UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 10-K
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(MARK ONE)
|X| ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES
EXCHANGE ACT OF 1934
FOR THE FISCAL YEAR ENDED DECEMBER 31, 2006
OR
|_| TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES
EXCHANGE ACT OF 1934
FOR THE TRANSITION PERIOD FROM______________________TO________________________
COMMISSION FILE NUMBER 000-50884
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STEREOTAXIS, INC.
(Exact name of Registrant as Specified in its Charter)
DELAWARE 94-3120386
(State or Other Jurisdiction of Incorporation (I.R.S. Employer
or Organization) Identification Number)
4320 Forest Park Avenue
St. Louis, MO 63108
(Address of Principal Executive Offices including Zip Code)
(314) 678-6100
(Registrant's Telephone Number, Including Area Code)
Securities registered pursuant to Section 12(b) of the Act: Common Stock, $.001
Par Value
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark if the registrant is a well-known seasoned issuer, as
defined in Rule 405 of the Securities Act. Yes |_| No |X|
Indicate by check mark if the registrant is not required to file reports
pursuant to Section 13 or Section 15(d) of the Act. Yes |_| No |X|
Indicate by check mark whether the registrant (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or for such shorter period that the registrant was
required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days. Yes |X| No |_|
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405
of Regulation S-K is not contained herein, and will not be contained, to the
best of Registrant's knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this Form 10-K, or any amendment to
this Form 10-K.| |
Indicate by check mark whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated filer. See definition of "accelerated
filer and large accelerated filer" in Rule 12b-2 of the Exchange Act.
Large accelerated filer |_| Accelerated filer|X| Non-accelerated filer |_|
Indicate by check mark whether the registrant is a shell company (as defined in
Rule 12b-2 of the Exchange Act). Yes |_| No |X|
The aggregate market value of the registrants common stock held by
non-affiliates of the registrant on the last business day of the registrant's
most recently completed second fiscal quarter (based on the closing sales prices
on the NASDAQ Global Market on June 30, 2006) was approximately $274 million.
The number of outstanding shares of the registrant's common stock on February
28, 2007 was 34,835,427.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the Proxy Statement for the Registrant's next Annual Meeting of
Stockholders to be held on May 24, 2007 are incorporated by reference into Part
III of this Form 10-K.
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STEREOTAXIS, INC.
INDEX TO ANNUAL REPORT ON FORM 10-K
PART I.
Item 1. Business
Item 1a. Risk Factors
Item 1b Unresolved Staff Comments
Item 2. Properties
Item 3. Legal Proceedings
Item 4. Submission of Matters to a Vote of Security Holders
PART II.
Item 5. Market for the Registrant's Common Equity, Related Stockholder
Matters and Registrant Purchases of Equity Securities
Item 6. Selected Financial Data
Item 7. Management's Discussion and Analysis of Financial Condition and
Results of Operations
Item 7a. Quantitative and Qualitative Disclosures About Market Risk
Item 8. Financial Statements and Supplementary Data
Item 9. Changes in and Disagreements with Accountants on Accounting and
Financial Disclosure
Item 9a. Controls and Procedures
Item 9b. Other Information
PART III.
Item 10. Directors and Executive Officers of the Registrant
Item 11. Executive Compensation
Item 12. Security Ownership of Certain Beneficial Owners and Management and
Related Stockholder Matters
Item 13. Certain Relationships and Related Transactions
Item 14. Principal Accounting Fees and Services
PART IV.
Item 15. Exhibits and Financial Statement Schedules
SIGNATURES
SCHEDULE II - Valuation and Qualifying Accounts
INDEX TO EXHIBITS
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PART I
ITEM 1. BUSINESS
FORWARD-LOOKING STATEMENTS
This annual report on Form 10-K, including the sections entitled
"Business" and "Management's Discussion and Analysis of Financial Condition and
Results of Operations", contains forward-looking statements. These statements
relate to, among other things:
o our business strategy;
o our value proposition;
o the timing and prospects for regulatory approval of our additional
disposable interventional devices;
o our estimates regarding our capital requirements;
o the ability of physicians to perform certain medical procedures with our
products safely, effectively and efficiently;
o the adoption of our products by hospitals and physicians;
o the market opportunity for our products, including expected demand for our
products;
o our plans for hiring additional personnel; and
o any of our other plans, objectives, expectations and intentions contained
in this annual report that are not historical facts.
These statements relate to future events or future financial performance,
and involve known and unknown risks, uncertainties and other factors that may
cause our actual results, levels of activity, performance or achievements to be
materially different from any future results, levels of activity, performance or
achievements expressed or implied by such forward-looking statements. In some
cases, you can identify forward-looking statements by terminology such as "may",
"will", "should", "could", "expects", "plans", "intends", "anticipates",
"believes", "estimates", "predicts", "potential" or "continue" or the negative
of such terms or other comparable terminology. Although we believe that the
expectations reflected in the forward-looking statements are reasonable, we
cannot guarantee future results, levels of activity, performance or
achievements. These statements are only predictions.
Factors that may cause our actual results to differ materially from our
forward-looking statements include, among others, changes in general economic
and business conditions and the risks and other factors set forth in "Item
1A--Risk Factors" and elsewhere in this annual report on Form 10-K.
Our actual results may be materially different from what we expect. We
undertake no duty to update these forward-looking statements after the date of
this annual report, even though our situation may change in the future. We
qualify all of our forward-looking statements by these cautionary statements.
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OVERVIEW
We design, manufacture and market an advanced cardiology instrument
control system for use in a hospital's interventional surgical suite, or "cath
lab", that we believe revolutionizes the treatment of arrhythmias and coronary
artery disease by enabling important new therapeutic solutions and enhancing the
efficiency and efficacy of existing catheter-based, or interventional,
procedures. Our Stereotaxis System allows physicians to more effectively
navigate proprietary catheters, guidewires and other delivery devices, both our
own and those we are co-developing with strategic partners, through the blood
vessels and chambers of the heart to treatment sites in order to effect
treatment. This is achieved using computer-controlled, externally applied
magnetic fields that precisely and directly govern the motion of the internal,
or working, tip of the catheter, guidewire or other delivery device. We believe
that our Stereotaxis System represents a revolutionary technology in the cath
lab, bringing precise remote digital instrument control and programmability to
the cath lab, and has the potential to become the standard of care for a broad
range of complex cardiology procedures.
We believe that our Stereotaxis System is the only technology to be
commercialized that allows remote, computerized control of catheters, guidewires
and other delivery devices directly at their working tip. To our knowledge, we
have no direct competitors in this field that have currently commercially
available devices. We also believe that our technology represents an important
advance in the ongoing trend toward digital instrumentation in the cath lab and
provides substantial, clinically important improvements and cost efficiencies
over manual interventional methods, which require years of physician training
and often result in long and unpredictable procedure times with suboptimal
therapeutic outcomes.
We began commercial shipments in 2003, following U.S. and European
regulatory approval of the core components of the Stereotaxis System. As of
December 31, 2006, we had sold and delivered 66 Stereotaxis NIOBE (R) Systems
and had approximately $45.3 million in outstanding purchase orders and other
commitments. Of the December 31, 2006 purchase orders and commitments, we expect
approximately 25% to be filled beyond calendar year 2007. There can be no
assurance that we will recognize revenue in any particular period or at all
because some of our purchase orders and other commitments are subject to
contingencies that are outside our 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.
The Stereotaxis System is designed primarily for the interventional
treatment of abnormal heart rhythms known as arrhythmias, or electrophysiology,
including enhancing the placement of complex pacemakers for cardiac
resynchronization therapy, or CRT and for the interventional treatment of
coronary artery disease, or interventional cardiology. To date the preponderance
of the Stereotaxis installations worldwide are intended for use in
electrophysiology.
Our Stereotaxis System consists of the following proprietary components:
o our NIOBE(R) magnetic navigation system, which utilizes permanent magnets
to navigate catheters, guidewires and other delivery devices through complex
paths in the blood vessels and chambers of the heart to carry out treatment;
o our NAVIGANT(R) advanced user interface, or physician control center,
which physicians use to visualize and track procedures and to provide instrument
control commands that govern the motion of the working tip of the catheter,
guidewire or other delivery device;
o our CARDIODRIVE(R) catheter advancement system, which is used to remotely
advance and retract the catheter in the patient's heart; and
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o our suite of interventional catheters, guidewires and other delivery
devices, which we refer to as disposable interventional devices as further
discussed on Page 11.
The Stereotaxis System is designed to be installed in both new and
replacement cath labs worldwide. We currently have regulatory clearance to
market our NIOBE magnetic navigation system, our NAVIGANT advanced user
interface, our CARDIODRIVE catheter advancement system and various disposable
interventional devices in the U.S., Canada, Europe and in China, and we
anticipate applying through Siemens and Biosense Webster to begin clinical
trials in Japan in 2007. Current and potential purchasers of our Stereotaxis
System include leading research and academic hospitals as well as community and
regional medical centers around the world.
We have alliances with each of Siemens AG Medical Solutions, Philips
Medical Systems and Biosense Webster, a subsidiary of Johnson & Johnson. Through
these alliances, we integrate our Stereotaxis System with Siemens' and Philips'
market leading digital imaging and Biosense Webster's 3D catheter location
sensing technology, and develop compatible disposable interventional devices, in
order to continue to introduce new solutions to the cath lab. The Siemens and
Philips alliances provide for coordination of our sales and marketing efforts
with those of our partners to facilitate co-placement of integrated systems. In
addition, Siemens has agreed to provide worldwide service for our integrated
systems and we are in discussions with Philips to provide the same.
The core elements of our Stereotaxis System are protected by an extensive
patent portfolio, as well as substantial know-how and trade secrets.
BACKGROUND
Traditionally, cardiac procedures have been performed via open chest heart
bypass surgery. This procedure is very invasive, requiring cutting open the rib
cage and spreading it apart in order to gain access to the heart. This enables
the physician to directly view the patient's heart during the procedure and to
operate manually. Additionally, the patient is typically placed on a heart lung
bypass device. While generally very effective, the procedure is highly traumatic
for the patient, and usually requires a long hospital stay, followed by a
significant period of convalescence. Conventional cardiac surgery is also
expensive.
Minimally invasive surgical procedures for cardiology were devised to
mitigate many of the drawbacks of bypass surgery while maintaining essential
elements of visualization and instrument control. These procedures utilize an
endoscope for visualization, which is inserted through an incision in the
patient's body. While these minimally invasive surgical techniques have been
used for a number of cardiac procedures, in most instances they have not been as
effective as conventional cardiac surgery. As a result, bypass surgery, despite
its drawbacks, has remained the predominant method for cardiac surgical
procedures.
Interventional cardiology represents the next, and most recent, step in
the evolution of less invasive cardiac procedures. These procedures are
performed in the cath lab, where real-time x-ray imaging, often enhanced by the
injection of contrast dye, provides visualization enabling physicians to insert
and navigate guidewires, catheters and other delivery devices into the
vasculature or open chambers of the heart to deliver therapy. Instrument control
in typical interventional cardiology procedures for the treatment of coronary
artery disease requires the physician to manually manipulate the external end of
a long, slender guidewire in order to indirectly control and position the
working tip of the instrument. This requires significant skill and, depending
upon the type and location of the lesion being treated, can be very difficult
and time consuming. The guidewire is typically used for navigation to the
treatment site, after which a catheter or other delivery device is threaded over
the guidewire to perform the necessary treatment. Guidewires are also typically
used to place pacemaker
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leads used in cardiac resynchronization therapy for the treatment of congestive
heart failure. In electrophysiology mapping and ablation procedures, physicians
use specialized catheters that are manually navigated using a system of
mechanical control cables to map the patient's heart, and then to ablate the
heart tissue to eliminate arrhythmias. This also requires significant skill,
and, depending on the type and location of the arrhythmia, can be very difficult
and time consuming to perform.
Electrophysiology and interventional cardiology procedures have proven to
be very effective at treating arrhythmias and coronary artery disease at sites
accessible through the vasculature without the patient trauma, complications,
recovery times and cost generally associated with open surgery. With the advent
of drug-eluting stents, the number of potential patients who could benefit from
interventional cardiology procedures has grown. However, major challenges
associated with manual approaches to interventional cardiology and
electrophysiology persist. In electrophysiology, these challenges include
precisely navigating the tip of the mapping and ablation catheter to the
treatment site on the heart wall and maintaining tissue contact throughout the
cardiac cycle to effect treatment, and, for atrial fibrillation, performing
complex ablations within the left atrium of the heart. As a result, large
numbers of patients are referred to palliative drug therapy that can have
harmful side effects. In interventional cardiology, these challenges include
difficulty in navigating the disposable interventional device through tortuous
vasculature and crossing certain types of complex lesions to deliver
drug-eluting stents to effect treatment. As a result, numerous patients who
could be candidates for an interventional approach continue to be referred to
bypass surgery.
We believe the Stereotaxis System represents a revolutionary step in the
trend toward highly effective, but less invasive, cardiac procedures. As the
first technology to permit direct, computerized control of the working tip of a
disposable interventional device, the Stereotaxis System enables physicians to
perform cardiac procedures interventionally that historically would have been
very difficult or impossible to perform in this way and significantly improves
the efficiency of existing complex procedures in the cath lab.
CURRENT CHALLENGES IN THE CATH LAB
Although great strides have been made in devices and in applying manual
interventional techniques, significant challenges remain that reduce cath lab
productivity and limit both the number of complex procedures and the types of
diseases that can be treated. These challenges primarily involve the limitations
of manual instrument control and the lack of integration of the information
systems used by physicians in the cath lab. As a result, many complex cases in
electrophysiology are treated with palliative drug therapy and many complex
procedures in interventional cardiology are referred to highly invasive bypass
surgery.
Limitations of Instrument Control
Navigation in the blood vessels and the chambers of the heart can be
difficult because the path that a disposable interventional device must follow
to arrive at the treatment site and deliver therapy can be complex and tortuous.
Physicians using manual methods often utilize a range of different catheters and
guidewires in succession in an attempt to find the right device or devices for
the procedure being performed.
Manually controlled catheters, guidewires and other delivery devices, even
in the hands of the most skilled specialist, have inherent instrument control
limitations. In traditional interventional procedures, the device is manually
manipulated by the physician who twists and pushes the external end of the
instrument in an iterative process to thread the instrument through the blood
vessels to the treatment site. Manual control of the working tip becomes
increasingly difficult as more turns are required to navigate the instrument to
the treatment site, as the blood vessels to be navigated become
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smaller and less accessible or more blocked, and as greater precision is
required to carry out therapy at the treatment site.
Lack of Integration of Information Systems
While sophisticated imaging, mapping and location-sensing systems have
provided visualization for interventional procedures and allowed interventional
physicians to treat more complex conditions, the substantial lack of integration
of these information systems requires the physician to mentally integrate and
process large quantities of information from different sources in real time
during an interventional procedure. For example, a physician ablating heart
tissue to eliminate an arrhythmia will often be required to mentally integrate
information from a number of sources, including:
o real-time x-ray fluoroscopy images;
o a real-time location-sensing system providing the 3D location of the
catheter tip;
o a pre-operative map of the electrical activity or anatomy of the patient's
heart;
o real-time recording of electrical activity of the heart; and
o temperature feedback from an ablation catheter.
Each of these systems displays data differently, requiring physicians to
continuously reorient themselves to the different formats and displays as they
shift their focus from one data source to the next while at the same time
manually controlling the interventional instrument.
THE STEREOTAXIS VALUE PROPOSITION
The Stereotaxis System addresses the current challenges in the cath lab by
providing precise computerized control of the working tip of the interventional
instrument and by integrating this control with the visualization and
information systems used during electrophysiology and interventional cardiology
procedures, on a cost justified basis. We believe that the Stereotaxis System is
the only technology to be commercialized that allows remote, computerized
control of disposable interventional devices directly at their working tip.
We believe that the Stereotaxis System will:
o Expand the market by enabling new treatments for major diseases and
enhancing the treatment of more complex existing cases. Treatment of a number of
major diseases, including placement of bi-ventricular pacing devices, atrial
fibrillation and chronic total occlusions is highly problematic using
conventional catheter-based techniques. Additionally, many patients with
multi-vessel disease and certain complex arrhythmias are often referred to other
therapies because of the difficulty in controlling the working tip of disposable
interventional devices. As a result, these patients are typically referred to
more invasive surgeries or largely ineffective drug therapy. Because the
Stereotaxis System provides precise, computerized control of the working tip of
disposable interventional devices, we believe that it will potentially enable
chronic total occlusions and atrial fibrillation to be treated interventionally
on a much broader scale than today, and may permit physicians to predictably
treat complex cases involving arrhythmias and partially occluded coronary
arteries.
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o Improve outcomes by optimizing therapy. Difficulty in controlling the
working tip of disposable interventional devices leads to sub-optimal results in
many procedures. Precise instrument control is necessary for treating a number
of cardiac conditions. To treat arrhythmias, precise placement of an ablation
catheter against a beating inner heart wall is necessary. To treat congestive
heart failure, precise navigation within the coronary venous system for optimal
placement of pacemaker leads is required. For coronary artery disease, precise
and correct navigation and placement of expensive drug-eluting stents also have
a significant impact on procedure costs and outcomes. We believe the Stereotaxis
System can enhance procedure results by improving navigation of disposable
interventional devices to treatment sites, and by effecting more precise
treatments once these sites are reached.
o Enhance hospital efficiency by reducing and standardizing procedure times,
disposables utilization and staffing needs. Interventional procedure times
currently range from several minutes to many hours as physicians often engage in
repetitive, "trial and error" maneuvers due to difficulties with manually
controlling the working tip of disposable interventional devices. By reducing
both navigation time and the time needed to carry out therapy at the target
site, we believe that the Stereotaxis System can reduce complex interventional
procedure times compared to manual procedures. We believe the Stereotaxis System
can also reduce the variability in procedure times compared to manual methods.
Greater standardization of procedure times allows for more efficient cath lab
scheduling. We also believe that additional cost savings from the Stereotaxis
System result from decreased use of multiple catheters and guidewires in
procedures compared with manual methods and also from decreased staff
requirements during procedures, which further enhances the rate of return to
hospitals.
o Enhance physician skill levels in order to improve the efficacy of complex
cardiology procedures. Training required for physicians to carry out manual
interventional procedures typically takes years, over and above the training
required to become a specialist in cardiology. This has led to a shortage of
interventional physicians for more complex procedures. The Stereotaxis System
can allow procedures that previously required the highest levels of manual
dexterity and skill to be performed effectively by a broader range of
interventionalists, with more standardized outcomes. In addition, interventional
physicians can be trained to use the Stereotaxis System in a relatively short
period of time. The Stereotaxis System can also be programmed to carry out
sequences of complex navigation automatically.
o Improve patient and physician safety by reducing procedure times and
minimizing x-ray exposure. During conventional catheter-based procedures, both
the physician, who stands by the patient table to manually control the catheter,
and the patient are exposed to the potentially harmful x-ray fluoroscopy field.
This exposure can be minimized by reducing procedure times. Reducing procedure
times is also beneficial to the patient because of the direct correlation
between complication rates and procedure length. The Stereotaxis System can
further improve physician safety by enabling them to conduct procedures remotely
from an adjacent control room, which reduces their exposure to harmful
radiation.
OVERVIEW OF THE STEREOTAXIS SYSTEM
Our proprietary Stereotaxis System provides the physician with precise
remote digital instrument control through user friendly "point and click" and/or
virtual catheter technology. It can be operated either from beside the patient
table, as in traditional interventional procedures, or from a room adjacent to
the patient and outside the x-ray fluoroscopy field. The NIOBE magnetic
navigation system navigates disposable interventional devices to the treatment
site through complex paths in the blood vessels and chambers of the heart to
carry out treatment using computer controlled, externally applied magnetic
fields to directly govern the motion of the working tip of
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these devices, each of which has a magnetically sensitive tip that predictably
responds to magnetic fields generated by our system. Because the working tip of
the disposable interventional device is directly controlled by these external
magnetic fields, the physician has the same degree of control regardless of the
number or type of turns, or the distance traveled, by the working tip to arrive
at its position in the blood vessels or chambers of the heart, which results in
highly precise digital control of the working tip of the disposable
interventional device while still giving the physician the option to manually
advance the catheter.
Through our alliances with Siemens, Philips and Biosense Webster, this
precise digital instrument control has been integrated with the visualization
and information systems used during interventional cardiology and
electrophysiology procedures in order to provide the physician with a
fully-integrated and automated information and instrument control system. We
have integrated our Stereotaxis System with Siemens' digital x-ray fluoroscopy
system, and with Philips' digital x-ray fluoroscopy system. In addition, we have
integrated the Stereotaxis System with Biosense Webster's 3D catheter location
sensing technology, to provide accurate real-time information as to the 3D
location of the working tip of the instrument, and with Biosense Webster's
ablation tip technology. The combination of these technologies was fully
launched in 2005.
The components of the Stereotaxis System are identified and described
below:
Systems
NIOBE Magnetic Navigation System. Our NIOBE magnetic navigation system
utilizes two permanent magnets mounted on articulating or pivoting arms that are
enclosed within a stationary housing, with one magnet on either side of the
patient table, inside the cath lab. These magnets generate magnetic navigation
fields that are less than 10% of the strength of fields typically generated by
MRI equipment and therefore require significantly less shielding, and cause
significantly less interference, than MRI equipment. The NIOBE is indicated for
use in cardiac, peripheral and neurovascular applications.
NAVIGANT Advanced User Interface. The NAVIGANT advanced user interface is
an integrated information and control center that integrates the key information
sources used by electrophysiologists and interventional cardiologists and allows
these physicians to provide instrument control directions to precisely govern
the motion of the working tip of disposable interventional devices.
The NAVIGANT advanced user interface consists of:
o configurable display screens located both next to the patient table inside
the cath lab and in the adjacent control room, outside the x-ray fluoroscopy
field, that provide advanced visualization and information integration to the
physician;
o sophisticated embedded device software and system control algorithms that
are integrated with our disposable interventional devices to facilitate ease of
use automation, and improved navigation of these devices;
o virtual catheter or mouse control which the physician uses to direct the
motion of the working tip of the disposable interventional device, either from
inside the cath lab or from the adjacent control room; and
o a software package designed for electrophysiology or interventional
cardiology, or both, as well as optional application software tailored for
specific clinical procedures.
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CARDIODRIVE Catheter Advancement System. Where the physician is conducting
the procedure from the adjacent control room, the CARDIODRIVE catheter
advancement system is used to advance and retract the catheter in the patient's
heart while the NIOBE magnets precisely steer the working tip of the device.
We have received regulatory marketing clearance, licensing and CE Mark
approvals necessary for us to market the NIOBE magnetic navigation system, the
NAVIGANT advanced user interface and the CARDIODRIVE catheter advancement system
in the U.S., Canada, Europe and China.
DISPOSABLES AND OTHER ACCESSORIES
Our system is designed to use a toolkit of proprietary disposable
interventional devices. The toolkit currently consists of:
o our suite of CRONUS(R), ASSERT and TITAN(TM) coronary guidewires suitable
for use in interventional cardiology procedures for the introduction and
placement of over-the-wire therapeutic devices, such as biventricular pacing
leads used in cardiac resynchronization therapy for treating congestive heart
failure as well as stents and angioplasty balloons;
o our TANGENT(R) electrophysiology mapping catheter used to locate aberrant
electrical signals in the heart;
o our HELIOS II(R) electrophysiology ablation catheter used for certain
arrhythmia treatments; and
o the CARTO(R) RMT navigation and ablation system, CELSIUS(R) RMT and
NAVISTAR(R) RMT and NAVISTAR (R) RMT DS Diagnostic/Ablation Steerable Tip
Catheters co-developed with Biosense Webster, as described below.
We have received FDA clearance, Canadian licensing and the CE Mark
necessary for us to market our suite of CRONUS, ASSERT and TITAN coronary
guidewires in the U.S., Canada and Europe. In addition, we have received FDA
clearance for our TANGENT mapping catheter in the U.S. and the CE Mark for our
HELIOS II electrophysiology ablation catheter in Europe. In the U.S. we
completed clinical trials with the HELIOS II in 2004 and filed for a PMA in 2005
for which we anticipate approval in 2007.
In March 2005, we announced the first commercial use of our Stereotaxis
System with the CELSIUS(R) RMT ablation catheter, the NAVISTAR(R) RMT
Diagnostic/Ablation Steerable Tip catheter and the CARTO(R) RMT navigation and
ablation system in Europe. Biosense Webster received FDA approval in September
2005 for use in the U.S. of the CARTO(R) RMT navigation system with the
Stereotaxis NIOBE system. In December 2005, Biosense Webster received approval
from the FDA for the CELSIUS(R) RMT Diagnostic/Ablation Steerable Tip Catheter
and in February 2006 Biosense Webster received FDA approval for the NAVISTAR(R)
RMT Diagnostic/Ablation Steerable Tip Catheter. These products are the first
products to be commercialized pursuant to our strategic alliance with Biosense
Webster. We continue to co-develop a range of ablation catheters that can be
navigated with our system, with and without Biosense Webster's 3D catheter
location sensing technology. We are also developing disposable interventional
devices for other applications. In addition, we can utilize plastic security
keys, with embedded smart chips and associated software that allow our system to
recognize specific disposable interventional devices in order to prevent
unauthorized use of our system.
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We believe that we can adapt most disposable interventional devices for
use with our system by using our proprietary technology to add an inexpensive
micro-magnet at their working tip. This micro-magnet is activated by an external
magnetic field, which allows interventional devices with tip dimensions as small
as 14 thousandths (0.014) of an inch to be oriented and positioned in a
predictable and controllable fashion. We believe this approach to bringing
digital control to disposable interventional devices using embedded magnets can
simplify the overall design of these devices because mechanical controls are no
longer required.
CLINICAL APPLICATIONS
We have initially focused our clinical and commercial efforts on
applications of the Stereotaxis System in electrophysiology procedures for the
treatment of arrhythmias and in complex interventional cardiology procedures for
the treatment of coronary artery disease. Our system potentially has broad
applicability in other areas, such as interventional neurosurgery,
interventional neuroradiology, peripheral vascular, pulmonology, urology,
gynecology and gastrointestinal medicine, and our patent portfolio has been
structured to permit expansion into these areas.
Electrophysiology
The rhythmic beating of the heart results from the transmission of
electrical impulses through the heart. When these electrical impulses are
mistimed or uncoordinated, the heart fails to function properly, resulting in
complications that can range from fatigue to stroke or death. Over four million
people in the U.S. currently suffer from the resulting abnormal heart rhythms,
which are known as arrhythmias.
Drug therapies for arrhythmias often fail to adequately control the
arrhythmia and may have significant side effects. Consequently, physicians have
increasingly sought more permanent, non- pharmacological, solutions for
arrhythmias. The most common interventional treatment for arrhythmias, and in
particular tachyarrhythmias, where the patient's heart rate is too high or
irregular, is an ablation procedure in which the diseased tissue giving rise to
the arrhythmia is isolated or destroyed. Prior to performing an
electrophysiology ablation, a physician typically performs a diagnostic
procedure in which the electrical signal patterns of the heart wall are "mapped"
to identify the heart tissue generating the aberrant electrical signals.
Following the mapping procedure, the physician may then use an ablation catheter
to disable the aberrant signal or signal path, restoring the heart to its normal
rhythm. In cases where an ablation is anticipated, physicians will choose an
ablation catheter and perform both the mapping and ablation with the same
catheter.
We believe the Stereotaxis System is particularly well-suited for those
electrophysiology procedures which are time consuming or which can only be
performed by highly experienced physicians. These procedures include:
o General Mapping and Ablations. For the more routine mapping and ablation
procedures, our system offers the unique benefit of precise catheter movement
and consistent heart wall contact. Additionally, the system can control the
procedure and direct catheter movement from the control room, saving the
physician time and helping to avoid unnecessary exposure to high doses of
radiation.
o Atrial Fibrillation. A common cause of sustained abnormal heart rhythm,
atrial fibrillation, is a particular type of arrhythmia characterized by rapid,
disorganized contractions of the heart's upper chambers, the atria, which lead
to ineffective heart pumping and blood flow and can be a major risk factor for
stroke. The majority of potential patients cannot benefit from manual
catheter-based
12
procedures for atrial fibrillation because the procedures are extremely complex
and are performed by only the most highly skilled electrophysiologists. They
also typically have much longer procedure times than conventional ablation cases
and lower success rates. We believe that our system can allow these procedures
to be performed by a broader range of electrophysiologists and, by automating
some of the more complex ablation routines, can standardize and reduce procedure
times and significantly improve outcomes.
o Bi-Ventricular Pacing. Congestive heart failure is a potentially fatal
condition in which the heart muscle is damaged to the point that it is unable to
provide adequate blood flow rate through the body. A new therapy, dual chamber
cardiac resynchronization therapy, or bi-ventricular pacing, has shown promise
in the treatment of a certain type of congestive heart failure in which the left
and right sides of the left ventricle do not contract at the same time. The
procedure used to carry out this therapy involves the placement of a pacemaker
lead into the coronary venous system of the heart. Interventional treatment of
this patient population is growing rapidly but the placement of the venous
pacing lead with manual interventional technologies is highly challenging and
time consuming, and less than optimal lead placement can contribute to poor
outcomes. The unpredictability of procedure times also makes efficient cath lab
scheduling very difficult in these cases.
