Cardiovascular Systems (CSII) 8-KQ4 FY22 Financial Results

Capital Markets Day August 3, 2022

 

Welcome Jack Nielsen Vice President, Investor Relations & Corporate Communications

 

Q4 FY22 Financial Results

 

Capital Markets Day – August 3, 2022 Company Overview Scott R. Ward Chairman, President & Chief Executive Officer

 

Forward Looking Statements Safe Harbor 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, goals, growth, future financial measurements, product development and introductions, geographic expansion, reimbursement expectations, acquisition of products in development, distributed products, clinical trials, future investments and financing needs, and market 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 Disclaimers 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. Market Estimates Unless noted otherwise, any references to market sizes, market share positions, and market growth rates are CSI internal estimates. Non-GAAP Financial Measures This presentation also refers to certain non-GAAP financial measures, such as Adjusted EBITDA. Non-GAAP financial measures have limitations as analytical tools and should not be considered in isolation or as a substitute for CSI's financial results prepared in accordance with GAAP.

 

Regulatory Disclaimers Product Availability Diamondback 360® Coronary Orbital Atherectomy System FDA-approved. Available for sale in the U.S. Diamondback 360® Peripheral Orbital Atherectomy System FDA-cleared. Available for sale in the U.S. Diamondback 360® Peripheral Orbital Atherectomy System – Exchangeable Series FDA-cleared. Available for sale in the U.S. Stealth 360® Peripheral Orbital Atherectomy System FDA-cleared. Available for sale in the U.S. Peripheral Orbital Atherectomy System 2.00 Max Crown (available with Diamondback 360®, Exchangeable Series, and Stealth 360® Peripheral Orbital Atherectomy Systems) FDA-cleared. Available under a Limited Market Release in the U.S. ViperCath™ XC Peripheral Exchange Catheter FDA-cleared. Available for sale in the U.S. Zilient® Peripheral Guidewire FDA-cleared. Available for sale in the U.S. Jade® PTA Balloon Dilatation Catheter FDA-cleared. Available for sale in the U.S. Sapphire® II PRO Balloon Dilatation Catheter FDA-cleared. Available for sale in the U.S. Sapphire® NC 24 Coronary Dilatation Catheter FDA-cleared. Available for sale in the U.S. Sapphire® NC Plus Coronary Dilatation Catheter FDA-cleared. Available for sale in the U.S. Scoreflex® NC Scoring PTCA Catheter FDA-approved. Available for sale in the U.S. Shepherd™ Peripheral Guidewire FDA-cleared. Available for sale in the U.S. Product Availability Teleport® Microcatheter FDA-cleared. Available for sale in the U.S. ViperCross™ Support Catheter FDA-cleared. Available for sale in the U.S. Diamondback 360 Precision™ Coronary Orbital Atherectomy System Product is in development. Not available for sale. Next Gen Orbital Atherectomy System (Coronary and Peripheral) Product is in development. Not available for sale. Coronary Orbital Atherectomy System Guidance Platform Product is in development. Not available for sale. Coronary Orbital Atherectomy System Crown Extensions (1.0mm Piloting) Product is in development. Not available for sale. Coronary Antegrade/Retrograde Microcatheters Product is in development. Not available for sale. Coronary Dual Access Catheter Product is in development. Not available for sale. Coronary Guide Extension Catheter Product is in development. Not available for sale. Everolimus Drug Coated Balloon (Coronary and Peripheral) Product is in development. Not available for sale. Intravascular Lithotripsy (Coronary and Peripheral) Product is in development. Not available for sale. Thrombectomy Clot Retriever Product is in development. Not available for sale. Thrombectomy Aspiration Catheter Product is in development. Not available for sale. Next Gen WIRION® Embolic Protection System Product is in development. Not available for sale. Percutaneous Ventricular Assist Device (pVAD) Product is in development. Not available for sale.

 

 

Vision To eliminate cardiovascular disease as a barrier to living a full life by providing awareness and access to quality treatment. Mission Saving Limbs. Saving Lives. Every Day. Patient Centric and Customer Focused Cardiovascular Systems, Inc. 700,000 Over 700,000 patients worldwide successfully treated with OAS

 

CSI Board of Directors Sachin H. Jain, M.D. Director since 2021 Scott R. Ward Chairman, President & CEO Director since 2013 Kelvin Womack Director since 2020 Martha G. Aronson Director since 2017 Erik Paulsen Director since 2019 William Cohn, M.D. Director since 2015 Stephen Stenbeck Director since 2019 Augustine Lawlor Lead Independent Director Director since 2009

 

CSI Today 2 Manufacturing facilities (St. Paul, Minn. and Pearland, Texas) Serving patients in 31 Countries worldwide 750 Employees 100 Engineers and Scientists Over 300 U.S. Patents and Patents pending

 

Key Goals Analyst Day: 2018 Innovation Launch 20 New Products Global Expansion Deliver $25M - $50M in FY23 Grow the Core Business Achieve 10% growth in the core business

 

Grow and protect the core while we expand into larger and faster growing markets Focused Transformation Grow and protect Expand global OAS franchises Focused on our complex coronary and peripheral patient population Leveraging the capacity and competency of our U.S. sales channel Innovation to pursue larger and faster growing markets Broaden product portfolio beyond atherectomy

 

