cardiovascular systems, inc....nov 18, 2020 · expected launch fy21 adding essentials of the...
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©2020 Cardiovascular Systems, Inc. All Rights Reserved.
Cardiovascular Systems, Inc.Stifel 2020 Virtual Healthcare Conference
November 18, 2020
Safe HarborFORWARD LOOKING STATEMENTS
This presentation contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended, or the “Securities Act”, and
Section 21E of the Securities Exchange Act of 1934, as amended, or the “Exchange Act”, which are subject to the safe harbor created by those sections. These forward-looking
statements include, but are not limited to, statements in this presentation regarding CSI’s strategy and goals; growth; future financial measurements and investments;
shareholder value; product development plans, milestones and introductions; geographic expansion; clinical trials and evidence; professional education efforts; market
estimates and opportunities; and developments, goals and expectations relating to the COVID-19 pandemic and the recovery therefrom. Forward-looking statements are only
predictions and are not guarantees of performance. These statements are based on CSI management’s beliefs and assumptions, which in turn are based on their interpretation
of currently available information.
These statements involve known and unknown risks, uncertainties and other factors that may cause CSI’s results or CSI’s industry’s actual results, levels of activity,
performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. CSI may not actually achieve the plans,
intentions or expectations disclosed in these forward-looking statements and you should not place undue reliance on our forward-looking statements. These forward-looking
statements involve known and unknown risks and uncertainties that could cause CSI’s actual results, performance or achievements to differ materially from those expressed or
implied by the forward-looking statements, including, without limitation, the risks set forth in our filings with the Securities and Exchange Commission.
CSI’s actual future results may be materially different from what CSI expects. You should not place undue reliance on these forward-looking statements. You should assume
that the information contained in this presentation is accurate only as of the date of this presentation. Except as required by law, CSI assumes no obligation to update these
forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new
information becomes available in the future. CSI qualifies all of the information presented in this presentation, and particularly the forward-looking statements, by these
cautionary statements.
FINANCIAL INFORMATION
This presentation includes calculations or figures that have been prepared internally and have not been reviewed or audited by CSI’s independent registered accounting firm.
Use of different methods for preparing, calculating or presenting information may lead to differences, which may be material.
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Our Mission
Saving Limbs, Saving Lives Every Day
2 Million+Patients with Critical
Limb Ischemia (CLI)1
160,000Annual Amputations
in the U.S.2
370,000Deaths Annually From
Coronary Artery
Disease in the U.S.3
525,000High Risk or Complex
High Risk Procedures
Annually in the U.S.4
Focused on Complex Peripheral and Coronary Artery Disease
3
1. Yost ML, CLI U.S. Supplement, Beaufort, SC. 2016 as presented at NCVH 2017
2. Allie DE, Hebert CJ, Ingraldi A, Patlola RR, Walker CM. 24-Carat Gold, 14-Carat Gold, or Platinum Standards in the Treatment of Critical Limb Ischemia: Bypass Surgery or Endovascular Intervention? J Endovsc Ther. 2009;16(Suppl I):I134–I146.
