IRVINE, Calif., Oct. 27, 2021 /PRNewswire/ -- Edwards
Lifesciences (NYSE: EW) today reported financial results for the
quarter ended September 30, 2021.
Third Quarter Highlights and 2021 Outlook
- Sales grew 15 percent to $1.3
billion; underlying1 sales grew 14 percent
- TAVR sales grew 15 percent; underlying 14 percent
- U.S. TAVR sales grew 12 percent; OUS approximately 20
percent
- Full year 2021 sales guidance range unchanged
- Q3 EPS was $0.54; full year EPS
guidance remains unchanged
- Continued progress on five pivotal trials in TMTT
"Third quarter sales increased 15 percent versus the year-ago
period, despite the pronounced impact of the Delta variant in the
U.S.," said Michael A. Mussallem,
chairman and CEO. "We believe some procedures were
unfortunately deferred in the third quarter, and we expect many of
these patients who deferred treatment will be treated in the
future. We continue to expect total company sales growth to
be in the high-teens for the full year."
Third Quarter 2021 Results
Sales for the quarter ended September 30, 2021, were
$1.3 billion, up 15 percent over the
prior year, or 14 percent on an underlying basis. All four
product groups delivered strong sales growth. Diluted and
adjusted earnings per share for the quarter were $0.54.
Transcatheter Aortic Valve Replacement (TAVR)
For the quarter, the company reported TAVR sales of $858 million, a year-over-year increase of 15
percent on a reported basis, or 14 percent on an underlying
basis. TAVR sales were negatively impacted in the last two
months of the third quarter due to the significant impact COVID had
on hospital resources. Globally, the company's average
selling prices and market position were stable.
Outside the U.S., in the third quarter, Edwards' TAVR sales grew
approximately 20 percent on a year-over-year basis, and the company
continues to be encouraged by the strong international adoption of
TAVR broadly in all regions.
The company remains confident that the global TAVR opportunity
will exceed $7 billion by 2024,
implying a low double digit compound annual growth rate.
Transcatheter Mitral and Tricuspid Therapies (TMTT)
Edwards progressed during the quarter in the enrollment of five
pivotal trials across the company's differentiated portfolio of
technologies to support patients suffering from mitral and
tricuspid regurgitation. The company continues to build a
body of compelling clinical evidence and remains on track for U.S.
approval of the PASCAL platform for patients with degenerative
mitral regurgitation late next year.
Third quarter TMTT sales were $22
million, driven by continued adoption of the PASCAL platform
in Europe.
Edwards continues to estimate that the global TMTT opportunity
will triple to approximately $3
billion by 2025. The company remains committed to
transforming the treatment of patients with mitral and tricuspid
valve disease around the world.
Surgical Structural Heart and Critical Care
Surgical Structural Heart sales for the quarter were
$217 million, up 7 percent compared
to the third quarter of 2020, or 6 percent on an underlying
basis. The growth was driven by steady adoption of the
company's premium RESILIA technologies around the world.
Critical Care sales were $213
million for the quarter, representing an increase of 18
percent versus the third quarter of 2020, or 17 percent on an
underlying basis. Sales growth was driven by contributions
from all product lines, led primarily by strong HemoSphere platform
sales in the U.S., as hospital capital spending continued to
recover.
Additional Financial Results
For the quarter, the adjusted gross profit margin was 76.3
percent, compared to 75.5 percent in the same period last year.
Selling, general and administrative expenses in the third
quarter were $364 million, or 27.8
percent of sales, compared to $307
million in the prior year. This increase was primarily
driven by personnel-related costs and increased commercial
activities compared to the COVID-impacted prior year.
Research and development expenses in the third quarter grew 22
percent to $238 million, or 18.2
percent of sales, compared to $196
million in the prior year. This increase was primarily
the result of continued investments in transcatheter innovations,
including increased clinical trial activity.
Free cash flow for the third quarter was $471 million, defined as cash flow from operating
activities of $532 million, less
capital spending of $61
million. Year-to-date free cash flow was $1.1 billion.
Cash and investments totaled $3.1
billion as of September 30, 2021. Total debt was
$596 million.
Outlook
Overall, the company still expects full year 2021 sales to fall
within the previous guidance range of $5.2 to $5.4
billion and adjusted earnings per share guidance at the high
end of $2.07 to $2.27.
For the fourth quarter of 2021, the company projects sales to be
between $1.30 and $1.38 billion, including TAVR between
$850 and $910
million, and adjusted EPS of $0.53 to $0.59.
"We are very pleased with our strong year-to-date performance
despite headwinds associated with the pandemic, and we remain
optimistic about our long-term growth opportunity," said
Mussallem. "We remain confident that the innovative therapies
resulting from our investments will benefit a broader group of
patients suffering from structural heart disease and continue to
drive strong organic growth."
2021 Investor Conference
As previously announced, Edwards will host its annual 2021
Investor Conference on December 8th
at the company's corporate headquarters in Irvine, California. Discussion topics
will include Edwards' focused innovation strategy, product
pipeline, and financial outlook for 2022. The conference will
be hosted onsite with appropriate safety precautions as well as
available via webcast. For more information, please visit the
"Investor Relations" section of the Edwards web site at
ir.edwards.com.
