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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(Mark One)
/X/ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
FOR THE FISCAL YEAR ENDED SEPTEMBER 30, 2000
OR
/ / TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
FOR THE TRANSITION PERIOD FROM..............TO..........
COMMISSION FILE NUMBER 0-20225
ZOLL MEDICAL CORPORATION
(Exact name of registrant as specified in its charter)
Massachusetts 04-2711626
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(State or other jurisdiction of (I.R.S. Employer Identification No.)
incorporation or organization)
32 Second Avenue, Burlington, Massachusetts 01803
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (781) 229-0020
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Securities registered pursuant to Section 12(b) of the Act:
Title of each class Name of each exchange on which registered
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None None
Securities registered pursuant to Section 12(g) of the Act:
Common Stock, $.02 Par Value
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(Title of class)
Indicate by check mark whether the registrant (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or for such shorter period that the registrant was
required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days. Yes _X_ No ___.
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405
of Regulation S-K is not contained herein, and will not be contained, to the
best of registrant's knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this Form 10-K or any amendment to this
Form 10-K [X]
The aggregate market value of the voting stock held by non-affiliates of the
registrant as of December 21, 2000 was $306,747,909 based on closing sales price
of $35-11/16 per share as reported for the NASDAQ-composite transactions.
The number of shares of the registrant's classes of common stock outstanding, as
of December 21, 2000 was 8,805,133.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the 2000 Annual Report to Shareholders are incorporated by reference
into Parts I, II and IV.
Portions of the definitive Proxy statement dated January 8, 2001 to be delivered
to shareholders in connection with the Annual Meeting of Shareholders to be held
February 8, 2001 are incorporated by reference into Part III.
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PART I
ITEM 1. BUSINESS
OVERVIEW
We design, manufacture and market an integrated line of proprietary,
noninvasive cardiac resuscitation devices, our external
defibrillators/pacemakers, as well as disposable electrodes and emergency
medical system software data management solutions. Our cardiac resuscitation
products are designed to improve survival rates from sudden cardiac arrest,
which is a leading cause of death in the United States. Sudden cardiac arrest
claims over 250,000 victims each year in the United States alone. For victims of
sudden cardiac arrest, time is the most critical element for survival. According
to the American Heart Association, more than 95% of victims with sudden cardiac
arrest die, in many cases because life saving defibrillators arrive on the scene
too late, if at all.
The importance of immediate treatment creates an annual worldwide market
for external defibrillator products, which we estimate to have been $580 million
in 2000. We divide this market into three principal areas: the hospital,
pre-hospital and public access defibrillation markets. The hospital market
consists of doctors, nurses and other medical personnel who use defibrillators
in hospital settings. The pre-hospital market consists of care providers such as
paramedics, ambulance operators, emergency medical technicians,
medically-trained firefighters and other emergency medical personnel. The public
access market includes non-traditional providers such as police, non-medically
trained firefighters and other non-medically trained personnel. We currently
sell our products in the hospital and pre-hospital markets and plan to enter the
public access defibrillation market during calendar year 2001. We believe we are
currently the second largest company in the world in external defibrillator
product sales. From fiscal 1999 to fiscal 2000, our revenues increased 35%,
making us the fastest growing worldwide external defibrillator company. In that
time, our revenues in the hospital market increased 31%. Comparatively, we
estimate that the overall hospital market grew at a rate of only 3% to 5%.
Our newest line of defibrillators is the M Series, which we began shipping
with the conventional monophasic waveform in September 1998. M Series
defibrillators are smaller and lighter than competitive products, making them
easier to use, carry and transport. We recently began shipping M Series
defibrillators equipped with our proprietary biphasic waveform that provides
improved defibrillation efficacy as compared to conventional monophasic
waveforms. We have received clearance from the U.S. Food and Drug
Administration, or the FDA, to label our M Series defibrillators equipped with
our biphasic waveform as being clinically superior to defibrillators with a
monophasic waveform for particular uses. We are the only company to have
received a claim of superiority on its biphasic waveform. We believe the
clinical superiority of our biphasic waveform combined with product advantages
including small size, light weight and relative ease-of-use offer compelling
reasons for customers to choose our products.
OUR BUSINESS STRATEGY
The cardiac resuscitation market is a large and growing market driven by a
demonstrated and increasing clinical need. Our business strategy is to continue
to gain an increased share in both the domestic and international markets by
offering superior products through direct sales distribution. While we plan to
increase our share in markets that we currently serve, we also seek future
growth by entering into new markets with significant opportunities. We believe
that the following elements of our strategy may provide current and longer-term
growth to our business:
-CONTINUE TO EXPAND SUCCESSFUL SALES OF M SERIES DEFIBRILLATORS. A major
element of our business strategy is to capitalize on the success of the M
Series defibrillators in order to increase our market share in the hospital
and pre-hospital markets. To date, the M Series is our best selling
defibrillator, representing more than 80% of our capital equipment device
sales in fiscal 2000. We plan to increase our profits in this segment by
doing the following:
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-- improving on the M Series platform by adding more optional
features and new technologies, which will increase revenues from
each M Series defibrillator sold with such features;
-- expanding our presence in both the domestic and international
markets by hiring additional salespeople; and
-- decreasing our cost of production for the M Series defibrillators
through improved engineering of the defibrillator and more
cost-effective manufacturing.
- ESTABLISH A PRE-EMINENT CLINICAL POSITION IN BIPHASIC DEFIBRILLATION. We
plan to capitalize on the industry-wide move towards biphasic waveforms. We
believe that this trend will give customers a compelling reason to replace
their monophasic defibrillators with biphasic defibrillators. Thus, we
expect that the size of the external defibrillator market will increase. We
are currently the only company to have received clearance from the FDA to
label our M Series biphasic defibrillators as clinically superior to
monophasic defibrillators for particular uses. We believe that the
demonstrated clinical superiority of our proprietary biphasic waveform will
offer a significant reason for customers to choose our biphasic
defibrillator over the biphasic defibrillators of our competitors. We
intend to capitalize on our clinically superior biphasic defibrillators to
allow us to capture a larger percentage of the growing external
defibrillator market.
-ENTER THE PUBLIC ACCESS DEFIBRILLATION MARKET WITH A WELL-DIFFERENTIATED
DEVICE. We are developing a device for the large and relatively
unpenetrated public access defibrillation market, also referred to as the
AED market. Our device will be relatively low-cost and easy to operate. We
believe we will be able to leverage our experience selling to EMS personnel
in our efforts to sell our device to police and fire departments. We also
intend to market our device to other non-traditional providers of care.
-SEEK ADDITIONAL GROWTH OPPORTUNITIES IN THE EMS DATA MANAGEMENT MARKET. We
believe that the market for EMS data management solutions is significant
and relatively unpenetrated. We are currently selling several products to
this market. We are developing an integrated dispatch, clinical
information, data collection, data transfer, billing and quality assurance
software solution for sale to the EMS market. We intend to leverage our
existing relationships with purchasing decision-makers in this market to
sell our data management solutions. We believe our software solution will
be differentiated by our ability to offer a complete data management
solution that incorporates the clinical information collected by our
defibrillators.
OVERVIEW OF SUDDEN CARDIAC ARREST AND RESUSCITATION THERAPIES
Sudden cardiac death results from the unresuscitated, sudden, abrupt loss
or disruption of heart function. This loss of heart function, also known as
sudden cardiac arrest, is caused by the heart beating too rapidly and/or
chaotically. The American Heart Association, or AHA, estimates that sudden
cardiac arrest claims more than 250,000 lives each year in the United States
alone, making it a leading cause of death in the United States. According to the
AHA, early defibrillation is the single most critical factor in rescuing a
victim of sudden cardiac arrest. Each minute of delay in returning the heart to
its normal pattern of beating decreases the chance of survival by 7% to 10%.
The Human Heart. The normal human heart has four chambers and expands and
contracts over 100,000 times each day. The two smaller, upper chambers are the
atria and the two larger, lower chambers are the ventricles. The walls of the
atria and the ventricles are made up of cardiac muscle which contracts
rhythmically when stimulated by an electrical current. Normally, the heartbeat
starts in the right atrium when a specialized group of cells sends an electrical
signal. This signal spreads though the atria and then
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moves to the ventricles. As a result, the atria contract a fraction of a second
before the ventricles. This exact pattern must be followed to ensure that the
heart beats properly. This contraction and relaxation of the four chambers pumps
blood to the lungs and the rest of a body.
Arrhythmias are abnormal rhythms of the heart caused by insufficient
circulation of oxygenated blood, drugs, electrical shock, mechanical injury,
disease or other causes. The three types of arrhythmias that our devices treat
are ventricular fibrillation, atrial fibrillation and bradycardia. It is
possible for a patient to experience more than one type of arrhythmia during a
sudden cardiac arrest. In these situations, it is important to have
resuscitation equipment that has both defibrillation and pacing capabilities.
Ventricular Fibrillation. Ventricular fibrillation is a condition in which
disordered electrical activity causes the ventricles to contract in a rapid,
unsynchronized and uncoordinated fashion. When this occurs, an insufficient
amount of blood is pumped from the heart. Ventricular fibrillation is the most
common arrhythmia that causes sudden cardiac arrest. The onset of ventricular
fibrillation often occurs without warning and causes the heart to stop abruptly.
This sudden stopping of the heart is known as cardiac arrest, and is the cause
of sudden cardiac death.
The only accepted treatment of ventricular fibrillation is defibrillation,
in which a powerful electric shock is delivered to the heart to stop the
fibrillation and permit the return of coordinated cardiac contractions. In
emergency situations, external defibrillation has conventionally been
administered through hand-held paddles placed on the patient's chest. However,
external defibrillation can also be administered through disposable adhesive
electrodes, which we believe are safer and easier to use than paddles.
Atrial Fibrillation. The AHA estimates that close to 2 million Americans
suffer from atrial fibrillation. Atrial fibrillation is a condition in which
disordered electrical activity causes the atria to contract in a rapid,
unsynchronized and uncoordinated fashion. This inefficient contraction results
in a smaller amount of blood entering the ventricles, which in turn results in
an insufficient level of circulation. Since blood is not pumped completely out
of the atria, the blood can pool and clot. While not immediately life
threatening, atrial fibrillation can lead to significant health threats such as
stroke. Over time, poorly functioning atria can also cause the ventricles to
work harder, wear out sooner and eventually lead to cardiac arrest.
