IRVINE, Calif., Oct. 26, 2015 /PRNewswire/ -- Edwards
Lifesciences Corporation (NYSE: EW), the global leader in the
science of heart valves and hemodynamic monitoring, today reported
financial results for the quarter ended September 30,
2015.
Highlights for the third quarter of 2015 as compared to the
third quarter of 2014:
- Global sales grew 1.3% to $615.5
million, and underlying1 sales were up
13.6%.
- Global THV sales grew 10.8% to $296.1
million, and underlying sales were up 29.4%.
- The U.S. rollout of the Edwards SAPIEN 3 transcatheter heart
valve is on track.
- Diluted EPS was $1.07, an
increase of 23.0%, or 33.8% on a non-GAAP basis.
- 2015 THV underlying sales guidance raised to between
$1.1 billion and $1.2 billion.
- 2015 non-GAAP EPS guidance increased to between $4.43 and $4.53.
"Strong third quarter results were driven by total underlying
sales growth of 14 percent," said Michael
A. Mussallem, chairman and CEO. "Adoption of our
SAPIEN 3 transcatheter valve system continued to propel our growth,
which exceeded our projections. Furthermore, the growing body of
compelling clinical outcomes gives us confidence that with expanded
evidence, larger populations of patients suffering from aortic
stenosis will be eligible for TAVR."
Third Quarter 2015 Results
Net sales for the quarter ended September 30, 2015 were
$615.5 million. U.S. and
international segment sales for the third quarter were $323.1 million and $292.4
million, respectively. The strong U.S. dollar continued to
have a significant negative impact on reported sales. On an
underlying basis, sales grew 13.6 percent. Net income
for the quarter ended September 30, 2015 was $118.1 million, or $1.07 per diluted share.
For the third quarter, the company reported Transcatheter Heart
Valve Therapy (THV) sales of $296.1
million, a 10.8 percent growth rate over the third quarter
last year, or 29.4 percent on an underlying basis. Strong
global sales were led by the company's market-leading products in
both the U.S. and Europe.
In the U.S., THV sales for the quarter were $166.4 million. On an underlying basis, sales
were $167.6 million and grew 33.1
percent compared to the prior year period. Outside the U.S., THV
sales were $129.7 million,
representing 4.7 percent growth, or 25.1 percent on an underlying
basis.
"Our THV performance was driven by strong procedure growth and
the on-going SAPIEN 3 launch, which is on track, and clinicians are
rapidly adopting our best-in-class technology," said Mussallem.
"Based on our year-to-date results and the strong demand for SAPIEN
3, we now expect our underlying THV sales in 2015 to be at the high
end of our previously estimated 25 to 35 percent growth rate."
Surgical Heart Valve Therapy product group sales for the quarter
were $187.9 million. Reported sales
decreased 7.6 percent compared to the third quarter last year, and
increased 0.2 percent on an underlying basis. Against a tough year
over year comparison, global surgical heart valve units grew, but
were mostly offset by the continued exit of non-strategic
products.
Critical Care product group sales were $131.5 million for the quarter, representing a
decrease of 3.8 percent versus last year, or an increase of 5.0
percent on an underlying basis.
For the quarter, the company's gross profit margin was 76.2
percent, compared to 72.3 percent in the same period last year. The
year over year increase resulted primarily from favorable foreign
exchange and favorable product mix. Assuming foreign exchange rates
remain at current levels, the company expects its gross profit rate
in the fourth quarter to be approximately 75 percent.
Selling, general and administrative expenses decreased to
$212.0 million for the quarter, or
34.4 percent of sales. This decrease was driven primarily by
the favorable foreign exchange impact on expenses outside the
U.S.
Research and development investments for the quarter increased
to $101.0 million compared to
$87.6 million in the prior year
period. This increase was primarily a result of continued
investments in the company's valve programs, including the recent
acquisition of CardiAQ.
Cash flow from operating activities for the quarter was
$202.5 million. After capital
spending of $26.0 million, free cash
flow was $176.5 million.
Cash, cash equivalents and short-term investments totaled
$1.3 billion at September 30,
2015. Total debt was $604.9
million.
