cardiovascular systems, inc. · sources: sage group, millennium research group “us markets for...

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Cardiovascular Systems, Inc. Redefining Interventional Vascular Solutions LEERINK Partners Global Healthcare Conference February 10, 2016

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Page 1: Cardiovascular Systems, Inc. · Sources: Sage Group, Millennium Research Group “US Markets for Peripheral Intervention Devices 2014,” iData “US Market for ... therapy in patients

Cardiovascular Systems, Inc. Redefining Interventional Vascular Solutions

LEERINK Partners Global Healthcare Conference

February 10, 2016

Page 2: Cardiovascular Systems, Inc. · Sources: Sage Group, Millennium Research Group “US Markets for Peripheral Intervention Devices 2014,” iData “US Market for ... therapy in patients

Safe Harbor

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FORWARD-LOOKING STATEMENTS Certain statements made in this presentation are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are provided under the protection of the safe harbor for forward-looking statements provided by that Act. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “could,” “would,” “expect,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “potential” and similar expressions intended to identify forward-looking statements. Examples of these statements include, but are not limited to, statements regarding Cardiovascular System, Inc.’s (“CSI” or the “Company”) future financial performance, product sales distribution, industry and market expectations and estimates, the benefits and uses of the Company’s products, market opportunity potential, clinical trials, international expansion, regulatory approvals, future profitability, debt capacity, use of proceeds, results of operations, prospects, plans and

objectives of management, and other statements that are other than statements of historical fact.

These statements involve risks and uncertainties which could cause results to differ materially from those projected, including those described under the heading “Risk Factors” contained in the prospectus filed with the Securities and Exchange Commission (the “SEC”) for our recent public offering, and as detailed from time to time in CSI’s SEC reports, including its Reports on Form 10-K and Form 10-Q. 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 presented. The forward-looking statements are made only as of the date of this presentation, and CSI undertakes no obligation to update them to reflect subsequent events or circumstances.

Page 3: Cardiovascular Systems, Inc. · Sources: Sage Group, Millennium Research Group “US Markets for Peripheral Intervention Devices 2014,” iData “US Market for ... therapy in patients

Investment Rationale

• Multi-billion dollar market opportunity, early stage of adoption

• Unique products modify calcified plaque in large and small vessels

• Supported by robust clinical data

• Large clinically-focused direct sales force

• Attractive reimbursement

• Financial flexibility/attractive growth and profit potential

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Page 4: Cardiovascular Systems, Inc. · Sources: Sage Group, Millennium Research Group “US Markets for Peripheral Intervention Devices 2014,” iData “US Market for ... therapy in patients

Diseases dominated by calcium

Large and Growing Markets

PAD: 18 million people affected in U.S. • Up to 4 million with critical limb ischemia • Only 300,000 CLI patients receive interventions

annually (160,000 get debilitating amputations)

CAD: 16 million people affected in U.S. • 1.4 million annual U.S. procedures • Diamondback 360 is the only device approved for the

treatment of calcified coronary calcified lesions

Untapped international market

$14B Combined

PAD and CAD U.S. Market Opportunity

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Page 5: Cardiovascular Systems, Inc. · Sources: Sage Group, Millennium Research Group “US Markets for Peripheral Intervention Devices 2014,” iData “US Market for ... therapy in patients

2.5 Million Diagnosed with PAD

Only 600K Interventions (300K for CLI)

PAD: Large and Underserved

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Sources: Sage Group, Millennium Research Group “US Markets for Peripheral Intervention Devices 2014,” iData “US Market for

Peripheral Vascular Devices and Accessories” 2014, and Go, et al “Heart Disease and Stroke Statistics -- 2014 Update,” Circulation.

$12B+ CLI market opportunity in U.S. and growing

18 Million People in U.S. with PAD

4 Million with CLI*

(* 6 Million by 2030)

600K Procedural Interventions

Amputations and bypass

Plaque removal

High pressure

balloons and stents

Page 6: Cardiovascular Systems, Inc. · Sources: Sage Group, Millennium Research Group “US Markets for Peripheral Intervention Devices 2014,” iData “US Market for ... therapy in patients

Below the Knee Above the

Knee

OAS Technology Expands PAD Market

6 Source: CSI data on file, Millennium Research Group

Industry Procedure Mix

BTK - 80% calcified 20% require ankle/foot access

CSI Mix/Disease Prevalence

ATK - 40% calcified

Only device to broadly treat the disease

Below the Knee

Above the Knee

Page 7: Cardiovascular Systems, Inc. · Sources: Sage Group, Millennium Research Group “US Markets for Peripheral Intervention Devices 2014,” iData “US Market for ... therapy in patients

Sources: Millennium Research Group Inc 2014., National Hospital Discharge Survey 2009, CSI estimates.

