Form 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(D) OF THE

SECURITIES EXCHANGE ACT OF 1934

Date of report (Date of earliest event reported): September 28, 2010

 

 

STEREOTAXIS, INC.

(Exact Name of Registrant as Specified in Its Charter)

 

 

Delaware

(State or Other Jurisdiction of Incorporation)

 

000-50884   94-3120386
(Commission File Number)   (IRS Employer Identification No.)

 

4320 Forest Park Avenue, Suite 100, St. Louis, Missouri   63108
(Address of Principal Executive Offices)   (Zip Code)

(314) 678-6100

(Registrant’s Telephone Number, Including Area Code)

 

(Former Name or Former Address, if Changed Since Last Report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


Item 7.01. Regulation FD Disclosure.

On September 28, 2010, executive management of Stereotaxis, Inc. (the “Company”) will present at the Fifth Annual JMP Securities Healthcare Conference. The investor presentation slides are being furnished as Exhibit 99.1 and can be accessed on the Investor Relations portion of the Company’s website at http://www.stereotaxis.com/Investor-Relations.

The presentation slides are being furnished pursuant to Item 7.01, and the information contained therein shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

The presentation slides that are attached to this Current Report on Form 8-K as Exhibit 99.1 include statements that may constitute “forward-looking” statements, usually containing the words “believe,” “estimate,” “project,” “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, continued acceptance for the Company’s products in the marketplace, the effect of global credit and economic conditions on the ability and willingness of customers to purchase our systems, competitive factors, changes in government reimbursement procedures, dependence upon third-party vendors, timing of regulatory approval and return of the irrigated catheter to the market, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments in any particular period or at all because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company’s control. In addition, these orders and commitments may be revised, modified or canceled, either by their express terms, as a result of negotiations, or by project changes or delays.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

99.1 Investor presentation


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    STEREOTAXIS, INC.

Date: September 28, 2010

    By:  

/s/    DANIEL J. JOHNSTON        

      Name:   Daniel J. Johnston
      Title:   Chief Financial Officer


EXHIBIT INDEX

 

Exhibit

No.

 

Document

99.1   Investor presentation
Investor presentation
NASDAQ: STXS
Exhibit 99.1


Forward-Looking Statements
2
During the course of this presentation, the Company may make projections and other forward-
looking statements regarding future events or the future financial performance of the Company,
including without limitation, statements regarding future operating results, growth opportunities
and other statements that refer to Stereotaxis’ plans, prospects, expectations, strategies,
intentions and beliefs. These statements are subject to many risks and uncertainties that could
cause actual results to differ materially from expectations.
For a detailed discussion of risks and uncertainties that affect the Company’s business and
qualify the forward-looking statements made in this presentation, we refer you to the Company’s
recent public filings filed with the SEC, specifically the Form 10-K for the fiscal year ended
December 31, 2009.
The Company’s projections and forward-looking statements are based on factors that are subject
to change and therefore these statements speak only as of the date they are given. The
Company assumes no obligation to update any projections or forward-looking statements.
In addition, regarding orders and backlog, there can be no assurance that the Company will
recognize revenue related to its purchase orders and other commitments in any particular period,
or at all, because some of these purchase orders and other commitments are subject to
contingencies that are outside of our control. These orders and commitments may be revised,
modified, or canceled either by their express terms, as a result of negotiations, or by project
changes or delays.


Investment Considerations
Two innovative technology platforms:
Niobe
®
Magnetic Navigation System
Odyssey
Enterprise Solutions
Substantial IP portfolio
Large, fast growing (+20%) cardiology ablation market
Poised for continued growth in electrophysiology (EP)
Expansion into new markets
New geographic opportunities
Broad clinical applications beyond EP
Multi-dimensional strategy to accelerate growth
3


Niobe
Magnetic Navigation System
Magnet-guided catheter distal tip provides precise remote control of therapeutic
devices.
4


Niobe Provides Precision and Safety
Precise control of catheter distal tip provides:
Effective lesion creation through
constant contact
Exceptional mapping capability
Exemplary safety
Proven in all chambers of the heart
5


Manual
Niobe
Physician
Efficacy
Safety
Efficiency
In procedure room exposed to fluoroscopy
Physician:
Significant X-ray exposure
Patient:  Major event rate ~2.8%
Higher variability in procedure times
In control room outside fluoroscopy field
Clearly better in several applications
-
VT, pediatrics, congenital heart diseases
Other applications comparable to manual
Physician:
Almost no X-ray exposure
Patient:  Major event rate ~0.1%
Standardized process drives tighter
distribution around procedure times
High re-do rates
Niobe’s Advantages
6


Atrial
Fibrillation
30 Publications
Up
to
100%
acute
success
4
Improved
chronic
outcomes
5
Pediatric Arrhythmia
5 publications
93%
acute
success
3
Low fluoro, no complications
Congenital Heart
6 publications
90%
success
rate
6
“As easy as normal adults”
Ventricular Tachycardia
13 publications
Up
to
100%
acute
success
7
85%
freedom
at
1
year
8
Radiation Reduction
Patients –
67%
1
Physicians –
90%
2
1. Haghjoo,  JCE 2009.  2. Latcu, Arch Cardiovasc
Dis
2009.  3. Schwagten, PACE 2009.  4. DiBiase, JCE 2009.
5. Augello, Heart Rhythm 2009. 6. Schwagten, PACE 2009. 7. Haghjoo, JCE 2009.  8. Dibiase, Heart Rhythm 2009.
7
Strong Clinical Validation
More than 150 peer-reviewed publications highlight Niobe’s
value