Nine-Month Results
For the nine months ended September 30, 2015, the company
recorded net income of $354.2
million, or $3.22 per diluted
share, compared to $701.9 million, or
$6.49 per diluted share, for the same
period in 2014. The year-ago period included a $750 million payment to Edwards from a litigation
settlement. Diluted earnings per share decreased 50.4 percent over
last year, or increased 36.6 percent, excluding special items.
Net sales for the nine months of 2015 grew 6.9 percent to
$1.8 billion. On an underlying
basis, sales grew 17.4 percent.
U.S. and international segment sales for the nine months of 2015
were $909.3 million and $913.3 million, respectively.
During the nine months of 2015, the company repurchased
approximately 1.3 million shares of common stock for $180.1 million.
Outlook
The company continues to expect full year 2015 total sales to be
between $2.3 billion to $2.5
billion. The company is increasing its guidance for
full year 2015 diluted earnings per share, excluding special items,
to a range of $4.43 to $4.53, from
its previous range of $4.30 to
$4.40. For the fourth quarter of 2015, at current
foreign exchange rates, the company projects total sales to be
between $620 million and $660
million, and diluted earnings per share, excluding special
items, to be between $1.11 and
$1.21.
"Our strong year-to-date financial performance demonstrates the
strength of our market-leading product portfolio," said Mussallem.
"We believe our strategy of focused innovation can transform
patient care and drive value to the healthcare system and to
shareholders. In light of the impressive body of clinical
evidence, we are enthusiastic about the continued expansion of
transcatheter-based therapies for the many structural heart
patients still in need, which positions us for a bright
future."
About Edwards Lifesciences
Edwards Lifesciences is the global leader in the science of
heart valves and hemodynamic monitoring. Driven by a passion
to help patients, the company partners with clinicians to develop
innovative technologies in the areas of structural heart disease
and critical care monitoring, enabling them to save and enhance
lives. Additional company information can be found at
www.edwards.com.
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) 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 13620647. 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, information in the
Outlook section and the company's financial guidance.
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 timing and
effectiveness of new product launches; competitive dynamics and
potential for therapy expansion, particularly for THV; the timing
and extent 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 currency hedge contracts; the timing or
results of pending or future clinical trials; 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, 2014. 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, 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 the THV sales
return reserve. See the Non-GAAP Financial Information page 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,
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
Net sales
|
$
|
615.5
|
|
|
$
|
607.4
|
|
|
$
|
1,822.6
|
|
|
$
|
1,704.9
|
|
Cost of
sales
|
146.7
|
|
|
168.1
|
|
|
441.3
|
|
|
465.2
|
|
|
|
|
|
|
|
|
|
Gross
profit
|
468.8
|
|
|
439.3
|
|
|
1,381.3
|
|
|
1,239.7
|
|
|
|
|
|
|
|
|
|
Selling, general, and
administrative expenses
|
212.0
|
|
|
222.2
|
|
|
628.4
|
|
|
634.9
|
|
Research and
development expenses
|
101.0
|
|
|
87.6
|
|
|
284.9
|
|
|
262.5
|
|
Intellectual property
litigation expenses (income), net
|
2.4
|
|
|
0.9
|
|
|
3.7
|
|
|
(741.0)
|
|
Special
charges
|
—
|
|
|
3.0
|
|
|
—
|
|
|
60.5
|
|
Interest expense,
net
|
2.5
|
|
|
2.5
|
|
|
6.7
|
|
|
9.1
|
|
Other expense,
