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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, 2001
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
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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
The aggregate market value of the voting stock held by non-affiliates of the
registrant as of December 24, 2001 was $233,768,072 based on closing sales price
of $37.37 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 24, 2001 was 8,908,134.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the 2001 Annual Report to Shareholders are incorporated by reference
into Parts I, II and IV.
Portions of the definitive Proxy statement dated on or about January 11, 2002 to
be delivered to shareholders in connection with the Annual Meeting of
Shareholders to be held February 12, 2002 are incorporated by reference into
Part III.
Page 1 of 34
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
approximately $650 million in 2001. 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 2002. From fiscal 2000 to fiscal 2001, our revenues increased 12%.
Our main line of defibrillators is the M Series. M Series defibrillators
are smaller and lighter than competitive products, making them easier to use,
carry and transport. In fiscal 2000, we began shipping M Series defibrillators
equipped with our proprietary biphasic waveform that provide 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.
We recently introduced a new product line designed for critical care
transport and designated the CCT. Based on an M Series platform this new model
incorporates the same defibrillation and pacing technologies and general
elements of the M Series design but adds significantly expanded monitoring,
battery capacity, and display capability. A larger color display that shows
three traces simultaneously combined with the addition of invasive pressure
measurement capability and temperature monitoring expands the M Series
application to a new segment of patients.
The AED Plus to be introduced in 2002 is a simplified, lower cost
automated external defibrillator (AED) designed for the infrequent user,
developed to assist the user in defibrillation and CPR. The device incorporates
a number of unique and proprietary elements designed to better meet the needs of
inexperienced rescuers and provides highly differentiated product positioning.
The device includes a highly simplified graphical user interface, one piece
electrode pads, consumer battery operation and feedback to rescuers on CPR
performance.
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 strengthening distribution. While we plan to
increase our share in markets that we currently serve, we also seek future
growth by entering into new
Page 2 of 34
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 90% of our capital
equipment device sales in fiscal 2001. We plan to increase our profits
in this segment by doing the following:
-- selling additional monitoring and display capabilities on the M
Series such that in combination with its small size and weight
the new feature set make it a likely substitute for a "transport
monitor" because the defibrillator is integrated instead of a
separate additionally carried device; and
-- expanding our presence in both the domestic and international
markets by 1) hiring additional salespeople, 2) in international
markets of a significant size, where our market share is weak,
move from the selling through a distributor to selling direct,
and 3) increasing distributor sales in emerging markets.
- ENTER THE PUBLIC ACCESS DEFIBRILLATION MARKET WITH A WELL-DIFFERENTIATED
DEVICE. We are developing a device for the large and relatively untapped
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 emergency medical
services (EMS) personnel in our efforts to sell our device to first
responders such as police and fire departments. We also intend to market
our device to other non-traditional providers of healthcare.
- 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 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.
- SEEK ADDITIONAL GROWTH OPPORTUNITIES IN THE EMS DATA MANAGEMENT MARKET.
We believe that the market for EMS data management solutions is
significant and relatively un-penetrated. 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
intend on expanding the sale of our products into the public safety
area. 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 un-resuscitated, 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%.
Page 3 of 34
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 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
Page 4 of 34
In September 1998, we shipped the first M Series defibrillators. The M
Series is a line of defibrillators for both the hospital and pre-hospital
markets. For fiscal 2001, our M Series defibrillators represented over 90% of
our capital equipment device sales. The M Series defibrillator is our best
selling product to date and has been selected as the standard device in such
places as The Mayo Clinic, 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 of one and less than one-half of the size of the two 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 M Series defibrillators are designed to be upgradeable, 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:
- 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.
- 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.
Page 5 of 34
- GE CATALYST MUSE CARDIOLOGY INFORMATION SYSTEM. In March 2001, we
enhanced our M Series defibrillators to allow communication directly
with the GE Medical Systems Information Technologies' Catalyst MUSE
cardiology information system. This Catalyst MUSE Interface provides
direct communication of pre-hospital 12-lead ECG data into GE's family
of Catalyst cardiovascular information systems eliminating the need for
a dedicated receiving station or gateway.
- 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 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 received
510(k) clearance to incorporate this pulse oximetry technology into our
M Series defibrillators in March, 1999. The 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.
- 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 in March, 2000.
