Upload
medtechy
View
119
Download
4
Tags:
Embed Size (px)
DESCRIPTION
CSI IR Presentation
Citation preview
Cardiovascular Systems, Inc.Redefining InterventionalVascular Solutions
William Blair Healthcare ConferenceJune 11, 2015
SAFE HARBOR
FORWARD-LOOKING STATEMENTS
Certain statements made in this presentation are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are provided under the protection of the safe harbor for forward-looking statements provided by that Act. In some cases, you can identify forward-looking statements by terms such as may, will, should, could, would, expect, plans, anticipates, believes, estimates, projects, predicts, potential and similar expressions intended to identify forward-looking statements. Examples of these statements include, but are not limited to, statements regarding Cardiovascular System, Inc.s (CSI or the Company) future financial performance, product sales distribution, industry and market expectations, the benefits and uses of the Companys products, use of proceeds, results of operations, prospects, plans and objectives of management, and other statements that are other than statements of historical fact.
These statements involve risks and uncertainties which could cause results to differ materially from those projected, including those described under the heading Risk Factors contained in the prospectus filed with the Securities and Exchange Commission (the SEC) for our recent public offering, and as detailed from time to time in CSIs SEC reports, including its Reports on Form 10-K and Form 10-Q. As a result of these matters, changes in facts, assumptions not being realized or other circumstances, CSI's actual results may differ materially from the expected results discussed in the forward-looking statements presented. The forward-looking statements are made only as of the date of this presentation, and CSI undertakes no obligation to update them to reflect subsequent events or circumstances.
2
Large, underserved markets
Highly differentiated products
Strong clinical data
Attractive financial profile
CSI TODAY
37%CSIs revenue growth
YTD fiscal 2015
$14BCombined PAD
and CAD U.S. market opportunity
200,000Orbital Atherectomy
Systems that have been sold
5,000+Patients enrolled
in CSI clinical studies
2High-margin,
high-growth orbital atherectomy
franchises
3
Nearly
Simple Speed Settings
Instant Response On/Off Switch
Saline Pump Mounts on I.V. pole Bathes shaft and crown for smooth operation
Crowns Offset weight = orbital action Small profile for small vessels and
alternative access sites
CSI ORBITAL ATHERECTOMY SYSTEMS (OAS)Power and simplicity for streamlined setup and treatment
Sleek Electric-Powered Handle Simple set-up Optimum torque transfer to the shaft and crown Short treatment times
Crowns shown are not to scale and for illustrative purposes only.
Coronary Approved October 2013
Peripheral
4
Heart to heels capabilityWe treat 11 vessels.Large and small.
1 1Above the Knee
3HeartCSI: WHY WERE UNIQUE
Effective in calcium
Excellent safety
Long-term durability
Economical
Below the Knee 33
Alternative access sites
5
CSI: WHY WERE UNIQUE
Alternative access sites
Femoral
PedalTibial
Radial
Brachial
6
93% < red blood cell size
99% < lumen size of capillaries
UNIQUE MECHANISM OF ACTIONBi-directional and differential sanding
Calculation of mean particulate size is based particles larger than 1 micron from a representative study using carbon blocks and cadaver model systems.
7
OAS DELIVERS OPTIMAL VESSEL PREP AS THE PRIMARY TREATMENT FOR CALCIFIED LESIONS
OAS
Scoring Balloon
Rotablator
High Pressure Balloon
Smooth Concentric Lumen Incomplete Vessel Prep
Poly-traumatic vessel Injury Flow Limiting Dissection
8
LARGE AND GROWING MARKETS
CAD 1.4 million U.S. interventional procedures 38% with significant calcium $1.5+ billion market opportunity
PAD Affects 18 million people in U.S. 4.0 million with critical limb ischemia Only 300,000 CLI patients receive interventions
annually (160,000 get debilitating amputations) $12+ billion market opportunity
Innovation for unmet needs driving market expansion
$14BCombined
PAD and CAD U.S.market opportunity
9
Annual U.S. CAD procedures % with significant calcium
CSI market potential(>$1.5 Billion)
Sources: Millennium Research Group Inc 2014., National Hospital Discharge Survey 2009, CSI estimates.
