IRVINE, Calif., Oct. 25,
2016 /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 September 30,
2016.
Third Quarter Highlights:
- Sales grew 20.1% to $739.4
million; underlying1 sales were up 18.4%
- Global Transcatheter Heart Valve Therapy (THVT) sales grew
38.5%
- U.S. THVT sales were up 55.9% to $259.5
million
- GAAP EPS was $0.65, an increase
of 20.4%; adjusted2 EPS grew 25.9% to $0.68
- Reiterated 2016 global sales guidance and increased earnings
guidance
"We are pleased to report strong third quarter underlying sales
growth of 18 percent, which was consistent with our increased
expectations," said Michael A.
Mussallem, chairman and CEO. "2016 has been a
remarkable year for our company. This performance reflects
continued strong global adoption of our Edwards SAPIEN 3 valve
platform, which remains on track to generate over $300 million more in sales than we originally
expected for the year. Consistent with our strategy, we are
aggressively investing to bring break-through therapies to an even
broader group of patients around the world."
Third Quarter 2016 Results
Sales for the quarter ended September 30, 2016 were
$739.4 million, up 20.1
percent. U.S. and international segment sales for the third
quarter were $417.1 million and
$322.3 million, respectively.
On an underlying basis, sales grew 18.4 percent over the third
quarter last year. Net income for the quarter ended
September 30, 2016 was $141.4
million, or $0.65 per diluted
share.
For the third quarter, the company reported Transcatheter Heart
Valve Therapy sales of $410.1
million, a 38.5 percent growth rate over the third quarter
last year, or 37.3 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 $259.5 million, a 55.9 percent growth rate over
the third quarter last year, or 54.8 percent on an underlying
basis. "Overall growth was consistent with our expectations,
with robust performance driven by continued strong procedure growth
within both large and small TAVR programs," said Mussallem.
Surgical Heart Valve Therapy product group sales for the quarter
were $190.9 million. Reported sales
increased 1.6 percent compared to the third quarter last year, or
flat on an underlying basis. Globally, mitral valve sales grew
slightly, while aortic valve sales declined modestly, compared to
last year's results.
Critical Care product group sales were $138.4 million for the quarter, representing an
increase of 5.2 percent versus last year, or 2.5 percent on an
underlying basis. Overall results were driven primarily by
double-digit growth of our Enhanced Surgical Recovery Program
across most regions.
For the quarter, the company's gross profit margin was 72.8
percent, compared to 76.2 percent in the same period last year.
This decrease, which was expected, was driven predominately by
foreign exchange.
Selling, general and administrative expenses increased to
$229.6 million for the quarter, or
31.1 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 $113.1 million, compared to
$101.0 million in the prior year
period. This increase was primarily the result of continued
investments in our aortic and mitral transcatheter valve programs.
The company increased investments with the benefit of this year's
Medical Device Excise Tax suspension.
Cash flow from operating activities for the quarter was
$205.9 million. After capital
spending of $48.1 million, free cash
flow was $157.8 million.
Cash, cash equivalents and short-term investments totaled
$1.2 billion at September 30,
2016. Total debt was $600.6
million.
Nine-Month Results
For the nine months ended September 30, 2016, the company
recorded net income of $411.0
million, or $1.89 per diluted
share, compared to $354.2 million, or
$1.61 per diluted share, for the same
period in 2015. Net income increased for the nine months by
16.0 percent, or 26.3 percent, on an adjusted basis. And, diluted
earnings per share increased 17.4 percent over last year, or
increased 27.4 percent, on an adjusted basis.
Net sales for the first nine months of 2016 grew 20.5 percent to
$2.2 billion. On an underlying
basis, sales grew 19.7 percent.
U.S. and international segment sales for the first nine months
of 2016 were $1.2 billion and
$1.0 billion, respectively.
During the first nine months of 2016, the company repurchased
4.6 million shares of common stock for $415.9 million.
Outlook
For the full year 2016, the company continues to expect sales to be
at the high end of its previous $2.7 to $3.0
billion range based on its strong year-to-date results, and
the momentum of transcatheter valve therapy adoption
globally.3 Due to strong performance in the third
quarter, the company now expects adjusted earnings per share to be
between $2.82 and $2.92.
