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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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Page 1: Transcatheter Cardiovascular Therapeutics 2018/media/Files/B/... · 2018. 9. 24. · termination charges, debt extinguishment charges, certain investment impairments, certain discrete

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

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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

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Q&A

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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.