net
|
0.2
|
|
|
2.5
|
|
|
2.2
|
|
|
2.6
|
|
|
|
|
|
|
|
|
|
Income before
provision for income taxes
|
150.7
|
|
|
120.6
|
|
|
455.4
|
|
|
1,011.1
|
|
|
|
|
|
|
|
|
|
Provision for income
taxes
|
32.6
|
|
|
26.0
|
|
|
101.2
|
|
|
309.2
|
|
|
|
|
|
|
|
|
|
Net income
|
$
|
118.1
|
|
|
$
|
94.6
|
|
|
$
|
354.2
|
|
|
$
|
701.9
|
|
|
|
|
|
|
|
|
|
Earnings per
share:
|
|
|
|
|
|
|
|
Basic
|
$
|
1.10
|
|
|
$
|
0.89
|
|
|
$
|
3.29
|
|
|
$
|
6.61
|
|
Diluted
|
$
|
1.07
|
|
|
$
|
0.87
|
|
|
$
|
3.22
|
|
|
$
|
6.49
|
|
|
|
|
|
|
|
|
|
Weighted-average
common shares outstanding:
|
|
|
|
|
|
|
|
Basic
|
107.6
|
|
|
106.4
|
|
|
107.7
|
|
|
106.2
|
|
Diluted
|
110.0
|
|
|
108.4
|
|
|
110.1
|
|
|
108.1
|
|
|
|
|
|
|
|
|
|
Operating
Statistics
|
|
|
|
|
|
|
|
As a percentage of
net sales:
|
|
|
|
|
|
|
|
Gross
profit
|
76.2
|
%
|
|
72.3
|
%
|
|
75.8
|
%
|
|
72.7
|
%
|
Selling, general, and
administrative expenses
|
34.4
|
%
|
|
36.6
|
%
|
|
34.5
|
%
|
|
37.2
|
%
|
Research and
development expenses
|
16.4
|
%
|
|
14.4
|
%
|
|
15.6
|
%
|
|
15.4
|
%
|
Income before
provision for income taxes
|
24.5
|
%
|
|
19.9
|
%
|
|
25.0
|
%
|
|
59.3
|
%
|
Net income
|
19.2
|
%
|
|
15.6
|
%
|
|
19.4
|
%
|
|
41.2
|
%
|
|
|
|
|
|
|
|
|
Effective tax
rate
|
21.6
|
%
|
|
21.6
|
%
|
|
22.2
|
%
|
|
30.6
|
%
|
|
Note: Numbers may not
calculate due to rounding.
|
EDWARDS
LIFESCIENCES CORPORATION
|
Unaudited Balance
Sheets
|
(in
millions)
|
|
|
September 30,
2015
|
|
December 31,
2014
|
ASSETS
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
Cash and cash
equivalents
|
$
|
646.1
|
|
|
$
|
653.8
|
|
Short-term
investments
|
604.4
|
|
|
785.0
|
|
Accounts and other
receivables, net
|
338.4
|
|
|
325.0
|
|
Inventories,
net
|
333.5
|
|
|
296.8
|
|
Deferred income
taxes
|
79.0
|
|
|
63.5
|
|
Prepaid
expenses
|
47.5
|
|
|
48.8
|
|
Other current
assets
|
96.6
|
|
|
121.7
|
|
Total current
assets
|
2,145.5
|
|
|
2,294.6
|
|
|
|
|
|
Long-term accounts
receivable, net
|
5.5
|
|
|
5.8
|
|
Long-term
investments
|
366.0
|
|
|
240.9
|
|
Property, plant, and
equipment, net
|
454.8
|
|
|
442.9
|
|
Goodwill
|
621.2
|
|
|
376.0
|
|
Other intangible
assets, net
|
207.3
|
|
|
23.4
|
|
Deferred income
taxes
|
21.4
|
|
|
91.5
|
|
Other
assets
|
54.9
|
|
|
49.2
|
|
|
|
|
|
Total
assets
|
$
|
3,876.6
|
|
|
$
|
3,524.3
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
Accounts payable and
accrued liabilities
|
$
|
532.5
|
|
|
$
|
434.4
|
|
|
|
|
|
Long-term
debt
|
604.9
|
|
|
598.1
|
|
Other long-term
liabilities
|
317.8
|
|
|
300.4
|
|
|
|
|
|
Stockholders'
equity
|
|
|
|
Common
stock
|
130.2
|
|
|
128.9
|
|
Additional paid-in
capital
|
1,001.3
|
|
|
878.4
|
|
Retained
earnings
|
3,196.1
|
|
|
2,841.9
|
|
Accumulated other
comprehensive loss
|
(169.2)
|
|
|
(100.9)
|
|
Treasury stock, at
cost
|
(1,737.0)
|
|
|
(1,556.9)
|
|
Total stockholders'
equity
|
2,421.4
|
|
|
2,191.4
|
|
|
|
|
|
Total liabilities and
stockholders' equity
|
$
|
3,876.6
|
|
|
$
|
3,524.3
|
|
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. 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
("THV") product upgrades, and "excluding special items" to also
exclude gains and losses from special items such as significant
investments, impairments, litigation, and business development
transactions. 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 the same non-GAAP
(or "excluding special items") basis due to the inherent difficulty
in forecasting such items. The Company is not able to provide
a reconciliation of these non-GAAP items to expected reported
results 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 does not consider the excluded items or
adjustments as part of day-to-day business or reflective of the
core operational activities of the Company as they result from
transactions outside the ordinary course of business.