About Edwards
Lifesciences
Edwards Lifesciences is the global leader of patient-focused
innovations for structural heart disease and critical care
monitoring. We are driven by a passion for patients,
dedicated to improving and enhancing lives through partnerships
with clinicians and stakeholders across the global healthcare
landscape. For more information, visit Edwards.com and follow us on
Facebook, Instagram, LinkedIn, Twitter and YouTube.
Conference Call and Webcast
Information
Edwards Lifesciences will be hosting a conference call today at
2:00 p.m. PT to discuss its third quarter results. To
participate in the conference call, dial (877) 704-2848 or (201)
389-0893. The call will also be available live and archived
on the "Investor Relations" section of the Edwards web site at
ir.edwards.com or www.edwards.com.
This news release includes 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. These
forward-looking statements can sometimes be identified by the use
of words such as "may," "will," "should," "anticipate," "believe,"
"plan," "project," "estimate," "potential," "predict," "early
clinician feedback," "expect," "intend," "guidance," "outlook,"
"optimistic," "aspire," "confident" or other forms of these
words or similar expressions and include, but are not limited to,
statements made by Mr. Mussallem, treatment of patients whose
procedures were deferred as a result of COVID, fourth quarter and
full year 2021 financial guidance, statements regarding the TAVR
and TMTT opportunity, the compounded annual growth rate for the
company and TAVR, statements regarding transforming patient
treatment for TAVR and TMTT, approvals, clinical outcomes,
adoption, and the information in the Outlook section. No
inferences or assumptions should be made from statements of past
performance, efforts, or results which may not be indicative of
future performance or results. Forward-looking statements are
based on estimates and assumptions made by management of the
company and are believed to be reasonable, though they are
inherently uncertain, difficult to predict, and may be outside of
the company's control. The company's forward-looking
statements speak only as of the date on which they are made and the
company does not undertake any obligation to update any
forward-looking statement to reflect events or circumstances after
the date of the statement. If the company does update or
correct one or more of these statements, investors and others
should not conclude that the company will make additional updates
or corrections.
Forward-looking statements involve risks and uncertainties that
could cause actual results or experience to differ materially from
that expressed or implied by the forward-looking statements.
Factors that could cause actual results or experience to differ
materially from that expressed or implied by the forward-looking
statements include risk and uncertainties associated with the
COVID pandemic, clinical trial or commercial results or new product
approvals and therapy adoption; 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 R&D 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 in the company's
filings with the Securities and Exchange Commission (SEC),
including its Annual Report on Form 10-K for the year ended
December 31, 2020, its Quarterly Reports on Form 10-Q for the
quarters ended March 31, 2021 and
June 30, 2021, and its other filings
with the SEC. These filings, along with important safety
information about our products, may be found at edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo, HemoSphere,
PASCAL, and RESILIA are trademarks of Edwards Lifesciences
Corporation or its affiliates. All other trademarks are
the property of their respective owners. This statement is
made on behalf of Edwards Lifesciences Corporation and its
subsidiaries.
__________________
|
[1]
|
"Adjusted" amounts
are non-GAAP items. "Underlying" growth rates in this press
release exclude foreign exchange fluctuations and include the prior
year sales results of a business acquired as if the acquisition had
occurred at the beginning of the earliest period presented.
Adjusted earnings per share is a non-GAAP item computed on a
diluted basis and in this press release also excludes intellectual
property litigation expenses, amortization of intangible assets,
and fair value adjustments to contingent consideration liabilities
arising from acquisitions. See "Non-GAAP Financial
Information" and reconciliation tables below.
