rd cardiovascular systems, inc
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©2020 Cardiovascular Systems, Inc. All Rights Reserved.
Cardiovascular Systems, Inc.23rd Annual Needham Virtual Growth ConferenceJanuary 13, 2021
Safe HarborFORWARD LOOKING STATEMENTSThis 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 INFORMATIONThis 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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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
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1. Yost ML, CLI U.S. Supplement, Beaufort, SC. 2016 as presented at NCVH 20172. 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
Company ProfileDeveloping innovative solutions for treating peripheral & coronary arterial disease
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800+ Employees and a highly experienced leadership team
#1 U.S. market leader in calcified peripheral and coronary atherectomy
5,700+ Real-world patients studied through clinical studies as of FY20
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
CSII: A Growth CompanyBroadening Our Value Streams
Financial Goal: Accelerate Profitable Revenue Growth
Strategy is supported by a strong balance sheetOver $200 million in cash and no long-term debt
Grow and Protectthe Core Business
Innovation DrivesIncremental Growth
Global Expansion AcceleratesGrowth 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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VESSEL WALLMEDIAL
CALCIUMCROWNDRIVE
SHAFTINTIMAL CALCIUM
DIFFERENTIAL SANDING MODIFIES INTIMAL
CALCIUM1
PULSATILE FORCES FACILITATES FRACTURE OF
MEDIAL CALCIUM1,2
Crown’s diamond surface sands intimal calcium2,3,5
Generated particulates are average ~2 microns in size, smaller than red blood cells 2,4
Facilitates fracture to affect medial calcium.2
Fracture
Dual-Action Mechanism of ActionUniquely designed for calcium:
Enables simultaneous modification of both intimal and medial calcium
Grow and Protectthe Core Business
FY19 FY21FY20
Peripheral
Radial OAS
Next Gen Diamondback® with GlideAssist
Coronary
Sapphire NC 4.5-5.0 mm balloons*
Coronary ScoreFlex® NC*+
Sapphire® II PRO 1.0 OTW balloon*+
Sapphire® OTW 1.0 mm balloon*
0.035 ViperCath Fem Length+
ViperWire Advance® with Flex Tip
Exchangeable Series with GlideAssist® PTA balloons (inc. Radial)+
WIRION® Embolic Protection System+
ARRIVAL™ Guiding Sheath+
Next gen OAS with GlideAssist
Zilient® Peripheral Guide Wire
Teleport® Microcatheter*
ViperCathTM XC
Next Gen Stealth with GlideAssist
Next Gen Coronary Diamondback 360®
A Strong Cadence of InnovationProduct Portfolio
80,000
350,000
FY22+
Small Vessel (BTA) +
Large Vessel ATK Mixed Plaque+
WIRION® Radial EPD+
High-Risk PCI hemodynamic pump platform+
CTO portfolio+
Next Gen Coronary Diamondback 360+
PATIENTS TREATED ANNUALLY (U.S.)
+ These products are not approved for sale in the United States. Safety and effectiveness have not been established. Features and performance of future approved product may vary. All future product launch dates are current estimates and subject to change.* Product is manufactured by OrbusNeich Medical.
Next Gen PTCA Balloons+
Fiscal Year: July - June
Grow and Protectthe Core Business
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 360 n=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.2017.01.0112. L.P. Garrison Jr. et al., Cardiovascular Revascularization Medicine 18 (2017) 86–90
Grow and Protectthe Core Business
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Stable ReimbursementCPT® LER Code Review to Reflect Advances in Technologies
Code set update to reflect advances in technologies since 2011 creation of current codes.Changes will take effect in CY 2023 at earliest and could be 2024-25.
AMA Action Plan: January 2019
Specialty Societies: SVS, SIR, ACC and ACRScreen: In October 2018, code 37229 was identified by the High-Volume Growth screen, for services with 2017e Medicare utilization of 10,000 or more that has increased by at least 100% from 2012-2017CPT descriptor: Revascularization, endovascular, open or percutaneous, tibial, peroneal artery, unilateral, initial vessel; with atherectomy, includes angioplasty within the same vessel when performed.The specialties will recommend referring this set of codes to CPT to update the code descriptors and to accommodate new technologies.
AMA reasoning for review:
“We believe the growth in CPT Code 37229 (BTK Atherectomy) is appropriate and in line with the best practices for limb sparing.
However, there have been many advances in lower extremity endovascular treatment since the creation of the family of codes.”
Grow and Protectthe Core Business
See appendix for historical reimbursement by site of service
Excellence in Quality and ManufacturingScalable and Continuous COGS Management
Manufacturing Initiatives
Sourcing andSupply Chain
Volume driven overhead leverage
Scalable and continuous reductions to protect strong gross
margins
Labor productivity
LEAN continuous improvement
Material cost reductions
Vertical Integration
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Grow and Protectthe Core Business
FY19 FY21FY20
Peripheral
Radial OAS
Next Gen Diamondback® with GlideAssist
Coronary
Sapphire NC 4.5-5.0 mm balloons*
Coronary ScoreFlex® NC*+
Sapphire® II PRO 1.0 OTW balloon*+
Sapphire® OTW 1.0 mm balloon*
0.035 ViperCath Fem Length+
ViperWire Advance® with Flex Tip
Exchangeable Series with GlideAssist®
PTA balloons (including Radial)+
WIRION® Embolic Protection System+
ARRIVAL™ Guiding Sheath+
Next gen OAS with GlideAssist
Zilient® Peripheral Guide Wire
Teleport® Microcatheter*
ViperCathTM XC
Next Gen Stealth with GlideAssist
Next Gen Coronary Diamondback 360®
A Strong Cadence of InnovationProduct Portfolio
80,000
350,000
FY22+
Small Vessel (BTA) +
Large Vessel ATK Mixed Plaque+
WIRION® Radial EPD+
High-Risk PCI hemodynamic pump platform+
CTO portfolio+
Next Gen Coronary Diamondback 360+
PATIENTS TREATED ANNUALLY (U.S.)
