sv3za
As filed with the Securities and Exchange Commission on
February 8, 2006.
Registration
No. 333-131394
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Amendment
No. 1 To
FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
SOMANETICS CORPORATION
(Exact name of registrant as specified in its charter)
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MICHIGAN |
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38-2394784 |
(State or other jurisdiction of
incorporation or organization) |
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(I.R.S. Employer
Identification No.) |
1653 East Maple Road
Troy, Michigan 48083-4208
(248) 689-3050
(Address, including zip code, and telephone number, including
area code, of
registrants principal executive offices)
Bruce J. Barrett
President and Chief Executive Officer
Somanetics Corporation
1653 East Maple Road
Troy, Michigan 48083-4208
(248) 689-3050
(Name, address, including zip code, and telephone number,
including area code, of agent for service)
Copies to:
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Robert J. Krueger
Honigman Miller Schwartz and Cohn LLP
2290 First National Building
660 Woodward Ave
Detroit, Michigan 48226-3506
(313) 465-7452
Fax No.: (313) 465-7453 |
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Marjorie Sybul Adams
DLA Piper Rudnick Gray Cary US LLP
1251 Avenue of the America
New York, New York 10020
(212) 835-6017
Fax No.: (212) 884-8517 |
Approximate date of commencement of proposed sale to the
public: As soon as practicable after this Registration
Statement becomes effective.
If the only securities being registered on this Form are being
offered pursuant to dividend or interest reinvestment plans,
please check the following
box. o
If any of the securities being registered on this Form are to be
offered on a delayed or continuous basis pursuant to
Rule 415 under the Securities Act of 1933, other than
securities offered only in connection with dividend or interest
reinvestment plans, check the following
box: o
If this Form is filed to register additional securities for an
offering pursuant to Rule 462(b) under the Securities Act,
please check the following box and list the Securities Act
registration statement number of the earlier effective
registration statement for the same
offering. o
If this Form is a post-effective amendment filed pursuant to
Rule 462(c) under the Securities Act, check the following
box and list the Securities Act registration statement number of
the earlier effective registration statement for the same
offering. o
If this Form is a registration statement pursuant to General
Instruction I.D. or a post-effective amendment thereto that
shall become effective upon filing with the Commission pursuant
to Rule 462(e) under the Securities Act, check the
following
box. o
If this Form is a post-effective amendment to a registration
statement filed pursuant to General Instruction I.D. filed to
register additional securities or additional classes of
securities pursuant to Rule 413(b) under the Securities
Act, check the following
box. o
CALCULATION OF REGISTRATION FEE
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Proposed Maximum |
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Proposed Maximum |
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Amount of |
Title of Each Class of |
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Amount to be |
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Offering Price Per |
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Aggregate Offering |
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Registration |
Securities to be Registered |
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Registered(1) |
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Share(2) |
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Price(2) |
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Fee(3) |
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Common Shares, par value $.01 per share
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2,300,000 |
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$23.145 |
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$53,233,500 |
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$5,695.99 |
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(1) |
Includes 300,000 shares which the underwriters have the
option to purchase to cover over-allotments, if any. |
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(2) |
Estimated solely for the purpose of computing the registration
fee, based on the average of the high and low reported sale
prices of the Registrants common shares on
February 7, 2006 as reported on The Nasdaq National Market,
pursuant to Rule 457(c). |
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(3) |
$7,002.78 paid with the original filing. |
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The Registrant hereby amends this registration statement on
such date or dates as may be necessary to delay its effective
date until the Registrant shall file a further amendment which
specifically states that this registration statement shall
thereafter become effective in accordance with Section 8(a)
of the Securities Act of 1933 or until the registration
statement shall become effective on such date as the Commission,
acting pursuant to said Section 8(a), may determine.
The information in
this prospectus is not complete and may be changed. We may not
sell these securities until the registration statement filed
with the Securities and Exchange Commission is effective. This
prospectus is not an offer to sell these securities and it is
not soliciting an offer to buy these securities in any state
where the offer or sale is not permitted.
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SUBJECT TO COMPLETION, DATED
FEBRUARY 8, 2006
PROSPECTUS
2,000,000 Shares
Somanetics Corporation
Common Shares
$ per
share
We are selling 2,000,000 common shares. We have granted the
underwriters an option to purchase up to 300,000 additional
common shares to cover over-allotments.
Our common shares are quoted on The Nasdaq National Market under
the symbol SMTS. The last reported sale price of our
common shares on The Nasdaq National Market on February 7,
2006 was $22.58 per share.
Investing in our common shares involves risks. See Risk
Factors beginning on page 7.
Neither the Securities and Exchange Commission nor any state
securities commission has approved or disapproved of these
securities or determined if this prospectus is truthful or
complete. Any representation to the contrary is a criminal
offense.
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Per Share | |
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Total | |
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Public Offering Price
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$ |
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$ |
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Underwriting Discount
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$ |
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$ |
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Proceeds to Somanetics Corporation (before expenses)
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$ |
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$ |
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The underwriters expect to deliver the shares to purchasers on
or
about ,
2006.
Citigroup
SG Cowen & Co.
SunTrust Robinson Humphrey
,
2006
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The INVOS System
[Picture of operating room with INVOS System being used] |
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Disposable SomaSensors
[Picture of SomaSensors placed on mans head] |
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The INVOS System is a non-invasive patient monitoring system
that continuously measures changes in the blood oxygen levels in
the brain and somatic, or skeletal muscle, tissue. |
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For multi-channel cerebral monitoring, SomaSensors are placed on
both sides of a patients forehead and are connected to the
monitor. |
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The INVOS System is used with multiple single-use disposable
SomaSensors, the sales of which represented approximately
75 percent of fiscal 2005 net revenues. |
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Financial Overview |
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[Illustration of how SomaSensor works] |
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[Graph of net revenues (five years) and gross margin as a
percentage of net revenues (five years)] |
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Each SomaSensor contains a light source and two light detectors. |
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Light signals are received and analyzed to determine oxygen
saturation of the blood in the area of the brain beneath the
sensors, delivering a reading of changes in blood oxygen levels. |
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Market Evolution
[Graphic of Companys entrance into various markets] |
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Next Generation Monitor
[Picture of next generation INVOS System] |
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Our next generation INVOS System monitor displays up to four
data channels for continuous monitoring of changes in brain and
somatic, or skeletal muscle, tissue oxygen saturation. |
You should rely only on the information contained in or
incorporated by reference in this prospectus. We have not
authorized anyone to provide you with different information. We
are not making an offer of these securities in any state where
the offer is not permitted. You should not assume that the
information contained in this prospectus is accurate as of any
date other than the date on the front of this prospectus.
TABLE OF CONTENTS
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SUMMARY
This summary highlights information contained elsewhere in
this prospectus. This summary may not contain all of the
information that is important to you. Before investing in our
common shares, you should read this prospectus carefully in its
entirety, especially the description of risks of investing in
our common shares set forth under Risk Factors, and
our financial statements and related notes beginning on
page F-1.
Somanetics Corporation Overview
We develop, manufacture and market the INVOS System, a
non-invasive patient
monitoring system that continuously measures changes in the
blood oxygen levels in the brain. The brain is the organ least
tolerant of oxygen deprivation. Without sufficient oxygen, brain
damage may occur within minutes, which can result in paralysis,
other disabilities or death. Brain oxygen information,
therefore, is important, especially in surgical procedures
requiring general anesthesia and in other critical care
situations with a high risk of the brain getting less oxygen
than it needs. Clinical studies have shown that when the INVOS
System is used to monitor and provide information to help manage
the regional brain blood oxygen saturation of patients, the
occurrence of adverse clinical outcomes can be reduced, which
can significantly improve patient outcomes and reduce hospital
costs. The INVOS System consists of a portable monitoring
system, including proprietary software, which is used with
multiple single-use disposable sensors, called SomaSensors.
During our fiscal year ended November 30, 2005, net
revenues from SomaSensors comprised approximately
75 percent of our net revenues. As of November 30,
2005, we had an installed base of approximately 1,100 INVOS
System monitors in the United States in approximately
500 hospitals, and during fiscal 2005 we sold approximately
213,000 SomaSensors worldwide.
Our INVOS System has U.S. Food and Drug Administration, or
FDA, clearance in the United States for use on adults, children
and infants. We target the sale of the INVOS System for use in
surgical procedures and other critical care situations with a
high risk of oxygen imbalances. We initially focused our
marketing efforts primarily on adult and pediatric cardiac
surgeries and carotid artery surgeries. In the first quarter of
fiscal 2005, we initiated selling and marketing efforts for the
INVOS System in the pediatric intensive care unit, or ICU. We
plan to launch the product into the neonatal ICU in late 2006,
after completing development of a smaller SomaSensor. Some of
our potential future markets may include major surgeries
involving diabetic and elderly patients. While our initial focus
has been commercializing the INVOS System to measure blood
oxygen saturation changes in the brain, we believe that there
are opportunities to use the INVOS System in regions of the body
other than the brain. In November 2005, we received 510(k)
clearance from the FDA to market our INVOS System to monitor
changes in blood oxygen saturation elsewhere in the body in
somatic, or skeletal muscle, tissue in patients with or at risk
for restricted blood flow. Our next generation INVOS System
monitor, which we expect to launch in the first half of 2006,
can display information from four SomaSensors, which will allow
for the simultaneous monitoring of changes in blood oxygen
saturation in the brain and, in patients with or at risk for
restricted blood flow, in somatic tissue.
We are currently sponsoring a prospective, randomized, blinded
clinical trial involving diabetic patients over age 50 who
are undergoing major general surgery. The study group will
consist of patients whose surgeries are managed based on
information provided by the INVOS System, and the control group
will consist of similarly situated patients whose surgeries are
not managed based on information provided by the INVOS System.
The two groups will be compared across measures of patient
outcomes and hospital costs, including length of hospital stay.
Diabetics are at particular risk of oxygen imbalances because of
a higher incidence of vascular disease. If results of this trial
are positive, we intend to target more actively the sale of the
INVOS System for use in diabetic patients undergoing major
general surgeries, consistent with FDA requirements. We expect
to begin this marketing in 2008. We are also evaluating
sponsorship of other clinical trials which may allow us to more
actively target the sale of the INVOS System for use in other
patient populations. There are also numerous other independent
clinical studies evaluating the use of the INVOS System.
1
We sell the INVOS System through a direct sales team in the
United States, consisting of salespersons and clinical
specialists, the size of which has increased from
17 persons at the end of fiscal 2004 to 26 persons at
the end of fiscal 2005, and 10 independent sales
representative firms. Outside the United States, we market
the INVOS System through independent distributors, including
Tyco Healthcare in Europe, Canada, the Middle East and Africa,
and Edwards Lifesciences Ltd. in Japan. We expect to increase
significantly the size of our U.S. direct sales team in
fiscal 2006 and are evaluating placing direct salespersons and
clinical specialists in Europe to support Tyco Healthcare. Our
net revenues have increased from $9.4 million in the fiscal
year ended November 2003 to $20.5 million in fiscal 2005,
representing a compounded annual growth rate of
47.6 percent. As a percentage of net revenues, our gross
margin improved from 77 percent in fiscal 2003 to
87 percent in fiscal 2005.
Market Opportunity
We believe that in the United States in 2006 there will be
approximately five million surgeries involving elderly patients
who, due to the type of surgery, age of the patient or other
factors, have a higher risk of developing post-operative
complications. Such surgeries include cardiac surgeries, carotid
surgeries and other major general surgeries involving elderly
patients. In addition, we believe that there are other patient
populations, such as non-elderly adult, pediatric and neonatal
patients, undergoing major surgeries and patients undergoing ICU
treatment or in other critical care situations that face a high
risk of brain oxygen imbalances.
Brain oxygen imbalances can be caused by several factors,
including changes in arterial blood oxygen saturation, which is
the percentage of oxygenated hemoglobin contained in a given
amount of blood which carries oxygen in the arteries to the
tissues of the body, blood flow to the brain, hemoglobin
concentration and oxygen consumption by the brain. Once alerted
to these imbalances, medical professionals can use this and
other information to take corrective action through the
introduction of medications, anesthetic agents or mechanical
intervention, potentially improving patient outcomes and
reducing the costs of care. Immediate and continuous information
about changes in brain oxygen levels also provides immediate
feedback regarding the adequacy of the selected therapy. Equally
important, without information about brain oxygen levels,
therapy that may not be necessary might be initiated in an
attempt to ensure adequate brain oxygen levels and may have an
adverse impact on patient safety and increase hospital costs.
We believe that it is uncommon for patients undergoing surgery
to receive any sort of direct neuromonitoring of brain blood
oxygen saturation, in part due to some of the shortcomings of
the traditional technologies. When patients are monitored
directly, several different methods are used to detect one or
more of the factors affecting brain oxygen levels or the effects
of brain oxygen imbalances. These methods include invasive
jugular bulb catheter monitoring, transcranial Doppler,
electroencephalograms, or EEGs, intracranial pressure monitoring
and neurological examination. The use of these methods is
limited because they are either expensive, difficult or
impractical to use, invasive, not reliable under some
circumstances, not organ specific, not able to measure more than
one factor affecting oxygen imbalances in the brain or not able
to provide continuous information.
In addition, hospitals in the United States have economic
incentives to control health care costs. Therefore, hospitals
are increasingly focused on avoiding unexpected costs, such as
those associated with increased hospital stays of patients with
brain or other organ damage or other adverse outcomes following
surgery or ICU treatment. In addition, lack of immediate
knowledge about blood oxygen levels in areas such as the brain
or somatic tissue can result in unnecessary medical treatments
and associated costs. With the increasing focus by hospitals on
avoiding unexpected costs, especially in the operating room, ICU
and other critical care areas, we believe that there are
significant incentives to evaluate and adopt new monitoring
technologies which could provide information to improve patient
care and reduce costs.
2
Our Solution
Our INVOS System is a non-invasive patient monitoring system
that provides continuous information about changes in blood
oxygen saturation levels. We believe that our INVOS System
addresses the markets need for a solution that is
non-invasive, continuous, immediate, effective and easy to use.
The INVOS System is predominantly used in hospital critical
care areas, such as operating rooms and ICUs. For multi-channel
cerebral monitoring, SomaSensors are placed on both sides of a
patients forehead. The INVOS System uses our
proprietary software to analyze information received from the
SomaSensors and provides a continuous digital and trend display
of an index of the oxygen saturation in the area of the body
under the SomaSensors. Our next generation INVOS System
monitor, which we expect to launch in the first half of 2006,
can display information from four SomaSensors, which will allow
for the simultaneous monitoring of changes in blood oxygen
saturation in the brain and, in patients with or at risk for
restricted blood flow, in somatic tissue.
Surgeons, anesthesiologists and other medical professionals can
use the information provided by the INVOS System, in conjunction
with other available information, to identify brain oxygen
imbalances and take necessary corrective action, potentially
improving patient outcomes and reducing the costs of care. Once
the cause of a cerebral oxygen imbalance is identified and
therapy is initiated, the INVOS System provides immediate
feedback regarding the adequacy of the selected therapy. It can
also provide medical professionals with an additional level of
assurance when they make decisions regarding the need for
therapy.
Unlike some existing monitoring methods, the INVOS System
functions even when the patient is unconscious, lacks a strong
peripheral pulse or has suppressed neural activity. The
measurement made by the INVOS System is dominated by information
from the blood in the veins, where the balance of oxygen supply
and demand can be more effectively assessed. Therefore, it
responds to the changes in factors that affect the balance
between cerebral oxygen supply and demand, including changes in
arterial oxygen saturation, cerebral blood flow, hemoglobin
concentration and cerebral oxygen consumption. The INVOS System
responds to global changes in brain oxygen levels and to events
that affect brain oxygen levels in the region beneath the
SomaSensor.
Our Strategy
Our objective is to establish the INVOS System as a standard of
care in surgical procedures requiring general anesthesia and in
other critical care situations. Key elements of our strategy
include to:
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Target Surgical Procedures and Other Critical Care Situations
with a High Risk of Oxygen Imbalances. We target surgical
procedures and other critical care situations with a high risk
of oxygen imbalances. Some of our current and potential future
markets include cardiac surgeries, carotid artery surgeries,
pediatric and neonatal ICU applications and other major
surgeries involving diabetic or elderly patients. |
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Sponsor Clinical Studies to Promote Expanded Acceptance
of the INVOS System. We plan to sponsor clinical studies
using the INVOS System to demonstrate its benefits. We use the
results of clinical studies to help convince the medical
community of the clinical importance of the information provided
by the INVOS System. We also sponsor
peer-to-peer
educational opportunities and promote use of the INVOS System in
regional centers of influence that we believe will influence its
adoption by others. |
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Invest in Sales and Marketing Activities. We continue to
increase our investment in our distribution network consisting
of our direct sales employees, independent sales representative
firms and distributors. We expect to increase significantly the
size of our U.S. direct sales team in fiscal 2006 and are
evaluating placing direct salespersons and clinical specialists
in Europe to support Tyco Healthcare. |
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Interface and Integrate Our Technology into Other
Manufacturers Multi-Modality Systems. There are many
existing monitoring systems in the operating room and the ICU.
We would like to interface with these monitors. We have
interfaced the INVOS System with the Philips Medical
Systems VueLink System to provide data, alarm events and
status messages from the INVOS System on any monitor that
accepts the VueLink module, a multi-parameter monitor. We plan
to support the interface and integration of our INVOS System
technology with other medical device manufacturers to expand the
installed base of INVOS System monitors and increase the demand
for SomaSensors. We expect that such arrangements will provide
another distribution channel for our INVOS System. |
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Develop Additional Applications and Markets for the INVOS
System. We are developing a smaller SomaSensor for use with
newborns, developing a product-line extension of the INVOS
System for monitoring non-brain tissues and making other
advances to the design and performance features of the INVOS
System, including the SomaSensor. We are also evaluating
additional potential market segments for our INVOS System, such
as use in other major surgeries, in the adult ICU, in the
emergency room, in ambulances, in the catheterization
laboratory, for blood transfusions, for muscle ischemia, for
cosmetic surgery, for non-surgical neurology or cardiology
applications, for psychiatric applications and for sleep
disorders. Pursuit of some of these potential market segments
may require additional FDA clearance. |
The CorRestore System
We also develop and market the CorRestore System, which includes
a cardiac implant, which we call the CorRestore Patch, for use
in cardiac repair and reconstruction, including heart surgeries
called surgical ventricular restoration, or SVR. During SVR, the
surgeon restores an enlarged, poorly functioning left ventricle
to more normal size and function by inserting an implant, in
most instances, or closing the defect directly. Sales of
CorRestore Systems represented two percent of our fiscal
2005 net revenues.
Risk Factors
Our business is subject to numerous risks, as more fully
described in the section entitled Risk Factors
immediately following this prospectus summary on page 7.
Our Corporate Information
We were incorporated under the laws of the State of Michigan in
1982. Our principal executive offices are located at 1653 East
Maple Road, Troy, Michigan 48083-4208, and our telephone number
is (248) 689-3050. Our website address is
www.somanetics.com. The information on, or that can be accessed
through, our website is not a part of this prospectus. Unless
the context indicates otherwise, as used in this prospectus, the
terms Somanetics, Somanetics
Corporation, the Company, we,
us and our refer to Somanetics
Corporation, a Michigan corporation.
Somanetics®,
INVOS®,
SomaSensor®,
Window to the
Brain®
and
CorRestore®
are our registered trademarks. Each of the other trademarks,
trade names or service marks appearing in this prospectus
belongs to its respective holder.
4
The Offering
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Common shares offered by us |
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2,000,000 shares |
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Common shares to be outstanding immediately after the offering |
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12,715,885 shares |
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Use of Proceeds |
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We expect to use the net proceeds of this offering to expand our
direct sales team and other sales and marketing activities, to
sponsor additional clinical trials, to expand our research and
development efforts, and for working capital and general
corporate purposes, including potential acquisitions of
complementary products, technologies or businesses. See
Use of Proceeds. |
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Nasdaq National Market Symbol |
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SMTS |
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The number of shares to be outstanding immediately after this
offering do not include the following:
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1,914,232 common shares issuable upon exercise of outstanding
options granted under our stock option plans and independent of
our stock option plans at an average exercise price of $4.59 per
share; |
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505,785 common shares reserved for future grants and awards
under our 1997 Stock Option Plan and 2005 Stock Incentive
Plan; and |
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2,100,000 common shares issuable upon exercise of the warrants
issued to CorRestore LLC and its agent Wolfe & Company
in connection with our license agreement. The exercise of these
warrants is dependent upon our cumulative net sales of
CorRestore products. The sales requirements for exercise of
these warrants have not been met to date, and we do not expect
that they will be met before these warrants expire in November
2006. |
Unless otherwise noted, the information in this prospectus
assumes that the underwriters do not exercise their
over-allotment option.
5
Summary Financial Data
You should read the following summary financial data together
with our financial statements and related notes and with
Selected Financial Data and Managements
Discussion and Analysis of Financial Condition and Results of
Operations included elsewhere in this prospectus. We have
derived the statement of operations data for the years ended
November 30, 2003, 2004 and 2005 and the balance sheet data
as of November 30, 2005 from our audited financial
statements, which appear elsewhere in this prospectus. Our
historical results for any prior period are not necessarily
indicative of results to be expected for any future period.
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Year Ended November 30, | |
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2003 | |
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2004 | |
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2005 | |
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(in thousands, except per share data) | |
Statement of Operations Data:
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Net revenues
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$ |
9,361 |
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$ |
12,609 |
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$ |
20,509 |
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Cost of sales
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2,140 |
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2,050 |
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2,601 |
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Gross margin
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7,221 |
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10,558 |
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17,908 |
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Operating expenses:
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Research, development and engineering
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413 |
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369 |
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526 |
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Selling, general and administrative
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6,759 |
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8,237 |
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13,241 |
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Total operating expenses(1)
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7,172 |
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8,606 |
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13,767 |
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Operating income
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49 |
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1,952 |
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4,141 |
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Other income:
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Interest income
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23 |
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55 |
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310 |
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Total other income
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23 |
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55 |
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310 |
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Income before income taxes
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72 |
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2,007 |
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4,451 |
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Income tax benefit(2)
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6,700 |
|
|
|
3,300 |
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
$ |
72 |
|
|
$ |
8,707 |
|
|
$ |
7,751 |
|
|
|
|
|
|
|
|
|
|
|
Net income per common share basic
|
|
$ |
0.01 |
|
|
$ |
0.89 |
|
|
$ |
0.75 |
|
|
|
|
|
|
|
|
|
|
|
Net income per common share diluted
|
|
$ |
0.01 |
|
|
$ |
0.77 |
|
|
$ |
0.66 |
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares outstanding
basic
|
|
|
9,114 |
|
|
|
9,780 |
|
|
|
10,322 |
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares outstanding
diluted
|
|
|
9,467 |
|
|
|
11,323 |
|
|
|
11,798 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of November 30, 2005 | |
|
|
| |
|
|
Actual | |
|
As Adjusted(3) | |
|
|
| |
|
| |
|
|
(in thousands) | |
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$ |
13,148 |
|
|
$ |
55,099 |
|
Working capital
|
|
|
18,044 |
|
|
|
59,995 |
|
Total assets
|
|
|
29,719 |
|
|
|
71,669 |
|
Total liabilities
|
|
|
1,878 |
|
|
|
1,878 |
|
Accumulated deficit
|
|
|
(37,131 |
) |
|
|
(37,131 |
) |
Total shareholders equity
|
|
|
27,841 |
|
|
|
69,791 |
|
|
|
(1) |
Includes an impairment expense of $929,093 in fiscal 2005 in
connection with the write-off of our intangible asset associated
with the acquisition of the license for the CorRestore System. |
|
(2) |
Represents income recognized in fiscal 2004 and fiscal 2005 as a
result of a reversal of a portion of our income tax valuation
allowance. |
|
|
(3) |
As adjusted to give effect to the sale of the 2,000,000 common
shares offered by us in this offering at an assumed public
offering price of $22.58 per share, after deducting
underwriting discounts and commissions and estimated offering
expenses payable by us. |
|
6
RISK FACTORS
An investment in our common shares involves a high degree of
risk. You should carefully consider the specific factors
described below, together with the cautionary statement under
the caption Forward-Looking Statements and the other
information included in this prospectus, before purchasing our
common shares. The risks described below are not the only ones
that we face. Additional risks that are not yet known to us or
that we currently think are immaterial could also impair our
business, financial condition or results of operations. If any
of the following risks actually occurs, our business, financial
condition or results of operations could be adversely affected.
In such case, the trading price of our common shares could
decline, and you may lose all or part of your investment.
Risks Relating to Our Business
|
|
|
Our future growth depends on increased market acceptance
of our INVOS System in existing market segments and market
acceptance in new market segments. |
Since sales of the INVOS System, including SomaSensors,
currently account for substantially all of our revenues, our
future growth will depend on the degree to which our INVOS
System is accepted by hospitals and clinicians in our existing
market segments and in new market segments, such as the neonatal
ICU, major surgeries involving diabetic and elderly patients and
other applications. There are numerous factors that could
adversely impact market acceptance of our INVOS System.
Part of our marketing strategy is to encourage and support
clinical research programs. We depend on favorable peer-reviewed
publication and successful clinical use of our products for our
success. The INVOS System has not had extensive clinical use in
the new market segments. We cannot assure you that additional
research papers will be published or that any such papers will
conclude that the INVOS System provides information that is
clinically important. In addition, researchers might publish
results that do not support the clinical importance of the
information provided by the INVOS System or that conclude that
another product provides better or more important information.
Performance problems or adverse research results could prevent
acceptance of the product in existing and new market segments,
adversely affect our reputation in the medical community, result
in unexpected expense and adversely affect future sales.
In addition, we compete with numerous medical equipment
companies for the portions of hospital budgets allocated to
capital equipment and for the limited amount of forehead space
on patients to place sensors for all types of monitoring. Sales
of our INVOS System might be limited or delayed because of
resistance to major capital equipment expenditures by hospital
purchasing committees. Even if we are successful in convincing
physicians, other medical professionals and hospital purchasing
committees that the INVOS System provides valuable benefits,
they might be unwilling or unable to commit funds to the
purchase of the INVOS System due to budgetary constraints.
Moreover, even if one or two units are sold to a hospital, we
believe that it will take additional time and experience with
the INVOS System before additional medical professionals in the
hospital might be interested in using the INVOS System in other
procedures or other areas of the hospital.
Sales of all of our products might be limited because hospitals
might fear that the cost of a new device or product will lower
their profits because medical insurers generally fix
reimbursement amounts for the procedures in which our products
might be used. Moreover, medical professionals may be reluctant
to use our INVOS System in some new market segments,
particularly those involving diagnostic applications, unless
they receive reimbursement from medical insurers for using the
system. Our INVOS System is not currently cleared by the FDA for
use in the diagnosis of disease states. Additionally, the INVOS
System is not currently approved for separate reimbursement, and
we might not be able to obtain reimbursement for these uses of
our INVOS System.
If the INVOS System fails to achieve market acceptance in
existing or new market segments or if these market segments fail
to develop as rapidly as expected, our business, financial
condition and results of operations could be adversely affected
and our plan to increase our investments in our direct sales
team, additional clinical trials and our research and
development team might not produce favorable results.
7
|
|
|
We are dependent on our distributors and our independent
sales representative firms for a substantial portion of our
sales, and their failure to sell our products adequately would
adversely affect our business. |
We are dependent on our distributors to generate all of our
international sales, and on our independent sales representative
firms for a substantial portion of our sales in the United
States. Independent distributors or independent sales
representative firms might fail to commit the necessary
resources to market and sell our products to the level of our
expectations, especially as significant customer education and
long lead times are typically required to market and sell our
products successfully. If our distributors or independent sales
representative firms fail to market, promote and sell our
products adequately, our business, financial condition and
results of operations would be adversely affected. We might not
be able to engage additional distributors on a timely basis,
enter into other third-party marketing arrangements or retain or
replace our existing distributors, when required. If we are
unable to engage, replace or retain distributors, our ability to
market and sell our products internationally could be adversely
affected. In addition, if any of our distributor arrangements is
terminated or discontinued, we will likely be faced with
increased costs as we attempt to replace these arrangements.
Even if we are able to engage new distributors or retain
existing ones, they might incur conflicting obligations to sell
other companies products or they might distribute other
products that provide greater revenues to them than are provided
by our products.
Tyco Healthcare, part of Tyco International Ltd., our
international distributor in Europe, the Middle East, Africa and
Canada for our INVOS System, accounted for 11 percent and
12 percent of our net revenues for fiscal 2005 and for
fiscal 2003, respectively. Edwards Lifesciences Ltd., formerly
Baxter Limited, our international distributor in Japan for our
INVOS System, was our largest customer for fiscal 2004, although
it accounted for less than 10 percent of our net revenues
for fiscal 2004. The loss of either of these distributors could
have an adverse effect on our business, financial condition and
results of operations.
We plan to increase the number of our direct sales team
personnel in the United States and reduce our dependence on our
independent sales representative firms. As a result, we might
terminate some of our existing independent sales
representatives, which could result in claims by terminated
sales representative firms. If we are required to pay any
significant amounts to terminated sales representatives, our
results of operations and financial condition would be adversely
affected.
|
|
|
We currently depend on single-source suppliers for key
components of the INVOS System, and the loss of any of these
suppliers could harm our ability to manufacture and sell our
products, increase the cost of our components or delay our
clinical trials. |
We are dependent on various suppliers for manufacturing the
components for our INVOS System. Although we believe that most
components are generally available from several potential
suppliers, we depend on one supplier for one of our components.
We are not aware of any validated alternative supplier for this
component, although we are currently in the process of
validating in accordance with FDA requirements a second source
of supply. Moreover, we typically use one supplier for
custom-designed components, including the unit enclosure, the
printed circuit boards, other mechanical components and the
SomaSensor. SomaSensors represented approximately
75 percent of our net revenues in fiscal 2005. Engaging
additional or replacing existing suppliers of custom-designed
components is costly and time consuming. We estimate that it
would require approximately four to five months to change
SomaSensor suppliers. We do not intend to maintain significant
inventories of components, other than an approximate six-month
supply of the one component for which we currently have no
alternative supplier. If we fail to obtain custom-designed
components from our sole suppliers, if we lose any of our
present suppliers and cannot replace them on a timely basis when
necessary, if there is an interruption of production at one or
more of our suppliers, or if any supplier is otherwise unable or
unwilling to meet our requirements at current prices or at all,
our ability to manufacture and sell our products would be
impaired or we might have to pay higher prices for our
components or our clinical trials could be delayed. In addition,
because we do not have long-term agreements with our suppliers,
we might be subject to unexpected price increases which might
adversely affect our profit margins.
8
In addition, we do not have direct control over the activities
of our suppliers and are dependent on them for quality control,
capacity, processing technologies and, in required cases,
compliance with FDA Quality System Regulation requirements. If
we are unsuccessful in managing our suppliers, our business
could be adversely affected.
|
|
|
We may become subject to competition which may adversely
affect us. |
We believe that the markets for cerebral and somatic oximetry
products may become highly competitive. In the United States, we
believe there is currently only one other company with FDA
clearance to sell a cerebral oximeter. In December 2005, CAS
Medical Systems, Inc. announced that it received 510(k)
clearance to market a cerebral oximeter for the adult market,
with plans to launch the product in late 2006. Outside the
United States, several Japanese manufacturers offer competitive
products for sale in that country and primarily for research in
other parts of the world, but, to our knowledge, as of yet, none
has pursued FDA clearance to market its product in the
United States. We are aware that several companies and
individuals are engaged in the research and development of
non-invasive cerebral oximeters, and we believe that there are
several other potential entrants into the market. Other
companies have FDA clearance to market somatic oximeters in the
United States. Competition might cause our sales cycle to
lengthen to the extent that customers take longer to make
purchasing decisions. Competition might also reduce our gross
margins and market share and prevent us from achieving further
market penetration. Competitors might be more successful than we
are in obtaining FDA clearance with broader claims in their
labeling or more successful than we are in manufacturing and
marketing their products and may be able to take advantage of
the significant time and effort we have invested to gain medical
acceptance of cerebral oximetry.
|
|
|
We also compete with companies that have longer operating
histories, more established products and greater resources than
we do for, among other things, forehead monitoring space,
limited hospital capital budgets and alternative
products. |
The medical products industry is characterized by extensive
research and development and intense competition in an
increasingly cost-conscious environment. Some of these potential
competitors have well-established reputations, customer
relationships and marketing, distribution and service networks.
Some of them have substantially longer histories in the medical
products industry, larger product lines and greater financial,
technical, manufacturing, research and development and
management resources than we do. Many of these potential
competitors have long-term product supply relationships with our
potential customers. These potential competitors might be able
to use their resources, reputations and ability to leverage
existing customer relationships to give them a competitive
advantage over us, including in securing forehead sensor space
for their products and dollars from hospital capital equipment
budgets to purchase their products. They might also succeed in
developing products that are at least as reliable and effective
as our products, that make additional measurements, that are
less costly than our products or that provide alternatives to
our products.
|
|
|
If we fail to manage our growth effectively, our business
and operating results could be harmed. |
If we experience growth in our business, our growth could place
a significant strain on our management, customer service,
operations, sales and administrative personnel and other
resources. To serve the needs of our existing and future
customers, we will be required to train, motivate and manage
qualified employees. We have incurred and will continue to incur
significant costs to retain qualified management, sales and
marketing, engineering, production, manufacturing and
administrative personnel, as well as expenses for marketing and
promotional activities. Our ability to manage our planned growth
depends upon our success in expanding our operating, management
and information and financial systems, which might significantly
increase our operating expenses.
We have invested substantial resources to develop the INVOS
System. We expect to continue to invest substantial resources to
develop a smaller SomaSensor for use with newborns, product-line
extension of the INVOS System for monitoring non-brain tissues
and other advances to the design and performance
9
features of the INVOS System, including the disposable
SomaSensor. New products require extensive testing and
regulatory clearance before they can be marketed, and
substantial customer education concerning the products
use, advantages and effectiveness. We might not be able to
develop commercially viable products. We might not be able to
manage effectively our future growth, and if we fail to do so,
our business, financial condition and results of operations
would be adversely affected.
|
|
|
Patients might assert product liability claims against
us. |
Because we test, market and sell a patient monitoring device and
a heart patch, patients might assert product liability claims
against us. The INVOS System is used in operating rooms and
other critical care hospital units with patients who might be
seriously ill or might be undergoing dangerous procedures. The
CorRestore Patch is used on seriously ill patients undergoing a
dangerous procedure. On occasion, patients on whom the INVOS
System is being used, or in whom a CorRestore Patch is
implanted, may be injured or die as a result of their medical
treatment or condition. We might be sued because of such injury
or death, and regardless of whether we are ultimately determined
to be liable or our products are determined to be defective and
a contributing factor in such injury or death, we might incur
significant legal expenses not covered by insurance. In
addition, product liability litigation could damage our
reputation and impair our ability to market our products,
regardless of the outcome. Litigation could also impair our
ability to retain product liability insurance or make our
insurance more expensive. We have product liability insurance
with a liability limit of $5,000,000. This insurance is costly
and even though it has been obtained, we might not be able to
retain it. Even if we are able to retain this insurance, it
might not be sufficient to protect us in the event of a major
defect in the INVOS System or the CorRestore Patch. If we are
subject to an uninsured or inadequately insured product
liability claim based on the performance of the INVOS System or
the CorRestore Patch, our business, financial condition and
results of operations could be adversely affected.
|
|
|
If we fail to obtain and maintain necessary U.S. Food
and Drug Administration clearances for our products and
indications or if clearances for future products and indications
are delayed or not issued, our business would be harmed. |
Our products are classified as medical devices and are subject
to extensive regulation in the United States by the FDA, and
other federal, state and local authorities. These regulations
relate to manufacturing, labeling, sale, promotion,
distribution, importing and exporting and shipping of our
products. In the United States, before we can market a new
medical device, or a new use of, or claim for, an existing
product such as the INVOS System, we must first receive
either 510(k) clearance or premarket approval from the FDA,
unless an exemption applies. Both of these processes can be
expensive and lengthy. The FDAs 510(k) clearance
process usually takes from three to six months, but it can
last longer. The process of obtaining premarket approval is much
more costly and uncertain than the 510(k) clearance
process. It generally takes from one to three years, or even
longer, from the time the premarket approval application is
submitted to the FDA until an approval is obtained.
In order to obtain premarket approval and, in some cases, a
510(k) clearance, a product sponsor must conduct
well-controlled clinical trials designed to test the safety and
effectiveness of the product. Conducting clinical trials
generally entails a long, expensive and uncertain process that
is subject to delays and failure at any stage. The data obtained
from clinical trials may be inadequate to support approval or
clearance of a submission. In addition, the occurrence of
unexpected findings in connection with clinical trials may
prevent or delay obtaining approval or clearance. If we conduct
clinical trials, they may be delayed or halted, or be inadequate
to support approval or clearance.
Medical devices may be marketed only for the indications for
which they are approved or cleared. The FDA may fail to approve
or clear indications that are necessary or desirable for
successful commercialization. Indeed, the FDA may refuse our
requests for 510(k) clearance or premarket approval of new
products, new intended uses or modifications to existing
products. Our clearances can be revoked if safety or
effectiveness problems develop.
10
|
|
|
The FDA might require us to obtain a new clearance to
label or promote the INVOS System for specific patient
subgroups, such as diabetics; if we fail to obtain such
clearances, our sales and revenues may be adversely
affected. |
Our INVOS System 510(k) clearance states that the
prospective clinical value of the INVOS System has not been
demonstrated in patients with specific disease states. If we
wish to label or promote more actively the INVOS System for
specific types of patients, such as diabetics, the FDA may
require us to obtain a new 510(k) clearance and would
likely carefully scrutinize the data support for any such claim.