For the fourth quarter of 2016, at current foreign exchange
rates, the company projects sales to be between $750 and $790 million, and adjusted earnings per
share to be between $0.67 and
$0.77.
"We are very pleased with our strong year-to-date performance,"
said Mussallem. "As patients and clinicians increasingly prefer
TAVR, we remain as optimistic as ever about the long-term growth
opportunity. We are committed to aggressively investing in our
future, consistent with our focused innovation strategy. We
are confident these investments will result in innovative therapies
that will enable us to treat a broader group of patients and drive
continued strong organic growth."
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 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 13646430. 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, 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; 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 and Enhanced
Surgical Recovery Program 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 income and
earnings per share are non-GAAP items and exclude amortization of
intellectual property, gains and losses from significant
investments, impairments, litigation, and business development
transactions.
|
|
|
[3]
|
Guidance for adjusted
earnings per share is provided on a non-GAAP basis adjusted for the
items identified on the Non-GAAP Financial Information page 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.
|
EDWARDS
LIFESCIENCES CORPORATION
Unaudited
Consolidated Statements of Operations
(in millions, except per share data)
|
|
|
Three Months
Ended September
30,
|
|
Nine Months
Ended September
30,
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
Net sales
|
$
|
739.4
|
|
|
$
|
615.5
|
|
|
$
|
2,196.0
|
|
|
$
|
1,822.6
|
|
Cost of
sales
|
201.4
|
|
|
146.7
|
|
|
584.2
|
|
|
441.3
|
|
|
|
|
|
|
|
|
|
Gross
profit
|
538.0
|
|
|
468.8
|
|
|
1,611.8
|
|
|
1,381.3
|
|
|
|
|
|
|
|
|
|
Selling, general, and
administrative expenses
|
229.6
|
|
|
212.0
|
|
|
671.1
|
|
|
628.4
|
|
Research and
development expenses
|
113.1
|
|
|
101.0
|
|
|
328.4
|
|
|
284.9
|
|
Intellectual property
litigation expenses
|
6.5
|
|
|
2.4
|
|
|
27.8
|
|
|
3.7
|
|
Special
charges
|
—
|
|
|
—
|
|
|
34.5
|
|
|
—
|
|
Interest expense,
net
|
2.1
|
|
|
2.5
|
|
|
6.9
|
|
|
6.7
|
|
Other expenses,
net
|
1.5
|
|
|
0.2
|
|
|
5.6
|
|
|
2.2
|
|
|
|
|
|
|
|
|
|
Income before
provision for income taxes
|
185.2
|
|
|
150.7
|
|
|
537.5
|
|
|
455.4
|
|
|
|
|
|
|
|
|
|
Provision for income
taxes
|
43.8
|
|
|
32.6
|
|
|
126.5
|
|
|
101.2
|
|
|
|
|
|
|
|
|
|
Net income
|
$
|
141.4
|
|
|
$
|
118.1
|
|
|
$
|
411.0
|
|
|
$
|
354.2
|
|
|
|
|
|
|
|
|
|
Earnings per
share: (A)
|
|
|
|
|
|
|
|
Basic
|
$
|
0.66
|
|
|
$
|
0.55
|
|
|
$
|
1.93
|
|
|
$
|
1.65
|
|
Diluted
|
$
|
0.65
|
|
|
$
|
0.54
|
|
|
$
|
1.89
|
|
|
$
|
1.61
|
|
|
|
|
|
|
|
|
|
Weighted-average
common shares outstanding:(A)
|
|
|
|
|
|
|
|
Basic
|
213.2
|
|
|
215.2
|
|
|
212.8
|
|
|
215.3
|
|
Diluted
|
218.1
|
|
|
219.9
|
|
|
217.7
|
|
|
220.1
|
|
|
|
|
|
|
|
|
|
Operating
Statistics
|
|
|
|
|
|
|
|
As a percentage of
net sales:
|
|
|
|
|
|
|
|
Gross
profit
|
72.8
|
%
|
|
76.2
|
%
|
|
73.4
|
%
|
|
75.8
|
%
|
Selling, general, and
administrative expenses
|
31.1
|
%
|
|
34.4
|
%
|
|
30.6
|
%
|
|
34.5
|
%
|
Research and
development expenses
|
15.3
|
%
|
|
16.4
|
%
|
|
15.0
|
%
|
|
15.6
|
%
|
Income before
provision for income taxes
|
25.0
|
%
|
|
24.5
|
%
|
|
24.5
|
%
|
|
25.0
|
%
|
Net income
|
19.1
|
%
|
|
19.2
|
%
|
|
18.7
|
%
|
|
19.4
|
%
|
|
|
|
|
|
|
|
|
Effective tax
rate
|
23.7
|
%
|
|
21.6
|
%
|
|
23.5
|
%
|
|
22.2
|
%
|
|
|
|
|
|
Note: Numbers may not
calculate due to rounding.
