Transcatheter Cardiovascular Therapeutics 2018
Jeff Mirviss, SVP & President, Peripheral Interventions
Kevin Ballinger, EVP & President, Interventional Cardiology
Dr. Ian Meredith, EVP & Global Chief Medical Officer
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Safe Harbor for Forward-Looking Statements
This presentation contains 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. Forward-looking statements may be identified by words like “anticipate,” “expect,” “project,”
“believe,” “plan,” “estimate,” “intend” and similar words. These forward-looking statements are based on our beliefs, assumptions and
estimates using information available to us at the time and are not intended to be guarantees of future events or performance. If our
underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could differ materially from the
expectations and projections expressed or implied by our forward-looking statements.
Factors that may cause such differences can be found in our most recent Form 10-K and Forms 10-Q filed or to be filed with the Securities
and Exchange Commission under the headings “Risk Factors” and “Safe Harbor for Forward-Looking Statements.” Accordingly, you are
cautioned not to place undue reliance on any of our forward-looking statements. We disclaim any intention or obligation to publicly
update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions, or circumstances on
which they may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking
statements.
Non-GAAP Measures:
This document contains non-GAAP measures (denoted with *) in talking about our company’s performance. For reconciliations of non-GAAP financial measures to the most directly comparable GAAP figures, please refer to the addendum to this presentation and the Investor Relations section of our website at www.bostonscientific.com.
Market Estimates:
Unless noted otherwise, all references to market sizes, market share positions, and market growth rates are BSX internal estimates.
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Peripheral Interventions
Jeff Mirviss, SVP & President, Peripheral Interventions
Catherine Jennings, Vice President, Marketing
4 © 2018 Boston Scientific Corporation. All rights reserved.
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ELUVIA | FDA Approval
The ELUVIA DES Received FDA Approval Earlier Than Expected
Early Approval Speaks to Quality of Submission
• Excellent data and clinical program
• Collaboration with investigators
• Early/frequent engagement with FDA
• Results published in The Lancet
Accelerating Manufacturing to Meet Demand
• Full launch ASAP – expect October timing
• Sales team will be fully trained on product/data
© 2018 Boston Scientific Corporation. All rights reserved.
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IMPERIAL | Effectiveness
1 Superiority determined in Post Hoc Superiority Analysis (Continuity Adjusted Chi-Square p-value). Primary Effectiveness Endpoint: Primary patency rate of 86.8% in the Eluvia arm vs. 77.5% in the Zilver PTX arm (p-value = 0.0210). Primary Safety Endpoint: Major
adverse event rate of 4.9% in the Eluvia arm vs. 9.0% in the Zilver PTX arm (p-value = 0.0975).
2 Primary patency defined as percentage (%) of lesions (target stented segments) that reach endpoint without a hemodynamically significant stenosis on DUS and without clinically-driven TLR or bypass of the target lesion before or on the DUS FU visit (PSVR ≤ 2.5).
Superior Results in the First Head-to-Head DES SFA Trial
ELUVIA DES demonstrated a statistically significant difference in
primary patency2 compared to Zilver PTX1 at 12 months in the IMPERIAL Trial
K-M Survival Analysis
© 2018 Boston Scientific Corporation. All rights reserved.
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IMPERIAL | Safety Results
1. Major Adverse Events (MAEs) defined as all causes of death through 1 month, target limb major
amputation through 12 months and/or target lesion revascularization through 12 months.
ELUVIA DES demonstrated half the target lesion revascularization rate of Zilver PTX at 12 months
95.1% of ELUVIA DES Patients Were Free of Major Adverse Events at 12 months
© 2018 Boston Scientific Corporation. All rights reserved.
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ELUVIA | Economic Value
1 Based on 2018 Medicare national average Hospital Outpatient Prospective Payment System
Economics & Outcomes for Eluvia DES Create Compelling Value Proposition
© 2018 Boston Scientific Corporation. All rights reserved.
Hospital Reimbursement 1 $10,510 $5,085 $16,019 $10,510
DES DCBDES +
ATH
DCB +
ATH
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ELUVIA | Data Expand Market for DES
Imperial Data Expand DES Consideration
• ELUVIA DES an option for many patient types
• Clear superiority over existing DES options
• Large $1B addressable market
Category Leadership Offers Contracting Advantage
• Only company with DES, DCB & atherectomy
• Technology solution for virtually every case
Sustainable Competitive Advantage
• Portfolio drives share & pull-through
• Expect pricing commensurate with value
Data Demonstrate ELUVIA DES Is Treatment Option for Many Patients
2020E SFA Market
~$2.7B
• ELUVIA DES expected to lead in $150M+ 2020E SFA DES market
• May take procedural share from DCB, BMS and POBA
$1Baddressable
market for
ELUVIA DES
2020E
© 2018 Boston Scientific Corporation. All rights reserved.