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 core operations that, when viewed
with its GAAP results, provide a more complete understanding of
factors and trends affecting the Company's business. 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:
THV Sales Return Reserve and Related Costs - In the first
and second quarters of 2014, and in the second quarter of 2015, the
Company recorded a net sales return reserve and related costs,
primarily related to inventory reserves, of $15.6 million, $6.1
million, and $15.9 million,
respectively, related to estimated THV product returns expected
upon introduction of next-generation THV products. The
Company recorded a net $2.4 million
and $16.0 million reversal of these
reserves in the third quarter of 2015 and 2014, respectively, upon
delivery of the next-generation THV products.
Intellectual Property Litigation Expenses (Income), net -
The Company incurred intellectual property litigation expenses of
$0.3 million and $5.5 million in the first quarter of 2015 and
2014, respectively, $1.0 million and
$2.6 million in the second quarter of
2015 and 2014, respectively, and $2.4
million and $0.9 million in
the third quarter of 2015 and 2014, respectively. In
addition, in the second quarter of 2014, the Company recorded a
$750.0 million gain related to an
agreement with Medtronic to settle all outstanding patent
litigation.
Asset Write-down - The Company recorded a $5.0 million charge in the third quarter of 2014
to write-down assets related to its automated glucose monitoring
program. The charge related primarily to intellectual
property, fixed assets, inventory and severance expenses.
Charitable Foundation Contribution - The Company recorded
a $50.0 million charge in the second
quarter of 2014 for a charitable contribution to the Edwards
Lifesciences Foundation.
Settlement - The Company recorded a $7.5 million charge in the first quarter of 2014
to settle past and future obligations related to one of its
intellectual property agreements.
Provision for Income Taxes - During the second
quarter of 2014, the Company recorded a $6.2
million tax benefit due to the remeasurement of its
uncertain tax positions.
Foreign Exchange - 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."
EDWARDS
LIFESCIENCES CORPORATION
|
Unaudited
Reconciliation of GAAP to Non-GAAP Financial
Information
|
|
RECONCILIATION OF
GAAP TO NON-GAAP NET INCOME
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
(in millions, except per share data)
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
GAAP Net
Income
|
|
$
|
118.1
|
|
