SECURITIES
AND EXCHANGE COMMISSION
x Annual Report Under Section 13 or 15(d) of
The Securities Exchange Act of 1934
For
the fiscal Year Ended December 31, 2004
OR
o Transition Report Under Section 13 or 15(d)
of the Securities Exchange Act of 1934
For
the transition period from
to
Commission
File Number 0-19567
CARDIAC
SCIENCE, INC.
(Exact
Name of registrant as specified in its Charter)
Delaware |
33-0465681 |
(State
or Other Jurisdiction of Incorporation or
Organization) |
(I.R.S.
Employer Identification
No.) |
1900
Main Street, Suite 700, Irvine, CA 92614
(Address
of Principal Executive Offices) (Zip
Code)
Issuer’s
telephone number (949) 797-3800
Securities
registered under Section 12(b) of the Exchange Act:
None.
Securities
registered under Section 12(g) of the Exchange Act:
Common
Stock, $0.001 Par Value
Indicate
by check mark whether the registrant (1) has filed all reports required by
Section 13 or 15(d) of the Exchange Act during the past 12 months (or for such
shorter period that the registrant was required to file such reports) and (2)
has been subject to such filing requirements for the past 90 days:
Yes x No ¨
Indicate
by check mark if there is no disclosure of delinquent filers pursuant to Item
405 of Regulation S-K contained in this form, and no disclosure will be
contained, to the best of registrant’s knowledge, in definitive proxy or
information statements incorporated by reference in Part III of this Form 10-K
or any amendments to this Form 10-K: x
Indicate
by check mark if the registrant is an accelerated filer (as defined in Exchange
Act Rule 12b-2). Yes x No ¨
The
aggregate market value of the voting stock held by non-affiliates of the
registrant, based upon the closing price of Common Stock on June 30, 2004, as
reported by the Nasdaq National Market System, was approximately $180,400,000.
Shares of voting stock held by each officer and director and by each person who
owns 10% or more of the outstanding voting stock have been excluded in that such
persons may be deemed to be affiliates. This assumption regarding affiliate
status is not necessarily a conclusive determination for other
purposes.
There
were 85,941,534 shares of the registrant’s Common Stock outstanding as of March
14, 2005.
TABLE
OF CONTENTS
Item
Number and Caption |
Page
Number |
PART
I
|
|
Item 1. |
Business |
1 |
Item
2. |
Properties |
20 |
Item
3. |
Legal
Proceedings |
20 |
Item
4. |
Submission
of Matters to a Vote of Security Holders |
21 |
PART
II
|
|
Item
5. |
Market
for Registrant’s Common Equity, Related Stockholder Matters and Issuer
Purchases of Equity Securities |
22 |
Item
6. |
Selected
Financial Data |
23 |
Item
7. |
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations |
25 |
Item
7A. |
Quantitative
and Qualitative Disclosures about Market Risk |
35 |
Item
8. |
Financial
Statements and Supplementary Data |
36 |
Item
9. |
Changes
in and Disagreements with Accountants on Accounting and Financial
Disclosure |
70 |
Item 9A. |
Controls
and Procedures |
70 |
Item
9B. |
Other
Information |
71 |
PART
III
|
|
Item 10. |
Directors
and Executive Officers of the Registrant |
72 |
Item
11. |
Executive
Compensation |
75 |
Item
12. |
Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters |
80 |
Item
13. |
Certain
Relationships and Related Transactions |
81 |
Item
14. |
Principal
Accountant Fees and Services |
81 |
Item
15. |
Exhibits
and Financial Statement Schedules |
83 |
0
PART
I
ITEM
1. BUSINESS
Overview
Cardiac
Science, Inc. is a leading developer, manufacturer and marketer of life-saving
public access defibrillators, or Automated External Defibrillators (“AEDs”), and
the largest corporate provider of comprehensive AED/CPR training and AED program
management services. We also manufacture and market a unique therapeutic
in-hospital patient monitor-defibrillator that instantly and automatically
treats cardiac patients with life-threatening abnormal heart rhythms without
human intervention. It is estimated that over 450,000 people in the United
States die each year from sudden cardiac arrest (“SCA”) or what is commonly
referred to as a massive heart attack. SCA is the leading cause of death in both
the United States and Europe. Approximately two thirds of SCA deaths occur
outside a hospital with the balance occurring while people are at work, home or
play. In situations outside of a hospital where an AED in not readily available,
survival rates for victims of SCA average only 5%. For victims of SCA, survival
is directly linked to the amount of time between the onset of SCA and receiving
a defibrillation shock, so that for every minute that goes by without a
defibrillation shock, a victim’s chance of survival is reduced by approximately
10%. Additionally, the average survival rate for patients suffering an
in-hospital SCA-event, is estimated to be less than 25% — a rate that has not
improved since the 1960s.
Our
proprietary RHYTHMx® software
algorithm technology, and STAR® biphasic
energy delivery system, form the technology platform for our line of
Powerheart® brand
AED products, and our unique therapeutic monitor-defibrillator, the
Powerheart® Cardiac
Rhythm Module®, or
CRM®. Our
products and technology are designed to easily and effectively treat victims of
SCA whether outside or inside a hospital in the shortest time frame possible,
thereby significantly increasing a victim’s chance of survival. Our AED products
are designed to be used by lay people and provide detailed voice instructions in
over 30 languages. Once the user applies the electrode pads of our Powerheart
AED to a person suffering a SCA, our device instantly and accurately detects the
presence of any life-threatening arrhythmias and will advise the user to deliver
a shock if required. During 2004, the Company introduced a third generation AED,
the Powerheart AED G-3 Automatic which detects the presence of life-threatening
arrhythmias and delivers, when appropriate, defibrillation shock(s)
automatically.
We are
active in new product development initiatives, including expanding and enhancing
our existing Powerheart AED product line, as well as integrating our RHYTHMx and
STAR Biphasic technology into new cardiac resuscitation product platforms for
our strategic Original Equipment Manufacturer (“OEM”) partner GE Healthcare
("GE" or "GE Healthcare"). We have a portfolio of 77 issued patents relating to
our core technology and products.
In
September 2001, we acquired Survivalink Corporation (“Survivalink”), a privately
held Minneapolis, Minnesota-based manufacturer of AEDs. The acquisition of
Survivalink enabled us to enter the rapidly growing public-access AED
marketplace.
In
November 2001, we acquired substantially all the outstanding shares of Artema
Medical AB, (“Artema”) a Swedish based developer, manufacturer and marketer of
standard hospital-based emergency defibrillators and patient monitoring
equipment, which also had operations in Denmark. This acquisition provided us
with a network of international distributors and the infrastructure required to
establish our international headquarters in Copenhagen, Denmark.
In
October 2003, we acquired substantially all the assets and certain liabilities
of Complient Corporation (“Complient”), a privately held Cleveland, Ohio based
provider of AED/CPR training and AED program management services. This
acquisition provided us with a network of 150 certified employee-educators
and sophisticated software technology that allows us to provide, initial
and ongoing management of customer AED deployments.
Our
corporate headquarters is located in Irvine, California, our research and
development facility is located in Lake Forest, California, our manufacturing
facility is located in Minneapolis, Minnesota, and our international sales
offices are located in Copenhagen, Denmark and Manchester, England. Our
corporate headquarters is located at 1900 Main Street, Suite 700, Irvine,
California 92614 and the telephone number is (949) 797-3800.
Business
Strategy
Our
primary business objective is to become the market leader in the rapidly growing
global AED marketplace, which according to Frost & Sullivan should grow at a
rate of approximately 20% per year over the next several years. Our secondary
objective is to increase the rate of adoption of our in-hospital Powerheart CRM
product, and to enter the traditional hospital “crash-cart” defibrillation
market, where we estimate that approximately $300 million of these types of
defibrillators are purchased per year. We believe that achieving these
objectives will result in consistent and significant revenue growth and allow us
to attain profitability. We expect to achieve our objectives by focusing on the
following core strategies:
|
• |
Increase AED
market share - In
2004, our AED products and accessories revenue totaled $57 million, up 3%
over 2003. A significant increase in international AED revenue,
particularly in the U.K. and Japan compared to 2003, was offset by a
decrease in U.S. AED revenue as a result of a strategic shift in our
indirect distribution strategy and a heightened competitive environment.
Based on Frost & Sullivan's estimated AED unit sales, we estimate
our market share in 2004 was approximately 25%. In order for us
to achieve market share growth and become the AED market leader we
intend to focus on the following: |
• Expanding
our AED distribution channels - We
currently sell our AEDs through direct, indirect and OEM channels in the U.S.
and internationally. During 2004, we rationalized our direct selling efforts and
ended the year with a direct U.S. sales force of 50 persons, compared to 62
persons at the end of 2003. We have direct operations in the U.K. with a 6-
person sales team and another 7 area managers who work with our international
distributors in over 50 countries worldwide. Our U.S.
direct sales force is primarily focused on selling our AEDs and training
services in the corporate and government workplace markets, and secondarily on
the schools and first responder (police/fire/ambulance) markets, and is
supported by direct marketing lead generation efforts in these market segments.
In 2005, we intend to expand our direct sales force in order to maximize the
revenue potential of our direct marketing efforts, and to leverage the large
national distribution relationships we established in the second half of 2004.
During 2004, we made a strategic shift in our indirect distribution channel from
the smaller, local distributors we had focused on in 2003, to establishing
relationships with large, national distribution organizations such as Airgas
Safety, Hagemeyer North America, Concentra Health Services and Fisher Safety.
Unlike a traditional distributor model, our relationship with these national
companies allow us to combine the efforts of the hundreds of dedicated sales
representatives they have in the field with our direct sales force, and provides
us access to their existing customer base for direct marketing activities. In
2005, our indirect channel focus will be on maximizing the potential revenue
from the national distribution relationships we established last year.
Internationally, we continue to sell primarily through country specific
distributors, except in the U.K. where we established a direct operation in
2003, and in Japan, where we entered into an OEM relationship with Nihon Kohden
in 2002. In 2005, in addition to expanding our direct efforts in the U.K. in
order to leverage the sole source British Heart Foundation contract we were
awarded in 2004, and we intend to increase the number of distributors worldwide
by identifying and signing additional distributors in non-medical market
segments, particularly in Europe. In addition to the OEM relationships we have
established with Nihon Kohden for Japan, Criticare Systems, Inc. for the dental
market and Quinton Cardiology Systems, Inc. for the U.S. physician’s office
market, in 2003, we entered into a multi-dimensional agreement with GE
Healthcare, the medical arm of General Electric Company, which included
providing GE-branded AEDs and CRMs for sale by GE Healthcare outside the U.S. We
recently expanded this relationship when GE Healthcare agreed to sell our
Cardiac Science branded Powerheart AED and CRM product line in U.S. hospitals
beginning in the first quarter of 2005.
• Enhancing
our AED product line - We plan
to continue to enhance our core Powerheart AED product line as we did in 2003
with the launch of the Powerheart G3 and FirstSave G3 products in the second
half of the year, and the introductions in the second half of 2004 of the
Powerheart G3 Automatic and the Powerheart G3 Pro. During 2005, we expect to
file for clearance from the U.S. Food and Drug Administration (“FDA”) and offer
for sale a consumer version AED that can be purchased without the need of a
physician prescription. Future product improvements will be driven by the
requirements of certain specific market segments and continued efforts to reduce
product costs.
• Leveraging
our AED services - Our October 2003 purchase of Complient’s assets allows
us to provide a unique, single source, turnkey AED deployment solution to
purchasers of AEDs. Through our nationwide network of 200 certified
employee-educators, we now provide the AED/CPR training required by most states
to deploy AEDs. In addition to providing certified training services, we provide
the medical direction and information management necessary for AED users to be
in compliance with various state laws and regulations. We believe that the
ability to offer a turnkey solution differentiates us from other AED
manufacturers and provides us with a competitive advantage at point of sale
particularly with multi-unit, multi-facility transactions with larger customers
in the corporate and government workplace sectors.
• Increasing
the rate of adoption of our Powerheart CRM - Our
therapeutic monitoring product, the Powerheart CRM, is the only hospital bedside
monitor defibrillator cleared by the FDA for prophylactic attachment and
continuous monitoring of patients at risk of life-threatening arrhythmias that
can deliver a potentially lifesaving shock without human intervention. It has
the potential to become a new “standard of care” in the treatment of in-hospital
SCA. However, despite clinical evidence which demonstrates the positive impact
the CRM may have on the survival rate of SCA victims, adoption of the technology
has been much slower than we expected. We believe that the adoption of the
product has been hindered by a lack of (a) peer reviewed clinical evidence
demonstrating the cost/benefit of the technology; and (b) distribution
capability. We intend to address these issues by:
• Conducting
several clinical studies at recognized hospitals, for publication in
peer-reviewed medical journals, to further support improved patient outcomes and
cost effectiveness of our Powerheart CRM.
• Supporting
GE in its efforts to market the Powerheart CRM in the U.S. and internationally.
• Developing
new product embodiments for our existing technology - In 2003,
we entered into a strategic relationship with GE. In addition to OEM
distribution of our Powerheart AED and CRM products, we agreed to develop and
manufacture for GE a traditional “crash cart” hospital defibrillator utilizing
our core RHYTHMx and STAR Biphasic technology. We anticipate that this
development project will be completed in the second quarter of 2005. This
development arrangement allows us to enter what we estimate to be a $300 million
hospital defibrillator market by leveraging the distribution strength of GE
Healthcare. We have identified and have had preliminary discussions regarding
other product development projects where GE technology and our RHYTHMx and STAR
Biphasic core technology could be brought together to create a new line of
hospital based patient monitor and defibrillation products. We believe that
continued collaboration with GE Healthcare will allow us to develop additional
hospital based products which incorporate our core technology, ultimately
allowing increased adoption of our technology through the marketing strength and
hospital presence of GE Healthcare.
Sudden
Cardiac Arrest
SCA is
the leading cause of death of Americans and accounts for over 450,000 deaths
annually. Factors contributing to the onset of SCA include coronary heart
disease, drug abuse, respiratory arrest, electrocution, drowning, choking and
trauma. Death from SCA is sudden and unexpected, occurring without warning or
immediately after the onset of symptoms. The American Heart Association (“AHA”)
estimates that 50% of SCA victims have no prior indication of heart
disease—their first symptom is SCA. And for those with a known history of heart
attacks, the chance of sudden cardiac death is four to six times greater than
that of the general population.
According
to the AHA, almost 60% of SCA incidents are witnessed. However, it is estimated
that 95% of SCA victims die before reaching the hospital due to delays in
effective treatment. Survival is directly linked to the amount of time between
the onset of SCA and defibrillation: a victim’s chances of survival are reduced
by approximately 10% with every minute of delay.
The
Heart
The heart
has four chambers, the two upper, smaller chambers are called the left and right
atria and the two lower, larger and stronger chambers are referred to as the
left and right ventricles. Blood is pumped throughout the circulatory system by
a series of highly coordinated contractions of the heart’s four chambers. If
these contractions do not occur in a synchronized manner, then the
transportation of blood throughout the body is diminished. Under normal
conditions, an electrical impulse is initiated in a bundle of highly specialized
cells located in the right atrium. This bundle of cells, referred to as the
sinus node, is also appropriately known as the heart’s natural pacemaker. From
the sinus node, this electrical current moves across a specific path in the
atria, and to the ventricles, causing the chambers to contract and pump blood.
If the heart is to beat properly, then the electrical current, beginning in the
atria, must follow a precise path so that the heart’s chambers beat in a
synchronized and coordinated fashion.
Arrhythmias
If the
heart deviates from this normal series of electrical impulses, then abnormal
heart rhythms result, and the ability of the heart to effectively pump blood
throughout the circulatory system is diminished. Although some arrhythmias are
short in duration and have little effect on the heart’s normal rhythm, certain
other arrhythmias cause the heart to beat too fast—tachycardia—or too
slow—bradycardia. If tachycardia originates in the ventricles, it is referred to
as ventricular tachycardia (“VT”). Sustained ventricular tachycardia, and
ventricular fibrillation, as described below, are immediately life threatening
and must be corrected by defibrillation to prevent sudden cardiac death. Our
products are designed to detect and treat these types of
arrhythmia.
Ventricular
Fibrillation and SCA
Ventricular
fibrillation (“VF”) is a lethal form of arrhythmia in which disordered
electrical activity in the heart causes the ventricles to contract in a rapid,
unsynchronized, uncoordinated fashion. With the onset of VF, little or no blood
is pumped from the heart to the brain and vital organs, resulting in the victim
becoming quickly unconscious and experiencing sudden death unless appropriate
therapy is provided immediately. This loss of normal heart function, or sudden
cardiac arrest requires an application of an electric shock—defibrillation—to
resynchronize the heart’s disordered electrical activity to a normal
rhythm.
Where
Does SCA Strike?
According
to numerous clinical studies it is estimated that two-thirds of sudden cardiac
arrests occurs while people are at work, home or play. The AHA, almost 60% of
SCA incidents are witnessed, however if AEDs are not on premise, only about 5%
of victims survive given that after calling 911, it takes on average, about 8-12
minutes for emergency personnel to arrive on scene. Clinical studies have shown
that when police vehicles are equipped with AEDs it can cut response times to
SCA victims by about three minutes when compared to historical response times
and significantly improved victim survival rates. Communities with public access
defibrillation (“PAD”) programs in place, where AEDs are placed in public
buildings, airports, at sporting events and in emergency response vehicles, have
reported community survival rates approaching 50 percent. In some venues, such
as casino’s and corporate workplaces, when the first shock is delivered within
3-5 minutes, reported survival rates from SCA are ranging from as high as 48% to
74%.
Our
Core Technology
All of
our products incorporate our proprietary RHYTHMx technology. This platform
technology is designed to detect and discriminate life-threatening arrhythmias.
Our STAR Biphasic technology is designed to optimize the delivery of a
potentially life-saving electric shock to victims of SCA. We have integrated our
core technology, along with other proprietary technology that we have developed
into our Powerheart AED and CRM product lines. We also sell accessories and
disposable products, including our proprietary disposable defibrillator
electrode pads, and are actively licensing certain components of our core
technology to third-parties for integration into other products.
Our
RHYTHMx Technology
Our
proprietary RHYTHMx technology allows for the detection and identification of
life-threatening arrhythmias and automatic delivery of defibrillation therapy.
Our patented RHYTHMx software algorithm is capable of filtering noise and
artifact from a patient’s electrocardiogram (“ECG”) signal without compromising
its ability to correctly identify heart rhythms that are
life-threatening—shockable, or non-life-threatening—non-shockable.
RHYTHMx
begins by filtering the patient’s electrocardiogram signal to reduce noise
artifact and then detects the heart’s QRS complexes in conjunction with the
patient’s heart rate. The heart’s ECG signals contain wave shapes that are
referred to as P-QRS-T waves. While a normal heartbeat contains each of these
wave shapes, in the case of the chaotic and disorganized rhythm of ventricular
fibrillation, these wave shapes—or QRS complexes—are absent or
indistinguishable. If the heart rhythm is considered shockable by RHYTHMx, and
it persists, then a shock is indicated. Further analysis by RHYTHMx, which
occurs in a fraction of a second, classifies the shockable rhythm as requiring a
synchronous shock—in the case of a life-threatening VT—or an asynchronous
shock—in the case of life-threatening VF.
Clinical
results with our RHYTHMx technology demonstrated 100% sensitivity (correct
identification of shockable rhythms) and 99.4% specificity (correct
identification of non-shockable rhythms). RHYTHMx technology has been clinical
validated by leading researchers in numerous clinical studies and received FDA
clearance in 1998.
Our
STAR Biphasic Technology
Our
Self-Tracking Active Response (“STAR”) Biphasic waveform technology allows our
line of defibrillator devices to deliver the most effective therapy possible by
delivering an optimized amount of energy in response to SCA. STAR Biphasic
quickly assesses the unique characteristics of a patient and customizes the
defibrillation energy he or she receives.
The STAR
Biphasic waveform treats cardiac patients individually, based on three important
characteristics: impedance, defibrillation threshold and cellular
response.
Impedance
is the number one difficulty in delivering current to the heart in external
defibrillation. Tissue such as skin, fat, muscle and bone, surround the heart
and impede the flow of energy delivered by a defibrillator. Impedance varies
from person to person and in order to optimize energy delivery, adjustments must
be made for a patient’s impedance. Our STAR Biphasic waveform technology
provides optimized energy delivery by measuring a patient’s impedance and
customizing a waveform to deliver the most effective defibrillation energy. This
customization occurs for even the most difficult high-impedance patients. STAR
Biphasic technology delivers optimal therapy for every patient.
Defibrillation
threshold (“DFT”) is defined as the minimum current required to defibrillate the
heart and establish normal rhythm. DFT varies from person to person, based
primarily on a person’s anatomy, disease condition and metabolic state of the
heart. Failure to exceed a patient’s DFT means failure to defibrillate a
patient’s heart. STAR Biphasic technology automatically escalates defibrillation
energy to ensure that a patient’s DFT is exceeded as rapidly as
possible.
During
the delivery of any defibrillation shock, the cell membranes of the heart are
charged, until the cells depolarize. This allows normal electrical pathways to
reestablish control and produce a coordinated rhythm. If any residual charge
remains on the cells, i.e., they do not fully depolarize, then re-fibrillation
may occur. The STAR Biphasic waveform has been uniquely designed to neutralize
any residual charge through a process of charge balancing. STAR Biphasic
precisely controls the energy delivered in the first phase of defibrillation and
balances any residual cellular charge during the second phase of defibrillation.
By neutralizing the residual charge, STAR Biphasic minimizes the likelihood of
re-fibrillation and provides the optimal environment to defibrillate the
heart.
The STAR
Biphasic waveform was validated in a clinical trial led by researchers at the
Cleveland Clinic and Cedars-Sinai Medical Center. This multi-center study,
designed according to FDA guidelines, determined that the STAR Biphasic waveform
was safe and effective
In
addition to the use of STAR Biphasic waveform technology in our defibrillator
devices, we also license this technology to selected partners
internationally.
Our
Products
The
Powerheart G-3 Line of AEDs
Our
Powerheart AED product line is powered by our RHYTHMx and STAR Biphasic
technology, and is the only AED that can provide continuous monitoring
capabilities before, during and after SCA, protecting the victim against delays
in therapy and the reoccurrence of another life-threatening arrhythmia following
resuscitation.
Reflecting
the merger of Survivalink and Cardiac Science in September 2001, our Powerheart
AED combines industry-leading AED expertise with advanced arrhythmia detection
technology. In 2004, sales of Powerheart AEDs, accessories and related services
represented 94% of our total revenue. To date, there are approximately 110,000
Cardiac Science AEDs deployed around the world.
Our AEDs
devices have been deployed by in virtually every setting imaginable. Powerheart
AEDs have been deployed at hundreds of educational institutions, federal, state
and local municipal agencies, fire and police departments, ambulances,
railroads, airports, airlines, military bases, hospitals, nursing homes, health
clubs, physician and dental offices, and leading corporations.
Our
Powerheart brand AEDs has also been chosen by many local governments and
municipalities for use in community based Public Access Defibrillation (“PAD”)
programs in cities such as London, San Diego, Miami, Minneapolis, Nashville, and
St. Louis.
We
believe that our Powerheart line of AEDs offers the following competitive
advantages:
• Our
patented RescueReady®
technology tests not only the battery and system components, but also verifies
that the pre-connected disposable electrodes are properly
functioning.
• Clear,
concise voice prompts guide the user through the rescue process and our
exclusive one-button operation eliminates confusion and
uncertainty.
• Our
innovative RHYTHMx technology provides continuous monitoring capability and our
STAR Biphasic waveform technology allows for customized defibrillation and
escalating variable energy delivery.
• Pre-connected
electrodes save time and ensure the AED is ready at time of rescue.
•
Our proprietary self-testing AED defibrillator electrodes are
interchangeable for body placement and are supplied pre-gelled with a
self-adhesive. We have also developed and are marketing our proprietary
FDA-cleared pediatric defibrillation electrode system, designed for use with our
AED, to deliver reduced defibrillation energy to infants and children up to
8-years old, or up to 55 lbs. These innovative pediatric electrodes are suitably
sized for a child’s smaller torso, and are less than half the size of our adult
AED electrodes
In 2004,
we added two new Powerheart AEDs to our line, they include:
• Powerheart
AED G-3 “PRO” is a technologically advanced AED designed for use by
sophisticated users of lifesaving equipment such as hospital personnel, medical
professionals and emergency medical technicians. The G3 PRO is unique in that it
displays the victim’s heart rhythm on a built-in high resolution color
electrocardiogram (ECG) display and gives professional users the option of
delivering defibrillation shocks either semi-automatically or manually during
the emergency treatment of victims of sudden cardiac arrest. Other advanced
features include continuous cardiac monitoring capability via an ECG patient
cable, multiple rescue data storage, clear and comprehensive AED and CPR voice
prompts, infrared data transfer and optional rechargeable battery.
• Powerheart
AED G-3 Automatic is the first fully automatic AED in the Powerheart product
line. This new generation AED has been designed specifically for public places
and corporate workplace settings. A rescuer need only listen to the Powerheart's
detailed voice instructions explaining how to attach the device to the heart
attack victim to potentially save a life. There are no buttons to push or
additional action required since the Powerheart analyzes the patient's condition
to detect a life-threatening heart rhythm and, if appropriate, automatically
delivers a potentially life-saving defibrillation shock(s) to restore the heart
to a normal rhythm.
The
Powerheart CRM
The
chances of survival for a patient suffering SCA in a hospital remains at less
than 25%. Because of the time it takes to defibrillate patients, even under
monitored conditions, this survival rate has not changed in the last 40 years.
And those that do survive are typically faced with a longer and more expensive
hospital stay.
The
Powerheart CRM is a
lightweight fully-featured external defibrillator that offers a complete
therapeutic monitoring package in a single device - continuous cardiac
monitoring, synchronized cardioversion, non-invasive pacing as well as manual,
semi-automatic or fully-automatic defibrillation. Once
attached to patients via our disposable defibrillator electrodes, the CRM
continuously monitors a patient’s cardiac rhythm, and if a life-threatening
arrhythmia is detected, automatically delivers a life-saving defibrillation
shock within seconds and with no human intervention.
Therapeutic
monitoring with the Powerheart CRM offers cardiac patients the best chance of
survival from SCA and represents a potential new standard of care for medical
facilities worldwide. In December 2001, we received clearance from the FDA to
market the Powerheart CRM to medically supervised environments such as
hospitals, medical and dental surgery centers, physician offices, clinics and
nursing homes in the United States. We have also received the necessary
approvals to market the Powerheart CRM in Europe, Canada, Australia and other
regions around the world. Our Powerheart CRM is in a number of hospitals
worldwide.
Our
Powerheart CRM is a unique therapeutic monitor incorporating state-of-the-art
technology that offers medical facilities the following features and
benefits:
• Powerheart
CRM provides reliable, continuous monitoring, detection and treatment of
life-threatening arrhythmias;
• Biphasic
waveform technology customizes defibrillation energy to deliver optimal therapy
for each patient;
• Non
invasive external pacing;
• The
Powerheart CRM’s compact design and battery operation allows for use in
transporting patients and also provides for multiple mounting options at the
bedside and uninterrupted operation in any hospital setting. The Powerheart
CRM’s footprint measures 11 inches x 4 inches x 8.25 inches and weighs only 11.5
pounds; and
• User
friendly programmable interface software and control buttons permit simple
operation and a color LCD provides exceptional viewing and resolution. The
Powerheart CRM can operate in manual, advisory or fully automatic
modes.
We also
market our proprietary disposable defibrillator electrodes for use with the
Powerheart CRM. These disposable defibrillator electrodes provide reliable ECG
monitoring, defibrillation and external pacing performance and offer reduced
motion artifact caused by patient movement. The compact design and
radiotransluscence of the Powerheart CRM disposable defibrillator electrodes
also allows clearer views of the chest under x-ray and fluoroscopy and a new
hydrogel adhesive reduces the potential for skin irritation.
Miscellaneous
Products
As part
of the Artema acquisition in 2001, we marketed a low-end line of patient
monitors. The Diascope G2 is a compact, transportable vital signs monitor
designed for use in hospitals and day surgery units and has been marketed in
certain international markets. In 2004 we sold approximately $1.4 million of
this product, compared to $2.5 million in 2003.
In
connection with the Complient acquisition, we marketed a line of CPR related
resuscitation products and accessories, including training mannequins and an
audible CPR prompt device. These products accounted for approximately $1.6
million in revenue for the year ended December 31, 2004.
In
February 2004, we made a strategic decision to discontinue the Diascope patient
monitor product line and sell the CPR training related product line, both of
which had below average gross margins and used disproportionate manufacturing,
sales and administrative resources. We completed the transactions to execute
this strategy in the third quarter of 2004.
Our
Markets
We
segment the market for our devices and technology into two principal categories:
AEDs and related accessories and AED/CPR services, and in-hospital therapeutic
monitoring-defibrillation (Powerheart CRM).
AED
Market Segments
Based on
Frost & Sullivan estimates of unit sales in 2004, our market share of
the worldwide AED market was approximately 25%. We believe that we have a
leading position in at least two of our market segments, the U.S. government
agency workplace segment and the U.S. corporate workplace market. The following
are our market segment highlights:
• The
corporate workplace and government market segments have been our primary focus,
and accounted for approximately 70% of our total U.S. AED sales in 2004. We
believe these market segments are less than 10% penetrated and we will continue
to focus a significant portion of our sales and marketing resources in this
area.
• We
estimate that less than 10% of schools in the United States have AEDs and to
date only New York has mandated deployment of AEDs in public schools. In 2004,
we generated 10% of our U.S. AED sales from schools and colleges.
• In the
U.S. first responder market segment, we estimate that between 25 to 35% of the
285,000 police and fire vehicles are equipped with AEDs. Sales in this segment
represented 12% of our U.S. 2004 AED sales.
• The
medical market segment includes physician and dental offices and hospitals. We
estimate that less than 10% of approximately 200,000 physician and dental
offices have AEDs and only a small percentage of the 6,600 hospitals have AEDs
available. About 8% of our U.S. AED sales in 2004 were to the medical market
segment.
• We
believe that we are the market leader in the Japanese AED market due to our
strategic partnership with Nihon Kohden. We also have more than 50 distributors
in all major world markets, and we continue to focus our sales and marketing
efforts on growing our market share in the three largest and fastest growing
global markets, Japan, Germany and the U.K. International sales represented 40%
of our total 2004 AED sales.
In-Hospital
Therapeutic Monitoring-Defibrillation (Powerheart
CRM)
Traditionally,
hospitals have deployed manual or semi-automatic defibrillators to treat SCA
victims. Standard defibrillators require supervision by highly skilled medical
personnel to analyze and interpret the patient’s electrocardiogram and to
manually deliver a shock using handheld paddles. Standard defibrillators are
typically positioned in the hospital at locations such as critical care and
cardiac care units, emergency and operating rooms and electrophysiology labs. We
estimate that there are 6,600 hospitals in the United States.
Despite
the availability of standard defibrillators to treat SCA in hospitals, numerous
hospital studies have documented delays of five minutes or more between the
onset of cardiac arrest to the arrival of the first medical team member.
Clinical studies show that the average survival rate of patients who have an
in-hospital SCA is estimated at less than 25%, a rate of survival that has not
improved since the 1960s. We believe that our Powerheart CRM is well positioned
to provide hospitals with a therapeutic monitoring alternative which will result
in an increase in survival rates and a reduction in patient care
costs.
Technology
Licensing
We are
seeking strategic relationships with third parties to license our RHYTHMx and
STAR Biphasic proprietary technologies for use in patient monitoring type
devices.
