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1 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. © 2016 Boston Scientific Corporation or its affiliates. All rights reserved.

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Page 1: Safe harbor for forward-looking statementsinvestors.bostonscientific.com/~/media/Files/B/Boston... · 2017-07-12 · Safe harbor for forward-looking statements ... Drainage catheters

1

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.

© 2016 Boston Scientific Corporation or its affiliates. All rights reserved.

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2

Disclaimers

Product Approvals

This presentation includes discussion of products that have not been approved or cleared by the U.S.

Food and Drug Administration (FDA) and are not available for sale in the U.S.

All future product approval and launch dates are based on estimates of completion of regulatory

submissions, review and approval or clearance, as well as other business considerations.

Market Estimates

Unless noted otherwise, all references to market sizes, market share positions, and market growth rates

are BSC internal estimates.

Non-GAAP Financial Measures

For reconciliations of non-GAAP financial measures used in these presentations to the most directly

comparable GAAP figures, please refer to the footnotes referenced in this presentation and the Investor

Relations section of our website at www.bostonscientific.com.

© 2016 Boston Scientific Corporation or its affiliates. All rights reserved.

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3

Peripheral Interventions Overview

Jeff Mirviss SVP and Global President

Dave Van Horne Vice President, Global Marketing

Boston Scientific Peripheral Interventions

PI-366203-AA © 2016 Boston Scientific Corporation or its affiliates. All rights reserved.

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4 © 2016 Boston Scientific Corporation or its affiliates. All rights reserved.

BSX Peripheral Interventions

• Market leader: #1 market share with strong positions in key growth categories

• Patient Impact: Large, under-treated and under-diagnosed patient populations

• Clinical Demand: Unmet clinical needs provide significant opportunity to innovate

2015

Market BSX

Size Growth Share Position Growth

$4.5B +4-6% #1 +13%*

* Excluding the impacts of .foreign currency of (7)%, Peripheral Inventions net sales grew 6% on a reported basis

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5 © 2016 Boston Scientific Corporation or its affiliates. All rights reserved.

BSX PI Strategy

Build a Broad, Differentiated and Complete Portfolio in High Impact Areas

Peripheral

Arterial Disease

Venous

Disease

Interventional

Oncology

• >200m patients globally

• Est. $3.75B global market

• +4-5% growth

− Rapid DE adoption

− Shift to endovascular vs open

• >1.5m w/VTE in US & Europe

• Est. $500m global market

• +8-10% growth

− Physician interest very high

− New evidence (ATTRACT)

• >700K w/liver cancer annually

• Est. $1.5B global market

• +5-6% growth

− Expense/side effects of chemo

− Emerging markets opportunity

DE = Drug-Elution PAD = Peripheral Artery Disease VTE = Venous Thromboembolism (DVT and Pulmonary Embolism)

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6 © 2016 Boston Scientific Corporation or its affiliates. All rights reserved.

Broadest Portfolio of Technology Solutions

PTA balloons Stents

Crossing

Atherectomy

Embolic spheres

Drainage catheters

Thrombectomy

Microcatheters & guidewires

Detachable & pushable embolization coils

Vena Cava filters

DCB DES

Carotid stents

Cutting balloon

Guidewires

Guidesheaths

Tumor ablation

Peripheral

Arterial Disease

Venous

Disease

Interventional

Oncology

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7

Interventional Oncology: Global Growth Opportunity

CeloNova Embolics

• Examining chemoembolization

• Currently enrolling in SOLACE Trial

• Randomized, controlled trial

examining the use of ONCOZENE™

Microspheres* loaded with doxorubicin

in the treatment of unresectable, locally

advanced hepatocellular carcinoma

Clinical Research Future Technologies**

• Completed acquisition in Dec 2015

• Includes both ONCOZENE™ and

EMBOZENE™ (bland) Microspheres

• Clinical: UFE/PAE Indications

• New embolization technologies

• Liver cancer, oral cancer; anywhere

accessible via vascular system

*CAUTION: Investigational device in the U.S.

and is not available for sale.

Expand IO Portfolio into Areas of Unmet Need

** Concept technology, Not available for sale.

UFE = Uterine Fibroid Embolization PAE = Prostate Artery Embolization

© 2016 Boston Scientific Corporation or its affiliates. All rights reserved.

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8

Venous Disease: The Next Frontier for Peripheral Intervention

Angiojet ZelanteDVT

• Preparing for ATTRACT data – 2017

• Drive patient awareness:

ClearingtheClot.com &

World Thrombosis Day 10/13/16

• Referring physician engagement

Accelerate Adoption

• Built on category-leading AngioJet

Thrombectomy System

• Large-diameter, dedicated DVT catheter

• 4x power of previous AngioJet catheters

• Complete portfolio could include

thrombectomy, filters, CDT, PE, stents

• Unmet clinical need: chronic clot, PTS

• Equity investments: Veniti, InterVene

* CAUTION: Not available for use or sale in the U.S..

Build on Category-Leading AngioJet Platform

to Create Complete Venous Portfolio

Portfolio Expansion

DVT = Deep Vein Thrombosis CDT = Cather-Delivered Thrombolysis PE = Pulmonary Embolism PTS = Post Thrombotic Syndrome © 2016 Boston Scientific Corporation or its affiliates. All rights reserved.

