IRVINE, Calif., Feb. 1,
2017 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW),
the global leader in patient-focused innovations for structural
heart disease and critical care monitoring, today reported
financial results for the quarter ended December 31,
2016.
Fourth Quarter and Recent Highlights:
- Sales grew 14 percent to $768
million; underlying1 sales were up 15
percent
- Global Transcatheter Heart Valve Therapy (THVT) sales grew 29
percent to $432 million
- U.S. THVT sales were up 38 percent
- EPS was $0.73, an increase of 14
percent; adjusted2 EPS grew 17 percent to $0.75
- FDA approved groundbreaking EARLY-TAVR Trial
"We are pleased to report strong fourth quarter results, which
contributed to another successful year for Edwards, as we
strengthened our financial performance and product leadership
positions," said Michael A.
Mussallem, chairman and CEO. "We ended the quarter
with underlying sales growth of 15 percent, driven by strong
adoption of transcatheter aortic valve replacement (TAVR) therapy,
and finished the year with global sales of nearly $3 billion. And, I'm proud to report
we invested aggressively in 2016 to bring innovative medical
technologies to more patients and drive future growth."
Fourth Quarter 2016
Results
Sales for the quarter ended December 31, 2016 were
$767.7 million, up 14.4
percent. U.S. and international segment sales for the fourth
quarter were $421.5 million and
$346.2 million, respectively. On
an underlying basis, sales grew 15.0 percent over the fourth
quarter last year. Net income for the quarter ended
December 31, 2016 was $158.5
million, or $0.73 per share,
or $0.75 per share on an adjusted
basis.
For the fourth quarter, the company reported Transcatheter Heart
Valve Therapy (THVT) sales of $432.0
million, a 29.2 percent growth rate over the fourth quarter
last year, or 31.8 percent on an underlying basis. Growth was led
by continued strong therapy adoption across all geographies, with
notable strength in the U.S. and Japan.
In the U.S., THVT sales for the quarter were $267.2 million, a 37.8 percent growth rate over
the fourth quarter last year, or 41.1 percent on an underlying
basis. "Once again, overall performance was strong, with
procedures growing broadly across more than 500 hospitals, in both
large and small TAVR programs," said Mussallem.
Surgical Heart Valve Therapy sales for the quarter were
$189.4 million. Reported sales
decreased 3.5 percent compared to the fourth quarter last year,
driven by lower aortic valve sales, primarily due to the impact of
SAPIEN 3 and continued constrained mitral supply. The company
expects the introduction of its next generation platforms to lift
underlying sales growth to 1 to 3 percent in 2017.
Critical Care sales were $146.3
million for the quarter, representing an increase of 4.1
percent versus last year, or 2.5 percent on an underlying
basis. Growth was driven by its Enhanced Surgical Recovery
Program in the U.S. and developing markets.
For the quarter, the company's gross profit margin was 72.2
percent, compared to 73.8 percent in the same period last year.
This expected decrease was driven by a reduced year-over-year
benefit from foreign exchange hedge contracts and manufacturing
expenses associated with capacity expansion. The company
expects its gross profit margin, excluding special items, to
strengthen in 2017 to between 74 and 76 percent.
Selling, general and administrative expenses increased to
$233.6 million for the quarter, or
30.4 percent of sales. This increase was driven by sales and
personnel related expenses, primarily in transcatheter heart
valves.
Research and development investments for the quarter increased
to $114.9 million, compared to
$98.2 million in the prior year
period. This increase was primarily the result of continued
investments in transcatheter aortic and mitral valve programs.
Cash flow from operating activities for the quarter was
$201.1 million. After capital
spending of $63.2 million, free cash
flow was $137.9 million.
Cash, cash equivalents and short-term investments totaled
$1.3 billion at December 31,
2016. Total debt was $0.8
billion.
During the fourth quarter, the company repurchased approximately
2.7 million shares for $246 million
largely to offset dilution associated with its Valtech Cardio, Ltd.
acquisition, which closed on January 23. Average diluted
shares outstanding during the quarter were 218 million.
Twelve-Month Results
For the twelve months ended December 31, 2016, compared to
the prior year:
- Sales grew 19 percent to $2.96
billion
- U.S. and international segment sales were $1.6 billion and $1.3
billion, respectively
- EPS was $2.61, an increase of 16
percent; adjusted EPS grew 24.6 percent to $2.89
- Repurchased 7.3 million shares of common stock for $662 million
EARLY-TAVR Clinical Trial
The U.S. Food and Drug Administration has approved an IDE study
of the Edwards SAPIEN 3 valve evaluating patients diagnosed with
severe aortic stenosis who have not yet developed symptoms.