During
2002, we entered into three separate licensing agreements with Zoll Medical,
Inc., Lifecor, Inc., and Innomed Medical Corporation. During 2003, we entered
into a license agreement with Medical Research Laboratories (“MRL”). We licensed
our STAR Biphasic technology for use in standard emergency defibrillators for
sales internationally and licensed certain patents relating to wearable
defibrillators and other proprietary features of our AEDs, as well as licensing
our platform RHYTHMx technology. In consideration for these licenses we received
cash and ongoing royalty payments.
AED
Market Drivers
SCA kills
approximately 450,000 people in the United States each year. A few minutes after
the onset of SCA, brain damage can start to occur and death will result unless
the victim’s heart is shocked back into rhythm by a defibrillator. According to
the AHA almost 60% of all SCAs are witnessed by a bystander. Moreover, the AHA
currently estimates that 95% of SCA victims die before reaching the hospital.
Communities that strategically place AEDs in public buildings, arenas, airports
and emergency vehicles can significantly reduce response times. In venues where
bystanders or first responders can defibrillate a victim within three to five
minutes, the reported survival rates from SCA are as high as 48% to
74%.
There is
now widespread acknowledgement and increasing awareness that AEDs save lives and
can be safely used by lay people. The AHA has publicly encouraged widespread
deployment of AEDs through community AED programs.
Legislation
is a key market driver, and numerous AED-related bills have been introduced at
the Federal level and in State governments in the past several years, which we
believe will facilitate the growth of new and existing markets for
AEDs:
• In 2000,
the 106th Congress of the United States passed the Cardiac Arrest Survival Act,
which directs placement of AEDs in all Federal buildings in order to improve
survival rates of SCA victims in those buildings and establishes protections
from civil liability arising from the emergency use of AEDs.
• The Rural
Access to Emergency Devices Act, signed into law in 2000, authorized the
spending of $25 million in federal funds over three years to help rural
communities purchase AEDs and to provide training on how to use
them.
• In 2001,
the Office of Management and Budget directed the Occupational Safety and Health
Administration (“OSHA”) to consider whether promotion of AEDs should be elevated
to a priority. In response, OSHA issued a technical bulletin encouraging all
employers to consider making AEDs available in the workplace. According to OSHA,
13% of all workplace fatalities are attributable to SCA
• The
Community Access Emergency Defibrillation Act of 2001 was added to the Public
Health Security and Bioterrorism Preparedness and Response Act of 2002, and was
signed into law in June 2002. The Act provided federal funding for
implementation of PAD programs.
• In 2002,
the New York State Legislature passed laws requiring public school facilities,
regardless of size, to retain at least one AED on school premises. Currently,
seven other states are considering legislative alternatives to either recommend
or mandate the use of AEDs in schools and certain other facilities and public
places.
• State of
Illinois House Bill 43, was passed on March 5, 2003 creating the Physical
Fitness Facility Medical Emergency Preparedness Act which requires various
physical fitness facilities, including (i) facilities owned or operated by a
unit of local government or by a school, college, or university, (ii) golf
courses, and (iii) health or fitness clubs, to have on its premises at least one
AED and a trained AED user.
• On March
7, 2005, New York City based a bill Number 211-A that requires the placement of
AEDs in the publicly accessible areas of certain City buildings, ferry
terminals, nursing homes, senior centers, health clubs, golf courses, stadiums,
arenas and selected New York City parks.
Sales
and Marketing
We
currently sell our AEDs through direct, indirect and OEM channels in the U.S.
and internationally. During 2004, we rationalized our direct selling efforts and
ended the year with a 50-person direct U.S. sales force. Internationally, we
have direct operations in the U.K. with a 6-person sales team and another 7 area
managers who work with our international distributors in over 50 countries
worldwide. Our marketing efforts were focused on the U.S. corporate workplace
and the U.S. government agency workplace market segments. As a result of this
effort, we believe that we are the market leaders in those
segments.
Our U.S.
direct sales force is primarily focused on selling our AEDs and training
services in the corporate and government workplace markets, and secondarily on
the schools and first responder (police/fire/ambulance) markets, and is
supported by direct marketing lead generation efforts in these market segments.
In 2005, we intend to expand our direct sales force in order to maximize the
revenue potential of our direct marketing efforts, and to leverage the large
national distribution relationships we recently established in the second half
of 2004. During 2004, we made a strategic shift in our indirect distribution
channel from the smaller, local distributors we had focused on in 2003, to
establishing relationships with large, national distribution organizations such
as Airgas Safety, Hagemeyer North America, Concentra Health Services and Fisher
Safety. Unlike a traditional distributor model, our relationships with these
national companies allow us to combine the efforts of the hundreds of dedicated
sales reps they have in the field with our direct sales force, thereby providing
us access to their existing customer base for direct marketing activities. In
2005, our indirect channel focus will be on maximizing the potential revenue
from the national distribution relationships we established last year.
Internationally, we continue to sell primarily through country specific
distributors, except in the U.K. where we established a direct operation in
2003, and in Japan, where we entered into an OEM relationship with Nihon Kohden
in 2002. In 2005, in addition to expanding our direct efforts in the U.K. in
order to leverage the sole source British Heart Foundation contract we were
awarded in 2004, and we intend to increase the number of distributors worldwide
by identifying and signing additional distributors in non-medical market
segments, particularly in Europe. In addition to the OEM relationships we have
established with Nihon Kohden for Japan, Criticare Systems, Inc. for the dental
market and Quinton Cardiology Systems, Inc. for the U.S. physician’s office
market, in 2003, we entered into a multi-dimensional agreement with GE, which
included providing GE-branded AEDs and CRMs for sale by GE outside the U.S. We
recently expanded this relationship when GE Healthcare agreed to sell our
Cardiac Science branded Powerheart AED and CRM product line in U.S. hospitals
through its sub-acute sales force, beginning in the first quarter of 2005.
We
currently have one specialist supporting our CRM clinical studies efforts, and
also utilize distributors in certain regions in the United States and
internationally. In addition, in 2003 we signed an OEM agreement with GE
Healthcare whereby it distributes the CRM through its distribution channels. We
are also focused on the collection of clinical data supporting the
cost-effectiveness and improved patient outcomes of our Powerheart
CRM.
Competition
Our
principal competitors in the worldwide AED market, both public-access and
medical AED markets are Philips Medical’s Heartstream division, Medtronic’s
Emergency Response Systems division (formerly Physio-Control) and Zoll Medical
Corporation. Overall, we believe that Philips Medical is currently the market
leader.
Our
experience indicates that the key criteria that buyers of AEDs exhibit in their
purchasing decision are:
• ease of
use,
• reliability
and self testing,
• overall
value—a combination of features and price, and
• capability
to assist in deployment and training.
We
believe that our Powerheart AED compares favorably with our competitors’
products in the AED market based on these factors as well as on other
competitive determinants. We also believe that our ability to provide a complete
turnkey AED deployment solution provides us with a competitive advantage over
other manufacturers, particularly in the government and corporate workplace
segments.
Our most
significant competitive disadvantage relates to our relatively small size and
inferior financial position as compared to our much larger competitors. This
differential in size, the debt on our balance sheet and our lack
of profitability are routinely raised by our competitors at point of sale
in an effort to discourage potential customers from buying from us.
The
Powerheart CRM is the only FDA-cleared external defibrillator that provides
fully automatic detection and treatment for patients suffering from
life-threatening arrhythmias. We compete against numerous companies in the
hospital marketplace where we sell our Powerheart CRM.
Manufacturing
We
manufacture our Powerheart AEDs and Powerheart CRMs at our 31,000 square foot
manufacturing facility in Minnetonka, Minnesota. Our current in-place test and
final assembly capacity will allow us to build approximately 80,000 AEDs
annually. In 2004, we manufactured approximately 37,000 AEDs, compared with
30,000 in 2003. We outsource the manufacture of major subassembly components
such as printed circuit boards primarily for the benefit of reduced cost, and
perform final assembly and testing in our facility.
Our
FDA-registered Minnetonka facility is ISO certified for the design and
manufacture of medical products. Our certifications allow us to design and
manufacture medical products with the CE mark for shipment to Europe and to ship
FDA-cleared products in the United States.
The
manufacturing processes used to produce our products are required to comply with
FDA enforced Good Manufacturing Practices (“GMP”) regulations which cover the
design, testing, production, control and documentation of our products. In those
foreign jurisdictions where we market our products, we are also required to
comply with and obtain regulatory approvals and clearances. These regulatory
requirements also apply to our third party contract manufacturers, as well as to
some of our suppliers. The FDA and foreign counterparts conduct periodic
inspections of manufacturing facilities to ensure compliance with “Quality
System Regulation,” GMP, and other regulations, such as those promulgated by the
International Standards Association. Any concern raised by such inspections
could result in regulatory action, delays or termination of
production.
Intellectual
Property
We
believe that our intellectual assets, including trademarks, patents, trade
secrets and proprietary technology, are extremely valuable and constitute a
cornerstone of our business. We own 77 U.S. and foreign patents relating to our
automatic defibrillation technology platform and its various applications. We
intend to file additional patent applications relating to each of our products
and our underlying proprietary technology, as well as around new technological
inventions that we are developing. We believe that our patents and proprietary
technology provide us with a competitive advantage over our competitors. We will
aggressively defend our inventions and also look for opportunities to generate
royalty fees from licensing our intellectual property.
We have a
wide range of patents covering the technology found in our AEDs, including our
RescueReady technology, which features one button operation, pre-connected
disposable electrode pads and self-test capabilities. Other patents we have been
issued cover our proprietary RHYTHMx arrhythmia detection software technology,
our STAR Biphasic defibrillation waveform technology and our disposable therapy
electrodes.
Clinical
Studies
We are
actively engaged in, and are pursuing the sponsorship of, clinical studies at
hospital medical centers both in the U.S. and Europe, relating to our Powerheart
CRM product. These studies are primarily focused on demonstrating clinical
efficacy, along with improved survival rates and the economic benefits
associated with deployment of our Powerheart technology for hospitalized at-risk
cardiac patients. We anticipate that the results of these studies will be
presented in abstract form at conferences, and if accepted, as manuscripts
published in peer reviewed medical journals. Various studies are ongoing,
planned or proposed, at luminary medical centers in the U.S. and Europe.
Currently, three clinical studies are underway to determine both clinical
efficacy and cost-effectiveness of bedside CRM monitoring,
including:
· |
An
economic and safety effectiveness study being performed at New York
Methodist Hospital under the direction of Dr. Charles E. Oribabor,
Director, Cardiac Surgery ICU at that institution,
and; |
· |
On-going
clinical and observational study at Maimonides Medical Center in Brooklyn,
NY under the direction of Maimonides
Director of Clinical Cardiology, Gerald Hollander M.D. Based on early
positive results, the hospital elected to deploy more than 100 Powerheart
CRM devices and has been accumulating data for more than two years
and; |
· |
An
outcomes study under the lead of Antonio Martinez-Rubio, M.D. in the
Cardiology department at the Hospital de Sabadell in Barcelona,
Spain. |
In
November 2004, a study published in the Journal Resuscitation
authored
by Henry Cusnir, M.D., et al, was conducted at Maimonides Medical Center in
Brooklyn, N.Y. The study looked at response times by staff in monitored wards to
simulated cardiac arrest as compared to the Powerheart response programmed in
its fully-automatic mode. Staff verses Powerheart response time was on average
nearly 3 minutes verses 38 seconds.
In
October 2004, a study published in the Journal Resuscitation
and
authored by André Moreira Bento, M.D., et al, was conducted principally at the
Instituto do Coroçào, University of Sao Paulo Medical School in Sao Paulo,
Brazil. The study monitored 55 cardiac patients located in special
monitoring wards. During approximately 1,300 hours of monitoring, 18 episodes of
life-threatening rhythm events were documented that required treatment through
defibrillation. The mean response time to defibrillation shock delivered
automatically by the Powerheart was 33.4 seconds and the therapy was successful
in converting the patient to a normal heart rhythm 94.4 percent of the time on
the first shock (17/18) and 100 percent by the second shock (1/1). There
were no patient complications.
In
February 2003, a European study authored by Antonio Martinez-Rubio, M.D. et al,
was published in the Journal
of the American College of Cardiology. The
117-patient study was conducted at 10 European medical centers in Germany,
Spain, Italy and Finland. The patients included 51 at risk cardiac patients
located in special monitoring wards (intensive or coronary care units or in the
emergency room), and 66 who were undergoing electrophysiological testing or
implantation of cardioverter-defibrillators (ICDs) because of suspected or
documented ventricular tachyarrhythmias. During a total of 1,240 hours of
testing, 1,988 heart rhythm events were documented and 115 of those needed
treatment through defibrillation. The mean response time was 14.4 seconds and
there were no complications.
In June
2003, a study published in The
American Journal of Cardiology authored
by Thomas Mattioni, M.D., et al, conducted at the Arizona Heart Institute,
Phoenix, AZ measured the ability of the Powerheart to accurately discriminate
superventricular (SVT) from life-threatening ventricular tachyarrhythmias (VT)
in patients undergoing a conventional EP study the electrophysiology lab. In a
total of 98 patients the Powerheart correctly identified 122 episodes of SVT for
a resultant sensitivity of 100 percent and a specificity of 94 percent. The
authors concluded that the Powerheart accurately discriminates SVT from VT and
is expected to correctly deliver automatic shocks in the presence of spontaneous
life-threatening arrhythmia and appropriately withhold therapy during
SVT.
Government
Regulation
In the
United States, clinical testing, manufacturing, packaging, labeling, promotion,
marketing, distribution, registration, record keeping and reporting, clearance
or approval of medical devices generally are subject to regulation by the FDA.
Medical devices intended for human use are classified into three categories,
subject to varying degrees of regulatory control. Class III devices, which we
believe cover certain of our products, are subject to the most stringent
control.
In
October 1997, we received 510(k) clearance from the FDA to market the clinical
version of the original Powerheart in the United States. In August 1998, we
received 510(k) clearance from the FDA to market RHYTHMx and to integrate it
into other stand-alone defibrillator monitors. In January 2000, we received
clearance from the FDA to market the commercial version of the original
Powerheart in the United States. In February 2001, we received notification from
the FDA that allows our original Powerheart to be used in outpatient surgery
centers, nursing homes and at home when prescribed by a physician. In December
2001, the FDA granted us 510(k) clearance to market our Powerheart CRM in
medically supervised environments such as hospitals, medical and dental surgery
centers, physician offices, clinics and nursing homes. In October 2001, the FDA
granted us 510(k) clearance to market a new advanced version of our
monitoring-defibrillation-pacing electrodes.
In
February, 2002, the FDA granted us 510(k) clearance to market our Powerheart AED
for the emergency treatment of victims of sudden cardiac arrest and in January
2003, the FDA granted us 510(k) clearance to market our Powerheart AED for use
on children under eight-years of age. In July 2004, the FDA granted us 510(k)
clearance to market our Powerheart G-3 Automatic AED and in August 2004, the FDA
granted us 510(k) clearance to market our Powerheart G-3 AED Pro.
We have
also received the necessary approvals to market the Powerheart CRM, Powerheart
AEDs and related product accessories within Europe, Canada, Australia and other
regions of the world.
Our
products are subject to FDA review of labeling, advertising and promotional
materials, as well as record keeping and reporting requirements. Failure to
comply with any of the FDA’s requirements, or the discovery of a problem with
any of the products, could result in FDA regulatory or enforcement action.
Further, any changes to the products or their labeling may require additional
FDA submissions, review, clearance or approval.
In early
April 2004, we received a Warning Letter from the U.S. Food and Drug
Administration (FDA) following a routine inspection of our manufacturing
facility in Minneapolis. The letter specified certain procedural and
documentation items in the Company’s quality system. We took corrective and
preventive action to bring our quality system into compliance. In addition,
during May 2004, we initiated a limited, voluntary recall of approximately 5,800
units of our older model Powerheart AEDs in order to replace a potentially
faulty capacitor component. As of December 31, 2004, the majority of the
recalled units in the U.S. have been replaced or repaired and we are in the
process of executing our international recall plan which represents
approximately 10% of total affected units.
Also, in
May 2004, we initiated a limited, voluntary recall of approximately 4,800 AED
batteries due to an error made by our battery supplier whereby an incorrect fuse
was used in the manufacture of a certain lot of batteries. As of December 31,
2004, the recall has been completed and customers have received replacement
batteries.
We
estimate the cost of these voluntary recall actions could range from $1 million
to $1.2 million, however, we have received from our suppliers, credits against
existing and future amounts totaling $1.2 million, which have been recorded to
accrued expenses to establish a warranty accrual for these recall matters and
are included in accruals for warranties issued during the period. Actual recall
related costs incurred have been charged against this accrual and totaled
approximately $1.1 million as of December 31, 2004. At this time, we believe our
remaining accrual related to the recall will cover any future costs.
Research
and Development
We are
committed to improving and expanding our product line through the application of
our existing patented and proprietary technology, and through the research and
development of new technology. Our core RHYTHMx and STAR Biphasic technologies
have multiple patient monitoring and therapeutic applications, and we continue
to seek out new device embodiments integrating our proprietary technology,
enhancing or expanding our own product line, or by licensing to a
third-party.
Research
and development expenses for the years ended December 31, 2004, 2003 and 2002
were $6 million, $5.5 million, and $6.1 million, respectively. We intend to
continue to devote resources and capital to research and development so we can
improve and refine our existing products and technology, develop and
commercialize our products currently under development, and develop new
applications for our technology.
Backlog
As of
December 31, 2004, we had no significant backlog of orders and approximately
$1.1 million of deferred AED/CPR training and program management services
revenue that was undelivered, compared to a backlog of approximately $700,000 as
of December 31, 2003 of AED/CPR training and program management services orders
not processed, and $61,000 of deferred AED/CPR training and program management
services revenue that was undelivered. Revenue on AED/CPR training services is
recognized when the services are delivered.
Employees
As of
December 31, 2004, we had 212 full-time employees, of which 93 employees
were involved in worldwide sales and marketing functions, 27 were involved
in supporting our research and development activities, 57 were in
manufacturing and 35 were general and administrative personnel. None of our
employees are represented by a collective bargaining arrangement and we believe
our relationship with our employees is satisfactory. We may add additional
personnel as we grow.
Material
Subsequent Events
On
February 28, 2005, we entered into an Agreement and Plan of Merger (the “Merger
Agreement”) with Quinton Cardiology Systems, Inc., a Delaware corporation
(“Quinton”), CSQ Holding Company, a Delaware corporation (“Holding Company”),
Rhythm Acquisition Corporation, a Delaware corporation and wholly-owned
subsidiary of Holding Company (“Quinton Merger Sub”) and Heart Acquisition
Corporation, a Delaware corporation and wholly-owned subsidiary of Holding
Company (“Cardiac Merger Sub”).
The
Merger Agreement provides for the strategic combination by means of (i) a merger
of Quinton Merger Sub with and into Quinton, followed immediately by a merger of
Quinton with and into Holding Company, with Holding Company surviving the merger
as the surviving corporation, and (ii) a merger of Cardiac Merger Sub with and
into us, as a result of which we will become a wholly-owned subsidiary of
Holding Company (collectively, the “Mergers”). Following the Mergers, Holding
Company will change its name to “Cardiac Science Corporation” and, upon approval
by Nasdaq, anticipates that its shares of common stock will be quoted on the
Nasdaq National Market under the symbol “DFIB.”
As a
result of the Mergers, each issued and outstanding share of our common stock
will be exchanged for 0.10 shares of Holding Company common stock and each
issued and outstanding share of Quinton common stock will be exchanged for
approximately 0.77 shares of Holding Company common stock. Additionally, the
number of shares and exercise prices of outstanding options and warrants to
purchase our common stock and Quinton common stock will be adjusted based on the
foregoing exchange ratios. Such options and warrants will be assumed by Holding
Company and will represent the right to purchase shares of Holding Company
common stock.
In
connection with the Mergers, our senior note holders have agreed to exchange the
entire balance of principal and accrued interest under such notes, or
approximately $61 million, as well as warrants to purchase approximately 13.4
million shares of our common stock, for an aggregate of $20 million in cash and
2.8 million shares of Holding Company common stock.
Consummation
of the Mergers is subject to customary closing conditions, including, among
others (i) the approval of the Merger Agreement, the Mergers and any other
transactions contemplated by the Merger Agreement by our stockholders and the
stockholders of Quinton, (ii) the absence of any material adverse effect with
respect to our business and the business of Quinton and (iii) the receipt of
opinions from counsel that the Mergers will qualify as tax-free reorganizations
for federal income tax purposes. The Merger Agreement contains certain
termination rights and further provides that upon termination of the Merger
Agreement under certain specified circumstances we or Quinton, as the case may
be, may be required to pay the other a termination fee of $4 million.
We and
Quinton intend to cause the Holding Company to file a registration statement on
Form S-4 containing a proxy statement/prospectus in connection with the Mergers.
For more information regarding the pending Mergers, please refer to this filing
when it becomes available because it will contain important information about
the transaction. Investors and security holders may obtain free copies of this
document (when it becomes available) and other documents filed with the
Securities and Exchange Commission at the Securities and Exchange Commission’s
web site at www.sec.gov.
General
Information
We
maintain an Internet website at www.cardiacscience.com where our Annual Report
on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and
all amendments to those reports are available without charge, as reasonably
practicable following the date they are filed with or furnished to the SEC. All
such reports are also available free of charge via EDGAR through the SEC website
at www.sec.gov. In addition, the public may read and copy materials that we file
with the SEC at the SEC’s public reference room located at 450 Fifth St., N.W.,
Washington, D.C., 20549. Information regarding operation of the SEC’s public
reference room can be obtained by calling the SEC at 1-800-SEC-0330.
A
Warning About Forward-Looking Information and the Safe Harbor Under the
Securities Litigation Reform Act of 1995
This
Annual Report on Form 10-K and the other reports, releases, and statements (both
written and oral) issued by us and our officers from time to time may contain
statements concerning our future results, future performance, intentions,
objectives, plans, and expectations that are deemed to be “forward-looking
statements.” These statements, including statements regarding:
• products
under development;
• technological
and competitive advantages;
• timetable
for commercial introduction of our products;
• our
ability to improve patient care, increase survival rates, decrease recovery
time, lessen patient debilitation, and reduce patient care costs; markets,
demand for our services, purchase orders and commitments;
• strategic
alliances;
• the
competitive and regulatory environment;
• planned
integration of technologies with products; • the
completion of the Mergers;
• the
expected synergies of the combined companies after the Mergers;
• the
anticipated cost savings resulting from the Mergers;
• the
ability of the combined companies to achieve significantly greater size and
scale;
• the
ability of the combined companies to achieve sustainable profitability and to
continue to develop competitive new products; and
• business
strategies.
Such
statements are made in reliance upon safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. Our actual results, performance, and
achievements may differ significantly from those discussed or implied in the
forward-looking statements as a result of a number of known and unknown risks
and uncertainties including, without limitation, those discussed below and in
“Management’s Discussion and Analysis of Financial Condition and Results of
Operations.” Although we believe that our assumptions underlying the
forward-looking statements are reasonable, any of the assumptions could prove
inaccurate and, therefore, we cannot assure you that the results discussed or
implied in such forward-looking statements will prove to be accurate. In light
of the significant uncertainties inherent in such forward-looking statements,
the inclusion of such statements should not be regarded as a representation by
us or any other person that our objectives and plans will be achieved. Words
such as “believes,” “anticipates,” “expects,” “intends,” “may,” “plans,” and
similar expressions are intended to identify forward-looking statements, but are
not the exclusive means of identifying such statements. We undertake no
obligation to revise any of these forward-looking statements.
Sometimes
we communicate with securities analysts. It is against our policy to disclose to
analysts any material non-public information or other confidential commercial
information. You should not assume that we agree with any statement or report
issued by any analyst regardless of the content of the statement or report. We
have a policy against issuing financial forecasts or projections or confirming
the accuracy of forecasts or projections issued by others. If reports issued by
securities analysts contain projections, forecasts or opinions, those reports
are not our responsibility.
Risk
Factors
The
risks set forth below are not intended to be exhaustive. These are the factors
that we believe could cause actual results to be different from expected and
historical results. Our industry is very competitive and changes rapidly.
Sometimes new risks emerge and we may not be able to predict all of them, or be
able to predict how they may cause actual results to be different from those
contained in any forward-looking statements. You should not rely upon
forward-looking statements as a prediction of future results.
If
the worldwide AED market does not grow as projected, our sales and results may
suffer.
According
to Frost & Sullivan, the worldwide AED market is expected to grow at
approximately 20% per year over the next several years. Our current level of
operations is based on assumptions concerning the future expected growth of AED
markets, and if such assumptions are significantly different from actual AED
market growth rates, or if we are not able to maintain or increase our market
share, then we may not be able to successfully grow our revenue and, as a
result, our level of revenue may not be able to support our current or future
level of operations.
If we
fail to successfully compete against new or existing competitors, our operating
results may suffer.
Our
principal competitors relating to our AED product line are Medtronic Emergency
Response Systems, a unit of Medtronic, Inc., Philips Medical Systems, a unit of
Koninklijke Philips Electronics N.V., and ZOLL Medical Corporation. Due to their
size, financial resources, market position and well established customer
relationships, it may be difficult for us to maintain or increase our market
share and/or penetrate new markets. In addition, these competitors are part of
much larger organizations, and thus have significantly greater resources than we
do. Accordingly, Medtronic Emergency Response Systems, Philips Medical Systems
and ZOLL Medical Corporation may increase the resources they devote to the
development and marketing of AEDs, which could materially impact our
results.
We also
compete against other companies that manufacture and sell external defibrillator
devices to hospitals, where we sell our Powerheart CRM. These companies include
Medtronic Emergency Response Systems, Philips Medical Systems, and ZOLL Medical
Corporation. These manufacturers of competing external devices are well
established in the medical device field, have substantially greater experience
than us in research and development, obtaining regulatory clearances,
manufacturing, and sales and marketing, and have significantly greater
financial, research, manufacturing, and marketing resources than
us.
Other
companies may develop invasive or non-invasive products capable of delivering
comparable or greater therapeutic benefits than our products, or which offer
greater safety or cost effectiveness than our products. Furthermore, future
technologies or therapies developed by others may render our products obsolete
or uneconomical, and we may not be successful in marketing our products against
such competitors.
|
|
The
markets for our products, in particular our Powerheart AED, are subject to
price competition, which could be detrimental to our
profitability. |
The
market for AEDs is highly competitive and is subject to significant price
competition because price is an important purchase decision criteria for many
customers. Average selling prices for AEDs have eroded during recent years and
are projected to continue declining, and principal competitors have
substantially greater resources and experience than we do, which may provide
them with a competitive advantage as price erosion continues or if it
accelerates. If this occurs, our level of sales and profitability may
suffer.
If we
are not able to satisfy the conditions to consummate the Mergers, Quinton will
be able to terminate the Merger Agreement.
Consummation
of the Mergers is subject to closing conditions, including, among others (i) the
approval of the Merger Agreement, the Mergers and any other transactions
contemplated by the Merger Agreement by our stockholders and the stockholders of
Quinton, (ii) the absence of any material adverse effect with respect to our
business and the business of Quinton, (iii) the expiration of any waiting
periods under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and (iv)
that there be no injunction or decree which enjoins or prohibits the Mergers. We
may not be able to satisfy all of the closing conditions required to consummate
the Mergers, in which case Quinton could elect to terminate the Merger
Agreement. If Quinton elects to terminate the Merger Agreement, we may need to
seek additional financing to continue operating our business and repay the
senior notes. In addition, a termination by Quinton may cause securities
analysts or other investors to have a negative perception of us, which could
cause our stock price to decline.
The
uncertainties associated with the Mergers may cause us to lose key personnel,
which could negatively impact our operations.
Some of
our employees may experience uncertainty about their future roles with the
combined company resulting from the Merger until or after strategies with regard
to the combined company are announced or executed. This uncertainty may
adversely affect our ability to attract and retain key personnel until the
consummation of the Mergers, which could negatively impact our operations.
General
economic conditions and geopolitical uncertainty may affect the purchasing
decisions of our customers, which may result in lower
revenues.
Many of
our customers face challenges in their respective markets due to general
economic conditions relating to fluctuating demand for their services and
budgetary or financing constraints. As a result, an economic downturn in any of
the markets in which we compete may affect the purchase decisions of our
customers, which may in turn negatively impact our revenue and sales growth. In
addition, global geopolitical uncertainty and war may also negatively impact a
customer’s decision making process or timing.
We
have a history of losses.
We have a
history of losses, and expect to incur some losses in the future. We were formed
in 1991 and have been engaged primarily in organizational activities, research
and development, pre-clinical testing, human clinical trials, and capital
raising activities, until the introduction of our first commercial product in
December 1999. As of December 31, 2004, we had an accumulated deficit of
approximately $124.4 million. We believe our current cash and cash equivalents
on hand will be sufficient to finance anticipated capital and operating
requirements for the next twelve months. If we are unable to generate sufficient
product revenues, we may be required to raise additional capital in the future
through collaborative agreements, private investment in public equity
financings, and various other public or private equity or debt financings. If we
are required to raise additional capital in the future, there can be no
assurance that the additional financing will be available on favorable terms, or
at all. If we fail to obtain additional capital as and when required, such
failure could have a material adverse impact on our operating plan and business.
We
are a relatively new entrant without a significant presence in the hospital
market. If we are not successful in this market, our operating results may
suffer.
Our
Powerheart CRM is designed for bedside use in hospitals and clinics and competes
against other external defibrillator products. We are relatively new to this
market, and as such, face a number of challenges, including acceptance by
hospital administrative and medical staff, long purchasing decision processes,
and competitors’ pre-existing relationships with customers. If we are not
successful in gaining market acceptance of our Powerheart CRM, our operating
results may suffer.
Recurring
sales of our disposable defibrillator electrodes may not grow.
Our
business strategy within the in-hospital marketplace, where we market our
Powerheart CRM, is to generate recurring revenue from the sale of our disposable
defibrillator electrode pads, which for sanitary, performance and safety
reasons, must be replaced every 24-hours. Although we have developed proprietary
smart chip technology to ensure that only our electrodes will be used with the
Powerheart CRM, there can be no assurance that other companies will not develop
electrode adapters that will allow generic electrodes to be used with our
devices. If we are not successful in preventing the use of generic electrodes
with our products, or if customers do not follow the recommended protocol of
regularly changing electrodes, we may not experience future sales growth of our
proprietary disposable electrode pads.
Uncertain
customer decision processes and long sales cycles may cause fluctuations in our
operating results.
Many of
our AED customers are municipalities and other quasi-governmental groups, such
as schools and law enforcement agencies. As a result, these customers have
numerous decision makers, as well as varying levels of procedures that must be
adhered to before a purchase of our products can be made. The same is true
regarding our in-hospital Powerheart CRM product, which faces several levels of
purchase decision makers, at the departmental and hospital-wide level.
Accordingly, the purchasing decisions of many of our customers are characterized
by a protracted decision making process, which may result in period-to-period
fluctuations in our operating results.
Supply
shortages can cause delays in manufacturing and delivering
products.
We rely
upon unaffiliated suppliers for the material components and parts used to
assemble our products. Most parts and components purchased from suppliers are
available from multiple sources. We believe that we will be able to continue to
obtain most required components and parts from a number of different suppliers,
although there can be no assurance of continued availability. The lack of
availability of certain components could require a major redesign of our
products and could result in production and delivery delays.
During
2002, we issued $50 million in 6.9% senior notes, which are collateralized by
all of our assets. Any default on such notes could cause us to substantially
curtail our operations.
In May
2002, we placed $50 million in 6.9% senior notes due May 2007 with investors.