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9 © 2016 Boston Scientific Corporation or its affiliates. All rights reserved.

ATTRACT Trial Overview

• NIH-funded, Phase III, multicenter, randomized, open-label,

assessor-blind, parallel two-arm, controlled clinical trial.

• 692 patients at 30-60 centers

• Determining if the use of Pharmamechanical CDT (e.g.,

AngioJet) in acute DVT reduces occurrence of post

thrombotic syndrome (PTS) over 24 months

• Includes both clinical and economic outcomes

• Expect data H1:2017

• Trellis™-8

• AngioJet™ System

• Catheter-Directed Thrombolysis

• Anticoagulant therapy

• Elastic compression stockings

Treatment Arm Control Arm

ATTRACT Trial Data Could Drive Increased Utilization of AngioJet™ System

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10 © 2016 Boston Scientific Corporation or its affiliates. All rights reserved.

VENITI Equity Investment

Boston Scientific and VENITI, Inc. have entered into an agreement by which

Boston Scientific has made a $25M investment in VENITI

• Investment makes Boston Scientific the largest individual

shareholder in VENITI

• VENITI developing the VICI Venous Stent® System, a nitinol-

based stent designed specifically for venous application

• CE Mark received in 2013

• Currently enrolling in VIRTUS IDE study

• Chronic venous insufficiency affects more than 20 million adults

across the United States and Western Europe

• Venous stents may be used in many venous procedures alongside

other endovascular technologies (e.g., thrombectomy, imaging

catheters, balloons)

• Venous physiology demands dedicated stent design: typically

larger diameter, designed for strength and flexibility

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11

Drug-Eluting Technologies: Improving Patency in the Lower Limbs

Ranger™ DCB*

• CE Mark / launched in 2016

• 24-month results from MAJESTIC:

92.5% Freedom from clinically

driven TLR at 24 months

• Currently enrolling in IMPERIAL

IDE Study

Eluvia ™ DES*

Drug-Elution BTK**

• CE Mark / launched in 2014

• 6-month results from RANGER

SFA study: 94.4% Freedom from

clinically relevant TLR at 6 months

• Interim data from the Ranger All-

Comer Registry: 91.9% freedom

from TLR and a primary patency of

91.1% at 6 months

• Significant unmet clinical need

• Longer, more calcified lesions

• DCB and DES applications

• BSC research has begun

• Assessing clinical pathway

* CAUTION: Not available for use or sale in the U.S..

Compelling Portfolio of State-of-the-Art Technologies

** Concept technology, Not available for sale. TLR = Target Lesion Revascularization © 2016 Boston Scientific Corporation or its affiliates. All rights reserved.

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12 © 2016 Boston Scientific Corporation or its affiliates. All rights reserved.

MAJESTIC Trial Results: CIRSE 2016

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MAJESTIC Trial:

Efficacy and Safety Data

At risk: 56 53.5 36.5

Time Post-procedure (months)

Cum

ula

tive

TL

R-F

ree

Rate

24-Month Freedom from TLR Kaplan-Meier Estimate

Efficacy

• 2-year Freedom from TLR: 92.5% (7.5% TLR)

– KM estimate: 91.3%

– Highest-reported TLR-free rate among SFA stent trials

• Only 2 new TLRs between 1 and 2 years

Safety Profile

• 7.5% (4/53) MAE rate

• No target limb major amputations

Stent Integrity

• No stent fractures observed by the core lab

TLR = target lesion revascularization; MAE = major adverse events

91.3%

12 Months 24 Months

Primary Patencya 96.4% 78.2%

Note: Kaplan-Meier Estimates. aDuplex ultrasound peak systolic velocity ratio ≤2.5 and absence of TLR or bypass.

© 2016 Boston Scientific Corporation or its affiliates. All rights reserved.

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14 © 2016 Boston Scientific Corporation or its affiliates. All rights reserved.

Ranger SFA Trial Results: CIRSE 2016

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• Similar Adverse Event and Serious Adverse

Event rates between groups

No target limb amputations

1 death within 6 months (control group)

0%

20%

40%

60%

80%

100%

0 100 200 300 400TL

R-F

ree

Rat

e

Time Since Procedure (days)

Freedom From TLR at 6 Months*

Freedom from TLR of 94.4% at 6 months, with significantly less late lumen loss vs. PTA

Ranger DCB PTA

Late Lumen Loss

Ranger -0.16

Late Lumen Loss (mm)

*Kaplan-Meier Analysis

*

Ranger SFA Trial:

Efficacy & Safety Data

TLR = target lesion revascularization; MAE = major adverse events © 2016 Boston Scientific Corporation or its affiliates. All rights reserved.

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16 © 2016 Boston Scientific Corporation or its affiliates. All rights reserved.

Summary

• Peripheral vascular represents a large, under-diagnosed &

under-treated market

– BSX building a broad, differentiated and complete portfolio in high impact areas

– Focus on areas of greatest need and opportunity: Drug-Elution, Venous and Cancer

• Technologies designed to enable better outcomes and

reduce healthcare costs

– Eluvia Drug-Eluting SFA Stent – IMPERIAL IDE Trial currently enrolling

– Ranger DCB – Continue to work to bring to additional markets

– Thrombectomy – ATTRACT trial expected to drive significant growth

– Interventional Oncology – Strong portfolio & pipeline; opportunity in emerging markets