
Compliance
Katie M. Szyman
Corporate Vice President,
Critical Care
Scott B. Ullem
Corporate Vice President,
Chief Financial Officer
Huimin Wang, M.D.
Corporate Vice President,
Japan, Asia & Pacific
Larry L. Wood
Corporate Vice President,
Transcatheter Aortic Valve
Replacement
Bernard J. Zovighian
Corporate Vice President,
Transcatheter Mitral
& Tricuspid Therapies
Trademarks
Edwards, Edwards Lifesciences, the stylized E logo, 1-800-4-A-HEART, Acumen, Acumen IQ, Alterra, Cardioband, ClearSight,
Edwards SAPIEN, Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, Edwards SAPIEN M3, Every Heartbeat Matters, EVOQUE, FloTrac,
ForeSight, HARPOON, HemoSphere, Hypotension Prediction Index, INSPIRIS, INSPIRIS RESILIA, KONECT, KONECT RESILIA, Life is Now,
PARTNER, PARTNER 3, PASCAL, PASCAL Ace, RESILIA, SAPIEN, SAPIEN 3, SAPIEN 3 Ultra, SAPIEN M3, and VFit are all trademarks of
Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.
© 2021 Edwards Lifesciences Corporation. All rights reserved.
Edwards Lifesciences • One Edwards Way, Irvine CA 92614 USA • edwards.com