|
EDWARDS
LIFESCIENCES CORPORATION
|
Unaudited
Consolidated Statements of Operations
|
(in millions, except per share data)
|
|
|
Three Months
Ended
September
30,
|
|
Nine Months
Ended
September
30,
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
Net sales
|
$
|
1,310.2
|
|
|
$
|
1,140.9
|
|
|
$
|
3,902.8
|
|
|
$
|
3,194.6
|
|
Cost of
sales
|
311.7
|
|
|
281.0
|
|
|
939.4
|
|
|
784.3
|
|
|
|
|
|
|
|
|
|
Gross
profit
|
998.5
|
|
|
859.9
|
|
|
2,963.4
|
|
|
2,410.3
|
|
|
|
|
|
|
|
|
|
Selling, general, and
administrative expenses
|
364.4
|
|
|
307.2
|
|
|
1,069.7
|
|
|
889.9
|
|
Research and
development expenses
|
238.0
|
|
|
195.5
|
|
|
670.3
|
|
|
565.0
|
|
Intellectual property
litigation expenses, net
|
4.7
|
|
|
8.4
|
|
|
13.5
|
|
|
400.8
|
|
Change in fair value
of contingent consideration liabilities
|
1.1
|
|
|
(9.0)
|
|
|
(106.0)
|
|
|
8.4
|
|
|
|
|
|
|
|
|
|
Operating
income
|
390.3
|
|
|
357.8
|
|
|
1,315.9
|
|
|
546.2
|
|
|
|
|
|
|
|
|
|
Interest expense
(income), net
|
0.8
|
|
|
(0.8)
|
|
|
1.5
|
|
|
(7.1)
|
|
Other income,
net
|
(1.4)
|
|
|
(5.7)
|
|
|
(11.3)
|
|
|
(7.3)
|
|
|
|
|
|
|
|
|
|
Income before
provision for income taxes
|
390.9
|
|
|
364.3
|
|
|
1,325.7
|
|
|
560.6
|
|
|
|
|
|
|
|
|
|
Provision for income
taxes
|
50.8
|
|
|
39.1
|
|
|
157.9
|
|
|
46.7
|
|
|
|
|
|
|
|
|
|
Net income
|
$
|
340.1
|
|
|
$
|
325.2
|
|
|
$
|
1,167.8
|
|
|
$
|
513.9
|
|
|
|
|
|
|
|
|
|
Earnings per
share:
|
|
|
|
|
|
|
|
Basic
|
$
|
0.55
|
|
|
$
|
0.52
|
|
|
$
|
1.87
|
|
|
$
|
0.83
|
|
Diluted
|
$
|
0.54
|
|
|
$
|
0.52
|
|
|
$
|
1.85
|
|
|
$
|
0.82
|
|
|
|
|
|
|
|
|
|
Weighted-average
common shares outstanding:
|
|
|
|
|
|
|
|
Basic
|
623.6
|
|
|
622.1
|
|
|
623.0
|
|
|
622.3
|
|
Diluted
|
631.7
|
|
|
631.0
|
|
|
631.0
|
|
|
628.8
|
|
|
|
|
|
|
|
|
|
Operating
statistics
|
|
|
|
|
|
|
|
As a percentage of
net sales:
|
|
|
|
|
|
|
|
Gross
profit
|
76.2
|
%
|
|
75.4
|
%
|
|
75.9
|
%
|
|
75.4
|
%
|
Selling, general, and
administrative expenses
|
27.8
|
%
|
|
26.9
|
%
|
|
27.4
|
%
|
|
27.9
|
%
|
Research and
development expenses
|
18.2
|
%
|
|
17.1
|
%
|
|
17.2
|
%
|
|
17.7
|
%
|
Operating
income
|
29.8
|
%
|
|
31.4
|
%
|
|
33.7
|
%
|
|
17.1
|
%
|
Income before
provision for income taxes
|
29.8
|
%
|
|
31.9
|
%
|
|
34.0
|
%
|
|
17.5
|
%
|
Net income
|
26.0
|
%
|
|
28.5
|
%
|
|
29.9
|
%
|
|
16.1
|
%
|
|
|
|
|
|
|
|
|
Effective tax
rate
|
13.0
|
%
|
|
10.7
|
%
|
|
11.9
|
%
|
|
8.3
|
%
|
____________________
|
Note: Numbers may not
calculate due to rounding.
|
EDWARDS
LIFESCIENCES CORPORATION
|
Unaudited Balance
Sheets
|
(in
millions)
|
|
|
September 30,
2021
|
|
December 31,
2020
|
ASSETS
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
Cash and cash
equivalents
|
$
|
1,506.9
|
|
|
$
|
1,183.2
|
|
Short-term
investments
|
287.8
|
|
|
219.4
|
|
Accounts receivable,
net
|
600.6
|
|
|
514.6
|
|
Other
receivables
|
63.6
|
|
|
88.2
|
|
Inventories
|
737.8
|
|
|
802.3
|
|
Prepaid
expenses
|
76.9
|
|
|
75.1
|
|
Other current
assets
|
241.9
|
|
|
208.2
|
|
Total current
assets
|
3,515.5
|
|
|
3,091.0
|
|
|
|
|
|
Long-term
investments
|
1,282.0
|
|
|
801.6
|
|
Property, plant, and
equipment, net
|
1,464.6
|
|
|
1,395.2
|
|
Operating lease
right-of-use assets
|
84.8
|
|
|
94.2
|
|
Goodwill
|
1,170.4
|
|
|
1,173.2
|
|
Other intangible
assets, net
|
325.3
|
|
|
331.4
|
|
Deferred income
taxes
|
184.0
|
|
|
230.9
|
|
Other
assets
|
133.7
|
|
|
119.6
|
|
|
|
|
|
Total
assets
|
$
|
8,160.3
|
|
|
$
|
7,237.1
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
Accounts payable and
accrued liabilities
|
$
|
942.3
|
|
|
$
|
866.7
|
|
Operating lease
liabilities
|
24.2
|
|
|
27.2
|
|
Total current
liabilities
|
966.5
|
|
|
893.9
|
|
|
|
|
|
Long-term
debt
|
595.5
|
|
|
595.0
|
|
Contingent
consideration liabilities
|
80.1
|
|
|
186.1
|
|
Taxes
payable
|
190.2
|
|
|
215.3
|
|
Operating lease
liabilities
|
64.4
|
|
|
72.7
|
|
Uncertain tax
positions
|
245.4
|
|
|
214.4
|
|
Litigation settlement
accrual
|
201.4
|
|
|
233.0
|
|
Other
liabilities
|
275.5
|
|
|
252.4
|
|
Total
liabilities
|
2,619.0
|
|
|
2,662.8
|
|
|
|
|
|
Stockholders'
equity
|
|
|
|
Common
stock
|
641.2
|
|
|
636.4
|
|
Additional paid-in
capital
|
1,643.1
|
|
|
1,438.1
|
|
Retained
earnings
|
5,732.8
|
|
|
4,565.0
|
|
Accumulated other
comprehensive loss
|
(155.4)
|
|
|
(161.1)
|
|
Treasury stock, at
cost
|
(2,320.4)
|
|
|
(1,904.1)
|
|
Total stockholders'
equity
|
5,541.3
|
|
|
4,574.3
|
|
|
|
|
|
Total liabilities and
stockholders' equity
|
$
|
8,160.3
|
|
|
$
|
7,237.1
|
|
EDWARDS LIFESCIENCES CORPORATION
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 "underlying" when
referring to non-GAAP sales and sales growth information, which
excludes currency exchange rate fluctuations and includes the
impact of acquisitions. The Company uses the term "adjusted" to
also exclude intellectual property litigation expenses,
amortization of intangible assets, and fair value adjustments to
contingent consideration liabilities arising from
acquisitions.