Approximately 1,000 patients will be enrolled in 65 leading
cardiovascular centers in the new EARLY-TAVR Trial, a superiority
study with a two-year composite endpoint. Patients will be
randomized to receive either transfemoral TAVR with the SAPIEN 3
valve or clinical surveillance.
Outlook
For the full year 2017, the company continues to expect sales to
be between $3.0 and $3.4 billion and
adjusted earnings per share to be between $3.30 and $3.45.
For the first quarter of 2017, the company projects sales to be
between $760 and $800 million, and
adjusted earnings per share to be between $0.79 and $0.89.
"We were very pleased to achieve strong financial performance
and significant progress on transformational new therapies across
our businesses in 2016, and expect continued growth and progress in
2017," said Mussallem. "We are enthusiastic about the
continued expansion of transcatheter-based therapies for the many
structural heart patients still in need, which positions us for
long-term success. We believe our patient-focused innovation
strategy can transform care and bring value to both healthcare
systems and shareholders."
About Edwards
Lifesciences
Edwards Lifesciences, based in Irvine,
Calif., is 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, the
company collaborates with the world's leading clinicians and
researchers to address unmet healthcare needs, working to improve
patient outcomes and enhance lives. For more information, visit
www.Edwards.com and follow us on Twitter @EdwardsLifesci.
Conference Call and Webcast
Information
Edwards Lifesciences will be hosting a conference call today at
2:00 p.m. PT to discuss its fourth quarter results. To
participate in the conference call, dial (877) 407-8037 or (201)
689-8037. For 72 hours following the call, an audio replay
can be accessed by dialing (877) 660-6853 or (201) 612-7415 and
using conference number 13652092. The call will also be
available via live or archived webcast on the "Investor Relations"
section of the Edwards web site at ir.edwards.com or
www.edwards.com. A live stream and archived replay can also be
accessed via mobile devices by downloading Edwards' IR App for
iPhone and iPad or Android.
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," "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, 2017 and first
quarter financial guidance, and information in the Outlook
section. 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 and
difficult to predict. Our 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
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 uncertainties associated with the effectiveness
and timing of new product launches, competitive dynamics and rate
of therapy adoption, particularly for THVT; the timing and scope of
regulatory approvals and reimbursement levels for our products; the
company's success in developing new products and avoiding
manufacturing and quality issues; the impact of currency exchange
rates and related hedge contracts; the timing or results of pending
or future clinical trials and research and development efforts;
actions by the U.S. Food and Drug Administration and other
regulatory agencies; unexpected litigation results or expenses; and
other risks detailed in the company's filings with the Securities
and Exchange Commission, including its Annual Report on Form 10-K
for the year ended December 31, 2015. These filings, along
with important safety information about our products, may be found
at edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo, Edwards
SAPIEN, Edwards SAPIEN 3, Enhanced Surgical Recovery Program,
SAPIEN and SAPIEN 3 are trademarks of Edwards Lifesciences
Corporation. All other trademarks are the property of their
respective owners.
|
|
|
|
|
[1]
|
"Underlying" amounts
are non-GAAP items and in this press release exclude foreign
exchange fluctuations, and sales return reserves associated with
THVT product upgrades. See the Non-GAAP Financial Information page
and reconciliation tables below.
|
[2]
|
Adjusted earnings per
share is a non-GAAP item computed on a diluted basis and excludes
amortization of intellectual property, gains and losses from
significant investments, impairments, litigation, and business
development transactions.
