IRVINE,
Calif., Oct. 25, 2023 /PRNewswire/ -- Edwards
Lifesciences (NYSE: EW) today reported financial results for the
quarter ended Sept. 30, 2023.
Recent Highlights and Outlook
- Q3 sales grew 12 percent to $1.48
billion; constant currency1 sales grew 11
percent
- Q3 TAVR sales grew 11 percent; constant currency sales grew 10
percent
- Q3 EPS of $0.63;
adjusted1 EPS of $0.59
- Received CE Mark for EVOQUE, the first transfemoral tricuspid
replacement system
- Received approval for PASCAL Precision system in Japan
- Received CE Mark for MITRIS RESILIA surgical mitral valve
- Completed pivotal trial enrollment for SAPIEN M3, the first
transfemoral mitral replacement system
- Reiterated full year 2023 financial guidance of 10 to 13
percent constant currency sales growth
"We are pleased with our strong third quarter performance, which
included multiple new therapy approvals for the treatment of
patients globally and important achievements on clinical
milestones, as well as another quarter of double-digit sales
growth," said Bernard Zovighian,
CEO. "The increasing demand for our advanced technologies,
coupled with the successful execution of our innovation strategy,
gives us confidence in the tremendous opportunity to address unmet
patient needs and drive differentiated long-term value."
Transcatheter Aortic Valve Replacement (TAVR)
For the quarter, the company reported TAVR sales of $961 million, which grew 11 percent versus the
prior year, or 10 percent on a constant currency basis. The
company's U.S. and OUS sales growth rates were comparable.
Globally, on a constant currency basis, the company's average
selling prices were stable.
In the U.S., Edwards' TAVR sales were in-line with overall
procedure growth and driven by the continued successful launch of
the SAPIEN 3 Ultra RESILIA valve.
"After more than 20 years of rigorous clinical experience and
over 1 million patients treated, TAVR with SAPIEN is now a highly
effective standard of care for patients suffering from aortic heart
valve failure," said Larry Wood,
group president of TAVR and Surgical Structural Heart. "We remain
focused on improving diagnosis and treatment of the many more
patients who remain untreated."
The combination of Edwards' global TAVR leadership, along
with the data presented at TCT, gives the company further
confidence in the future of TAVR and the company's expectation of a
$10 billion opportunity by 2028.
Transcatheter Mitral and Tricuspid Therapies (TMTT)
Third quarter sales were $52
million, driven by accelerated adoption of the PASCAL
Precision system, overall transcatheter edge-to-edge repair
procedure growth and activation of more centers across Europe and the U.S.
As previously announced, the company received CE Mark for the
EVOQUE tricuspid valve replacement system. This groundbreaking
therapy will be introduced to patients in Europe through a disciplined launch that will
focus on ensuring excellent outcomes. In addition, earlier this
month, Edwards received approval in Japan for the PASCAL Precision system to treat
patients with degenerative mitral regurgitation. The company also
completed the enrollment in the ENCIRCLE pivotal trial, studying
patients treated with Edwards' innovative SAPIEN M3 transfemoral
mitral valve replacement therapy.
Surgical Structural Heart and Critical Care
Surgical Structural Heart sales for the quarter were
$247 million, which grew 12 percent,
or 11 percent on a constant currency basis. The growth was
driven by a balanced combination of strong adoption of Edwards'
premium RESILIA products and overall procedure growth.
Critical Care sales for the quarter were $221 million, which grew 7 percent, or 6 percent
on a constant currency basis. Sales growth was led by the
Smart Recovery technology portfolio and strong adoption of the
Acumen IQ sensor equipped with the Hypotension Prediction Index
algorithm.
Additional Financial Results
For the quarter, the adjusted gross profit margin was 76.4
percent, compared to 81.0 percent in the same period last
year. This year-over-year reduction was driven by impacts
from foreign exchange. Last year, Edwards' gross profit
margin was lifted by an unusually positive impact from foreign
exchange.