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 understanding
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 currency exchange rates impact the comparative
results and sales growth rates of the Company's underlying
business. Management believes that excluding the impact of currency
exchange rate fluctuations from its sales growth provides investors
a more useful comparison to historical financial results. The
impact of the fluctuations has been detailed in the "Reconciliation
of Sales by Product Group and Region."
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 efforts. 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.
The items described below are adjustments to the GAAP
financial results in the reconciliations that follow:
Intellectual Property Litigation Expenses, net - The
Company incurred net intellectual property litigation expenses of
$6.4 million and $12.5 million in the first quarter of 2021 and
2020, respectively, $2.4 million and
$12.0 million in the second quarter
of 2021 and 2020, respectively, and $4.7
million and $8.4 million in
the third quarter of 2021 and 2020, respectively.
Change in Fair Value of Contingent Consideration
Liabilities - The Company recorded income of $4.5 million and $2.2
million in the first quarter of 2021 and 2020, respectively,
income of $102.6 million and expense
of $19.6 million in the second
quarter of 2021 and 2020, respectively, and expense of $1.1 million and income of $9.0 million in the third quarter of 2021 and
2020, respectively, related to changes in the fair value of its
contingent consideration liabilities arising from acquisitions.
Amortization of Intangible Assets - The Company recorded
amortization expense related to developed technology and patents in
the amount of $1.1 million and
$1.7 million in the first quarter of
2021 and 2020, respectively, $3.3
million and $1.3 million in
the second quarter of 2021 and 2020, respectively, and $1.7 million and $1.0
million in the third quarter of 2021 and 2020,
respectively.
Litigation Settlement - In the second quarter of
2020, the Company recorded a $367.9
million charge to settle certain patent litigation related
to transcatheter mitral and tricuspid repair products.
Provision for Income Taxes - The income tax impact of the
expenses and gains discussed above is based upon the items'
forecasted effect upon the Company's full year effective tax rate.
Adjustments to forecasted items unrelated to these expenses and
gains, as well as impacts related to interim reporting, will have
an effect on the income tax impact of these items in subsequent
periods.
EDWARDS
LIFESCIENCES CORPORATION
|
Unaudited
Reconciliation of GAAP to Non-GAAP Financial
Information
|
(in millions,
except per share and percentage data)
|
|
|
|
Three Months Ended
September 30, 2021
|
|
|
Net
Sales
|
|
Gross
Profit
Margin
|
|
Operating
Income
|
|
Net
Income
|
|
Diluted
EPS
|
|
Effective
Tax Rate
|
GAAP
|
|
$
|
1,310.2
|
|
|
76.2
|
%
|
|
$
|
390.3
|
|
|
$
|
340.1
|
|
|
$
|
0.54
|
|
|
13.0
|
%
|
Non-GAAP
adjustments: (A) (B)
|
|
|
|
|
|
|
|
|
|
|
|
|
Intellectual property
litigation expenses, net
|
|
—
|
|
|
—
|
|
|
4.7
|
|
|
3.5
|
|
|
0.01
|
|
|
0.1
|
|