We believe that our system can address the current challenges in
electrophysiology by permitting the physician to remotely navigate disposable
interventional devices from a control room outside the x-ray field. Our system
also allows for more predictable and efficient navigation of these devices to
the treatment site, including the left atrium for atrial fibrillation
procedures, and enables appropriate contact force to be maintained to effect
ablations on the wall of the beating heart. We also believe that our system will
significantly lower the skill barriers required for physicians to perform
complex electrophysiology procedures and, additionally, improve cath lab
efficiency and reduce disposable interventional device utilization.
Interventional Cardiology
Nearly half a million people die annually from coronary artery disease, a
condition in which the formation of plaque in the coronary arteries obstructs
the supply of blood to the heart, making this the leading cause of death in the
U.S. Despite various attempts to reduce risk factors, each year over one million
patients undergo interventional procedures in an attempt to open blocked vessels
and another half a million patients undergo open heart surgery to bypass blocked
coronary arteries.
Blockages within a coronary artery, often called lesions, are categorized
by degree of obstruction as partial occlusions, non-chronic total occlusions and
chronic total occlusions. Lesions are also categorized by the degree of
difficulty with which they can be opened as simple or complex. If the blockage
is in an easy to reach location, it can typically be treated by pushing a
guidewire through the portion of the vessel that is blocked with plaque,
expanding a small balloon to compress the plaque against the artery walls in
order to open the artery, and then finally deploying a stent, which is a small
metal scaffold, to help keep the artery open. If a blockage is located within
tortuous vasculature, however, the physician must navigate the guidewire through
a series of sharp turns, making the blockage very difficult to reach. Even if
such lesions are reached, delivering a balloon or stent to the treatment site
through tortuous anatomy can be difficult. In addition, complex lesions, such as
chronic total occlusions, longer lesions, and lesions located within smaller
diameter vessels, are often very difficult or time consuming to open with manual
interventional techniques.
We estimate that approximately 15% of these interventional cardiology
procedures currently being performed are complex and therefore require longer
procedure times and may have sub-
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optimal outcomes. We believe that our system can substantially benefit this
subset of complex interventional cardiology procedures, including procedures
involving:
o Occlusions. Complex partial occlusions, complex non-chronic total
occlusions and chronic total occlusions. Treatment of these complex lesions is
generally more problematic due to the difficulty in steering and pushing a
guidewire through them. Because our system provides precise computerized control
of the working tip of a guidewire, it can enable physicians to more easily
locate small openings in, and to advance a guidewire across, these lesions. The
ability to cross complex lesions such as chronic total occlusions has grown
increasingly important due to the effectiveness of drug eluting stents in
treating these lesions. Since approximately one-fifth of patients referred to
bypass surgery have chronic total occlusions, we believe a significant number of
patients could be treated interventionally instead of surgically if more of
these lesions could be opened for stenting.
o Tortuous Anatomy. Some interventional procedures require physicians to
navigate a disposable interventional device through a series of sharp turns in
the patient's vasculature. Navigating through tortuous anatomy using manual
interventional techniques can be very time consuming and physicians often cannot
reach the lesion or manipulate the balloon or stent across the lesion once it is
reached. Because our system allows the working tip of disposable interventional
devices to be precisely oriented regardless of the number of turns that have
occurred, our technology allows physicians to more effectively navigate these
devices through complex vasculature and deliver balloons and stents to treatment
sites for therapy.
o Stent Placement. The likelihood of restenosis, or re-blockage of cleared
arteries, is greatly increased in multi-vessel diseased patients whose blockages
are typically more diffusely distributed throughout longer lengths of the
vessel. As a result, these patients are often referred to invasive bypass
surgery. We expect that drug-eluting stents, which dramatically reduce the
likelihood of restenosis, will enable patients with more complex lesions to be
treated interventionally rather than with bypass surgery. In order to treat this
new group of patients, however, physicians will need to place stents in more
challenging or remote locations. By using externally applied magnetic fields to
precisely direct a stent through a patient's vasculature, we believe that our
system allows these devices to be more easily navigated to these difficult to
reach treatment sites.
o Small Vessels. Based on our interpretation of various medical studies, we
have determined that diabetic patients usually comprise about 20 to 30% of U.S.
hospital's interventional procedure volume. These patients generally have
smaller vessels, which often contain longer lesions with more diffusely
distributed blockages, as well as tortuous anatomy, making guidewire navigation
and stent delivery extremely difficult. We believe that these patients can
benefit significantly from the improved disposable interventional device
navigation enabled by our system.
Interventional Neuroradiology, Neurosurgery and Other Interventional
Applications
Physicians used a predecessor to our NIOBE system to conduct a number of
procedures for the treatment of brain aneurysms, a condition in which a portion
of a blood vessel wall balloons and which can result in debilitating or fatal
hemorrhagic strokes. Traditional treatment for brain aneurysms involves highly
invasive open brain surgery. Interventional procedures have evolved for filling
the aneurysm with platinum micro-coils delivered to the site in order to reduce
blood flow within the aneurysm. We believe that the Stereotaxis System has the
potential to be adapted for use in the interventional treatment of brain
aneurysms, by enabling physicians to reach a broader range of aneurysm targets,
and by making procedure times for these cases more predictable.
The Stereotaxis System also has a range of potential applications in
minimally invasive neurosurgery, including biopsies and the treatment of tumors,
treatment of vascular malformations
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and, when deliverables are commercialized by third parties, delivery of
pharmacological compounds and deep brain stimulators. We have successfully
conducted what we believe to be the first human surgical procedures ever
conducted using computerized control in our neurosurgery program by navigating
complex pathways through brain tissue to multiple target sites. The Stereotaxis
System also has applicability in the respiratory, gastro-intestinal and
genito-urinary systems, for diagnosis and treatment of diseases affecting the
lungs, prostate, kidneys, colon and small intestine. We do not anticipate any
significant revenue from these programs in the near term.
COLLABORATIONS
We have entered into collaborations with technology leaders in the global
cath lab market, including Siemens, Philips, and Biosense Webster that we
believe will aid us in commercializing our Stereotaxis System. We believe our
two imaging partners, Siemens and Philips, have a significant percentage of the
installed base in the U.S.
We believe that these collaboration arrangements are favorable to
Stereotaxis because they:
o provide for the integration of our system with market leading digital
imaging and 3D catheter location sensing technology, as well as disposable
interventional devices;
o allow us to leverage the sales, distribution, service and maintenance
expertise of our strategic partners; and
o enable operational flexibility by not requiring us to provide any of our
strategic partners with a right of first refusal in the event that another party
wants to acquire us or with board representation where a strategic partner has
made a debt or equity investment in us.
Imaging Partners
Siemens Alliance. In June 2001, we entered into an alliance with Siemens,
a global leader in cath lab equipment sales, including x-ray fluoroscopy
systems. Under this alliance, we successfully integrated our Stereotaxis System
with Siemens' digital fluoroscopy system to provide advanced cath lab
visualization and instrument control through user-friendly computerized
interfaces. We also coordinate our sales efforts with Siemens to co-place
integrated systems at leading hospital sites in the U.S., Europe and in Asia.
Under this alliance and under a separate services agreement, Siemens provides
site planning, project management, equipment maintenance and support services
for our products directly to our customers. To date, most of our systems placed
for clinical use have been integrated with Siemens' digital fluoroscopy systems.
In May 2003, we entered into an expanded alliance with Siemens, under
which we are collaborating to produce what we believe will be market leading
technology to provide physicians with real-time 3D visualization of a patient's
anatomy during a procedure by integrating pre-operative MRI and CT data with
x-ray fluoroscopic data. We also agreed to integrate our instrument control
technology with Siemens' imaging technology in order to develop new solutions in
cardiology and, potentially, in interventional radiology. We have also entered
into a separate development agreement for the Japanese market under which
Siemens will coordinate regulatory approval and distribute, install and service
our Stereotaxis Systems, whether integrated with the x-ray system of Siemens, or
other third parties, in Japan. We have also entered into a software distribution
agreement with Siemens under which we have the right to sublicense Siemens' 3D
pre-operative image navigation software as part of our NAVIGANT advanced user
interface.
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Philips Alliance. In October 2003, we entered into an alliance with
Philips, another recognized global leader in cath lab sales, pursuant to which
we agreed to integrate our Stereotaxis System with Philips' digital x-ray
fluoroscopy system. We also agreed to identify areas of concentration for
bringing new solutions to integration of information sources and instrument
control in the cath lab in cardiology and neurology. Under this alliance, we
will coordinate our sales efforts with Philips in order to co-place our
integrated systems. We also have an agreement relating to shared engineering and
development costs.
Disposables Devices Partner
Biosense Webster Alliance. We entered into an alliance in May 2002
pursuant to which we agreed to integrate Biosense Webster's advanced 3D catheter
location sensing technology, which we believe has the leading market position in
this important field of visualization for electrophysiology procedures, with our
instrument control system, and to jointly develop associated location sensing
electrophysiology mapping and ablation catheters that are navigable with the
Stereotaxis System. We believe that these integrated products will provide
physicians with the elements required for effective complex electrophysiology
procedures: highly accurate information as to the exact location of the catheter
in the body and highly precise control over the working tip of the catheter. We
also agreed to coordinate our sales force efforts with Biosense Webster in order
to place Biosense CARTO(R) RMT Systems and our Stereotaxis Systems that,
together with the co-developed catheters, comprise the full integration of our
instrument control and 3D location sensing technologies in the cath lab. We
expanded this alliance in November 2003 to include the parallel integration of
our instrument control technology with Biosense Webster's full line of
non-location sensing mapping and ablation catheters that are relevant to our
targeted applications in electrophysiology.
The co-developed catheters are manufactured and distributed by Biosense
Webster, and each of the parties agreed to contribute to the resources required
for their development. We are entitled to royalty payments from Biosense
Webster, payable quarterly based on a profit formula for sales of the
co-developed catheters, and our revenue share increases under certain
circumstances. Under this alliance, we agreed to certain restrictions on our
ability to co-develop and distribute catheters competitive with those we are
developing with Biosense Webster and granted Biosense Webster certain notice and
discussion rights for product development activities we undertake relating to
localization and magnetically enabling interventional disposable devices in
cardiology fields outside of electrophysiology and mapping.
Either party may terminate this alliance in certain specified "change of
control" situations, although the termination would not be effective until one
year after the change of control and then would be subject to a wind-down period
during which Biosense Webster would continue to supply co-developed catheters to
us or to our customers for three years (or, for non-location sensing mapping and
ablation catheters, until our first sale of a competitive product after a change
of control, if earlier than three years). If we terminate the agreement under
this provision, we must pay a termination fee to Biosense Webster equal to 5% of
the total equity value of Stereotaxis in the change of control transaction, up
to a maximum of $10 million. We also agreed to notify Biosense Webster if we
reasonably believe that we are engaged in substantive discussions in respect of
the sale of the company or substantially all of our assets.
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RESEARCH AND DEVELOPMENT
We have assembled an experienced group of engineers and physicists with
recognized expertise in magnetics, software, control algorithms, systems
integration and disposable interventional device modeling and design.
Our research and development efforts are focused in three major areas:
o continuing to enhance our existing system through ongoing product and
software development;
o designing new proprietary disposable interventional devices for use with
our system; and
o developing next generation versions of our system.
Our research and development team collaborates with our strategic
partners, Siemens, Philips, and Biosense Webster, to integrate our Stereotaxis
System's open architecture platform with key imaging, location sensing and
information systems in the cath lab. We have also collaborated with a number of
highly regarded interventional physicians in key clinical areas and have entered
into agreements with a number of universities and research institutions, which
serve to increase our access to world class physicians and scientists and to
expand our name recognition in the medical community.
CUSTOMER SERVICE AND SUPPORT
Stereotaxis has contracted with Siemens to provide worldwide maintenance
and support services to our customers for our integrated products. This allows
us to leverage Siemens' extensive maintenance and support infrastructure for
direct, on-site technical support activities, including its call center,
customer support engineers and service parts logistics and delivery. It also
provides a single point of contact for the customer and allows us to focus on
providing installation, training, and back-up technical support. We intend to
follow the same strategy with Philips and with other potential collaboration
partners in the future.
Our back-up technical support includes a combination of on-line, telephone
and on-site technical assistance services 24 hours a day, seven days a week. We
have also hired service and support engineers with networking and medical
equipment expertise, and have outsourced a portion of our installation and
support services. We offer several different levels of support to our customers,
including basic hardware and software maintenance, extended product maintenance,
and rapid response capability for both parts and service.
MANUFACTURING
NIOBE Systems
Our manufacturing strategy for our NIOBE system is to sub-contract the
manufacture and testing of our system. This permits us to focus on our core
competencies in magnet design, magnetic physics, magnetic instrument control and
navigational algorithms.
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Disposable Interventional Devices
Our manufacturing strategy for disposable interventional devices is to
outsource their manufacture through subcontracting and through our alliance with
Biosense Webster and to expand partnerships for other interventional devices. We
currently maintain pilot level manufacturing capability along with strong
relationships with component level suppliers. We have approximately 5,000 square
feet available for disposables manufacturing, assembly, testing and inspection
with approximately 1,300 square feet of clean rooms in Maple Grove, Minnesota.
We have entered into manufacturing agreements to provide high volume capability
for devices other than catheters.
Software
The software components of the Stereotaxis System, including control and
application software, are developed both internally and with integrated modules
we purchase or license. We perform final testing of software products in-house
prior to their commercial release.
General
Our manufacturing facilities operate under processes that meet the FDA's
requirements under the Quality System Regulation, or QSR. In 2003 and 2006, the
FDA audited our Maple Grove, Minnesota facility for regulatory compliance, and
no deficiencies were noted. A European notified body has regularly audited each
facility annually since 2001 and found the facilities to be in compliance with
European requirements. The initial certification was issued in January 2002 for
compliance with ISO 9001. The most recent issuance of formal certification is
for ISO 13485:2003.
SALES AND MARKETING
We market our products in the U.S and internationally through a direct
sales force of senior sales specialists, distributors and sales agents,
supported by account managers and clinical specialists that provide training,
clinical support, and other services to our customers. In addition, our
strategic alliances form an important part of our sales and marketing strategy.
We leverage the sales forces of our imaging partners to co-market integrated
systems on a worldwide basis. This approach allows us to maximize our leads and
knowledge of the market opportunities while using our resources to sell directly
to the customer. Biosense Webster will exclusively distribute our
electrophysiology mapping and ablation catheters, co-developed pursuant to our
alliance with them. We intend to increase our capital sales personnel and
clinical account managers over the next 12 months and to enter into additional
distribution and sales representative arrangements to market our products in the
rest of the world.
Our sales and marketing process has two important steps: (1) selling
systems directly and through co-marketing agreements with our imaging partners,
Siemens and Philips and through distributors; and (2) leveraging our installed
base of systems to drive recurring sales of disposable interventional devices,
software and service.
REIMBURSEMENT
We believe that substantially all of the procedures, whether commercial or
in clinical trials, conducted in the U.S. with the Stereotaxis System have been
reimbursed to date and that substantially all commercial procedures in Europe
have been reimbursed. We expect that third-party payors will reimburse, under
existing billing codes, our line of guidewires, as well as our line of ablation
catheters and those on which we are collaborating with Biosense Webster. We
expect healthcare facilities in the U.S. to bill various third-party payors,
such as Medicare, Medicaid, other
18
government programs and private insurers, for services performed with our
products. We believe that procedures performed using our products, or targeted
for use by products that do not yet have regulatory clearance or approval, are
generally already reimbursable under government programs and most private plans.
Accordingly, we believe providers in the U.S. will generally not be required to
obtain new billing authorizations or codes in order to be compensated for
performing medically necessary procedures using our products on insured
patients. We cannot assure you that reimbursement policies of third-party payors
will not change in the future with respect to some or all of the procedures
using the Stereotaxis System. See "Item 1A--Risk Factors" for a discussion of
various risks associated with reimbursement from third-party payors.
INTELLECTUAL PROPERTY
Our strategy is to patent the technology, inventions and improvements that
we consider important to the development of our business. As a result, we have
an extensive patent portfolio that we believe protects the fundamental scope of
our technology, including our magnet technology, navigational methods,
procedures, systems, disposables interventional devices and our 3D integration
technology. As of December 31, 2006, we had 56 issued U.S. patents, 6
exclusively licensed U.S. patents, 1 exclusively licensed non-U.S. patent and 3
non-exclusively licensed U.S. patents. In addition, we had 113 pending U.S.
patent applications, 7 co-owned U.S. patent applications, 9 licensed U.S. patent
applications, 28 pending non-U.S. patent applications, and 20 Patent Cooperation
Treaty applications. We also have a number of invention disclosures under
consideration and several applications that are being prepared for filing.
Accordingly, we anticipate that the number of pending U.S. patent applications
will increase.
The patent positions of medical device companies, including ours, can be
highly uncertain and involve complex and evolving legal and factual questions.
One or more of the above patent applications may be denied. In addition, our
issued patents may be challenged, based on prior art circumvented or otherwise
not provide protection for the products we develop. Furthermore, we may not be
able to obtain patent licenses from third parties required for the development
of new products for use with our system. We also note that U.S. patents and
patent applications may be subject to interference proceedings and U.S. patents
may be subject to reexamination proceedings in the U.S. Patent and Trademark
Office (and foreign patents may be subject to opposition or comparable
proceedings in the corresponding foreign patent office), which proceedings could
result in either loss of the patent or denial of the patent application or loss
or reduction in the scope of one or more of the claims of the patent or patent
application. In addition, such interference, reexamination and opposition
proceedings may be costly. In the event that we seek to enforce any of our owned
or exclusively licensed patents against an infringing party, it is likely that
the party defending the claim will seek to invalidate the patents we assert,
which, if successful could result in the entire loss of our patent or the
relevant portion of our patent and not just with respect to that particular
infringer. Any litigation to enforce or defend our patents rights, even if we
were to prevail, could be costly and time-consuming and would divert the
attention of our management and key personnel from our business operations.
It would be technically difficult and costly to reverse engineer our
Stereotaxis System, which contains numerous complex algorithms that control our
disposable devices inside the magnetic fields generated by the Stereotaxis
System. We further believe that our patent portfolio is broad enough in scope to
enable us to obtain legal relief if any entity not licensed by us attempted to
market disposable devices that can be navigated by the NIOBE system. We can also
utilize plastic security keys, with embedded smart chips and associated software
that allow our system to recognize specific disposable interventional devices in
order to prevent unauthorized use of our system.
19
We have also developed substantial know-how in magnet design, magnetic
physics and magnetic instrument control that was developed in connection with
the development of the Stereotaxis System, which we maintain as trade secrets.
This centers around our proprietary magnet design, which is a critical aspect of
our ability to design, manufacture and install a cost-effective magnetic
navigation system that is small enough to be installed in a standard cath lab.
We seek to protect our proprietary information by requiring our employees,
consultants, contractors, outside partners and other advisers to execute
nondisclosure and assignment of invention agreements upon commencement of their
employment or engagement, through which we seek to protect our intellectual
property. These agreements to protect our unpatented technology provide only
limited and possibly inadequate protection of our rights. Third parties may
therefore be able to use our unpatented technology, reducing our ability to
compete. In addition, employees, consultants and other parties to these
agreements may breach them and adequate remedies may not be available to us for
their breaches. Many of our employees were previously employed at universities
or other medical device companies, including potential competitors. We could in
the future be subject to claims that these employees or we have used or
disclosed trade secrets or other proprietary information of their former
employers. Litigation may be necessary to defend against these claims. If we
fail in defending such claims, in addition to paying monetary damages, we may
lose valuable intellectual property rights or personnel. Even if we are
successful in defending against these claims, litigation could result in
substantial costs and divert the attention of management and key personnel from
our business operations. We also generally seek confidentiality agreements from
third parties that receive our confidential data or materials.
Our intellectual property involves certain risks and uncertainties. Please
refer to "Item 1A--Risk Factors" in this annual report for a description of
these risks and uncertainties.
COMPETITION
The markets for medical devices are intensely competitive and are
characterized by rapid technological advances, frequent new product
introductions, evolving industry standards and price erosion.
We consider our primary competition to be existing manual catheter-based
interventional techniques and surgical procedures. To our knowledge, we are the
only company that has commercialized remote, digital and direct control of the
working tip of catheters and guidewires for interventional use. Our success
depends in part on convincing hospitals and physicians to convert existing
interventional procedures to computer-assisted procedures.
We expect to face competition from companies that are developing new
approaches and products for use in interventional procedures, including robotic
approaches that may be directly competitive with our technology. We are aware of
one public company that is currently developing a catheter delivery system which
might compete with the Stereotaxis System and one private company at a much
earlier stage of development. Many of these companies have an established
presence in the field of interventional cardiology, including the major imaging,
capital equipment and disposables companies that are currently selling products
in the cath lab. We also face competition from companies who currently market or
are developing drugs or gene therapies to treat the conditions for which our
products are intended.
We believe that the primary competitive factors in the market we address
are capability, safety, efficacy, ease of use, price, quality, reliability and
effective sales, support, training and service. The length of time required for
products to be developed and to receive regulatory and reimbursement
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approval is also an important competitive factor. See "Item 1A--Risk Factors"
for a discussion of other competitive risks facing our business.
GOVERNMENT REGULATION
The healthcare industry, and thus our business, is subject to extensive
federal, state, local and foreign regulation. Some of the pertinent laws have
not been definitively interpreted by the regulatory authorities or the courts,
and their provisions are open to a variety of interpretations. In addition,
these laws and their interpretations are subject to change.
Both federal and state governmental agencies continue to subject the
healthcare industry to intense regulatory scrutiny, including heightened civil
and criminal enforcement efforts. As indicated by work plans and reports issued
by these agencies, the federal government will continue to scrutinize, among
other things, the billing practices of healthcare providers and the marketing of
healthcare products. The federal government also has increased funding in recent
years to fight healthcare fraud, and various agencies, such as the U.S.
Department of Justice, the Office of Inspector General of the Department of
Health and Human Services, or OIG, and state Medicaid fraud control units, are
coordinating their enforcement efforts.
We believe that we have structured our business operations and
relationships with our customers to comply with all applicable legal
requirements. However, it is possible that governmental entities or other third
parties could interpret these laws differently and assert otherwise. We discuss
below the statutes and regulations that are most relevant to our business and
most frequently cited in enforcement actions.
U.S. Food and Drug Administration, or FDA, Regulation
The Food and Drug Administration strictly regulates the medical devices we
produce under the authority of the Federal Food, Drug and Cosmetic Act, or
FFDCA, the regulations promulgated under the FFDCA, and other federal and state
statutes and regulations. The FFDCA governs, among other things, the
pre-clinical and clinical testing, design, manufacture, safety, efficacy,
labeling, storage, record keeping, post market reporting and advertising and
promotion of medical devices.
Our medical devices are categorized under the statutory framework
described in the FFDCA. This framework is a risk-based system which classifies
medical devices into three classes from lowest risk (Class I) to highest risk
(Class III). In general, Class I and II devices are either exempt from the need
for FDA clearance or cleared for marketing through a premarket notification, or
510(k), process. Our devices that are considered to be general tools, such as
our NIOBE magnetic navigation system and our suite of guidewires, or that
provide diagnostic information, such as our TANGENT electrophysiology mapping
catheters, are subject to 510(k) requirements. These devices are cleared for use
as general tools which have utility in a variety of interventional procedures.
Our therapeutic devices, such as our HELIOS II ablation catheters, are subject
to the premarket approval, or PMA, process.
If clinical data are needed to support a marketing application for our
devices, generally, an investigational device exemption, or IDE, is assembled
and submitted to the FDA. The FDA reviews and must approve the IDE before the
study can begin. In addition, the study must be approved by an Institutional
Review Board covering each clinical site. When all approvals are obtained, we
initiate a clinical study to evaluate the device. Following completion of the
study, we collect, analyze and present the data in an appropriate submission to
the FDA, either a 510(k) or PMA.
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Under the 510(k) process, the FDA determines whether or not the device is
"substantially equivalent" to a predicate device. In making this determination,
the FDA compares both the new device and the predicate device. If the two
devices are comparable in intended use, safety, and effectiveness, the device
may be cleared for marketing.
Under the PMA process, the FDA examines detailed data relating to the
safety and effectiveness of the device. This information includes design,
development, manufacture, labeling, advertising, pre-clinical testing, and
clinical study data. Prior to approving the PMA, the FDA generally will conduct
an inspection of the facilities producing the device and one or more clinical
sites where the study was conducted. The facility inspection evaluates the
company's readiness to commercially produce and distribute the device. The
inspection includes an evaluation of compliance under the Quality System
Regulation (QSR). Under certain circumstances, the FDA may convene an advisory
panel meeting to seek review of the data presented in the PMA. If the FDA's
evaluation is favorable, the PMA is approved, and we can market the device in
the U.S. The FDA may approve the PMA with conditions, such as post-market
surveillance requirements.
We evaluate changes made following 510(k) clearance or PMA approval for
significance and if appropriate, make a subsequent submission to the FDA. In the
case of a significant change being made to a 510(k) device, we submit a new
510(k). For a PMA device, we will either need approval through a PMA supplement
or will need to notify the FDA.
For our 510(k) devices, we design the submission to cover multiple models
or variations in order to minimize the number of submissions. For our PMA
devices, we often rely upon the PMA approvals of our strategic partners to
utilize the PMA supplement regulatory path rather than pursue an original PMA.
Because of the differences in the amount of data and numbers of patients in
clinical trials, a PMA supplement process is often much shorter than the amount
of time and data required for approval of an original PMA.
Currently our NIOBE magnetic navigation system, NAVIGANT advanced user
interface, CARDIODRIVE catheter advancement system, the CRONUS and ASSERT
families of coronary guidewires, TANGENT electrophysiology mapping catheter and
TITAN family of guidewire have been cleared by the FDA to be used in
interventional procedures. We have received the CE Mark for our HELIOS II
electrophysiology ablation catheter and, in the U.S., we have filed a PMA for
this device. In addition, we have received the CE Mark for our NIOBE magnetic
navigation system, NAVIGANT advanced user interface, CARDIODRIVE catheter
advancement system, the CRONUS and ASSERT family of coronary guidewires and our
family of TITAN guidewires. In addition, Biosense Webster received FDA approval
for the CELSIUS(R) RMT Diagnostic/Ablation Steerable Tip Catheter and the
NAVISTAR(R) RMT Diagnostic/Ablation Steerable Tip Catheter as described above.
Foreign Regulation
In order for us to market our products in other countries, we must obtain
regulatory approvals and comply with extensive safety and quality regulations in
other countries. These regulations, including the requirements for approvals or
clearance and the time required for regulatory review, vary from country to
country. Failure to obtain regulatory approval in any foreign country in which
we plan to market our products may harm our ability to generate revenue and harm
our business.
The primary regulatory environment in Europe is that of the European
Union, which consists of 25 countries encompassing most of the major countries
in Europe. The European Union requires that manufacturers of medical products
obtain the right to affix the CE Mark to their products before selling them in
member countries of the European Union. The CE Mark is an international
22
symbol of adherence to quality assurance standards and compliance with
applicable European medical device directives. In order to obtain the right to
affix the CE Mark to products, a manufacturer must obtain certification that its
processes meet certain European quality standards. Compliance with the Medical
Device Directive, as certified by a recognized European Notified Body, permits
the manufacturer to affix the CE Mark on its products and commercially
distribute those products throughout the European Union.
We have received the right to affix the CE Mark to each of our products
that has received 510(k) clearance in the U.S. and also for our HELIOS II
ablation catheter. We have not applied for the right to affix the CE Mark to our
TANGENT mapping catheter as it is not currently marketed. If we modify existing
products or develop new products in the future, including new devices, we will
need to apply for permission to affix the CE Mark to such products. We will be
subject to regulatory audits, currently conducted biannually, in order to
maintain any CE Mark permissions we have already obtained. We cannot be certain
that we will be able to obtain permission to affix the CE Mark for new or
modified products or that we will continue to meet the quality and safety
standards required to maintain the permissions we have already received. If we
are unable to maintain permission to affix the CE Mark to our products, we will
no longer be able to sell our products in member countries of the European
Union.