|
EDWARDS
LIFESCIENCES CORPORATION
|
Unaudited
Consolidated Statements of Operations
|
(in millions, except per share data)
|
|
|
Three Months
Ended December 31,
|
|
Twelve Months
Ended December 31,
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
Net sales
|
$
|
767.7
|
|
|
$
|
671.1
|
|
|
$
|
2,963.7
|
|
|
$
|
2,493.7
|
|
Cost of
sales
|
213.2
|
|
|
175.9
|
|
|
797.4
|
|
|
617.2
|
|
|
|
|
|
|
|
|
|
Gross
profit
|
554.5
|
|
|
495.2
|
|
|
2,166.3
|
|
|
1,876.5
|
|
|
|
|
|
|
|
|
|
Selling, general, and
administrative expenses
|
233.6
|
|
|
222.3
|
|
|
904.7
|
|
|
850.7
|
|
Research and
development expenses
|
114.9
|
|
|
98.2
|
|
|
443.3
|
|
|
383.1
|
|
Intellectual property
litigation expenses
|
4.8
|
|
|
3.3
|
|
|
32.6
|
|
|
7.0
|
|
Special
charges
|
—
|
|
|
—
|
|
|
34.5
|
|
|
—
|
|
Interest expense,
net
|
1.5
|
|
|
2.6
|
|
|
8.4
|
|
|
9.3
|
|
Other (income)
expense, net
|
(0.7)
|
|
|
1.8
|
|
|
4.9
|
|
|
4.0
|
|
|
|
|
|
|
|
|
|
Income before
provision for income taxes
|
200.4
|
|
|
167.0
|
|
|
737.9
|
|
|
622.4
|
|
|
|
|
|
|
|
|
|
Provision for income
taxes
|
41.9
|
|
|
26.3
|
|
|
168.4
|
|
|
127.5
|
|
|
|
|
|
|
|
|
|
Net income
|
$
|
158.5
|
|
|
$
|
140.7
|
|
|
$
|
569.5
|
|
|
$
|
494.9
|
|
|
|
|
|
|
|
|
|
Earnings per
share:
|
|
|
|
|
|
|
|
Basic
|
$
|
0.74
|
|
|
$
|
0.65
|
|
|
$
|
2.67
|
|
|
$
|
2.30
|
|
Diluted
|
$
|
0.73
|
|
|
$
|
0.64
|
|
|
$
|
2.61
|
|
|
$
|
2.25
|
|
|
|
|
|
|
|
|
|
Weighted-average
common shares outstanding:
|
|
|
|
|
|
|
|
Basic
|
213.7
|
|
|
215.8
|
|
|
213.0
|
|
|
215.5
|
|
Diluted
|
217.9
|
|
|
220.6
|
|
|
217.8
|
|
|
220.3
|
|
|
|
|
|
|
|
|
|
Operating
statistics
|
|
|
|
|
|
|
|
As a percentage of
net sales:
|
|
|
|
|
|
|
|
Gross
profit
|
72.2
|
%
|
|
73.8
|
%
|
|
73.1
|
%
|
|
75.2
|
%
|
Selling, general, and
administrative expenses
|
30.4
|
%
|
|
33.1
|
%
|
|
30.5
|
%
|
|
34.1
|
%
|
Research and
development expenses
|
15.0
|
%
|
|
14.6
|
%
|
|
15.0
|
%
|
|
15.4
|
%
|
Income before
provision for income taxes
|
26.1
|
%
|
|
24.9
|
%
|
|
24.9
|
%
|
|
25.0
|
%
|
Net income
|
20.6
|
%
|
|
21.0
|
%
|
|
19.2
|
%
|
|
19.8
|
%
|
|
|
|
|
|
|
|
|
Effective tax
rate
|
20.9
|
%
|
|
15.7
|
%
|
|
22.8
|
%
|
|
20.5
|
%
|
|
|
|
Note: Numbers may not
calculate due to rounding.
