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Cardiovascular Systems, Inc.Redefining Interventional Vascular Solutions
Annual Meeting of Stockholders
November 16, 2016
Safe Harbor
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FORWARD-LOOKING STATEMENTSCertain 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 and estimates, the benefits and uses of the Company’s products, market opportunity potential, clinical trials, international expansion, regulatory approvals, future profitability, debt capacity, 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 CSI’s 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.
Fiscal Year 2016 Achievements
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• Refined sales strategy and stabilized sales force• Resumed sequential quarterly sales growth• Successfully transitioned the senior leadership team• Settled the DOJ investigation• Lowered operating expenses• Significantly reduced quarterly net loss• Positioned CSI for revenue growth, positive cash flow and
profitability
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$0
$50
$100
$150
$200
FY12 FY13 FY14 FY15 FY16 Q1 FY17
Revenue Growth From CSI Products *FY16 Slowed by Sales Force Transition
Return to Growth in FY17
$ in
Mill
ion
s
* CSI Products exclude revenue from distribution agreement terminated on June 30, 2015
14% Growth
21% CAGR
Strong, Improving Gross Margins
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70%
75%
80%
85%
FY12 FY13 FY14 FY15 FY16 Q1 FY17
78.2%
80.1%
76.5%77.3%
76.7%
81.0%
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$20
$30
$40
$50
$60
Q1 FY16 Q2 FY16 Q3 FY16 Q4 FY16 Q1 FY 17
Declining Operating ExpensesCost Realignment, Reduction in Workforce
$ in
Mill
ion
s
Q3 FY16 operating expenses include $12.4 million of one-time costs for DOJ settlement/severance
-13% From Prior Year
One-Time Costs
Achieved Positive Adjusted EBITDA
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$41.4$44.5
$48.5 $49.8
Q2 '16 Q3 '16 Q4 '16 Q1 '17
-$11.1
-$6.4
-$1.4
$2.6
Q2 '16 Q3 '16 * Q4 '16 Q1 '17
Revenue Adjusted EBITDA
* Excludes $12.2 million of DOJ settlement and severance costs (net of stock-based compensation)
$ in millions
Reconciliations of Adjusted EBITDA to the most comparable U.S. GAAP measure for the respective periods can be found in the appendix
Solid Cash Position/No Debt
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$84
$65$61 $58
$68
$0
$20
$40
$60
$80
$100
Q4 FY15 Q2 FY16 Q4 FY16 Q1 FY17 Q1 FY17Pro-forma*
Cash Adequate to Reach Positive Cash Flow and Profitability
$ M
illio
ns
• Decreasing cash burn from cost reductions/increasing revenues• Positive cash flow in Q1 FY17 excluding $3M DOJ payment• $10M upfront payment received for Japan Distribution Rights (Nov. 2016)• Additional cushion potential from facility financing/debt capacity
*Includes $10M upfront payment for Japan distribution rights
Sales Force Stabilization
9
240 Professionals
Rev
en
ue
Pe
r Sa
les
Pro
fess
ion
al
• One sales force selling two, high-margin, high-growth products• Deeper adoption into fewer high potential accounts• Higher productivity per sales professional• Drives future profitability
Leadership in Clinical Evidence
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LIBERTY 360°(Enrollment Complete)
ORBIT II(3-year Data)
COAST(Enrollment Complete)
OASIS, CONFIRM series, CALCIUM 360 and COMPLIANCE 360
• Supports 2nd Gen OAS in U.S. and Japan approval• Shonin application submitted in June 2016
• 92% freedom from revascularization at 3-years• Up to $4,946 per patient cost savings at 2-years
• High rates of procedural success and durability• Low adverse events/bail-out stenting
• “All-comers” trial vs. any other treatment• Nearly 700 Rutherford class 4, 5, or 6
n=1,204
n=100
Trial ImportanceSize
n=3,359
PAD
CA
D
n=443
Patients Lesions Physicians
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OPTIMIZE (Enrolling)
n=50 • OAS + DCB vs. DCB alone• Calcified below-the-knee lesions
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ECLIPSE(Enrollment Begins 2017)
• Largest randomized trial to study coronary atherectomy for calcified coronary lesions
• OAS + DES vs. angioplasty + DESn=2,000
LIBERTY 360° Acute/30-Day Results
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• Diamondback OAS was the most frequently used atherectomy device across all Rutherford Classes
• Physicians reported high satisfaction regarding device selection and patient outcome
• 78% of Rutherford 6 patients were discharged to their homes• Favorable freedom from Major Adverse Events (MAE) and
Target Vessel Revascularization (TVR)
Rutherford Class
Freedom from MAE at 30 Days
Freedom from TVR at 30 Days
2-3 99.0% 99.4%
4-5 95.7% 96.9%
6 90.7% 97.9%
Principal investigators: Philippe Généreux, Ajay Kirtane; Study chairman: Gregg W. StoneSponsor: Cardiovascular Systems Inc.
