<PAGE> 1
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 OCTOBER 2, 1999
OR
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
FOR THE TRANSITION PERIOD FROM..............TO..........
COMMISSION FILE NUMBER 0-20225
-------
ZOLL MEDICAL CORPORATION
------------------------------------------------------
(Exact name of registrant as specified in its charter)
Massachusetts 04-2711626
- ------------------------------- -------------------
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
32 Second Avenue, Burlington, Massachusetts 01803
- ------------------------------------------- -------------------
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (781) 229-0020
--------------
Securities registered pursuant to Section 12(b) of the Act:
Title of each class Name of each exchange on which registered
------------------- -----------------------------------------
None None
Securities registered pursuant to Section 12(g) of the Act:
Common Stock, $.02 Par Value
----------------------------
(Title of class)
Indicate by check mark whether the registrant (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or for such shorter period that the registrant was
required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days. Yes [X] No [ ].
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405
of Regulation S-K is not contained herein, and will not be contained, to the
best of registrant's knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this Form 10-K or any amendment to this
Form 10-K [X]
The aggregate market value of the voting stock held by non-affiliates of the
registrant as of December 17, 1999 was $235,255,934 based on closing sales price
of $34-3/8 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 17, 1999 was 6,843,809
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the 1999 Annual Report to Shareholders are incorporated by reference
into Parts I, II and IV.
Portions of the definitive Proxy statement dated January 8, 2000 to be delivered
to shareholders in connection with the Annual Meeting of Shareholders to be held
February 8, 2000 are incorporated by reference into Part III.
<PAGE> 2
PART I
ITEM 1. BUSINESS
GENERAL
Incorporated in Massachusetts in 1980, ZOLL Medical Corporation ("ZOLL")
designs, manufactures and markets an integrated line of proprietary, noninvasive
cardiac resuscitation devices, external pacemaker/defibrillators, disposable
electrodes, mobile ECG Systems, and EMS data management solutions. Our product
line includes combination pacemaker/defibrillators, stand-alone pacemakers and
defibrillators and disposable multi-function electrodes that permit cardiac
monitoring, pacing and defibrillation through a single pair of electrodes. We
also produce and sell software and associated hardware for data collection and
management in the EMS market.
The principal markets for cardiac resuscitation equipment are hospitals and
prehospital care providers such as paramedics, ambulance operators, emergency
medical technicians ("EMTs"), firefighters, police and other "first response"
emergency personnel and the so called "public access" care providers including
police and security officers. We also sell data management products primarily to
the prehospital market.
MARKET BACKGROUND
Cardiac arrest accounts for approximately one-quarter of all deaths in the
United States. Cardiac arrest can result from a heart attack or from many other
causes. Victims of cardiac arrest may experience two basic types of
"arrhythmia's," which are abnormal rhythms of the heart caused by insufficient
circulation of oxygenated blood, drugs, electrical shock, mechanical injury,
disease or other causes. In one class of arrhythmia, the heart beats too slowly
(bradycardia) or stops (asystole). Pacing is a method of electrical therapy used
to treat bradycardia and asystole. In the other class of arrhythmia, the heart
beats chaotically (fibrillation) or too quickly (tachycardia). The definitive
treatment for these conditions is defibrillation. We estimate that approximately
40% of cardiac arrest patients initially suffer from bradycardia/asystole and
60% suffer from fibrillation/tachycardia. It is possible for a patient to
experience both types of arrhythmias during a cardiac arrest. In these
situations, it is important to have resuscitation equipment with both pacing and
defibrillation capabilities available.
The most important factor in treating cardiac arrest successfully is time.
Unless treatment is begun within four to eight minutes of the onset of cardiac
arrest, the victim is likely to die. The importance of immediate treatment
creates a need for cardiac resuscitation equipment specifically designed for
emergency use. Noninvasive temporary pacemakers and defibrillators, such as
those that 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.
<PAGE> 3
CARDIAC THERAPIES/DIAGNOSTICS PROVIDED
BRADYCARDIA/PACING. 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.
Drugs utilized in treating bradycardia include isoproterenol and atropine, which
are injected into the patient to stimulate the heartbeat. Cardiac pacing
utilizes an electrical pulse to stimulate the patient's heartbeat. For the
permanent treatment of chronic arrhythmia's, a pacemaker may be surgically
implanted. 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.
The American Heart Association ("AHA") has established standard protocols for
the emergency treatment of cardiac arrest, including bradycardia. These Advanced
Cardiac Life Support ("ACLS") protocols are widely followed by practicing
physicians. In 1992, the AHA released new ACLS protocols recommending
noninvasive pacing as the initial treatment method for certain serious cardiac
conditions.
FIBRILLATION/DEFIBRILLATION/CARDIOVERSION. The other type of life-threatening
cardiac arrhythmia is ventricular fibrillation, in which the heart's normal,
regular electrical impulses become chaotic and the heart ceases to pump blood.
The only accepted emergency treatment of 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, defibrillation has conventionally been administered
through hand-held paddles placed on the patient's chest. However, defibrillation
can also be administered through disposable adhesive electrodes, which we
believe are safer and easier to use than paddles.
In the hospital, most physicians and critical care nurses are trained and
certified to operate defibrillators. Outside the hospital, these persons, as
well as paramedics and other highly trained personnel were traditionally the
only persons authorized to provide defibrillation. Most jurisdictions allow
treatment by EMTs and many now permit the use of automated defibrillators (AEDs)
by less extensively-trained nurses, firefighters, police and other emergency
response personnel, following a brief course in the use of the device.
Cardioversion is a type of defibrillation used to treat tachycardias, which have
not degenerated into fibrillation. During cardioversion, the defibrillator
delivers an electric shock, which is synchronized to the patient's heartbeat in
order to slow the heart to a normal rhythm. Our defibrillators include
cardioversion capability.
ACUTE MYOCARDIAL INFARCTION. Rapid and accurate diagnosis of acute myocardial
infarction (heart attack) and the early administration of thrombolytic (clot
busting) drugs can reduce both mortality and morbidity from this disease. A
growing number of communities are implementing programs to add highly accurate
and sophisticated ECG acquisition capability to allow prehospital care providers
to obtain this diagnostic information. With this information, paramedics and
other prehospital providers can advise hospitals as to the nature of the
patient's conditions and expedite treatment on arrival at the hospital with
drugs that reopen coronary arteries and ultimately minimize or reduce the extent
or damage to the heart. The procedure can be lifesaving for some patients.
<PAGE> 4
CARDIAC RESUSCITATION EQUIPMENT MARKETS
The principal markets for cardiac resuscitation equipment can be divided between
the hospital and prehospital markets.
HOSPITAL MARKET. The hospital market for cardiac resuscitation equipment in the
United States consists of approximately 6,000 acute care community hospitals and
1,000 other hospitals. Hospitals have traditionally been the largest users of
cardiac resuscitation equipment, both for patients admitted for cardiac arrest
and for patients undergoing treatment for other reasons. Many hospital
procedures such as surgery, cardiac catheterization, stress testing and general
anesthesia may induce arrhythmias or cardiac arrest. Hospitals frequently use
cardiac resuscitation devices on a standby basis in connection with these
procedures. Since immediate treatment is the critical factor for successful
cardiac resuscitation, hospitals typically place resuscitation devices
throughout their facilities, including the cardiac and critical care units,
emergency rooms, operating rooms, electrophysiology laboratories and,
increasingly, in general wards. Hospitals also use portable devices during
in-hospital transportation of cardiac patients. Some hospitals are now using
AEDs in remote settings and for use by nursing staff.
The hospital market outside of the United States is less developed and is
expected to grow as more hospitals are built and existing hospitals modernize
and update their approaches to cardiac and emergency care. In the international
market, unlike the United States market, the administration of pacing and
defibrillation is generally viewed as a skill reserved for physicians. Few other
staff members are trained or certified to administer such treatment. It is
expected that emerging standards of care and the acceptance of automated
equipment will eventually result in increased use of cardiac resuscitation
equipment by a broader range of health care personnel in the international
market.
PREHOSPITAL 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
prehospital market is comprised of paramedics, who are generally authorized to
use defibrillators. Paramedics are becoming increasingly aware of pacing as a
standard of care and we believe that as noninvasive temporary pacing has become
more widely accepted in the hospital market, the use of combination
pacemaker/defibrillators will become more widespread in the prehospital setting
as well. Paramedics are also able to use more advanced diagnostics, such as
Diagnostic 12 Lead and SpO2 technologies.
In addition to paramedics, there are numerous other first responders such as
EMTs and many ambulance operators, firefighters, police and other emergency
personnel, who are currently authorized to use automated defibrillators. We
believe that these first responders and their emergency vehicles will represent
an increasingly important market for cardiac resuscitation equipment as the
medical community places increased priority on providing such equipment and the
necessary training to all first responders.
PRODUCTS
We design, manufacture and market an integrated line of noninvasive cardiac
resuscitation devices, EMS information systems, and single-use disposable
electrodes to meet the needs of health care providers treating cardiac arrest in
a variety of settings. The following table summarizes our principal products. In
addition, we provide a full line of cables and other accessories.
<PAGE> 5
<TABLE>
<CAPTION>
Target Date First
Product Description Market Shipped
- ------- ----------- ------ -------
Equipment
- ---------
<S> <C> <C> <C>
PD 1400 Portable combination pacemaker/ Prehospital February 1992
defibrillator and hospital
D 1400 Portable stand-alone defibrillator Prehospital October 1994
and hospital
PD 2000 Combination pacemaker/ defibrillator Hospital October 1994
with advisory capability
D 2000 Stand-alone defibrillator with advisory Hospital October 1994
capability
1600 Semi-automatic pacemaker/ defibrillator Prehospital April 1995
Westech Data EMS Data Management Prehospital November 1996
Management Software
1700 Semi-automatic pacemaker/ defibrillator Hospital March 1997
System 12 ECG/Cardiac Data Management Prehospital November 1997
M Series Combination pacemaker/ Prehospital September 1998
defibrillator/monitor with manual and hospital
capabilities comprising multiple
products based on customer selected
features
M Series AED Semi-automatic pacemaker/defibrillator Prehospital April 1999
with automated capabilities and hospital
M Series-Options SpO2 Prehospital March 1999
and hospital
12 Lead with interpretive algorithm Prehospital September 1999
and hospital
M Series Biphasic Combination pacemaker/ Prehospital September 1999
defibrillator/monitor with rectilinear and hospital
biphasic waveform technology for low
energy defibrillation and cardioversion
Disposable Electrodes
- ---------------------
PRO-padz Pacing only Adult pacing only electrodes Hospital October 1999
(formerly NTP 2000) (12-pair per case)
PEDI-padz Pacing only Pediatric pacing only electrodes Prehospital October 1999
(formerly NTP 2100) (6-pair per case) and hospital
</TABLE>
<PAGE> 6
<TABLE>
<CAPTION>
Target Date First
Product Description Market Shipped
- ------- ----------- ------ -------
<S> <C> <C> <C>
PEDI-padz pacing only Pediatric Multi-function electrodes Prehospital October 1999
(12-pair per case) and hospital
STAT-padz Adult Multi-function electrodes Prehospital October 1999
(12-pair per case) and hospital (original: March
1994)
PRO-padZ Sterile Adult Multi-function electrodes Hospital October 1999
(formerly Sterile Stat (6-pair per case) (original:
Padz) December 1995)
PRO-padZ Radiolucent Adult Multi-function electrodes Hospital October 1999
(formerly Radiolucent (12-pair per case) (original:
Stat Padz) November 1996)
PRO-padZ Cardiology Adult multi-function Electrodes Hospital September 1999
Specialty (12 pair per case)
PRO-padZ Biphasic Adult multi-function Electrodes Hospital November 1999
Multi-Function (12 pair per case)
Electrodes
Battery Systems
- ---------------
Power Charger AC and battery support system module for Prehospital September 1994
PD 1400 and 1600 (includes lead-acid and hospital
batteries)
Base Powercharger 4x4 Battery support system module for PD Prehospital November 1995
1400 and 1600 (includes lead-acid and hospital
batteries)
Smart Battery Battery pack for 1400, 1600, 1700, 2000 Prehospital November 1998
and M Series that provides battery life and hospital
information
Base Powercharger 1x1 Limited release product for battery Prehospital September 1999
support system module for AEDs and hospital
</TABLE>
PRODUCT DETAILS
1400. The PD 1400 is a portable combination pacemaker/defibrillator designed for
both prehospital and hospital use. It is a full conventional
pacemaker/defibrillator that is used for emergency care at bedside and for the
transport of patients either in the ambulance or within the hospital. In
prehospital applications, where patients may be difficult to reach and treat,
the weight, size and reliability of the resuscitation device (including the
battery system) are important purchase considerations. In the hospital, its
combination AC and battery operation make it ideal for versatile use in both
fixed and portable applications. The PD 1400 weighs only 13 to 15 pounds
depending on the electrode configuration, while retaining all of the pacing and
defibrillation capabilities and the
<PAGE> 7
standardized design of previous ZOLL models. The PD 1400 incorporates a
reliable, rechargeable, lead-acid battery system and accessory chargers. The D
1400 incorporates the basic design of the PD 1400, but without pacing
capability. The D 1400 resuscitation system is an entry level device that can be
upgraded to include the advisory feature and ZOLL non-invasive external pacing
capability as hospital needs expand in the future.