|
EDWARDS
LIFESCIENCES CORPORATION
|
Unaudited Balance
Sheets
|
(in
millions)
|
|
|
December
31,
|
|
2016
|
|
2015
|
ASSETS
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
Cash and cash
equivalents
|
$
|
930.1
|
|
|
$
|
718.4
|
|
Short-term
investments
|
341.0
|
|
|
506.3
|
|
Accounts and other
receivables, net
|
414.6
|
|
|
371.8
|
|
Inventories,
net
|
396.6
|
|
|
339.9
|
|
Prepaid
expenses
|
45.9
|
|
|
45.1
|
|
Other current
assets
|
111.8
|
|
|
66.4
|
|
Total current
assets
|
2,240.0
|
|
|
2,047.9
|
|
|
|
|
|
Long-term
investments
|
532.1
|
|
|
379.9
|
|
Property, plant, and
equipment, net
|
580.0
|
|
|
482.5
|
|
Goodwill
|
626.1
|
|
|
628.3
|
|
Other intangible
assets, net
|
204.8
|
|
|
205.4
|
|
Deferred income
taxes
|
203.8
|
|
|
180.5
|
|
Other
assets
|
123.2
|
|
|
131.8
|
|
|
|
|
|
Total
assets
|
$
|
4,510.0
|
|
|
$
|
4,056.3
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
Accounts payable and
accrued liabilities
|
$
|
532.5
|
|
|
$
|
476.2
|
|
|
|
|
|
Long-term
debt
|
822.3
|
|
|
596.9
|
|
Other long-term
liabilities
|
536.2
|
|
|
480.1
|
|
|
|
|
|
Stockholders'
equity
|
|
|
|
Common
stock
|
242.6
|
|
|
239.1
|
|
Additional paid-in
capital
|
1,167.8
|
|
|
946.8
|
|
Retained
earnings
|
3,906.3
|
|
|
3,336.8
|
|
Accumulated other
comprehensive loss
|
(198.4)
|
|
|
(182.6)
|
|
Treasury stock, at
cost
|
(2,499.3)
|
|
|
(1,837.0)
|
|
Total stockholders'
equity
|
2,619.0
|
|
|
2,503.1
|
|
|
|
|
|
Total liabilities and
stockholders' equity
|
$
|
4,510.0
|
|
|
$
|
4,056.3
|
|
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 information, which excludes foreign
exchange fluctuations, adjustments for discontinued and acquired
products, and sales return reserves associated with transcatheter
heart valve therapy ("THVT") product upgrades; and "adjusted" to
also exclude intellectual property litigation expenses,
amortization of intellectual property, gains and losses from
significant investments, impairments, litigation, and business
development transactions. 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 meaningful comparison to
historical financial results. The impact of foreign exchange rate
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 below due to the inherent difficulty in
forecasting such items. 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.
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.
The items described below are adjustments to the GAAP
financial results in the reconciliations that follow:
THVT Sales Return Reserve and Related Costs - In the
first quarter of 2016, the Company recorded a $1.7 million reversal of the sales return reserve
($1.5 million, net of related costs)
upon delivery of the next-generation THVT products in the United States. In addition, in the
first quarter of 2016, the Company recorded inventory reserves of
$1.6 million related to estimated
excess THVT inventory expected upon introduction of next-generation
THVT products in Japan. In the second quarter of 2015, the
Company recorded a net sales return reserve and related costs,
primarily related to inventory reserves, of $15.9 million related to estimated THVT product
returns expected upon introduction of next-generation THVT
products. The Company recorded a net reversal of these
reserves in the third and fourth quarters of 2015 of $2.4 million and $4.4
million, respectively, upon delivery of next-generation THVT
products.
Intellectual Property Litigation Expenses - The Company
incurred intellectual property litigation expenses of $12.2 million and $0.3
million in the first quarter of 2016 and 2015, respectively,
$9.1 million and $1.0 million in the second quarter of 2016 and
2015, respectively, $6.5 million and
$2.4 million in the third quarter of
2016 and 2015, respectively, and $4.8
million and $3.3 million in
the fourth quarter of 2016 and 2015, respectively.
Amortization of Intellectual Property - The Company
recorded amortization expense of $1.7
million and $1.8 million in
the first quarter of 2016 and 2015, respectively, $1.9 million and $1.7
million in the second quarter of 2016 and 2015,
respectively, $2.0 million and
$1.8 million in the third quarter of
2016 and 2015, respectively, and $1.9
million and $1.8 million in
the fourth quarter of 2016 and 2015, respectively, related to
intellectual property.
Purchased In-process Research and Development
("IPR&D") - The Company recorded a $34.5 million charge in the second quarter of
2016 related to the acquisition of technology for use in its
transcatheter heart valve programs.