Highly differentiated and proprietary orbital atherectomy technology Grow and Protect Executing core growth initiatives, improving commercial execution and near-term product pipeline 01 Proven strategy to drive higher revenue per OAS procedure 02 Adoption of OAS internationally remains strong03

 

Strategy Expands Total Addressable U.S. Markets to $18.8B Innovation: Pursuing Larger and Faster Growing Markets $18.8B $9.2B TAM HEMODYNAMIC SUPPORT HR-PCI $9.6B $800M TAM PERIPHERAL & CORONARY DCB $8.8B $6.6B TAM THROMBECTOMY PAD & VTE $2.2B PERIPHERAL AND CORONARY OAS AND IVL

 

Financial Outlook Summary Long-term revenue growth fueled by execution of new platform development into large, high-growth markets 5 Year CAGR of 17% Significant investments in product development and clinical research Attractive and stable gross margins Long-term, sustainable profitability achieved with launch of platform products late in the plan period

 

Today’s Agenda 01 Grow & Protect Global OAS Franchises Scott Ward, Chairman, President & CEO 02 Expanding Product Portfolio Dramatically Increases TAM Matt Cambronne, Vice President, Research & Development 03 Growth Summary & Financial Projections Jeff Points, Chief Financial Officer 04 Closing Comments Scott Ward, Chairman, President & CEO 05 Q&A CSI Executive Team

 

CSI Leadership John M. Hastings Executive Vice President, Operations & Technology Robert T. Beverly Vice President & General Manager, Peripheral Sales Harrison T. Boyd II Vice President & General Manager, Coronary Sales Jack E. Nielsen Vice President, Investor Relations & Corporate Communications Jeffrey W. Chambers, M.D. Chief Medical Officer Rejoined CSI in 2021 Joined CSI in 2015Joined CSI in 2022 Joined CSI in 2014 Sandra M. Sedo Chief Compliance Officer Andrew P. O’Brien Vice President, Information Technology Jeffrey S. Points Chief Financial Officer Stephen J. Rempe Chief Human Resources Officer Alexander Rosenstein General Counsel & Corporate Secretary Joined CSI in 2022 Joined CSI in 2019 Joined CSI in 2014 Joined CSI in 2016 Joined CSI in 2014 Christopher R. Volker Vice President & General Manager, International Joined CSI in 2017 Joined CSI in 2007 Joined CSI in 2007 Matt Cambronne Vice President, Research & Development

 

Grow and Protect Core OAS Business Scott R. Ward Chairman, President and Chief Executive Officer

 

US PERIPHERAL US CORONARY INTERNATIONAL Orbital Atherectomy and Interventional Support Devices in the US and International markets Core OAS Business 7% FY22 Revenue: $16.4M OAS: $16.4M OAS Device Sales in: • Japan • Europe • Asia Pacific • Canada • ROW 66% FY22 Revenue: $155.3M OAS: $149.7M ISD: $5.6M OAS devices: Diamondback, Stealth, Exchangeable, Radial ISDs PTA balloons, wires, and catheters Specialty ISDs Wirion EPD 27% FY22 Revenue: $64.5M OAS: $52.3M ISD: $12.2M OAS devices: Diamondback with GlideAssist, Radial, Precision ISDs PTCA balloons, wires, and catheters Specialty ISDs ScoreFlex NC Scoring Balloon, Microcatheters for CTOs

 

Leadership in medical evidence Durable patient outcomes Over 83,000 Patients Treated WW in FY22 OAS Has Transformed the Care of Complex Patients Best-in-class professional education Over 700,000 patients Treated with orbital atherectomy since 2007 Innovation Exceptional clinical support

 

Committed to Partnering with our Customers with the Highest Quality Products, Services and Relationships Excellence in Quality and Manufacturing Scalable and continuous COGS reductions (volume and materials costs) to protect OAS margins from ASP declines Manufacturing Initiatives Sourcing and Supply Chain Volume driven overhead leverage Labor productivity LEAN continuous improvement Material cost reductions Vertical Integration ~80% U.S. OAS Margins

 

Customer Service and Relationships are a Core Competitive Advantage US Commercial Sales US Sales Organization Summary 01 02 03 04 05 Deep Clinical Acumen Case Support and Medical Education Long Tenure and Historically Low Turnover Durable Relationships Built on Successful Outcomes Exceptional Sales Leadership Peripheral and Coronary Franchise Leaders Exceptional Clinical Support for all Sites of Service Clinical Specialists provide coverage for ~67% of cases Comprehensive Sales Coverage: ~200 Sales Professionals Sales professional Dedicated to Peripheral, Coronary and Hybrid Territories

 

Orbital Atherectomy for treating peripheral & coronary arterial disease Strong Fundamentals Large, underserved markets High unmet medical need and economic cost OAS is highly differentiated – over 200 patents Partnering with Customers to treat complex cases Robust medical evidence A patient is treated with a CSI device every ~6 min. ~125,000 Devices used to treat CAD patients since launch More than 7,400 Patients studied ~575,000 Devices used to treat PAD patients since launch

 

Unprecedented Evidence in Treating Arterial Calcium Leadership in Medical Evidence Trial Size Importance Peripheral 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 360 n=3,359 • High rates of procedural success and durability • Low adverse events/bail-out stenting Coronary 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 • ~1,850+ patients enrolled 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 600+ Physicians 7,000+ Patients ~9,800 Lesions 325 Peer Reviewed Manuscripts