2000. The PD 2000 product responds specifically to American Heart Association
initiatives recommending early defibrillation. This resuscitation system
includes an advisory algorithm that detects ventricular fibrillation and
ventricular tachycardia, a life threatening arrhythmia for which rapid
defibrillation is the only effective treatment. The PD 2000 device is designed
for use by non-critical care staff to deliver defibrillation upon onset of
cardiac arrest in accordance with the latest American Heart Association
guidelines. The PD 2000 is a complete resuscitation system, designed to be used
by either the first person to arrive at the patient's side or the ACLS team
after a "code" is initiated in the hospital. Additionally, the unit provides
monitoring, external pacing, and documentation of all treatment during both BLS
and ACLS use. The D 2000 incorporates the basic design of the PD 2000, but
without pacing capabilities. The D 2000 was introduced to meet the needs of
hospitals, which seek only to purchase an advisory defibrillator.
1600. The 1600 models comprise four semi-automatic defibrillators combined with
optional features including strip chart recorder, voice recording, manual
override, and external pacing. The four models are designed for use by many
levels of prehospital care providers. Their optional features and configurable
operation and design allow one 1600 model to be used by personnel trained at
different skill levels, such as first responders and paramedics. The units can
be switched between semi-auto and manual operation via a unique key switch. All
units incorporate a sophisticated data collection system utilizing a removable
solid state memory. ZOLL's proprietary software programs can be loaded onto a PC
to provide data collection, review and archiving.
WESTECH DATA MANAGEMENT SOFTWARE. These products are proprietary software
programs for the electronic collection of all EMS system and patient information
on pen based computers, a master administration computer, and interface with
other software applications used by the customer for billing, dispatching and
training, and archiving. The Westech System improves productivity and efficiency
by automating all data entry, eliminating paperwork and creating electronic
files that are more accurate, complete and easily integrated with other
electronic files for billing and system management. Data entry requirements from
paper forms are reduced or eliminated all together and the electronic files are
more easily used for system administration needs.
1700. This device is an AC and battery powered semi-automated defibrillator for
hospitals with a resuscitation data collection feature and is used by
non-critical care nursing staff for early defibrillation. The device can switch
to full-featured manual operation for physician and critical care staff use,
providing the capabilities of two different devices in one product.
SYSTEM 12. This product obtains a diagnostic ECG tracing consisting of 12 leads
(views) of the heart's electrical activity. It is used to provide rapid and
early identification of myocardial infarction (heart attack) in the prehospital
setting. The tracing obtained can be transmitted to a receiving hospital to
shorten the time to treatment after the patient arrives by ambulance. The system
includes acquisition hardware and software that is used in conjunction with a
portable computer.
M SERIES. The M Series comprises a new line of products that range over a wide
spectrum of customer needs in both the hospital and prehospital markets. M
Series models match all existing ZOLL product's capabilities and offer advanced
monitoring capabilities, additional data collection and information technology
features. The product platforms are specifically designed for the addition of
new features and capabilities, such as SpO2 and interpretive 12 Lead ECG, as
well as the upgrading of units to these new capabilities at a later date. The
products are significantly smaller and lighter than existing ZOLL and
competitive products making them easier to use, carry and transport with
patients and are produced in multiple language labeling as well as multiple
language voice prompts to meet international needs and requirements.
<PAGE> 8
A new display technology provides a high contrast screen display of all
information, making the displayed information easier to see from virtually any
angle and in any lighting condition. The new screen also includes the capability
of displaying multiple waveforms when additional monitoring parameters are
added. A high degree of user selectable operation is provided through an
extensive configuration menu allowing the unit to be easily adapted to local
preferences related to operation.
The M Series incorporates the ZOLL Uniform Operating System common to all ZOLL
products to reduce the need for retraining, enhance operator confidence during
use and reduce the probability of errors during use. An integrated AC or DC main
power supply as well as a standard ZOLL battery pack common to all newer ZOLL
products are built into the unit.
M SERIES BIPHASIC. During September 1999 the Company initiated shipment of a
version of the M Series with a rectilinear biphasic waveform technology.
Protected by six United States patents, this technology has been shown to
deliver superior performance at lower energy levels. Clinical studies to date
have shown that ZOLL's rectilinear biphasic waveform outperforms conventional
monophasic defibrillation for ventricular fibrillation in high impedance
patients and cardioversion of atrial fibrillation.
DISPOSABLE ELECTRODES. We offer a variety of single-patient-use, proprietary
disposable electrodes for use with its resuscitation devices. All of the
Company's multi-function disposable electrodes permit monitoring, pacing and
defibrillation through a single pair of electrodes. In the conventional
electrode configuration, three ECG electrodes are required for monitoring, two
electrodes are required for pacing and two electrodes or paddles were required
for defibrillation, all with accompanying cables. By reducing the number of
electrodes and cables required for emergency treatment, the multi-function
electrodes increase the ease and the speed of use. If simultaneous pacing and
monitoring is required, a separate set of ECG-only electrodes can be used in
addition to the multi-function electrodes.
The disposable multi-function electrodes allow the user to select monitoring,
pacing or defibrillation by turning a single control knob on our resuscitation
devices. The electrodes are pre-gelled, which saves critical time in the
treatment of cardiac arrest and permits "hands-off" therapy. Conventional paddle
electrodes for defibrillation must be manually gelled for each use, which
increases the risk of electrical shock to the operator.
In 1994, we began selling the STAT-padz multi-function electrodes. The STAT-padz
electrode expands our disposable product line to meet the need for speed in
defibrillation and specialized requirements in disposables. STAT-padz are
supplied in a proprietary ZOLL Speed Pack that eliminates unnecessary packaging,
reduces application steps and provides an organized means to apply lifesaving
electrical therapy to the patient.
In 1996, we introduced both radiolucent and sterile multi-function electrodes.
The PRO-padz Radiolucent are made from a specially formulated conductive
material, which is virtually invisible to x-ray. The PRO-padz Sterile are
specially packaged and sterilized, allowing for use in surgical and other
sterile environments.
In 1999, we introduced PRO-padz Cardiology Specialty Multi-function Electrodes
that utilize a new conductive liquid gel to carry the energy from a conductive
plate to the patient. The liquid gel technology allows for the best skin
coupling and reduces the incidences of post procedural patient skin effects.
PRO-padz Biphasic Multi-Function Electrodes, introduced in November 1999, are an
integral part of the ZOLL Rectilinear Biphasic System shown to improve efficacy
in converting atrial fibrillation. We expect that the growing installed base of
its pacing and defibrillation devices will generate increased demand for our
disposable electrodes.
<PAGE> 9
In addition to the disposable multi-function electrodes, we sell both a
pacing-only electrode for use on adults and children (new PRO-padz AND
PEDI-padz) and standard ECG electrodes.
We expect that the growing installed base of its pacing and defibrillation
devises will generate increased demand for its disposable electrodes.
POWERCHARGER, BASE POWERCHARGER 4X4 AND BASE POWERCHARGER 1X1. These products
are used to power and recharge ZOLL devices that store a common rechargeable
battery. This system of compatible chargers and batteries provides customers
with extensive flexibility in adopting ZOLL products for use on both AC power
and portable battery operation. The Base PowerCharger 4x4 and Base PowerCharger
1x1 also provides automated battery testing, eliminating testing batteries
manually and identifying batteries that need replacement before use without
dependence on technicians or clinical staff.
SMART BATTERY. The ZOLL Smart Battery contains a "smart chip" that calculates
actual battery capacity and the amount of charge within the battery to provide
the user with the correct amount of "run-time" when used in a ZOLL 1400, 1600,
1700, 2000 or M Series defibrillator. This product minimizes battery failure and
is an important part of the ZOLL battery management system.
PRODUCT DESIGN AND NEW PRODUCT DEVELOPMENT
Our strategy has been to improve and expand our product line through the
application of our proprietary technology to both devices and disposable
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, which include both digital (microprocessor) and
analog (high voltage) design.
We plan to focus our research and development efforts on the design of safer,
more clinically efficacious, user friendly and cost effective manual and
semi-automatic defibrillators. We also intend to continue our research and
development with respect to noninvasive pacing and defibrillation technologies.
Further, we intend to continue our research and development with respect to
disposable electrodes and electrode materials, including all phases of electrode
design, testing and manufacture.
We have developed an advanced biphasic defibrillation waveform. Clinical trials
have demonstrated that this new waveform provides improved defibrillation
efficacy compared to conventional monophasic waveforms. We believe that this new
proprietary biphasic defibrillation waveform will offer compelling clinical
benefits such that current defibrillator replacement cycles may be accelerated.
SALES AND MARKETING
NORTH AMERICA. Our sales channels in North America include a direct sales force
and distributors, which service certain less accessible geographic areas. Our
North American marketing efforts are directed from our headquarters in
Burlington, Massachusetts, with the sales force calling on hospitals and
ambulance/paramedic services across the United States and Canada.
Significant involvement by the sales person is generally required to establish
new customers. A sales person must call on multiple parties within a hospital,
including both the primary decision maker for the hospital area in which the
device is to be used (e.g., cardiac care unit or emergency room) and the
hospital administrators or equipment purchasing committees. By employing a
direct sales force, we retain greater flexibility and control of our marketing
efforts. The sales force reinforces its ties to our customers by training the
users of the products in their operation.
<PAGE> 10
Nine regional sales managers and two national sales managers manage the sales
force, which currently consists of 79 full time sales people (1998: 66), split
into two distinct markets, hospital and prehospital.
INTERNATIONAL. We have established a network of approximately 60 distributors in
targeted international markets. International operations are based in
Burlington, Massachusetts, with area managers in Europe, Latin America, the
Middle East, and the Far East. We have a direct sales subsidiary in the United
Kingdom and during 1999 we established a direct subsidiary to focus on the
prehospital market in Germany. We believe that there is significant growth
potential in the international market.
RISK FACTORS
NEW PRODUCTS MAY NOT BE ACCEPTED BY OUR CUSTOMERS. Our financial performance
will depend in part upon market acceptance of, and our ability to deliver and
support, our new products such as the M Series defibrillators and our
proprietary biphasic technology. There can be no assurance that we will be
successful in gaining market acceptance of these products or that we will be
able to develop and introduce other new products in a timely manner, that such
new products will gain market acceptance, that new product technologies can be
successfully implemented or that we will have adequate financial or technical
resources for future product development and promotion.
THE MARKET FOR OUR PRODUCTS IS HIGHLY COMPETITIVE. The domestic and
international markets for our products are highly competitive. Some of our
competitors have significantly greater financial, technical, research and
development and marketing resources than we do.
Our principal competitors in the United States are Physio-Control Corporation
("Physio"), a subsidiary of Medtronic Inc., and Agilent Corporation (formerly
Hewlett-Packard Co.'s medical division). Physio and Agilent are the only
competitors that compete across our entire defibrillator product line. Physio
has been for over two decades and continues to be the market leader in the
defibrillator industry. Physio has a broader line of product offerings and
accessories than we do. In addition, Physio and its parent have significantly
greater resources than we do. As a result, there can be no assurance that
Physio, Agilent and other competitors will not substantially increase the
resources they devote to the development and marketing of products competitive
with ours. Moreover, 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. As a
consequence, such competing medical devices may render our products obsolete. In
addition to defibrillation and external pacing, there are other alternative
therapeutic approaches to the treatment of sudden cardiac arrest. Moreover,
there can be no assurance that superior pacing or defibrillation technologies
will not be developed or that these alternative therapies or approaches,
including pharmaceutical or other alternatives, will not prove to be superior to
our products. There can be no assurance that we will be able to compete
successfully in the future against existing or potential competitors or that our
operating results will not be adversely affected by increased price competition.
Competition in the business of developing and marketing software for data
collection, billing and management in the EMS market is intense. Our principal
competitors in this business are Tritech Software Systems, Inc., Sweet Computer
Systems, Inc., RAM Software Systems, Inc., and AmbPac, Inc., some of which have
significantly greater financial, technical, research and development and
marketing resources than we do. Moreover, the barriers to entry in this business
are relatively low, so additional competitors may enter this market in the
future. Many potential customers currently use manual systems instead of
automated systems and no automated platform has become the market standard. It
is possible that customers will continue to use manual systems or that systems
based on DOS or Unix will prevail over our Windows based system. In either
eventuality, our ability to sell our Windows based system would be impacted and
our financial results would be materially and adversely impacted.
<PAGE> 11
WE CAN BE SUED FOR PRODUCING DEFECTIVE PRODUCTS. The manufacture and sale of
medical products entail significant risk of product liability claims. While we
believe that the amount of product liability insurance we maintain is adequate,
there can be no assurance that the amount of such insurance will be sufficient
to satisfy claims made against us in the future or that we will be able to
maintain insurance in the future at satisfactory rates or in adequate amounts.
Product liability claims could result in costs or litigation and could have a
material adverse effect on our business, financial condition and results of
operations. A successful claim brought against us in excess of 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.
WE MAY BE REQUIRED TO IMPLEMENT A COSTLY PRODUCT RECALL. In the event that any
of our products prove to be defective, the FDA could require us to redesign or
implement a recall of any of our products. Such a recall could result in
significant costs to our company 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.
GOVERNMENT REGULATION INCREASES COSTS AND MAY CHANGE. The manufacture and sale
of our products is subject to regulation by numerous governmental authorities,
principally the United States Food and Drug Administration (the "FDA") and
corresponding state and foreign agencies. The FDA administers the Federal Food,
Drug and Cosmetic Act, as amended (the "FDA Act").
Under the FDA Act, products we develop in the future will generally require FDA
clearance pursuant to the Section 510(k) notification process or the more
lengthy pre-market approval ("PMA") process. The process of obtaining FDA
approvals is lengthy, expensive and uncertain. Moreover, approvals, if granted,
may limit the uses for which a product may be marketed. In addition, no
assurance can be given that future changes in the FDA Act or the FDA's
regulations will not have an adverse effect on any FDA clearance previously
received with respect to our products.