Change in fair value
of contingent consideration
liabilities
|
|
—
|
|
|
—
|
|
|
1.1
|
|
|
1.1
|
|
|
—
|
|
|
—
|
|
Amortization of
intangible assets
|
|
—
|
|
|
0.1
|
|
|
1.7
|
|
|
1.5
|
|
|
—
|
|
|
—
|
|
Prior period ongoing
tax impacts
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(3.2)
|
|
|
(0.01)
|
|
|
0.8
|
|
Adjusted
|
|
$
|
1,310.2
|
|
|
76.3
|
%
|
|
$
|
397.8
|
|
|
$
|
343.0
|
|
|
$
|
0.54
|
|
|
13.9
|
%
|
|
|
|
|
|
Three Months Ended
September 30, 2020
|
|
|
Net
Sales
|
|
Gross
Profit
Margin
|
|
Operating
Income
|
|
Net
Income
|
|
Diluted
EPS
|
|
Effective
Tax Rate
|
GAAP
|
|
$
|
1,140.9
|
|
|
75.4
|
%
|
|
$
|
357.8
|
|
|
$
|
325.2
|
|
|
$
|
0.52
|
|
|
10.7
|
%
|
Non-GAAP
adjustments: (A) (B)
|
|
|
|
|
|
|
|
|
|
|
|
|
Intellectual property
litigation expenses, net
|
|
—
|
|
|
—
|
|
|
8.4
|
|
|
6.6
|
|
|
0.01
|
|
|
0.3
|
|
Change in fair value
of contingent consideration
liabilities
|
|
—
|
|
|
—
|
|
|
(9.0)
|
|
|
(8.1)
|
|
|
(0.02)
|
|
|
—
|
|
Amortization of
intangible assets
|
|
—
|
|
|
0.1
|
|
|
1.0
|
|
|
0.9
|
|
|
—
|
|
|
—
|
|
Prior period ongoing
tax impacts
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(0.8)
|
|
|
—
|
|
|
0.2
|
|
Adjusted
|
|
$
|
1,140.9
|
|
|
75.5
|
%
|
|
$
|
358.2
|
|
|
$
|
323.8
|
|
|
$
|
0.51
|
|
|
11.2
|
%
|
|
|
|
|
|
Nine Months Ended
September 30, 2021
|
|
|
Net
Sales
|
|
Gross
Profit
Margin
|
|
Operating
Income
|
|
Net
Income
|
|
Diluted
EPS
|
|
Effective
Tax Rate
|
GAAP
|
|
$
|
3,902.8
|
|
|
75.9
|
%
|
|
$
|
1,315.9
|
|
|
$
|
1,167.8
|
|
|
$
|
1.85
|
|
|
11.9
|
%
|
Non-GAAP
adjustments: (A) (B)
|
|
|
|
|
|
|
|
|
|
|
|
|
Intellectual property
litigation expenses, net
|
|
—
|
|
|
—
|
|
|
13.5
|
|
|
10.5
|
|
|
0.02
|
|
|
0.1
|
|
Change in fair value
of contingent consideration
liabilities
|
|
—
|
|
|
—
|
|
|
(106.0)
|
|
|
(97.0)
|
|
|
(0.15)
|
|
|
0.3
|
|
Amortization of
intangible assets
|
|
—
|
|
|
0.2
|
|
|
6.1
|
|
|
5.5
|
|
|
0.01
|
|
|
—
|
|
Prior period ongoing
tax impacts
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(3.2)
|
|
|
(0.01)
|
|
|
0.3
|
|
Adjusted
|
|
$
|
3,902.8
|
|
|
76.1
|
%
|
|
$
|
1,229.5
|
|
|
$
|
1,083.6
|
|
|
$
|
1.72
|
|
|
12.6
|
%
|
|
|
|
|
|
Nine Months Ended
September 30, 2020
|
|
|
Net
Sales
|
|
Gross
Profit
Margin
|
|
Operating
Income
|
|
Net
Income
|
|
Diluted
EPS
|
|
Effective
Tax Rate
|
GAAP
|
|
$
|
3,194.6
|
|
|
75.4
|
%
|
|
$
|
546.2
|
|
|
$
|
513.9
|
|
|
$
|
0.82
|
|
|
8.3
|
%
|
Non-GAAP
adjustments: (A) (B)
|
|
|
|
|
|
|
|
|
|
|
|
|
Litigation
settlement
|
|
—
|
|
|
—
|
|
|
367.9
|
|
|
306.9
|
|
|
0.48
|
|
|
2.9
|
|
Intellectual property
litigation expenses, net
|
|
—
|
|
|
—
|
|
|
32.9
|
|
|
26.1
|
|
|
0.04
|
|
|
0.6
|
|
Change in fair value
of contingent consideration
liabilities
|
|
—
|
|
|
—
|
|
|
8.4
|
|
|
8.1
|
|
|
0.01
|
|
|
—
|
|
Amortization of
intangible assets
|
|
—
|
|
|
0.2
|
|
|
4.0
|
|
|
3.5
|
|
|
0.01
|
|
|
—
|
|
Prior period ongoing
tax impacts
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(0.8)
|
|
|
—
|
|
|
0.1
|
|
Adjusted
|
|
$
|
3,194.6
|
|
|
75.6
|
%
|
|
$
|
959.4
|
|
|
$
|
857.7
|
|
|
$
|
1.36
|
|
|
11.9
|
%
|
_______________________
|
(A)
|
See description of
non-GAAP adjustments under "Non-GAAP Financial
Information."