Through Siemens and in collaboration with Biosense, we intend to submit an
application for regulatory approval to commence a clinical study with the
Japanese Ministry of Health, Labor and Welfare for commercial use of the
Stereotaxis System in Japan. Siemens has agreed to coordinate the regulatory
approval process and act as distributor for our NIOBE magnetic navigation system
and NAVIGANT advanced user interface in Japan. We have received regulatory
approval for our system and for our TANGENT mapping catheter and the NIOBE
magnetic navigation system in China. We will continue to pursue regulatory
approval of additional devices. We will evaluate regulatory approval in other
foreign countries on an opportunistic basis.
In addition, Biosense Webster has obtained the right to affix the CE Mark
to the CELSIUS(R) RMT Diagnostic/Ablation Steerable Tip Catheter and the
NAVISTAR(R) RMT and NAVISTAR(R) RMT DS Diagnostic/Ablation Steerable Tip
Catheter as described above.
Anti-Kickback Statute
The federal healthcare program Anti-Kickback Statute prohibits persons
from knowingly and willfully soliciting, offering, receiving or providing
remuneration, directly or indirectly, in exchange for or to induce either the
referral of an individual, or furnishing or arranging for a good or service, for
which payment may be made under a federal healthcare program such as the
Medicare and Medicaid programs. The definition of "remuneration" has been
broadly interpreted to include anything of value, including for example gifts,
discounts, the furnishing of supplies or equipment, credit arrangements,
payments of cash and waivers of payments. Several courts have interpreted the
statute's intent requirement to mean that if any one purpose of an arrangement
involving remuneration is to induce referrals of federal healthcare covered
business, the statute has been violated. Penalties for violations include
criminal penalties and civil sanctions such as fines, imprisonment and possible
exclusion from Medicare, Medicaid and other federal healthcare programs. In
addition, some kickback allegations have been claimed to violate the Federal
False Claims Act, discussed in more detail below.
The Anti-Kickback Statute is broad and prohibits many arrangements and
practices that are lawful in businesses outside of the healthcare industry.
Recognizing that the Anti-Kickback Statute is broad and may technically prohibit
many innocuous or beneficial arrangements, Congress authorized
23
the OIG to issue a series of regulations, known as the "safe harbors" which it
did, beginning in July of 1991. These safe harbors set forth provisions that, if
all their applicable requirements are met, will assure healthcare providers and
other parties that they will not be prosecuted under the federal Anti-Kickback
Statute. The failure of a transaction or arrangement to fit precisely within one
or more safe harbors does not necessarily mean that it is illegal or that
prosecution will be pursued. However, conduct and business arrangements that do
not fully satisfy each applicable safe harbor may result in increased scrutiny
by government enforcement authorities such as the OIG.
Many states have adopted laws similar to the federal Anti-Kickback
Statute. Some of these state prohibitions apply to referral of patients for
healthcare items or services reimbursed by any source, not only the Medicare and
Medicaid programs.
Government officials have focused their enforcement efforts on marketing
of healthcare services and products, among other activities, and recently have
brought cases against sales personnel who allegedly offered unlawful inducements
to potential or existing customers in an attempt to procure their business. As
part of our compliance program, we have established a formal Clinical Compliance
Committee and appointed a Clinical Compliance Officer to help ensure compliance
with the Anti-Kickback Statute and similar state laws and we train our employees
on our healthcare compliance policies. However, we cannot rule out the
possibility that the government or other third parties could interpret these
laws differently and assert otherwise.
HIPAA
The Health Insurance Portability and Accountability Act of 1996, or HIPAA,
created two new federal crimes: healthcare fraud and false statements relating
to healthcare matters. The healthcare fraud statute prohibits knowingly and
willfully executing a scheme to defraud any healthcare benefit program,
including private payors. A violation of this statute is a felony and may result
in fines, imprisonment or exclusion from government sponsored programs. The
false statements statute prohibits knowingly and willfully falsifying,
concealing or covering up a material fact or making any materially false,
fictitious or fraudulent statement in connection with the delivery of or payment
for healthcare benefits, items or services. A violation of this statute is a
felony and may result in fines or imprisonment.
In addition to creating the two new federal healthcare crimes, HIPAA also
establishes uniform standards governing the conduct of certain electronic
healthcare transactions and protecting the security and privacy of individually
identifiable health information maintained or transmitted by healthcare
providers, health plans and healthcare clearinghouses. Two standards have been
promulgated under HIPAA: the Standards for Privacy of Individually Identifiable
Health Information, which restrict the use and disclosure of certain
individually identifiable health information, and the Standards for Electronic
Transactions, which establish standards for common healthcare transactions, such
as claims information, plan eligibility, payment information and the use of
electronic signatures. In addition, the Security Standards required covered
entities to implement certain security measures to safeguard certain electronic
health information by April 21, 2005. Although we believe we are not a covered
entity and therefore do not need to comply with these standards, our customers
generally are covered entities and frequently ask us to comply with certain
aspects of these standards. While the government intended this legislation to
reduce administrative expenses and burdens for the healthcare industry, our
compliance with certain provisions of these standards may entail significant and
costly changes for us. If we fail to comply with these standards, it is possible
that we could be subject to criminal penalties.
In addition to federal regulations issued under HIPAA, some states and
foreign countries have enacted privacy and security statutes or regulations
that, in some cases, are more stringent than those
24
issued under HIPAA. In those cases, it may be necessary to modify our operations
and procedures to comply with the more stringent state laws, which may entail
significant and costly changes for us. We believe that we are in compliance with
such state laws and regulations. However, if we fail to comply with applicable
state laws and regulations, we could be subject to additional sanctions.
Federal False Claims Act
Another trend affecting the healthcare industry is the increased use of
the federal False Claims Act and, in particular, actions under the False Claims
Act's "whistleblower" or "qui tam" provisions. Those provisions allow a private
individual to bring actions on behalf of the government alleging that the
defendant has defrauded the federal government. The government must decide
whether to intervene in the lawsuit and to become the primary prosecutor. If it
declines to do so, the individual may choose to pursue the case alone, although
the government must be kept apprised of the progress of the lawsuit. Whether or
not the federal government intervenes in the case, it will receive the majority
of any recovery. If the individual's litigation is successful, the individual is
entitled to no less than 15%, but no more than 30%, of whatever amount the
government recovers. In recent years, the number of suits brought against
healthcare providers by private individuals has increased dramatically. In
addition, various states have enacted laws modeled after the federal False
Claims Act.
When an entity is determined to have violated the federal False Claims
Act, it may be required to pay up to three times the actual damages sustained by
the government, plus civil penalties from $5,500 to $11,000 for each separate
false claim. There are many potential bases for liability under the federal
False Claims Act. Liability arises, primarily, when an entity knowingly submits,
or causes another to submit, a false claim for reimbursement to the federal
government. Although simple negligence should not give rise to liability,
submitting a claim with reckless disregard or deliberate ignorance of its truth
or falsity could result in substantial civil liability. The False Claims Act has
been used to assert liability on the basis of inadequate care, improper
referrals, and improper use of Medicare numbers when detailing the provider of
services, in addition to the more predictable allegations as to
misrepresentations with respect to the services rendered. We are unable to
predict whether we could be subject to actions under the False Claims Act, or
the impact of such actions. However, the costs of defending claims under the
False Claims Act, as well as sanctions imposed under the Act, could
significantly affect our financial performance.
Certificate of Need Laws
In approximately two-thirds of the states, a certificate of need or
similar regulatory approval is required prior to the acquisition of high-cost
capital items or various types of advanced medical equipment, such as our
Stereotaxis System. At present, many of the states in which we sell Stereotaxis
Systems have laws that require institutions located in those states to obtain a
certificate of need in connection with the purchase of our system, and some of
our purchase orders are conditioned upon our customer's receipt of necessary
certificate of need approval. Certificate of need laws were enacted to contain
rising health care costs, prevent the unnecessary duplication of health
resources, and increase patient access for health services. In practice,
certificate of need laws have prevented hospitals and other providers who have
been unable to obtain a certificate of need from acquiring new equipment or
offering new services. A further increase in the number of states regulating our
business through certificate of need or similar programs could adversely affect
us. Moreover, some states may have additional requirements. For example, we
understand that California's certificate of need law also incorporates seismic
safety requirements which must be met before a hospital can acquire our
Stereotaxis System.
25
Employees
As of December 31, 2006, we had 180 employees, 55 of whom were engaged
directly in research and development, 62 in sales and marketing activities, 18
in manufacturing and service, 21 in regulatory, clinical affairs and quality
activities, 7 in training activities and 17 in general administrative and
accounting activities. None of our employees is covered by a collective
bargaining agreement, and we consider our relationship with our employees to be
good.
Availability of Information
We make certain filings with the SEC, including our annual report on Form
10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and all
amendments and exhibits to those reports, available free of charge in the
Investor Relations section of our website, http://www.stereotaxis.com, as soon
as reasonably practicable after they are filed with the SEC. The filings are
also available through the SEC at the SEC's Public Reference Room at 100 F
Street, N.E., Washington, D.C. 20549 or by calling 1-800-SEC-0330. Further,
these filings are available on the Internet at http://www.sec.gov. Information
contained on our website is not part of this report and such information is not
incorporated by reference into this report.
ITEM 1A. RISK FACTORS
The following uncertainties and factors, among others, could affect future
performance and cause actual results to differ materially from those expressed
or implied by forward looking statements.
Hospital decision-makers may not purchase our Stereotaxis System or may think
that it is too expensive.
The market for our products and related technology is not well
established. To achieve continued sales, hospitals must purchase our products,
and in particular, our NIOBE magnetic navigation system. The NIOBE magnetic
navigation system, which is the core of our Stereotaxis System, is a novel
device, and hospitals and physicians are traditionally slow to adopt new
products and treatment practices. In addition, hospitals may delay their
purchase or installation decision based on the disposable interventional devices
that have received regulatory clearance or approval. Moreover, the Stereotaxis
System is an expensive piece of capital equipment, representing a significant
portion of the cost of a new or replacement cath lab. If hospitals do not widely
adopt our Stereotaxis System, or if they decide that it is too expensive, we may
never become profitable. Any failure to sell as many Stereotaxis Systems as our
business plan requires could also have a seriously detrimental impact on our
results of operations, financial condition and cash flow.
Physicians may not use our products if they do not believe they are safe and
effective.
We believe that physicians will not use our products unless they determine
that the Stereotaxis System provides a safe, effective and preferable
alternative to interventional methods in general use today. Currently, there is
only limited clinical data on the Stereotaxis System with which to assess safety
and efficacy. If longer-term patient studies or clinical experience indicate
that treatment with our system or products is less effective, less efficient or
less safe than our current data suggest, our sales would be harmed, and we could
be subject to significant liability. Further, unsatisfactory patient outcomes or
patient injury could cause negative publicity for our products, particularly in
the early phases of product introduction. In addition, physicians may be slow to
adopt our products if they perceive liability risks arising from the use of
these new products. It is also
26
possible that as our products become more widely used, latent defects could be
identified, creating negative publicity and liability problems for us and
adversely affecting demand for our products. If physicians do not use our
products, we likely will not become profitable or generate sufficient cash to
survive as a going concern.
Our collaborations with Siemens, Philips, Biosense Webster or other parties may
fail, or we may not be able to enter into additional partnerships or
collaborations in the future.
We are collaborating with Siemens, Philips, Biosense Webster and other
parties to integrate our instrument control technology with their respective
imaging products or disposable interventional devices and to co-develop
additional disposable interventional devices for use with our Stereotaxis
System. For the immediate future, a significant portion of our revenue from
system sales will be derived from these integrated products. Siemens has agreed
to provide post-installation maintenance and support services to our customers
for our integrated systems and we are in discussions with Philips to provide the
same.
Our product commercialization plans could be disrupted, leading to lower
than expected revenue and a material and adverse impact on our results of
operations and cash flow, if:
o any of our collaboration partners delays or fails in the integration of
its technology with our Stereotaxis System as planned;
o any of our collaboration partners does not co-market and co-promote our
integrated products diligently or does not provide maintenance and support
services as we expect; or
o we become involved in disputes with one or more of our collaboration
partners regarding our collaborations.
Siemens, Philips and Biosense Webster, as well as some of our other
collaborators, are large, global organizations with diverse product lines and
interests that may diverge from our interests in commercializing our products.
Accordingly, our collaborators may not devote adequate resources to our
products, or may experience financial difficulties, change their business
strategy or undergo a business combination that may affect their willingness or
ability to fulfill their obligations to us. In particular, we have had only
limited experience with respect to the integration of our system with Philips'
imaging products.
The failure of one or more of our collaborations could have a material
adverse effect on our financial condition, results of operations and cash flow.
In addition, if we are unable to enter into additional partnerships in the
future, or if these partnerships fail, our ability to develop and commercialize
products could be impacted negatively and our revenue could be adversely
affected.
Investors may have difficulty evaluating our business and operating results
because we are still in the early stages of commercializing our products.
We have been engaged in research and product development since our
inception in 1990. Our initial focus was on the development of neurosurgical
applications for our technology, and during the first several years following
our inception, we devoted our resources primarily to developing prototypes and
performing research and development activities in this area. Starting around
1998, we shifted our primary focus to developing applications for our technology
to treat cardiovascular disease and, in 2003, began limited commercial shipments
of products we developed for treatment in this area. To date, our investments in
our products have produced relatively little revenue, and our operating expenses
are high relative to that revenue. Our lack of a significant operating history
also impairs an investor's ability to make a comparative evaluation of us, our
products and our prospects.
27
We have limited experience selling, marketing and distributing products, which
could impair our ability to increase revenue.
We currently market our products in the U.S., Europe and the rest of the
world through a direct sales force of sales specialists, distributors and sales
agents, supported by account managers and clinical specialists who provide
training, clinical support, and other services to our customers. If we are
unable to increase our sales force or effectively utilize our existing sales
force significantly in the foreseeable future, we may be unable to generate the
revenue we have projected in our business plan. Factors that may inhibit our
sales and marketing efforts include:
o our inability to recruit and retain adequate numbers of qualified sales
and marketing personnel;
o the inability of sales personnel to obtain access to or persuade adequate
numbers of hospitals and physicians to purchase and use our products;
o unforeseen costs associated with maintaining and expanding an independent
sales and marketing organization; and
o increased government scrutiny with respect to marketing activities in the
health care industry.
In addition, if we fail to effectively use distributors or contract sales
persons for distribution of our products where appropriate, our revenue and
profitability would be adversely affected.
Our marketing strategy is dependent on collaboration with physician "thought
leaders."
Our research and development efforts and our marketing strategy depend
heavily on obtaining support and collaboration from highly regarded physicians
at leading commercial and research hospitals, particularly in the U.S. and
Europe. If we are unable to gain and/or maintain such support and collaboration
or if the reputation or standing of these physicians is impaired or otherwise
adversely affected, our ability to market the Stereotaxis System and, as a
result, our financial condition, results of operations and cash flow could be
materially and adversely affected.
We may not be able to rapidly train physicians in numbers sufficient to generate
adequate demand for our products.
In order for physicians to learn to use the Stereotaxis System, they must
attend one or more training sessions in order to familiarize themselves with a
sophisticated user interface. Market acceptance could be delayed by lack of
physician willingness to attend training sessions or by the time required to
complete this training. An inability to train a sufficient number of physicians
to generate adequate demand for our products could have a material adverse
impact on our financial condition and cash flow.
Customers may choose to purchase competing products and not ours.
Our products must compete with established manual interventional methods.
These methods are widely accepted in the medical community, have a long history
of use and do not require the purchase of an additional expensive piece of
capital equipment. In addition, many of the medical conditions that can be
treated using our products can also be treated with existing pharmaceuticals or
other medical devices and procedures. Many of these alternative treatments are
widely accepted in the medical community and have a long history of use.
28
We also face competition from companies that are developing drugs or other
medical devices or procedures to treat the conditions for which our products are
intended. The medical device and pharmaceutical industries make significant
investments in research and development, and innovation is rapid and continuous.
For example, we are aware of one public company that is developing a catheter
delivery system that could compete with the Stereotaxis System and an earlier
stage private one. However, to the best of our knowledge, their products have
not been commercialized. If these or other new products or technologies emerge
that provide the same or superior benefits as our products at equal or lesser
cost, it could render our products obsolete or unmarketable. We cannot be
certain that physicians will use our products to replace or supplement
established treatments or that our products will be competitive with current or
future products and technologies.
Many of our other competitors also have longer operating histories,
significantly greater financial, technical, marketing and other resources,
greater name recognition and a larger base of customers than we do. In addition,
as the markets for medical devices develop, additional competitors could enter
the market. We cannot assure you that we will be able to compete successfully
against existing or new competitors. Our revenue would be reduced or eliminated
if our competitors develop and market products that are more effective and less
expensive than our products.
If we are unable to fulfill our current purchase orders and other commitments on
a timely basis or at all, we may not be able to achieve future sales growth.
Our backlog, which consists of purchase orders and other commitments is
considered by some investors to be a significant indicator of future
performance. Consequently, negative changes to this backlog or its failure to
grow commensurate with expectations could negatively impact our future operating
results or our share price. Our backlog includes those outstanding purchase
orders and other commitments that management believes will result in recognition
of revenue upon delivery or installation of our systems. We cannot assure you
that we will recognize revenue in any particular period or at all because some
of our purchase orders and other commitments are subject to contingencies that
are outside our control. In addition, these orders and commitments may be
revised, modified or cancelled, either by their express terms, as a result of
negotiations or by project changes or delays. System installation is by its
nature subject to the cath lab construction or renovation process which
comprises multiple stages, all of which are outside of our control. Although the
actual installation of our system requires only a few weeks, and can be
accomplished by either our staff or by subcontractors, successful installation
of our system can be subjected to delays related to the overall construction or
renovation process. If we experience any failures or delays in completing the
installation of these systems, our reputation would suffer and we may not be
able to sell additional systems. We have experienced situations in which our
purchase orders and other commitments did not result in recognizing revenue from
placement of a system with a customer. In addition to construction delays, there
are risks that an institution will attempt to cancel a purchase order as a
result of subsequent project review by the institution or the departure from the
institution of physicians or physician groups who have expressed an interest in
the Niobe system.
These, or similar events, have occurred in the past and are likely to
occur in the future, causing delays in revenue recognition or even removal of
orders and other commitments from our backlog. Such events could have a negative
effect on our revenue and results of operations.
29
We will likely experience long and variable sales and installation cycles, which
could result in substantial fluctuations in our quarterly results of operations.
We anticipate that our system will continue to have a lengthy sales cycle
because it consists of a relatively expensive piece of capital equipment, the
purchase of which requires the approval of senior management at hospitals,
inclusion in the hospitals' cath lab budget process for capital expenditures,
and, in some instances, a certificate of need from the state or other regulatory
approval. In addition, our system has historically been installed six to eight
months after the receipt of a purchase order from a hospital depending on the
construction cycle for the new or replacement interventional suite in which the
equipment will be installed. In some cases, this time frame has been extended
further because the interventional suite construction is part of a larger
construction project at the customer site (typically the construction of a new
building), which may occur with our existing and future purchase orders. This
may contribute to substantial fluctuations in our quarterly operating results.
As a result, in future quarters our operating results could fall below the
expectations of securities analysts or investors, in which event our stock price
would likely decrease.
If the magnetic fields generated by our system are not compatible with, or
interfere with, other widely used equipment in the cath lab, sales of our
products would be negatively affected.
Our system generates magnetic fields that directly govern the motion of
the internal, or working, tip of disposable interventional devices. If other
equipment in the cath lab or elsewhere in a hospital is incompatible with the
magnetic fields generated by our system, or if our system interferes with such
equipment, we may be required to install additional shielding, which may be
expensive and which may not solve the problem. Although we have modified our
shielding approach, if magnetic interference is a problem at additional
institutions, it would increase our installation costs at those institutions and
could limit the number of hospitals that would be willing to purchase and
install our systems, either of which would adversely affect our financial
condition, results of operations and cash flow.
The use of our products could result in product liability claims that could be
expensive, divert management's attention and harm our reputation and business.
Our business exposes us to significant risks of product liability claims.
The medical device industry has historically been litigious, and we could face
product liability claims if the use of our products were to cause injury or
death. The coverage limits of our product liability insurance policies may not
be adequate to cover future claims, and we may be unable to maintain product
liability insurance in the future at satisfactory rates or adequate amounts. A
product liability claim, regardless of its merit or eventual outcome, could
divert management's attention, result in significant legal defense costs,
significant harm to our reputation and a decline in revenue.
Our costs could substantially increase if we receive a significant number of
warranty claims.
We generally warrant each of our products against defects in materials and
workmanship for a period of 12 months following the installation of our system.
If product returns or warranty claims increase, we could incur unanticipated
additional expenditures for parts and service. In addition, our reputation and
goodwill in the cath lab market could be damaged. While we have established
reserves for liability associated with product warranties, unforeseen warranty
exposure in excess of those reserves could materially and adversely affect our
financial condition, results of operations and cash flow.
30
We may not generate cash from operations necessary to commercialize our existing
products and invest in new products.
We may require additional funds to meet our working capital and capital
expenditure needs in the future. We cannot be certain that we will be able to
obtain additional financing on favorable terms or at all. If we need additional
capital and cannot raise it on acceptable terms, we may not be able to, among
other things:
o enhance our existing products or develop new ones;
o expand our operations;
o hire, train and retain employees; or
o respond to competitive pressures or unanticipated capital requirements.
Our failure to do any of these things could result in lower revenue and
adversely affect our financial condition and results of operations, and we may
have to curtail or cease operations.
We have incurred substantial losses in the past and may not be profitable in the
future.
We have incurred substantial net losses since inception, and we expect to
incur substantial net losses in 2007 and into 2008 as we seek additional
regulatory approvals, launch new products and generally continue to scale up our
sales and marketing operations to continue the commercialization of our
products. We may not be successful in completing the development or
commercialization of our technology. Moreover, the extent of our future losses
and the timing of profitability are highly uncertain, and we may never achieve
profitable operations. If we require more time than we expect to generate
significant revenue and achieve profitability, we may not be able to continue
our operations. Our failure to achieve profitability could negatively impact the
market price of our common stock. Even if we do become profitable, we may not be
able to sustain or increase profitability on a quarterly or annual basis.
Furthermore, even if we achieve significant revenue, we may choose to pursue a
strategy of increasing market penetration and presence or expand or accelerate
new product development or clinical research activities at the expense of
profitability.
Our reliance on contract manufacturers and on suppliers, and in some cases, a
single supplier, could harm our ability to meet demand for our products in a
timely manner or within budget.
We depend on contract manufacturers to produce and assemble most of the
components of our systems and other products such as our guidewires and
electrophysiology catheters. We also depend on various third party suppliers for
the magnets we use in our NIOBE magnetic navigation systems. In addition, some
of the components necessary for the assembly of our products are currently
provided to us by a single supplier, including the magnets for our NIOBE
magnetic navigation system, and we generally do not maintain large volumes of
inventory. Our reliance on these third parties involves a number of risks,
including, among other things, the risk that:
o we may not be able to control the quality and cost of our system or
respond to unanticipated changes and increases in customer orders;
o we may lose access to critical services and components, resulting in an
interruption in the manufacture, assembly and shipment of our systems; and
o we may not be able to find new or alternative components for our use or
reconfigure our system and manufacturing processes in a timely manner if
the components necessary for our system become unavailable.
31
If any of these risks materialize, it could significantly increase our costs and
impair product delivery.
Lead times for materials and components ordered by us and our contract
manufacturers vary and depend on factors such as the specific supplier, contract
terms and demand for a component at a given time. We and our contract
manufacturers acquire materials, complete standard subassemblies and assemble
fully configured systems based on sales forecasts. If orders do not match
forecasts, we and our contract manufacturers may have excess or inadequate
inventory of materials and components.
In addition, if these manufacturers or suppliers stop providing us with
the components or services necessary for the operation of our business, we may
not be able to identify alternate sources in a timely fashion. Any transition to
alternate manufacturers or suppliers would likely result in operational problems
and increased expenses and could delay the shipment of, or limit our ability to
provide, our products. We cannot assure you that we would be able to enter into
agreements with new manufacturers or suppliers on commercially reasonable terms
or at all. Additionally, obtaining components from a new supplier may require a
new or supplemental filing with applicable regulatory authorities and clearance
or approval of the filing before we could resume product sales. Any disruptions
in product flow may harm our ability to generate revenue, lead to customer
dissatisfaction, damage our reputation and result in additional costs or
cancellation of orders by our customers.
We also rely on our collaboration partner, Biosense Webster, and other
parties to manufacture a number of disposable interventional devices for use
with our Stereotaxis System. If these parties cannot manufacture sufficient
quantities of disposable interventional devices to meet customer demand, or if
their manufacturing processes are disrupted, our revenue and profitability would
be adversely affected.
Risks associated with international manufacturing and trade could negatively
impact the availability and cost of our products because materials used to
manufacture our magnets, one of our key system components, are sourced from
Japan.
We purchase the permanent magnets for our NIOBE magnetic navigation system
from a manufacturer that uses material produced in Japan, and we anticipate that
certain of the production work for these magnets will be performed for this
manufacturer in China. In addition, our subcontractor purchases magnets for our
disposable interventional devices directly from a manufacturer in Japan. Any
event causing a disruption of imports, including the imposition of import
restrictions, could adversely affect our business. The flow of components from
our vendors could also be adversely affected by financial or political
instability in any of the countries in which the goods we purchase are
manufactured, if the instability affects the production or export of product
components from those countries. Trade restrictions in the form of tariffs or
quotas, or both, could also affect the importation of those product components
and could increase the cost and reduce the supply of products available to us.
In addition, decreases in the value of the U.S. dollar against foreign
currencies could increase the cost of products we purchase from overseas
vendors.
We have limited experience in manufacturing and assembling our products and may
encounter problems at our manufacturing facilities or those of our
subcontractors or otherwise experience manufacturing delays that could result in
lost revenue.
We do not have extensive experience in manufacturing, assembling or
testing our products on a commercial scale as we subcontract the manufacture,
assembly and testing of our NIOBE magnetic navigation system and our disposable
devices. We may be unable to meet the expected future demand for our Stereotaxis
System. In addition, the products we design may not satisfy all of
32
the performance requirements and we may need to improve or modify the design or
ask our subcontractors to modify their production process in order to do so. We
or our subcontractors may experience quality problems, substantial costs and
unexpected delays related to efforts to upgrade and expand manufacturing,
assembly and testing capabilities. If we incur delays due to quality problems or
other unexpected events, we will be unable to produce a sufficient supply of
product necessary to meet our future growth expectations.
We may be unable to protect our technology from use by third parties.
Our commercial success will depend in part on obtaining patent and other
intellectual property right protection for the technologies contained in our
products and on successfully defending these rights against third party
challenges. The patent positions of medical device companies, including ours,
can be highly uncertain and involve complex and evolving legal and factual
questions. We cannot assure you that we will obtain the patent protection we
seek, that any protection we do obtain will be found valid and enforceable if
challenged or that it will confer any significant commercial advantage. U.S.
patents and patent applications may also be subject to interference proceedings
and U.S. patents may be subject to re-examination proceedings in the U.S. Patent
and Trademark Office, and foreign patents may be subject to opposition or
comparable proceedings in the corresponding foreign patent office, which
proceedings could result in either loss of the patent or denial of the patent
application or loss, or reduction in the scope of one or more of the claims of,
the patent or patent application. In addition, such interference, re-examination
and opposition proceedings may be costly. Thus, any patents that we own or
license from others may not provide any protection against competitors. Our
pending patent applications, those we may file in the future or those we may
license from third parties may not result in patents being issued. If issued,
they may not provide us with proprietary protection or competitive advantages
against competitors with similar technology.
Some of our technology was developed in conjunction with third parties,
and thus there is a risk that a third party may claim rights in our intellectual
property. Outside the U.S., we rely on third-party payment services for the
payment of foreign patent annuities and other fees. Non-payment or delay in
payment of such fees, whether intentional or unintentional, may result in loss
of patents or patent rights important to our business. Many countries, including
certain countries in Europe, have compulsory licensing laws under which a patent
owner may be compelled to grant licenses to third parties (for example, the
patent owner has failed to "work" the invention in that country, or the third
party has patented improvements). In addition, many countries limit the
enforceability of patents against government agencies or government contractors.
In these countries, the patent owner may have limited remedies, which could
materially diminish the value of the patent. We also cannot assure you that we
will be able to develop additional patentable technologies. If we fail to obtain
adequate patent protection for our technology, or if any protection we obtain
becomes limited or invalidated, others may be able to make and sell competing
products, impairing our competitive position.
Our trade secrets, nondisclosure agreements and other contractual
provisions to protect unpatented technology provide only limited and possibly
inadequate protection of our rights. As a result, third parties may be able to
use our unpatented technology, and our ability to compete in the market would be
reduced. In addition, employees, consultants and others who participate in
developing our products or in commercial relationships with us may breach their
agreements with us regarding our intellectual property, and we may not have
adequate remedies for the breach.