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ELUVIA | Clinical Program
ELUVIA DES Supported by Unprecedented Clinical and Economic Data
2,000Patients expected to
be enrolled across 100
centers in the ELUVIA DES
clinical program
© 2018 Boston Scientific Corporation. All rights reserved.
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PI | Growth Driven by Breadth
Critical Limb
Ischemia
• SAVAL DES BTK
• Atherectomy
Venous Disease
• AngioJet System
• Venous stenting
• Adjunctive
technologies
Interventional
Oncology
• Spherical embolics
• Emerging markets
• Indication expansion
Differentiated Solutions Across Disease States
Expanding Category Leadership in PI
Peripheral Artery
Disease
• Ranger DCB SFA
• ELUVIA DES SFA
• Clinical leadership
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Interventional Cardiology
Kevin Ballinger, EVP & President, Interventional Cardiology
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Coronary Therapies: Market Leadership with Broad Portfolio
Unmatched Breadth
Across
Coronary Therapies
Complex PCIConsistent Upper Single Digit Growth
Stent PortfolioGlobal DES Leadership
PCI GuidanceGlobal Imaging Leader
Significant diversification of the IC Business:
DES anticipated to be <40% of the IC Revenue Mix in 2019
JUDO™ 1, 3 & 6
WOLVERINE™
OPTICROSS™ HD
ROTAPRO™
SYNERGY™
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Broad Range of Commercial Activities
• 60K patients treated worldwide with WATCHMANTM LAAC Device
• TV campaign – expanded in 8 new U.S. markets
• U.S. & European approval of TruSeal Access System
• CMS increase to DRG 273/274 - 2nd consecutive increase
o ~9% increase in commonly used DRG - October 1, 2018
PATIENTS and Counting
Continued International Expansion
• China: Increased adoption – 5M strokes per year
• Japan: Approval H1:19E, reimbursement H2:19E
• Europe: WATCHMAN FLX™ commercial approval H1:19E
Strong Execution of Clinical Milestones
• Initiated WATCHMAN PINNACLE FLX clinical trial
o Q4:18E enrollment completion
o WATCHMAN NOAC Trial – OPTION Trial – start in 2019E
WATCHMAN FLX™
TruSeal Access System
WATCHMAN™: LAAC Global Market Leadership
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TAVR: Driving Execution of Dual-Valve Strategy
Global expansion of
ACURATE neo™ valve
Fastest growing TAVR valve in Europe
>40% growth in 2018 YTD
Opened ~130 new accounts since acquisition
~20% share in launched accounts
Expect ACURATE neo2™ CE Mark in H1:19E
Enhanced PVL sealing technology
File U.S. IDE with ACURATE neo2™ valve in Q4:18E
High and intermediate risk trial
500 patients randomized to any approved device
ACURATE neo™
Aortic Valve System
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Global launch of LOTUS Edge™ valve
Final technical module of PMA filed with FDA
August 15, 2018
File REPRISE IV Intermediate Risk IDE Q4:18E
Includes 810 patients in a single arm study, with a
bicuspid sub-study
Currently enrolling in the REPRISE III Nested
Registry
LOTUS Edge™
Aortic Valve System
Lotus Edge™ EU launch Q1:19E
U.S. launch mid-19E
TAVR: Driving Execution of Dual-Valve Strategy
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Compelling Breadth of Structural Heart Valves Portfolio
Broad SHV Portfolio
Execute the dual-valve portfolio globally
Continue ACURATE neoTM valve global expansion
Launch Lotus Edge into major global markets
Market-leading accessory portfolio
SAFARI2 market leading TAVI wire
Expanding patient access with iSLEEVE Expandable Sleeve
Sentinel Cerebral Protection System acquisition
NTAP ($1,400) effective October 1, 2018
Increasing clinical evidence to support broad use
Millipede progressing on clinical milestones
Anticipate Q1:19 deal close
Millipede Iris™
Sentinel™ SAFARI2 ™
iSLEEVE™
LOTUS Edge™ ACURATE neo™
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2017A2015-2017
CAGRGoals2018E
Goals2019 & 2020E
OperationalRevenue* Growth
+8% +9% +6.4-7.4% +7-10%
Contribution from Recent M&A
+120 bps inorganic
(EndoChoice, Symetis)
+40bps
inorganic
(Symetis)
~+150bps
(organic/inorganic split TBD based on deal size & timing of anniversaries)
Organic Revenue* Growth
+7% +7% +6-7%>+5.5-8.5%
(organic/inorganic split TBD based on deal size & timing of anniversaries)
Adjusted
Op. Margin*25.0%
~+175 bps Y/Y
annually+50-75bps Y/Y +50-100bps Y/Y
Adjusted Tax Rate* 11.2% 13-14% <15%
Adjusted EPS* Growth+13%
(+20% ex FX)+15% +9-12% Double-digit goal
Sept 2018: Raising Long Term Growth Outlook
Q&A
Appendix ADisclaimers & Non-GAAP Reconciliations
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Regulatory & Financial Disclaimers
Revenue Growth Rates:
Operational revenue growth is a non-GAAP measure that excludes the impact of changes in foreign currency exchange rates. Organic revenue
growth is a non-GAAP measure that excludes the impact of changes in foreign currency exchange rates and significant acquisitions.