EDWARDS
LIFESCIENCES CORPORATION
|
Unaudited
Reconciliation of GAAP to Non-GAAP Financial
Information
|
(in millions,
except per share data)
|
|
RECONCILIATION OF
GAAP TO ADJUSTED NET INCOME
|
|
|
|
Three Months
Ended December 31,
|
|
Twelve Months
Ended December
31,
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
GAAP Net
Income
|
|
$
|
158.5
|
|
|
$
|
140.7
|
|
|
$
|
569.5
|
|
|
$
|
494.9
|
|
Growth Rate
%
|
|
12.7
|
%
|
|
|
|
15.1
|
%
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP adjustments:
(A)
|
|
|
|
|
|
|
|
|
THVT sales return
reserve and related costs
|
|
—
|
|
|
(4.4)
|
|
|
0.1
|
|
|
9.1
|
|
Intellectual property
litigation expenses
|
|
4.8
|
|
|
3.3
|
|
|
32.6
|
|
|
7.0
|
|
Amortization of
intellectual property
|
|
1.9
|
|
|
1.8
|
|
|
7.5
|
|
|
7.1
|
|
Purchased
IPR&D
|
|
—
|
|
|
—
|
|
|
34.5
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
Provision for income
taxes
|
|
|
|
|
|
|
|
|
Tax effect on
reconciling items (B)
|
|
(3.6)
|
|
|
(0.7)
|
|
|
(17.9)
|
|
|
(8.0)
|
|
On-going tax impact of
second quarter 2016 purchased IPR&D
|
|
2.0
|
|
|
—
|
|
|
3.7
|
|
|
—
|
|
Adjusted Net
Income
|
|
$
|
163.6
|
|
|
$
|
140.7
|
|
|
$
|
630.0
|
|
|
$
|
510.1
|
|
Growth Rate
%
|
|
16.3
|
%
|
|
|
|
23.5
|
%
|
|
|
|
RECONCILIATION OF
GAAP TO ADJUSTED DILUTED EARNINGS PER SHARE
|
|
GAAP Diluted
Earnings Per Share
|
|
$
|
0.73
|
|
|
$
|
0.64
|
|
|
$
|
2.61
|
|
|
$
|
2.25
|
|
Growth Rate
%
|
|
14.1
|
%
|
|
|
|
16.0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP adjustments:
(A), (C)
|
|
|
|
|
|
|
|
|
THVT sales return
reserve and related costs
|
|
—
|
|
|
(0.02)
|
|
|
—
|
|
|
0.03
|
|
Intellectual property
litigation expenses
|
|
0.01
|
|
|
0.01
|
|
|
0.10
|
|
|
0.02
|
|
Amortization of
intellectual property
|
|
—
|
|
|
0.01
|
|
|
0.02
|
|
|
0.02
|
|
Purchased
IPR&D
|
|
—
|
|
|
—
|
|
|
0.14
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
Provision for income
taxes
|
|
|
|
|
|
|
|
|
On-going tax impact
of second quarter 2016 purchased IPR&D
|
|
0.01
|
|
|
—
|
|
|
0.02
|
|
|
—
|
|
Adjusted Diluted
Earnings Per Share
|
|
$
|
0.75
|
|
|
$
|
0.64
|
|
|
$
|
2.89
|
|
|
$
|
2.32
|
|
Growth Rate
%
|
|
17.2
|
%
|
|
|
|
24.6
|
%
|
|
|
|
|
|
Note: Numbers may not
calculate due to rounding.
|
|
(A)
|
See description of
non-GAAP adjustments on the "Non-GAAP Financial Information"
page.
|
|
|
(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.
|
|
|
(C)
|
All amounts are tax
effected, 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.
|
EDWARDS
LIFESCIENCES CORPORATION
|
Unaudited
Reconciliation of GAAP to Non-GAAP Financial
Information
|
($ in
millions)
|
|