- NONINVASIVE BLOOD PRESSURE MEASUREMENT. We developed a noninvasive blood
pressure measurement capability, also known as NiBP, and integrated it
into our M Series defibrillators. The technology encompassing this
product is licensed from a third party. We received 510(k) clearance to
incorporate NiBP into our M Series defibrillators and began shipments in
December 2000.
CRITICAL CARE TRANSPORT (CCT) DEFIBRILLATORS
In October 2001, we introduced our newest M Series model that has been
designed for critical care transport, the CCT. Based on an M Series platform
this new model incorporates the same defibrillation and pacing technologies and
general elements of the M Series design but adds significantly expanded
monitoring, battery capacity, and display capability. A larger color display
that shows three traces simultaneously combined with the addition of invasive
pressure measurement capability and temperature monitoring expands the M Series
application to a new segment of patients.
The two new features for the CCT are:
- INVASIVE BLOOD PRESSURE MEASUREMENT. We developed an invasive blood
pressure measurement capability, also known as IBP, and integrated it
into our M Series CCT defibrillators. We received 510(k) clearance to
incorporate IBP into our M Series defibrillators in August 2001.
- TEMPERATURE MEASUREMENT. We developed a temperature measurement
capability, also known as TEMP, and integrated it into our M Series CCT
defibrillators. We received 510(k) clearance to incorporate TEMP into
our M Series defibrillators in August 2001.
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 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 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
Page 6 of 34
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. Our
new biphasic waveform reduces the heart's exposure to high peak current. In
addition, our biphasic waveform keeps the waveform shape and duration constant
over a wide range of patients whose differing physiologies impact the
transmittal of current.
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. Those 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.
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 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 2000 we
introduced pro-padz(TM) Biphasic Multi-function Electrodes specifically designed
for use with the ZOLL Rectilinear Biphasic waveform for cardioversion of atrial
fibrillation. Our sales of electrodes in the North American market grew 13% from
2000 to 2001 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
Page 7 of 34
We also manufacture and sell four other older 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 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 $650 million in 2001.
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 extensively in the top 30 cardiac hospitals in the
United States as listed by U.S. News and World Report in July 2001.
Hospitals have traditionally used 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 general
wards. Hospitals also use portable devices during in-hospital transportation of
cardiac patients.
We believe that the M Series defibrillators have positioned us very well
competitively in the U.S. hospital market, however, we believe the overall
hospital market decreased in 2001. We believe this decrease reflects the fact
that some customers accelerated prior year shipments as a result of their Y2K
preparation programs. We also believe this decrease reflected customer
uncertainty regarding the current state of the U.S. economy which affected our
customers' plans for capital spending. As a result, our revenues in the U.S.
hospital capital equipment device market decreased in 2001. Going forward, we
believe that we are still able 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
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 the use of
combination pacemakers/defibrillators will become more widespread in the
pre-hospital setting. 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 under penetrated pre-hospital
market is large. Presently, we believe that less than 70% 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
Page 8 of 34
resuscitation equipment as the medical community places increased priority on
providing such equipment and the necessary training to all first responders. We
believe that as ambulances and other first responder emergency vehicles replace
their older defibrillators with newer units, they will include additional
monitoring parameters which we are positioned to capitalize upon.
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 trained to administer such treatment, although this is
changing. 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 continued 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. Germany, which is second only to
the United States in market size, may be a strong market for future growth. We
have recently expanded our direct sales force in Germany. In addition, we are
completing our fulfillment of our largest sales contract ever, a four year
agreement with the German Army that included over 1,600 defibrillators. In
Australia, we have made sales of 179 defibrillators, which were entirely
biphasic, to the New South Wales Ambulance Service, a 1,100 vehicle service. We
opened a new direct sales subsidiary in Australia in October 2001 to better
focus on the needs of our customers and to communicate the benefits of our
biphasic technology more clearly and consistently. We intend to continue
expanding our global 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 completing our development of 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, the time from onset of sudden cardiac arrest to defibrillation
Page 9 of 34
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 broad market include police and fire departments, office buildings,
shopping malls, airports, health clubs and any other location where people work,
travel or gather. Ultimately, AEDs could be marketed to private homes, where
approximately 70% of cardiac arrests occur.
Some of our competitors offer cardiac resuscitation equipment in the PAD
market. We expect to enter the PAD market in the second quarter of fiscal 2002.