LARGE CORONARY MARKET POTENTIAL
38%28%
400,0001.4
MILLION
16 MILLION U.S. CAD PATIENTS DIAGNOSED
10
PAD IS A LARGE AND UNDERSERVED MARKETCritical limb ischemia (CLI) is vastly undertreated
18 million people in U.S. with PAD4 million people with CLI
2.5 milliondiagnosed
600K proceduralinterventions
Sources: Sage Group, Millennium Research Group US Markets for Peripheral Intervention Devices 2014, iData US Market for Peripheral Vascular Devices and Accessories 2014, and Go, et al Heart Disease and Stroke Statistics -- 2014 Update, Circulation.
600K Interventions(300K for CLI)
$12B+ CLI market opportunity in U.S. and growing
Amputationsand Bypass
(CLI)
High Pressure Balloons and
Stents
PlaqueRemoval
CLI(6 Million by
2030)
Growth StrategyMarket expansion (underserved CLI patients)Reduce amputation/bypassReduce high pressure ballooning/stenting
65% calcified
11
Only device to broadly treat the disease
Source: CSI data on file, Millennium Research Group
Industry Procedure Mix
BTK - 80% calcified20% require ankle/foot access
CSI mix/disease prevalence
ATK - 40% calcified
OAS TECHNOLOGY EXPANDS PAD MARKET
ABOVE THE KNEE
BELOWTHE KNEE
BELOWTHE KNEE
ABOVETHE KNEE
12
HOSPITAL
INPATIENT
OUTPATIENT
PAD $10,150 $19,148CAD $11,032 $18,985
PAD (ATK) $ 9,624PAD (BTK)/CAD $14,841
NON-HOSPITAL FACILITY
ATTRACTIVE REIMBURSEMENT RATES (2015)
PAD $11,083 $15,175
Small vessels receive higher reimbursement
1. DRG Codes 246, 247, 248, 249, 250, 251, 252, 253, 2542. CPT Codes 37225, 37227, 37229, 37231, 929333. APC Codes 0229, 0319, 083 4. HCPCS Code C9602
13
CSI has studied more than 5,000real-world patients, treated 7,000lesions and worked with 600+ physicians
OASIS, CONFIRM series, Calcium 360 and Compliance 360, demonstrated: Low rates of adverse events
and bail-out stenting High rates of success Durable results
LIBERTY 360 (enrolling) Evaluating acute and long-term
clinical and economic outcomes of CSIs OAS vs. any other treatment
Up to 1,200 patients (noexclusions) at up to 100 U.S. sites
Study will include claudication, CLI, patients scheduled for amputation
BACKED BY CLINICAL SCIENCE
Key PAD Trials
14
BACKED BY CLINICAL SCIENCE
Key CAD Trials
ORBIT II Beat primary endpoints by significant
margins in severely calcified lesions
Two-year data showed 94% freedom from target lesion revascularization
Two-year extrapolated economic analysis cost savings of up to $4,946per patient from shorter hospital stays and lower readmission rates
COAST (enrolling) International investigational
study to assess safety, efficacy and economic outcomes of new micro crown OAS
Up to 100 patients at up to20 sites in the U.S. and Japan
Japan enrollment completed
Designed to secure commercialapproval for second-gen OASdevice in Japan
15
SALES OPTIMIZATION STRATEGY
December 2013 Today December 2015
Hybrid100
Hybrid 200+CAD 5
PAD 100
Expand sales footprint One rep selling two, high-margin, high-growth franchises Cover largest procedure accounts Deeper penetration into existing accounts Hybrid productivity well above PAD- or CAD-only reps
CAD 10
PAD 130
16
$82.5
$103.9
$131.2
$95.0
$113.9
$136.6$133.1
$0
$40
$80
$120
$160
FY 12 FY 13 FY 14 FY 14 (9 mo.) FY 15 (9 mo.)
