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Page 1: Cardiovascular Systems, Inc....Nov 18, 2020  · Expected Launch FY21 Adding Essentials of the Complex PCI Toolkit Increasing the Clinical Utility of the Sapphire Portfolio in the

©2020 Cardiovascular Systems, Inc. All Rights Reserved.

Cardiovascular Systems, Inc.Stifel 2020 Virtual Healthcare Conference

November 18, 2020

Page 2: Cardiovascular Systems, Inc....Nov 18, 2020  · Expected Launch FY21 Adding Essentials of the Complex PCI Toolkit Increasing the Clinical Utility of the Sapphire Portfolio in the

Safe HarborFORWARD LOOKING STATEMENTS

This presentation contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended, or the “Securities Act”, and

Section 21E of the Securities Exchange Act of 1934, as amended, or the “Exchange Act”, which are subject to the safe harbor created by those sections. These forward-looking

statements include, but are not limited to, statements in this presentation regarding CSI’s strategy and goals; growth; future financial measurements and investments;

shareholder value; product development plans, milestones and introductions; geographic expansion; clinical trials and evidence; professional education efforts; market

estimates and opportunities; and developments, goals and expectations relating to the COVID-19 pandemic and the recovery therefrom. Forward-looking statements are only

predictions and are not guarantees of performance. These statements are based on CSI management’s beliefs and assumptions, which in turn are based on their interpretation

of currently available information.

These statements involve known and unknown risks, uncertainties and other factors that may cause CSI’s results or CSI’s industry’s actual results, levels of activity,

performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. CSI may not actually achieve the plans,

intentions or expectations disclosed in these forward-looking statements and you should not place undue reliance on our forward-looking statements. These forward-looking

statements involve known and unknown risks and uncertainties that could cause CSI’s actual results, performance or achievements to differ materially from those expressed or

implied by the forward-looking statements, including, without limitation, the risks set forth in our filings with the Securities and Exchange Commission.

CSI’s actual future results may be materially different from what CSI expects. You should not place undue reliance on these forward-looking statements. You should assume

that the information contained in this presentation is accurate only as of the date of this presentation. Except as required by law, CSI assumes no obligation to update these

forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new

information becomes available in the future. CSI qualifies all of the information presented in this presentation, and particularly the forward-looking statements, by these

cautionary statements.

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.

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Page 3: Cardiovascular Systems, Inc....Nov 18, 2020  · Expected Launch FY21 Adding Essentials of the Complex PCI Toolkit Increasing the Clinical Utility of the Sapphire Portfolio in the

Our Mission

Saving Limbs, Saving Lives Every Day

2 Million+Patients with Critical

Limb Ischemia (CLI)1

160,000Annual Amputations

in the U.S.2

370,000Deaths Annually From

Coronary Artery

Disease in the U.S.3

525,000High Risk or Complex

High Risk Procedures

Annually in the U.S.4

Focused on Complex Peripheral and Coronary Artery Disease

3

1. Yost ML, CLI U.S. Supplement, Beaufort, SC. 2016 as presented at NCVH 2017

2. Allie DE, Hebert CJ, Ingraldi A, Patlola RR, Walker CM. 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;16(Suppl I):I134–I146.

3. American Heart Association - Heart Disease and Stroke Statistics- 2018 Update

4. CSI estimates

Page 4: Cardiovascular Systems, Inc....Nov 18, 2020  · Expected Launch FY21 Adding Essentials of the Complex PCI Toolkit Increasing the Clinical Utility of the Sapphire Portfolio in the

CSI Today Building on our orbital atherectomy foundation

4

Coronary Peripheral

z

Page 5: Cardiovascular Systems, Inc....Nov 18, 2020  · Expected Launch FY21 Adding Essentials of the Complex PCI Toolkit Increasing the Clinical Utility of the Sapphire Portfolio in the

Company ProfileDeveloping innovative solutions for treating peripheral & coronary arterial disease