|
|
(A) All share and per share amounts
for the prior year were adjusted for the December 11, 2015
two-for-one stock split.
|
EDWARDS
LIFESCIENCES CORPORATION
Unaudited Balance
Sheets
(in
millions)
|
|
|
September 30,
2016
|
|
December 31,
2015
|
ASSETS
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
Cash and cash
equivalents
|
$
|
645.0
|
|
|
$
|
718.4
|
|
Short-term
investments
|
555.3
|
|
|
506.3
|
|
Accounts and other
receivables, net
|
454.2
|
|
|
371.8
|
|
Inventories,
net
|
401.0
|
|
|
339.9
|
|
Prepaid
expenses
|
49.8
|
|
|
45.1
|
|
Other current
assets
|
66.1
|
|
|
66.4
|
|
Total current
assets
|
2,171.4
|
|
|
2,047.9
|
|
|
|
|
|
Long-term accounts
receivable, net
|
5.3
|
|
|
3.6
|
|
Long-term
investments
|
467.5
|
|
|
379.9
|
|
Property, plant, and
equipment, net
|
543.7
|
|
|
482.5
|
|
Goodwill
|
630.0
|
|
|
628.3
|
|
Other intangible
assets, net
|
207.0
|
|
|
205.4
|
|
Deferred income
taxes
|
189.3
|
|
|
180.5
|
|
Other
assets
|
124.8
|
|
|
131.2
|
|
|
|
|
|
Total
assets
|
$
|
4,339.0
|
|
|
$
|
4,059.3
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
Accounts payable and
accrued liabilities
|
$
|
532.8
|
|
|
$
|
476.2
|
|
|
|
|
|
Long-term
debt
|
600.6
|
|
|
599.9
|
|
Other long-term
liabilities
|
513.8
|
|
|
480.1
|
|
|
|
|
|
Stockholders'
equity
|
|
|
|
Common
stock
|
242.0
|
|
|
239.1
|
|
Additional paid-in
capital
|
1,091.1
|
|
|
946.8
|
|
Retained
earnings
|
3,747.8
|
|
|
3,336.8
|
|
Accumulated other
comprehensive loss
|
(171.2)
|
|
|
(182.6)
|
|
Treasury stock, at
cost
|
(2,217.9)
|
|
|
(1,837.0)
|
|
Total stockholders'
equity
|
2,691.8
|
|
|
2,503.1
|
|
|
|
|
|
Total liabilities and
stockholders' equity
|
$
|
4,339.0
|
|
|
$
|
4,059.3
|
|
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
("THVT") product upgrades; and "adjusted" to also exclude
amortization of intellectual property, gains and losses from
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 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 makes adjustments to
the GAAP measures for items (both charges and gains) that do not
reflect the core operational activities of the Company or are
inconsistent in amount or frequency between periods (albeit such
items are monitored and controlled with equal diligence relative to
core operations).
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 cash 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 $2.4 million reversal of these reserves in the
third quarter of 2015 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, and $6.5 million
and $2.4 million in the third 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, and $2.0 million and
$1.8 million in the third 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.
Provision for Income Taxes - The income tax impact of the
expenses discussed above is based upon forecasted items affecting
the Company's 2016 full year effective tax rate. Adjustments
to forecasted items unrelated to these expenses, as well as impacts
related to interim reporting, will have an effect on the income tax
impact of these items in subsequent periods.