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. Failure to
comply with FDA regulations could result in sanctions being imposed on us,
including restrictions on the marketing or recall of our products.
Our products have been classified by the FDA as Class II devices (contain no
advisory functions), and as Class III devices (contain advisory functions, e.g.
automated external defibrillators). These devices must secure either a 510(k)
pre-market notification clearance or an approved Pre-Market Approval Application
("PMA") before they can be introduced into the United States market. The process
of obtaining 510(k) clearance typically takes several months and involves the
submission of limited clinical data supporting assertions that the product is
substantially equivalent to another medical device on the market prior to 1976.
The PMA process typically requires substantially more time than does 510(k)
clearance and requires the submission of significant quantities of clinical data
and supporting information. Delays in obtaining either 510(k) or if necessary,
PMA clearance could have an adverse effect on the introduction of future
products.
Medical device manufacturers are routinely subject to periodic inspections by
the FDA. If the FDA believes that a company may not be operating in compliance
with applicable laws and regulations, it can place the company under observation
and reinspect the facilities; issue a warning letter apprising of violative
conduct; detain or seize products; mandate a recall; enjoin future violations;
and assess civil and criminal penalties against the company, its officers or its
employees.
On November 21, 1997, we received a warning letter from the FDA. The warning
letter was issued as a procedural follow-up to a Form 483 resulting from a
routine inspection. The warning letter
<PAGE> 12
included observations that our definitions for complaints and Medical Device
Reports (MDR) were not appropriate. The FDA completed an inspection relating to
these issues and our manufacturing facility on March 13, 1998 and determined
that the areas inspected appear to be in substantial compliance with the
applicable requirements of the FDA and its implementing regulations. We are also
subject to regulation in each of the foreign countries in which we sell
products. Many of the regulations applicable to ours 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. No assurance can be given that such
clearances will be obtained. Regulations regarding the manufacture and sale of
our products are subject to change.
There can be no assurance that federal, state, local, or foreign governments
will not change existing laws or regulations, adopt new laws or regulations that
would increase our cost of doing business, lower reimbursement levels, or
otherwise have a material adverse effect on our business, financial condition,
cash flows, and results of operations, or that we will be able to comply with
applicable laws or regulations.
THE GOVERNMENT MAY REQUIRE US TO CHARGE LESS FOR OUR PRODUCTS. Trends toward
managed care, health care cost containment, and other changes in government and
private sector initiatives in the United States and other countries in which we
do business are placing increased emphasis on the delivery of more
cost-effective medical therapies. During the last few years, the major
third-party payers of hospital service, Medicare, Medicaid and private health
care insurers, have substantially revised their payment methodologies resulting
in tighter standards for reimbursement of hospital charges for certain medical
procedures. In addition, there is also downward price pressure in the
pre-hospital market due to Medicare, Medicaid and private health care insurer
cutbacks. Recently, proposals were adopted that will change the reimbursement
procedures for the capital expenditure portion of the cost of providing care to
Medicare patients. A material decrease in the care reimbursement levels could
adversely affect future sales of our products.
Numerous legislative proposals have been considered that would result in major
reforms in the United States health care system. We cannot predict which, if
any, health care reforms may be proposed or enacted or the effect that any such
legislation would have on our business. In addition, managed care providers are
attempting to contain health care costs through the use of outpatient services
and specialized treatment facilities. No assurance can be given that changing
industry practices will not have an adverse effect on our business, financial
condition, and results of operations.
Uncertainty remains with regard to future changes within the health care
industry. The trend towards managed care and economically motivated buyers may
result in downward pressure on selling prices and deterioration of gross
margins. The United States marketplace is increasingly characterized by
consolidation among health care facilities and purchasers of medical devices who
prefer to limit the number of suppliers from whom they purchase medical
products. There can be no assurance that these entities will continue to
purchase our products or that they will not seek to impose discounts from our
normal prices. In addition, international markets are also being affected by
economic pressure to contain health care costs.
Our levels of revenues and profitability of sales may be affected by the
continuing efforts of governmental and third party payers to contain or reduce
the costs of health care through various means and the initiatives of third
party payers with respect to the availability of reimbursement. For example, in
certain foreign markets, pricing or profitability is subject to government
control. In the United States there have been, and we expect that there will
continue to be, a number of federal and state proposals to implement similar
governmental control. Although we cannot predict what legislative reforms may be
proposed or adopted or what actions federal, state or private payers for health
care products may take in response to any health care reform proposals or
legislation, the existence and dependency of such proposals could have a
material adverse effect on us. Whether a
<PAGE> 13
medical procedure is subject to reimbursement from third party payers impacts
upon the likelihood that a medical product associated with such a procedure will
be purchased. Third party payers are increasingly challenging the prices charged
for medical products. To the extent any or all of our products, and any
accompanying medical procedures, are not reimbursable by third party payers or
the amount reimbursed is adversely adjusted, our ability to sell products on a
competitive basis will be adversely affected, which could have a material
adverse effect on us.
UNCERTAIN CUSTOMER DECISION PROCESSES. Many of the customers in the pre-hospital
market consist of municipal fire and EMS departments. As a result, there are
numerous decision-makers and governmental procedures in the decision process. In
addition, at most hospitals decisions concerning the purchase of new medical
devices are made on a department-by-department basis. Accordingly, we believe
the purchasing decisions of many of our customers may be characterized by long
decision processes, which may result in long sales cycles for our products.
INTEGRATION OF ACQUISITIONS IS UNCERTAIN AND TIME-CONSUMING. On October 15,
1999, we have merged a wholly-owned subsidiary with and into Pinpoint
Technologies. Pinpoint is now our wholly-owned subsidiary. We expect this merger
to result in certain benefits, but achieving the benefits of the merger will
depend in part upon the integration of the businesses of our operations with
those of Pinpoint in an efficient manner, and there can be no assurance that
this will occur. Integrating our operations with those of Pinpoint may be
difficult, time consuming and costly. The difficulties of such integration may
be increased by the necessity of coordinating geographically separated
organizations and addressing possible differences in corporate cultures and
management philosophies.
The transition to a combined company will require substantial attention from
management of both ZOLL and Pinpoint. The diversion of management attention and
any difficulties encountered in the transition process could have adverse
effects on our business, financial condition and results of operation. In
addition, the process of combining the two organizations could cause the
interruption of, or a disruption in, the companies' businesses, which could have
a material adverse effect on their combined operations. There can be no
assurance that we will realize any of the anticipated benefits of the merger. If
we are not able to effectively integrate our operations, technology and
personnel in a timely and efficient manner, then we will not realize the
benefits we expect from the merger. In particular, if the integration is not
successful our operating results may be harmed, we may lose key personnel, and
the market price of our common stock may decline.
INTERNATIONAL SALES EXPOSE US TO CURRENCY EXCHANGE RATE FLUCTUATIONS AND OTHER
RISKS. We sell many of our products to foreign purchasers, particularly in
countries located in Europe and Asia. As a result, a significant portion of our
sales is 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,
difficulties in accounts receivable collections, difficulties in managing
distributors, the burden of complying with a wide variety of complex treaties
and foreign laws, accepting customer purchase orders governed by foreign laws
which may differ significantly from United States 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. We also
resell trade-in products through distributors in Latin America. Economic
disruption in that region could affect our ability to resell trade-in products.
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.
Our revenue from international operations can be denominated in or significantly
influenced by the currency 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,
<PAGE> 14
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.
There can be no assurance 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. In addition, revenues we earn in foreign countries may be subject to
taxation by more than one jurisdiction, including foreign jurisdictions, which
might have higher tax rates than the U.S., thereby adversely affecting our
earnings.
OUR DEPENDENCE ON SOLE AND SINGLE SOURCE SUPPLIERS AND INDEPENDENT MANUFACTURERS
EXPOSES US TO SUPPLY INTERRUPTIONS THAT COULD RESULT IN PRODUCT DELIVERY DELAYS.
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. Our inability to obtain
sufficient quantities of these components may result in future delays or
reductions in product shipments, which could materially adversely affect our
business, financial condition and results of operations. We currently purchase
proprietary components including, but not necessarily limited to, capacitors,
screens, gate arrays and integrated circuits for which there are no direct
substitutes. These components could be replaced with alternatives from other
suppliers, but that would involve a redesign of our products. Such redesign
would involve considerable time and expense. We currently enter into purchase
orders with our suppliers for materials based on forecasts, but have no
guaranteed supply arrangements with these suppliers.
In addition, we currently use a small number of independent manufacturers to
manufacture several components to our design including, but not necessarily
limited to, circuit boards, molded plastic components, cables and high voltage
assemblies. Our reliance on 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
interruption of supply. Moreover, the manufacture of these components is
extremely complex, and our reliance on the suppliers of these components exposes
us to potential production difficulties and quality variations, which could
negatively impact cost and timely delivery of our products. We currently enter
into purchase orders with independent manufacturers of materials based on
forecasts, but have no guaranteed arrangements with these manufacturers. 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.
COMPETITORS CAN USE SOME OF OUR PREVIOUSLY PROPRIETARY TECHNOLOGY; POTENTIAL
CLAIMS OF PATENT INFRINGEMENT. Our United States pacing system patent, which
expired in 1999, related to the combination of the duration and shape of the
pacing pulse and the characteristics of the electrodes used in its non-invasive
pacing system. We believe that our competitors are focusing their efforts on new
technologies and accordingly, we believe that the expiration of this patent will
not have a material affect on operations. Corresponding patents have been issued
in Canada, France, United Kingdom and Japan. A number of additional U.S. and
foreign patents are now pending or have been issued relating to novel biphasic
defibrillation waveform technologies. Several United States patents related to
features of the 1400, 1600 and 2000 pacer/defibrillator, Powercharger and Stat
Padz electrodes have been issued. Foreign patents relating to the 1400/1600/2000
pacer/defibrillator are pending.
Any claims asserting that our products infringe or may infringe proprietary
rights of third parties, if determined adversely to us, could have a material
adverse effect on our business, financial condition and results of operations.
Any claims, with or without merit, could be time-consuming, result in costly
litigation, divert the efforts of our technical and management personnel, cause
product shipment delays or require us to enter into royalty or licensing
agreements, any of which could have
<PAGE> 15
a material adverse effect upon our operating results. Legal action claiming
patent infringement may be commenced against us. We cannot assure you that we
would prevail in such litigation given the complex technical issues and inherent
uncertainties in patent litigation. In the event a claim against us was
successful, and we could not obtain a license to the relevant technology on
acceptable terms or license a substitute technology or redesign to avoid
infringement, this could have a material adverse effect on our business,
financial condition and results of operations.
YEAR 2000 PROBLEMS COULD DISRUPT OUR BUSINESS. Many existing computer software
programs and operating systems were designed such that the year 1999 is the
maximum date that many computer systems will be able to process. We have
undertaken an assessment of our vulnerability to the so-called "Year 2000 issue"
with respect to our computer systems. The assessment was based upon formal and
informal communications with the software vendors, literature supplied with the
software, literature received in connection with maintenance contracts, and test
evaluations of the software.
We have completed a review of our business systems with regard to Year 2000
compliance. Our information technology systems are being upgraded with a vendor
supplied Year 2000 software package. Although we are testing these systems,
there can be no assurance that these systems will function properly in an
operational environment. We have also assessed the readiness of our factory,
facility, and telecommunications systems and the equipment used to support our
manufacturing processes. Again there can be no assurance that the tests
performed adequately ensure that these systems will function properly in Year
2000. We rely on a variety of either single source or critical source vendors in
the production of our products. There can be no assurance that third party
suppliers will not experience unforeseen difficulties and be unable to supply
components for our products or that third party providers of the hardware upon
which our software runs will not be materially harmed by Year 2000 and be unable
to continue to provide such hardware to us. Year 2000 problems could cause our
banks to experience disruptions, which could adversely affect our operations.
Year 2000 problems could also adversely affect our customers and their ability
to pay us, which would adversely affect our operating results. We might also be
affected by the failure of government agencies on which we depend to maintain
services essential to our operations. Any Year 2000 related problems in the
airline industry might impact our sales force and thus our operating results. We
could also be harmed materially by any significant economic, financial market or
infrastructure disruption attributable to Year 2000 problems. We have completed
our Year 2000 testing of our products and believe them to be Year 2000
compliant. It is possible that this testing did not identify problems that might
still occur in an operational environment.
RELIANCE ON OVERSEAS VENDORS FOR SOME COMPONENTS EXPOSES US TO INTERNATIONAL
BUSINESS RISKS. Some of the components we use in our products are acquired from
foreign manufacturers worldwide, 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, 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 components being
implemented by the United States or these foreign countries, timing and
availability of import/export licenses, political and economic instability and
the general economies of these countries in which we purchase components.
WE RELY HEAVILY ON SEVERAL EMPLOYEES WHO MAY LEAVE. 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 whom would be difficult to replace. Mr. Rolf Stutz, our
former Chief Executive Officer, died in November 1999 and was replaced by Mr.
Richard Packer, who has been serving as our President since 1996. In addition,
our future success will depend in part upon our ability to attract and retain
highly qualified personnel, particularly product design engineers. There can be
no assurance that we will be successful in hiring or retaining
<PAGE> 16
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.
CHANGES IN QUARTERLY OPERATING RESULTS WILL IMPACT MARKET PRICES. Our results of
operations may fluctuate significantly from quarter to quarter. Various factors
may affect results of operations, including quarterly variations in product
orders, timing of new product introductions, the extent to which the products
gain market acceptance, changes in distribution channels, actions of
competitors, the ability of our sales force to effectively market our products,
regulatory actions, and delays in domestic or foreign regulatory approvals. As a
result of such quarterly fluctuations, the market for our common stock may be
volatile.