Our competitors may independently develop similar or alternative
technologies or products that are equal or superior to our technology and
products without infringing any of our patent or other intellectual property
rights, or may design around our proprietary technologies. In addition, the
33
laws of some foreign countries do not protect intellectual property rights to
the same extent as do the laws of the U.S., particularly in the field of medical
products and procedures.
Third parties may assert that we are infringing their intellectual property
rights.
Successfully commercializing our products will depend in part on not
infringing patents held by third parties. It is possible that one or more of our
products, including those that we have developed in conjunction with third
parties, infringes existing patents. We may also be liable for patent
infringement by third parties whose products we use or combine with our own and
for which we have no right to indemnification. In addition, because patent
applications are maintained under conditions of confidentiality and can take
many years to issue, there may be applications now pending of which we are
unaware and which may later result in issued patents that our products infringe.
Determining whether a product infringes a patent involves complex legal and
factual issues and may not become clear until finally determined by a court in
litigation. Our competitors may assert that our products infringe patents held
by them. Moreover, as the number of competitors in our market grows, the
possibility of a patent infringement claim against us increases. If we were not
successful in obtaining a license or redesigning our products, we could be
subject to litigation. If we lose in this kind of litigation, a court could
require us to pay substantial damages or prohibit us from using technologies
essential to our products covered by third-party patents. An inability to use
technologies essential to our products would have a material adverse effect on
our financial condition, results of operations and cash flow and could undermine
our ability to continue operating as a going concern.
Expensive intellectual property litigation is frequent in the medical device
industry.
Infringement actions, validity challenges and other intellectual property
claims and proceedings, whether with or without merit, can be expensive and
time-consuming and would divert management's attention from our business. We
have incurred, and expect to continue to incur, substantial costs in obtaining
patents and may have to incur substantial costs defending our proprietary
rights. Incurring such costs could have a material adverse effect on our
financial condition, results of operations and cash flow.
We may not be able to obtain all the licenses from third parties necessary for
the development of new products.
As we develop additional disposable interventional devices for use with
our system, we may find it advisable or necessary to seek licenses or otherwise
make payments in exchange for rights from third parties who hold patents
covering technology used in specific interventional procedures. For example, in
2005 we made a substantial payment to the University of Virginia Patent
Foundation to eliminate any requirement for us to pay royalties on Stereotaxis
products that address clinical applications in the cardiovascular, peripheral
vascular and certain other clinical fields. If we cannot obtain the desired
licenses or rights, we could be forced to try to design around those patents at
additional cost or abandon the product altogether, which could adversely affect
revenue and results of operations. If we have to abandon a product, our ability
to develop and grow our business in new directions and markets would be
adversely affected.
Our products and related technologies can be applied in different industries,
and we may fail to focus on the most profitable areas.
The Stereotaxis System is designed to have the potential for expanded
applications beyond electrophysiology and interventional cardiology, including
congestive heart failure, structural heart repair, interventional neurosurgery,
interventional neuroradiology, peripheral vascular, pulmonology,
34
urology, gynecology and gastrointestinal medicine. However, we have limited
financial and managerial resources and therefore may be required to focus on
products in selected industries and to forego efforts with regard to other
products and industries. Our decisions may not produce viable commercial
products and may divert our resources from more profitable market opportunities.
Moreover, we may devote resources to developing products in these additional
areas but may be unable to justify the value proposition or otherwise develop a
commercial market for products we develop in these areas, if any. In that case,
the return on investment in these additional areas may be limited, which could
negatively affect our results of operations.
We may be subject to damages resulting from claims that our employees or we have
wrongfully used or disclosed alleged trade secrets of their former employers.
Many of our employees were previously employed at hospitals, universities
or other medical device companies, including our competitors or potential
competitors. We could in the future be subject to claims that these employees or
we have used or disclosed trade secrets or other proprietary information of
their former employers. Litigation may be necessary to defend against these
claims. If we fail in defending such claims, in addition to paying monetary
damages, we may lose valuable intellectual property rights or personnel. Even if
we are successful in defending against these claims, litigation could result in
substantial costs and be a distraction to management. Incurring such costs could
have a material adverse effect on our financial condition, results of operations
and cash flow.
If we or our strategic partners fail to obtain or maintain necessary FDA
clearances or approvals for our medical device products, or if such clearances
or approvals are delayed, we will be unable to continue to commercially
distribute and market our products.
Our products are medical devices that are subject to extensive regulation
in the U.S. and in foreign countries where we do business. Unless an exemption
applies, each medical device that we wish to market in the U.S. must first
receive either 510(k) clearance or pre-market approval, or PMA, from the U.S.
Food and Drug Administration pursuant to the Federal Food, Drug, and Cosmetic
Act. The FDA's 510(k) clearance process usually takes from four to 12 months,
but it can take longer. The process of obtaining PMA approval is much more
costly, lengthy and uncertain, generally taking from one to three years or even
longer. Although we have 510(k) clearance for our current Stereotaxis System,
including a limited number of disposable interventional devices, and are able to
market our system commercially in the U.S., our business model relies
significantly on revenue from additional disposable interventional devices for
which there is no current FDA clearance or approval. We cannot commercially
market our unapproved disposable interventional devices in the U.S. until the
necessary clearance or approvals from the FDA have been received. Until such
time, we can only supply these devices to research institutions for permitted
investigational use. In addition, we are working with third parties to
co-develop disposable products. In some cases, these companies are responsible
for obtaining appropriate regulatory clearance or approval to market these
disposable devices. If these clearances or approvals are not received or are
substantially delayed or if we are not able to offer a sufficient array of
approved disposable interventional devices, we may not be able to successfully
market our system to as many institutions as we currently expect, which could
have a material adverse impact on our financial condition, results of operations
and cash flow.
Furthermore, obtaining 510(k) clearances, pre-market approvals, or PMAs,
or premarket approval supplements, or PMA supplements, from the FDA could result
in unexpected and significant costs for us and consume management's time and
other resources. The FDA could ask us to supplement our submissions, collect
non-clinical data, conduct clinical trials or engage in other time-consuming
actions, or it could simply deny our applications. In addition, even if we
obtain a 510(k) clearance or PMA or PMA supplement approval, the clearance or
approval could be revoked
35
or other restrictions imposed if post-market data demonstrates safety issues or
lack of effectiveness. We cannot predict with certainty how, or when, the FDA
will act. Obtaining regulatory approvals in foreign markets entails similar
risks and uncertainties and can involve additional product testing and
additional administrative review periods. If we are unable to obtain the
necessary regulatory approvals, our financial condition and cash flow may be
adversely affected. Also, a failure to obtain approvals may limit our ability to
grow domestically and internationally.
If we or our strategic partners fail to obtain regulatory approvals in other
countries for products under development, we will not be able to commercialize
these products in those countries.
In order to market our products outside of the U.S., we and our strategic
partners must establish and comply with numerous and varying regulatory
requirements of other countries regarding safety and efficacy. Approval
procedures vary among countries and can involve additional product testing and
additional administrative review periods. The time required to obtain approval
in other countries might differ from that required to obtain FDA approval. The
regulatory approval process in other countries may include all of the risks
detailed above regarding FDA approval in the U.S. Regulatory approval in one
country does not ensure regulatory approval in another, but a failure or delay
in obtaining regulatory approval in one country may negatively impact the
regulatory process in others. Failure to obtain regulatory approval in other
countries or any delay or setback in obtaining such approval could have the same
adverse effects described above regarding FDA approval in the U.S. In addition,
we are relying on our strategic partners in some instances to assist us in this
regulatory approval process in countries outside the U.S. and Europe, for
example, in Japan and China.
We may fail to comply with continuing regulatory requirements of the FDA and
other authorities and become subject to substantial penalties.
Even after product clearance or approval, we must comply with continuing
regulation by the FDA and other authorities, including the FDA's Quality System
Regulation, or QSR, requirements, labeling and promotional requirements and
medical device adverse event and other reporting requirements. Any failure to
comply with continuing regulation by the FDA or other authorities could result
in enforcement action that may include suspension or withdrawal of regulatory
approvals, recalling products, ceasing product marketing, seizure and detention
of products, paying significant fines and penalties, criminal prosecution and
similar actions that could limit product sales, delay product shipment and harm
our profitability.
Additionally, any modification to an FDA 510(k)-cleared device that could
significantly affect its safety or effectiveness, or that would constitute a
major change in its intended use, requires a new 510(k) clearance. Device
modifications to a PMA approved device or its labeling may require either a new
PMA or PMA supplement approval, which could be a costly and lengthy process. In
the future, we may modify our products after they have received clearance or
approval, and we may determine that new clearance or approval is unnecessary. We
cannot assure you that the FDA would agree with any of our decisions not to seek
new clearance or approval. If the FDA requires us to seek clearance or approval
for any modification, we also may be required to cease marketing or recall the
modified product until we obtain FDA clearance or approval which could also
limit product sales, delay product shipment and harm our profitability. In
addition, Congress could amend the Federal Food, Drug and Cosmetic Act, and the
FDA could modify its regulations promulgated under this law in a way so as to
make ongoing regulatory compliance more burdensome and difficult.
In many foreign countries in which we market our products, we are subject
to regulations affecting, among other things, product standards, packaging
requirements, labeling requirements,
36
import restrictions, tariff regulations, duties and tax requirements. Many of
these regulations are similar to those of the FDA. In addition, in many
countries the national health or social security organizations require our
products to be qualified before procedures performed using our products become
eligible for reimbursement. Failure to receive, or delays in the receipt of,
relevant foreign qualifications could have a material adverse effect on our
business, financial condition and results of operations. Due to the movement
toward harmonization of standards in the European Union, we expect a changing
regulatory environment in Europe characterized by a shift from a
country-by-country regulatory system to a European Union-wide single regulatory
system. We cannot predict the timing of this harmonization and its effect on us.
Adapting our business to changing regulatory systems could have a material
adverse effect on our business, financial condition and results of operations.
If we fail to comply with applicable foreign regulatory requirements, we may be
subject to fines, suspension or withdrawal of regulatory approvals, product
recalls, seizure of products, operating restrictions and criminal prosecution.
Our suppliers or subcontractors or we may fail to comply with the FDA quality
system regulation.
Our manufacturing processes must comply with the FDA's quality system
regulation, or QSR, which covers the methods and documentation of the design,
testing, production, control, quality assurance, labeling, packaging and
shipping of our products. The FDA enforces the QSR through inspections. We
cannot assure you that we or our suppliers or subcontractors would pass such an
inspection. If we or our suppliers or subcontractors fail to remain in
compliance with the FDA or ISO 9001 standards, we or they may be required to
cease all or part of our operations for some period of time until we or they can
demonstrate that appropriate steps have been taken to comply with such
standards. We cannot be certain that our facilities or those of our suppliers or
subcontractors will comply with the FDA or ISO 9001 standards in future audits
by regulatory authorities. Failure to pass such an inspection could force a shut
down of manufacturing operations, a recall of our products or the imposition of
other sanctions, which would significantly harm our revenue and profitability.
Further, we cannot assure you that our key component suppliers are or will
continue to be in compliance with applicable regulatory requirements and will
not encounter any manufacturing difficulties. Any failure to comply with the
FDA's QSR by us or our suppliers could significantly harm our available
inventory and product sales.
Software or other defects may be discovered in our products.
Our products incorporate many components, including sophisticated computer
software. Complex software frequently contains errors, especially when first
introduced. Because our products are designed to be used to perform complex
interventional procedures, we expect that physicians and hospitals will have an
increased sensitivity to the potential for software defects. We cannot assure
you that our software or other components will not experience errors or
performance problems in the future. If we experience software errors or
performance problems, we would likely also experience:
o loss of revenue;
o delay in market acceptance of our products;
o damage to our reputation;
o additional regulatory filings;
o product recalls;
o increased service or warranty costs; and/or
o product liability claims relating to the software defects.
37
If we fail to comply with health care regulations, we could face substantial
penalties and our business, operations and financial condition could be
adversely affected.
While we do not control referrals of health care services or bill directly
to Medicare, Medicaid or other third-party payors, many health care laws and
regulations apply to our business. We could be subject to health care fraud and
patient privacy regulation by both the federal government and the states in
which we conduct our business. The regulations that may affect our ability to
operate include:
o the federal healthcare program Anti-Kickback Law, which prohibits, among
other things, persons from soliciting, receiving or providing
remuneration, directly or indirectly, to induce either the referral of an
individual, for an item or service or the purchasing or ordering of a good
or service, for which payment may be made under federal health care
programs such as the Medicare and Medicaid programs;
o federal false claims laws which prohibit, among other things, individuals
or entities from knowingly presenting, or causing to be presented, claims
for payment from Medicare, Medicaid, or other third-party payors that are
false or fraudulent, and which may apply to entities like us which provide
coding and billing advice to customers;
o the federal Health Insurance Portability and Accountability Act of 1996,
or HIPAA, which prohibits executing a scheme to defraud any health care
benefit program or making false statements relating to health care matters
and which also imposes certain requirements relating to the privacy,
security and transmission of individually identifiable health information;
o state law equivalents of each of the above federal laws, such as
anti-kickback and false claims laws which may apply to items or services
reimbursed by any third-party payor, including commercial insurers, and
state laws governing the privacy of health information in certain
circumstances, many of which differ from each other in significant ways
and often are not preempted by HIPAA, thus complicating compliance
efforts; and
o Federal self-referral laws, such as STARK, which prohibits a physician
from making a referral to a provider of certain health services with which
the physician or the physician's family member has a financial interest.
If our operations are found to be in violation of any of the laws
described above or any other governmental regulations that apply to us, we may
be subject to penalties, including civil and criminal penalties, damages, fines,
loss of reimbursement for our products under federal or state government health
programs such as Medicare and Medicaid and the curtailment or restructuring of
our operations. Any penalties, damages, fines, curtailment or restructuring of
our operations could adversely affect our ability to operate our business and
our financial results. The risk of our being found in violation of these laws is
increased by the fact that many of them have not been fully interpreted by the
regulatory authorities or the courts, and their provisions are open to a variety
of interpretations. Any action against us for violation of these laws, even if
we successfully defend against it, could cause us to incur significant legal
expense and divert our management's attention from the operation of our
business. Moreover, to achieve compliance with applicable federal and state
privacy, security, and electronic transaction laws, we may be required to modify
our operations with respect to the handling of patient information. Implementing
these modifications may prove costly. At this time, we are not able to determine
the full consequences to us, including the total cost of compliance, of these
various federal and state laws.
38
The application of state certificate of need regulations and compliance with
federal and state licensing or other international requirements could
substantially limit our ability to sell our products and grow our business.
Some states require health care providers to obtain a certificate of need
or similar regulatory approval prior to the acquisition of high-cost capital
items such as our Stereotaxis System. In many cases, a limited number of these
certificates are available. As a result of this limited availability, hospitals
and other health care providers may be unable to obtain a certificate of need
for the purchase of our Stereotaxis System. Further, our sales and installation
cycle for the Stereotaxis System is typically longer in certificate of need
states due to the time it takes our customers to obtain the required approvals.
In addition, our customers must meet various federal and state regulatory and/or
accreditation requirements in order to receive payments from
government-sponsored health care programs such as Medicare and Medicaid, receive
full reimbursement from third party payors and maintain their customers. Our
international customers may be required to meet similar or other requirements.
Any lapse by our customers in maintaining appropriate licensure, certification
or accreditation, or the failure of our customers to satisfy the other necessary
requirements under government-sponsored health care programs or other
requirements, could cause our sales to decline.
Hospitals or physicians may be unable to obtain reimbursement from third-party
payors for procedures using the Stereotaxis System, or reimbursement for
procedures may be insufficient to recoup the costs of purchasing our products.
We expect that U.S. hospitals will continue to bill various third-party
payors, such as Medicare, Medicaid and other government programs and private
insurance plans, for procedures performed with our products, including the costs
of the disposable interventional devices used in these procedures. If in the
future our disposable interventional devices do not fall within U.S.
reimbursement categories and our procedures are not reimbursed, or if the
reimbursement is insufficient to cover the costs of purchasing our system and
related disposable interventional devices, the adoption of our systems and
products would be significantly slowed or halted, and we may be unable to
generate sufficient sales to support our business. Our success in international
markets also depends upon the eligibility of our products for reimbursement
through government-sponsored health care payment systems and third-party payors.
In both the U.S. and foreign markets, health care cost-containment efforts are
prevalent and are expected to continue. These efforts could reduce levels of
reimbursement available for procedures involving our products and, therefore,
reduce overall demand for our products as well. A failure to generate sufficient
sales could have a material adverse impact on our financial condition, results
of operations and cash flow.
We may lose our key personnel or fail to attract and retain additional
personnel.
We are highly dependent on the principal members of our management,
scientific and sales staff. To pursue our plans and accommodate planned growth,
we may choose to hire additional personnel. Attracting and retaining qualified
personnel will be critical to our success, and competition for qualified
personnel is intense. We may not be able to attract and retain personnel on
acceptable terms given the competition for qualified personnel among technology
and healthcare companies and universities. The loss of personnel or our
inability to attract and retain other qualified personnel could harm our
business and our ability to compete. In addition, the loss of members of our
scientific staff may significantly delay or prevent product development and
other business objectives. A loss of key sales personnel could result in a
reduction of revenue.
39
Our growth will place a significant strain on our resources, and if we fail to
manage our growth, our ability to develop, market and sell our products will be
harmed.
Our business plan contemplates a period of substantial growth and business
activity. This growth and activity will likely result in new and increased
responsibilities for management personnel and place significant strain upon our
operating and financial systems and resources. To accommodate our growth and
compete effectively, we will be required to improve our information systems,
create additional procedures and controls and expand, train, motivate and manage
our work force. We cannot be certain that our personnel, systems, procedures and
controls will be adequate to support our future operations. Any failure to
effectively manage our growth could impede our ability to successfully develop,
market and sell our products.
We face currency and other risks associated with international sales.
We intend to continue to devote significant efforts to marketing our
systems and products outside of the U.S. This strategy will expose us to
numerous risks associated with international operations, which could adversely
affect our results of operations and financial condition, including the
following:
o currency fluctuations that could impact the demand for our products or
result in currency exchange losses;
o export restrictions, tariff and trade regulations and foreign tax laws;
o customs duties, export quotas or other trade restrictions;
o economic and political instability; and
o shipping delays.
In addition, contracts may be difficult to enforce and receivables
difficult to collect through a foreign country's legal system.
Risks Related To Our Common Stock
Our principal stockholders continue to own a large percentage of our voting
stock, and they have the ability to substantially influence matters requiring
stockholder approval.
As of December 31, 2006, our executive officers, directors and individuals
or entities affiliated with them beneficially own or control a substantial
percentage of the outstanding shares of our common stock. Accordingly, these
executive officers, directors and their affiliates, acting as a group, will have
substantial influence over the outcome of corporate actions requiring
stockholder approval, including the election of directors, any merger,
consolidation or sale of all or substantially all of our assets or any other
significant corporate transaction. These stockholders may also delay or prevent
a change of control, even if such a change of control would benefit our other
stockholders. This significant concentration of stock ownership may adversely
affect the trading price of our common stock due to investors' perception that
conflicts of interest may exist or arise.
We have never paid dividends on our capital stock, and we do not anticipate
paying any cash dividends in the foreseeable future.
We have paid no cash dividends on any of our classes of capital stock to
date and we currently intend to retain our future earnings to fund the
development and growth of our business. In addition, the terms of our loan
agreement prohibit us from declaring dividends without the prior consent of our
lender. As a result, capital appreciation, if any, of our common stock will be
an investor's sole source of gain for the foreseeable future.
40
Our certificate of incorporation and bylaws, Delaware law and one of our
alliance agreements contain provisions that could discourage a takeover.
Our certificate of incorporation and bylaws and Delaware law contain
provisions that might enable our management to resist a takeover. These
provisions may:
o discourage, delay or prevent a change in the control of our company or a
change in our management;
o adversely affect the voting power of holders of common stock; and
o limit the price that investors might be willing to pay in the future for
shares of our common stock.
In addition, our alliance with Biosense Webster, contains provisions that
may similarly discourage a takeover and negatively affect our share price as
described above.
Sales of a substantial number of shares of our common stock in the public
market, or the perception that they may occur, may depress the market price of
our common stock.
Sales of substantial amounts of our common stock in the public market, or
the perception that substantial sales may be made, could cause the market price
of our common stock to decline. These sales might also make it more difficult
for us to sell equity securities at a time and price that we deem appropriate.
Evolving regulation of corporate governance and public disclosure may result in
additional expenses and continuing uncertainty.
Changing laws, regulations and standards relating to corporate governance
and public disclosure, including the Sarbanes-Oxley Act of 2002, new SEC
regulations and NASDAQ Global Market rules are creating uncertainty for public
companies. We continue to evaluate and monitor developments with respect to new
and proposed rules and cannot predict or estimate the amount of the additional
compliance costs we may incur or the timing of such costs. These new or changed
laws, regulations and standards are subject to varying interpretations, in many
cases due to their lack of specificity, and as a result, their application in
practice may evolve over time as new guidance is provided by courts and
regulatory and governing bodies. This could result in continuing uncertainty
regarding compliance matters and higher costs necessitated by ongoing revisions
to disclosure and governance practices. Maintaining appropriate standards of
corporate governance and public disclosure may result in increased general and
administrative expense and a diversion of management time and attention from
revenue-generating activities to compliance activities. In addition, if we fail
to comply with new or changed laws, regulations and standards, regulatory
authorities may initiate legal proceedings against us and our business and
reputation may be harmed.
Our future operating results may be below securities analysts' or investors'
expectations, which could cause our stock price to decline.
The revenue and income potential of our products and our business model
are unproven, and we may be unable to generate significant revenue or grow at
the rate expected by securities analysts or investors. In addition, our costs
may be higher than we, securities analysts or investors expect. If we fail to
generate sufficient revenue or our costs are higher than we expect, our results
of operations will suffer, which in turn could cause our stock price to decline.
Our results of operations will depend upon numerous factors, including:
41
o demand for our products;
o the performance of third-party contract manufacturers and component
suppliers;
o our ability to develop sales and marketing capabilities;
o the success of our collaborations with Siemens, Philips and Biosense
Webster and others;
o our ability to develop, introduce and market new or enhanced versions of
our products on a timely basis;
o our ability to obtain regulatory clearances or approvals for our new
products; and
o our ability to obtain and protect proprietary rights.
Our operating results in any particular period may not be a reliable
indication of our future performance. In some future quarters, our operating
results may be below the expectations of securities analysts or investors. If
this occurs, the price of our common stock will likely decline.
We expect that the price of our common stock could fluctuate substantially,
possibly resulting in class action securities litigation.
We have only been publicly traded since August 12, 2004. A limited number
of our shares trade actively in the market. The market price of our common stock
will be affected by a number of factors, including:
o actual or anticipated variations in our results of operations or those of
our competitors;
o the receipt or denial of regulatory approvals;
o announcements of new products, technological innovations or product
advancements by us or our competitors;
o developments with respect to patents and other intellectual property
rights;
o changes in earnings estimates or recommendations by securities analysts or
our failure to achieve analyst earnings estimates; and
o developments in our industry.
The stock prices of many companies in the medical device industry have
experienced wide fluctuations that have often been unrelated to the operating
performance of these companies. Following periods of volatility in the market
price of a company's securities, stockholders have often instituted class action
securities litigation against those companies. Class action securities
litigation, if instituted against us, could result in substantial costs and a
diversion of our management resources, which could significantly harm our
business.
ITEM 1B. UNRESOLVED STAFF COMMENTS
We have nor received any written comments regarding our periodic or
current reports from the staff of the SEC that were issued 180 days or more
preceding the end of our 2006 fiscal year and that remain unresolved.
ITEM 2. PROPERTIES
Our primary company facilities are located in St. Louis, Missouri where we
lease approximately 34,000 square feet of office and 12,000 square feet of
demonstration and assembly space. This space is leased under an agreement that
expires in 2015.
We also lease approximately 10,000 square feet in Maple Grove, Minnesota.
The Minnesota facility is leased through May 31, 2010.
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ITEM 3. LEGAL PROCEEDINGS
We are involved from time to time in various lawsuits and claims arising
in the normal course of business. Although the outcomes of these lawsuits and
claims are uncertain, we do not believe any of them will have a material adverse
effect on our business, financial condition or results of operations.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
No matters were submitted to a vote of security holders during the quarter
ended December 31, 2006.
43
ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND
ISSUER PURCHASES OF EQUITY SECURITIES
PRICE RANGE OF COMMON STOCK
Our common stock has been traded on The NASDAQ Global Market under the
symbol "STXS" since August 12, 2004. The following table sets forth the high and
low closing prices of our common stock for the periods indicated and reported by
NASDAQ.
Quarter Ended High Low
------------- ---- ---
Year Ended December 31, 2006
First Quarter $14.67 $8.77
Second Quarter 12.22 8.98
Third Quarter 11.72 8.17
Fourth Quarter 12.55 9.88
Year Ended December 31, 2005
First Quarter $10.43 $7.61
Second Quarter 8.09 6.08
Third Quarter 10.15 7.41
Fourth Quarter 9.11 5.83
As of February 28, 2007, there were approximately 155 stockholders of
record of our common stock, although we believe that there is a significantly
larger number of beneficial owners of our common stock.
DIVIDEND POLICY
We have never declared or paid any cash dividends. We currently expect to
retain earnings for use in the operation and expansion of our business, and
therefore do not anticipate paying any cash dividends for the next several
years.
The information required by this item regarding equity compensation is
incorporated by reference to the information set forth in Item 12 of this Annual
Report on Form 10-K.
44
ITEM 6. SELECTED FINANCIAL DATA
The following selected consolidated financial data has been derived from,
and should be read in conjunction with our consolidated financial statements and
the accompanying notes and "Management's Discussion and Analysis of Financial
Condition and Results of Operations" included elsewhere in this report. The
selected data in this section is not intended to replace the consolidated
financial statements. Historical results are not indicative of the results to be
expected in the future.
Year Ended December 31,
2006 2005 2004 2003 2002
-------------------------------------------------------------------------------
Consolidated Statements of
Operations Data:
Revenue $ 27,191,706 $ 15,026,390 $ 18,816,860 $ 5,014,877 $ 18,900
Cost of revenue 12,892,749 7,720,706 10,672,262 4,051,313 39,760
-------------------------------------------------------------------------------
Gross margin 14,298,957 7,305,684 8,144,598 963,564 (20,860)
-------------------------------------------------------------------------------
Operating costs and expenses:
Research and development 21,794,177 17,829,282 17,215,414 13,590,922 14,742,015
Sales and marketing 22,533,882 16,106,621 11,447,857 5,999,310 2,230,565
General and administrative 16,642,359 14,449,326 6,900,016 5,323,682 4,528,637
Royalty settlement -- 2,923,111 -- -- --
-------------------------------------------------------------------------------
Total operating expenses 60,970,418 51,308,340 35,563,287 24,913,914 21,501,217
-------------------------------------------------------------------------------
Operating loss (46,671,461) (44,002,656) (27,418,689) (23,950,350) (21,522,077)
Interest and other income (expense), net 951,691 444,821 161,220 (86,487) 63,419
-------------------------------------------------------------------------------
Net loss $ (45,719,770) $ (43,557,835) $ (27,257,469) $(24,036,837) $(21,458,658)
===============================================================================
Basic and diluted net loss per common share (1) $ (1.39) $ (1.60) $ (2.38) $ (18.37) $ (19.21)
===============================================================================
Shares used in computing basic and
diluted net loss per common share 32,979,403 27,301,822 11,470,310 1,308,805 1,117,301
===============================================================================
Consolidated Balance Sheet Data:
Cash, cash equivalents and short-term
investments $ 36,983,781 $ 10,735,587 $ 45,648,834 $ 26,480,612 $ 28,834,123
Working capital 40,383,798 15,896,719 50,404,840 22,764,719 25,483,149
Total assets 69,290,660 36,658,189 71,044,697 37,323,419 32,920,872
Long-term debt, less current maturities 305,556 1,972,222 1,000,000 2,243,768 2,281,321
Accumulated deficit (203,950,839) (158,231,069) (114,673,234) (87,415,765) (63,378,928)
Total stockholders' equity 44,788,992 18,125,842 58,394,468 25,266,428 24,006,646
(1) The one-for-3.6 reverse stock split effective as of July 2004 has been
reflected in the calculation of the basic and diluted net loss per share
for all periods presented above.
45
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
The following discussion and analysis should be read in conjunction with
our financial statements and notes thereto included in this report on Form 10-K.
Operating results are not necessarily indicative of results that may occur in
future periods.