The senior notes are collateralized by a senior blanket security interest in our
assets. In
November 2004, we obtained a waiver from the holders of the senior notes for
non-compliance with a financial covenant for the quarter ended September 30,
2004. In addition, at that time, based on our expected results for the quarter
and year ending December 2004, we anticipated that we would also be in
non-compliance with certain financial covenants for those periods. Accordingly
we reclassified the senior notes payable to current liabilities as of September
30, 2004. In January 2005, we obtained a waiver of non-compliance for certain
covenants, including financial covenants for the quarter and year ended December
31, 2004. Additionally, we restructured the financial covenants and certain
other terms of the senior notes for future periods. As part of the
restructuring, we extended the maturity date of the senior notes and accrued
interest thereon to May 2008, with interest accruing and added to the principal
balance until maturity. If in
the future we fail to comply with the financial covenants as amended, we could
be in default under the senior notes. If we are in default we may become subject
to claims by note holders seeking to enforce their security interest in our
assets. Such claims, if they arise, may substantially restrict or even eliminate
our ability to utilize our assets in conducting our business, and may cause us
to incur substantial legal and administrative costs.
Our
auditors have expressed doubt about our ability to continue as a going
concern.
We
received a report on our consolidated financial statements from our independent
registered public accounting firm for the years ended December 31, 2004 and 2003
that includes an explanatory paragraph expressing substantial doubt as to our
ability to continue as a going concern without, among other things, obtaining
additional financing to support expansion plans, manufacturing, research and
development activities, or achieving a level of revenues adequate to support our
cost structure.
Our
operating results may fluctuate from quarter to quarter, which could cause our
stock price to be volatile.
The
market prices of many publicly traded companies, including emerging companies in
the healthcare industry, have been and can be expected to be highly volatile.
The future market price of our common stock could be significantly impacted
by:
• future
sales of our common stock;
• general
stock market conditions;
• announcements
of technological innovations for new commercial products by our present or
potential competitors;
• developments
concerning proprietary rights;
• adverse
results in our field or with clinical tests;
• adverse
litigation;
• unfavorable
legislation or regulatory decisions;
• public
concerns regarding our products;
• variations
in quarterly operating results;
• general
trends in the health care industry; and
• other
factors outside of our control.
Our
quarterly financial results are often impacted by the receipt of a large number
of customer orders in the last weeks of a quarter. Absent these orders, our
sales could fall short of our targets, thus causing our stock price to
decline.
We
must comply with governmental regulations and industry
standards.
We are
subject to significant regulation by authorities in the United States and
foreign jurisdictions regarding the clearance of our products and the subsequent
manufacture, marketing, and distribution of our products once approved. The
design, efficacy, and safety of our products are subject to extensive and
rigorous testing before receiving marketing clearance from the FDA. The FDA also
regulates the registration, listing, labeling, manufacturing, packaging,
marketing, promotion, distribution, record keeping and reporting for medical
devices. The process of obtaining FDA clearances is lengthy and expensive, and
we cannot assure you that we will be able to obtain the necessary clearances for
marketing our products on a timely basis, if at all. Failure to receive, or
delays in receiving, regulatory clearances would limit our ability to
commercialize our products, which would have a material adverse effect on our
business, financial condition, and results of operations. Even if such
clearances are granted by the FDA, our products will be subject to continual
regulatory review. Later discovery of previously undetected problems or failure
to comply with regulatory standards may result in product labeling restrictions,
costly and time-consuming product recalls, withdrawals of clearances, or other
regulatory or enforcement actions. Moreover, future governmental statutes,
regulations, or policies, or changes in existing statutes, regulations, or
policies, may have an adverse effect on the development, production, or
distribution of our products.
Any
regulatory clearance, if granted, may include significant limitations on the
uses for which our products may be marketed. FDA enforcement policy strictly
prohibits the marketing of cleared medical devices for unapproved uses. In
addition, the manufacturing processes used to produce our products will be
required to comply with the Good Manufacturing Practices or “GMP” regulations of
the FDA. These regulations cover design, testing, production, control,
documentation, and other requirements. Enforcement of GMP regulations has
increased significantly in the last several years, and the FDA has publicly
stated that compliance will be more strictly scrutinized. Our facilities and
manufacturing processes and those of certain of our third party contract
manufacturers and suppliers, if any, will be subject to periodic inspection by
the FDA and other agencies. Failure to comply with applicable regulatory
requirements could result in, among other things:
• warning
letters;
• fines;
• injunctions;
• civil
penalties;
• recalls
or seizures of products;
• total or
partial suspension of production;
• refusal
of the government to grant pre-market clearance or pre-market approval for
devices;
• withdrawal
of clearances; and/or
• criminal
prosecution.
To market
our products in certain foreign jurisdictions, we must obtain required
regulatory clearances and approvals and otherwise comply with extensive
regulations regarding safety and quality. Compliance with these regulations and
the time required for regulatory reviews vary from country to country. We cannot
assure you that we will obtain regulatory clearances and approvals in foreign
countries, and we may be required to incur significant costs in applying for,
obtaining, or maintaining foreign regulatory clearances and
approvals.
We
are exposed to numerous risks associated with international
operations.
We market
our products in international markets. International operations entail various
risks, including:
• political
instability;
• economic
instability and recessions;
• exposure
to currency fluctuations;
• difficulties
of administering foreign operations generally;
• reduced
protection for intellectual property rights;
• potentially
adverse tax consequences; and
• obligations
to comply with a wide variety of foreign laws and other regulatory
requirements.
Our
business is dependent upon our executive officers, and our ability to attract
and retain other key personnel.
Our
success is dependent in large part on the continued employment and performance
of our Chairman and Chief Executive Officer, Raymond W. Cohen, as well as other
key management and operating personnel. The loss of any of these persons could
have a material adverse effect on our business. We do not have key person life
insurance on any of our employees other than Mr. Cohen.
Our
future success will also depend upon our ability to retain existing key
personnel, and to hire and to retain additional qualified technical,
engineering, scientific, managerial, marketing, and sales personnel. The failure
to recruit such personnel, the loss of such existing personnel, or failure to
otherwise obtain such expertise would have a material adverse effect on our
business and financial condition.
We
may face product liability claims
The
testing, manufacturing, marketing and sale of medical devices subjects us to the
risk of liability claims or product recalls. For example, it is possible that
our products will fail to deliver an energy charge when needed by the patient,
or that they will deliver an energy charge when it is not needed. As a result,
we may be subject to liability claims or product recalls for products to be
distributed in the future or products that have already been distributed.
Although we maintain product liability insurance in the countries in which we
conduct business, we cannot assure you that such coverage is adequate or will
continue to be available at affordable rates. Product liability insurance is
expensive and may not be available in the future on acceptable terms, if at all.
A successful product liability claim could inhibit or prevent commercialization
of our products, impose a significant financial burden on us, or both, and could
have a material adverse effect on our business and financial
condition.
The
outcome of and costs relating to pending shareholder class action and
shareholder derivative actions are uncertain.
During
March 2005, numerous complaints were
filed in the Chancery Court of Delaware concerning the recent Merger Agreement
entered into with Quinton. The complaints allege that the board breached its
fiduciary obligations with respect to the transaction in two ways. First, the
board purportedly did not negotiate for sufficient compensation for Cardiac, as
opposed to the compensation received by Quinton. Second, the board allegedly
engaged in self-dealing because the senior note holders purportedly received
more than their fair share in the Mergers, as opposed to the common
stockholders. The complaints seek an injunction enjoining the proposed Mergers,
rescissionary damages if the Mergers are completed, and an order that the board
hold an auction to obtain our best value.
We cannot
predict with certainty the eventual outcome of such pending litigation. We
intend to defend against such lawsuits vigorously and may have to expend
significant efforts and incur substantial expense in such defense.
Our
technology may become obsolete.
The
medical equipment and healthcare industries are characterized by extensive
research and rapid technological change. The development by others of new or
improved products, processes, or technologies may make our products obsolete or
less competitive. Accordingly, we plan to devote continued resources, to the
extent available, to further develop and enhance our existing products and to
develop new products. We cannot assure you that these efforts will be
successful.
We
depend on patents and other intellectual property rights that we may not be able
to protect.
Our
success will depend, in part, on our ability to obtain and maintain patent
rights, preserve our trade secrets, and operate without infringing on the
proprietary rights of third parties. The validity and breadth of claims covered
in medical technology patents involve complex legal and factual questions and
therefore may be highly uncertain. We cannot assure you that:
• any
additional patents will be issued to us;
• the scope
of any existing or future patents will exclude competitors or provide us with
competitive advantages;
• any of
our patents will be held valid and enforceable if challenged;
or
• others
will not claim rights in or ownership to our patents and other proprietary
rights held by us.
Furthermore,
others may have developed or could develop similar products or patent rights,
may duplicate our products, or design around our current or future patents. In
addition, others may hold or receive patents which contain claims having a scope
that covers products developed by us. We also rely upon trade secrets to protect
our proprietary technology. Others may independently develop or otherwise
acquire substantially equivalent know-how, or gain access to and disclose our
proprietary technology. We cannot assure you that we can ultimately protect
meaningful rights to our proprietary technology. There has been substantial
litigation regarding patent and other intellectual property rights in the
medical device industry. Such litigation, if it occurs, could result in
substantial expense to us and a diversion of our efforts, but may be necessary
to enforce our patents;
• enforce
our patents;
• protect
our trade secrets and know-how;
• defend us
against claimed infringement of the rights of others; or
• determine
the enforceability, scope, and validity of the proprietary rights of
others.
An
adverse determination in any such litigation could subject us to significant
liability to third parties or require us to seek licenses from third parties.
Although patent and intellectual property disputes in the medical device
industry have often been settled through licensing or similar arrangements,
costs associated with such arrangements may be substantial and could include
ongoing royalties. Moreover, we cannot assure you that necessary licenses would
be available to us on satisfactory terms, if at all. If such licenses cannot be
obtained on acceptable terms, we could be prevented from marketing our products.
Accordingly, an adverse determination in such litigation could have a material
adverse effect on our business and financial condition.
In
February 2003, we filed a patent infringement action against Philips Medical
Systems North America, Inc., Philips Electronics North America Corporation and
Koninklijke Philips Electronics N.V. (“Philips”) in the United States District
Court for the District of Minnesota. The suit alleges that Philips’ automated
external defibrillators sold under the names “HeartStart OnSite Defibrillator”,
“HeartStart”, “HeartStart FR2” and the “HeartStart Home Defibrillator,” infringe
at least ten of our United States patents. In the same action, Philips
counterclaimed for infringement of certain of its patents and we have sought a
declaration from the Court that our products do not infringe such patents. Many
of the Philips defibrillators’ are promoted by Philips as including, among other
things, pre-connected disposable defibrillation electrodes and daily
self-testing of electrodes and battery, features that the suit alleges are key
competitive advantages of our Powerheart and Survivalink AEDs and are covered
under our patents. At this stage, we are unable to predict the outcome of this
litigation. We have not established an accrual for this matter because a loss is
not determined to be probable.
Our
ability to issue preferred stock could adversely affect common
stockholders.
Our
certificate of incorporation authorizes the issuance of preferred stock with
such designations, rights, and preferences as may be determined from time to
time by our board of directors, without any further vote or action by our
stockholders. Therefore, our board of directors is empowered, without
stockholder approval, to issue a class of stock with dividend, liquidation,
conversion, voting, or other rights, which could adversely affect the voting
power or other rights of the holders of our common stock.
Anti-takeover
provisions may discourage takeover attempts.
Provisions
of the Delaware General Corporation Law and our certificate of incorporation may
discourage potential acquisition proposals, or delay or prevent a change of
control.
Future
issuances of our common stock could cause our stock price to
decline.
We
currently have reserved 14,000,000 shares of common stock for issuance upon the
exercise of options that may be granted under our 1997 Stock Option/Stock
Issuance Plan, as amended, 1,000,000 shares of common stock for issuance upon
the exercise of options outside of our 1997 Stock Option/Stock Issuance Plan and
16,747,695 shares for issuance upon the exercise of currently outstanding
warrants. The holders of these options or warrants may exercise them at a time
when we would otherwise be able to obtain additional equity capital on terms
more favorable to us. The exercise of these options or warrants and the sale of
the common stock obtained upon exercise would have a dilutive effect on our
stockholders and may have a material adverse effect on the market price of our
common stock.
Significant
decreases in our stock price could result in our having to record an impairment
charge related to our goodwill.
Applicable
accounting standards require that goodwill be tested for impairment at least
annually or whenever evidence of potential impairment exists. If, in any period,
our stock price decreases to the point where the fair value of our goodwill, as
determined by our market capitalization, is less than the book value of our
goodwill, we would be required to record an impairment charge in that
period.
ITEM
2. PROPERTIES.
Our
corporate headquarters is located in Irvine, California, and encompass
approximately 22,000 square feet. Our lease for this property expires in 2008
and our annual base rent expense for this facility is approximately $458,000.
Our R&D facility, located in Lake Forest, California comprises approximately
10,000 square feet. This lease expires in 2008 and our annual base rent expense
is approximately $124,000. We also have a manufacturing facility located in
Minnetonka, Minnesota, totaling approximately 31,000 square feet. The lease on
this facility expires in 2007 and our annual net rent expense for this facility
is approximately $335,000. As of the date of this filing, we also have
international sales and marketing offices in Copenhagen, Denmark and Manchester,
England.
ITEM
3. LEGAL PROCEEDINGS.
In
February 2003, we filed a patent infringement action against Philips Medical
Systems North America, Inc., Philips Electronics North America Corporation and
Koninklijke Philips Electronics N.V. (“Philips”) in the United States District
Court for the District of Minnesota. The suit alleges that Philips’ automated
external defibrillators sold under the names “HeartStart OnSite Defibrillator”,
“HeartStart”, “HeartStart FR2” and the “HeartStart Home Defibrillator,” infringe
at least ten of our United States patents. In the same action, Philips
counterclaimed for infringement of certain of its patents and we had sought a
declaration from the Court that our products do not infringe such patents. Many
of the Philips defibrillators’ are promoted by Philips as including, among other
things, pre-connected disposable defibrillation electrodes and daily
self-testing of electrodes and battery, features that the suit alleges are key
competitive advantages of our Powerheart and Survivalink AEDs and are covered
under our patents. At this stage, we are unable to predict the outcome of this
litigation. We have not established an accrual for this matter because a loss is
not determined to be probable.
On April
30, 2003, we filed a Complaint against Defibtech, LLC for patent infringement in
the United States District Court for the District of Minnesota. The Complaint
alleged that Defibtech’s Sentry and Reviver AEDs infringe our patented
disposable electrode pre-connect technology as well as other patents. Defibtech
answered the Complaint and asserted counterclaims alleging that we have engaged
in activities that constitute tortious interference with present and prospective
contractual relations, common law business disparagement and statutory business
disparagement. We responded to the counterclaims with a complete and general
denial of the allegations. At this stage, the we are unable to predict the
outcome of this litigation. We have not established an accrual for this matter
because a loss is not determined to be probable.
On March
19, 2004, William S. Parker filed suit against us for patent infringement in the
United States District Court for the Eastern Division of Michigan. The Parker
patent generally covers the use of a synthesized voice to instruct a person to
perform certain tasks. The Complaint alleges that certain of our AEDs infringe
the patent. The patent is now expired. We have filed an Answer to the Complaint
stating the patent is not infringed and is otherwise invalid and unenforceable.
The patent has been submitted before the United States Patent and Trademark
Office for reexamination. On October 25, 2004, the District Court issued an
order staying the litigation pending resolution of the reexamination. At this
stage of the litigation, we are unable to predict the outcome of this
litigation. We have not established an accrual for this matter because a loss is
not determined to be probable.
In early
March 2005, several class action complaints were filed in the Chancery Court of
Delaware concerning the recent Merger Agreement entered into with Quinton. The
complaints allege that the board breached its fiduciary obligations with respect
to the transaction in two ways. First, the board purportedly did not negotiate
for sufficient compensation for Cardiac, as opposed to the compensation received
by Quinton. Second, the board allegedly engaged in self-dealing because the
senior note holders purportedly are entitled to receive more than their fair
share in the Mergers, as opposed to the common stockholders. The complaints
seek, inter alia, an injunction enjoining the proposed Mergers, rescissionary
damages if the Mergers are completed, and an order that the board hold an
auction to obtain our best value. We have retained legal counsel and intend to
defend the cases vigorously.
In the
ordinary course of business, various lawsuits and claims are filed against us
including product liability suits. While the outcome of these matters is
currently not determinable, management believes that the ultimate resolution of
these matters will not have a material adverse effect on our operations or
financial position.
ITEM
4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY
HOLDERS.
On
December 21, 2004, we held an annual meeting of the stockholders. Seven persons,
all of whom were existing members of the board of directors, were nominees for
election at the annual meeting. All of the following persons were elected as
directors at the annual meeting:
Name |
|
|
Votes
For |
|
|
Votes
Against |
|
|
Abstentions |
|
|
Broker
Non-votes |
|
Raymond
W. Cohen |
|
|
67,407,363 |
|
|
— |
|
|
1,093,534 |
|
|
— |
|
Howard
L. Evers |
|
|
67,460,602 |
|
|
— |
|
|
1,040,295 |
|
|
— |
|
Peter
Crosby |
|
|
67,509,354 |
|
|
— |
|
|
991,543 |
|
|
— |
|
Raymond
E. Newton III |
|
|
67,483,524 |
|
|
— |
|
|
1,017,373 |
|
|
— |
|
Jeffrey
F. O’Donnell Sr. |
|
|
66,771,301 |
|
|
— |
|
|
1,729,596 |
|
|
— |
|
Brian
H. Dovey |
|
|
66,749,623 |
|
|
— |
|
|
1,751,274 |
|
|
— |
|
Bruce
J. Barclay |
|
|
66,847,466 |
|
|
— |
|
|
1,653,431 |
|
|
— |
|
Proposals
voted on at the annual meeting were:
1. To elect
seven members to the board of directors to serve until the next annual meeting
of stockholders and until their successors are duly elected and qualified.
2. To ratify
the selection by the audit committee of the board of directors of
PricewaterhouseCoopers LLP as our independent registered public accounting firm
for the year ending December 31, 2004.
The
following table shows the matter voted upon except the election of the directors
which is detailed above, votes cast for, against or withheld as the number of
abstentions and broker non-votes.
Matter |
|
|
Votes
For |
|
|
Votes
Against |
|
|
Abstentions |
|
|
Broker
Non-votes |
|
Selection
of PricewaterhouseCoopers LLP |
|
|
67,995,564 |
|
|
351,252 |
|
|
154,081 |
|
|
— |
|
PART
II
ITEM
5. MARKET
FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS, AND ISSUER
PURCHASES OF EQUITY SECURITIES.
Market
Information
In
September 2000, our common stock was accepted for trading on the NASDAQ National
Market under the symbol “DFIB”. The following table sets forth for the periods
indicated the high and low closing sales prices for our common stock as reported
on NASDAQ National Market.
|
|
|
High |
|
|
Low |
|
4th
Quarter 2004, ended 12/31/04 |
|
$ |
2.27 |
|
$ |
1.58 |
|
3rd
Quarter 2004, ended 9/30/04 |
|
$ |
3.05 |
|
$ |
1.43 |
|
2nd
Quarter 2004, ended 6/30/04 |
|
$ |
4.20 |
|
$ |
1.97 |
|
1st
Quarter 2004, ended 3/31/04 |
|
$ |
5.33 |
|
$ |
3.72 |
|
4th
Quarter 2003, ended 12/31/03 |
|
$ |
4.65 |
|
$ |
3.40 |
|
3rd
Quarter 2003, ended 9/30/03 |
|
$ |
4.99 |
|
$ |
2.54 |
|
2nd
Quarter 2003, ended 6/30/03 |
|
$ |
3.19 |
|
$ |
2.22 |
|
1st
Quarter 2003, ended 3/31/03 |
|
$ |
2.94 |
|
$ |
1.98 |
|
Holders
As of
December 31, 2004, there were approximately 629 holders of record of our common
stock.
Dividends
We have
never paid any cash dividends on our common stock. We presently intend to retain
earnings, if any, to finance our operations and therefore do not anticipate
paying any cash dividends in the foreseeable future. The payment of any
dividends will depend upon, among other things, our earnings, assets and general
financial condition.
Issuer
Purchases of Equity Securities
In
November 2004, we agreed to cancel 277,682 shares of our common stock
beneficially owned by Raymond W. Cohen, our Chairman and Chief Executive
Officer, in exchange for the cancellation of an outstanding promissory note
payable to us by Mr. Cohen in an aggregate amount of approximately $588,690,
including accrued interest. The cancellation of the shares held by Mr. Cohen was
not part of a publicly announced repurchase plan or program.
ITEM
6. SELECTED FINANCIAL DATA.
The
following selected financial information is derived from our consolidated
financial statements. You should read this summary financial information in
conjunction with “Management’s Discussion and Analysis of Financial Condition
and Results of Operations” and the Consolidated Financial Statements and related
notes.
Statement
of Operations Data:
(In
thousands, except per share data)
|
|
For
the Year Ended December 31, |
|
|
|
2004 |
|
|
2003 |
|
|
2002 |
|
|
2001 |
|
|
2000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
revenue |
|
$ |
68,513 |
|
$ |
61,982 |
|
$ |
50,043 |
|
$ |
10,651 |
|
$ |
4,242 |
|
Gross
profit |
|
|
38,151 |
|
|
33,439 |
|
|
25,306 |
|
|
2,676 |
|
|
417 |
|
Gross
profit % |
|
|
56 |
% |
|
54 |
% |
|
51 |
% |
|
25 |
% |
|
10 |
% |
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales
and marketing |
|
|
23,959 |
|
|
18,616 |
|
|
17,325 |
|
|
8,972 |
|
|
4,371 |
|
Research
and development |
|
|
6,027 |
|
|
5,538 |
|
|
6,053 |
|
|
8,575 |
|
|
8,248 |
|
General
and administrative |
|
|
19,241 |
|
|
14,720 |
|
|
11,474 |
|
|
6,935 |
|
|
5,159 |
|
Acquired
in-process research and development |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
13,587 |
|
Amortization
of intangible assets(1) |
|
|
1,931 |
|
|
1,656 |
|
|
2,111 |
|
|
1,740 |
|
|
1,063 |
|
Amortization
of restricted stock |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
1,551 |
|
Impairment
of assets |
|
|
— |
|
|
— |
|
|
— |
|
|
1,438 |
|
|
— |
|
Gain
on sales and other, net |
|
|
(1,077 |
) |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
Gain
on Settlement |
|
|
— |
|
|
— |
|
|
(832 |
) |
|
— |
|
|
— |
|
Total
Operating Expenses |
|
|
50,081 |
|
|
40,530 |
|
|
36,131 |
|
|
27,660 |
|
|
33,979 |
|
Loss
from operations |
|
|
(11,930 |
) |
|
(7,091 |
) |
|
(10,825 |
) |
|
(24,984 |
) |
|
(33,562 |
) |
Interest
income (expense) and other, net |
|
|
(6,739 |
) |
|
(5,891 |
) |
|
(4,142 |
) |
|
(538 |
) |
|
618 |
|
Loss
on sale of marketable securities |
|
|
— |
|
|
— |
|
|
— |
|
|
(707 |
) |
|
— |
|
Minority
interest in (income) loss of subsidiary |
|
|
— |
|
|
(48 |
) |
|
(33 |
) |
|
16 |
|
|
— |
|
Provision
for income taxes |
|
|
|
|
|
— |
|
|
— |
|
|
(2 |
) |
|
(2 |
) |
|
|
|
(6,739 |
) |
|
(5,939 |
) |
|
(4,175 |
) |
|
(1,231 |
) |
|
616 |
|
Loss
from continuing operations |
|
|
(18,669 |
) |
|
(13,030 |
) |
|
(15,000 |
) |
|
(26,215 |
) |
|
(32,946 |
) |
Income
(loss) from discontinued operations |
|
|
— |
|
|
493 |
|
|
(52 |
) |
|
— |
|
|
— |
|
Net
loss |
|
$ |
(18,669 |
) |
$ |
(12,537 |
) |
$ |
(15,052 |
) |
$ |
(26,215 |
) |
$ |
(32,946 |
) |
Basic
and diluted loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing
operations |
|
$ |
(0.22 |
) |
$ |
(0.19 |
) |
$ |
(0.22 |
) |
$ |
(0.78 |
) |
$ |
(1.82 |
) |
Discontinued
operations |
|
|
— |
|
|
0.01 |
|
|
— |
|
|
— |
|
|
— |
|
Net
loss per share |
|
$ |
(0.22 |
) |
$ |
(0.18 |
) |
$ |
(0.22 |
) |
$ |
(0.78 |
) |
$ |
(1.82 |
) |
Weighted
average shares used in computing net loss per share |
|
|
83,094 |
|
|
69,848 |
|
|
67,199 |
|
|
33,507 |
|
|
18,080 |
|
(1)
Effective
January 1, 2002, the Company ceased amortizing goodwill in accordance with SFAS
No. 142.
Selected
Balance Sheet Data:
(In
thousands)
|
|
December
31, |
|
|
|
2004 |
|
|
2003 |
|
|
2002 |
|
|
2001 |
|
|
2000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents |
|
$ |
13,913 |
|
$ |
8,871 |
|
$ |
15,598 |
|
$ |
15,830 |
|
$ |
13,537 |
|
Working
capital |
|
|
27,046 |
|
|
22,981 |
|
|
19,177 |
|
|
12,388 |
|
|
18,022 |
|
Total
assets |
|
|
203,334 |
|
|
203,001 |
|
|
153,920 |
|
|
145,469 |
|
|
33,336 |
|
Long
term debt, net of current portion |
|
|
52,648 |
|
|
46,522 |
|
|
41,145 |
|
|
27,780 |
|
|
192 |
|
Total
stockholders’ equity |
|
|
132,915 |
|
|
137,591 |
|
|
94,270 |
|
|
98,344 |
|
|
28,985 |
|
Summarized
Quarterly Data:
(In
thousands, except per share data)
|
|
Quarter
Ended |
|
|
|
March
31 |
|
|
June
30 |
|
|
September
30 |
|
|
December
31 |
|
2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
revenue |
|
$ |
15,604 |
|
$ |
17,509 |
|
$ |
14,747 |
|
$ |
20,653 |
|
Gross
profit |
|
|
9,096 |
|
|
9,686 |
|
|
8,111 |
|
|
11,258 |
|
Gross
profit % |
|
|
58 |
% |
|
55 |
% |
|
55 |
% |
|
55 |
% |
Operating
loss |
|
|
(3,245 |
) |
|
(3,538 |
) |
|
(3,303 |
) |
|
(1,844 |
) |
Net
loss |
|
|
(4,832 |
) |
|
(5,321 |
) |
|
(5,070 |
) |
|
(3,446 |
) |
Basic
and diluted loss per share |
|
$ |
(0.06 |
) |
$ |
(0.07 |
) |
$ |
(0.06 |
) |
$ |
(0.04 |
) |
2003 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
revenue |
|
$ |
14,024 |
|
$ |
14,527 |
|
$ |
15,728 |
|
$ |
17,703 |
|
Gross
profit |
|
|
7,935 |
|
|
8,306 |
|
|
9,511 |
|
|
7,687(2 |
) |
Gross
profit % |
|
|
57 |
% |
|
57 |
% |
|
61 |
% |
|
43 |
% |
Operating
loss |
|
|
(1,240 |
) |
|
(621 |
) |
|
(264 |
) |
|
(4,966 |
) |
Net
loss |
|
|
(2,582 |
) |
|
(1,974 |
) |
|
(1,490 |
) |
|
(6,491 |
) |
Basic
and diluted loss per share |
|
$ |
(0.04 |
) |
$ |
(0.03 |
) |
$ |
(0.02 |
) |
$ |
(0.08 |
) |
2002 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
revenue |
|
$ |
9,361 |
|
$ |
12,841 |
|
$ |
13,588 |
|
$ |
14,253 |
|
Gross
profit |
|
|
4,451 |
|
|
6,174 |
|
|
6,800 |
|
|
7,881 |
|
Gross
profit % |
|
|
48 |
% |
|
48 |
% |
|
50 |
% |
|
55 |
% |
Operating
loss |
|
|
(2,839 |
) |
|
(2,926 |
) |
|
(2,789 |
) |
|
(2,271 |
) |
Net
loss |
|
|
(3,482(1 |
)) |
$ |
(3,753 |
) |
|
(4,136 |
) |
|
(3,681 |
) |
Basic
and diluted loss per share |
|
$ |
(0.05 |
) |
$ |
(0.06 |
) |
$ |
(0.06 |
) |
$ |
(0.05 |
) |
(1) |
Loss
from operations includes a gain of $832 related to a Settlement Agreement
and Mutual Release with Medtronic Physio-Control
Corp. |
(2)
|
The
gross profit for the quarter ended December 31, 2003 includes an
impairment change of $2,917 related to the Company’s in-hospital
defibrillators as a result of a strategic decision to terminate the “no
cap” placement business model in U.S. hospitals. |
ITEM
7. MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
(In
thousands, except share and per share data)
The
following discussion should be read in conjunction with the consolidated
financial statements and notes thereto set forth herein.
Year
Ended December 31, 2004 Compared to Year Ended December 31,
2003
Results
of Operations
In 2004,
the Powerheart AED G3 product line continued to be our principal revenue driver
complemented by a full year of our AED/CPR training services resulting from our
acquisition of the assets and liabilities of Complient Corporation in October
2003. International sales grew at a higher than expected rate due in part to
delivering over half of a $3,000 British government contract and significant
growth in the Japanese market. This international revenue growth was partially
offset by lower sales in the U.S., particularly to U.S. distributors, resulting
from competitive pressures and a strategic shift from smaller dealers to
recently signed large distribution partners such as Airgas Safety, Concentra
Health Services, Hagemeyer North America and Fisher Safety. Our gross margin as
a percentage of revenue increased in 2004 to 55.7% from 53.9% in 2003. Our gross
margin in 2004, compared with the 2003 margin excluding the impact of the one
time inventory impairment charge, decreased due to a higher mix of lower margin
international OEM sales and the impact of a full year of lower margin service
revenue. In 2004, we sold our training related equipment and supplies product
lines acquired from Complient and discontinued selling our Diascope patient
monitoring line, as these product lines were not part of our core AED and
hospital defibrillation markets.
Revenue
The
following is a summary of net revenue by product line:
|
|
|
2004 |
|
|
2003 |
|
|
Change |
|
AEDs
and related accessories |
|
$ |
56,666 |
|
|
82.7 |
% |
$ |
55,010 |
|
|
88.8 |
% |
$ |
1,656 |
|
|
3.0 |
% |
AED/CPR
training and program management services |
|
|
7,406 |
|
|
10.8 |
% |
|
1,519 |
|
|
2.4 |
% |
|
5,887 |
|
|
387.6 |
% |
Powerheart
in-hospital defibrillators and accessories |
|
|
1,169 |
|
|
1.7 |
% |
|
1,259 |
|
|
2.0 |
% |
|
(90 |
) |
|
7.1 |
% |
Patient
monitors, training products and accessories |
|
|
3,272 |
|
|
4.8 |
% |
|
4,194 |
|
|
6.8 |
% |
|
(922 |
) |
|
22.0 |
% |
Total
net revenue |
|
$ |
68,513 |
|
|
100.0 |
% |
$ |
61,982 |
|
|
100.0 |
% |
$ |
6,531 |
|
|
10.5 |
% |
Net
revenue for the year ended December 31, 2004 increased $6,531 or 10.5% compared
to the year ended December 31, 2003. This increase was attributable to higher
services revenue resulting from a full year of ownership of the Complient
business and increased international AED sales, partially offset by lower sales
in the U.S. resulting from competitive pressures and a shift in our indirect
distribution strategy. Sales of AED products and related accessories and
services, which represented 93.5% of our total revenue, increased by $7,543, or
13.3%, a significant portion of which was attributable to AED/CPR training and
program management services, which accounted for $7,406 of sales in 2004
compared to $1,519 in 2003, all of which was in the fourth quarter following the
Complient acquisition. In addition, we sold $3,272 of patient monitors, training
equipment and accessories in 2004 compared to $4,194 in 2003. The decrease of
$922, or 22.0%, is due to the fact that we dedicated less resources to our
patient monitoring line, which is not part of our core AED and hospital
defibrillation markets, and resulted in a strategic change for 2004 to exit the
patient monitoring line at the end of the third quarter, along with the training
related equipment and supplies product line we acquired from Complient, which we
sold in August 2004. Sales of Powerheart CRMs were $451 for 2004 compared to
$431 in 2003, which represents less than 1% of total revenue in both years.