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
(in millions,
except per share data)
|
|
RECONCILIATION OF
GAAP TO ADJUSTED NET INCOME
|
|
|
|
Three Months
Ended September
30,
|
|
Nine Months
Ended September
30,
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
GAAP Net
Income
|
|
$
|
141.4
|
|
|
$
|
118.1
|
|
|
$
|
411.0
|
|
|
$
|
354.2
|
|
Growth Rate
%
|
|
19.7
|
%
|
|
|
|
16.0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP adjustments:
(A)
|
|
|
|
|
|
|
|
|
THVT sales return
reserve and related costs
|
|
—
|
|
|
(2.4)
|
|
|
0.1
|
|
|
13.5
|
|
Intellectual property
litigation expenses
|
|
6.5
|
|
|
2.4
|
|
|
27.8
|
|
|
3.7
|
|
Amortization of
intellectual property
|
|
2.0
|
|
|
1.8
|
|
|
5.6
|
|
|
5.3
|
|
Purchased
IPR&D
|
|
—
|
|
|
—
|
|
|
34.5
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
Provision for income
taxes
|
|
|
|
|
|
|
|
|
Tax effect on
reconciling items (B)
|
|
(3.4)
|
|
|
(1.2)
|
|
|
(14.3)
|
|
|
(7.3)
|
|
On-going tax impact of
second quarter 2016 purchased IPR&D
|
|
1.7
|
|
|
—
|
|
|
1.7
|
|
|
—
|
|
Adjusted Net
Income
|
|
$
|
148.2
|
|
|
$
|
118.7
|
|
|
$
|
466.4
|
|
|
$
|
369.4
|
|
Growth Rate
%
|
|
24.9
|
%
|
|
|
|
26.3
|
%
|
|
|
|
RECONCILIATION OF
GAAP TO ADJUSTED DILUTED EARNINGS PER SHARE
|
|
GAAP Diluted
Earnings Per Share (C)
|
|
$
|
0.65
|
|
|
$
|
0.54
|
|
|
$
|
1.89
|
|
|
$
|
1.61
|
|
Growth Rate
%
|
|
20.4
|
%
|
|
|
|
17.4
|
%
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP adjustments:
(A), (D)
|
|
|
|
|
|
|
|
|
THVT sales return
reserve and related costs
|
|
—
|
|
|
(0.01)
|
|
|
—
|
|
|
0.04
|
|
Intellectual property
litigation expenses
|
|
0.02
|
|
|
0.01
|
|
|
0.09
|
|
|
0.01
|
|
Amortization of
intellectual property
|
|
—
|
|
|
—
|
|
|
0.02
|
|
|
0.02
|
|
Purchased
IPR&D
|
|
—
|
|
|
—
|
|
|
0.13
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
Provision for income
taxes
|
|
|
|
|
|
|
|
|
On-going tax impact
of second quarter 2016 purchased IPR&D
|
|
0.01
|
|
|
—
|
|
|
0.01
|
|
|
—
|
|
Adjusted Diluted
Earnings Per Share
|
|
$
|
0.68
|
|
|
$
|
0.54
|
|
|
$
|
2.14
|
|
|
$
|
1.68
|
|
Growth Rate
%
|
|
25.9
|
%
|
|
|
|
27.4
|
%
|
|
|
|
|
|
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 per share amounts
for the prior year were adjusted for the December 11, 2015
two-for-one stock split.