We believe that this market has expanded to the point where we can profitably
sell AEDs. More distributors are requesting and selling AEDs. The passage of
Federal and State Good Samaritan legislation increases the likelihood that
non-medically trained personnel will be providing care to victims of sudden
cardiac arrest. The AHA and virtually all corresponding international
organizations have established programs to bring early defibrillation to the
community. Early defibrillation is included in AHA CPR training for all
healthcare personnel and some lay persons. In the U.S., recent governmental
activity and recommendations about AEDs include the passage of the Cardiac
Arrest Survival Act in November 2000, which encourages the placement of AEDs in
federal buildings around the nation. The Rural Access to Emergency Devices Act,
also signed into law in November 2000, authorized $25 million in federal funds
over three years which could help rural communities purchase AEDs and provide
training on how to use them. In September 2001, the Office of Management and
Budget (OMB) asked the Occupational Safety and Health Administration (OSHA) to
consider whether promotion of AEDs should be elevated to a priority. In
response, OSHA, in December 2001, issued a technical information bulletin
encouraging employers to consider making AEDs available in the workplace. OSHA
stated that 13% of workplace fatalities in 1999 and 2000 were due to sudden
cardiac arrest. The Community Access Emergency Defibrillation Act of 2001 was
pending in Congress prior to the year-end recess. If this proposal becomes law,
it may provide approximately $50 million a year for several years for
communities to establish public access defibrillation programs, including the
purchase and placement of AEDs in public places, community-based demonstration
projects, and a national information clearinghouse to provide information to
increase public awareness and promote access to defibrillators in schools.
Another bill is currently in the House of Representatives, called the Automatic
Defibrillators in Adams Memory Act, which would provide guidance and resources
to schools for public access defibrillation programs. We believe that these
developments, together with the introduction of AEDs in highly visible places,
will lead to a larger market for AEDs. We estimate that in calendar year 2002
the market for low-cost AEDs will exceed $100 million.
Our low-cost AED for the PAD market has been introduced at trade shows
and is currently awaiting FDA clearance. We expect to begin selling our low-cost
AED during the second quarter of fiscal 2002. The device will assist the user in
defibrillation and CPR and will incorporate a number of unique and proprietary
elements that better meet the needs of inexperienced rescuers and provides
highly differentiated product positioning. The device will include a highly
simplified graphical user interface, one piece electrode pads, consumer battery
operation and feedback to rescuers on CPR performance. 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 series of products with data capabilities
(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 products through a series of small acquisitions 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 are key factors in the receipt of payments from third party payers.
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 EMS data management is significant and
relatively un-penetrated.
COMPETITION
Page 10 of 34
Our principal competitors in the United States are Physio-Control
Corporation and Royal Phillips Electronics. Physio-Control is a subsidiary of
Medtronic, Inc., a leading medical technology company. Both Physio-Control and
Phillips compete across our entire defibrillator product line. We also compete
with Medical Research Labs, Inc. and Cardiac Sciences, Inc. in specific
geographic areas and markets. In the international market we compete with
Physio-Control and Phillips, 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) products.
RESEARCH AND DEVELOPMENT
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 are completing our development of our inexpensive,
easy-to-operate AED Plus for the PAD market. In addition, we are continuing our
work on the development of RescueNet(TM) products.
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 98,000 square feet of office, warehouse and assembly space
in Burlington under a lease expiring in August 2003. We also have administrative
offices in Manchester, England, Dodewaard, the Netherlands, Cologne, Germany,
Sydney, Australia, and in Mississauga, Ontario, 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 2001, 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. During 2001, we also filed a U.S. patent application for our
new ZOLL AED Plus PAD defibrillator, and intend to file foreign patent
applications soon.
Page 11 of 34
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, 2001, we employed 585 people on a full-time basis, 549
in the United States and 36 internationally. We also employed 20 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, split into dedicated
groups, focused on the hospital and pre-hospital markets. We sell our
RescueNet(TM) products through a separate dedicated sales force. In the United
States, we currently have 60 sales representatives and managers calling on
hospitals, 56 calling on pre-hospital accounts and 6 selling our data management
products. We have 8 sales representatives in Canada, 5 in the United Kingdom, 1
in the Netherlands, 3 in France, 6 in Australia, and 6 in Germany.
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 a
510(k) pre-market notification clearance 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.