The FDA may also determine that our current promotion of the
INVOS System as suitable for use in diabetics constitutes
promotion for an unapproved use and may take regulatory action
against us and require us to cease and desist from such
promotion until a new clearance or approval is obtained. We
cannot assure you that the FDA would grant additional
510(k) clearances in a timely fashion, or at all, or that
the FDA would not require us to undertake the more burdensome
premarket approval process as a prerequisite for marketing the
INVOS System with this type of claim. Any of the above
could delay our ability to market and sell new products or to
promote the INVOS System for specific patient subgroups
such as diabetics and would thereby have an adverse effect on
our business, financial condition and results of operations.
|
|
|
After clearance or approval of our products, we are
subject to continuing regulation by the FDA, and if we fail to
comply with FDA regulations, our business could
suffer. |
Even after clearance or approval of a product, we are subject to
continuing regulation by the FDA, including the requirements
that our facility be registered and our devices listed with the
agency. We are subject to Medical Device Reporting regulations,
which require us to report to the FDA if our products may have
caused or contributed to a death or serious injury or
malfunction in a way that would likely cause or contribute to a
death or serious injury if the malfunction were to recur. We
must report corrections and removals to the FDA where the
correction or removal was initiated to reduce a risk to health
posed by the device or to remedy a violation of the Federal
Food, Drug, and Cosmetic Act caused by the device that may
present a risk to health, and maintain records of other
corrections or removals. The FDA closely regulates promotion and
advertising, and our promotional and advertising activities
could come under scrutiny. If the FDA objects to our promotional
and advertising activities or finds that we failed to submit
reports under the Medical Device Reporting regulations, for
example, the FDA may allege our activities resulted in
violations.
The FDA and state authorities have broad enforcement powers. Our
failure to comply with applicable regulatory requirements could
result in enforcement action by the FDA or state agencies, which
may include any of the following sanctions:
|
|
|
|
|
untitled letters, warning letters, fines, injunctions, consent
decrees and civil penalties; |
|
|
|
repair, replacement, refunds, recall or seizure of our products; |
|
|
|
operating restrictions or partial suspension or total shutdown
of production; |
|
|
|
refusing or delaying our requests for 510(k) clearance or
premarket approval of new products or new intended uses; |
|
|
|
withdrawing 510(k) clearance or premarket approvals that
have already been granted; and |
|
|
|
criminal prosecution. |
If any of these events were to occur, they could harm our
business.
|
|
|
We have modified some of our products without
FDA clearance. The FDA could retroactively determine that
the modifications were improper and require us to stop marketing
and recall the modified products. |
Any modifications to one of our FDA-cleared devices 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 or a premarket approval. We may be
required to submit extensive pre-clinical and clinical data
depending
11
on the nature of the changes. We may not be able to obtain
additional 510(k) clearances or premarket approvals for
modifications to, or additional indications for, our existing
products in a timely fashion, or at all. Delays in obtaining
future clearances or approvals would adversely affect our
ability to introduce new or enhanced products in a timely
manner, which in turn would harm our revenue and operating
results. We have made modifications to our devices in the past,
such as changes to the SomaSensor, and may make additional
modifications in the future that we believe do not or will not
require additional clearances or approvals. We believe that
these changes do not require the submission of a new 510(k)
notice. If the FDA disagrees, and requires new clearances or
approvals for the modifications, we may be required to recall
and to stop marketing the modified devices, which could harm our
operating results and require us to redesign our products.
|
|
|
If we fail to comply with the FDAs Quality System
Regulation, our manufacturing operations could be halted, and
our business would suffer. |
We are currently required to demonstrate and maintain compliance
with the FDAs Quality System Regulation, or QSR. The QSR
is a complex regulatory scheme that covers the methods and
documentation of the design, testing, control, manufacturing,
labeling, quality assurance, packaging, storage and shipping of
our products. The FDA enforces the QSR through periodic
unannounced inspections. We have been, and anticipate in the
future being, subject to such inspections. Our failure to comply
with the QSR or to take satisfactory corrective action in
response to an adverse QSR inspection could result in
enforcement actions, including a public warning letter, a
shutdown of or restrictions on our manufacturing operations,
delays in approving or clearing a product, refusal to permit the
import or export of our products, a recall or seizure of our
products, fines, injunctions, civil or criminal penalties, or
other sanctions, any of which could cause our business and
operating results to suffer.
|
|
|
Failure to obtain or maintain regulatory approval in
foreign jurisdictions would prevent us from marketing our
products abroad. |
We market our products through distributors in foreign markets.
In order to market our products in the European Community and
many other foreign jurisdictions, we must obtain separate
regulatory approvals. We depend on our distributors to obtain
and maintain certain of these regulatory approvals. The approval
procedure varies among countries and can involve additional
requirements and testing, and the time required to obtain
approval may differ from that required to obtain FDA clearance.
The foreign regulatory approval process may include all of the
risks associated with obtaining FDA clearance in addition to
other risks. Our distributors might not be able to obtain or
maintain foreign approvals on a timely basis or at all.
Clearance by the FDA does not ensure approval by regulatory
authorities in other countries, and approval by one foreign
regulatory authority does not ensure approval by regulatory
authorities in other foreign countries or approval or clearance
by the FDA. Failure to obtain or maintain regulatory approval in
foreign jurisdictions would prevent us from marketing our
products abroad.
|
|
|
Federal regulatory reforms may adversely affect our
ability to sell our products profitably. |
From time to time, legislation is drafted and introduced in
Congress that could significantly change the statutory
provisions governing clearance or approval, manufacture and
marketing of a device. In addition, FDA regulations and guidance
are often revised or reinterpreted by the agency in ways that
may significantly affect our business and our products. We
cannot predict whether legislative changes will be enacted or
FDA regulations, guidance or interpretations changed, and what
the impact of such changes, if any, may be.
|
|
|
Changes in our actual or estimated future taxable income
could change the value of our deferred tax asset, potentially
resulting in a decrease in net income, which could adversely
affect the price of our common shares. |
We have recognized deferred tax assets relating to the expected
future benefits of our net operating loss carryforwards. Our
assessment of our deferred tax assets, and the reversal of part
of our valuation
12
allowance relating to those assets in fiscal 2005 and 2004,
included assuming that our net revenues and pre-tax income will
grow in future years consistent with the growth guidance given
for fiscal 2006 and making allowance for the uncertainties
surrounding, among things, our future rate of growth in net
revenues, the rate of adoption of our products in the
marketplace and the potential for competition to enter the
marketplace. Given the assumptions inherent in our financial
plans, it is possible to calculate a different value for our
deferred tax assets by changing one or more of the variables in
our assessment. In addition, changes in our actual or estimated
future taxable income could change the value of our deferred tax
asset, potentially resulting in a decrease in net income, which
could adversely affect the price of our common shares.
|
|
|
New stock option accounting rules will increase our
reported expenses, which could adversely affect the price of our
common shares. |
Effective December 1, 2005, we became subject to new stock
option accounting rules that require that compensation costs
related to share-based payment transactions, including stock
options, stock appreciation rights and restricted stock, be
recognized in our financial statements. Previously, we accounted
for stock-based compensation of employees using the intrinsic
value method, which resulted in no compensation expense charged
against income for stock option grants to employees for fiscal
2005, 2004 or 2003. In addition, in November 2005, we
accelerated the vesting of all unvested stock options to
eliminate compensation expense that we would otherwise have
recognized in our results of operations after the adoption of
the new stock option accounting rules when those options would
have otherwise vested. Future grants of options, however, will
require us to recognize compensation expense in our income
statement, increasing our reported expenses for the same
activities, which could adversely affect the price of our common
shares.
|
|
|
The lengthy sales cycle for the INVOS System could cause
variability in our operating results. |
The decision-making process for our INVOS System customers is
often complex and time-consuming. We believe the period between
initial discussions with a potential customer and a sale of even
one unit is typically approximately six to nine months. The
process can be delayed as a result of hospital capital budgeting
procedures. These delays could have an adverse effect on our
business, financial condition and results of operations and
cause variability in our operating results from quarter to
quarter, which could cause fluctuations in the trading price of
our common shares.
|
|
|
If we are unable to obtain or maintain intellectual
property rights relating to our technology and products, the
commercial value of our technology and products will be
adversely affected and our competitive position could be
harmed. |
Our success and ability to compete depends in part upon our
ability to obtain protection in the United States and other
countries for our products by establishing and maintaining
intellectual property rights relating to or incorporated into
our technology and products. We own or license a variety of
patents and patent applications in the United States and
corresponding patents and patent applications in certain foreign
jurisdictions. Pending and future patent applications owned or
licensed by us may not issue as patents or, if issued, may not
issue in a form that will be commercially advantageous to us.
Even if issued, patents may be challenged, narrowed, invalidated
or circumvented, which could limit our ability to stop
competitors from marketing similar products or limit the length
of term of patent protection we may have for our products. In
addition, already issued patents owned or licensed by us may not
be valid or enforceable. Further, even if valid and enforceable,
these already issued patents may not be sufficiently broad to
prevent others from marketing competitive products, despite our
patent rights. Changes in either patent laws or in
interpretations of patent laws in the United States and other
countries may diminish the value of our intellectual property or
narrow the scope of our patent protection.
For example, one of our significant patents is the subject of a
reissue proceeding in the U.S. Patent and Trademark Office.
Our reissue application was filed for the sole purpose of
seeking to broaden certain claims. We cannot predict the outcome
of this proceeding, which may result in some or all of the claims
13
being broadened, narrowed or rejected. Another of our patents
may be expired for ultimately claiming priority to a patent that
was filed more than 20 years ago. We believe that this
patent does not have a claim of priority that extends back for
more than 20 years, and that the patent is still extant and
will expire on March 29, 2009. However, there is a risk
that a court might find that the earliest effective filing date
for this patent is more than 20 years ago, and rule that
this patent is expired and unenforceable.
The validity of our patent claims depends, in part, on whether
prior art references disclosed or rendered obvious our
inventions as of the filing date of our patent applications. We
may not have identified all prior art, such as U.S. and foreign
patents or published applications or published scientific
literature, that could adversely affect the validity of our
issued patents or the patentability of our pending patent
applications. For example, patent applications in the United
States are maintained in confidence for up to 18 months
after their filing. In some cases, however, patent applications
remain confidential in the U.S. Patent and Trademark Office
for the entire time prior to issuance as a U.S. patent.
Patent applications filed in countries outside the United States
are also not typically published until at least 18 months
from their first filing date. Similarly, publication of
discoveries in the scientific or patent literature often lags
behind actual discoveries.
We may initiate litigation to enforce our patent rights, which
may prompt our adversaries in such litigation to challenge the
validity, scope or enforceability of our patents. If a court
decides that our patents are not valid, not enforceable or of a
limited scope, we will not have the right to stop others from
using our inventions.
The outcome of litigation to enforce our patent rights is
subject to substantial uncertainties, especially in medical
device-related patent cases that may, for example, turn on the
interpretation of patent claim language by the court which may
not be to our advantage, and also the testimony of experts as to
technical facts upon which experts may reasonably disagree. Our
involvement in such intellectual property litigation could
result in significant expense.
We also cannot be certain that we were the first to invent, or
the first to file patent applications relating to, our cerebral
oximeter technologies. In the event that a third party has also
filed a U.S. patent application covering our cerebral
oximeter devices, the sensors used with these devices, or a
similar invention, we may have to participate in an adversarial
proceeding known as an interference, which is declared by the
U.S. Patent and Trademark Office to determine priority of
invention in the United States. It is possible that we may be
unsuccessful in the interference, resulting in a loss of some or
all of our U.S. patent claims. We may also face similar
proceedings outside the United States, including oppositions, to
determine priority of invention or patentability. Even if we are
successful in these proceedings, we may incur substantial costs,
and the time and attention of our management and scientific
personnel will be diverted in pursuit of these proceedings.
Moreover, the laws of some foreign jurisdictions may not protect
intellectual property rights to the same extent as in the United
States, and many companies have encountered significant
difficulties in protecting and defending such rights in foreign
jurisdictions. If we encounter such difficulties or we are
otherwise precluded from effectively protecting our intellectual
property rights in foreign jurisdictions, we may incur
substantial costs and our business prospects could be
substantially harmed.
We rely on trade secret and copyright protection to protect our
interests in proprietary information and know-how, and for
processes for which patents are undesirable to obtain or are
difficult to obtain or enforce. We may not be able to protect
our trade secrets or copyrights adequately. For example, none of
our copyrights have been registered with the U.S. Copyright
Office, which limits our ability to sue for and collect damages
from third party infringers. In addition, we rely on
non-disclosure and confidentiality agreements with employees,
consultants and other parties to protect, in part, trade secrets
and other proprietary technology. These agreements may be
breached, and we may not have adequate remedies for any breach.
Moreover, others may independently develop equivalent
proprietary information, and third parties may otherwise gain
access to our trade secrets and proprietary knowledge. Any
disclosure of confidential data into the public domain or to
third parties could allow our competitors to learn our trade
secrets and use the information in competition against us.
14
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If we are found to infringe or are alleged to infringe any
third party intellectual property rights, then our business may
be adversely affected. |
There are numerous U.S. and foreign issued patents and pending
patent applications owned by third parties with patent claims in
the field of tissue or organic matter oximetry, including
cerebral oximetry and areas that are the focus of our product
development efforts. We are aware of patents owned by third
parties, to which we do not have licenses, that relate to, among
other things, optical spectroscopy and the interaction of light
with tissue and optical spectroscopy in the area of brain
metabolism. For example, possible competitors own patents that
are directed to the non-invasive determination of blood oxygen
saturation levels with a near infra-red spectrophotometric
sensor and to an apparatus for measuring oxygen saturation in
blood using two different wavelengths of light. There may be
other patents in addition to those of which we are aware that
relate to aspects of our technology and that may materially and
adversely affect our business. Moreover, because patent
applications can take many years to issue, there may be
currently pending applications, unknown to us, which may later
result in issued patents that pose a material risk to us.
We may pose a threat to companies who own or control patents
relating to cerebral oximetry systems or their components, or to
the manufacture and use of such systems, and one or more third
parties may file a lawsuit asserting a patent infringement claim
against the manufacture, use or sale of the INVOS System based
on one or more of these patents. We are not aware of any
infringement of the claims of any issued patents by our
products, and no charge of patent infringement has been asserted
against us. However, potential competitors would have more
incentive to assert infringement claims or challenge our patents
if a more significant market for the INVOS System develops.
Whether the manufacture, sale or use of the INVOS System, or
whether any products under development would, upon
commercialization, infringe any patent claim will not be known
with certainty unless and until a court interprets the patent
claim in the context of litigation. If an infringement
allegation is made against us, we may seek to invalidate the
asserted patent claim and/or to allege non-infringement of the
asserted patent claim. In order for us to invalidate a
U.S. patent claim, we would need to rebut the presumption
of validity afforded to issued patents in the United States with
clear and convincing evidence of invalidity, which is a high
burden of proof.
The outcome of infringement litigation is subject to substantial
uncertainties, especially in medical device-related patent cases
that may, for example, turn on the interpretation of patent
claim language by the court which may not be to our advantage,
and also the testimony of experts as to technical facts upon
which experts may reasonably disagree. Our defense of an
infringement litigation lawsuit could result in significant
expense. Regardless of the outcome, infringement litigation
could significantly disrupt our marketing, development and
commercialization efforts, divert our managements
attention and quickly consume our financial resources.
In the event that we are found to infringe any valid claim in a
patent held by a third party, we may, among other things, be
required to:
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pay damages, including up to treble damages and the other
partys attorneys fees, which may be substantial; |
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cease the development, manufacture, importation, use and sale of
products that infringe the patent rights of others, including
our INVOS System, through a court-imposed sanction called an
injunction; |
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expend significant resources to redesign our technology so that
it does not infringe others patent rights, or to develop
or acquire non-infringing intellectual property, which may not
be possible; |
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discontinue manufacturing or other processes incorporating
infringing technology; and/or |
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obtain licenses to the infringed intellectual property, which
may not be available to us on acceptable terms, or at all. |
15
Any development or acquisition of non-infringing products or
technology or licenses could require the expenditure of
substantial time and other resources and could have a material
adverse effect on our business and financial results. If we are
required to, but cannot, obtain a license to valid patent rights
held by a third party, we would likely be prevented from
commercializing the relevant product, or from further
manufacture, sale or use of the relevant product. If we need to
redesign products to avoid third-party patents, we may suffer
significant regulatory delays associated with conducting
additional studies or submitting technical, manufacturing or
other information related to the redesigned product and,
ultimately, in obtaining approval.
While our products are in clinical trials, and prior to
commercialization, we believe our activities in the United
States related to the submission of data to the FDA fall within
the scope of the exemptions that cover activities related to
developing information for submission to the FDA and fall under
general investigational use or similar laws in other countries.
However, the U.S. exemptions would not cover the
manufacturing, sale or use of products which are no longer in
clinical trials, or other activities in the United States that
support overseas clinical trials if those activities are not
also reasonably related to developing information for submission
to the FDA. In any event, the fact that no third party has
asserted a patent infringement claim against us to date should
not be taken as an indication, or a level of comfort, that a
patent infringement claim will not be asserted against us prior
to or upon commercialization.
Some of our agreements, including our distribution and sales
representative agreements require us to indemnify the other
party in certain circumstances where our products have been
found to infringe a patent or other proprietary rights of
others. An indemnification claim against us may require us to
pay substantial sums to the indemnified party, including its
attorneys fees.
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Our success depends on our ability to attract and retain
key personnel. |
Our future performance depends in significant part on the
continued service of our senior management, including Bruce J.
Barrett, our President and Chief Executive Officer, and various
scientific, technical and manufacturing personnel. Our loss of
any of these key personnel could have an adverse effect on us.
We do not maintain key-man life insurance on any of our key
personnel, and our employment agreement with Mr. Barrett
currently expires April 30, 2006. In addition, competition
for qualified employees is intense, and if we are unable to
attract, retain and motivate additional, highly-skilled
employees required for the expansion of our operations, our
business, financial condition and results of operations could be
adversely affected. We cannot assure you that we will be able to
retain our existing personnel or attract additional, qualified
persons when required and on acceptable terms.
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Any acquisitions that we make could disrupt our business
and harm our financial condition. |
From time to time, we evaluate potential strategic acquisitions
of complementary businesses, products or technologies, as well
as consider joint ventures and other collaborative projects. We
may not be able to identify appropriate acquisition candidates
or strategic partners, or successfully negotiate, finance or
integrate any businesses, products or technologies that we
acquire. We do not have any experience with acquiring companies
or products, other than the CorRestore System. Any acquisition
we pursue could diminish the proceeds from this offering
available to us for other uses or be dilutive to our
shareholders, and could divert managements time and
resources from our core operations.
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We have had limited success in marketing the CorRestore
System, which could result in claims against us. |
Since we acquired rights in the CorRestore System in 2000, we
have had limited success in marketing the system. The CorRestore
System competes against existing patches also used for cardiac
reconstruction and repair that are significantly less expensive
and at least one study indicates are effective. We also compete
against alternative methods of treating congestive heart
failure. Surgical Ventricular Restoration, or SVR, is in the
early stages of its development and will likely require
significant clinical studies before it is widely accepted. There
are many larger companies in this industry that have
significantly larger research and development budgets than ours.
Competitors may be able to develop additional or better
treatments
16
for congestive heart failure and may be able to take advantage
of the significant time and effort we have invested to gain
medical acceptance of SVR surgeries.
We are dependent on a third party to manufacture the CorRestore
System. Our license agreement limits the parties that we may
engage. The ultimate success of our CorRestore business is
dependent on our ability to manage the manufacturer of the
CorRestore System. If we are unsuccessful in managing the
manufacturer of the CorRestore System, our business could be
adversely affected.
We entered into a license agreement with respect to the
CorRestore System in 2002. Although we believe we have complied
with our obligations under the license agreement, our limited
success in marketing the CorRestore System could result in
claims against us. As part of the compensation for the
acquisition of our CorRestore licenses, we issued five-year
warrants to purchase an aggregate of 2,100,000 common shares at
$3.00 per share, exercisable based on our cumulative net sales
of the CorRestore System products. We do not expect the sales
requirements for exercise of these warrants to be met before the
November 2006 expiration date of these warrants. Expiration of
these warrants before they become exercisable could cause the
holders of these warrants to make claims against us under the
license agreement. If we are required to pay any significant
amounts to defend or as a result of any such claims, our results
of operations would be adversely affected.
Risks Relating to This Offering
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We have broad discretion to determine how to allocate the
net proceeds of this offering and may not use them
effectively. |
We intend to use the net proceeds of this offering primarily to
expand our direct sales team and other sales and marketing
activities, sponsor additional clinical trials and expand our
research and development efforts and for working capital and
general corporate purposes. A significant portion of the net
proceeds of the offering may be allocated to working capital and
general corporate purposes. We are raising money for these
purposes to strengthen our balance sheet and provide us with
greater flexibility in implementing our business plans and
responding to future business conditions and opportunities. The
amounts listed in Use of Proceeds for these purposes
are estimates and the amounts actually spent for each of these
purposes and the timing of these payments may vary depending on
numerous factors. We will retain broad discretion to determine
how to allocate the net proceeds of this offering and the timing
of the payments. If we fail to apply these funds effectively,
the failure could result in financial losses that could have a
material adverse effect on our business and cause the price of
our common shares to decline. Pending the application of such
proceeds, we intend to keep sufficient net proceeds of sales of
common shares in cash and bank accounts to avoid becoming an
inadvertent investment company subject to regulation under the
Investment Company Act of 1940. The remaining proceeds are
expected to be invested in short-term, U.S. government or
other investment grade, interest-bearing investments. These
restrictions on our investments might limit the income otherwise
available from investing these funds, lowering our income and
potentially decreasing our earnings and the price of our common
shares.
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Provisions of our corporate charter documents and Michigan
law may delay or prevent attempts by our shareholders to change
our management and hinder efforts to acquire a controlling
interest in us. |
Our board of directors has the authority, without further
approval of our shareholders, to issue preferred shares having
such rights, preferences and privileges as the board may
determine. Any such issuance of preferred shares could, under
some circumstances, have the effect of delaying or preventing a
change in control of us and might adversely affect the rights of
holders of common shares. In addition, we are subject to
Michigan statutes regulating business combinations, takeovers
and control share acquisitions, which might also hinder or delay
a change in control of our company. Anti-takeover provisions
that could be included in the preferred shares when issued and
the Michigan statutes regulating business combinations,
takeovers and control share acquisitions can depress the market
price of our securities and can limit the shareholders
ability to receive a premium on their shares by discouraging
takeover and tender offer bids, even if such events could be
viewed as beneficial by our shareholders.
17
Our directors serve staggered three-year terms, and directors
may be removed only for cause by a vote of the holders of a
majority of the shares entitled to vote at an election of
directors. Our Restated Articles of Incorporation also set the
minimum number of directors constituting the entire board at
three and the maximum at fifteen, and they require approval of
holders of 90 percent of our voting shares to amend these
provisions. Our bylaws contain procedures, including notice
requirements, for nominating persons for election to our board
of directors. These provisions could have an anti-takeover
effect by making it more difficult to acquire our company by
means of a tender offer, a proxy contest or otherwise or by
removing incumbent officers and directors. These provisions
could delay, deter or prevent a tender offer or takeover attempt
that a shareholder might consider in his or her best interests,
including those attempts that might result in a premium over the
market price for the common shares held by our shareholders.
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The market price of our common shares has been volatile
and may continue to remain so. |
The market price of our common shares has been highly volatile.
The following could cause the market price of the common shares
to continue to fluctuate substantially:
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changes in our quarterly financial condition or operating
results; |
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changes in general conditions in the economy; |
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changes in the financial markets; |
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changes in the medical equipment industry; |
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changes in financial estimates by securities analysts or
differences between those estimates and our actual results; |
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the liquidity of the market for the common shares; |
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developments with respect to patents and proprietary rights; |
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publication of clinical research results regarding our products; |
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changes in health care policies in the United States or foreign
countries; |
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grants or exercises of stock options or warrants; |
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news announcements; |
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litigation involving us; |
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actions by governmental agencies, including the FDA, or changes
in regulations; and |
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other developments affecting us or our competitors. |
In particular, the stock market might experience significant
price and volume fluctuations that might affect the market price
of the common shares for reasons that are unrelated to our
operating performance and that are beyond our control.
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We have never paid cash dividends on our capital stock,
and we do not anticipate paying any cash dividends in the
foreseeable future. |
We have never paid cash dividends on our common shares and do
not expect to pay dividends in the foreseeable future. We
currently intend to retain any future earnings for use in our
business. The payment of any future dividends will be determined
by the board in light of the conditions then existing, including
our financial condition and requirements, future prospects,
restrictions in financing agreements, business conditions and
other factors deemed relevant by the board. As a result, capital
appreciation, if any, of our common shares will be your sole
source of gain for the foreseeable future.
18
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The market price of the common shares might be lower
because of shares eligible for future sale and shares reserved
for future issuance upon the exercise of options and warrants we
have granted. |
Future sales of substantial amounts of common shares in the
public market or the perception that such sales could occur
could adversely affect the market price of the common shares.
Any substantial sale of common shares or even the possibility of
such sales occurring may have an adverse effect on the market
price of the common shares. We have outstanding options and
warrants to purchase an aggregate of 4,014,232 common shares. We
have also reserved up to an additional 505,785 common shares for
issuance upon exercises of options or awards of restricted stock
or restricted stock units which have not yet been granted or
awarded under our stock incentive plans. We have effective
registration statements for the shares underlying these options
and stock awards. Therefore, except for volume limitations
imposed by Securities and Exchange Commission Rule 144 and
the lock-up agreements
described below, these shares are freely tradeable. Our
executive officers and directors, including Bruce J. Barrett,
our largest shareholder, have agreed not to sell their shares
for a period of 120 days after the date of this prospectus
without the consent of Citigroup Global Markets Inc. Our
directors and executive officers as a group beneficially own
1,962,137 common shares, including 1,654,943 common shares they
have a right to acquire upon the exercise of options within
60 days of the date of this prospectus. As these
restrictions on resale end, the market price of our common
shares could fall if the holders of these shares sell them or
are perceived by the market as intending to sell them.
19
FORWARD-LOOKING STATEMENTS
Some of the statements in this prospectus are forward-looking
statements. These forward-looking statements include statements
relating to our performance in the sections entitled
Summary, Risk Factors,
Managements Discussion and Analysis of Financial
Condition and Results of Operations, Use of
Proceeds and Business and elsewhere in this
prospectus. Forward-looking statements include statements
regarding the intent, belief or current expectations of us or
our management, including statements preceded by, followed by or
including forward-looking terminology such as may,
will, should, believe,
expect, anticipate, plan,
intend, propose, estimate,
continue, predict or similar
expressions, with respect to various matters.
These statements involve known and unknown risks, uncertainties
and other factors which may cause our actual results,
performance time frames or achievements to be materially
different from any future results, performance, time frames or
achievements expressed or implied by the forward-looking
statements. We discuss many of these risks, uncertainties and
other factors in this prospectus in greater detail under the
heading Risk Factors. Given these risks,
uncertainties and other factors, you should not place undue
reliance on these forward-looking statements. Also, these
forward-looking statements represent our estimates and
assumptions only as of the date of this prospectus. You should
read this prospectus and the documents that we have filed as
exhibits and incorporated by reference to the registration
statement, of which this prospectus is a part, completely and
with the understanding that our actual future results may be
materially different from what we expect. We hereby qualify all
of our forward-looking statements by these cautionary statements.
All forward-looking statements in this prospectus are based on
information available to us on the date of this prospectus. We
do not undertake to update any forward-looking statements that
may be made by us or on our behalf in this prospectus or
otherwise.
20
USE OF PROCEEDS
We estimate that we will receive approximately $41,950,400 in
net proceeds from the 2,000,000 common shares that we are
offering, or approximately $48,317,960 if the underwriters
exercise their over-allotment option in full, based upon the
estimated public offering price of $22.58 per share, after
deducting underwriting discounts and commissions and estimated
offering expenses payable by us.
We estimate that we will use:
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approximately $5 million of our net proceeds to accelerate
the expansion of our direct sales team and other sales and
marketing activities; |
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approximately $2 million of our net proceeds to sponsor
additional clinical trials; and |
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approximately $1 million of our net proceeds to expand our
research and development efforts. |
We intend to use the remainder of our net proceeds for working
capital and general corporate purposes. We may use a portion of
our net proceeds to acquire complementary products, technologies
or businesses. We currently have no agreements or commitments to
complete any such transactions. The amounts and timing of our
actual expenditures may vary significantly depending upon
numerous factors, including our future revenues and cash
generated by operations. Accordingly, we will retain broad
discretion in the allocation of our net proceeds of this
offering.
A significant portion of the net proceeds of the offering may be
allocated to working capital and general corporate purposes. We
are raising money for these purposes to strengthen our balance
sheet and provide us with greater flexibility in implementing
our business plans and responding to future business conditions
and opportunities.
Pending the application of such proceeds, we intend to invest
the proceeds in short-term, U.S. government or other
investment grade, interest-bearing investments.
21
PRICE RANGE OF COMMON SHARES AND DIVIDEND POLICY
Our common shares trade on The Nasdaq National Market (until
February 7, 2006 on The Nasdaq Capital Market) under the
trading symbol SMTS. The following table sets forth,
for the periods indicated, the range of high and low sales
prices of our common shares as reported by Nasdaq.
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High | |
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Low | |
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Fiscal Year Ended November 30, 2004
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First Quarter
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$ |
10.00 |
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$ |
6.00 |
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Second Quarter
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15.86 |
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8.77 |
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Third Quarter
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16.70 |
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9.23 |
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Fourth Quarter
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14.98 |
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10.65 |
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Fiscal Year Ended November 30, 2005
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First Quarter
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$ |
16.00 |
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$ |
13.00 |
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Second Quarter
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18.85 |
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12.50 |
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Third Quarter
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25.74 |
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17.66 |
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Fourth Quarter
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36.95 |
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21.51 |
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Fiscal Year Ending November 30, 2006
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First Quarter (through February 7, 2006)
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$ |
36.64 |
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$ |
21.98 |
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On February 7, 2006, the last reported sales price for the
common shares on The Nasdaq National Market was $22.58 per
share. As of February 6, 2006, we had 657 shareholders
of record of our common shares.
We have never paid cash dividends on our common shares and do
not expect to pay dividends in the foreseeable future. We
currently intend to retain any future earnings for use in our
business. The payment of any future dividends will be determined
by the board in light of the conditions then existing, including
our financial condition and requirements, future prospects,
restrictions in any financing agreements, business conditions
and other factors deemed relevant by the board.
22
CAPITALIZATION
The following table sets forth our capitalization as of
November 30, 2005 and as adjusted to give effect to the
sale of 2,000,000 common shares that we are offering at an
assumed public offering price of $22.58 per share, after
deducting underwriting discounts and commissions and estimated
offering expenses payable by us. You should read this table
together with Managements Discussion and Analysis of
Financial Condition and Results of Operations and our
financial statements and related notes included elsewhere in
this prospectus.
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As of November 30, 2005 | |
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Actual | |
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As Adjusted | |
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(in thousands, except | |
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share data) | |
Long-Term Debt
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Shareholders Equity:
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Preferred shares; authorized 1,000,000 shares of
$0.01 par value; no shares issued or outstanding
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Common shares, authorized 20,000,000 shares of
$0.01 par value; issued and outstanding, 10,715,885 as of
November 30, 2005 and 12,715,885 shares, as adjusted
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$ |
107 |
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$ |
127 |
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Additional paid-in capital
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64,865 |
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106,795 |
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Accumulated deficit
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(37,131 |
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(37,131 |
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Total shareholders equity
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27,841 |
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69,791 |
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Total capitalization
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$ |
27,841 |
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$ |
69,791 |
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The number of our common shares outstanding as of
November 30, 2005 does not include:
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1,914,232 common shares issuable upon exercise of
outstanding options granted under our stock option plans and
independent of our stock option plans at an average exercise
price of $4.59 per share; |
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505,785 common shares reserved for future grants and awards
under our 1997 Stock Option Plan and 2005 Stock Incentive
Plan; and |
|
|
|
2,100,000 common shares issuable upon exercise of the
warrants issued to CorRestore LLC and its agent Wolfe &
Company in connection with our license agreement. The exercise
of these warrants is dependent upon our cumulative net sales of
CorRestore products. The sales requirements for exercise of
these warrants have not been met to date, and we do not expect
that they will be met before these warrants expire in November
2006. |
23
SELECTED FINANCIAL DATA
You should read the following selected financial data together
with our financial statements and related notes and with
Managements Discussion and Analysis of Financial
Condition and Results of Operations included elsewhere in
this prospectus. We have derived the statement of operations
data for the years ended November 30, 2003, 2004 and 2005
and the balance sheet data as of November 30, 2004 and 2005
from our audited financial statements, which are included
elsewhere in this prospectus. We have derived the statement of
operations data for the years ended November 30, 2001 and
2002 and the balance sheet data as of November 30, 2001,
2002 and 2003 from our audited financial statements, which are
not included in this prospectus. Our historical results for any
prior period are not necessarily indicative of results to be
expected for any future period.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended November 30, | |
|
|
| |
|
|
2001 | |
|
2002 | |
|
2003 | |
|
2004 | |
|
2005 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(in thousands, except per share data) | |
Statement of Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues
|
|
$ |
5,656 |
|
|
$ |
6,706 |
|
|
$ |
9,361 |
|
|
$ |
12,609 |
|
|
$ |
20,509 |
|
Cost of sales
|
|
|
2,094 |
|
|
|
2,049 |
|
|
|
2,140 |
|
|
|
2,050 |
|
|
|
2,601 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin
|
|
|
3,561 |
|
|
|
4,657 |
|
|
|
7,221 |
|
|
|
10,558 |
|
|
|
17,908 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research, development and engineering
|
|
|
778 |
|
|
|
571 |
|
|
|
413 |
|
|
|
369 |
|
|
|
526 |
|
|
Selling, general and administrative(1)
|
|
|
5,133 |
|
|
|
5,344 |
|
|
|
6,759 |
|
|
|
8,237 |
|
|
|
13,241 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
5,911 |
|
|
|
5,915 |
|
|
|
7,172 |
|
|
|
8,606 |
|
|
|
13,767 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income (loss)
|
|
|
(2,350 |
) |
|
|
(1,258 |
) |
|
|
49 |
|
|
|
1,952 |
|
|
|
4,141 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
22 |
|
|
|
52 |
|
|
|
23 |
|
|
|
55 |
|
|
|
310 |
|
|
Interest expense and other
|
|
|
(3 |
) |
|
|
(1 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income
|
|
|
19 |
|
|
|
51 |
|
|
|
23 |
|
|
|
55 |
|
|
|
310 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income taxes
|
|
|
(2,331 |
) |
|
|
(1,207 |
) |
|
|
72 |
|
|
|
2,007 |
|
|
|
4,451 |
|
Income tax benefit(2)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,700 |
|
|
|
3,300 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
|
|
$ |
(2,331 |
) |
|
$ |
(1,207 |
) |
|
$ |
72 |
|
|
$ |
8,707 |
|
|
$ |
7,751 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per common share basic
|
|
$ |
(0.31 |
) |
|
$ |
(0.13 |
) |
|
$ |
0.01 |
|
|
$ |
0.89 |
|
|
$ |
0.75 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per common share diluted
|
|
$ |
(0.31 |
) |
|
$ |
(0.13 |
) |
|
$ |
0.01 |
|
|
$ |
0.77 |
|
|
$ |
0.66 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares outstanding
basic
|
|
|
7,606 |
|
|
|
8,951 |
|
|
|
9,114 |
|
|
|
9,780 |
|
|
|
10,322 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares outstanding
diluted
|
|
|
7,606 |
|
|
|
8,951 |
|
|
|
9,467 |
|
|
|
11,323 |
|
|
|
11,798 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of November 30, | |
|
|
| |
|
|
2001 | |
|
2002 | |
|
2003 | |
|
2004 | |
|
2005 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(in thousands) | |
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$ |
168 |
|
|
$ |
2,382 |
|
|
$ |
2,239 |
|
|
$ |
7,070 |
|
|
$ |
13,148 |
|
Working capital
|
|
|
1,724 |
|
|
|
4,047 |
|
|
|
4,480 |
|
|
|
9,311 |
|
|
|
18,044 |
|
Total assets
|
|
|
3,587 |
|
|
|
6,164 |
|
|
|
7,156 |
|
|
|
18,785 |
|
|
|
29,719 |
|
Total liabilities
|
|
|
575 |
|
|
|
664 |
|
|
|
991 |
|
|
|
1,232 |
|
|
|
1,878 |
|
Accumulated deficit
|
|
|
(52,445 |
) |
|
|
(53,661 |
) |
|
|
(53,589 |
) |
|
|
(44,882 |
) |
|
|
(37,131 |
) |
Total shareholders equity
|
|
|
3,013 |
|
|
|
5,501 |
|
|
|
6,165 |
|
|
|
17,553 |
|
|
|
27,841 |
|
|
|
(1) |
Includes an impairment expense of $929,093 in fiscal 2005 in
connection with the write-off of our intangible asset associated
with the acquisition of the license for the CorRestore System. |
|
(2) |
Represents income recognized in fiscal 2004 and fiscal 2005 as a
result of a reversal of a portion of our income tax valuation
allowance. |
24
MANAGEMENTS DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion and analysis of our
financial condition and results of operations together with our
financial statements and the related notes and other financial
data included elsewhere in this prospectus. Some of the
information contained in this discussion and analysis or set
forth elsewhere in this prospectus, including information with
respect to our plans and strategy for our business, includes
forward-looking statements that involve risks and uncertainties.