 

The Diamondback 360® Advantage for Calcified Coronary Artery Disease Robust Medical Evidence: Proven Performance Consistently high rates of procedure success Low rates of procedural complications across large study populations TLR rate of 3.4% at one year in the DES Subset 1. Chambers J, et al. JACC Cardiovasc Interv. 2014;7(5):510-8. 2. Lee MS, et al. J Interv Cardiol. 2016;29(4):357–62. 3. Beohar N. Orbital Atherectomy for Treating De Novo Severely Calcified Coronary Lesions: A Tertiary Center Experience. Presented at TCT Connect 2020. 1.Chambers J, et al. JACC Cardiovasc Interv. 2014;7(5):510-8. 2. Lee MS, et al. J Interv Cardiol. 2016;29(4):357–62. 3. Beohar N. Orbital Atherectomy for Treating De Novo Severely Calcified Coronary Lesions: A Tertiary Center Experience. Presented at TCT Connect 2020. 1.Chambers J, et al. JACC Cardiovasc Interv. 2014;7(5):510-8. 2020.4. Généreux P, et al. Catheter Cardiovasc Interv. 2016 Sep;88(3):369-77. 5. Lee M, et al. Cardiovasc Revasc Med. 2017 Jun;18(4):261-264. 6. Lee MS, et al. Coronary Orbital Atherectomy. 2018. P. Lanzer (ed.), Textbook of Catheter-Based Cardiovascular Interventions, https://doi.org/10.1007/978-3-319- 55994-0_42. Based on literature search of coronary DES randomized control trials on file at CSI. Studies may not be directly comparable due to differences in trial design and patient population.

 

LIBERTY 360 OAS Sub-analysis (n=503) High Freedom from TVR & Major Amputation at 3 Years 1. CSI Data on File 2. Giannopoulos S, et al. J Endovasc Ther. 2020;27(5):714-725 RC 2-3 RC 4-5 RC 6 RC 2-3 RC 4-5 RC 6 Freedom from TVR/ TLR at 3 Years1 Kaplan-Meier Estimate Freedom from Major Limb Amputation at 3 Years2 Kaplan-Meier Estimate 74.8% 67.2% 65.7% 100% 95.3% 88.6%

 

Evolving to Become a Broad-Based PAD Business Peripheral Executive Summary Innovation and Portfolio Advancement Accelerate Revenue per Procedure • Leveraging ISD portfolio, launching differentiated new products and providing case coverage Restore Growth in Core OAS Drive Market Expansion and OAS adoption • ~300,000 total atherectomy treatments in the U.S. today

 

Prevent Amputations by Accelerating Patient Access to Care Catalysts for Market Expansion and Growth Market Expansion Broaden Call Points Professional Education • Train 200 new customers per year • Offer advanced procedural training • CLI pathway education • Outcomes and efficiency optimization • Vascular Surgeon • Interventional Radiologist • High volume and complex cases • Critical Limb Ischemia • Improve commercial execution • Expand into the ATK mixed plaque market • Increase BTK and CLI adoption • DTC awareness and education Key Initiatives 160,000 PAD Amputations Annually Interventional cardiologist Best-in-Class

 

CMS 2023 proposed rules weighted average impact on CSI procedures increase by 1% Reimbursement Continues to Stabilize AMA CPT Code Restructure (OBL non-facility, Physician) • LER codes are not on September CPT Panel Agenda. Delays push effective date to 2025 or beyond CMS CY2023 Proposed Physician Fee Schedule (PFS) Reduction • Office Based Lab (OBL) average atherectomy procedure payments decrease 8.0% CMS CY2023 Proposed Hospital Outpatient Payment (OPPS) Increase • Peripheral average atherectomy procedure payments increase 6.25% • Coronary average atherectomy procedure payments increase 6.0% CMS FY2023 Proposed Hospital Inpatient (IPPS) Payment Flat • Peripheral average MS-DRG procedure payments increase 0.7% • Coronary average MS-DRG procedure payments decrease 0.7%

 

Strategy for building high volume OBL accounts focused on the care of complex PAD Customized Outpatient Resources – Comprehensive Resources to support high volume OBLs: Pricing Programs Inventory Management Consulting Product Portfolio Claim Assistance Patient Access to Care Clinical Support Professional Education Programs

 

Full Leg Revascularization Embolic Protection Radial and Pedal Access ATK Mixed Plaque Robust portfolio of options to treat multi-level peripheral disease Innovation and Portfolio Enhancement Exchangeable Series with GlideAssist® Launched 2019 2.0 Max Crown Mixed Plaque Device Launch 2023 Extended Length Orbital Atherectomy System Launched 2018 WIRION Embolic Protection Device Launch 2024

 

Full Portfolio of Balloons, Catheters and Guidewires Leverage scale: 60,000 cases performed in FY22 Accelerate Revenue per Procedure ViperCross™ Support Catheter Zilient® Peripheral Guidewire Launched 2022Launched 2021 Launched 2019 JADE® OTW and Sapphire® 1.0 mm Balloons Shepherd™ Peripheral Guidewire Launched 2022 WIRION™ EPD Launch 2024 Teleport® Microcatheter Launched 2019 ViperCath™ XC Radial Length Launched 2019 JADE® OTW 200 cm Length for Radial Access Launched 2021 Deliver $400 of incremental revenue per procedure in FY27 Full portfolio of ISDs: Jade, PTA Balloons, catheters and guidewires Enhanced opportunity for bundling and contracting with hospitals and GPOs Leverage presence and pull- through without significantly increasing selling costs

