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ANNUAL REPORT PURSUANT TO SECTION
13 OR 15(d) OF THE |
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FOR THE FISCAL YEAR ENDED SEPTEMBER 30, 2007. |
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TRANSITION REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE |
FOR THE TRANSITION PERIOD FROM TO |
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COMMISSION FILE NUMBER 0-18793 |
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VITAL SIGNS, INC. |
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(Exact name of registrant as specified in its charter) |
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New Jersey |
11-2279807 |
(State or
other jurisdiction of |
(I.R.S.
Employer |
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Title of each class |
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Common Stock, no par value |
Indicate
by checkmark if the registrant is a well-known seasoned issuer, as defined in
Rule 405 of the Securities Act.
o Yes x No
Indicate
by checkmark if the registrant is not required to file reports pursuant to
Section 13 or 15(d) of the Act.
o Yes x
No
Indicate by checkmark 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. x Yes o No
Indicate by checkmark 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 registrants 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. o
Indicate by checkmark whether the registrant is a large accelerated filer, an accelerated filer or a non-accelerated filer. See definition of accelerated filer and large accelerated filer in Rule 12b-2 of the Exchange Act. o Large accelerated filer x Accelerated filer o Non-Accelerated filer
Indicate by checkmark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act) o Yes x No
The aggregate market value of the voting and non-voting common equity of the registrant held by non-affiliates (for this purpose, persons and entities other than executive officers, directors, and 5% or more shareholders) of the registrant, as of the last business day of the registrants most recently completed second fiscal quarter (March 31, 2007), was approximately $398,176,946
Documents incorporated by reference: Definitive Proxy Statement for 2008 Annual Meeting of Shareholders (Part III).
VITAL
SIGNS, INC.
TABLE OF CONTENTS
Fiscal year in this Annual Report means the twelve months ended on September 30th. Unless the context expressly indicates a contrary intention, all references to years in this Annual Report are to fiscal years.
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Vital Signs, Inc. was initially incorporated in New York in 1972 and reincorporated in New Jersey in 1988. The Companys principal executive office is located at 20 Campus Road, Totowa, New Jersey 07512; the telephone number at this location is (973) 790-1330.
The Company and markets
In response to rising health-care costs, managed care companies and other third-party payors in the Companys anesthesia and respiratory/critical care businesses are placing pressure on health care providers to reduce costs. Although this could hamper a health-care providers revenue growth, the Company believes that these cost-reduction efforts have increased the market preference for the Companys single-patient-use medical products because these products improve health care professionals productivity, minimize transfer of infections and disease, reduce overall provider costs, and improve patient care. As a result of the following factors, the Company believes that single-patient-use medical products have become the products of choice in the United States anesthesia and respiratory/critical care markets.
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improved patient care - by reducing the risk of contracting infections from reusable products that have been inadequately sterilized, thereby reducing the risk of additional patient care; |
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cost effectiveness - by lowering the labor costs associated with sterilizing, reassembling and re-testing reusable products, lowering inventory costs, reducing the initial capital outlays for new reusable products, and allowing costs to be charged directly to individual patients; and |
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reduced set up time and improved productivity - single-patient-use products packaged in disposable kits allow medical practitioners to reduce set up time and perform more procedures. |
The
Company views international markets as a significant growth opportunity as
single-patient-use products have not fully penetrated those markets. The trend
towards single-patient-use products replacing traditional reusable products is
accelerating in developing countries as health care standards improve due to
heightened concerns about cross-contamination and sterilization costs as well
as high incidences of communicable diseases and nosocomial infections.
The
Company categorizes its product and service offerings within five business
segments: anesthesia, respiratory/critical care, sleep disorder, interventional
cardiology/radiology and pharmaceutical technology services. (See Note 20)
Anesthesia
Anesthesia products were the Companys first line of business over 30 years ago and continue to be its leading source of revenue. The Companys single-patient-use anesthesia products and systems deliver oxygen and anesthesia from a gas source, such as an anesthesia machine, to a patients pulmonary system. These products also remove anesthetic gases, carbon dioxide, and expiratory oxygen from a patient and link a patient to various monitors. The principal anesthesia products consist of face masks, breathing circuits, and general anesthesia products.
The breadth of the Companys product offerings provides an advantage of selling customized circuits comprised of multiple products that are compatible with the anesthesia equipment manufactured by most companies. The Company also manufactures a wide range of accessories and components for use with its
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anesthesia products, including heat/moisture exchangers, bacterial/viral filters, anesthesia breathing bags (including latex-free bags), airways, and temperature-monitoring devices.