Selling, general and administrative expenses in the third
quarter were $440 million, or 29.7
percent of sales, compared to $377
million in the prior year. This increase was driven by
investments in transcatheter field-based personnel in support of
the company's growth strategy and performance-based
compensation.
Research and development expenses in the third quarter were
$270 million, or 18.3 percent of
sales, compared to $234 million in
the prior year. This increase was primarily the result of
continued investments in the company's transcatheter valve
innovations, including increased clinical trial activity.
Free cash flow for the third quarter was $356 million, defined as cash flow from operating
activities of $411 million, less
capital spending of $55 million.
Cash, cash equivalents and short-term investments totaled
$1.9 billion as of
Sept. 30, 2023. During the third quarter, the company
repurchased approximately $174
million of stock through a pre-established 10b5-1
program. Total debt was approximately $600 million.
Outlook
Edwards' full-year sales guidance remains unchanged for both the
total company and each product group. The company continues
to expect full-year total company and TAVR sales growth to be in
the 10 to 13 percent range on a constant currency basis.
Additionally, the company continues to expect full year 2023
adjusted earnings per share of $2.50
to $2.60. For the fourth
quarter of 2023, the company projects total sales to be between
$1.45 and $1.53 billion and diluted earnings per share of
$0.60 and $0.66.
"We are confident in our focused and differentiated strategy
given heart valve failure is largely underdiagnosed and
undertreated for patients globally. We remain convinced in
the tremendous opportunity to drive success in the future through
our focus, innovation and leadership," said Zovighian.
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," "forecast," "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. Zovighian, fourth quarter and full year
2023 financial guidance, statements regarding the international
adoption of TAVR, statements regarding transforming patient
treatment, 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 supply 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, 2022, 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, Acumen,
Acumen IQ, ENCIRCLE, EVOQUE, Hypotension Prediction Index, MITRIS,
MITRIS RESILIA, PASCAL, PASCAL Precision, RESILIA, SAPIEN, SAPIEN
M3, SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA are
trademarks of Edwards Lifesciences Corporation or its
affiliates. All other trademarks are the property of their
respective owners.
___________________
|
[1]
|
"Adjusted" amounts are
non-GAAP items. "Underlying" and "constant currency" growth
rates in this press release exclude foreign exchange