Orbital Atherectomy Strategy
(1.25 mm Crown followed by non-compliant balloon optimization)
Conventional Angioplasty Strategy
(conventional and/or specialty balloons per operator discretion)
2nd generation DES implantation and optimization
2nd generation DES implantation and optimization
Randomize1:1
Primary endpoints: 1) Post-PCI minimal stent area assessed by OCT (N≈400 in imaging study) 2) 1-year TVF (all patients)
≈2000 pts with severely calcified lesions; ≈60 US sites
ECLIPSE Trial DesignEvaluation of Treatment Strategies for Severe CaLcifIc Coronary Arteries:
Orbital Atherectomy vs. Conventional Angioplasty Prior to Implantation of Drug Eluting StEnts
Consistent, Attractive Reimbursement
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Hospital Procedure 2017 Reimbursement% Change from 2016
Inpatient PAD $10,593-$19,754 4%-3%
Inpatient CAD $10,072-$19,396 1%-1%
Outpatient PAD/CAD $9,727-$14,511 2%-(1%)
Non-Hospital Facility
Procedure * 2017 Reimbursement% Changefrom 2016
Outpatient PAD (ATK) $10,957-$14,853 (2%)-(2%)
Outpatient PAD (BTK) $10,804-$13,371 (2%)-(2%)
* Procedures using atherectomy
MS-DRG 246, 247, 248, 249, 250, 251, 252, 253, 254; CPT Codes 37225, 37227, 37229, 37231, 92933; C-APCs 5191,5192,5193,5194; HCPCS Code C9602
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• CSI is the market leader in peripheral and coronary atherectomy • OAS treats untreatable patients with calcified lesions • CSI supports physicians with an expanding portfolio of
compelling medical evidence• Reimbursement for our atherectomy procedures remains stable • We can maintain strong, steady gross margins• CSI’s sales force, now stabilized, is a significant asset • Improving productivity combined with expense control
demonstrates a strong business model poised for future profitability.
Renewed Confidence
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 guide wire cannot pass across the coronary lesion or the target lesion is within a bypass graft or stent. The OAS is contraindicated when the patient is not an appropriate candidate for bypass surgery, angioplasty, or atherectomy therapy, 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 vessels or bifurcations may result in vessel damage; The OAS was only evaluated in severely calcified lesions, A temporary pacing lead may be necessary when treating lesions in the right coronary and circumflex arteries; On-site surgical back-up should be included as a clinical consideration; Use in patients with an ejection fraction (EF) of less than 25% has not been evaluated. See the instructions for use before performing DIAMONDBACK 360 coronary orbital 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 CSI’s website at www.csi360.com.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Diamondback 360® and Stealth 360®Peripheral Atherectomy Systems
The 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 stenotic material from artificial arteriovenous dialysis fistulae. The Systems arecontraindicated for use in coronary arteries, bypass grafts, stents, or where thrombus 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 CSI’s website at www.csi360.com.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
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Appendix
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Adjusted EBITDA Reconciliation
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Non-GAAP Financial MeasuresTo supplement CSI's presentation prepared in accordance with GAAP, CSI uses a non-GAAP financial measure referred to as "Adjusted EBITDA" in this presentation. Reconciliations of Adjusted EBITDA to the most comparable U.S. GAAP measure for the respective periods can be found here. In addition, an explanation of the manner in which CSI's management uses Adjusted EBITDA to conduct and evaluate its business, the economic substance behind management's decision to use Adjusted EBITDA, the substantive reasons why management believes that Adjusted EBITDA provides useful information to investors, the material limitations associated with the use of Adjusted EBITDA and the manner in which management compensates for those limitations can be found in CSI’s most recent quarterly earnings release, dated, Oct. 26, 2016.
Three Months EndedDec. 31,
2015Mar. 31, 2016 June 30, 2016 Sept. 30, 2016
Net Loss $(15,163) $(22,716) $(4,884) $ (1,856)
Less: Other (Income) Expense, net (3) (33) (111) (33)
Less: Provision for income taxes 23 23 23 24
Loss from Operations (15,143) (22,726) (4,972) (1,867)
Add: Stock-based compensation 3,112 3,173 2,585 3,450
Add: Depreciation and amortization 981 979 1,017 1,017
Adjusted EBITDA (11,050) (18,574) (1,370) 2,600
Add: One-time costs (net of stock-based compensation) * - 12,218 - -
Adjusted EBITDA (net of one-time costs) $(11,050) $(6,356) $(1,370) $2,600
* One-time costs include: Department of Justice settlement, restructuring charges from a workforce reduction, and CEO retirement benefits.
Pro-Forma Cash Reconciliation
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$ in millions
Cash and cash equivalents as of Sept. 30, 2016 $58
Add: Upfront payment received from Medikit for exclusive distribution rights in Japan (November 2016)
10
Q1 FY17 Pro-forma cash position * $68
Investor Contact:Jack NielsenSenior Director Corporate Communications & Investor [email protected]
©2016 Cardiovascular Systems, Inc.All Rights ReservedDiamondback 360 and CSI are registered trademarks of Cardiovascular Systems, Inc.www.csi360.com
NASDAQ: CSII
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