|
$
|
94.6
|
|
|
$
|
354.2
|
|
|
$
|
701.9
|
|
Growth Rate
%
|
|
24.8
|
%
|
|
|
|
(49.5)
|
%
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP adjustments:
(A)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
THV sales return
reserve and related costs
|
|
(2.4)
|
|
|
(16.0)
|
|
|
13.5
|
|
|
5.7
|
|
Intellectual property
litigation expenses (income), net
|
|
2.4
|
|
|
0.9
|
|
|
3.7
|
|
|
(741.0)
|
|
Asset
write-down
|
|
—
|
|
|
5.0
|
|
|
—
|
|
|
5.0
|
|
Charitable foundation
contribution
|
|
—
|
|
|
—
|
|
|
—
|
|
|
50.0
|
|
Settlement
|
|
—
|
|
|
—
|
|
|
—
|
|
|
7.5
|
|
|
|
|
|
|
|
|
|
|
Provision for income
taxes
|
|
|
|
|
|
|
|
|
Tax effect on
reconciling items (B)
|
|
(0.7)
|
|
|
2.5
|
|
|
(5.9)
|
|
|
240.2
|
|
Remeasurement of
uncertain tax position reserve (A)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(6.2)
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP Net
Income
|
|
$
|
117.4
|
|
|
$
|
87.0
|
|
|
$
|
365.5
|
|
|
$
|
263.1
|
|
Growth Rate
%
|
|
34.9
|
%
|
|
|
|
38.9
|
%
|
|
|
|
RECONCILIATION OF
GAAP TO NON-GAAP DILUTED EARNINGS PER SHARE
|
|
GAAP Diluted
Earnings Per Share
|
|
$
|
1.07
|
|
|
$
|
0.87
|
|
|
$
|
3.22
|
|
|
$
|
6.49
|
|
Growth Rate
%
|
|
23.0
|
%
|
|
|
|
(50.4)
|
%
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP adjustments:
(A), (C)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
THV sales return
reserve and related costs
|
|
(0.02)
|
|
|
(0.10)
|
|
|
0.08
|
|
|
0.03
|
|
Intellectual property
litigation expenses (income), net
|
|
0.02
|
|
|
—
|
|
|
0.02
|
|
|
(4.45)
|
|
Asset
write-down
|
|
—
|
|
|
0.03
|
|
|
—
|
|
|
0.03
|
|
Charitable foundation
contribution
|
|
—
|
|
|
—
|
|
|
—
|
|
|
0.33
|
|
Settlement
|
|
—
|
|
|
—
|
|
|
—
|
|
|
0.06
|
|
|
|
|
|
|
|
|
|
|
Provision for income
taxes
|
|
|
|
|
|
|
|
|
Remeasurement of
uncertain tax position reserve
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(0.06)
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP Diluted
Earnings Per Share
|
|
$
|
1.07
|
|
|
$
|
0.80
|
|
|
$
|
3.32
|
|
|
$
|
2.43
|
|
Growth Rate
%
|
|
33.8
|
%
|
|
|
|
36.6
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note: Numbers may not
calculate due to rounding.
|
|
(A)
|
See description of
"THV Sales Return Reserve and Related Costs," "Intellectual
Property Litigation Expenses (Income), net," "Asset Write-down,"
"Charitable Foundation Contribution," "Settlement," and "Provision
for Income Taxes" 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
|
|
THV UNITED STATES
UNDERLYING SALES GROWTH
|
|
|
|
Three Months Ended
September 30,
|
(in millions)
|
|
2015
|
|