3. American Heart Association - Heart Disease and Stroke Statistics- 2018 Update
4. CSI estimates
CSI Today Building on our orbital atherectomy foundation
4
Coronary Peripheral
z
Company ProfileDeveloping innovative solutions for treating peripheral & coronary arterial disease
5
800+Employees and a highly
experienced leadership team
#1U.S. market leader in calcified
peripheral and coronary atherectomy
5,700+Real-world patients studied through
clinical studies as of FY19
80,000+ Patients treated annually
200+ Patents
1,700+U.S. customers; hospital and
office-based labs
200 U.S. direct sales representatives
125 U.S. clinical specialists
Driving Future GrowthBroaden Our Value Streams
Financial Goal: Accelerate Profitable Revenue Growth
Financial strength and the talent to execute
Grow and Protect
the Core Business
Innovation Drives
Incremental Growth
Global Expansion Accelerates
Growth of Core Business
Sustain Market Leadership
Attractive and Consistent Growth
in Core Business
Expand Product Portfolio and
Addressable Markets
Drive higher revenue per orbital
atherectomy procedure
Steady Cadence of Commercial
Launches
Capturing Market Share and
Driving Market Development
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Expansion of the Complex Coronary Product OfferingDrives Incremental Revenue Opportunity Per Case
Coronary Diamondback 360®
with GlideAssist®Sapphire® Expansion
ScoreFlex NC
Sapphire® Balloons
Teleport® Microcatheter
Launched FY19Launched FY19
Sapphire SC II PRO 1.0-4.0mm
Sapphire NC Plus 2.0-4.0mm
Launched FY19
FY20 Launches
• Sapphire SC II PRO 1.0mm OTW
• Sapphire NC Plus 4.5-5.0mm
Expected Launch FY21
Adding Essentials of
the Complex PCI Toolkit
Increasing the Clinical Utility
of the Sapphire Portfolio in
the Near-Term
Continuing to Innovate around
the Complex Patient Long-TermViperWire Advance® with Flex Tip
Launched Q1 FY20
Represents $800-$1,000 of
incremental revenue
opportunity
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Expansion of the Peripheral ToolkitIncreasing Revenue Opportunity Per Case Launching in FY21
Radial PAD Products: $800-$1,000/OAS Procedure
Extended Length:
Exchange Catheters
PTA Balloons
Radial Access Sheaths
Guidewires
Exchange Catheters
PTA Balloons
Access Sheaths
Guidewires
WIRION Embolic Protection
System
PAD Products: $1,600-$1,800/OAS Procedure
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Supporting Complete Leg RevascularizationExchangeable Series with GlideAssist® – Reduces Rehospitalization
Patient and economic benefits with more efficient procedures aligned to market
dynamics
Future Portfolio: New 1.0mm crown for small vessel / below-the-ankle lesions
and a larger crown intended for larger vessels like the common femoral and
iliac arteries
GlideAssist to facilitate tracking, repositioning and removal of OAD through
challenging anatomy
Exchangeable cartridges with different catheter lengths and crown options to
optimally treat patients with multi-level disease (seen ~50% of the time)
within the same procedure
Ease-of-Use Enhancements to Handle: Backloadable system facilitating easier
wire exchanges and improved tactile feel
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Percutaneous Ventricular Assist Device (pVAD) SystemMulti-Generational Platform Highly Synergistic with Our Strategy and Competency
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• Millennium Research Group (2017 December) Medtech360 Market Analysis – Cardiac Assist Devices– US – 2018
Entering a High Growth pVAD Market*Generation 1 Overview
IDE clinical studies planned to highlight
procedural safety and perfusion
metrics/endpoints
* Includes Complex PCI and Cardiogenic Shock
$0
$300
$600
$900
$1,200
$1,500
$1,800
FY19 FY23 FY27
$ M
illio
ns
16% CAGR
Recent Accomplishments / Status
Multiple animal studies completed successfully
Pre-submission meetings completed and underway with the FDA
First-in-human in FY21
• Leverages CSI core
competency in motor control
and spinning cables
• Easy setup and use
• Flow: 3-5 LPM
• Crossing Profile: 10-14 Fr
• Catheter Profile: 6-8 Fr
• Improved deliverability
• Physician control in the
sterile field
• Simplified touch
screen display
• Compact console design
(<15 lbs.)
