EX-99.1 2 a06-10883_2ex99d1.htm EX-99




































 

Searchable text section of graphics shown above

 


 

 

[LOGO]

 

THE ENDOVASCULAR COMPANY

 

Investor Presentation

Jim Corbett

CEO

 


 

Safe Harbor Statement

 

[LOGO]

 

Certain matters discussed today or answers that may be given to questions asked could constitute forward-looking statements that are subject to risks and uncertainties relating to ev3’s future financial or business performance. ev3’s actual results could differ materially from those anticipated in these forward-looking statements. The factors that might affect our results are found in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of our most recent periodic report filed with the Securities and Exchange Commission. You can access this report in the SEC’s EDGAR database found at www.sec.gov. Please note that ev3 is under no obligation to update any of the forward-looking statements discussed today.

 


 

Who We Are

 

 

 

Catheter-Based Devices for Treating Circulatory and Vascular Disorders

 

Peripheral
Vascular Disorders

Coronary
Artery Disease

Neuro
Vascular Disease

 

 

 

[GRAPHIC]

[GRAPHIC]

[GRAPHIC]

 

 

 

•                  Radiologists

•                                          Cardiologists

•                  Neuro Radiologists

•                  Vascular Surgeons

 

•                  Neuro Surgeons

•                  Cardiologists

 

 

 


 

How We Are Organized

 

 

ev3

 

 

 

2 Operating Divisions

CARDIO PERIPHERAL
DIVISION

NEURO VASCULAR
DIVISION

 

 

 

1 Sales/Marketing Division

ev3
INTERNATIONAL

 


 

Our Technology Focus

 

 

CARDIO PERIPHERAL
DIVISION

NEURO VASCULAR
DIVISION

 

 

 

DISEASE

•                  PVD

•                  Hemorrhagic Stroke

•                  Carotid Artery Disease

•                  Ischemic Stroke

•                  AMI/SVG

 

 

 

 

CUSTOMERS

•                  Radiologists

•                  Neuro Radiologists

•                  Vascular Surgeons

•                  Neuro Surgeons

•                  Cardiologists

 

 


 

Extensive Global Presence

 

[GRAPHIC]

 

 

 

U.S.

 

EUROPE

 

JAPAN

 

OTHER INT’L

 

TOTAL

 

SALES

 

109

 

80

 

10

 

10

 

209

 

Clinical/ Regulatory/ Operations/ Marketing

 

627

 

31

 

16

 

 

 

674

 

TOTAL

 

736

 

111

 

26

 

10

 

883

 

 


 

Accelerating Revenue Growth

 

[CHART]

[CHART]

 

 

ANNUAL

QUARTERLY

 

$ MILLIONS

 


 

Revenue Growth Across Business Units

 

CARDIO PERIPHERAL

NEURO

 

 

[CHART]

[CHART]

 

 

TOTAL U.S.

TOTAL INTERNATIONAL

 

 

[CHART]

[CHART]

 


 

Revenue Growth Across Products

 

 

STENTS

 

[CHART]

 

 

THROMBECTOMY & EMBOLIC PROTECTION

PROCEDURAL SUPPORT & OTHER CP

 

 

[CHART]

[CHART]

 


 

EMBOLIC PRODUCTS

NEURO ACCESS & DELIVERY

 

 

[CHART]

[CHART]

 


 

Compelling Rationale for Our Strategy

 

LARGE & GROWING
UNDERSERVED/EMERGING MARKETS

COMPETITIVE GAP

 

 

[CHART]

•                  Vascular Disease

SMALL CAP,
NARROW
FOCUS

[GRAPHIC]

LARGE CAP,
CONGLOMERATE

•                  Stroke Prevention

•                  Stroke Treatment

 

PRODUCT BREADTH,
GLOBAL PRESENCE

 

 

STRIKING OCCLUSIVE DISEASE OVERLAP

OPPORTUNITIES FOR LEVERAGE

 

 

[CHART]

•                  CUSTOMER

 

•                  PRODUCT

 

•                  GEOGRAPHIC

 

•                  TECHNOLOGY

 


 

Organic Innovation to Drive Growth

 

ANNUAL GROWTH

[CHART]

 

 

 

 

