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 14, 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 14, 2010, Stereotaxis, Inc. (the “Company”) issued a press release (the “Press Release”) announcing that executive management will present at the CL King 8th Annual Best Ideas Conference to be held September 15-16, 2010 at the Omni Berkshire Place Hotel in New York City and the Stifel Nicolaus Healthcare Conference to be held September 15-17, 2010 at the Four Seasons Hotel in Boston. The Press Release is attached hereto as Exhibit 99.1.

The audio web cast of the presentation, and the investor presentation are available online on the Investor Relations portion of the Company’s website at at http://www.stereotaxis.com/Investor-Relations. The slides are attached hereto as Exhibit 99.2.

The Press Release and 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 99.2 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 Press release dated September 14, 2010.

 

99.2 Stereotaxis, Inc. presentation slides for conferences to be held on September 15-17


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 14, 2010     By:  

/s/ Daniel J. Johnston

    Name:   Daniel J. Johnston
    Title:   Chief Financial Officer


EXHIBIT INDEX

 

Exhibit No.

  

Document

99.1    Press release dated September 14, 2010.
99.2    Stereotaxis, Inc. Presentation Slides for conferences to be held on September 15-17
Press release

Exhibit 99.1

 

LOGO   

Company Contact:

Dan Johnston

Chief Financial Officer

314-678-6007

 

Investor Contact:

EVC Group, Inc.

Douglas Sherk & Greg Gin

415-896-6820

 

Media Contact:

EVC Group, Inc.

Steve DiMattia

646-201-5445

Stereotaxis to Present at the CL King Best Ideas Conference and the Stifel Nicolaus

Healthcare Conference

St. Louis, MO, September 14, 2010 —Stereotaxis, Inc. (NASDAQ: STXS) today announced that executive management will present at the following investor conferences:

 

   

The CL King 8th Annual Best Ideas Conference to be held September 15-16, 2010 at the Omni Berkshire Place Hotel in New York City. Mr. Dan Johnston, Chief Financial Officer, is scheduled to review the Company’s business strategy and recent corporate developments at 2:45 PM ET on Wednesday, September 15, 2010.

 

   

The Stifel Nicolaus Healthcare Conference to be held September 15-17, 2010 at the Four Seasons Hotel in Boston. Mr. Johnston is scheduled to review the Company’s business strategy and recent corporate developments at 10:20 AM ET on Thursday, September 16, 2010.

To listen to the audio web cast of the presentation during or after the event, or to view the investor presentation online, please visit: http://www.stereotaxis.com/Investor-Relations. The replay for the CL King presentation will be available for ninety days after the event. The replay for the Stifel Nicolaus presentation will be available for thirty days after the event.

About Stereotaxis

Stereotaxis designs, manufactures and markets an advanced cardiology instrument control system for use in a hospital’s interventional surgical suite to enhance the treatment of arrhythmias and coronary artery disease. The Stereotaxis system is designed to enable physicians to complete more complex interventional procedures by providing image guided delivery of catheters and guidewires through the blood vessels and chambers of the heart to treatment sites. This is achieved using computer-controlled, externally applied magnetic fields that govern the motion of the working tip of the catheter or guidewire, resulting in improved navigation, shorter procedure time and reduced x-ray exposure. The unparalleled clinical capability of Stereotaxis has driven more than 130 hospitals to adopt magnetic navigation for a growing number of complex ablation cases in all four chambers of the heart. Stereotaxis technology is now installed and used by 9 out of the Top 10 Best U.S. Heart Hospitals as ranked by U.S. News and World Report, and more than one third of the EP academic training


centers in the United States have included Stereotaxis into their arrhythmia treatment laboratories. The core components of the Stereotaxis system have received regulatory clearance in the U.S., Europe, Canada and elsewhere.

About Odyssey

The Odyssey portfolio of products provides an innovative enterprise solution for integrating, recording and networking interventional lab information around the world. Odyssey Vision standardizes data integration for magnetic and standard interventional labs by enhancing the physician workflow through a consolidated display of multiple systems and eliminating the challenge of interacting simultaneously with many separate diagnostic systems. Odyssey Enterprise Cinema then captures a complete record of synchronized procedure data that can be viewed live or from a comprehensive archive of cases performed. Through its proprietary data compression technology, Cinema enables sharing of live and recorded procedure data via a laptop anywhere over a secure high speed Internet connection. Hospitals can also share procedures with other institutions using Odyssey Network Connect providing a global forum for defining clinical best practices across a broad spectrum of medical procedures.