You should review the Risk Factors section of this
prospectus for a discussion of important factors that could
cause actual results to differ materially from the results
described in or implied by the forward-looking statements
contained in the following discussion and analysis. See also
Forward-Looking Statements.
Overview
We develop, manufacture and market the INVOS System, a
non-invasive patient monitoring system that continuously
measures changes in the blood oxygen levels in the brain. We
began commercializing our current INVOS System, which we
call the model 5100, internationally in the third quarter
of fiscal 1999 and in the United States in the fourth quarter of
fiscal 2000. Unlike earlier models, the model 5100 has the
added capability of being able to monitor pediatric patients.
From product launch until the first quarter of fiscal 2005, we
focused our marketing efforts primarily on adult and pediatric
cardiac surgeries and carotid artery surgeries. During the
second quarter of fiscal 2004, results of both the first
prospective, randomized clinical trial and a larger
retrospective review evaluating the INVOS System were
presented, which we believe have contributed to the
INVOS System gaining further market penetration.
In the first quarter of fiscal 2005, we initiated selling and
marketing efforts for the INVOS System in the pediatric
intensive care unit, or ICU. We plan to launch the product into
the neonatal ICU in late 2006, after completing development of a
smaller SomaSensor. We are currently sponsoring a clinical trial
evaluating the use of the INVOS System on diabetic patients over
age 50. If results of this trial are positive, we intend to
target more actively the sale of the INVOS System for use in
diabetic patients undergoing major surgeries, consistent with
FDA requirements. We expect to begin this marketing in 2008.
In November 2005, we received 510(k) clearance from the FDA to
market our INVOS System to monitor changes in somatic tissue
blood oxygen saturation in regions of the body other than the
brain in patients with or at risk for restricted blood flow. Our
next generation INVOS System monitor, which we expect to launch
in the first half of 2006, can display information from four
SomaSensors, which will allow for the simultaneous monitoring of
changes in blood oxygen saturation in the brain and, in patients
with or at risk for restricted blood flow, in somatic tissue.
We also develop and market the CorRestore System for use in
cardiac repair and reconstruction. In June 2000, we entered into
a license agreement for the CorRestore System. In November 2001,
we received clearance from the FDA to market the CorRestore
Patch in the United States, and in April 2003 we met the
requirements under the European Medical Device Directive to use
the CE Mark, thereby allowing us to market the product in the
European Economic Community. However, in September 2004, the
European Economic Community changed its regulations, limiting
approval authority for animal tissue implant products sold in
Europe to some independent registration agencies that do not
include our registrar. Sales of CorRestore Systems represented
two percent of our fiscal 2005 net revenues. We expect that
as sales of our INVOS System increase, the CorRestore
System will become an even less significant component of our
business.
|
|
|
Net Revenues and Cost of Sales |
We derive our revenues from sales of INVOS Systems and
CorRestore Systems to hospitals in the United States through our
direct sales team and independent sales representative firms.
Outside the United States, we have distribution agreements with
independent distributors for the INVOS System, including Tyco
Healthcare in Europe, Canada, the Middle East and Africa, and
Edwards Lifesciences Ltd. in Japan. Our cost of sales represent
the cost of producing monitors and disposable SomaSensors.
Revenues from
25
outside the United States contributed 16 percent to our
fiscal 2005 net revenues. As a percentage of net revenues,
the gross margins from our international sales are typically
lower than gross margins from our U.S. sales, reflecting the
difference between the prices we receive from distributors and
from direct customers.
We recognize revenue when there is persuasive evidence of an
arrangement with the customer, the product has been delivered,
the sales price is fixed or determinable, and collectibility is
reasonably assured. The product is considered delivered to the
customer once we have shipped it, as this is when title and risk
of loss have transferred. Payment terms are generally net
30 days for U.S. sales and net 60 days or longer
for international sales.
Our INVOS System revenues are derived from the sale of monitors
and our disposable SomaSensors. We intend that disposables will
form the basis of a recurring revenue stream. We expect the
percentage of revenue from disposables to increase over time as
our installed base of monitors grows.
We offer to our customers in the United States a no capital cost
sales program whereby we ship the INVOS System monitor to
the customer at no charge. Under this program, we do not
recognize any revenue upon the shipment of the monitor. We
recognize SomaSensor revenue when we receive purchase orders and
ship the product to the customer. At the time of shipment of the
monitor, we capitalize the monitor as an asset and depreciate
this asset over five years, and this depreciation is included in
cost of goods sold.
Selling, general and administrative expenses generally consist
of:
|
|
|
|
|
salaries, wages and related expenses of our employees and
consultants; |
|
|
|
sales and marketing expenses, such as employee sales
commissions, commissions to independent sales representatives,
travel, entertainment, advertising, education and training
expenses, depreciation of demonstration monitors and attendance
at selected medical conferences; |
|
|
|
clinical research expenses, such as costs of supporting clinical
trials; and |
|
|
|
general and administrative expenses, such as the cost of
corporate operations, professional services, insurance, warranty
and royalty expenses, investor relations, depreciation and
amortization, facilities expenses and other general operating
expenses. |
We have increased the size of our direct sales team from
17 persons at the end of fiscal 2004 to 26 persons at the
end of fiscal 2005. We expect to increase significantly the size
of our U.S. direct sales team in fiscal 2006 and are
evaluating placing direct salespersons and clinical specialists
in Europe to support Tyco Healthcare. We also expect our
clinical research expenses to increase in fiscal 2006 as a
result of sponsoring a clinical trial evaluating the use of the
INVOS System on diabetic patients over age 50. As a result,
we expect selling, general and administrative expenses to
increase in fiscal 2006.
Research, development and engineering expenses consist of:
|
|
|
|
|
salaries, wages and related expenses of our research and
development personnel and consultants; |
|
|
|
costs of various development projects; and |
|
|
|
costs of preparing and processing applications for FDA clearance
of new products. |
|
|
|
Deferred Tax Assets and Impairment Charges |
As of November 30, 2004, we adjusted our deferred tax asset
valuation allowance resulting in the recognition of a deferred
tax asset of $6,700,000 as a result of expected future tax
benefits related to our net operating loss carryforwards.
Recognition of this deferred tax asset resulted in a non-cash
tax benefit on our statement of operations for fiscal 2004 of
$6,700,000.
26
For the fiscal year ended November 30, 2005:
|
|
|
|
|
We recorded an impairment expense of $929,093 associated with
the write-down of our intangible asset associated with the
acquisition of the license for the CorRestore System. |
|
|
|
We further adjusted our deferred tax asset valuation allowance
resulting in the recognition of additional deferred tax assets
due to expected future tax benefits related to our net operating
loss carryforwards. Recognition of this additional deferred tax
asset resulted in a non-cash tax benefit on our statement of
operations for fiscal 2005 of $3,300,000. |
Results of Operations
|
|
|
Fiscal Year Ended November 30, 2005 Compared to
Fiscal Year Ended November 30, 2004 |
Net Revenues. Our net revenues increased
$7,900,637, or 63 percent, from $12,608,615 in the fiscal
year ended November 30, 2004 to $20,509,252 in the fiscal
year ended November 30, 2005. The increase in net revenues
is primarily attributable to:
|
|
|
|
|
an increase in U.S. sales of $6,688,546, or
64 percent, from $10,517,014 in fiscal 2004 to
approximately $17,205,560 in fiscal 2005. The increase in
U.S. sales was primarily due to an increase in sales of the
disposable SomaSensor of $4,900,660, or 54 percent, as a
result of a 38 percent increase in SomaSensor unit sales
and a 12 percent increase in SomaSensor average selling
prices. This increase in our average selling prices is
attributable to the addition of new customers at our higher
suggested retail prices and increased sales of our pediatric
SomaSensor which sells for a higher price than the adult
SomaSensor. In addition, sales of the INVOS System monitor in
the United States increased $1,817,406, or 180 percent,
primarily as a result of increased purchases by pediatric
hospitals after the launch of our products into the pediatric
ICU in the first quarter of fiscal 2005; and |
|
|
|
an increase in international sales of $1,212,090, or
58 percent, from $2,091,602 in fiscal 2004 to $3,303,692 in
fiscal 2005. The increase in international sales was primarily
due to increased purchases of the INVOS System monitor and
disposable SomaSensor by Tyco Healthcare in Europe, which was
partially offset by decreased purchases by Edwards Lifesciences
in Japan. In fiscal 2005, international sales represented
16 percent of our net revenues, compared to 17 percent
of our net revenues in fiscal 2004. Purchases by Tyco Healthcare
accounted for 11 percent of net revenues in fiscal 2005. |
In the United States, we sold 153,197 SomaSensors in fiscal
2005, and internationally, we sold 59,890 SomaSensors in
fiscal 2005. We placed 306 INVOS System monitors in the United
States and 215 internationally in fiscal 2005, and our
installed base of INVOS System monitors in the United States was
approximately 1,100, in 500 hospitals, as of
November 30, 2005.
Sales of our products as a percentage of net revenues were as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Year | |
|
|
Ended | |
|
|
November 30, | |
|
|
| |
Product |
|
2005 | |
|
2004 | |
|
|
| |
|
| |
SomaSensors
|
|
|
75 |
% |
|
|
78 |
% |
INVOS System Monitors
|
|
|
23 |
% |
|
|
18 |
% |
|
|
|
|
|
|
|
|
Total INVOS System
|
|
|
98 |
% |
|
|
96 |
% |
CorRestore Systems
|
|
|
2 |
% |
|
|
4 |
% |
|
|
|
|
|
|
|
|
Total
|
|
|
100 |
% |
|
|
100 |
% |
|
|
|
|
|
|
|
Effective December 1, 2005, we increased the suggested list
price of the adult SomaSensor and the pediatric SomaSensor in
the United States to $140.00 and $155.00, respectively. Although
these prices may not apply to existing customers or to any
existing sales quotations issued before the price increase was
effective, we expect that the average selling price of
SomaSensors in the United States will increase in
27
fiscal 2006, primarily as a result of the addition of new
customers at our suggested retail prices and increased sales of
our pediatric SomaSensor.
Gross Margin. Gross margin as a percentage of net
revenues was 87 percent for the fiscal year ended
November 30, 2005 and 84 percent for the fiscal year
ended November 30, 2004. The increase in gross margin as a
percentage of net revenues is primarily attributable to the
increase in the average selling price of SomaSensors in the
United States and increased sales of the INVOS System monitors
to pediatric hospitals in the United States.
Research, Development and Engineering Expenses.
Our research, development and engineering expenses increased
approximately $156,573, or 42 percent, from $369,106 in
fiscal 2004 to $525,679 in fiscal 2005. The increase is
primarily attributable to development costs associated with our
next generation INVOS System monitor, scheduled to be launched
in the first half of 2006. We expect our research, development
and engineering expenses to increase in fiscal 2006, primarily
as a result of our hiring additional research and development
personnel.
Selling, General and Administrative Expenses.
Selling, general and administrative expenses increased
$5,003,652, or 61 percent, from $8,237,401 for the fiscal
year ended November 30, 2004 to $13,241,053 for the fiscal
year ended November 30, 2005, primarily due to a
62 percent increase in our sales and marketing expenses
during fiscal 2005 because of our increased sales personnel and
our increased sales and marketing efforts. The increase in
selling, general and administrative expense is primarily
attributable to:
|
|
|
|
|
a $1,031,964 increase in salaries, wages and related expenses,
primarily as a result of an increase in the number of employees,
principally in sales and marketing (from an average of
32 employees for the fiscal year ended November 30,
2004 to an average of 42 employees for the fiscal year
ended November 30, 2005); |
|
|
|
an impairment expense of $929,093 as a result of the write-down
of our intangible asset associated with the acquisition of the
license for the CorRestore System; |
|
|
|
an $832,012 increase in employee sales commissions as a result
of increased sales and increased sales personnel during fiscal
2005; |
|
|
|
an $811,524 increase in commissions paid to our independent
sales representative firms as a result of increased sales; |
|
|
|
a $661,785 increase in travel and selling-related expenses as a
result of our increased sales personnel and increased sales and
marketing activities; |
|
|
|
a $377,153 increase in audit-related expenses, primarily as a
result of costs associated with our first internal control
assessment under Section 404 of the Sarbanes-Oxley Act and
related regulations; |
|
|
|
a $365,770 increase in accrued incentive compensation expense
due to our fiscal 2005 financial performance, primarily
increased sales and net income, in accordance with the 2005
Incentive Compensation Plan; and |
|
|
|
a $105,120 increase in employer 401(k) matching contributions as
a result of increased personnel and increased salaries and wages
as described above. |
During fiscal 2004 we incurred $95,998 of expenses as a result
of the termination of some of our independent sales
representative firms.
We expect our selling, general and administrative expenses to
increase in fiscal 2006, primarily as a result of our hiring
additional direct sales personnel in fiscal 2005 and 2006,
increased sales commissions payable to our independent sales
representative firms, increased clinical research expense, and
increased sales and marketing expenses.
Income Tax Benefit. As of November 30, 2005,
we further adjusted our deferred tax asset valuation allowance
resulting in the recognition of additional deferred tax assets
as a result of expected future tax benefits related to our net
operating loss carryforwards. Recognition of this additional
deferred tax asset
28
resulted in a non-cash tax benefit on our statement of
operations for fiscal 2005 of $3,300,000, and increased our net
income for fiscal 2005 to $7,751,087, or $0.66 per diluted
common share. As 2006 progresses and we assess our plans for
future years, we will continue to review the appropriateness of
adjusting our deferred tax asset valuation allowance and
recognizing additional deferred tax assets.
|
|
|
Fiscal Year Ended November 30, 2004 Compared to
Fiscal Year Ended November 30, 2003 |
Net Revenues. Our net revenues increased
$3,247,722, or 35 percent, from $9,360,893 in the fiscal
year ended November 30, 2003 to $12,608,615 in the fiscal
year ended November 30, 2004. The increase in net revenues
is primarily attributable to:
|
|
|
|
|
an increase in U.S. sales of $3,100,634, or
42 percent, from $7,416,380 in fiscal 2003 to $10,517,014
in fiscal 2004. The increase in U.S. sales was primarily
due to an increase in sales of the disposable SomaSensor of
$2,967,150, or 49 percent, as a result of a 22 percent
increase in SomaSensor unit sales and a 22 percent increase
in SomaSensor average selling prices. This increase in our
average selling prices is attributable to the addition of new
customers at our higher suggested retail prices, which were
effective September 1, 2003, increased sales of our small
adult SomaSensor that was launched in the third quarter of
fiscal 2003 and sells for a premium price compared to the adult
SomaSensor, increased sales of our pediatric SomaSensor which
also sells for a higher price than the adult SomaSensor, and the
upgrade of certain customers to our most recent model INVOS
System monitor in exchange for the customer agreeing to pay a
higher price for the disposable SomaSensor. In addition, sales
of the INVOS System monitor in the United States increased
$332,779, or 49 percent, as a result of increased purchases
by pediatric hospitals. These increases were partially offset by
a decrease in CorRestore System revenues of $199,295, or
29 percent; and |
|
|
|
an increase in international sales of $147,089, or
8 percent, from $1,944,513 in fiscal 2003 to $2,091,602 in
fiscal 2004. The increase in international sales was primarily
due to increased purchases of the INVOS System monitor and
disposable SomaSensor by Edwards Lifesciences in Japan, which
was partially offset by decreased purchases by Tyco Healthcare
in Europe. In fiscal 2004, international sales represented
17 percent of our net revenues, compared to 21 percent
of our net revenues in fiscal 2003. Purchases by Tyco Healthcare
accounted for 12 percent of net revenues in fiscal 2003. |
In the United States, we sold 111,406 SomaSensors in fiscal
2004. We placed 193 INVOS System monitors in the United
States and 133 internationally in fiscal 2004, and our
installed base of INVOS System monitors in the United States was
approximately 800, in 380 hospitals, as of
November 30, 2004.
Sales of our products as a percentage of net revenues were as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Year | |
|
|
Ended | |
|
|
November 30, | |
|
|
| |
Product |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
SomaSensors
|
|
|
78 |
% |
|
|
71 |
% |
INVOS System Monitors
|
|
|
18 |
% |
|
|
21 |
% |
|
|
|
|
|
|
|
|
Total INVOS System
|
|
|
96 |
% |
|
|
92 |
% |
CorRestore Systems
|
|
|
4 |
% |
|
|
8 |
% |
|
|
|
|
|
|
|
|
Total
|
|
|
100 |
% |
|
|
100 |
% |
|
|
|
|
|
|
|
Gross Margin. Gross margin as a percentage of net
revenues was 84 percent for the fiscal year ended
November 30, 2004 and 77 percent for the fiscal year
ended November 30, 2003. The increase in gross margin as a
percentage of net revenues is primarily attributable to:
|
|
|
|
|
a change in the sales mix with increased sales of the disposable
SomaSensor, which has a higher gross margin percentage than the
INVOS System monitor or CorRestore System; |
29
|
|
|
|
|
the increase in the average selling price of SomaSensors; |
|
|
|
a significant reduction in the cost of our SomaSensor in May
2004 as a result of changes in our manufacturing
process; and |
|
|
|
the change in sales mix with increased sales in the United
States, which have higher gross margins than our international
sales to distributors. |
Research, Development and Engineering Expenses.
Our research, development and engineering expenses decreased
$43,847, or 11 percent, from $412,953 in fiscal 2003 to
$369,106 in fiscal 2004. The decrease is primarily attributable
to $46,891 in decreased costs associated with the development of
the CorRestore System and $24,516 in decreased costs associated
with the development of the INVOS System monitor, partially
offset by increased costs associated with the development of the
disposable SomaSensor and increased engineering salaries.
Selling, General and Administrative Expenses.
Selling, general and administrative expenses increased
$1,478,674, or 22 percent, from $6,758,637 for the fiscal
year ended November 30, 2003 to $8,237,401 for the fiscal
year ended November 30, 2004. The increase in selling,
general and administrative expense is primarily attributable to:
|
|
|
|
|
a $398,329 increase in salaries, wages and related expenses,
primarily as a result of an increase in the number of employees,
principally in sales and marketing (from an average of
28 employees for the fiscal year ended November 30,
2003 to an average of 32 employees for the fiscal year
ended November 30, 2004); |
|
|
|
a $393,196 increase in employee sales commissions as a result of
increased sales and increased sales headcount during fiscal 2004; |
|
|
|
a $352,948 increase in commissions paid to our independent sales
representative firms as a result of increased sales; |
|
|
|
a $226,588 increase in accrued incentive compensation expense
due to our fiscal 2004 financial performance, primarily
increased sales and net income, in accordance with the 2004
Incentive Compensation Plan; |
|
|
|
a $117,416 increase in travel and selling-related expenses as a
result of our increased sales headcount and increased sales and
marketing activities; |
|
|
|
$96,254 in costs associated with a 401(k) matching contribution
program that we implemented in fiscal 2004; and |
|
|
|
$95,998 in costs associated with the termination of some of our
independent sales representative firms in the second quarter of
fiscal 2004. |
These increases were partially offset by a $169,522 decrease in
customer education expenses for the CorRestore System.
Income Tax Benefit. As of November 30, 2004,
we adjusted our deferred tax asset valuation allowance resulting
in the recognition of a deferred tax asset of $6,700,000 as a
result of expected future tax benefits related to our net
operating loss carryforwards. Recognition of this deferred tax
asset resulted in a non-cash tax benefit on our statement of
operations for fiscal 2004, and increased our net income for
fiscal 2004 to $8,706,576, or $0.77 per diluted common
share.
We do not believe that inflation has had a significant impact on
our financial position or results of operations in the past
three years.
30
Liquidity and Capital Resources
Our principal sources of operating funds have been the proceeds
of equity investments from sales of our common shares and, in
fiscal years 2004 and 2005, cash provided by operating
activities. See Statements of Shareholders Equity of our
financial statements included elsewhere in this prospectus.
As of November 30, 2005, we did not have any outstanding or
available debt financing arrangements, we had working capital of
$18.0 million and our primary source of liquidity was
$13.1 million of cash and cash equivalents. Pending their
ultimate use, we currently invest our available funds in bank
savings accounts.
We believe that cash and cash equivalents on hand at
November 30, 2005 will be adequate to satisfy our operating
and capital requirements for more than the next twelve months.
|
|
|
Cash Flows From Operating Activities |
Net cash provided by (used in) operations during fiscal 2005,
2004 and 2003 was $3,687,653, $2,233,331 and ($630,577),
respectively. In fiscal 2005, cash was provided primarily by:
|
|
|
|
|
$5,764,166 of net income before income taxes, non-cash
intangible impairment expense, and non-cash depreciation and
amortization expense; |
|
|
|
a $462,485 increase in accrued liabilities, primarily as a
result of the increased accrued incentive compensation and
accrued sales commissions as a result of our fiscal 2005
financial performance, partially offset by reduced accrued
401(k) matching contributions as of the end of the fiscal year
and decreased accrued professional fees; and |
|
|
|
a $183,699 increase in accounts payable, primarily as a result
of increased inventory and operating expenses, partially offset
by more timely payments made to vendors. |
Cash provided by operations in fiscal 2005 was partially offset
by:
|
|
|
|
|
a $1,509,196 increase in accounts receivable primarily as a
result of higher fourth quarter sales in fiscal 2005 than in the
fourth quarter of fiscal 2004, and the timing of more of the
sales in fiscal 2005 towards the end of the fourth quarter; |
|
|
|
a $859,312 increase in inventories, primarily due to the
acquisition of SomaSensors and components associated with our
INVOS System monitor due to anticipated sales; inventories on
our balance sheet increased less because we capitalized INVOS
System monitors to property and equipment that are being used as
demonstration units and no capital cost sales equipment, as
described below; and |
|
|
|
a $365,410 increase in prepaid expenses, primarily due to the
timing of the renewal of our product liability and general
liability insurance policies, and increased prepaid expenses for
trade shows and marketing programs. |
We expect our working capital requirements to increase as sales
increase.
The increase in inventories described above is greater than
shown on our balance sheet because it includes INVOS System
monitors that we capitalized because they are being used as
demonstration units and no capital cost sales equipment. We
capitalized $484,121 of costs from inventory for INVOS System
monitors being used as demonstration units and no capital cost
sales equipment at customers during fiscal 2005, compared to
$565,962 in fiscal 2004. As of November 30, 2005, we have
capitalized $1,916,655 in costs for INVOS System monitors being
used as demonstration and no capital cost sales equipment, and
these assets have a net book value of $1,096,730. We depreciate
these assets over five years.
31
|
|
|
Cash Flows From Investing Activities |
Net cash used in investing activities in fiscal 2005, 2004 and
2003 was $134,637, $84,003 and $50,665, respectively. In fiscal
2005, these expenditures were primarily for computer equipment
for our new employees and furniture and fixtures associated with
leasehold improvements to our facilities.
|
|
|
Cash Flows From Financing Activities |
Net cash provided by financing activities in fiscal 2005, 2004
and 2003 was $2,525,679, $2,681,022 and $538,626, respectively.
During fiscal 2005, we issued 561,839 common shares as a result
of stock option exercises, for proceeds of $2,525,679. During
fiscal 2004, we issued 321,276 common shares as a result of
stock option exercises by employees, directors and former
employees, for proceeds of $1,541,022. In April 2004, CorRestore
LLC exercised its warrant to purchase 380,000 of our
newly-issued common shares, at $3.00 per share, for
proceeds of $1,140,000. During fiscal 2003, we issued 148,371
common shares as a result of stock option exercises by
employees, directors and former employees, for proceeds of
$538,626.
Contractual Obligations
The following information is provided as of November 30,
2005 with respect to our known contractual obligations specified
in the following table, aggregated by type of contractual
obligation:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period | |
|
|
| |
|
|
|
|
Less Than | |
|
|
|
More Than | |
Contractual Obligations |
|
Total | |
|
1 Year | |
|
1-3 Years | |
|
3-5 Years | |
|
5 Years | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
Long-term debt obligations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital lease obligations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating lease obligations
|
|
$ |
590,200 |
|
|
$ |
140,400 |
|
|
$ |
288,700 |
|
|
$ |
161,100 |
|
|
|
|
|
Purchase obligations
|
|
|
2,010,000 |
|
|
|
2,010,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other long-term liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase obligations consist primarily of purchase orders
executed for inventory components.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements or financing
activities.
New Accounting Pronouncements
In December 2004, the Financial Accounting Standards Board
issued Statement of Financial Accounting Standards No. 123
(revised), Share Based Payment. This Statement
revises Statement No. 123, Accounting for Stock-Based
Compensation, and requires that compensation costs related
to share-based payment transactions, including stock options, be
recognized in the financial statements. In November 2005, we
approved the acceleration of vesting of all unvested stock
options as of November 30, 2005. The primary purpose of
this accelerated vesting was to eliminate compensation expense
we would recognize in our results of operations upon the
adoption of SFAS 123R, which is effective for our fiscal
quarter beginning December 1, 2005. After the effects of
the accelerated vesting, the initial adoption of SFAS 123R
is expected to be immaterial. However, the issuance of
additional stock compensation under the 2005 Stock Incentive
Plan in future years will have an additional impact on our
financial statements.
Critical Accounting Policies
We believe our most significant accounting policies relate to
the recording of an intangible asset for license acquisition
costs related to our acquisition of exclusive, worldwide,
royalty-bearing licenses to specified rights relating to the
CorRestore System and related products and accessories, our
accounting
32
treatment of stock options issued to employees, our accounting
treatment for income taxes, and our revenue recognition
associated with our no capital cost sales program.
|
|
|
CorRestore Intangible Asset |
In fiscal years 2000, 2001 and 2003, we recorded an intangible
asset related to our acquisition of exclusive, worldwide,
royalty-bearing licenses to specified rights relating to the
CorRestore System and related products and accessories. License
acquisition costs include our estimate of the fair value of
ten-year vested stock options to purchase common shares granted
to one of our directors in connection with negotiating and
assisting us in completing the transaction, and our estimate of
the fair value of the vested portion of five-year warrants to
purchase common shares issued in the transaction. Consistent
with the treatment of the vested warrants to purchase common
shares, we intend to include in license acquisition costs, and
additional paid in capital, the fair value of the vested portion
of the unvested warrants to purchase common shares, estimated
using the Black-Scholes valuation model, when and if they become
vested. However, we do not expect any of these remaining
warrants to become vested before their November 21, 2006
expiration date, based on sales of CorRestore products to date.
We estimated the value of the stock options to purchase common
shares and the vested warrants to purchase common shares using
the Black-Scholes valuation model. The Black-Scholes valuation
model requires the following assumptions: expected life period
of the security, expected volatility of our stock price during
the period, risk-free interest rate, and dividend yield. Given
the assumptions inherent in the Black-Scholes valuation model,
it would have been possible to calculate a different value for
our intangible asset by changing one or more of the valuation
model variables or by using a different valuation model.
However, we believe that the model is appropriate, that the
judgments and assumptions that we have made at the time of
valuation were also appropriate, and that the reported results
would not be materially different had one or more of the
variables been different or had a different valuation model been
used.
We have adopted Statement of Financial Accounting Standards
No. 142, Goodwill and Other Intangible Assets.
This statement establishes accounting and reporting standards
for goodwill and other intangible assets. The effect of adopting
this Statement has been to discontinue amortizing our license
acquisition costs related to our acquisition of exclusive,
worldwide, royalty-bearing licenses to specified rights relating
to the CorRestore System and related products and accessories
described above because we believe these licenses have an
indefinite life. Therefore, we recorded no amortization expense
related to these license acquisition costs in fiscal 2005, 2004
or 2003. It is possible to determine a different life for these
licenses, and if they had a definite life, we would amortize the
intangible asset over the remaining useful life. However, we
believe it is appropriate to use an indefinite life for these
licenses. Indefinite lived intangible assets are reviewed
annually for impairment at the end of our fiscal year, and
whenever events or changes in circumstances indicate that the
carrying value of the asset may not be recovered. We evaluate
impairment by comparing the fair value of the intangible asset,
determined using a cash flow method, with its carrying value.
In November 2005, we wrote off the remaining CorRestore license
acquisition cost intangible asset and recorded an impairment
expense of $929,093. We wrote this off based on the cash flow
impairment analysis that was performed, the declining sales of
CorRestore products and the uncertainty regarding future
prospective, randomized clinical data. Management does not
expect net positive future cash flow from the CorRestore product
for the foreseeable future.
In December 2004, the Financial Accounting Standards Board
issued Statement of Financial Accounting Standards No. 123
(revised), Share Based Payment. This Statement requires that
compensation costs related to share-based payment transactions,
including stock options, stock appreciation rights and
restricted stock be recognized in the financial statements. This
Statement will be effective for our fiscal quarter beginning
December 1, 2005.
33
We currently account for stock-based compensation of employees
using the intrinsic value method prescribed in Accounting
Principles Board Opinion No. 25, Accounting for Stock
Issued to Employees, and related interpretations.
Accordingly, compensation costs for stock options granted to
employees are measured as the excess, if any, of the market
price of our stock at the date of the grant over the amount an
employee must pay to acquire the stock. No compensation expense
has been charged against income for fiscal 2005, 2004 and 2003
for stock option grants to employees because our stock option
grants are priced at the market value as of the date of grant.
In November 2005, we approved the acceleration of vesting of all
unvested stock options as of November 30, 2005. The primary
purpose of this accelerated vesting was to eliminate
compensation expense we would recognize in our results of
operations upon the adoption of SFAS 123R, which is
effective for our fiscal quarter beginning December 1,
2005. After the effects of the accelerated vesting, the initial
adoption of SFAS 123R is expected to be immaterial. The
issuance of additional stock compensation under the 2005 Stock
Incentive Plan in future years will have an additional impact on
our financial statements.
Stock-based compensation of consultants and advisors is
determined based on the fair value of the options or warrants on
the grant date pursuant to the methodology of
SFAS No. 123, estimated using the Black-Scholes model.
The resulting amount is recognized as compensation expense and
an increase in additional paid-in capital over the vesting
period of the options or warrants. As a result, we recorded
$11,221 of compensation expense, and an equal increase in
additional paid in capital, for stock options vesting in favor
of non-employees in fiscal 2005, and $8,471 of compensation
expense in fiscal 2003.
During fiscal 2005, we granted 162,146 stock options to our
employees and directors, in fiscal 2004 we granted 53,500 stock
options to our employees and directors, and in fiscal 2003 we
granted 471,000 stock options to our employees and directors.
Had we recognized compensation expense for our stock options
that vested in fiscal 2005 using the fair value method of
accounting based on the fair value of the options on the grant
date using the Black-Scholes valuation model, we would have
recorded $1,804,000 in compensation expense and realized pro
forma net income of $5,958,308, or $0.51 per diluted common
share. For fiscal 2004, had we recognized compensation expense
for our stock options that vested in fiscal 2004, using the fair
value method of accounting based on the fair value of the
options on the grant date using the Black-Scholes valuation
model, we would have recorded $796,000 in compensation expense
and realized pro forma net income of $7,911,576, or
$0.70 per diluted common share. For fiscal 2003, had we
recognized compensation expense for stock options that vested in
fiscal 2003, using the fair value method of accounting based on
the fair value of the options on the grant date using the
Black-Scholes valuation model, we would have recorded $962,000
in compensation expense and incurred a pro forma net loss of
$880,943, or $0.09 per diluted common share.
Income Taxes
We have performed the required assessment of positive and
negative evidence regarding realization of our deferred tax
assets in accordance with SFAS No. 109, including our
past operating results, the existence of cumulative losses over
our history up to the most recent three fiscal years and our
forecast for future net income. Our assessment of our deferred
tax assets, and the reversal of part of our valuation allowance,
included assuming that our net revenues and pre-tax income will
grow in future years consistent with the growth guidance given
for fiscal 2006 and making allowance for the uncertainties
surrounding, among other things, our future rate of growth in
net revenues, the rate of adoption of our products in the
marketplace and the potential for competition to enter the
marketplace. In reversing a portion of our valuation allowance,
we have concluded that it is more likely than not that such
assets will be realized.
During fiscal 2004, we adjusted our deferred tax asset valuation
allowance resulting in the recognition of a deferred tax asset
of $6,700,000 related to the expected future benefits of our net
operating loss carryforwards, in accordance with Statement of
Financial Accounting Standards No. 109, Accounting for
34
Income Taxes. During fiscal 2005, we further adjusted our
deferred tax asset valuation allowance resulting in the
recognition of an additional net deferred tax asset of
$3,300,000.
The effect of recognizing this asset on our balance sheet, and
associated tax benefit on our statement of operations, is to
increase our net income for fiscal 2005 to $7,751,087, or
$0.66 per diluted common share, and to increase our net
income for fiscal 2004 to $8,706,576, or $0.77 per diluted
common share. Given the assumptions inherent in our financial
plans, it is possible to calculate a different value for our
deferred tax asset by changing one or more of the variables in
our assessment. However, we believe that our evaluation of our
financial plans was reasonable, and that the judgments and
assumptions that we made at the time of developing the plan were
appropriate.
|
|
|
No Capital Cost Sales Revenue Recognition |
We offer to our customers in the United States a no capital cost
sales program whereby we ship the INVOS System monitor to the
customer at no charge. Under this program, we do not recognize
any revenue upon the shipment of the INVOS System monitor. We
recognize SomaSensor revenue when we receive purchase orders and
ship the product to the customer. At the time of shipment of the
monitor, we capitalize the INVOS System monitor as an asset and
depreciate this asset over five years. We believe this is
consistent with our stated revenue recognition policy, which is
compliant with Staff Accounting Bulletin No. 104 and
Emerging Issues Task Force
No. 00-21,
Revenue Arrangements with Multiple Deliverables.
35
BUSINESS
Overview
We develop, manufacture and market the INVOS System, a
non-invasive patient monitoring system that continuously
measures changes in the blood oxygen levels in the brain. The
brain is the organ least tolerant of oxygen deprivation. Without
sufficient oxygen, brain damage may occur within minutes, which
can result in paralysis, other disabilities or death. Brain
oxygen information, therefore, is important, especially in
surgical procedures requiring general anesthesia and in other
critical care situations with a high risk of the brain getting
less oxygen than it needs. The INVOS System consists of a
portable monitoring system, including proprietary software,
which is used with multiple single-use disposable sensors,
called SomaSensors. During our fiscal year ended
November 30, 2005, net revenues from SomaSensors comprised
approximately 75 percent of our net revenues. As of
November 30, 2005, we had an installed base of
approximately 1,100 INVOS System monitors in the United States
in approximately 500 hospitals, and during fiscal 2005 we sold
approximately 213,000 SomaSensors worldwide.
Clinical studies have shown that when the INVOS System is used
to monitor and provide information to help manage the regional
brain blood oxygen saturation of patients, the occurrence of
adverse clinical outcomes can be reduced, which can
significantly improve patient outcomes and reduce hospital
costs. During fiscal 2004, the results of the first prospective,
randomized, blinded intervention trial were presented. The study
showed that when the INVOS System was used to monitor and
provide information to help manage the regional brain blood
oxygen saturation of coronary artery bypass surgery patients,
the occurrence of adverse clinical outcomes was reduced from
12.5 percent to two percent. Additionally, in 2004, the
results of a large retrospective review showed a statistically
significant greater than 50 percent reduction (2.01 percent
versus 0.97 percent) in the incidence of permanent stroke when
information from the INVOS System was used to help manage brain
blood oxygen saturation of cardiac surgery patients. The results
also showed a reduced length of hospital stay and reduced
incidence of prolonged ventilation when the INVOS System was
used.
Our INVOS System has U.S. Food and Drug Administration, or
FDA, clearance in the United States for use on adults, children
and infants. We target the sale of the INVOS System for use in
surgical procedures and other critical care situations with a
high risk of oxygen imbalances. We initially focused our
marketing efforts primarily on adult and pediatric cardiac
surgeries and carotid artery surgeries. In the first quarter of
fiscal 2005, we initiated selling and marketing efforts for the
INVOS System in the pediatric ICU. We plan to launch the product
into the neonatal ICU in late 2006, after completing development
of a smaller SomaSensor. Some of our potential future markets
may include major surgeries involving diabetic and elderly
patients. While our initial focus has been commercializing the
INVOS System to measure blood oxygen saturation changes in the
brain, we believe that there are opportunities to use the INVOS
System in regions of the body other than the brain. In November
2005, we received 510(k) clearance from the FDA to market our
INVOS System to monitor changes in blood oxygen saturation
elsewhere in the body in somatic, or skeletal muscle, tissue in
patients with or at risk for restricted blood flow. Our next
generation INVOS System monitor, which we expect to launch in
the first half of 2006, can display information from four
SomaSensors, which will allow for the simultaneous monitoring of
changes in blood oxygen saturation in the brain and, in patients
with or at risk for restricted blood flow, in somatic tissue.
We are currently sponsoring a prospective, randomized, blinded
clinical trial involving diabetic patients over age 50 who
are undergoing major general surgery. The study group will
consist of patients whose surgeries are managed based on
information provided by the INVOS System, and the control group
will consist of similarly situated patients whose surgeries are
not managed based on information provided by the INVOS System.
The two groups will be compared across measures of patient
outcomes and hospital costs, including length of hospital stay.