This report includes various forward-looking statements that are subject
to risks and uncertainties, many of which are beyond our control. Our actual
results could differ materially from those anticipated in these forward looking
statements as a result of various factors, including those set forth in Item 1A.
"Risk Factors." Forward-looking statements discuss matters that are not
historical facts. Forward-looking statements include, but are not limited to,
discussions regarding our operating strategy, sales and marketing strategy,
regulatory strategy, industry, economic conditions, financial condition,
liquidity and capital resources and results of operations. Such statements
include, but are not limited to, statements preceded by, followed by or that
otherwise include the words "believes," "expects," "anticipates," "intends,"
"estimates," "projects," "can," "could," "may," "will," "would," or similar
expressions. For those statements, we claim the protection of the safe harbor
for forward-looking statements contained in the Private Securities Litigation
Reform Act of 1995. You should not unduly rely on these forward-looking
statements, which speak only as of the date on which they were made. They give
our expectations regarding the future but are not guarantees. We undertake no
obligation to update publicly or revise any forward-looking statements, whether
as a result of new information, future events or otherwise, unless required by
law.
Overview
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 externally applied magnetic fields that govern the
motion of the working tip of the catheter or guidewire, resulting in improved
navigation, efficient procedures and reduced x-ray exposure. The core components
of the Stereotaxis System have received regulatory clearance in the U.S., Canada
and Europe.
We believe that our system represents a revolutionary technology in the
interventional surgical suite, or "cath lab", and has the potential to become
the standard of care for a broad range of complex cardiology procedures. We also
believe that our system is the only technology to be commercialized that allows
remote, computerized control of catheters and guidewires directly at their
working tip. We also believe that our technology represents an important advance
in the ongoing trend toward digital instrumentation in the cath lab and provides
substantial, clinically important improvements and cost efficiencies over manual
interventional methods, which require years of physician training and often
result in long and unpredictable procedure times and sub-optimal therapeutic
outcomes.
From our inception in June 1990 through 2002, our principal activities
were obtaining capital, business development, performing research and
development activities, funding prototype development, funding clinical trials
and funding collaborations to integrate our products with other interventional
technologies. Accordingly, we were classified as a development stage company for
accounting purposes through December 31, 2002.
Our initial focus was on the development of neurosurgical applications for
our technology, including delivery of devices to specific sites within the
brain. During that time, we primarily devoted our resources to developing
prototypes and performing research and development activities in this area.
Following receipt of FDA approval to begin human clinical trials in the field of
brain biopsies,
46
we successfully completed our initial human clinical procedures in this area in
late 1998. Over the next two years, we shifted our primary focus to developing
applications for our technology to treat cardiovascular diseases because of the
significantly larger market opportunities for these applications. During 2003,
following receipt of marketing clearance from the FDA for our current system, we
emerged from the development stage and began to generate revenue from the
placement of investigational systems and the commercial launch of our cardiology
system in the U.S. and Europe.
In August 2004, we completed an initial public offering in which we issued
and sold 5,500,000 shares of our common stock at $8.00 per share. In September
2004, the underwriters exercised an option to purchase 462,352 additional
shares. In connection with the initial public offering (including the
over-allotment option exercise), we received approximately $41.4 million in net
proceeds. In February 2006, we completed an underwritten take-down of our common
stock from our shelf registration in which we issued and sold 5,500,000 shares
of our common stock at $12.00 per share including the underwriters' exercise of
their option to purchase an additional 500,000 shares. In conjunction with the
February 2006 shelf take-down, we received approximately $61.7 million in net
proceeds. Since our inception, we have generated significant losses. As of
December 31, 2006, we had incurred cumulative net losses of approximately $204
million. We expect to incur additional losses into 2008 as we continue the
development and commercialization of our products, conduct our research and
development activities and advance new products into clinical development from
our existing research programs and fund our sales and marketing initiatives. We
believe that by the end of 2008 we will be positioned to achieve break-even
operating performance.
We have alliances with each of Siemens AG Medical Solutions, Philips
Medical Systems and Biosense Webster, Inc., through which we integrate our
Stereotaxis System with market leading digital imaging and 3D catheter location
sensing technology, as well as disposable interventional devices, in order to
continue to develop new solutions in the cath lab. Each of these alliances
provides for coordination of our sales and marketing activities with those of
our partners. In addition, Siemens has agreed to provide worldwide service for
our integrated systems.
Critical Accounting Policies and Estimates
Our discussion and analysis of our financial condition and results of
operations are based on our financial statements, which have been prepared in
accordance with U.S. generally accepted accounting principles. The preparation
of these financial statements requires us to make estimates and judgments that
affect the reported amounts of assets, liabilities, revenue and expenses and
related disclosures. We review our estimates and judgments on an on-going basis.
We base our estimates and judgments on historical experience and on various
other assumptions that we believe to be reasonable under the circumstances.
Actual results may differ from these estimates. We believe the following
accounting policies are critical to the judgments and estimates we use in
preparing our financial statements.
Revenue Recognition
For arrangements with multiple deliverables, we allocate the total revenue
to each deliverable based on its relative fair value in accordance with the
provisions of Emerging Issues Task Force (EITF) Issue No. 00-21, Revenue
Arrangements with Multiple Deliverables, and recognize revenue for each separate
element as the above criteria are met.
When installation is a required part of our contractual obligation to a
customer but not considered a separate element, we recognize revenue from system
sales upon installation, provided there are no uncertainties regarding
acceptance, persuasive evidence of an arrangement exists, the sales price is
fixed and determinable, and collection of the related receivable is reasonably
assured. The determination of acceptance is made by our employees based on
criteria set forth in the terms of the sale. Revenue from system sales where
installation is the responsibility of the customer is recognized upon shipment
since these arrangements do not include an installation element or right of
return privileges. If uncertainties exist regarding collectability, we recognize
revenue when those uncertainties are resolved. Amounts collected prior to
satisfying the above revenue recognition criteria are reflected as deferred
revenue.
47
Amounts due beyond 12 months are reflected as long term receivables in the
balance sheet. Revenue from services is derived primarily from the sale of
annual product maintenance plans. Revenue from services and license fees,
whether sold individually or as a separable unit of accounting in a
multi-element arrangement, is deferred and amortized over the service or license
fee period, which is typically one year. We recognize revenue from disposable
device sales or accessories upon shipment and establish an appropriate reserve
for returns.
Stock-based Compensation
Effective January 1, 2006, we adopted the fair value recognition
provisions of Financial Accounting Standards Board Statement No. 123(R),
"Share-Based Payment" ("SFAS 123(R)"), using the modified prospective transition
method to account for its grants of stock options, stock appreciation rights,
restricted shares and share purchases under our employee stock purchase plan.
Prior to January 1, 2006, we accounted for those plans under the provisions of
Accounting Principles Board (APB) Opinion No. 25, Accounting for Stock Issued to
Employees, and related interpretations in accounting for stock-based employee
compensation as permitted by SFAS 123, Accounting for Stock-Based Compensation.
SFAS 123(R) supersedes APB Opinion No. 25 and requires the determination of the
fair value of the share-based compensation at the grant date and the recognition
of the related expense over the period in which the share-based compensation
vests.
Stock compensation expense, which is a non-cash charge, results from stock
option and stock appreciation rights grants made to employees, directors and
consultants at the fair value of the option granted, from grants of restricted
shares to employees and from share purchases by employees under our employee
stock purchase plan. The fair value of options and stock appreciation rights
granted was determined using the Black-Scholes valuation method which gives
consideration to the estimated value of the underlying stock at the date of
grant, the exercise price of the option, the expected dividend yield and
volatility of the underlying stock, the expected life of the option and the
corresponding risk-free interest rate. When we were a private company, the
deemed fair value of the underlying common stock was determined by management
and the Board of Directors based on their best estimates using information from
preferred stock financing transactions or other significant changes in the
business. The fair value of the grants of restricted shares, all of which were
granted after we became a public company, was determined based on the closing
price of our stock on the date of grant. Stock compensation expense for options,
stock appreciation rights and for time-based restricted share grants is
amortized on a straight-line basis over the vesting period of the underlying
issue, generally over four years except for grants to directors which generally
vest over one to two years. Stock compensation expense for performance-based
restricted shares is amortized on a straight-line basis over the anticipated
vesting period and is subject to adjustment based on the actual achievement of
objectives. Compensation expenses related to option grants to non-employees is
periodically remeasured through the vesting date. Compensation expense is
recognized only for those options expected to vest, with forfeitures estimated
based on our historical experience and future expectations.
The amount of compensation expense to be recorded in future periods may
increase if we make additional grants of options, stock appreciation rights or
restricted shares or if employees continue to purchase shares under our employee
stock purchase plan or if we determine that actual forfeiture rates are less
than anticipated. The amount of expense to be recorded in future periods may
decrease if we do not achieve the performance objectives by which certain
restricted shares are
48
contingent, if the requisite service periods are not completed or if the actual
forfeiture rates are greater than anticipated.
Additional detail regarding the adoption of SFAS 123(R) may be found in
the notes to the financial statements which are included elsewhere in this
Annual Report or Form 10-K.
Investments
In accordance with SFAS No. 115, Accounting for Certain Investments in
Debt and Equity Securities, our investment securities are classified as
available-for-sale and are carried at market value, which approximates cost.
Realized gains or losses, calculated based on the specific identification
method, were not material for the periods presented. Interest on securities
classified as available-for-sale is included in interest income.
Valuation of Inventory
We value our inventory at the lower of the actual cost of our inventory,
as determined using the first-in, first-out (FIFO) method, or its current
estimated market value. We periodically review our physical inventory for
obsolete items and provide a reserve upon identification of potential obsolete
items.
Intangible Assets
Intangible assets are comprised of purchased technology with a finite
life. The acquisition cost of purchased technology is capitalized and amortized
over its useful life in accordance with SFAS No. 142, Goodwill and Other
Intangible Assets. We review the assigned useful life on an on-going basis for
consistency with the period over which cash flows are expected to be generated
from the asset and consider the potential for impairment whenever events or
changes in circumstances indicate that the carrying amount of an asset may not
be recoverable. The process of estimating useful lives and evaluating potential
impairment is subjective and requires management to exercise judgment in making
assumptions related to future cash flows and discount rates.
Deferred Income Taxes
We account for income taxes under the provisions of SFAS No. 109,
Accounting for Income Taxes. Under this method, deferred assets and liabilities
are determined based on the difference between the financial statement and tax
bases of assets and liabilities using the enacted tax rates in effect for the
year in which the differences are expected to affect taxable income. Valuation
allowances are established when necessary to reduce deferred tax assets to the
amounts expected to be realized. We have established a valuation allowance
against the entire amount of our deferred tax assets because we are not able to
conclude, due to our history of operating losses, that it is more likely than
not that we will be able to realize any portion of the deferred tax assets.
In assessing whether and to what extent deferred tax assets are
realizable, we consider whether it is more likely than not that some portion or
all of the deferred tax assets will not be realized. The ultimate realization of
deferred tax assets is dependent upon the generation of future taxable income
during the periods in which those temporary differences become deductible. We
consider projected future taxable income and tax planning strategies in making
this assessment. Based upon the level of historical taxable losses, limitations
imposed by Section 382 of the Internal Revenue Code and projections for future
losses over periods which the deferred tax assets are deductible, we determined
that a 100% valuation allowance of deferred tax assets was appropriate.
49
Results of Operations
Comparison of the Years ended December 31, 2006 and 2005
Revenue. Revenue increased to $27.2 million for the year ended December
31, 2006 from $15.0 million for the year ended December 31, 2005, an increase of
approximately 81%. Revenue from sales of systems increased to $22.7 million for
the year ended December 31, 2006 from $12.8 million for the year ended December
31, 2005, an increase of approximately 78%. Revenue from the sale of systems
increased primarily because we sold 23 systems in 2006 compared to 13 systems in
2005. Average selling price increased approximately 11% in 2006 as contrasted
with 2005. Revenue from sales of disposable interventional devices, service and
accessories increased to $4.5 million for the year ended December 31, 2006 from
$2.3 million for the year ended December 31, 2005, an increase of approximately
100%. This increase was attributable to the increased base of installed systems.
Cost of Revenue. Cost of revenue increased to $12.9 million for the year
ended December 31, 2006 from $7.7 million for the year ended December 31, 2005,
an increase of approximately 67%. This increase in cost of revenue was
attributable primarily to the increased number of systems sold and associated
cost of goods sold for those systems. As a percentage of our revenue, cost of
revenue was 47% in the year ended December 31, 2006 compared to 51% in the year
ended December 31, 2005 due principally to an increase in the average selling
price.
Research and Development Expense. Research and development expense
increased to $21.8 million for the year ended December 31, 2006 from $17.8
million for the year ended December 31, 2005, an increase of approximately 22%.
The increase was due principally to an increase in research and development
projects, including continued integration and development related to disposable
interventional devices, further development of the NIOBE platform technology, as
well as user interface improvements.
Sales and Marketing Expense. Sales and marketing expense increased to
$22.5 million for the year ended December 31, 2006 from $16.1 million for the
year ended December 31, 2005, an increase of approximately 40%. The increase
related primarily to increased salary, benefits and travel expenses associated
with hiring additional sales personnel and expanded marketing programs.
General and Administrative Expense. General and administrative expense
increased to $16.6 million for the year ended December 31, 2006 from $14.4
million for the year ended December 31, 2005, an increase of approximately 15%.
The increase relates to increased stock compensation costs due to the adoption
of SFAS 123(R) and expanded activity in training, clinical compliance and
regulatory affairs.
Royalty Settlement. Royalty settlement expense related to the resolution
of a patent licensing dispute with the University of Virginia were $2.9 million
for the year ended December 31, 2005. There was no such settlement expense in
2006.
Interest Income. Interest income increased approximately 124% to $2.1
million for the year ended December 31, 2006 from $950,000 for the year ended
December 31, 2005. Interest income increased due to higher invested balances due
to our February 2006 take-down and higher realized rates on investments during
the year ended December 31, 2006.
Interest Expense. Interest expense increased approximately 133% to $1.2
million for the year ended December 31, 2006 from $505,000 for the year ended
December 31, 2005. Interest expense
50
increased primarily due to the amortization of commitment fees related to the
affiliate line of credit entered into in the fourth quarter of 2005.
Comparison of the Years ended December 31, 2005 and 2004
Revenue. Revenue decreased to $15.0 million for the year ended December
31, 2005 from $18.8 million for the year ended December 31, 2004, a decrease of
approximately 20%. Revenue from sales of systems decreased to $12.8 million for
the year ended December 31, 2005 from $17.2 million for the year ended December
31, 2004, a decrease of approximately 26%. Revenue from the sale of systems
decreased primarily because we sold 13 systems in 2005 compared to 22 systems in
2004 as domestic revenue and order rates were negatively impacted by delays in
approval of catheters for use with the system. Average selling price increased
approximately 19% in 2005 as contrasted with 2004. Revenue from sales of
disposable interventional devices, service and accessories increased to $2.3
million for the year ended December 31, 2005 from $1.6 million for the year
ended December 31, 2004, an increase of approximately 42%. This increase was
attributable to the increased base of installed systems.
Cost of Revenue. Cost of revenue decreased to $7.7 million for the year
ended December 31, 2005 from $10.7 million for the year ended December 31, 2004,
a decrease of approximately 28%. This decrease in cost of revenue was
attributable primarily to the decreased number of systems sold and associated
cost of goods sold for those systems. As a percentage of our revenue, cost of
revenue was 51% in the year ended December 31, 2005 compared to 57% in the year
ended December 31, 2004. During the year ended December 31, 2005, the vast
majority of the systems delivered were the advanced NIOBE II systems whereas the
majority of the systems delivered during the prior year were NIOBE I systems.
Although the average cost of the NIOBE II systems exceeded the average cost of
the NIOBE I system, the increase in the average selling price of the system
resulted in the increased gross margin.
Research and Development Expense. Research and development expense
increased to $17.8 million for the year ended December 31, 2005 from $17.2
million for the year ended December 31, 2004, an increase of approximately 4%.
The increase was due principally to an increase in the number of research and
development projects, including continued integration and development related to
disposable interventional devices, further development of the NIOBE platform
technology, as well as user interface improvements.
Sales and Marketing Expense. Sales and marketing expense increased to
$16.1 million for the year ended December 31, 2005 from $11.4 million for the
year ended December 31, 2004, an increase of approximately 41%. The increase
related primarily to increased salary, benefits and travel expenses associated
with hiring additional sales personnel and expanded marketing programs.
General and Administrative Expense. General and administrative expense
increased to $14.4 million for the year ended December 31, 2005 from $6.9
million for the year ended December 31, 2004, an increase of 109%. The increase
relates to increased regulatory, insurance, audit and other costs associated
with the Company's public company status following the August 2004 IPO, expanded
activity in clinical compliance and regulatory affairs, as well as limited
headcount additions in the general and administrative and training departments.
Royalty Settlement. Royalty settlement expense related to the resolution
of a patent licensing dispute with the University of Virginia were $2.9 million
for the year ended December 31, 2005. There was no such settlement expense in
2004.
51
Interest Income. Interest income increased approximately 45% to $950,000
for the year ended December 31, 2005 from $656,000 for the year ended December
31, 2004. Interest income increased due to higher realized rates on investments
during the year ended December 31, 2005.
Interest Expense. Interest expense remained relatively unchanged as the
decrease in average borrowings was offset by amortization of warrant expense
related to the affiliate line of credit.
Income Taxes
Realization of deferred tax assets is dependent upon future earnings, the
timing and amount of which are uncertain. Accordingly, net deferred tax assets
have been fully offset by valuation allowances as of December 31, 2006, 2005 and
2004 to reflect these uncertainties. As of December 31, 2006, we had federal and
state net operating loss carryforwards of approximately $192 million of which
approximately $2.9 million will expire between 2007 and 2010 and approximately
$189 million will expire between 2011 and 2026. As of December 31, 2006, we had
federal research and development credit carryforwards of approximately $3.7
million of which approximately $59,000 will expire between 2007 and 2010 and
$3.6 million will expire between 2011 and 2026, if not utilized. We may not be
able to utilize certain of these loss carryforwards and credits prior to their
expiration.
Liquidity and Capital Resources
Prior to our initial public offering, we financed our operations almost
entirely from the private sale of equity securities, totaling approximately $127
million net of offering expenses. To a much lesser extent, we also financed our
operations through working capital and equipment financing loans. We raised
funds from these sources because, as a developing company, we were not able to
fund our activities solely from the cash provided by our operations.
In August 2004, we completed an initial public offering in which we issued
and sold 5,500,000 shares of common stock. In September 2004, the underwriters
exercised their option to purchase an additional 462,352 shares. In connection
with the initial public offering and over-allotment exercise, we received
approximately $41.4 million in net proceeds.
In February 2006, we completed an underwritten take-down of our common
stock from our shelf registration in which we issued and sold 5,500,000 shares
of our common stock at $12.00 per share including the underwriters' exercise of
their option to purchase an additional 500,000 shares. In conjunction with the
February 2006 shelf take-down, we received approximately $61.7 million in net
proceeds. Since our inception, we have generated significant losses. At December
31, 2006, we had working capital of approximately $40.4 million, compared to
$15.9 million at December 31, 2005.
In August 2006, we filed a universal shelf registration statement for the
issuance and sale from time to time to the public of up to $75 million in
securities, including debt, preferred stock, common stock and warrants. The
shelf registration was declared effective by the SEC in September 2006. We have
not sold any securities pursuant to this shelf registration.
Liquidity refers to the liquid financial assets available to fund our
business operations and pay for near-term obligations. These liquid financial
assets consist of cash and cash equivalents, as well as short-term investments.
In addition to our cash and cash equivalent balances, we maintained $21.8
million and $7.1 million of investments in corporate debt securities, U.S.
government agency notes and commercial paper at December 31, 2006 and 2005,
respectively.
52
The following table summarizes our cash flow by operating, investing and
financing activities for each of years ended December 31, 2006, 2005 and 2004
(in thousands):
- -----------------------------------------------------------------------------------------------
2006 2005 2004
---- ---- ----
- -----------------------------------------------------------------------------------------------
Cash Flow (used in) Operating Activities $(38,983) $(40,986) $(31,814)
- -----------------------------------------------------------------------------------------------
- -----------------------------------------------------------------------------------------------
Cash Flow provided by (used in) Investing Activities (16,394) 25,052 (29,654)
- -----------------------------------------------------------------------------------------------
- -----------------------------------------------------------------------------------------------
Cash Flow provided by Financing Activities 66,988 2,625 57,019
- -----------------------------------------------------------------------------------------------
Net cash used in operating activities. We used approximately $39.0
million, $41.0 million and $31.8 million of cash in operating activities during
the year ended December 31, 2006, 2005 and 2004, respectively, primarily as a
result of operating losses during these periods. Cash generated from working
capital purposes increased to $829,000 during the year ended December 31, 2006
from $458,000 generated during the year ended December 31, 2005 primarily as a
result of an increase in general liabilities, a decrease in prepaid expenses
related to certain development projects, an increase in deferred revenue related
to systems on which revenue has not yet been recognized and for service and
license fees not yet recognized and a decrease in inventory levels offset by an
increase in accounts receivable from increased sales in the fourth quarter of
2006.
Net cash provided by (used in) investing activities. We used approximately
$16.4 million of cash for investing activities during the year ended December
31, 2006 principally for the purchase or sale of investments, compared to $25.1
million provided by investing activities during the year ended December 31,
2005. In 2005, we generated $27.4 million in cash from the purchase and sale of
investments. We used $2.3 million in each of 2006 and 2005 for the purchase of
property and equipment. Cash used in investing activities of $29.7 million
during the year ended December 31, 2004 included purchases of property and
equipment of approximately $1.5 million, with the balance used for the purchase
of investments.
Net cash provided by financing activities. We realized approximately $67.0
million from financing activities during the year ended December 31, 2006
principally from the public offering of our common stock in which we realized
approximately $61.7 million in net proceeds. We realized approximately $2.6
million from financing activities during the year ended December 31, 2005
including $1.1 million in proceeds from the issuance of long-term debt from our
equipment and revolving credit facilities, net of repayments and $1.6 million
from the issuance of stock as a result of exercises of warrants and options. We
received approximately $57.0 million from financing activities during the year
ended December 31, 2004, primarily as a result of the completion of our initial
public offering (and exercise by the underwriters of their over-allotment
option) in August and September 2004 and the sale of our Series E-2 preferred
stock and related common stock warrants in January and February 2004. We also
realized $2.0 million in proceeds from the issuance of long-term debt from our
equipment loan and repaid approximately $2.6 million of equipment loans and
revolving credit facility during 2004.
As of December 31, 2006, we had outstanding balances under various
equipment loan agreements, consisting of an aggregate of $972,222. As of
December 31, 2006, we had $1.0 million outstanding under our working capital
line of credit and had borrowing capacity of $9.0 million, subject to
collateralization by qualifying receivables and inventory balances.
These credit facilities are secured by substantially all of our assets.
The credit agreements include customary affirmative, negative and financial
covenants. For example, we are restricted from incurring additional debt,
disposing of or pledging our assets, entering into merger or acquisition
53
agreements, making certain investments, allowing fundamental changes to our
business, ownership, management or business locations, and from making certain
payments in respect of stock or other ownership interests, such as dividends and
stock repurchases. Under our loan arrangements, we are required to maintain a
ratio of "quick" assets (cash, cash equivalents, accounts receivable and
short-term investments) to current liabilities minus deferred revenue of at
least 1.25 to 1. We are also required under the credit agreements to maintain
our primary operating account and the majority of our cash and investment
balances in accounts with the lender. As of December 31, 2006, we are in
compliance with all covenants of this agreement.
We expect to have negative cash flow from operations through 2007.
Throughout 2007, we expect to continue the development and commercialization of
our products, the continuation of our research and development programs and the
advancement of new products into clinical development. We expect that our
research and development expenditures will continue to increase in 2007 and our
selling, general and administrative expenses will continue to increase in order
to support our product commercialization efforts. Until we can generate
significant cash flow from our operations, we expect to continue to fund our
operations with existing cash resources that were primarily generated from the
proceeds of our public offerings, private sales of our equity securities and
working capital and equipment financing loans. In the future, we may finance
future cash needs through the sale of other equity securities, strategic
collaboration agreements and debt financings. We cannot accurately predict the
timing and amount of our utilization of capital, which will depend on a number
of factors outside of our control.
While we believe our existing cash, cash equivalents and investments will
be sufficient to fund our operating expenses and capital equipment requirements
through the next 12 months, we cannot ensure that we will not require additional
financing before that time. We also cannot ensure that such additional financing
will be available on a timely basis on terms acceptable to us or at all, or that
such financing will not be dilutive to our stockholders. If adequate funds are
not available to us, we could be required to delay development or
commercialization of new products, to license to third parties the rights to
commercialize products or technologies that we would otherwise seek to
commercialize ourselves or to reduce the marketing, customer support or other
resources devoted to our products, any of which could have a material adverse
effect on our business, financial condition and results of operations.
Off-Balance Sheet Arrangements
We do not currently have, nor have we ever had, any relationships with
unconsolidated entities or financial partnerships, such as entities often
referred to as structured finance or special purpose entities, which would have
been established for the purpose of facilitating off-balance sheet arrangements
or other contractually narrow or limited purposes. In addition, we do not engage
in trading activities involving non-exchange traded contracts. As a result, we
are not materially exposed to any financing, liquidity, market or credit risk
that could arise if we had engaged in these relationships.
54
Contractual Obligations
The following table summarizes all significant contractual payment
obligations by payment due date:
Payments by Period
(In thousands)
Under 1 - 3 3 - 5 Over
Contractual Obligations 1 Year Years Years 5 Years Total
Long-term debt (1) $ 1,667 $ 305 $ -- $ -- $ 1,972
Operating leases 935 1,798 1,781 3,589 8,103
Capital leases 7 16 5 -- 28
Research and alliance agreements 7,833 1,475 113 -- 9,421
---------------------------------------------
Total $10,442 $3,594 $1,899 $ 3,589 $19,524
=============================================
(1) We have not included interest payable on our revolving credit agreement in
these amounts because it is calculated at a variable rate.
Commercial Commitments
We have entered into two letters of credit to support certain purchase and
other commitments in the amount of approximately $2.6 million which expire in
2007
We have entered into a line of credit with our primary lender which has a
maximum borrowing capacity of up to $10,000,000 and expires April 2007 and was
subsequently amended in March 2007 as described in Note 18 to our financial
statements.
ITEM 7A. Quantitative and Qualitative Disclosures About Market Risk
We have exposure to currency fluctuations. We operate mainly in the U.S.,
Europe and Asia and we expect to continue to sell our products both within and
outside of the U.S. We expect to transact this business primarily in U.S.
dollars and in Euros, although we may transact business in other currencies to a
lesser extent. Future fluctuations in the value of these currencies may affect
the price competitiveness of our products. In addition, because we have a
relatively long installation cycle for our systems, we will be subject to risk
of currency fluctuations between the time we execute a purchase order and the
time we deliver the system and collect payments under the order, which could
adversely affect our operating margins. We have not hedged exposures in foreign
currencies or entered into any other derivative instruments. As a result, we
will be exposed to some exchange risks for foreign currencies. For example, if
the currency exchange rate were to fluctuate by 10%, we believe that our revenue
could be affected by as much as 2 to 3%.
We also have exposure to interest rate risk related to our investment
portfolio and our borrowings. The primary objective of our investment activities
is to preserve principal while at the same time maximizing the income we receive
from our invested cash without significantly increasing the risk of loss.
Our interest income is sensitive to changes in the general level of U.S.
interest rates, particularly since the majority of our investments are in
short-term debt instruments. We invest our excess cash primarily in U.S.
government securities and marketable debt securities of financial institutions
and corporations with strong credit ratings. These instruments generally have
maturities of two years or
55
less when acquired. We do not utilize derivative financial instruments,
derivative commodity instruments or other market risk sensitive instruments,
positions or transactions. Accordingly, we believe that while the instruments we
hold are subject to changes in the financial standing of the issuer of such
securities, we are not subject to any material risks arising from changes in
interest rates, foreign currency exchange rates, commodity prices, equity prices
or other market changes that affect market risk sensitive instruments.
We do not believe that inflation has had a material adverse impact on our
business or operating results during the periods covered by this report.
56
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
Financial Statements
Index To Financial Statements
PAGE
----
Report of Ernst & Young LLP, Independent Registered Public Accounting Firm 58
Balance Sheets at December 31, 2006 and 2005 59
Statements of Operations for the years ended December 31, 2006, 2005 and 2004 60
Statements of Stockholders' Equity for the years ended December 31, 2006, 2005
and 2004 61
Statements of Cash Flows for the years ended December 31, 2006, 2005 and 2004 64
Notes to the Financial Statements 65
Schedule II--Valuation and Qualifying Accounts 89
All other schedules have been omitted because they are not applicable or the
required information is shown in the Financial Statements or the Notes thereto.