GLOBAL EXPANSION

DIRECT WORLDWIDE SALES FORCE

 

 

 

[GRAPHIC]

 

 

 

 

DEVELOPMENT &
NEW PRODUCT FLOW

R&D  New Products

[GRAPHIC]

Over 90% of Revenue Growth from Products Developed in Last 2 Years

[GRAPHIC]

20 New Product Launches Since Q4 ‘04

[GRAPHIC]

 


 

Large, Growing Addressable Endovascular Device Markets

 

ev3 CURRENT SHARE– 5% OF ADDRESSABLE MARKETS

 

[CHART]

 

GROWTH OPPORTUNITY

KEY DRIVERS

 

•                  Minimally Invasive Procedures

•                  Aging Population

•                  Improved Outcome

•                  Improved Diagnosis

 


 

The PVD Market Opportunity

 

[GRAPHIC]

 

Carotid

Renals

Iliac

SFA

Tibial/Lower Leg

 

[CHART]

 

GROWTH OPPORTUNITY

KEY DRIVERS

 

•                  Aging Demographic

•                  Expanding Diabetes Population

•                  Improved Prevention/Diagnosis

•                  Shift from Surgery to Endovascular Procedures

 


 

ev3’s Comprehensive Global PVD Product Strategy

 

[GRAPHIC]

 

 

 

BROADEST STENT/
PTA PORTFOLIO

 

THROMBECTOMY/
EMBOLIC PROTECTION

 

 

 

 

 

Carotid

 

•                  Protégé

 

•                  SpideRX

 

•                  Protégé Rx

 

•                  MoMa

 

•                  Protégé Tapered

 

 

 

 

 

 

•                  SpideRX SVG

Renals

 

•                  Paramount Mini

 

 

 

•                  Protégé Bigs

 

•                  SpideRX

Iliac

 

•                  Primus

 

•                  Diver CE

 

 

•                  Sailor PTA

 

•                  X-Sizer

SFA

 

•                  Submarine PTA

 

 

 

•                  Protégé Long

 

 

 

 

•                  Protégé EverFlex

 

 

Tibial/Lower Leg

 

•                  EverFlex BTK

 

 

 

 

•                  Amphirion PTA

 

 

 


 

PROTÉGÉ EverFlex Durability

 

Up to 5-10 Times More Durable Than Competitive Stents

 

[CHART]

 

* Bench testing conducted at ev3. Data on file.

** Tests stopped with no stent fractures.

Test was not intended to be indicative of clinical performance.

 

•                                          Spiral cell interconnections are constructed to withstand extreme movement

•                                          New wave peak design produces expansion force that resists compression while providing excellent wall apposition

•                                          Multi-step finishing process reduces surface imperfections

•                                          Offers the longest, bare metal stents in the marketplace (up to 150 mm)

 


 

The Carotid Stenting Opportunity

 

THE MARKET

 

CAROTID PERIPHERAL VASCULAR DISEASE

 

[CHART]

 

THE ADVANTAGES

 

STANDARD OF CARE: SURGERY

 

STENTING

 

 

 

LIMITATIONS

 

BENEFITS

 

 

 

Invasive

 

Minimally Invasive

 

 

 

Requires General Anesthesia

 

Safe/Well Tolerated

 

 

 

Restricted Patient Population

 

Large Patient Population

 

 

 

A Powerful Parallel

 

 

 

OPEN HEART SURGERY

 

CORONARY ANGIOPLASTY

 


 

ev3 Carotid Stenting System

 

STENT

 

[GRAPHIC]

 

EMBOLIC PROTECTION

 

[GRAPHIC]

 

DEEP CLINICAL

 

 

 

 

 

CREATE II

 

 

 

TRIAL EXPERIENCE

 

PROCAR

 

CREATE

 

APPROVED 02/06

 

SVG

 

 

 

 

 

 

 

 

 

 

 

RAPID COMMERCIALIZATION

 

Protégé,
Protégé RX,
Protégé Tapered
SpideRX

 

Protégé,
Protégé RX,
Protégé Tapered
SpideRX

 

SpideRX
Carotid

 

SpideRX

 

 

 

 

 

 

 

 

 

 

 

 

 

LAUNCHED
IN EUROPE

 