|
|
|
(D)
|
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 September
30,
|
|
|
2016
|
|
2015
|
THVT United States
GAAP Sales
|
|
$
|
259.5
|
|
|
$
|
166.4
|
|
Adjustment for THVT
sales return reserve
|
|
—
|
|
|
1.2
|
|
THVT United States
Underlying Sales
|
|
$
|
259.5
|
|
|
$
|
167.6
|
|
Underlying Growth
Rate %
|
|
54.8
|
%
|
|
|
|
THVT OUTSIDE THE
UNITED STATES UNDERLYING SALES GROWTH
|
|
|
|
Three Months
Ended September
30,
|
(in millions)
|
|
2016
|
|
2015
|
GAAP THV Outside
the United States Sales
|
|
$
|
150.6
|
|
|
$
|
129.7
|
|
Foreign exchange
impact
|
|
—
|
|
|
1.3
|
|
THV Outside the
United States Underlying Sales
|
|
$
|
150.6
|
|
|
$
|
131.0
|
|
Underlying Growth
Rate %
|
|
15.0
|
%
|
|
|
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)
|
|
3Q
2016
|
|
3Q
2015
|
|
Change
|
|
GAAP
Growth
Rate*
|
|
Sales Return
Reserve
|
|
3Q 2016
Underlying
Sales
|
|
Sales Return
Reserve
|
|
FX Impact
|
|
3Q 2015
Underlying
Sales
|
|
Underlying
Growth
Rate *
|
Transcatheter
Heart Valve Therapy
|
|
$
|
410.1
|
|
|
$
|
296.1
|
|
|
$
|
114.0
|
|
|
38.5
|
%
|
|
$
|
—
|
|
|
$
|
410.1
|
|
|
$
|
1.2
|
|
|
$
|
1.3
|
|
|
$
|
298.6
|
|
|
37.3
|
%
|
Surgical Heart
Valve Therapy
|
|
190.9
|
|
|
187.9
|
|
|
3.0
|
|
|
1.6
|
%
|
|
—
|
|
|
190.9
|
|
|
—
|
|
|
2.9
|
|
|
190.8
|
|
|
0.1
|
%
|
Critical
Care
|
|
138.4
|
|
|
131.5
|
|
|
6.9
|
|
|
5.2
|
%
|
|
—
|
|
|
138.4
|
|
|
—
|
|
|
3.5
|
|
|
135.0
|
|
|
2.5
|
%
|
Total
|
|
$
|
739.4
|
|
|
$
|
615.5
|
|
|
$
|
123.9
|
|
|
20.1
|
%
|
|
$
|
—
|
|
|
$
|
739.4
|
|
|
$
|
1.2
|
|
|
$
|
7.7
|
|
|
$
|
624.4
|
|
|
18.4
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2016 Adjusted
|
|
2015 Adjusted
|
|
|
Sales by Product Group (YTD)
|
|
YTD
3Q 2016
|
|
YTD
3Q 2015
|
|
Change
|
|
GAAP
Growth
Rate*
|
|
Sales Return
Reserve
|
|
YTD 3Q
2016
Underlying
Sales
|
|
Sales Return
Reserve
|
|
FX Impact
|
|
YTD 3Q
2015
Underlying
Sales
|
|
Underlying
Growth
Rate *
|
Transcatheter
Heart Valve Therapy
|
|
$
|
1,196.5
|
|
|
$
|
846.0
|
|
|
$
|
350.5
|
|
|
41.4
|
%
|
|
$
|
(1.7)
|
|
|
$
|
1,194.8
|
|
|
$
|
6.2
|
|
|
$
|
(0.5)
|
|
|
$
|
851.7
|
|
|
40.3
|
%
|
Surgical Heart
Valve Therapy
|
|
585.5
|
|
|
588.8
|
|
|
(3.3)
|
|
|
(0.6)
|
%
|
|
—
|
|
|
585.5
|
|
|
—
|
|
|
1.6
|
|
|
590.4
|
|
|
(0.8)
|
%
|
Critical
Care
|
|
414.0
|
|
|
387.8
|
|
|
26.2
|
|
|
6.8
|
%
|
|
—
|
|
|
414.0
|
|
|
—
|
|
|
2.8
|
|
|
390.6
|
|
|
6.0
|
%
|
Total
|
|
$
|
2,196.0
|
|
|
$
|
1,822.6
|
|
|
$
|
373.4
|
|
|
20.5
|
%
|
|
$
|
(1.7)
|
|
|
$
|
2,194.3
