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©2019 Cardiovascular Systems, Inc. All Rights Reserved. 9 th Annual SVB Leerink Global Healthcare Conference February 25, 2020

9th Annual SVB Leerink Global Healthcare Conference€¦ · • Leverages CSI core competency in motor control and spinning cables • Easy setup and use • Flow: 3-5 LPM • Crossing

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Page 1: 9th Annual SVB Leerink Global Healthcare Conference€¦ · • Leverages CSI core competency in motor control and spinning cables • Easy setup and use • Flow: 3-5 LPM • Crossing

©2019 Cardiovascular Systems, Inc. All Rights Reserved.

9th AnnualSVB LeerinkGlobal Healthcare ConferenceFebruary 25, 2020

Page 2: 9th Annual SVB Leerink Global Healthcare Conference€¦ · • Leverages CSI core competency in motor control and spinning cables • Easy setup and use • Flow: 3-5 LPM • Crossing

Safe HarborFORWARD LOOKING STATEMENTS

This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Report Act of 1995, which are

provided under the protection of the safe harbor for forward-looking statements provided by that Act. For example, statements in this

presentation regarding CSI’s strategy; growth; future financial measurements and investments; product development plans, milestones

and introductions; geographic expansion; clinical trials and evidence; professional education efforts; and market estimates and

opportunities, are forward-looking statements. These statements involve risks and uncertainties that could cause results differ materially

from those projected, including, but not limited to, those described in CSI’s filings with the Securities and Exchange Commission, including

its most recent annual report on Form 10-K and subsequent quarterly and annual reports. CSI encourages you to consider all of these

risks, uncertainties and other factors carefully in evaluating the forward-looking statements contained in this presentation. As a result of

these matters, changes in facts, assumptions not being realized or other circumstances, CSI’s actual results may differ materially from the

expected results discussed in the forward-looking statements contained in this presentation. The forward-looking statements contained in

this presentation are made only as of the date of this presentation, and CSI undertakes no obligation to update them to reflect subsequent

events or circumstances.

FINANCIAL INFORMATION

This presentation includes calculations or figures that have been prepared internally and have not been reviewed or audited by CSI’s

independent registered accounting firm. Use of different methods for preparing, calculating or presenting information may lead to

differences, which may be material.

2

Page 3: 9th Annual SVB Leerink Global Healthcare Conference€¦ · • Leverages CSI core competency in motor control and spinning cables • Easy setup and use • Flow: 3-5 LPM • Crossing

Driving Sustainable GrowthBroaden Our Value Streams

Financial Goal: Revenue of $435M - $500M in FY23

FY19 - FY23 CAGR of 15% - 18%

Financial strength and the talent to execute

Grow and Protect

the Core Business

Innovation Drives

Incremental Growth

Global Expansion Accelerates

Growth of Core Business

Sustain Market Leadership

10+% Growth in Core Business

Launch 20+ New Products

$70M - $100M in FY23

OrbusNeich and Medikit

$25M - $50M in FY23

3

Page 4: 9th Annual SVB Leerink Global Healthcare Conference€¦ · • Leverages CSI core competency in motor control and spinning cables • Easy setup and use • Flow: 3-5 LPM • Crossing

Q2 Worldwide Revenues of $68.3 Million – 13.5% Increase

US Peripheral,

$47.5US Coronary,

$18.5

International, $2.4

Revenues, $ in millions

US Peripheral US Coronary International

US Coronary grew 22%

Drivers

14% unit growth

Launch of full line of

support products

International grew 48%

Drivers

Coronary Classic and

ViperWire Flex Tip in Japan

OAS launched in 13

countries to-date

US Peripheral grew 9%

Drivers

12% unit growth

21% OBL revenue growth

4% hospital revenue growth

4

Page 5: 9th Annual SVB Leerink Global Healthcare Conference€¦ · • Leverages CSI core competency in motor control and spinning cables • Easy setup and use • Flow: 3-5 LPM • Crossing

Q2 FY19 Q3 FY19 Q4 FY19 Q1 FY20 Q2 FY20

Q2 FY20 Financial Results: $68.3 Million and 13.5% Growth

Q2 FY19 Q3 FY19 Q4 FY19 Q1 FY20 Q2 FY20

$20.8

$16.0

$18.2

$20.0$19.0

$48.3$45.2$44.2

$47.6$45.5

Worldwide Peripheral Revenue Growth Worldwide Coronary Revenue Growth

Gross Margin

Q2 FY19 Q3 FY19 Q4 FY19 Q1 FY20 Q2 FY20

80.3%80.8%80.9% 79.9%80.4%

Q2 FY19 Q3 FY19 Q4 FY19 Q1 FY20 Q2 FY20

Cash and Marketable Securities

$105.0 $109.4$119.2 $115.7 $122.7

8%

growth

in Q2

30%

growth

in Q2

($ in millions)5

Page 6: 9th Annual SVB Leerink Global Healthcare Conference€¦ · • Leverages CSI core competency in motor control and spinning cables • Easy setup and use • Flow: 3-5 LPM • Crossing