|
(B)
|
The tax effect on
non-GAAP adjustments is calculated based upon the impact of the
relevant tax jurisdictions' statutory tax rates on the Company's
estimated annual effective tax rate, or discrete rate in the
quarter, as applicable. The impact on the effective tax rate
is reflected on each individual non-GAAP adjustment line
item.
|
RECONCILIATION OF
GAAP DILUTED WEIGHTED-AVERAGE SHARES TO ADJUSTED
DILUTED WEIGHTED-AVERAGE SHARES
|
|
|
Nine Months
Ended
September 30, 2020
|
GAAP Diluted
Weighted-Average Shares Outstanding
|
628.8
|
|
Dilutive effect of
stock plans
|
3.0
|
|
Adjusted Diluted
Weighted-Average Shares Outstanding (A)
|
631.8
|
|
_____________________
|
(A)
|
GAAP diluted
weighted-average shares outstanding excludes shares associated with
the Edwards' stock plans during the three months ended June 30,
2020 as the impact is anti-dilutive since Edwards reported a net
loss during that period. After reflecting the non-GAAP adjustments
above, these shares become dilutive.
|
COMPUTATION OF
FREE CASH FLOW
|
|
|
Nine Months
Ended
September 30, 2021
|
Net cash provided
by operating activities
|
$
|
1,358.5
|
|
Capital
expenditures
|
(236.0)
|
|
Free Cash
Flow
|
$
|
1,122.5
|
|
RECONCILIATION OF
SALES BY PRODUCT GROUP AND REGION
|
|
|
|
|
|
|
|
|
|
|
|
2020 Adjusted
|
|
|
Sales by Product Group (QTD)
|
|
3Q
2021
|
|
3Q
2020
|
|
Change
|
|
GAAP
Growth
Rate*
|
|
FX
Impact
|
|
3Q 2020
Adjusted
Sales
|
|
Underlying
Growth
Rate *
|
Transcatheter
Aortic Valve Replacement
|
|
$
|
857.8
|
|
|
$
|
744.6
|
|
|
$
|
113.2
|
|
|
15.2
|
%
|
|
$
|
4.9
|
|
|
$
|
749.5
|
|
|
14.5
|
%
|
Transcatheter
Mitral and Tricuspid Therapies
|
|
22.3
|
|
|
12.1
|
|
|
10.2
|
|
|
83.6
|
%
|
|
0.2
|
|
|
12.3
|
|
|
81.3
|
%
|
Surgical
Structural Heart
|
|
217.4
|
|
|
203.3
|
|
|
14.1
|
|
|
6.9
|
%
|
|
2.1
|
|
|
205.4
|
|
|
5.9
|
%
|
Critical
Care
|
|
212.7
|
|
|
180.9
|
|
|
31.8
|
|
|
17.6
|
%
|
|
1.0
|
|
|
181.9
|
|
|
17.0
|
%
|
Total
|
|
$
|
1,310.2
|
|
|
$
|
1,140.9
|
|
|
$
|
169.3
|
|
|
14.8
|
%
|
|
$
|
8.2
|
|
|
$
|
1,149.1
|
|
|
14.1
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2020 Adjusted
|
|
|
Sales by Product Group (YTD)
|
|
YTD 3Q
2021
|
|
YTD 3Q
2020
|
|
Change
|
|
GAAP
Growth
Rate*
|
|
FX
Impact
|
|
YTD 3Q
2020
Adjusted
Sales
|
|
Underlying
Growth
Rate *
|
Transcatheter
Aortic Valve Replacement
|
|
$
|
2,551.0
|
|
|
$
|
2,081.1
|
|
|
$
|
469.9
|
|
|
22.6
|
%
|
|
$
|
39.6
|
|
|
$
|
2,120.7
|
|
|
20.3
|
%
|
Transcatheter
Mitral and Tricuspid Therapies
|
|
60.7
|
|
|
28.7
|
|
|
32.0
|
|
|
111.5
|
%
|
|
1.5
|
|
|
30.2
|
|
|
101.1
|
%
|
Surgical
Structural Heart
|
|
667.8
|
|
|
557.6
|
|
|
110.2
|
|
|
19.8
|
%
|
|
14.8
|
|
|
572.4
|
|
|
16.7
|
%
|
Critical
Care
|
|
623.3
|
|
|
527.2
|
|
|
96.1
|
|
|
18.2
|
%
|
|
11.1
|
|
|
538.3
|
|
|
15.8
|
%
|
Total
|
|
$
|
3,902.8
|
|
|
$
|
3,194.6
|
|
|
$
|
708.2
|
|
|
22.2