2014
|
GAAP THV United
States Sales
|
|
$
|
166.4
|
|
|
$
|
143.3
|
|
Adjustment for THV
sales return reserve
|
|
1.2
|
|
|
(17.4)
|
|
THV United States
Underlying Sales
|
|
$
|
167.6
|
|
|
$
|
125.9
|
|
Underlying Growth
Rate %
|
|
33.1
|
%
|
|
|
|
THV OUTSIDE THE
UNITED STATES UNDERLYING SALES GROWTH
|
|
|
|
Three Months Ended
September 30,
|
(in millions)
|
|
2015
|
|
2014
|
GAAP THV Outside
the United States Sales
|
|
$
|
129.7
|
|
|
$
|
123.9
|
|
Adjustment for THV
sales return reserve
|
|
—
|
|
|
(1.0)
|
|
Foreign exchange
impact
|
|
—
|
|
|
(19.2)
|
|
THV Outside the
United States Underlying Sales
|
|
$
|
129.7
|
|
|
$
|
103.7
|
|
Underlying Growth
Rate %
|
|
25.1
|
%
|
|
|
EDWARDS
LIFESCIENCES CORPORATION
|
Unaudited
Reconciliation of GAAP to Non-GAAP Financial
Information
|
($ in
millions)
|
RECONCILIATION OF
SALES BY PRODUCT GROUP AND REGION
|
|
|
|
|
|
|
|
|
|
|
|
2015 Adjusted
|
|
2014 Adjusted
|
|
|
Sales by Product Group (QTD)
|
|
3Q
2015
|
|
3Q
2014
|
|
Change
|
|
GAAP
Growth Rate*
|
|
Sales Return Reserve
|
|
3Q 2015 Underlying
Sales
|
|
Sales Return Reserve
|
|
FX Impact
|
|
3Q 2014 Underlying
Sales
|
|
Underlying Growth Rate *
|
Transcatheter
Heart Valve Therapy
|
|
$
|
296.1
|
|
|
$
|
267.2
|
|
|
$
|
28.9
|
|
|
10.8
|
%
|
|
$
|
1.2
|
|
|
$
|
297.3
|
|
|
$
|
(18.4)
|
|
|
$
|
(19.2)
|
|
|
$
|
229.6
|
|
|
29.4
|
%
|
Surgical Heart
Valve Therapy
|
|
187.9
|
|
|
203.4
|
|
|
(15.5)
|
|
|
(7.6)
|
%
|
|
—
|
|
|
187.9
|
|
|
—
|
|
|
(15.8)
|
|
|
187.6
|
|
|
0.2
|
%
|
Critical
Care
|
|
131.5
|
|
|
136.8
|
|
|
(5.3)
|
|
|
(3.8)
|
%
|
|
—
|
|
|
131.5
|
|
|
—
|
|
|
(11.5)
|
|
|
125.3
|
|
|
5.0
|
%
|
Total
Sales
|
|
$
|
615.5
|
|
|
$
|
607.4
|
|
|
$
|
8.1
|
|
|
1.3
|
%
|
|
$
|
1.2
|
|
|
$
|
616.7
|
|
|
$
|
(18.4)
|
|
|
$
|
(46.5)
|
|
|
$
|
542.5
|
|
|
13.6
|
%
|
|
|
|
|
|
|
|
|
|
|
|
2015 Adjusted
|
|
2014 Adjusted
|
|
|
Sales by Product Group (YTD)
|
|
YTD 3Q
2015
|
|
YTD 3Q
2014
|
|
Change
|
|
GAAP
Growth Rate*
|
|
Sales Return Reserve
|
|
YTD 3Q 2015
Underlying Sales
|
|
Sales Return Reserve
|
|
FX Impact
|
|
YTD 3Q 2014
Underlying Sales
|
|
Underlying Growth Rate *
|
Transcatheter
Heart Valve Therapy
|
|
$
|
846.0
|
|
|
$
|
676.1
|
|
|
$
|
169.9
|
|
|
25.1
|
%
|
|
$
|
6.2
|
|
|
$
|
852.2
|
|
|
$
|
(10.3)
|
|
|
$
|
(56.7)
|
|
|
$
|
609.1
|
|
|
39.9
|
%
|
Surgical Heart
Valve Therapy
|
|
588.8
|
|
|
620.0
|
|
|
(31.2)
|
|
|
(5.0)
|
%
|
|
—
|
|
|
588.8
|
|
|
—
|
|
|
(47.5)
|
|
|
572.5
|
|
|
2.9
|
%
|
Critical
Care
|
|
387.8
|
|
|
408.8
|
|
|
(21.0)
|
|
|
(5.1)
|
%
|
|
—
|
|
|
387.8
|
|
|
—
|
|
|
(32.6)
|
|
|
376.2
|
|
|
3.1
|
%
|
Total
Sales
|
|
