Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
Patient-Focused Innovations
for Structural Heart Disease
and Critical Care Monitoring
Cautionary Statement
Presentations and comments made today by the management of Edwards Lifesciences Corporation will include 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. These may
include, but are not limited to, the companys financial goals or expectations for 2016, 2017 and beyond (including sales, earnings per share,
R&D, and other financial expectations); potentials for fluctuations in financial results due to a new accounting standard on stock-based
compensation; unanticipated changes associated with pending acquisitions or unanticipated developments with our products (including the
timing and results of clinical trials, regulatory approvals, and reimbursement coverage), industry growth projections, the ability to extend
leadership positions and build clinical and economic evidence, forecasted trends in patient treatment and demographics, timing and impact of
competitor developments, strategies for the companys new and existing products, and the impact of foreign exchange and special items on the
companys 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 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 are 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,
are available at www.edwards.com.
1/9/17 2
Use of Non-GAAP Financial Measures
Unless otherwise indicated, all figures are GAAP financial measures
The Company uses the term underlying when referring to non-GAAP sales information,
which excludes discontinued and acquired products, foreign exchange fluctuations, and the
THVT sales return reserves and excluding special items and adjusted net income and
adjusted EPS to also exclude gains and losses from special items such as significant
investments, litigation, amortization and business development transactions.
A reconciliation of non-GAAP historical financial measures to the most comparable GAAP
measure is available at www.edwards.com
The Company is not able to provide a reconciliation of future projections that exclude
special items to expected reported results due to the unknown effect, timing and potential
significance of special charges or gains, and managements inability to forecast charges
associated with future transactions and initiatives
1/9/17 3
Driven by a Passion to Help Patients
1/9/17 4
Global Leadership
10%
Surgical 11% ROW
Heart
Valve
Therapy Japan
Critical
$1.7B Care
Surgical U.S.
Heart 54%
Valve Europe
Therapy Transcatheter
Heart
Critical
Care
Valve Therapy 25%
THVT
2011 2016E
1/9/17 6
Business Overview
Transcatheter Heart Valve Therapy
Expect the TAVR Opportunity to Exceed $5B by 2021
1/9/17 8
New Data Analysis Doubles the Size of the ssAS
Prevalence Pool, While Treatment Rates Are Lower
Previous Edwards View of ssAS Patients in the U.S.1 Current Edwards View of ssAS Patients in the U.S. 2
Patients Patients
Total Prevalence: Total Prevalence:
30,000 30,000 ~650K
~300K
25,000 25,000
20,000 20,000
15,000 15,000
10,000 10,000
5,000 5,000
-
-
50 55 60 65 70 75 80 85 90 95 100
Age 50 55 60 65 70 75Age 80 85 90 95 100
1Nkomo 2006, Iivanainen 1996, Aronow 1991, Bach 2007, Freed 2010, Iung 2007, Pellikka 2005, Brown 2008, Thourani 2015, internal estimates.
1/9/17 9
2 Incorporated new studies with more accuracy of diagnostics methods and definitions: Danielson 2014, Vaes 2011
STS Score is Insufficient as Heart Team Assessment
is the Way Physicians Evaluate Patients
Heart Team Assessment includes
Current Edwards View of ssAS
surgical risk, age, frailty and
Patients in the U.S.1 anatomical consideration
1/9/17 (1) Nkomo 2006, Iivanainen 1996, Aronow 1991, Bach 2007, Danielsen 2014, Vaes 2011 (2) Internal estimates, Freed 2010, Lung 2007, Pellikka 2005; Brown 2008 10
Robust Pipeline Investments Expected to Generate
Transformational New Product Launches
The Edwards SAPIEN 3 Ultra System CENTERA Design Expected to be
Further Streamlines the TAVR Procedure Best-in-Class Self-Expanding Platform
On-balloon design removes need for valve alignment Enhanced delivery system articulation
Axela seamless sheath features dynamic expansion Repositionable
and contraction Low 14F profile
14F compatibility across all valve sizes Quick device preparation
Ergonomic handle design allows for single-handed control Stable and predictable deployment
1/9/17 Ultra System, Axela sheath and CENTERA are investigational devices and not approved for sale. 11
Global TAVR Opportunity Beyond 2021 is Significant
2021 2021 and beyond
2016 >$5B
~$2.5B
ROW
Japan
EU
U.S.