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 re-inspect the facilities;
- issue a warning letter apprising of violating conduct;
- detain or seize products;
- mandate a recall;
- enjoin future violations; and
Page 12 of 34
- 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
Royal Phillips Electronics. Physio-Control is a subsidiary of Medtronic,
Inc., a leading medical technology company, and Royal Phillips Electronics
recently completed their purchase of Agilent Technologies' Healthcare
Solutions Group, which was one of our major competitors. Physio-Control has
been the market leader in the defibrillator industry for over twenty years.
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 Royal Phillips Electronics and
other competitors each have significantly greater resources than we do.
Accordingly, Physio-Control, Royal Phillips Electronics 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. In
addition, although our biphasic waveform technology is unique, our
competitors have devised alternative biphasic waveform technology and we
have licensed our biphasic waveform technology to GE Medical Systems
Information Technologies.
In addition, there are a number of smaller competitors. In the United
States, these competitors include MRL, and Cardiac Sciences, Inc. It is
possible the market may embrace these competitor's products which could
negatively impact our market share.
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
Page 13 of 34
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:
- high demand for our products which could disrupt our normal
factory utilization and cause shipments to occur in uneven
patterns;
- variations in product orders;
- timing of new product introductions;
- temporary disruptions on buying behavior due to changes in
technology (e.g. shift to biphasic technology)
- changes in distribution channels;
- actions taken by our competitors such as the introduction of new
products or the offering of sales incentives;
- the ability of our sales force to effectively market our products;
- supply interruptions from our single source vendors;
- regulatory actions, including actions taken by the U.S. Food and
Drug Administration; and
- delays in obtaining domestic or foreign regulatory approvals.
In addition, a large percentage of our sales are made toward the end of each
quarter. As a consequence, our quarterly financial results are often
dependent on the receipt of large customer orders in the last weeks of a
quarter. We may not receive these large orders each quarter. The absence of
these large orders could cause us to fall short of our quarterly sales
targets, which in turn could cause our stock price to decline sharply.
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.
Recalls can occur on all of our products, and most do not have a material
impact. For example, in December 2001, we implemented a voluntary product
corrective action to apply a software fix to a problem on approximately
15,000 of our M-Series defibrillators. This action is expected to cost
approximately $100,000 and is not expected to have a material impact to our
financial results or our consolidated financial position.
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
Page 14 of 34
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:
- major third-party payers of hospital and pre-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 and pre-hospital charges for certain medical procedures;
- Medicare, Medicaid and private health care insurer cutbacks could
create downward price pressure in the cardiac resuscitation pre-
hospital market;
- proposals were adopted recently that will change the reimbursement
procedures for the capital expenditure portion of the cost of
providing care to Medicare patients;
- 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;
- 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;
- there is economic pressure to contain health care costs in
international markets;
- 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
- 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.
WE MAY EXPERIENCE SHORT TERM OPERATING FLUCTUATIONS AS WE CONTINUE TO 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. As more
customers convert to biphasic technology, it may become more difficult for
us to sell the older monophasic technology products resulting in inventory
obsolesence. This risk related to a shift towards biphasic technology
could also be affected by uncertainty of the governing bodies'
recommendations concerning biphasic technology.
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
Page 15 of 34
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 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 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:
Page 16 of 34
- our ability to develop and introduce new products in the time
frames we currently estimate;
- our ability to successfully implement new product technologies;
- the market's readiness to accept new products such as our M
Series defibrillators and data management products;
- the standardization of an automated platform for data management
systems;
- our ability to obtain adequate financial and technical resources
for future product development and promotion;
- the efficacy of our products;
- the ability to obtain timely regulatory approval for new products;
and
- 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 a 510(k)
pre-market notification clearance before they can be introduced 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. Delays in obtaining
510(k) clearance could have an adverse effect on the introduction of future
products. As an example, we are currently in the process of obtaining 510(k)
clearance of our AED Plus. Delays in obtaining this clearance may slow our
penetration into this market. 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:
- place the company under observation and re-inspect the facilities;
Page 17 of 34
- issue a warning letter apprising of violating 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, 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,
pulse oximetry, EtCO2, and NIBP 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.