 

Peripheral Growth Outlook ISD Growth Estimate: ~40% Core OAS Growth Estimate: Mid-Single Digits Strive to become a $230M business in FY27 Headwinds COVID Recovery: Staffing and Indirect Supply Chain Vulnerability Competitive Pressure OBL Reimbursement 60,000 Patients treated in FY22 Tailwinds Leveraging the Full Portfolio Accelerating Procedure Volumes Hospital Reimbursement

 

A trusted partner in the treatment of complex coronary artery disease Coronary Executive Summary Restore growth in Core OAS with focus on lesion segmentation Leverage imaging adoption to drive market expansion and vessel preparation with OAS Expansion of medical evidence with ECLIPSE Improve commercial execution and focus Accelerate ISD growth with differentiated new products for complex coronary procedures

 

Assuring orbital atherectomy is the treatment of choice for properly selected patients Lesion Segmentation Serving Unique Market Needs Treatment Algorithms Have Formed Balloon Crossable Concentric Short Focal Uniform Single Vessel Uncrossable Eccentric Long Diffuse Nodular Multivessel disease

 

Imaging leads to 28% increase in vessel preparation 1 Imaging: A Catalyst for Market Expansion and Growth Diagnosis Enables physicians to accurately identify calcium and calcium morphology for patient selection and case planning. Increasing Diamondback utilization Assessment Enables physicians and CSI team to confirm Diamondback performance Optimization Enables physicians to optimize lesion treatment, including stent sizing, expansion and strut apposition for durable PCI outcomes Best Practice Incorporating imaging and calcium assessment into OAS best practices Program Integration Develop imaging first approach to training Treatment Algorithms Partnering with customers to build lesion specific algorithms Clinical Expertise Customer engagement and support, deep clinical acumen Case Expertise IVUS/OCT acumen for case support through CSI and/or imaging companies Evidence Leverage emerging imaging data (e.g. ILUMIEN) and CSI OCT studies Case courtesy of Takashi Ashikaga, MD, Japanese Red Cross Musashino Hospital –Tokyo, Japan

 

Grow and Protect the Coronary Business Improve Commercial Execution and Focus Reinforce safety data, Versatility, Efficiency and Diamondback Advantage to Capture Cases Leverage Full Portfolio using ISDs, Lesion Targeting, Clinical Acumen and Advanced Techniques to Support Customers Professional education to increase capacity and expand competencies from Fellowship through Complex Case Training Increase focus on high volume centers treating complex disease while optimizing tools for best outcomes Drive imaging adoption for case identification, planning and optimization

 

Expanding the Coronary Complex Portfolio Accelerate ISD Growth Teleport® Microcatheter Launched 2022 Launched 2019 Scoreflex® NC Sapphire® NC24 Specialty catheters for chronic total occlusions Launch 2023 Sapphire® ExpansionSapphire® Balloons ViperWire Advance® with Flex Tip Launched 2019 ISD Revenue Per OAS and Non-OAS Cases Driving Continued Growth Deliver $2,000 of incremental revenue per procedure in FY27 Enhanced opportunity for bundling and contracting with hospitals and GPOs Leverage presence and pull- through without significantly increasing selling costs Sapphire II PRO 1.0-4.0 mm Sapphire NC Plus 2.0-4.0 mm Sapphire SC II PRO 1.0 mm OTW Sapphire NC Plus 4.5-5.0 mm Launched 2021Launched 2018 Full Portfolio of Balloons, Catheters and Guidewires

 

Coronary Growth Outlook ISD Growth Estimate: Mid-20% Core OAS Growth Estimate: Mid-Single Digits Strive to become a $100M business in FY27 Headwinds COVID Recovery: Staffing and Indirect Supply Chain Vulnerability Competitive Pressure 14,000 Patients treated in FY22 Tailwinds Leveraging the Full Portfolio Increase Adoption of Imaging Emerging Medical evidence

 

Rapidly increasing scale in International markets International Executive Summary $1.8M $16.4M FY18 FY19 FY20 FY21 FY22 Focused on Established Market Opportunities in Coronary Commercial Execution Through Focused Distribution Network A large, underpenetrated market opportunity for OAS: 4.5 million OUS PVI and PCI procedures Successful Launches in Japan, EU and ROW Strong Growth in a Competitive Market

 

Focused on Coronary in Japan, EU and ROW Commercial Execution Key Drivers Longer Term OpportunitiesGeographic Priorities Invest in high-impact Market Development customized for select target markets Scalability – expand business capabilities/processes & leverage technologies to accelerate growth Product Portfolio – leverage CSI portfolio globally Leverage global and regional Medical Evidence to advance adoption of CSI therapies Focused KOL Engagement Strategies to build strong relationships, OAS faculty & advocates Japan PAD: 3rd largest International PAD market opportunity (~2/3rd the size of US CLI patient population) China CAD: Largest global CAD market based on current PCI volume China PAD: Largest global PAD market opportunity (~3x size of US CLI patient population) Japan – become CAD atherectomy market leader Europe – CAD launch is keeping pace with the launch in Japan China – Address Pre Market clinical and regulatory requirements. Continue to evaluate market timing and opportunity Rest of World (ROW) – accelerate global expansion delivering through distributor channel Launch Totals Cases MD Cert Accts JAPAN 948 83 33 EU 1291 69 30