Diabetics are at particular risk of oxygen imbalances because of
a higher incidence of vascular disease. If results of this trial
are positive, we intend to target more actively the sale of the
INVOS System for use in diabetic patients undergoing major
general surgeries, consistent with FDA requirements. We expect
to begin this marketing in 2008. We are also
36
evaluating sponsorship of other clinical trials which may allow
us to more actively target the sale of the INVOS System for use
in other patient populations. There are also numerous other
independent clinical studies evaluating the use of the INVOS
System.
We sell the INVOS System through a direct sales team in the
United States, consisting of salespersons and clinical
specialists, the size of which has increased from 17 persons at
the end of fiscal 2004 to 26 persons at the end of fiscal 2005,
and 10 independent sales representative firms. Outside the
United States, we market the INVOS System through independent
distributors, including Tyco Healthcare in Europe, Canada, the
Middle East and Africa, and Edwards Lifesciences Ltd. in Japan.
We expect to increase significantly the size of our
U.S. direct sales team in fiscal 2006 and are evaluating
placing direct salespersons and clinical specialists in Europe
to support Tyco Healthcare. Our net revenues have increased from
$9.4 million in the fiscal year ended November 2003 to
$20.5 million in fiscal 2005, representing a compounded
annual growth rate of 47.6 percent. As a percentage of net
revenues, our gross margin improved from 77 percent in
fiscal 2003 to 87 percent in fiscal 2005.
Industry
We believe that in the United States in 2006 there will be
approximately five million surgeries involving elderly
patients who, due to the type of surgery, age of the patient or
other factors, have a higher risk of developing post-operative
complications. Such surgeries include cardiac surgeries, carotid
surgeries and other major general surgeries involving elderly
patients. In addition, we believe that there are other patient
populations, such as non-elderly adult, pediatric and neonatal
patients, undergoing major surgeries and patients undergoing ICU
treatment or in other critical care situations that face a high
risk of brain oxygen imbalances.
Hospitals in the United States have economic incentives to
control health care costs. They often receive a fixed fee from
Medicare, managed care organizations and private insurers based
on the disease diagnosed, rather than on the services actually
performed. Therefore, hospitals are increasingly focused on
avoiding unexpected costs, such as those associated with
increased hospital stays of patients with brain or other organ
damage or other adverse outcomes following surgery or ICU
treatment. The costs to the health care system associated with
adverse surgical and ICU outcomes and lengthened hospital stays
can be significant. In addition, lack of immediate knowledge
about blood oxygen levels in areas such as the brain or somatic
tissue can result in unnecessary medical treatments and
associated costs. With the increasing focus by hospitals on
avoiding unexpected costs, especially in the operating room, ICU
and other critical care areas, we believe that there are
significant incentives to evaluate and adopt new monitoring
technologies which could provide information to improve patient
care and reduce costs.
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Brain Oxygen Imbalances and Its Effects |
Oxygen is carried to the brain by hemoglobin in the blood.
Hemoglobin passes through the lungs, bonds with oxygen and is
pumped by the heart through arteries and capillaries to the
brain. Brain cells extract oxygen and the blood carries away
carbon dioxide through the capillaries and veins back to the
lungs.
The brain is the human organ least tolerant of oxygen
deprivation. Without sufficient oxygen, brain damage may occur
within minutes, which can result in paralysis, severe and
complex disabilities, or death. Undetected brain hypoxia, which
is a condition in which there is a decrease of oxygen supply to
the brain even though there is adequate blood flow, and
ischemia, which is a condition in which blood flow, and thus
oxygen, is restricted to a part of the body, are common causes
of brain damage and death during and after many surgical
procedures and in other critical care situations.
Brain oxygen imbalances can be caused by several factors,
including changes in arterial blood oxygen saturation, which is
the percentage of oxygenated hemoglobin contained in a given
amount of blood which carries oxygen in the arteries to the
tissues of the body, blood flow to the brain, hemoglobin
concentration and oxygen consumption by the brain.
37
Brain oxygen information is important in surgical procedures
requiring general anesthesia, in other critical care situations
with a high risk of brain oxygen imbalances, as well as in the
treatment of patients with head injuries or strokes. Once
alerted to these imbalances, medical professionals can use this
and other information to take corrective action through the
introduction of medications, anesthetic agents or mechanical
intervention, potentially improving patient outcomes and
reducing the costs of care. Immediate and continuous information
about changes in brain oxygen levels also provides immediate
feedback regarding the adequacy of the selected therapy. Equally
important, without information about brain oxygen levels,
therapy that may not be necessary might be initiated in an
attempt to ensure adequate brain oxygen levels and may have an
adverse impact on patient safety and increase hospital costs.
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Limitations of Traditional Monitoring Technologies |
We believe that it is uncommon for patients undergoing surgery
to receive any sort of direct neuromonitoring of brain blood
oxygen saturation, in part due to some of the shortcomings of
the traditional technologies. When patients are monitored
directly, several different methods are used to detect one or
more of the factors affecting brain oxygen levels or the effects
of brain oxygen imbalances. These methods include invasive
jugular bulb catheter monitoring, transcranial Doppler,
electroencephalograms, or EEGs, intracranial pressure monitoring
and neurological examination. These methods have not been widely
adopted to monitor brain oxygen levels in critical care
situations for a variety of reasons. The use of these methods is
limited because they are either expensive, difficult or
impractical to use, invasive, not reliable under some
circumstances, not organ specific, not able to measure more than
one factor affecting oxygen imbalances in the brain or not able
to provide continuous information.
Our Solution
Our INVOS System is a non-invasive patient monitoring system
that provides continuous information about changes in blood
oxygen saturation levels. We believe that our INVOS System
addresses the markets need for a solution that is
non-invasive, continuous, immediate, effective and easy to use.
The INVOS System, which is predominantly used in hospital
critical care areas such as operating rooms and ICUs, consists
of a portable monitoring system, including proprietary software,
which is used with multiple single-use disposable SomaSensors.
For multi-channel cerebral monitoring, SomaSensors are placed on
both sides of a patients forehead and are connected to the
monitor. The INVOS System uses our proprietary software to
analyze information received from the SomaSensors and provides a
continuous digital and trend display of an index of the blood
oxygen saturation in the area of the body under the SomaSensors.
Our next generation INVOS System monitor, which we expect to
launch in the first half of 2006, can display information from
four SomaSensors, which will allow for the simultaneous
monitoring of changes in blood oxygen saturation in the brain
and, in patients with or at risk for restricted blood flow, in
somatic tissue.
Surgeons, anesthesiologists and other medical professionals can
use the information provided by the INVOS System, in conjunction
with other available information, to identify brain oxygen
imbalances and take necessary corrective action, potentially
improving patient outcomes and reducing the costs of care. Once
the cause of a cerebral oxygen imbalance is identified and
therapy is initiated, the INVOS System provides immediate
feedback regarding the adequacy of the selected therapy. It can
also provide medical professionals with an additional level of
assurance when they make decisions regarding the need for
therapy.
Unlike some existing monitoring methods, the INVOS System
functions even when the patient is unconscious, lacks a strong
peripheral pulse or has suppressed neural activity. The
measurement made by the INVOS System is dominated by information
from the blood in the veins, where the balance of oxygen supply
and demand can be more effectively assessed. Therefore, it
responds to the changes in factors that affect the balance
between cerebral oxygen supply and demand, including changes in
arterial oxygen saturation, cerebral blood flow, hemoglobin
concentration and cerebral oxygen consumption. The INVOS System
responds to global changes in brain oxygen levels and to events
that affect brain oxygen levels in the region beneath the
SomaSensor.
38
The following table summarizes some of the principal features
and related benefits of the INVOS System:
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Features |
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Benefits |
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Non-invasive
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Reduced risk to patients and medical
professionals |
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Consistent with market trend toward less
invasive medical procedures |
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Continuous Information
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Immediate information regarding brain oxygen
imbalances to help guide therapeutic interventions |
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Trend information, rather than at a single
point in time |
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Cost-Effective
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Low cost relative to traditional brain
monitoring methods |
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Small portion of the total cost of the
procedures in which it is used |
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Information can potentially improve patient
outcomes and reduce the overall cost of care |
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Easy to Use
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Does not require a dedicated technician to
operate or interpret |
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Automatic SomaSensor calibration |
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Simple user interface and controls |
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Effective in Difficult Circumstances
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Provides information when the patient is
unconscious, lacks a strong peripheral pulse or has suppressed
neural activity, specifically during cardiac arrest,
hypothermia, hypertension, hypotension and hypovolemia |
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Portable/Compatible
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Placed at patients bedside |
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Lightweight |
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Can be integrated or interfaced with existing
multi-modality systems |
The CorRestore System
In addition to the INVOS System, we also develop and market the
CorRestore System, which includes a cardiac implant, which we
call the CorRestore Patch, for use in cardiac repair and
reconstruction, including heart surgeries called surgical
ventricular restoration, or SVR. During SVR, the surgeon
restores an enlarged, poorly functioning left ventricle to more
normal size and function by inserting an implant, in most
instances, or closing the defect directly. Sales of CorRestore
Systems represented two percent of our fiscal 2005 net
revenues.
Business Strategy
Our objective is to establish the INVOS System as a standard of
care in surgical procedures requiring general anesthesia and in
other critical care situations. Key elements of our strategy
include to:
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Target Surgical Procedures and Other Critical Care
Situations with a High Risk of Oxygen Imbalances. We
target surgical procedures and other critical care situations
with a high risk of oxygen imbalances. Some of our current and
potential future markets include cardiac surgeries, carotid
artery surgeries, pediatric and neonatal ICU applications and
other major surgeries involving diabetic or elderly patients. We
believe that the medical professionals involved in these
surgeries and ICU treatments are most aware of the risks of
brain and other damage resulting from oxygen |
39
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imbalances. Therefore, we believe that it will be easier to
demonstrate the clinical importance of the information provided
by the INVOS System to these professionals and potentially gain
market acceptance for our products in connection with these
surgeries and ICU treatments. |
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Sponsor Clinical Studies to Promote Expanded
Acceptance of the INVOS System. We believe that our
INVOS System has been evaluated in over 400 presentations, study
abstracts and published papers. During the second quarter of
fiscal 2004, results of both the first prospective, randomized
clinical trial and a larger retrospective review evaluating the
INVOS System were presented, which we believe have contributed
to the INVOS System gaining further market penetration. We plan
to sponsor clinical studies using the INVOS System to
demonstrate its benefits. We are currently sponsoring a
prospective, randomized, blinded clinical trial involving
diabetic patients over age 50 who are undergoing major
general surgery. The study group will consist of patients whose
surgeries are managed based on information provided by the INVOS
System, and the control group will consist of similarly situated
patients whose surgeries are not managed based on information
provided by the INVOS System. The two groups will be compared
across measures of patient outcomes and hospital costs,
including length of hospital stay. Diabetics are at particular
risk of oxygen imbalances because of a higher incidence of
vascular disease. If results of this trial are positive, we
intend to target more actively the sale of the INVOS System for
use in diabetic patients undergoing major general surgeries,
consistent with FDA requirements . We expect to begin this
marketing in 2008. We are also evaluating sponsorship of other
clinical trials which may allow us to more actively target the
sale of the INVOS System for use in other patient populations.
We use the results of clinical studies to help convince the
medical community of the clinical importance of the information
provided by the INVOS System. We also sponsor
peer-to-peer
educational opportunities and promote use of the INVOS System in
regional centers of influence that we believe will influence its
adoption by others. |
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Invest in Sales and Marketing Activities. We
continue to increase our investment in our distribution network
consisting of our direct sales employees, independent sales
representative firms and distributors. We sell the INVOS System
through a direct sales team in the United States, the size of
which has increased from 17 persons at the end of fiscal
2004 to 26 persons at the end of fiscal 2005, and
10 independent sales representative firms. We expect to
increase significantly the size of our U.S. direct sales
team in fiscal 2006 and are evaluating placing direct
salespersons and clinical specialists in Europe to support Tyco
Healthcare. We also have a co-promotion relationship with
Fresenius Medical Care Cardiovascular Resources, Inc.s
North American Extracorporeal Alliance. We participate in trade
shows and medical conferences, ongoing
peer-to-peer
educational programs and targeted public relations opportunities. |
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Interface and Integrate Our Technology into Other
Manufacturers Multi-Modality Systems. There are
many existing monitoring systems in the operating room and the
ICU. We would like to interface with these monitors. We have
interfaced the INVOS System with the Philips Medical
Systems VueLink System to provide data, alarm events and
status messages from the INVOS System on any monitor that
accepts the VueLink module, a multi-parameter monitor. This
enables oximetry data from our INVOS System to be displayed on
the VueLink screen and integrated with other vital patient
information. We plan to support the interface and integration of
our INVOS System technology with other medical device
manufacturers to expand the installed base of INVOS System
monitors and increase the demand for SomaSensors. We expect that
such arrangements will provide another distribution channel for
our INVOS System. |
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Develop Additional Applications and Markets for the INVOS
System. We are developing a smaller SomaSensor
for use with newborns, developing a product-line extension of
the INVOS System for monitoring non-brain tissues and making
other advances to the design and performance features of the
INVOS System, including the SomaSensor. We are also evaluating
additional potential market segments for our INVOS System, such
as use in other major surgeries, in the adult ICU, in the
emergency room, in ambulances, in the catheterization
laboratory, for blood transfusions, for muscle ischemia, for
cosmetic surgery, for non-surgical neurology or cardiology |
40
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applications, for psychiatric applications and for sleep
disorders. Pursuit of some of these potential market segments
may require additional FDA clearance. We believe that these
natural extensions of our technology will increase our market
potential without the more significant risks and costs
associated with developing entirely new products. |
The INVOS System
Components of the INVOS
System
The INVOS System consists of a portable monitoring system,
including proprietary software, which is used with multiple
single-use disposable SomaSensors.
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Monitor and Software. Our oximeter is a portable
monitor that uses our proprietary software to analyze
information received from the SomaSensors. It provides a
continuous digital and trend display of an index of the oxygen
saturation in the region of the body under the SomaSensors. The
monitor includes menus for users to set high and low audible
alarms, customize the display and retrieve data. Single-function
keys allow users to silence alarms, mark important events, store
data for up to 28 surgical procedures, and retrieve data by
disk or through a USB link to a computer. The monitor measures
approximately 9 inches wide, 8 inches high, and
8 inches deep and weighs approximately 14 pounds. Our
next generation INVOS System monitor, which we expect to launch
in the first half of 2006, measures approximately 11 inches
wide, 9 inches high, and 6 inches deep and weighs
approximately 11 pounds. We provide a one-year warranty on
the monitor, and we offer service for the monitor for a fee
after the warranty expires. As of November 30, 2005, we had
an installed base of approximately 1,100 INVOS System
monitors in the United States in approximately
500 hospitals. |
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SomaSensors. Each single-use SomaSensor contains a
light source and two light detectors. For multi-channel cerebral
monitoring, SomaSensors are placed on both sides of a
patients forehead and are connected to the monitor, which
allows for monitoring both sides of the brain. Our next
generation INVOS System monitor, which we expect to launch in
the first half of 2006, can display information from four
SomaSensors, which will allow for the simultaneous monitoring of
changes in blood oxygen saturation in the brain and, in patients
with or at risk for restricted blood flow, in somatic tissue.
The number of sensors used will depend on the application. We
expect that the INVOS System will be used to monitor
simultaneously the brain and somatic tissue initially for
patients in the pediatric and neonatal ICU, and will later also
be used on adults and for monitoring somatic tissue alone. The
SomaSensors contain information that is processed by the INVOS
System allowing it to automatically calibrate each sensor.
During our fiscal year ended November 30, 2005, net
revenues from SomaSensors comprised approximately
75 percent of our net revenues. During fiscal 2005 we sold
approximately 213,000 SomaSensors worldwide. |
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Overview of INVOS Technology |
Our proprietary In Vivo Optical Spectroscopy, or INVOS,
technology is based primarily on the physics of optical
spectroscopy. Optical spectroscopy is the interpretation of the
interaction between matter and light. Spectrometers and
spectrophotometers function primarily by shining light through
matter and measuring the extent to which the light is
transmitted through, scattered by or absorbed by the matter.
Physicians and scientists can use spectrophotometers to examine
human blood and tissue. Although most human tissue is opaque to
ordinary light, some wavelengths penetrate tissue more easily
than others. Therefore, by shining appropriate wavelengths of
light into the body and measuring its transmission, scattering
and absorption, or a combination of each, physicians can obtain
information about the matter under analysis. Optical
spectroscopy generates no ionizing radiation and produces no
known hazardous effects.
By identifying the hemoglobin and the oxygenated hemoglobin and
measuring the relative amounts of each, oxygen saturation of
hemoglobin can be measured. However, traditional optical
spectroscopy was generally not useful when the substances to be
measured were surrounded by, were behind or were near
41
bone, muscle or other tissue, because they produce extraneous
data that interferes with analysis of the data from the area
being examined.
We have developed a method of reducing extraneous spectroscopic
data caused by surrounding bone, muscle and other tissue. This
method, which is embedded in our INVOS System, allows us to
gather information about portions of the body that previously
could not be analyzed using traditional optical spectroscopy.
The INVOS System measurement is made by our SomaSensors
transmitting low-intensity visible and near-infrared light
through a portion of the body and detecting the manner in which
the molecules of the exposed substance interact with light at
specific wavelengths.
Each single-use SomaSensor contains a light source and two light
detectors. The dual detector design of the SomaSensor enables us
to measure scattered light intensities from the intermediate
tissues of skin, muscle and bone in a separate process. While
both detectors receive similar information about the tissue
between the sensor and the area under examination, the detector
further from the light source detects light that has penetrated
deeper into the body, and, therefore, receives more information
specific to the brain or skeletal muscle tissue under
examination than does the detector closer to the light source.
By comparing the two measurements, our INVOS technology is able
to suppress the influence of the tissues between the sensor and
the brain or somatic tissue under examination to provide a
measurement of changes in brain or skeletal muscle tissue blood
oxygen saturation.
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Applications and Market Segments |
We target the sale of the INVOS System for use in surgical
procedures and other critical care situations with a high risk
of oxygen imbalances. We believe that our INVOS System has
applications for cerebral and somatic monitoring in the
following key market segments:
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Cardiac and Carotid Artery Surgery. Until the
first quarter of fiscal 2005, we focused our marketing efforts
primarily on cardiac and carotid artery surgeries. We believed
it would be easier to demonstrate clinical importance of the
information provided by the INVOS System and potentially gain
market acceptance for our products in connection with these
surgeries. Moreover, much of the earliest clinical data
regarding the use of the INVOS System involved these surgeries.
In September 2000, we received 510(k) clearance from the FDA to
market the model 5100 INVOS System in the United States. Unlike
earlier models, the model 5100 INVOS System has the added
capability of being able to monitor pediatric patients. After
receiving this clearance, we expanded our marketing efforts to
include pediatric cardiac surgeries. |
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Pediatric and Neonatal ICU. We are not aware of
any other FDA-cleared cerebral oximeter commercially available
in the United States that is cleared for monitoring non-adult
patients. In the first quarter of fiscal 2005, we initiated
selling and marketing efforts for the INVOS System in the
pediatric ICU. We plan to launch the product into the neonatal
ICU in late 2006, after completing development of a smaller
SomaSensor. Our next generation INVOS System monitor, which we
expect to launch in the first half of 2006, can display
information from four SomaSensors, which will allow for the
simultaneous monitoring of changes in blood oxygen saturation in
the brain and, in patients with or at risk for restricted blood
flow, in somatic tissue. We expect that the INVOS System will be
used to monitor simultaneously the brain and somatic tissue
initially for patients in the pediatric and neonatal ICU. |
|
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|
Diabetic Patient Major Surgeries. We are currently
sponsoring a prospective, randomized, blinded clinical trial
involving diabetic patients over age 50 who are undergoing
major general surgery. The study group will consist of patients
whose surgeries are managed based on information provided by the
INVOS System, and the control group will consist of similarly
situated patients whose surgeries are not managed based on
information provided by the INVOS System. The two groups will be
compared across measures of patient outcomes and hospital costs,
including length of hospital stay. Diabetics are at particular
risk of oxygen imbalances because of a higher incidence of
vascular disease. If results of this trial are positive, we
intend to target more actively the sale of the INVOS |
42
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System for use in diabetic patients undergoing major general
surgeries, consistent with FDA requirements. We expect to begin
this marketing in 2008. |
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Other Applications. We are also evaluating
sponsorship of other clinical trials which may allow us to more
actively target the sale of the INVOS System for use in other
patient populations. If the results of these trials are
positive, following completion of these trials and publication
of the results, we intend to target the sale of the INVOS System
for use on elderly patients undergoing major surgeries. We are
also evaluating additional potential market segments for our
INVOS System, such as use in other major surgeries, in the adult
ICU, in the emergency room, in ambulances, in the
catheterization laboratory, for blood transfusions, for muscle
ischemia, for cosmetic surgery, for non-surgical neurology or
cardiology applications, for psychiatric applications and for
sleep disorders. Pursuit of some of these potential market
segments may require additional FDA clearance. |
Clinical Development
We believe that favorable peer-reviewed publication is a key
element to the INVOS Systems success. Accordingly, we
support clinical research programs with third-party clinicians
and researchers intended to demonstrate the need for the INVOS
System and the clinical importance of the information it
provides with the specific objective of publishing the results
in peer-reviewed journals. The research includes studies
comparing patients managed based on information provided by the
INVOS System with other patients, based on measures of patient
outcome and hospital costs, including patient length of stay,
length of time on the ventilator, cognitive dysfunction and
incidence of stroke. In addition to the studies described below,
we believe that our INVOS System has been evaluated in over
400 presentations, study abstracts and published papers.
During the second quarter of fiscal 2004, results of the studies
described below were presented, which we believe have
contributed to the INVOS System gaining further market
penetration.
In the second quarter of 2004, the results of the first
prospective, randomized, blinded intervention study using the
INVOS System were presented. The study showed a statistically
significant reduction in the overall number of adverse clinical
outcomes when the INVOS System was used to provide information
to help manage regional brain blood oxygen saturation in
coronary artery bypass surgery patients. The
200-patient study was
conducted by John Murkin, M.D., professor of anesthesiology
at the University of Western Ontario, and was presented at
Outcomes 2004: Neurobehavioral Assessment, Physiological
Monitoring and Cerebral Protective Strategies held in Key West,
Florida. The data and results of the intervention study reported
on by Dr. Murkin at Outcomes 2004 have not been published in a
peer-reviewed publication. We believe Dr. Murkin is preparing an
article for presentation to a peer-reviewed publication.
Patients undergoing coronary artery bypass surgery were randomly
assigned to the control or intervention group. Patients in both
groups were monitored with the INVOS System during their
operations, but the monitor display in the control group
(99 patients) was covered and patients treatments
were managed routinely. In the intervention group
(101 patients) the patients treatments were managed
using information from the INVOS System, and the patients
received a pre-determined series of interventions to maintain
the INVOS Systems index of regional cerebral blood oxygen
saturation within 75 percent of baseline values taken at
the beginning of the operation.
Independent observers assessed all of the patients for adverse
clinical outcomes. The complication criteria were those reported
by cardiac surgeons to the Society of Thoracic Surgeons National
Database. These complications consist of common adverse outcomes
following cardiac surgery, such as stroke, respiratory failure,
renal failure and other major morbidities.
Dr. Murkin found that regional brain oxygen desaturations
were quite common and are related to adverse outcomes. The
intervention group experienced statistically significantly fewer
adverse clinical outcomes than the control group: two patients
in the intervention group experienced adverse clinical
43
outcomes, compared to 12 patients in the control group.
With respect to stroke specifically, one patient in the
intervention group experienced a stroke, compared to four
patients in the control group. The difference was not
statistically significant.
A financial analysis of Dr. Murkins data was
conducted by Leaden Hickman, Ph.D., assistant professor,
health sciences and administration at the University of
Michigan, and Dr. Murkin. This analysis was presented at
Outcomes 2005: Neurobehavioral Assessment, Physiological
Monitoring and Cerebral Protective Strategies held in Key West,
Florida in May 2005. The analysis showed measurable cost
differences between the intervention and control groups. Total
cost per patient was lower in the intervention group than in the
control group ($14,921 vs. $15,619). This difference was not
statistically significant. The potential complication avoidance
results in a total savings of $231,540, or a savings of $1,158
per patient averaged over the entire study group. The data and
results of the financial analysis conducted by Leaden Hickman,
Ph.D, and presented at Outcomes 2005, have not been published in
a peer-reviewed publication.
In the second quarter of 2004, the results of a retrospective,
blinded intervention study using the INVOS System were
presented. The study showed a statistically significant
reduction in permanent stroke when information from the INVOS
System was used to help manage regional brain blood oxygen
saturation in cardiac surgery patients. The principal
investigator in the
2,279-patient study was
Scott Goldman, M.D., chairman of the department of surgery
at Pennsylvania-based Main Line Health Center, Lankenau
Hospital. Findings from the study were presented at the
Cardiothoracic Techniques and Technologies Annual Meeting in
March 2004 and were published as Scott Goldman, M.D., et al.,
Optimizing Intraoperative Cerebral Oxygen Delivery Using
Noninvasive Cerebral Oximetry Decreases the Incidence of Stroke
for Cardiac Surgical Patients, in The Heart Surgery Forum
#2004-1062 (September
2004).
The study included all patients who underwent cardiac surgery
for any reason at the Lankenau Hospital and Institute for
Medical Research from July 1, 2000 to June 30, 2003.
The control group consisted of 1,245 patients who underwent
surgery in the 18 months before cerebral oximetry
monitoring with the INVOS System was introduced at the hospital
on January 1, 2002. The study group consisted of
1,034 patients who underwent surgery during the following
18 months and were monitored with the INVOS System.
Operative techniques were modified in the study group to
maintain cerebral oximetry values at or near the pre-operative
baseline throughout the surgery. The study group included a
significantly sicker population of patients than the control
group, as determined by pre-operative New York Heart
Association, or NYHA, classification and co-morbidities.
The incidence of permanent stroke in the study group
(0.97 percent) was statistically significantly less than in
the control group (2.01 percent), despite a sicker
population according to the higher NYHA class of the study
group. Although the incidence of permanent stroke was lower in
the study group, the incidence of all neurologic dysfunction,
including stroke and transient ischemic attach, was similar in
the two groups. The proportion of patients requiring prolonged
ventilation also was statistically significantly smaller in the
study group, 6.8 percent, compared to 10.6 percent in
the control group. Total ventilator time was statistically
significantly shorter in the study group (four hours) than the
control group (five hours). The length of hospital stay was
similar overall in the two groups, but was statistically
significantly shorter in the study group when examined by
pre-operative NYHA classifications of patients.
Dr. Goldmans later analysis of these data concluded
that the difference in incidence of cerebrovascular accidents,
or CVA, between the two groups translated into a potential
avoidance of 12 CVAs in the study group and approximately
$254,214 in direct costs and more than $425,000 in total costs.
44
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Diabetic Patients Studies |
In the second quarter of 2005, Dr. Murkin presented the
results of a 56-patient
sub-study of his prospective, randomized, blinded intervention
study using the INVOS System described above under Murkin
Study. The sub-study showed that avoidance of cerebral
oxygen desaturations in actively managed diabetic coronary
artery bypass graft patients was associated with improved
clinical outcomes. The sub-study was presented at the Society of
Cardiovascular Anesthesiologists 27th Annual Meeting in
Baltimore. The data and results of the intervention study
presented by Dr. Murkin in Baltimore have not been
published in a peer-reviewed publication. We believe
Dr. Murkin is preparing an article for presentation to a
peer-reviewed publication.
Diabetic patients have impaired cerebral autoregulation and
oxygenation during cardiopulmonary bypass surgery. This
sub-study analyzed outcomes of two coronary artery bypass graft
patient groups: an intervention group of diabetic and
non-diabetic patients who were monitored with the INVOS System
and received a pre-determined series of interventions to
maintain the INVOS Systems index of regional cerebral
blood oxygen saturation within 75 percent of baseline
values taken at the beginning of the operation and a control
group of diabetic and non-diabetic patients who were monitored
with the INVOS System, but the display was covered and the
patients were managed routinely. Diabetic patients in the
intervention group required shorter ventilation (nine hours
versus 30 hours), shorter stays in the ICU (30 hours
versus 69 hours) and shorter hospital stays (5.5 days
versus 8.4 days) than diabetic patients in the control
group. All of these differences were statistically significant.
There were no statistically significant differences between the
regional cerebral oxygen saturation levels of the diabetic
patients in the intervention group and the levels of the
non-diabetic patients in the intervention group.
We are currently sponsoring a prospective, randomized, blinded
clinical trial involving diabetic patients over age 50 who
are undergoing major general surgery. The study group will
consist of patients whose surgeries are managed based on
information provided by the INVOS System, and the control group
will consist of similarly situated patients whose surgeries are
not managed based on information provided by the INVOS System.
The two groups will be compared across measures of patient
outcomes and hospital costs, including length of hospital stay.
The initial phase of this trial is being conducted at Duke
University Medical Center and the neighboring Veterans
Administration Hospital. In the initial phase, which began in
2006, the investigators will determine the number of patients to
study in each of the intervention and control groups so that the
results are expected to be statistically significant. If results
of this trial are positive, we intend to target more actively
the sale of the INVOS System for use in diabetic patients
undergoing major general surgeries, consistent with FDA
requirements. We expect to begin this marketing in 2008.
We are evaluating sponsoring other clinical trials which may
allow us to more actively target the sale of the INVOS System
for use in other patient populations.
The CorRestore System
We develop and market the CorRestore System for use in cardiac
repair and reconstruction, including heart surgeries called
surgical ventricular restoration, or SVR. During SVR, the
surgeon restores an enlarged, poorly functioning left ventricle
to more normal size and function by inserting an implant, in
most instances, or closing the defect directly. Before the
availability of the CorRestore System, SVR was generally
performed using a patch formed by the surgeon from medical grade
fabrics or bovine pericardium tissue. These hand-formed patches
take time for the surgeon to make, can be difficult to insert,
and can leak around the edges.
As a result of these problems, two heart surgeons and their
company developed and patented the CorRestore System with the
intent to make SVR easier for the surgeon, to standardize the
operation and to provide a better seal on the edges of the patch
to minimize leaking. The CorRestore System consists of
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a non-circular bovine pericardium, or cow heart-sac, tissue
patch with an integrated pericardial suture ring, as well as
accessories for aiding the implantation of the patch.
Our initial target market is SVR surgeries on Class III and
IV congestive heart failure patients with dilated ischemic
cardiomyopathy due to a previous myocardial infarction in the
anterior wall of the left ventricle. Dilated ischemic
cardiomyopathy is a damaged heart muscle caused by the
obstruction of the inflow of blood from the arteries and
resulting in an enlarged ventricle. Myocardial infarction is
death of an area of the middle muscle layer in the heart wall.
We promote SVR by sponsoring education programs teaching the
concepts of ventricular geometry, the benefits of SVR and the
operative technique of SVR with the CorRestore System to cardiac
surgeons and cardiologists.
In October 2004, the results of a multi-center,
1,198-patient study
evaluating the safety and effectiveness of the SVR surgical
technique, not using the CorRestore Patch, were reported. SVR
was performed on all patients. Surgeries performed concurrently
included coronary artery bypass grafting (95 percent),
mitral valve repair (22 percent) and mitral valve
replacement (one percent). Patients experienced a
statistically significant improvement in ejection fraction and
ventricular volume. Thirty-day mortality after SVR was
5.3 percent, and the overall five-year survival rate was
68.3 percent. In addition, the re-hospitalization rate in
this high-risk population was low, as 78 percent of the
patients were not readmitted to the hospital for congestive
heart failure during the five years after their SVR surgery.
Pre-operatively, 67 percent of the patients in the study
had severe New York Hospital Association functional
Class III and Class IV symptoms. For those patients
whose New York Hospital Association Class was reported at last
follow-up, 85 percent were functionally Class I or
Class II, with lower or no symptoms of congestive heart
failure than Class III or Class IV. Findings from the
study were published as Constantine L. Athanasuleas, M.D.
and Gerald D. Buckberg, M.D., et al., Surgical Ventricular
Restoration in the Treatment of Congestive Heart Failure Due to
Post-Infarction Ventricular Dilation, in the Journal of the
American College of Cardiology, Volume 44, No. 7
(2004).
The retail price of the CorRestore System is approximately
$4,000. Sales of CorRestore Systems represented two percent of
our fiscal 2005 net revenues. We expect that as sales of
our INVOS System increase, the CorRestore System will become an
even less significant component of our business. In November
2005, we wrote off the remaining CorRestore license acquisition
cost intangible asset and recorded an impairment expense of
$929,093. We wrote this off based on the cash flow impairment
analysis that was performed, the declining sales of CorRestore
products and the uncertainty regarding future prospective,
randomized clinical data.
In 2000, we entered into a license agreement with the inventors
of the CorRestore System and their company, CorRestore LLC,
granting us exclusive, worldwide, royalty-bearing licenses to
specified rights relating to the CorRestore System and related
products and accessories for SVR. Transfer and sublicensing of
our licenses are restricted by the license agreement.
In exchange for the licenses and consulting services, we agreed
to the following compensation for CorRestore LLC and its agent,
Joe B. Wolfe: (1) a royalty of 10 percent in the
aggregate of our net sales of products subject to the licenses,
for the term of the patent relating to the CorRestore System,
(2) five-year warrants to purchase an aggregate of 400,000
common shares at $3.00 per share, which were exercised in full
in 2004 and 2005, (3) five-year warrants to purchase an
aggregate of 2,100,000 common shares at $3.00 per share,
exercisable based on our cumulative net sales of the CorRestore
System products (we do not expect the sales requirements for
exercise of these warrants to be met before the November 2006
expiration date of these warrants), and (4) a consulting
fee of $25,000 a year to each of the two inventors until we sell
1,000 CorRestore Patches.
CorRestore LLC and the inventors may terminate the licenses
(1) if we materially breach specified covenants in the
license agreement, (2) if our common shares are delisted
from the Nasdaq Stock Market, and (3) in connection with
specified bankruptcy and insolvency events. CorRestore LLC and
the inventors may exclude specified countries from the
geographic scope of the license to the extent we did not begin
46
marketing the CorRestore System products or begin the process of
obtaining necessary regulatory approval to sell CorRestore
System products in that country by May 15, 2002. Countries
may be excluded from the license only if we fail to cure the
breach of this provision within 90 days after CorRestore
LLC notifies us of the breach. We have not received any such
notice.
We may terminate the licenses (1) in our sole discretion,
within 120 days after we sign a definitive agreement for
specified types of business combination transactions with
another entity, if we pay at total of $1,000,000 to CorRestore
LLC and the inventors, or (2) if CorRestore LLC or either
of the inventors materially breaches specified covenants in the
license agreement.
Marketing, Sales and Distribution
We market the INVOS System primarily to cardiac and vascular
surgeons, anesthesiologists and other medical professionals. We
believe that these specialists are the medical professionals
most aware of the risks of brain and other damage resulting from
oxygen imbalances.
We believe that favorable peer-reviewed publication is a key
element to the INVOS Systems success. Accordingly, we
support clinical research programs with third-party clinicians
and researchers intended to demonstrate the need for the
INVOS System and the clinical importance of the information
it provides with the specific objective of publishing the
results in peer-reviewed journals. The research includes studies
comparing patients managed based on information provided by the
INVOS System with similarly situated patients not managed
based on information provided by the INVOS System, based on
measures of patient outcomes and hospital costs, including
patient length of stay, length of time on the ventilator,
cognitive dysfunction and incidence of stroke.
We attend trade shows and medical conferences to promote the
INVOS System and to meet medical professionals with an interest
in performing research and reporting their results in
peer-reviewed medical journals and at major international
medical conferences. We also sponsor
peer-to-peer
educational opportunities, promote use of the INVOS System
in regional centers of influence that we believe will influence
its adoption by others, and participate in targeted public
relations opportunities.
We sell the INVOS System through a direct sales team in the
United States, the size of which has increased from
17 persons at the end of fiscal 2004 to 26 persons at
the end of fiscal 2005, and 10 independent sales
representative firms. We expect to increase significantly the
size of our U.S. direct sales team in fiscal 2006. We
believe the selling cycle for the INVOS System is typically
approximately six to nine months.
We also have a co-promotion relationship with Fresenius Medical
Care Cardiovascular Resources, Inc.s North American
Extracorporeal Alliance where Fresenius provides INVOS Systems
to its cardiovascular perfusion customers. Fresenius provides
extracorporeal therapies and provides contract perfusion
services, which are services to operate the heart-lung machine
in cardiac procedures. In exchange for profits on SomaSensor
sales, Fresenius assists us in placing our INVOS Systems in
hospitals for which it provides contract perfusion services and
facilitates the use of INVOS technology during cardiac surgery
by supplying hospitals with SomaSensors.
Outside the United States, we have distribution agreements with
independent distributors covering 56 countries for the
INVOS System. Our distributors for the INVOS System include Tyco
Healthcare, part of Tyco International Ltd., in Europe, the
Middle East, Africa and Canada, and Edwards Lifesciences Ltd.,
formerly Baxter Limited, in Japan. We are evaluating placing
direct salespersons and clinical specialists in Europe to
support Tyco Healthcare. We also have one international sales
consultant. For fiscal 2005, approximately 16 percent of
our net revenues were represented by international sales.
47
We offer a no capital cost sales program in the United States
whereby we ship the INVOS System monitor to the customer at
no charge. It has been our experience that hospitals in the
United States prefer to use this method to acquire
INVOS System monitors.