Key Events & Milestones

FY19A FY20E FY21E

Sold 80,650 OAS

International revenue = $7.9M

Launched OAS in SE Asia, Europe

and Middle East

Certified 120 OUS physicians

Launched Classic Crown and

ViperWire Flex Tip in Japan

New product revenue = $3.9 million

Launched Teleport Microcatheter

Launched ViperCath XC

Launched Peripheral ViperWire with

Flex Tip

Radial full market release

Exchangeable limited market release

81% consolidated gross margin

Enrolled first patient in REACH PVI

Enrollment of ECLIPSE passes 950

Pre-submission meetings with FDA

for hemodynamic support

Completed $350M shelf filing

WIRION acquisition

LIBERTY 360 3-Year Data

• Launch OAS in up to 10 new countries

Certify >120 international physicians

• International revenue = $11M

• New product launches:

PAD Exchangeable full market release

CAD Nitinol ViperWire Flex Tip

PAD Next Gen OAS with GlideAssist

• PAD JADE angioplasty balloons

• Sapphire 1.0mm over-the-wire

Sapphire NC Plus 4.5-5.0mm

REACH PVI enrollment completion

• ECLIPSE enrollment reaches 1500

• Hemodynamic support - First in Human

• International revenue = $15-$17.5M

• Launch OAS in Canada and other

countries

• Japan peripheral first enrollment

• ECLIPSE enrollment complete

• REACH PVI data release

• US IDE Small Vessel first enrollment

• Manufacturing transfer of WIRION

• WIRION launch in U.S.

• CAD ScoreFlex NC in U.S.

• PAD radial support products

6

Page 7: 9th Annual SVB Leerink Global Healthcare Conference€¦ · • Leverages CSI core competency in motor control and spinning cables • Easy setup and use • Flow: 3-5 LPM • Crossing

Portfolio expansion will drive a

>4X increasein CSI’s addressable market

FY19 FY23

Diversification Accelerates Growth

• Millennium Research Group (2018 December) Medtech360 Market Analysis - Interventional Cardiology Devices – US –2019

• Millennium Research Group (2018 December) Medtech360 Market Analysis – Peripheral Vascular Devices – US – 2019• Millennium Research Group (2017 December) Medtech360 Market Analysis – Cardiac Assist Devices– US – 2018• CSI Internal Estimates

• * Coronary markets include device revenue attributed to PTCA balloon catheters, microcatheters / guidecatheters, PTCA guidewires, CTO / STO devices, and hemodynamics pumps. Peripheral markets include device revenue attributed to lower extremity (iliac, fempop, infrapop) endovascular procedures for PTA guidewires, catheters / sheaths, embolic protection devices, CTO / STO devices, and PTA balloon catheters

Broadens Value Streams

~$3.7B

$650M

CSI’s Addressable Markets (US)

Interventional Support Devices

Atherectomy

Hemodynamic Support

7

Page 8: 9th Annual SVB Leerink Global Healthcare Conference€¦ · • Leverages CSI core competency in motor control and spinning cables • Easy setup and use • Flow: 3-5 LPM • Crossing

Current Market Dynamics Favor InnovationLarge Under-Served and Under-Treated Disease States

• Heart Disease and Stroke Statistics- 2019 Update: A report from the American Heart Association. Circulation. 2019;139:e56–e528• Millennium Research Group (2018 December) Medtech360 Market Analysis - Interventional Cardiology Devices – US – 2019• Millennium Research Group (2018 December) Medtech360 Market Analysis – Peripheral Vascular Devices – US – 2019• Bortnick, et. al. Am J Cardiol 2014;113:573-579; iData Research (2018 March) U.S, CSI Internal Estimates• Allie DE , et al. (n.d.). 24-carat gold, 14-carat gold, or platinum standards in the treatment of critical limb ischemia: bypass surgery or endovascular intervention? J Endovsc Ther. 2009