$
|
1,822.6
|
|
|
$
|
1,704.9
|
|
|
$
|
117.7
|
|
|
6.9
|
%
|
|
$
|
6.2
|
|
|
$
|
1,828.8
|
|
|
$
|
(10.3)
|
|
|
$
|
(136.8)
|
|
|
$
|
1,557.8
|
|
|
17.4
|
%
|
|
|
|
|
|
|
|
|
|
|
|
2015 Adjusted
|
|
2014 Adjusted
|
|
|
Sales by Region (QTD)
|
|
3Q
2015
|
|
3Q
2014
|
|
Change
|
|
GAAP
Growth Rate*
|
|
Sales Return Reserve
|
|
3Q 2015 Underlying
Sales
|
|
Sales Return
Reserve
|
|
FX Impact
|
|
3Q 2014 Underlying
Sales
|
|
Underlying Growth Rate *
|
United
States
|
|
$
|
323.1
|
|
|
$
|
296.3
|
|
|
$
|
26.8
|
|
|
9.0
|
%
|
|
$
|
1.2
|
|
|
$
|
324.3
|
|
|
$
|
(17.4)
|
|
|
$
|
—
|
|
|
$
|
278.9
|
|
|
16.3
|
%
|
Europe
|
|
166.4
|
|
|
176.9
|
|
|
(10.5)
|
|
|
(5.9)
|
%
|
|
—
|
|
|
166.4
|
|
|
(1.0)
|
|
|
(26.6)
|
|
|
149.3
|
|
|
11.5
|
%
|
Japan
|
|
60.3
|
|
|
66.8
|
|
|
(6.5)
|
|
|
(9.9)
|
%
|
|
—
|
|
|
60.3
|
|
|
—
|
|
|
(10.6)
|
|
|
56.2
|
|
|
7.4
|
%
|
Rest of
World
|
|
65.7
|
|
|
67.4
|
|
|
(1.7)
|
|
|
(2.4)
|
%
|
|
—
|
|
|
65.7
|
|
|
—
|
|
|
(9.3)
|
|
|
58.1
|
|
|
13.1
|
%
|
International
|
|
292.4
|
|
|
311.1
|
|
|
(18.7)
|
|
|
(6.0)
|
%
|
|
—
|
|
|
292.4
|
|
|
(1.0)
|
|
|
(46.5)
|
|
|
263.6
|
|
|
11.2
|
%
|
Total
|
|
$
|
615.5
|
|
|
$
|
607.4
|
|
|
$
|
8.1
|
|
|
1.3
|
%
|
|
$
|
1.2
|
|
|
$
|
616.7
|
|
|
$
|
(18.4)
|
|
|
$
|
(46.5)
|
|
|
$
|
542.5
|
|
|
13.6
|
%
|
|
|
|
|
|
|
|
|
|
|
|
2015 Adjusted
|
|
2014 Adjusted
|
|
|
Sales by Region (YTD)
|
|
YTD 3Q
2015
|
|
YTD 3Q
2014
|
|
Change
|
|
GAAP
Growth Rate*
|
|
Sales Return Reserve
|
|
YTD 3Q 2015
Underlying Sales
|
|
Sales Return
Reserve
|
|
FX Impact
|
|
YTD 3Q 2014
Underlying Sales
|
|
Underlying Growth Rate *
|
United
States
|
|
$
|
909.3
|
|
|
$
|
760.7
|
|
|
$
|
148.6
|
|
|
19.5
|
%
|
|
$
|
6.2
|
|
|
$
|
915.5
|
|
|
$
|
(4.4)
|
|
|
$
|
—
|
|
|
$
|
756.3
|
|
|
21.1
|
%
|
Europe
|
|
533.6
|
|
|
551.0
|
|
|
(17.4)
|
|
|
(3.1)
|
%
|
|
—
|
|
|
533.6
|
|
|
(5.9)
|
|
|
(89.6)
|
|
|
455.5
|
|
|
17.2
|
%
|
Japan
|
|
180.7
|
|
|
192.2
|
|
|
(11.5)
|
|
|
(6.0)
|
%
|
|
—
|
|
|
180.7
|
|
|
—
|
|
|
(28.6)
|
|
|
163.6
|
|
|
10.5
|
%
|
Rest of
World
|
|
199.0
|
|
|
201.0
|
|
|
(2.0)
|
|
|
(1.0)
|
%
|
|
—
|
|
|
199.0
|
|
|
—
|
|
|
(18.6)
|
|
|
182.4
|
|
|
9.1
|
%
|
International
|
|
913.3
|
|
|
944.2
|
|
|
(30.9)
|
|
|
(3.3)
|
%
|
|
—
|
|
|
913.3
|
|
|
(5.9)
|
|
|
(136.8)
|
|
|
801.5
|
|
|
14.4
|
%
|
Total
|
|
$
|
1,822.6
|
|
|
$
|
1,704.9
|
|
|
$
|
117.7
|
|
|
6.9
|
%
|
|
$
|
6.2
|
|
|
$
|
1,828.8
|
|
|
$
|
(10.3)
|
|
|
$
|
(136.8)
|
|
|
$
|
1,557.8
|
|
|
17.4
|
%
|
|
|
|
* Numbers may not
calculate due to rounding.
|
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SOURCE Edwards Lifesciences Corporation