THVT UNITED STATES
UNDERLYING SALES GROWTH
|
|
|
|
Three Months
Ended December
31,
|
|
|
2016
|
|
2015
|
THVT United States
GAAP Sales
|
|
$
|
267.2
|
|
|
$
|
193.9
|
|
Adjustment for THVT
sales return reserve
|
|
—
|
|
|
(4.5)
|
|
THVT United States
Underlying Sales
|
|
$
|
267.2
|
|
|
$
|
189.4
|
|
Underlying Growth
Rate %
|
|
41.1
|
%
|
|
|
|
THVT OUTSIDE THE
UNITED STATES UNDERLYING SALES GROWTH
|
|
|
|
Three Months
Ended December
31,
|
(in millions)
|
|
2016
|
|
2015
|
GAAP THVT Outside
the United States Sales
|
|
$
|
164.8
|
|
|
$
|
140.4
|
|
Foreign exchange
impact
|
|
—
|
|
|
(2.0)
|
|
THVT Outside the
United States Underlying Sales
|
|
$
|
164.8
|
|
|
$
|
138.4
|
|
Underlying Growth
Rate %
|
|
19.1
|
%
|
|
|
EDWARDS
LIFESCIENCES CORPORATION
|
Unaudited
Reconciliation of GAAP to Non-GAAP Financial
Information
|
($ in
millions)
|
|
RECONCILIATION OF
SALES BY PRODUCT GROUP AND REGION
|
|
|
|
|
|
|
|
|
|
|
|
2016 Adjusted
|
|
2015 Adjusted
|
|
|
Sales by Product Group (QTD)
|
|
4Q
2016
|
|
4Q
2015
|
|
Change
|
|
GAAP Growth Rate*
|
|
Sales Return Reserve
|
|
4Q 2016
Underlying
Sales
|
|
Sales Return Reserve
|
|
FX Impact
|
|
4Q 2015
Underlying
Sales
|
|
Underlying Growth Rate *
|
Transcatheter
Heart Valve Therapy
|
|
$
|
432.0
|
|
|
$
|
334.3
|
|
|
$
|
97.7
|
|
|
29.2
|
%
|
|
$
|
—
|
|
|
$
|
432.0
|
|
|
$
|
(4.5)
|
|
|
$
|
(2.0)
|
|
|
$
|
327.8
|
|
|
31.8
|
%
|
Surgical Heart
Valve Therapy
|
|
189.4
|
|
|
196.2
|
|
|
(6.8)
|
|
|
(3.5)
|
%
|
|
—
|
|
|
189.4
|
|
|
—
|
|
|
0.6
|
|
|
196.8
|
|
|
(3.8)
|
%
|
Critical
Care
|
|
146.3
|
|
|
140.6
|
|
|
5.7
|
|
|
4.1
|
%
|
|
—
|
|
|
146.3
|
|
|
—
|
|
|
2.2
|
|
|
142.8
|
|
|
2.5
|
%
|
Total
|
|
$
|
767.7
|
|
|
$
|
671.1
|
|
|
$
|
96.6
|
|
|
14.4
|
%
|
|
$
|
—
|
|
|
$
|
767.7
|
|
|
$
|
(4.5)
|
|
|
$
|
0.8
|
|
|
$
|
667.4
|
|
|
15.0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
2016 Adjusted
|
|
2015 Adjusted
|
|
|
Sales by Product Group (YTD)
|
|
YTD
4Q 2016
|
|
YTD
4Q 2015
|
|
Change
|
|
GAAP Growth Rate*
|
|
Sales Return Reserve
|
|
YTD 4Q
2016
Underlying
Sales
|
|
Sales Return Reserve
|
|
FX Impact
|
|
YTD 4Q
2015
Underlying
Sales
|
|
Underlying Growth Rate *
|
Transcatheter
Heart Valve Therapy
|
|
$
|
1,628.5
|
|
|
$
|
1,180.3
|
|
|
$
|
448.2
|
|
|
38.0
|
%
|
|
$
|
(1.7)
|
|
|
$
|
1,626.8
|
|
|
$
|
1.7
|
|
|
$
|
(2.5)
|
|
|
$
|
1,179.5
|
|
|
37.9
|
%
|
Surgical Heart
Valve Therapy
|
|
774.9
|
|
|
785.0
|
|
|
(10.1)
|
|
|
(1.3)
|
%
|
|
—
|
|
|
774.9
|
|
|
—
|
|
|
2.2
|
|
|
787.2
|
|
|
(1.6)
|
%
|
Critical
Care
|
|
560.3
|
|
|
528.4
|
|
|
31.9
|
|
|
6.0
|
%
|
|
—
|
|
|
560.3
|
|
|
—
|
|
|
5.0
|
|
|
533.4
|
|
|
5.0
|
%
|
Total
|
|
$