PAD CAD
31
%
37
%
26
% $97.0
ACCELERATING REVENUE GROWTHQuality Revenue
$ M
illio
ns
Sales life-to-date
Nearly 200,000 Devices, 1,700 Accounts
96% Reorder Revenue
U.S. only, CAD launch in Q2 2014
$19.2 CAD
17
Quarterly Revenue growth over prior year11 Quarters 25% or greater growth
0%
10%
20%
30%
40%
Q113
Q213
Q313
Q413
Q114
Q214
Q314
Q414
Q115
Q215
Q315
25% 28% 25% 26%28% 28%
31%
37%39% 38%
35%
% Y
ear
ove
r Ye
ar G
row
th
Growth accelerated with CAD
18
STRONG, IMPROVING GROSS MARGINS
70%
75%
80%
FY 13 FY 14 FY 15 (9 mo.)
76.5%
77.3%
78.5%
19
INVESTING FOR ACCELERATED REVENUE GROWTHFuture profitability potential
Adjusted EBITDA = EBITDA, excluding stock-based compensation expense. For a reconciliation of this non-GAAP financial measure, please refer to the reconciliation tables in our most recent Form 10-K and Form 10-Q.
-20%
-15%
-10%
-5%
0%
5%
10%
15%
20%
25%
FY 13 FY 14 FY 15 (9 mo.) Future Target
(9%)
2%
(16%)
Adjusted EBITDA Margin Adjusted EBITDA Margin (excluding net coronary investment)
6%
(13%)
5%
% o
f R
eve
nu
e20%-25%
Upfront CAD investment = long-term growth/operating leverage
20
SOLID BALANCE SHEETAmple cash to implement current strategy
$0
$20
$40
$60
$80
$100
Jun. 2013 Mar. 2015
$12
$93.5
$68
$0.0
Debt Principal Cash
$ M
illio
ns
21
Large, underserved markets
Highly differentiated products
Strong clinical data
Attractive financial profile
WHY CSI?
22
DIAMONDBACK 360 Coronary Orbital Atherectomy System
Indications: The DIAMONDBACK 360 Coronary Orbital Atherectomy System(OAS) is a percutaneous orbital atherectomy system indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.
Contraindications: The OAS is contraindicated when the VIPERWIRE guidewire cannot pass across the coronary lesion or the target lesion is within abypass graft or stent. The OAS is contraindicated when the patient is not anappropriate candidate for bypass surgery, angioplasty, or atherectomytherapy, or has angiographic evidence of thrombus, or has only one open vessel, or has angiographic evidence of significant dissection at the treatment site and for women who are pregnant or children.
Warnings/Precautions:; Performing treatment in excessively tortuous vesselsor bifurcations may result in vessel damage; The OAS was only evaluated inseverely calcified lesions, A temporary pacing lead may be necessary whentreating lesions in the right coronary and circumflex arteries; On-site surgicalback-up should be included as a clinical consideration; Use in patients with anejection fraction (EF) of less than 25% has not been evaluated.See the instructions for use before performing DIAMONDBACK 360 coronaryorbital atherectomy procedures for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential adverse events. For further information call CSI at 1-877-274-0901 and/or consult CSIs website at www.csi360.com .
Caution: Federal law (USA) restricts this device to sale by or on the order of aphysician.
The Diamondback 360 and Stealth 360 Peripheral Atherectomy SystemsThe Diamondback 360 and Stealth 360 PAD Systems are percutaneous orbital atherectomy systems indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and stenoticmaterial from artificial arteriovenous dialysis fistulae. The Systems arecontraindicated for use in coronary arteries, bypass grafts, stents, or wherethrombus or dissections are present. Although the incidence of adverse events is rare, potential events that can occur with atherectomy include: pain, hypotension, CVA/TIA, death, dissection, perforation, distal embolization, thrombus formation, hematuria, abrupt or acute vessel closure, or arterial spasm. For further information call CSI at 1-877-274-0901 and/or consult CSIs website at www.csi360.com .
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
23
Investor Contact:Jack NielsenSenior Director Corporate Communications & Investor [email protected]
2015 Cardiovascular Systems, Inc.All Rights ReservedDiamondback 360 and CSI are registered trademarks of Cardiovascular Systems, Inc.www.csi360.com
NASDAQ: CSII
24