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NASDAQ: CSII
San Francisco Investor Meetings
January 11, 2017
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 forwardlooking 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
Companys products, market opportunity potential,
clinical trials, international expansion, regulatory
approvals, future profitability, debt capacity, use of
proceeds, results of operations, prospects, plans and
Investment Merits
Orbital atherectomy addresses calcified arterial plaque
- a large, unmet medical need
Three attractive markets:
Peripheral - below the knee
Peripheral - above the knee
Coronary
Heart-to-heels solution
Effective in calcium
Excellent safety
Alternate access sites
Long-term durability
Economical
Heart
With systems for coronary or peripheral indications, the CSI product line offers heart-to-heels capability.
Centrifugal Force:
Increasing speed = increased orbit
radius
360 crown contact designed to
create a smooth, concentric lumen
Allows constant blood flow and
particulate flushing during orbit
Treat large vessels through small
sheaths, multiple vessels with one
crown
Crowns shown are not to scale and for illustrative purposes only.
Anterior tibial
90% occluded
After
< 5% residual
Smooth, tubular
lumen
Plaque safely
removed, blood
flow restored
with durable
results
Case courtesy of Dr. Jihad Mustapha, Metro Health (Results may vary)
Calculation of mean particulate size is based particles larger than 1 micron from a
representative study using carbon blocks and cadaver model systems.
700,000
CLI
2.6 Million
Treated
1.9 Million
Claudicant
750,000
Below The Knee
(BTK)
Treatments
1.8 Million
Above The Knee
(ATK)
Treatments
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.
60,000
Medical
120,000
Interventions Management
170,000
Interventions
130,000
Amputations
*CSI estimates
450,000
Medical
Management
120,000
Amputations
300,000
Interventions
30,000
Amputations
1.5M
Medical
Management
150,000
Interventions
100,000
Medical
Management
30,000
Amputations
*CSI estimates
10
11
250,000
CABG
120,000
CHIP Patients
30,000
CABG
880,000
PCI
48,000
CHIP Patients
100,000
PCI
12
7000
600
Patients
Lesions
Physicians
Trial
PAD
LIBERTY 360
(Enrollment Complete)
Size
n=1,204
Importance
All-comers trial vs. any other treatment
Nearly 700 Rutherford class 4, 5, or 6
-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
OPTIMIZE
(Enrolling)
n=50
-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
CAD
ECLIPSE
(Enrollment Begins 2017)
n=3,359
n=2,000
-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
ORBIT II
(3-year Data)
n=443
-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
COAST
(Enrollment Complete)
n=100
13
30-Day Results
Rutherford
Class
Freedom from
TVR at 30 Days
2-3
99.0%
99.4%
4-5
95.7%
96.9%
90.7%
97.9%
Adams, LIBERTY Late Breaking Clinical Trial, AMP Conference, Aug 11, 2016.
14
Randomize
1:1
Primary endpoints: 1) Post-PCI minimal stent area assessed by OCT (N400 in imaging study)
2) 1-year TVF (all patients)
Principal investigators: Philippe Gnreux, Ajay Kirtane; Study chairman: Gregg W. Stone
Sponsor: Cardiovascular Systems Inc.
15
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
% Change
from 2016
Outpatient
PAD (ATK)
$10,957-$14,853
(2%)-(2%)
Outpatient
PAD (BTK)
$10,804-$13,371
(2%)-(2%)
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
16
$ Millions
$150
$100
+14%
$50
$0
FY12
FY13
FY14
FY15
Amounts exclude revenue from distribution agreement terminated on June 30, 2015
FY16
Q1 FY17
17
80.1%
80%
76.7%
76.5%
FY12
FY13
77.3%
81.0%
78.2%
75%
70%
FY14
FY15
FY16
Q1 FY17
18
$100
$84
$ Millions
$80
$65
$60
$68
$61
$58
Q4 FY16
Q1 FY17
$40
$20
$0
Q4 FY15
Q2 FY16
Q1 FY17
Pro-forma*
19
Adjusted EBITDA
$2.6
$48.5
$49.8
$44.5
-$1.4
$41.4
-$6.4
-$11.1
Q2 '16
Q3 '16
Q4 '16
Q1 '17
Q2 '16
Q3 '16 *
Q4 '16
Q1 '17
Reconciliations of Adjusted EBITDA to the most comparable U.S. GAAP measure for the respective periods can be found in the appendix
20
Why CSI?
Orbital atherectomy addresses calcified arterial plaque
- a large, unmet medical need
Three attractive markets:
Peripheral - below the knee
Peripheral - above the knee
Coronary
21
Appendix
22
$(15,163)
$(22,716)
$(4,884)
$ (1,856)
(3)
(33)
(111)
(33)
23
23
23
24
(15,143)
(22,726)
(4,972)
(1,867)
3,112
3,173
2,585
3,450
981
979
1,017
1,017
(11,050)
(18,574)
(1,370)
2,600
12,218
$(11,050)
$(6,356)
$(1,370)
$2,600
Net Loss
* One-time costs include: Department of Justice settlement, restructuring charges from a workforce reduction, and CEO retirement benefits.
Non-GAAP Financial Measures
To supplement CSI's consolidated condensed financial statements 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 in the appendix. 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 CSIs most
recent quarterly earnings release, dated, Oct. 26, 2016.
23
$ in millions
Cash and cash equivalents as of Sept. 30, 2016
$58
10
$68
24
Net revenues
Cost of goods sold
49,800 $
9,466
43,871
8,771
40,334
35,100
36,866
41,395
5,335
6,941
42,201
48,336
(1,867)
(33)
(13,236)
2
(1,834)
24
(13,238)
23
(1,858) $
(13,261)
(0.06) $
(0.41)
Gross profit
Expenses:
Selling, general and administrative
Research and development
Total expenses
Net loss
Net loss per common share:
Basic and diluted
Weighted average common shares used in computation:
Basic and diluted
32,985,081
32,210,874
25
June 30,
2016
ASSETS
Current assets
Cash and cash equivalents
58,194
60,638
24,308
23,128
Inventories
16,887
17,440
Marketable securities
Prepaid expenses and other current assets
Total current assets
Property and equipment, net
Patents, net
Other assets
705
684
1,998
2,992
102,092
31,820
104,882
32,471
4,352
5,013
70
Total assets
40
138,334
8,763
142,406
Accrued expenses
Total current liabilities
Long-term liabilities
Other liabilities
Total liabilities
Commitments and contingencies
Common stock, $0.001 par value; authorized 100,000,000 common shares at September
30, 2016 and June 30, 2016; issued and outstanding 33,046,180 at September 30, 2016
and 32,792,497 at June 30, 2016, respectively
Additional paid in capital
Accumulated other comprehensive income
30,451
35,499
4,939
6,010
35,390
41,509
33
33
432,119
428,235
40
(329,269)
26,993
61
Accumulated deficit
(327,411)
102,944
$
8,506
21,688
138,334
100,897
$
142,406
26
(1,858) $
(13,261)
957
807
86
150
175
3,450
4,107
Stock-based compensation
887
(1,330)
Inventories
Prepaid expenses and other assets
(1,480)
1,314
Accounts payable
1,043
257
(166)
(2,076)
(4,836)
(282)
(1,847)
(18)
(6,376)
(350)
(17)
(170)
(160)
(452)
(2,374)
84
19
84
3,791
553
19
(2,444)
(7,191)
60,638
$
58,194
83,842
$
76,651
27
Caution: Federal law (USA) restricts this device to sale by or on the order of a
physician.
28
Investor Contact:
Jack Nielsen
651-202-4919
j.nielsen@csi360.com
NASDAQ: CSII