Sales of our Powerheart proprietary disposable defibrillation electrodes used
with the first generation Powerheart and the Powerheart CRM were $718 for 2004
compared to $828 for 2003.
Gross
Margin
Cost of
goods sold for the year ended December 31, 2004 was $30,362, compared to $28,543
including an impairment charge of $2,917 for the year ended December 31, 2003.
Gross margins as a percentage of revenue, including the impairment charge in
2003, were 55.7% in 2004 compared to 53.9% in 2003. Excluding the impairment
charge in 2003, gross margins as a percentage of revenue declined to 55.7% in
2004 from 58.7% in 2003. This decrease was a result of a higher mix of lower
margin international OEM sales and the impact of a full year of service revenue
in 2004 which has lower margins. Cost of service revenue was $4,282 for the year
ended December 31, 2004, with a gross margin of 42.2%, compared to cost of
service revenue of $747 in 2003, all of which was in the fourth quarter
following the Complient acquisition, with a gross margin of 50.8%. The decrease
was primarily the result of significantly higher than normal costs we incurred
for personnel and travel associated with meeting a deadline to fulfill certain
installment services and AED training for the New York City Schools contract.
After the deadline, margins on service revenue related to the New York City
Schools increased to normal levels.
During
2004, sales of first generation Powerhearts and accessories that were written
off in 2003 totaled $229 and had a favorable impact to our margin in 2004. The
majority of the inventory written off in 2003 is still on hand. We will continue
to try to sell some of these units internationally, but it is still uncertain as
to how many units we will be able to sell and at what price. Eventually we will
scrap the units or use them for parts.
Operating
Expenses
The
following is a summary of operating expenses as a percentage of net
revenue:
|
|
|
2004 |
|
|
2003 |
|
|
Change |
|
Sales
and marketing |
|
$ |
23,959 |
|
|
35.0 |
% |
$ |
18,616 |
|
|
30.0 |
% |
$ |
5,343 |
|
|
28.7 |
% |
Research
and development |
|
|
6,027 |
|
|
8.8 |
% |
|
5,538 |
|
|
8.9 |
% |
|
489 |
|
|
8.8 |
% |
General
and administrative |
|
|
19,241 |
|
|
28.1 |
% |
|
14,720 |
|
|
23.8 |
% |
|
4,521 |
|
|
30.7 |
% |
Amortization |
|
|
1,931 |
|
|
2.8 |
% |
|
1,656 |
|
|
2.7 |
% |
|
275 |
|
|
16.6 |
% |
Gain
on sales and other, net |
|
|
(1,077 |
) |
|
(1.6 |
%) |
|
— |
|
|
— |
|
|
(1,077 |
) |
|
— |
|
Total
operating expenses |
|
$ |
50,081 |
|
|
73.1
|
% |
$ |
40,530 |
|
|
65.4 |
% |
$ |
9,551 |
|
|
23.6 |
% |
Sales and
marketing expenses increased by 28.7% to $23,959 for the year ended December 31,
2004, and as a percentage of revenue to 35.0% in 2004 from 30.0% in 2003. The
increase is primarily attributable to the expansion of our international sales
operations of $2,113, particularly in the U.K and Germany, a full year of sales
and marketing expenses related to program management and training services of
$2,454 pursuant to the acquisition of Complient in the fourth quarter of 2003,
higher direct marketing costs of $2,706, and a full year of our inside sales
team established in late 2003 of $560. This increase is offset by reductions in
sales and marketing headcount and related expenses in the U.S., primarily in the
indirect sales channel, of $2,612.
Research
and development expenses for the year ended December 31, 2004 increased $489 or
8.8% compared to 2003. The increase is directly related to additional headcount
and project costs of $991 associated with the development of an in-hospital
crash-cart defibrillator for GE Healthcare pursuant to a development agreement
signed in July 2003, increased facility costs of $203 year over year resulting
from the relocation of the research and development team to a new facility in
mid 2003, offset by the reallocation of resources of $711 focused on
engineering support in 2003 to regulatory and quality assurance activities
included in general and administrative expenses in 2004.
General
and administrative expenses increased $4,521 or 30.7% for the year ended
December 31, 2004 compared to 2003. The increase was primarily due to: (i)
increased legal costs of $1,707 related to the Philips patent litigation, (ii)
increased provision for bad debts of $1,314 resulting from uncertainty as to the
collectibility of certain accounts, (iii) increased audit, tax and consulting
fees primarily related to Sarbanes-Oxley compliance of $835, (iv) a full year of
headcount and facilities resulting from the Complient acquisition in October
2003 of $751, (v) increased corporate insurance costs of $396, and (vi)
increased regulatory and quality assurance costs, including the reallocation of
resources that were focused on engineering support in 2003 to regulatory and
quality assurance activities included in general and administrative expenses in
2004, of $972. This increase is partially offset by: (i) a decrease in costs
related to our relocation and expansion of facilities expenses in 2003 of $718,
(ii) a reduction of headcount and related expenses from consolidating our
international operations of $237, and (iii) a decrease in executive headcount
and compensation of $392.
Amortization
of intangibles included in operating expenses was $1,931 for the year ended
December 31, 2004, an increase of $275 or 16.6% from the $1,656 for the year
ended December 31, 2003. The increase is primarily the result of a full year of
amortization on certain identifiable intangible assets in 2004 that were related
to the Complient acquisition in October 2003.
Net gain
on sales of assets and other costs was $1,077 for the year ended December 31,
2004 and consisted of the gains on sales of the CPR Prompt product line of
$1,368 and the AED trainer product of $387, offset by a loss on sales of fixed
assets of $203, an impairment of assets related to the discontinuance of the
Diascope product line of $190, and severance related to headcount reductions
from consolidating our international operations of $285.
Interest
Expense
Interest
expense for the year ended December 31, 2004 was $7,031 compared to interest
expense of $6,031 for 2003. The increase was primarily due to a higher average
outstanding balance on the Senior Notes, higher amortization of the note
discount using the effective interest rate method, and the amortization of the
value of warrants issued in March 2004 in connection with an amendment to the
Senior Note and Warrant Purchase Agreement.
Year
Ended December 31, 2003 Compared to Year Ended December 31,
2002
Results
of Operations
On
October 21, 2003, in a move to capture additional revenue related to the sale of
our AEDs, we acquired substantially all the assets and liabilities of Complient
Corporation, the nation’s leading independent provider of AED and CPR training
and comprehensive AED program management. Corporations, municipalities, schools,
government agencies and others who purchase and deploy AEDs are required by
certain federal and state laws to obtain a medical prescription and have
designated personnel trained annually in AED use and CPR by a certified trainer.
Traditionally, buyers of AEDs have had to arrange for their own training with
non-profit organizations or off-duty paramedics, coordinate their own site
assessment and deployment, and assure ongoing compliance with recertification
and other regulations. Complient was the first organization of its kind to offer
a comprehensive training program that included the management and coordination
of all aspects of AED deployment including site surveys, medical direction,
web-based software for record-keeping and AED/CPR training with 150 certified
trainers on staff covering all 50 states nationwide. Strategically, Complient
fit well with us and was a logical extension of our core business. The
acquisition provides additional point-of-sale revenue as well as a recurring
revenue opportunity linked to AED sales. Moreover, we believe this will provide
us with a significant competitive advantage over our competitors who do not
offer comparable programs. We reduced Complient’s non-trainer staff by
approximately one third and substantially completed the integration of its
operations into ours as of December 31, 2003. In 2002, Complient generated
revenue of approximately $12,600 from sales of AEDs and related services.
At the
end of 2003, we made a strategic decision to discontinue the “no cap” Powerheart
CRM placement business model in U.S. hospitals in favor of a capital sale model
focused on key distribution relationships such as those we entered into in 2003
with General Electric Medical Systems and the Premier, Inc. buying group. In
2001, we adopted the “no cap” model, whereby we marketed the Powerheart to U.S.
hospitals directly, and agreed to place Powerheart units in a customer’s
facility, while retaining ownership of the unit, with no upfront capital
equipment charge to the customer in exchange for an agreement to purchase our
proprietary, disposable defibrillation electrodes monthly or quarterly. We
believed this “no cap” model would increase the rate of adoption of our AECD/CRM
technology by addressing the capital budget constraints many U.S. hospitals face
and would ultimately result in higher levels of recurring revenue from
disposable electrodes. While this model did initially increase adoption of the
technology, it has failed to produce the expected levels of revenue required to
continue with this business model going forward. As a result of this strategic
change, we incurred a $2,917 inventory impairment charge to write down the value
of first generation Powerheart and Powerheart CRM in-hospital defibrillators in
inventory and at certain customer sites. However, there are a number of customer
sites where the technology has been successfully deployed and that are
generating sufficient revenue on disposable electrode sales to justify the
continuation of this program for those specific customers. At December 31, 2003,
we still had on hand all of the inventory that was written off. We will attempt
to sell some of these units internationally, but it is uncertain as to how many
units we will be able to sell, at what price, and over what time frame.
Eventually, we will scrap the units or use them for parts.
Revenue
The
following is a summary of net revenue by product line:
|
|
|
2003 |
|
|
2002 |
|
|
Change |
|
AED
and related accessories and services |
|
$ |
56,529 |
|
|
91.2 |
% |
$ |
38,572 |
|
|
77.1 |
% |
$ |
17,957 |
|
|
46.6 |
% |
Powerheart
in-hospital defibrillators and accessories |
|
|
1,259 |
|
|
2.0 |
% |
|
1,278 |
|
|
2.5 |
% |
|
(19 |
) |
|
(1.5 |
)% |
Emergency
defibrillators, monitors, training products and
accessories |
|
|
4,194 |
|
|
6.8 |
% |
|
10,193 |
|
|
20.4 |
% |
|
(5,999 |
) |
|
(58.9 |
)% |
Total
net revenue |
|
$ |
61,982 |
|
|
100.0
|
% |
$ |
50,043 |
|
|
100.0 |
% |
$ |
11,939 |
|
|
23.9 |
% |
Net
revenue for the year ended December 31, 2003 increased $11,939 or 23.9% compared
to the year ended December 31, 2002. This increase was primarily attributable to
our expanding share of the growing worldwide market for AEDs. Sales of AED
products and related accessories and services, which represented 91.2% of our
total revenue, increased by $17,957, or 46.6%. The AED product line, led by the
Powerheart AED G3, continued to be the principal growth driver and was fueled
and complemented by the acquisition of Complient and the addition of AED/CPR
training and program management services, which accounted for $1,519 of sales in
2003, primarily in the period following the acquisition of Complient on October
21, 2003. In addition, we sold $4,194 of emergency defibrillators, monitors,
training equipment and accessories in 2003 compared to $10,193 in 2002. This
decrease of $5,999, or 58.9%, is due to the fact that we dedicated less
resources to our patient monitoring line, which is not part of our core AED and
hospital defibrillation markets, and has resulted in a strategic change for 2004
to exit the patient monitoring line, along with the training related equipment
and supplies product line we acquired from Complient. Sales of Powerheart CRMs
and related accessories were $431 for 2003 compared to $240 in 2002, which
represents less than 1% of total revenue in both years. Sales of our Powerheart
proprietary disposable defibrillation electrodes related to the first generation
Powerheart and the Powerheart CRM were $828 for 2003 and $1,038 for 2002. The
lack of growth in these in-hospital products contributed to the business model
change in late 2003 discussed earlier under “Results of
Operations.”
Gross
Margin
Cost of
revenue for the year ended December 31, 2003 was $28,543, including an
impairment charge of $2,917, compared to $24,737 for the year ended December 31,
2002. Gross margins as a percentage of revenue, including the impairment charge,
improved to 53.9% in 2003 from 50.6% in 2002. The improvement was a result of
increased sales of higher margin AEDs as a percentage of total revenue from
77.1% in 2002 to 91.2% in 2003, as well as the reduced cost of the AED product
line due to significant cost reduction initiatives taken in 2003 and the
introduction of our new lower cost version Powerheart AED G3 in August 2003.
Cost of service revenue for the year ended December 31, 2003 was $747, for a
gross margin on the AED/CPR training business acquired from Complient of 50.8%.
Operating
Expenses
The
following is a summary of operating expenses as a percentage of net revenue:
|
|
|
2003 |
|
|
2002 |
|
|
Change |
|
Sales
and marketing |
|
$ |
18,616 |
|
|
30.0 |
% |
$ |
17,325 |
|
|
34.6 |
% |
$ |
1,291 |
|
|
7.5 |
% |
Research
and development |
|
|
5,538 |
|
|
8.9 |
% |
|
6,053 |
|
|
12.1 |
% |
|
(515 |
) |
|
(8.5 |
)% |
General
and administrative |
|
|
14,720 |
|
|
23.8 |
% |
|
11,474 |
|
|
22.9 |
% |
|
3,246 |
|
|
28.3 |
% |
Amortization |
|
|
1,656 |
|
|
2.7 |
% |
|
2,111 |
|
|
4.2 |
% |
|
(455 |
) |
|
(21.6 |
)% |
Gain
on settlement |
|
|
— |
|
|
— |
|
|
(832 |
) |
|
(1.6 |
)% |
|
832 |
|
|
100.0 |
% |
Total
operating expenses |
|
$ |
40,530 |
|
|
65.4 |
% |
$ |
36,131 |
|
|
72.2 |
% |
$ |
4,399 |
|
|
12.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales and
marketing expenses increased by 7.5% to $18,616 for the year ended December 31,
2003, but decreased as a percentage of revenue to 30.0% in 2003 from 34.6% in
2002. The absolute dollar increase is primarily attributable to increased sales
and marketing activities related to international sales operations ($1,228),
including the establishment of direct sales operations in the U.K and Germany,
and increased U.S. sales activities related to the growth of AED related sales
($1,073), including new sales and marketing expenses related to program
management and training services pursuant to the acquisition of Complient. This
increase is offset by a decrease in the sales and clinical efforts associated
with the Powerheart CRM in-hospital product line ($1,129). The decrease in
expenses as a percentage of revenue reflects our operating leverage and an
increasing mix of revenue flowing through lower-cost indirect distribution
channels.
Research
and development expenses for the year ended December 31, 2003 decreased 8.5%
compared to 2002. In 2003, research and development expenses were 8.9% of
revenue, down from 12.1% of revenue in 2002. The absolute dollar decrease is
primarily attributable to: (i) the development and completion of the Powerheart
CRM project in 2002 which resulted in higher salaries, bonuses and benefits as
well as project design, consulting and materials expenses during 2002 and (ii)
the fact that we reallocated resources previously focused on preproduction
activities included in research and development expenses in 2002, but now
focused on Company-wide operations which are included in general and
administrative in 2003. The second half of 2003 compared with the first half of
2003 shows an increase in research and development expenses directly related to
more headcount and project costs associated with the development of a standard
crash-cart biphasic defibrillator for GE Healthcare pursuant to a development
agreement signed in July 2003.
General
and administrative expenses increased $3,246 or 28.3% during the year ended
December 31, 2003 compared with 2002. As a percentage of revenue, general and
administrative expenses increased to 23.8% in 2003 from 22.9% in 2002. This
increase was primarily comprised of new expenses, primarily headcount and
facilities, related to the Complient acquisition ($435), our relocation of
corporate headquarters and expansion of corporate, manufacturing and R&D
facilities in 2003 ($936), increased salaries and benefits ($675), depreciation
expense ($449) and the fact that we reallocated resources previously focused on
preproduction activities included in research and development expenses in 2002,
but now focused on Company-wide operations which are included in general and
administrative in 2003 ($585).
Amortization
of intangibles was $1,656 for the year ended December 31, 2003, a decrease of
$455 or 21.6% from the $2,111 for the year ended December 31, 2002. The decrease
is primarily the result of certain identifiable intangible assets becoming fully
amortized during 2003 offset by approximately two months of amortization of
intangibles related to the Complient acquisition.
Gain on
settlement of $832 in 2002 relates to a settlement agreement with Medtronic
Physio-Control (“MPC”) to terminate a distribution and licensing agreement
between the parties (see Note 20 of the financial statements).
Interest
Interest
expense for the year ended December 31, 2003 was $6,031 compared to interest
expense of $4,452 for 2002. The increase was a result of a full year of interest
expense and warrant and debt issuance cost amortization in 2003 associated with
the senior secured promissory notes issued in May 2002.
Liquidity
and Capital Resources
|
|
December
31 |
|
|
|
2004 |
|
|
2003 |
|
Working
capital |
|
$ |
27,046 |
|
$ |
22,981 |
|
Current
ratio (current assets to current liabilities) |
|
|
2.6
: 1.0 |
|
|
2.3:1.0 |
|
Cash
and cash equivalents |
|
$ |
13,913 |
|
$ |
8,871 |
|
Accounts
receivable, net |
|
$ |
17,978 |
|
$ |
20,410 |
|
Inventories |
|
$ |
9,680 |
|
$ |
9,575 |
|
Short-term
and long-term borrowings |
|
$ |
52,664 |
|
$ |
46,575 |
|
The
increase in our current ratio, working capital and cash and cash equivalents is
primarily due to proceeds from our private placement of common stock in July
2004.
At
December 31, 2004, our days sales outstanding on accounts receivable (“DSO”) was
approximately 79 days compared to approximately 105 days at December 31, 2003,
calculated based on a quarterly period using the ending net accounts receivable
balance. We anticipate that our DSO will average less than 90 days during 2005.
The decrease in our DSO is primarily due to more aggressive collection efforts
and a decrease in the revenue mix in 2004 compared to 2003 for sales in the U.S.
indirect distribution channel which typically have longer payment terms.
In
February 2004, we secured a $5,000 line of credit with Silicon Valley Bank. The
line of credit may be used to provide additional working capital, as needed, to
fund our continued growth. This 24-month facility is collateralized by accounts
receivable, inventory and cash and cash equivalents, has an interest rate of the
bank’s prime rate plus .75% (with a floor of 5%) payable monthly, and requires
us to maintain certain financial covenants. In January 2005, we obtained a
waiver from the bank for the quarter and year ended December 31, 2004 for
non-compliance with certain financial covenants required by the line of credit
agreement. There was no outstanding balance on the line at December 31, 2004 or
through the date of this filing.
From
inception, our sources of funding for operations and mergers and acquisition
activity were derived from placements of debt and equity securities. In 2001, we
raised approximately $37,000 in a series of private equity placements and
through the exercise of outstanding options and warrants. In May 2002, we issued
notes payable totaling $50,000. With the proceeds from these notes, we repaid
the $26,468 plus accrued interest in senior promissory notes relating to the
Survivalink acquisition. In September 2003, we raised $8,375 in a private equity
placement of 2,233,334 shares of our common stock at $3.75 per share to a small
group of institutional and accredited investors. In connection with this
offering, we also issued 223,333 five-year warrants with an exercise price of
$5.00 per share. In July 2004, we raised gross proceeds of $12,370 in a private
equity placement of 5,219,409 shares of our common stock at $2.37 per share. In
connection with this offering, we issued five-year warrants to purchase
2,087,763 shares of common stock at a price of $2.84 per share. In January 2005,
as consideration for delays in filing the required registration statement for
the July 2004 private placement, we agreed with the investors to make a cash
payment of $556, to issue an additional aggregate of 476,637 shares of common
stock at the fair market value on the date of the agreement, and to reduce the
exercise price on all the investors’ warrants to $2.50 per share. We expect to
incur expense of approximately $1,500 in 2005 as a result of this agreement.
In May
2002, we entered into a Senior Note and Warrant Purchase Agreement (“the
Agreement”) with investors, pursuant to which the investors loaned the Company
$50,000. Under the original terms of the Agreement, the Senior Notes (the
“Notes”) were due and payable in cash on May 30, 2007, unless accelerated
pursuant to the terms of the Agreement, and accrue interest at 6.9% per annum.
During the first three years of the term of the Notes, accrued and unpaid
interest on the Notes would, at the option of the Company, a) be due and payable
in cash, or b) accrue and be paid in kind, in each case quarterly in arrears,
and then due on the termination date of the Notes. After the end of the third
year of the term of the Notes, any additional accrued and unpaid interest on the
Notes would be due and payable in cash quarterly in arrears, and on the
termination date of the Notes. The Notes have certain monthly and quarterly
financial and non-financial covenants. The Notes are collateralized by our
assets and the assets of our subsidiaries, to the extent permitted by law.
Proceeds from the Notes were used to repay $26,468 of senior promissory notes
plus accrued interest issued in connection with the acquisition of Survivalink
Corporation and the remaining proceeds were used for working capital purposes.
In
connection with the Notes, the investors were issued warrants (the “Warrants”)
for the purchase of an aggregate of 10,000,000 shares of our common stock at an
exercise price of $3.00 per share, and an aggregate of 3,000,000 shares of
common stock at an exercise price of $4.00 per share. The Warrants are
immediately exercisable, expire by their terms on May 30, 2009 and are subject
to certain limited antidilution adjustments. After two years, we have the right
to force the exercise of the Warrants pursuant to the terms of the Agreement.
The proceeds from the Notes were allocated between the Notes and the Warrants
based on their relative fair values which resulted in a discount being recorded
on the Notes pursuant to APB No. 14 “Accounting for Convertible Debt and Debt
Issued with Stock Purchase Warrants.” We considered a number of factors,
including an independent valuation, when determining the fair value of the
Warrants. The significant assumptions used in the Black-Scholes model were:
stock price of $2.90, adjusted downward for a dilution factor to $2.68; risk
free rate of 4.98%; volatility of 0.90; dividend yield of 0%; and contractual
term of 7 years. Such allocation resulted in a discount being recorded on the
Notes in the amount of $11,815, which is being amortized over the five-year term
of the Notes using the effective interest method. In addition, we paid
approximately $2,760 in debt issuance costs which are being amortized over the
five-year term of the Notes using the effective interest method.
In March
2004, we amended the Agreement in order to ease certain financial covenants into
2005 to reflect our actual and expected financial results. In exchange for these
modifications, we issued the note holders 500,000 additional warrants to
purchase shares of common stock at $3.95 per share. The warrants were valued at
$1,301 using a Black-Scholes model. The significant assumptions used in the
model were: stock price of $3.98; risk free rate of 3.2%; volatility of 0.65;
dividend yield of 0%; and contractual term of seven years. The value of the
warrants was recorded as additional discount to the Senior Notes to be amortized
over the remaining term of the Senior Notes using the effective interest method.
This modification was not considered to be a significant modification of the
Agreement.
Under the
antidilution provisions of the Agreement, which were triggered by the September
2003 and July 2004 private placements (see Note 15 to the financial statements)
and the July 2003 warrant issuance to GE Healthcare (see Note 20 to the
financial statements), an additional 205,451 warrants were issuable to the note
holders at exercise prices ranging from $2.97 to $3.88. In addition, the
exercise prices of the original warrants issued were also reduced to: (i) $2.97
for the 10,000,000 warrants that had an original exercise price of $3.00, (ii)
$3.88 for the 3,000,000 warrants that had an original exercise price of $4.00,
and (iii) $3.86 for the 500,000 warrants that had an original exercise price of
$3.95.
In
January 2005, we entered into an amendment and limited waiver (the “Amendment”)
to the Agreement with the senior note holders. Pursuant to the terms of the
Amendment, we and the Senior Note Holders agreed to: (i) extend the maturity
date of the $50,000 in aggregate principal amount of Senior Notes issued under
the Agreement by twelve months to May 29, 2008; (ii) defer all cash interest
payments until maturity; and (iii) modify certain financial covenants regarding
minimum EBITDA, minimum debt to capitalization and maximum capital expenditures,
and delete certain other financial covenants for 2005 through maturity.
Additionally, the senior note holders waived certain covenant violations,
including all financial covenant violations for the quarter and year ended
December 31, 2004. In exchange for the foregoing amendments and waiver contained
in the Amendment, we and the senior note holders agreed to reduce the number of
warrants to purchase shares of common stock to 13,438,599 and reduce the
exercise price of those warrants to $2.00 per share, down from the original
weighted average price of approximately $3.21 per share.
The
accompanying consolidated financial statements have been prepared on the basis
that we will continue as a going concern and that we will recover our assets and
satisfy our liabilities in the normal course of business. From inception, we
have incurred substantial losses and negative cash flows from operations. For
the years ended December 31, 2004 and 2003, we incurred losses of $18,669 and
$12,537, respectively, and negative cash from operations of $8,776 and $16,347,
respectively. As of December 31, 2004, we had cash on hand of $13,913, working
capital of $27,046, short and long term debt of $52,664, and an accumulated
deficit of $124,357.
We
believe that our current cash balance, in combination with net cash expected to
be generated from operations and our unused line of credit of $5,000, will fund
ongoing operations for the next twelve months. Our expected net cash from
operations is predicated on achieving certain revenue levels and maintaining our
cost of goods, operating expenses, DSO ratio.
If we do
not realize the expected revenue and cost of goods, or if operating expenses
increase substantially, or if we cannot maintain our DSO ratio, we may not be
able to fund our operations for the next twelve months. In addition, our line of
credit and our Senior Notes require maintenance of certain financial covenants,
of which we were in violation during 2004. Even though we have obtained waivers
for all covenant violations and have amended the covenants for 2005 and going
forward, if in the future, we fail to comply with these financial covenants as
amended, we could be unable to use our line of credit or be in default under the
Senior Notes. If we are in default, we may be subject to claims by the note
holders seeking to enforce their security interest in our assets. Such claims,
if they arise, may substantially restrict or even eliminate our ability to
utilize our assets in conducting our business, and may cause us to incur
substantial legal and administrative costs.
In the
event that we require additional funding during the next twelve months, we will
attempt to raise the required capital through either debt or equity
arrangements. We cannot provide any assurance that the required capital would be
available on acceptable terms, if at all, or that any financing activity would
not be dilutive to our current stockholders. If we are not able to raise
additional funds, we may be required to significantly curtail our operations and
this would have an adverse effect on our financial position, results of
operations and cash flows and as such, there may be substantial doubt about our
ability to continue as a going concern.
Cash
Flows
The
following table presents the abbreviated cash flows for the years ended December
31, 2004 and 2003:
|
|
|
2004 |
|
|
2003 |
|
Net
cash used in operating activities |
|
$ |
(8,776 |
) |
$ |
(16,347 |
) |
Net
cash provided by investing activities |
|
|
596 |
|
|
219 |
|
Net
cash provided by financing activities |
|
|
13,227 |
|
|
9,509 |
|
Effect
of exchange rates on cash and cash equivalents |
|
|
(5 |
) |
|
(108 |
) |
Net
increase (decrease) in cash and cash equivalents |
|
|
5,042 |
|
|
(6,727 |
) |
Cash
and cash equivalents, beginning of year |
|
|
8,871 |
|
|
15,598 |
|
Cash
and cash equivalents, end of year |
|
$ |
13,913 |
|
$ |
8,871 |
|
Cash used
by operating activities for the year ended December 31, 2004 was $8,776, a
decrease of $7,571 or 46.3% from $16,347 in 2003. The decrease is primarily due
to a reduction in cash used in accounts receivable, inventory, and accounts
payable of $12,935 and a reduction of cash used in net assets and liabilities
held for sale of $1,460, offset by an increase in our net loss of
$6,132.
Cash
provided by investing activities for the year ended December 31, 2004 was $596,
an increase of $377 or 172.1% from $219 in 2003. This change was primarily
attributable to a decrease in purchases or property and equipment of $1,080 year
over year and an increase in proceeds from sales of assets of $1,731 year over
year, substantially offset by cash inflows in 2003 related to the refund of the
MRL investment of $3,001 and goodwill cash adjustments of $1,050, offset by the
purchase of Artema minority interest of $843.
Cash
provided by financing activities for the year ended December 31, 2004 was
$13,227, an increase of $3,718 or 39.1% from $9,509 in 2003. This increase was
primarily due to an increase in proceeds from private placements of common stock
year over year of $3,995 offset by a decrease in proceeds from the exercise of
common stock options and warrants year over year of $365.
Off-Balance
Sheet Arrangements
At December 31, 2004, our Danish
subsidiary has outstanding bank guarantees/performance bonds totaling 2,373
Danish Kroner (approximately $435 in U.S. dollars) that were issued in 1999
through 2002 in connection with sales contracts to foreign governments. These
performance bonds expire in ____. In addition, during 2004, we issued a
performance bond for $88 collateralized by a letter of credit issued by Silicon
Valley Bank under our line of credit in connection with a sales contract with a
city municipality. The performance bond expires in November 2007. We have no
further performance obligations under these contracts other than providing
normal warranty service on the products sold under the contracts.
In
addition, we have non-cancelable operating leases entered into in the ordinary
course of business. For liquidity purposes, we choose to lease our facilities,
automobiles, and certain equipment instead of purchasing them.
Contractual
Obligations and Other Commercial Commitments
We had no
material commitments for capital expenditures as of December 31,
2004.
The
following table presents our expected cash requirements for contractual
obligations outstanding as of December 31, 2004:
|
|
|
Total |
|
|
Less
than
1
Year |
|
|
1-3
Years |
|
|
4-5
Years |
|
|
After
5
Years |
|
Senior
Notes, including interest |
|
$ |
69,945 |
|
$ |
2,474 |
|
$ |
67,471 |
|
|
— |
|
|
— |
|
Other
long-term debt |
|
|
41 |
|
|
16 |
|
|
25 |
|
|
— |
|
|
— |
|
Non-cancelable
operating leases |
|
|
5,765 |
|
|
1,752 |
|
|
3,251 |
|
|
762 |
|
|
— |
|
|
|
$ |
75,751 |
|
$ |
4,242 |
|
$ |
70,747 |
|
$ |
762 |
|
$ |
— |
|
In
January 2005, the terms of the Senior Notes were amended (see Note 22 of the
financial statements). The following table presents our expected cash
requirements for contractual obligations reflecting the amendment:
|
|
|
Total |
|
|
Less
than
1
Year |
|
|
1-3
Years |
|
|
4-5
Years |
|
|
After
5
Years |
|
Senior
Notes, including interest expense |
|
$ |
75,553 |
|
$ |
— |
|
$ |
— |
|
$ |
75,553 |
|
|
— |
|
Long-term
obligations |
|
|
41 |
|
|
16 |
|
|
25 |
|
|
— |
|
|
— |
|
Operating
leases |
|
|
5,765 |
|
|
1,752 |
|
|
3,251 |
|
|
762 |
|
|
— |
|
|
|
$ |
81,359 |
|
$ |
1,768 |
|
$ |
3,276 |
|
$ |
76,315 |
|
$ |
— |
|
Income
Taxes
As of
December 31, 2004, we have research and experimentation credit carry forwards
for federal and state purposes of approximately $3,000 and $1,000, respectively.
These credits begin to expire in 2006 for federal purposes and carry forward
indefinitely for California state purposes. We have capital loss carry forwards
of approximately $1,000 for both federal and state purposes which begin to
expire in 2006 for federal purposes and carry forward indefinitely for state
purposes. We also have approximately $139,000 and $69,000, respectively, of
federal and state net operating loss carry forwards which will begin to expire
in 2006 and 2005, respectively.
Internal
Revenue Code Sections 382 and 383, and similar state provisions place certain
limitations on the annual amount of loss and credit carryforwards that can be
utilized if certain changes to a company’s ownership occur. The acquisition of
Survivalink in 2001 resulted in a change in ownership pursuant to Section 382 of
the Internal Revenue Code. The annual limitation is as follows: $8,300 for 2005,
$6,500 for 2006 and $1,800 thereafter. The amount of net operating loss subject
to this limitation, for federal and state purposes, is approximately $53,000 and
$24,000, respectively. Research and experimentation credits and capital loss
carryovers are also subject to the limitation under Internal Revenue Code
Sections 382 and 383 and similar state provisions. The utilization of net
operating loss carryovers and other tax attributes may be subject to further
substantial limitations if certain ownership changes occur in future periods.
