CSI IR Presentation

24
Cardiovascular Systems, Inc. Redefining Interventional Vascular Solutions William Blair Healthcare Conference June 11, 2015

description

CSI IR Presentation

Transcript of CSI IR Presentation

  • Cardiovascular Systems, Inc.Redefining InterventionalVascular Solutions

    William Blair Healthcare ConferenceJune 11, 2015

  • SAFE HARBOR

    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, the benefits and uses of the Companys products, 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 CSIs 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.

    2

  • Large, underserved markets

    Highly differentiated products

    Strong clinical data

    Attractive financial profile

    CSI TODAY

    37%CSIs revenue growth

    YTD fiscal 2015

    $14BCombined PAD

    and CAD U.S. market opportunity

    200,000Orbital Atherectomy

    Systems that have been sold

    5,000+Patients enrolled

    in CSI clinical studies

    2High-margin,

    high-growth orbital atherectomy

    franchises

    3

    Nearly

  • Simple Speed Settings

    Instant Response On/Off Switch

    Saline Pump Mounts on I.V. pole Bathes shaft and crown for smooth operation

    Crowns Offset weight = orbital action Small profile for small vessels and

    alternative access sites

    CSI ORBITAL ATHERECTOMY SYSTEMS (OAS)Power and simplicity for streamlined setup and treatment

    Sleek Electric-Powered Handle Simple set-up Optimum torque transfer to the shaft and crown Short treatment times

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

    Coronary Approved October 2013

    Peripheral

    4

  • Heart to heels capabilityWe treat 11 vessels.Large and small.

    1 1Above the Knee

    3HeartCSI: WHY WERE UNIQUE

    Effective in calcium

    Excellent safety

    Long-term durability

    Economical

    Below the Knee 33

    Alternative access sites

    5

  • CSI: WHY WERE UNIQUE

    Alternative access sites

    Femoral

    PedalTibial

    Radial

    Brachial

    6

  • 93% < red blood cell size

    99% < lumen size of capillaries

    UNIQUE MECHANISM OF ACTIONBi-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.

    7

  • OAS DELIVERS OPTIMAL VESSEL PREP AS THE PRIMARY TREATMENT FOR CALCIFIED LESIONS

    OAS

    Scoring Balloon

    Rotablator

    High Pressure Balloon

    Smooth Concentric Lumen Incomplete Vessel Prep

    Poly-traumatic vessel Injury Flow Limiting Dissection

    8

  • LARGE AND GROWING MARKETS

    CAD 1.4 million U.S. interventional procedures 38% with significant calcium $1.5+ billion market opportunity

    PAD Affects 18 million people in U.S. 4.0 million with critical limb ischemia Only 300,000 CLI patients receive interventions

    annually (160,000 get debilitating amputations) $12+ billion market opportunity

    Innovation for unmet needs driving market expansion

    $14BCombined

    PAD and CAD U.S.market opportunity

    9

  • Annual U.S. CAD procedures % with significant calcium

    CSI market potential(>$1.5 Billion)

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

    LARGE CORONARY MARKET POTENTIAL

    38%28%

    400,0001.4

    MILLION

    16 MILLION U.S. CAD PATIENTS DIAGNOSED

    10

  • PAD IS A LARGE AND UNDERSERVED MARKETCritical limb ischemia (CLI) is vastly undertreated

    18 million people in U.S. with PAD4 million people with CLI

    2.5 milliondiagnosed

    600K proceduralinterventions

    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.

    600K Interventions(300K for CLI)

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

    Amputationsand Bypass

    (CLI)

    High Pressure Balloons and

    Stents

    PlaqueRemoval

    CLI(6 Million by

    2030)

    Growth StrategyMarket expansion (underserved CLI patients)Reduce amputation/bypassReduce high pressure ballooning/stenting

    65% calcified

    11

  • Only device to broadly treat the disease

    Source: CSI data on file, Millennium Research Group

    Industry Procedure Mix

    BTK - 80% calcified20% require ankle/foot access

    CSI mix/disease prevalence

    ATK - 40% calcified

    OAS TECHNOLOGY EXPANDS PAD MARKET

    ABOVE THE KNEE

    BELOWTHE KNEE

    BELOWTHE KNEE

    ABOVETHE KNEE

    12

  • HOSPITAL

    INPATIENT

    OUTPATIENT

    PAD $10,150 $19,148CAD $11,032 $18,985

    PAD (ATK) $ 9,624PAD (BTK)/CAD $14,841

    NON-HOSPITAL FACILITY

    ATTRACTIVE REIMBURSEMENT RATES (2015)

    PAD $11,083 $15,175

    Small vessels receive higher reimbursement

    1. DRG Codes 246, 247, 248, 249, 250, 251, 252, 253, 2542. CPT Codes 37225, 37227, 37229, 37231, 929333. APC Codes 0229, 0319, 083 4. HCPCS Code C9602

    13

  • CSI has studied more than 5,000real-world patients, treated 7,000lesions and worked with 600+ physicians

