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©2020 Cardiovascular Systems, Inc. All Rights Reserved.
Cardiovascular Systems, Inc.Stifel Virtual Bus Tour
December 16, 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
Company ProfileDeveloping innovative solutions for treating peripheral & coronary arterial disease
4
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 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 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
5
6
VESSEL WALL
MEDIAL CALCIUM
CROWN
DRIVE SHAFT
INTIMAL CALCIUM
DIFFERENTIAL SANDING
MODIFIES INTIMAL
CALCIUM1
PULSATILE FORCES
FACILITATES FRACTURE OF
MEDIAL CALCIUM1,2
1.Shlofmitz E, et al. Interv Cardiol. 2019;14(3):169-173.2.Adams GL, Khanna PK, Staniloae CS, et al. Optimal techniques with the Diamondback 360° System achieve effective results for the treatment of peripheral arterial disease. J Cardiovasc Transl Res. 2011 Apr;4(2):220-9.3.Chambers J, et al. JACC Cardiovasc Interv. 2014;7(5):510-518.4.Shlofmitz E, et al. Expert Rev Med Devices. 2017;14(11):867-879. 5.Krishnan P, Martinsen BJ, Tarricone A, et al. Minimal Medial Injury After Orbital Atherectomy. J Endovasc Ther. 2017 Feb;24(1):167-168.
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 Action
Uniquely designed for calcium:
Enables simultaneous modification of both intimal and medial calcium
Grow and Protect
the 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 Innovation
Product 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 Protect
the 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 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
8
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
Grow and Protect
the 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 ACR
Screen: 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 2012-2017
CPT 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 Protect
the Core Business
See appendix for historical reimbursement by site of service
Excellence in Quality and ManufacturingScalable and Continuous COGS Management
Manufacturing
Initiatives
Sourcing and
Supply 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 Protect
the 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 Innovation
Product 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 Drives
Incremental Growth
Next Generation
Coronary Diamondback 360®Sapphire® Expansion
ScoreFlex® NC*
Sapphire® Balloons
Teleport® Microcatheter
Launched FY19Launched FY18
Sapphire II PRO 1.0-4.0 mm
Sapphire 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®
1. Bourantas, C. V. et al. Prognostic implications of coronary calcification in patients with 1. obstructive coronary artery disease treated by percutaneous coronary intervention: a patient-level pooled analysis of 7 contemporary stent trials. Heart 100, 1158-1164, doi:10.1136/heartjnl-2013-305180 (2014).2. Genereux, P. et al. Ischemic outcomes after coronary intervention of calcified vessels in acute coronary syndromes. Pooled analysis from the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) and ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) TRIALS. J Am Coll Cardiol 63, 1845-1854, doi:10.1016/j.jacc.2014.01.034 (2014).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).
*Not approved for sale in the United States. Future product launch date is a current estimate and subject to change.
Innovation Drives
Incremental Growth
Peripheral Product PortfolioRobust portfolio of options to treat multi-level peripheral disease
13
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
1. CSI Proprietary Research (n=251
*Not approved for sale in the United States. Future product launch date is a current estimate and subject to change.
Innovation Drives
Incremental 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 products
limits the ability to perform
peripheral interventions from
a radial access site.
ViperCath™ XC
Extended length PTA
Balloons*
* Not approved for sale in the United States. Safety and effectiveness have not been established. Features and performance of future approved product may vary.
Launched FY19 Launch FY22Launched FY19
FY21Launch FY21(Spring CY21)
Extended length
WIRION® Embolic
Protection System*
Expected Launch H2 FY22(1H CY22)
Innovation Drives
Incremental Growth
Percutaneous Ventricular Assist Device (pVAD) System
Providing temporary hemodynamic support for use in high risk PCI procedures
15* Product is in development and not approved for sale in the United States. Safety and effectiveness have not been established. Features and performance of future approved product may vary.
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 Drives
Incremental 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
16
Partnerships to Expand Orbital Atherectomy Across the Globe
Global Expansion Accelerates
Growth 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
17
©2020 Cardiovascular Systems, Inc. All Rights Reserved.
Appendix
US Peripheral$42.9
US Coronary$15.9
US Peripheral US Coronary International
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
19
• 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
International
$1.7
Q1 FY20 Q2 FY20 Q3 FY20 Q4 FY20 Q1 FY21
Financial Results ($ in millions): Q1 FY21
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% YOY
decline
WW in Q1
due to
Covid-19
7% YOY
decline
WW in Q4
due to
Covid-19
300 basis
point
sequential
improvement
20
Quarterly Scorecard: Q1 FY21
$ in (000) Q1 FY21 YOY Sequential
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 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%
21
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
23
Stable Reimbursement: Peripheral
24
Stable Reimbursement: Coronary
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
25