We
recorded deferred tax assets of approximately $16,000 upon the acquisition of
Survivalink in 2001. The deferred tax assets are composed primarily of loss and
tax credit carryforwards and other temporary differences. The deferred tax
assets recorded were reduced by a valuation allowance of $16,000. Due to the
expiration of some of the net operating loss carryovers the balance is $13,000
as of December 31, 2004. If we determine that we will realize the tax benefit
related to these Survivalink deferred assets in the future, the related decrease
in the valuation allowance will reduce goodwill instead of the provision for
taxes.
We also
recorded deferred tax assets of approximately $8,000 upon the acquisition of
Cadent in 2000. The deferred tax asset was composed primarily of loss
carryforwards and other temporary differences. The deferred tax assets recorded
were also reduced by a valuation allowance of $8,000. Due to the expiration of
some of the net operating loss carryovers, the balance is $7,000 as of December
31, 2004. If we determine that we will realize the tax benefit related to these
Cadent deferred assets in the future, the related decrease in the valuation
allowance will reduce goodwill instead of the provision for taxes.
Additionally,
approximately $1,600 of the net operating loss carryforward represents
deductions claimed as the result of stock options. If we determine that we will
realize the benefit of this net operating loss carryforward in the future, the
related decrease in the valuation allowance will be credited to additional
paid-in capital instead of the provision for taxes.
At
December 31, 2004, we had foreign net operating loss carryforwards. The losses
carry over indefinitely, unless certain defined changes in business operations
occur during the carryover period. We have established a full valuation
allowance against these deferred tax assets since it cannot be established that
these foreign subsidiaries’ net operating loss carryforwards will be fully
utilized.
Critical
Accounting Policies and Estimates
Our
discussion and analysis of our financial condition and results of operations are
based upon our consolidated financial statements, which have been prepared in
accordance with accounting principles generally accepted in the United States.
The preparation of these financial statements requires us to make estimates and
judgments that affect the reported amount of assets and liabilities and
disclosure of contingent assets and liabilities at the date of the financial
statements and the reported amount of revenue and expenses for each
period.
The
following represents a summary of our critical accounting policies, defined as
those policies that we believe are: (a) the most important to the portrayal of
our financial condition and results of operations, and (b) that require our most
difficult, subjective or complex judgments, often as a result of the need to
make estimates about the effects of matters that are inherently
uncertain.
Valuation
of Accounts Receivable
We
maintain an allowance for uncollectible accounts receivable to estimate the risk
of extending credit to customers. The allowance is estimated based on customer
compliance with credit terms, the financial condition of the customer, and
collection history, where applicable. Additional allowances could be required if
the financial condition of our customers were to be impaired beyond our
estimates.
Valuation
of Inventory
Inventory
is valued at the lower of cost (estimated using the first-in, first-out method)
or market. We periodically evaluate the carrying value of inventories and
maintain an allowance for obsolescence to adjust the carrying value, as
necessary, to the lower of cost or market. The allowance is based on our
assessment of future product demand, historical experience and technical
obsolescence, as well as other factors affecting the recoverability of the asset
through future sales. Unfavorable changes in estimates of obsolete inventory
would result in an increase in the allowance and a decrease in gross
profit.
Goodwill
and Other Intangibles
In
accordance with SFAS No. 142 “Goodwill and Other Intangible Assets,” goodwill
and other intangible assets with indeterminate lives are no longer subject to
amortization but are tested for impairment annually or whenever events or
changes in circumstances indicate that the asset might be impaired. We operate
in one operating segment and have one reporting unit, therefore, we test
goodwill for impairment at the consolidated level against the fair market value
of the Company. Per SFAS No. 142, the fair value of a reporting unit refers to
the amount at which the unit as a whole could be bought or sold in a current
transaction between willing parties. Quoted market prices in active markets are
the best evidence of fair value and shall be used as the basis on the last day
of the year for the measurement, if available. We assess potential impairment on
an annual basis on the last day of the year and compare our market
capitalization to the carrying amount of goodwill. A significant decrease in our
stock price could indicate a material impairment of goodwill which, after
further analysis, could result in a material charge to operations. To date, we
have not determined or recorded an impairment of goodwill since our market
capitalization at the date of the impairment tests has never been less than the
carrying amount of goodwill. Other intangible assets with finite lives continue
to be subject to amortization, and any impairment is determined in accordance
with SFAS No. 144 “Accounting for the Impairment or Disposal of Long-Lived
Assets.
Valuation
of Long-Lived Assets
In
accordance with SFAS No. 144, long-lived assets and intangible assets with
determinate lives are reviewed for impairment whenever events or changes in
circumstances indicate that the carrying amount of an asset may not be
recoverable. We evaluate potential impairment by comparing the carrying amount
of the asset with the estimated undiscounted future cash flows associated with
the use of the asset and its eventual disposition. Should the review indicate
that the asset is not recoverable, our carrying value of the asset would be
reduced to its estimated fair value, which is generally measured by future
discounted cash flows. In our estimate, no provision for impairment is currently
required on any of our long-lived assets.
Valuation
of Warrants
We
periodically issue warrants in connection with debt issuances and in exchange
for goods and services. We follow the guidance of APB No. 14 “Accounting for
Convertible Debt and Debt Issued with Stock Purchase Warrants” for warrants we
issue in connection with debt. We follow the guidance in EITF No. 96-18
“Accounting for Equity Instruments That are Issued to Other Than Employees for
Acquiring, or in Conjunction with Selling, Goods or Services” and EITF No. 01-9
“Accounting for Consideration Given by a Vendor to a Customer (Including a
Reseller of the Vendor’s Products)” for warrants we issue in exchange for or in
connection with goods and services. Management considers a number of factors,
including independent valuations, when determining the fair value of warrants
issued. We estimate the fair value of warrants issued using the Black-Scholes
model. Of the various assumptions considered by the Black-Scholes model, the
volatility and the risk free rate used require us to make certain assumptions
and estimations. We estimate volatility using a statistical method based on the
historical daily stock price for the historical period equal to the expected
life of the warrant being valued. The risk free interest rate is determined
using the treasury note rate for the number of years corresponding to the
expected life of the warrant being valued. Potentially, the value of warrants
could be materially different if different assumptions were used and under
different markets conditions.
Revenue
Recognition
We record
revenue in accordance with Securities and Exchange Commission (“SEC”) Staff
Accounting Bulletin No. 104, Revenue Recognition in Financial Statements (SAB
104). SAB 104 requires that product sales be recognized when there is persuasive
evidence of an arrangement which states a fixed and determinable price and
terms, delivery of the product has occurred in accordance with the terms of the
sale, and collectibility of the sale is reasonably assured. We record product
sales when we have received a valid customer purchase order for product at a
stated price, the customer’s credit is approved, and we have shipped the product
to the customer whereby title and risk have passed to the customer.
We are
not contractually obligated to repurchase any inventory from distributors or end
user customers. Some of our customers are distributors that sell goods to third
party end users. For certain identified distributors where collection may be
contingent on the distributor’s resale, revenue recognition is deferred and
recognized on a “sell through” basis. The determination of whether sales to
distributors are contingent on resale is subjective because we must assess the
financial wherewithal of the distributor to pay us regardless of resale. For
sales to distributors, we consider several factors, including past payment
history, where available, trade references, bank account balances, Dun &
Bradstreet reports and any other financial information provided by the
distributor, in assessing whether the distributor has the financial wherewithal
to pay regardless of, or prior to, resale of the product and that collection of
the receivable is not contingent on resale.
We offer
limited volume price discounts and rebates to certain customers. Volume price
discounts are on a per order basis based on the size of the order and are netted
against the revenue recorded at the time of shipment. We have no arrangements
that provide for volume discounts at a later date, such as based on meeting
certain quarterly or annual purchase levels. Rebates are paid quarterly or
annually based on sales performance and are accrued for at the end of a
reporting period. To date, all rebate arrangements have been immaterial.
We follow
the guidance of EITF No. 00-21 “Accounting
for Revenue Arrangements with Multiple Deliverables.” In
accordance, we consider our program management packages and training and other
services as separate units of accounting when sold with an AED based on the fact
that the items have value to the customer on a stand alone basis and could be
acquired from another vendor. Training and AED program management service
revenue is deferred and recognized at the time the training occurs. AED program
management services pursuant to agreements that existed with Complient customers
pursuant to annual or multi-year terms are deferred and amortized straight-line
over the related contract period.
Upfront
license fees are deferred and recognized to revenue using the straight-line
method over the term of the related license agreement. Royalty revenue are due
and payable quarterly (generally 60 days after period end) pursuant to the
related license agreements. An estimate of royalty revenue is recorded quarterly
in the period it is earned based on the prior quarter’s historical results
adjusted for any new information or trends known to management at the time of
estimation.
Product
Warranty
Products
sold are generally covered by a warranty against defects in material and
workmanship for a period of one to seven years. We accrue a warranty reserve to
estimate the risk of incurring costs to provide warranty services. The accrual
is based on our historical experience and our expectation of future conditions.
An increase in warranty claims or in the costs associated with servicing those
claims would result in an increase in the accrual and a decrease in gross
profit.
Litigation
and Others Contingencies
We
regularly evaluate our exposure to threatened or pending litigation and other
business contingencies. Because of the uncertainties related to the amount of
loss from litigation and other business contingencies, the recording of losses
relating to such exposures requires significant judgment about the potential
range of outcomes. We are not presently affected by any litigation or other
contingencies that have had, or are currently anticipated to have, a material
impact on our results of operations or financial position. As additional
information about current or future litigation or other contingencies becomes
available, we will assess whether such information warrants the recording of
additional expense relating to these contingencies. To be recorded as expense, a
loss contingency must generally be both probable and measurable. If a loss
contingency is material but is not both probable and estimable, we will disclose
it in notes to the financial statements.
New
Accounting Standards
In
November 2004, the FASB issued SFAS No. 151 “Inventory Costs, an Amendment of
ARB No. 43, Chapter 4, ‘Inventory Pricing,’” to clarify the accounting for
abnormal amounts of idle facility expense, freight, handling costs and wasted
material. This statement requires those items be recognized as current-period
charges. The provisions of this statement shall be effective for inventory costs
incurred during fiscal periods beginning after June 15, 2005. We do not expect
adoption of this statement to have a material impact on our financial
statements.
In
December 2004, the FASB issued SFAS No. 123 (revised 2004) “Share-Based Payment”
or FAS 123R. FAS 123R revises SFAS No. 123 “Accounting for
Stock-Based Compensation.” and supersedes APB No. 25 “Accounting for Stock
Issued to Employees” and related interpretations and SFAS No. 148
“Accounting for Stock-Based Compensation-Transition and Disclosure.”
FAS 123R requires compensation cost relating to all share-based payments to
employees to be recognized in the financial statements based on their fair
values in the first interim or annual reporting period beginning after
June 15, 2005. The pro forma disclosures previously permitted under
FAS 123 will no longer be an alternative to financial statement
recognition. We are evaluating the requirements of FAS 123R and expect that
the adoption of FAS 123R will have a material impact on our consolidated
financial position or results of operation. We have not determined the method of
adoption or determined whether the adoption will result in amounts recognized in
the income statement that are similar to the current pro forma disclosures under
FAS 123.
In
December 2004, the FASB issued SFAS No. 153 “Exchanges of Non-monetary Assets --
an amendment of Accounting Principles Board ("APB") Opinion No. 29 “Accounting
for Non-monetary Transactions.” The guidance in APB 29 is based on the principle
that exchanges of non-monetary assets should be measured based on the fair value
of the assets exchanged. The guidance in that Opinion, however, included certain
exceptions to that principle. SFAS 153 amends APB 29 to eliminate the exception
for non-monetary exchanges of similar productive assets and replaces it with a
general exception for exchanges of non-monetary assets that do not have
commercial substance. A non-monetary exchange has commercial substance if the
future cash flows of the entity are expected to change significantly as a result
of the exchange. The provisions of SFAS 153 are applicable for non-monetary
asset exchanges occurring in fiscal periods beginning after June 15, 2005. We
are currently evaluating the provisions of this statement.
In
December 2004, the FASB issued FSP 109-2 “Accounting and Disclosure Guidance for
the Foreign Earnings Repatriation Provision within the American Jobs Creation
Act of 2004” ("FSP 109-2"). FSP 109-2 provides enterprises more time (beyond the
financial-reporting period during which the American Jobs Creation Act took
effect) to evaluate the impact on the enterprise's plan for reinvestment or
repatriation of certain foreign earnings for purposes of applying SFAS No. 109.
The FSP, issued on December 21, 2004, went into effect upon being issued. We are
not yet in a position to decide on whether, and to what extent, it might
repatriate foreign earnings that have not yet been remitted to the U.S. We
expect to conclude our analysis of this repatriation incentive during
2005.
ITEM
7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT
MARKET RISK
Interest
Rate and Market Risk
We do not
use derivative financial instruments in our investment portfolio. We are averse
to principal loss and try to ensure the safety and preservation of our invested
funds by limiting default risk, market risk, and reinvestment risk. We attempt
to mitigate default risk by investing in only the safest and highest credit
quality securities. At December 31, 2004, we invested our available cash in
money market securities of high credit quality financial
institutions.
Interest
expense on our existing long-term debt commitments is based on a fixed interest
rate and therefore it is unaffected by fluctuations in interest rates. However,
our line of credit with our bank bears interest at our bank’s prime rate plus
..75% and if we ever draw down upon the line of credit, the outstanding balance
could be affected by fluctuations in interest rates.
Foreign
Currency Exchange Rate Risk
The
majority of our international sales are made in U.S. dollars, however, some
sales to the U.K. are in pounds and to Germany and other parts of Europe in
Euros, and thus may be adversely affected by fluctuations in currency exchange
rates. Additionally, fluctuations in currency exchange rates may adversely
affect foreign demand for our products by increasing the price of our products
in the currency of the countries in which the products are sold. The majority of
inventory purchases, both components and finished goods, in our foreign
operations are made in U.S. dollars. The functional currency of our foreign
operations in Denmark, the U.K. and Germany is the U.S. dollar and therefore,
the financial statements of these operations are maintained in U.S. dollars. Any
assets and liabilities in foreign currencies, such as bank accounts and certain
payables, are re-measured in U.S. dollars at period-end exchange rates in
effect. Any transactions in foreign currencies, such as wages paid in local
currencies, are re-measured in U.S. dollars using an average monthly exchange
rate. Any resulting gains and losses are included in operations and were not
material in any period.
The
functional currency of our Swedish holding company is the local currency. Thus,
assets and liabilities are translated to U.S. dollars at period end exchange
rates in effect. Translation adjustments are included in accumulated other
comprehensive income in stockholders’ equity. Gains and losses on foreign
currency transactions are included in operations and were not material in any
period.
Our
Danish subsidiary has outstanding performance bonds totaling $2,373 Danish
Kroner (approximately $435 U.S. dollars). Fluctuations in currency could
increase the U.S. dollar value exposure under these guarantees.
ITEM
8. FINANCIAL
STATEMENTS AND SUPPLEMENTARY DATA.
For an
index to the financial statements and supplementary data, see Item
15(a).
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The Board
of Directors and Stockholders
Cardiac
Science, Inc.
We have
completed an integrated audit of Cardiac Science, Inc.’s 2004 consolidated
financial statements and of its internal control over financial reporting as of
December 31, 2004 and audits of its 2003 and 2002 consolidated financial
statements in accordance with the standards of the Public Company Accounting
Oversight Board (United States). Our opinions, based on our audits, are
presented below.
Consolidated
financial statements and financial statement schedule
In our
opinion, the consolidated financial statements listed in the index appearing
under Item 15(a)(1) present
fairly, in all material respects, the financial position of Cardiac Science,
Inc. and its subsidiaries at December 31, 2004 and 2003, and the results of
their operations and their cash flows for each of the three years in the period
ended December 31, 2004 in conformity with accounting principles generally
accepted in the United States of America. In addition, in our opinion, the
financial statement schedule listed in the index appearing under Item
15(a)(2) presents
fairly, in all material respects, the information set forth therein when read in
conjunction with the related consolidated financial statements. These
financial statements and financial statement schedules are the responsibility of
the Company’s management. Our responsibility is to express an opinion on these
financial statements and financial statement schedules based on our
audits. We conducted our audits of these statements 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 of financial statements includes examining, on a test
basis, evidence supporting the amounts and disclosures in the financial
statements, assessing the accounting principles used and significant estimates
made by management, and evaluating the overall financial statement presentation.
We believe that our audits provide a reasonable basis for our
opinion.
The
accompanying consolidated financial statements have been prepared assuming that
the Company will continue as a going concern. As discussed in Note 2 to
the consolidated financial statements, the Company has suffered recurring losses
from operations that raise substantial doubt about its ability to continue as a
going concern. Management's plans in regard to these matters are also
described in Note 2. The consolidated financial statements do not include
any adjustments that might result from the outcome of this
uncertainty.
Internal
control over financial reporting
Also, in
our opinion, management’s assessment, included in Management Report on Internal
Control over Financial Reporting appearing under Item 9A, that the Company
maintained effective internal control over financial reporting as of December
31, 2004 based on criteria established in Internal Control - Integrated
Framework issued by the Committee of Sponsoring Organizations of the Treadway
Commission (COSO), is fairly stated, in all material respects, based on those
criteria. Furthermore, in our opinion, the Company maintained, in all material
respects, effective internal control over financial reporting as of December 31,
2004, based on criteria established in Internal Control - Integrated Framework
issued by the COSO. The Company’s management is responsible for maintaining
effective internal control over financial reporting and for its assessment of
the effectiveness of internal control over financial reporting. Our
responsibility is to express opinions on management’s assessment and on the
effectiveness of the Company’s internal control over financial reporting based
on our audit. We conducted our audit of internal control over financial
reporting 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. An audit of internal control over financial reporting includes
obtaining an understanding of internal control over financial reporting,
evaluating management’s assessment, testing and evaluating the design and
operating effectiveness of internal control, and performing such other
procedures as we consider necessary in the circumstances. We believe that our
audit provides a reasonable basis for our opinions.
A
company’s internal control over financial reporting is a process designed to
provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance
with generally accepted accounting principles. A company’s internal control over
financial reporting includes those policies and procedures that (i) pertain
to the maintenance of records that, in reasonable detail, accurately and fairly
reflect the transactions and dispositions of the assets of the company;
(ii) 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 (iii) provide reasonable assurance
regarding prevention or timely detection of unauthorized acquisition, use, or
disposition of the company’s assets that could have a material effect on the
financial statements.
Because
of its inherent limitations, internal control over financial reporting may not
prevent or detect misstatements. Also, projections of any evaluation of
effectiveness to future periods are subject to the risk that controls may become
inadequate because of changes in conditions, or that the degree of compliance
with the policies or procedures may deteriorate.
/s/ PRICEWATERHOUSECOOPERS
LLP
PricewaterhouseCoopers
LLP
Orange
County, California
March 16,
2005
CARDIAC
SCIENCE, INC.
CONSOLIDATED BALANCE SHEETS
(In
thousands, except share and per share data)
|
|
|
December
31,
2004 |
|
|
December
31,
2003 |
|
ASSETS |
|
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
|
Cash
and cash equivalents |
|
$ |
13,913 |
|
$ |
8,871 |
|
Accounts
receivable, net of allowance for doubtful accounts of $3,611 in 2004 and
$1,626 in 2003 |
|
|
17,978 |
|
|
20,410 |
|
Inventories,
net |
|
|
9,680 |
|
|
9,575 |
|
Prepaid
expenses and other current assets |
|
|
2,517 |
|
|
2,154 |
|
Total
current assets |
|
|
44,088 |
|
|
41,010 |
|
Property
and equipment, net |
|
|
4,932 |
|
|
7,003 |
|
Goodwill |
|
|
140,544 |
|
|
139,859 |
|
Intangibles,
net |
|
|
9,677 |
|
|
11,626 |
|
Other
assets |
|
|
4,093 |
|
|
3,503 |
|
|
|
$ |
203,334 |
|
$ |
203,001 |
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
8,266 |
|
$ |
8,955 |
|
Accrued
expenses |
|
|
6,820 |
|
|
6,542 |
|
Deferred
revenue |
|
|
1,940 |
|
|
2,479 |
|
Current
portion of long term debt |
|
|
16 |
|
|
53 |
|
Total
current liabilities |
|
|
17,042 |
|
|
18,029 |
|
Deferred
revenue |
|
|
697 |
|
|
859 |
|
Senior
secured promissory notes |
|
|
52,623 |
|
|
46,481 |
|
Other
long term debt |
|
|
25 |
|
|
41 |
|
Other
liabilities |
|
|
32 |
|
|
— |
|
Total
liabilities |
|
|
70,419 |
|
|
65,410 |
|
Commitments
and contingencies (Note 16) |
|
|
|
|
|
|
|
Stockholders’
equity: |
|
|
|
|
|
|
|
Preferred
stock—$.001 par value; 1,000,000 shares authorized, none issued or
outstanding |
|
|
— |
|
|
— |
|
Common
stock—$.001 par value; 160,000,000 shares authorized, 86,258,913 and
80,465,585 shares issued in 2004 and 2003, respectively, and
85,981,231 and 80,465,585 shares outstanding in 2004 and 2003,
respectively |
|
|
86 |
|
|
80 |
|
Additional
paid-in capital |
|
|
257,211 |
|
|
243,219 |
|
Accumulated
other comprehensive income (loss) |
|
|
(25 |
) |
|
(20 |
) |
Accumulated
deficit |
|
|
(124,357 |
) |
|
(105,688 |
) |
Total
stockholders’ equity |
|
|
132,915 |
|
|
137,591 |
|
|
|
$ |
203,334 |
|
$ |
203,001 |
|
The
accompanying notes are an integral part of these consolidated financial
statements.
CARDIAC
SCIENCE, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In
thousands, except share and per share data)
|
|
For
the Years Ended December 31, |
|
|
|
2004 |
|
|
2003 |
|
|
2002 |
|
Net
revenue: |
|
|
|
|
|
|
|
|
|
|
Product
sales |
|
$ |
61,107 |
|
$ |
60,463 |
|
$ |
50,043 |
|
Services |
|
|
7,406 |
|
|
1,519 |
|
|
— |
|
Net
revenue |
|
|
68,513 |
|
|
61,982 |
|
|
50,043 |
|
Cost
of revenue: |
|
|
|
|
|
|
|
|
|
|
Cost
of goods sold |
|
|
26,080 |
|
|
24,879 |
|
|
24,737 |
|
Cost
of services |
|
|
4,282 |
|
|
747 |
|
|
— |
|
Total
cost of revenue |
|
|
30,362 |
|
|
25,626 |
|
|
24,737 |
|
Write
down of inventory |
|
|
— |
|
|
2,917 |
|
|
— |
|
Gross
profit |
|
|
38,151 |
|
|
33,439 |
|
|
25,306 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
Sales
and marketing |
|
|
23,959 |
|
|
18,616 |
|
|
17,325 |
|
Research
and development |
|
|
6,027 |
|
|
5,538 |
|
|
6,053 |
|
General
and administrative |
|
|
19,241 |
|
|
14,720 |
|
|
11,474 |
|
Amortization
of intangibles |
|
|
1,931 |
|
|
1,656 |
|
|
2,111 |
|
Gain
on settlement |
|
|
— |
|
|
— |
|
|
(832 |
) |
Gain
on sales and other, net |
|
|
(1,077 |
) |
|
— |
|
|
— |
|
|
|
|
50,081 |
|
|
40,530 |
|
|
36,131 |
|
Loss
from operations |
|
|
(11,930 |
) |
|
(7,091 |
) |
|
(10,825 |
) |
Interest
income |
|
|
127 |
|
|
106 |
|
|
402 |
|
Interest
expense |
|
|
(7,031 |
) |
|
(6,031 |
) |
|
(4,452 |
) |
Other
non-operating income (expense) |
|
|
165 |
|
|
34 |
|
|
(92 |
) |
Loss
before income taxes |
|
|
(18,669 |
) |
|
(12,982 |
) |
|
(14,967 |
) |
Provision
for income taxes |
|
|
— |
|
|
— |
|
|
— |
|
Loss
before minority interest |
|
|
(18,669 |
) |
|
(12,982 |
) |
|
(14,967 |
) |
Minority
interest in consolidated subsidiary |
|
|
— |
|
|
(48 |
) |
|
(33 |
) |
Loss
from continuing operations |
|
|
(18,669 |
) |
|
(13,030 |
) |
|
(15,000 |
) |
Income
(loss) from discontinued operations |
|
|
— |
|
|
493 |
|
|
(52 |
) |
Net
loss |
|
$ |
(18,669 |
) |
$ |
(12,537 |
) |
$ |
(15,052 |
) |
Basic
and diluted loss per share: |
|
|
|
|
|
|
|
|
|
|
Continuing
operations |
|
|
(0.22 |
) |
|
(0.19 |
) |
|
(0.22 |
) |
Discontinued
operations |
|
|
— |
|
|
.01 |
|
|
— |
|
Net
loss per share (basic and diluted) |
|
$ |
(0.22 |
) |
$ |
(0.18 |
) |
$ |
(0.22 |
) |
Weighted
average number of shares used in the computation of net loss per share
(basic and diluted) |
|
|
83,094,008 |
|
|
69,848,014 |
|
|
67,199,419 |
|
The
accompanying notes are an integral part of these consolidated financial
statements.
CARDIAC
SCIENCE, INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE
LOSS
(In
thousands, except share and per share data)
|
|
For
the Years Ended December 31, |
|
|
|
2004 |
|
|
2003 |
|
|
2002 |
|
Net
loss |
|
$ |
(18,669 |
) |
$ |
(12,537 |
) |
$ |
(15,052 |
) |
Other
comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
|
Foreign
currency translation adjustments |
|
|
(5 |
) |
|
(135 |
) |
|
37 |
|
Comprehensive
loss |
|
$ |
(18,674 |
) |
$ |
(12,672 |
) |
$ |
(15,015 |
) |
The
accompanying notes are an integral part of these consolidated financial
statements.
CARDIAC
SCIENCE, INC.
CONSOLIDATED STATEMENT OF STOCKHOLDERS’
EQUITY
(In
thousands, except share and per share data)
|
|
|
Common
Stock |
|
|
|
|
|
Accumulated
Other |
|
|
|
|
|
|
|
|
|
|
Number
of Shares |
|
|
Amount |
|
|
Additional Paid-In
Capital |
|
|
Comprehensive Income
(Loss) |
|
|
Accumulated Deficit |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances
at December 31, 2001 |
|
|
67,158,531 |
|
$ |
67 |
|
$ |
176,298 |
|
$ |
78 |
|
$ |
(78,099 |
) |
$ |
98,344 |
|
Ascribed
value of warrants issued at $3.00 and $4.00 per share in connection with
debt offering |
|
|
|
|
|
|
|
|
11,815 |
|
|
|
|
|
|
|
|
11,815 |
|
Common
stock options exercised at $2.00 to $2.06 per share |
|
|
39,537 |
|
|
|
|
|
83 |
|
|
|
|
|
|
|
|
83 |
|
Issuance
of common stock for cash at $3.00 per share |
|
|
78,333 |
|
|
|
|
|
235 |
|
|
|
|
|
|
|
|
235 |
|
Issuance
of common stock for finders fees at $2.00 per share |
|
|
25,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
Equity
issuance costs related to 2001 |
|
|
|
|
|
|
|
|
(97 |
) |
|
|
|
|
|
|
|
(97 |
) |
Return
and cancellation of shares in escrow related to the Survivalink
acquisition |
|
|
(474,231 |
) |
|
|
|
|
(1,095 |
) |
|
|
|
|
|
|
|
(1,095 |
) |
Foreign
currency translation |
|
|
|
|
|
|
|
|
|
|
|
37 |
|
|
|
|
|
37 |
|
Net
loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(15,052 |
) |
|
(15,052 |
) |
Balances
at December 31, 2002 |
|
|
66,827,170 |
|
|
67 |
|
|
187,239 |
|
|
115 |
|
|
(93,151 |
) |
|
94,270 |
|
Ascribed
value of warrants issued at $3.00 and $3.27 per share |
|
|
|
|
|
|
|
|
936 |
|
|
|
|
|
|
|
|
936 |
|
Common
stock options exercised at $1.60 to $3.83 per share |
|
|
658,552 |
|
|
1 |
|
|
1,415 |
|
|
|
|
|
|
|
|
1,416 |
|
Common
stock warrants exercised at $0.01 to $2.00 per share |
|
|
496,529 |
|
|
|
|
|
5 |
|
|
|
|
|
|
|
|
5 |
|
Issuance
of common stock for cash at $3.75 per share |
|
|
2,233,334 |
|
|
2 |
|
|
8,373 |
|
|
|
|
|
|
|
|
8,375 |
|
Issuance
of common stock for acquisition of Complient at $4.42 per
share |
|
|
10,250,000 |
|
|
10 |
|
|
45,295 |
|
|
|
|
|
|
|
|
45,305 |
|
Equity
issuance costs |
|
|
|
|
|
|
|
|
(44 |
) |
|
|
|
|
|
|
|
(44 |
) |
Foreign
currency translation |
|
|
|
|
|
|
|
|
|
|
|
(135 |
) |
|
|
|
|
(135 |
) |
Net
loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(12,537 |
) |
|
(12,537 |
) |
Balance
at December 31, 2003 |
|
|
80,465,585 |
|
|
80 |
|
|
243,219 |
|
|
(20 |
) |
|
(105,688 |
) |
|
137,591 |
|
Ascribed
value of warrants issued at $2.60 per share |
|
|
|
|
|
|
|
|
1,301 |
|
|
|
|
|
|
|
|
1,301 |
|
Common
stock options exercised at $1.60 to $4.63 per share |
|
|
535,929 |
|
|
1 |
|
|
1,061 |
|
|
|
|
|
|
|
|
1,062 |
|
Common
stock warrants exercised at $0.01 to $2.40 per share |
|
|
37,990 |
|
|
─ |
|
|
─ |
|
|
|
|
|
|
|
|
─ |
|
Issuance
of common stock for cash at $2.37 per share |
|
|
5,219,409 |
|
|
5 |
|
|
12,365 |
|
|
|
|
|
|
|
|
12,370 |
|
Equity
issuance costs |
|
|
|
|
|
|
|
|
(146 |
) |
|
|
|
|
|
|
|
(146 |
) |
Foreign
currency translation |
|
|
|
|
|
|
|
|
|
|
|
(5 |
) |
|
|
|
|
(5 |
) |
Surrender
of shares by CEO to settle note receivable plus accrued interest
|
|
|
(277,682 |
) |
|
─ |
|
|
(589 |
) |
|
|
|
|
|
|
|
(589 |
) |
Net
loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(18,669 |
) |
|
(18,669 |
) |
Balance
at December 31, 2004 |
|
|
85,981,231 |
|
$ |
86 |
|
$ |
257,211 |
|
$ |
(25 |
) |
$ |
(124,357 |
) |
$ |
132,915 |
|
The
accompanying notes are an integral part of these consolidated financial
statements.