+ These products are not approved for sale in the United States. Safety and effectiveness have not been established. Features and performance of future approved product may vary. All future product launch dates are current estimates and subject to change.* Product is manufactured by OrbusNeich Medical.
Next Gen PTCA Balloons+
Fiscal Year: July - June
Innovation DrivesIncremental Growth
Next Generation Coronary Diamondback 360® Sapphire® Expansion
ScoreFlex® NC*
Sapphire® Balloons
Teleport® Microcatheter
Launched FY19Launched FY18
Sapphire II PRO 1.0-4.0 mmSapphire NC Plus 2.0-4.0 mm
Launched FY19
Launched FY20
• Sapphire SC II PRO 1.0 mm OTW• Sapphire NC Plus 4.5-5.0 mm
Expected Launch H2 FY21(Spring CY21)
ViperWire Advance® with Flex Tip
Launched FY20
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Prep. Place. Perform.
Severe coronary calcium is present in 6-20% of patients undergoing PCI.1,2
Calcium considered mild or moderate by angiography may actually be severe in advanced imaging (IVUS or OCT).3,4
Complex Coronary Product PortfolioComprehensive portfolio to treat the most complex coronary patients
Product portfolio in collaboration with OrbusNeich®
3. Lee, M. S. & Shah, N. The Impact and Pathophysiologic Consequences of Coronary Artery Calcium Deposition in Percutaneous Coronary Interventions. J Invasive Cardiol 28, 160-167 (2016).4. Mintz, G. S. Intravascular imaging of coronary calcification and its clinical implications. JACC Cardiovasc Imaging 8, 461-471, doi:10.1016/j.jcmg.2015.02.003 (2015).
Innovation DrivesIncremental Growth
Peripheral Product PortfolioRobust portfolio of options to treat multi-level peripheral disease
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Exchangeable Series with GlideAssist®
Femoral length ViperCath™ XC*
WIRION® Embolic Protection System
Zilient® Peripheral Guidewire
Launched FY20 Launch FY21(Spring/Summer CY21)
Launch FY21(Spring CY21)
Launch FY21(Spring CY21)
Launched FY19
JADE® OTW and Sapphire® 1.0 mm
Balloons
Increased flexibility to treat different size vessels above and below the knee in a single procedure.
Over 50% of patients undergoing a PVI have multi-level disease.1
~50% of the time ATK and BTK are treated in separate procedures.1
Product portfolio in collaboration with OrbusNeich®
Teleport® Microcatheter
Launched FY19
*
Innovation DrivesIncremental Growth
Radial Product PortfolioEnabling a complete peripheral intervention from the radial artery
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Extended length Orbital Atherectomy System
ARRIVAL™ Guiding Sheath*
Optimize the patient experience. CSI offers the first and only atherectomy devices enabling radial access to deliver significant patient, clinical, and economic benefits.
Femoral access is not possible with some patients.
Lack of longer-length productslimits the ability to perform peripheral interventions from a radial access site.
ViperCath™ XC
Extended length PTA Balloons*
.
Launched FY19 Launch FY22Launched FY19
FY21Launch FY21(Spring CY21)
Extended length WIRION® Embolic
Protection System*
Expected Launch H2 FY22(1H CY22)
Innovation DrivesIncremental Growth
Percutaneous Ventricular Assist Device (pVAD) System
Providing temporary hemodynamic support for use in high risk PCI procedures
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Provide optimal Profile-to-Output (PTO) to support high risk interventions
• Flow: 3-5 LPM• Crossing Profile: 10-14 Fr Access• Catheter Profile: 6-8 Fr
Deliver hemodynamic support to aide in complete revascularization during high risk PCI procedures
Physician control and flow monitoring within the sterile field
Improving ease of use, simplified user interface, hospital mobility, and increased runtime (12+ hours), Compact console design (<15 lbs)
Marker band
Innovation DrivesIncremental Growth
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
Global Expansion AcceleratesGrowth of Core Business
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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US Peripheral revenue increased 40.0% sequentially
Q1 FY21 Revenues of $60.5 Million42% Sequential Quarterly Increase
US Coronary revenue increased 62.5% sequentially
International declined 18.2% sequentially
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• Units sold increased 39.9% sequentially as procedure volumes rebounded
• Units sold increased 62.6% sequentially as procedure volumes rebounded
• 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
$1.7
Financial Results ($ in millions): Q1 FY21
$20.8 $18.5
$11.9$17.6$19.0
$42.9
$30.6$42.6
$47.6$45.5Worldwide Peripheral Revenue Worldwide Coronary Revenue
Gross Margin80.4% 79.2%76.2%80.0%79.9%
Cash and Marketable Securities
$105.0 $109.4 $107.3
$232.2 $222.9
6% YOY decline
WW in Q1 due to
Covid-19
7% YOY decline
WW in Q4 due to
Covid-19
300 basis point sequential
improvement
Quarterly Scorecard: Q1 FY21
$ in (000) Q1 FY21 YOY SequentialTotal 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 Peripheral Unit Growth - -2.7% 39.9% US Coronary Revenue $15,899 -2.2% 62.5% US Coronary Unit Growth - -5.9% 62.6%International Revenue $1,713 -42.1% -18.2%
Highlights: 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
Investor Contact:Jack [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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