Common forms of treatment for atrial fibrillation include cardioversion and
drug therapies. During cardioversion, a defibrillator delivers an electric shock
that is synchronized with a patient's heartbeat in order to return the atria to
a normal rhythm. Cardioversion is usually an elective therapy, scheduled and
performed in a controlled environment. All of our manual defibrillators include
cardioversion capability.
Bradycardia. Bradycardia is a condition in which the heart beats too
slowly. The principal therapies for the emergency treatment of bradycardia are
drugs and temporary cardiac pacing, either or both of which may be used to
stimulate effective cardiac contractions and restore circulation. Cardiac pacing
utilizes an electrical pulse to stimulate the patient's heartbeat. For the
emergency treatment of bradycardia, there are two primary techniques for
temporary pacing: invasive endocardial pacing, in which a wire is inserted
directly into the heart to provide the electrical stimulus; and noninvasive
temporary pacing, which uses gelled electrodes applied to the patient's chest to
conduct an electrical stimulus. Noninvasive temporary pacing is an option on
most of our defibrillators and is recommended as the first intervention for
bradycardia in the AHA's resuscitation protocols.
OUR CARDIAC RESUSCITATION PRODUCTS
M SERIES DEFIBRILLATORS
In September 1998, we shipped the first M Series defibrillators. The M
Series is a new line of defibrillators for both the hospital and pre-hospital
markets. For fiscal 2000, our M Series defibrillators represented over 80% of
our capital equipment device sales. The M Series defibrillator has quickly
become our best selling product to date and has been recently selected as the
standard device in such places as The Mayo Clinic,
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Scripps Health System, The Johns Hopkins Hospitals and the White House. We
believe the clinical superiority of our biphasic waveform combined with product
advantages including portability, ease-of-use and the vivid screen display offer
compelling reasons for customers to choose our M Series defibrillators. Our M
Series is a standardized platform that allows for expandable features. As a
result, we believe that this will help maximize customer retention by reducing
the need for operator retraining and enhancing operator confidence.
We believe that our standard M Series defibrillators offer the following
competitive advantages:
- PORTABILITY. The M Series defibrillator is the smallest, lightest
full-featured external defibrillator. It is approximately one-half the
weight and less than one-half of the size of the other leading devices
in this class. This allows M Series defibrillators to be easily used,
carried and transported with patients.
- EASE-OF-USE WITH SIMPLE CONTROLS. The M Series defibrillators enable
users to efficiently configure each unit, allowing local operating
preferences to be individually programmed into each unit.
Additionally, M Series defibrillators offer multiple language labeling
as well as multiple language voice prompts to meet both domestic and
international needs.
- VIVID SCREEN DISPLAY. One of the distinguishing features included in M
Series defibrillators is their high contrast screen. Our screen
incorporates the most technologically advanced defibrillator display
with a wider viewing angle than any LCD display.
The following chart summarizes the features of the M Series as
compared to the primary competitive products.
PRODUCT COMPARISONS
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ZOLL PHYSIO-CONTROL AGILENT (PHILLIPS)
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M SERIES LIFEPAK 12 HEARTSTREAM XL
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<S> <C> <C> <C>
SIZE 574 cubic in. 1680 cubic in. 1531 cubic in.
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WEIGHT 11 lbs. 22 lbs. 14 lbs.
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FUNCTIONS Multiple Multiple Limited
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12 LEAD Integrated Integrated Add-On
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The M Series defibrillators are designed to be upgradable, allowing
customers to add features depending upon their individual needs. The M Series
defibrillators use our unique pacing technology, which has been clinically shown
to provide superior capture rates, lower mean capture thresholds, less muscle
impact and better patient tolerance. The M Series defibrillators are also
available with our patented biphasic waveform. Some of the features that we
currently offer include:
- DIAGNOSTIC 12 LEAD ECG WITH INTERPRETIVE ALGORITHM. In October 1999,
we received clearance from the FDA to include the GE Marquette Medical
Systems 12SL analysis program, or 12 lead, in our M Series line of
defibrillators. The 12 lead feature enables a user to see a diagnostic
electrocardiogram, or ECG, tracing consisting of 12 leads, or views,
of the heart's electrical activity. 12 lead is used to provide rapid
and early identification of myocardial infarction, commonly called a
heart attack, in the pre-hospital setting. We pay royalties on each
12SL analysis program we sell.
- PULSE OXIMETRY. Pulse oximeters determine the oxygen saturation levels
in blood, allowing a rapid identification of potential problems in the
cardiopulmonary system. Since pulse oximeters can help
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detect the onset of cardiovascular incidents, pulse oximetry is now
widely used in both hospital and pre-hospital settings when monitoring
patients' vital signs. While conventional pulse oximeters do not
perform well in motion or in intense light, we use Masimo
Corporation's patented technology that is designed to overcome these
technical problems. We have received 510(k) clearance to incorporate
this pulse oximetry technology into our M Series defibrillators. The
new pulse oximetry technology adds a new monitoring parameter that is
essential during the transport and monitoring of critical patients. We
purchase circuit boards and sensors from Masimo Corporation. We have a
non-exclusive license to use the patented technology incorporated in
these parts that we then incorporate into our products.
- CODE MARKERS WITH COMPLETE DATA MANAGEMENT. Our new code marker system
follows protocols established by the AHA and allows complete
documentation of an event with our unique "one touch" data annotation
feature. The record made of the event includes all information
collected by the defibrillator and can be upgraded to include an
optional voice recording. All of this data is stored on a removable
data card.
- CAPNOGRAPHY. Capnography, also known as EtCO(2), is the measurement of
the amount of carbon dioxide being exhaled, allowing for rapid
identification of potential problems in the cardio-pulmonary system.
We purchase circuit boards and sensors from Novametrix Medical Systems
Inc. to provide this feature and received 510(k) clearance to
incorporate EtC0(2) into our M Series defibrillators.
- NONINVASIVE BLOOD PRESSURE MEASUREMENT. We developed a noninvasive
blood pressure, also known as NiBP, measurement capability and
integrated it into our M Series defibrillators. The technology
encompassing this product is licensed from a third party. We have
received 510(k) clearance to incorporate NiBP into our M Series
defibrillators and began shipments in December 2000.
BIPHASIC WAVEFORM
External defibrillators deliver current over time to the heart, which
results in a defined waveform shape. The waveform in general use today is
monophasic, meaning that current is delivered in a single pulse that flows in
one direction. A biphasic waveform, in contrast, delivers current that first
flows in a positive direction for a period of time and then reverses direction
so that it flows in a negative direction. Typical biphasic waveforms such as
those used by our competitors appear to achieve the same defibrillation success
rates as monophasic waveforms but at significantly lower current levels. Since
less current is used, potential injury to the heart and skin is reduced with a
biphasic shock compared to a monophasic shock. All of the major manufacturers of
external defibrillators are beginning to produce devices that use biphasic
waveforms.
Biphasic waveforms are the first major advance in defibrillation technology
since the current monophasic waveform was adopted in the early 1960's. Although
there have been feature enhancements that make new monophasic defibrillators
easier to use and maintain, they have not proven to make defibrillators more
clinically effective or safer and thus have not rendered the older models
obsolete. At present, users generally replace existing defibrillators for
mechanical and other reasons unrelated to any clinical superiority of a new
defibrillator. Based on our sales and marketing experience, we estimate that
users replace defibrillators after approximately seven to ten years of service.
In light of the demonstrated clinical superiority of biphasic technology,
however, we believe that the introduction of biphasic waveforms could accelerate
the replacement of the large installed base of monophasic defibrillators. We
believe this accelerated replacement will increase the size of the market for
our defibrillators.
OUR BIPHASIC WAVEFORM
Our two primary competitors offer biphasic waveforms using the same general
shape. We have developed a uniquely shaped biphasic waveform, however, which
achieves higher efficacy at lower current levels than monophasic waveforms. We
have received clearance from the FDA to market this new technology. Our new
biphasic waveform reduces the heart's exposure to high peak current. In
addition, our biphasic waveform
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keeps the waveform shape and duration constant over a wide range of patients
whose differing physiologies impact the transmittal of current. Our M Series
defibrillator equipped with our biphasic waveform is the only device cleared by
the FDA to be labeled clinically superior to monophasic defibrillators for
conversion of ventricular fibrillation in high-impedance patients, those
patients who are difficult to defibrillate, and for cardioversion of atrial
fibrillation. We therefore believe that our proprietary biphasic waveform is
superior to the biphasic waveform utilized by any of our competitors. Moreover,
we are able to achieve the highest reported efficacy with lower current levels
than utilized by our competitors. We believe that our proprietary biphasic
waveform will offer compelling clinical benefits that should give customers a
reason to choose our biphasic defibrillators over those of our competitors.
We have sponsored two clinical trials that have demonstrated that our
proprietary biphasic waveform provides improved efficacy compared to
conventional monophasic waveforms. In a randomized study for ventricular
fibrillation of 184 patients, our biphasic waveform converted 99% of patients on
the first shock compared to 93% of patients converted with the monophasic
waveform. This compares favorably with the results obtained by other parties in
similar trials. These studies also showed that our waveform required less than
half the current for converting ventricular and atrial fibrillation than the
conventional monophasic waveform.
A second randomized trial of 165 patients compared the efficacy of our
biphasic waveform to a conventional monophasic waveform for cardioversion of
atrial fibrillation. Our investigators reported a 68% first shock efficacy for
our waveform compared to just 21% for a conventional monophasic waveform.
Overall, 94% of the patients randomized to our biphasic waveform were
successfully cardioverted as compared to 79% of the patients treated with a
monophasic waveform. To our knowledge, no other competitor has published results
relating to their biphasic waveform in atrial fibrillation.
We have received seven U.S. patents covering various aspects of our novel
biphasic waveform technology. Several corresponding foreign patents are still
pending.
DISPOSABLE ELECTRODES
We offer a variety of single-patient-use, proprietary disposable electrodes
for use with our resuscitation devices. Among our primary competitors, we are
the only company to engineer and manufacture our own electrodes. We have
continually innovated and upgraded our electrode product line, and in 1999 we
introduced pro-padz(TM) Cardiology Specialty Multi-function Electrodes that
utilize a new conductive liquid gel to carry the energy from a conductive plate
to the patient. Our sales of electrodes in the North American market grew 17%
from 1998 to 1999 and 8% from 1999 to 2000. Our margins for electrodes are
generally higher than our margins for devices. We hope to sell more disposable
electrodes in the future as more customers recognize the benefits of electrodes,
which are safer for an operator of a defibrillator than traditional paddles.