CARDIAC
SCIENCE, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In
thousands, except share and per share data)
|
|
For
the Years Ended
December
31, |
|
|
|
2004 |
|
|
2003 |
|
|
2002 |
|
Cash
flows from operating activities: |
|
|
|
|
|
|
|
|
|
|
Net
loss |
|
$ |
(18,669 |
) |
$ |
(12,537 |
) |
$ |
(15,052 |
) |
Adjustments
to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
|
|
|
|
|
Depreciation |
|
|
2,533 |
|
|
2,623 |
|
|
1,935 |
|
Amortization
of intangibles |
|
|
2,034 |
|
|
1,656 |
|
|
2,111 |
|
Minority
interest |
|
|
— |
|
|
48 |
|
|
33 |
|
Gain
on sales of assets |
|
|
(1,531 |
) |
|
— |
|
|
— |
|
Provision
for doubtful accounts |
|
|
2,045 |
|
|
725 |
|
|
463 |
|
Write
down of inventories and inventory obsolescence |
|
|
408 |
|
|
2,917 |
|
|
— |
|
Impairment
of assets |
|
|
190 |
|
|
— |
|
|
— |
|
Gain
on contractual settlement |
|
|
— |
|
|
— |
|
|
(832 |
) |
Gain
on collection of note receivable previously written off |
|
|
— |
|
|
— |
|
|
(236 |
) |
Accrued
interest and amortization of debt discount/issuance costs |
|
|
6,975 |
|
|
5,983 |
|
|
3,207 |
|
Changes
in operating assets and liabilities, net of acquisitions: |
|
|
|
|
|
|
|
|
|
|
Accounts
receivable |
|
|
(326 |
) |
|
(8,365 |
) |
|
(2,840 |
) |
Inventories |
|
|
(958 |
) |
|
(4,398 |
) |
|
(3,926 |
) |
Placement
of Powerhearts at customer locations |
|
|
(45 |
) |
|
(531 |
) |
|
(1,397 |
) |
Prepaid
expenses and other current assets |
|
|
(861 |
) |
|
(562 |
) |
|
(687 |
) |
Other
assets |
|
|
385 |
|
|
254 |
|
|
54 |
|
Accounts
payable and accrued expenses |
|
|
(384 |
) |
|
(1,840 |
) |
|
(4,640 |
) |
Assets
and liabilities held for sale |
|
|
— |
|
|
(1,460 |
) |
|
543 |
|
Deferred
revenue |
|
|
(572 |
) |
|
(860 |
) |
|
483 |
|
Net
cash used in operating activities |
|
|
(8,776 |
) |
|
(16,347 |
) |
|
(20,781 |
) |
Cash
flows from investing activities: |
|
|
|
|
|
|
|
|
|
|
Purchase
of property and equipment |
|
|
(1,664 |
) |
|
(2,744 |
) |
|
(1,499 |
) |
Purchase
of Artema minority interest |
|
|
— |
|
|
(843 |
) |
|
— |
|
Reduction
in Artema goodwill |
|
|
— |
|
|
1,050 |
|
|
— |
|
Sale
of Artema subsidiary, net of costs of $111 |
|
|
— |
|
|
489 |
|
|
— |
|
Increase
in Complient goodwill |
|
|
(103 |
) |
|
— |
|
|
— |
|
Refund
of (investment in) MRL transactions |
|
|
— |
|
|
3,001 |
|
|
(3,001 |
) |
Proceeds
from the sales of assets, net of selling costs |
|
|
2,498 |
|
|
767 |
|
|
470 |
|
Proceeds
from note receivable previously written off |
|
|
— |
|
|
— |
|
|
236 |
|
Cash
acquired in Complient acquisition |
|
|
— |
|
|
308 |
|
|
— |
|
Increase
in intangible assets |
|
|
(85 |
) |
|
(560 |
) |
|
— |
|
Additional
Complient acquisition costs paid |
|
|
(50 |
) |
|
(955 |
) |
|
(308 |
) |
Cash
refund from (advance to) Survivalink shareholders tax
escrow |
|
|
— |
|
|
— |
|
|
2,108 |
|
Refund
of Survivalink purchase price escrow |
|
|
— |
|
|
— |
|
|
1,901 |
|
Acquisition
of Lifetec, net of cash acquired of $89 |
|
|
— |
|
|
(294 |
) |
|
— |
|
Net
cash provided by (used) in investing activities |
|
|
596 |
|
|
219 |
|
|
(93 |
) |
Cash
flows from financing activities: |
|
|
|
|
|
|
|
|
|
|
Proceeds
from issuance of common stock |
|
|
12,370 |
|
|
8,375 |
|
|
235 |
|
Payment
of Survivalink promissory notes |
|
|
— |
|
|
— |
|
|
(26,468 |
) |
Proceeds
from Senior secured promissory notes, net of issuance costs of
$2,786 |
|
|
— |
|
|
— |
|
|
47,214 |
|
Payments
on long term obligations |
|
|
(53 |
) |
|
(243 |
) |
|
(498 |
) |
Proceeds
from exercise of common stock options and warrants |
|
|
1,056 |
|
|
1,421 |
|
|
83 |
|
Costs
of equity issuances |
|
|
(146 |
) |
|
(44 |
) |
|
(97 |
) |
Net
cash provided by financing activities |
|
|
13,227 |
|
|
9,509 |
|
|
20,469 |
|
Effect
of exchange rates on cash and cash equivalents |
|
|
(5 |
) |
|
(108 |
) |
|
173 |
|
Net
increase (decrease) in cash and cash equivalents |
|
|
5,042 |
|
|
(6,727 |
) |
|
(232 |
) |
Cash
and cash equivalents at beginning of year |
|
|
8,871 |
|
|
15,598 |
|
|
15,830 |
|
Cash
and cash equivalents at end of year |
|
$ |
13,913 |
|
$ |
8,871 |
|
$ |
15,598 |
|
The
accompanying notes are an integral part of these consolidated financial
statements.
CARDIAC
SCIENCE, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(In
thousands, except share and per share data)
1.
Organization and Description of the Business
Cardiac
Science, Inc. (the “Company”) was incorporated in May 1991 and develops,
manufactures and markets portable public access defibrillators and a
fully-automatic in-hospital bedside defibrillator-monitor that continuously
monitors cardiac patients, instantly detects the onset of life-threatening
abnormal heart rhythms, and, when appropriate, delivers defibrillation shocks
within seconds and without human intervention to convert the heart back to its
normal rhythm. The Company’s core technology platform consists of its
proprietary arrhythmia detection and discrimination software
(“RHYTHMx®”), which
is combined with its proprietary STAR® Biphasic
defibrillation hardware and electrode technology to create the only fully
automatic in-hospital cardioverter defibrillator (the “Powerheart®
CRM®” or
“CRM”) and a unique semi-automatic, or automated defibrillator, (the “Powerheart
AED” or “AED”) for use in out-of-hospital settings. The Company’s
Powerheart® Cardiac
Rhythm Module™ and
Powerheart® brand
AEDs along with Diascope G2® patient
monitoring products are marketed by its direct sales force and distribution
network in the United States and by international distributors around the
world.
On July
1, 2000, the Company acquired Cadent Medical Corporation, a privately held
company, for an aggregate of 4,500,000 shares of the Company’s common
stock.
On
September 26, 2001, the Company acquired Survivalink Corporation, a privately
held company, for $10,500 in cash, $25,800 in Senior secured promissory notes,
and 18,150,000 shares of the Company’s common stock.
On
November 30, 2001, the Company acquired 94.7% of Artema Medical AB and
Subsidiaries (“Artema”) for 4,150,976 shares of common stock and approximately
$215 in cash. During 2003, the Company acquired the remaining minority interest
for $843 in cash. On September 1, 2003, the Company transferred ownership of the
shares in Cardiac Science International A/S, its Danish operations and a
subsidiary of Artema, from Artema to Cardiac Science, Inc. in exchange for
forgiveness of intercompany debt. Then on September 21, 2003, the Company sold
100% of its shares in Artema to an outside party for $600 in cash.
On May
29, 2003, the Company acquired Lifetec Medical Limited, its U.K. distributor,
for $383 in cash.
On
October 21, 2003, the Company acquired substantially all of the assets and
liabilities of Complient Corporation, a privately held company, for 10,250,000
shares of the Company’s common stock.
2.
Continued Existence
The
accompanying consolidated financial statements have been prepared on the basis
that the Company will continue as a going concern and that the Company will
recover its assets and satisfy its liabilities in the normal course of business.
From inception, the Company has incurred substantial losses and negative cash
flows from operations. For the years ended December 31, 2004, 2003, and 2002,
the Company incurred losses of $18,669, $12,537, and $15,052, respectively, and
negative cash from operations of $8,776, $16,347, and $20,781, respectively. As
of December 31, 2004, the Company had cash on hand of $13,913, working capital
of $27,046, short and long term debt of $52,664, and an accumulated deficit of
$124,357.
The
Company believes that its current cash balance, in combination with net cash
expected to be generated from operations and its unused line of credit of
$5,000, will fund ongoing operations for the next twelve months. The Company’s
expected net cash from operations is predicated on achieving certain revenue
levels and maintaining its cost of goods, operating expenses and DSO ratio.
If the
Company does not realize the expected revenue and cost of goods, or if operating
expenses increase substantially, or if it cannot maintain its DSO ratio, it may
not be able to fund its operations for the next twelve months. In addition, the
Company’s line of credit and its Senior Notes require maintenance of certain
financial covenants, of which the Company was in violation during 2004. Even
though the Company has obtained waivers for all covenant violations and has
amended the covenants for 2005 and going forward, if in the future, it fails to
comply with these financial covenants as amended, the Company could be unable to
use its line of credit or be in default under the Senior Notes. If the Company
is in default, it may be subject to claims by the note holders seeking to
enforce its security interest in its assets. Such claims, if they arise, may
substantially restrict or even eliminate the Company’s ability to utilize its
assets in conducting its business, and may cause the Company to incur
substantial legal and administrative costs.
CARDIAC
SCIENCE, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(In
thousands, except share and per share data)
In the
event that the Company requires additional funding during the next twelve
months, it will attempt to raise the required capital through either debt or
equity arrangements. The Company cannot provide any assurance that the required
capital would be available on acceptable terms, if at all, or that any financing
activity would not be dilutive to its current stockholders. If the Company is
not able to raise additional funds, it may be required to significantly curtail
its operations and this would have an adverse effect on its financial position,
results of operations and cash flows, and as such there may be substantial doubt
about the Company’s ability to continue as a going concern.
3.
Summary of Significant Accounting Policies
Principles
of Consolidation
The
consolidated financial statements include the accounts of the Company and its
wholly-owned subsidiaries. All inter-company accounts and transactions have been
eliminated in consolidation.
Use
of Estimates
The
preparation of financial statements in conformity with generally accepted
accounting principles requires management to make estimates and assumptions that
affect the reported amounts of assets and liabilities and disclosure of
contingent assets and liabilities at the date of the financial statements and
the reported amounts of revenues and expenses during the reporting period.
Actual results could materially differ from those estimates.
Cash
and Cash Equivalents
The
Company considers all highly liquid investments with original maturities of
three months or less when purchased to be cash equivalents.
Allowance
for Doubtful Accounts
The
Company maintains an allowance for uncollectible accounts receivable to estimate
the risk of extending credit to customers. The allowance is based on customer
compliance with credit terms, the financial condition of the customer, and
collection history, where applicable.
Inventories
Inventories
are valued at the lower of cost (estimated using the first-in, first-out method)
or market. The Company periodically evaluates the carrying value of inventories
and maintains an allowance for obsolescence to adjust the carrying value, as
necessary, to the lower of cost or market. The allowance is based on its
assessment of future product demand, historical experience, and technical
obsolescence, as well as other factors affecting the recoverability of the asset
through future sales. Inventories consist of the following at December 31:
|
|
|
2004 |
|
|
2003 |
|
Raw
materials |
|
$ |
3,705 |
|
$ |
3,593 |
|
Work
in process |
|
|
13 |
|
|
157 |
|
Finished
goods |
|
|
7,146 |
|
|
6,601 |
|
Reserve
for obsolescence |
|
|
(1,184 |
) |
|
(776 |
) |
|
|
$ |
9,680 |
|
$ |
9,575 |
|
The
Company placed $45, $531 and $1,397 during 2004, 2003 and 2002, respectively, of
completed Powerheart units at customer locations. The Company retains title to
these units and such amounts were transferred to property and equipment where
they are being depreciated through cost of goods sold over a five year
period.
During
the year ended December 31, 2003, the Company wrote down $2,917 of inventory
related to its first generation Powerheart and CRM in-hospital defibrillators as
a result of a strategic decision to terminate the “no cap” placement business
model in U.S. hospitals, in favor of a capital sale model.
CARDIAC
SCIENCE, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(In
thousands, except share and per share data)
Property
and Equipment
Property
and equipment is stated at cost, less accumulated depreciation and amortization.
Depreciation and amortization are provided using the straight-line method over
the estimated useful lives of the related assets, or over the lesser of the term
of the lease or the estimated useful life of the asset for assets under capital
lease. Computer equipment and tooling are depreciated over 3 years. Equipment,
vehicles, Powerhearts on loan to hospitals and equipment on lease to customers
are depreciated over 5 years. Furniture is depreciated over 7 years. Leasehold
improvements are amortized over the lesser of the term of the lease or the
estimated useful life of the improvements. Normal repairs and maintenance are
expensed as incurred whereas significant improvements that materially increase
values or extend useful lives are capitalized and depreciated over the remaining
estimated useful lives of the related assets. Upon sale or retirement of
depreciable assets pursuant to SFAS No. 144 “Accounting for the Impairment or
Disposal of Long-Lived Assets,” the related cost and accumulated depreciation or
amortization are removed from the accounts, and any gain or loss not previously
recognized during an impairment analysis is recognized at the date of sale or
retirement.
Goodwill
and Other Intangibles
In
accordance with SFAS No. 142 “Goodwill and Other Intangible Assets,” goodwill
and other intangible assets with indeterminate lives are no longer subject to
amortization but are tested for impairment annually or whenever events or
changes in circumstances indicate that the asset might be impaired. The Company
operates in one operating segment and has one reporting unit, therefore, the
Company tests goodwill for impairment at the consolidated level against the fair
market value of the Company. Per SFAS No. 142, the fair value of a reporting
unit refers to the amount at which the unit as a whole could be bought or sold
in a current transaction between willing parties. Quoted market prices in active
markets are the best evidence of fair value and shall be used as the basis for
the measurement, if available. The Company assesses potential impairment on an
annual basis on December 31 and compares its market capitalization to the
carrying amount of goodwill. Other intangible assets with finite lives continue
to be subject to amortization, and any impairment is determined in accordance
with SFAS No. 144 “Accounting for the Impairment or Disposal of Long-Lived
Assets.”
Goodwill
and other intangible assets consist of the following at:
|
|
|
December 31,
2004 |
|
|
December
31, 2003 |
|
|
|
|
Cost |
|
|
Accumulated
Amortization |
|
|
Net |
|
|
Cost |
|
|
Accumulated
Amortization |
|
|
Net |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Goodwill |
|
$ |
140,544 |
|
$ |
¾ |
|
$ |
140,544 |
|
$ |
139,859 |
|
$ |
— |
|
$ |
139,859 |
|
Intangible
assets subject to amortization: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Patents
and patent applications |
|
|
10,465 |
|
|
(4,505 |
) |
|
5,960 |
|
|
10,396 |
|
|
(3,372 |
) |
|
7,024 |
|
Customer
base |
|
|
4,082 |
|
|
(1,381 |
) |
|
2,701 |
|
|
4,082 |
|
|
(894 |
) |
|
3,188 |
|
Covenants
not to compete |
|
|
726 |
|
|
(282 |
) |
|
444 |
|
|
726 |
|
|
(41 |
) |
|
685 |
|
URL
website address |
|
|
656 |
|
|
(162 |
) |
|
494 |
|
|
640 |
|
|
(32 |
) |
|
608 |
|
Trade
name |
|
|
378 |
|
|
(378 |
) |
|
¾ |
|
|
378 |
|
|
(378 |
) |
|
— |
|
Purchased
software |
|
|
128 |
|
|
(50 |
) |
|
78 |
|
|
128 |
|
|
(7 |
) |
|
121 |
|
|
|
$ |
16,435 |
|
$ |
(6,758 |
) |
$ |
9,677 |
|
$ |
16,350 |
|
$ |
(4,724 |
) |
$ |
11,626 |
|
The
increase in goodwill during the year ended December 31, 2004 was due to
adjustments to finalize the purchase price allocation related to the Complient
acquisition as follows:
Goodwill
at December 31, 2002 |
|
$ |
97,850 |
|
Record
preliminary goodwill for Complient acquisition |
|
|
42,494 |
|
Record
goodwill for Lifetec acquisition |
|
|
584 |
|
Adjustment
to Artema goodwill |
|
|
(1,069 |
) |
Goodwill
at December 31, 2003 |
|
$ |
139,859 |
|
Adjustment
to net realizable value of certain fixed assets |
|
|
532 |
|
Adjustment
to net realizable value of other receivable |
|
|
25 |
|
Adjustment
to accrued liabilities |
|
|
128 |
|
Goodwill
at December 31, 2004 |
|
$ |
140,544 |
|
CARDIAC
SCIENCE, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(In
thousands, except share and per share data)
Patents
and patent applications are being amortized over three to twenty years. Customer
base is being amortized over two to seven years while the trade name was
amortized over one year. The covenants not to compete and software are being
amortized over 3 years. The URL website addresses are being amortized over 5
years.
The
Company had amortization expense for identifiable intangibles with finite lives
of $2,034, $1,656, and $2,111 for the years ended December 31, 2004, and 2003
and 2002, respectively. Future amortization expense on existing identifiable
intangibles for the years ending December 31 is as follows:
2005 |
|
$ |
2,029 |
|
2006 |
|
|
1,981 |
|
2007 |
|
|
1,744 |
|
2008 |
|
|
1,696 |
|
2009 |
|
|
1,191 |
|
Thereafter |
|
|
1,036 |
|
|
|
$ |
9,677 |
|
Long-Lived
Assets
In
accordance with SFAS No. 144, long-lived assets and intangible assets with
determinate lives are reviewed for impairment whenever events or changes in
circumstances indicate that the carrying amount of an asset may not be
recoverable. The Company evaluates potential impairment by comparing the
carrying amount of the asset with the estimated undiscounted future cash flows
associated with the use of the asset and its eventual disposition. Should the
review indicate that the asset is not recoverable, the Company’s carrying value
of the asset would be reduced to its estimated fair value, which is generally
measured by future discounted cash flows.
Per
Share Information
The
Company has adopted SFAS No. 128 “Earnings Per Share.” This statement requires
the presentation of basic and diluted earnings per share, as defined, on the
statement of operations for companies whose capital structure includes
convertible securities and options.
Net loss
per share as presented in the accompanying statements of operations is computed
based on the weighted average number of common shares outstanding. Shares
issuable upon exercise of outstanding stock options and warrants are not
included since the effects would be anti-dilutive.
Valuation
of Warrants
The
Company periodically issues warrants in connection with debt issuances and in
exchange for goods and services. The Company follows the guidance of Accounting
Principles Bulletin (“APB”) No. 14 “Accounting for Convertible Debt and Debt
Issued with Stock Purchase Warrants” for warrants the Company issues in
connection with debt. The Company follows the guidance in Emerging Issues Task
Force (“EITF”) No. 96-18 “Accounting for Equity Instruments That are Issued to
Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or
Services” and EITF No. 01-9 “Accounting for Consideration Given by a Vendor to a
Customer (Including a Reseller of the Vendor’s Products)” for warrants the
Company issues in exchange for or in connection with goods and services.
Management considers a number of factors, including third party valuations, when
determining the fair value of warrants issued. The Company estimates the fair
value of warrants issued using the Black-Scholes model. Of the various
assumptions considered by the Black-Scholes model, the volatility and the risk
free rate used require the Company to make certain assumptions and estimations.
The Company estimates volatility using a statistical method based on the
historical daily stock price for the historical period equal to the life of the
warrant being valued. The risk free interest rate is determined using the
treasury note rate for the number of years corresponding to the life of the
warrant being valued.
Revenue
Recognition
The
Company records revenue in accordance with Securities and Exchange Commission
(“SEC”) Staff Accounting Bulletin No. 104, Revenue Recognition in Financial
Statements (“SAB 104”). SAB 104 requires that product sales be recognized when
there is persuasive evidence of an arrangement which states a fixed and
determinable price and terms, delivery of the product has occurred in accordance
with the terms of the sale, and collectibility of the sale is reasonably
assured. The Company records product sales when it has received a valid customer
purchase order for product at a stated price, the customer’s credit is approved,
and it has shipped the product to the customer whereby title and risk have
passed to the customer.
CARDIAC
SCIENCE, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(In
thousands, except share and per share data)
The
Company is not contractually obligated to repurchase any inventory from
distributors or end user customers. Some of the Company’s customers are
distributors that sell goods to third party end users. For certain identified
distributors where collection may be contingent on the distributor’s resale,
revenue recognition is deferred and recognized on a “sell through” basis. The
determination of whether sales to distributors are contingent on resale is
subjective because the Company must assess the financial wherewithal of the
distributor to pay us regardless of resale. For sales to distributors, the
Company considers several factors, including past payment history, where
available, trade references, bank account balances, Dun & Bradstreet reports
and any other financial information provided by the distributor, in assessing
whether the distributor has the financial wherewithal to pay regardless of, or
prior to, resale of the product and that collection of the receivable is not
contingent on resale.
The
Company offers limited volume price discounts and rebates to certain
distributors. Volume price discounts are on a per order basis based on the size
of the order and are netted against the revenue recorded at the time of
shipment. The Company has no arrangements that provide for volume discounts at a
later date, such as based on meeting certain quarterly or annual purchase
levels. Rebates are paid quarterly or annually based on sales performance and
are accrued for at the end of a reporting period. To date, all rebate
arrangements have been immaterial.
The
Company follows the guidance of EITF No. 00-21 “Accounting for Revenue
Arrangements with Multiple Deliverables.” In
accordance, the Company considers our program management packages and training
and other services as separate units of accounting when sold with an AED based
on the fact that the items have value to the customer on a stand alone basis and
could be acquired from another vendor. Training and AED program management
service revenue is deferred and recognized at the time the training occurs. AED
program management services pursuant to agreements that existed with Complient
customers pursuant to annual or multi-year terms are deferred and amortized
straight-line over the related contract period.
Upfront
license fees are deferred and recognized to revenue using the straight-line
method over the term of the related license agreement. Royalty revenue are due
and payable quarterly (generally 60 days after period end) pursuant to the
related license agreements. An estimate of royalty revenue is recorded quarterly
in the period it is earned based on the prior quarter’s historical results
adjusted for any new information or trends known to management at the time of
estimation.
Deferred
Revenue
Deferred
revenue consists of license fees received in connection with certain licensing
agreements and invoiced training and service revenue that has not been
delivered. License fees are amortized over the term of the respective agreements
using the straight-line method and deferred service revenue is recognized at the
time the service is provided.
Product
Warranty
The
Company’s products are generally under warranty against defects in material and
workmanship for a period of one to five years. Warranty costs are estimated at
the time of sale based on historical experience. Estimated warranty expenses are
recorded as an accrued liability, with a corresponding provision to cost of
sales.
Changes
in the product warranty accrual for the years ended December 31, 2004, 2003, and
2002 were as follows:
|
|
|
2004 |
|
|
2003 |
|
|
2002 |
|
Warranty
accrual, Beginning of period |
|
$ |
836 |
|
$ |
1,604 |
|
$ |
1,945 |
|
Change
in liability for warranties issued during the period |
|
|
1,669 |
|
|
204 |
|
|
803 |
|
Warranty
expenditures |
|
|
(1,888 |
) |
|
(1,005 |
) |
|
(1,144 |
) |
Currency
translation adjustments |
|
|
─ |
|
|
33 |
|
|
─ |
|
Warranty
accrual, End of period |
|
$ |
617 |
|
$ |
836 |
|
$ |
1,604 |
|
In early
April 2004, the Company received a Warning Letter from the U.S. Food and Drug
Administration (FDA) following a routine inspection of its manufacturing
facility in Minneapolis. The letter specified certain procedural and
documentation items in the Company’s quality system. The Company took corrective
and preventive action to bring its quality system into compliance. In addition,
during May 2004, the Company initiated a limited, voluntary recall of
approximately 5,800 units of its older model Powerheart AEDs in order to replace
a potentially faulty capacitor component. As of December 31, 2004, the majority
of the recalled units in the U.S. have been replaced or repaired and the Company
is in the process of executing its international recall plan which represents
approximately 10% of total affected units.
CARDIAC
SCIENCE, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(In
thousands, except share and per share data)
Also in
May 2004, the Company initiated a limited, voluntary recall of approximately
4,800 AED batteries due to an error made by the Company’s battery supplier
whereby an incorrect fuse was used in the manufacture of a certain lot of
batteries. As of December 31, 2004, the recall has been completed and customers
have received replacement batteries.
The
Company estimates the cost of these voluntary recall actions could range from
$1,000 to $1,200, however, the Company has received from its suppliers credits
against existing and future amounts due to these suppliers totaling $1,240,
which have been recorded to accrued expenses to establish a warranty accrual for
these recall matters and are included in accruals for warranties issued during
the period in the table above. Actual recall related costs incurred have been
charged against this accrual and totaled approximately $1,131 as of December 31,
2004. At this time, the Company believes its remaining accrual related to the
recall will cover any future costs.
Excluding
the impact of the recall costs incurred and vendor credits recorded discussed
above, the Company’s warranty accrual as of December 31, 2004 would be $508. The
decrease in warranty reserve requirements in 2004 compared with 2003 result
primarily from AED battery design changes, which dramatically extended the life
of the battery, and battery warranty policy enforcement, both of which resulted
in a significant reduction in the overall warranty reserve necessary.
In 2003,
the company experienced an increase in AED unit returns that was due to a faulty
component on the board and resulted in the 2004 recall discussed above.
Approximately $500 of costs were incurred in 2003 related to this one-time
component defect. The decrease in the warranty reserve at December 31, 2003
compared with 2002 is based on the Company’s determination that future warranty
requirements were anticipated to be significantly less due to AED battery design
changes in 2002 and 2003 that dramatically extended the life of the battery, and
batter warranty policy enforcement, both of which resulted in a significantly
reduction in battery replacements in 2003.
Foreign
Currency
The
functional currency of the Company’s foreign operations in Denmark, the U.K. and
Germany is the U.S. dollar and therefore, the financial statements of these
operations are maintained in U.S. dollars. Any assets and liabilities in foreign
currencies, such as bank accounts and certain payables, are re-measured in U.S.
dollars at period-end exchange rates in effect. Any transactions in foreign
currencies, such as wages paid in local currencies, are re-measured in U.S.
dollars using an average monthly exchange rate. Any resulting gains and losses
are included in operations and were not material in any period.
The
functional currency of the Company’s Swedish holding company is the local
currency. Thus, assets and liabilities are translated to U.S. dollars at period
end exchange rates in effect. Translation adjustments are included in
accumulated other comprehensive income in stockholders’ equity. Gains and losses
on foreign currency transactions are included in operations and were not
material in any period.
Research
and Development Costs
Research
and development costs are expensed as incurred.
Advertising
Costs
The
Company expenses advertising costs as incurred. Advertising expense was $3,174,
$925 and $1,280, for the years ended December 31, 2004, 2003, and 2002,
respectively.
Software
Development Costs
The
Company expenses all costs incurred, prior to the achievement of technological
feasibility of a working model, related to the development of the proprietary
software used in its products. Such costs incurred subsequent to the attainment
of technological feasibility have been nominal.
Discontinued
Operations
The
Company has classified certain facilities operations related to its MCS gas
business (see Note 9) as discontinued operations in accordance with SFAS No.
144. SFAS No. 144 established accounting and reporting standards requiring that
long-lived assets to be disposed of be reported as discontinued operations if
management has committed to a plan to dispose of the asset under usual and
customary terms within one year of establishing the plan. Subsequent to the
initial one year period, the Company follows the guidance of EITF 90-6
“Accounting for Certain Events Not Addressed in Issue No. 87-11 Relating to an
Acquired Operating Unit to Be Sold.”
CARDIAC
SCIENCE, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(In
thousands, except share and per share
data)
Fair
Value of Financial Instruments
The fair
value of the Company’s financial instruments, which include cash equivalents,
accounts receivable, accounts payable, and notes payable, are based on
assumptions concerning the amount and timing of estimated future cash flows. The
carrying value of these financial instruments, excluding the Senior Notes,
approximated their fair value at December 31, 2004 and 2003. In February
2005, the Company entered into a definitive merger agreement with Quinton
Cardiology Systems (see Note 22). In connection with the merger, the Senior Note
Holders agreed to exchange approximately $61,000 in principal and accrued
interest ($59,726 at December 31, 2004) and warrants to purchase 13.4 million
shares of Cardiac Science, Inc. common stock having an exercise price of $2.00,
for $20,000 in cash and 2.8 million shares in the newly combined entity which
had an imputed value of approximately $53,750.
Stock-Based
Compensation
On
December 31, 2002, the Financial Accounting Standards Board (“FASB”) issued SFAS
148 “Accounting
for Stock-Based Compensation—Transition and Disclosure,” which amends SFAS 123
“Accounting for Stock-Based Compensation.” SFAS 148 allows for three methods of
transition for those companies that adopt SFAS 123’s provisions for fair value
recognition. SFAS 148’s transition guidance and provisions for annual and
interim disclosures are effective for fiscal periods ending after December 15,
2002. The Company has not adopted fair value accounting for employee stock
options under SFAS 123 and SFAS 148.
The
Company has adopted the disclosure-only provisions of SFAS No. 123. SFAS No. 123
defines a fair value based method of accounting for an employee stock option.
Fair value of the stock option is determined considering factors such as the
exercise price, the expected life of the option, the current price of the
underlying stock, expected dividends on the stock, volatility of the expected
market prices, and the risk-free interest rate for the expected term of the
option. Under the fair value based method, compensation cost is measured at the
grant date based on the fair value of the award and is recognized over the
service period. Pro forma disclosures are required for entities that elect to
continue to measure compensation cost under the intrinsic method provided by APB
No. 25.
Additionally,
in accordance with SFAS 123 and EITF Issue No. 96-18 “Accounting for Equity
Instruments That are Issued to Other Than Employees for Acquiring, or in
Conjunction with Selling Goods or Services,” the Company measures stock based
non-employee compensation at fair value.
Under
SFAS No. 123, stock based compensation expense related to stock options granted
to consultants is recognized as the stock options are earned. The fair value of
the stock options granted is calculated at each reporting date using the
Black-Scholes option pricing model. As a result, the stock based compensation
expense will fluctuate as the fair market value of the Company’s stock
fluctuates.
Pro
Forma Effect of Stock-Based Compensation
In
calculating pro forma information as required by SFAS No. 123, the fair value
was estimated at the date of grant using a Black-Scholes option pricing model
with the following assumptions for the options on the Company’s common stock for
the years ended December 31, 2004, 2003, and 2002: risk free weighted average
rate 3.15%, 2.64% and 2.81%, respectively; dividend yield of 0%; volatility of
the expected market prices of the Company’s common stock of 74.7%, 63.0%, and
63.0%, respectively; and expected life of the options of four
years.
Had
compensation costs been determined based upon the fair value at the grant date,
consistent with the methodology prescribed under SFAS 123, the Company’s total
stock-based compensation cost, proforma net loss, and proforma net loss per
share, basic and diluted, would have been as follows:
|
|
|
2004 |
|
|
2003 |
|
|
2002 |
|
Net
loss, as reported |
|
$ |
(18,669 |
) |
$ |
(12,537 |
) |
$ |
(15,052 |
) |
Add:
Compensation expense included in reported net loss |
|
|
— |
|
|
— |
|
|
— |
|
Deduct:
Compensation expense determined under fair value based
method |
|
|
(3,535 |
) |
|
(3,751 |
) |
|
(3,923 |
) |
Pro
forma net loss |
|
$ |
(22,204 |
) |
$ |
(16,288 |
) |
$ |
(18,975 |
) |
Net
loss per share, as reported (basic and diluted) |
|
$ |
(0.22 |
) |
$ |
(0.18 |
) |
$ |
(0.22 |
) |
Pro
forma net loss per share (basic and diluted) |
|
$ |
(0.27 |
) |
$ |
(0.23 |
) |
$ |
(0.28 |
) |
CARDIAC
SCIENCE, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
(In
thousands, except share and per share data)
Income
Taxes
The
Company follows SFAS No. 109 “Accounting for Income Taxes,” which requires the
recognition of deferred tax liabilities and assets for the expected future tax
consequences of events that have been included in the financial statements or
tax returns. Under this method, deferred income taxes are recognized for the tax
consequences in future years of differences between the tax basis of assets and
liabilities and their financial reporting amounts at each year-end based on
enacted tax laws and statutory rates applicable to the periods in which the
differences are expected to affect taxable income. Valuation allowances are
established, when necessary, to reduce deferred tax assets when it is more
likely than not that a portion of such assets will not be recoverable through
future operations. The provision for income taxes represents the tax payable for
the period and the change during the period in deferred tax assets and
liabilities.