|
%
|
|
$
|
67.0
|
|
|
$
|
3,261.6
|
|
|
19.7
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2020 Adjusted
|
|
|
Sales by Region (QTD)
|
|
3Q
2021
|
|
3Q
2020
|
|
Change
|
|
GAAP
Growth Rate*
|
|
FX
Impact
|
|
3Q 2020
Adjusted
Sales
|
|
Underlying
Growth
Rate *
|
United
States
|
|
$
|
753.2
|
|
|
$
|
662.0
|
|
|
$
|
91.2
|
|
|
13.8
|
%
|
|
$
|
—
|
|
|
$
|
662.0
|
|
|
13.8
|
%
|
Europe
|
|
291.1
|
|
|
253.8
|
|
|
37.3
|
|
|
14.7
|
%
|
|
7.4
|
|
|
261.2
|
|
|
11.5
|
%
|
Japan
|
|
125.9
|
|
|
113.9
|
|
|
12.0
|
|
|
10.6
|
%
|
|
(4.2)
|
|
|
109.7
|
|
|
14.7
|
%
|
Rest of
World
|
|
140.0
|
|
|
111.2
|
|
|
28.8
|
|
|
25.7
|
%
|
|
5.0
|
|
|
116.2
|
|
|
20.6
|
%
|
International
|
|
557.0
|
|
|
478.9
|
|
|
78.1
|
|
|
16.3
|
%
|
|
8.2
|
|
|
487.1
|
|
|
14.4
|
%
|
Total
|
|
$
|
1,310.2
|
|
|
$
|
1,140.9
|
|
|
$
|
169.3
|
|
|
14.8
|
%
|
|
$
|
8.2
|
|
|
$
|
1,149.1
|
|
|
14.1
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2020 Adjusted
|
|
|
Sales by Region (YTD)
|
|
YTD 3Q
2021
|
|
YTD 3Q
2020
|
|
Change
|
|
GAAP
Growth Rate*
|
|
FX
Impact
|
|
YTD 3Q
2020
Adjusted
Sales
|
|
Underlying
Growth
Rate *
|
United
States
|
|
$
|
2,223.6
|
|
|
$
|
1,845.6
|
|
|
$
|
378.0
|
|
|
20.5
|
%
|
|
$
|
—
|
|
|
$
|
1,845.6
|
|
|
20.5
|
%
|
Europe
|
|
880.9
|
|
|
707.8
|
|
|
173.1
|
|
|
24.5
|
%
|
|
51.5
|
|
|
759.3
|
|
|
15.9
|
%
|
Japan
|
|
390.0
|
|
|
330.7
|
|
|
59.3
|
|
|
17.9
|
%
|
|
(1.6)
|
|
|
329.1
|
|
|
18.4
|
%
|
Rest of
World
|
|
408.3
|
|
|
310.5
|
|
|
97.8
|
|
|
31.5
|
%
|
|
17.1
|
|
|
327.6
|
|
|
24.5
|
%
|
International
|
|
1,679.2
|
|
|
1,349.0
|
|
|
330.2
|
|
|
24.5
|
%
|
|
67.0
|
|
|
1,416.0
|
|
|
18.5
|
%
|
Total
|
|
$
|
3,902.8
|
|
|
$
|
3,194.6
|
|
|
$
|
708.2
|
|
|
22.2
|
%
|
|
$
|
67.0
|
|
|
$
|
3,261.6
|
|
|
19.7
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2019 Adjusted
|
|
|
Sales by Product Group (QTD)
|
|
3Q
2021
|
|
3Q
2019
|
|
Change
|
|
GAAP
2-Year
CAGR*
|
|
CASMED
Acquisition
|
|
FX
Impact
|
|
3Q 2019
Adjusted
Sales
|
|
Underlying
2-Year
CAGR*
|
Transcatheter
Aortic Valve Replacement
|
|
$
|
857.8
|
|
|
$
|
700.0
|
|
|
$
|
157.8
|
|
|
10.7
|
%
|
|
$
|
—
|
|
|
$
|
9.3
|
|
|
$
|
709.3
|
|
|
10.0
|
%
|
Transcatheter
Mitral and Tricuspid Therapies
|
|
22.3
|
|
|
9.7
|
|
|
12.6
|
|
|
50.7
|
%
|
|
—
|
|
|
0.6
|
|
|
10.3
|
|
|
47.3
|
%
|
Surgical
Structural Heart
|
|
217.4
|
|
|
204.1
|
|
|
13.3
|
|
|
3.2
|
%
|
|
—
|
|
|
3.1
|
|
|
207.2
|
|
|
2.4
|
%
|
Critical
Care
|
|
212.7
|
|
|
180.2
|
|
|
32.5
|
|
|
8.7
|
%
|
|
—
|
|
|
1.1
|
|
|
181.3
|
|
|
8.3
|
%
|
Total
|
|
$
|
1,310.2
|
|
|
$
|
1,094.0
|
|
|
$
|
216.2
|
|
|
9.4
|
%
|
|
$
|
—
|
|
|
$
|
14.1
|
|
|
$
|
1,108.1
|
|
|
8.7
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2019 Adjusted
|
|
|
Sales by Product Group (YTD)
|
|
YTD 3Q
2021
|
|
YTD 3Q
2019
|
|
Change
|
|
GAAP
2-Year
CAGR*
|
|
CASMED
Acquisition
|
|
FX
Impact
|
|
YTD 3Q