Large Coronary Market Potential

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16 MILLION U.S. CAD PATIENTS DIAGNOSED

Annual U.S. CAD procedures

1.4 MILLION

% with Significant Calcium

38%

Potentially Treatable with

Diamondback 360

28% 400,000

$1.5 Billion

CSI Market Potential

Page 8: Cardiovascular Systems, Inc. · Sources: Sage Group, Millennium Research Group “US Markets for Peripheral Intervention Devices 2014,” iData “US Market for ... therapy in patients

SIMPLE SPEED SETTINGS

INSTANT RESPONSE ON/OFF SWITCH

SALINE PUMP REUSABLE, COMPACT

CROWNS SMALL PROFILE, ORBITAL ACTION

SLEEK ELECTRIC-POWERED HANDLE

Crowns shown are not to scale and for illustrative purposes only.

CSI Orbital Atherectomy Systems (OAS) Power and simplicity for streamlined set-up and treatment

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PERIPHERAL

CORONARY

Page 9: Cardiovascular Systems, Inc. · Sources: Sage Group, Millennium Research Group “US Markets for Peripheral Intervention Devices 2014,” iData “US Market for ... therapy in patients

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HEART-TO-HEELS CAN TREAT 11 VESSELS

CSI: Why We’re Unique

1 1 Above the Knee

3 Heart

Below the Knee 3 3

EFFECTIVE IN CALCIUM

EXCELLENT SAFETY

LONG-TERM DURABILITY

ECONOMICAL

Page 10: Cardiovascular Systems, Inc. · Sources: Sage Group, Millennium Research Group “US Markets for Peripheral Intervention Devices 2014,” iData “US Market for ... therapy in patients

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CSI: Why We’re Unique

Femoral

Pedal

Tibial

Radial

Brachial

ALTERNATE ACCESS SITES

Page 11: Cardiovascular Systems, Inc. · Sources: Sage Group, Millennium Research Group “US Markets for Peripheral Intervention Devices 2014,” iData “US Market for ... therapy in patients

• 93% < red blood cell size

• 99% < lumen size of capillaries

Unique Mechanism of Action Bi-directional and differential sanding

Calculation of mean particulate size is based particles larger than 1 micron from a representative study using carbon blocks and cadaver model systems. 11

Page 12: Cardiovascular Systems, Inc. · Sources: Sage Group, Millennium Research Group “US Markets for Peripheral Intervention Devices 2014,” iData “US Market for ... therapy in patients

Fundamentally Superior Technology

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EN-2260.A

Mechanical / Laser Atherectomy

• Challenged by hard calcium

• Lumen size limitations • Doesn’t fully protect native vessel

• Technique dependent

Laser Directional Rotational

• Treats all calcified vessels (65% of market)

• Lowest profile catheter; ideal for BTK

• Substantially reduced procedure time

• Maintains healthy vessel tissue

• Superior ease of use

Orbital Atherectomy: Diamondback 360

Page 13: Cardiovascular Systems, Inc. · Sources: Sage Group, Millennium Research Group “US Markets for Peripheral Intervention Devices 2014,” iData “US Market for ... therapy in patients

Leadership in Clinical Evidence

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LIBERTY 360 (Enrollment Complete)

ORBIT II (2-year Data)

COAST (Enrollment Complete)

OASIS, CONFIRM series, Calcium 360 and Compliance 360

• Supports 2nd Gen OAS in U.S. and Japan approval

• 94% freedom from revascularization

• Up to $4,946 per patient cost savings

• High rates of success and durability

• Low adverse events/bail-out stenting

• “All-comers” trial vs. any other treatment

• Over 600 Rutherford class 4, 5, or 6 n=1,200

n=100

Trial Importance Size

n=3,359

PAD

C

AD

n=443

Patients Lesions Physicians

-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

OPTIMIZE (Enrolling)

n=50 • OAS + DCB vs. DCB alone

• Calcified below-the-knee lesions

Page 14: Cardiovascular Systems, Inc. · Sources: Sage Group, Millennium Research Group “US Markets for Peripheral Intervention Devices 2014,” iData “US Market for ... therapy in patients

ORBIT II1: Results Out to 2 Years

1. ORBIT II INCLUDED PATIENTS WITH EJECTION FRACTIONS OF 25%+; MOST PCI STUDIES HAVE EXCLUDED PATIENTS BELOW 35% 2. KAPLAN-MEIER ESTIMATES

1-YEAR2 2-YEAR2

FREEDOM FROM TVR/TLR 94.2% 91.9%

FREEDOM FROM TVR 98.1% 97.1%

FREEDOM FROM TLR 95.3% 93.8%

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Page 15: Cardiovascular Systems, Inc. · Sources: Sage Group, Millennium Research Group “US Markets for Peripheral Intervention Devices 2014,” iData “US Market for ... therapy in patients

Attractive Reimbursement Rates (2016)

HOSPITAL

INPATIENT

OUTPATIENT

PAD $10,177 − $19,415 CAD $9,960 − $19,191 PAD (ATK) $9,542 PAD (BTK)/CAD $14,612

NON-HOSPITAL FACILITY PAD $11,085 − $15,186*

Small vessels receive higher reimbursement

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MS-DRG 246, 247, 248, 249, 250, 251, 252, 253, 254; CPT Codes 37225, 37227, 37229, 37231, 92933; C-APCs 5191,5192,5193; HCPCS Code C9602