Another factor that might lead to higher electrode sales is the use of
interpretive algorithms for automated defibrillation. The monitoring required to
assess the patient's condition can only be achieved with electrodes and not with
the traditional defibrillation paddles. Accordingly, we believe that the
defibrillator industry is moving toward a greater relative use of electrodes.
OTHER EXTERNAL DEFIBRILLATORS/PACEMAKERS
We also manufacture and sell four other product lines of portable and
stand-alone defibrillators with advisory capability, semi-automatic and manual
operation as well as ancillary accessories and chargers.
MARKET OVERVIEW
We divide the market for noninvasive cardiac resuscitation equipment into
three principal markets: the hospital, pre-hospital and public access
defibrillation markets. The hospital market consists of doctors, nurses
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and other medical personnel who use defibrillators in a hospital setting. The
pre-hospital market consists of care providers such as paramedics, ambulance
operators, emergency medical technicians, medically-trained firefighters and
other "first response" emergency medical personnel. The public access
defibrillation market includes non-traditional providers such as police,
non-medically trained firefighters, security officers, and other non-medically
trained first responders. We estimate that the size of the worldwide market for
external defibrillator products was approximately $580 million in 2000.
OUR CURRENT MARKET
U.S. Hospital Market. The U.S. hospital market consists of approximately
6,000 acute care community hospitals and 1,000 additional hospitals. Presently,
Zoll defibrillators are used at each of the top 12 cardiac hospitals in the
United States as listed by U.S. News and World Report in July 2000.
Hospitals have traditionally been the largest users of cardiac
resuscitation equipment, both for patients admitted with sudden cardiac arrest
and for patients at risk of sudden cardiac arrest undergoing other treatments.
Many hospital procedures such as surgery, cardiac catheterization, stress
testing and general anesthesia may induce arrhythmias or sudden cardiac arrest,
and hospitals frequently use cardiac resuscitation devices on a standby basis in
connection with these procedures. Since immediate treatment is the critical
factor for successful cardiac resuscitation, hospitals typically place
resuscitation devices throughout their facilities, including the cardiac and
critical care units, emergency rooms, operating rooms, electrophysiology
laboratories and, increasingly, general wards. Hospitals also use portable
devices during in-hospital transportation of cardiac patients.
We believe that the M Series defibrillators have allowed us to
significantly increase our market share in the U.S. hospital market. Our
revenues in the capital equipment device market in 2000 increased at a rate of
37% compared to the market's growth which we estimate to be between 3% and 5%.
We hope to capitalize on the success of our M Series defibrillators to further
expand our share of the U.S. hospital market.
U.S. Pre-hospital Market. Most sudden cardiac arrests and heart attacks
occur outside of the hospital. Due to the importance of immediate treatment,
there is a substantial market for portable cardiac resuscitation equipment
designed for use by various emergency responders. The most highly trained
segment of the pre-hospital market is comprised of paramedics, who are all
authorized and trained to use defibrillators to treat sudden cardiac arrest. In
addition, paramedics are becoming increasingly aware of external pacing as a
standard of care for the treatment of bradycardia. We believe that as
noninvasive temporary pacing becomes more widely accepted in the hospital
market, the use of combination pacemakers/defibrillators will become more
widespread in the pre-hospital setting as well. Paramedics are also able to use
more advanced diagnostics, such as diagnostic 12 lead. Emergency medical
technicians, who are authorized to use automated external defibrillators,
comprise a significant portion of the potential pre-hospital market as well.
We believe the opportunity for growth in the underpenetrated pre-hospital
market is large. Presently, approximately 60% of the estimated 35,000 ambulances
in the United States are equipped with defibrillators. We believe that the
percentage of ambulances equipped with defibrillators will grow, and that
ambulances and other first response emergency vehicles will represent an
increasingly important market for cardiac resuscitation equipment as the medical
community places increased priority on providing such equipment and the
necessary training to all first responders. Additionally, we believe that growth
of our sales in the pre-hospital market has been constrained in the recent past
due to the absence of 12 lead technology in our defibrillators. With our recent
introduction of diagnostic 12 lead in the M Series defibrillators, we intend to
increase our sales in the pre-hospital market and take greater market share
within the paramedic segment of the pre-hospital market.
International Market. The international market for defibrillators is less
developed than the market in the United States. In some international markets,
unlike the U.S. market, the administration of pacing and defibrillation in
hospitals is generally viewed as a skill reserved for physicians. Few other
staff members are
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trained to administer such treatment, although this is slowly beginning to
change. The international market for defibrillators for use outside of hospitals
varies considerably from country to country and is somewhat less developed than
the market in North America.
We believe that the international market for defibrillators will grow for a
number of reasons.
- The international hospital market for defibrillators is expected to
grow as more hospitals are built and existing hospitals modernize and
update their approaches to cardiac and emergency care.
- Emerging standards of care and the acceptance of automated equipment
could result in increased use of cardiac resuscitation equipment by a
broader range of health care personnel in the international market.
- The European Resuscitation Council, the British Heart Foundation and
virtually all cardiac- oriented organizations in Europe as well as the
Australian Resuscitation Council have strongly supported initiatives
to expand the availability of defibrillators as a major public health
initiative.
- External pacing is used much less frequently in Europe and other parts
of the world than it is in the United States, but many countries are
beginning to implement cardiac life support protocols which
incorporate external pacing as a standard component. Because most
international defibrillators do not presently feature external pacing,
the move to defibrillators with external pacing could drive the
international demand for defibrillators generally.
We believe that we are positioned to take advantage of the growth in the
international market for defibrillators, based on the recent success of the M
Series defibrillators, our superior biphasic waveform, and the multiple language
and other capabilities of the M Series defibrillators.
We believe that there are significant opportunities to increase sales in
the international market through the use of direct sales. Historically, we have
used distributors instead of a direct sales force to sell our products
internationally. We believe using a direct sales force could increase our
revenues and market share in many countries. For example, we doubled our sales
in the United Kingdom in 1999, which we believe was at least partially due to
the efforts of our direct sales force established four years ago. In addition,
Germany, which is second only to the United States in market size, may be a
strong market for future growth. We have established a direct sales force in
Germany and expect to expand this sales force in the coming year. In addition,
we have begun to fulfill our largest sales contract ever, a multi-year agreement
with the German Army to supply up to 1,500 defibrillators. We intend to further
expand our direct selling efforts in the coming years.
OUR MARKET OPPORTUNITIES
PUBLIC ACCESS DEFIBRILLATION USING AEDS
Public access defibrillation, or PAD, involves providing low cost automated
external defibrillators, or AEDs, to persons outside a hospital setting who are
not medically trained. Automated defibrillators use an algorithm to determine if
a patient's heart requires defibrillation and prompt the operator to deliver the
shock. Although we presently offer AEDs in the hospital and pre-hospital
markets, we are seeking to develop a low cost AED specifically targeted to the
needs of the PAD market. Traditionally, defibrillators have only been used by
personnel in hospitals and trained emergency medical service personnel in the
pre-hospital market. As mentioned above, time from onset of sudden cardiac
arrest to defibrillation is the most important factor in successfully treating
sudden cardiac arrest. Victims are likely to die if they are not defibrillated
within four to eight minutes of the onset of sudden cardiac arrest. This need
for immediate treatment of cardiac arrest suggests that if more automated
defibrillators can be deployed outside of the hospital setting, the likelihood
of defibrillating a victim in the critical time frame will increase. Potential
customers for such devices in this
<PAGE> 10
broad market include police and fire departments, office buildings and any other
location where a large number of people congregate. Ultimately, AEDs could be
marketed to private homes, where approximately 70% of cardiac arrests occur. In
addition, we expect that demand for AEDs could increase as public awareness of
the time constraints inherent in treating cardiac arrest grows and as more AEDs
are introduced into highly visible, public places.
Some of our competitors offer cardiac resuscitation equipment in the PAD
market. We have not yet entered the PAD market due to its early stage of
development and the high selling costs inherent to such a market. We do not
believe the current AED manufacturers have generated significant profitable
operations from the PAD market in the past. We believe, however, that this
market is now expanding to the point where AEDs can be profitably sold. More
distributors are requesting and selling AEDs. In addition, the recent passage of
federal good samaritan legislation increases the likelihood that non-medically
trained personnel will be providing care to victims of sudden cardiac arrest.
Good samaritan legislation generally protects persons who render emergency
assistance to others from liability for negligence in connection with their
rendering of assistance. At least one state, Massachusetts, has amended its good
samaritan law to specifically cover the use of AEDs by the general public. In
addition, the AHA has begun to actively advocate PAD as a critical link in the
"Chain of Survival," which refers to the four crucial links in the treatment of
cardiac arrest. The AHA and virtually all corresponding international
organizations have established programs to try to bring early defibrillation to
every community. Early defibrillation is now included in AHA CPR training for
all healthcare personnel and some lay persons. We believe that these
developments, together with the introduction of AEDs in highly visible places,
will lead to a larger market for AEDs.
Because we expect the PAD market to mature, we intend to produce and sell
low-cost AEDs in this market. We estimate that in calendar year 2000 the market
for low-cost AEDs will exceed $63 million. We expect to introduce our low-cost
AED during calendar 2001. The device will monitor the patient's ECG and
automatically prompt the operator throughout the defibrillation process. We
intend to use a direct sales force to sell our AEDs wherever it proves cost
effective to do so, and will sell through alternate distribution, such as
distributors or manufacturers' representatives, in those markets that are too
small to support a direct sales force. In addition, we expect that this market
can be serviced by other alternative distribution methods, such as e-commerce,
that can supplement and reduce our need for an expensive sales force. We also
intend to use our experience of selling to emergency medical service personnel
in our future efforts to sell AEDs to police and fire departments.
EMS DATA MANAGEMENT SOLUTIONS
We are developing a product called RescueNet(TM) to address what we
consider to be a growing need in the EMS market for an integrated data
management system. RescueNet(TM) will combine existing technologies developed by
two of our subsidiaries with data collected from our cardiac resuscitation
devices. This will allow our customers to purchase a single data management
system that integrates dispatch, resuscitation information, data collection,
data transfer, billing and quality assurance functions. Today, most EMS data is
entered by hand on clipboards and then distributed or reentered manually into
databases or to meet regulatory and insurance reporting requirements. The
timeliness, accuracy and efficiency of this process is a key factor in the
receipt of payments from third party payors. Nevertheless, a significant amount
of revenue is lost due to data entry errors, misplaced paperwork or data, and
additional time is lost duplicating data entries. As a result, we believe that
the market for electronic field data collection is significant and relatively
unpenetrated. Of the estimated 35,000 ambulances in the United States today, we
estimate that less than 5,000 of them have any type of computer in place for the
routine entry of data. Based upon our experience market interest in electronic
field data collection is very high in part because EMS organizations are
increasingly pressured to become more efficient.