 

Significant Growth opportunity in International Markets International Growth Outlook Core OAS Growth Estimate: Mid-20% Strive to become a $50M business in FY27 Headwinds COVID Recovery: Staffing and Indirect Supply Chain Vulnerability Competitive Pressure Tailwinds Enter the China Market Emerging Medical Evidence Leveraging CSI Portfolio Globally 11,000 Patients treated in FY22

 

Orbital Atherectomy and Interventional Support Devices in the US and International markets Core Business Growth Vectors US PERIPHERAL FY27: ~$230M US CORONARY FY27: ~$100M INTERNATIONAL FY27: ~$50M OAS Device Sales in: • Japan • Europe • Asia Pacific • Canada • ROW OAS devices: Diamondback, Stealth, Exchangeable, Radial ISDs PTA balloons, wires, and catheters Specialty ISDs Wirion EPD OAS devices: Diamondback with GlideAssist, Radial, Precision ISDs PTCA balloons, wires, and catheters Specialty ISDs ScoreFlex NC Scoring Balloon, Microcatheters for CTOs CORE BUSINESS FY27: ~$380M Organic Growth from sale of OAS devices in US and International Markets: • US Peripheral and Coronary OAS Growth: Mid-Single Digits • International OAS Growth: Mid-20% ISD Growth from the sale of distributed products in the US: ~30%

 

Expanding Product Portfolio Dramatically Increases TAM Matt Cambronne Vice President, Research & Development

 

Strategy Expands Total Addressable U.S. Markets to $18.8B Diversification Accelerates Growth $18.8B $9.2B TAM HEMODYNAMIC SUPPORT HR-PCI $9.6B $800M TAM PERIPHERAL & CORONARY DCB $8.8B $6.6B TAM THROMBECTOMY PAD AND VTE $2.2B PERIPHERAL AND CORONARY OAS AND IVL

 

Product Portfolio Expands into New Segments *Prototype products and components are depicted, actual commercial embodiments may vary Product FY22 FY23 FY24 FY25 FY26 FY27 Orbital Atherectomy 2.00 Max Crown OAS Next Generation Coronary Interventional Support Devices Coronary Scoring Balloon CTO Toolkit Thrombectomy Peripheral Vascular Expanded DV Indication Pulmonary Embolism Intravascular Lithotripsy Peripheral Coronary Drug Coated Balloon Peripheral Coronary Mechanical Circulatory Support High Risk PCI A th e re c to m y + I S D N e w P la tf o rm s

 

New Atherectomy & ISD Products OrbusNeich ® Scoreflex ® NC • First non-compliant scoring balloon in the US. Highest rated burst pressure in the US. Intended for in-stent restenosis, mixed plaque, ostial and bifurcated lesions • Initiated launch in Q3 FY22. Commercial performance has exceeded expectations since launch 2.00 Max Crown Peripheral OAS • 70-micron crown available on Stealth, Diamondback and Exchangeable platforms for treatment of mixed-plaque, above-the-knee lesions • Currently in limited market release with full market release planned for Q2 FY23 CTO Toolkit* • Toolkit portfolio containing Antegrade/Retrograde Microcatheters, Dual-Access Catheters and Guide Extension Catheters intended to assist in the treatment of complex coronary lesions • 510(k) clearance and initial commercialization expected in Q4 FY23 Diamondback 360 PrecisionTM Coronary OAS* • Modified drive shaft designed to improve 1:1 motion and result in more predictable handling and greater operational efficiency • PMAs submitted to the FDA in Q4 FY22. Approval anticipated in Q3 FY23 *Product is not available for sale in the United States and/or in-development. Prototype products and components are depicted, actual commercial embodiments and names may vary. CTO Toolkit 2.00 Max Crown Peripheral OAS

 

Thrombectomy

 

Venous ThromboEmbolism Deep Vein Thrombosis (DVT) Deep Vein Thrombosis (DVT) occurs when a blood clot forms in one or more deep veins, usually in the legs. When a clot formed in deep veins travels to the lungs and blocks the main pulmonary artery or its branches, it causes a Pulmonary Embolism (PE) Therapies used to treat DVT and PE include: Blood thinning medications Lytic treatments Aspiration Mechanical clot retrieval As clot ages it becomes more well-formed and harder to treat effectively with lytics and/or aspiration systems alone. As a result, the use of mechanical clot retrievers has grown considerably. Peripheral Arterial Thrombus also under consideration Pulmonary Embolism (PE)

 

US Thrombectomy Market Opportunity FY27 FY22 Mechanical Pump-based Aspiration Catheter-directed thrombolysis Mechanical = 20%+ CAGR Mechanical = ~15% CAGR FY22-FY27 Market Size FY27 FY22 Mechanical Pump-based Aspiration Catheter-directed thrombolysis FY22-FY27 Market Size Analyst Estimates, Company Estimates Pulmonary EmbolismDeep Vein Thrombosis (DVT) $110M Mech (~20% of Procedures) $250M-$300M Mech (40%+ of Procedures) $220M Mech (~35% of Proc) $425M-$475M Mech (~60% of Procedures)