5

800+Employees and a highly

experienced leadership team

#1U.S. market leader in calcified

peripheral and coronary atherectomy

5,700+Real-world patients studied through

clinical studies as of FY19

80,000+ Patients treated annually

200+ Patents

1,700+U.S. customers; hospital and

office-based labs

200 U.S. direct sales representatives

125 U.S. clinical specialists

Page 6: Cardiovascular Systems, Inc....Nov 18, 2020  · Expected Launch FY21 Adding Essentials of the Complex PCI Toolkit Increasing the Clinical Utility of the Sapphire Portfolio in the

Driving Future GrowthBroaden Our Value Streams

Financial Goal: Accelerate Profitable Revenue Growth

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

Attractive and Consistent Growth

in Core Business

Expand Product Portfolio and

Addressable Markets

Drive higher revenue per orbital

atherectomy procedure

Steady Cadence of Commercial

Launches

Capturing Market Share and

Driving Market Development

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Page 7: Cardiovascular Systems, Inc....Nov 18, 2020  · Expected Launch FY21 Adding Essentials of the Complex PCI Toolkit Increasing the Clinical Utility of the Sapphire Portfolio in the

Expansion of the Complex Coronary Product OfferingDrives Incremental Revenue Opportunity Per Case

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

Represents $800-$1,000 of

incremental revenue

opportunity

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Page 8: Cardiovascular Systems, Inc....Nov 18, 2020  · Expected Launch FY21 Adding Essentials of the Complex PCI Toolkit Increasing the Clinical Utility of the Sapphire Portfolio in the

Expansion of the Peripheral ToolkitIncreasing Revenue Opportunity Per Case Launching in FY21

Radial PAD Products: $800-$1,000/OAS Procedure

Extended Length:

Exchange Catheters

PTA Balloons

Radial Access Sheaths

Guidewires

Exchange Catheters

PTA Balloons

Access Sheaths

Guidewires

WIRION Embolic Protection

System

PAD Products: $1,600-$1,800/OAS Procedure

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Page 9: Cardiovascular Systems, Inc....Nov 18, 2020  · Expected Launch FY21 Adding Essentials of the Complex PCI Toolkit Increasing the Clinical Utility of the Sapphire Portfolio in the

Supporting Complete Leg RevascularizationExchangeable Series with GlideAssist® – Reduces Rehospitalization

Patient and economic benefits with more efficient procedures aligned to market

dynamics

Future Portfolio: New 1.0mm crown for small vessel / below-the-ankle lesions

and a larger crown intended for larger vessels like the common femoral and

iliac arteries

GlideAssist to facilitate tracking, repositioning and removal of OAD through

challenging anatomy

Exchangeable cartridges with different catheter lengths and crown options to

optimally treat patients with multi-level disease (seen ~50% of the time)

within the same procedure

Ease-of-Use Enhancements to Handle: Backloadable system facilitating easier

wire exchanges and improved tactile feel

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Page 10: Cardiovascular Systems, Inc....Nov 18, 2020  · Expected Launch FY21 Adding Essentials of the Complex PCI Toolkit Increasing the Clinical Utility of the Sapphire Portfolio in the

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

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• 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.)

Page 11: Cardiovascular Systems, Inc....Nov 18, 2020  · Expected Launch FY21 Adding Essentials of the Complex PCI Toolkit Increasing the Clinical Utility of the Sapphire Portfolio in the

Excellence in Quality and ManufacturingScalable and Continuous COGS Reductions

Manufacturing

Initiatives

Sourcing and

Supply Chain

Volume driven overhead leverage

Scalable and

continuous reductions

to protect margins

from ASP declines

Labor productivity

LEAN continuous improvement

Material cost reductions

Vertical Integration

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Page 12: Cardiovascular Systems, Inc....Nov 18, 2020  · Expected Launch FY21 Adding Essentials of the Complex PCI Toolkit Increasing the Clinical Utility of the Sapphire Portfolio in the