Comprehensive
Income
In June
1997, the FASB issued SFAS No. 130 “Reporting Comprehensive Income.” SFAS No.
130 requires disclosure of all components of comprehensive income on an annual
and interim basis. Comprehensive income is defined as the change in equity of a
business enterprise during a period from transactions and other events and
circumstances from non-owner sources. In 2004, 2003, and 2002, comprehensive
income includes only foreign currency translation adjustments.
Reclassifications
Certain
reclassifications have been made in the 2003 and 2002 statements to conform to
the 2004 presentation.
New
Accounting Standards
In
November 2004, the FASB issued SFAS No. 151 “Inventory Costs, an Amendment of
ARB No. 43, Chapter 4, ‘Inventory Pricing,’” to clarify the accounting for
abnormal amounts of idle facility expense, freight, handling costs and wasted
material. This statement requires those items be recognized as current-period
charges. The provisions of this statement shall be effective for inventory costs
incurred during fiscal periods beginning after June 15, 2005. The Company does
not expect adoption of this statement to have a material impact on its financial
statements.
In
December 2004, the FASB issued SFAS No. 123 (revised 2004) “Share-Based Payment”
or FAS 123R. FAS 123R revises SFAS No. 123 “Accounting for
Stock-Based Compensation.” and supersedes APB No. 25 “Accounting for Stock
Issued to Employees” and related interpretations and SFAS No. 148
“Accounting for Stock-Based Compensation-Transition and Disclosure.”
FAS 123R requires compensation cost relating to all share-based payments to
employees to be recognized in the financial statements based on their fair
values in the first interim or annual reporting period beginning after
June 15, 2005. The pro forma disclosures previously permitted under
FAS 123 will no longer be an alternative to financial statement
recognition. The Company is evaluating the requirements of FAS 123R and
expects that the adoption of FAS 123R will have a material impact on the
Company’s consolidated financial position or results of operation. The Company
has not determined the method of adoption and it has not determined whether the
adoption will result in amounts recognized in the income statement that are
similar to the current pro forma disclosures under FAS 123.
In
December 2004, the FASB issued SFAS No. 153 “Exchanges of Non-monetary Assets --
an amendment of Accounting Principles Board ("APB") Opinion No. 29 “Accounting
for Non-monetary Transactions.” The guidance in APB 29 is based on the principle
that exchanges of non-monetary assets should be measured based on the fair value
of the assets exchanged. The guidance in that Opinion, however, included certain
exceptions to that principle. SFAS 153 amends APB 29 to eliminate the exception
for non-monetary exchanges of similar productive assets and replaces it with a
general exception for exchanges of non-monetary assets that do not have
commercial substance. A non-monetary exchange has commercial substance if the
future cash flows of the entity are expected to change significantly as a result
of the exchange. The provisions of SFAS 153 are applicable for non-monetary
asset exchanges occurring in fiscal periods beginning after June 15, 2005. The
Company is currently evaluating the provisions of this statement.
In
December 2004, the FASB also issued FSP 109-2 “Accounting and Disclosure
Guidance for the Foreign Earnings Repatriation Provision within the American
Jobs Creation Act of 2004” ("FSP 109-2"). FSP 109-2 provides enterprises more
time (beyond the financial-reporting period during which the American Jobs
Creation Act took effect) to evaluate the impact on the enterprise's plan for
reinvestment or repatriation of certain foreign earnings for purposes of
applying SFAS No. 109. The FSP, issued on December 21, 2004, went into effect
upon being issued. The Company is not yet in a position to decide on whether,
and to what extent, it might repatriate foreign earnings that have not yet been
remitted to the U.S. The Company expects to conclude its analysis of this
repatriation incentive during 2005.
CARDIAC
SCIENCE, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
(In
thousands, except share and per share data)
4.
Segment Reporting
The
Company follows the provisions of SFAS No. 131 “Disclosures about Segments of an
Enterprise and Related Information.”
SFAS No.
131 established standards for reporting information about operating segments in
annual financial statements and requires selected information about operating
segments in interim financial reports issued to stockholders. It also
established standards for related disclosures about products and services,
geographic areas and major customers. An operating segment is defined as a
component of an enterprise that engages in business activities from which it may
earn revenues and incur expenses whose separate financial information is
available and is evaluated regularly by the Company’s chief operating decision
makers, or decision making group, to perform resource allocations and
performance assessments.
The
Company’s chief operating decision makers are the Executive Management Team
which is comprised of the Chief Executive Officer (“CEO”) and senior executive
officers of the Company. Based on evaluation of the Company’s financial
information, management believes that the Company operates in one reportable
segment with its various product lines that service the external defibrillation
and cardiac monitoring industry. The product lines include AEDs and related
training, services, and accessories; Powerhearts, electrodes and related
accessories; and emergency defibrillators, monitors, CPR products and related
accessories.
The
Company’s chief operating decision makers evaluate revenue performance of
product lines, both domestically and internationally, however, operating,
strategic and resource allocation decisions are not based on product line
performance, but rather on the Company’s overall performance in its operating
segment.
The
following is a breakdown of net revenue by product line for the years ended
December 31:
|
|
2004 |
|
2003 |
|
2002 |
|
AEDs
and related accessories |
|
$ |
56,666 |
|
$ |
55,010 |
|
$ |
38,572 |
|
AED/CPR
training and program management services |
|
|
7,406 |
|
|
1,519 |
|
|
— |
|
AED
related revenue |
|
|
64,072 |
|
|
56,529 |
|
|
38,572 |
|
Powerhearts,
electrodes and related accessories |
|
|
1,169 |
|
|
1,259 |
|
|
1,278 |
|
Emergency
defibrillators, monitors, CPR products and related
accessories |
|
|
3,272 |
|
|
4,194 |
|
|
10,193 |
|
|
|
$ |
68,513 |
|
$ |
61,982 |
|
$ |
50,043 |
|
The
following is a breakdown of net sales by geographic location for the years ended
December 31:
|
|
2004 |
|
2003 |
|
2002 |
|
United
States |
|
$ |
43,434 |
|
$ |
47,778 |
|
$ |
34,091 |
|
Foreign |
|
|
25,079 |
|
|
14,204 |
|
|
15,952 |
|
|
|
$ |
68,513 |
|
$ |
61,982 |
|
$ |
50,043 |
|
In 2004,
one customer represented 15.7% of net revenue and 13.5% of net accounts
receivable at December 31, 2004. In 2004, sales to Japan were 16.1% of net
revenue. No other country had sales greater than 10% in 2004, 2003, or 2002.
The
following is a breakdown of the Company’s long-lived assets by geographic
location at December 31:
|
|
2004 |
|
2003 |
|
|
|
United
States |
|
$ |
4,773 |
|
$ |
6,758 |
|
|
|
Foreign |
|
|
159 |
|
|
245 |
|
|
|
|
|
$ |
4,932 |
|
$ |
7,003 |
|
|
|
CARDIAC
SCIENCE, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
(In
thousands, except share and per share data)
5.
Property and Equipment
Property
and equipment consist of the following at December 31:
|
|
2004 |
|
2003 |
|
Equipment
and furniture |
|
$ |
6,337 |
|
$ |
6,643 |
|
Equipment
on lease to customers |
|
|
810 |
|
|
1,633 |
|
Leasehold
improvements |
|
|
1,003 |
|
|
764 |
|
Tooling |
|
|
1,265 |
|
|
316 |
|
Vehicles |
|
|
66 |
|
|
66 |
|
Powerhearts
on loan to hospitals |
|
|
1,056 |
|
|
1,263 |
|
|
|
|
10,537 |
|
|
10,685 |
|
Less:
accumulated depreciation |
|
|
(5,605 |
) |
|
(3,682 |
) |
|
|
$ |
4,932 |
|
$ |
7,003 |
|
Equipment
on lease to customers relates to contracts originally entered into by Complient,
whereby Complient leased AED units to customers in connection with comprehensive
AED deployment, training and maintenance programs with a stated contract term.
The majority of the contracts have annual lease/contract billings which are
deferred and amortized straight-line over the contract term with the
corresponding cost of the leased units being recorded to fixed assets and
depreciated to cost of goods sold over the same period. The Company recognizes
revenue and depreciation costs with respect to these units leased to customers
in accordance with paragraph 19 of SFAS No. 13, “Accounting for Leases.”
Powerhearts
on loan to hospitals relates to the “no cap” placement program, whereby the
Company placed in-hospital Powerheart or CRM defibrillation units in a
customer’s facility at no charge in exchange for an agreement to purchase the
Company’s proprietary, disposable defibrillation electrodes monthly or quarterly
pursuant to the related contract. Agreements under the “no cap” program are
typically open-ended (i.e. no stated term or expiration date). The customer has
the option to cancel the agreement with 30 days written notice, or discuss
purchase options at any time during the agreement. The Company retains title and
risk of loss to equipment placed under the “no cap” program, and as such,
placements are considered withdrawals from inventory and capitalized as Property
and Equipment. The Company estimated that the useful life (i.e.
revenue-generating life) of a Powerheart or CRM unit is five years and
depreciates the placed units over this period. If the Company and the customer
agree to discontinue the agreement, the customer can either discuss purchase
options for the equipment or return the equipment to the Company. If the
customer returns the unit before the five year depreciation period is completed,
the net book value of the unit in Property & Equipment is reclassified to
inventory and is available for resale as used equipment or shipped to another
customer under the “no cap” program. The Company then evaluates the carrying
value in inventory based on the expected selling price to determine if an
impairment write-down is necessary as was determined in 2003 for $2,917 of
returned placed units in inventory at December 31, 2003 (See Note 3).
6.
Other Assets
In July
2002, the Company entered into preliminary negotiations regarding a possible
transaction with Medical Research Laboratories, Inc. (“MRL”), a privately-held
medical device manufacturer. The Company made an initial investment in the
common stock of the manufacturer in the amount of $1,000 and placed $2,001 into
an escrow account pending the outcome of further negotiations. On December 3,
2002, the Company filed a Complaint in Orange County Superior Court against
Medical Research Laboratories, Inc. (“MRL”) alleging declaratory relief and
breach of contract arising out of a July 29, 2002 letter of intent entered into
between the parties. The Company alleged that MRL failed to comply with certain
conditions of closing set forth in the letter of intent whereby the Company
would acquire all of MRL’s stock. MRL filed a cross-complaint, also seeking
breach of contract and declaratory relief arising out of the same letter of
intent. On February 25, 2003, the Company filed suit against MRL for patent
infringement in the United States District Court for the District of Minnesota.
The Company alleged that MRL’s LifeQuest JumpStart AED infringed the Company’s
patented disposable electrode pre-connect technology. The Company settled both
law suits with MRL on June 24, 2003. Under the terms of the confidential
settlement agreement, the Company received a settlement amount from MRL and MRL
received the right to license two of the Company’s patents for additional
royalties.
On
December 18, 2000, the Company entered into a non-binding letter of intent to
acquire Inovise Medical, Inc., a privately held Oregon based corporation, which
potential acquisition was terminated in February 2001. In connection with this
proposed transaction, the Company advanced funds for a bridge loan to support
working capital requirements. The bridge loan was collateralized by all assets
of Inovise, excluding certain receivables from royalty payments, accrued
interest at 6% and was convertible into equity of Inovise. The total amount
advanced to Inovise was $1,038. In February 2002, the Company’s convertible
bridge loan was converted into 13,000,000 shares of Inovise’s Series D
convertible preferred stock. As there is currently no market for these shares
and there is no foreseeable recovery of the initial investment, the Company has
determined that these shares have no value. Accordingly, the Company has written
down the cost basis of this investment to zero at December 31, 2004 and
2003.
CARDIAC
SCIENCE, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
(In
thousands, except share and per share data)
Included
in other assets at December 31, 2004 and 2003 is $246 of restricted cash in the
form of two certificates of deposit that are collateral on letters of credit
issued in connection with facilities leases. The letters of credit, and the
underlying certificates of deposit, renew annually unless requested otherwise by
the landlord, until the final expiration dates of May 2008 and January 2009,
respectively, when the facilities leases expire.
7.
Accrued Expenses
Accrued
expenses consist of the following as of December 31:
|
|
|
2004 |
|
|
2003 |
|
Accrued
warranty |
|
$ |
617 |
|
$ |
836 |
|
Accrued
commissions |
|
|
1,000 |
|
|
961 |
|
Accrued
lease obligations and deferred rent |
|
|
1,549 |
|
|
1,895 |
|
Accrued
legal |
|
|
495 |
|
|
334 |
|
Accrued
bonus |
|
|
515 |
|
|
315 |
|
Accrued
vacation and payroll tax |
|
|
825 |
|
|
965 |
|
Accrued
other expenses |
|
|
1,819 |
|
|
1,236 |
|
|
|
$ |
6,820 |
|
$ |
6,542 |
|
8.
Business Combinations
Complient
Corporation
On
October 21, 2003, the Company acquired substantially all of the assets and
certain liabilities of Cleveland-based Complient Corporation, a privately-held
company that is the nation’s leading independent provider of AED and CPR
training and comprehensive AED program management in order to strategically
position itself in the AED market as the first and only manufacturer to provide
customers with a complete, turnkey AED deployment solution. In addition to the
revenue generated from Complient’s existing customer base, the acquisition was a
logical vertical market extension for the Company and should generate additional
point of sale revenue, as well as a future recurring revenue opportunity, linked
to AED sales. As consideration, the Company issued to Complient 10,250,000
shares of its common stock. The common stock was subject to a lock-up agreement,
which expired in November 2004, and a general indemnification escrow. The resale
of the shares was registered with the Securities and Exchange Commission. In
February 2005, the Company and Complient agreed that 512,500 of the 1,025,000
shares of common stock previously held in escrow would be returned to us in
settlement of the escrow and the remaining 512,500 shares were released to
Complient Liquidating Trust.
The
acquisition was accounted for as a purchase under SFAS No. 141 “Business
Combinations.” In accordance with SFAS No. 141, the Company allocated the
purchase price based on the fair value of the assets acquired and liabilities
assumed. Portions of the purchase price were identified by management as
intangible assets and were valued based on a number of factors including an
independent appraisal. These intangible assets include $42,494 for goodwill,
$2,907 in customer relationships, $726 for covenants not to compete, and $128
for custom-developed software. The customer relationships are being amortized
over 7 years, and the covenants not to compete and the software are being
amortized over 3 years.
The
Company determined the value of the stock consideration ($4.42 per share) using
the average closing stock price for a five day period before and a five day
period after the October 21, 2003 transaction announcement date. The Company
believes this method is consistent with guidance provided in EITF No. 99-12,
“Determination of the Measurement Date for the Market Price of Acquirer
Securities Issued in a Purchase Business Combination” and paragraph 22 of SFAS
NO. 141 “Business Combinations.” Historically, the Company has used an average
closing stock price based on a two day period before and a five day period after
the measurement date due to the stock’s volatility during 2003.
CARDIAC
SCIENCE, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
(In
thousands, except share and per share data)
The
components of the purchase price allocation are as follows:
Purchase
Price: |
|
|
|
Stock
consideration (10,250,000 shares @ $4.42/share) |
|
$ |
45,305 |
|
Acquisition
costs |
|
|
894 |
|
Total |
|
$ |
46,199 |
|
Allocation
of Purchase Price: |
|
|
|
|
Current
assets |
|
$ |
2,569 |
|
Property
and equipment, net |
|
|
2,685 |
|
Current
liabilities |
|
|
(3,053 |
) |
Deferred
revenue |
|
|
(2,257 |
) |
Customer
relationships |
|
|
2,907 |
|
Covenants
not to compete |
|
|
726 |
|
Software |
|
|
128 |
|
Goodwill |
|
|
42,494 |
|
Total |
|
$ |
46,199 |
|
The
following unaudited pro forma data summarizes the results of operations for the
periods indicated as if the Complient acquisition had been completed as of the
beginning of the periods presented. The pro forma data gives effect to actual
operating results prior to the acquisition, adjusted to include the pro forma
effect of amortization of identified intangible assets and the elimination of
sales to Complient prior to the acquisition.
|
|
2003 |
|
2002 |
|
|
|
(unaudited) |
|
Net
sales |
|
$ |
69,869 |
|
$ |
62,629 |
|
Net
loss |
|
$ |
(15,471 |
) |
$ |
(20,061 |
) |
Pro
forma net loss per share (basic and diluted) |
|
$ |
(0.20 |
) |
$ |
(0.26 |
) |
Pro
forma weighted-averaged shares |
|
|
78,104,179 |
|
|
77,449,419 |
|
During
2004, final adjustments to Complient goodwill were made related to the purchase
price allocation as follows:
Preliminary
Complient goodwill |
|
$ |
42,494 |
|
Adjustment
to net realizable value of certain fixed assets |
|
|
532 |
|
Adjustment
to net realizable value of other receivable |
|
|
25 |
|
Adjustment
to accrued liabilities |
|
|
128 |
|
Adjusted
Complient goodwill |
|
$ |
43,179 |
|
Lifetec
Medical Limited
On May
29, 2003, the Company acquired Lifetec Medical Limited, its U.K. distributor.
The purchase price was $383 in cash and $61 in acquisition costs. The
acquisition was accounted for as a purchase under SFAS No. 141. The Company
allocated the purchase price based on the fair value of the assets and
liabilities assumed. Current assets acquired were valued at $418, including cash
of $89, and current liabilities assumed were valued at $557, and goodwill was
valued at $583.
Artema
Medical AB
On
November 30, 2001, the Company acquired a 94.7% ownership interest in Artema
Medical AB (“Artema”), a Swedish based manufacturer of patient monitors and
external defibrillator devices. As consideration, the Company paid approximately
$215 in cash and issued 4,150,976 shares of common stock to Artema
shareholders.
CARDIAC
SCIENCE, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
(In
thousands, except share and per share data)
The
components of the purchase price and original allocation were as
follows:
Purchase
Price: |
|
|
|
Stock
consideration (4,150,976 shares @ $3.75/share) |
|
$ |
15,566 |
|
Cash |
|
|
215 |
|
Acquisition
costs |
|
|
1,586 |
|
Total |
|
$ |
17,367 |
|
Allocation
of Purchase Price: |
|
|
|
|
Current
assets |
|
$ |
7,741 |
|
Property,
plant and equipment, net |
|
|
1,819 |
|
Current
liabilities |
|
|
(9,578 |
) |
Long
term liabilities |
|
|
(519 |
) |
Minority
interest |
|
|
(883 |
) |
Developed
technology |
|
|
796 |
|
Customer
base |
|
|
499 |
|
MCS
Gas intangible assets |
|
|
1,426 |
|
Goodwill |
|
|
16,066 |
|
Total |
|
$ |
17,367 |
|
During
2002, goodwill related to the Artema acquisition was adjusted for the
following:
Preliminary
Artema goodwill |
|
$ |
16,066 |
|
Artema
restructuring (see note 9): |
|
|
|
|
Building
and other impairments |
|
|
544 |
|
Inventory
reserve |
|
|
922 |
|
Accounts
receivable reserve |
|
|
11 |
|
Loss
on closure of Copenhagen facility |
|
|
664 |
|
Copenhagen
facility severance and other miscellaneous costs |
|
|
123 |
|
Disposal
of MCS gas business (see note 9): |
|
|
|
|
Asset
impairments |
|
|
1,868 |
|
Warranty
reserve |
|
|
50 |
|
Losses
from MCS gas business |
|
|
(711 |
) |
MCS
gas business severance and other miscellaneous costs |
|
|
1,280 |
|
Adjusted
Artema goodwill at December 31, 2002 |
|
$ |
20,817 |
|
During
2003, final adjustments to Artema goodwill were made related to acquiring the
minority interest and subsequent sale of the MCS gas business.
Artema
goodwill at December 31, 2002 |
|
$ |
20,817 |
|
Change
in minority interest value when purchased, net of costs |
|
|
(83 |
) |
VAT
refund |
|
|
(163 |
) |
Cash
sales price of MCS gas business |
|
|
(600 |
) |
Legal
expenses related to the sale |
|
|
111 |
|
Change
in estimate of MCS gas business assets and liabilities
sold |
|
|
(334 |
) |
Adjusted
Artema goodwill at December 31, 2003 |
|
$ |
19,748 |
|
Survivalink
Corporation
On
September 26, 2001, the Company acquired Survivalink Corporation
(“Survivalink”), a privately held Minneapolis-based company that is a leading
provider of Automated External Defibrillators (“AEDs”), in order to enter the
rapidly growing public access defibrillation market. Through the acquisition,
the Company acquired patents and know-how relating to biphasic defibrillation
waveform and AED technology which the Company believes is essential to its
competitiveness, as well as a manufacturing facility and an assembled and
experienced workforce which allows it to build a range of defibrillation
products. As consideration, the Company paid $10,500 in cash, issued $25,800 in
senior secured promissory notes (see Note 11) and tendered 18,150,000 shares of
common stock to Survivalink shareholders.
CARDIAC
SCIENCE, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
(In
thousands, except share and per share data)
The
shares and cash were released after a settlement was reached on certain breaches
of representation on November 6, 2002. On November 6, 2002, the Company received
$1,901 in cash and 474,231 shares of Cardiac Science common stock valued at
$1,095. The remaining balance of the escrow was 430,227 shares of Cardiac
Science common stock which has been transferred to the original Survivalink
shareholders. These settlement proceeds from the escrow account were recorded
against goodwill associated with the Survivalink acquisition.
As
partial consideration for the acquisition of Survivalink, the Company issued
senior promissory notes to Survivalink shareholders in the principal amount of
$25,800 with simple interest payable upon maturity at the rate of 10% per annum.
In addition, the Company assumed $1,500 plus accrued interest of bridge notes
from certain shareholders of Survivalink. The Company and the bridge note
holders agreed to convert the bridge notes into a senior note payable with terms
and conditions similar to the notes issued as merger consideration. During 2002,
the Company issued $50,000 of Senior Notes to a third party (see Note 11) and
the proceeds of the Notes were used to redeem the senior promissory notes issued
to the Survivalink shareholders and held in escrow, the assumed bridge loan and
all accrued interest.
The
Company entered into an agreement with Survivalink shareholders to establish a
tax escrow fund to make loans to employees of Survivalink who owned options to
purchase Survivalink common stock to help them meet their tax obligations
arising from the exercise of their employee stock options. The Company deposited
$2,108 of cash into this fund as of December 31, 2001. Each loan from the fund
was documented by an individual secured tax note. The tax notes were
collateralized by any amounts payable to the Survivalink employee under the
senior secured promissory notes issued to the employee as consideration in the
acquisition of Survivalink. During 2002, upon repayment of the senior secured
promissory notes, all loans to employees were paid back to the Company and the
tax escrow account was refunded to the Company.
The
acquisition was accounted for as a purchase under SFAS No. 141 “Business
Combinations.” In accordance with SFAS No. 141, the Company allocated the
purchase price based on the fair value of the assets acquired and liabilities
assumed. Portions of the purchase price were identified by management as
intangible assets and were valued based on a number of factors including an
independent appraisal. These intangible assets included $73,803 for goodwill,
$7,584 for patents, $676 for customer base, and $378 for the Survivalink
tradename. The patents are being amortized over seven years, the customer base
over two years, and the Survivalink tradename over one year.
The
Company determined the value of the stock consideration ($2.31 per share) using
the average closing stock price for a two day period before and a two day period
after the August 3, 2001 “measurement date.” The August 3, 2001 date was
determined as the measurement date as that was when the purchase agreement fixed
an absolute number of shares to be issued as consideration consistent with the
requirements of EITF No. 99-12.
The
components of the purchase price allocation are as follows:
Purchase
Price: |
|
|
|
Stock
consideration (18,150,000 shares @ $2.31/share) |
|
$ |
41,927 |
|
Cash |
|
|
10,500 |
|
Senior
secured promissory notes |
|
|
25,800 |
|
Acquisition
costs |
|
|
2,184 |
|
Total |
|
$ |
80,411 |
|
Allocation
of Purchase Price: |
|
|
|
|
Current
assets |
|
$ |
5,369 |
|
Property,
plant and equipment, net |
|
|
390 |
|
Other
assets |
|
|
21 |
|
Current
liabilities |
|
|
(6,299 |
) |
Bridge
notes |
|
|
(1,500 |
) |
Long
term liabilities |
|
|
(11 |
) |
Patents |
|
|
7,584 |
|
Customer
base |
|
|
676 |
|
Tradename |
|
|
378 |
|
Goodwill |
|
|
73,803 |
|
Total |
|
$ |
80,411 |
|
CARDIAC
SCIENCE, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
(In
thousands, except share and per share data)
During
2002, goodwill related to the Survivalink acquisition was adjusted for the
following:
Preliminary
Survivalink goodwill |
|
$ |
73,803 |
|
Cash
received from escrow |
|
|
(1,901 |
) |
Value
of shares received from escrow |
|
|
(1,095 |
) |
Bad
debt reserve |
|
|
(56 |
) |
Warranty
reserve |
|
|
847 |
|
Adjusted
Survivalink goodwill |
|
$ |
71,598 |
|
9.
Artema Restructuring and Disposition of the MCS Gas
Business
As part
of the Artema acquisition, the Company developed a plan to restructure the
operations of the manufacturing facility in Denmark (“the plan”). Originally,
the Company recorded certain purchase price adjustments in connection with the
plan totaling $3,064. The plan included plant and facility closure costs that
were either contractually obligated or were incremental in nature, adjustments
to fair market value for owned facilities to be disposed of based on market
assessments, adjustments to fair value for raw materials that would not be
converted into finished goods and certain severance related costs for employees
in closed facilities that the Company was obligated to pay upon execution of the
plan.
The plan,
which included closing the manufacturing facility in Denmark, relocating from
the then current facility in Copenhagen, as well as discontinuing or
subcontracting the manufacturing of certain product lines, was completed in the
quarter ended September 30, 2002. Additionally, an existing defibrillator
product line and the accompanying future service obligations were sold to a
European company as part of the plan. The Company sold related inventories,
manufacturing assets and the right to manufacture and sell the existing products
for consideration of cash and future royalty payments based on future units
produced. No gain or loss was recognized on the transaction as the disposal of
these assets was contemplated as a part of the plan. Upon execution of the plan,
the Company recorded an additional $905 of purchase price adjustments to reflect
the fair value of the assets disposed.
The
Company also entered into a licensing agreement with the European company
granting them the right to use Cardiac Science’s proprietary biphasic
defibrillation technology. In consideration, the Company received an upfront
payment of $487 and eight quarterly installments over the next 2 years totaling
$500. The total licensing revenue of $987 will be recognized on a pro-rata basis
over the next seven years, which is the term of the agreement and, accordingly,
the Company recognized $141 and $141 of licensing revenue in the years ended
December 31, 2004 and 2003, respectively.
Also as
part of the Artema acquisition, the Company identified the MCS gas business,
located in Stockholm, Sweden, as a business segment acquired in a business
combination accounted for as a purchase, to be disposed of. The MCS gas business
designs, develops and manufactures gas analyzers, which are sold to OEM patient
monitoring customers. The MCS gas business is a distinct and separate business
unit. The Company was, for the period from acquisition through November 30, 2002
accounting for this in accordance with EITF 87-11 “Allocation of Purchase Price
to Assets to be Sold,” which
requires that the operations of the MCS gas business be excluded from the
consolidated operating results of the Company. The Company had initially
estimated that the operating loss of the MCS gas business from the acquisition
date until disposition would be approximately $1,017 and had included this as a
liability assumed in the acquisition and included it in the purchase price
allocation. This estimated loss was subsequently revised to an estimated
operating loss of $306. The Company sold the MCS gas business to an outside
party for $600 in cash excluding selling costs of $111, on September 21, 2003.
The operating loss of $306 has been excluded from the statements of operations
for the one year period from acquisition through November 30, 2002 (i.e.
included in the purchase price allocation) and the MCS operating loss of $52 in
December 2002 and the net operating income of $493 for the period from January
1, 2003 through the sale on September 21, 2003, has been recorded as
discontinued operations in accordance with EITF 90-6 “Accounting for Certain
Events not Addressed in Issue No. 87-11 Relating to Acquired Operating Unit to
be Sold.”
CARDIAC
SCIENCE, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
(In
thousands, except share and per share data)
The
following is a breakdown of the restructuring accruals recorded related to the
Danish facilities shutdown and relocation and the MCS gas business
disposal:
|
|
Original
Adjustment |
|
Balance
at
December
31,
2001 |
|
Cash
Payments |
|
Non-Cash
Adjustments |
|
Adjustments
to
Goodwill |
|
Balance
at
December
31,
2002 |
|
Restructuring
accruals: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
on closure of Danish facilities |
|
$ |
648 |
|
$ |
648 |
|
$ |
(692 |
) |
$ |
108 |
|
$ |
664 |
|
$ |
728 |
|
Danish
facilities severance and other miscellaneous costs |
|
|
520 |
|
|
520 |
|
|
(607 |
) |
|
— |
|
|
123 |
|
|
36 |
|
Losses
from MCS gas business |
|
|
1,017 |
|
|
872 |
|
|
(161 |
) |
|
— |
|
|
(711 |
) |
|
— |
|
MCS
gas business severance and other miscellaneous costs |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
1,280 |
|
|
1,280 |
|
|
|
$ |
2,185 |
|
$ |
2,040 |
|
$ |
(1,460 |
) |
$ |
108 |
|
$ |
1,356 |
|
$ |
2,044 |
|
|
|
Balance
at December 31, 2002 |
|
Cash
Payments |
|
Currency
Fluctuations |
|
Adjustment
to
Goodwill |
|
Balance
Sold |
|
Balance
at December 31, 2003
and 2004 |
|
Restructuring
accruals: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
on closure of Danish facilities |
|
$ |
728 |
|
$ |
(652 |
) |
$ |
29 |
|
$ |
— |
|
$ |
— |
|
$ |
105 |
|
Danish
facilities severance and other miscellaneous costs |
|
|
36 |
|
|
(40 |
) |
|
4 |
|
|
— |
|
|
— |
|
|
— |
|
Losses
from MCS gas business |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
MCS
gas business severance and other miscellaneous costs |
|
|
1,280 |
|
|
(514 |
) |
|
— |
|
|
(332 |
) |
|
(434 |
) |
|
— |
|
|
|
$ |
2,044 |
|
$ |
(1,206 |
) |
$ |
33 |
|
$ |
(332 |
) |
$ |
(434 |
) |
$ |
105 |
|
10.
Relocation, Restructuring, and Disposal of Assets
During
the first quarter of 2003, the Company commenced its plan to relocate its
corporate headquarters, expanded its manufacturing capacity, and consolidate its
accounting and finance functions in Irvine, California.
The costs
which were incurred are included in general and administrative expenses in the
accompanying consolidated statement of operations for the year ended December
31, 2003. All expansion, relocation, and restructuring activities were completed
in the second quarter of 2003 and there are no future expected
costs.