 

Application PE, PV PE, PV PE PE Configuration Straight, 45o Curve Straight, 30o Curve Straight, 20o Curve Straight, 10 o Curve Thrombectomy System Product & Indications System consists of a mechanical clot retrieval device and aspiration catheter Initial indication for removal of thrombus from peripheral vessels Peripheral vascular indication will expand to DVT indication following post-market trial Indication to treat pulmonary embolism follows pre-market clinical trial PE = Pulmonary Embolism | PV = Peripheral Vascular Aspiration Configurations 12F 16F 20F 24F Retriever Devices in 10mm and 14mm Configurations *Product is in development and not approved for sale in the United States. Safety and effectiveness have not been established. Prototype products and components are depicted, actual commercial embodiments and names may vary.

 

Competitive Advantage Removed Simulated Soft Clot Aspiration Catheter • Low-profile, navigable design with atraumatic tip • Sizes and curves shapes will address needs across the spectrum of PE and peripheral vascular anatomy Mechanical Retriever • Laser-cut retrieval basket designed for optimizing clot capture • Radiopaque marker bands to enable excellent fluoroscopic visibility • Basket sizes designed to cover the spectrum of PE and peripheral vascular anatomy CSI • Large experienced peripheral sales force already calling on interventional cardiologists, interventional radiologists and vascular surgeons • System is complimentary to existing portfolio of atherectomy, balloons, wires and catheters Product is in development and not approved for sale in the United States. Safety and effectiveness have not been established. Prototype products and components are depicted, actual commercial embodiments and names may vary. Under the terms of the agreements signed with Innova, CSI has provided financing to Innova for the development of the thrombectomy devices. Under an acquisition option agreement, upon Innova’s completion of key technical, regulatory and clinical milestones in the development program, CSI will have exclusive rights to acquire the thrombectomy devices, subject to the satisfaction of closing conditions set forth in the agreement. Removed Simulated Firm Clot

 

Clinical / Regulatory Strategy Preliminary Study Designs Indication N Design Endpoints DVT ~130 Single Arm, Prospective, Post- Market Study • Acute Thrombus Removal • Adverse Events/PTS Severity @ 30 days PE ~120 Single Arm, Prospective Multicenter Pivotal Study • Percent reduction in RVLV ratio @ 48 hours post-procedure • Adverse Events @ 48 hours Product FY22 FY23 FY24 FY25 FY26 FY27 Peripheral Vascular Expanded DV Indication Pulmonary Embolism Product Development & 510(k) Post-Market Study & 510(k) Pre-Market Trial & 510(k) Regulatory Pathway Peripheral Vascular – Traditional 510(k) Deep Vein Thrombosis –510(k) with post-market study Pulmonary Embolism –510(k) with pre-market study

 

Intravascular Lithotripsy

 

Intravascular Lithotripsy The technology has since been miniaturized and used in a variety of catheter-based interventions, including treatment of calcified peripheral and coronary arteries High-energy waves including shockwaves have been used in the body for decades for diverse therapeutic uses in the fields of urology, ophthalmology and orthopedics CSI Intravascular Lithotripsy and Atherectomy both have a role to play in the treatment of calcific artery disease CSI Atherectomy CSI IVL • Longer, diffuse disease • Nodular or eccentric calcium • Difficult to cross lesions • Less diffuse disease • Circumferential calcium • Balloon crossable lesions Circumferential calcium Eccentric or nodular calcium Images courtesy of Takashi Ashikaga MD, Japanese Red Cross Musashino Hospital – Tokyo Japan *Product is in development and not approved for sale in the United States. Safety and effectiveness have not been established.

 

US IVL Market Opportunity 20%+ CAGR FY27 FY22 ATK/Iliac BTK FY27 FY22 Coronary Coronary IVLPeripheral IVL FY22-FY27 Market SizeFY22-FY27 Market Size 15%+ CAGR ~$215M $600M-700M+ ~$80M PAD (-80% ATK) $150M-200M Total PAD (~75% ATK) Analyst Estimates. Company Estimates

 

IVL System Balloon Configurations Coronary Peripheral ATK/Iliac Peripheral BTK Lengths 12 mm 20 mm 60 mm 40 mm Diameter 2.5 – 4.0 mm 4.0 – 8.0 mm 2.5 – 5.0 mm Guidewire Config RX OTW OTW Product & Indications System consists of a console-based generator, connector and portfolio of catheters Three balloon portfolio configurations to be commercialized: • Coronary • Peripheral – Above-The-Knee including the iliac • Peripheral – Below-The-Knee *Product is in development and not approved for sale in the United States. Safety and effectiveness have not been established. Prototype products and components are depicted, actual commercial embodiments and names may vary.

 

Competitive Advantage Electrode test in fluid bath Product design targets • Improved crossing profile • Enhanced deliverability • Wider range of balloon sizes • Greater number of pulses per catheter for more efficient treatment • Simplified system set-up • Improved balloon durability CSI • Large and experienced sales force already selling into coronary and peripheral IVL call points • IVL positions CSI as the only company with the full suite of products to treat the entire range of calcified disease *Product is in development and not approved for sale in the United States. Safety and effectiveness have not been established. Prototype products and components are depicted, actual commercial embodiments and names may vary.