Using RescueNet(TM), caller information collected by the dispatcher would
first be organized and compared to existing databases in the system. Almost
immediately, useful information on the patient such as the patient's previous
medical history, the closest ambulance to the patient's address, the patient's
insurance numbers from previous service, and the patient's personal physician
would be provided to the ambulance or EMS system
<PAGE> 11
through the use of wireless communications and radio links that already exist in
most EMS systems. Data collected by EMS personnel on the road, including simple
data such as arrival time at a scene or transport time to the hospital, as well
as clinical data derived from our defibrillators such as the number of shocks
given, when those shocks were given and at what energy levels, could be
immediately shared via wireless connection with the hospital to which the
patient is being brought. Information regarding services provided to the patient
could be stored electronically for billing and record-keeping purposes. Such
seamless information sharing would allow for better integration of information
with the dispatcher and with the hospital to which the patient is being
transported, while eliminating duplicative information collection.
Ease-of-use and the need for efficiency in the use of information in
billing, case review, training and operations analysis are the fundamental
factors that we believe could drive the market for an integrated data management
system in the pre-hospital market. Although we plan to sell RescueNet(TM)
through a dedicated sales force, we intend to utilize our existing relationships
with purchasing decision-makers in the EMS market who have purchased our
defibrillators in the past and to obtain sales efficiencies and synergies
through cross-selling.
Our competition in dispatch, billing and mobile computing solutions
consists of mostly smaller software companies. We believe we have a competitive
advantage over other software companies due to our familiarity with the
information collected and stored by our defibrillators. Our ability to analyze,
store and retrieve this clinically important data could make our electronic
field data collection products more attractive.
We expect that the EMS data management business will be a significant part
of our long-term growth strategy. We believe that this market could expand
rapidly and that we are particularly well-positioned to become a significant
competitor in this business.
COMPETITION
Our principal competitors in the United States are Physio-Control
Corporation and Agilent Technologies, Inc. Physio-Control is a subsidiary of
Medtronic, Inc., a leading medical technology company, and Agilent, which now
includes Heartstream, Inc., whose Healthcare Solutions Group is currently in the
process of being acquired by Royal Phillips Electronics. Both Physio-Control and
Agilent compete across our entire defibrillator product line. We also compete
with Medical Research Labs, Inc. and SurVivaLink, Inc. in specific geographic
areas and markets. In the international market we compete with both
Physio-Control and Agilent, as well as approximately 12 other companies
depending upon the country. Physio-Control is generally the market leader in the
industry.
We believe that the principal competitive factors in the hospital market
for cardiac resuscitation equipment are clinical efficacy, reliability,
portability, ease-of-use and standardization. In the pre-hospital market, in
addition to the foregoing considerations, durability, a reliable battery system,
and availability of 12 lead ECG capability are significant competitive factors.
We believe that our products compete favorably with respect to each of these
factors. Noninvasive temporary pacemakers and external defibrillators, such as
those we sell, are used in emergency situations and, accordingly, do not compete
with permanent, implantable pacemakers or defibrillators that are used to treat
chronic arrhythmias. In fact, the products are complementary, because emergency
cardiac resuscitation is often required during the implantation of a permanent
device.
The business of developing and marketing software for data collection,
billing and management in the EMS market is competitive. Competitors in this
business include PAD Systems, Healthware Technologies, Inc., Tritech Software
Systems, Sweet Computer Services, Inc., RAM Software Systems, Inc., Intergraph
Corporation and AmbPac, Inc. None of these competitors currently have a product
that provides an integrated solution comparable to the RescueNet(TM) product
currently in development.
RESEARCH AND DEVELOPMENT
<PAGE> 12
Our research and development strategy is to improve and expand our product
line through the application of our proprietary technology to both devices and
electrodes. We pursue a multi-disciplinary approach to product design. We are
currently focusing our research and development program in mechanical, software
and electronic engineering, including both digital (microprocessor) and analog
(high voltage) design. We hope to develop an inexpensive, easy-to-operate AED
for the PAD market. We are also seeking to expand the M Series features and
parameters and to develop further efficiencies in our M Series production,
leading to lower costs. In addition, we are continuing our work on the
development of the RescueNet(TM) product.
MANUFACTURING
Our facilities are located in Burlington, Massachusetts and Pawtucket,
Rhode Island. Our executive headquarters are located at the Burlington facility,
where we also conduct our device manufacturing operations and all of our
research and development other than electrode and EMS data management research
and development. We generally assemble our devices from components produced to
our specifications by our suppliers. We own a 33,000 square foot building in
Rhode Island, where we manufacture our electrode products and conduct related
research and development. We own a 17,500 square foot building in Boulder,
Colorado where our data management software business offices are located. We
lease approximately 90,000 square feet of office and assembly space in
Burlington under a lease expiring in August 2003, and 2,685 square feet of
office space in Vancouver, British Columbia, under a lease expiring in 2002. We
also have administrative offices in Manchester, England, Dodewaard, The
Netherlands, Cologne, Germany, and in Mississauga, Canada.
PATENTS AND PROPRIETARY INFORMATION
Seven U.S. patents have now been issued covering various aspects of our
unique biphasic waveform technology. Several corresponding foreign patents
relating to this waveform technology are still pending.
During fiscal 1999, we filed several U.S. and foreign patent applications
covering novel technology related to our pacing and defibrillation electrodes.
These patents supplement other electrode patents issued in the United States,
Europe and Japan.
A number of U.S. patents covering technologies incorporated into our other
products have been issued. Foreign patents related to some of these technologies
are pending.
EMPLOYEES
As of September 30, 2000, we employed 524 people on a full-time basis, 491
in the United States and 33 internationally. We also employed 15 part-time
employees. None of our employees are subject to collective bargaining
agreements. We believe that our relations with our employees are excellent.
MARKETING AND SALES
We use a direct sales force in the United States. In 1998, we split our
sales force into dedicated groups, focused on the hospital and pre-hospital
markets. Our total sales force has increased by 20% in each of the last three
fiscal years. We sell our RescueNet(TM) product through a separate dedicated
sales force. In the United States, we currently have 59 sales representatives
calling on hospitals, 44 calling on pre-hospital accounts and 6 selling our data
management products. We have 7 sales representatives in Canada, 4 in the United
Kingdom and 5 in Germany.
<PAGE> 13
GOVERNMENT REGULATION
The manufacture and sale of our products are subject to extensive
regulation by numerous governmental authorities, principally by the FDA and
corresponding foreign agencies. The FDA administers the Federal Food, Drug and
Cosmetic Act and the regulations promulgated thereunder. We are subject to the
standards and procedures with respect to the manufacture of medical devices and
are subject to inspection by the FDA for compliance with such standards and
procedures.
The FDA classifies medical devices into one of three classes depending on
the degree of risk associated with each medical device and the extent of control
needed to ensure safety and effectiveness. Our manual defibrillation and pacing
products have been classified by the FDA as Class II devices. Our AED products
have been classified as Class III devices. These devices must secure either a
510(k) pre-market notification clearance or an approved pre-market approval
application before they can be introduced into the United States market. The
process of obtaining 510(k) clearance typically takes several months and may
involve the submission of limited clinical data supporting assertions that the
product is substantially equivalent to another medical device on the market
prior to 1976. The pre-market approval process typically requires substantially
more time than does 510(k) clearance and requires the submission of significant
quantities of clinical data and supporting information.
Every company that manufactures or assembles medical devices is required to
register with the FDA and to adhere to certain "good manufacturing practices
(per the FDA's Quality System Regulation)" which regulate the manufacture of
medical devices and prescribe record keeping procedures and provide for the
routine inspection of facilities for compliance with such regulations. The FDA
also has broad regulatory powers in the areas of clinical testing, marketing and
advertising of medical devices.
Medical device manufacturers are routinely subject to periodic inspections
by the FDA. If the FDA believes that a company may not be operating in
compliance with applicable laws and regulations, it can:
- place the company under observation and reinspect the facilities;
- issue a warning letter apprising of violative conduct;
- detain or seize products;
- mandate a recall;
- enjoin future violations; and
- assess civil and criminal penalties against the company, its officers
or its employees.
We are also subject to regulation in each of the foreign countries in which
we sell our products. Many of the regulations applicable to our products in such
countries are similar to those of the FDA. However, the national health or
social security organizations of certain countries require our products to be
qualified before they can be marketed in those countries.
RISK FACTORS
IF WE FAIL TO COMPETE SUCCESSFULLY IN THE FUTURE AGAINST EXISTING OR POTENTIAL
COMPETITORS, OUR OPERATING RESULTS MAY BE ADVERSELY AFFECTED
Our principal global competitors with respect to our entire cardiac
resuscitation equipment product line are Physio-Control Corporation and
Agilent Technologies, Inc. Physio-Control is a subsidiary of Medtronic,
Inc., a leading medical technology company, and Agilent, which includes
Heartstream, Inc., whose Healthcare Solutions Group is currently in the
process of being acquired by Royal Phillips Electronics. Physio-Control
<PAGE> 14
has been the market leader in the defibrillator industry for over twenty
years and has a broader line of product offerings and accessories than we
do. As a result of Physio-Control's dominant position in this industry,
many potential customers have relationships with Physio-Control that could
make it difficult for us to continue to penetrate the markets for our
products. In addition, Physio-Control, its parent and Agilent and other
competitors each have significantly greater resources than we do.
Accordingly, Physio-Control, Agilent and other competitors could
substantially increase the resources they devote to the development and
marketing of products that are competitive with ours. Moreover, these and
other competitors may develop and successfully commercialize medical
devices that directly or indirectly accomplish what our products are
designed to accomplish in a superior and/or less expensive manner. For
example, we expect our competitors to develop and sell devices in the
future that will compete directly with our M Series product line and our
biphasic waveform technology. As a consequence, such competing medical
devices may render our products obsolete.
In addition to external defibrillation and external pacing with cardiac
resuscitation equipment, it is possible that other alternative therapeutic
approaches to the treatment of sudden cardiac arrest may be developed.
These alternative therapies or approaches, including pharmaceutical or
other alternatives, could prove to be superior to our products.