Coronary Artery DiseaseGrowing proportion of coronary

interventions represented by complex

or complex high-risk PCIs

16-18

million

People living with coronary

artery disease

18-20

million

People living with peripheral

artery disease in the U.S. with

2 million+ patients suffering

from critical limb ischemia

370,000Deaths annually from coronary

artery disease>740K Lower extremity PVIs

Peripheral Artery DiseaseSignificantly under-diagnosed and

under-treated patient populations

160K 525KComplex or complex

high-risk PCIsAmputations per year

8

Page 9: 9th Annual SVB Leerink Global Healthcare Conference€¦ · • Leverages CSI core competency in motor control and spinning cables • Easy setup and use • Flow: 3-5 LPM • Crossing

Consistent Reimbursement

FacilityInpatient/

OutpatientProcedure 2020 Reimbursement % Change from 2019

Hospital Inpatient PAD $11,400 - $20,548 4.4% - 4.5%

Hospital Inpatient CAD $10,542 - $19,874 4.2% - 1.7%

Hospital Outpatient PAD/CAD $9,907 - $15,938 2.5% - 3.8%

Non-Hospital Outpatient/OBL PAD (ATK) $11,582 - $14,891 (6.9)% - (7.1)%

Non-Hospital Outpatient/OBL PAD (BTK) $11,626 - $14,476 (6.6)% - (5.0)%

$0

$5,000

$10,000

$15,000

$20,000

PAD OBL

PTA Ath/PTA

Stent Ath/Stent

$0

$5,000

$10,000

$15,000

$20,000

PAD Hospital Outpatient

PTA Ath/PTA

Stent Ath/Stent

$0

$5,000

$10,000

$15,000

$20,000

CAD Inpatient

PCI PCI/BMS PCI/DES

$0

$5,000

$10,000

$15,000

$20,000

CAD Outpatient

PTCA Ath/PTCA

Stent Ath/Stent

MS-DRG 246, 247, 248, 249, 250, 251, 252, 253, 254; CPT® Codes 37225, 37227,

37229, 37231, 92924, 92933; C-APCs 5193,5194; HCPCS Code C9602

Payment amounts based on National Medicare Averages and will vary by provider.9

Grow and Protect

the Core Business

Page 10: 9th Annual SVB Leerink Global Healthcare Conference€¦ · • Leverages CSI core competency in motor control and spinning cables • Easy setup and use • Flow: 3-5 LPM • Crossing

ECLIPSE TrialGenerating Level One Evidence to Impact Guidelines

2000Patients with Severely

Calcified Lesions

2nd generation DES implantation

and optimization

2nd generation DES implantation

and optimization

1. Post-PCI in-stent MSA by OCT (N=~500 in imaging sub-study)

2. 1-year TVF (all subjects)1o Endpoints

2o Endpoints 1. Procedural Success: Successful stent delivery (all subjects)

2. Strategy Success: Procedural success without crossover

1.25 mm Classic Crown followed by

balloon pre-dilation

Orbital Atherectomy Strategy

Conventional and/or specialty balloons

per operator discretion

Conventional Angioplasty Strategy

Principal Investigators

Study Chairman

Randomize

1:1

Ajay Kirtane, MD; Philippe Généreux, MD;

Gregg W. Stone, MD

~500 subjects in OCT cohort

OAS >1 mm2 superior MSA vs. POBAMSA

All subjects

OAS >5% reduction in TVF vs. POBATVF

Primary Endpoints

Grow and Protect

the Core Business

10

Page 11: 9th Annual SVB Leerink Global Healthcare Conference€¦ · • Leverages CSI core competency in motor control and spinning cables • Easy setup and use • Flow: 3-5 LPM • Crossing

LIBERTY 360°Orbital Atherectomy Subanalysis: 3-Year Freedom from Major Amputation on Target Limb

Mustapha J. LIBERTY 360 3-Year Data. Presented at AMP 2019.

Kaplan-Meier method used to obtain estimate rates. Greenwood’s method used to obtain the 95% confidence interval for the estimate.