POTENTIAL ANTI-TAKEOVER EFFECTS OF CHARTER, BY-LAW AND OTHER PROVISIONS. Certain
provisions of Massachusetts law, our Restated Articles of Organization and
Restated By-Laws and our Shareholder Rights Agreement could delay or impede the
removal of incumbent directors and could make more difficult a merger, tender
offer or proxy contest involving the Company, even if such events could be
beneficial, in the short term, to the interests of the stockholders. Such
provisions could limit the price that certain investors might be willing to pay
in the future for shares of our common stock. Our Board of Directors is divided
into three classes, with directors in each class elected for three-year terms.
The Restated Articles of Organization and the Restated By-Laws also impose
various procedural and other requirements, which could make it more difficult
for stockholders to effect certain corporate actions. Shares of preferred stock
may be issued by the Board of Directors without stockholder approval on such
terms as the Board may determine.
We have adopted a so-called "poison pill." This poison pill significantly
increases the costs that would be incurred by an unwanted third party acquirer
if such party owns more than 15% of our outstanding common stock. The existence
of this poison pill could deter a takeover of the Company.
WE HAVE ONLY ONE MANUFACTURING FACILITY FOR EACH OF OUR MAJOR 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 to reduce the
output of products at the damaged facility. This would materially and adversely
impact our business, financial condition and results of operations.
TIGHT LABOR MARKETS COULD MAKE IT DIFFICULT TO RECRUIT EMPLOYEES. Our business
is dependent upon our ability to hire and retain qualified personnel.
Increasingly tight labor markets could make it more difficult and/or expensive
to recruit and retain employees, which could adversely affect our operations and
financial results. In addition, in order to grow our business, we will need to
hire more qualified personnel. There can be no assurance that we will be able to
hire such persons in a cost effective manner.
OUR INVESTMENTS MAY LOSE VALUE IN THE FUTURE. We own and may in the future
invest in the securities of other companies and participate in joint venture
agreements. These investments will be subject to the risks that the entities in
which we invest will become bankrupt or lose money. Investing in securities
involves risks and no assurance can be made as to the profitability of any
investment. Our inability to identify profitable investments could adversely
affect our financial condition and results of operations. Unless we hold a
majority position in an investment or joint venture, we will not be able to
control all of the activities of the companies in which we invest or the joint
ventures in which we are participating. Because of this, such entities may take
actions against our wishes and not in furtherance of, and even opposed to, our
business plans and objectives. These investments are also subject to the risk of
impasse if no one party exercises ultimate control over the business decisions.
WE MAY BE UNABLE TO OBTAIN DEBT OR EQUITY FINANCING WHICH WE NEED TO GROW. Our
future growth is dependent upon our ability to obtain debt and/or equity
financing. Changes in the capital
<PAGE> 17
markets or our ability to access the capital markets could prevent us from
obtaining financing on acceptable terms. This could impact our ability to grow
our business.
OUR OPERATING RESULTS ARE LIKELY TO FLUCTUATE AND CAUSE OUR STOCK PRICE TO BE
VOLATILE, ANTICIPATION OF A VOLATILE STOCK PRICE CAN CAUSE GREATER VOLATILITY.
Our quarterly and annual operating results are fluctuating due to the recent
increased demand for our products. The current high demand for our products has
disrupted our normal factory utilization and caused shipments to occur in uneven
patterns. During this period of high demand, our quarterly and annual operating
results will vary based on our ability to deliver products. Thus, 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 your investment to decline rapidly.
EMPLOYEES
As of October 2, 1999, we employed 423 people on a full-time basis, of which 392
are employed in the U.S. and 31 are employed internationally.
None of our employees are subject to collective bargaining agreements.
We believe that our relations with our employees are excellent.
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
disposable products. We own a 17,500 square foot building in Boulder, Colorado
where the executive offices of our data management software business is located.
We lease approximately 90,000 square feet of office and assembly space in
Burlington under a lease expiring in August 2003, and 2,685 square feet of
office space in Vancouver, British Columbia expiring in 2002. We also have
administrative offices in Manchester, England and in Cologne, Germany. We
believe that our current facilities are adequate for its current needs.
ITEM 3. LEGAL PROCEEDINGS
In the course of normal operations, we are involved in litigation arising from
commercial disputes and claims of former employees which management believes
will not have a material impact on our financial position or our results of
operations.
<PAGE> 18
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
Not Applicable.
EXECUTIVE OFFICERS OF REGISTRANT
Name Age Position
Richard A. Packer 42 Chairman and Chief Executive Officer
A. Ernest Whiton 38 Vice President - Administration and Chief
Financial Officer
Steven K. Flora 48 Vice President - North American Sales
E.J. Jones 57 Vice President - International Sales
Donald R. Boucher 47 Vice President - Research and Development
Ward M. Hamilton 52 Vice President - Marketing
Mr. Packer joined the Company in 1992 and in November 1999, was appointed Chief
Executive Officer. Mr. Packer served as President, Chief Operating Officer and
director from May 1996 to his appointment as CEO. Since 1992 he has served as
Chief Financial Officer and Vice President of Operations of the Company. Prior
to this time, Mr. Packer served from 1987 to 1992 as Vice President of various
functions for Whistler Corporation, a consumer electronics company. Prior to
this, Mr. Packer was a manager with the consulting firm of PRTM/KPMG,
specializing in operations of high technology companies. Mr. Packer has received
B.S. and M. Eng. degrees from the Rensselaer Polytechnic Institute and a M.B.A.
from the Harvard Graduate School of Business Administration.
Mr. Whiton joined the Company as Vice President of Administration and Chief
Financial Officer in January 1999. Prior to joining the Company, Mr. Whiton was
Vice President and Chief Accounting Officer of Ionics, Inc., a global
separations technology company, which he joined in 1993. Prior to Ionics, he was
a manager at Price Waterhouse. Mr. Whiton has received a B.S. in Accounting from
Bentley College and a M.B.A. from the Harvard Graduate School of Business
Administration.
Mr. Flora joined the Company as Vice President of North American Sales in
September 1998. 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 1998. 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
Business School.
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
<PAGE> 19
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. in public administration
from the University of Southern California.
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 "Common Stock Market Prices and Dividends" on page 27 of our 1999 Annual
Report ("Annual Report") is incorporated herein by this reference.
We have never declared or paid cash dividends on its capital stock. We currently
intend 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 October 2, 1999, there were 153 stockholders of record of our Common
Stock. We believe there were substantially in excess of 3,500 beneficial holders
of the Common Stock.
ITEM 6. SELECTED FINANCIAL DATA
The selected consolidated financial data set forth under the caption "Five Year
Financial Summary" on page 10 of the Annual Report are incorporated herein by
this reference and are qualified in their entirety by reference to the more
fully detailed consolidated financial statements and the report of the
independent auditors thereon which are included in the Annual Report.
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
The discussion set forth under the caption "Management's Discussion and Analysis
of Financial Condition and Results of Operations" on pages 11 through 13 of the
Annual Report is incorporated herein by this reference and should be read in
conjunction with "Business" (Item 1) "Selected Consolidated Financial Data"
(Item 6).
This Form 10-K, including the information incorporated by reference into this
Form 10-K, contains statements that are forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934. When we use the words "believe," "expect,"
"anticipate," "intend," "estimate," "assume" and other similar expressions, they
are generally forward-looking statements. These statements include, among other
things, statements regarding our intent, belief or expectations with respect to:
<PAGE> 20
- market acceptance of new products;
- competition in the industry;
- the impact of pending or future litigation;
- the impact of future product recalls;
- changes in, or the failure or inability to comply with, governmental
regulation;
- the integration of the personnel, products and operations of Pinpoint
Technologies, Inc., which we recently acquired;
- exchange rate fluctuations;
- the implementation of our plan to address Year 2000 issues;
- the availability of debt and equity financing;
- development of new competitive technologies;
- availability of key components for our products;
- availability of qualified personnel;
- international, national, regional and local economic and political
changes;
- the value of our investments;
- our factory loading;
- general economic conditions; and
- trends affecting the medical device industry or our financial
- condition or results of operations.
You should not rely on forward-looking statements, because they involve known
and unknown risks, uncertainties and other factors, some of which are beyond our
control. These risks, uncertainties and other factors may cause our actual
results, performance or achievements to differ materially from the anticipated
future results, performance or achievements expressed or implied by the
forward-looking statements. In addition to the factors discussed under the
preceding "Risk Factors" section, some of the factors that might cause these
differences include, but are not limited to, the following:
- competition may lead to worse than expected financial condition or
results of operations;
- the demand for new products is unpredictable;
- pending or future litigation may negatively impact our financial
condition or results of operations;
- future recalls may negatively impact our financial condition or
results of operations;
- government regulation may negatively impact our financial condition or
results of operations;
- costs associated with integrating acquisitions may be larger than we
anticipate;
- exchange rate fluctuations may affect profitability of overseas sales;
- failure to implement our plan to address Year 2000 issues could
adversely impact our products and operations;
- failure to obtain debt and/or equity financing could negatively impact
our ability to grow our business;
- manufacturing disruptions could negatively impact our financial
condition or results of operations;
- qualified personnel may not be available which could negatively impact
our ability to grow our business;
- the value of our investments may decline which could negatively impact
our financial condition or results of operations; and
- the production of commercially feasible products may take longer and
cost more than expected.
We caution you that while forward-looking statements reflect our estimates and
beliefs, they are not guarantees of future performance. These forward-looking
statements were based on information, plans and estimates at the date of this
prospectus, and we disclaim any obligation to update or revise any
forward-looking statements to reflect changes in underlying assumptions or
factors, new information, future events or other changes.
<PAGE> 21
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not applicable.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
The Consolidated Financial Statements, Notes thereto, Independent Auditors
Report and Quarterly Financial Data (Unaudited) on pages 14 through 27 of the
Annual Report and listed below in Item 14 are incorporated herein by this
reference.
ITEM 9. CHANGES AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING FINANCIAL
DISCLOSURE
Not Applicable.
PART III
ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT
The information appearing in our Proxy Statement for our 2000 Annual Meeting of
Stockholders (the "Proxy Statement") under the caption "Proposal I - Election of
a Class of Directors" is incorporated herein by this reference. Information
regarding Executive Officers of the Company called for by Item 10 is set forth
at the end of Part I of this Report under the caption "Executive Officers of
Registrant."
ITEM 11. EXECUTIVE COMPENSATION
The information appearing in the Proxy Statement under the captions "Proposal I
- - Election of a Class of Directors" and "Executive Compensation" is incorporated
herein by this reference.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
The information appearing in the Proxy Statement under the captions "Proposal I
- - Election of a Class of Directors" and "Other Matters - Principal Stockholders"
is incorporated herein by this reference.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
The information appearing in the Proxy Statement under the captions "Proposal I
- - Election of a Class of Directors" and "Certain Relationships" is incorporated
herein by this reference.
<PAGE> 22
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 14 through 27 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
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*****
13.1 Portions of the Annual Report incorporated by reference.***
21.1 Subsidiaries of the Company.***
23.1 Consent of Ernst & Young LLP.***
27.1 Financial Data Schedule for 1999 ***
<PAGE> 23
No reports on Form 8-K were filed by the Company during the last
quarter of the period covered by this Report.
* Incorporated by reference from the Company's Registration
Statement on Form S-1, as amended, under the Securities Act of
1933 (Registration Statement No. 33-47937).
** Incorporated by reference from the Company's Annual Report for
1996 Form 10-K, as amended, filed with the Securities and
Exchange Commission on December 27, 1996.
*** Filed herewith.
**** Incorporated by reference from the Company's 8-K filed with
the Securities and Exchange Commission on June 11, 1998.
***** Incorporated by reference from the Company's Registration
Statement on Form S-8, under the Securities Act of 1933
(Registration Statement No. 33-368401).
<PAGE> 24
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 30, 1999.
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 and Chief Executive December 30, 1999
- ---------------------------- Officer
Richard A. Packer
/s/ A. Ernest Whiton Chief Financial Officer December 30, 1999
- ----------------------------
A. Ernest Whiton
/s/ Willard M. Bright Director December 30, 1999
- ----------------------------
Willard M. Bright
/s/ Thomas M. Claflin, II Director December 30, 1999
- ----------------------------
Thomas M. Claflin, II
/s/ Dr. James W. Biondi Director December 30, 1999
- ----------------------------
Dr. James W. Biondi
/s/ M. Stephen Heilman, M.D. Director December 30, 1999
- ----------------------------
M. Stephen Heilman, M.D.
/s/ Daniel M. Mulvena Director December 30, 1999
- ----------------------------
Daniel M. Mulvena
<PAGE> 25
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*****
13.1 Portions of the Annual Report incorporated by reference.***
21.1 Subsidiaries of the Company.***
23.1 Consent of Ernst & Young LLP.***
27.1 Financial Data Schedule for 1999. ***
No reports on Form 8-K were filed by the Company during the last
quarter of the period covered by this Report.
* Incorporated by reference from the Company's Registration
Statement on Form S-1, as amended, under the Securities Act of
1933 (Registration Statement No. 33-47937).
** Incorporated by reference from the Company's Annual Report for
1996 Form 10-K, as amended, filed with the Securities and
Exchange Commission on December 27, 1996.
*** Filed herewith.
**** Incorporated by reference from the Company's 8-K filed with
the Securities and Exchange Commission on June 11, 1998.
***** Incorporated by reference from the Company's Registration
Statement on Form S-8, under the Securities Act of 1933
(Registration Statement No. 33-368401).