Moreover, there is significant competition in the business of developing
and marketing software for data collection, billing and data management in
the emergency medical system market. Our principal competitors in this
business include PAD Systems, Healthware Technologies, Inc., Tritech
Software Systems, Inc., Sweet Computer Services, Inc., RAM Software
Systems, Inc., Intergraph Corporation and AmbPac, Inc., some of which have
greater financial, technical, research and development and marketing
resources than we do. In addition, because the barriers to entry in this
business are relatively low, additional competitors may easily enter this
market in the future. It is possible that systems developed by competitors
could be superior to our data management system. Consequently, our ability
to sell our data management system could be materially impacted and our
financial results could be materially and adversely affected.
OUR OPERATING RESULTS ARE LIKELY TO FLUCTUATE WHICH COULD CAUSE OUR STOCK PRICE
TO BE VOLATILE, AND THE ANTICIPATION OF A VOLATILE STOCK PRICE CAN CAUSE GREATER
VOLATILITY
Our quarterly and annual operating results have fluctuated and may continue
to fluctuate. Various factors have and may continue to affect our operating
results, including:
o high demand for our products which could disrupt our normal
factory utilization and cause shipments to occur in uneven
patterns;
o variations in product orders;
o timing of new product introductions;
o temporary disruptions on buying behavior due to changes in
technology (e.g. shift to biphasic technology)
o changes in distribution channels;
o actions taken by our competitors such as the introduction of new
products or the offering of sales incentives;
o the ability of our sales force to effectively market our
products;
o supply interruptions from our single source vendors;
o regulatory actions, including actions taken by the U.S. Food and
Drug Administration; and
<PAGE> 15
o delays in obtaining domestic or foreign regulatory approvals.
Based on these factors, period-to-period comparisons should not be relied
upon as indications of future performance. In addition, in anticipation of
less successful quarterly results, parties may take short positions in our
stock. The actions of parties shorting our stock might cause even more
volatility in our stock price. The volatility of our stock may cause the
value of a stockholder's investment to decline rapidly.
WE MAY BE REQUIRED TO IMPLEMENT A COSTLY PRODUCT RECALL
In the event that any of our products proves to be defective, we can
voluntarily recall, or the U.S. Food and Drug Administration, the FDA,
could require us to redesign or implement a recall of, any of our products.
We and our competitors have voluntarily recalled products in the past, and
based on this experience, we believe that future recalls could result in
significant costs to us and significant adverse publicity which could harm
our ability to market our products in the future. Though it is not possible
to quantify the economic impact of a recall, it could have a material
adverse effect on our business, financial condition and results of
operations.
WE CAN BE SUED FOR PRODUCING DEFECTIVE PRODUCTS AND WE MAY BE REQUIRED TO PAY
SIGNIFICANT AMOUNTS TO THOSE HARMED IF WE ARE FOUND LIABLE, AND OUR BUSINESS
COULD SUFFER FROM ADVERSE PUBLICITY
The manufacture and sale of medical products such as ours entail
significant risk of product liability claims. Our quality control standards
comply with FDA requirements and we believe that the amount of product
liability insurance we maintain is adequate based on past product liability
claims in our industry. We cannot assure you, however, that the amount of
such insurance will be sufficient to satisfy claims made against us in the
future or that we will be able to maintain insurance in the future at
satisfactory rates or in adequate amounts. Product liability claims could
result in significant costs or litigation. In addition, a successful claim
brought against us in excess of our available insurance coverage or any
claim that results in significant adverse publicity against us could have a
material adverse effect on our business, financial condition and results of
operations.
OUR DEPENDENCE ON SOLE AND SINGLE SOURCE SUPPLIERS EXPOSES US TO SUPPLY
INTERRUPTIONS THAT COULD RESULT IN PRODUCT DELIVERY DELAYS AND SUBSTANTIAL COSTS
TO REDESIGN OUR PRODUCTS
Although we use many standard parts and components for our products, some
key components are purchased from sole or single source vendors for which
alternative sources are not currently readily available. For example, we
currently purchase proprietary components, including capacitors, screens,
gate arrays and integrated circuits, for which there are no direct
substitutes. Our inability to obtain sufficient quantities of these
components may result in future delays or reductions in product shipments
which could cause a fluctuation in our results of operations.
These components could be replaced with alternatives from other suppliers,
which could involve a redesign of our products. Such redesign could involve
considerable time and expense. For example, in 1999, one of our vendors was
unable to provide sufficient quantities of screens that were used in our M
Series products. To keep up with the demand for our products, we sought
alternative screens from another supplier and redesigned our product
accordingly. Redesigning our products resulted in additional costs and
delays in the shipment of some of our products. Although we believe we have
solved this supply problem, we cannot assure you that we will not have
similar supply problems in the future.
OUR RELIANCE ON INDEPENDENT MANUFACTURERS CREATES SEVERAL RISKS THAT COULD
RESULT IN PRODUCT DELIVERY DELAYS, INCREASED COSTS AND OTHER ADVERSE EFFECTS ON
OUR BUSINESS
We currently engage a small number of independent manufacturers to
manufacture several components for our products, including circuit boards,
molded plastic components, cables and high voltage assemblies. Our
<PAGE> 16
reliance on these independent manufacturers involves a number of risks,
including the potential for inadequate capacity, unavailability of, or
interruptions in access to, process technologies, and reduced control over
delivery schedules, manufacturing yields and costs.
If our manufacturers are unable or unwilling to continue manufacturing our
components in required volumes, we will have to transfer manufacturing to
acceptable alternative manufacturers whom we have identified, which could
result in significant interruptions of supply. Moreover, the manufacture of
these components is complex, and our reliance on the suppliers of these
components exposes us to potential production difficulties and quality
variations, which could negatively impact the cost and timely delivery of
our products. Accordingly, any significant interruption in the supply, or
degradation in the quality, of any component would have a material adverse
effect on our business, financial condition and results of operations.
FAILURE TO PRODUCE NEW PRODUCTS OR OBTAIN MARKET ACCEPTANCE FOR OUR NEW PRODUCTS
IN A TIMELY MANNER COULD HARM OUR BUSINESS
Because substantially all of our revenue comes from the sale of cardiac
resuscitation devices and related products, our financial performance will
depend upon market acceptance of, and our ability to deliver and support,
new products such as upgrades to the M Series defibrillator, a product for
the public access defibrillation market and an integrated product for the
emergency medical system data management market. We cannot assure you that
we will be able to produce viable products in the time frames we currently
estimate. Factors which could cause delay in these schedules or even
cancellation of our projects to produce and market these new products
include research and development delays, the actions of our competitors
producing competing products and the actions of other parties who may
provide alternative therapies or solutions which could reduce or eliminate
the markets for pending products.
The degree of market acceptance of any of our products will depend on a
number of factors, including:
o our ability to develop and introduce new products in the time
frames we currently estimate;
o our ability to successfully implement new product technologies;
o the market's readiness to accept new products such as our M
Series defibrillators and data management products;
o the standardization of an automated platform for data management
systems;
o having adequate financial and technical resources for future
product development and promotion;
o the efficacy of our products; and
o the prices of our products compared to the prices of our
competitors' products.
If our new products do not achieve market acceptance, our financial
performance will be adversely affected.
WE MAY NOT BE ABLE TO OBTAIN APPROPRIATE REGULATORY APPROVALS FOR OUR NEW
PRODUCTS
The manufacture and sale of our products are subject to regulation by
numerous governmental authorities, principally the FDA and corresponding
state and foreign agencies. The FDA administers the Federal Food, Drug and
Cosmetic Act, as amended, and the rules and regulations promulgated
thereunder. Some of our products have been classified by the FDA as Class
II devices and others, such as our automated external defibrillators, have
been classified as Class III devices. All of these devices must secure
either a 510(k) pre-market notification clearance or an approved pre-market
approval application before they can be introduced
<PAGE> 17
into the U.S. market. The process of obtaining 510(k) clearance typically
takes several months and may involve the submission of limited clinical
data supporting assertions that the product is substantially equivalent to
another medical device on the market prior to 1976. The pre-market approval
process typically requires substantially more time than does 510(k)
clearance and requires the submission of significant quantities of clinical
data and supporting information. Delays in obtaining either 510(k), or if
necessary, pre-market approval clearance could have an adverse effect on
the introduction of future products. Moreover, approvals, if granted, may
limit the uses for which a product may be marketed, which could reduce or
eliminate the commercial benefit of manufacturing any such product.
We are also subject to regulation in each of the foreign countries in which
we sell products. Many of the regulations applicable to our products in
such countries are similar to those of the FDA. However, the national
health or social security organizations of certain countries require our
products to be qualified before they can be marketed in those countries. We
cannot assure you that such clearances will be obtained.
IF WE FAIL TO COMPLY WITH APPLICABLE REGULATORY LAWS AND REGULATIONS, THE FDA
COULD EXERCISE ANY OF ITS REGULATORY POWERS THAT COULD HAVE A MATERIAL ADVERSE
EFFECT ON OUR BUSINESS
Every company that manufactures or assembles medical devices is required to
register with the FDA and to adhere to certain good manufacturing
practices, which regulate the manufacture of medical devices and prescribe
record keeping procedures and provide for the routine inspection of
facilities for compliance with such regulations. The FDA also has broad
regulatory powers in the areas of clinical testing, marketing and
advertising of medical devices. To ensure that manufacturers adhere to good
manufacturing practices, medical device manufacturers are routinely subject
to periodic inspections by the FDA. If the FDA believes that a company may
not be operating in compliance with applicable laws and regulations, it
could take any of the following actions:
o place the company under observation and reinspect the facilities;
o issue a warning letter apprising of violative conduct;
o detain or seize products;
o mandate a recall;
o enjoin future violations; and
o assess civil and criminal penalties against the company, its
officers or its employees.
We, like most of our U.S. competitors, have received warning letters from
the FDA in the past, and may receive warning letters in the future. We have
always complied with the warning letters we have received. However, our
failure to comply with FDA regulations could result in sanctions being
imposed on us, including restrictions on the marketing or recall of our
products. These sanctions could have a material adverse effect on our
business.
WE ARE DEPENDENT UPON LICENSED AND PURCHASED TECHNOLOGY FOR UPGRADEABLE FEATURES
IN OUR PRODUCTS, AND WE MAY NOT BE ABLE TO RENEW THESE LICENSES OR PURCHASE
AGREEMENTS IN THE FUTURE
We license and purchase technology from third parties for upgradeable
features in our products, including 12 lead analysis program and pulse
oximetry technologies. We anticipate that we will need to license and
purchase additional technology to remain competitive. We may not be able to
renew our existing licenses and purchase agreements or to license and
purchase other technologies on commercially reasonable terms or at all. If
we are unable to renew our existing licenses and purchase agreements or we
are unable to license or purchase new technologies, we may not be able to
offer competitive products.