We did not have any backlog of firm orders as of
January 10, 2006 or as of January 10, 2005. We
generally do not have a backlog of firm orders because we
generally ship product upon receipt of a customer order.
For a description of sales to major customers, see Note 9
of Notes to Financial Statements included elsewhere in this
prospectus. Tyco Healthcare was our largest customer in fiscal
2005 and 2003, and Edwards Lifesciences was our largest customer
in fiscal 2004. We are dependent on our sales to Tyco Healthcare
and Edwards Lifesciences, and the loss of either of them as a
customer would have an adverse effect on our business, financial
condition and results of operations in the near-term, until such
time as they could be replaced as our distributor in the
respective market.
Our international sales were $3,303,692 for the fiscal year
ended November 30, 2005, $2,091,602 for the fiscal year
ended November 30, 2004 and $1,944,513 for the fiscal year
ended November 30, 2003 including approximately $2,202,000
in fiscal 2005, $944,000 in fiscal 2004 and $1,166,000 in fiscal
2003 to Tyco Healthcare, our distributor in Europe, the Middle
East, Africa and Canada, and approximately $707,000 in fiscal
2005, $970,000 in fiscal 2004 and $616,000 in fiscal 2003 to
Edwards Lifesciences Ltd., our distributor in Japan. See
Note 9 of Notes to Financial Statements. For a description
of the breakdown of sales between INVOS System monitors,
SomaSensors and CorRestore Systems, see Managements
Discussion and Analysis of Financial Condition and Results of
Operations Results of Operations.
We sell the CorRestore System through our 26 direct salespersons
and nine independent sales representative firms in the United
States. In September 2004, the European Economic Community
changed its regulations, limiting approval authority for animal
tissue implant products sold in Europe to some independent
registration agencies that do not include our registrar.
Research and Development
Our research and development activities are conducted internally
by a staff consisting of five employees. We are developing a
smaller SomaSensor for use with newborns, developing a
product-line extension of the INVOS System for monitoring
non-brain tissues and making other advances to the design and
performance features of the INVOS System, including the
SomaSensor. We are also working to interface our
INVOS System with multi-functional monitors provided by
other manufacturers. Our research, development and engineering
expenditures were $525,679 during fiscal 2005, $369,106 during
fiscal 2004, and $412,953 during fiscal 2003. We expect our
research and development expenditures to increase as we add
additional research and development staff in fiscal 2006.
Manufacturing
We assemble the INVOS System in our facilities in Troy,
Michigan, from components purchased from outside suppliers. We
assemble the INVOS System to control its quality and costs and
to permit us to make changes to the INVOS System faster than we
could if third parties assembled it. Although we believe that
most components are generally available from several potential
suppliers, we depend on one supplier for one of our components.
We are not aware of any validated alternative supplier for this
component, although we are currently in the process of
validating in accordance with FDA requirements a second source
of supply and are carrying approximately a six-month supply of
this component. Moreover, we typically use one supplier for
custom-designed components, including the unit enclosure, the
printed circuit boards, other mechanical components and the
SomaSensor. We are currently dependent on one manufacturer of
the SomaSensor and another component of the INVOS System, and we
believe that it would require approximately four to five months
to change SomaSensor suppliers. We do not currently intend to
manufacture on a commercial scale the disposable SomaSensor or
the components of the INVOS System.
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We received ISO 13485 certification and met the
requirements under the European Medical Device Directive to use
the CE Mark, thereby allowing us to continue to market our
INVOS System and SomaSensor in the European Economic
Community. Our most recent ISO 13485 compliance
surveillance audit occurred in August 2005.
Competition
We believe that the markets for cerebral and somatic oximetry
products may become highly competitive. In the United States, we
believe there is currently only one other company with FDA
clearance to sell a cerebral oximeter. In December 2005, CAS
Medical Systems, Inc. announced that it received 510(k)
clearance to market a cerebral oximeter for the adult market,
with plans to launch the product in late 2006. Outside the
United States, several Japanese manufacturers offer competitive
products for sale in that country and primarily for research in
other parts of the world, but, to our knowledge, as of yet, none
has pursued FDA clearance to market its product in the United
States. We are aware that several companies and individuals are
engaged in the research and development of non-invasive cerebral
oximeters, and we believe that there are several other potential
entrants into the market. Other companies have FDA clearance to
market somatic oximeters in the United States. Competition might
cause our sales cycle to lengthen to the extent that customers
take longer to make purchasing decisions. Competition might also
reduce our gross margins and market share and prevent us from
achieving further market penetration. Competitors might be more
successful than we are in obtaining FDA clearance with broader
claims in their labeling or more successful than we are in
manufacturing and marketing their products and may be able to
take advantage of the significant time and effort we have
invested to gain medical acceptance of cerebral oximetry.
We also compete with numerous medical equipment companies for
the portions of hospital budgets allocated to capital equipment
and for the limited amount of forehead space on patients to
place sensors for all types of monitoring. The medical products
industry is characterized by extensive research and development
and intense competition in an increasingly cost-conscious
environment. Some of these potential competitors have
well-established reputations, customer relationships and
marketing, distribution and service networks. Some of them have
substantially longer histories in the medical products industry,
larger product lines and greater financial, technical,
manufacturing, research and development and management resources
than we do. Many of these potential competitors have long-term
product supply relationships with our potential customers. These
potential competitors might be able to use their resources,
reputations and ability to leverage existing customer
relationships to give them a competitive advantage over us,
including in securing forehead sensor space for their products
and dollars from hospital capital equipment budgets to purchase
their products. They might also succeed in developing products
that are at least as reliable and effective as our products,
that make additional measurements, that are less costly than our
products or that provide alternatives to our products.
Competitors might be more successful than we are in
manufacturing and marketing their products and may be able to
take advantage of the significant time and effort we have
invested to gain medical acceptance of cerebral oximetry.
The CorRestore System competes against existing patches.
Although we believe the CorRestore System has important
advantages over hand-formed patches, hand-formed patches are
significantly less expensive. At least one study using medical
grade fabric patches indicates that they are effective. We also
compete against alternative methods of treating congestive heart
failure. SVR is in the early stages of its development and will
likely require significant clinical studies before it is widely
accepted. There are many larger companies in this industry that
have significantly larger research and development budgets than
ours. Competitors may be able to develop additional or better
treatments for congestive heart failure and may be able to take
advantage of the significant time and effort we have invested to
gain medical acceptance of SVR surgeries.
We believe that a manufacturers reputation for producing
accurate, reliable, effective, sterile, patented and technically
advanced products, clinical literature associated with leaders
in the field, references from users, features (speed, safety,
ease of use, patient and surgeon convenience and range of
49
applicability), product effectiveness and price are the
principal competitive factors in the medical products industry.
Proprietary Rights Information
We have 12 United States patents and three patents in
various foreign countries. These patents expire on various dates
from February 2006 to October 2019. We currently have two patent
applications pending in the United States, including one
reissuance application, and have patent applications in various
foreign countries with respect to aspects of our technology
relating to the interaction of light with tissue.
In September 2003, we were issued a new patent by the United
States Patent and Trademark Office covering the application of
non-invasive, near-infrared spectroscopy to measure continuously
and substantially concurrently a blood metabolite (such as
oxygen saturation) in at least two separate internal regions of
the brain. This patent is now the subject of a reissue
proceeding in the United States Patent and Trademark Office. We
requested the reissuance of this patent because we believe that
we are entitled to broader claims than those that were
originally issued. However, the outcome of the reissue
proceeding cannot be predicted, and the claims which ultimately
issue may be broader in scope than the original claims, they may
be narrower in scope than the original claims, or they may be
rejected. The corresponding Australian patent for
Multi-Channel, Noninvasive, Tissue Oximeter issued
in December 2003, will expire in October 2019. This patent is
pending in other markets outside the United States. We believe
the design concepts covered in this patent are important to
providing a clinically viable cerebral oximeter.
Our other patents cover methods and apparatuses for introducing
light into a body part and receiving, measuring and analyzing
the transmitted light and its interaction with tissue. These
methods also involve receiving, measuring and analyzing the
light transmissivity of various body parts of a single subject,
as well as of body parts of different subjects, which provides a
standard against which a single subject can be compared. Eleven
of the issued patents expressly refer to examination of the
brain or developments involving the INVOS System.
Many other patents have previously been issued to third parties
involving optical spectroscopy and the interaction of light with
tissue, some of which relate to the use of optical spectroscopy
in the area of brain metabolism monitoring, the primary use of
the INVOS System. We are not aware of any infringement by our
products of the claims of any issued patents, and no charge of
patent infringement has been asserted against us.
In addition to our patent rights, we have obtained United States
Trademark registrations for our trademarks
SOMANETICS, INVOS,
SOMASENSOR and WINDOW TO THE BRAIN. A
United States service mark application for Enlightening
Medicine, and a United States Trademark application for
Reflecting the Color of Life, are pending. We have
also obtained registrations of our basic mark,
SOMANETICS, in eleven foreign countries.
We also rely on trade secret, copyright and other laws and on
confidentiality agreements to protect our technology, but we
believe that neither our patents nor our other legal rights will
necessarily prevent third parties from developing or using a
similar or a related technology to compete against our products.
Moreover, our technology primarily represents improvements or
adaptations of known optical spectroscopy technology, which
might be duplicated or discovered through our patents, reverse
engineering or both.
The inventors of the CorRestore System and their company filed
for a patent with respect to their patch, which was issued in
the United States in February 2000 and expires in May 2018. The
claims allowed relate primarily to the product design of a soft
suture ring integrated with a patch. Subsequently five other
United States patents have been issued to the inventors, also
relating primarily to the product design of a soft suture ring
integrated with a patch. Two of those issued patents also expire
in May 2018 and the third one expires in July 2018. In addition,
other United States and foreign patent applications are pending.
We have also obtained United States Trademark registration for
the trademark CorRestore.
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Government Regulation
Our products are medical devices subject to extensive regulation
by the U.S. Food and Drug Administration, or FDA, under the
Federal Food, Drug, and Cosmetic Act, or FDCA. FDA regulations
govern, among other things, the following activities that we
will perform:
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product testing; |
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product labeling; |
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product storage; |
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premarket clearance or approval; |
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advertising and promotion; and |
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Medical devices to be commercially distributed in the
U.S. must receive either 510(k) clearance or PMA approval
prior to marketing from the FDA pursuant to the FDCA. Devices
deemed to pose relatively less risk are placed in either
class I or II, which requires the manufacturer to
submit a premarket notification requesting permission for
commercial distribution; this is known as 510(k) clearance. Some
low risk devices are exempted from this requirement. Devices
deemed by the FDA to pose the greatest risk, such as
life-sustaining, life-supporting or implantable devices, or
devices deemed not substantially equivalent to a previously
510(k) cleared device or a preamendment class III device
for which PMA applications have not been called, are placed in
class III requiring PMA approval.
510(k) Clearance Pathway. To obtain 510(k)
clearance, a manufacturer must submit a premarket notification
demonstrating that the proposed device is substantially
equivalent in intended use and in safety and effectiveness to a
previously 510(k) cleared device or a device that was in
commercial distribution before May 28, 1976 for which the
FDA has not yet called for submission of PMA applications. The
FDAs 510(k) clearance pathway usually takes from three to
six months, but it can last longer.
After a device receives 510(k) clearance, any modification 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 or could require a PMA approval. The FDA
requires each manufacturer to make this determination in the
first instance, but the FDA can review any such decision. If the
FDA disagrees with a manufacturers decision not to seek a
new 510(k) clearance, the agency may retroactively require the
manufacturer to seek 510(k) clearance or PMA approval. The FDA
also can require the manufacturer to cease marketing and/or
recall the modified device until 510(k) clearance or PMA
approval is obtained.
PMA Approval Pathway. A product not eligible for
510(k) clearance must follow the PMA approval pathway, which
requires proof of the safety and effectiveness of the device to
the FDAs satisfaction. The PMA approval pathway is much
more costly, lengthy and uncertain. It generally takes from one
to three years or even longer. A PMA application must provide
extensive preclinical and clinical trial data and also
information about the device and its components regarding, among
other things, device design, manufacturing and labeling. As part
of the PMA review, the FDA will typically inspect the
manufacturers facilities for compliance with Quality
System Regulation, or QSR, requirements, which impose elaborate
testing, control, documentation and other quality assurance
procedures. The PMA can include postapproval conditions that the
FDA believes necessary to ensure the safety and effectiveness of
the device including, among other things, restrictions on
labeling, promotion, sale and distribution. Failure to comply
with the conditions of approval can result in material adverse
enforcement action, including the loss or withdrawal of the
approval. Even after approval of a PMA, a new PMA or PMA
supplement is required in the event of a modification to the
device, its labeling or its manufacturing process. Supplements
to a PMA often require the submission of the same type of
information required for an original PMA, except that the
supplement is generally limited to that information needed to
support the proposed change from the product covered by the
original PMA.
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Clinical Trials. A clinical trial is almost always
required to support a PMA application and is sometimes required
for a premarket notification. All clinical studies of
investigational devices must be conducted in compliance with
FDAs requirements. If an investigational device could pose
a significant risk to patients (as defined in the regulations),
the FDA must approve an Investigational Device Exemption, or
IDE, application prior to initiation of investigational use. An
IDE application must be supported by appropriate data, such as
animal and laboratory test results, showing that it is safe to
test the device in humans and that the testing protocol is
scientifically sound. FDA typically grants IDE approval for a
specified number of patients to be treated at specified study
centers. A nonsignificant risk device does not require FDA
approval of an IDE. Both significant risk and nonsignificant
risk investigational devices require approval from institutional
review boards, or IRBs, at the study centers where the device
will be used.
During the study, the sponsor must comply with the FDAs
IDE requirements for investigator selection, trial monitoring,
reporting, and record keeping. The investigators must obtain
patient informed consent, rigorously follow the investigational
plan and study protocol, control the disposition of
investigational devices, and comply with all reporting and
record keeping requirements. The IDE requirements apply to all
investigational devices, whether considered significant or
nonsignificant risk. Prior to granting PMA approval, the FDA
typically inspects the records relating to the conduct of the
study and the clinical data supporting the PMA application for
compliance with IDE requirements.
Postmarket. After a device is placed on the
market, numerous regulatory requirements apply. These include:
the QSR, labeling regulations, the FDAs general
prohibition against promoting products for unapproved or
off-label uses, the Medical Device Reporting
regulation (which requires that manufacturers report to the FDA
if their device may have caused or contributed to a death or
serious injury or malfunctioned in a way that would likely cause
or contribute to a death or serious injury if it were to recur),
and the Reports of Corrections and Removals regulation (which
requires manufacturers to report recalls and field actions to
the FDA if initiated to reduce a risk to health posed by the
device or to remedy a violation of the FDCA).
FDA enforces these requirements by inspection and market
surveillance. If the FDA finds a violation, it can institute a
wide variety of enforcement actions, ranging from a public
warning letter to more severe sanctions such as:
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In October 1997, we obtained FDA clearance for an earlier
generation INVOS System incorporating advances in our INVOS
technology. In September 2000, we received 510(k) clearance from
the FDA to market the model 5100 INVOS System in the United
States. Unlike earlier models, the model 5100 INVOS System has
the added capability of being able to monitor pediatric
patients. In November 2005, we received 510(k) clearance from
the FDA to market our INVOS System to monitor changes in somatic
tissue blood oxygen saturation in regions of the body other than
the brain in patients with or at risk for restricted blood flow.
In November 2001, we received clearance from the FDA to market
the CorRestore Patch in the United States. Our most recent FDA
QSR inspection occurred in June 2004.
If any of our current or future FDA clearances or approvals are
rescinded or denied, sales of our applicable products in the
United States would be prohibited during the period we do not
have such clearances or approvals. In such cases we would
consider shipping the product internationally and/or assembling
it overseas if permissible and if we determine such product to
be ready for commercial
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shipment. The FDAs current policy is that a medical device
that is not in commercial distribution in the United States, but
which needs 510(k) clearance to be commercially distributed in
the United States, can be exported without submitting an export
request and prior FDA clearance under certain conditions.
Congress has enacted the Medical Device User Fee Modernization
Act of 2002. Among other things, this law has provisions which
permit the assessment of user fees for product approvals and
clearances. Given the recent enactment of this law, the effect
of the law as it relates to us and our products is still
unknown, other than that we will have to pay the FDA to review
our 510(k) submissions. We do not currently have any 510(k)
submissions pending.
We are also subject to numerous federal, state and local laws
relating to such matters as safe working conditions,
manufacturing practices, environmental protection, fire hazard
control and disposal of hazardous or potentially hazardous
substances.
Seasonality
Our business is seasonal. Our fourth quarter has typically been
our strongest quarter due to a larger number of patients
undergoing procedures using the INVOS System, including
SomaSensors, and higher INVOS System monitor revenues associated
with hospital budgeting cycles.
Facilities
Our headquarters, manufacturing facility and warehouse space are
located in a single building in Troy, Michigan. We lease
approximately 23,000 square feet, including approximately
12,000 square feet of office space for sales and marketing,
engineering, accounting and other administrative activities. Our
lease expires on December 31, 2009. The minimum monthly
lease payment will be approximately $11,700 for fiscal 2006,
$11,900 for fiscal 2007, $12,200 for fiscal 2008 and $12,400 for
fiscal 2009, excluding other occupancy costs. We believe that
this facility is suitable and adequate for our needs now and for
the foreseeable future and will allow for substantial expansion
of our business and number of employees.
Employees
As of January 23, 2006, we had 49 full-time employees,
including 29 in sales and marketing, five in research and
development, six in general and administration and nine in
manufacturing, quality and service. We also employed two
part-time individuals in general and administration. In
addition, we use three contract manufacturing employees, and we
use one consultant. We believe that our future success is
dependent, in large part, on our ability to attract and retain
highly qualified managerial, sales, marketing and technical
personnel. We expect to add additional sales and marketing and
research and development employees in fiscal 2006. Our employees
are not represented by a union or subject to a collective
bargaining agreement. We believe that our relations with our
employees are good.
Insurance
Because the INVOS System and the CorRestore System are intended
to be used in hospital critical care units with patients who may
be seriously ill or may be undergoing dangerous procedures, we
might be exposed to serious potential product liability claims.
We have obtained product liability insurance with a liability
limit of $5,000,000. We also maintain coverage for property
damage or loss, general liability, business interruption,
travel-accident, directors and officers liability
and workers compensation. We do not maintain key-man life
insurance.
Litigation
We are not a party to any pending legal proceedings.
53
MANAGEMENT
Directors and Executive Officers
Our executive officers and directors are as follows:
|
|
|
|
|
|
|
Name |
|
Age |
|
Position |
|
|
|
|
|
Bruce J. Barrett
|
|
|
46 |
|
|
President, Chief Executive Officer and a Director |
William M. Iacona
|
|
|
35 |
|
|
Vice President and Chief Financial Officer, Controller and
Treasurer |
Richard S. Scheuing
|
|
|
50 |
|
|
Vice President, Research and Development |
Dominic J. Spadafore
|
|
|
46 |
|
|
Vice President, Sales and Marketing |
Mary Ann Victor
|
|
|
48 |
|
|
Vice President and Chief Administrative Officer and Secretary |
Ronald A. Widman
|
|
|
55 |
|
|
Vice President, Medical Affairs |
Pamela A. Winters
|
|
|
47 |
|
|
Vice President, Operations |
Dr. James I. Ausman(1)(2)(3)
|
|
|
68 |
|
|
Director |
Daniel S. Follis(1)(2)(3)
|
|
|
68 |
|
|
Director |
Robert R. Henry(1)(2)(3)
|
|
|
65 |
|
|
Director |
|
|
(1) |
Member of the Compensation Committee. |
|
(2) |
Member of the Audit Committee. |
|
(3) |
Member of the Nominating Committee. |
Bruce J. Barrett. Mr. Barrett has served as
our President and Chief Executive Officer and as one of our
directors since June 1994. Earlier in his career,
Mr. Barrett served as the Director, Hospital Products
Division, for Abbott Laboratories, Ltd., a health care equipment
manufacturer and distributor, and as the Director, Sales and
Marketing, for Abbott Critical Care Systems, a division of
Abbott Laboratories, Inc., a health care equipment manufacturer
and distributor. While at Abbott Critical Care Systems,
Mr. Barrett managed Abbotts invasive oximetry
products for approximately four years. Prior to joining Abbott
Laboratories, he served as the group product manager of
hemodynamic monitoring products of Baxter Edwards Critical Care,
an affiliate of Baxter International, Inc., another health care
equipment manufacturer and distributor. Mr. Barrett
received a B.S. degree in marketing from Indiana State
University and an M.B.A. degree from Arizona State
University. Mr. Barrett is a party to an employment
agreement with us that requires us to elect him to the offices
he currently holds.
William M. Iacona. Mr. Iacona has served as
our Vice President and Chief Financial Officer since January
2006, as our Treasurer since February 2000 and as our Controller
since April 1997. From December 2000 until January 2006, he
served as our Vice President, Finance. Before joining us, he was
in the Finance Department of Ameritech Advertising Services, a
telephone directory company and a division of Ameritech
Corporation (now SBC Communications), and was on the audit staff
of Deloitte & Touche LLP, independent auditors. He is a
certified public accountant and received a B.S. degree in
accounting from the University of Detroit.
Richard S. Scheuing. Mr. Scheuing has served
as our Vice President, Research and Development, since January
1998 and prior to that was our Director of Research and
Development and Director of Mechanical Engineering. He is an
inventor on five of our issued patents. Before joining us, he
was Director of Mechanical Engineering for Irwin Magnetic
Systems, Inc. and was a Development Engineer with the Sarns
division of Minnesota Mining and Manufacturing Company,
or 3M. He received a B.S. degree in mechanical
engineering from the University of Michigan.
Dominic J. Spadafore. Mr. Spadafore has
served as our Vice President, Sales and Marketing, since August
2002. Mr. Spadafore previously served, from July 2000 until
July 2002, as National Sales and
54
Clinical Director of the Cardiac Assist Division of Datascope
Corporation, a medical device company that manufactures and
markets healthcare products including medical devices used in
high-risk cardiac patients. In this position, Mr. Spadafore
supervised approximately 50 sales and clinical personnel and
approximately $80 million in domestic revenues. From July
1997 until July 2000, he served as Western Area Manager of the
Patient Monitoring Division of Datascope Corporation, and prior
to that he held field sales representative and regional manager
positions with progressive responsibilities with Datascope
Corporation. Earlier in his career Mr. Spadafore was a
sales representative with the Upjohn Company, a pharmaceutical
manufacturer, and a sales representative with White and White
Incorporated, a medical supply distributor. He received a BA
degree in pre-medicine from Oakland University.
Mr. Spadafore is a party to an employment agreement with us
that requires us to elect him to the office he currently holds.
Mary Ann Victor. Ms. Victor has served as our
Vice President and Chief Administrative Officer since
January 2006 and as our Secretary since January 1998. From
January 1998 until January 2006, she served as our
Vice President, Communications and Administration. Prior to that
she was our Director, Communications and Administration. Her
prior experience includes various investor relations and public
relations positions with publicly-held companies. She also is an
attorney and practiced with the law firm Varnum Riddering
Schmidt & Howlett. Ms. Victor received a B.S. in
political science from the University of Michigan and a J.D.
from the University of Detroit.
Ronald A. Widman. Mr. Widman has served as
our Vice President, Medical Affairs, since January 1998 and
prior to that was our Director of Medical Affairs and Marketing
Manager. Prior to joining us in 1991, he was employed by Mennen
Medical, Inc., a manufacturer and marketer of medical monitoring
and diagnostic devices, where he held various positions in
domestic and international medical product marketing. He is the
author of several papers and articles related to medical care
and monitoring devices.
Pamela A. Winters. Ms. Winters has served as
our Vice President, Operations, since January 1998 and since
joining Somanetics in 1991 has served as Director of Operations
and Manager of Quality Assurance. Ms. Winters received a
B.S. degree in management from the University of Phoenix.
James I. Ausman, M.D., Ph.D.
Dr. Ausman has served as one of our directors since June
1994. Since July 2002, he has served as a consultant for
Navigant Consulting, Inc. (formerly The Tiber Group), a
healthcare strategic planning and market research company. He
has been Professor of the Department of Neurosurgery at the
University of Illinois at Chicago since 1991 and served as its
head from 1991 until September 2001. From September 1978 until
August 1991, he was Chairman of the Department of Neurosurgery
at Henry Ford Hospital in Detroit. From December 1987 until July
1991, he served as Director of the Henry Ford Neurosurgical
Institute, also at Henry Ford Hospital. In addition, he was
Clinical Professor of Surgery, Section of Neurosurgery at the
University of Michigan in Ann Arbor from 1980 until 1991.
Dr. Ausman received a B.S. degree in chemistry and
biology from Tufts University, a Doctorate of Medicine from
Johns Hopkins University School of Medicine, a Masters of Arts
in Physiology from the State University of New York at Buffalo,
and a Ph.D. in Pharmacology from George Washington University.
He has also received graduate training in neurosurgery at the
University of Minnesota and has obtained board certification
from the American Board of Neurological Surgery. He is now a
Clinical Professor of Neurosurgery at the University of
California at Los Angeles and, since 1994, has been the editor
of Surgical Neurology. He serves as the medical expert for
KMIR 6 TV in Palm Desert, California.
Daniel S. Follis. Mr. Follis has served as
one of our directors since April 1989. Since 1981, he has served
as President of Verschuren & Follis, Inc., which
advises and administers The Infinity Fund, a limited partnership
that invests in emerging growth companies. Since 1995 he has
also served as President of Follis Corporation, a sales and
marketing company engaged in media sales, television production,
serving as a manufacturers representative and investment
management. Mr. Follis received a B.A. degree in business
from Michigan State University.
Robert R. Henry. Mr. Henry has served as one
of our directors since December 1998. He has been President of
Robert R. Henry & Co., Inc., a financial consulting and
investment firm, since 1989. Mr. Henry has been an advisory
director of Morgan Stanley & Co. Incorporated since
1989, and from
55
1977 to 1989 was a managing director of Morgan Stanley. He
received an M.B.A. from Harvard Business School and a B.A. from
Williams College.
Our officers serve at the discretion of the board of directors.
Our directors serve staggered three-year terms. Our directors
will hold office until the Annual Meeting of Shareholders to be
held in 2006 for Messrs. Follis and Henry, the Annual
Meeting of Shareholders to be held in 2007 for Mr. Barrett,
and the Annual Meeting of Shareholders to be held in 2008 for
Dr. Ausman, and until their successors are elected and
qualified, or until their earlier death, resignation or removal.
Directors may be removed only for cause by a vote of the holders
of a majority of the shares entitled to vote at an election of
directors.
Board of Directors and Committees of the Board of
Directors
Our board of directors consists of Dr. Ausman,
Mr. Follis, Mr. Henry and Mr. Barrett. Our board
of directors has determined that Dr. Ausman,
Mr. Follis and Mr. Henry are independent as defined in
the listing standards of The Nasdaq Stock Market, Inc.
Marketplace Rules, as those standards have been modified or
supplemented.
Our board of directors has established a separately-designated,
standing Audit Committee that consists of three directors and is
established for the purpose of overseeing our accounting and
financial reporting processes and audits of our financial
statements. Mr. Henry (Chairman), Dr. Ausman and
Mr. Follis are the current members of this committee. Each
of the members of our Audit Committee is independent as
independence for audit committee members is defined in the
listing standards of The Nasdaq Stock Market, Inc. Marketplace
Rules, as those standards have been modified or supplemented,
and SEC rules and regulations. The Audit Committee:
|
|
|
|
|
is directly responsible for the appointment, compensation,
retention and oversight of the work of any registered public
accounting firm engaged for the purpose of preparing or issuing
an audit report or performing other audit, review or attest
services for us, including responsibility for the resolution of
disagreements between management and the auditor regarding
financial reporting; each such registered public accounting firm
must report directly to the Audit Committee; |
|
|
|
ensures that before the independent accountant is engaged by us
to render audit or non-audit services, the engagement is
approved by the Audit Committee or the engagement to render the
service is entered into pursuant to pre-approval policies and
procedures established by the Audit Committee; this pre-approval
authority may be delegated to one or more members of the Audit
Committee; |
|
|
|
takes, or recommends that the full board takes, appropriate
action to oversee the independence of our independent
accountants; |
|
|
|
oversees our independent accountants relationship by
discussing with our independent accountants the nature, scope
and rigor of the audit process, receiving and reviewing audit
and other reports from the independent accountants and providing
our independent accountants with full access to the committee
and the board to report on any and all appropriate matters; |
|
|
|
reviews and discusses the audited financial statements and the
matters required to be discussed by SAS 61 with management
and the independent accountants, including discussions
concerning the independent accountants judgments about the
quality of our accounting principles, applications and practices
as applied in our financial reporting; |
|
|
|
recommends to the board whether the audited financial statements
should be included in our Annual Report on
Form 10-K;
|
56
|
|
|
|
|
reviews with management and the independent accountants the
quarterly financial information before we file our
Form 10-Qs; this
review is performed by the committee or its chairperson; |
|
|
|
discusses with management and the independent accountants the
quality and adequacy of our internal controls; |
|
|
|
establishes procedures for (1) the receipt, retention, and
treatment of complaints received by us regarding accounting,
internal accounting controls, or auditing matters, and
(2) confidential, anonymous submission by our employees of
concerns regarding questionable accounting or auditing matters; |
|
|
|
reviews related party transactions required to be disclosed in
our proxy statement for potential conflict of interest
situations and approves all such transactions; |
|
|
|
discusses with management the status of pending litigation as it
pertains to the financial statements and disclosure and other
areas of oversight as the committee deems appropriate; and |
|
|
|
reports committee activities to the full board. |
Our board of directors has determined that Mr. Henry is an
Audit Committee financial expert, as defined by the Securities
and Exchange Commission, serving on our Audit Committee.
Mr. Henrys experience that qualifies him as our Audit
Committee financial expert includes investment banking
experience serving as managing director of Morgan Stanley from
1977 to 1989, corporate securities underwriting experience with
Morgan Stanley from 1965 to 1977 and an M.B.A. from Harvard
Business School in 1964.
Our board of directors has a standing Compensation Committee
which consists of three independent directors. Mr. Follis
(Chairman), Dr. Ausman and Mr. Henry are the current
members of this committee. The Compensation Committee makes
recommendations to the board of directors with respect to
compensation arrangements and plans for senior management,
officers and directors of the Company and administers the
Companys 1991 Incentive Stock Option Plan and 1997 Stock
Option Plan, and 2005 Stock Incentive Plan.
Our board of directors has a standing Nominating Committee which
consists of three directors. Dr. Ausman (Chairman),
Mr. Henry and Mr. Follis are the current members of
this committee. Each of the members of our Nominating Committee
is independent as independence is defined in the listing
standards of The Nasdaq Stock Market, Inc. Marketplace Rules, as
those standards have been modified or supplemented. The
Nominating Committee identifies individuals to become board
members and selects, or recommends for the boards
selection, director nominees to be presented for shareholder
approval at the annual meeting of shareholders or to fill
any vacancies.
Compensation Committee Interlocks and Insider
Participation
During the fiscal year ended November 30, 2005,
Dr. Ausman, Mr. Follis (Chairman) and Mr. Henry
served as the members of our Compensation Committee. None of the
members of our Compensation Committee was, during the fiscal
year ended November 30, 2005, one of our officers or
employees, or one of our former officers. None of the committee
members had any relationship with us requiring disclosure by us
pursuant to Securities and Exchange Commission rules regarding
disclosure of related-party transactions.
Compensation of Directors
We refer to our directors who are not our officers or employees
as Outside Directors. Effective June 1, 2005, each Outside
Director receives a fee of $1,000 a month and reimbursement of
reasonable
57
expenses of attending board and board committee meetings. In
addition, the board of directors may grant options to Outside
Directors on a case by case basis. On May 4, 2005, we
granted a total of 30,000 non-qualified stock options to our
Outside Directors under the 2005 Stock Incentive Plan. The
options are 10-year
options, exercisable at $14.92 a share, the average of the high
and low sales prices of the common shares on May 4, 2005.
The options vested on November 30, 2005 and continue to be
exercisable after termination of the directors service
unless the director is terminated for cause. Until May 4,
2005, our Outside Directors received $1,000 for each board
meeting attended in person, $250 for each telephonic board
meeting attended and $250 for each board committee meeting
attended on a date other than the date of a board meeting. The
board had also determined to grant Outside Directors who
continued to serve as our directors after each annual meeting of
shareholders, 10-year
options to purchase 3,500 common shares each year on the
date of the annual meeting of shareholders, although such
options were not granted in fiscal 2005. We also reimbursed
Outside Directors for their reasonable expenses of attending
board and board committee meetings.
Executive Compensation
|
|
|
Summary Compensation Table |
The following table sets forth information for each of the
fiscal years ended November 30, 2005, 2004 and 2003
concerning compensation of (1) all individuals serving as
our Chief Executive Officer during the fiscal year ended
November 30, 2005, and (2) our four most
highly-compensated other executive officers in fiscal 2005 who
were serving as executive officers as of November 30, 2005
and whose total annual salary and bonus exceeded $100,000:
Summary Compensation Table
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-Term | |
|
|
|
|
|
|
|
|
|
|
Compensation | |
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
|
|
Awards | |
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
Annual Compensation | |
|
Securities | |
|
All Other | |
|
|
|
|
| |
|
Underlying | |
|
Compensation | |
Name and Principal Position |
|
Year | |
|
Salary($) | |
|
Bonus($) | |
|
Options(#) | |
|
($)(1) | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
Bruce J. Barrett
|
|
|
2005 |
|
|
|
250,377 |
|
|
|
302,999 |
|
|
|
31,919 |
|
|
|
11,574 |
|
|
President and Chief Executive Officer
|
|
|
2004 |
|
|
|
238,415 |
|
|
|
184,653 |
|
|
|
|
|
|
|
11,374 |
|
|
|
|
|
2003 |
|
|
|
225,500 |
|
|
|
103,253 |
|
|
|
132,000 |
|
|
|
3,174 |
|
|
Richard S. Scheuing
|
|
|
2005 |
|
|
|
119,853 |
|
|
|
76,030 |
|
|
|
12,220 |
|
|
|
7,855 |
|
|
Vice President, Research and
|
|
|
2004 |
|
|
|
114,811 |
|
|
|
49,162 |
|
|
|
|
|
|
|
6,574 |
|
|
Development
|
|
|
2003 |
|
|
|
111,100 |
|
|
|
19,002 |
|
|
|
56,000 |
|
|
|
|
|
|
Dominic J. Spadafore
|
|
|
2005 |
|
|
|
136,097 |
|
|
|
190,376 |
|
|
|
11,680 |
|
|
|
11,015 |
|
|
Vice President, Sales and Marketing
|
|
|
2004 |
|
|
|
133,486 |
|
|
|
100,570 |
|
|
|
|
|
|
|
9,778 |
|
|
|
|
|
2003 |
|
|
|
130,866 |
|
|
|
64,553 |
|
|
|
36,000 |
|
|
|
1,578 |
|
|
Mary Ann Victor
|
|
|
2005 |
|
|
|
117,699 |
|
|
|
93,360 |
|
|
|
12,861 |
|
|
|
9,297 |
|
|
Vice President and Chief
|
|
|
2004 |
|
|
|
111,384 |
|
|
|
57,861 |
|
|
|
|
|
|
|
7,689 |
|
|
Administrative Officer and Secretary
|
|
|
2003 |
|
|
|
106,400 |
|
|
|
29,005 |
|
|
|
56,000 |
|
|
|
897 |
|
|
Pamela A. Winters
|
|
|
2005 |
|
|
|
119,853 |
|
|
|
76,030 |
|
|
|
12,220 |
|
|
|
8,890 |
|
|
Vice President, Operations
|
|
|
2004 |
|
|
|
114,811 |
|
|
|
49,461 |
|
|
|
|
|
|
|
7,621 |
|
|
|
|
2003 |
|
|
|
111,100 |
|
|
|
26,562 |
|
|
|
50,000 |
|
|
|
948 |
|
|
|
(1) |
Amounts for 2005 include (a) the following matching
contributions paid by us into our 401(k) plan on behalf of the
following persons: $8,400 for Mr. Barrett, $7,855 for
Mr. Scheuing, $8,400 for Mr. Spadafore, $8,400 for
Ms. Victor and $7,855 for Ms. Winters, and
(b) the following premiums paid for additional disability
insurance for the following persons: $3,174 for
Mr. Barrett, $2,615 for Mr. Spadafore, $897 for
Ms. Victor and $1,035 for Ms. Winters. |
58
The following table sets forth information concerning individual
grants of stock options made during the fiscal year ended
November 30, 2005 to each of our executive officers named
in the Summary Compensation Table above. Amounts in the
following table represent potential realizable gains that could
be achieved for the options if exercised at the end of the
option term. The five percent and ten percent assumed annual
rates of compounded stock price appreciation are calculated
based on the requirements of the Securities and Exchange
Commission and do not represent an estimate or projection of our
future stock prices. These amounts represent certain assumed
rates of appreciation in the value of our common shares from the
fair market value on the date of grant. Actual gains, if any, on
stock option exercises depend on the future performance of the
common shares and overall stock market conditions. The amounts
reflected in the following table may not necessarily be achieved.