Freedom from Major

Amputation on Target Limb

2-Year

RC2-3 100%

RC4-5 95.3%

RC6 88.6%

3-Year

RC2-3 100%

RC4-5 95.3%

RC6 88.6%

RC2-3 RC4-5 RC6

Grow and Protect

the Core Business

11

Survival Time (Days)

Su

rviv

al P

rob

ab

ility

Page 12: 9th Annual SVB Leerink Global Healthcare Conference€¦ · • Leverages CSI core competency in motor control and spinning cables • Easy setup and use • Flow: 3-5 LPM • Crossing

Expansion of the Complex Coronary ToolkitDrives Incremental Revenue Opportunity Per Case Today

Coronary Diamondback 360®

with GlideAssist®Sapphire® Expansion

ScoreFlex NC

Sapphire® Balloons

Teleport® Microcatheter

Launched FY19Launched FY19

• Sapphire SC II PRO 1.0-4.0mm

• Sapphire NC Plus 2.0-4.0mm

Launched FY19

FY20 Launches

• Sapphire SC II PRO 1.0mm OTW

• Sapphire NC Plus 4.5-5.0mm

Expected Launch FY21

Adding Essentials of

the Complex PCI Toolkit

Increasing the Clinical Utility

of the Sapphire Portfolio in

the Near-Term

Continuing to Innovate around

the Complex Patient Long-TermViperWire Advance® with Flex Tip

Launched Q1 FY20

Innovation Drives

Incremental Growth

Represents ≈$800-$1000 of

incremental revenue

opportunity

12

Page 13: 9th Annual SVB Leerink Global Healthcare Conference€¦ · • Leverages CSI core competency in motor control and spinning cables • Easy setup and use • Flow: 3-5 LPM • Crossing

Percutaneous Ventricular Assist Device (pVAD) SystemMulti-Generational Platform Highly Synergistic with Our Strategy and Competency

• Millennium Research Group (2017 December) Medtech360 Market Analysis – Cardiac Assist Devices– US – 2018

Entering a High Growth pVAD Market*Generation 1 Overview

IDE clinical studies planned to highlight

procedural safety and perfusion

metrics/endpoints

* Includes Complex PCI and Cardiogenic Shock

$0

$300

$600

$900

$1,200

$1,500

$1,800

FY19 FY23 FY27

$ M

illio

ns

16% CAGR

Recent Accomplishments / Status

Multiple animal studies completed successfully

Pre-submission meetings completed and underway with the FDA

First-in-human in FY21

• Leverages CSI core

competency in motor control

and spinning cables

• Easy setup and use

• Flow: 3-5 LPM

• Crossing Profile: 10-14 Fr

• Catheter Profile: 6-8 Fr

• Improved deliverability

• Physician control in the

sterile field

• Simplified touch

screen display

• Compact console design

(<15 lbs.)

Innovation Drives

Incremental Growth

13

Page 14: 9th Annual SVB Leerink Global Healthcare Conference€¦ · • Leverages CSI core competency in motor control and spinning cables • Easy setup and use • Flow: 3-5 LPM • Crossing

Innovation on Our Core Peripheral TechnologyProvides comprehensive approach for each patient

Grow and Protect

the Core Business

Launched Q1 FY19

Extended Length Orbital Atherectomy

System with Low 5Fr Profile

Launched Q1 FY20

14

Page 15: 9th Annual SVB Leerink Global Healthcare Conference€¦ · • Leverages CSI core competency in motor control and spinning cables • Easy setup and use • Flow: 3-5 LPM • Crossing

Expansion of the Peripheral ToolkitIncreasing Revenue Opportunity Per Case in FY21

Radial PAD Products: $800-$1000/OAS Procedure

Innovation Drives

Incremental Growth

Extended Length:

Exchange Catheters

PTA Balloons

Radial Access Sheaths

Guidewires

WIRION Embolic

Protection System

Exchange Catheters

PTA Balloons

Access Sheaths

Guidewires

PAD Products: $1600-$1800/OAS Procedure

15

Page 16: 9th Annual SVB Leerink Global Healthcare Conference€¦ · • Leverages CSI core competency in motor control and spinning cables • Easy setup and use • Flow: 3-5 LPM • Crossing

Global Distribution Network

MediKit

OrbusNeich

Key

CSI Direct Sales

ST. PAUL

Corporate Headquarters

• ≈ 800 employees

• United States direct sales

force includes 200 quota

reps and 100+ clinical

specialists

HONG KONG

Corporate Headquarters

• ≈ 600 employees

• Supplies medical devices

in more than 60 countries

on six continents

• Exclusive distributor for

CSI outside U.S. and

Japan

TOKYO

Corporate Headquarters

• ≈ 1,000 employees

• Exclusive distributor for

CSI in Japan

Global Expansion Accelerates

Growth of Core Business

16

Page 17: 9th Annual SVB Leerink Global Healthcare Conference€¦ · • Leverages CSI core competency in motor control and spinning cables • Easy setup and use • Flow: 3-5 LPM • Crossing