 

Product FY22 FY23 FY24 FY25 FY26 FY27 Peripheral (ATK/BTK) Coronary IVL Clinical/Regulatory Strategy Preliminary Study Designs Indication N Design Endpoints Peripheral (ATK & BTK) ~120 Multi-center, Prospective Single-arm • Freedom from MAEs at 30 days • Angiographic success (i.e., residual stenosis <50% per core lab) Coronary ~400 Multi-center, Prospective • Freedom from MACE at 30 days • Angiographic success (i.e., residual stenosis <50% per core lab) US Regulatory Pathway Peripheral ATK/Iliac/BTK – Pre-market prospective study with Traditional 510(k) Coronary – Pre-market prospective study with PMA Product Development & IDE Submissions Product Development & IDE Submissions Pre-Market Trial & 510(k) Pre-Market Trial & PMA

 

Drug Coated Balloons

 

US Drug Coated Balloon Market Opportunity FY27 FY22 Peripheral ATK DCB $0M FY27 FY22 Coronary ISR DCB 60%+ CAGR (FY24-FY27) Coronary DCBPeripheral DCB FY22-FY27 Market SizeFY22-FY27 Market Size ~15% CAGR ~$200M $350M-$400M $150M-$200M Analyst Estimates, Company Estimates

 

Drug Coated Balloons Product & Indications • A portfolio of Everolimus coated balloons intended to treat coronary and peripheral arterial disease • Initial coronary indication will be for the treatment of in-stent restenotic (ISR) lesions • Initial peripheral indication will be for the treatment of lesions in above- the-knee femoropopliteal arteries Competitive Advantage • Expect to be one of the first limus-based DCBs to the US market • Everolimus has been proven as an effective anti-restenotic drug over the last two decades in coronary stent applications • Polymer Free: direct drug delivery to tissue without the use of polymers or nanoparticles, which may increase risk of late-stage thrombosis • Strong fit into existing coronary and peripheral sales channel US Regulatory Pathway • Peripheral DCB: 75 patient EU feasibility study (underway), followed by a pivotal study and PMA • Coronary: 50 patient EU feasibility study (enrollment complete), followed by a pivotal study and PMA Product FY22 FY23 FY24 FY25 FY26 FY27 CAD First-in Human CAD Pivotal & PMA PAD First-in Human PAD Pivotal & PMA FIH Study & Follow-up IDE Submission, Pivotal Study and PMA FIH Study & Follow-up IDE Submission, Pivotal Study and PMA Image provided by Chansu Vascular Technologies Under the terms of the agreements signed with CVT, CSI is providing milestone-based financing to CVT for the development of the drug-coated balloons. Under an acquisition option agreement, upon CVT’s completion of key technical and clinical milestones in the development program, CSI will have exclusive rights and obligations to acquire CVT, subject to the satisfaction of closing conditions set forth in the agreement. Product is under investigation and not approved for sale in the United States. Safety and effectiveness have not been established. Prototype products and components are depicted, actual commercial embodiments and names may vary.

 

Mechanical Circulatory Support

 

US High Risk PCI Support Market Opportunity FY27 FY22 High Risk PCI pVAD 15%+ CAGR High Risk PCI Mechanical Circulatory Support FY22-FY27 Market Size United States Coronary Artery Disease1 16.7 Million Annual PCI procedures (excludes CABG) 2 ~1 Million Addressable Market3 400k+ Est. Procedures FY22 ~14k Net Incident (ACS)1 1.4 Million, annually ~$340M $675M-$750M Major Opportunity for Market Development 1. AHA Heart Disease and Stroke Statistics – 2021 Update 2. Analyst, Company Estimates 3. Company Estimates, Competitive Intelligence Analyst Estimates, Company Estimates

 

Mechanical Circulatory Support (MCS) Product & Indications • System consists of a disposable micro-axial flow pump catheter and controller, a reusable console, a custom delivery guide wire and a custom introducer kit • Initial indication and use in high-risk PCI procedures to support left ventricular function during the intervention Competitive Advantage • Platform to balance optimal cardiac support with a low- profile catheter and easy-to-use, lower cost system • Designed for greater perfusion over the entire cardiac cycle, including during diastolic coronary artery filling phase • MCS to complement CSI’s focus on complex coronary disease and leverage our existing sales channel and call points US Regulatory Pathway • Anticipate a 15-30 patient US EFS clinical study to freeze the system design followed by a pivotal trial to support a PMA approval Product FY22 FY23 FY24 FY25 FY26 FY27 First-in-Human US Early Feasibility Study Pivotal Trial & PMA FIH Study IDE Submission & EFS IDE Submission, Pivotal Trial & PMA *Product is in development and not approved for sale in the United States. Safety and effectiveness have not been established. Prototype products and components are depicted, actual commercial embodiments and names may vary.