Option Grants In Last Fiscal Year
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Individual Grants | |
|
Potential Realizable | |
|
|
| |
|
Value at Assumed | |
|
|
Number of | |
|
% of Total | |
|
|
|
Annual Rates of | |
|
|
Securities | |
|
Options | |
|
|
|
Stock Price Appreciation | |
|
|
Underlying | |
|
Granted to | |
|
Exercise | |
|
|
|
for Option Term | |
|
|
Options | |
|
Employees in | |
|
Price | |
|
Expiration | |
|
| |
Name |
|
Granted (#)(1) | |
|
Fiscal Year | |
|
($/Sh) | |
|
Date | |
|
5%($) | |
|
10%($) | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
Bruce J. Barrett
|
|
|
31,919 |
|
|
|
24.2 |
|
|
|
13.55 |
|
|
|
4/21/15 |
|
|
|
271,998 |
|
|
|
689,298 |
|
Richard S. Scheuing
|
|
|
12,220 |
|
|
|
9.2 |
|
|
|
13.55 |
|
|
|
4/21/15 |
|
|
|
104,133 |
|
|
|
263,893 |
|
Dominic J. Spadafore
|
|
|
11,680 |
|
|
|
8.8 |
|
|
|
13.55 |
|
|
|
4/21/15 |
|
|
|
99,531 |
|
|
|
252,232 |
|
Mary Ann Victor
|
|
|
12,861 |
|
|
|
9.7 |
|
|
|
13.55 |
|
|
|
4/21/15 |
|
|
|
109,595 |
|
|
|
277,736 |
|
Pamela A. Winters
|
|
|
12,220 |
|
|
|
9.2 |
|
|
|
13.55 |
|
|
|
4/21/15 |
|
|
|
104,133 |
|
|
|
263,893 |
|
|
|
(1) |
The options listed in the table were non-qualified stock options
granted to Messrs. Barrett, Scheuing and Spadafore,
Ms. Victor and Ms. Winters in fiscal 2005 under our
2005 Stock Incentive Plan or 1997 Stock Option Plan, exercisable
at the then current fair market value of the underlying common
shares. Each of these options is exercisable in full beginning
November 30, 2005. Each option also becomes
100 percent exercisable 10 days before or immediately
upon specified changes in control. The portion of these options
that is exercisable at the date of termination of employment
remains exercisable until the expiration date of the option,
unless termination is for cause. |
If, upon exercise of any of the options described above, we must
pay any amount for income tax withholding, in the Compensation
Committees or the board of directors sole
discretion, either the optionee will pay such amount to us or we
will appropriately reduce the number of common shares we deliver
to the optionee to reimburse us for such payment. The
Compensation Committee or the board may also permit the optionee
to choose to have these shares withheld or to tender common
shares the optionee already owns. The Compensation Committee or
the board may also make such other arrangements with respect to
income tax withholding as it shall determine.
59
|
|
|
Aggregated Option Exercises and Fiscal Year-End Option
Value Table |
The following table sets forth information concerning each
exercise of stock options during the fiscal year ended
November 30, 2005 by each of the executive officers named
in the Summary Compensation Table above and the value of
unexercised options held by them as of November 30, 2005:
Aggregated Option Exercises in Last Fiscal Year and FY-End
Option Values
|
|
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|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of Securities | |
|
Value of Unexercised | |
|
|
|
|
|
|
Underlying Unexercised | |
|
In-the-Money Options | |
|
|
Shares | |
|
|
|
Options at FY-End (#) | |
|
at FY-End ($) | |
|
|
Acquired on | |
|
Value | |
|
| |
|
| |
Name |
|
Exercise (#) | |
|
Realized ($)(1) | |
|
Exercisable | |
|
Unexercisable | |
|
Exercisable | |
|
Unexercisable | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
Bruce J. Barrett
|
|
|
178,200 |
|
|
|
3,198,532 |
|
|
|
761,919 |
|
|
|
|
|
|
|
20,488,234 |
|
|
|
|
|
Richard S. Scheuing
|
|
|
50,000 |
|
|
|
875,000 |
|
|
|
138,220 |
|
|
|
|
|
|
|
3,709,399 |
|
|
|
|
|
Dominic J. Spadafore
|
|
|
30,000 |
|
|
|
723,100 |
|
|
|
117,680 |
|
|
|
|
|
|
|
3,178,185 |
|
|
|
|
|
Mary Ann Victor
|
|
|
51,000 |
|
|
|
977,300 |
|
|
|
153,261 |
|
|
|
|
|
|
|
4,083,211 |
|
|
|
|
|
Pamela A. Winters
|
|
|
75,750 |
|
|
|
1,620,713 |
|
|
|
163,220 |
|
|
|
|
|
|
|
4,257,089 |
|
|
|
|
|
|
|
(1) |
Value Realized represents the fair value of the
underlying securities on the exercise date, based on the average
of the high and low sales prices on the date of exercise, minus
the aggregate exercise price of the options. |
|
|
|
Employment Contracts and Termination of Employment and
Change-in-Control
Arrangements |
Bruce J. Barrett. Pursuant to an employment
agreement entered into in May 1994, we employ Bruce J. Barrett
as our President and Chief Executive Officer, or in such other
position as the board of directors determines. His employment
under the agreement expires on April 30, 2006.
Mr. Barretts annual salary is currently $258,544,
which may be increased by the board of directors.
Mr. Barrett is also entitled to participate in any bonus
plan established by the Compensation Committee of the board of
directors. Mr. Barrett is entitled to various fringe
benefits under the agreement, including 12 months of
compensation and six months of benefits if his employment under
the agreement is terminated without cause or if the agreement
expires without being renewed. Mr. Barrett has agreed not
to compete with us during specified periods following the
termination of his employment.
Dominic J. Spadafore. Pursuant to an employment
agreement entered into in August 2002, we employ Dominic J.
Spadafore as our Vice President, Sales and Marketing, or in such
other position as the board of directors determines. His
employment under the agreement expires upon his death,
termination by us upon his disability or with or without cause
or termination by Mr. Spadafore. Mr. Spadafores
annual salary is currently $142,015, which may be increased by
the board of directors. Mr. Spadafore is also entitled to
participate in commission incentive plans. Mr. Spadafore is
entitled to various fringe benefits under the agreement.
As of June 13, 2005, we entered into an amended and
restated employment agreement with Dominic J. Spadafore. The
amendment and restatement primarily replaces provisions in his
employment agreement to match those in the new Change in
Control, Invention, Confidentiality, Non-Compete and
Non-Solicitation Agreements entered into with five other
executive officers and described below. The agreement now
provides for severance benefits equal to one years salary
upon termination of employment without cause or for good reason
90 days before to one year after a change of control of the
Company that occurs by June 13, 2008. Mr. Spadafore
has agreed not to compete with us and not to solicit our
employees during specified periods following the termination of
his employment, and he has agreed to various confidentiality
obligations.
Change in Control, Invention, Confidentiality, Non-Compete
and Non-Solicitation Agreements. In June 2005, we
entered into Change in Control, Invention, Confidentiality,
Non-Compete and Non-Solicitation Agreements with five of our
executive officers: William M. Iacona, Richard S. Scheuing, Mary
Ann Victor, Ronald A. Widman and Pamela A. Winters. These
agreements provide for severance
60
benefits equal to one years salary upon termination of
employment without cause or for good reason 90 days before
to one year after a change of control of the Company that occurs
by June 13, 2008, June 29, 2008 for Mr. Scheuing.
The officers have agreed not to compete with us and not to
solicit our employees during specified periods following the
termination of employment, and they have agreed to various
confidentiality obligations.
Stock Option Terms. All options granted under our
stock option plans that are not already 100 percent
exercisable immediately, including options granted to
Messrs. Barrett, Scheuing and Spadafore, Ms. Victor
and Ms. Winters, become 100 percent exercisable
immediately ten days before or upon specified changes in control
of the Company. On November 30, 2005, our board of
directors accelerated all outstanding options that had not
already vested.
Stock Option Plans
We have adopted the Somanetics Corporation 2005 Stock Incentive
Plan. The plan allows us to grant stock options, including both
incentive stock options and nonqualified stock options,
restricted stock and restricted stock units to our officers,
other employees, non-employee directors, consultants, advisors,
independent contractors and agents to purchase up to an
aggregate of 600,000 common shares. Options to
purchase 99,716 common shares are outstanding under the
plan, no options granted under the plan have been exercised and
500,284 common shares remain available for grants and awards
under the plan. See Executive Compensation
Option Grants Table. Under the plan, stock options to
purchase no more than 300,000 common shares may be granted to
any one participant in any calendar year. The plan also contains
provisions to ensure that incentive stock options qualify under
the Internal Revenue Code. Options granted under the plan expire
within 10 years of the date of grant. The plan is
administered by our board of directors or by the Compensation
Committee of our board of directors, which determines the terms
and conditions of grants and awards under the plan, including
the exercise prices and vesting periods of options granted under
the plan.
We have also adopted the Somanetics Corporation 1997 Stock
Option Plan. The plan allows us to grant stock options,
including both incentive stock options and nonqualified stock
options, to our key employees (including officers), directors,
consultants and advisors. Options to purchase 1,726,253
common shares are outstanding under the plan and 5,501 common
shares remain available for grants and awards under the plan.
See Executive Compensation Stock Option
Grants. Under the plan, stock options to purchase no more
than 300,000 common shares may be granted to any one participant
in any calendar year. The plan also contains provisions to
ensure that incentive stock options qualify under the Internal
Revenue Code. Options granted under the plan expire within
10 years of the date of grant. The plan is administered by
our board of directors or by the Compensation Committee of our
board of directors, which determines the terms and conditions of
grants under the plan, including the exercise prices and vesting
periods of options granted under the plan.
We have also granted options under our 1991 Incentive Stock
Option Plan, which terminated in 2001, except for the options
granted before that date, our 1993 Director Stock Option
Plan, which terminated in 1998, except for the options granted
before that date, and independent of our stock option plans.
Options to purchase 88,263 shares are outstanding
under these plans or independent of our stock option plans.
61
401(k) Plan
In December 1991, we amended and restated our profit sharing
plan to include a 401(k) plan covering substantially all
employees. Under provisions of the plan, participants may
contribute, annually, between one percent and 25 percent of
their compensation. In November 2004, our board of directors
approved a discretionary contribution to the 401(k) Plan, as
soon as practicable after December 31, 2004, equal to $2
for every $1 contributed by our employees to the 401(k) Plan
during calendar 2004, up to our contribution of 4 percent
of the employees compensation, and also approved matching
contributions to the 401(k) Plan equal to $2 for every $1
contributed by our employees to the 401(k) Plan at each payroll
date on or after January 1, 2005, up to our contribution of
4 percent of the employees compensation, and
continuing until terminated by further action of the board of
directors. In addition, at the discretion of the board of
directors, we may make other annual discretionary contributions
to the plan. Matching contributions made for fiscal 2005 were
approximately $202,000. The discretionary contribution made in
February 2005, for calendar 2004, was approximately $113,000. We
did not make any matching or discretionary contributions to the
plan for the year ended November 30, 2003.
62
CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS
In connection with our April 2001 private placement of common
shares, Brean Murray & Co., Inc. was our placement
agent and received for its services warrants to
purchase 25,000 common shares at $2.10 per share
exercisable during the four-year period beginning April 9,
2002. At the time, A. Brean Murray, one of our directors from
June 1999 to December 2003, and his wife controlled Brean
Murray & Co., Inc. In October 2003, Brean
Murray & Co., Inc. transferred the 25,000 warrants to
persons who are or were employees of Brean Murray &
Co., Inc., and in November 2003, those persons exercised the
warrants to purchase all 25,000 common shares under the warrants
by a cashless exercise. As a result of this cashless exercise,
we issued 18,832 restricted common shares to those individuals,
retaining 6,168 common shares in payment of the exercise price,
and no common shares remain subject to these warrants.
In connection with our CorRestore license, effective
June 2, 2000, we granted Joe B. Wolfe a five-year warrant
to purchase 20,000 common shares, exercisable at
$3.00 per share and effective November 21, 2001, we
granted Mr. Wolfe five-year warrants to
purchase 180,000 common shares, exercisable at
$3.00 per share. Mr. Wolfe was one of our directors
from November 2001 until April 2005. In May 2005,
Mr. Wolfe, agent for CorRestore LLC and one of our other
former directors, purchased 20,000 common shares under his
warrants by a cashless exercise. As a result of this cashless
exercise, we issued 16,264 common shares to Mr. Wolfe,
retaining 3,736 common shares in payment of the exercise price.
Mr. Wolfe has no vested warrants remaining to purchase
common shares.
In connection with our January 2002 public offering of common
shares, Brean Murray & Co., Inc. was our placement
agent and received for its services (1) $340,000 as a
placement agent fee, and (2) warrants to
purchase 100,000 common shares at $5.10 per share
exercisable during the four-year period beginning
January 11, 2003. In June 2004, Brean Murray &
Co., Inc. purchased 100,000 common shares under these warrants
by a cashless exercise. As a result of this cashless exercise,
we issued 66,265 common shares to Brean Murray & Co.,
Inc., retaining 33,735 common shares in payment of the exercise
price. Brean Murray & Co., Inc. now has no warrants
remaining to purchase common shares.
63
PRINCIPAL SHAREHOLDERS
The following table sets forth information with respect to the
beneficial ownership of our common shares and as adjusted to
reflect the sale of the common shares offered by this
prospectus, by the following:
|
|
|
|
|
each of our directors; |
|
|
|
each of our executive officers named in the Summary Compensation
Table above; |
|
|
|
all of our directors and executive officers as a group; and |
|
|
|
each person known by us to own more than 5 percent of our
common shares. |
For purposes of the table below, and in accordance with the
rules of the Securities and Exchange Commission, we deem common
shares that are subject to options that are currently
exercisable or exercisable within 60 days of the date of
this prospectus to be outstanding and beneficially owned by the
person holding the options for the purpose of computing the
percentage ownership of that person, but we do not treat them as
outstanding for the purpose of computing the percentage
ownership of any other person. Except as otherwise noted, the
persons or entities in this table have sole voting and
investment power with respect to all of the common shares
beneficially owned by them. The street address of
Mr. Barrett is 1653 East Maple Road, Troy, Michigan
48083-4208.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Shares | |
|
Common Shares | |
|
|
Beneficially Owned | |
|
Beneficially Owned | |
|
|
Before Offering | |
|
After Offering | |
|
|
| |
|
| |
|
|
|
|
Percent of | |
|
|
|
Percent of | |
|
|
Number | |
|
Class (1) | |
|
Number | |
|
Class (2) | |
|
|
| |
|
| |
|
| |
|
| |
Dr. James I. Ausman(3)
|
|
|
46,785 |
|
|
|
* |
|
|
|
46,785 |
|
|
|
* |
|
Daniel S. Follis(4)
|
|
|
31,620 |
|
|
|
* |
|
|
|
31,620 |
|
|
|
* |
|
Robert R. Henry(5)
|
|
|
283,200 |
|
|
|
2.6 |
|
|
|
283,200 |
|
|
|
2.2 |
|
Bruce J. Barrett(6)
|
|
|
778,919 |
|
|
|
6.8 |
|
|
|
778,919 |
|
|
|
5.8 |
|
Richard S. Scheuing(7)
|
|
|
138,220 |
|
|
|
1.3 |
|
|
|
138,220 |
|
|
|
1.1 |
|
Dominic J. Spadafore(8)
|
|
|
121,180 |
|
|
|
1.1 |
|
|
|
121,180 |
|
|
|
* |
|
Mary Ann Victor(9)
|
|
|
158,361 |
|
|
|
1.5 |
|
|
|
158,361 |
|
|
|
1.2 |
|
Pamela A. Winters(10)
|
|
|
163,220 |
|
|
|
1.5 |
|
|
|
163,220 |
|
|
|
1.3 |
|
All directors and executive officers as a group (10 persons)(11)
|
|
|
1,968,137 |
|
|
|
15.9 |
|
|
|
1,968,137 |
|
|
|
13.7 |
|
|
|
|
|
* |
Represents less than 1 percent of the outstanding common
shares. |
|
|
|
|
(1) |
Based on 10,715,885 common shares outstanding. |
|
|
|
(2) |
Based on 12,715,885 common shares outstanding, assuming all
2,000,000 common shares offered by this prospectus are sold to
third parties. |
|
|
|
(3) |
Includes 34,011 common shares that Dr. Ausman has the right
to acquire within 60 days of the date of this prospectus,
9,744 common shares owned jointly with his wife, and
3,030 shares held in an individual retirement account over
which Dr. Ausman exercises sole voting and investment
control. |
|
|
|
(4) |
Includes 13,500 common shares that Mr. Follis has the right
to acquire within 60 days of the date of this prospectus.
The 31,620 common shares shown above as beneficially owned by
Mr. Follis include 8,820 common shares owned by The
Infinity Fund, a limited partnership in which Mr. Follis is
a six percent limited partner and a 50 percent general
partner and which is administered by Verschuren &
Follis, Inc., a corporation in which Mr. Follis is a
50 percent shareholder, a director and the President. |
|
|
|
(5) |
Includes 26,500 common shares that Mr. Henry has the right
to acquire within 60 days of the date of this prospectus. |
64
|
|
|
|
(6) |
Includes 761,919 common shares that Mr. Barrett has the
right to acquire within 60 days of the date of this
prospectus and 17,000 common shares owned jointly with his wife. |
|
|
(7) |
Includes 138,220 common shares that Mr. Scheuing has the
right to acquire within 60 days of the date of this
prospectus. |
|
|
(8) |
Includes 117,680 common shares that Mr. Spadafore has the
right to acquire within 60 days of the date of this
prospectus and 3,500 common shares that Mr. Spadafore owns
jointly with his spouse. |
|
|
(9) |
Includes 153,261 common shares that Ms. Victor has the
right to acquire within 60 days of the date of this
prospectus, 2,000 common shares held by Ms. Victors
husband and 3,100 common shares held by Ms. Victors
husband jointly with his mother. |
|
|
(10) |
Includes 163,220 common shares that Ms. Winters has the
right to acquire within 60 days of the date of this
prospectus. |
|
(11) |
Includes 1,654,943 common shares that all executive officers and
directors as a group have the right to acquire within
60 days of the date of this prospectus. |
Lock-up
Agreements
We, our executive officers and our directors have agreed that,
for a period of 120 days from the date of this prospectus,
we and they will not, without the prior written consent of
Citigroup Global Markets Inc., dispose of or hedge any of our
common shares or any securities convertible into or exchangeable
for our common shares, except that we may issue up to 2,000,000
common shares or securities convertible into common shares in
connection with any acquisition, licensing or similar strategic
arrangement if the recipients agree to these lock-up
restrictions. Citigroup in its sole discretion may release any
of the securities subject to these
lock-up agreements at
any time without notice.
65
DESCRIPTION OF CAPITAL STOCK
The following descriptions of our capital stock and provisions
of our restated articles of incorporation and our amended and
restated bylaws are summaries and are qualified by reference to
our restated articles of incorporation and our amended and
restated bylaws, copies of which are filed as exhibits to the
registration statement of which this prospectus is a part.
Our authorized capital shares consist of an aggregate of
20,000,000 common shares, par value $0.01 per share, and
1,000,000 preferred shares, par value $0.01 per share. As
of February 6, 2006, an aggregate of 10,715,885 common
shares, held by 657 shareholders of record, and no
preferred shares were outstanding. All of the shares being
offered in this offering are common shares. We have outstanding
options and warrants to purchase an aggregate of 4,014,232
common shares, consisting of (1) options to purchase an
aggregate of 1,914,232 common shares at a weighted average
exercise price of $4.59 per share, and (2) warrants to
purchase an aggregate of 2,100,000 common shares at an exercise
price of $3.00 per share. Exercise of the warrants is
dependent on cumulative net sales of CorRestore products. The
sales requirements for exercise of those warrants have not been
met and we do not expect that they will be met before these
warrants expire in November 2006.
Common Shares
Holders of common shares have one vote per share on each matter
submitted to a vote of the shareholders and a right to
participate ratably in our net assets upon liquidation. Holders
of common shares participate ratably in dividends and
distributions that may be declared by the board of directors
from funds legally available for that purpose. See Price
Range of Common Shares and Dividend Policy. The common
shares have no conversion rights, are not redeemable and are not
entitled to any preemptive or subscription rights. The common
shares currently outstanding are, and the shares to be issued in
connection with this offering will be, duly authorized, validly
issued, fully paid and non-assessable. Holders of common shares
have no cumulative voting rights, and accordingly, holders of a
majority of the outstanding common shares are able to elect all
of our directors.
Our board of directors is divided into three classes and the
directors serve staggered three-year terms. Our directors will
hold office until the Annual Meeting of Shareholders to be held
in 2006 for Daniel S. Follis and Robert R. Henry, the Annual
Meeting of Shareholders to be held in 2007 for Bruce J. Barrett,
and the Annual Meeting of Shareholders to be held in 2008 for
Dr. James I. Ausman, and until their successors are elected
and qualified, or until their earlier death, resignation or
removal. Directors may be removed only for cause by a vote of
the holders of a majority of the shares entitled to vote at an
election of directors. Our Restated Articles of Incorporation
set the minimum number of directors constituting the entire
board at three and the maximum at fifteen and require approval
of holders of 90 percent of our voting shares to amend this
provision.
In addition, our bylaws require advance notice of any
nominations for director, along with information about the
nominee and the shareholder. See Management
Board of Directors and Committees of the Board of
Directors Nominating Committee.
Business Combination Provisions
Chapters 7A and 7B of the Michigan Business Corporation Act
may affect attempts to acquire control of us. In general, under
Chapter 7A, business combinations (defined to
include, among other transactions, certain mergers, dispositions
of assets or shares and recapitalizations) between covered
Michigan business corporations or their subsidiaries and an
interested shareholder (defined as the direct or
indirect beneficial owner of at least 10 percent of the
voting power of a covered corporations outstanding shares)
can only be consummated if there is an advisory statement by the
board of directors and the combination is approved by at least
90 percent of the votes of each class of the
corporations shares entitled to vote and by at least
two-thirds of such voting shares not held by the interested
shareholder or affiliates, unless five years have elapsed after
the person involved became an interested shareholder
and unless certain price and other conditions are satisfied. The
board of directors has the
66
power to elect to be subject to Chapter 7A as to
specifically identified or unidentified interested shareholders.
In general, under Chapter 7B, an entity that acquires
Control Shares of us may vote the Control Shares on
any matter only if a majority of all shares, and of all
non-Interested Shares, of each class of shares
entitled to vote as a class, approve such voting rights.
Interested Shares are shares owned by our officers, our
employee-directors and the entity making the Control Share
Acquisition. Control Shares are shares that when added to shares
already owned by an entity, would give the entity voting power
in the election of directors over any of the three thresholds:
one-fifth, one-third and a majority. The effect of the statute
is to condition the acquisition of voting control of a
corporation on the approval of a majority of the pre-existing
disinterested shareholders. The board of directors may amend the
bylaws before a Control Share Acquisition occurs to provide that
Chapter 7B does not apply to us. In addition, certain
provisions of our bylaws could have the effect of delaying,
deterring or preventing changes in control of us. See Risk
Factors Provisions of our corporate charter
documents and Michigan law may delay or prevent attempts by our
shareholders to change our management and hinder efforts to
acquire a controlling interest in us.
Indemnification of Directors and Officers
The Michigan Business Corporation Act permits Michigan
corporations to limit the personal liability of directors for a
breach of their fiduciary duties. Our Restated Articles of
Incorporation so limit the liability of directors. Our bylaws
also provide for indemnification of directors and executive
officers. We believe that such indemnification will assist us in
continuing to attract and retain talented directors and officers
in light of the risk of litigation directed against directors
and officers of publicly-held corporations.
Our Restated Articles of Incorporation limit director liability
to the maximum extent permitted by Michigan law. Michigan law
allows the articles of incorporation of a Michigan corporation
to contain a provision eliminating or limiting a directors
liability to the corporation or its shareholders for money
damages for any action taken or any failure to take any action
as a director, except for liability for specified acts. As a
result of the inclusion of such a provision, our shareholders
may be unable to recover monetary damages against directors for
actions taken by them which constitute negligence or gross
negligence or which are in violation of their fiduciary duties,
although it may be possible to obtain injunctive or other
equitable relief with respect to such actions. If equitable
remedies are found not to be available to shareholders in any
particular case, shareholders may not have any effective remedy
against the challenged conduct. These provisions, however, do
not affect liability under the Securities Act.
The Michigan Business Corporation Act authorizes a corporation
under specified circumstances to indemnify its directors and
officers, including reimbursement for expenses incurred. The
provisions of our bylaws relating to indemnification of
directors and executive officers generally provide that
directors and executive officers will be indemnified to the
fullest extent permissible under Michigan law. The provision
also provides for advancing litigation expenses at the request
of a director or executive officer. These obligations are broad
enough to permit indemnification with respect to liabilities
arising under the Securities Act or the Michigan Uniform
Securities Act. Mr. Barretts employment agreement
also provides for indemnification.
In addition, we have obtained directors and officers
liability insurance. The policy provides for $2,000,000 in
coverage including prior acts dating to our inception and
liabilities under the Securities Act in connection with this
offering.
Insofar as indemnification for liabilities arising under the
Securities Act of 1933 may be permitted to directors, officers
or persons controlling us pursuant to the foregoing provisions,
we have been informed that in the opinion of the Securities and
Exchange Commission such indemnification is against public
policy as expressed in the Securities Act and is therefore
unenforceable.
67
Preferred Shares
We have also authorized the issuance of up to 1,000,000
preferred shares, $0.01 par value per share, none of which
is outstanding as of the date of this prospectus. The preferred
shares may be issued from time to time in one or more series.
Our board of directors is authorized to determine the rights,
preferences, privileges and restrictions granted to, and imposed
upon, each series of preferred shares and to fix the number of
shares of any series of preferred shares and the designation of
any such series. We could issue preferred shares, under certain
circumstances, to prevent a takeover of our company, and our
board of directors may issue preferred shares without any action
of the holders of the common shares, which could have a
detrimental effect on the rights of holders of the common
shares, including loss of voting control. Anti-takeover
provisions that could be included in the preferred shares when
issued might depress the market price of our securities and
might limit the shareholders ability to receive a premium
on their shares by discouraging takeover and tender offer bids.
We have no present plans to issue any preferred shares.
Transfer Agent
American Stock Transfer & Trust Company is the transfer
agent for the common shares.
Listing
Our common shares are quoted on The Nasdaq National Market under
the symbol SMTS.
68
MATERIAL U.S. FEDERAL INCOME AND ESTATE TAX CONSEQUENCES
TO
NON-U.S. HOLDERS
The following is a general discussion of material
U.S. federal income and estate tax consequences of the
ownership and disposition of our common shares by a
non-U.S. holder
that acquires our common shares pursuant to this offering. The
discussion is based on provisions of the Internal Revenue Code
of 1986, as amended, which we refer to as the Code, applicable
U.S. Treasury regulations promulgated thereunder and
administrative and judicial interpretations, all as in effect on
the date of this prospectus, and all of which are subject to
change, possibly on a retroactive basis. The discussion is
limited to
non-U.S. holders
that hold our common shares as a capital asset
within the meaning of Section 1221 of the Code
generally, property held for investment. As used in this
discussion, the term
non-U.S. holder
means a beneficial owner of our common shares that is not, for
U.S. federal income tax purposes:
|
|
|
|
|
an individual who is a citizen or resident of the United States; |
|
|
|
a corporation or partnership, including any entity treated as a
corporation or partnership for U.S. federal income tax
purposes, created or organized in or under the laws of the
United States or any state of the United States or the District
of Columbia, other than a partnership treated as foreign under
U.S. Treasury regulations; |
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an estate the income of which is includible in gross income for
U.S. federal income tax purposes regardless of its source;
or |
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a trust (1) if a U.S. court is able to exercise
primary supervision over the administration of the trust and one
or more U.S. persons have authority to control all
substantial decisions of the trust, or (2) that has a valid
election in effect under applicable U.S. Treasury
regulations to be treated as a U.S. person. |
This discussion does not consider:
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U.S. federal gift tax consequences, or U.S. state or
local or non-U.S.
tax consequences; |
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the tax consequences for partnerships or persons who hold their
interests through a partnership or other entity classified as a
partnership for U.S. federal income tax purposes; |
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the tax consequences for the shareholders or beneficiaries of a
non-U.S. holder; |
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all of the U.S. federal tax considerations that may be
relevant to a
non-U.S. holder in
light of its particular circumstances or to
non-U.S. holders
that may be subject to special treatment under U.S. federal
tax laws, such as financial institutions, insurance companies,
tax-exempt organizations, certain trusts, hybrid entities,
certain former citizens or residents of the United States,
holders subject to U.S. federal alternative minimum tax,
broker-dealers, traders in securities, pension plans and
regulated investment companies; or |
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special tax rules that may apply to a
non-U.S. holder
that holds our common shares as part of a straddle,
hedge, conversion transaction,
synthetic security, or other integrated investment. |
Prospective investors are urged to consult their own tax
advisors regarding the U.S. federal, state, local, and
non-U.S. income
and other tax considerations with respect to owning and
disposing of our common shares.
Dividends
As previously discussed, we do not expect to pay dividends on
our common shares in the foreseeable future. See Price
Range of Common Shares and Dividend Policy. If we make
distributions on our common shares, those payments will
constitute dividends for U.S. federal income tax purposes
to the extent paid from our current or accumulated earnings and
profits, as determined under U.S. federal income tax
principles. To the extent those distributions exceed our current
and accumulated earnings and
69
profits, the excess will constitute a return of capital and
first reduce the
non-U.S. holders
basis, but not below zero, and then will be treated as gain from
the sale of stock.
We will have to withhold U.S. federal income tax at a rate
of 30%, or a lower rate under an applicable income tax treaty,
from the gross amount of the dividends paid to a
non-U.S. holder,
unless the dividend is effectively connected with the conduct of
a trade or business of the
non-U.S. holder
within the United States and is not exempted from
U.S. federal income tax at graduated rates under an income
tax treaty by reason of not being attributable to a permanent
establishment or fixed base of the
non-U.S. holder
within the United States. Dividends that are effectively
connected with a
non-U.S. holders
conduct of a trade or business in the United States and, if an
income tax treaty applies, attributable to a permanent
establishment or fixed base of the
non-U.S. holder
within the United States, are taxed on a net income basis at the
regular graduated U.S. federal income tax rates in the same
manner as if the
non-U.S. holder
were a resident of the United States. In such cases, we will not
have to withhold U.S. federal income tax if the
non-U.S. holder
complies with applicable certification and disclosure
requirements. In addition, a branch profits tax may
be imposed at a 30% rate, or a lower rate under an applicable
income tax treaty, on dividends received by a foreign
corporation that are effectively connected with the conduct of a
trade or business in the United States.
In order to claim the benefit of an income tax treaty or to
claim exemption from withholding because the income is
effectively connected with the conduct of a trade or business in
the United States, the
non-U.S. holder
must provide a properly executed IRS
Form W-8BEN, for
treaty benefits, or
W-8ECI, for effectively
connected income, respectively, or such successor forms as the
IRS designates prior to the payment of dividends. These forms
must be periodically updated.
Non-U.S. holders
should consult their tax advisors regarding their entitlement to
benefits under a relevant income tax treaty and the preparation
and filing of the forms necessary to claim such benefits.
A non-U.S. holder
that is eligible for reduced rate of U.S. federal
withholding tax under an income tax treaty may obtain a refund
of any excess amounts withheld by filing an appropriate claim
for a refund together with the required information with
the IRS.
Gain on Disposition of Common Shares
A non-U.S. holder
generally will not be subject to U.S. federal income tax or
withholding tax with respect to gain realized on a sale or other
disposition of our common shares unless one of the following
applies:
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the gain is effectively connected with the
non-U.S. holders
conduct of a trade or business in the United States and, if an
income tax treaty applies, is attributable to a permanent
establishment or fixed base maintained by the
non-U.S. holder in
the United States; in these cases, the
non-U.S. holder
will generally be taxed on its net gain derived from the
disposition in the manner and at the regular graduated
U.S. federal income tax rates applicable to United States
persons, as defined in the Code, and, if the
non-U.S. holder is
a foreign corporation, the branch profits tax
described above may also apply; or |
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the
non-U.S. holder is
a nonresident alien individual who is present in the United
States for 183 days or more in the taxable year of the
disposition and meets certain other requirements; in this case,
the
non-U.S. holder
will be subject to a 30% tax on the gain derived from the
disposition which may be offset by U.S. source capital
losses of the
non-U.S. holder,
if any. |
Federal Estate Tax
Common shares owned or treated as owned at the time of death by
an individual who is not a citizen or resident of the United
States, as specifically defined for U.S. federal estate tax
purposes, will be included in the individuals gross estate
for U.S. federal estate tax purposes, unless an applicable
estate tax or other treaty provides otherwise and, therefore,
may be subject to U.S. federal estate tax.
70
Information Reporting and Backup Withholding Tax
We must report annually to the IRS and to each
non-U.S. holder
the gross amount of the distributions paid to that holder and
the tax withheld from those distributions. These reporting
requirements apply regardless of whether withholding was reduced
or eliminated by an applicable income tax treaty. Copies of the
information returns reporting those distributions and
withholding may also be made available under the provisions of
an applicable income tax treaty or agreement to the tax
authorities in the country in which the
non-U.S. holder is
a resident or incorporated.
Under some circumstances, U.S. Treasury regulations require
backup withholding and additional information reporting on
reportable payments on common shares. The gross amount of
dividends paid to a
non-U.S. holder
that fails to certify its
non-U.S. holder
status in accordance with applicable U.S. Treasury
regulations generally will be reduced by backup withholding at
the applicable rate, currently 28%. Dividends paid to
non-U.S. holders
subject to the U.S. withholding tax at a rate of 30%,
described above in Dividends, generally will be
exempt from U.S. backup withholding.
The payment of the proceeds of the sale or other disposition of
common shares by a
non-U.S. holder
effected by or through the U.S. office of any broker,
U.S. or non-U.S.,
generally will be reported to the IRS and reduced by backup
withholding, unless the
non-U.S. holder
either certifies its status as a
non-U.S. holder
under penalties of perjury or otherwise establishes an
exemption. The payment of the proceeds from the disposition of
common shares by a
non-U.S. holder
effected by or through a
non-U.S. office of
a non-U.S. broker
generally will not be reduced by backup withholding or reported
to the IRS, unless the
non-U.S. broker
has certain enumerated connections with the United States. In
general, the payment of proceeds from the disposition of common
shares effected by or through a
non-U.S. office of
a broker that is a U.S. person or has certain enumerated
connections with the United States will be reported to the IRS
and may be reduced by backup withholding unless the broker
receives a statement from the
non-U.S. holder
that certifies its status as a
non-U.S. holder
under penalties of perjury or the broker has documentary
evidence in its files that the holder is a
non-U.S. holder.
Backup withholding is not an additional tax. Any amounts
withheld under the backup withholding rules from a payment to a
non-U.S. holder
can be refunded or credited against the
non-U.S. holders
U.S. federal income tax liability, if any, provided that
the required information is furnished to the IRS in a timely
manner. These backup withholding and information reporting rules
are complex and
non-U.S. holders
are urged to consult their own tax advisors regarding the
application of these rules to them.
The foregoing discussion of U.S. federal income and
estate tax considerations is not tax advice and is not based on
an opinion of counsel. Accordingly, each prospective
non-U.S. holder of
our common shares should consult that holders own tax
advisor with respect to the federal, state, local and
non-U.S. tax
consequences of the ownership and disposition of our common
shares.
71
UNDERWRITING
Citigroup Global Markets Inc. is acting as the bookrunning
manager of this offering, and, together with SG Cowen &
Co., LLC and SunTrust Capital Markets, Inc. are acting as
representatives of the underwriters named below. Subject to the
terms and conditions stated in the underwriting agreement dated
the date of this prospectus, each underwriter named below has
agreed to purchase, and we have agreed to sell to that
underwriter, the number of common shares set forth below
opposite the underwriters name.
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Number of | |
Underwriter |
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Common Shares | |
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Citigroup Global Markets Inc.
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SG Cowen & Co., LLC
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SunTrust Capital Markets, Inc.
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Total
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2,000,000 |
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The underwriting agreement provides that the obligations of the
underwriters to purchase the shares included in this offering
are subject to approval of legal matters by counsel and to other
conditions. The underwriters are obligated to purchase all the
shares (other than those covered by the over-allotment option
described below) if they purchase any of the shares.
The underwriters propose to offer some of the shares directly to
the public at the public offering price set forth on the cover
page of this prospectus and some of the shares to dealers at the
public offering price less a concession not to exceed
$ per
share. The underwriters may allow, and dealers may reallow, a
concession not to exceed
$ per
share on sales to other dealers. If all of the shares are not
sold at the initial offering price, the representatives may
change the public offering price and the other selling terms.
We have granted to the underwriters an option, exercisable for
30 days from the date of this prospectus, to purchase up to
300,000 additional common shares at the public offering price
less the underwriting discount. The underwriters may exercise
the option solely for the purpose of covering over-allotments,
if any, in connection with this offering. To the extent the
option is exercised, each underwriter must purchase a number of
additional shares approximately proportionate to that
underwriters initial purchase commitment.
We, our executive officers and our directors have agreed that,
for a period of 120 days from the date of this prospectus,
we and they will not, without the prior written consent of
Citigroup Global Markets Inc., dispose of or hedge any of our
common shares or any securities convertible into or exchangeable
for our common shares, except that we may issue up to
2,000,000 common shares or securities convertible into
common shares in connection with any acquisition, licensing or
similar strategic arrangement if the recipients agree to these
lock-up restrictions. Citigroup in its sole discretion may
release any of the securities subject to these
lock-up agreements at
any time without notice.