FUTURE CHANGES IN APPLICABLE LAWS AND REGULATIONS COULD HAVE AN ADVERSE
EFFECT ON OUR BUSINESS
<PAGE> 18
Although we are not aware of any pending changes in applicable laws and
regulations, we cannot assure you that federal, state or foreign
governments will not change existing laws or regulations or adopt new laws
or regulations that regulate our industry. Changes in or adoption of new
laws or regulations could result in the following consequences that would
have an adverse effect on our business:
o regulatory clearance previously received for our products could
be revoked;
o costs of compliance could increase; or
o we may be unable to comply with such laws and regulations so that
we would be unable to sell our products.
CHANGES IN THE HEALTH CARE INDUSTRY MAY REQUIRE US TO DECREASE THE SELLING PRICE
FOR OUR PRODUCTS OR COULD RESULT IN A REDUCTION IN THE SIZE OF THE MARKET FOR
OUR PRODUCTS, EACH OF WHICH COULD HAVE A NEGATIVE IMPACT ON OUR FINANCIAL
PERFORMANCE
Trends toward managed care, health care cost containment, and other changes
in government and private sector initiatives in the United States and other
countries in which we do business are placing increased emphasis on the
delivery of more cost-effective medical therapies which could adversely
affect the sale and/or the prices of our products. For example:
o major third-party payers of hospital services, including
Medicare, Medicaid and private health care insurers, have
substantially revised their payment methodologies during the last
few years which has resulted in stricter standards for
reimbursement of hospital charges for certain medical procedures;
o Medicare, Medicaid and private health care insurer cutbacks could
create downward price pressure in the cardiac resuscitation
pre-hospital market;
o proposals were adopted recently that will change the
reimbursement procedures for the capital expenditure portion of
the cost of providing care to Medicare patients;
o numerous legislative proposals have been considered that would
result in major reforms in the U.S. health care system that could
have an adverse effect on our business;
o there has been a consolidation among health care facilities and
purchasers of medical devices in the United States who prefer to
limit the number of suppliers from whom they purchase medical
products, and these entities may decide to stop purchasing our
products or demand discounts on our prices;
o there is economic pressure to contain health care costs in
international markets;
o there are proposed and existing laws and regulations in domestic
and international markets regulating pricing and profitability of
companies in the health care industry; and
o there have been recent initiatives by third party payers to
challenge the prices charged for medical products which could
affect our ability to sell products on a competitive basis.
Both the pressure to reduce prices for our products in response to these
trends and the decrease in the size of the market as a result of these
trends could adversely affect our levels of revenues and profitability of
sales, which could have a material adverse effect on our business.
UNCERTAIN CUSTOMER DECISION PROCESSES MAY RESULT IN LONG SALES CYCLES WHICH
COULD RESULT IN UNPREDICTABLE FLUCTUATIONS IN REVENUES AND DELAY THE REPLACEMENT
OF CARDIAC RESUSCITATION DEVICES
<PAGE> 19
Many of the customers in the pre-hospital market consist of municipal fire
and emergency medical systems departments. As a result, there are numerous
decision-makers and governmental procedures in the decision-making process.
In addition, decisions at hospitals concerning the purchase of new medical
devices are sometimes made on a department-by-department basis.
Accordingly, we believe the purchasing decisions of many of our customers
may be characterized by long decision-making processes, which have resulted
in and may continue to result in long sales cycles for our products. For
example, the sales cycles for cardiac resuscitation products typically have
been between six to nine months, although some sales efforts have taken as
long as two years.
OUR INTERNATIONAL SALES EXPOSE OUR BUSINESS TO A VARIETY OF RISKS THAT COULD
RESULT IN SIGNIFICANT FLUCTUATIONS IN OUR RESULTS OF OPERATIONS
Approximately 20% of our sales in fiscal 2000 were made to foreign
purchasers, particularly in countries located in Europe and Asia, and we
plan to increase the sale of our products to foreign purchasers in the
future. As a result, a significant portion of our sales is and will
continue to be subject to the risks of international business, including:
o fluctuations in foreign currencies;
o trade disputes;
o changes in regulatory requirements, tariffs and other barriers;
o the possibility of quotas, duties, taxes or other changes or
restrictions upon the importation or exportation of the products
being implemented by the United States or these foreign
countries;
o timing and availability of import/export licenses;
o political and economic instability;
o difficulties in accounts receivable collections;
o difficulties in managing laws;
o increased tax exposure if our revenues in foreign countries are
subject to taxation by more than one jurisdiction;
o accepting customer purchase orders governed by foreign laws which
may differ significantly from U.S. laws and limit our ability to
enforce our rights under such agreements and to collect damages,
if awarded; and
o the general economies of these countries in which we transact
business.
As international sales become a larger portion of our total sales, these
risks could create significant fluctuations in our results of operations.
In addition, these risks could affect our ability to resell trade-in
products to domestic distributors, who in turn often resell the trade-in
products in international markets. Our inability to sell trade-in products
might require us to offer lower trade-in values, which might impact our
ability to sell new products to customers desiring to trade in older models
and then purchase newer products.
FLUCTUATIONS IN CURRENCY EXCHANGE RATES MAY ADVERSELY AFFECT OUR INTERNATIONAL
SALES
<PAGE> 20
Our revenue from international operations can be denominated in or
significantly influenced by the currency and general economic climate of
the country in which we make sales. A decrease in the value of such foreign
currencies relative to the U.S. dollar could result in downward price
pressure for our products or losses from currency exchange rate
fluctuations. As we continue to expand our international operations,
downward price pressure and exposure to gains and losses on foreign
currency transactions may increase. We may choose to limit such exposure by
entering into forward-foreign exchange contracts or engaging in similar
hedging strategies. We cannot assure you that any currency exchange
strategy would be successful in avoiding losses due to exchange rate
fluctuations, or that the failure to manage currency risks effectively
would not have a material adverse effect on our business, financial
condition, cash flows, and results of operations.
WE MAY FAIL TO ADEQUATELY PROTECT OR ENFORCE OUR INTELLECTUAL PROPERTY RIGHTS OR
SECURE RIGHTS TO THIRD PARTY PATENTS, AND OUR COMPETITORS CAN USE SOME OF OUR
PREVIOUSLY PROPRIETARY TECHNOLOGY
Our success will depend in part on our ability to obtain and maintain
patent protection for our products, methods, processes and other
technologies, to preserve our trade secrets and to operate without
infringing the proprietary rights of third parties. To date, we have been
issued 22 U.S. patents for our various inventions and technologies.
Additional patent applications have been filed with the U.S. Patent and
Trademark Office and are currently pending. The patents that have been
granted to us are for a definitive period of time and will expire. We have
filed certain corresponding foreign patent applications and intend to file
additional foreign and U.S. patent applications as appropriate. We cannot
assure you as to:
o the degree and range of protection any patents will afford
against competitors with similar products;
o if and when patents will be issued;
o whether or not others will obtain patents claiming aspects
similar to those covered by our patent applications;
o whether or not competitors will use information contained in our
expired patents, such as our U.S. pacing system patent which will
expire in 2000;
o whether or not others will design around our patents or obtain
access to our know-how; or
o the extent to which we will be successful in avoiding any patents
granted to others.
For example, we have patents and pending patent applications for our
proprietary biphasic technology. Our competitors could develop biphasic
technology that has comparable or superior clinical efficacy to our
biphasic technology if our patents do not adequately protect our
technology, our competitors are able to obtain patents claiming aspects
similar to our biphasic technology or our competitors can design around our
patents.
If certain patents issued to others are upheld or if certain patent
applications filed by others issue and are upheld, we may be:
o required to obtain licenses or redesign our products or processes
to avoid infringement;
o prevented from practicing the subject matter claimed in those
patents; or
o required to pay damages.
Litigation or administrative proceedings, including interference
proceedings before the U.S. Patent and Trademark Office, related to
intellectual property rights could be brought against us or be initiated by
us. Any judgment adverse to us in any litigation or other proceeding
arising in connection with a patent or patent application could materially
and adversely affect our business, financial condition and results of
<PAGE> 21
operations. In addition, the costs of any such proceeding may be
substantial whether or not we are successful.
Our success is also dependent upon the skills, knowledge and experience,
none of which is patentable, of our scientific and technical personnel. To
help protect our rights, we require all employees, consultants and advisors
to enter into confidentiality agreements, which prohibit the disclosure of
confidential information to anyone outside of our company and require
disclosure and assignment to us of their ideas, developments, discoveries
and inventions. We cannot assure you, however, that these agreements will
provide adequate protection for our trade secrets, know-how or other
proprietary information in the event of any unauthorized use or disclosure
of the lawful development by others of such information.
RELIANCE ON OVERSEAS VENDORS FOR SOME OF THE COMPONENTS FOR OUR PRODUCTS EXPOSES
US TO INTERNATIONAL BUSINESS RISKS, WHICH COULD HAVE AN ADVERSE EFFECT ON OUR
BUSINESS
Some of the components we use in our products are acquired from foreign
manufacturers, particularly countries located in Europe and Asia. As a
result, a significant portion of our purchases of components is subject to
the risks of international business. The failure to obtain these components
as a result of any of these risks can result in significant delivery delays
of our products, which could have an adverse effect on our business.
WE RELY HEAVILY ON SEVERAL EMPLOYEES WHO MAY LEAVE, AND TIGHT LABOR MARKETS MAY
MAKE IT DIFFICULT TO RECRUIT EMPLOYEES
Our future operating results will depend in part upon the contributions of
the persons who will serve in senior management positions and the continued
contributions of key technical personnel, some of who would be difficult to
replace. In addition, our future success will depend in part upon our
ability to attract and retain highly qualified personnel, particularly
product design engineers. Increasingly tight labor markets could make it
more difficult and/or expensive to recruit and retain employees in a cost
effective manner. There can be no assurance that such key personnel will
remain in our employment or that we will be successful in hiring qualified
personnel. Any loss of key personnel or the inability to hire or retain
qualified personnel could have a material adverse effect on our business,
financial condition and results of operations.