2019
Adjusted
Sales
|
|
Underlying
2-Year
CAGR*
|
Transcatheter
Aortic Valve Replacement
|
|
$
|
2,551.0
|
|
|
$
|
1,975.4
|
|
|
$
|
575.6
|
|
|
13.6
|
%
|
|
$
|
—
|
|
|
$
|
31.2
|
|
|
$
|
2,006.6
|
|
|
12.8
|
%
|
Transcatheter
Mitral and Tricuspid Therapies
|
|
60.7
|
|
|
21.0
|
|
|
39.7
|
|
|
69.9
|
%
|
|
—
|
|
|
1.1
|
|
|
22.1
|
|
|
65.7
|
%
|
Surgical
Structural Heart
|
|
667.8
|
|
|
636.6
|
|
|
31.2
|
|
|
2.4
|
%
|
|
—
|
|
|
13.6
|
|
|
650.2
|
|
|
1.4
|
%
|
Critical
Care
|
|
623.3
|
|
|
540.9
|
|
|
82.4
|
|
|
7.3
|
%
|
|
7.5
|
|
|
7.1
|
|
|
555.5
|
|
|
5.9
|
%
|
Total
|
|
$
|
3,902.8
|
|
|
$
|
3,173.9
|
|
|
$
|
728.9
|
|
|
10.9
|
%
|
|
$
|
7.5
|
|
|
$
|
53.0
|
|
|
$
|
3,234.4
|
|
|
9.8
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2019 Adjusted
|
|
|
Sales by Region (QTD)
|
|
3Q
2021
|
|
3Q
2019
|
|
Change
|
|
GAAP
2-Year
CAGR*
|
|
CASMED
Acquisition
|
|
FX
Impact
|
|
3Q 2019
Adjusted
Sales
|
|
Underlying
2-Year
CAGR*
|
United
States
|
|
$
|
753.2
|
|
|
$
|
647.8
|
|
|
$
|
105.4
|
|
|
7.8
|
%
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
647.8
|
|
|
7.8
|
%
|
Europe
|
|
291.1
|
|
|
222.6
|
|
|
68.5
|
|
|
14.3
|
%
|
|
—
|
|
|
14.9
|
|
|
237.5
|
|
|
10.8
|
%
|
Japan
|
|
125.9
|
|
|
112.9
|
|
|
13.0
|
|
|
5.6
|
%
|
|
—
|
|
|
(2.6)
|
|
|
110.3
|
|
|
7.1
|
%
|
Rest of
World
|
|
140.0
|
|
|
110.7
|
|
|
29.3
|
|
|
12.5
|
%
|
|
—
|
|
|
1.8
|
|
|
112.5
|
|
|
11.5
|
%
|
International
|
|
557.0
|
|
|
446.2
|
|
|
110.8
|
|
|
11.7
|
%
|
|
—
|
|
|
14.1
|
|
|
460.3
|
|
|
10.1
|
%
|
Total
|
|
$
|
1,310.2
|
|
|
$
|
1,094.0
|
|
|
$
|
216.2
|
|
|
9.4
|
%
|
|
$
|
—
|
|
|
$
|
14.1
|
|
|
$
|
1,108.1
|
|
|
8.7
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2019 Adjusted
|
|
|
Sales by Region (YTD)
|
|
YTD 3Q
2021
|
|
YTD 3Q
2019
|
|
Change
|
|
GAAP
2-Year
CAGR*
|
|
CASMED
Acquisition
|
|
FX
Impact
|
|
YTD 3Q
2019
Adjusted
Sales
|
|
Underlying
2-Year
CAGR*
|
United
States
|
|
$
|
2,223.6
|
|
|
$
|
1,835.5
|
|
|
$
|
388.1
|
|
|
10.1
|
%
|
|
$
|
6.7
|
|
|
$
|
—
|
|
|
$
|
1,842.2
|
|
|
9.9
|
%
|
Europe
|
|
880.9
|
|
|
699.0
|
|
|
181.9
|
|
|
12.2
|
%
|
|
0.4
|
|
|
45.7
|
|
|
745.1
|
|
|
8.7
|
%
|
Japan
|
|
390.0
|
|
|
324.4
|
|
|
65.6
|
|
|
9.6
|
%
|
|
0.2
|
|
|
2.8
|
|
|
327.4
|
|
|
9.1
|
%
|
Rest of
World
|
|
408.3
|
|
|
315.0
|
|
|
93.3
|
|
|
13.9
|
%
|
|
0.2
|
|
|
4.5
|
|
|
319.7
|
|
|
13.0
|
%
|
International
|
|
1,679.2
|
|
|
1,338.4
|
|
|
340.8
|
|
|
12.0
|
%
|
|
0.8
|
|
|
53.0
|
|
|
1,392.2
|
|
|
9.8
|
%
|
Total
|
|
$
|
3,902.8
|
|
|
$
|
3,173.9
|
|
|
$
|
728.9
|
|
|
10.9
|
%
|
|
$
|
7.5
|
|
|
$
|
53.0
|
|
|
$
|
3,234.4
|
|
|
9.8
|
%
|
______________________
|
* Numbers may not
calculate due to rounding.
|
View original content to download
multimedia:https://www.prnewswire.com/news-releases/edwards-lifesciences-reports-third-quarter-results-301410222.html
SOURCE Edwards Lifesciences Corporation