    OASIS, CONFIRM series, Calcium 360 and Compliance 360, demonstrated: Low rates of adverse events

    and bail-out stenting High rates of success Durable results

    LIBERTY 360 (enrolling) Evaluating acute and long-term

    clinical and economic outcomes of CSIs OAS vs. any other treatment

    Up to 1,200 patients (noexclusions) at up to 100 U.S. sites

    Study will include claudication, CLI, patients scheduled for amputation

    BACKED BY CLINICAL SCIENCE

    Key PAD Trials

    14

  • BACKED BY CLINICAL SCIENCE

    Key CAD Trials

    ORBIT II Beat primary endpoints by significant

    margins in severely calcified lesions

    Two-year data showed 94% freedom from target lesion revascularization

    Two-year extrapolated economic analysis cost savings of up to $4,946per patient from shorter hospital stays and lower readmission rates

    COAST (enrolling) International investigational

    study to assess safety, efficacy and economic outcomes of new micro crown OAS

    Up to 100 patients at up to20 sites in the U.S. and Japan

    Japan enrollment completed

    Designed to secure commercialapproval for second-gen OASdevice in Japan

    15

  • SALES OPTIMIZATION STRATEGY

    December 2013 Today December 2015

    Hybrid100

    Hybrid 200+CAD 5

    PAD 100

    Expand sales footprint One rep selling two, high-margin, high-growth franchises Cover largest procedure accounts Deeper penetration into existing accounts Hybrid productivity well above PAD- or CAD-only reps

    CAD 10

    PAD 130

    16

  • $82.5

    $103.9

    $131.2

    $95.0

    $113.9

    $136.6$133.1

    $0

    $40

    $80

    $120

    $160

    FY 12 FY 13 FY 14 FY 14 (9 mo.) FY 15 (9 mo.)

    PAD CAD

    31

    %

    37

    %

    26

    % $97.0

    ACCELERATING REVENUE GROWTHQuality Revenue

    $ M

    illio

    ns

    Sales life-to-date

    Nearly 200,000 Devices, 1,700 Accounts

    96% Reorder Revenue

    U.S. only, CAD launch in Q2 2014

    $19.2 CAD

    17

  • Quarterly Revenue growth over prior year11 Quarters 25% or greater growth

    0%

    10%

    20%

    30%

    40%

    Q113

    Q213

    Q313

    Q413

    Q114

    Q214

    Q314

    Q414

    Q115

    Q215

    Q315

    25% 28% 25% 26%28% 28%

    31%

    37%39% 38%

    35%

    % Y

    ear

    ove

    r Ye

    ar G

    row

    th

    Growth accelerated with CAD

    18

  • STRONG, IMPROVING GROSS MARGINS

    70%

    75%

    80%

    FY 13 FY 14 FY 15 (9 mo.)

    76.5%

    77.3%

    78.5%

    19

  • INVESTING FOR ACCELERATED REVENUE GROWTHFuture profitability potential

    Adjusted EBITDA = EBITDA, excluding stock-based compensation expense. For a reconciliation of this non-GAAP financial measure, please refer to the reconciliation tables in our most recent Form 10-K and Form 10-Q.

    -20%

    -15%

    -10%

    -5%

    0%

    5%

    10%

    15%

    20%

    25%

    FY 13 FY 14 FY 15 (9 mo.) Future Target

    (9%)

    2%

    (16%)

    Adjusted EBITDA Margin Adjusted EBITDA Margin (excluding net coronary investment)

    6%

    (13%)

    5%

    % o

    f R

    eve

    nu

    e20%-25%

    Upfront CAD investment = long-term growth/operating leverage

    20

  • SOLID BALANCE SHEETAmple cash to implement current strategy

    $0

    $20

    $40

    $60

    $80

    $100

    Jun. 2013 Mar. 2015

    $12

    $93.5

    $68

    $0.0

    Debt Principal Cash

    $ M

    illio

    ns

    21

  • Large, underserved markets

    Highly differentiated products

    Strong clinical data

    Attractive financial profile

    WHY CSI?

    22

  • 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 guidewire 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 anappropriate candidate for bypass surgery, angioplasty, or atherectomytherapy, 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 vesselsor bifurcations may result in vessel damage; The OAS was only evaluated inseverely calcified lesions, A temporary pacing lead may be necessary whentreating lesions in the right coronary and circumflex arteries; On-site surgicalback-up should be included as a clinical consideration; Use in patients with anejection fraction (EF) of less than 25% has not been evaluated.See the instructions for use before performing DIAMONDBACK 360 coronaryorbital 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 CSIs website at www.csi360.com .

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

    The Diamondback 360 and Stealth 360 Peripheral Atherectomy SystemsThe 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 stenoticmaterial from artificial arteriovenous dialysis fistulae. The Systems arecontraindicated for use in coronary arteries, bypass grafts, stents, or wherethrombus 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 CSIs website at www.csi360.com .

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

    23

  • Investor Contact:Jack NielsenSenior Director Corporate Communications & Investor [email protected]

    2015 Cardiovascular Systems, Inc.All Rights ReservedDiamondback 360 and CSI are registered trademarks of Cardiovascular Systems, Inc.www.csi360.com

    NASDAQ: CSII

    24