* Procedures using atherectomy

Page 16: Cardiovascular Systems, Inc. · Sources: Sage Group, Millennium Research Group “US Markets for Peripheral Intervention Devices 2014,” iData “US Market for ... therapy in patients

Sales Force Optimization Strategy

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250 Professionals

• One sales professional selling two, high-margin, high-growth products

• Deeper penetration into fewer high potential accounts

• Higher productivity per sales professional

• Drives future profitability

Rev

en

ue

Pe

r Sa

les

Pro

fess

ion

al

Page 17: Cardiovascular Systems, Inc. · Sources: Sage Group, Millennium Research Group “US Markets for Peripheral Intervention Devices 2014,” iData “US Market for ... therapy in patients

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$0

$40

$80

$120

$160

$200

FY 12 FY 13 FY 14 FY 15 FY 16 -6 mo.

FY 15 -6 mo.

Revenue

Track Record of Revenue Growth Temporarily Affected by Sales Force Transition

$ in

Mill

ion

s

Amounts exclude revenue from distribution agreement terminated on June 30, 2015

Page 18: Cardiovascular Systems, Inc. · Sources: Sage Group, Millennium Research Group “US Markets for Peripheral Intervention Devices 2014,” iData “US Market for ... therapy in patients

Strong, Improving Gross Margins

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70%

75%

80%

85%

FY 13 FY 14 FY 15 H1 FY 16

78.2%

80.2%

76.5% 77.3%

Page 19: Cardiovascular Systems, Inc. · Sources: Sage Group, Millennium Research Group “US Markets for Peripheral Intervention Devices 2014,” iData “US Market for ... therapy in patients

Solid Balance Sheet

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$0

$20

$40

$60

$80

$100

June 2015 Dec. 2015

Cash

Adequate cash on hand to implement current strategy $

Mill

ion

s

Financial Flexibility • $65 million in cash • Potential facility financing • Debt capacity

Page 20: Cardiovascular Systems, Inc. · Sources: Sage Group, Millennium Research Group “US Markets for Peripheral Intervention Devices 2014,” iData “US Market for ... therapy in patients

Why CSI?

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Supported by robust clinical data

Large, clinically focused direct sales force

Multi-billion dollar market opportunity, early adoption stage

Financial flexibility/attractive growth and profit potential

Unique products

Attractive reimbursement

Page 21: Cardiovascular Systems, Inc. · Sources: Sage Group, Millennium Research Group “US Markets for Peripheral Intervention Devices 2014,” iData “US Market for ... therapy in patients

DIAMONDBACK 360® Coronary Orbital Atherectomy System

Indications: The DIAMONDBACK 360® Coronary Orbital Atherectomy System (OAS) is a percutaneous orbital atherectomy system indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.

Contraindications: The OAS is contraindicated when the VIPERWIRE guide wire cannot pass across the coronary lesion or the target lesion is within abypass graft or stent. The OAS is contraindicated when the patient is not an appropriate candidate for bypass surgery, angioplasty, or atherectomy therapy, or has angiographic evidence of thrombus, or has only one open vessel, or has angiographic evidence of significant dissection at the treatment site and for women who are pregnant or children.

Warnings/Precautions:; Performing treatment in excessively tortuous vessels or bifurcations may result in vessel damage; The OAS was only evaluated in severely calcified lesions, A temporary pacing lead may be necessary when treating lesions in the right coronary and circumflex arteries; On-site surgical back-up should be included as a clinical consideration; Use in patients with an ejection fraction (EF) of less than 25% has not been evaluated. See the instructions for use before performing DIAMONDBACK 360 coronary orbital atherectomy procedures for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential adverse events. For further information call CSI at 1-877-274-0901 and/or consult CSI’s website at www.csi360.com.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Diamondback 360® and Stealth 360®Peripheral Atherectomy Systems The Diamondback 360® and Stealth 360® PAD Systems are percutaneous orbital atherectomy systems indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and stenotic material from artificial arteriovenous dialysis fistulae. The Systems are contraindicated for use in coronary arteries, bypass grafts, stents, or where thrombus or dissections are present. Although the incidence of adverse events is rare, potential events that can occur with atherectomy include: pain, hypotension, CVA/TIA, death, dissection, perforation, distal embolization, thrombus formation, hematuria, abrupt or acute vessel closure, or arterial spasm. For further information call CSI at 1-877-274-0901 and/or consult CSI’s website at www.csi360.com. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

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Page 22: Cardiovascular Systems, Inc. · Sources: Sage Group, Millennium Research Group “US Markets for Peripheral Intervention Devices 2014,” iData “US Market for ... therapy in patients

Investor Contact: Jack Nielsen Senior Director Corporate Communications & Investor Relations 651-202-4919 [email protected] ©2016 Cardiovascular Systems, Inc. All Rights Reserved Diamondback 360 and CSI are registered trademarks of Cardiovascular Systems, Inc. www.csi360.com

NASDAQ: CSII

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