fluctuations. Adjusted earnings per share is a non-GAAP item
computed on a diluted basis and in this press release also excludes
an intellectual property agreement and litigation expenses,
amortization of intangible assets, fair value adjustments to
contingent consideration liabilities arising from acquisitions, a
significant program discontinuation, and the impact from tax law
change. 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,
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Net sales
|
$
1,480.9
|
|
$
1,319.0
|
|
$
4,470.7
|
|
$
4,034.1
|
Cost of
sales
|
350.4
|
|
253.8
|
|
1,022.9
|
|
822.5
|
|
|
|
|
|
|
|
|
Gross profit
|
1,130.5
|
|
1,065.2
|
|
3,447.8
|
|
3,211.6
|
|
|
|
|
|
|
|
|
Selling, general, and
administrative expenses
|
439.6
|
|
377.3
|
|
1,344.6
|
|
1,156.6
|
Research and
development expenses
|
270.3
|
|
233.6
|
|
801.8
|
|
713.0
|
Intellectual property
agreement and litigation expense (income), net
|
2.2
|
|
(2.4)
|
|
193.6
|
|
10.8
|
Change in fair value of
contingent consideration liabilities
|
—
|
|
(12.5)
|
|
(26.2)
|
|
(36.3)
|
Special
charge
|
—
|
|
66.8
|
|
—
|
|
66.8
|
|
|
|
|
|
|
|
|
Operating
income
|
418.4
|
|
402.4
|
|
1,134.0
|
|
1,300.7
|
|
|
|
|
|
|
|
|
Interest income,
net
|
(15.1)
|
|
(6.9)
|
|
(32.8)
|
|
(8.4)
|
Other (income) expense,
net
|
(5.8)
|
|
2.0
|
|
(9.6)
|
|
1.0
|
|
|
|
|
|
|
|
|
Income before provision
for income taxes
|
439.3
|
|
407.3
|
|
1,176.4
|
|
1,308.1
|
|
|
|
|
|
|
|
|
Provision for income
taxes
|
55.6
|
|
63.8
|
|
146.7
|
|
184.6
|
|
|
|
|
|
|
|
|
Net income
|
383.7
|
|
343.5
|
|
$
1,029.7
|
|
$
1,123.5
|
|
|
|
|
|
|
|
|
Net loss attributable
to noncontrolling interest
|
(1.2)
|
|
—
|
|
(2.8)
|
|
—
|
|
|
|
|
|
|
|
|
Net income attributable
to Edwards Lifesciences Corporation
|
$ 384.9
|
|
$ 343.5
|
|
$
1,032.5
|
|
$
1,123.5
|
|
|
|
|
|
|
|
|
Earnings per
share:
|
|
|
|
|
|
|
|
Basic
|
$
0.63
|
|
$
0.55
|
|
$
1.70
|
|
$
1.81
|
Diluted
|
$
0.63
|
|
$
0.55
|
|
$
1.69
|
|
$
1.79
|
|
|
|
|
|
|
|
|
Weighted-average
common shares outstanding:
|
|
|
|
|
|
|
|
Basic
|
607.0
|
|
619.8
|
|
607.2
|
|
621.0
|
Diluted
|
609.5
|
|
624.5
|
|
610.2
|
|
626.9
|
|
|
|
|
|
|
|
|
Operating
statistics
|
|
|
|
|
|
|
|
As a percentage of net
sales:
|
|
|
|
|
|
|
|
Gross
profit
|
76.3 %
|
|
80.8 %
|
|
77.1 %
|
|
79.6 %
|
Selling, general, and
administrative expenses
|
29.7 %
|
|
28.6 %
|
|
30.1 %
|
|
28.7 %
|
Research and
development expenses
|
18.3 %
|
|
17.7 %
|
|
17.9 %
|
|
17.7 %
|
Operating
income
|
28.3 %
|
|
30.5 %
|
|
25.4 %
|
|
32.2 %
|
Income before
provision for income taxes
|
29.7 %
|
|
30.9 %
|
|
26.3 %
|
|
32.4 %
|
Net income
|
25.9 %
|
|
26.0 %
|
|
23.0 %
|
|
27.9 %
|
|
|
|
|
|
|
|
|
Effective tax
rate
|
12.7 %
|
|
15.7 %
|
|
12.5 %
|
|
14.1 %
|
____________________
|
Note: Numbers may not
calculate due to rounding.