WE HAVE LICENSED OUR BIPHASIC TECHNOLOGY TO GE MEDICAL SYSTEMS INFORMATION
TECHNOLOGIES
In 2001, we entered into a five year license agreement with GE Medical
Systems Information Technologies that permits GE to incorporate our patented
biphasic waveform technology into their defibrillator and monitoring
systems. We believe that GE's global marketing and distribution channels
will help increase the growing acceptance of our biphasic technology. GE has
significantly greater resources than we do and has a competing product in
the global market. This could impact our ability to market and sell our
products, potentially lowering our revenues.
FUTURE CHANGES IN APPLICABLE LAWS AND REGULATIONS COULD HAVE AN ADVERSE EFFECT
ON OUR BUSINESS
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:
- regulatory clearance previously received for our products could be
revoked;
- costs of compliance could increase; or
- we may be unable to comply with such laws and regulations so that
we would be unable to sell our products.
GENERAL ECONOMIC CONDITIONS MAY CAUSE OUR CUSTOMERS TO DELAY BUYING OUR
PRODUCTS RESULTING IN LOWER REVENUES
The national economy of the United States and the global economy are both
subject to economic downturns. An economic downturn in any market in which
we sell our products may have a significant impact on the
Page 18 of 34
ability of our customers, in both the hospital and pre-hospital markets, to
secure adequate funding to buy our products or might cause purchasing
decisions to be delayed. Any delay in purchasing our products may result in
decreased revenues and also allow our competitors additional time to develop
products which may have a competitive edge over our M Series products,
making future sales of our products more difficult.
THE WAR ON TERRORISM AND THE IMPACT OF A BIO-TERROR THREAT MAY CAUSE OUR
CUSTOMERS TO STOP OR DELAY BUYING OUR PRODUCTS, RESULTING IN LOWER REVENUES
The current war on terrorism and a threat of a bio-terror attack may have a
significant impact on our customers' ability or willingness to buy our
products. Our customers may have to divert their funding, earmarked for
capital equipment purchase to the purchase of other medical equipment and
supplies to fight any potential bio-terror attack. The war on terrorism may
cause the diversion of any government funding of hospitals and EMS services
for capital equipment purchases to the war effort. Such diversion of money
may result in decreased revenues.
THE POTENTIAL DISRUPTION IN THE TRANSPORTATION INDUSTRY ON THE COMPANY'S SUPPLY
CHAIN AND PRODUCT DISTRIBUTION CHANNELS MAY CAUSE DELAYS IN THE DELIVERY OF OUR
PRODUCTS, RESULTING IN LOWER REVENUES
Any future disruption in the transportation industry, as the country
experienced during September 2001, could impact our ability to deliver our
products to our customers in time to be able to recognize revenues in a
period, resulting in lower revenues.
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
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 26% of our sales in fiscal 2001 were made to foreign
purchasers 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:
- fluctuations in foreign currencies;
- trade disputes;
- changes in regulatory requirements, tariffs and other barriers;
- 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;
- timing and availability of import/export licenses;
- political and economic instability;
Page 19 of 34
- difficulties in accounts receivable collections;
- difficulties in managing laws;
- increased tax exposure if our revenues in foreign countries are
subject to taxation by more than one jurisdiction;
- 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
- 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
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 INTELLECTUAL PROPERTY, 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:
- the degree and range of protection any patents will afford against
competitors with similar products;
- if and when patents will be issued;
- whether or not others will obtain patents claiming aspects similar
to those covered by our patent applications;
- whether or not competitors will use information contained in our
expired patents;
- whether or not others will design around our patents or obtain
access to our know-how; or
Page 20 of 34
- 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:
- required to obtain licenses or redesign our products or processes to
avoid infringement;
- prevented from practicing the subject matter claimed in those
patents; or
- 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
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 U.S. 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. Although the tightness of the labor markets has
recently begun to ease, it could still be 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
Page 21 of 34
We may attempt to acquire or make strategic investments in businesses and
other assets. Such acquisitions will involve risks, including:
- the inability to achieve the strategic and operating goals of the
acquisition;
- the inability to raise the required capital to fund the
acquisition;
- difficulty in assimilating the acquired operations and personnel;
- disruption of our ongoing business; and
- 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 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
Page 22 of 34
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.
RECURRING SALES OF ELECTRODES TO OUR CUSTOMERS MAY DECLINE
We typically have recurring sales of electrodes to our customers. If other
vendors develop electrode adaptors which allow generic electrodes to be
compatible with our defribrillators, our future revenue from the sale of
electrodes could be reduced.