57
Report of Independent Registered Public Accounting Firm
The Board of Directors and Shareholders
Stereotaxis, Inc.
We have audited the accompanying balance sheets of Stereotaxis, Inc. (the
Company) as of December 31, 2006 and 2005, and the related statements of
operations, stockholders' equity, and cash flows for each of the three years in
the period ended December 31, 2006. Our audits also included the financial
statement schedule listed in the Index at Item 15(a). These financial statements
and schedule are the responsibility of the Company's management. Our
responsibility is to express an opinion on these financial statements and
schedule based on our audits.
We conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we plan
and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. An audit also includes examining,
on a test basis, evidence supporting the amounts and disclosures in the
financial statements. An audit also includes assessing the accounting principles
used and significant estimates made by management, as well as evaluating the
overall financial statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly, in
all material respects, the financial position of Stereotaxis, Inc. at December
31, 2006 and 2005, and the results of its operations and its cash flows for each
of the three years in the period ended December 31, 2006, in conformity with
U.S. generally accepted accounting principles. Also, in our opinion, the related
financial statement schedule, when considered in relation to the basic financial
statements taken as a whole, presents fairly in all material respects the
information set forth therein.
As discussed in Note 2 to the financial statements, on January 1, 2006, the
Company changed its method of accounting for share-based payments.
We also have audited, in accordance with the standards of the Public Company
Accounting Oversight Board (United States), the effectiveness of Stereotaxis,
Inc.'s internal control over financial reporting as of December 31, 2006, based
on criteria established in Internal Control - Integrated Framework issued by the
Committee of Sponsoring Organizations of the Treadway Commission, and our report
dated March 12, 2007, expressed an unqualified opinion thereon.
/s/ Ernst & Young LLP
St. Louis, Missouri
March 12, 2007
58
STEREOTAXIS, INC.
BALANCE SHEETS
December 31,
2006 2005
------------------------------
Assets
Current assets:
Cash and cash equivalents $ 15,210,493 $ 3,598,493
Short-term investments 21,773,288 7,137,094
Accounts receivable, net of allowance of $90,716 and $29,576
in 2006 and 2005, respectively 15,280,628 5,897,072
Current portion of long-term receivables 163,362 461,520
Inventories 8,285,825 9,404,792
Prepaid expenses and other current assets 2,580,773 5,128,852
------------------------------
Total current assets 63,294,369 31,627,823
Property and equipment, net 4,130,295 3,078,313
Intangible assets, net 1,544,444 1,677,778
Long-term receivables -- 146,520
Other assets 321,552 127,755
------------------------------
Total assets $ 69,290,660 $ 36,658,189
==============================
Liabilities and stockholders' equity
Current liabilities:
Current maturities of long-term debt $ 1,666,666 $ 1,000,000
Accounts payable 5,555,121 4,866,156
Accrued liabilities 10,025,231 5,648,693
Deferred contract revenue 5,663,553 4,216,255
------------------------------
Total current liabilities 22,910,571 15,731,104
Long-term debt, less current maturities 305,556 1,972,222
Long-term deferred contract revenue 1,220,174 801,005
Other liabilities 65,367 28,016
Stockholders' equity:
Preferred stock, par value $0.001; 10,000,000 shares
authorized at 2006 and 2005, none outstanding at 2006 and
2005 -- --
Common stock, par value of $0.001; 100,000,000 shares
authorized at 2006 and 2005, 34,755,397 and 27,873,111
shares issued at 2006 and 2005, respectively 34,755 27,873
Additional paid-in capital 248,908,918 179,286,575
Deferred compensation -- (2,569,760)
Treasury stock, 40,151 and 36,519 shares at 2006 and 2005, respectively (205,999) (162,546)
Notes receivable from sales of stock -- (180,619)
Accumulated deficit (203,950,839) (158,231,069)
Accumulated other comprehensive income (loss) 2,157 (44,612)
------------------------------
Total stockholders' equity 44,788,992 18,125,842
------------------------------
Total liabilities and stockholders' equity $ 69,290,660 $ 36,658,189
==============================
See accompanying notes.
59
STEREOTAXIS, INC.
STATEMENTS OF OPERATIONS
Year Ended December 31,
2006 2005 2004
--------------------------------------------
Systems revenue $ 22,656,092 $ 12,760,593 $ 17,219,080
Disposables, service and accessories revenue 4,535,614 2,265,797 1,597,780
--------------------------------------------
Total revenue 27,191,706 15,026,390 18,816,860
Costs of revenue 12,892,749 7,720,706 10,672,262
--------------------------------------------
Gross margin 14,298,957 7,305,684 8,144,598
Operating expenses:
Research and development 21,794,177 17,829,282 17,215,414
Sales and marketing 22,533,882 16,106,621 11,447,857
General and administrative 16,642,359 14,449,326 6,900,016
Royalty settlement -- 2,923,111 --
--------------------------------------------
Total operating expenses 60,970,418 51,308,340 35,563,287
--------------------------------------------
Operating loss (46,671,461) (44,002,656) (27,418,689)
Interest income 2,126,987 949,918 656,316
Interest expense (1,175,296) (505,097) (495,096)
--------------------------------------------
Net loss $(45,719,770) $(43,557,835) $(27,257,469)
============================================
Net loss per common share:
Basic and diluted $ (1.39) $ (1.60) $ (2.38)
============================================
Weighted average shares used in computing net loss per
common share:
Basic and diluted 32,979,403 27,301,822 11,470,310
============================================
See accompanying notes.
60
STEREOTAXIS, INC.
STATEMENTS OF STOCKHOLDERS' EQUITY
Convertible
Preferred Stock Common Stock
Additional
Comprehensive Paid-In
Income (Loss) Shares Amount Shares Amount Capital
------------------------------------------------------------------------------
Balance at December 31, 2003 61,055,286 $61,055 1,515,150 $ 1,515 $ 113,921,587
------------------------------------------------------------------------------
Issuance of Series E-2
convertible preferred stock
at $10.55 per share, net
issuance costs of $85,523 $ -- 5,380,830 $ 5,381 -- -- $ 14,087,572
Issuance of warrants to
purchase common stock -- -- -- -- -- 1,603,493
Amortization of stock-based
compensation -- -- -- -- -- --
Payments of notes receivable
from sale of stock -- -- -- -- -- --
Interests receivable from sale
of stock -- -- -- -- -- --
Conversion of convertible
preferred stock into common
stock -- (66,436,116) (66,436) 19,282,324 19,282 47,154
Conversion of convertible
promissory note -- -- -- 271,739 272 2,173,646
Repurchase of common stock -- -- -- -- -- --
Issue of common stock -- -- -- (13) -- (103)
Issuance of common stock upon
filing of initial public
offering and underwriter
over-allotment, net of issuance
costs of $2,919,794 -- -- -- 5,962,352 5,963 41,434,041
Exercise of stock warrants -- -- -- 20,104 20 (20)
Exercise of stock options -- -- -- 135,386 135 385,567
Payments of interest on notes
receivable -- -- -- -- -- --
Stock-based compensation -- -- -- -- -- 490,650
Net Loss (27,257,469) -- -- -- -- --
Unrealized loss on short term
investments (95,144) -- -- -- -- --
-------------
Comprehensive Loss $ (27,352,613) -- -- -- -- --
--------------------------------------------------------------
Balance at December 31, 2004 -- $ -- 27,187,042 $27,187 $ 174,143,587
==============================================================
Notes Accumulated
Receivable Other Total
Deferred Treasury From Sale Accumulated Comprehensive Stockholders'
Compensation Stock Of Stock Deficit Income (Loss) Equity
----------------------------------------------------------------------------------------------
Balance at December 31, 2003 $ (835,801) $ (17,750) $ (448,413) $ (87,415,765) -- $ 25,266,428
----------------------------------------------------------------------------------------------
Issuance of Series E-2
convertible preferred stock
at $10.55 per share, net
issuance costs of $85,523 -- -- -- -- -- $ 14,092,953
Issuance of warrants to
purchase common stock -- -- -- -- -- 1,603,493
Amortization of stock-based
compensation 654,501 -- -- -- -- 654,501
Payments of notes receivable
from sale of stock -- -- 239,560 -- -- 239,560
Interests receivable from sale
of stock -- -- 10,212 -- -- 10,212
Conversion of convertible
preferred stock into common
stock -- -- -- -- -- --
Conversion of convertible
promissory note -- -- -- -- -- 2,173,918
Repurchase of common stock -- (144,899) -- -- -- (144,899)
Issue of common stock -- 103 -- -- -- --
Issuance of common stock upon
filing of initial public
offering and underwriter
over-allotment, net of issuance
costs of $2,919,794 -- -- -- -- -- 41,440,004
Exercise of stock warrants -- -- -- -- -- --
Exercise of stock options -- -- -- -- -- 385,702
Payments of interest on notes
receivable -- -- 25,209 -- -- 25,209
Stock-based compensation (490,650) -- -- -- -- --
Net Loss -- -- -- $ (27,257,469) -- (27,257,469)
Unrealized loss on short term
investments -- -- -- -- (95,144) (95,144)
Comprehensive Loss -- -- -- -- -- --
----------------------------------------------------------------------------------------------
Balance at December 31, 2004 $ (671,950) $ (162,546) $ (173,432) $ (114,673,234) $ (95,144) $ 58,394,468
==============================================================================================
See accompanying notes
61
STEREOTAXIS, INC.
STATEMENTS OF STOCKHOLDERS' EQUITY (CONTINUED)
Common Stock
------------
Comprehensive Additional Deferred Treasury
Income (Loss) Shares Amount Paid-In Capital Compensation Stock
--------------------------------------------------------------------------------------
Balance at December 31, 2004 $ -- 27,187,042 $ 27,187 $ 174,143,587 $ (671,950) $ (162,546)
Issuance of warrants to
purchase common stock 938,850
Amortization of stock-based
compensation 747,412
Payments of notes receivable
from sale of stock
Interests receivable from sale
of stock
Issuance of stock under stock
purchase plan 29,554 30 201,097
Exercise of stock warrants 14,888 15 (15)
Exercise of stock options 282,527 282 1,358,193
Grant of restricted shares, net
of forfeitures 359,100 359 2,644,863 (2,645,222)
Net Loss (43,557,835)
Unrealized loss on short term
investments 50,532
-------------
Comprehensive Loss $ (43,507,303)
----------------------------------------------------------------------
Balance at December 31, 2005 27,873,111 $ 27,873 $ 179,286,575 $ (2,569,760) $ (162,546)
======================================================================
Notes
Receivable Accumulated Other Total
from Sale of Accumulated Comprehensive Stockholders'
Stock Deficit Income (Loss) Equity
-------------------------------------------------------------------------
Balance at December 31, 2004 $ (173,432) $ (114,673,234) $ (95,144) $ 58,394,468
Issuance of warrants to
purchase common stock $ 938,850
Amortization of stock-based
compensation 747,412
Payments of notes receivable
from sale of stock 3,750 3,750
Interests receivable from sale
of stock (10,937) (10,937)
Issuance of stock under stock
purchase plan 201,127
Exercise of stock warrants --
Exercise of stock options 1,358,475
Grant of restricted shares, net
of forfeitures --
Net Loss (43,557,835) (43,557,835)
Unrealized loss on short term
investments 50,532 50,532
Comprehensive Loss
-------------------------------------------------------------------------
Balance at December 31, 2005 $ (180,619) $ (158,231,069) $ (44,612) $ 18,125,842
=========================================================================
See accompanying notes
62
STEREOTAXIS, INC.
STATEMENTS OF STOCKHOLDERS' EQUITY (CONTINUED)
Common Stock
------------
Comprehensive Additional Deferred Treasury
Income (Loss) Shares Amount Paid-In Capital Compensation Stock
Balance at December 31, 2005 $ -- 27,873,111 $27,873 $ 179,286,575 $ (2,569,760) $ (162,546)
Adoption of SFAS 123(R) (2,569,760) 2,569,760
Issuance common stock 5,500,000 5,500 61,746,903
Amortization of stock-based
compensation 4,301,807
Payments of notes receivable
from sale of stock
Interests receivable from sale
of stock
Issuance of stock under stock
purchase plan 74,917 75 574,507
Purchase of treasury stock, at
cost (43,453)
Exercise of stock warrants 638,472 638 4,264,909
Exercise of stock options and
stock appreciation rights 325,893 326 1,304,320
Grant of restricted shares, net
of forfeitures 343,004 343 (343)
Net Loss (45,719,770)
Unrealized gain (loss) on short
term investments 46,769
-------------
Comprehensive Loss $ 45,673,001
=============-----------------------------------------------------------------------
Balance at December 31, 2006 34,755,397 $34,755 $ 248,908,918 $ -- $ (205,999)
====================================================================
Notes
Receivable Accumulated Other Total
from Sale of Accumulated Comprehensive Stockholders'
Stock Deficit Income (Loss) Equity
Balance at December 31, 2005 $ (180,619) $(158,231,069) $ (44,612) $ 18,125,842
Adoption of SFAS 123(R) --
Issuance common stock 61,752,403
Amortization of stock-based
compensation 4,301,807
Payments of notes receivable
from sale of stock 134,700 134,700
Interests receivable from sale
of stock 45,919 45,919
Issuance of stock under stock
purchase plan 574,582
Purchase of treasury stock, at
cost (43,453)
Exercise of stock warrants 4,265,547
Exercise of stock options and
stock appreciation rights 1,304,646
Grant of restricted shares, net
of forfeitures --
Net Loss (45,719,770) (45,719,770)
Unrealized gain (loss) on short
term investments 46,769 46,769
Comprehensive Loss
-------------------------------------------------------------------
Balance at December 31, 2006 $ -- $(203,950,839) $ 2,157 $ 44,788,992
===================================================================
See accompanying notes.
63
STEREOTAXIS, INC.
STATEMENTS OF CASH FLOWS
Year Ended December 31,
2006 2005 2004
---------------------------------------------
Cash flows from operating activities
Net loss $(45,719,770) $(43,557,835) $(27,257,469)
Adjustments to reconcile net loss to cash used in operating activities:
Depreciation 1,214,280 769,617 754,710
Amortization 387,480 397,070 133,333
Non-cash compensation 4,301,807 747,412 452,130
Interest receivable from sale of stock 48,992 -- --
Noncash interest receivable (74,708) 150,359 --
Loss on asset disposal 29,658 48,783 42,425
Changes in operating assets and liabilities:
Accounts receivable (9,383,556) 2,542,002 (7,879,353)
Long-term receivables 444,678 (101,655) 114,939
Inventories 1,118,967 (4,730,798) (243,766)
Prepaid expenses and other current assets 1,873,767 (2,064,410) (1,311,481)
Other assets (193,797) (7,058) (19,338)
Accounts payable 688,965 2,736,683 431,976
Accrued liabilities 4,376,538 81,536 630,924
Deferred revenue 1,866,467 1,975,502 2,227,365
Other 37,351 26,609 109,735
--------------------------------------------
Net cash used in operating activities (38,982,881) (40,986,183) (31,813,870)
Cash flows from investing activities
Sale of equipment 10,072 -- 1,489,904
Purchase of equipment (2,305,992) (2,338,866) (1,535,420)
Proceeds from the maturity/sale of available-for-sale investments 18,604,217 37,154,608 6,936,710
Purchase of available-for-sale investments (32,701,841) (9,763,722) (36,545,431)
--------------------------------------------
Net cash provided by (used in) investing activities (16,393,544) 25,052,020 (29,654,237)
Cash flows from financing activities
Proceeds from long-term debt -- 2,000,000 2,000,000
Payments under long-term debt (1,000,000) (938,212) (2,622,647)
Proceeds from issuance of stock, net of issuance costs 67,897,178 1,559,602 57,522,153
Purchase of treasury stock (43,453) -- (90)
Payments received on notes receivable from sale of common stock 134,700 3,750 119,960
--------------------------------------------
Net cash provided by financing activities 66,988,425 2,625,140 57,019,376
--------------------------------------------
Net increase (decrease) in cash and cash equivalents 11,612,000 (13,309,023) (4,448,731)
Cash and cash equivalents at beginning of period 3,598,493 16,907,516 21,356,247
--------------------------------------------
Cash and cash equivalents at end of period $ 15,210,493 $ 3,598,493 $ 16,907,516
============================================
Supplemental disclosures of cash flow information:
Noncash items:
Conversion of note payable and accrued interest to common stock -- -- $ 2,173,918
============================================
Acquisition of treasury shares in lieu of payment of notes receivable -- -- $ 144,809
============================================
Interest paid $ 207,775 $ 216,763 $ 422,085
============================================
See accompanying notes.
64
Notes to Financial Statements
1. Description of Business
Stereotaxis, Inc. (the Company) designs, manufactures, and markets an
advanced cardiology instrument control system for the interventional treatment
of arrhythmias and coronary artery disease. The Company also markets and sells
various disposable interventional devices, including catheters, guidewires and
other delivery devices, for use in conjunction with its system. By 2003, the
Company had received U.S. and European regulatory approval for the core
components of its system.
2. Summary of Significant Accounting Policies
Cash and Cash Equivalents
The Company considers all short-term deposits purchased with original
maturities of three months or less to be cash equivalents. The Company places
its cash with high-credit-quality financial institutions and invests primarily
in money market accounts. As of December 31, 2006 and 2005, $713,865 and
$625,104 of cash is restricted subject to satisfaction of certain conditions
related to a delivered system.
Investments
In accordance with Statement of Financial Accounting Standards (SFAS) No.
115, Accounting for Certain Investments in Debt and Equity Securities, the
Company's investment securities are classified as available-for-sale and are
carried at market value, which approximates cost. Realized gains or losses,
calculated based on the specific identification method, were not material for
the years ended December 31, 2006, 2005 and 2004. Interest and dividends on
securities classified as available-for-sale are included in interest income.
Accounts Receivable and Allowance for Uncollectible Accounts
Accounts receivable primarily include amounts due from hospitals and
distributors for acquisition of magnetic systems and associated disposable
device sales. Credit is granted on a limited basis, with balances due generally
within 30 days of billing. The provision for bad debts is based upon
management's assessment of historical and expected net collections considering
business and economic conditions and other collection indicators.
Financial Instruments
Financial instruments consist of cash and cash equivalents, short-term
investments, accounts receivable, accounts payable and long-term debt. The
carrying value of such amounts reported at the applicable balance sheet dates
approximates fair value.
Inventory
The Company values its inventory at the lower of cost, as determined using
the first-in, first-out (FIFO) method, or market. The Company periodically
reviews its physical inventory for obsolete items and provides a reserve upon
identification of potential obsolete items.
Property and Equipment
Property and equipment consist primarily of computer, office and research
and demonstration equipment equipment held for lease and leasehold improvements
and are stated at cost. Depreciation is calculated using the straight-line
method over the estimated useful lives or life of the base lease term, ranging
from three to ten years.
65
Long-Lived Assets
If facts and circumstances suggest that a long-lived asset may be
impaired, the carrying value is reviewed. If this review indicates that the
carrying value of the asset will not be recovered, as determined based on
projected undiscounted cash flows related to the asset over its remaining life,
the carrying value of the asset is reduced to its estimated fair value.
Intangible Assets
Intangible assets consist of purchased technology arising out of
collaboration with a strategic investor valued at the cost of acquisition on the
acquisition date and amortized over its estimated useful life of 15 years.
Accumulated amortization at December 31, 2006 and 2005 is $455,555 and $322,222,
respectively. Amortization expense in 2006, 2005 and 2004 is $133,333 during
each year, as determined under the straight-line method. The estimated future
amortization of intangible assets is $133,333 annually through July 2018.
Use of Estimates
The preparation of financial statements in conformity with U.S. generally
accepted accounting principles requires management to make estimates and
assumptions that affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of the financial
statements and the reported amounts of income and loss during the reporting
period. Actual results could differ from those estimates.
Revenue and Costs of Revenue
For arrangements with multiple deliverables, the Company allocates the
total revenue to each deliverable based on its relative fair value in accordance
with the provisions of Emerging Issues Task Force (EITF) Issue No. 00-21,
Revenue Arrangements with Multiple Deliverables, and recognize revenue for each
separate element as the above criteria are met.
Where installation is a required part of our contractual obligation to a
customer but not considered a separate element, the Company recognizes systems
revenue upon installation, provided there are no uncertainties regarding
acceptance, persuasive evidence of an arrangement exists, the sales price is
fixed or determinable, and collection of the related receivable is reasonably
ensured. When installation is required for revenue recognition, the
determination of acceptance is made by the Company's employees based on criteria
set forth in the terms of the sale. When installation is the responsibility of
the customer, revenue from system sales is recognized upon shipment since these
arrangements do not include an installation element or right of return
privileges. If uncertainties exist regarding collectability, the Company
recognizes revenue when those uncertainties are resolved. Amounts collected
prior to satisfying the above revenue recognition criteria are reflected as
deferred revenue. Revenue from services and license fees, whether sold
individually or as a separable unit of accounting in a multi-element
arrangement, is deferred and amortized over the service or license fee period,
which is typically one year. Revenue from services is derived primarily from the
sale of annual product maintenance plans. The Company recognizes revenue from
disposable device sales or accessories upon shipment, and an appropriate reserve
for returns is established. The Company recognizes fees earned on the shipment
of product to customers as revenue and recognizes costs incurred on the shipment
of product to customers as cost of revenue.
Costs of revenue include direct product costs, installation labor and
other costs, estimated warranty costs, and training and product maintenance
costs and are recorded at the time of sale. The Company also includes in cost of
revenue any expected loss related to executed contracts in the period in which
the loss becomes known. In the years ended December 31, 2005 and 2004 the
Company incurred $135,560 and $103,494, respectively, for costs in excess of
contractual revenue, primarily on certain system sales.
Research and Development Costs
Internal research and development costs are expensed in the period
incurred. Amounts receivable from strategic partners under research
reimbursement agreements are recorded as a contra-research and
66
development expense in the period reimbursable costs are incurred. Advance
receipts or other unearned reimbursements are included in accrued liabilities on
the accompanying balance sheet until earned.
Stock-Based Compensation
Effective January 1, 2006, the Company adopted the fair value recognition
provisions of Financial Accounting Standards Board Statement No. 123(R),
Share-Based Payment ("SFAS 123(R)"), using the modified prospective transition
method to account for its grants of stock options, stock appreciation rights,
restricted shares and its employee stock purchase plan. SFAS 123(R) supersedes
the provisions of Accounting Principles Board (APB) Opinion No. 25, Accounting
for Stock Issued to Employees ("APB Opinion No. 25") and requires recognition of
an expense when goods or services are provided. SFAS 123(R) requires the
determination of the fair value of the share-based compensation at the grant
date and the recognition of the related expense over the period in which the
share-based compensation vests. Prior to January 1, 2006, the Company accounted
for those plans under the provisions of APB Opinion No. 25, and related
interpretations in accounting for stock-based employee compensation as permitted
by SFAS 123, Accounting for Stock-Based Compensation. Prior to the adoption of
SFAS 123(R), stock-based compensation for grants of stock options was included
as a pro forma disclosure in the Notes to the Consolidated Financial Statements
as permitted by SFAS 123. Results for prior periods have not been restated.
Under the modified prospective transition method of SFAS 123(R), the
Company recognized stock-based compensation expense related to 1) the remaining
unvested portion of all stock option, stock appreciation rights and restricted
share awards granted prior to January 1, 2006, based on the grant date fair
value estimated in accordance with the original provisions of SFAS 123; and 2)
expense related to all stock option, stock appreciation rights and restricted
share awards modified or granted on or subsequent to January 1, 2006, based on
the grant date fair value estimated in accordance with the provisions of SFAS
123(R). The Company utilizes the Black-Scholes valuation model to determine the
fair value of share-based payments at the date of grant with the following
inputs: 1) expected dividend rate of 0%; 2) expected volatility of 50% based on
the Company's historical volatility and a review of the volatilities of
comparable companies; 3) risk-free interest rate based on the Treasury yield on
the date of grant and; 4) expected term for grants made subsequent to the
adoption of SFAS 123(R) determined in accordance with Staff Accounting Bulletin
No. 107 using the simplified method ranging from 3.75 to 5.5 years. The
resulting compensation expense is recognized over the requisite service period,
generally one to four years. Compensation expense is recognized only for those
awards expected to vest, with forfeitures estimated based on the Company's
historical experience and future expectations. Prior to the adoption of SFAS
123(R), the effect of forfeitures on the pro forma expense amounts was
recognized as the forfeitures occurred.
Stock options or stock appreciation rights issued to non-employees,
including individuals for scientific advisory services, are recorded at their
fair value as determined in accordance with SFAS 123 and Emerging Issues Task
Force (EITF) No. 96-18, Accounting for Equity Instruments That Are Issued to
Other Than Employees for Acquiring, or in Conjunction With Selling, Goods or
Services, and recognized over the service period for those options with graded
vesting. Deferred compensation for options granted to non-employees is
periodically remeasured through the vesting or forfeiture date.
Restricted shares granted to employees are valued at the fair market value
at the date of grant. The Company amortizes the amount to expense over the
service period on a straight-line basis for those shares with graded vesting. If
the shares are subject to performance objectives, the resulting compensation
expense is amortized over the anticipated vesting period and is subject to
adjustment based on the actual achievement of objectives. Under APB 25, if the
shares granted were subject to variable performance criteria, the compensation
expense was periodically remeasured through the vesting or forfeiture date.
Shares purchased by employees under the 2004 Employee Stock Purchase Plan
are considered to be compensatory and are accounted for in accordance with SFAS
123(R). Under APB Opinion 25, these shares were not considered to be
compensatory and were not included in expense but were included in the pro forma
expense calculation.
67
As a result of adopting SFAS 123(R), the Company recorded approximately
$4.3 million of share based compensation expense during year ended December 31,
2006. As a result, the Company's net loss for the year ended December 31, 2006
was approximately $2.0 million lower than if it had continued to account for
share-based compensation under APB Opinion No. 25. Net loss per share for the
year ended December 31, 2006 was $0.06 lower than if the Company had continued
to account for share-based compensation under APB Opinion No. 25.
At December 31, 2006, the total compensation cost related to options,
stock appreciation rights and non-vested stock granted to employees under the
Company's stock award plans but not yet recognized was approximately $8.3
million, net of estimated forfeitures of approximately $1.7 million. This cost
will be amortized over a period of up to four years on a straight-line basis
over the underlying estimated service periods and will be adjusted for
subsequent changes in estimated forfeitures.
Net Loss per Share
Basic loss per common share is computed by dividing the net loss for the
period by the weighted average number of common shares outstanding during the
period. Diluted loss per share is computed by dividing the loss for the period
by the weighted average number of common and common equivalent shares
outstanding during the period.
The Company has deducted shares subject to repurchase from the calculation
of shares used in computing net loss per share, basic and diluted. The Company
has excluded all outstanding convertible preferred stock, options, stock
appreciation rights, warrants, shares subject to repurchase and unearned
restricted shares from the calculation of diluted loss per common share because
all such securities are anti-dilutive for all periods presented. All of the
Company's shares of preferred stock outstanding immediately prior to the
Company's initial public offering in August 2004 were converted into 19,282,325
shares of common stock. As of December 31, 2006, the Company had 2,403,507
shares of common stock issuable upon the exercise of outstanding options and
stock appreciation rights at a weighted average exercise price of $7.08 per
share and 510,626 shares of common stock issuable upon the exercise of
outstanding warrants at a weighted average exercise price of $8.52 per share.
Income Taxes
In accordance with SFAS No. 109, Accounting for Income Taxes, a deferred
income tax asset or liability is determined based on the difference between the
financial statement and tax basis of assets and liabilities as measured by the
enacted tax rates that will be in effect when these differences reverse. The
Company provides a valuation allowance against net deferred income tax assets
unless, based upon available evidence, it is more likely than not the deferred
income tax assets will be realized.
Product Warranty Provisions
The Company's standard policy is to warrant all NIOBE systems against
defects in material or workmanship for one year following installation. The
Company's estimate of costs to service the warranty obligations is based on
historical experience and current product performance trends. A regular review
of warranty obligations is performed to determine the adequacy of the reserve
and adjustments are made to the estimated warranty liability as appropriate.
During the year ended December 31, 2006, the Company expensed
approximately $237,000 related to a warranty obligation for a system installed
at a hospital whose President and Chief Executive Officer is a member of our
board of directors.
68
Patent Costs
Costs related to filing and pursuing patent applications are expensed as
incurred, as recoverability of such expenditures is uncertain.
Concentrations of Risk
The majority of the company's cash, cash equivalents and investments are
deposited with one major financial institution in the United States of America.
Deposits in this institution exceed the amount of insurance provided on such
deposits.