<PAGE> 26
SCHEDULE II - VALUATION AND QUALIFYING ACCOUNTS
<TABLE>
<CAPTION>
Additions
Balance Charged to
Beginning of Costs and Balance At
Classifications Period Expenses Deductions End of Period
--------------- ------------ ---------- ---------- -------------
<S> <C> <C> <C> <C>
Year Ended October 2, 1999
Allowance for doubtful accounts $ 914,000 $1,207,000 $126,000 $1,995,000
========== ========== ======== ==========
Year Ended September 26, 1998
Allowance for doubtful
accounts $1,207,000 $ 170,000 $463,000 $ 914,000
========== ========== ======== ==========
Year Ended September 27, 1997
Allowance for doubtful accounts $ 888,000 $ 319,000 $ -- $1,207,000
========== ========== ======== ==========
</TABLE>
<PAGE> 1
EXHIBIT 13.1
ZOLL Medical Corporation
Five Year Financial Summary
<TABLE>
<CAPTION>
YEAR ENDED
Oct. 2, Sept. 26, Sept. 27, Sept. 28, Sept. 30,
(000's omitted, except per share data) 1999 1998 1997 1996 1995
- -------------------------------------- ---- ---- ---- ---- ----
<S> <C> <C> <C> <C> <C>
Income Statement Data:
Net sales $ 73,977 $ 55,080 $ 56,336 $ 54,762 $ 45,664
Cost of goods sold 32,057 23,813 25,089 24,390 20,384
-------- -------- -------- -------- --------
Gross profit 41,920 31,267 31,247 30,372 25,280
Expenses:
Selling and marketing 24,084 20,045 18,422 16,709 15,553
General and administrative 5,490 5,351 6,176* 4,423 4,151
Research and development 6,289 6,233 6,235* 4,355 4,360
-------- -------- -------- -------- --------
Total expenses 35,863 31,629 30,833 25,487 24,064
-------- -------- -------- -------- --------
Income (loss) from operations 6,057 (362) 414 4,885 1,216
Net investment income 34 423 367 286 243
-------- -------- -------- -------- --------
Income before income taxes 6,091 61 781 5,171 1,459
Provision for income taxes 2,010 18 266 1,758 496
-------- -------- -------- -------- --------
Net income $ 4,081 $ 43 $ 515* $ 3,413 $ 963
======== ======== ======== ======== ========
Basic earnings per common share $ 0.66 $ 0.01 $ 0.08* $ 0.56 $ 0.16
Weighted average common
shares outstanding 6,223 6,192 6,192 6,153 6,110
-------- -------- -------- -------- --------
Diluted earnings per common and
equivalent share $ 0.63 $ 0.01 $ 0.08 $ 0.55 $ 0.16
Weighted average common and
equivalent shares outstanding 6,448 6,225 6,228 6,214 6,192
======== ======== ======== ======== ========
Balance Sheet Data:
Working capital $ 26,406 $ 21,153 $ 24,032 $ 24,920 $ 24,147
Total assets $ 55,635 $ 45,288 $ 44,210 $ 42,089 $ 36,139
Total long-term debt, excluding
current portion $ 352 $ 442 $ 552 $ 661 $ 767
Stockholders' equity $ 39,923 $ 34,082 $ 34,039 $ 33,422 $ 29,590
</TABLE>
* During the year ended September 27, 1997, excluding a one-time charge taken in
Q1 aggregating $2.3 million, net income would have been $2,033 and earnings
per common and equivalent share would have been $0.33.
10
<PAGE> 2
Management's Discussion and Analysis
of Financial Condition and Results of Operations
1999 COMPARED TO 1998
Net sales reached record levels, increasing 34% from the prior year to $74.0
million, reflecting the rapid market acceptance of the M Series platform
introduced to the market during the fourth quarter of 1998. Sales growth also
reflected the reorganization and enlargement of the North American sales force
to allow for a market-focused structure. Dedicated selling teams are now focused
on each of North America's markets: hospital and prehospital.
The Company experienced significant growth in all major geographies and segments
of its business. During 1999, North American sales increased 33% to $60.3
million. Equipment sales to the hospital and prehospital markets increased 55%
and 16%, to $30.9 million and $14.4 million, respectively. The increased
equipment sales to the prehospital market include a reduction in sales of
Westech equipment. Sales in the international market increased 39% from the
prior year.
Gross margin remained flat in 1999. An improvement in costs reflecting the M
Series introduction was offset by lower margins, reflecting a heavier hardware
mix in our Westech equipment business and an overall reduction in the mix of
electrodes due to rapid capital equipment growth.
Selling and marketing costs increased 20% over the prior year, due to the
increase in size of the North American sales force. Additionally, the Company
established a direct sales force in Germany during the fourth quarter of 1999.
Selling and marketing costs as a percentage of sales decreased from 36% to 33%,
reflecting leverage from the reorganized North American sales force, focused on
each market.
General and administrative expenses decreased as a percentage of sales, from 10%
to 7%, due to emphasis on expense controls and absorption of relatively fixed
expenses by higher sales.
Research and development expenses decreased as a percentage of sales, from 11%
to 9%. Total expenses increased slower than revenues, reflecting the completion
of development of the initial M Series platform and the related transfer of
available resources to the biphasic project and other initiatives.
Investment income decreased from the prior year due to the decrease in average
cash balances from 1998 to 1999.
The effective income tax rate increased from 30% in 1998 to 33% in 1999. This
increase results primarily from increased domestic profitability partially
offset by the benefits resulting from the utilization of tax loss carryforwards
from foreign operations.
1998 COMPARED TO 1997
The Company's net sales decreased by 2% to $55.1 million, reflecting the net
effect of an increase in sales of disposable electrodes and Westech management
data software and hardware and a decrease in equipment sales.
North American equipment sales decreased slightly from 1997, which the Company
believes was primarily the result of customers holding back on purchases while
waiting for the release of the M Series, which was not shipped until the end of
the fourth quarter of 1998. Equipment sales to the hospital market decreased by
7% while sales to the prehospital market increased 11%. Sales to the prehospital
market benefited from an increase in sales of Westech equipment. Depressed
foreign markets contributed to the 16% decrease in sales in the international
markets. The M Series did not have any significant impact on sales to the
international markets in 1998 as the rollout to international distributors
occurred in 1999.
Gross profit increased as a percentage of sales to 56.7% from 55.4%. This
increase is primarily a result of the improved business mix.
Selling and marketing expenses increased as a percentage of sales to 36% from
33%. This increase primarily reflected higher payroll related costs and travel
expenditures reflecting the reorganization of the North American sales force.
This mid-year reorganization increased the size of and split the sales force to
focus on two distinct markets. This increase also reflected higher expenditures
for promotion, advertising and other selling activities related to the
introduction of the M Series.
General and administrative expenses decreased as a percentage of sales from 11%
to 10%, and decreased in total by 13% to $5.4 million. This decrease was due
primarily to the occurrence of a one-time charge recognized in 1997 of $1.3
million related to the estimated cost of proceeding to trial in a class action
shareholder lawsuit.
11
<PAGE> 3
Research and development expenses remained consistent as a percentage of sales.
Excluding a charge of $1.0 million that was made to account for the value of
in-process research and development acquired in the purchase of assets from
Westech, research and development expenses increased by 19%. This increase was
due primarily to an increase in prototype and testing expenses for new
technology and start-up costs for the M Series.
Net investment income increased from the prior year due primarily to higher
average cash balances.
At September 26, 1998, the Company had available tax loss carryforwards of
approximately $1.6 million which were primarily attributable to the Company's
foreign operations and were not available to offset domestic taxable income.
LIQUIDITY AND CAPITAL RESOURCES
The Company's cash and investments decreased $3.5 million from the prior year.
While net income increased over $4.0 million from the prior year, cash used for
operating activities for the year ended October 2, 1999 increased $1.3 million
over the same period in 1998. The cash usage was due primarily to an increase in
accounts receivable and inventories, partially offset by an increase in accounts
payable. The increase in accounts receivable reflected both overall sales growth
and significant shipments made during the latter part of the fourth quarter of
1999. The increase in inventory reflected the introduction of the M Series
platform. During this period of introduction, the Company's mix of product
shipments is shifting and the Company is carrying a broader mix of product in
inventory to meets its customers' needs.
The amount of cash required to fund investing activities decreased from the
prior year by $1.0 million. This decrease reflected a reduction in capital
expenditures, as significant expenditures incurred in 1998 were related to
production tooling for the M Series introduction.
The increase in cash provided by financing activities primarily results from the
cash provided from the exercise of stock options during the year.
The Company maintains a working capital line of credit with its bank. Borrowings
under this line bear interest at the bank's base rate (8.25% at October 2,
1999). The full amount of the line was available to the Company at October 2,
1999. Currently, the Company may borrow up to $12.0 million on a demand basis.
The Company expects that the combination of existing funds, cash generated from
operations and its existing line of credit will be adequate to meet its
operational liquidity and capital requirements for the foreseeable future.
YEAR 2000
Introduction: Many computer and software systems in use today are not designed
to process date information after 1999. This deficiency results from the
inability of most computer programs that perform arithmetic and logic operations
after this date to use only the last two digits of the year when they make their
calculations. If not corrected, this year 2000 problem could cause computer
applications and other equipment used and manufactured by the Company, its
suppliers and its customers to fail to operate properly.
Year 2000 Project: In early 1998, the Company began a project to assess its
potential vulnerability to the year 2000 problem and to minimize the effect of
the problem on its operations. The project addresses five major areas of the
business at each of its locations: business systems, including management
information systems; factory and facilities equipment, including equipment that
uses a computer to control its operation either for producing end product or to
supply services; products, including equipment and software supplied to
customers; suppliers, including businesses that provide services and raw
materials to the Company; and customers.
The Company has completed a review of its business systems with regard to year
2000 compliance and will either replace or correct through programming
modifications those critical computer systems that have been found to have date
related deficiencies. The Company's information technology systems were upgraded
with vendor supplied year 2000 software packages. Although the Company is
testing these systems, there can be no assurance that these systems will
function properly in an operational environment. The Company expects to complete
testing of these systems by December 31, 1999. The Company is also assessing
factory, facility and telecommunication systems and equipment used to support
manufacturing processes. The Company has assessed the year 2000 readiness of
the equipment used in the
12
<PAGE> 4
manufacturing and testing of its products and believes this equipment to be year
2000 compliant, but there can be no assurance that the tests performed
adequately ensure that such equipment will not experience year 2000 failure. In
addition, the Company is assessing the readiness of third parties (vendors,
customers, etc.) that interact with the Company's systems. The Company has
tested its products and has found them to be year 2000 compliant. It is possible
that this testing did not identify problems that might still occur in an
operational environment.
Year 2000 Costs: External and internal costs specifically associated with
modifying internal use software for year 2000 compliance are expensed as
incurred. To date, those costs have totaled less than $600,000. Based on
currently available information, the Company expects the total cost of
addressing the potential year 2000 issues to be less than $750,000. The Company
does not expect the costs of addressing potential year 2000 problems to have a
material adverse effect on the Company's financial position, results of
operations or liquidity in future periods.
Risks and Contingency Plans: The Company relies on a variety of either single or
critical source vendors in the production of its products. The Company
anticipates a reasonably worst case scenario to be the failure of a single or
critical source vendor to be year 2000 compliant. Such failure might cause the
third party vendor to be unable to supply critical components or other resources
that would have a material adverse effect on the Company.
If not remediated, year 2000 issues have the potential to severely disrupt the
Company's operations and to adversely affect its financial condition. While the
Company may monitor the readiness for the year 2000 of its suppliers and its
customers, it has very limited ability to assure year 2000 readiness by such
parties. The failure of any supplier or customer to ensure its own year 2000
readiness could have a material adverse impact on the Company. There can be no
assurance that third party suppliers will not experience unforeseen difficulties
and be unable to supply components of the Company's products or that third party
providers of the hardware upon which its software runs will not be materially
harmed by year 2000 problems and be unable to continue to provide such hardware
to the Company. Year 2000 problems could cause the Company's banks to experience
disruptions, which could adversely affect operations. Year 2000 problems could
also adversely affect customers and their ability to pay the Company, which
would adversely affect operating results. The Company could also be affected by
the failure of government agencies on which the Company depends to maintain
services essential to operations and the failure of the airline industry on
which the Company relies to support the activities of the sales force. The
Company could also be harmed materially by any significant economic, financial
market or infrastructure disruption attributable to year 2000 problems. The
Company is finalizing contingency plans to cover situations in which year 2000
problems arise despite its efforts. These plans are expected to be substantially
ready by December 31, 1999.
SAFE HARBOR STATEMENTS
Except for the historical information contained herein, the matters set forth
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, that 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 set forth in the Company's registration statement on form S-3
filed on November 16, 1999, product demand and market acceptance risks, the
effect of economic conditions, results of pending or future litigation, the
impact of competitive products and pricing, product development and
commercialization, technological difficulties, the government regulatory
environment and actions, trade environment, capacity and supply constraints or
difficulties, the results of financing efforts, actual purchases under
agreements, year 2000 issues, including expectations of readiness, and the
effect of the Company's accounting policies.
13
<PAGE> 5
Report of Independent Auditors
BOARD OF DIRECTORS AND STOCKHOLDERS ZOLL MEDICAL CORPORATION
We have audited the accompanying consolidated balance sheets of ZOLL Medical
Corporation as of October 2, 1999 and September 26, 1998, and the related
consolidated statements of income, stockholders' equity and cash flows for each
of the three years in the period ended October 2, 1999. These financial
statements are the responsibility of the Company's management. Our
responsibility is to express an opinion on these financial statements based on
our audits.