|
EDWARDS LIFESCIENCES
CORPORATION Unaudited Balance Sheets (in
millions)
|
|
|
September 30,
2023
|
|
December 31,
2022
|
ASSETS
|
|
|
|
Current
assets
|
|
|
|
Cash and cash
equivalents
|
$
1,410.1
|
|
$
769.0
|
Short-term
investments
|
453.8
|
|
446.3
|
Accounts receivables,
net
|
739.8
|
|
643.0
|
Other
receivables
|
62.3
|
|
56.1
|
Inventories
|
1,032.4
|
|
875.5
|
Prepaid
expenses
|
133.3
|
|
110.0
|
Other current
assets
|
235.8
|
|
195.9
|
Total current
assets
|
4,067.5
|
|
3,095.8
|
Long-term
investments
|
704.6
|
|
1,239.0
|
Property, plant, and
equipment, net
|
1,681.3
|
|
1,632.8
|
Operating lease
right-of-use assets
|
90.9
|
|
92.3
|
Goodwill
|
1,297.4
|
|
1,164.3
|
Other intangible
assets, net
|
429.8
|
|
285.2
|
Deferred income
taxes
|
651.9
|
|
484.0
|
Other assets
|
447.4
|
|
299.1
|
Total assets
|
$
9,370.8
|
|
$
8,292.5
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities
|
|
|
|
Accounts payable and
accrued liabilities
|
$
1,214.6
|
|
$
996.9
|
Operating lease
liabilities
|
24.3
|
|
25.5
|
Total current
liabilities
|
1,238.9
|
|
1,022.4
|
Long-term
debt
|
596.8
|
|
596.3
|
Contingent
consideration liabilities
|
—
|
|
26.2
|
Taxes
payable
|
81.2
|
|
143.4
|
Operating lease
liabilities
|
70.0
|
|
69.5
|
Uncertain tax
positions
|
312.1
|
|
267.5
|
Litigation agreement
accrual
|
104.4
|
|
143.0
|
Other
liabilities
|
240.3
|
|
217.5
|
Total
liabilities
|
2,643.7
|
|
2,485.8
|
Stockholders'
equity
|
|
|
|
Common stock
|
649.9
|
|
646.3
|
Additional paid-in
capital
|
2,211.3
|
|
1,969.3
|
Retained
earnings
|
8,622.5
|
|
7,590.0
|
Accumulated other
comprehensive loss
|
(250.1)
|
|
(254.9)
|
Treasury stock, at
cost
|
(4,576.1)
|
|
(4,144.0)
|
Total Edwards
Lifesciences Corporation stockholders' equity
|
6,657.5
|
|
5,806.7
|
Noncontrolling
interest
|
69.6
|
|
—
|
Total
equity
|
6,727.1
|
|
5,806.7
|
Total liabilities and
equity
|
$
9,370.8
|
|
$
8,292.5
|
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. The Company uses the
term "adjusted" to also exclude intellectual property litigation
expenses, intellectual property agreements, amortization of
intangible assets, fair value adjustments to contingent
consideration liabilities arising from acquisitions, a significant
program discontinuation, and the impact from tax law
changes.
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 - The Company
incurred intellectual property litigation expenses of $6.5 million and $7.1
million in the first quarter of 2023 and 2022,
respectively, $8.9 million and
$6.1 million in the second quarter of
2023 and 2022, respectively, and expense of $2.2 million and income of $2.4 million in the third quarter of 2023 and
2022, respectively.
Change in Fair Value of Contingent Consideration
Liabilities - The Company recorded expense of $0.7 million and a gain of $2.9 million in the first quarter of 2023 and
2022, respectively, gains of $26.9
million and $20.9 million in
the second quarter of 2023 and 2022, respectively, and a gain of
$12.5 million in the third quarter of
2022 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 $1.5 million and
$1.7 million in the first quarter of
2023 and 2022, respectively, $1.3
million and $1.2 million in
the second quarter of 2023 and 2022, respectively, and $1.2 million and $1.5
million in the third quarter of 2023 and 2022,
respectively.
Intellectual Property Agreement - The Company
recorded a $37.0 million and a
$139.0 million charge in the first
and second quarter of 2023, respectively, related to an
Intellectual Property Agreement with Medtronic, Inc. for a 15-year
covenant not to sue.
Program Discontinuation - The Company recorded a
$68.4 million charge in the third
quarter of 2022 as a result of its decision to exit its
HARPOON surgical mitral repair system program. The charge
primarily related to the impairment of intangible assets.associated
with the technology and other related exit costs.
Provision for Income Taxes - During the third quarter of
2023, the Company recorded a $23.2
million tax gain related to the suspension of certain
United States tax regulations
surrounding foreign tax credits.