WE MAY ACQUIRE OTHER BUSINESSES, AND WE MAY HAVE DIFFICULTY INTEGRATING THESE
BUSINESSES OR GENERATING AN ACCEPTABLE RETURN FROM ACQUISITIONS
We may attempt to acquire or make strategic investments in businesses and
other assets. Such acquisitions will involve risks, including:
o the inability to achieve the strategic and operating goals of the
acquisition;
o the inability to raise the required capital to fund the
acquisition;
o difficulty in assimilating the acquired operations and personnel;
o disruption of our ongoing business; and
o inability to successfully incorporate acquired technology into
our existing product lines and maintain uniform standards,
controls, procedures and policies.
PROVISIONS IN OUR CHARTER DOCUMENTS, OUR SHAREHOLDER RIGHTS AGREEMENT AND STATE
LAW MAY MAKE IT HARDER FOR OTHERS TO OBTAIN CONTROL OF ZOLL EVEN THOUGH SOME
STOCKHOLDERS MIGHT CONSIDER SUCH A DEVELOPMENT TO BE FAVORABLE
Our board of directors has the authority to issue up to 1,000,000 shares of
undesignated preferred stock and to determine the rights, preferences,
privileges and restrictions of such shares without further vote or action
<PAGE> 22
by our stockholders. The rights of the holders of common stock will be
subject to, and may be adversely affected by, the rights of the holders of
any preferred stock that may be issued in the future. The issuance of
preferred stock could have the effect of making it more difficult for third
parties to acquire a majority of our outstanding voting stock.
In addition, our restated articles of organization provide for staggered
terms for the members of the board of directors which could delay or impede
the removal of incumbent directors and could make a merger, tender offer or
proxy contest involving the Company more difficult. Our restated articles
of organization, restated by-laws and applicable Massachusetts law also
impose various procedural and other requirements that could delay or make a
merger, tender offer or proxy contest involving us more difficult.
In addition, we have implemented a so-called poison pill by adopting our
shareholders rights agreement. This poison pill significantly increases the
costs that would be incurred by an unwanted third party acquirer if such
party owns or announces its intent to commence a tender offer for more than
15% of our outstanding common stock. The existence of this poison pill
could delay, deter or prevent a takeover of ZOLL.
All of these provisions could limit the price that investors might be
willing to pay in the future for shares of our common stock which could
preclude our shareholders from recognizing a premium over the prevailing
market price of our stock.
WE HAVE ONLY ONE MANUFACTURING FACILITY FOR EACH OF OUR MAJOR PRODUCTS AND ANY
DAMAGE OR INCAPACITATION OF EITHER OF THE FACILITIES COULD IMPEDE OUR ABILITY TO
PRODUCE THESE PRODUCTS
We have only one manufacturing facility, which produces defibrillators and
one separate manufacturing facility which produces electrodes. Damage to
either facility could render us unable to manufacture the relevant product
or require us to reduce the output of products at the damaged facility.
This could materially and adversely impact our business, financial
condition and results of operations.
OUR CURRENT AND FUTURE INVESTMENTS MAY LOSE VALUE IN THE FUTURE
We have made a $2.0 million investment in LifeCor, Inc., a development
stage company, and may in the future invest in the securities of other
companies and participate in joint venture agreements. This investment and
future investments are subject to the risks that the entities in which we
invest will become bankrupt or lose money. Investing in securities involves
risks and no assurance can be made as to the profitability of any
investment. Our inability to identify profitable investments could
adversely affect our financial condition and results of operations. Unless
we hold a majority position in an investment or joint venture, we will not
be able to control all of the activities of the companies in which we
invest or the joint ventures in which we are participating. Because of
this, such entities may take actions against our wishes and not in
furtherance of, and even opposed to, our business plans and objectives.
These investments are also subject to the risk of impasse if no one party
exercises ultimate control over the business decisions.
WE MAY EXPERIENCE SHORT TERM OPERATING FLUCTUATIONS AS WE INTRODUCE OUR NEW
BIPHASIC TECHNOLOGY
While we believe our biphasic technology offers substantial opportunity for
future growth, there can be no guarantee that this will occur. In addition,
in the short term, an industry shift towards biphasic technology could
cause a lengthening of buying cycles, take additional sales time, and
reduce the salability of existing inventory and trade-in products. This
risk related to a shift towards biphasic technology could also be affected
by uncertainty of the governing bodies' recommendations of biphasic
technology.
ITEM 2. PROPERTIES
Our facilities are located in Burlington, Massachusetts and Pawtucket, Rhode
Island. Our executive headquarters are located at the Burlington facility, along
with our research and development and our device manufacturing operations. We
own a 33,000 square foot building in Rhode Island, where we manufacture our
<PAGE> 23
electrode products and conduct related research and development. We own a 17,500
square foot building in Boulder, Colorado where our data management software
business offices are located. We lease approximately 90,000 square feet of
office and assembly space in Burlington under a lease expiring in August 2003,
and 2,685 square feet of office space in Vancouver, British Columbia, under a
lease expiring in 2002. We also have administrative offices in Manchester,
England, Dodewaard, The Netherlands, Cologne, Germany, and in Mississauga,
Canada.
ITEM 3. LEGAL PROCEEDINGS
In the course of normal operations, we are involved in litigation arising from
commercial disputes, claims of former employees, and other matters. We do not
believe any of these current claims will have a material impact on our financial
position or results of operations.
<PAGE> 24
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDER
Not Applicable.
EXECUTIVE OFFICERS OF REGISTRANT
Name Age Position
------------------ ------- -------------------------------------------------
Richard A. Packer 43 Chairman, Chief Executive Officer and President
A. Ernest Whiton 39 Vice President of Administration and Chief
Financial Officer
Steven K. Flora 49 Vice President, North American Sales
E.J. Jones 58 Vice President, International Sales
Donald R. Boucher 48 Vice President, Research and Development
Ward M. Hamilton 53 Vice President, Marketing
John P. Bergeron 48 Vice President and Corporate Treasurer
Mr. Packer joined the Company in 1992 and in November 1999, was appointed Chief
Executive Officer. Mr. Packer served as President, Chief Operating Officer and
director from May 1996 to his appointment as CEO. Since 1992 he has served as
Chief Financial Officer and Vice President of Operations of the Company. Prior
to this time, Mr. Packer served from 1987 to 1992 as Vice President of various
functions for Whistler Corporation, a consumer electronics company. Prior to
this, Mr. Packer was a manager with the consulting firm of PRTM/KPMG,
specializing in operations of high technology companies. Mr. Packer has received
B.S. and M. Eng. degrees from the Rensselaer Polytechnic Institute and a M.B.A.
from the Harvard Graduate School of Business Administration.
Mr. Whiton joined the Company as Vice President of Administration and Chief
Financial Officer in January 1999. Prior to joining the Company, Mr. Whiton was
Vice President and Chief Accounting Officer of Ionics, Inc., a global
separations technology company, which he joined in 1993. Prior to Ionics, he was
a manager at Price Waterhouse. Mr. Whiton has received a B.S. in Accounting from
Bentley College and a M.B.A. from the Harvard Graduate School of Business
Administration.
Mr. Flora joined the Company as Vice President of North American Sales in
September 1999. Prior to joining the Company, Mr. Flora served from 1981 to 1998
in various positions with Marquette Medical systems, a manufacturer of
cardiovascular and physiological monitoring systems, most recently as Vice
President of Sales. Mr. Flora received his B.S. in Biology from the University
of Illinois.
Mr. Jones joined the Company as Vice President of International Sales in
November 1999. Prior to joining the Company, Mr. Jones was Vice President of
Operations with Apple Medical Corporation. He also spent 15 years with Millipore
Corporation, holding various positions in Domestic and International Sales. Mr.
Jones holds a B.S. in Microbiology/Biochemistry from the University of Illinois
and is a graduate of the Advanced Management Program (AMP) from the Harvard
Graduate School of Business Administration.
Mr. Boucher joined the Company as Vice President of Research and Development in
December 1993. Prior to joining the Company, Mr. Boucher served from 1977 to
1993, with Corometrics Medical Systems, Inc., a manufacturer of fetal and
neonatal monitors, most recently as Vice President of Engineering. Mr. Boucher
received a M.B.A. from the University of Connecticut, an M.S.E. in
bioengineering from the University of Pennsylvania, and a B.S. in engineering
from Northeastern University.
<PAGE> 25
Mr. Hamilton joined the Company as Vice President of Marketing in February 1992.
Prior to this time, Mr. Hamilton served from 1985 to 1991 as Director of New
Business Development and Director of Marketing for ACLS products for Laerdal
Medical Corporation, a manufacturer of portable automated defibrillators, and
from 1977 to 1985 as Marketing Manager for defibrillators and noninvasive blood
pressure monitors for Datascope Corporation. Mr. Hamilton received a B.A. in
political science from Hartwick College and an M.P.A. in public administration
from the University of Southern California.
Mr. Bergeron joined the Company as Vice President and Corporate Treasurer in
August 2000. Prior to joining the Company, Mr. Bergeron was Vice President at
Ionics Corporation, a global separations technology company, where he also
served as Corporate Treasurer and Tax Director. Prior to joining Ionics in 1988,
Mr. Bergeron served in a variety of tax positions at other multinational
corporations. Mr. Bergeron received a B.B.A. from the University of
Massachusetts at Amherst and a M.S. in Taxation from Bentley College.
<PAGE> 26
PART II
ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
The information regarding the market price of Common Stock appearing under the
caption "Market for Registrant's Common Equity and Related Stockholder Matters"
on page 24 of the Company's 2000 Annual Report ("Annual Report") is incorporated
herein by this reference.
The Company has never declared or paid cash dividends on its capital stock. The
Company currently intends to retain any future earnings to finance the growth
and development of its business and therefore does not anticipate paying any
cash dividends in the foreseeable future.
As of September 30, 2000, there were 102 stockholders of record of the Company's
Common Stock. The Company believes there were substantially in excess of 4,500
beneficial holders of the Common Stock.
ITEM 6. SELECTED FINANCIAL DATA
The selected consolidated financial data set forth under the caption "Five Year
Financial Summary" on page 8 of the Annual Report are incorporated herein by
this reference and are qualified in their entirety by reference to the more
fully detailed consolidated financial statements and the report of the
independent auditors thereon which are included in the Annual Report.
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
The discussion set forth under the caption "Management's Discussion and Analysis
of Financial Condition and Results of Operations" on pages 9 through 10 of the
Annual Report is incorporated herein by this reference and should be read in
conjunction with "Business" (Item 1) "Selected Consolidated Financial Data"
(Item 6).
Except for the historical information contained herein and the above referenced
"Management's Discussion and Analysis of Financial Condition and Results of
Operations," the matters set forth herein and herein are forward looking
statements within the meaning of Section 27A of the Securities Act of 1933 as
amended, and Section 21E of the Securities Exchange Act of 1934, as amended.