Our common shares are quoted on The Nasdaq National Market under
the symbol SMTS.
The following table shows the underwriting discounts and
commissions that we are to pay to the underwriters in connection
with this offering. These amounts are shown assuming both no
exercise and full exercise of the underwriters option to
purchase additional common shares.
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No Exercise | |
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Full Exercise | |
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Per share
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$ |
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$ |
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Total
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$ |
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$ |
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In connection with the offering, Citigroup on behalf of the
underwriters, may purchase and sell common shares in the open
market. These transactions may include short sales, syndicate
covering transactions and stabilizing transactions. Short sales
involve syndicate sales of common shares in excess of the number
of shares to be purchased by the underwriters in the offering,
which creates a syndicate short
72
position. Covered short sales are sales of shares
made in an amount up to the number of shares represented by the
underwriters over-allotment option. In determining the
source of shares to close out the covered syndicate short
position, the underwriters will consider, among other things,
the price of shares available for purchase in the open market as
compared to the price at which they may purchase shares through
the over-allotment option. Transactions to close out the covered
syndicate short involve either purchases of the common shares in
the open market after the distribution has been completed or the
exercise of the over-allotment option. The underwriters may also
make naked short sales of shares in excess of the
over-allotment option. The underwriters must close out any naked
short position by purchasing common shares in the open market. A
naked short position is more likely to be created if the
underwriters are concerned that there may be downward pressure
on the price of the shares in the open market after pricing that
could adversely affect investors who purchase in the offering.
Stabilizing transactions consist of bids for or purchases of
shares in the open market while the offering is in progress.
The underwriters may also impose a penalty bid. Penalty bids
permit the underwriters to reclaim a selling concession from a
syndicate member when Citigroup repurchases shares originally
sold by that syndicate member in order to cover syndicate short
positions or make stabilizing purchases.
Any of these activities may have the effect of preventing or
retarding a decline in the market price of the common shares.
They may also cause the price of the common shares to be higher
than the price that would otherwise exist in the open market in
the absence of these transactions. The underwriters may conduct
these transactions on the Nasdaq Stock Market or in the
over-the-counter
market, or otherwise. If the underwriters commence any of these
transactions, they may discontinue them at anytime.
In addition, in connection with this offering, some of the
underwriters (and selling group members) may engage in passive
market making transactions in the common shares on the Nasdaq
Stock Market, prior to the pricing and completion of the
offering. Passive market making consists of displaying bids on
the Nasdaq Stock Market no higher than the bid prices of
independent market makers and making purchases at prices no
higher than those independent bids and effected in response to
order flow. Net purchases by a passive market maker on each day
are limited to a specified percentage of the passive market
makers average daily trading volume in the common shares
during a specified period and must be discontinued when that
limit is reached. Passive market making may cause the price of
the common shares to be higher than the price that otherwise
would exist in the open market in the absence of those
transactions. If the underwriters commence passive market making
transactions, they may discontinue them at any time.
We estimate that the total expenses of this offering, paid and
payable by us, not including the underwriting discounts and
commissions, will be $500,000.
Other than in connection with this offering, the underwriters
have not performed investment banking and advisory services for
us. The underwriters may, from time to time, engage in
transactions with and perform services for us in the ordinary
course of their business.
A prospectus in electronic format may be made available on the
websites maintained by one or more of the underwriters. The
representatives may agree to allocate a number of shares to
underwriters for sale to their online brokerage account holders.
The representatives will allocate shares to underwriters that
may make Internet distributions on the same basis as other
allocations. In addition, shares may be sold by the underwriters
to securities dealers who resell shares to online brokerage
account holders.
We have agreed to indemnify the underwriters against certain
liabilities, including liabilities under the Securities Act of
1933, or to contribute to payments the underwriters may be
required to make because of any of those liabilities.
73
LEGAL MATTERS
The validity of the common shares offered by this prospectus
will be passed upon by Honigman Miller Schwartz and Cohn LLP,
Detroit, Michigan. DLA Piper Rudnick Gray Cary US LLP, New York,
New York, is counsel for the underwriters in connection with
this offering.
EXPERTS
The financial statements and managements report on the
effectiveness of internal control over financial reporting
included in this prospectus have been audited by
Deloitte & Touche LLP, an independent registered public
accounting firm, as stated in their reports appearing herein,
and are included in reliance upon the reports of such firm given
upon their authority as experts in accounting and auditing.
WHERE YOU CAN GET MORE INFORMATION
We have filed with the Securities and Exchange Commission a
registration statement on
Form S-3 under the
Securities Act of 1933 with respect to the common shares we are
offering to sell. This prospectus, which constitutes part of the
registration statement, does not include all of the information
contained in the registration statement and the exhibits,
schedules and amendments to the registration statement. For
further information about us and our common shares, we refer you
to the registration statement and to the exhibits and schedules
to the registration statement. Statements contained in this
prospectus about the contents of any contract or any other
document are not necessarily complete, and, in each instance, we
refer you to the copy of the contract or other documents filed
as an exhibit to, or incorporated by reference into, the
registration statement. Each of these statements is qualified in
all respects by this reference.
We file annual, quarterly and special reports, proxy statements
and other information with the Securities and Exchange
Commission. You can read and copy any materials we file with the
Securities and Exchange Commission at the Securities and
Exchange Commissions Public Reference Room at 100 F
Street, N.E., Room 1580, Washington, D.C. 20549. You
may obtain information on the operation of the Public Reference
Room by calling the Securities and Exchange Commission at
1-800-SEC-0330. The
Securities and Exchange Commission also maintains an Internet
site that contains reports, proxy and information statements and
other information regarding issuers, such as us, that file
electronically with the Securities and Exchange Commission. The
address of the Securities and Exchange Commissions website
is http://www.sec.gov.
You may read and copy the registration statement of which this
prospectus is a part, any related exhibits and schedules and any
other materials we file with the Securities and Exchange
Commission at the Securities and Exchange Commissions
Public Reference Room, which is located at 100 F Street, N.E.,
Room 1580, Washington, D.C. 20549. You can request
copies of the registration statement by writing to the
Securities and Exchange Commission and paying a fee for the
copying cost. Please call the Securities and Exchange Commission
at 1-800-SEC-0330 for
more information about the operation of the Securities and
Exchange Commissions Public Reference Room. You may access
the registration statement of which this prospectus is a part at
the Securities and Exchange Commissions Internet website.
We also maintain a website at http://www.somanetics.com. We make
available free of charge on or through our website, our annual
report on
Form 10-K,
quarterly reports on
Form 10-Q, current
reports on
Form 8-K and
amendments to those reports filed or furnished pursuant to
Section 13(a) or 15(d) of the Exchange Act as soon as
reasonably practicable after we electronically file such
material with, or furnish it to, the Securities and Exchange
Commission. We will voluntarily provide electronic or paper
copies of our filings free of charge upon request.
This prospectus includes statistical data that were obtained
from industry publications. These industry publications
generally indicate that the authors of these publications have
obtained information from
74
sources believed to be reliable but do not guarantee the
accuracy and completeness of their information. While we believe
these industry publications to be reliable, we have not
independently verified their data.
DOCUMENTS INCORPORATED BY REFERENCE
This prospectus incorporates documents by reference that are not
presented in or delivered with it. The following documents,
which we have filed with the Securities and Exchange Commission,
are incorporated by reference into this prospectus:
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Our Annual Report on
Form 10-K for the
fiscal year ended November 30, 2005; |
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Our Current Report on
Form 8-K filed
January 31, 2006 reporting on January 27, 2006
events; and |
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The description of our common shares included in our prospectus,
dated March 20, 1991, included in our registration
statement on
Form S-1 (file no.
33-38438) effective
March 20, 1991, under the caption Description of
Securities on pages 41 through 46 of the prospectus
and incorporated by reference into our registration statement on
Form 8-A effective
March 27, 1991, including any amendment or report filed for
the purpose of updating such description. |
In addition, all documents subsequently filed by us pursuant to
Section 13(a), 13(c), 14 or 15(d) of the Securities
Exchange Act of 1934 before termination of this offering are
deemed to be incorporated by reference into this prospectus and
will constitute a part of this prospectus from the date of
filing of those documents.
The documents incorporated by reference into this prospectus are
available from us upon request. We will provide to each person,
including any beneficial owner, to whom this prospectus is
delivered, at no cost to the requester, upon your written or
oral request, a copy of any or all of the information that is
incorporated by reference in this prospectus, but not delivered
with this prospectus, except for exhibits unless the exhibits
are specifically incorporated by reference into this prospectus.
Please submit your requests for any of such documents to:
Somanetics Corporation, 1653 East Maple Road, Troy, Michigan
48083-4208, Attn: Mary Ann Victor, Vice President and Chief
Administrative Officer and Secretary,
(248) 689-3050.
75
SOMANETICS CORPORATION
INDEX TO FINANCIAL STATEMENTS
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F-2 |
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F-1
MANAGEMENTS REPORT ON INTERNAL CONTROL OVER FINANCIAL
REPORTING
The management of Somanetics Corporation is responsible for
establishing and maintaining adequate internal control over
financial reporting. Somanetics Corporations internal
control system was designed to provide reasonable assurance to
the companys management and board of directors regarding
the preparation and fair presentation of published financial
statements. All internal control systems, no matter how well
designed, have inherent limitations. Therefore, even those
systems determined to be effective can provide only reasonable
assurance with respect to financial statement preparation and
presentation.
Somanetics Corporation management assessed the effectiveness of
the companys internal control over financial reporting as
of November 30, 2005. In making this assessment, it 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, we
believe that, as of November 30, 2005, the companys
internal control over financial reporting is effective based on
those criteria.
Somanetics Corporations independent auditors have audited
the financial statements prepared by the company. Their report
on the financial statements appears on the next page.
Managements assessment of the companys internal
control over financial reporting has been audited by our
independent auditors, as stated in their report included on the
next page.
January 23, 2006
F-2
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Shareholders of
Somanetics Corporation
Troy, Michigan
We have audited managements assessment, included in the
accompanying Managements Report on Internal Control
Over Financial Reporting, that Somanetics Corporation (the
Company) maintained effective internal control over
financial reporting as of November 30, 2005, based on the
criteria established in Internal Control-Integrated Framework
issued by the Committee of Sponsoring Organizations of the
Treadway Commission. The Companys 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 managements assessment and an
opinion on the effectiveness of the Companys 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
managements 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 opinions.
A companys internal control over financial reporting is a
process designed by, or under the supervision of, the
companys principal executive and principal financial
officers, or persons performing similar functions, and effected
by the companys board of directors, management, and other
personnel 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 companys
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
companys assets that could have a material effect on the
financial statements.
Because of the inherent limitations of internal control over
financial reporting, including the possibility of collusion or
improper management override of controls, material misstatements
due to error or fraud may not be prevented or detected on a
timely basis. Also, projections of any evaluation of the
effectiveness of the internal control over financial reporting
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, managements assessment that the Company
maintained effective internal control over financial reporting
as of November 30, 2005, is fairly stated, in all material
respects, based on the criteria established in Internal
Control-Integrated Framework issued by the Committee of
Sponsoring Organizations of the Treadway Commission. Also in our
opinion, the Company maintained, in all material respects,
effective internal control over financial reporting as of
November 30, 2005, based on criteria established in
Internal Control-Integrated Framework issued by the
Committee of Sponsoring Organizations of the Treadway Commission.
F-3
We have also audited, in accordance with the standards of the
Public Company Accounting Oversight Board (United States), the
balance sheets as of November 30, 2005 and 2004, and the
related statements of operations, shareholders equity, and
cash flows for each of the three years in the period ended
November 30, 2005 of the Company and our report dated
January 26, 2006 expressed an unqualified opinion on those
financial statements.
/s/ DELOITTE & TOUCHE LLP
Detroit, Michigan
January 26, 2006
F-4
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Shareholders of
Somanetics Corporation
Troy, Michigan
We have audited the accompanying balance sheets of Somanetics
Corporation (the Company) as of November 30,
2005 and 2004, and the related statements of operations,
shareholders equity, and cash flows for each of the three
years in the period ended November 30, 2005. These
financial statements are the responsibility of the
Companys management. Our responsibility is to express an
opinion on these financial statements 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 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, such financial statements present fairly, in all
material respects, the financial position of Somanetics
Corporation at November 30, 2005 and 2004, and the results
of their operations and their cash flows for each of the three
years in the period ended November 30, 2005, in conformity
with accounting principles generally accepted in the United
States of America.
We have also audited, in accordance with the standards of the
Public Company Accounting Oversight Board (United States), the
effectiveness of the Companys internal control over
financial reporting as of November 30, 2005, based on the
criteria established in Internal Control
Integrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission and our report dated
January 26, 2006 expressed an unqualified opinion on
managements assessment of the effectiveness of the
Companys internal control over financial reporting and an
unqualified opinion on the effectiveness of the Companys
internal control over financial reporting.
/s/ DELOITTE & TOUCHE LLP
Detroit, Michigan
January 26, 2006
F-5
SOMANETICS CORPORATION
BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
|
|
November 30, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
ASSETS |
CURRENT ASSETS:
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents (Note 2)
|
|
$ |
13,148,237 |
|
|
$ |
7,069,542 |
|
|
Accounts receivable
|
|
|
3,531,740 |
|
|
|
2,022,544 |
|
|
Inventory (Note 2)
|
|
|
1,058,101 |
|
|
|
682,910 |
|
|
Prepaid expenses
|
|
|
623,303 |
|
|
|
257,893 |
|
|
Deferred tax asset current (Note 5)
|
|
|
1,561,322 |
|
|
|
510,000 |
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
19,922,703 |
|
|
|
10,542,889 |
|
|
|
|
|
|
|
|
PROPERTY AND EQUIPMENT: (Note 2)
|
|
|
|
|
|
|
|
|
|
Demonstration and no capital cost sales equipment at customers
|
|
|
1,916,655 |
|
|
|
1,628,431 |
|
|
Machinery and equipment
|
|
|
768,992 |
|
|
|
704,581 |
|
|
Furniture and fixtures
|
|
|
289,397 |
|
|
|
255,044 |
|
|
Leasehold improvements
|
|
|
187,135 |
|
|
|
171,882 |
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
3,162,179 |
|
|
|
2,759,938 |
|
|
Less accumulated depreciation and amortization
|
|
|
(1,836,438 |
) |
|
|
(1,675,881 |
) |
|
|
|
|
|
|
|
|
|
Net property and equipment
|
|
|
1,325,741 |
|
|
|
1,084,057 |
|
|
|
|
|
|
|
|
OTHER ASSETS:
|
|
|
|
|
|
|
|
|
|
Deferred tax asset non-current (Note 5)
|
|
|
8,438,678 |
|
|
|
6,190,000 |
|
|
Intangible assets, net (Note 2)
|
|
|
16,921 |
|
|
|
952,926 |
|
|
Other
|
|
|
15,000 |
|
|
|
15,000 |
|
|
|
|
|
|
|
|
|
|
Total other assets
|
|
|
8,470,599 |
|
|
|
7,157,926 |
|
|
|
|
|
|
|
|
TOTAL ASSETS
|
|
$ |
29,719,043 |
|
|
$ |
18,784,872 |
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS EQUITY |
CURRENT LIABILITIES:
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$ |
712,796 |
|
|
$ |
529,097 |
|
|
Accrued liabilities (Notes 4 and 6)
|
|
|
1,165,594 |
|
|
|
703,109 |
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
1,878,390 |
|
|
|
1,232,206 |
|
|
|
|
|
|
|
|
COMMITMENTS AND CONTINGENCIES (Note 6)
|
|
|
|
|
|
|
|
|
SHAREHOLDERS EQUITY: (Note 3)
|
|
|
|
|
|
|
|
|
|
Preferred shares; authorized, 1,000,000 shares of
$.01 par value; no shares issued or outstanding
|
|
|
|
|
|
|
|
|
|
Common shares; authorized, 20,000,000 shares of
$.01 par value; issued and outstanding,
10,715,885 shares at November 30, 2005, and
10,137,782 shares at November 30, 2004
|
|
|
107,159 |
|
|
|
101,378 |
|
|
Additional paid-in capital
|
|
|
64,864,554 |
|
|
|
62,333,435 |
|
|
Accumulated deficit
|
|
|
(37,131,060 |
) |
|
|
(44,882,147 |
) |
|
|
|
|
|
|
|
|
|
Total shareholders equity
|
|
|
27,840,653 |
|
|
|
17,552,666 |
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND SHAREHOLDERS EQUITY
|
|
$ |
29,719,043 |
|
|
$ |
18,784,872 |
|
|
|
|
|
|
|
|
See notes to financial statements
F-6
SOMANETICS CORPORATION
STATEMENTS OF OPERATIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Years Ended November 30, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
NET REVENUES (Notes 2 and 9)
|
|
$ |
20,509,252 |
|
|
$ |
12,608,615 |
|
|
$ |
9,360,893 |
|
COST OF SALES
|
|
|
2,601,488 |
|
|
|
2,050,253 |
|
|
|
2,139,827 |
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin
|
|
|
17,907,764 |
|
|
|
10,558,362 |
|
|
|
7,221,066 |
|
|
|
|
|
|
|
|
|
|
|
OPERATING EXPENSES:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research, development and engineering (Note 2)
|
|
|
525,679 |
|
|
|
369,106 |
|
|
|
412,953 |
|
|
Selling, general and administrative (Note 2)
|
|
|
13,241,053 |
|
|
|
8,237,401 |
|
|
|
6,758,637 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
13,766,732 |
|
|
|
8,606,507 |
|
|
|
7,171,590 |
|
|
|
|
|
|
|
|
|
|
|
OPERATING INCOME
|
|
|
4,141,032 |
|
|
|
1,951,855 |
|
|
|
49,476 |
|
|
|
|
|
|
|
|
|
|
|
OTHER INCOME:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
310,055 |
|
|
|
54,721 |
|
|
|
23,110 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income
|
|
$ |
310,055 |
|
|
$ |
54,721 |
|
|
$ |
23,110 |
|
|
|
|
|
|
|
|
|
|
|
INCOME BEFORE INCOME TAXES
|
|
$ |
4,451,087 |
|
|
$ |
2,006,576 |
|
|
$ |
72,586 |
|
INCOME TAX BENEFIT
|
|
|
3,300,000 |
|
|
|
6,700,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET INCOME
|
|
$ |
7,751,087 |
|
|
$ |
8,706,576 |
|
|
$ |
72,586 |
|
|
|
|
|
|
|
|
|
|
|
NET INCOME PER COMMON SHARE BASIC (Note 2)
|
|
$ |
.75 |
|
|
$ |
.89 |
|
|
$ |
.01 |
|
|
|
|
|
|
|
|
|
|
|
NET INCOME PER COMMON SHARE DILUTED (Note 2)
|
|
$ |
.66 |
|
|
$ |
.77 |
|
|
$ |
.01 |
|
|
|
|
|
|
|
|
|
|
|
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING
BASIC (Note 2)
|
|
|
10,322,226 |
|
|
|
9,780,104 |
|
|
|
9,113,854 |
|
|
|
|
|
|
|
|
|
|
|
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING
DILUTED (Note 2)
|
|
|
11,797,799 |
|
|
|
11,323,272 |
|
|
|
9,466,838 |
|
|
|
|
|
|
|
|
|
|
|
See notes to financial statements
F-7
SOMANETICS CORPORATION
STATEMENTS OF SHAREHOLDERS EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional | |
|
|
|
Total | |
|
Comprehensive | |
|
|
Share | |
|
Paid-In | |
|
Accumulated | |
|
Shareholders | |
|
Income | |
|
|
Value | |
|
Capital | |
|
Deficit | |
|
Equity | |
|
(Loss) | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
Balance at December 1, 2002
|
|
$ |
90,779 |
|
|
$ |
59,071,122 |
|
|
$ |
(53,661,309 |
) |
|
$ |
5,500,592 |
|
|
|
|
|
For cash, exercise of stock options
|
|
|
1,484 |
|
|
|
537,142 |
|
|
|
|
|
|
|
538,626 |
|
|
|
|
|
Warrants issued to acquire license
|
|
|
|
|
|
|
44,793 |
|
|
|
|
|
|
|
44,793 |
|
|
|
|
|
Stock options issued to non-employees
|
|
|
|
|
|
|
8,471 |
|
|
|
|
|
|
|
8,471 |
|
|
|
|
|
Cashless exercise of warrants
|
|
|
724 |
|
|
|
(724 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net income and comprehensive income
|
|
|
|
|
|
|
|
|
|
|
72,586 |
|
|
|
72,586 |
|
|
$ |
72,586 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at November 30, 2003
|
|
$ |
92,987 |
|
|
$ |
59,660,804 |
|
|
$ |
(53,588,723 |
) |
|
$ |
6,165,068 |
|
|
|
|
|
For cash, exercise of stock options
|
|
|
3,213 |
|
|
|
1,537,809 |
|
|
|
|
|
|
|
1,541,022 |
|
|
|
|
|
For cash, exercise of warrants
|
|
|
3,800 |
|
|
|
1,136,200 |
|
|
|
|
|
|
|
1,140,000 |
|
|
|
|
|
Cashless exercise of warrants
|
|
|
1,378 |
|
|
|
(1,378 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net income and comprehensive income
|
|
|
|
|
|
|
|
|
|
|
8,706,576 |
|
|
|
8,706,576 |
|
|
$ |
8,706,576 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at November 30, 2004
|
|
$ |
101,378 |
|
|
$ |
62,333,435 |
|
|
$ |
(44,882,147 |
) |
|
$ |
17,552,666 |
|
|
|
|
|
For cash, exercise of stock options
|
|
|
5,618 |
|
|
|
2,520,061 |
|
|
|
|
|
|
|
2,525,679 |
|
|
|
|
|
Cashless exercise of warrants
|
|
|
163 |
|
|
|
(163 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Consultant stock option expense
|
|
|
|
|
|
|
11,221 |
|
|
|
|
|
|
|
11,221 |
|
|
|
|
|
Net income and comprehensive income
|
|
|
|
|
|
|
|
|
|
|
7,751,087 |
|
|
|
7,751,087 |
|
|
$ |
7,751,087 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at November 30, 2005
|
|
$ |
107,159 |
|
|
$ |
64,864,554 |
|
|
$ |
(37,131,060 |
) |
|
$ |
27,840,653 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See notes to financial statements
F-8
SOMANETICS CORPORATION
STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Years Ended November 30, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
CASH FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
$ |
7,751,087 |
|
|
$ |
8,706,576 |
|
|
$ |
72,586 |
|
|
Adjustments to reconcile net income to net cash provided by
(used in) operations:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax benefit
|
|
|
(3,300,000 |
) |
|
|
(6,700,000 |
) |
|
|
|
|
|
|
Intangible asset impairment
|
|
|
929,093 |
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
383,986 |
|
|
|
282,558 |
|
|
|
235,537 |
|
|
|
Compensation expense for consultant stock options
|
|
|
11,221 |
|
|
|
|
|
|
|
8,471 |
|
|
|
Changes in assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable (increase)
|
|
|
(1,509,196 |
) |
|
|
(3,929 |
) |
|
|
(790,830 |
) |
|
|
|
Inventory (increase)
|
|
|
(859,312 |
) |
|
|
(158,611 |
) |
|
|
(456,579 |
) |
|
|
|
Prepaid expenses (increase)
|
|
|
(365,410 |
) |
|
|
(134,690 |
) |
|
|
(26,895 |
) |
|
|
|
Accounts payable increase (decrease)
|
|
|
183,699 |
|
|
|
(112,135 |
) |
|
|
170,352 |
|
|
|
|
Accrued liabilities increase
|
|
|
462,485 |
|
|
|
353,562 |
|
|
|
156,781 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) operating activities
|
|
|
3,687,653 |
|
|
|
2,233,331 |
|
|
|
(630,577 |
) |
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquisition of property and equipment (net)
|
|
|
(134,637 |
) |
|
|
(84,003 |
) |
|
|
(50,665 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net cash (used in) investing activities
|
|
|
(134,637 |
) |
|
|
(84,003 |
) |
|
|
(50,665 |
) |
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of Common Shares
|
|
|
2,525,679 |
|
|
|
2,681,022 |
|
|
|
538,626 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities
|
|
|
2,525,679 |
|
|
|
2,681,022 |
|
|
|
538,626 |
|
|
|
|
|
|
|
|
|
|
|
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
|
|
6,078,695 |
|
|
|
4,830,350 |
|
|
|
(142,616 |
) |
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD
|
|
|
7,069,542 |
|
|
|
2,239,192 |
|
|
|
2,381,808 |
|
|
|
|
|
|
|
|
|
|
|
CASH AND CASH EQUIVALENTS, END OF PERIOD
|
|
$ |
13,148,237 |
|
|
$ |
7,069,542 |
|
|
$ |
2,239,192 |
|
|
|
|
|
|
|
|
|
|
|
Supplemental Disclosure of Non cash investing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Demonstration and no capital cost sales equipment capitalized
from inventory (Note 2)
|
|
$ |
484,121 |
|
|
$ |
565,962 |
|
|
$ |
370,623 |
|
|
Issuance of warrants and stock options in connection with
license acquisition (Note 2)
|
|
$ |
|
|
|
$ |
|
|
|
$ |
44,793 |
|
See notes to financial statements
F-9
SOMANETICS CORPORATION
NOTES TO FINANCIAL STATEMENTS
|
|
1. |
Organization and Operations |
We are a Michigan corporation that was formed in 1982. We
develop, manufacture and market the
INVOS®
System, a non-invasive patient monitoring system that
continuously measures changes in blood oxygen levels. The
principal markets for our products are the United States,
Europe, and Japan. The INVOS System, based on our In Vivo
Optical Spectroscopy, or INVOS, technology, is used to measure
changes in regional blood oxygen saturation in the brain and in
somatic, or skeletal muscle, tissue in regions of the body other
than the brain. The INVOS System measurement is made by
transmitting low-intensity visible and near-infrared light
through a portion of the body with sensors, called SomaSensors,
and detecting the manner in which the exposed substance
interacts with light at specific wavelengths.
In June 1996 we received clearance from the FDA to market our
model 3100A INVOS System in the United States, and in
October 1997 we received clearance from the FDA to market
enhancements to our INVOS System in the United States. In
September 2000 we received FDA clearance to market our latest
model INVOS System in the United States, which has the added
capability of being able to monitor pediatric patients. In
November 2005, we received FDA clearance to market the INVOS
System to monitor changes in blood oxygen saturation in skeletal
muscle tissue in regions of the body other than the brain in
patients with or at risk for restricted blood flow.
We also develop and market the
CorRestore®
System, including the CorRestore Patch, for use in cardiac
repair and reconstruction, including heart surgeries called
surgical ventricular restoration, or SVR. In 2000, we entered
into a license agreement with the inventors of the CorRestore
System and their company, CorRestore LLC, granting us exclusive,
worldwide, royalty-bearing licenses to specified rights relating
to the CorRestore System and related products and accessories
for SVR (Note 2).
In November 2001, we received clearance from the FDA to market
the CorRestore Patch in the United States. In April 2003, we met
the requirements to use the CE Mark for the CorRestore
Patch, which allows us to market the CorRestore System in the
European Economic Community. However, in September 2004, the
European Economic Community changed its regulations, limiting
approval authority for animal tissue implant products sold in
Europe to some independent registration agencies that do not
include our registrar. Refer to Note 2 for a discussion of
the impairment of the CorRestore license acquisition cost
intangible asset.
|
|
2. |
Summary of Significant Accounting Policies |
Cash Equivalents consist of short-term,
interest-bearing investments maturing within three months of our
acquisition of them.
Inventory is stated at the lower of cost or market
on a first-in,
first-out (FIFO) basis. Inventory consists of:
|
|
|
|
|
|
|
|
|
|
|
|
November 30, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
Purchased components
|
|
$ |
652,876 |
|
|
$ |
323,053 |
|
Finished goods
|
|
|
352,560 |
|
|
|
358,815 |
|
Work in process
|
|
|
52,665 |
|
|
|
1,042 |
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
1,058,101 |
|
|
$ |
682,910 |
|
|
|
|
|
|
|
|
Property and Equipment are stated at cost.
Depreciation and amortization are computed using the
straight-line method over the estimated useful lives of the
assets, which range from two to five years. Depreciation expense
was $377,074, $275,646 and $228,625 for the fiscal years ended
November 30, 2005, November 30, 2004 and
November 30, 2003, respectively. We offer to our United
States customers a no
F-10
SOMANETICS CORPORATION
NOTES TO FINANCIAL STATEMENTS (Continued)
capital cost sales program whereby we ship the INVOS System
monitor to the customer at no charge. The INVOS System monitors
that are shipped to our customers are classified as no capital
cost sales equipment and are depreciated over five years. As of
November 30, 2005, we have capitalized $1,916,655 in costs
for INVOS System monitors being used as demonstration and no
capital cost sales equipment, and these assets had a net book
value of $1,096,730. As of November 30, 2004, we have
capitalized approximately $1,628,000 in costs for INVOS System
monitors being used as demonstration and no capital cost sales
equipment, and these assets had a net book value of
approximately $901,000. Property and equipment are reviewed for
impairment whenever events or changes in circumstances indicate
that the net book value of the asset may not be recovered.
Intangible Assets consist of patents and
trademarks, and license acquisition costs. Patents and
trademarks are recorded at cost and are being amortized on the
straight-line method over 17 years. The carrying amount and
accumulated amortization of these patents and trademarks is as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
November 30, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
Patents and trademarks
|
|
$ |
111,733 |
|
|
$ |
111,733 |
|
Less: accumulated amortization
|
|
|
(94,812 |
) |
|
|
(87,900 |
) |
|
|
|
|
|
|
|
|
Total
|
|
$ |
16,921 |
|
|
$ |
23,833 |
|
|
|
|
|
|
|
|
Amortization expense was $6,912 for the fiscal years ended
November 30, 2005, November 30, 2004, and
November 30, 2003. Amortization expense for each of the
next two fiscal years is expected to be approximately
$6,900 per year, and approximately $3,100 in
fiscal 2008.
License acquisition costs related to our acquisition of
exclusive, worldwide, royalty-bearing licenses to specified
rights relating to the CorRestore System, and related products
and accessories. On June 2, 2000, we entered into a License
Agreement with the inventors and their company, CorRestore LLC,
granting us exclusive, worldwide, royalty-bearing licenses to
specified rights relating to the CorRestore System and related
products and accessories for SVR. Pursuant to the license
agreement, CorRestore LLC has agreed to provide various
consulting services to us. We have agreed to pay all of the
expenses of such consultation, of clinical testing of the
CorRestore System, training doctors in SVR and training our
personnel and customers in the use of the CorRestore System.
In exchange for the licenses and consulting services, we agreed
to the following compensation for CorRestore LLC and its agent,
Joe B. Wolfe: (1) a royalty of 10 percent of our
net sales of products subject to the licenses,
(2) five-year warrants to purchase up to
400,000 common shares at $3.00 per share, exercisable to
purchase 300,000 shares immediately and to purchase an
additional 50,000 shares upon our receipt of clearance or
approval from the FDA to market the CorRestore Patch in the
United States and another 50,000 shares upon our receipt of
CE certification for the CorRestore System, (3) additional
five-year warrants to purchase up to 2,100,000 common
shares at $3.00 per share, granted when we received clearance
from the FDA to market the CorRestore Patch in the United
States, exercisable based on our cumulative net sales of the
CorRestore System products, and (4) a consulting fee of
$25,000 a year to each of the two inventors until we sell 1,000
CorRestore Patches. In April 2004, CorRestore LLC exercised its
warrant to purchase 380,000 of our newly-issued common
shares, at $3.00 per share, for proceeds of $1,140,000. In
May 2005, Joe B. Wolfe, agent for CorRestore LLC and one of our
former directors, purchased 20,000 common shares under his
warrants by a cashless exercise. As a result of this cashless
exercise, we issued 16,264 common shares to Mr. Wolfe,
retaining 3,736 common shares in payment of the exercise
price.
License acquisition costs consist of professional service fees
recorded at cost, our estimate of the fair value of the ten-year
vested stock options to purchase 50,000 common shares at
$3.00 per share granted to
F-11
SOMANETICS CORPORATION
NOTES TO FINANCIAL STATEMENTS (Continued)
one of our then current directors in connection with negotiating
and assisting us in completing the transaction, and our estimate
of the fair value of the 400,000 common share vested
portion of the five-year warrants to purchase common shares at
$3.00 per share issued in the transaction. Consistent with the
treatment of the vested warrants to purchase common shares, we
intend to include in license acquisition costs, and additional
paid in capital, the fair value of the vested portion of the
unvested warrants to purchase common shares, estimated using the
Black-Scholes valuation model, when and if they become vested.
However, we do not expect any of these remaining warrants to
become vested before their November 21, 2006 expiration
date, based on sales of CorRestore products to date.
We estimated the value of the stock options to
purchase 50,000 common shares using the Black-Scholes
valuation model with the following assumptions: expected
volatility (the measure by which the stock price has fluctuated
or is expected to fluctuate during the period)
111.16 percent, risk-free interest rate of
7.5 percent, expected life of 4 years and dividend
yield of 0 percent. We estimated the value of the warrants
to purchase 300,000 common shares that vested immediately
in this transaction using the Black-Scholes valuation model with
the following assumptions: expected volatility (the measure by
which the stock price has fluctuated or is expected to fluctuate
during the period) 111.16 percent, risk-free interest rate
of 7.5 percent, expected life of 5 years and dividend
yield of 0 percent. We estimated the value of the warrants
to purchase 50,000 common shares that vested upon receipt
of FDA clearance in November 2001 using the Black-Scholes
valuation model with the following assumptions: expected
volatility (the measure by which the stock price has fluctuated
or is expected to fluctuate during the period)
100.68 percent, risk-free interest rate of
4.0 percent, expected life of 42 months and dividend
yield of 0 percent. We estimated the value of the warrants
to purchase 50,000 common shares that vested upon receipt
of CE Mark certification in April 2003 using the Black-Scholes
valuation model with the following assumptions: expected
volatility (the measure by which the stock price has fluctuated
or is expected to fluctuate during the period)
64.70 percent, risk-free interest rate of 2.0 percent,
expected life of 25 months and dividend yield of
0 percent.
In June 2001, the Financial Accounting Standards Board issued
Statement of Financial Accounting Standards No. 142,
Goodwill and Other Intangible Assets. This statement
establishes accounting and reporting standards for goodwill and
other intangible assets. We adopted this statement in the first
quarter of fiscal 2002. The effect of adopting this statement
has been to discontinue amortizing our license acquisition costs
related to our acquisition of exclusive, worldwide,
royalty-bearing licenses to specified rights relating to the
CorRestore System and related products and accessories described
above because we believe these licenses have an indefinite life.
The carrying amount and accumulated amortization of these
license acquisition costs is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
November 30, | |
|
|
| |
|
|
2005 |
|
2004 | |
|
|
|
|
| |
License acquisition costs
|
|
$ |
|
|
|
$ |
1,258,163 |
|
Less: accumulated amortization
|
|
|
|
|
|
|
(329,070 |
) |
|
|
|
|
|
|
|
|
Total
|
|
$ |
|
|
|
$ |
929,093 |
|
|
|
|
|
|
|
|
In November 2005, we wrote off the remaining CorRestore license
acquisition cost intangible asset, based on the cash flow
impairment analysis that was performed, the declining sales of
CorRestore products and the uncertainty regarding future
prospective, randomized clinical data. Management does not
expect net positive future cash flow from the CorRestore
product. This impairment expense has been recognized in selling,
general and administrative expenses in the financial statements.
Revenue Recognition occurs when there is
persuasive evidence of an arrangement with the customer, the
product has been delivered, the sales price is fixed or
determinable, and collectibility is reasonably
F-12
SOMANETICS CORPORATION
NOTES TO FINANCIAL STATEMENTS (Continued)
assured. The product is considered delivered to the customer
once we have shipped it, as this is when title and risk of loss
have transferred.
Research, Development and Engineering costs are
expensed as incurred.
Net Income (Loss) Per Common Share basic and
diluted is computed using the weighted average number of
common shares outstanding during each period. Weighted average
shares outstanding diluted, for the years ended
November 30, 2005, November 30, 2004 and
November 30, 2003, include the potential dilution that
could occur for common stock issuable under stock options or
warrants. As of November 30, 2005, 2004 and 2003, the
difference between weighted average shares diluted
and weighted average shares basic is calculated as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
Weighted average shares basic
|
|
|
10,322,226 |
|
|
|
9,780,104 |
|
|
|
9,113,854 |
|
Add: effect of dilutive common shares and warrants
|
|
|
1,475,573 |
|
|
|
1,543,168 |
|
|
|
352,984 |
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares diluted
|
|
|
11,797,799 |
|
|
|
11,323,272 |
|
|
|
9,466,838 |
|
At November 30, 2005, there were no stock options
outstanding that were excluded from the computation of net
income per common share diluted, at
November 30, 2004, there were approximately 500 stock
options outstanding that were excluded from the computation of
net income per common share diluted, and at
November 30, 2003 there were approximately
99,000 stock options outstanding that were excluded from
the computation of net income per common share
diluted, as the exercise price of these options exceeded the
average price per share of our common stock. In addition, there
were approximately 2,100,000 warrants outstanding that were
excluded from the computation, as the warrants are contingent on
achieving specified future sales targets that we do not expect
to achieve. As of November 30, 2005, we had outstanding
4,014,232 warrants and options to purchase common shares,
as of November 30, 2004, we had outstanding 4,436,315
warrants and options to purchase common shares, and as of
November 30, 2003, we had outstanding
5,308,819 warrants and options to purchase common shares.