The income tax impacts of the expenses and gains discussed above
are based upon the items' forecasted effect upon the Company's full
year effective tax rate. Adjustments to forecasted items unrelated
to the expenses and gains above, 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, 2023
|
|
|
Net
Sales
|
|
Gross
Profit
Margin
|
|
Operating
Income
|
|
Net Income
Attributable to
Edwards
Lifesciences
Corporation
|
|
Diluted
EPS
|
|
Effective
Tax Rate
|
GAAP
|
|
$
1,480.9
|
|
76.3 %
|
|
$ 418.4
|
|
$
384.9
|
|
$ 0.63
|
|
12.7 %
|
Non-GAAP adjustments:
(A) (B)
|
|
|
|
|
|
|
|
|
|
|
|
|
Intellectual property
litigation expenses
|
|
—
|
|
—
|
|
2.2
|
|
1.3
|
|
—
|
|
0.1
|
Amortization of
intangible assets
|
|
—
|
|
0.1
|
|
1.2
|
|
1.0
|
|
—
|
|
—
|
Foreign tax credit
suspension
|
|
—
|
|
—
|
|
—
|
|
(23.2)
|
|
(0.04)
|
|
5.3
|
Prior period ongoing
tax impacts
|
|
—
|
|
—
|
|
—
|
|
(3.4)
|
|
—
|
|
0.7
|
Adjusted
|
|
$
1,480.9
|
|
76.4 %
|
|
$ 421.8
|
|
$
360.6
|
|
$ 0.59
|
|
18.8 %
|
|
|
|
Three Months Ended
September 30, 2022
|
|
|
Net
Sales
|
|
Gross
Profit
Margin
|
|
Operating
Income
|
|
Net Income
Attributable to
Edwards
Lifesciences
Corporation
|
|
Diluted
EPS
|
|
Effective
Tax Rate
|
GAAP
|
|
$
1,319.0
|
|
80.8 %
|
|
$ 402.4
|
|
$
343.5
|
|
$ 0.55
|
|
15.7 %
|
Non-GAAP adjustments:
(A) (B)
|
|
|
|
|
|
|
|
|
|
|
|
|
Intellectual property
litigation expenses
|
|
—
|
|
—
|
|
(2.4)
|
|
(2.2)
|
|
—
|
|
—
|
Change in fair value
of contingent consideration liabilities
|
|
—
|
|
—
|
|
(12.5)
|
|
(12.1)
|
|
(0.02)
|
|
0.4
|
Amortization of
intangible assets
|
|
—
|
|
0.1
|
|
1.5
|
|
1.3
|
|
—
|
|
—
|
Program
discontinuation
|
|
—
|
|
0.1
|
|
68.4
|
|
53.3
|
|
0.08
|
|
0.9
|
Adjusted
|
|
$
1,319.0
|
|
81.0 %
|
|
$ 457.4
|
|
$
383.8
|
|
$ 0.61
|
|
17.0 %
|
|
|
|
Nine Months Ended
September 30, 2023
|
|
|
Net
Sales
|
|
Gross
Profit
Margin
|
|
Operating
Income
|
|
Net Income
Attributable to
Edwards
Lifesciences
Corporation
|
|
Diluted
EPS
|
|
Effective
Tax Rate
|
GAAP
|
|
$
4,470.7
|
|
77.1 %
|
|
$
1,134.0
|
|
$
1,032.5
|
|
$ 1.69
|
|
12.5 %
|
Non-GAAP adjustments:
(A) (B)
|
|
|
|
|
|
|
|
|
|
|
|
|
Intellectual property
agreement
|
|
—
|
|
—
|
|
176.0
|
|
138.7
|
|
0.23
|
|
1.1
|
Intellectual property