This press release includes 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.

Stereotaxis, Inc. presentation slides for conferences
NASDAQ: STXS
Exhibit 99.2


Forward-Looking Statements
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 risk 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.
2


Investment Considerations
Addressing market opportunity through two distinct
platforms:
Magnetic Navigation (Niobe)
Enterprise Solutions (Odyssey)
Large, high growth (+20%) cardiology ablation market
Commercial ramp began in mid 2008; leading peer
group grower in 2009 through strong fundamentals
Poised for continued growth in EP
Long term platform expansion into new markets
3


Stereotaxis
Magnetic Platform
Stereotaxis
steers the catheter’s distal tip through external magnetic fields thus
giving the physician precise remote control of therapeutic devices.
4


Stereotaxis
Value –
Magnetic Platform
Precise control of the distal tip of the catheter results in:
Exemplary safety
Effective lesion creation through
constant contact
Exceptional mapping capability 
Proven in all chambers of the heart
5


Before Stereotaxis
After Stereotaxis
Physician
Efficacy
Safety
Efficiency
In procedure room
Physician:
significant X-ray exposure
Patient:
major event rate ~2.8%
Wide standard deviation based on
patient and physician
In control room
Several applications clearly better than manual
-
VT, pediatrics, congenital heart diseases
Other applications comparable to manual
Almost no X-ray exposure
Major event rate reduced to 0.1%
Standardized process drives tighter distribution
around procedure times
High re-do rates
Clinical Environment Overview Market
6


Global EP Market
Source: Millennium Research Group (2009); Stereotaxis internal analysis
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%
Our
Focus
7


Strong
Clinical Validation
More than 150 Peer-Reviewed
Publications
Atrial
Fibrillation
30 Publications
Up
to
100%
acute
success
Improved
chronic
outcomes
Pediatric Arrhythmia
5 publications
93% acute success
Low fluoro, no complications
Congenital Heart
6 publications
90%
success
rate
“As easy as normal adults”
Ventricular Tachycardia
13 publications
Up
to
100%
acute
success
85%
freedom
at
1
year
Radiation Reduction
Patients
67%
Physicians
90%
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.
8
3
6
4
5
7
8
2
1


VT Comparison Study Erasmus MC
64 consecutive VT ablation patients
37 Stereotaxis
27 manual
Idiopathic & Scar-Related
No complications in Stereotaxis
group
1 tamponade/death in manual group
Conclusion: “Major
clinical & cost advantages for VT ablation”
97%
14%
170
25
8
81%
50%
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
< 0.01
p
< 0.001
NS
9
Schwagten, et al. Eur Heart J 2010, 31(Supp):932.


Odyssey Enterprise
TM
Solutions
Odyssey Vision
10


The Odyssey Product Line
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
140 Niobe
Labs
$10K / Year
$190K List
$225K -
$360K List
11


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
Equipment service
Technical service
Software license
1-year warranty
Niobe
Utilization
Stereotaxis
disposables
Royalty from J&J BWI
27% growth (2009 vs. 2008); 65+% margin
12


Market Adoption & Procedure Growth
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
13


$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
14


$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
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
-$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
Stereotaxis
Financial Update
15
-$7.9
-$5.6
2008
2009
2010


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
$26.3
$19.4
* Cash burn includes repayment of Biosense
Webster advance.
*
16
$6.6
$12.8
$4.3
$30.3
$23.8
$20.7
$22.0
$0
$5
$10
$15
$20
$25
$30
$35
Cash Burn
Cash
Credit Line Availabilty
2008
2009
TTM June
30, 2010
June 30,
2010
June 30,
2009


2010 Focus
I.
Drive Commercial Success
Clinical training/process accelerates adoption
Adoption
creates
stronger
reference
sites
Reference
sites
accelerate
capital
pipeline
&
sales
Niobe
orders generate Odyssey opportunities
Odyssey
(robotic
labs)
placements
generate
standard
lab interest
II.Strengthen EP Product Offering
Product
extensions
Odyssey
link,
Interface,
Carto
III
New
capabilities
launched
with
VDrive
* Year to Date 2010
17
Metrics
25% growth recurring revenue*
5
17
Q2 2010 orders doubled over 2009
Odyssey revenue up 164%*
Standard lab sales 36% of total
Odyssey*


Q & A
18

Innovation Day