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
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 98,000 square feet of
office, warehouse and assembly space in Burlington under a lease expiring in
August 2003. We also have administrative offices in Manchester, England,
Dodewaard, the Netherlands, Cologne, Germany, Sydney, Australia, and in
Mississauga, Ontario, 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.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDER
Not Applicable.
EXECUTIVE OFFICERS OF REGISTRANT
Name Age Position
- ---- --- --------
Richard A. Packer 44 Chairman, Chief Executive Officer and President
A. Ernest Whiton 40 Vice President of Administration and Chief
Financial Officer
Steven K. Flora 50 Vice President, North American Sales
E.J. Jones 59 Vice President, International Sales
Donald R. Boucher 49 Vice President, Research and Development
Ward M. Hamilton 54 Vice President, Marketing
John P. Bergeron 50 Vice President and Corporate Treasurer
Edward T. Dunn 48 Vice President, Operations
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
Page 23 of 34
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.
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. 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.
Mr. Dunn joined the Company as Director of Materials in April 1995. In November
1997, he was appointed Vice President of Operations. Prior to joining the
Company, Mr. Dunn was Materials Manager at Baird Corporation, a manufacturer of
spectrometers and night vision devices, which he joined in 1986. Prior to
joining Baird, Mr. Dunn was Manufacturing Manager at Chelsea Clock Company, a
manufacturer of marine clocks. Mr. Dunn received a B.S. in Industrial
Engineering from Northeastern University.
Page 24 of 34
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 2001 Annual Report ("Annual Report") is incorporated
herein by 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, 2001, there were 102 stockholders of record of the Company's
Common Stock. The Company believes there were substantially in excess of 5,000
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
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 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 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
money market accounts and asset-backed corporate securities. The majority of
these investments have maturities within one to five years. We believe that our
exposure to 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
Page 25 of 34
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 reference.
ITEM 9. CHANGES AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL
DISCLOSURE
Not Applicable.
Page 26 of 34
PART III
ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT
The information appearing in our Proxy Statement for our 2002 Annual Meeting of
Stockholders (the "Proxy Statement") under the caption "Proposal I - Election of
a Class of Directors" is incorporated herein by 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 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 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 reference.
Page 27 of 34
PART IV
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.***
Page 28 of 34
* 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 on
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).
****** Incorporated by reference from the Company's Annual Report for 2000 on
Form 10-K, as amended, filed with the Securities and Exchange Commission
on December 29, 2000.
Page 29 of 34
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 31, 2001.
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.
SIGNATURE TITLE DATE
--------- ----- ----
/s/ Richard A. Packer Chairman, Chief Executive Officer and December 31, 2001
- ------------------------------------ President (Principal Executive Officer)
Richard A. Packer
/s/ A. Ernest Whiton Chief Financial Officer (Principal December 31, 2001
- ------------------------------------ Financial and Accounting Officer)
A. Ernest Whiton
/s/ Willard M. Bright Director December 31, 2001
- ------------------------------------
Willard M. Bright
/s/ Thomas M. Claflin, II Director December 31, 2001
- ------------------------------------
Thomas M. Claflin, II
/s/ Dr. James W. Biondi Director December 31, 2001
- ------------------------------------
Dr. James W. Biondi
/s/ M. Stephen Heilman, M.D. Director December 31, 2001
- ------------------------------------
M. Stephen Heilman, M.D.
/s/ Daniel M. Mulvena Director December 31, 2001
- ------------------------------------
Daniel M. Mulvena
/s/ Benson F. Smith Director December 31, 2001
- ------------------------------------
Benson F. Smith
Page 30 of 34
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.***
* 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).
****** Incorporated by reference from the Company's Annual Report for 2000
Form 10-K, as amended, filed with the Securities and Exchange
Commission on December 29, 2000.
Page 31 of 34
S-1
SCHEDULE II - VALUATION AND QUALIFYING ACCOUNTS
Additions
Charged to
Balance Costs
Beginning of and Balance At End
Classifications Period Expenses Deductions of Period
--------------- ------------ ----------- ---------- ---------------
Year Ended September 30, 2001
Allowance for doubtful
accounts $1,895,000 $1,648,000 $763,000 $2,780,000
========== ========== ======== ==========
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
========== ========== ======== ==========
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