The Companys primary anesthesia products and systems include:
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Anesthesia breathing circuits are single-patient-use devices used to ventilate and carry oxygen and anesthesia to a patient while under general anesthesia during surgery as well as to connect the patient to an anesthesia machine and to monitors. The traditional system is referred to as a circuit because it is comprised of two tubes, one carrying inspiratory gases to a patient and the other carrying expiratory gases away from a patient. Each traditional breathing circuit consists of flexible hoses, a breathing bag, and a Y and elbow attachment. Because the breathing circuit needs of hospitals vary significantly, the Company offers a large variety of circuits compatible with various anesthesia equipment. The Company expanded its breathing circuit products as the result of technological advances in the areas of gas sampling, temperature monitoring, humidification, and bacterial/viral filtration. In late 2000, the Company introduced the patented product Limb-OTM, a single limb breathing circuit used for general anesthesia, transport and/or critical care situations. The single limb incorporates a patented technology with a septum to separate inspiratory and expiratory gases. The expiratory portion of the tube contains warmed exhalation gas which helps to warm the inspiratory gas. The Limb-OTM competes with the traditional two limb system on the basis of the added benefit of heat and moisture provided to the patient and the reduction of bulk and weight associated with traditional two limb circuits and is an alternative to the tube within a tube circuit. |
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Face masks are single-patient-use devices that cover the nose and mouth of a patient while general anesthesia is administered. The Company was first to sell the now standard air-filled clear cushion face mask for single-patient anesthesia and respiratory use. This soft air-filled cushion face mask provides a better seal on most patients than other face masks, thereby improving the delivery of anesthetic gases and oxygen to the patient. A clear face mask also permits the clinician to better observe certain patient problems, such as life-threatening aspiration, while the patient is anesthetized. The Company offers various sizes and types of face masks and anticipates that the usage of single-patient-use face masks in surgical procedures internationally will continue to increase as single-patient-use products become more acceptable in international hospitals. |
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General anesthesia systems are customized single-patient-use anesthesia kits that can include more than 20 of the Companys single-patient-use products, such as air filled cushion face masks, breathing circuits, blood pressure cuffs, and temperature monitoring probes. The Company markets these kits under the name GAS. Company sales representatives assist each customer in determining the particular products that its institution desires in its anesthesia kits. |
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Pressure infusors are single-patient-use devices utilized hospital-wide to apply pressure to a sealed bag of fluid, such as intravenous solutions or blood products. The Companys INFUSABLE® pressure infusor is a patented system consisting of a pressure gauge, an inflatable bladder, and a bulb to pump air into the bladder. INFUSABLE® has a mesh netting to hold a package of sterile fluid or solution bag and can deliver blood or fluids to a patient at a rapid rate, usually under trauma conditions or at a level designed to maintain the pressure required by the monitoring system. The Companys InfusaScanTM pressure infusor incorporates a clear window to enable bar coding scanning of fluid contents to prevent medication errors. |
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Fiberoptic laryngoscope systems are single-patient-use devices used by anesthesiologists to correctly place an endotracheal tube within the trachea of a patient. The Companys Vital View and Greenlight II systems have single-patient-use blades that offer several advantages over traditional reusable metal blade laryngoscope systems, including lowering the risk to both patient and physician of infection associated with reusable metal blades. Both systems incorporate the latest LED technology that produces unsurpassed brightness for increased visibility. Hospital capital outlays for emergency crash carts can be reduced by purchasing the |
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Companys single-patient-use system rather than a reusable fiberoptic system. The new SteeLite single-patient-use stainless steel blades provide the strength of reusable metal blades at a cost-effective price. |
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Laryngeal airway devices are single-patient-use airway devices used for airway management during general anesthesia procedures. The Company has several patented features intended to address known complications, including a reinforced tongue within the tip of the sealing cuff to resist over-folding and ribbed slots to minimize the possibility of occlusion by a patients epiglottis. |
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Blood and fluid warming devices are used during delivery of IV fluids or of blood during surgery to lower the risk of infection and decrease post-operative recovery time. The Companys new enFlow® blood and fluid warming product has a unique single-patient-use dry-heating technology that provides rapid, consistent temperature in close physical proximity to the patient. |
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Oral/nasal tracheal tubes and stylets are single-patient-use airway devices used during general anesthesia procedures and mechanical ventilation. The Companys RediTube is a tracheal tube combined with a pre-loaded stylet incorporated into a single product to reduce costs and reduce SKUs. The product comes in both cuffed and uncuffed versions. |
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For fiscal 2007, 2006 and 2005, the anesthesia segment contributed 36.4%, 36.5%, and 35.1%, respectively, on net revenue.
Respiratory/critical care
The
Company has supplied products to the respiratory/critical care market for over
25 years. Single-patient-use respiratory/critical care products assist
hospitals with infection control programs by reducing infections caused by
cross-contamination when products are used by more than one patient. These
products also offer patient benefits because they are generally lighter than
reusable products which results in better patient care, for example, by causing
less torque on the endotracheal tube. The Company believes that there is an increasing
incidence of respiratory illnesses, such as asthma and emphysema, due in part
to an increasingly susceptible aging population, environmental pollution,
smoking-related illnesses, as well as communicable diseases with significant
respiratory impact, such as tuberculosis, HIV, and influenza. People with these
conditions have a need for Vital Signs products in acute care, such as manual
resuscitators and arterial blood gas kits.