International Atherectomy Market

1 Key Source: 2017/2018/2019 Medtech 360.

Coronary

# Country 2020 PCI’s1

Potential OAS Procedures

(~12% Severe Calcium x

PCI’s)

1 China 1,220,000 146,000

2 India 730,000 88,000

3 Germany 330,000 40,000

4 Turkey 290,000 35,000

5 Japan 280,000 34,000

6 France 180,000 22,000

7 Italy 160,000 19,000

8 Brazil 160,000 19,000

9 UK 110,000 13,000

10 Russia 80,000 10,000

Total Coronary

International4,200,000 500,000

Peripheral

# Country 2020 PVI’s1 Potential OAS Procedures

(~50% Calcium x PVI’s)

1 Germany 220,000 110,000

2 Russia 100,000 50,000

3 France 100,000 50,000

4 China 80,000 40,000

5 Japan 70,000 35,000

6 Italy 60,000 30,000

7 South Korea 50,000 25,000

8 Brazil 50,000 25,000

9 India 30,000 15,000

10 South Africa 30,000 15,000

Total Peripheral

International860,000 430,000

The Coronary market is the largest International opportunity for CSI

representing 500,000 potential Coronary OAS procedures.

International represents 430,000 potential Peripheral

OAS procedures

International Atherectomy Total Addressable Market is over $1.6 Billion in 2020. 1

17

Global Expansion Accelerates

Growth of Core Business

Page 18: 9th Annual SVB Leerink Global Healthcare Conference€¦ · • Leverages CSI core competency in motor control and spinning cables • Easy setup and use • Flow: 3-5 LPM • Crossing

Steady Cadence of New Geographies

18

OUS Launches

FY18 FY19 FY20E

Co

ron

ary

• Japan • Hong Kong*

• Kingdom of Saudi Arabia

• Malaysia*

• Singapore*

• United Arab Emirates

• EU

• Indonesia

• Kuwait

• Lebanon

• New Zealand

• Thailand

• Vietnam

Pe

rip

he

ral

• France

• Germany

• Hong Kong*

• Malaysia*

• Singapore*

• Spain

• Switzerland

• EU (Austria, Belgium, Czech

Republic, Denmark, Finland,

Iceland, Ireland, Italy,

Netherlands, Norway,

Romania, Sweden, UK)

• Indonesia

• Kingdom of Saudi Arabia

• Lebanon

• New Zealand

• Thailand

• United Arab Emirates

• Vietnam

1 9 Up to 10

FY19 - FY23 Revenue Growth

Targeting $25M - $50M in International Revenue in FY23

$1.8M

$7.9M

$10M-$11M

$15M - $17.5M

$25M - $50M

FY18 FY19 FY20E FY21E FY23E

Bold – OAS launched

* Coronary and Peripheral OAS launched

Italic – Anticipated OAS regulatory approval

Global Expansion Accelerates

Growth of Core Business

Page 19: 9th Annual SVB Leerink Global Healthcare Conference€¦ · • Leverages CSI core competency in motor control and spinning cables • Easy setup and use • Flow: 3-5 LPM • Crossing

Cardiovascular Systems, Inc. Creating Shareholder Value

Leveraging a

Strong Core Business

A Compelling

Growth Strategy

Creating

Competitive Advantage

Financially Strong

with the Team and

Talent to Win

Expanding into

new geographic markets

Driving market leading

performance in orbital

atherectomy

Launching an innovative

portfolio of new products

Positive cash flow, strong

cash position and no

long-term debt

Sustaining double digit

growth

with strong gross margins

Positioned to invest

in organic growth

A Mission driven organization

with the leadership and

talent to succeed

Innovation and robust

medical evidence

Highest quality

products, services

and relationships

Medical education

and superior clinical

support

Serving large and

growing markets

Proprietary

core technology

Improving outcomes for

complex coronary and

peripheral artery disease

19

Page 20: 9th Annual SVB Leerink Global Healthcare Conference€¦ · • Leverages CSI core competency in motor control and spinning cables • Easy setup and use • Flow: 3-5 LPM • Crossing

Investor Contact:

Jack Nielsen

651-202-4919

[email protected]

CSI®, Diamondback®, Diamondback 360®,

GlideAssist®, ViperWire®, WIRION® and

ViperWire Advance® are trademarks of

Cardiovascular Systems, Inc.

© 2019 Cardiovascular Systems, Inc.

OrbusNeich®, Teleport® and Sapphire® are

trademarks of OrbusNeich Medical, Inc.

For more information:

www.csi360.com

Cardiovascular Systems, Inc.

CSII

@csi360