One customer, Siemens AG, Medical Solutions and its affiliated entities,
as our distributor, accounted for $5,941,884, $4,392,349 and $3,996,568, or 22%,
29% and 21%, of total net sales for the years ended December 31, 2006, 2005 and
2004, respectively. At December 31, 2006 this customer had a balance due to us
of $1,708,000.
Comprehensive Income (Loss)
Comprehensive income (loss) generally represents all changes in
stockholders' equity except those resulting from investments by stockholders,
and includes the Company's unrealized income (loss) on marketable securities of
$46,769 and ($50,532) at December 31, 2006 and 2005, respectively.
Reclassifications
Certain amounts in the prior year financial statements have been
reclassified to conform to current year presentation with no impact to reported
net income.
Recent Accounting Pronouncements
In June 2006, the FASB issued FIN 48, Accounting for Uncertainty in Income
Taxes - an Interpretation of FASB Statement No. 109. FIN 48 clarifies the
accounting for uncertainty in income taxes recognized in an entity's financial
statements and provides guidance on the recognition, de-recognition and
measurement of benefits related to an entity's uncertain tax positions. FIN 48
is effective for us beginning January 1, 2007. We do not expect the adoption of
FIN 48 to have a significant impact on our financial position or results of
operations.
In September 2006, the FASB issued SFAS No. 157, "Fair Value
Measurements". SFAS No. 157 defines fair value, establishes a framework for
measuring fair value in generally accepted accounting principles, and expands
disclosures about fair value measurements. SFAS No. 157 applies under other
accounting pronouncements that require or permit fair value measurements and
does not require any new fair value measurements. The provisions of SFAS No. 157
are effective for us beginning January 1, 2008. We do not expect the adoption of
SFAS No. 157 to have a significant impact on our financial position or results
of operations.
69
3. Investments
The following table summarizes available-for-sale securities included in
short and long-term investments as of the respective dates:
December 31, 2006 December 31, 2005
----------------- -----------------
Fair Fair
Cost Unrealized Value Cost Unrealized Value
-------------------------------------------------------------------------------------------------
Gains Losses Gains Losses
----- ------ ----- ------
Short-term investments:
Corporate debt $ 1,844,463 $ -- $ (475) $ 1,843,988 $ 1,813,664 $ -- $ (22,294) $ 1,791,370
U.S. government
agency 9,274,072 2,559 9,276,631 5,368,042 (22,318) 5,345,724
Commercial paper 7,558,765 494 -- 7,559,259 --
Certificates of
deposit 2,092,674 -- (421) 2,092,253
Auction rate
securities 1,001,157 -- -- 1,001,157
-------------------------------------------------------------------------------------------------
Total $21,771,131 $3,053 $ (896) $21,773,288 $ 7,184,706 $ $ (44,612) $ 7,137,094
=================================================================================================
The Company views its available-for-sale portfolio as available for use in
its current operations.
4. Inventory
Inventory consists of:
December 31,
2006 2005
--------------------------
Raw Materials $ 2,501,312 $ 2,803,516
Work in Process 29,443 111,632
Finished Goods 5,966,525 6,533,082
Reserve for obsolescence (211,455) (43,438)
--------------------------
$ 8,285,825 $ 9,404,792
==========================
5. Prepaid Expenses and Other Assets
Prepaid and other assets consists of:
December 31,
2006 2005
--------------------------
Prepaid Expenses $ 1,424,224 $ 3,129,967
Other Assets 1,478,101 2,126,640
--------------------------
2,902,325 5,256,607
Less: Long-term other assets (321,552) (127,755)
--------------------------
Total prepaid expenses and other assets $ 2,580,773 $ 5,128,852
==========================
70
6. Property and Equipment
Property and equipment consist of the following:
December 31,
2006 2005
--------------------------
Equipment $ 5,307,519 $ 3,876,947
Equipment held for lease 303,412 303,412
Leasehold improvements 1,309,715 1,162,582
--------------------------
6,920,646 5,342,941
Less accumulated depreciation (2,790,351) (2,264,628)
--------------------------
$ 4,130,295 $ 3,078,313
==========================
Equipment held for lease at December 31, 2006 consisted of medical devices
provided to customers under operating lease arrangements, whereby the Company
was the lessor. Amounts prepaid under the five-year operating leases are
included in deferred revenue until earned over the term of the lease.
7. Related Party Transactions
In November 2005, the Company entered into a six-month commitment with
certain affiliated investors providing for the availability of $20 million in
unsecured borrowings. The lenders received five-year warrants to purchase shares
of the Company's common stock upon commitment of the funds. The Company recorded
the fair value of $938,850 to paid in capital and has amortized the expense over
the 6-month term of the commitment. During 2006 and 2005, the Company expensed
$674,312 and $264,538, respectively, related to these warrants. The facility
expired in May 2006.
8. Accrued Liabilities
Accrued liabilities consist of the following:
December 31,
2006 2005
-------------------------
Accrued salaries, bonus, and benefits $ 3,495,023 $ 2,519,080
Accrued research and development 3,471,094 1,189,107
Accrued legal and other professional fees 323,224 1,025,961
Other 2,735,890 914,545
-------------------------
$10,025,231 $ 5,648,693
=========================
9. Long-Term Debt
Long-term debt consists of the following:
December 31,
2006 2005
--------------------------
Revolving credit agreement, due April 2007 $ 1,000,000 $ 1,000,000
April, 2004 term note, due June 2007 333,333 1,000,000
November, 2005 term note, due November 2008 638,889 972,222
--------------------------
1,972,222 2,972,222
Less current maturities (1,666,666) (1,000,000)
--------------------------
$ 305,556 $ 1,972,222
==========================
Under the terms of the Company's Revolving Credit Agreement with its
primary lender effective as at December 31, 2006, the Company had a maximum
borrowing capacity of $10,000,000. Borrowings under the
71
Revolving Credit Agreement are subject to monthly interest at the lender's prime
rate plus 1.25% and are due in full in April 2007. The Company is required to
maintain a ratio of "quick" assets (cash, cash equivalents, accounts receivable
and short term investments) to current liabilities (less deferred revenue) of at
least 1.25 to 1.0. Remaining available borrowing capacity at December 31, 2006
was $8,992,250. This agreement was subsequently amended in March 2007 as
described in Note 18. As of December 31, 2006, the Company is in compliance with
all covenants.
In October 2002, the Company entered into a term note due in September
2005 with its primary lender for $1,000,000 (October 2002 term note). This note
was paid in full in September 2005.
In April 2004, the Company entered into a term note due in June 2007 with
its primary lender for $2,000,000, which was drawn down in June 2004 (April 2004
term note). The Company is required to make equal monthly payments of principal
and interest, at 7%, through June 2007.
In November 2005, the Company entered into a term note due in November
2008 with its primary lender for $1,000,000 which was drawn down in November
2005 (November 2005 term note). The Company is required to make equal monthly
payments of principal plus interest at prime plus 1.5% through November 2008.
The Revolving Credit Agreement, April 2004 term note and November 2005
term note (collectively, the Credit Agreements) are secured by substantially all
of the Company's assets. The Company is also required under the Credit
Agreements to maintain its primary operating account and the majority of its
cash and investment balances in accounts with the primary lender.
In November 2005, the Company entered into a six-month commitment with
certain affiliates providing for the availability of up to $20 million in
unsecured borrowings. This commitment was available to be drawn against at any
time through May 10, 2006, the initial six-month commitment period. The
commitment period, as well as the maturity date on any funds drawn under the
commitment, was subject to one six-month extension, through November 2006, at
the Company's sole election. The lenders received five-year warrants to purchase
shares of the Company's common stock upon commitment of the funds. The Company
did not draw funds under this agreement nor did it extend the commitment period
beyond its May 2006 expiration.
Contractual principal maturities of long-term debt at December 31, 2006
are as follows:
2007 1,666,666
2008 305,556
-----------
$1,972,222
===========
10. Lease Obligations
The Company leases its facilities under operating leases. For the years
ended December 31, 2006, 2005, and 2004 rent expense was $1,182,107, $942,937,
and $857,533 respectively.
In January 2006, the Company moved its primary operations into new
facilities. The new facility is subject to a 10 year lease, expiring in 2015.
Under the terms of the lease, the Company has options to expand its space and to
renew for up to six additional years. The lease contains an escalating rent
provision which the Company has straight-lined over the term of the lease.
72
The future minimum lease payments under noncancelable leases as of December 31,
2006 are as follows:
Operating
Year Lease
------------------------------------------------
2007 935,304
2008 897,800
2009 900,224
2010 934,316
2011 846,180
Beyond 2011 3,589,274
----------
Total minimum lease payments $8,103,098
==========
11. Stockholders' Equity
Public Offerings of Common Stock
In August 2004, the Company completed an initial public offering in which
it sold 5,500,000 shares of its common stock at $8.00 per share for proceeds of
approximately $38.0 million, net of underwriting discounts and other offering
costs. Upon the closing of the offering, all of the Company's outstanding shares
of convertible preferred stock converted into 19,282,325 shares of common stock
including 827,953 shares issued as a result of anti-dilution provisions with
respect to certain series of our preferred stock. In September 2004, the
underwriters exercised an over-allotment option to purchase an additional
462,352 shares, resulting in net cash proceeds of approximately $3.4 million.
In February 2006, the Company completed an underwritten take-down of our
common stock from our shelf registration in which we issued and sold 5,500,000
shares of its common stock at $12.00 per share, including the underwriters'
exercise of an option to purchase an additional 500,000 shares. In conjunction
with these transactions, the Company received approximately $61.7 million in net
proceeds after deduction of underwriting discounts and commissions and payment
of estimated offering expenses.
Common Stock
In July 2004, the Company completed a 1-for-3.6 reverse stock split
affecting all of its outstanding shares of common stock. As a result of this
split, the conversion ratio of our convertible preferred stock into common stock
was adjusted accordingly. Upon the closing of the initial public offering of the
Company's stock all of the shares of preferred stock automatically converted
into shares of common stock.
The holders of common stock are entitled one vote for each share held and
to receive dividends whenever funds are legally available and when declared by
the Board of Directors subject to the prior rights of holders of all classes of
stock having priority rights as dividends and the conditions of the our
Revolving Credit Agreement. No dividends have been declared or paid as of
December 31, 2006.
73
The Company has reserved shares of common stock for the exercise of
warrants, the issuance of options granted under the Company's stock option plan
and its stock purchase plan as follows:
December 31,
2006 2005
------------------------
Warrants 510,626 1,369,436
Stock option plan 2,795,907 2,668,971
Employee Stock Purchase Plan 173,319 248,236
------------------------
3,479,852 4,286,643
========================
Notes Receivable, Common Stock
At December 31, 2006 the Company had no outstanding notes receivable
related to common stock. As of December 31, 2005, the Company had outstanding
promissory notes from an officer, a member of the Board of Directors and a
consultant, including accrued and unpaid interest totaling $180,619 related to
the sale of common stock to such individuals. The notes were full-recourse and
were also secured by the underlying stock. These notes bore interest at a range
from 7.0% to 7.5% per annum and were due and paid in full during 2006. These
notes receivable are reflected on the balance sheets as a component of
stockholders' equity as of December 31, 2005.
Stock Award Plans
The Company has various stock plans that permit the Company to provide
incentives to employees and directors of the Company in the form of equity
compensation. In 2002, the Board of Directors adopted a stock incentive plan
(the 2002 Stock Incentive Plan) and a nonemployee directors' stock plan (2002
Director Plan). In 1994, the Board of Directors adopted the 1994 Stock Option
Plan. Each of these plans was subsequently approved by the Company's
stockholders. At December 31, 2006 and 2005, the Board of Directors has reserved
a total of 2,795,907 and 2,668,971 shares respectively, of the Company's common
stock to provide for current and future grants under the 2002 Stock Incentive
Plan and the 2002 Director Plan and for all current grants under the 1994 Stock
Option Plan. In 2002, the Board of Directors adopted a provision providing for
an annual increase in the number of shares reserved for stock options of the
lesser of 3.25% of outstanding common shares or 833,333 shares, on January 1 of
each year through January 1, 2007.
The 2002 Stock Incentive Plan allows for the grant of incentive stock
options, non-qualified stock options, stock appreciation rights and restricted
shares to employees, Board members, and consultants. Options granted under the
2002 Stock Incentive Plan expire no later than ten years from the date of grant.
The exercise price of each incentive stock option shall not be less than 100% of
the fair value of the stock subject to the option on the date the option is
granted. The exercise price of each non-qualified option shall not be less than
85% of the fair value of the stock subject to the option on the date the option
is granted. The vesting provisions of individual options may vary, but incentive
stock options generally vest 25% on the first anniversary of each grant and 1/48
per month over the next three years. Non-qualified stock options generally vest
ratably over a period of two to four years. Stock appreciation rights granted
under the 2002 Stock Incentive Plan generally vest 25% on the first anniversary
of such grant and 1/48 per month over the next three years and expire no later
than five years from the date of grant. The Company generally issues new shares
upon the exercise of stock options and stock appreciation rights.
Restricted share grants under the 2002 Stock Incentive Plan are either
time-based or performance-based. Time-based restricted shares generally vest 25%
on each anniversary of such grant. Performance-based
74
restricted shares vest upon the achievement of performance objectives which are
determined by the Company's Board of Directors.
The 2002 Director Plan allows for the grant of non-qualified stock options
to the Company's nonemployee directors. Options granted under the 2002 Director
Plan expire no later than ten years from the date of grant. The exercise price
of options under the 2002 Director Plan shall not be less than 100% of the fair
value of the stock subject to the option on the date the option is granted.
Initial grants of options to new directors generally vest over a two year
period. Annual grants to directors generally vest upon the earlier of one year
or the next shareholder meeting.
The 1994 Stock Option Plan allows for the grant of incentive stock options
and non-qualified stock options to employees, Board members, and consultants to
the Company. Options granted under the 1994 Stock Option Plan expire no later
than ten years from the date of grant and generally vest over a period of two to
four years. Options granted may be exercised prior to vesting, in which case the
related shares would be subject to repurchase by the Company at original
purchase price until vested. The Company no longer grants options under the 1994
Stock Option Plan.
As of December 31, 2006, 2005 and 2004, 1,566,886, 1,360,621 and 1,362,239
options and stock appreciation rights were vested and outstanding under all
stock plans, respectively.
A summary of the options outstanding is as follows:
Weighted
Number of Range of Average Price
Shares Exercise Price per Share
---------------------------------------------
Outstanding, December 31, 2003 1,676,220 $0.25-$5.94 $ 4.29
Granted 935,553 $4.75-$11.54 $ 7.49
Repurchased 115 $0.78 $ 0.78
Exercised (135,387) $0.25-$5.94 $ 2.84
Forfeited (223,331) $0.54-$7.02 $ 6.33
----------
Outstanding, December 31, 2004 2,253,170 $0.25-$11.54 $ 5.50
Granted 687,050 $7.20-$10.09 $ 8.05
Exercised (282,527) $0.25-$7.02 $ 4.81
Forfeited (201,205) $1.37-$11.54 $ 8.02
----------
Outstanding, December 31, 2005 2,456,488 $0.25-$11.54 $ 6.09
Granted 367,500 $9.90-$12.35 $11.45
Exercised (329,593) $0.25-$11.54 $ 4.09
Forfeited (90,888) $5.94-$12.03 $ 8.87
----------
Outstanding, December 31, 2006 2,403,507 $0.25-$12.35 $ 7.08
==========
As of December 31, 2006, 2005 and 2004, the weighted average remaining
contractual life of the options and stock appreciation rights outstanding was
5.7 years, 7.0 years and 8.1 years, respectively. Of the 2,403,507 options and
stock appreciation rights that were outstanding as of December 31, 2006,
1,566,886 were vested and exercisable with a weighted average exercise price of
$5.93 per share and a weighted average remaining term of 5.9 years.
75
A summary of the options outstanding by range of exercise price is as follows:
Year Ended December 31, 2006
----------------------------------------------------------------------------
Weighted Weighted Number of Weighted
Average Average Options Average
Range of Exercise Options Remaining Exercise Currently Exercise
Prices Outstanding Life Price Exercisable Price
----------------------------------------------------------------------------
$0.25 - $1.62 160,251 4.3 years $1.32 160,251 $1.32
$4.75 - $7.99 1,683,879 5.7 years 6.44 1,274,989 6.15
$8.00 - $12.35 559,377 6.0 years 10.64 131,646 9.41
----------------------------------------------------------------------------
2,403,507 5.7 years $7.08 1,566,886 $5.93
The intrinsic value of options and stock appreciation rights is calculated
as the difference between the exercise price of the underlying awards and the
quoted price of the Company's common stock for the 2,095,857 options that were
in-the-money at December 31, 2006. The intrinsic value of the options
outstanding at December 31, 2006 was approximately $8.2 million based on a
closing share price of $10.32 on December 31, 2006. The intrinsic value of fully
vested options and stock appreciation rights vested and outstanding at December
31, 2006 was approximately $6.9 million based on a closing price of $10.32 on
December 31, 2006. During the year ended December 31, 2006, the aggregate
intrinsic value of options exercised under the Company's stock option plans was
approximately $2.2 million.
During the year ended December 31, 2006, the Company realized
approximately $1.3 million from the exercise of stock options.
The 2002 Stock Incentive Plan allows for the grant of restricted shares to
employees. These grants expire no later than five years from the date of grant.
Restricted share grants under the 2002 Stock Incentive Plan are either
time-based or performance-based. Time-based restricted shares generally vest 25%
on each anniversary of such grant. Performance-based restricted shares vest upon
the achievement of performance objectives which are determined by the Company's
Compensation Committee.
A summary of the restricted share grant activity for the year ended
December 31, 2006 is as follows:
Weighted
Number of Average Grant
Shares Price per Share
--------------------------------
Outstanding, December 31, 2005 359,100 $7.70
Granted 432,610 $11.46
Vested (22,560) $7.91
Forfeited (89,606) $9.56
----------
Outstanding, December 31, 2006 679,544 $9.84
==========
A summary of the restricted stock outstanding as of December 31, 2006 is as
follows:
Number of
Shares
---------
Time based restricted shares 188,924
Performance based restricted shares 490,620
--------
Outstanding, December 31, 2006 679,544
========
The intrinsic value of restricted shares outstanding at December 31, 2006
was approximately $7.0 million based on a closing share price of $10.32 as of
December 31, 2006. During the year ended December 31,
76
2006, the aggregate intrinsic value of restricted shares vested was
approximately $68,000 determined at the date of vesting.
2004 Employee Stock Purchase Plan
Upon the effectiveness of the initial public offering in August 2004, the
Company adopted its 2004 Employee Stock Purchase Plan and reserved 277,777
shares of common stock for issuance pursuant to the plan. The Company offered
employees the opportunity to participate in the plan beginning January 1, 2005
with an initial purchase date of June 30, 2005. Eligible employees have the
opportunity to participate in a new purchase period every 6 months. Under the
terms of the plan, employees can purchase shares of stock at 85% of the fair
market value of the stock at the beginning or the end of the purchase period.
Eligible employees have the opportunity to participate in a new purchase period
every six months.
Pro Forma Net Loss
The following table illustrates the effect on net loss if the Company had
applied the fair value recognition provisions of SFAS 123 to stock-based
compensation:
Year Ended December 31,
2005 2004
------------------------------
Net loss, as reported $(43,557,835) $ (27,257,469)
Add total stock-based compensation cost
included in net loss 747,412 452,130
Deduct total stock-based compensation
expense under fair value method (3,374,460) (2,873,162)
------------------------------
Pro forma net loss $(46,184,883) $(29,678,501)
==============================
Net loss per share, basic and diluted, as
reported $(1.60) $(2.38)
Net loss per share, basic and diluted, pro
forma $(1.69) $(2.59)
For purposes of the above proforma disclosure, the fair value of each
option or stock appreciation right is estimated on the date of grant using the
Black-Scholes option pricing model using the following assumptions for the years
ended 2005 and 2004: dividend yield of 0%, expected volatility ranging from 50%
to 120%, risk free interest rates ranging from 1.09% to 5.28% an initial
expected life ranging from five to ten years.
Deferred Compensation
At December 31, 2005, deferred compensation was recorded as a separate
component of stockholders' equity and subsequently reclassified to additional
paid-in-capital upon the adoption of SFAS 123(R) in 2006.
Warrants
Prior to its public offering in 2004, the Company issued warrants to
purchase 418,819 shares of common stock at $7.81 per share exercisable through
December 2006, warrants to purchase 446,063 shares of common stock at $7.81
exercisable through December 2007, warrants to purchase 298,936 shares of common
stock at $10.55 per share exercisable through February 2009 in connection with a
corresponding issuance of convertible preferred stock. During 2005, the Company
issued warrants to purchase 306,418 shares of common stock at $6.53 in
conjunction a commitment for unsecured borrowing capacity from two affiliated
investors. Such warrants are exercisable through November 2010. The fair value
of the warrants was
77
credited to additional paid-in capital was recognized as commitment fees over
the term of the agreement.
During 2006 and 2005, warrants for 858,810 and 72,507 shares,
respectively, were exercised. Certain of these shares were exercised under the
cashless exercise provision of the warrant agreements for a net issuance of
638,472 and 14,888 shares of common stock during 2006 and 2005, respectively.
12. Income Taxes
The provision for income taxes consists of:
Year Ended December 31,
2006 2005 2004
--------------------------------------------
Deferred tax benefit:
Federal $ 14,321,316 $ 14,654,439 $ 9,502,076
State and local 2,384,413 2,361,140 950,374
--------------------------------------------
$ 16,705,729 $ 17,015,579 10,452,450
Valuation allowance $(16,705,729) $(17,015,579) (10,452,450)
--------------------------------------------
$ -- $ -- $ --
============================================
The provision for income taxes varies from the amount determined by
applying the U.S. federal statutory rate to income before income taxes as a
result of the following:
Year Ended December 31,
2006 2005 2004
--------------------------------
U.S. statutory income tax rate 34.0% 34.0% 34.0%
State and local taxes, net of federal
tax benefit 3.4% 3.6% 3.6%
Permanent differences between book and
tax and other (1.5%) (0.2%) (1.5%)
Research credits 0.6% 1.7% 2.2%
Valuation allowance (36.5%) (39.1%) (38.3%)
-------------------------------
Effective income tax rate 0.0% 0.0% 0.0%
===============================
In assessing the realizability of deferred tax assets, the Company
considers whether it is more likely than not that some portion or all of the
deferred tax assets will not be realized. The ultimate realization of deferred
tax assets is dependent upon the generation of future taxable income during the
periods in which those temporary differences become deductible. The Company
considers projected future taxable income and tax planning strategies in making
this assessment. Based upon the level of historical taxable losses, limitations
imposed by Section 382 of the Internal Revenue Code and projections for future
losses over periods which the deferred tax assets are deductible, the Company
determined that a 100% valuation allowance of deferred tax assets was
appropriate. Accordingly, a 100% valuation allowance has been established. The
valuation allowance for deferred tax assets includes approximately $0.4 million
for which subsequently recognized tax benefits will be applied directly to
contributed capital.
78
The components of the deferred tax asset are as follows:
December 31,
2006 2005
----------------------------
Current accruals $ 566,765 $ 710,833
Depreciation and amortization 1,525,704 1,169,265
Deferred compensation 1,626,847 887,519
Net operating loss carryovers 72,276,229 56,362,965
Other 361 125,492
Research and development credit carryovers 3,702,394 3,434,860
----------------------------
79,698,300 62,690,934
Valuation allowance (79,698,300) (62,690,394)
----------------------------
$ -- $ --
============================
As of December 31, 2006, the Company has federal net operating loss
carryforwards of $192,224,000. The net operating loss carryforwards will expire
at various dates beginning in 2007, approximately $2,913,000 will expire between
2007 and 2010 and approximately $189,311,000 will expire between 2011 and 2026,
if not utilized. As of December 31, 2006, the Company had federal research and
development credit carryforwards of $3,702,000, which may be subject to
limitations and will expire at various dates beginning in 2007, approximately
$59,000 will expire between 2007 and 2010 and $3,643,000 will expire between
2011 and 2026, if not utilized.
13. Net Loss per Share
The following is a reconciliation of the numerator (net loss) and the
denominator (number of shares) used in the basic and diluted earnings per share
calculations:
Year Ended
December 31,
2006 2005 2004
--------------------------------------------
Basic and diluted:
Net loss $(45,719,770) $(43,557,835) $(27,257,469)
Weighted average common
shares outstanding 32,979,403 27,312,041 11,502,781
Less weighted average shares
subject to repurchase 0 (10,219) (32,471)
--------------------------------------------
Weighted average shares used in
basic and diluted net loss per share 32,979,403 27,301,822 11,470,310
============================================
Net loss per share $ (1.39) $ (1.60) $ (2.38)
============================================
The following table sets forth the number of common shares that were
excluded from the computation of earnings per share because their inclusion
would have been anti-dilutive as follows:
December 31,
2006 2005 2004
---------------------------------------
Shares outstanding
Restricted shares 651,288 308,105 --
Common stock subject to repurchase -- -- 8,681
Shares issuable upon exercise of:
Options to purchase common stock 2,403,507 2,456,488 2,253,170
Warrants 510,626 1,369,436 1,135,526
---------------------------------------
3,565,421 4,134,029 3,397,377
=======================================
79
14. Employee Benefit Plan
The Company offers employees the opportunity to participate in a 401(k)
plan to which the Company matches employee contributions dollar for dollar up to
3% of the employee's salary during the employee's period of participation. For
the years ended December 31, 2006, 2005 and 2004, the Company expensed $492,142,
$450,370 and $361,008, respectively, related to the plan.
Beginning in 2005, the Company offered employees the opportunity to
participate in an Employee Stock Purchase Plan. Under the terms of the plan,
employees can purchase up to $12,500 of the Company's common stock during each
of two six-month purchase periods per year. Such shares are purchased at a 15%
discount to the lower of the market price at the beginning or the end of the
purchase period. As of December 31, 2006 and 2005, 104,458 and 29,541 shares,
respectively, had been purchased under this plan.
15. Commitments and Contingencies
The Company at times becomes a party to claims in the ordinary course of
business. Management believes that the ultimate resolution of pending or
threatened proceedings will not have a material effect on the financial
position, results of operations, or liquidity of the Company.
The Company has entered into two letters of credit to support certain
purchase and other commitments in the amount of approximately $2.6 million.
16. Quarterly Data (Unaudited)
The following tabulations reflect the unaudited quarterly results of
operations for the years ended December 31, 2006 and 2005:
Basic and
Net Gross Net Diluted Loss
Sales Profit Loss Per Share
-------------------------------------------------------
2006
First quarter $ 1,731,793 $ 499,802 $(14,595,306) $ (0.47)
Second quarter 3,814,020 1,631,595 (13,610,529) (0.41)
Third quarter 7,640,313 3,964,791 (11,353,573) (0.34)
Fourth quarter 14,005,580 8,202,769 (6,160,362) (0.18)
2005
First quarter $ 5,086,401 $2,649,041 $ (7,338,363) $ (0.27)
Second quarter 6,146,226 2,948,777 (11,333,477) (0.42)
Third quarter 1,688,339 896,903 (11,906,295) (0.44)
Fourth quarter 2,105,424 810,963 (12,979,700) (0.47)
17. Segment Information
The Company considers reporting segments in accordance with SFAS 131,
Disclosures about Segments of an Enterprise and Related Information. The
Company's system and disposable devices are developed and marketed to a broad
base of hospitals in the United States and internationally. The Company
considers all such sales to be part of a single operating segment.
80
Geographic revenue is as follows:
Year Ended December 31,
2006 2005 2004
---------------------------------------
United States $17,122,214 $10,998,617 $12,578,610
International 10,069,492 4,027,773 6,238,250
---------------------------------------
Total $27,191,706 $15,026,390 $18,816,860
=======================================
All of the Company's long-lived assets are located in the United States.
18. Subsequent Event
In March 2007 the Company amended its credit agreement with its primary
lending bank. The amended agreement retains substantially all of the same terms
and conditions as the agreement in place at December 31, 2006, but increases the
maximum borrowing capacity to $25 million, an increase of $15 million, and
provides for an additional $2 million in equipment advances to be drawn prior to
June 30, 2007. In the event the Company's quick asset ratio (as defined in the
agreement) falls below 1.75 to 1, the Company would also be required to maintain
certain operating performance measures. The maturity date of the revolving line
of credit is extended to March 2009 and the interest rate is adjusted to the
lender's prime rate plus either 0.25% or 0.75%, depending on a defined liquidity
measure.
81
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL DISCLOSURE
None.