litigation expenses
|
|
—
|
|
—
|
|
17.6
|
|
13.6
|
|
0.02
|
|
0.1
|
Change in fair value
of contingent consideration liabilities
|
|
—
|
|
—
|
|
(26.2)
|
|
(24.1)
|
|
(0.04)
|
|
0.1
|
Amortization of
intangible assets
|
|
—
|
|
0.1
|
|
4.0
|
|
3.3
|
|
0.01
|
|
—
|
Foreign tax credit
suspension
|
|
—
|
|
—
|
|
—
|
|
(23.2)
|
|
(0.04)
|
|
1.8
|
Adjusted
|
|
$
4,470.7
|
|
77.2 %
|
|
$
1,305.4
|
|
$
1,140.8
|
|
$ 1.87
|
|
15.6 %
|
|
|
|
Nine Months Ended
September 30, 2022
|
|
|
Net
Sales
|
|
Gross
Profit
Margin
|
|
Operating
Income
|
|
Net Income
Attributable to
Edwards
Lifesciences
Corporation
|
|
Diluted
EPS
|
|
Effective
Tax Rate
|
GAAP
|
|
$
4,034.1
|
|
79.6 %
|
|
$
1,300.7
|
|
$
1,123.5
|
|
$ 1.79
|
|
14.1 %
|
Non-GAAP adjustments:
(A) (B)
|
|
|
|
|
|
|
|
|
|
|
|
|
Intellectual property
litigation expenses
|
|
—
|
|
—
|
|
10.8
|
|
8.4
|
|
0.02
|
|
0.1
|
Change in fair value
of contingent consideration liabilities
|
|
—
|
|
—
|
|
(36.3)
|
|
(34.0)
|
|
(0.05)
|
|
0.2
|
Amortization of
intangible assets
|
|
—
|
|
0.1
|
|
4.4
|
|
3.8
|
|
—
|
|
—
|
Program
discontinuation
|
|
—
|
|
0.1
|
|
68.4
|
|
53.3
|
|
0.08
|
|
0.4
|
Adjusted
|
|
$
4,034.1
|
|
79.8 %
|
|
$
1,348.0
|
|
$
1,155.0
|
|
$ 1.84
|
|
14.8 %
|
_____________________
|
(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
SALES BY PRODUCT GROUP AND REGION
|
|
|
|
|
|
|
|
|
|
|
|
2022 Adjusted
|
|
|
Sales by Product Group (QTD)
|
|
3Q
2023
|
|
3Q
2022
|
|
Change
|
|
GAAP
Growth
Rate*
|
|
FX
Impact
|
|
3Q 2022
Adjusted
Sales
|
|
Underlying
Growth
Rate *
|
Transcatheter Aortic
Valve Replacement
|
|
$
960.9
|
|
$
862.3
|
|
$ 98.6
|
|
11.4 %
|
|
$ 11.4
|
|
$
873.7
|
|
9.9 %
|
Transcatheter Mitral
and Tricuspid Therapies
|
|
52.4
|
|
29.7
|
|
22.7
|
|
76.0 %
|
|
1.9
|
|
31.6
|
|
65.3 %
|
Surgical Structural
Heart
|
|
246.6
|
|
219.7
|
|
26.9
|
|
12.2 %
|
|
2.4
|
|
222.1
|
|
11.0 %
|
Critical
Care
|
|
221.0
|
|
207.3
|
|
13.7
|
|
6.6 %
|
|
0.5
|
|
207.8
|
|
6.3 %
|
Total
|
|
$
1,480.9
|
|
$
1,319.0
|
|
$
161.9
|
|
12.3 %
|
|
$
16.2
|
|
$
1,335.2
|
|
10.9 %
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2022 Adjusted
|
|
|
Sales by Product Group (YTD)
|
|
YTD
3Q 2023
|
|
YTD
3Q 2022
|
|
Change
|
|
GAAP
Growth
Rate*
|
|
FX
Impact
|
|
YTD 3Q
2022
Adjusted