These statements set forth our current view with respect to future events and
are based on assumptions and are subject to certain risks and uncertainties that
could cause actual results to differ materially from those set forth in the
forward looking statements. Such risks and uncertainties include, but are not
limited to: product demand and market acceptance risks, the effect of economic
conditions, results of pending or future litigation, the impact of competitive
products and pricing, product development and commercialization, technological
difficulties, the government regulatory environment and actions, trade
environment, capacity and supply constraints or difficulties, the results of
financing efforts, actual purchases under agreements, those risk and
uncertainties set forth above under "Risk Factors", and the effect of the
Company's accounting policies and those risk and uncertainties set forth.
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We have cash equivalents and marketable securities that primarily consist of
U.S. Treasuries, short-term repurchase agreements, and asset-backed corporate
securities. The majority of these investments have maturities within one year,
with 25% to 35% maturing in one to five years. We believe that our exposure to
<PAGE> 27
interest rate risk is minimal due to the short-term nature of our investments
and that fluctuations in interest rates would not have a material adverse effect
on our results of operations.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
The Consolidated Financial Statements, Notes thereto, Independent Auditors
Report and Quarterly Financial Data (Unaudited) on pages 11 through 24 of the
Annual Report and listed below in item 14 are incorporated herein by this
reference.
ITEM 9. CHANGES AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL
DISCLOSURE
Not Applicable.
PART III
ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT
The information appearing in our Proxy Statement for our 2001 Annual Meeting of
Stockholders (the "Proxy Statement") under the caption "Proposal I - Election of
a Class of Directors" is incorporated herein by this reference. Information
regarding Executive Officers of the Company called for by Item 10 is set forth
at the end of Part I of this Report under the caption "Executive Officers of
Registrant."
ITEM 11. EXECUTIVE COMPENSATION
The information appearing in the Proxy Statement under the captions "Proposal I
- Election of a Class of Directors" and "Executive Compensation" is incorporated
herein by this reference.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
The information appearing in the Proxy Statement under the captions "Proposal I
- Election of a Class of Directors" and "Other Matters - Principal Stockholders"
is incorporated herein by this reference.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
The information appearing in the Proxy Statement under the captions "Proposal I
- Election of a Class of Directors" and "Certain Relationships" is incorporated
herein by this reference.
PART IV
<PAGE> 28
ITEM 14. EXHIBITS, FINANCIAL STATEMENTS, FINANCIAL STATEMENT SCHEDULES AND
REPORTS ON FORM 8-K
(a)(1) The following Consolidated Financial Statements, Notes thereto
and Independent Auditors' Report on pages 11 through 24 of the
Annual Report are incorporated by reference in Item 8:
Report of Independent Auditors
Consolidated Balance Sheets
Consolidated Income Statements
Consolidated Statements of Stockholders' Equity and Comprehensive
Income
Consolidated Statements of Cash Flows
Notes to Consolidated Financial Statements
(a)(2) The following Consolidated Financial Statement Schedule is
included herein:
Schedule II - Valuation Accounts S-1
All other schedules have been omitted since the required
information is not presented, the amounts are not sufficient to
require submission of the schedules or because the information is
included in the consolidated financial statements.
(a)(3) The following is a complete list of Exhibits filed or incorporated
by reference as part of this Report:
3.1 Restated Articles of Organization.*
3.2 Amended and Restated By-laws.*
3.3 Shareholders Rights Plan****
10.1 1992 Stock Option Plan.*
10.2 1983 Incentive Stock Option Plan, as amended and restated February 6,
1990.*
10.3 Revolving Loan and Security Agreement dated March 9, 1992 between the
Company and Brown Brothers Harriman & Co.*
10.4.1 License Agreement dated as of November 21, 1984 between the Company and
S&W Medico Teknik A/S.*
10.4.2 License Agreement dated as of April 8, 1987 between the Company and S&W
Medico Teknik A/S.*
10.4.3 Amendment to License Agreement dated January 1, 1990 between the
Company and S&W Medico Teknik A/S.*
10.5 Stock Purchase Agreement dated July 1, 1985, as amended as of May 24,
1991, among the Company and certain purchasers of the Company's Common
Stock and Preferred Stock.*
10.8 Distributorship Agreement dated as of June 15, 1992 between the Company
and Fukuda Denshi Co., Ltd.*
10.10 Employment Agreement dated July 19, 1996 between the Company and
Richard A. Packer regarding Mr. Packer's employment. **
10.11 Non Employee Directors' Stock Option Plan*****
10.12 Senior Executive Severance Agreement dated January 21, 2000 between the
Company and Richard A. Packer.***
10.13 Executive Severance Agreement dated January 26, 2000 between the
Company and A. Ernest Whiton.***
13.1 Portions of the Annual Report incorporated by reference.***
21.1 Subsidiaries of the Company.***
23.1 Consent of Ernst & Young LLP.***
27.1 Financial Data Schedule for 2000 ***
<PAGE> 29
A report on Form 8-K was filed by the Company on September 15,
2000 regarding the change of it's fiscal year to end on the
Sunday closest to September 30 beginning in fiscal year 2001.
* Incorporated by reference from the Company's Registration
Statement on Form S-1, as amended, under the Securities Act
of 1933 (Registration Statement No. 33-47937).
** Incorporated by reference from the Company's Annual Report
for 1996 Form 10-K, as amended, filed with the Securities
and Exchange Commission on December 27, 1996.
*** Filed herewith.
**** Incorporated by reference from the Company's 8-K filed with
the Securities and Exchange Commission on June 11, 1998.
***** Incorporated by reference from the Company's Registration
Statement on Form S-8, under the Securities Act of 1933
(Registration Statement No. 33-368401).
<PAGE> 30
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange
Act of 1934, the Company has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized, on December 29, 2000.
ZOLL MEDICAL CORPORATION
By: /s/ Richard A. Packer
---------------------------------------------
Richard A. Packer
Chairman and Chief Executive Officer
Pursuant to the requirements of the Securities Exchange Act of 1934, this report
has been signed below by the following persons in the capacities and on the
dates indicated.
<TABLE>
<CAPTION>
Signature Title Date
--------- ----- ----
<S> <C> <C>
/s/ Richard A. Packer Chairman, Chief Executive Officer and December 29, 2000
------------------------------------ President (Principal Executive Officer)
Richard A. Packer
/s/ A. Ernest Whiton Chief Financial Officer (Principal December 29, 2000
------------------------------------ Financial and Accounting Officer)
A. Ernest Whiton
/s/ Willard M. Bright Director December 29, 2000
------------------------------------
Willard M. Bright
/s/ Thomas M. Claflin, II Director December 29, 2000
------------------------------------
Thomas M. Claflin, II
/s/ Dr. James W. Biondi Director December 29, 2000
------------------------------------
Dr. James W. Biondi
/s/ M. Stephen Heilman, M.D. Director December 29, 2000
------------------------------------
M. Stephen Heilman, M.D.
/s/ Daniel M. Mulvena Director December 29, 2000
------------------------------------
Daniel M. Mulvena
/s/ Benson F. Smith Director December 29, 2000
------------------------------------
Benson F. Smith
</TABLE>
<PAGE> 31
FINANCIAL STATEMENT SCHEDULE PAGE S-1
EXHIBIT INDEX
3.1 Restated Articles of Organization.*
3.2 Amended and Restated By-laws.*
3.3 Shareholders Rights Plan****
10.1 1992 Stock Option Plan.*
10.2 1983 Incentive Stock Option Plan, as amended and restated
February 6, 1990.*
10.3 Revolving Loan and Security Agreement dated March 9, 1992 between
the Company and Brown Brothers Harriman & Co.*
10.4.1 License Agreement dated as of November 21, 1984 between the
Company and S&W Medico Teknik A/S.*
10.4.2 License Agreement dated as of April 8, 1987 between the Company
and S&W Medico Teknik A/S.*
10.4.3 Amendment to License Agreement dated January 1, 1990 between the
Company and S&W Medico Teknik A/S.*
10.5 Stock Purchase Agreement dated July 1, 1985, as amended as of
May 24, 1991, among the Company and certain purchasers of the
Company's Common Stock and Preferred Stock.*
10.8 Distributorship Agreement dated as of June 15, 1992 between the
Company and Fukuda Denshi Co., Ltd.*
10.10 Employment Agreement dated July 19, 1996 between the Company and
Richard A. Packer regarding Mr. Packer's employment.**
10.11 Non Employee Directors' Stock Option Plan*****
10.12 Senior Executive Severance Agreement dated January 21, 2000
between the Company and Richard A. Packer.***
10.13 Executive Severance Agreement dated January 26, 2000 between the
Company and A. Ernest Whiton.***
13.1 Portions of the Annual Report incorporated by reference.***
21.1 Subsidiaries of the Company.***
23.1 Consent of Ernst & Young LLP.***
27.1 Financial Data Schedule for 2000. ***
A report on Form 8-K was filed by the Company on September 15,
2000 regarding the change of it's fiscal year to end on the
Sunday closest to September 30 beginning in fiscal year 2001.
* Incorporated by reference from the Company's Registration
Statement on Form S-1, as amended, under the Securities Act
of 1933 (Registration Statement No. 33-47937).
** Incorporated by reference from the Company's Annual Report
for 1996 Form 10-K, as amended, filed with the Securities
and Exchange Commission on December 27, 1996.
*** Filed herewith.
**** Incorporated by reference from the Company's 8-K filed with
the Securities and Exchange Commission on June 11, 1998.
***** Incorporated by reference from the Company's Registration
Statement on Form S-8, under the Securities Act of 1933
(Registration Statement No. 33-368401).
<PAGE> 32
S-1
SCHEDULE II - VALUATION AND QUALIFYING ACCOUNTS
<TABLE>
<CAPTION>
Additions
Charged
Balance to Costs
Beginning of and Balance At
Classifications Period Expenses Deductions End of Period
---------------------------------------------------------------- -------------- --------------- -----------------
<S> <C> <C> <C> <C>
Year Ended September 30, 2000
Allowance for doubtful
accounts $2,096,000 $302,000 $503,000 $1,895,000
=============== ============== =============== =================
Year Ended October 2, 1999
Allowance for doubtful
accounts $940,000 $1,294,000 $138,000 $2,096,000
=============== ============== =============== =================
Year Ended September 26, 1998
Allowance for doubtful
accounts $1,209,000 $244,000 $513,000 $940,000
=============== ============== =============== =================
</TABLE>