The
following is a breakdown of the accrual recorded related to the expansion,
relocation and restructuring activities:
|
|
Original
Estimate |
|
Costs
Incurred |
|
Cash
Payments |
|
Non-cash
Adjustment |
|
Balance
at December 31, 2003 |
|
Severance
costs |
|
$ |
199 |
|
$ |
199 |
|
$ |
(199 |
) |
$ |
— |
|
$ |
— |
|
Moving
and travel costs |
|
|
68 |
|
|
92 |
|
|
(92 |
) |
|
— |
|
|
— |
|
Lease
termination costs |
|
|
139 |
|
|
139 |
|
|
(139 |
) |
|
— |
|
|
— |
|
Accelerated
depreciation of leaseholds and other assets |
|
|
288 |
|
|
288 |
|
|
— |
|
|
(288 |
) |
|
— |
|
|
|
$ |
694 |
|
$ |
718 |
|
$ |
(430 |
) |
$ |
(288 |
) |
$ |
— |
|
The
accrual represented costs recognized pursuant to SFAS 146 “Accounting for Costs
Associated with Exit or Disposal Activities” and SAB 100 “Restructuring and
Impairment Charges.” The Company committed to a sufficiently detailed plan that
identified significant actions to be taken and the activities that would not be
continued. The plan was completed during the quarter ended June 30, 2003 and
there were no significant changes to the original plan. The involuntary one-time
employee-termination arrangement established the benefits to be paid to
employees and specifically identified the classifications or functions of those
employees, their locations, and their expected completion date. All employees
were informed about the terms of the benefit arrangement, including the benefits
that employees would receive upon termination (including but not limited to cash
payments), in sufficient detail to enable employees to determine the type and
amount of benefits they would receive. The Company reviewed the net book value
of leasehold improvements to be abandoned in certain facilities in accordance
with SFAS 144, and appropriately recorded an adjustment to accelerate the
related depreciation over the revised useful life through their cease-use
dates.
In May
2004, the Company sold fixed assets in connection with closing our Ohio facility
from the Complient acquisition for $23 in cash resulting in a loss of $203
recorded to other operating expenses in the year ended December 31, 2004.
In June
2004, the Company sold the rights to an AED trainer that the Company
manufactured for one specific customer for $700 in cash, resulting in a gain of
$387 recorded to other operating expenses in the year ended December 31, 2004.
In July
2004, the Company initiated a plan to streamline its international operations by
transferring certain administrative and logistics functions to the U.S. and
U.K., which resulted in headcount reductions and an accrual for severance of
$285 recorded to other operating expenses in the year ended December 31, 2004.
In August
2004, the Company sold the CPR Prompt product line, which includes products such
as CPR Prompt devices, manikins, and training related equipment and supplies,
for $1,875 in cash resulting in a net gain of $1,368 recorded to other operating
expenses in the year ended December 31, 2004.
In
September 2004, the Company discontinued its Diascope product line, which is
manufactured by a contract manufacturer in Asia and sold only in international
markets in the quarter ended September 30, 2004. Substantially all of the
inventory on hand was sold in the quarter ended September 30, 2004. The Company
recorded an impairment of assets related to the discontinuance of the product
line of $190 to other operating expenses in the year ended December 31, 2004.
11.
Senior Secured Promissory Notes
As
partial consideration for the acquisition of Survivalink (see Note 8), the
Company issued senior secured promissory notes to Survivalink shareholders
during 2001 in the principal amount of $25,800, with simple interest payable
upon maturity at the rate of 10% per annum. In addition, the Company assumed
$1,500 of bridge notes from certain shareholders of Survivalink. The Company and
the bridge note holders agreed to convert the bridge notes into a senior secured
promissory note with terms and conditions similar to the notes issued as merger
consideration. The notes issued to Survivalink shareholders were subsequently
redeemed pursuant to the note and warrant financing described in the immediately
following paragraph.
On May
29, 2002, the Company entered into a Senior Note and Warrant Purchase Agreement
(“the Agreement”) with investors, pursuant to which the investors loaned the
Company $50,000. Under the original terms of the Agreement, the Senior Notes
(the “Notes”) were due and payable in cash on May 30, 2007, unless accelerated
pursuant to the terms of the Agreement, and accrue interest at 6.9% per annum.
During the first three years of the term of the Notes, accrued and unpaid
interest on the Notes would, at the option of the Company, a) be due and payable
in cash, or b) accrue and be paid in kind, in each case quarterly in arrears,
and then due on the termination date of the Notes. After the end of the third
year of the term of the Notes, any additional accrued and unpaid interest on the
Notes would be due and payable in cash quarterly in arrears, and on the
termination date of the Notes. The Notes have certain monthly and quarterly
financial and non-financial covenants. The Notes are collateralized by all the
assets of the Company and its subsidiaries, to the extent permitted by law.
Proceeds from the Notes were used by the Company to repay $26,468 of senior
promissory notes including accrued interest issued in connection with the
acquisition of Survivalink Corporation (see Note 8). The remaining proceeds were
used for working capital purposes. Interest expense and amortization of the
discount and issuance costs related to these notes was $6,975, $5,983 and $3,207
for 2004, 2003 and 2002, respectively. The terms of the Notes have been amended
subsequent to December 31, 2004 (see Note 22). As of December 31, 2004, the
Company was not in compliance with certain of the required covenants, as
amended, however, the Company received a waiver for the quarter and year ended
December 31, 2004 (see Note 22).
In
connection with the Notes, the investors were issued warrants (the “Warrants”)
for the purchase of an aggregate of 10,000,000 shares of the Company’s common
stock at an exercise price of $3.00 per share, and an aggregate of 3,000,000
shares of common stock at an exercise price of $4.00 per share. The Warrants are
immediately exercisable, expire by their terms on May 30, 2009 and are subject
to certain limited antidilution adjustments. After two years, the Company has
the right to force the exercise of the warrants pursuant to the terms of the
Agreement. The proceeds from the Notes were allocated between the Notes and the
Warrants based on their relative fair values which resulted in a discount being
recorded on the Notes pursuant to APB No. 14 “Accounting for Convertible Debt
and Debt Issued with Stock Purchase Warrants.” The Company considered a number
of factors, including an independent valuation, when determining the fair value
of the Warrants. The significant assumptions used in the Black-Scholes model
were: stock price of $2.90, adjusted downward for a dilution factor to $2.68;
risk free rate of 4.98%; volatility of 0.90; dividend yield of 0%; and
contractual term of 7 years. Such allocation resulted in a discount being
recorded on the Notes in the amount of $11,815, which is being amortized over
the five-year term of the Notes using the effective interest method. In
addition, the Company paid approximately $2,760 in debt issuance costs which are
being amortized over the five-year term of the Notes using the effective
interest method.
CARDIAC
SCIENCE, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
(In
thousands, except share and per share data)
On March
15, 2004, the Company amended the Agreement, effective as of and for the year
ended December 31, 2003, in order to ease certain financial covenants into 2005
to reflect the Company’s actual and expected financial results. In exchange for
modifying these covenants, the Company issued warrants to the note holders to
purchase 500,000 shares of common stock at $3.95 per share. The warrants were
valued at $1,301 using a Black-Scholes model. The significant assumptions used
in the model were: stock price of $3.98; risk free rate of 3.2%; volatility of
0.65; dividend yield of 0%; and contractual term of seven years. The value of
the warrants was recorded as additional discount to the Senior Notes to be
amortized over the remaining term of the Senior Notes using the effective
interest method. This modification was not considered to be a significant
modification of the Agreement.
Under the
antidilution provisions that were triggered by the September 2003 and July 2004
private placements (see Note 15) and the July 2003 warrant issuance to GE
Healthcare (see Note 20), an additional 205,451 warrants were issuable to the
note holders at exercise prices ranging from $2.97 to $3.88. In addition,
pursuant to the antidilution provisions, the exercise prices of the original
warrants issued were also reduced to: (i) $2.97 for the 10,000,000 warrants that
had an original exercise price of $3.00, (ii) $3.88 for the 3,000,000 warrants
that had an original exercise price of $4.00, and (iii) $3.86 for the 500,000
warrants that had an original exercise price of $3.95.
12.
Promissory Note and Security Agreement
In July
1999, the Company terminated its agreement to acquire HeartSine Technologies,
Inc. (“HeartSine”). In December 1999, the Company entered into an exclusive
license and development agreement with HeartSine Technologies, Inc. to utilize
HeartSine’s biphasic defibrillation waveform technology in the Company’s
in-hospital defibrillation products. HeartSine Technologies is a privately held
research and development firm with its primary operations in Northern Ireland.
Pursuant to the agreement, the Company could have paid to HeartSine a total of
$650 upon the attainment of agreed upon milestones. During 2000 the Company
terminated the development portion of the agreement and therefore there are no
additional development fees to be earned by HeartSine. Included in the amount of
$650 was a one time license fee of $250 which was paid in December 1999 and
included in research and development expense for the year ended December 31,
1999. Also, during 1999, the Company advanced cash to HeartSine in the amount of
$189. The Company obtained a promissory note and security agreement with regard
to these advances. The principal amount plus interest at 10% was due and payable
on December 31, 2001.
In prior
periods, the Company wrote-off to research and development expense this $189, as
the Company believed that the note receivable was permanently impaired and
uncollectible. In February 2002, the Company received from HeartSine $236, which
represented full repayment of the original promissory note plus accrued interest
and late fees. The Company has included this recovery of $236 as an offset to
research and development expense in the statement of operations for the year
ended December 31, 2002. In November 2002, the Company agreed to terminate its
development and license agreement with HeartSine in exchange for $100. The
Company also included this $100 as an offset to research and development expense
in the statement of operations for the year ended December 31,
2002.
13.
Related Party Transaction
In
November 2001, the Company advanced $500 (the “Loan”) to its CEO. The principal
amount plus interest of 6% was due and payable in November 2004 and was not
collateralized. In November 2004, the Loan plus accrued interest was settled by
the CEO’s surrender of 277,682 shares of his common stock in the Company, valued
at $589 based on the closing share price on the due date of the Loan. The shares
were not legally cancelled until 2005 and were recorded as issued but not
outstanding in the consolidated balance sheet and consolidated statement of
stockholders’ equity at December 31, 2004. The Loan was included in other
current assets on the consolidated balance sheet at December 31,
2003.
In May
2002, the Company entered into a Senior Note and Warrant Purchase Agreement
(“the Agreement”) with investors, pursuant to which the investors loaned the
Company $50,000. In March 2004, the Company amended the Agreement in order to
ease certain financial covenants into 2005 to reflect our actual and expected
financial results. In exchange for these modifications, the Company issued the
note holders 500,000 additional warrants to purchase shares of common stock at
$3.95 per share. The warrants were valued at $1,301 using a Black-Scholes model.
The value of the warrants was recorded as additional discount to the Senior
Notes to be amortized over the remaining term of the Senior Notes using the
effective interest method.
Under the
antidilution provisions of the Agreement, which were triggered by the September
2003 and July 2004 private placements and our July 2003 warrant issuance to GE
Healthcare, an additional 205,451 warrants were issuable to the note holders at
exercise prices ranging from $2.97 to $3.88. In addition, the exercise prices of
the original warrants issued were also reduced to: (i) $2.97 for the 10,000,000
warrants that had an original exercise price of $3.00, (ii) $3.88 for the
3,000,000 warrants that had an original exercise price of $4.00, and (iii) $3.86
for the 500,000 warrants that had an original exercise price of
$3.95.
In
January 2005, the Company entered into an amendment and limited waiver (the
“Amendment”) to the Agreement with the Senior Note holders. Pursuant to the
terms of the Amendment, the Company and the Senior Note holders agreed to: (i)
extend the maturity date of the $50,000 in aggregate principal amount of Senior
Notes issued under the Agreement by twelve months to May 29, 2008; (ii) defer
all cash interest payments until maturity; and (iii) modify certain financial
covenants regarding minimum EBITDA, minimum debt to capitalization and maximum
capital expenditures, and delete certain other financial covenants for 2005
through maturity. Additionally, the Senior Note holders waived certain covenant
violations, including all financial covenant violations for the quarter and year
ended December
31, 2004. In exchange for the foregoing amendments and waiver contained in the
Amendment, the Company and the Senior Note holders agreed to reduce the number
of warrants to purchase shares of common stock to 13,438,599 and reduce the
exercise price of those warrants to $2.00 per share, down from the original
weighted average price of approximately $3.21 per share.
In
January 2005, as consideration for delays in filing a required registration
statement in connection with the July 2004 financing, the Company agreed with
the investors in such financing to make a cash payment of $556, to issue an
additional aggregate of 476,637 shares of common stock and to reduce the
exercise price on the investors’ warrants to $2.50 per share.
14.
Line of Credit
In
February 2004, the Company secured a $5,000 line of credit with Silicon Valley
Bank. The line of credit may be used to provide additional working capital, as
needed, to fund our continued growth. This 24-month facility is collateralized
by accounts receivable, inventory and cash and cash equivalents, has an interest
rate of the bank’s prime rate plus .75% (with a floor of 5%) payable monthly,
and requires us to maintain certain financial covenants. In January 2005, the
Company obtained a waiver from the bank for the quarter and year ended December
31, 2004 for non-compliance with certain financial covenants required by the
line of credit agreement. There was no outstanding balance on the line at
December 31, 2004, however, there was a letter of credit for $88 issued in
December 2004 as collateral for a performance bond (see Note 16) that reduces
the available balance on the line of credit.
CARDIAC
SCIENCE, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
(In
thousands, except share and per share data)
15.
Common Stock Issuances
During
September 2003, the Company completed a private placement of its common stock to
a small group of institutional and accredited investors, raising $8,375 in gross
proceeds. The transaction involved the sale of 2,233,334 newly issued shares of
Cardiac Science common stock at a price of $3.75 per share. In addition to the
common stock, 223,333 five-year warrants with an exercise price of $5.00 per
share were issued in connection with the transaction.
In July
2004, the Company completed a private placement of its common stock to a small
group of institutional and accredited investors, raising $12,370 in gross
proceeds. The transaction involved the sale of 5,219,409 newly issued shares of
Cardiac Science common stock at a price of $2.37 per share. In addition to the
common stock, 2,087,763 five-year warrants with an exercise price of $2.84 per
share were issued in connection with the transaction. See Note 22 regarding
subsequent amendment and settlement related to this private
placement.
16.
Commitments and Contingencies
Concentrations
of Risk
The
Company is exposed to credit loss for the amount of cash deposits with financial
institutions in excess of federally-insured limits. The Company invests its
excess cash deposits in money market cash portfolios with major financial
institutions.
Litigation
In
November 2002, the Company settled a patent infringement suit with ZOLL Medical
Corporation (“ZOLL”), which it originally initiated in March 2002. The terms of
the settlement included the cross licensing of a number of patents between the
two parties. Under the terms of the confidential settlement agreement, the
Company received a settlement amount and will be entitled to royalties under a
licensing agreement based on ZOLL’s AED sales. The Company recorded the
settlement as an offset to legal expense included in general and administrative
expenses in the quarter ended December 31, 2002.
On
December 3, 2002, the Company filed a Complaint in Orange County Superior Court
against Medical Research Laboratories, Inc. (“MRL”) alleging declaratory relief
and breach of contract arising out of a July 29, 2002 letter of intent entered
into between the parties. The Company alleged that MRL failed to comply with
certain conditions of closing set forth in the letter of intent whereby the
Company would acquire all of MRL’s stock. MRL filed a cross-complaint, also
seeking breach of contract and declaratory relief arising out of the same letter
of intent. On February 25, 2003, the Company filed suit against MRL for patent
infringement in the United States District Court for the District of Minnesota.
The Company alleged that MRL’s LifeQuest JumpStart AED infringed the Company’s
patented disposable electrode pre-connect technology. The Company settled both
law suits with MRL on June 24, 2003. Under the terms of the confidential
settlement agreement, the Company received a settlement amount from MRL and MRL
received the right to license two of the Company’s patents for additional
royalties.
In
February 2003, the Company filed a patent
infringement action against Philips Medical Systems North America, Inc., Philips
Electronics North America Corporation and Koninklijke Philips Electronics N.V.
(“Philips”) in the United States District Court for the District of Minnesota.
The suit alleges that Philips’ automated external defibrillators sold under the
names “HeartStart OnSite Defibrillator”, “HeartStart”, “HeartStart FR2” and the
“HeartStart Home Defibrillator,” infringe at least ten of the
Company’s United
States patents. In the same action, Philips counterclaimed for infringement of
certain of its patents and the
Company has sought a
declaration from the Court that the
Company’s products
do not infringe such patents. Many of the Philips defibrillators’ are promoted
by Philips as including, among other things, pre-connected disposable
defibrillation electrodes and daily self-testing of electrodes and battery,
features that the suit alleges are key competitive advantages of the
Company’s
Powerheart and Survivalink AEDs and are covered under the
Company’s patents.
At this stage, the
Company is unable
to predict the outcome of this litigation. The
Company has not
established an accrual for this matter because a loss is not determined to be
probable.
CARDIAC
SCIENCE, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
(In
thousands, except share and per share data)
On April
30, 2003, the
Company filed a
Complaint against Defibtech, LLC for patent infringement in the United States
District Court for the District of Minnesota. The Complaint alleged that
Defibtech’s Sentry and Reviver AEDs infringe the
Company’s patented
disposable electrode pre-connect technology as well as other patents. Defibtech
answered the Complaint and asserted counterclaims alleging that the
Company has engaged
in activities that constitute tortious interference with present and prospective
contractual relations, common law business disparagement and statutory business
disparagement. The
Company
responded to the counterclaims with a complete and general denial of the
allegations. At this stage, the
Company is unable
to predict the outcome of this litigation. The
Company has not
established an accrual for this matter because a loss is not determined to be
probable.
On March
19, 2004, William S. Parker filed suit against the
Company for
patent infringement in the United States District Court for the Eastern Division
of Michigan. The Parker patent generally covers the use of a synthesized voice
to instruct a person to perform certain tasks. The Complaint alleges that
certain of the
Company’s AEDs
infringe the patent. The patent is now expired. The
Company has filed an
Answer to the Complaint stating the patent is not infringed and is otherwise
invalid and unenforceable. The patent has been submitted before the United
States Patent and Trademark Office for reexamination. On October 25, 2004, the
District Court issued an order staying the litigation pending resolution of the
reexamination. At this stage of the litigation, the
Company is unable
to predict the outcome of this litigation. The
Company has not
established an accrual for this matter because a loss is not determined to be
probable.
In the
ordinary course of business, various lawsuits and claims are filed against the
Company. While the outcome of these matters is currently not determinable,
management believes that the ultimate resolution of these matters will not have
a material adverse effect on the Company’s operations or financial
position.
Employee
Benefit Plan
In 1995,
the Company adopted the Cardiac Science, Inc. 401(k) Profit Sharing Plan (the
“Plan”) which is a 401(k) plan covering all of the Company’s full-time employees
who meet certain eligibility requirements. The Company may contribute to the
Plan on a discretionary basis. As of December 31, 2004, the Company had never
contributed to the Plan.
Operating
Leases
The
Company leases office space and equipment under various operating lease
agreements. Most of our facilities leases include annual rent escalations which
are recognized on a straight-line basis over the lease term. In addition,
certain of these leases also include tenant improvement allowances and other
lease incentives which are recorded as deferred rent and amortized as reductions
to rent expense over the term of the lease. Total rent expense for the years
ended December 31, 2004, 2003 and 2002 was $1,614, $1,153, and $666,
respectively. The minimum lease payments, net of sublease payments, under the
terms of the lease agreements for the years ending December 31 are as
follows:
2005,
net of sublease income of $558 |
|
$ |
1,752 |
|
2006,
net of sublease income of $702 |
|
|
1,600 |
|
2007,
net of sublease income of $447 |
|
|
1,651 |
|
2008,
net of sublease income of $702 |
|
|
755 |
|
2009,
net of sublease income of $59 |
|
|
7 |
|
|
|
$ |
5,765 |
|
Performance
Guarantees
At
December 31, 2004 the Company’s Danish subsidiary has outstanding bank
performance guarantees totaling 2,373 Danish Kroner (approximately $435 in
U.S. dollars) issued in 1999 through 2002 in connection with sales contracts to
foreign governments. These bank performance guarantees expire in 2005 and
2006 but are not officially released until the customer notifies the bank that
renewal is not required. In addition, during 2004, the Company issued a
performance bond of $88 collateralized by a letter of credit issued by Silicon
Valley Bank under the Company’s line of credit in connection with a sales
contract with a city municipality. The performance bond expires in November
2007. The Company has no further performance obligations under these contracts
other than providing normal warranty service on the products sold under the
contracts.
17.
Income Taxes
The
Company’s provision for income tax represents the current state minimum taxes.
There is no deferred income tax provision due to the valuation
allowance.
CARDIAC
SCIENCE, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
(In
thousands, except share and per share data)
The
temporary differences which give rise to the deferred tax provision (benefit)
consist of the following for the years ended December 31:
|
|
2004 |
|
2003 |
|
2002 |
|
Property
and equipment |
|
$ |
27 |
|
$ |
(424 |
) |
$ |
341 |
|
Intangible
assets and goodwill |
|
|
715 |
|
|
— |
|
|
— |
|
Capitalized
costs |
|
|
411 |
|
|
302 |
|
|
168 |
|
Accrued
liabilities |
|
|
(762 |
) |
|
(380 |
) |
|
366 |
|
Tax
credit carry forwards |
|
|
(268 |
) |
|
(292 |
) |
|
(903 |
) |
Stock
options |
|
|
— |
|
|
211 |
|
|
337 |
|
Deferred
revenue |
|
|
(692 |
) |
|
(437 |
) |
|
— |
|
Charitable
contributions |
|
|
(66 |
) |
|
(4 |
) |
|
(139 |
) |
Capital
loss carry forwards |
|
|
— |
|
|
— |
|
|
(303 |
) |
Other |
|
|
(9 |
) |
|
4 |
|
|
64 |
|
Net
operating loss carry forwards |
|
$ |
(1,458 |
) |
$ |
(3,171 |
) |
$ |
(7,602 |
) |
|
|
|
(2,102 |
) |
|
(4,191 |
) |
|
(7,671 |
) |
Valuation
allowance |
|
|
2,102 |
|
|
4,191 |
|
|
7,671 |
|
|
|
$ |
— |
|
$ |
— |
|
$ |
— |
|
The
temporary differences which give rise to deferred income tax assets and
liabilities at December 31 are as follows:
|
|
2004 |
|
2003 |
|
|
|
Property
and equipment |
|
$ |
(13 |
) |
$ |
14 |
|
|
|
Intangible
assets and goodwill |
|
|
(715 |
) |
|
— |
|
|
|
Capitalized
costs |
|
|
— |
|
|
411 |
|
|
|
Accrued
liabilities/reserves |
|
|
2,983 |
|
|
2,221 |
|
|
|
Tax
credit carry forwards |
|
|
4,295 |
|
|
4,027 |
|
|
|
Deferred
revenue |
|
|
1,129 |
|
|
437 |
|
|
|
Capital
loss carry forwards |
|
|
524 |
|
|
524 |
|
|
|
Charitable
contributions |
|
|
209 |
|
|
143 |
|
|
|
Other |
|
|
10 |
|
|
1 |
|
|
|
Net
operating loss carry forwards |
|
|
53,463 |
|
|
52,005 |
|
|
|
|
|
|
61,885 |
|
|
59,783 |
|
|
|
Valuation
allowance |
|
|
(61,885 |
) |
|
(59,783 |
) |
|
|
|
|
$ |
— |
|
$ |
— |
|
|
|
The
provision for income taxes differs from the amount that would result from
applying the federal statutory rate for the years ended December 31 as
follows:
|
|
2004 |
|
2003 |
|
2002 |
|
Statutory
federal income tax rate |
|
|
(34.0 |
)% |
|
(34.0 |
)% |
|
(34.0 |
)% |
Nondeductible
expenses |
|
|
13.3 |
|
|
0.5 |
|
|
0.7 |
|
Tax
credits |
|
|
(0.7 |
) |
|
(2.9 |
) |
|
(5.1 |
) |
Other |
|
|
0.7 |
|
|
0.9 |
|
|
— |
|
Change
in valuation allowance |
|
|
20.7 |
|
|
35.5 |
|
|
38.4 |
|
|
|
|
0.0 |
% |
|
0.0 |
% |
|
0.0 |
% |
As of
December 31, 2004, the Company has research and experimentation credit carry
forwards for federal and state purposes of approximately $3,000 and $1,000,
respectively. These credits begin to expire in 2006 for federal purposes and
carry forward indefinitely for California state purposes. The Company has
capital loss carry forwards of approximately $1,000 for both federal and state
purposes which begin to expire in 2006 for federal purposes and carry forward
indefinitely for state purposes. The Company also has approximately $139,000 and
$69,000 of federal and state net operating loss carry forwards which will begin
to expire in 2006 and 2005, respectively.
CARDIAC
SCIENCE, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
(In
thousands, except share and per share data)
Internal
Revenue Code Sections 382 and 383, and similar state provisions place certain
limitations on the annual amount of loss and credit carryforwards that can be
utilized if certain changes to a company’s ownership occur. The acquisition of
Survivalink in 2001 resulted in a change in ownership pursuant to Section 382 of
the Internal Revenue Code. The annual limitation is as follows: $8,300 for 2005,
$6,500 for 2006 and $1,800 thereafter. The amount of net operating loss subject
to this limitation, for federal and state purposes, is approximately $53,000 and
$24,000, respectively. Research and experimentation credits and capital loss
carryovers are also subject to the limitation under Internal Revenue Code
Sections 382 and 383 and similar state provisions. The utilization of net
operating loss carryovers and other tax attributes may be subject to further
substantial limitations if certain ownership changes occur in future periods.
The
Company recorded deferred tax assets of approximately $16,000 upon the
acquisition of Survivalink in 2001. The deferred tax assets are composed
primarily of loss and tax credit carryforwards and other temporary differences.
The deferred tax assets recorded were reduced by a valuation allowance of
$16,000. Due to the expiration of some of the net operating loss carryovers the
balance is $13,000 as of December 31, 2004. If the Company determines that it
will realize the tax benefit related to these Survivalink deferred assets in the
future, the related decrease in the valuation allowance will reduce goodwill
instead of the provision for taxes.
The
Company also recorded deferred tax assets of approximately $8,000 upon the
acquisition of Cadent in 2000. The deferred tax asset was composed primarily of
loss carryforwards and other temporary differences. The deferred tax assets
recorded were also reduced by a valuation allowance of $8,000. Due to the
expiration of some of the net operating loss carryovers, the balance is $7,000
as of December 31, 2004. If the Company determines that it will realize the tax
benefit related to these Cadent deferred assets in the future, the related
decrease in the valuation allowance will reduce goodwill instead of the
provision for taxes.
Additionally,
approximately $1,600 of the net operating loss carryforward represents
deductions claimed as the result of stock options. If the Company determines
that it will realize the benefit of this net operating loss carryforward in the
future, the related decrease in the valuation allowance will be credited to
additional paid-in capital instead of the provision for taxes.
At
December 31, 2004, the Company had foreign net operating loss carryforwards. The
losses carryover indefinitely, unless certain defined changes in business
operations occur during the carryover period. The Company has established a full
valuation allowance against these deferred tax assets since it cannot be
established that these foreign subsidiaries’ net operating loss carryforwards
will be fully utilized.
The
American Jobs Creation Act of 2004 (the Act) was signed into law in October
2004, which allows companies to elect to repatriate cash into the United States
in 2005 at a special temporary effective tax rate of 5.25%. The Company’s
evaluation of the amount of foreign earnings that may elect to treat under this
special provision, and the financial statement impact, is in progress. As such,
the Company is not in a position to decide on whether, and to what extent, its
foreign earnings will be affirmatively designated for this treatment. The
related potential range of the income tax effect of the repatriation cannot be
reasonably estimated at this time.
18.
Stock Options
1997
Stock Option/Stock Issuance Plan
In May
1998, the Company’s 1997 Stock Option/Stock Issuance Plan (the “1997 Plan”) was
approved by stockholders at the Annual Meeting of Stockholders. All outstanding
stock options under the Company’s 1991 Stock Option Plan and 1993 Stock Option
Plan were exchanged for stock options in the 1997 Plan. The 1997 Plan provides
for the granting of stock options intended to qualify as incentive stock options
and stock options not intended to qualify as incentive stock options
(“non-statutory options”) to employees of the Company, including officers, and
non-statutory stock options to employees, including officers and directors of
the Company, as well as to certain consultants and advisors.
The 1997
Plan is administered by a Compensation Committee (the “Committee”) which is
comprised of three members appointed by the Company’s Board of Directors. The
Committee may grant options to any officers, directors or key employees of the
Company or its subsidiaries and to any other individuals whose participation in
the 1997 Plan the Committee determines is in the Company’s best interest. In
2001, stockholders approved an amendment to the 1997 Plan to increase the number
of shares of common stock up to a maximum of 8.8 million shares. In 2002,
stockholders approved another amendment to increase the number of shares of
common stock up to a maximum of 11 million shares. In 2003, stockholders
approved another amendment to increase the number of shares of common stock up
to a maximum of 14 million shares. The 1997 Plan is subject to adjustment upon
the occurrence of certain events, including, but not limited to, stock
dividends, stock splits, combinations, mergers, consolidations, reorganizations,
reclassifications, exchanges, or other capital adjustments. The 1997 Plan limits
to $100 the fair market value (determined at the time the option is granted) of
the common stock with respect to which incentive stock options are first
exercisable by any individual employee during any calendar year.
CARDIAC
SCIENCE, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
(In
thousands, except share and per share data)
The 1997
Plan incorporates the federal tax law requirements for incentive stock options.
Among other such requirements, the per share exercise price of an incentive
stock option granted under the 1997 Plan must not be less than 100% of the fair
market value of a share of the common stock on the date of grant and the option
may not be exercised more than 10 years after its grant date. If an incentive
stock option is granted to an employee owning more than 10% of the total
combined voting power of all classes of stock of the Company, the exercise price
may not be less than 110% of such fair market value and the option may not be
exercised more than five years after its grant date. Option grants under the
1997 Plan generally vest over a period of four years.
Outstanding
options may be terminated or accelerated in the event of certain corporate
acquisitions or other change of control events. An option granted under the 1997
Plan will not be assignable or transferable by the grantee other than by will or
the laws of inheritance, except that a non-statutory option will be transferable
by the grantee pursuant to a qualified domestic relations order as defined in
the Code, Title I of the Employee Retirement Income Security Act or the rules
thereunder. Other vesting, termination and payment provisions for incentive and
non-statutory options may be determined by the Committee.
Stock
option activity for the years ended December 31 is summarized as
follows:
|
|
Weighted
Average
Exercise
Price
Per Share |
|
Number
of
Shares
Outstanding |
|
Number
of
Shares
Exercisable |
|
Outstanding,
December 31, 2001 |
|
$ |
2.53 |
|
|
8,490,550 |
(1) |
|
1,166,086 |
|
Granted |
|
$ |
1.91 |
|
|
2,892,000 |
|
|
|
|
Exercised |
|
$ |
2.10 |
|
|
(39,537 |
) |
|
|
|
Cancelled |
|
$ |
2.86 |
|
|
(1,121,134 |
) |
|
|
|
Outstanding,
December 31, 2002 |
|
$ |
2.31 |
|
|
10,221,879 |
|
|
3,343,376 |
|
Granted |
|
$ |
3.63 |
|
|
4,295,000 |
(2) |
|
|
|
Exercised |
|
$ |
2.16 |
|
|
(658,552 |
) |
|
|
|
Cancelled |
|
$ |
2.43 |
|
|
(1,450,037 |
) |
|
|
|
Outstanding,
December 31, 2003 |
|
$ |
2.76 |
|
|
12,408,290 |
|
|
4,789,702 |
|
Granted |
|
$ |
2.16 |
|
|
2,785,000 |
(3) |
|
|
|
Exercised |
|
$ |
1.98 |
|
|
(535,929 |
) |
|
|
|
Cancelled |
|
$ |
3.12 |
|
|
(1,809,062 |
) |
|
|
|
Outstanding,
December 31, 2004 |
|
$ |
2.61 |
|
|
12,848,299 |
|
|
6,615,611 |
|