Increasing Indication
Technology
Awareness Expansion
1/9/17 ROW: Rest of World (EEMEA, Canada, Asia Pacific, Latin America) 12
Foundational Pivotal Trials to Revolutionize Treatment
for AS Patients
The >$5B by 2021 is predicated only on treating severe symptomatic patients
With SAPIEN 3, we believe patient tolerance for symptoms will decrease,
bringing them off the sidelines
Having a less invasive treatment option that is also superior to surgery, opens
the door to treating AS early even in asymptomatic and moderate patients
Expecting to initiate EARLY TAVR in 2017 to study asymptomatic patients
with severe AS
The UNLOAD Trial continues to enroll and studies moderate AS patients with
symptoms
1/9/17 13
Surgical Heart Valve Therapy
Advancing Core Leadership and Transforming the Business
1/9/17 14
Multiple Trends Support SAVR Growth and Significant
Opportunity to Transform Future Surgery
1/9/17 15
Innovative Introductions are Ideal for Aortic Patients
Remaining in Surgery
EDWARDS INTUITY Elite Valve System Facilitates INSPIRIS Valve Designed for Active Patients and
MIS & Complex Combined Procedures Greater Mechanical-to-Tissue Conversion
Continued innovation on proven platform with 20+ years of RESILIA Tissue: Bovine pericardial tissue enhanced by
durability data novel integrity preservation technology
Shorter cross-clamp time1 and excellent hemodynamics2 VFit Technology: Designed for potential future valve-in-
Ease of implantation through small incisions via three valve procedures
guiding sutures Potential to provide QoL benefits over mechanical valves
Potentially eliminates need for future surgery
FDA approval received
Expanded roll-out in 2017
CE Mark received
Anticipate U.S. FDA approval
in 2017
1 Clinical
Investigation Report: Study Number; 2011-2012 Report Date: 25 February 2016; TRANSFORM Database December 3, 2015; 2 Haverich A. Whalers TC, Borger MA, et at. Three-Year
Hemodynamic Performance, J Thorac Cardiovasc Surg. 2014 148(6):2854-60; MIS: Minimally Invasive Surgery.
1/9/17 INSPIRIS is an investigational device and not available for sale in the U.S. 16
Critical Care
All-in-One system provides invasive to non-invasive options Part of decision support suite for
Integrated solution with wireless connectivity and modular proactive management of adverse
design to allow for future technologies clinical events
Actionable intelligence through Acumen decision support FloTrac IQ is the first intelligent
software suite and IQ product portfolio disposable with Hypotension
Probability Indicator (HPI)
1/9/17 HemoSphere and Acumen not available for sale in the U.S. 18
Enhanced Surgical Recovery is Focused on Reducing
Complications and Length of Stay
Reduced Surgical Reduced Reduced Length Improper fluid balance can contribute to
Complications(1) Morbidity(2) of Stay(3) post-surgical complications
23- 1-2
32% days
56%
Median amount of fluid you will be given for colon surgery
1/9/17 19
Innovation to Fuel
Long-Term Growth
Mitral and Tricuspid Disease Burden is Significant
12/8/16 22
Our Focused Investment in Structural Heart Initiatives
Has Resulted in Multiple Clinical Stage Therapies
Edwards-CardiAQ for mitral replacement
Focused on transseptal delivery; implementing clinical learnings sequentially
CE Mark trial approved; enrollment pending
Early feasibility in U.S.; CE Mark planned in 2018
1/9/17 26
2017 Expected to be a Year of Continued
Growth and Investment in Our Future
Edwards has a
bright future
Expect underlying sales growth 10-14%
Expect Adjusted EPS of $3.30 - $3.45 Continued growth in the
treatment of AS through
R&D expected at 16-17% of sales to drive value creation TAVR
Continued investment in expansion of TAVR Introduction of multiple
Significant progress in structural heart initiatives break-through structural
heart valve therapies
Investments in driving leadership in core businesses
Innovation in our core
Guidance as of 12/8/16; not an update leadership franchises
of SHVT and CC
1/9/17 27
Edwards Proven Strategy Has Delivered Organic,
Double-Digit Sales Growth Over the Past 5+ Years
(underlying growth rates and actual $ in billions at actual FX rates)
1/9/17 Underlying growth rates and actual sales in billions at actual FX rates 28
Edwards is Poised for Long-Term Success
Patient focused culture
Innovative R&D to produce breakthrough therapies
Industry leading competitive positions
Credibility and trust with clinicians, regulators, payors
and patients
Strong geographic diversification
Nimble, adaptive business model
Focused strategy to deliver patient benefit and exceptional
shareholder value
1/9/17 29
Non-GAAP Reconciliations
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. During 2014, the Company
excluded from its calculation of free cash flow the impacts of the payment from Medtronic for the litigation settlement and its
contribution to the Edwards Lifesciences Foundation. During 2013, the Company excluded the impact of a payment from Medtronic
related to litigation. Management believes that excluding the impact of this item from its calculation of free cash flow provides investors
a more meaningful comparison to historical financial results.
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 2014 and 2015, the Company recorded a sales returns reserve related to
estimated THVT product returns expected upon introduction of next generation THVT products. The Company recorded a net reversal
of these reserves upon delivery of the next-generation THVT products.
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 "Unaudited Reconciliation of Sales by Product Group."
EDWARDS LIFESCIENCES CORPORATION
Unaudited Reconciliation of Sales by Product Group
($ in millions)
2015 Adjusted 2014 Adjusted
GAAP 2015 2014
Growth Sales Returns Underlying Sales Returns Underlying Underlying
Sales by Product Group (YTD) 2015 2014 Change Rate* Reserve Sales Reserve FX Impact Sales Growth Rate *
Transcatheter Heart Valve Therapy $ 1,180.3 $ 943.6 $ 236.7 25.1% $ 1.7 $ 1,182.0 $ (14.1) $ (71.2) $ 858.3 37.7%
Surgical Heart Valve Therapy 785.0 826.1 (41.1) (5.0%) - 785.0 - (59.7) 766.4 2.5%
Critical Care 528.4 553.2 (24.8) (4.5%) - 528.4 - (41.3) 511.9 3.2%
Total Sales $ 2,493.7 $ 2,322.9 $ 170.8 7.4% $ 1.7 $ 2,495.4 $ (14.1) $ (172.2) $ 2,136.6 16.8%