 

Focused on Complex Cardiovascular Disease CSI Product Portfolio 2.0 Max Crown - Mixed Plaque Device Vipercath XC, ViperCross & Teleport Catheters WIRION EPD Peripheral IVL Balloons Peripheral Everolimus DCB Thrombectomy: Aspiration Catheters and Clot Retrievers Diamondback & Stealth Diamondback - Exchangeable Series Viperwire and Zilient Guidewires JADE PTA Balloons Digital PAD Patient Management Sapphire 1.0mm and PTCA Balloons CTO Catheter Portfolio Coronary IVL Balloons Coronary Everolimus DCB Mechanical Circulatory Support for High-Risk PCI Diamondback with Glide Assist Viperwire Advance with Flex Tip Teleport Microcatheter Scoreflex NC Scoring Balloons Complex Peripheral Disease Complex Coronary Disease

 

Growth Summary & Financial Projections Jeffrey S. Points Chief Financial Officer

 

Financial Outlook Summary Long-term revenue growth (5 Yr CAGR of 17%) primarily fueled by execution of pipeline products into very large, high-growth markets Attractive gross margins • OAS • ISDs & International • Pipeline Significant investments in product development and clinical research Long-term, sustainable profitability achieved with launch of pipeline products late in the plan period

 

Key Investments Fuel Revenue Growth Investments in growth platforms… 65% 27% 8% FY23 43% 21% 9% 27% FY27 Global Base Business Peripheral Coronary International New Platform Products Revenue Contribution 57% 25% 10% 8% FY25 FY23 FY25 FY27 Revenue $255M - $265M $325M - $350M $500M - $550M CAGR (at midpoint) N/A 3 Yr ~ 13% 5 Yr ~17% Gross Margin 72% - 74% 72% - 74% Improving Net Income (Loss) (9%) - (11%) (3%) – (5%) Profitable Adj. EBITDA 1% - (1%) Positive Positive

 

Investing In Large, High-Growth Markets Targeting large, high growth markets fuels ~17% 5 Yr CAGR $0 $100 $200 $300 $400 $500 $600 FY23 FY25 FY27 High Growth Moderate Growth Lower Growth Drug Coated Balloons Intravascular Lithotripsy Thrombectomy Mechanical Circulatory Support International Atherectomy Balloons Microcatheters Embolic Protection Peripheral Atherectomy Coronary Atherectomy $255M - $265M 8% - 12% Growth $325M - $350M CAGR ~13% $500M - $550M CAGR ~17%

 

Long Range Outlook: Key Assumptions Outlook Assumes: Inflation normalizes in FY23 Platform product revenues in U.S. only Outlook Does Not Assume: COVID and related impacts A global recession Reimbursement changes New M&A activity

 

Gross Margin TailwindsHeadwinds Impact of inflation on component and freight costs Modest ASP declines Increased mix of lower margin ISDs and International revenue Direct OAS cost reduction programs Increasing volumes New platform products include higher margin profile

 

Research & Development Significant investments range from 14% - 17% of revenue TailwindsHeadwinds Investments in clinical trials related to new platform products and geographic markets Higher mechanical circulatory support development costs Outsourcing development costs for new platform products Completion of ECLIPSE patient enrollment expected in FY23

 

SG&A Incremental leverage drives SG&A spend down to approximately 55% of revenue in FY27 TailwindsHeadwinds Increased costs associated with several major product launches New sales channel for Pulmonary Embolism Thrombectomy product Improved sales rep productivity with new product launches Increased revenue per case with ISD launches and adoption

 

Capital Allocation Strong balance sheet with no long-term debt Disciplined organization focused on prioritizing and managing spending New platform product transactions begin H2 FY23 Strong banking relationships Current cash position of $160 million provides resources necessary to fund new platform product development and clinical research

 

Financial Outlook Summary Long-term revenue growth (5 Yr CAGR of 17%) primarily fueled by execution of pipeline products into very large, high-growth markets Attractive gross margins • OAS • ISDs & International • Pipeline Significant investments in product development and clinical research Long-term, sustainable profitability achieved upon launch of pipeline products late in the plan period

 

Capital Markets Day – August 3, 2022 Closing Comments Scott R. Ward Chairman, President & Chief Executive Officer

 

 

Transformation Drives Accelerating Growth $- $100 $200 $300 $400 $500 $600 FY22A FY27E New PlatformsInternationalU.S. Coronary FranchiseU.S. Peripheral Franchise $ in millions $500M - $550M CAGR ~17%

 

 

Meeting the Needs of our Key Stakeholders Cardiovascular Systems, Inc. Guided by our Mission Focused on complex peripheral and coronary artery disease Expanding TAM nearly ten-fold with new product platforms Financially strong with the team and talent to win Serving Over 250,000 Patients with $500-$550 Million by FY27

 

Capital Markets Day – August 3, 2022 Q&A Session CSI Executive Team

 

CSI®, Diamondback®, Diamondback 360®, GlideAssist®, Stealth 360®, Take a Stand Against Amputation®, ViperWire®, ViperWire Advance®, Wirion®, Zilient®, Diamondback 360 Precision™, Propel™, Shepherd™, ViperCath™ ViperCross™ and COR™ are trademarks of Cardiovascular Systems, Inc. © 2022 Cardiovascular Systems, Inc. OrbusNeich®, Sapphire®, Jade®, Teleport® and Scoreflex® are trademarks of OrbusNeich Medical, Inc. Sapphire®, Jade®, Teleport® and Scoreflex® products are manufactured by OrbusNeich. All other trademarks, trade names and service marks appearing in this presentation are the property of their respective owners.