Q3 ‘06
US LAUNCH
PENDING FDA CLEARANCE

 

Q1 ‘06
US LAUNCH

 

Q3 ‘06
US LAUNCH
PENDING FDA CLEARANCE

 

 


 

Our Carotid Stenting System in Action

 

[GRAPHIC]

 


 

Clinical Trial Momentum

* Pending FDA Clearance

 

 

 

CREATE PIVOTAL *

 

CREATE RX

 

SPIDER SVG*

 

PRINCIPAL
INVESTIGATORS

 

Dr. Rob Safian
Dr. Gary Ansel

 

Dr. Rob Safian
Dr. Gary Ansel

 

Dr. William O’Neil

 

 

 

 

 

 

 

 

 

TOTAL PATIENTS

 

 

 

 

 

747
(Device: 383) (Control: 364)

 

 

 

 

 

 

 

 

 

DEVICE EVALUATED

 

Spider RX + ProtégéRX

 

SpiderRX + ProtégéRX

 

Non Inferiority Compared to Guardwire and Filterwire

 

 

 

 

 

 

 

 

 

30 DAY ENDPOINT
(MACCE)

 

6.2%
(1 year: 7.7%)

 

5.6%

 

9.1%

 

 

 

 

 

 

 

 

 

COMPETITIVE TRIAL ENDPOINTS

 

AT 1 Year

• SAPPHIRE (Cordis) 11.9%
• SECURITY (Abbott) 8.5%
• ARCHER (Guidant) 10.2%

 

 

 

AT 30 Days

• SAFER (Medtronic Guardwire) 9.6%
• TRAP (ev3 TRAP) 12.7%
• FIRE (BSC Filterwire) 9.9%
• CAPTIVE (Abbott Emboshield) 11.4%
• PRIDE (Kensey Nash Triactive) 11.2%

 

 

 

 

 

 

 

 

 

TIMING

 

Submitted January 2006

 

• Submitted 510K
   Sept. 22, 2005
• Approved Q1, 2006

 

 

 

 


 

Critical Limb Ischemia – Global Product Strategy

 

[GRAPHIC]

 

 

 

BROADEST STENT/
PTA PORTFOLIO

 

THROMBECTOMY/
EMBOLIC PROTECTION

 

 

 

 

 

Iliac

 

• Sailor PTA

 

 

SFA

 

• Protégé EverFlex

 

 

 

• Submarine PTA

 

 

 

 

 

 

• SpideRX

 

 

 

 

• Diver CE

 

 

 

 

• X-Sizer

Tibial/Lower Leg

 

• EverFlex BTK

 

 

 

 

 

 

 

 

 

• Amphirion PTA

 

 

 


 

The Neuro Vascular Market Opportunity

 

20%+ GROWTH

 

[CHART]

 

GROWTH OPPORTUNITY

KEY DRIVERS

 

•                  Large Patient Population

•                  Improved Detection / Diagnosis

•                  Shift from Surgery to Endovascular Procedures

•                  Improving Device Technology

•                  Emerging Segments

•                  Ischemic Stroke

 


 

Treating Hemorrhagic Stroke

Broad Portfolio and Unique Solutions

 

[GRAPHIC]

 


 

Hemorrhagic Stroke: A Background

 

AVM

 

ANEURYSM

 

 

 

[GRAPHIC]

 

[GRAPHIC]

 


 

Neuro Product Platform/Pipeline

 

CATEGORY

 

KEY PRODUCTS

 

PIPELINE

 

 

 

 

 

 

 

 

 

EMBOLIC COILS

 

•                  Sapphire

•                  NXT

•                  Tetris

•                  NEXUS

 

•                  NXT

•                  3G

 

[GRAPHIC]

 

 

 

 

 

 

 

LIQUID EMBOLICS

 

•                  Onyx AVM

•                  Onyx Aneurysm

 

•                  Onyx Aneurysm

•             HDE Submission Q1 ‘06

 

[GRAPHIC]

 

 

 

 

 

 

 

MICROCATHETERS

 

•                  Echelon

•                  UltraFlow

•                  Marathon

 

 

 

[GRAPHIC]

 

 

 

 

 

 

 

OCCLUSION BALLOON SYSTEM

 