We conducted our audits in accordance with generally accepted auditing
standards. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material
misstatement. An audit includes examining, on a test basis, evidence supporting
the amounts and disclosures in the financial statements. An audit also includes
assessing the accounting principles used and significant estimates made by
management, as well as evaluating the overall financial statement presentation.
We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present
fairly, in all material respects, the consolidated financial position of ZOLL
Medical Corporation at October 2, 1999 and September 26, 1998, and the
consolidated results of its operations and its cash flows for each of the three
years in the period ended October 2, 1999, in conformity with generally accepted
accounting principles.
/s/ Ernest & Young LLP
November 12, 1999
Boston, Massachusetts
14
<PAGE> 6
ZOLL Medical Corporation
Consolidated Balance Sheets
<TABLE>
<CAPTION>
Oct. 2, Sept. 26,
(000's omitted) 1999 1998
- ---------------- ---- ----
<S> <C> <C>
Assets
Current assets:
Cash and cash equivalents $ 1,311 $ 4,824
Accounts receivable, less allowance of $1,995 at
October 2, 1999 and $914 at
September 26, 1998 24,659 14,147
Inventories:
Raw materials 5,332 3,990
Work-in-process 2,623 1,735
Finished goods 5,241 3,680
------- -------
13,196 9,405
Prepaid expenses and other current assets 2,253 3,253
------- -------
Total current assets 41,419 31,629
Property and equipment at cost:
Land and building 1,032 1,032
Machinery and equipment 15,033 12,580
Construction in progress 477 1,162
Tooling 2,695 2,225
Furniture and fixtures 720 674
Leasehold improvements 737 737
------- -------
20,694 18,410
Less accumulated depreciation 10,657 8,122
------- -------
Net property and equipment 10,037 10,288
Other assets, net of accumulated amortization of
$711 at October 2, 1999 and $496 at
September 26, 1998 4,179 3,371
------- -------
$55,635 $45,288
======= =======
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable $ 8,256 $ 2,776
Accrued expenses and other liabilities 6,667 7,595
Current maturities of long-term debt 90 105
------- -------
Total current liabilities 15,013 10,476
Deferred income taxes 347 288
Long-term debt 352 442
Commitments and contingencies
Stockholders' equity
Preferred stock, $.01 par value, authorized 1,000 shares,
none issued and outstanding
Common stock, $.02 par value, authorized 19,000 shares,
6,339 and 6,192 issued and outstanding at
October 2, 1999 and September 26, 1998,
respectively 127 124
Capital in excess of par value 22,399 20,642
Retained earnings 17,397 13,316
------- -------
Total stockholders' equity 39,923 34,082
------- -------
$55,635 $45,288
======= =======
</TABLE>
See notes to consolidated financial statements.
15
<PAGE> 7
ZOLL Medical Corporation
Consolidated Income Statements
<TABLE>
<CAPTION>
YEAR ENDED
Oct. 2, Sept. 26, Sept. 27,
(000's omitted, except per share data) 1999 1998 1997
- -------------------------------------------------------------------------------------------
<S> <C> <C> <C>
Net sales $ 73,977 $ 55,080 $ 56,336
Cost of goods sold 32,057 23,813 25,089
-------- -------- --------
Gross profit 41,920 31,267 31,247
Expenses:
Selling and marketing 24,084 20,045 18,422
General and administrative 5,490 5,351 6,176
Research and development 6,289 6,233 6,235
-------- -------- --------
Total expenses 35,863 31,629 30,833
-------- -------- --------
Income (loss) from operations 6,057 (362) 414
Investment income 107 474 427
Interest expense 73 51 60
-------- -------- --------
Income before income taxes 6,091 61 781
Provision for income taxes 2,010 18 266
-------- -------- --------
Net income $ 4,081 $ 43 $ 515
======== ======== ========
Basic earnings per common share $ 0.66 $ 0.01 $ 0.08
Weighted average common
shares outstanding 6,223 6,192 6,192
-------- -------- --------
Diluted earnings per common and
equivalent share $ 0.63 $ 0.01 $ 0.08
Weighted average common shares and
equivalent outstanding 6,448 6,225 6,228
======== ======== ========
</TABLE>
See notes to consolidated financial statements.
16
<PAGE> 8
ZOLL Medical Corporation
Statements of Stockholders' Equity
<TABLE>
<CAPTION>
CAPITAL IN TOTAL
COMMON EXCESS OF RETAINED STOCKHOLDERS'
(000'S OMITTED) SHARES AMOUNT PAR VALUE EARNINGS EQUITY
- ------------------------------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C> <C>
Balance at September 28, 1996 6,174 $124 $20,540 $12,758 $33,422
Exercise of stock options 18 59 59
Tax benefit realized upon
exercise of stock options 43 43
Net income 515 515
----- ---- ------- ------- -------
Balance at September 27, 1997 6,192 124 20,642 13,273 34,039
Net income 43 43
----- ---- ------- ------- -------
Balance at September 26, 1998 6,192 124 20,642 13,316 34,082
Exercise of stock options 147 3 1,129 1,132
Tax benefit realized upon
exercise of stock options 628 628
Net income 4,081 4,081
----- ---- ------- ------- -------
Balance at October 2, 1999 6,339 $127 $22,399 $17,397 $39,923
===== ==== ======= ======= =======
</TABLE>
See notes to consolidated financial statements.
17
<PAGE> 9
ZOLL Medical Corporation
Consolidated Statements of Cash Flows
<TABLE>
<CAPTION>
YEAR ENDED
OCT. 2, SEPT. 26, SEPT. 27,
(000'S OMITTED) 1999 1998 1997
- --------------------------------------------------------------------------------------------------
Operating Activities:
<S> <C> <C> <C>
Net income $ 4,081 $ 43 $ 515
Charges not affecting cash:
Depreciation and amortization 2,882 1,696 1,398
Accounts receivable allowances 1,207 170 319
Inventory reserve 129 53 318
Provision for warranty expense 180 (43) 275
Deferred income taxes (339) 188 (898)
In-process research and development -- -- 1,000
Changes in current assets and liabilities:
Accounts receivable (11,719) 175 1,460
Inventories (3,920) (1,982) (408)
Prepaid expenses and other current assets 1,398 (1,714) (23)
Accounts payable and accrued expenses 4,372 1,008 1,654
-------- -------- --------
Cash provided by (used for) operating activities (1,729) (406) 5,610
Investing Activities:
Additions to property and equipment, net (2,437) (4,476) (1,764)
Investment in marketable securities (419) (2,675) (2,575)
Redemption of marketable securities 419 2,953 5,262
Other assets, net (1,002) (214) (166)
Acquisition of assets from
Westech Information Systems, Inc. -- (3) (1,558)
-------- -------- --------
Cash used for investing activities (3,439) (4,415) (801)
Financing Activities:
Exercise of stock options,
including income tax benefits 1,760 -- 102
Repayment of long-term debt (105) (115) (113)
-------- -------- --------
Cash provided by (used for)
financing activities 1,655 (115) (11)
-------- -------- --------
Net increase (decrease) in cash (3,513) (4,936) 4,798
Cash and cash equivalents at
beginning of year 4,824 9,760 4,962
-------- -------- --------
Cash and cash equivalents
at end of year $ 1,311 $ 4,824 $ 9,760
-------- -------- --------
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:
Cash paid during the year:
Income taxes $ 555 $ 1,002 $ 551
Interest 73 51 60
</TABLE>
See notes to consolidated financial statements.
18
<PAGE> 10
ZOLL Medical Corporation
Notes to Consolidated Financial Statements
NOTE A-SIGNIFICANT ACCOUNTING POLICIES
DESCRIPTION OF BUSINESS: ZOLL Medical Corporation (the Company) designs,
manufactures and markets an integrated line of proprietary, non-invasive cardiac
resuscitation devices, disposable electrodes and accessories used for the
emergency resuscitation of cardiac arrest victims. The Company also designs and
markets software, which automates collection and management of both clinical and
non-clinical data for emergency medical service providers (prehospital market).
PRINCIPLES OF CONSOLIDATION: The consolidated financial statements include the
accounts of the Company and its wholly owned subsidiaries. All significant
intercompany accounts and transactions have been eliminated.
FISCAL YEAR: The Company's fiscal year ends on the Saturday closest to September
30. The year ended October 2, 1999 included 53 weeks and the years ended
September 26, 1998 and September 27, 1997 included 52 weeks.
CASH AND CASH EQUIVALENTS: The Company considers all highly liquid instruments
with an original maturity of three months or less to be cash equivalents.
Substantially all cash and cash equivalents are invested in a money market
investment account. These amounts are stated at cost, which approximates market.
INVENTORIES: Inventories, principally purchased parts, are valued at the lower
of first-in, first-out (FIFO) cost or market. Market is replacement value for
raw materials and net realizable value, after allowance for estimated costs of
completion and disposal, for work-in-process and finished goods.
INTANGIBLE ASSETS: Patents and software are stated at cost and amortized using
the straight-line method over five years. The excess of cost over fair value of
the net assets acquired is amortized on a straight-line basis over 15 years.
Prepaid license fees are amortized over the term of the related contract, once
commercialization of the related product begins.
PROPERTY AND EQUIPMENT: Property and equipment are stated at cost. In general,
depreciation is computed on a straight-line basis over the estimated economic
useful lives of the assets (forty years for buildings, three to ten years for
machinery and equipment and five years for tooling and furniture and fixtures).
Leasehold improvements are being amortized over the life of the lease.
REVENUE RECOGNITION: Revenue from product sales is recognized upon shipment of
the product and recorded net of estimated returns. Revenue from software license
fees and the sale of hardware products is recognized upon shipment of the
product, provided that no significant customizations remain and collection of
the receivable is considered probable. Service revenue earned on extended
warranty contracts is recognized on a straight-line basis over the life of the
contract period.
ADVERTISING COSTS: Advertising costs are expensed as incurred and totaled
$329,000, $360,000 and $348,000 in 1999, 1998 and 1997, respectively.
PRODUCT WARRANTY: Expected future product warranty costs, included in accrued
expenses and other liabilities, are recognized at the time of sale for all
products covered under warranty. Warranty periods range from one to five years.
FOREIGN CURRENCY: The financial position and results of operations of the
Company's foreign subsidiaries are measured using the U.S. dollar as the
functional currency. All material translation and transaction gains and losses
are recorded in the income statement.
EARNINGS PER SHARE: In 1998, the Company adopted Statement of Financial
Accounting Standards No. 128, "Earnings per Share," which requires the
presentation of basic and diluted earnings per share amounts. All periods
presented have been restated to reflect adoption of this statement.
The shares used for basic earnings per common share and diluted earnings per
common share are reconciled as follow:
<TABLE>
<CAPTION>
(000's omitted) 1999 1998 1997
- ------------------------------------------------------------------------
<S> <C> <C> <C>
Average shares outstanding
for basic earnings per share 6,223 6,192 6,192
Dilutive effect of stock options 225 33 36
----- ----- -----
Average shares outstanding
for diluted earnings per share 6,448 6,225 6,228
----- ----- -----
</TABLE>
19
<PAGE> 11
Reclassifications: Certain reclassifications have been made to the prior years'
consolidated financial statements to conform to the 1999 presentation.
USE OF ESTIMATES: The preparation of the financial statements in conformity with
generally accepted accounting principles requires management to make estimates
and assumptions that affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during the
reporting period. Actual results could differ from those estimates.
STOCK OPTION PLANS: As permitted by Statement of Financial Accounting Standards
No. 123, "Accounting for Stock-Based Compensation" (SFAS 123), the Company
measures compensation expense for its stock-based compensation plans using the
intrinsic method prescribed by Accounting Principles Board No. 25, "Accounting
for Stock Issued to Employees." In accordance with SFAS 123, the Company has
provided, in Note D, the pro forma disclosures of the effect on net income and
earnings per share as if SFAS 123 had been applied in measuring compensation
expense for all periods presented.
SEGMENT REPORTING: Effective October 2, 1999, the Company adopted Statement of
Financial Accounting Standards No. 131, "Disclosure about Segments of an
Enterprise and Related Information" (SFAS 131). This statement supersedes
Statement No. 14, "Financial Reporting for Segments of a Business Enterprise."
SFAS 131 establishes standards for the way that public companies report
information about operating segments in annual financial statements and requires
that those enterprises report selected information about operating segments in
interim financial reports. SFAS 131 also establishes standards for disclosures
about products and services, geographic areas and major customers. The adoption
of SFAS 131 did not affect results of operations or financial position, but did
affect the disclosure of segment information. See Note M.
COMPREHENSIVE INCOME: In June 1997, the Financial Accounting Standards Board
issued Statement of Accounting Standards (SFAS) No. 130, "Reporting
Comprehensive Income." SFAS 130 establishes standards for reporting and
displaying comprehensive income. Comprehensive income is equal to net income for
each fiscal year presented.
RECENT ACCOUNTING PRONOUNCEMENTS: In June 1998, the Financial Accounting
Standards Board issued Statement of Financial Accounting Standards No. 133,
"Accounting for Derivative Financial Instruments and for Hedging Activities,"
which provides a comprehensive and consistent standard for the recognition and
measurement of derivatives and hedging activities. SFAS 133 is effective for
years beginning after June 15, 2000 and is not anticipated to have a material
effect on the Company's financial statements when adopted.
NOTE B-INVESTMENTS
During 1996, the Company invested $2 million in the common stock of Lifecor,
Inc., which at the time represented approximately 6% of Lifecor's outstanding
common stock. The Company accounts for this investment at cost, which
approximates market. This investment is included in other assets on the balance
sheet.