Trial Size Importance

PAD

LIBERTY 360° (3-year Data) n=1,204• “All-comers” trial, any treatment option

• Nearly 700 Rutherford Class 4-6 patients enrolled

OPTIMIZE (Enrollment Complete) n=66• OAS + DCB vs. DCB alone

• Calcified below-the-knee lesions

OASIS, CONFIRM series, TRUTH,

CALCIUM 360, and COMPLIANCE 360n=3,359

• High rates of procedural success and durability

• Low adverse events/bail-out stenting

CAD

ECLIPSE (Enrollment Began March 2017) n=2,000

• Largest randomized trial to study coronary atherectomy for calcified

coronary lesions

• OAS + DES vs. angioplasty (including cutting/scoring balloons) + DES

• Currently paused due to Covid 19

ORBIT II (3-year Data) n=443 • High freedom from revascularization resulting in economic benefits1,2

COAST (1-year Data) n=100• Supported approvals of Coronary OAS in U.S. and Japan

• Japan commercialization began in FY18

Leadership in Medical Evidence

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600+Physicians

5,700+Patients

~8,000Lesions

1. Lee M, et al, Orbital atherectomy for treating de novo, severely calcified coronary lesions: 3-year results of the pivotal ORBIT II trial, Cardiovasc Revasc Med (2017), http://dx.doi.org/10.1016/j.carrev.2017.01.011

2. L.P. Garrison Jr. et al., Cardiovascular Revascularization Medicine 18 (2017) 86–90

Page 13: Cardiovascular Systems, Inc....Nov 18, 2020  · Expected Launch FY21 Adding Essentials of the Complex PCI Toolkit Increasing the Clinical Utility of the Sapphire Portfolio in the

Global Distribution Network

CSI Direct Sales OrbusNeich Medikit

St. PaulCorporate Headquarters

• ~ 800 employees

• United States direct sales force includes

~200 sales reps and ~125 clinical specialists

TokyoCorporate Headquarters

• ~ 1,000 employees

• Exclusive distributor for OAS in Japan

Hong KongCorporate Headquarters

• ~ 600 employees

• Develops, manufactures and distributes vascular

intervention devices in more than 60 countries

• Exclusive distributor for OAS outside U.S. and Japan

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Partnerships to Expand Orbital Atherectomy Across the Globe

Page 14: Cardiovascular Systems, Inc....Nov 18, 2020  · Expected Launch FY21 Adding Essentials of the Complex PCI Toolkit Increasing the Clinical Utility of the Sapphire Portfolio in the

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

Developing 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

High 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

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Page 15: Cardiovascular Systems, Inc....Nov 18, 2020  · Expected Launch FY21 Adding Essentials of the Complex PCI Toolkit Increasing the Clinical Utility of the Sapphire Portfolio in the

©2020 Cardiovascular Systems, Inc. All Rights Reserved.

Appendix

Page 16: Cardiovascular Systems, Inc....Nov 18, 2020  · Expected Launch FY21 Adding Essentials of the Complex PCI Toolkit Increasing the Clinical Utility of the Sapphire Portfolio in the

US Peripheral$42.9

US Coronary$15.9

US Peripheral US Coronary International

US Peripheral revenue declined 5%

Q1 Revenues of $60.5 Million42% Sequential Quarterly Increase (6% Decrease vs. LY)

US Coronary revenue declined 2%

International declined 42%

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• Units sold decreased 3% as COVID-19 negatively

impacted procedure volumes

• Units sold decreased 6% as COVID-19 negatively

impacted procedure volumes

• Support product revenue increased to $543 per coronary

OAS sold

• Ability to enroll new accounts and drive adoption outside

the U.S. is hindered by international travel restrictions

• OAS launched in 13 countries OUS to-date

($ in millions)

Q1 FY21 Revenue Breakdown

International

$1.7

Page 17: Cardiovascular Systems, Inc....Nov 18, 2020  · Expected Launch FY21 Adding Essentials of the Complex PCI Toolkit Increasing the Clinical Utility of the Sapphire Portfolio in the

Q1 FY20 Q2 FY20 Q3 FY20 Q4 FY20 Q1 FY21

Q1 FY21 Financial Results ($ in millions)