ITEM 9A. CONTROLS AND PROCEDURES
Report on Internal Control Over Financial Reporting
As of December 31, 2006, the Company's management, with the participation
of the Company's Chief Executive Officer and Chief Financial Officer, evaluated
the effectiveness of the Company's disclosure controls and procedures (as such
term is defined in Rules 13a-15(e) and 15d-15(e) promulgated under the
Securities Exchange Act of 1934, as amended (the "Exchange Act")). Based on such
evaluation, the Company's Chief Executive Officer and Chief Financial Officer
have concluded that, as of the end of such period, the Company's disclosure
controls and procedures were effective in recording, processing, summarizing and
reporting, on a timely basis, information required to be disclosed by the
Company in the report that it files or submits under the Exchange Act.
Internal Control over Financial Reporting: The Company's management is
responsible for establishing and maintaining adequate internal control over
financial reporting as defined in Rules 13a-15(f) and 15d-15(f) promulgated
under the Securities Exchange Act. The Company's internal control over financial
reporting is designed to provide reasonable assurance regarding the reliability
of financial reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting principles in the
United States of America. The Company's management assessed the effectiveness of
our internal control over financial reporting as of December 31, 2006. In making
this assessment, management used the criteria set forth by the Committee of
Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control
- -- Integrated Framework. Based on our assessment, our management has concluded
that our internal control over financial reporting is effective as of December
31, 2006. A control system, no matter how well conceived or operated, can
provide only reasonable, not absolute, assurance that the objectives of the
control system are met. Further, the design of a control system must reflect the
fact that there are resource constraints, and the benefits of controls must be
considered relative to their costs. Because of the inherent limitations in all
control systems, no evaluation of controls can provide absolute assurance that
all control issues and instances of fraud, if any, within the Company have been
detected. These inherent limitations include the realities that judgments in
decision-making can be faulty, and that breakdowns can occur because of simple
error or mistake. Additionally, controls can be circumvented by the individual
acts of some persons, by collusion of two or more people, or by management
override of the controls. The design of any system of controls is based in part
upon certain assumptions about the likelihood of future events, and there can be
no assurance that any design will succeed in achieving its stated goals under
all potential future conditions; over time, controls may become inadequate
because of changes in conditions, or the degree of compliance with the policies
or procedures may deteriorate. Because of the inherent limitations in a
cost-effective control system, misstatements due to error or fraud may occur and
not be detected.
The Company's independent registered public accounting firm, Ernst & Young
LLP, has issued an audit report on management's assessment of internal control
over financial reporting, which can be found below.
Based on the evaluation of internal control over financial reporting, the
Chief Executive Officer and Chief Financial Officer have concluded that there
have been no changes in the Company's internal controls over financial reporting
during the period that is covered by this report that has materially affected or
is reasonably likely to materially affect, the Company's internal control over
financial reporting.
82
Report of Independent Registered Public Accounting Firm
The Board of Directors and Shareholders
Stereotaxis, Inc.
We have audited management's assessment, included in the accompanying
Management's Report on Internal Control Over Financial Reporting, that
Stereotaxis, Inc. maintained effective internal control over financial reporting
as of December 31, 2006, based on criteria established in Internal Control -
Integrated Framework issued by the Committee of Sponsoring Organizations of the
Treadway Commission (the COSO criteria). Stereotaxis, Inc.'s management is
responsible for maintaining effective internal control over financial reporting
and for its assessment of the effectiveness of internal control over financial
reporting. Our responsibility is to express an opinion on management's
assessment and an opinion on the effectiveness of the company's internal control
over financial reporting based on our audit.
We conducted our audit in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we plan
and perform the audit to obtain reasonable assurance about whether effective
internal control over financial reporting was maintained in all material
respects. Our audit included obtaining an understanding of internal control over
financial reporting, evaluating management's assessment, testing and evaluating
the design and operating effectiveness of internal control, and performing such
other procedures as we considered necessary in the circumstances. We believe
that our audit provides a reasonable basis for our opinion.
A company's internal control over financial reporting is a process designed to
provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance
with generally accepted accounting principles. A company's internal control over
financial reporting includes those policies and procedures that (1) pertain to
the maintenance of records that, in reasonable detail, accurately and fairly
reflect the transactions and dispositions of the assets of the company; (2)
provide reasonable assurance that transactions are recorded as necessary to
permit preparation of financial statements in accordance with generally accepted
accounting principles and that receipts and expenditures of the company are
being made only in accordance with authorizations of management and directors of
the company; and (3) provide reasonable assurance regarding prevention or timely
detection of unauthorized acquisition, use, or disposition of the company's
assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting
may not prevent or detect misstatements. Also, projections of any evaluation of
effectiveness to future periods are subject to the risk that controls may become
inadequate because of changes in conditions or that the degree of compliance
with the policies or procedures may deteriorate.
In our opinion, management's assessment that Stereotaxis, Inc. maintained
effective internal control over financial reporting as of December 31, 2006, is
fairly stated, in all material respects, based on the COSO criteria. Also, in
our opinion, Stereotaxis, Inc. maintained, in all material respects, effective
internal control over financial reporting as of December 31, 2006, based on the
COSO criteria.
We also have audited, in accordance with the standards of the Public Company
Accounting Oversight Board (United States), the balance sheets of Stereotaxis,
Inc. as of December 31, 2006 and 2005, and the related statements of operations,
stockholders' equity, and cash flows for each of the three years in the period
ended December 31, 2006, of Stereotaxis, Inc., and our report dated March 12,
2007, expressed an unqualified opinion thereon.
/s/ Ernst & Young LLP
St. Louis, Missouri
March 12, 2007
83
ITEM 9B. OTHER INFORMATION
None.
PART III
Certain information required by Part III is omitted from this Report on
Form 10-K since we intend to file our definitive Proxy Statement for our next
Annual Meeting of Stockholders, pursuant to Regulation 14A of the Securities
Exchange Act of 1934, as amended (the "Proxy Statement"), no later than April
30, 2007, and certain information to be included in the Proxy Statement is
incorporated herein by reference.
ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT
Information required by this item concerning our executive officers and
directors is incorporated by reference to the information set forth in the
section entitled "Directors and Executive Officers" in our Proxy Statement.
Information regarding Section 16 reporting compliance is incorporated by
reference to the information set forth in the section entitled "Section 16(a)
Beneficial Ownership Reporting Compliance" in our Proxy Statement.
Our Board of Directors adopted a Code of Business Conduct and Ethics for
all of our directors, officers and employees effective August 1, 2004 as amended
from time to time. Stockholders may request a free copy of our Code of Business
Conduct and Ethics from our Chief Financial Officer as follows:
Stereotaxis, Inc.
Attention: James M. Stolze
4320 Forest Park Avenue, Suite 100
St. Louis, MO 63108
314-678-6100
To the extent required by law or the rules of the NASDAQ Stock Market, any
amendments to, or waivers from, any provision of the Code of Business Conduct
and Ethics will be promptly disclosed publicly. To the extent permitted by such
requirements, we intend to make such public disclosure by posting the relevant
material on our website (www.stereotaxis.com) in accordance with SEC rules.
ITEM 11. EXECUTIVE COMPENSATION
The information required by this item regarding executive compensation is
incorporated by reference to the information set forth in the sections titled
"Executive Compensation" in our Proxy Statement.
84
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND
RELATED STOCKHOLDER MATTERS
The information required by this item regarding security ownership of
certain beneficial owners and management is incorporated by reference to the
information set forth in the section titled "Security Ownership of Certain
Beneficial Owners and Management" in our Proxy Statement.
The following table summarizes certain information regarding our
securities that may be issued pursuant to our equity compensation plans as of
December 31, 2006.
Number of securities
Number of securities Weighted-average remaining available for future
to be issued upon exercise price of issuance under equity
exercise of outstanding compensation plans
outstanding options, options, warrants (excluding securities reflected
Plan Category warrants and rights and rights in column (a))(1)
- ---------------------------------------------------------------------------------------------------
(a) (b) (c)
Equity
compensation plans
approved by
security holders 2,403,507 $ 7.08 563,818
Equity
compensation plans
not approved by
security holders -- -- --
---------------------------------------------------------------------------
Total 2,403,507 $ 7.08 567,519
===========================================================================
(1) Includes 173,319 shares reserved for issuance under the 2004 Employee
Stock Purchase Plan. Excludes automatic annual increase to shares by which
on January 1 of 2007, the lesser of (i) 3.25% of the total outstanding
shares as of each such date or (ii) 833,333 shares will be allocated to
the 2002 Stock Incentive Plan. Number of shares of common stock is subject
to adjustment for changes in capitalization for stock splits, stock
dividends and similar events.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED PERSON TRANSACTIONS AND DIRECTOR
INDEPENDENCE
The information required by this item regarding certain relationships and
related transactions is incorporated by reference to the information set forth
in the section titled "Certain Relationships and Related Person Transactions and
Director Independence" in our Proxy Statement.
ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES
The information required by this item regarding principal accounting fees
and services is incorporated by reference to the information set forth in the
section titled "Principal Accounting Fees and Services" in our Proxy Statement.
85
PART IV
ITEM 15: EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(a) The following documents are filed as part of this Annual Report on
Form 10-K
(1) Financial Statements--See Index to the Financial Statements at
Item 8 of this Report on Form 10-K.
(2) The following financial statement schedule of Stereotaxis,
Inc. is filed as part of this Report and should be read in
conjunction with the financial statements of Stereotaxis,
Inc.:
-- Schedule II: Valuation and Qualifying Accounts.
All other schedules have been omitted because they are not
applicable, not required under the instructions, or the
information requested is set forth in the consolidated
financial statements or related notes thereto.
(3) Exhibits
See Exhibit Index appearing on page 90 herein.
86
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 thereunto duly authorized.
STEREOTAXIS, INC.
(Registrant)
Date: March 13, 2007 By: /s/ Bevil J. Hogg
-----------------------
Bevil J. Hogg,
Chief Executive Officer
KNOW ALL MEN BY THESE PRESENTS, that each person whose signature appears
below constitutes and appoints Bevil J. Hogg and James M. Stolze, and each of
them, his true and lawful attorneys-in-fact and agents, with full power of
substitution and resubstitution, for him and in his name, place and stead, in
any and all capacities to sign any and all amendments to this Annual Report on
Form 10-K and any other documents and instruments incidental thereto, and to
file the same, with all exhibits thereto, and other documents in connection
therewith, with the Securities and Exchange Commission, granting unto said
attorneys-in-fact and agents, and each of them, full power and authority to do
and perform each and every act and thing requisite or necessary to be done in
and about the premises, as fully to all intents and purposes as he might or
could do in person, hereby ratifying and confirming all that said
attorneys-in-fact and agents and/or any of them, or their or his substitute or
substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this
report has been signed below by the following persons on behalf of the
Registrant and in the capacities and on the dates indicated.
Signature Title Date
- ----------------------------------------------- ---------------------------------------- ------------------------
/s/ FRED A. MIDDLETON Chairman of the Board of Directors March 13, 2007
- -----------------------------------------------
Fred A. Middleton
/s/ BEVIL J. HOGG Chief Executive Officer March 13, 2007
- ----------------------------------------------- (principal executive officer)
Bevil J. Hogg
/s/ JAMES M. STOLZE Vice President and Chief Financial Officer March 13, 2007
- ----------------------------------------------- principal financial officer and
James M. Stolze (principal accounting officer)
- -----------------------------------------------
/s/ ABHI ACHARYA
- ----------------------------------------------- Director March 13, 2007
Abhi Acharya
/s/ CHRISTOPHER ALAFI Director March 13, 2007
- -----------------------------------------------
Christopher Alafi
87
/s/ DAVID W. BENFER Director March 13, 2007
- -----------------------------------------------
David W. Benfer
/s/ RALPH G. DACEY, JR. Director March 13, 2007
- -----------------------------------------------
Ralph G. Dacey, Jr.
/s/ GREGORY R. JOHNSON Director March 13, 2007
- -----------------------------------------------
Gregory R. Johnson
/s/ WILLIAM M. KELLEY Director March 13, 2007
- -----------------------------------------------
William M. Kelley
/s/ ABHIJEET J. LELE Director March 13, 2007
- -----------------------------------------------
Abhijeet J. Lele
/s/ WILLIAM C. MILLS III Director March 13, 2007
- -----------------------------------------------
William C. Mills III
/s/ ROBERT J. MESSEY Director March 13, 2007
- -----------------------------------------------
Robert J. Messey
/s/ ERIC N. PRYSTOWSKY Director March 13, 2007
- -----------------------------------------------
Eric N. Prystowsky
88
SCHEDULE II
VALUATION AND QUALIFYING ACCOUNTS
FOR THE YEARS ENDED DECEMBER 31, 2006, 2005 AND 2004
Additions
Balance at Charged to Balance at
Beginning Cost and the End of
Of Year Expenses Deductions Year
--------------------------------------------------
Allowance for doubtful accounts and returns:
Year ended December 31, 2006 $ 29,576 $ 248,280 $ (187,140) $ 90,716
Year ended December 31, 2005 146,223 132,221 (248,868) 29,576
Year ended December 31, 2004 116,725 151,971 (122,473) 146,223
Allowance for inventories valuation:
Year ended December 31, 2006 $ 43,438 $ 627,604 $ (459,586) $ 211,456
Year ended December 31, 2005 112,755 207,126 (276,443) 43,438
Year ended December 31, 2004 105,752 59,844 (52,841) 112,755
89
EXHIBIT INDEX
Number Description
- ------ -----------
3.1 Restated Articles of Incorporation of the Registrant, incorporated by
reference to Exhibit 3.1 of the Registrant's Form 10-Q (File No.
000-50884) for the fiscal quarter ended September 30, 2004.
3.2 Restated Bylaws of the Registrant, incorporated by reference to Exhibit
3.2 of the Registrant's Form 10-Q (File No. 000-50884) for the fiscal
quarter ended September 30, 2004.
4.1 Form of Specimen Stock Certificate, incorporated by reference to the
Registration Statement on Form S-1 (File No. 333-115253) originally
filed with the Commission on May 7, 2004, as amended thereafter, at
Exhibit 4.1.
4.2 Fourth Amended and Restated Investor Rights Agreement, dated December
17, 2002 by and among Registrant and certain stockholders, incorporated
by reference to the Registration Statement on Form S-1 (File No.
333-115253) originally filed with the Commission on May 7, 2004, as
amended thereafter, at Exhibit 4.2.
4.3 Joinder Agreement to Series D-2 Preferred Stock Purchase Agreement,
Fourth Amended and Restated Investor Rights Agreement and Amendment to
Second Amended and Restated Stockholders' Agreement dated January 21,
2003 by and among Registrant and certain stockholders, incorporated by
reference to the Registration Statement on Form S-1 (File No.
333-115253) originally filed with the Commission on May 7, 2004, as
amended thereafter, at Exhibit 4.3.
4.4 Joinder and Amendment to Second Amended and Restated Stockholders'
Agreement and Fourth Amended and Restated Investor Rights Agreement,
dated May 27, 2003 by and among Registrant and certain stockholders
incorporated by reference to the Registration Statement on Form S-1
(File No. 333-115253) originally filed with the Commission on May 7,
2004, as amended thereafter, at Exhibit 4.4.
4.5 Second Joinder and Amendment to Second Amended and Restated
Stockholders' Agreement and Fourth Amended and Restated Investor Rights
Agreement, dated December 22, 2003 by and among Registrant and certain
stockholders, incorporated by reference to the Registration Statement
on Form S-1 (File No. 333-115253) originally filed with the Commission
on May 7, 2004, as amended thereafter, at Exhibit 4.5.
4.6 Third Joinder and Amendment to Second Amended and Restated
Stockholders' Agreement and Fourth Amended and Restated Investor Rights
Agreement, dated January 28, 2004 by and among Registrant and certain
stockholders, incorporated by reference to the Registration Statement
on Form S-1 (File No. 333-115253) originally filed with the Commission
on May 7, 2004, as amended thereafter, at Exhibit 4.6.
4.7 Form of Warrant Agreement issued to Series D-1 investors, incorporated
by reference to the Registration Statement on Form S-1 (File No.
333-115253) originally filed with the Commission on May 7, 2004, as
amended thereafter, at Exhibit 4.7.
4.8 Warrant Agreement issued to Silicon Valley Bank dated January 31, 2002,
incorporated by reference to the Registration Statement on Form S-1
(File No. 333-115253) originally filed with the Commission on May 7,
2004, as amended thereafter, at Exhibit 4.8.
90
4.9 Form of Warrant Agreement issued to Series D-2 investors, incorporated
by reference to the Registration Statement on Form S-1 (File No.
333-115253) originally filed with the Commission on May 7, 2004, as
amended thereafter, at Exhibit 4.9.
4.10 Form of Warrant Agreement issued to Series E-2 investors, incorporated
by reference to the Registration Statement on Form S-1 (File No.
333-115253) originally filed with the Commission on May 7, 2004, as
amended thereafter, at Exhibit 4.10.
4.11 Warrant Agreement issued to Silicon Valley Bank dated March 19, 2002,
incorporated by reference to the Registration Statement on Form S-1
(File No. 333-115253) originally filed with the Commission on May 7,
2004, as amended thereafter, at Exhibit 4.11.
4.12 Warrant Agreement issued to Silicon Valley Bank dated September 30,
2002, incorporated by reference to the Registration Statement on Form
S-1 (File No. 333-115253) originally filed with the Commission on May
7, 2004, as amended thereafter, at Exhibit 4.12.
4.13 Form of Warrant issued pursuant to that certain Note and Warrant
Purchase Agreement, dated as of November 10, 2005, between the
Registrant and the investors named therein, incorporated by reference
to Exhibit 4.2 of the Registrant's Form 10-Q (File No. 000-50884) for
the fiscal quarter ended September 30, 2005.
10.1# 1994 Stock Option Plan, incorporated by reference to the Registration
Statement on Form S-1 (File No. 333-115253) originally filed with the
Commission on May 7, 2004, as amended thereafter, at Exhibit 10.1.
10.2a# 2002 Stock Incentive Plan, incorporated by reference to the
Registration Statement on Form S-1 (File No. 333-115253) originally
filed with the Commission on May 7, 2004, as amended thereafter, at
Exhibit 10.2.
10.2b# Form of Incentive Stock Option Agreement under the 2002 Stock Incentive
Plan, incorporated by reference to Exhibit 10.1 of the Registrant's
Form 10-Q (File No. 000-50884) for the fiscal quarter ended September
30, 2004.
10.2c# Form of Non-Qualified Stock Option Agreement under the 2002 Stock
Incentive Plan, incorporated by reference to Exhibit 10.2 of the
Registrant's Form 10-Q (File No. 000-50884) for the fiscal quarter
ended September 30, 2004.
10.2d# Form of Restricted Stock Agreement under the 2002 Stock Incentive Plan,
incorporated by reference to Exhibit 10.2 of the Registrant's Form 10-Q
(File No. 000-50884) for the fiscal quarter ended June 30, 2005.
10.2e# Form of Performance Share Award under the 2002 Stock Incentive Plan,
incorporated by reference to Exhibit 10.3 of the Registrant's Form 10-Q
(File No. 000-50884) for the fiscal quarter ended June 30, 2005.
10.2f# Form of Stock Appreciation Right Agreement under the 2002 Stock
Incentive Plan, incorporated by reference to Exhibit 10.4 of the
Registrant's Form 10-Q (File No. 000-50884) for the fiscal quarter
ended June 30, 2005.
10.3a# 2004 Employee Stock Purchase Plan, incorporated by reference to the
Registration Statement on Form S-1 (File No. 333-115253) originally
filed with the Commission on May 7, 2004, as amended thereafter, at
Exhibit 10.3.
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10.3b# Form of Subscription Agreement for the 2004 Employee Stock Purchase
Plan, incorporated by reference to Exhibit 10.6 of the Registrant's
Form 10-Q (File No. 000-50884) for the fiscal quarter ended September
30, 2004.
10.4a# 2002 Non-Employee Directors' Stock Plan, incorporated by reference to
the Registration Statement on Form S-1 (File No. 333-115253) originally
filed with the Commission on May 7, 2004, as amended thereafter, at
Exhibit 10.4.
10.4b# Amendment to 2002 Non-Employee Directors' Stock Plan, incorporated by
reference to Exhibit 10.5 of the Registrant's Form 10-Q (File No.
000-50884) for the fiscal quarter ended June 30, 2005.
10.4c# Form of Non-Qualified Stock Option Agreement under the 2002
Non-Employee Director Plan , incorporated by reference to Exhibit 10.1
of the Registrant's Form 10-Q (File No. 000-50884) for the fiscal
quarter ended June 30, 2005.
10.5# Restated Employment Agreement dated February 22, 2006 between Bevil J.
Hogg and the Registrant (filed herewith).
10.6# Employment Agreement dated April 4, 2001 between Douglas M. Bruce and
the Registrant, incorporated by reference to the Registration Statement
on Form S-1 (File No. 333-115253) originally filed with the Commission
on May 7, 2004, as amended thereafter, at Exhibit 10.6.
10.7# Employment Agreement dated February 16, 2001 between Melissa Walker and
the Registrant, incorporated by reference to the Registration Statement
on Form S-1 (File No. 333-115253) originally filed with the Commission
on May 7, 2004, as amended thereafter, at Exhibit 10.7.
10.8# Employment Agreement dated April 17, 2002 between Michael P. Kaminski
and the Registrant, incorporated by reference to the Registration
Statement on Form S-1 (File No. 333-115253) originally filed with the
Commission on May 7, 2004, as amended thereafter, at Exhibit 10.8.
10.9# Letter Agreement and Employment Agreement dated May 26, 2004 between
James M. Stolze and the Registrant, incorporated by reference to the
Registration Statement on Form S-1 (File No. 333-115253) originally
filed with the Commission on May 7, 2004, as amended thereafter, at
Exhibit 10.17.
10.10# Employment Agreement dated February 22, 2005 between Ruchir Sehra and
the Registrant, incorporated by reference to Exhibit 10.39 of the
Registrant's Form 10-K (File No. 000-50884) for the fiscal year ended
December 31, 2005.
10.11# Summary of annual cash compensation of executive officers, dated March
12, 2007 (filed herewith).
10.12# Summary of Non-Employee Directors' Compensation, incorporated by
reference to Exhibit 10.15 of the Registrant's Form 10-K (File No.
000-50884) for the fiscal year ended December 31, 2005.
10.13 Collaboration Agreement dated June 8, 2001 between the Registrant and
Siemens AG, Medical Solutions, incorporated by reference to the
Registration Statement on Form S-1 (File No. 333-115253) originally
filed with the Commission on May 7, 2004, as amended thereafter, at
Exhibit 10.9.
10.14+ Extended Collaboration Agreement dated May 27, 2003 between the
Registrant and Siemens AG, Medical Solutions, incorporated by reference
to the Registration Statement on Form S-1 (File No. 333-115253)
originally filed with the Commission on May 7, 2004, as amended
thereafter, at Exhibit 10.10.
92
10.14a Amendment to Collaboration Agreement dated May 5, 2006 between the
Company and Siemens Aktiengesellschaft, Medical Solutions, incorporated
by reference to Exhibit 10.1 of the Registrant's Form 10-Q (File No.
000-50884) for the fiscal quarter ended June 30, 2006.
10.15+ Development and Supply Agreement dated May 7, 2002 between the
Registrant and Biosense Webster, Inc., incorporated by reference to the
Registration Statement on Form S-1 (File No. 333-115253) originally
filed with the Commission on May 7, 2004, as amended thereafter, at
Exhibit 10.11.
10.16+ Amendment to Development and Supply Agreement dated November 3, 2003
between the Registrant and Biosense Webster, Inc., incorporated by
reference to the Registration Statement on Form S-1 (File No.
333-115253) originally filed with the Commission on May 7, 2004, as
amended thereafter, at Exhibit 10.12.
10.17 Settlement Agreement effective as of June 30, 2005 between the
Registrant and the University of Virginia Patent Foundation,
incorporated by reference to Exhibit 10.1 of the Registrant's current
report on Form 8-K (File No. 000-50884) dated July 8, 2005.
10.18 Form of Indemnification Agreement between the Registrant and its
directors and executive officers, incorporated by reference to the
Registration Statement on Form S-1 (File No. 333-115253) originally
filed with the Commission on May 7, 2004, as amended thereafter, at
Exhibit 10.14.
10.19+ Letter Agreement, dated September 12, 2003, between the Registrant and
Philips Medizin Systeme G.m.b.H., incorporated by reference to the
Registration Statement on Form S-1 (File No. 333-115253) originally
filed with the Commission on May 7, 2004, as amended thereafter, at
Exhibit 10.16.
10.20+ Japanese Market Development Agreement dated May 18, 2004 between the
Registrant, Siemens Aktiengesellschaft and Siemens Asahi Medical
Technologies Ltd., incorporated by reference to the Registration
Statement on Form S-1 (File No. 333-115253) originally filed with the
Commission on May 7, 2004, as amended thereafter, at Exhibit 10.32.
10.21+ Office Lease dated November 15, 2004 between the Registrant and Cortex
West Development I, LLC, incorporated by reference to Exhibit 10.39 of
the Registrant's Form 10-K (File No. 000-50884) for the fiscal year
ended December 31, 2005.
10.22 Loan and Security Agreement dated January 31, 2002 between the
Registrant and Silicon Valley Bank, incorporated by reference to the
Registration Statement on Form S-1 (File No. 333-115253) originally
filed with the Commission on May 7, 2004, as amended thereafter, at
Exhibit 10.21.
10.23 Loan Modification Agreement dated May 14, 2002 between the Registrant
and Silicon Valley Bank, incorporated by reference to the Registration
Statement on Form S-1 (File No. 333-115253) originally filed with the
Commission on May 7, 2004, as amended thereafter, at Exhibit 10.22.
10.24 Second Loan Modification Agreement dated July 11, 2002 between the
Registrant and Silicon Valley Bank, incorporated by reference to the
Registration Statement on Form S-1 (File No. 333-115253) originally
filed with the Commission on May 7, 2004, as amended thereafter, at
Exhibit 10.23.
10.25 Loan and Security Agreement dated September 30, 2002 between the
Registrant and Silicon Valley Bank, incorporated by reference to the
Registration Statement on Form S-1 (File No. 333-115253) originally
filed with the Commission on May 7, 2004, as amended thereafter, at
Exhibit 10.24.
10.26 Second Loan Modification Agreement dated September 30, 2002 to
Equipment Loan and Security Agreement dated January 31, 2002 and Third
Loan Modification Agreement to Revolving Loan and
93
Security Agreement dated March 19, 2002, incorporated by reference to
the Registration Statement on Form S-1 (File No. 333-115253) originally
filed with the Commission on May 7, 2004, as amended thereafter, at
Exhibit 10.25.
10.27 Third Loan Modification Agreement dated December 31, 2002 to Equipment
Loan and Security Agreement dated January 31, 2002 and Fourth Loan
Modification Agreement to Revolving Loan and Security Agreement dated
March 19, 2002 and First Loan Modification Agreement to Equipment Loan
and Security Agreement dated September 30, 2002 between the Registrant
and Silicon Valley Bank, incorporated by reference to the Registration
Statement on Form S-1 (File No. 333-115253) originally filed with the
Commission on May 7, 2004, as amended thereafter, at Exhibit 10.26.
10.28 Fourth Loan Modification Agreement dated April 2003 to Equipment Loan
and Security Agreement dated January 31, 2002 and Fifth Loan
Modification Agreement to Revolving Loan and Security Agreement dated
March 19, 2002 and Second Loan Modification Agreement to Equipment Loan
and Security Agreement dated September 30, 2002, incorporated by
reference to the Registration Statement on Form S-1 (File No.
333-115253) originally filed with the Commission on May 7, 2004, as
amended thereafter, at Exhibit 10.27.
10.29 Loan and Security Agreement dated April 30, 2004 between the Registrant
and Silicon Valley Bank, incorporated by reference to the Registration
Statement on Form S-1 (File No. 333-115253) originally filed with the
Commission on May 7, 2004, as amended thereafter, at Exhibit 10.28.
10.31 Second Loan Modification Agreement, dated as of November 8, 2005,
between Silicon Valley Bank and the Registrant, incorporated by
reference to Exhibit 10.2 of the Registrant's Form 10-Q (File No.
000-50884) for the fiscal quarter ended September 30, 2005.
10.40# Summary of annual cash compensation of executive officers, dated
February, 2006 (filed herewith).
23.1 Consent of Ernst & Young LLP
31.1 Rule 13a-14(a)/15d-14(a) Certification (pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002, executed by Chief Executive Officer).
31.2 Rule 13a-14(a)/15d-14(a) Certification (pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002, executed by Chief Financial Officer).
32.1 Section 1350 Certification (pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002, executed by Chief Executive Officer).
32.2 Section 1350 Certification (pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002, executed by Chief Financial Officer)
- -------------
# Indicates management contract or compensatory plan
+ Confidential treatment granted as to certain portions, which portions are
omitted and filed separately with the Securities and Exchange Commission.
94