Adjusted Operating Margin, Adjusted Tax Rate and Earnings Per Share (EPS) Measures:
Adjusted operating margin, effective tax rate, adjusted earnings per share and adjusted earnings per share excluding changes in foreign currency
exchange rates are non-GAAP measures that exclude the impact of amortization expense, intangible asset impairment charges, acquisition- and
divestiture-related net charges and credits, restructuring and restructuring-related net charges and credits, litigation-related net charges, pension
termination charges, debt extinguishment charges, certain investment impairments, certain discrete tax items and/or foreign currency exchange
rates.
Product Regulatory Disclaimer
RangerTM Drug-Coated BalloonCE Marked. US: Caution: Investigational Device. Limited by Federal (or US) law to investigational use only. Not available for sale.
SAVAL Drug Eluting Stent – Below-the-knee indicationCE Marked. US: Caution: Investigational Device. Limited by Federal (or US) law to investigational use only. Not available for sale
Lotus EdgeTMPending CE Mark. US: Caution: Investigational Device. Limited by Federal (or US) law to investigational use only.
ACURATETM Self Expanding Valve PlatformCE Marked. US: Caution: Investigational Device. Limited by Federal (or US) law to investigational use only. Not available for sale.
ACURATE neo2TM Valve System Pending CE Mark. Not available for use or sale in the U.S.
Mitral Valve technologies Devices under development. Not available for use or sale worldwide.
WATCHMANTM FLXPending CE Mark. US: Caution: Investigational Device. Limited by Federal (or US) law to investigational use only. Not available for sale
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Non-GAAP Reconciliations
Percentage Change in Net Sales 2017 2016 2015 3-year avg
Percentage change in net sales, reported 8% 12% 1% 7%
Less: Impact of foreign currency fluctations 0% 0% -7% -2%
Percentage change in net sales, operational 8% 12% 8% 9%
Less: Impact of significant acquisitions 1% 2% 3% 2%
Percentage change in net sales, organic 7% 10% 5% 7%
Operating Margin 2017 2016 2015* 2014
Operating margin, reported 14.2% 5.3% -3.8% -4.1%
Less: Non-GAAP adjustments -10.8% -18.8% -26.1% -24.3%
Operating margin, adjusted 25.0% 24.1% 22.3% 20.2%
Average change in basis points year-over-year 160
Tax Rate 2017
Tax Rate, Reported 88.8%
Less: Non-GAAP adjustments 77.6%
Effective Tax Rate 11.2%
Earnings per Diluted Share 2017 2016 2015 2014
GAAP net income (loss) per share 0.08$ 0.25$ (0.18)$ (0.09)$
Non-GAAP adjustments 1.18 0.86 1.11 a 0.93 b
Adjusted net income (loss) per share 1.26$ 1.11$ 0.93$ 0.84$
Less: Impact of foreign currency fluctations in 2017 (0.08) -
Adjusted net income (loss) per share, excluding foreign currency 1.34$ 1.11$
Adjusted EPS growth from prior year 13% 20% 11%
Adjusted EPS growth from prior year, excluding foreign currency 20%
3-year average adjusted EPS growth 15%
a, b - Assumes dilution of 21.5 million shares for 2015 and 23.7 million shares for 2014 for the non-GAAP adjustments.
*Certain prior year balances have been reclassified from Operating Expenses to Other, net to reflect our adoption of ASC Update 2017-07. Please refer to our 2017 annual report for details.
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