NOTE C-PREPAID EXPENSES AND OTHER CURRENT ASSETS
Prepaid expenses and other current assets consisted of:
<TABLE>
<CAPTION>
OCT. 2, SEPT. 26,
(000's omitted) 1999 1998
- --------------- ---- ----
<S> <C> <C>
Deferred income taxes -- Note G $1,522 $1,124
Insurance proceeds receivable -- Note K -- 1,674
Other 731 455
------ ------
Total prepaid expenses and other current assets $2,253 $3,253
====== ======
</TABLE>
NOTE D-STOCKHOLDERS' EQUITY
Preferred Stock: The Board of Directors is authorized to fix the designations,
relative rights, preferences and limitations on the Preferred Stock at the time
of issuance.
On June 8, 1998, the Company's Board of Directors adopted a Shareholder Rights
Plan. In connection with the Shareholder Rights Plan, the Board of Directors
declared a dividend distribution of one Preferred Stock purchase right for each
outstanding share of Common Stock to stockholders of record as of the close of
business day on June 9, 1998. Initially, these rights will not be exercisable
and will trade with the shares of ZOLL's Common Stock. Under the Shareholder
Rights Plan, the rights generally become exercisable if a person becomes an
"acquiring person" by acquiring 15% or more of the Common Stock of ZOLL, if a
person who owns 10% or more of the Common Stock of ZOLL is determined to be an
"adverse person" by the Board of Directors or if a person commences a tender
offer that would result in that person owning 15% or more of the Common Stock of
ZOLL.
20
<PAGE> 12
Under the Shareholder Rights Plan, a shareholder of ZOLL who beneficially owns
15% or more of the Company's Common Stock as of June 9, 1998 generally will be
deemed an "acquiring person" if such shareholder acquires additional shares of
the Company's Common Stock. In the event that a person becomes an "acquiring
person" or is declared an "adverse person" by the Board, each holder of a right
(other than the acquiring person or the adverse person) would be entitled to
acquire such number of shares of Preferred Stock which are equivalent to ZOLL
Common Stock having a value of twice the then-current exercise price of the
right. If ZOLL is acquired in a merger or other business combination transaction
after any such event, each holder of a right would then be entitled to purchase,
at the then-current exercise price, shares of the acquiring company's Common
Stock having a value twice the exercise price of the right.
STOCK OPTION PLANS: The Company's 1983 and 1992 stock option plans provide for
the granting of options to officers and other key employees to purchase the
Company's Common Stock at a purchase price, in the case of incentive stock
options, at least equal to the fair market value per share of the outstanding
Common Stock of the Company at the time the option is granted, as determined by
the Compensation Committee of the Board of Directors. Options are no longer
granted under the 1983 plan. The options become exercisable ratably over two or
four years and have maximum duration of 10 years. The Company's Non-employee
Director Stock Option Plan provides for the granting of options to purchase
shares of Common Stock to Directors of the Company who are not also employees of
the Company or any subsidiary of the Company. The options vest in four equal
annual installments over a four year period. The options may be exercised at a
price equal to the fair market value of the Common Stock on the date the option
is granted.
The number of shares authorized for these plans was 2,210,000. Approximately
1,208,000 shares of Common Stock are reserved for issuance under the Company's
stock option plans as of October 2, 1999.
The Company has adopted the disclosure-only provisions of Statement of Financial
Accounting Standards No. 123 (FAS 123), "Accounting for Stock-Based
Compensation." Accordingly, no compensation cost has been recognized with
respect to the Company's stock option grants. Had compensation cost for this
plan been determined based on the fair value methodology prescribed by FAS 123,
the Company's net earnings and earnings per share would have been reduced to the
pro forma amounts indicated below.
<TABLE>
<CAPTION>
(000's omitted, except per share data) 1999 1998
- -------------------------------------- ---- ----
<S> <C> <C>
Net income -- as reported $ 4,081 $ 43
Net income (loss) -- pro forma $ 3,598 $ (317)
Basic earnings per common share -- as reported $ 0.66 $ 0.01
Diluted earnings per common and equivalent
share -- as reported $ 0.63 $ 0.01
Basic earnings per common share -- pro forma $ 0.58 $ (0.05)
Diluted earnings per common and equivalent
share -- pro forma $ 0.54 $ (0.05)
</TABLE>
The above pro forma amounts may not be representative of the effects on reported
net earnings for future years. The fair value of each option grant is estimated
on the date of the grant using the Black-Scholes option-pricing model with the
following weighted-average assumptions used for grants in 1999 and 1998:
<TABLE>
<CAPTION>
1999 1998
---- ----
<S> <C> <C>
Dividend yield 0% 0%
Expected volatility 6.56% 6.48%
Risk-free interest rate 5.11% 4.53%
Expected lives 5 years 5 years
</TABLE>
21
<PAGE> 13
Activity as to stock options under the two plans is as follows:
<TABLE>
<CAPTION>
(000's omitted, except per share data) 1999 1998 1997
- -------------------------------------- ---- ---- ----
WEIGHTED- WEIGHTED- WEIGHTED-
AVERAGE AVERAGE AVERAGE
EXERCISE EXERCISE EXERCISE
SHARES PRICE SHARES PRICE SHARES PRICE
------ ----- ------ ----- ------ -----
<S> <C> <C> <C> <C> <C> <C>
Outstanding at the beginning
of the year 909 $ 7.23 793 $ 11.02 731 $ 11.19
Granted during the year 253 10.11 214 7.08 86 9.76
Exercised during the year (147) 7.70 -- -- (18) 3.43
Cancelled during the year (149) 6.06 (98) 9.05 (6) 12.55
--- ------- --- ------- --- -------
Outstanding at the end of
the year 866 $ 7.98 909 $ 7.23 793 $ 11.02
=== ======= === ======= === =======
Available for grant at the
end of the year 341 145 161
Weighted-average fair value
of options granted
during the year $ 6.83 $ 4.12 $ 4.48
Weighted-average exercise
price of options
exercisable at the
end of the year $ 7.14 $ 7.20 $ 10.08
</TABLE>
The following table summarizes information about stock options outstanding at
October 2, 1999.
<TABLE>
<CAPTION>
(000's omitted, except per share data) OPTIONS OUTSTANDING OPTIONS EXERCISABLE
-------------------------------------------------- -----------------------------
WEIGHTED-AVERAGE
RANGE OF NUMBER REMAINING WEIGHTED-AVERAGE NUMBER WEIGHTED-AVERAGE
EXERCISE PRICE OUTSTANDING CONTRACTUAL LIFE EXERCISE PRICE EXERCISABLE EXERCISE PRICE
- -------------- ----------- ---------------- -------------- ----------- --------------
<S> <C> <C> <C> <C> <C>
$3.687-$6.875 429 7.54 Years $ 6.54 142 $5.89
$7.000-$8.750 248 7.76 Years 8.27 95 8.50
$9.000-$10.000 72 7.92 Years 9.60 18 9.77
$10.750-$12.313 117 9.66 Years 11.70 -- --
- --------------- --- ---- ------ --- ----
$3.687-$12.313 866 255
=============== === ==== ====== === ====
</TABLE>
Under the Company's 1992 stock option plan, 417,850 options ranging in option
price from $10.00 to $14.75 per share were repriced to $6.88 per share during
1998. This repricing was accomplished by canceling the existing options and
issuing new options at new prices with vesting schedules recommencing as of the
date of reprice. The purpose of this transaction was to restore the incentive
effect of such options. In all other respects, the Plan remained unchanged.
NOTE E-ACCRUED EXPENSES AND OTHER LIABILITIES
Accrued expenses and other liabilities consisted of:
(000's omitted)
<TABLE>
<CAPTION>
OCT. 2, SEPT. 26,
(000's omitted) 1999 1998
- --------------- ---- ----
<S> <C> <C>
Accrued salaries, wages and related expenses $2,405 $3,286
Accrued warranty expense 1,133 953
Accrued income taxes 1,164 --
Accrued shareholder litigation settlement cost -- Note K -- 1,400
Other accrued expenses 1,965 1,956
------ ------
Total accrued expenses and other liabilities $6,667 $7,595
====== ======
</TABLE>
22
<PAGE> 14
NOTE F-INDEBTEDNESS
The Company maintains an unsecured working capital line of credit with its bank.
This line of credit bears interest at the bank's base rate (8.25% at October 2,
1999 and September 26, 1998). The full amount of the line ($6.0 million) was
available to the Company at October 2, 1999. On November 5, 1999, the Company
increased its line of credit to $12.0 million.
In 1994, the Company purchased land and building, which replaced leased
operating facilities, for $900,000. The land and building are mortgaged under a
$900,000 bank note bearing interest at 8.2%. The carrying value of the land and
building at October 2, 1999 and September 26, 1998 amounted to $915,000 and
$948,000, respectively. The mortgage requires equal monthly principal payments
of $7,500 plus interest over seven years, with a final payment of $270,000 due
in July 2001. The carrying amount of the long-term debt approximates the fair
value. The mortgage contains various covenants including minimum levels of net
worth, working capital and pre-tax earnings. The Company is in compliance with
all covenants of the agreement.
Long-term debt consisted of:
<TABLE>
<CAPTION>
OCT. 2, SEPT. 26,
(000's omitted) 1999 1998
---- ----
<S> <C> <C>
Mortgage note payable $442 $533
Capital lease obligations -- 14
---- ----
Total long-term debt 442 547
Less current portion 90 105
---- ----
$352 $442
==== ====
</TABLE>
The schedule of principal payments on long-term debt is as follows:
<TABLE>
<S> <C>
2000 90
2001 352
---- ----
$442
</TABLE>
NOTE G-INCOME TAXES
The provision for income taxes consists of the following:
<TABLE>
<CAPTION>
(000's omitted) 1999 1998 1997
- --------------- ---- ---- ----
<S> <C> <C> <C>
Federal:
Current $ 1,941 $ (277) $ 942
Deferred (58) 194 (722)
------- ------- -------
1,883 (83) 220
State:
Current 370 107 222
Deferred (18) (6) (176)
------- ------- -------
352 101 46
Foreign:
Current 37 -- --
Deferred (262) -- --
------- ------- -------
(225) -- --
------- ------- -------
$ 2,010 $ 18 $ 266
======= ======= =======
</TABLE>
The following table shows income before taxes:
<TABLE>
<CAPTION>
(000's omitted) 1999 1998 1997
- --------------- ---- ---- ----
<S> <C> <C> <C>
Domestic $5,121 $ 191 $ 765
Foreign 970 (130) 16
------ ------ ------
$6,091 $ 61 $ 781
====== ====== ======
</TABLE>
23
<PAGE> 15
The income taxes recorded differed from the statutory federal income tax rate
due to:
<TABLE>
<CAPTION>
(000's omitted) 1999 1998 1997
- --------------- ---- ---- ----
<S> <C> <C> <C>
Statutory income taxes $ 2,132 $ 21 $ 265
Tax credits, federal and state (48) -- --
State income taxes, net of federal benefit 229 32 31
Unbenefited (benefited) foreign losses (262) -- 13
Permanent differences 35 35 (20)
Other (76) (70) (23)
------- ------- -------
$ 2,010 $ 18 $ 266
======= ======= =======
</TABLE>
Deferred income taxes reflect the net tax effects of temporary differences
between the carrying amounts of assets and liabilities for financial reporting
purposes and the amounts used for income tax purposes. The valuation allowance
decreased $262,000 as a result of the utilization of foreign net operating
losses.
Significant components of the Company's deferred tax assets and liabilities are
as follow:
<TABLE>
<CAPTION>
OCT. 2, SEPT. 26,
(000's omitted) 1999 1998
- --------------- ---- ----
<S> <C> <C>
Deferred tax assets:
Accounts receivable and inventory $ 999 $ 625
Net operating loss carryforwards 68 365
Product warranty accruals 408 373
Purchased research and development 297 336
Other liabilities 258 379
Valuation allowance for deferred tax assets -- (262)
------- -------
Total deferred tax assets 2,030 1,816
Deferred tax liabilities:
Accelerated tax depreciation 712 731
Prepaid expenses 143 248
------- -------
Total deferred tax liabilities 855 979
------- -------
Net deferred tax asset $ 1,175 $ 837
======= =======
</TABLE>
NOTE H-LEASES
The Company leases certain office and manufacturing space under operating
leases. Listed below are the future minimum rental payments required under
operating leases with non-cancelable terms in excess of one year at October 2,
1999.
<TABLE>
<S> <C>
2000 $ 414
2001 371
2002 353
2003 281
------
$1,419
======
</TABLE>
The Company's office leases are subject to adjustments based on actual floor
space occupied. The leases also require payment of real estate taxes and
operating costs. In addition to the office leases, the Company leases
automobiles for business use by a portion of the sales force. Total rental
expense under operating leases for 1999, 1998 and 1997 was approximately
$870,000, $641,000 and $566,000, respectively.
24
<PAGE> 16
NOTE I-EMPLOYEE BENEFIT PLAN
The Company has a defined contribution retirement plan which contains a "401(k)"
program for all U.S. employees with six months of service who have attained 21
years of age. The Company may make a discretionary contribution and an
additional discretionary profit sharing contribution. For this plan the Company
contributed and charged to expense $113,000, $116,000 and $117,000 in 1999, 1998
and 1997, respectively.
NOTE J-CONCENTRATION OF RISK
The Company sells its products primarily to hospitals, emergency care providers
and universities. The Company performs periodic credit evaluations of its
customers' financial condition and does not require collateral.
In addition, the Company sells its products to the international market.