|
2,963.7
|
|
|
$
|
2,493.7
|
|
|
$
|
470.0
|
|
|
18.8
|
%
|
|
$
|
(1.7)
|
|
|
$
|
2,962.0
|
|
|
$
|
1.7
|
|
|
$
|
4.7
|
|
|
$
|
2,500.1
|
|
|
18.5
|
%
|
|
|
|
|
|
|
|
|
|
|
|
2016 Adjusted
|
|
2015 Adjusted
|
|
|
Sales by Region (QTD)
|
|
4Q
2016
|
|
4Q
2015
|
|
Change
|
|
GAAP Growth
Rate*
|
|
Sales Return Reserve
|
|
4Q 2016
Underlying
Sales
|
|
Sales Return
Reserve
|
|
FX Impact
|
|
4Q 2015
Underlying
Sales
|
|
Underlying Growth Rate *
|
United
States
|
|
$
|
421.5
|
|
|
$
|
353.6
|
|
|
$
|
67.9
|
|
|
19.2
|
%
|
|
$
|
—
|
|
|
$
|
421.5
|
|
|
$
|
(4.5)
|
|
|
$
|
—
|
|
|
$
|
349.1
|
|
|
20.7
|
%
|
Europe
|
|
184.6
|
|
|
183.7
|
|
|
0.9
|
|
|
0.5
|
%
|
|
—
|
|
|
184.6
|
|
|
—
|
|
|
(8.5)
|
|
|
175.2
|
|
|
5.4
|
%
|
Japan
|
|
83.0
|
|
|
65.5
|
|
|
17.5
|
|
|
26.6
|
%
|
|
—
|
|
|
83.0
|
|
|
—
|
|
|
6.8
|
|
|
72.3
|
|
|
14.8
|
%
|
Rest of
World
|
|
78.6
|
|
|
68.3
|
|
|
10.3
|
|
|
15.0
|
%
|
|
—
|
|
|
78.6
|
|
|
—
|
|
|
2.5
|
|
|
70.8
|
|
|
11.0
|
%
|
International
|
|
346.2
|
|
|
317.5
|
|
|
28.7
|
|
|
9.0
|
%
|
|
—
|
|
|
346.2
|
|
|
—
|
|
|
0.8
|
|
|
318.3
|
|
|
8.8
|
%
|
Total
|
|
$
|
767.7
|
|
|
$
|
671.1
|
|
|
$
|
96.6
|
|
|
14.4
|
%
|
|
$
|
—
|
|
|
$
|
767.7
|
|
|
$
|
(4.5)
|
|
|
$
|
0.8
|
|
|
$
|
667.4
|
|
|
15.0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
2016 Adjusted
|
|
2015 Adjusted
|
|
|
Sales by Region (YTD)
|
|
YTD
4Q 2016
|
|
YTD
4Q 2015
|
|
Change
|
|
GAAP Growth
Rate*
|
|
Sales Return Reserve
|
|
YTD 4Q
2016
Underlying
Sales
|
|
Sales Return
Reserve
|
|
FX Impact
|
|
YTD 4Q
2015
Underlying
Sales
|
|
Underlying Growth Rate *
|
United
States
|
|
$
|
1,615.7
|
|
|
$
|
1,262.9
|
|
|
$
|
352.8
|
|
|
27.9
|
%
|
|
$
|
(1.7)
|
|
|
$
|
1,614.0
|
|
|
$
|
1.7
|
|
|
$
|
—
|
|
|
$
|
1,264.6
|
|
|
27.6
|
%
|
Europe
|
|
749.0
|
|
|
717.3
|
|
|
31.7
|
|
|
4.4
|
%
|
|
—
|
|
|
749.0
|
|
|
—
|
|
|
(16.3)
|
|
|
701.0
|
|
|
6.8
|
%
|
Japan
|
|
309.3
|
|
|
246.2
|
|
|
63.1
|
|
|
25.6
|
%
|
|
—
|
|
|
309.3
|
|
|
—
|
|
|
27.6
|
|
|
273.8
|
|
|
13.0
|
%
|
Rest of
World
|
|
289.7
|
|
|
267.3
|
|
|
22.4
|
|
|
8.4
|
%
|
|
—
|
|
|
289.7
|
|
|
—
|
|
|
(6.6)
|
|
|
260.7
|
|
|
11.1
|
%
|
International
|
|
1,348.0
|
|
|
1,230.8
|
|
|
117.2
|
|
|
9.5
|
%
|
|
—
|
|
|
1,348.0
|
|
|
—
|
|
|
4.7
|
|
|
1,235.5
|
|
|
9.1
|
%
|
Total
|
|
$
|
2,963.7
|
|
|
$
|
2,493.7
|
|
|
$
|
470.0
|
|
|
18.8
|
%
|
|
$
|
(1.7)
|
|
|
$
|
2,962.0
|
|
|
$
|
1.7
|
|
|
$
|
4.7
|
|
|
$
|
2,500.1
|
|
|
18.5
|
%
|
|
|
|
* Numbers may not
calculate due to rounding.
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/edwards-lifesciences-reports-fourth-quarter-results-300400733.html
SOURCE Edwards Lifesciences Corporation