Q1 FY20 Q2 FY20 Q3 FY20 Q4 FY20 Q1 FY21

$20.8$18.5

$11.9

$17.6$19.0

$42.9

$30.6

$42.6$47.6$45.5

Worldwide Peripheral Revenue Worldwide Coronary Revenue

Gross Margin

Q1 FY20 Q2 FY20 Q3 FY20 Q4 FY20 Q1 FY21

80.4% 79.2%76.2%80.0%79.9%

Q1 FY20 Q2 FY20 Q3 FY20 Q4 FY20 Q1 FY21

Cash and Marketable Securities

$105.0 $109.4 $107.3

$232.2 $222.9

6% decline

WW in Q1

due to

Covid-19

7% decline

WW in Q4

due to

Covid-19

Page 18: Cardiovascular Systems, Inc....Nov 18, 2020  · Expected Launch FY21 Adding Essentials of the Complex PCI Toolkit Increasing the Clinical Utility of the Sapphire Portfolio in the

Q1 FY21 vs. Q1 FY20 and Q4 FY20

$ in (000) Q1 FY21 vs. Q1 FY20 vs. Q4 FY20

Total Revenue $60,544 -6.1% 42.3%

Worldwide Peripheral Revenue $42,932 -5.7% 40.0%

Worldwide Coronary Revenue $17,612 -7.1% 48.4%

US Revenue $58,831 -4.4% 45.4%

US Peripheral Revenue $42,932 -5.2% 40.0%

US Coronary Revenue $15,899 -2.2% 62.5%

International Revenue $1,713 -42.1% -18.2%

US Peripheral Units - -2.7% 39.9%

US Coronary Units - -5.9% 62.6%

Page 19: Cardiovascular Systems, Inc....Nov 18, 2020  · Expected Launch FY21 Adding Essentials of the Complex PCI Toolkit Increasing the Clinical Utility of the Sapphire Portfolio in the

Q1 FY21

Highlights

Financial

Revenues -6.1% vs. LY

Gross Margin 79.2%

SGA Expenses -13.8% to $40.3M

R&D Expenses -15.9% to $9.1M

Net Loss of $(2.1)M

Cash and marketable securities

decreased to $222.9M

No long-term debt

Operational - Peripheral

• Peripheral franchise performed

better than expected, led by an

8% year-over-year growth in the

OBL segment.

• Peripheral units sold were 97%

compared to last year.

• Exchangeable OAS now

represents nearly 20% of

peripheral volume.

• Targeting launch of WIRION

EPD in November

• Targeting launch of peripheral

support products in 2H FY21

• 7,900 patients clicked through to

identify physician using www.standagainstamputation.com

Operational - Coronary

• Coronary OAS units increased

63% compared to Q4 and were

94% compared to Q1 last year

• Continued adoption of coronary

toolkit featuring OAS with

GlideAssist, 1.0mm Sapphire

angioplasty balloons, Teleport

Microcatheter and nitinol

ViperWire with Flex Tip drove

$543 of incremental revenue

for every coronary OAS sold in

Q1

• Anticipate CE Mark in FY21

• ECLIPSE enrollment resumed

October 1, 2020

Other

• Sold 20,000 OAS units

• Nearly 1,000 medical

professionals attended CSI

virtual education programs

• Targeting FIH experience for

pVAD device in FY21

• Review of lower extremity

endovascular code set was

withdrawn from October 2020

CPT Editorial Panel agenda

• Amputation Reduction and

Compassion Act introduced in

U.S. House of

Representatives to cover PAD

screening, require diagnostic

testing prior to amputation

and increased PAD education

Page 20: Cardiovascular Systems, Inc....Nov 18, 2020  · Expected Launch FY21 Adding Essentials of the Complex PCI Toolkit Increasing the Clinical Utility of the Sapphire Portfolio in the

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.

© 2020 Cardiovascular Systems, Inc.

OrbusNeich®, Teleport® and Sapphire® are

trademarks of OrbusNeich Medical, Inc.

For more information:

www.csi360.com

Cardiovascular Systems, Inc.

CSII

@csi360

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