•                  HyperForm

•                  HyperGlide

 

 

 

[GRAPHIC]

 

 

 

 

 

 

 

GUIDEWIRES

 

•                  Mirage

 

 

 

[GRAPHIC]

 

 

 

 

 

 

 

NEURO STENTS

 

 

 

•                  Solo

•             European Availability ‘07

•             HDE ‘07 Anticipated

 

[GRAPHIC]

 


 

ev3’s NexusTM Coil

 

THE PROBLEM WITH TRADITIONAL COILS

Aneurysm Recanalization

 

•                  INCOMPLETE FILL

•                  COIL COMPACTION

•                  RE-GROWTH OF ANEURYSM

 

OUR NEXUSTM SOLUTION

 

[GRAPHIC]

 

SUPERIOR DESIGN

•                  Easier Deployment

•                  Increased Mass (99%+)

•                  Better Wall Contact

 

THE RESULT

SUCCESSFUL, LONG LASTING SOLUTION

 


 

The NexusTM Coil Cross Section

 

[GRAPHIC]

 


 

The NexusTM Coil Delivery

 

[GRAPHIC]

 


 

The Leverage of Multiple Platforms

 

DISEASE OVERLAP

 

TECHNOLOGY

 

 

 

[GRAPHIC]

 

[GRAPHIC]

 

 

 

PRODUCT

 

GEOGRAPHIC

 

 

 

[GRAPHIC]

 

[GRAPHIC]

 


 

Project Launch Momentum

 

•                  Accelerating New Product Launch Rate

•                  90%+ of Today’s Revenues from Products Developed in Last 2 Years

 

*                 Pending FDA Clearance

 

[CHART]

 


 

New Product Flow - 2006

 

* Pending FDA Clearance

 

[CHART]

 


 

Clinical Trial and Submission Progress

 

Driving Clinical Indications for Commercial Approval and Clinical Data

 

[CHART]

 


 

Senior Management Team

 

NAME

 

ev3 POSITION

 

PAST EXPERIENCE

 

 

 

 

 

JIM CORBETT

 

President & CEO

 

Boston Scientific, SciMED, Baxter

 

 

 

 

 

PAT SPANGLER

 

CFO

 

Empi, Medtronic

 

 

 

 

 

MATTHEW JENUSAITIS

 

President, Neuro Division

 

Boston Scientific, SciMED, Baxter

 

 

 

 

 

STACY ENXING SENG

 

President, Cardio Peripheral Division

 

Boston Scientific, SciMED, Baxter

 

 

 

 

 

PASCAL GIRIN

 

President, International

 

Baxter

 

 

 

 

 

JEFF PETERS

 

VP, R&D Cardio Peripheral Division & CTO

 

SciMED

 

 

 

 

 

CECILY HINES

 

VP, Secretary & Chief Legal Officer

 

Boston Scientific, SciMED

 

 

 

 

 

GREG MORRISON

 

VP, Human Resources

 

West Publishing, Pfizer

 


 

Diversified, Global Revenues

 

2005
$134M Revenue

 

[CHART]

 

[CHART]

 

 

 

BY MARKET SEGMENT

 

BY GEOGRAPHY

 


 

Target Operating Model

 

 

 

2004

 

TARGET

 

 

 

 

 

 

 

REVENUES

 

100

%

100

%

 

 

 

 

 

 

GROSS MARGIN

 

54

%

65-70

%

 

 

 

 

 

 

OPERATING EXPENSES

 

 

 

 

 

SG&A

 

119

%

30

%

R&D

 

45

%

15

%

AMORTIZATION

 

11

%

5

%

GAIN ON SALES OF ASSETS

 

(17

)%

 

%

 

 

 

 

 

 

OPERATING MARGIN

 

(105

)%

15-20

%

 


 

Strategies for Sustainable Growth

 

 

 

BROADEN
TECHNOLOGY
PLATFORM

 

 

 

 

GLOBAL EXPANSION
IN GEOGRAPHIC
MARKETS

 

 

 

 

CONTINUED PRODUCT
DEVELOPMENT
AND LAUNCHES

 

 

 


 

[GRAPHIC]

 

THE ENDOVASCULAR COMPANY