Major Advantages in Ventricular Tachycardia Ablation
97%
24%
170
25
8
81%
28%
228
57
13
0
50
100
150
200
250
Acute Success (%)
Recurrence (%)
Case Time (min)
Fluoro Time (min)
RF Apps
STXS
Manual
p
= 0.03
p
< 0.01
p
< 0.001
NS
8
NS
VT is an abnormally fast heart rhythm that originates from one of the ventricles and can
lead to potentially life threatening complications.
64 consecutive VT ablation patients
37 Niobe; 27 manual procedures
Idiopathic & Scar-Related
No complications in Niobe
group
1 tamponade/death in manual group
Conclusion:
Niobe
offers
“major
clinical
&
cost
advantages
for
VT
ablation”
Schwagten, et al. Eur
Heart J 2010, 31 (Supp):932.


Global EP Market is Large and Growing
Source: Millennium Research Group (2009); Stereotaxis internal analysis
9
EP Procedures
Routine
AF
VT
Other
Total
Complex
Prevalence
Annual
Procedures
Annual
Growth
>20M
>10M
>3M
>5M
>18M
170K
100K
30K
40K
170K
<10%
25%
15%
15%
20%
Stereotaxis
focused on
complex
ablation, 
high-growth
segments


Niobe
Market Adoption & Procedure Growth
30,000 + procedures
Cumulative Procedures
Growing Worldwide Penetration
141 Systems Installed
60% US -
40% OUS
Canada -
3
United States -
77
Europe -
49
Saudi Arabia -
1
Russia -
1
China -
5
Korea -
1
Japan -
1
Singapore -
1
Taiwan -
1
Australia -
1
10


Odyssey Enterprise
TM
Solutions
11
Odyssey
Vision
Integrates and centralizes all EP lab related information to significantly enhance
physicians’
efficiency


The Odyssey Product Line
12
140 Niobe
Labs
CONNECT
CINEMA
VISION
Efficiently integrate
data and control
during procedures
Standardize all labs
to increase staff
effectiveness
Drive world-class
practices by capturing,
compressing and
recording data for
storage and networking
NIOBE
Accelerate clinical
education by playing
back synchronized lab
data
Drive quality of
patient care by
connecting clinical
experts
Build market exposure
through live web events
showcasing clinical
capabilities
Enhance clinical
capabilities with a
robotic suite
15,000 Interventional
Standard Labs
ODYSSEY


Business Model
Capital Revenue
Recurring Revenue
Niobe
Odyssey
Workstation
Odyssey
Cinema
141 Niobe
systems installed
2,500 EP labs worldwide
20+% growth; ~60% margin
25% growth (YTD 2010 vs. 2009)
80% margin
Capital Driven
Technical service
Software license
Niobe
Utilization
Stereotaxis
disposables
Royalty from J&J BWI
27% growth (2009 vs. 2008); 65+% margin
13


14
Strategies to Accelerate Growth


$0.0
$4.0
$8.0
$12.0
$16.0
Q1
Q2
Q3
Q4
2008
2009
2010
$11.2
$8.8
$7.2
$7.3
$5.0
$10.2
$12.4
$6.3
$11.2
$7.7
New Orders to Backlog
Revenue Momentum
Recurring Revenue
$ millions
$ millions
$0
$2
$4
$6
$8
$10
$12
$14
$16
Q1
Q2
Q3
Q4
2008
2009
2010
$7.0
$11.1
$10.6
$10.7
$12.6
$15.0
$10.6
$13.3
$12.1
$14.1
$ millions
Stereotaxis
Financial Update
15


$0.0
$4.0
$8.0
$12.0
Q1
Q2
Q3
Q4
2008
2009
2010
Total Inventory
-$20.0
-$15.0
-$10.0
-$5.0
$0.0
$5.0
Q1
Q2
Q3
Q4
2008
2009
2010
Cash Flow (Burn)
$0.0
$5.0
$10.0
$15.0
$20.0
$25.0
Q1
Q2
Q3
Q4
2008
2009
2010
Operating Expenses
55.0%
60.0%
65.0%
70.0%
75.0%
Q1
Q2
Q3
Q4
2008
2009
2010
Gross Margin Percentage
$ millions
$ millions
$ millions
65.5%
68.9%
72.5%
60.8%
63.1%
65.5%
67.8%
67.6%
67.3%
$17.8
$14.8
$14.0
$18.7
$14.6
$16.1
$13.3
$14.6
$15.3
-$12.6
-$11.4
-$6.4
-$7.6
-$5.8
-$5.6
-$3.5
-$4.5
-$2.9
$10.5
$8.1
$4.9
$9.6
$7.5
$8.4
$7.0
$8.1
$4.4
67.2%
$15.8
$4.3
-$7.9
Stereotaxis
Financial Update
16


Liquidity
$3.0
$1.3
$3.6
$0
$2
$4
$6
$8
$10
2010
Operating Cash Flow Ex A/R
BWI Debt
Accounts Receivable
Q2 2010 Cash Burn Analysis
$ Millions
$7.9
$ Millions
17
* Cash burn includes repayment of Biosense Webster advance. 


Investment Considerations
Two innovative technology platforms:
Niobe
®
Magnetic Navigation System
Odyssey
Enterprise Solutions
Substantial IP portfolio
Large, fast growing (+20%) cardiology ablation market
Poised for continued growth in electrophysiology (EP)
Expansion into new markets
New geographic opportunities
Broad clinical applications beyond EP
Multi-dimensional strategy to accelerate growth
18


Q & A
19

Innovation Day