Although the Company does not foresee a credit risk associated with these
receivables, repayment is dependent upon the financial stability of the national
economies of the customer to which it sells. In order to hedge the risk of loss
in geographical areas with historical credit risks, in some cases the Company
requires letters of credit from its foreign customers. Export sales accounted
for 20%, 19% and 22% of the Company's total revenues in 1999, 1998 and 1997,
respectively.
The Company maintains reserves for potential trade receivable credit losses, and
such losses have been within management's expectations.
Certain materials and components used in the Company's devices and electrodes
are purchased from various single sources. Although the Company believes that
alternative sources of supply for such materials and components could be
developed over a relatively short period of time, the failure to secure such
alternative sources when needed could have a material adverse effect on the
Company's business.
NOTE K-CONTINGENCIES
In the course of normal operations, the Company is involved in litigation
arising from commercial disputes and claims from former employees which
management believes will not have a material impact on the Company's financial
position or its results of operations.
During the quarter ended December 28, 1996, the Company incurred a charge of
approximately $1,300,000 to cover the litigation costs to defend itself in a
shareholder lawsuit initiated in 1994. On July 9, 1998, the Company announced an
agreement in principle concerning the settlement of the lawsuit against it and
certain officers. The settlement, amounting to $1,500,000, was approved by the
court on October 5, 1998. There was no financial impact as a result of the
settlement. Included in accrued expenses at September 26, 1998 is the unpaid
settlement cost and remaining accrued legal fees related to the litigation. A
similar amount due from the insurance company is included in other current
assets at September 26, 1998. In November 1998, the Company received the
insurance reimbursements for the claim and legal costs and paid the remaining
settlement due to the shareholders.
NOTE L-ACQUISITION
On November 6, 1996, the Company acquired the assets of the mobile computing
business of Westech Information Systems, Inc. for approximately $1,500,000 in
cash. The acquisition was accounted for as a purchase and the purchase price was
allocated to the assets acquired and liabilities assumed based on their
respective fair values at the date of acquisition. The excess of the cost over
the fair value of net assets acquired is being amortized over fifteen years. In
connection with the acquisition, the Company incurred a non-recurring charge of
$1,000,000 for acquired in-process research and development which was charged to
operations because in management's opinion, technological feasibility for the
acquired research and development had not been established. The Company's
consolidated results of operations include the operations of the mobile
computing business of Westech Information Systems, Inc. from November 1996. The
following unaudited pro forma information for the year ended September 27, 1997
shows the results of operations as if the transaction occurred at the beginning
of the year of acquisition (in thousands, except per share amounts):
<TABLE>
<S> <C>
Net sales $56,438
Net income $ 504
Basic and diluted earnings per common and equivalent share $ 0.08
</TABLE>
The pro forma results of operations are not necessarily indicative of the actual
results of operations that would have occurred had the purchase actually been
made at the beginning of the period presented and are not necessarily indicative
of results that may be obtained in the future.
25
<PAGE> 17
NOTE M-SEGMENT AND GEOGRAPHIC INFORMATION
Segment information: The Company reports revenue information to the chief
operating decision maker for four operating segments, determined on the type of
customer or product. These segments include the sale of cardiac resuscitation
devices and accessories and data collection management software to the hospital
market and to the prehospital market in North America, the sale of
disposable/other products and the sale of cardiac resuscitation devices and
accessories and disposable electrodes to the international market. Each of these
segments has similar characteristics, manufacturing processes, distribution and
marketing strategies, as well as a similar regulatory environment.
In order to make operating and strategic decisions, ZOLL's chief operating
decision maker evaluates revenue performance based on the worldwide revenues of
each segment and, due to shared infrastructures, profitability based on an
enterprise-wide basis. Net sales by segment were as follow:
<TABLE>
<CAPTION>
(000's omitted) 1999 1998 1997
- --------------- ---- ---- ----
<S> <C> <C> <C>
Hospital Market -- North America devices $30,868 $19,962 $21,562
Prehospital Market -- North America devices 14,410 12,474 11,224
Other -- North America 15,035 12,841 11,855
International Market -- excluding North America 13,664 9,803 11,695
------- ------- -------
$73,977 $55,080 $56,336
======= ======= =======
</TABLE>
The Company reports assets on a consolidated basis to the chief operating
decision maker.
Geographic information: Net sales by major geographical area, determined on the
basis of destination of the goods, are as follow:
<TABLE>
<CAPTION>
(000's omitted, except per share data) 1999 1998 1997
- -------------------------------------- ---- ---- ----
<S> <C> <C> <C>
United States $59,133 $44,512 $44,026
Foreign 14,844 10,568 12,310
------- ------- -------
$73,977 $55,080 $56,336
======= ======= =======
</TABLE>
In each of the years in the three year period ended October 2, 1999, no single
customer represented over 10% of the Company's consolidated net sales.
NOTE N-SUBSEQUENT EVENT
In October 1999, the Company completed a merger with Pinpoint Technologies
(Pinpoint) in exchange for approximately 450,000 shares of ZOLL Common Stock.
The transaction is being accounted for as a pooling-of-interests. Pinpoint,
headquartered in Boulder, Colorado, develops computer-aided dispatch and billing
software for the emergency medical services market. Pinpoint's products are sold
to the same market to which ZOLL targets its Westech data collection system. At
October 2, 1999, Pinpoint had approximately 40 employees.
The following unaudited pro forma information has been prepared assuming
Pinpoint had been acquired as of the beginning of the periods presented. The pro
forma information is presented for information purposes only and is not
necessarily indicative of what would have occurred if the acquisition had been
made as of those dates. In addition, the pro forma information is not intended
to be a projection of future results and does not reflect synergies expected to
result from the integration of Pinpoint and the Company's Westech business.
<TABLE>
<CAPTION>
1999 1998 1997
---- ---- ----
<S> <C> <C> <C>
Net sales $ 78,786 $ 57,520 $ 57,831
Net income $ 4,775 $ 425 $ 738
Basic earnings per common share $ 0.72 $ 0.06 $ 0.11
Diluted earnings per common share and equivalent $ 0.69 $ 0.06 $ 0.11
</TABLE>
The 1999 proforma net income has been reduced by approximately $173,000, net of
related income taxes, to reflect certain incremental operating costs effective
upon consummation of the merger.
26
<PAGE> 18
NOTE O-QUARTERLY FINANCIAL DATA (UNAUDITED)
Summarized quarterly financial data for 1999 and 1998 is as follows:
<TABLE>
<CAPTION>
QUARTER ENDED
JAN. 2, APRIL 3, JUL. 3, OCT. 2,
(000's omitted, except per share data) 1999* 1999 1999 1999
- -------------------------------------- ----- ---- ---- ----
<S> <C> <C> <C> <C>
1999
Net sales $15,295 $16,989 $19,318 $22,375
Gross profit 8,828 9,650 10,937 12,505
Income from operations 669 1,063 1,520 2,805
Net income 488 712 1,020 1,861
Basic earnings per common share $ 0.08 $ 0.11 $ 0.16 $ 0.31
Diluted earnings per common
and equivalent share $ 0.08 $ 0.11 $ 0.16 $ 0.28
</TABLE>
<TABLE>
<CAPTION>
QUARTER ENDED
DEC. 27, MAR. 28, JUN. 27, SEPT. 26,
(000's omitted) 1997 1998 1998 1998
- --------------- ---- ---- ---- ----
<S> <C> <C> <C> <C>
1998
Net sales $ 12,440 $ 13,585 $ 12,852 $ 16,203
Gross profit 7,034 7,763 7,334 9,136
Income (loss) from operations 137 331 (1,269) 439
Net income (loss) 165 317 (814) 375
Basic and diluted earnings (loss)
per common and equivalent share $ 0.03 $ 0.05 $ (0.13) $ 0.06
</TABLE>
*Quarter contains 14 weeks
MARKET FOR REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
The Company's Common Stock is traded on the National Association of Securities
Dealers Automated Quotation (NASDAQ) National Market System under the symbol
"ZOLL." The following table sets forth the high and low sales prices during the
fiscal quarters specified:
<TABLE>
<CAPTION>
SALES PRICES
1999 1998
HIGH LOW HIGH LOW
---- --- ---- ---
<S> <C> <C> <C> <C>
First Quarter $ 11-7/16 $7-1/16 $ 7-1/4 $5-1/4
Second Quarter 12-3/4 8-1/2 7-7/16 4-7/8
Third Quarter 12-7/8 9 8 5-1/2
Fourth Quarter 31-13/16 11-7/8 10 7-1/8
</TABLE>
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.
27
<PAGE> 19
EXECUTIVE OFFICERS AND DIRECTORS
RICHARD A. PACKER
Chairman of the Board & Chief Executive Officer
A. ERNEST WHITON
Vice President of Administration & Chief Financial Officer
WARD M. HAMILTON
Vice President, Marketing
E. J. JONES
Vice President, International Sales
DONALD R. BOUCHER
Vice President, Research & Development
STEVEN K. FLORA
Vice President, North American Sales
WILLARD M. BRIGHT
Director
THOMAS M. CLAFLIN(1)
Director
M. STEPHEN HEILMAN, M.D.(1)
Director
DANIEL M. MULVENA (2)
Director
DR. JAMES W. BIONDI (1)
Director
(1) Member of the Audit Committee
(2) Member of the Compensation Committee
STOCKHOLDER INFORMATION
STOCK LISTING
ZOLL Medical Corporation Common Stock is traded on the NASDAQ National Market
System under the symbol "ZOLL."
TRANSFER AGENT
State Street Bank and Trust Company
C/O Equiserve
P.O. Box 9187
Canton, Massachusetts 02021-9187
1-877-282-1169
GENERAL COUNSEL
Goodwin, Procter & Hoar LLP
Boston, Massachusetts
INDEPENDENT AUDITORS
Ernst & Young LLP
Boston, Massachusetts
ANNUAL MEETING
The annual meeting of stockholders will be held at 10 a.m. on February 8, 2000
at State Street Bank and Trust Company, 225 Franklin Street, Boston,
Massachusetts 02110.
INFORMATION REQUESTS
A copy of our Form 10-K, as filed with the Securities and Exchange Commission,
may be obtained upon written request to the Company at:
Stockholder Relations
ZOLL Medical Corporation
32 Second Avenue
Burlington, Massachusetts 01803-4420
ZOLL, RescueNet and Westech are registered trademarks of ZOLL Medical
Corporation.
28
<PAGE> 1
Exhibit 21.1
List of Subsidiaries
Bio-Detek, Incorporated, incorporated in Massachusetts
ZMI France, S.A.R.L., incorporated in France
ZMD Corporation, incorporated in Delaware
ZOLL International, Inc., incorporated in U.S. Virgin Islands
ZOLL Medical (U.K.) Ltd, incorporated in United Kingdom
Westech Mobile Solutions. Inc., incorporated in Vancouver, B.C., Canada
ZOLL Medical Deutchland (GmbH), incorporated in Germany
Pinpoint Technologies, Inc.
<PAGE> 1
Exhibit 23.1
Consent of Independent Auditors
We consent to the incorporation by reference in this Annual Report (Form 10-K)
of ZOLL Medical Corporation of our report dated November 12, 1999, included in
the 1999 Annual Report to Shareholders of ZOLL Medical Corporation.
Our audit also included the financial statement schedule of ZOLL Medical
Corporation listed in Item 14(a). The schedule is the responsibility of the
Company's management. Our responsibility is to express an opinion based on our
audits. In our opinion, the financial statement schedule referred to above, when
considered in relation to the basic financial statements taken as a whole,
presents fairly in all material respects the information set forth therein.
We also consent to the incorporation by reference in Registration Statements
pertaining to the ZOLL Medical Corporation 1992 Stock Option Plan (Form S-8 No.
333-68403, Form S-8 No. 33-90764, Form S-8 No. 33-56244) and the Non-Employee
Directors' Stock Option Plan (Form S-8 333-68401) and Form S-3 No. 333-91071
and in the related Prospectus of our report dated November 12, 1999, with
respect to the consolidated financial statements of ZOLL Medical Corporation
report incorporated by reference in its Annual Report (Form 10-K) for the year
ended October 2, 1999, and our report included in the preceding paragraph with
respect to the financial statement schedule included in this Annual Report (Form
10-K) of ZOLL Medical Corporation.
ERNST & YOUNG LLP
Boston, Massachusetts
December 22, 1999
<TABLE> <S> <C>
<ARTICLE> 5
<MULTIPLIER> 1,000
<CURRENCY> U.S. DOLLARS
<S> <C>
<PERIOD-TYPE> YEAR
<FISCAL-YEAR-END> OCT-02-1999
<PERIOD-START> SEP-27-1998
<PERIOD-END> OCT-02-1999
<EXCHANGE-RATE> 1
<CASH> 1,311
<SECURITIES> 0
<RECEIVABLES> 24,659
<ALLOWANCES> 1,995
<INVENTORY> 13,196
<CURRENT-ASSETS> 41,419
<PP&E> 20,694
<DEPRECIATION> 10,657
<TOTAL-ASSETS> 55,635
<CURRENT-LIABILITIES> 15,013
<BONDS> 352
0
0
<COMMON> 127
<OTHER-SE> 39,796
<TOTAL-LIABILITY-AND-EQUITY> 55,635
<SALES> 73,977
<TOTAL-REVENUES> 73,977
<CGS> 32,057
<TOTAL-COSTS> 32,057
<OTHER-EXPENSES> 35,863
<LOSS-PROVISION> 1,207
<INTEREST-EXPENSE> 73
<INCOME-PRETAX> 6,091
<INCOME-TAX> 2,010
<INCOME-CONTINUING> 4,081
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> 4,081
<EPS-BASIC> .66
<EPS-DILUTED> .63
</TABLE>