Accounting Pronouncements In December 2002, the
Financial Accounting Standards Board issued Statement of
Financial Accounting Standards No. 148, Accounting
for Stock-Based Compensation Transition and
Disclosure. This Statement, which is effective for fiscal
years ending after December 15, 2002, amends Statement
No. 123, Accounting for Stock-Based
Compensation, and provides alternative methods of
transition for a voluntary change to the fair value based method
of accounting for stock-based compensation. In addition,
Statement No. 148 amends the disclosure requirements of
Statement No. 123 regardless of the accounting method used
to account for stock-based compensation. We have chosen to
continue to account for stock-based compensation of employees
using the intrinsic value method prescribed in Accounting
Principles Board Opinion No. 25, Accounting for Stock
Issued to Employees, and related interpretations. However,
we adopted the enhanced disclosure provisions as defined by
Statement No. 148 beginning with our fiscal quarter ended
February 28, 2003 (Note 7).
In December 2004, the Financial Accounting Standards Board
issued Statement of Financial Accounting Standards No. 123
(revised), Share Based Payment. This Statement revises Statement
No. 123, Accounting for Stock-Based
Compensation, and requires that compensation costs related
to share-based payment transactions, including stock options,
restricted stock and restricted stock units be recognized in the
financial statements. This Statement will be effective for our
fiscal quarter beginning December 1, 2005.
In November 2005, we approved the acceleration of vesting of all
unvested stock options as of November 30, 2005. The primary
purpose of this accelerated vesting was to eliminate
compensation expense we would recognize in our results of
operations upon the adoption of SFAS 123R, which is
effective for our fiscal quarter beginning December 1,
2005. After the effects of the accelerated vesting,
F-13
SOMANETICS CORPORATION
NOTES TO FINANCIAL STATEMENTS (Continued)
the initial adoption of SFAS 123R is expected to be
immaterial. However, the issuance of additional stock
compensation under the 2005 Stock Incentive Plan in future years
will have an additional impact on our financial statements.
Use Of Estimates The preparation of financial
statements in conformity with generally accepted accounting
principles requires us to make estimates and assumptions that
affect the reported amounts of assets and liabilities, the
disclosure of contingent assets and liabilities, and the
reported amounts of revenues and expenses for each fiscal
period. Actual results could differ from those estimated.
Reclassifications Certain reclassifications have
been made to the financial statements for 2004 and 2003 to
conform to 2005 presentation.
|
|
3. |
Stock Offerings and Common Shares |
On March 6, 2000, we entered into the Private Equity Line
Agreement with Kingsbridge Capital Limited, a private
institutional investor, which was subsequently terminated on
April 10, 2001. In connection with the Private Equity Line
Agreement, we issued to Kingsbridge Capital warrants which
entitled the holder to purchase 205,097 common shares,
after adjustment for the April 2001 private placement and the
January 2002 public offering, at a purchase price of
$4.25 per share. The exercise price of the warrants was
payable either in cash or by a cashless exercise.
In November 2003, Kingsbridge purchased 100,000 common
shares under the warrants by a cashless exercise. As a result of
this cashless exercise, we issued 53,603 common shares to
Kingsbridge, retaining 46,397 common shares in payment of
the exercise price. In March 2004, Kingsbridge Capital Limited
purchased 40,000 common shares under its warrants by a
cashless exercise. As a result of this cashless exercise, we
issued 24,097 common shares to Kingsbridge, retaining
15,903 common shares in payment of the exercise price. In
May 2004, Kingsbridge Capital Limited purchased the remaining
65,097 common shares under its warrants by a cashless
exercise. As a result of this cashless exercise, we issued
47,475 common shares to Kingsbridge, retaining
17,622 common shares in payment of the exercise price.
Kingsbridge now has no warrants remaining to
purchase common shares.
On April 9, 2001, we completed the private placement of
newly-issued common shares for which Brean Murray &
Co., Inc., as our exclusive placement agent, received warrants
to purchase 25,000 common shares at $2.10 per
share. In October 2003, Brean Murray & Co., Inc.
transferred the 25,000 warrants to persons who are or were
employees of Brean Murray & Co., Inc., and in November
2003, those persons exercised the warrants to purchase all
25,000 common shares under the warrants by a cashless
exercise. As a result of this cashless exercise, we issued
18,832 restricted common shares to those individuals,
retaining 6,168 common shares in payment of the exercise
price, and no more common shares remain subject to these
warrants.
On January 16, 2002, we completed a public offering of
1,000,000 newly-issued common shares at a price of
$4.25 per share, for gross proceeds of $4,250,000. Our
estimated net proceeds, after deducting the placement
agents commission and the estimated expenses of the
offering, were approximately $3,680,000. Brean Murray &
Co., Inc. was our placement agent for the offering and received
for its services (1) $340,000 as a placement agent fee, and
(2) warrants to purchase 100,000 common shares at
$5.10 per share exercisable during the four-year period
beginning January 11, 2003. In June 2004, Brean
Murray & Co., Inc. purchased 100,000 common shares
under these warrants by a cashless exercise. As a result of this
cashless exercise, we issued 66,265 common shares to Brean
Murray & Co., Inc., retaining 33,735 common shares
in payment of the exercise price. Brean Murray & Co.,
Inc. now has no warrants remaining to purchase common
shares.
Pursuant to the CorRestore License Agreement, CorRestore, LLC
and its agent, Joe B. Wolfe, received warrants to
purchase 400,000 common shares exercisable at
$3.00 per share until June 2, 2005,
F-14
SOMANETICS CORPORATION
NOTES TO FINANCIAL STATEMENTS (Continued)
and received warrants to purchase an additional
2,100,000 common shares exercisable at $3.00 per share
until November 21, 2006, dependent upon our cumulative net
sales of CorRestore products. In April 2004, CorRestore LLC
exercised its warrant to purchase 380,000 of our
newly-issued common shares, at $3.00 per share, for
proceeds of $1,140,000. In May 2005, Joe B. Wolfe, agent for
CorRestore LLC and one of our former directors, purchased
20,000 common shares under his warrants by a cashless
exercise. As a result of this cashless exercise, we issued
16,264 common shares to Mr. Wolfe, retaining
3,736 common shares in payment of the exercise price. As of
November 30, 2005, the 2,100,000 warrants remain
outstanding, but the sales requirements for exercise of those
warrants have not been met and we do not expect that they will
be met.
During fiscal 2005, we issued 561,839 common shares as a
result of stock option exercises, for proceeds of $2,525,679.
During fiscal 2004, we issued 321,276 common shares as a
result of stock option exercises by employees, directors and
former employees, for proceeds of $1,541,022. During fiscal
2003, we issued 148,371 common shares as a result of stock
option exercises by employees, directors and former employees,
for proceeds of $538,626.
Common shares reserved for future issuance upon exercise of
stock options and warrants as discussed above at
November 30, 2005, are as follows:
|
|
|
|
|
|
1991 Incentive Stock Option Plan
|
|
|
14,663 |
|
1993 Director Stock Option Plan
|
|
|
500 |
|
1997 Stock Option Plan
|
|
|
1,731,754 |
|
2005 Stock Incentive Plan
|
|
|
600,000 |
|
Options Granted Independent of Option Plans
|
|
|
73,100 |
|
License Acquisition Warrants
|
|
|
2,100,000 |
|
|
|
|
|
|
Total shares reserved for future issuance
|
|
|
4,520,017 |
|
|
|
|
|
Accrued liabilities consist of the following:
|
|
|
|
|
|
|
|
|
|
|
|
November 30, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
Incentive Compensation
|
|
$ |
701,658 |
|
|
$ |
390,978 |
|
Sales Commissions
|
|
|
352,459 |
|
|
|
153,180 |
|
401(k) Match
|
|
|
42,164 |
|
|
|
97,071 |
|
Clinical Research
|
|
|
21,675 |
|
|
|
|
|
Warranty
|
|
|
16,850 |
|
|
|
10,750 |
|
Royalty
|
|
|
13,788 |
|
|
|
9,130 |
|
Taxes
|
|
|
11,375 |
|
|
|
|
|
Professional Fees
|
|
|
5,625 |
|
|
|
42,000 |
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
1,165,594 |
|
|
$ |
703,109 |
|
|
|
|
|
|
|
|
Deferred income taxes reflect the estimated future tax effect of
(1) temporary differences between the amount of assets and
liabilities for financial reporting purposes and such amounts as
measured by tax laws and regulations and (2) net operating
loss and tax credit carryforwards. Our deferred tax assets
F-15
SOMANETICS CORPORATION
NOTES TO FINANCIAL STATEMENTS (Continued)
primarily represent the tax benefit of net operating loss
carryforwards and research and general business tax credit
carryforwards. We had deferred tax assets of approximately
$18,321,000 as of November 30, 2005, partially offset by
valuation allowances of approximately $8,321,000, due to the
uncertainty of utilizing such assets against future earnings,
prior to their expiration. Our deferred tax assets include
approximately $4,236,000, with a full valuation allowance,
related to the exercise of stock options. If realized in the
future, these tax benefits will be recognized in additional paid
in capital. As of November 30, 2004, we had deferred tax
assets of approximately $16,657,000, partially offset by
valuation allowances of approximately $9,957,000, due to the
uncertainty of utilizing such assets against future earnings,
prior to their expiration. We have used a statutory income tax
rate of 34 percent when calculating our deferred tax
assets. We have paid no income taxes for fiscal 2005 or
fiscal 2004.
The components of deferred income tax assets as of
November 30, 2005 and 2004 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
November 30, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
|
|
(In thousands) | |
Net operating loss carryforwards
|
|
$ |
17,620 |
|
|
$ |
16,216 |
|
Other
|
|
|
91 |
|
|
|
90 |
|
Basis difference of fixed assets and intangibles
|
|
|
167 |
|
|
|
(92 |
) |
Research and general business tax credit carryforwards
|
|
|
43 |
|
|
|
443 |
|
|
|
|
|
|
|
|
|
Subtotal
|
|
|
18,321 |
|
|
|
16,657 |
|
Valuation allowance
|
|
|
(8,321 |
) |
|
|
(9,957 |
) |
|
|
|
|
|
|
|
|
Deferred tax asset
|
|
$ |
10,000 |
|
|
$ |
6,700 |
|
|
|
|
|
|
|
|
The items accounting for the difference between income taxes
computed at the federal statutory rate and the provision for
income taxes are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Fiscal Year Ended November 30, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
Taxes at U.S. statutory rate 34 percent
|
|
$ |
1,513,370 |
|
|
$ |
682,236 |
|
|
$ |
24,679 |
|
Nondeductible meals and entertainment
|
|
|
24,050 |
|
|
|
15,109 |
|
|
|
9,531 |
|
Change in valuation allowance
|
|
|
(4,837,420 |
) |
|
|
(7,397,345 |
) |
|
|
(34,210 |
) |
|
|
|
|
|
|
|
|
|
|
Income tax expense (benefit) from continuing operations
|
|
$ |
(3,300,000 |
) |
|
$ |
(6,700,000 |
) |
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
Effective tax rate
|
|
|
(74.1 |
)% |
|
|
(333.9 |
)% |
|
|
0 |
% |
|
|
|
|
|
|
|
|
|
|
We have performed the required assessment of positive and
negative evidence regarding realization of our deferred tax
assets in accordance with SFAS No. 109,
Accounting for Income Taxes, including our past
operating results, the existence of cumulative losses over our
history up to the most recent three fiscal years and our
forecast for future net income. Our assessment of our deferred
tax assets, and the reversal of part of our valuation allowance,
included assuming that our net revenues and pre-tax income will
grow in future years consistent with the growth guidance given
for fiscal 2006 and making allowance for the uncertainties
surrounding, among other things, our future rate of growth in
net revenues, the rate of adoption of our products in the
marketplace and the potential for competition to enter the
marketplace. In reversing a portion of our valuation allowance,
we have concluded that it is more likely than not that our net
deferred tax assets will be realized.
For the fiscal year ended November 30, 2005, we recorded a
net income tax benefit of $3,300,000, which consisted on income
tax expense recorded at an estimated effective tax rate of
34 percent in the
F-16
SOMANETICS CORPORATION
NOTES TO FINANCIAL STATEMENTS (Continued)
amount of $1,261,223 for the first three quarters of fiscal 2005
and a deferred tax benefit of $4,561,223 recorded in the fourth
quarter of fiscal 2005. For the fiscal year ended
November 30, 2004, our income tax benefit of $6,700,000
consisted entirely of deferred tax benefits. We had no current
or deferred income tax expense or benefit for the fiscal year
ended November 30, 2003.
As of November 30, 2005, net operating loss carryforwards
of approximately $51.8 million were available for Federal
income tax purposes for future years. Our ability to use the net
operating loss carryforwards incurred on or before
March 27, 1991 (the date we completed our initial public
offering) is limited to approximately $296,000 per year.
Research and business general tax credits of approximately
$443,000 are also available to offset future taxes. These losses
and credits expire, if unused, at various dates from 2005
through 2025.
Use of our net operating loss carryforwards, tax credit
carryforwards and certain future deductions could be restricted,
in the event of future changes in our equity structure, by
provisions contained in the Tax Reform Act of 1986.
|
|
6. |
Commitments and Contingencies |
We have a lease agreement for a 23,392 square foot,
stand-alone office, assembly and warehouse facility. The current
lease, as amended, expires December 31, 2009.
Operating lease expense for the years ended November 30,
2005, 2004 and 2003 was approximately $162,800, $204,000, and
$216,000, respectively. Approximate future minimum lease
commitments are as follows:
|
|
|
|
|
|
Year Ending November 30, |
|
|
|
|
|
2006
|
|
$ |
140,400 |
|
2007
|
|
|
142,900 |
|
2008
|
|
|
145,800 |
|
2009
|
|
|
148,700 |
|
2010
|
|
|
12,400 |
|
|
|
|
|
|
Total
|
|
$ |
590,200 |
|
|
|
|
|
In December 1991, we amended and restated our profit sharing
plan to include a 401(k) plan covering substantially all
employees. Under provisions of the plan, participants may
contribute, annually, between 1 percent and 25 percent
of their compensation. In November 2004, our board of directors
approved a discretionary contribution to the 401(k) Plan, as
soon as practicable after December 31, 2004, equal to $2
for every $1 contributed by Company employees to the 401(k) Plan
during calendar 2004, up to a Company contribution of
4 percent of the employees compensation, and also
approved matching contributions to the 401(k) Plan equal to $2
for every $1 contributed by Company employees to the 401(k) Plan
at each payroll date on or after January 1, 2005, up to a
Company contribution of 4 percent of the employees
compensation, and continuing until terminated by further action
of the board of directors. In addition, at the discretion of the
board of directors, we may make other annual discretionary
contributions to the plan. Matching contributions made for
fiscal 2005 were approximately $202,000. The discretionary
contribution made in February 2005, for calendar 2004, was
approximately $113,000. We did not make any matching or
discretionary contributions to the plan for the year ended
November 30, 2003.
As of November 30, 2005, we have employment agreements or
change in control, invention, confidentiality, non-compete and
non-solicitation agreements with all of our executive officers.
The employment agreement with our Vice President, Sales and
Marketing and the change in control agreements with five of our
executive officers provide for severance benefits equal to one
years salary
F-17
SOMANETICS CORPORATION
NOTES TO FINANCIAL STATEMENTS (Continued)
upon termination of employment without cause or for good reason
90 days before to one year after a change in control of the
Company that occurs by June 13, 2008, June 29, 2008
for one executive. The employment agreement with our President
and Chief Executive Officer provides for severance benefits
equal to one years salary and six months of benefits upon
termination of his employment without cause or if his employment
terminates because his agreement expires. His employment
agreement expires April 30, 2006 unless earlier terminated
as provided in the agreement. All executive officers have agreed
not to compete with us and not to solicit our employees during
specified periods following the termination of employment, and
they have agreed to various confidentiality obligations. The
estimated financial exposure of these employment agreements,
upon a change of control of the Company and termination of all
of the executives without cause, is approximately $934,000.
We may become subject to product liability claims by patients or
physicians, and may become a defendant in product liability or
malpractice litigation. We have obtained product liability
insurance and an umbrella policy. We might not be able to
maintain such insurance or such insurance might not be
sufficient to protect us against product liability.
In February 1991 and January 1997, we adopted stock option
plans, and in February 2005, we adopted a stock incentive plan,
for our key employees, directors, consultants and advisors and,
under the 2005 plan, independent contractors and agents. The
stock option plans provide for our issuance of options to
purchase a maximum of 115,000 common shares under the 1991 plan
and 2,560,000 common shares under the 1997 plan. The 2005 plan
permits us to grant stock options, including both nonqualified
options and incentive options, restricted stock and restricted
stock units, up to 600,000 common shares. In addition, we
granted options to employees independent of the plans. Options
granted generally have a
10-year life, and vest
over a three-year period, except the options granted in 2005
vested on November 30, 2005. Awards and expirations under
the 1991 plan, 1997 plan, 2005 plan and independent of the plans
during the years ended November 30, 2005, 2004 and 2003 are
listed below.
At November 30, 2005, no additional options may be granted
under the 1991 plan, 5,501 common shares were available for
options to be granted under the 1997 plan, and 500,284 common
shares were available to be granted or awarded under the 2005
plan.
In January 1993, we adopted the Somanetics Corporation
1993 Director Stock Option Plan. The directors plan
provided up to 24,000 common shares for the grant of options to
each director who was not one of our officers or employees. In
January 1998, our board of directors terminated the directors
plan, except as to options previously granted under the
directors plan. Therefore, no additional options may be granted
under the directors plan.
In October 1995, SFAS No. 123, Accounting for
Stock-Based Compensation, was issued. In December 2004,
the Financial Accounting Standards Board issued Statement of
Financial Accounting Standards No. 123 (revised), Share
Based Payment. This Statement revises Statement No. 123,
Accounting for Stock-Based Compensation, and
requires that compensation costs related to share-based payment
transactions, including stock options, be recognized in the
financial statements. This Statement will be effective for our
fiscal quarter beginning December 1, 2005.
We currently account for stock-based compensation of employees
using the intrinsic value method prescribed in Accounting
Principles Board Opinion No. 25, Accounting for Stock
Issued to Employees, and related interpretations.
Accordingly, compensation costs for stock options granted to
employees are measured as the excess, if any, of the market
price of our stock at the date of the grant over the amount an
employee must pay to acquire the stock. No compensation expense
has been charged against income for stock option grants to
employees for fiscal 2005, 2004 and 2003.
F-18
SOMANETICS CORPORATION
NOTES TO FINANCIAL STATEMENTS (Continued)
In November 2005, we approved the acceleration of vesting of all
unvested stock options as of November 30, 2005. The primary
purpose of this accelerated vesting was to eliminate
compensation expense we would recognize in our results of
operations upon the adoption of SFAS 123R, which is
effective for our fiscal quarter beginning December 1,
2005. After the effects of the accelerated vesting, the initial
adoption of SFAS 123R is expected to be immaterial.
However, the issuance of additional stock compensation under the
2005 Stock Incentive Plan in future years will have an
additional impact on our financial statements.
Stock-based compensation of consultants and advisors is
determined based on the fair value of the options or warrants on
the grant date pursuant to the methodology of
SFAS No. 123, estimated using the Black-Scholes model
with the assumptions described in the next paragraph. The
resulting amount is recognized as compensation expense and an
increase in additional paid-in capital over the vesting period
of the options or warrants. As a result, we recorded $11,221 of
compensation expense, and an equal increase in additional paid
in capital, for stock options issued to non-employees in fiscal
2005, and $8,471 of compensation expense in fiscal 2003. We
recorded no such expense in fiscal 2004.
Had compensation expense for our stock options granted to
employees been determined based on the fair value of the options
on the grant date pursuant to the methodology of
SFAS No. 123, our results of operations on a pro forma
basis would have been as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Fiscal Year Ended November 30, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
Net income
|
|
$ |
7,751,087 |
|
|
$ |
8,706,576 |
|
|
$ |
72,586 |
|
Add: Stock-based employee compensation included in actual net
income
|
|
|
11,221 |
|
|
|
0 |
|
|
|
8,471 |
|
Deduct: Total stock-based employee compensation, had fair value
method been applied
|
|
|
(1,804,000 |
) |
|
|
(796,000 |
) |
|
|
(962,000 |
) |
|
|
|
|
|
|
|
|
|
|
Pro-forma net income (loss)
|
|
$ |
5,958,308 |
|
|
$ |
7,911,576 |
|
|
$ |
(880,943 |
) |
|
|
|
|
|
|
|
|
|
|
Net income per common share diluted
|
|
|
$.66 |
|
|
|
$.77 |
|
|
|
$.01 |
|
Pro-forma net income (loss) per common share
diluted, had fair value method been applied
|
|
|
$.51 |
|
|
|
$.70 |
|
|
|
$(.09 |
) |
The fair value of each option grant is estimated on the date of
grant using the Black-Scholes option-pricing model with the
following weighted-average assumptions used for 2005, 2004 and
2003: expected volatility (the measure by which the stock price
has fluctuated or is expected to fluctuate during the period)
57.00 percent for 2005 (61.00 percent for 2004 and
64.32 percent for 2003), risk-free interest rate of
4.0 percent for 2005 (4.0 percent for 2004 and 2003),
expected lives of 7 years for fiscal 2005 (7 years for
2004 and 2003) and dividend yield of 0 percent.
F-19
SOMANETICS CORPORATION
NOTES TO FINANCIAL STATEMENTS (Continued)
A summary of our stock option activity and related information
for the years ended November 30, 2005, 2004 and 2003 is as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
|
|
|
Weighted | |
|
|
|
Weighted | |
|
|
|
Weighted | |
|
|
|
|
Average | |
|
|
|
Average | |
|
|
|
Average | |
|
|
Common | |
|
Exercise | |
|
Common | |
|
Exercise | |
|
Common | |
|
Exercise | |
|
|
Shares | |
|
Price | |
|
Shares | |
|
Price | |
|
Shares | |
|
Price | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
Options outstanding
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 1,
|
|
|
2,316,315 |
|
|
$ |
3.83 |
|
|
|
2,603,722 |
|
|
$ |
3.89 |
|
|
|
2,332,753 |
|
|
$ |
4.04 |
|
|
Options granted
|
|
|
168,257 |
|
|
|
13.79 |
|
|
|
53,500 |
|
|
|
10.23 |
|
|
|
471,000 |
|
|
|
3.75 |
|
|
Options exercised
|
|
|
(561,839 |
) |
|
|
4.50 |
|
|
|
(321,276 |
) |
|
|
4.79 |
|
|
|
(148,371 |
) |
|
|
3.63 |
|
|
Options canceled
|
|
|
(8,501 |
) |
|
|
8.29 |
|
|
|
(19,631 |
) |
|
|
13.94 |
|
|
|
(51,660 |
) |
|
|
10.08 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding November 30,
|
|
|
1,914,232 |
|
|
|
4.59 |
|
|
|
2,316,315 |
|
|
|
3.83 |
|
|
|
2,603,722 |
|
|
|
3.89 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable November 30,
|
|
|
1,914,232 |
|
|
$ |
4.59 |
|
|
|
1,827,008 |
|
|
$ |
3.91 |
|
|
|
1,784,482 |
|
|
$ |
4.27 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
A summary of the price ranges of our stock options outstanding
and exercisable as of November 30, 2005 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding | |
|
Options exercisable | |
|
|
| |
|
| |
|
|
|
|
Weighted | |
|
Weighted | |
|
|
|
Weighted | |
|
|
|
|
Average | |
|
Average | |
|
|
|
Average | |
|
|
Options | |
|
Exercise | |
|
Remaining | |
|
Options | |
|
Exercise | |
Range of Exercise Prices |
|
Outstanding | |
|
Price | |
|
Life (years) | |
|
Exercisable | |
|
Price | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
$1.70 $5.00
|
|
|
1,391,001 |
|
|
$ |
3.03 |
|
|
|
6.11 |
|
|
|
1,391,001 |
|
|
$ |
3.03 |
|
$5.01 $10.00
|
|
|
332,478 |
|
|
|
5.95 |
|
|
|
2.56 |
|
|
|
332,478 |
|
|
|
5.95 |
|
$10.01 $26.30
|
|
|
190,753 |
|
|
|
13.56 |
|
|
|
9.43 |
|
|
|
190,753 |
|
|
|
13.56 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
1,914,232 |
|
|
$ |
4.59 |
|
|
|
5.83 |
|
|
|
1,914,232 |
|
|
$ |
4.59 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8. |
Related Party Transactions |
In connection with our April 2001 private placement of common
shares, Brean Murray & Co., Inc. was our placement
agent and received for its services warrants to
purchase 25,000 common shares at $2.10 per share
exercisable during the four-year period beginning April 9,
2002. At the time, A. Brean Murray, one of our then current
directors, and his wife controlled Brean Murray & Co.,
Inc. In October 2003, Brean Murray & Co., Inc.
transferred the 25,000 warrants to persons who are or were
employees of Brean Murray & Co., Inc., and in November
2003, those persons exercised the warrants to purchase all
25,000 common shares under the warrants by a cashless exercise.
As a result of this cashless exercise, we issued 18,832
restricted common shares to those individuals, retaining 6,168
common shares in payment of the exercise price, and no common
shares remain subject to these warrants.
In connection with our CorRestore license, effective
November 21, 2001, we granted Joe B. Wolfe five-year
warrants to purchase 180,000 common shares, exercisable at
$3.00 per share. Mr. Joe B. Wolfe was one of our then
current directors. In May 2005, Joe B. Wolfe, agent for
CorRestore LLC and one of our former directors, purchased 20,000
common shares under his warrants by a cashless exercise. As a
result of this cashless exercise, we issued 16,264 common shares
to Mr. Wolfe, retaining 3,736 common shares in payment of
the exercise price. Mr. Wolfe has no vested warrants
remaining to purchase common shares.
F-20
SOMANETICS CORPORATION
NOTES TO FINANCIAL STATEMENTS (Continued)
In connection with our January 2002 public offering of common
shares, Brean Murray & Co., Inc. was our placement
agent and received for its services (1) $340,000 as a
placement agent fee, and (2) warrants to
purchase 100,000 common shares at $5.10 per share
exercisable during the four-year period beginning
January 11, 2003. In June 2004, Brean Murray &
Co., Inc. purchased 100,000 common shares under these warrants
by a cashless exercise. As a result of this cashless exercise,
we issued 66,265 common shares to Brean Murray & Co.,
Inc., retaining 33,735 common shares in payment of the exercise
price. Brean Murray & Co., Inc. now has no warrants
remaining to purchase common shares.
|
|
9. |
Major Customers and Foreign Sales |
Tyco Healthcare, part of Tyco International Ltd., our
international distributor in Europe, the Middle East, Africa and
Canada for our INVOS System, accounted for 11 percent of
net revenues for the fiscal year ended November 30, 2005,
and 12 percent of net revenues for the fiscal year ended
November 30, 2003.
Additionally, foreign net revenues for the fiscal year ended
November 30, 2005 were $3,303,692, for the fiscal year
ended November 30, 2004 were $2,091,602, and for the fiscal
year ended November 30, 2003 were $1,944,513.
We operate our business in one reportable segment, the
development, manufacture and marketing of medical devices. Each
of our two product lines have similar characteristics,
customers, distribution and marketing strategies, and are
subject to similar regulatory requirements. In addition, in
making operating and strategic decisions, our management
evaluates net revenues based on the worldwide net revenues of
each major product line, and profitability on an enterprise-wide
basis due to shared costs. Approximately 98 percent of our
net revenues in fiscal 2005 were derived from our INVOS System
product line, compared to 96 percent of our net revenues in
fiscal 2004 and 92 percent of our net revenues in fiscal
2003.
F-21
QUARTERLY INFORMATION (unaudited)
The following is a summary of our quarterly operating results
for the fiscal years ended November 30, 2005 and 2004:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quarter | |
|
|
| |
Year Ended November 30, 2005 |
|
First | |
|
Second | |
|
Third | |
|
Fourth | |
|
|
| |
|
| |
|
| |
|
| |
|
|
(In thousands, except per share data) | |
Net revenues
|
|
$ |
4,032,617 |
|
|
$ |
5,082,746 |
|
|
$ |
5,242,848 |
|
|
$ |
6,151,041 |
|
Gross margin
|
|
|
3,482,468 |
|
|
|
4,437,906 |
|
|
|
4,581,652 |
|
|
|
5,405,738 |
|
Net income
|
|
|
563,926 |
|
|
|
890,183 |
|
|
|
994,147 |
|
|
|
5,302,831 |
* |
Net income per common share basic
|
|
|
$0.06 |
|
|
|
$0.09 |
|
|
|
$0.10 |
|
|
|
$0.50 |
|
Net income per common share diluted
|
|
|
$0.05 |
|
|
|
$0.08 |
|
|
|
$0.08 |
|
|
|
$0.43 |
|
|
|
* |
Includes the effects of a reversal of $4,561,223 of our
valuation allowance, as described in Note 5 of Notes to
Financial Statements. Also includes an impairment expense of
$929,093 in connection with the write-off of our intangible
asset associated with the acquisition of the license for the
CorRestore System, as described in Note 2 of Notes to
Financial Statements. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended November 30, 2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues
|
|
$ |
2,670,265 |
|
|
$ |
3,032,976 |
|
|
$ |
3,076,373 |
|
|
$ |
3,829,001 |
|
Gross margin
|
|
|
2,149,872 |
|
|
|
2,513,660 |
|
|
|
2,632,536 |
|
|
|
3,262,294 |
|
Net income
|
|
|
292,744 |
|
|
|
409,730 |
|
|
|
539,722 |
|
|
|
7,464,380 |
** |
Net income per common share basic
|
|
|
$0.03 |
|
|
|
$0.04 |
|
|
|
$0.05 |
|
|
|
$0.74 |
|
Net income per common share diluted
|
|
|
$0.03 |
|
|
|
$0.04 |
|
|
|
$0.05 |
|
|
|
$0.64 |
|
|
|
** |
Includes the effects of a reversal of $6,700,000 of our
valuation allowance, as described in Note 5 of Notes to
Financial Statements. |
F-22
2,000,000 Shares
Common Shares
PROSPECTUS
,
2006
Citigroup
SG Cowen & Co.
SunTrust Robinson Humphrey
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
|
|
Item 14. |
Other Expenses of Issuance and Distribution |
The following table sets forth the estimated amounts of expenses
to be borne by us in connection with the issuance and
distribution of the securities being registered, other than
underwriting discounts and commissions:
|
|
|
|
|
|
Securities and Exchange Commission Registration Fee
|
|
$ |
7,003 |
|
NASD Filing Fee
|
|
|
7,045 |
|
The Nasdaq National Market Listing Fee
|
|
|
110,000 |
|
Printing and Engraving Expenses
|
|
|
50,000 |
|
Accounting Fees and Expenses
|
|
|
100,000 |
|
Legal Fees and Expenses
|
|
|
150,000 |
|
Blue Sky Fees and Expenses
|
|
|
20,000 |
|
Transfer Agents and Registrars Fees and Expenses
|
|
|
3,600 |
|
Miscellaneous Expenses
|
|
|
52,352 |
|
|
|
|
|
|
Total
|
|
$ |
500,000 |
|
|
|
|
|
All of these expenses, except the Securities and Exchange
Commission registration fee, the NASD filing fee and the Nasdaq
National Market listing fee, represent estimates only.
|
|
Item 15. |
Indemnification of Directors and Officers |
Under Sections 561-571 of the Michigan Business Corporation
Act directors and officers of a Michigan corporation may be
entitled to indemnification by the corporation against
judgments, expenses, fines and amounts paid by the director or
officer in settlement of claims brought against them by third
persons or by or in the right of the corporation if those
directors and officers acted in good faith and in a manner
reasonably believed to be in, or not opposed to, the best
interests of the corporation or its shareholders.
We are obligated under our bylaws and our employment agreement
with Bruce J. Barrett to indemnify our present or former
directors or officers and may indemnify any other person, to the
fullest extent now or hereafter permitted by law in connection
with any actual or threatened civil, criminal, administrative or
investigative action, suit or proceeding arising out of their
past or future service to us or a subsidiary, or to another
organization at our request or at the request of one of our
subsidiaries. In addition, our Restated Articles of
Incorporation limit certain personal liabilities of our
directors.
Reference is also made to Section 8 of the Underwriting
Agreement, a form of which is attached to this Registration
Statement as Exhibit 1.1, with respect to undertakings by
the underwriters to indemnify us, our directors and officers and
each person who controls us within the meaning of the Securities
Act of 1933 against certain civil liabilities, including certain
liabilities under the Securities Act of 1933.
We have obtained directors and officers liability
insurance. The policy provides for $2,000,000 in coverage
including prior acts dating to our inception and liabilities
under the Securities Act in connection with this offering.
II-1
See Exhibit Index immediately preceding the exhibits.
(a) The undersigned registrant hereby undertakes that, for
purposes of determining any liability under the Securities Act
of 1933, each filing of the registrants annual report
pursuant to section 13(a) or section 15(d) of the
Securities Exchange Act of 1934 that is incorporated by
reference in the registration statement shall be deemed to be a
new registration statement relating to the securities offered
therein, and the offering of such securities at that time shall
be deemed to be the initial bona fide offering thereof.
(b) Insofar as indemnification for liabilities arising
under the Securities Act of 1933 may be permitted to directors,
officers and controlling persons of the registrant pursuant to
the foregoing provisions, or otherwise, the registrant has been
advised that in the opinion of the Securities and Exchange
Commission, such indemnification is against public policy as
expressed in the Act and is, therefore, unenforceable. In the
event that a claim for indemnification against such liabilities
(other than the payment by the registrant of expenses incurred
or paid by a director, officer or controlling person of the
registrant in successful defense of any action, suit or
proceeding) is asserted by such director, officer or controlling
person in connection with the securities being registered, the
registrant will, unless in the opinion of its counsel the matter
has been settled by controlling precedent, submit to a court of
appropriate jurisdiction the question whether such
indemnification by it is against public policy as expressed in
the Act and will be governed by the final adjudication of such
issue.
(c) The undersigned Registrant hereby undertakes that:
|
|
|
(1) For purposes of determining any liability under the
Securities Act of 1933, the information omitted from the form of
prospectus filed as part of this registration statement in
reliance upon Rule 430A and contained in a form of
prospectus filed by the registrant pursuant to
Rule 424(b)(1) or (4) or 497(h) under the Securities
Act shall be deemed to be part of this registration statement as
of the time it was declared effective. |
|
|
(2) For the purpose of determining any liability under the
Securities Act of 1933, each post-effective amendment that
contains a form of prospectus shall be deemed to be a new
registration statement relating to the securities offered
therein, and the offering of such securities at that time shall
be deemed to be the initial bona fide offering thereof. |
II-2
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the
registrant certifies that it has reasonable grounds to believe
that it meets all of the requirements for filing on
Form S-3 and has
duly caused this amendment no. 1 to registration statement
to be signed on its behalf by the undersigned, thereunto duly
authorized, in the City of Troy, State of Michigan, on
February 8, 2006.
|
|
|
SOMANETICS CORPORATION |
|
(Registrant) |
|
|
|
|
|
Bruce J. Barrett |
|
Its: President and Chief Executive Officer |
Pursuant to the requirements of the Securities Act of 1933, this
amendment no. 1 to registration statement has been signed
by the following persons in the capacities and on the dates
indicated.
|
|
|
|
|
Signature |
|
Title |
|
Date |
|
|
|
|
|
|
/s/ BRUCE J. BARRETT
Bruce J. Barrett |
|
President and Chief Executive Officer and a Director
(Principal Executive Officer) |
|
February 8, 2006 |
|
/s/ WILLIAM M. IACONA
William M. Iacona |
|
Vice President and Chief Financial Officer, Controller,
and Treasurer
(Principal Financial Officer and Principal Accounting Officer) |
|
February 8, 2006 |
|
*
James I. Ausman, M.D., Ph.D. |
|
Director |
|
February 8, 2006 |
|
*
Daniel S. Follis |
|
Director |
|
February 8, 2006 |
|
*
Robert R. Henry |
|
Director |
|
February 8, 2006 |
|
*By: /s/ WILLIAM M.
IACONA
William M. Iacona,
Attorney-in-fact |
|
|
|
February 8, 2006 |
II-3
EXHIBIT INDEX
|
|
|
|
|
Exhibit |
|
Description |
|
|
|
|
1 |
.1 |
|
Form of Underwriting Agreement.* |
|
|
4 |
.1 |
|
Restated Articles of Incorporation of Somanetics Corporation,
incorporated by reference to Exhibit 3(i) to the
Companys Quarterly Report on Form 10-Q for the
quarter ended February 28, 1998. |
|
|
4 |
.2 |
|
Amended and Restated Bylaws of Somanetics Corporation,
incorporated by reference to Exhibit 3(ii) to the
Companys Annual Report on Form 10-K for the fiscal
year ended November 30, 2003. |
|
|
5 |
.1 |
|
Opinion of Honigman Miller Schwartz and Cohn LLP concerning the
legality of the securities being offered.** |
|
|
23 |
.1 |
|
Consent of Deloitte & Touche LLP.** |
|
|
23 |
.2 |
|
Consent of Honigman Miller Schwartz and Cohn LLP (included in
the opinion filed as Exhibit 5.1 to this registration
statement).** |
|
|
24 |
.1 |
|
Powers of Attorney (included after the signature of the
registrant contained on page II-3 of the original
registration statement). |
|
|
|
|
* |
To be filed by amendment. |
|
|
** |
Filed with this amendment no. 1 to registration statement. |