Excellence in Quality and ManufacturingScalable and Continuous COGS Reductions
Manufacturing
Initiatives
Sourcing and
Supply Chain
Volume driven overhead leverage
Scalable and
continuous reductions
to protect margins
from ASP declines
Labor productivity
LEAN continuous improvement
Material cost reductions
Vertical Integration
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Trial Size Importance
PAD
LIBERTY 360° (3-year Data) n=1,204• “All-comers” trial, any treatment option
• Nearly 700 Rutherford Class 4-6 patients enrolled
OPTIMIZE (Enrollment Complete) n=66• OAS + DCB vs. DCB alone
• Calcified below-the-knee lesions
OASIS, CONFIRM series, TRUTH,
CALCIUM 360, and COMPLIANCE 360n=3,359
• High rates of procedural success and durability
• Low adverse events/bail-out stenting
CAD
ECLIPSE (Enrollment Began March 2017) n=2,000
• Largest randomized trial to study coronary atherectomy for calcified
coronary lesions
• OAS + DES vs. angioplasty (including cutting/scoring balloons) + DES
• Currently paused due to Covid 19
ORBIT II (3-year Data) n=443 • High freedom from revascularization resulting in economic benefits1,2
COAST (1-year Data) n=100• Supported approvals of Coronary OAS in U.S. and Japan
• Japan commercialization began in FY18
Leadership in Medical Evidence
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600+Physicians
5,700+Patients
~8,000Lesions
1. Lee M, et al, Orbital atherectomy for treating de novo, severely calcified coronary lesions: 3-year results of the pivotal ORBIT II trial, Cardiovasc Revasc Med (2017), http://dx.doi.org/10.1016/j.carrev.2017.01.011
2. L.P. Garrison Jr. et al., Cardiovascular Revascularization Medicine 18 (2017) 86–90
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
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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©2020 Cardiovascular Systems, Inc. All Rights Reserved.
Appendix
US Peripheral$42.9
US Coronary$15.9
US Peripheral US Coronary International
US Peripheral revenue declined 5%
Q1 Revenues of $60.5 Million42% Sequential Quarterly Increase (6% Decrease vs. LY)
US Coronary revenue declined 2%
International declined 42%
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• Units sold decreased 3% as COVID-19 negatively
impacted procedure volumes
• Units sold decreased 6% as COVID-19 negatively
impacted procedure volumes
• Support product revenue increased to $543 per coronary
OAS sold
• Ability to enroll new accounts and drive adoption outside
the U.S. is hindered by international travel restrictions
• OAS launched in 13 countries OUS to-date
($ in millions)
Q1 FY21 Revenue Breakdown
International
$1.7
Q1 FY20 Q2 FY20 Q3 FY20 Q4 FY20 Q1 FY21
Q1 FY21 Financial Results ($ in millions)
Q1 FY20 Q2 FY20 Q3 FY20 Q4 FY20 Q1 FY21
$20.8$18.5
$11.9
$17.6$19.0
$42.9
$30.6
$42.6$47.6$45.5
Worldwide Peripheral Revenue Worldwide Coronary Revenue
Gross Margin
Q1 FY20 Q2 FY20 Q3 FY20 Q4 FY20 Q1 FY21
80.4% 79.2%76.2%80.0%79.9%
Q1 FY20 Q2 FY20 Q3 FY20 Q4 FY20 Q1 FY21
Cash and Marketable Securities
$105.0 $109.4 $107.3
$232.2 $222.9
6% decline
WW in Q1
due to
Covid-19
7% decline
WW in Q4
due to
Covid-19
Q1 FY21 vs. Q1 FY20 and Q4 FY20
$ in (000) Q1 FY21 vs. Q1 FY20 vs. Q4 FY20
Total Revenue $60,544 -6.1% 42.3%
Worldwide Peripheral Revenue $42,932 -5.7% 40.0%
Worldwide Coronary Revenue $17,612 -7.1% 48.4%
US Revenue $58,831 -4.4% 45.4%
US Peripheral Revenue $42,932 -5.2% 40.0%
US Coronary Revenue $15,899 -2.2% 62.5%
International Revenue $1,713 -42.1% -18.2%
US Peripheral Units - -2.7% 39.9%
US Coronary Units - -5.9% 62.6%
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 Nielsen
651-202-4919
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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