|
|
|
$
|
6.2
|
|
|
$
|
3.9
|
|
|
$
|
1,832.7
|
|
|
19.7
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2016 Adjusted
|
|
2015 Adjusted
|
|
|
Sales by Region (QTD)
|
|
3Q
2016
|
|
3Q
2015
|
|
Change
|
|
GAAP
Growth
Rate*
|
|
Sales Return
Reserve
|
|
3Q 2016
Underlying
Sales
|
|
Sales Return
Reserve
|
|
FX Impact
|
|
3Q 2015
Underlying
Sales
|
|
Underlying
Growth
Rate *
|
United
States
|
|
$
|
417.1
|
|
|
$
|
323.1
|
|
|
$
|
94.0
|
|
|
29.1
|
%
|
|
$
|
—
|
|
|
$
|
417.1
|
|
|
$
|
1.2
|
|
|
$
|
—
|
|
|
$
|
324.3
|
|
|
28.6
|
%
|
Europe
|
|
172.3
|
|
|
166.4
|
|
|
5.9
|
|
|
3.5
|
%
|
|
—
|
|
|
172.3
|
|
|
—
|
|
|
(3.3)
|
|
|
163.1
|
|
|
5.6
|
%
|
Japan
|
|
79.8
|
|
|
60.3
|
|
|
19.5
|
|
|
32.5
|
%
|
|
—
|
|
|
79.8
|
|
|
—
|
|
|
11.5
|
|
|
71.8
|
|
|
11.1
|
%
|
Rest of
World
|
|
70.2
|
|
|
65.7
|
|
|
4.5
|
|
|
6.9
|
%
|
|
—
|
|
|
70.2
|
|
|
—
|
|
|
(0.5)
|
|
|
65.2
|
|
|
7.7
|
%
|
International
|
|
322.3
|
|
|
292.4
|
|
|
29.9
|
|
|
10.2
|
%
|
|
—
|
|
|
322.3
|
|
|
—
|
|
|
7.7
|
|
|
300.1
|
|
|
7.4
|
%
|
Total
|
|
$
|
739.4
|
|
|
$
|
615.5
|
|
|
$
|
123.9
|
|
|
20.1
|
%
|
|
$
|
—
|
|
|
$
|
739.4
|
|
|
$
|
1.2
|
|
|
$
|
7.7
|
|
|
$
|
624.4
|
|
|
18.4
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2016 Adjusted
|
|
2015 Adjusted
|
|
|
Sales by Region (YTD)
|
|
YTD
3Q 2016
|
|
YTD
3Q 2015
|
|
Change
|
|
GAAP
Growth
Rate*
|
|
Sales Return
Reserve
|
|
YTD 3Q
2016
Underlying
Sales
|
|
Sales Return
Reserve
|
|
FX Impact
|
|
YTD 3Q
2015
Underlying
Sales
|
|
Underlying
Growth
Rate *
|
United
States
|
|
$
|
1,194.2
|
|
|
$
|
909.3
|
|
|
$
|
284.9
|
|
|
31.3
|
%
|
|
$
|
(1.7)
|
|
|
$
|
1,192.5
|
|
|
$
|
6.2
|
|
|
$
|
—
|
|
|
$
|
915.5
|
|
|
30.3
|
%
|
Europe
|
|
564.4
|
|
|
533.6
|
|
|
30.8
|
|
|
5.8
|
%
|
|
—
|
|
|
564.4
|
|
|
—
|
|
|
(7.8)
|
|
|
525.8
|
|
|
7.3
|
%
|
Japan
|
|
226.3
|
|
|
180.7
|
|
|
45.6
|
|
|
25.3
|
%
|
|
—
|
|
|
226.3
|
|
|
—
|
|
|
20.8
|
|
|
201.5
|
|
|
12.3
|
%
|
Rest of
World
|
|
211.1
|
|
|
199.0
|
|
|
12.1
|
|
|
6.1
|
%
|
|
—
|
|
|
211.1
|
|
|
—
|
|
|
(9.1)
|
|
|
189.9
|
|
|
11.2
|
%
|
International
|
|
1,001.8
|
|
|
913.3
|
|
|
88.5
|
|
|
9.7
|
%
|
|
—
|
|
|
1,001.8
|
|
|
—
|
|
|
3.9
|
|
|
917.2
|
|
|
9.2
|
%
|
Total
|
|
$
|
2,196.0
|
|
|
$
|
1,822.6
|
|
|
$
|
373.4
|
|
|
20.5
|
%
|
|
$
|
(1.7)
|
|
|
$
|
2,194.3
|
|
|
$
|
6.2
|
|
|
$
|
3.9
|
|
|
$
|
1,832.7
|
|
|
19.7
|
%
|
|
|
|
* Numbers may not
calculate due to rounding.
|
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SOURCE Edwards Lifesciences Corporation