Sales
|
|
Underlying
Growth
Rate *
|
Transcatheter Aortic
Valve Replacement
|
|
$
2,900.4
|
|
$
2,650.5
|
|
$
249.9
|
|
9.4 %
|
|
$
(17.1)
|
|
$ 2,633.4
|
|
10.2 %
|
Transcatheter Mitral
and Tricuspid Therapies
|
|
141.6
|
|
84.6
|
|
57.0
|
|
67.3 %
|
|
1.1
|
|
85.7
|
|
65.2 %
|
Surgical Structural
Heart
|
|
751.1
|
|
669.0
|
|
82.1
|
|
12.3 %
|
|
(8.1)
|
|
660.9
|
|
13.7 %
|
Critical
Care
|
|
677.6
|
|
630.0
|
|
47.6
|
|
7.6 %
|
|
(10.8)
|
|
619.2
|
|
9.5 %
|
Total
|
|
$
4,470.7
|
|
$
4,034.1
|
|
$
436.6
|
|
10.8 %
|
|
$
(34.9)
|
|
$
3,999.2
|
|
11.8 %
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2022 Adjusted
|
|
|
Sales by Region (QTD)
|
|
3Q
2023
|
|
3Q
2022
|
|
Change
|
|
GAAP
Growth
Rate*
|
|
FX
Impact
|
|
3Q 2022
Adjusted
Sales
|
|
Underlying
Growth
Rate *
|
United
States
|
|
$
869.9
|
|
$
786.8
|
|
$ 83.1
|
|
10.6 %
|
|
$
—
|
|
$
786.8
|
|
10.6 %
|
Europe
|
|
322.3
|
|
270.1
|
|
52.2
|
|
19.3 %
|
|
22.7
|
|
292.8
|
|
10.0 %
|
Japan
|
|
108.4
|
|
104.1
|
|
4.3
|
|
4.1 %
|
|
(4.2)
|
|
99.9
|
|
8.0 %
|
Rest of
World
|
|
180.3
|
|
158.0
|
|
22.3
|
|
14.2 %
|
|
(2.3)
|
|
155.7
|
|
15.8 %
|
Outside of the
United States
|
|
611.0
|
|
532.2
|
|
78.8
|
|
14.8 %
|
|
16.2
|
|
548.4
|
|
11.3 %
|
Total
|
|
$
1,480.9
|
|
$
1,319.0
|
|
$
161.9
|
|
12.3 %
|
|
$
16.2
|
|
$
1,335.2
|
|
10.9 %
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2022 Adjusted
|
|
|
Sales by Region (YTD)
|
|
YTD
3Q 2023
|
|
YTD
3Q 2022
|
|
Change
|
|
GAAP
Growth
Rate*
|
|
FX
Impact
|
|
YTD 3Q
2022
Adjusted
Sales
|
|
Underlying
Growth
Rate *
|
United
States
|
|
$
2,614.3
|
|
$
2,337.1
|
|
$
277.2
|
|
11.9 %
|
|
$
—
|
|
$
2,337.1
|
|
11.9 %
|
Europe
|
|
989.6
|
|
884.0
|
|
105.6
|
|
11.9 %
|
|
8.6
|
|
892.6
|
|
10.9 %
|
Japan
|
|
340.4
|
|
362.5
|
|
(22.1)
|
|
(6.1) %
|
|
(27.4)
|
|
335.1
|
|
1.6 %
|
Rest of
World
|
|
526.4
|
|
450.5
|
|
75.9
|
|
16.9 %
|
|
(16.1)
|
|
434.4
|
|
21.2 %
|
Outside of the
United States
|
|
1,856.4
|
|
1,697.0
|
|
159.4
|
|
9.4 %
|
|
(34.9)
|
|
1,662.1
|
|
11.8 %
|
Total
|
|
$
4,470.7
|
|
$
4,034.1
|
|
$
436.6
|
|
10.8 %
|
|
$
(34.9)
|
|
$
3,999.2
|
|
11.8 %
|
______________________
|
* 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-301967772.html
SOURCE Edwards Lifesciences Corporation