The
Companys primary respiratory products are arterial blood gas (ABG) syringes
and kits, manual resuscitators, and single-use blood pressure cuffs. The
Company also distributes critical care equipment kits and modules that are
color-coded so emergency room workers can quickly and accurately determine the
proper equipment size to use with pediatric patients. In addition, the
Company manufactures a wide range of accessories and components for use with
its respiratory/critical care products and systems, including bacterial/viral
filters and heat and moisture exchangers.
The Companys primary respiratory/critical care products and systems include:
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Arterial blood gas syringes and collection kits are used to collect arterial blood for blood gas analyses routinely performed in hospitals on patients suspected of having metabolic, respiratory, or other cardiopulmonary difficulties. The Company offers a broad line of disposable arterial blood gas syringes and collection systems in both standard configurations and in customized kits that meet a hospitals specific needs and to function with the hospitals blood gas analyzers. The Company offers syringes containing the SURE-LOK needle protection device to protect the health care worker from the risk of being punctured by a needle. |
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Manual resuscitators are single-patient-use devices that are hand-squeezed to force oxygen into a patients lungs and are used throughout the hospital in a variety of settings. For example, patients on a ventilator require the use of a resuscitator prior to tracheal suctioning procedures. Another use is in providing oxygen while transporting the patient between the operating room and other critical care units. In addition, resuscitators are typically placed strategically throughout the hospital to provide assistance to patients who have stopped breathing and require resuscitation. The Companys Code Blue II resuscitators alleviate certain problems involved in mouth-to-mouth emergency resuscitation, including the risk to both the rescuer and the |
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individual of transmitting infections and are sold in different sizes for infants, children, and adults. Most reusable manual resuscitators are costly to sterilize and require re-assembly that may result in errors that compromise proper function. In contrast, Code Blue II resuscitators are relatively inexpensive and are delivered fully assembled. |
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Blood pressure cuffs are single-patient-use devices that are wrapped around the arm or thigh of a patient to obtain a blood pressure reading. The Companys CUFF-ABLETM single-patient-use blood pressure cuffs provide hospitals with an alternative to traditional reusable blood pressure cuffs that can become contaminated by touch with blood and other bodily fluids. While all patients admitted to hospitals are candidates for their own dedicated blood pressure cuffs, the Company believes that the primary market for disposable cuffs has been where infection control is a high priority and where there is a break in the skin. CUFF-ABLETM blood pressure cuffs are sold in a variety of sizes (including neonatal) and are adaptable to all manual and electronic blood pressure monitors that utilize blood pressure cuffs. The Company recently introduced the Click-It Universal Connection System that makes hospital-wide standardization simple and easy because it eliminates misconnections common with luer fittings and ensures compatibility with both manual and electronic blood pressure monitors. |
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Hyperinflation systems are devices used for patient resuscitation. The Company offers both its Babysafe and traditional hyperinflation systems for infant resuscitation in transport and prior to tracheal suctioning. These products are used in labor and delivery rooms and in neonatal intensive care units, where controlling the spread of infection is particularly critical. BabySafe adjusts and limits the level of pressure that can be delivered during resuscitation, and oxygen can be delivered with limited risk of barotrauma. These systems are available in a variety of configurations and sizes to meet infant needs. |
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Continuous positive airway pressure systems, or CPAP systems, consist of a compact flow-generator connected to a dual-port, air-filled cushion face mask and are used as therapy for various respiratory diseases. The face mask is attached to a single-patient-use positive end expiratory pressure valve designed to maintain positive airway pressure in the lungs, allowing for more oxygen to diffuse into a patients blood system. The Companys face mask CPAP systems provide a less-invasive and more-comfortable way of supplying oxygen to certain patients than conventional ventilator-based systems by eliminating the need to insert an endotracheal tube into the patients trachea and then attaching the patient to a ventilator. The Companys face mask CPAP systems are also used in the hospital and pre-hospital setting to treat patients with cardiogenic pulmonary edema and other respiratory deficiencies. |
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Heated humidification systems provide a flow of warm moist air to a patient at risk from loss of body temperature and drying of the lung linings. The Companys MistyOx® line consists of two respiratory products that deliver hydration to a patient, a nebulizer which delivers medium to high flow and high concentrations of oxygen to patients, combined with a regulated heater. These products may be used by infants, children, and adults in many areas of the hospital, including emergency, recovery and critical care. |
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CPR training mannequins are training aids for teaching cardiopulmonary resuscitation, or CPR. The Companys Actar® training mannequin provides a low-cost alternative to many of the other training mannequins on the market. Its low cost allows each trainee to practice on their own mannequin rather than waiting to take turns on a single mannequin shared by an entire class. The Companys newest model, Actar D-FIBTM, incorporates additional functionality to meet the updated requirements of the American Heart Association and the Red Cross. New features include jaw thrust, abdominal thrust, and anatomical landmarks for proper defibrillation training. |
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Broselow® pediatric emergency products. The Broselow/Hinkle Pediatric Emergency System and the Broselow-Luten System are part of the Companys Color Coding Kids® product line. These products resulted from extensive clinical efforts by James Broselow, M.D., Robert Luten, M.D., and Alan Hinkle, M.D. to enable emergency care providers to determine the appropriate |
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equipment size for infants in emergency situations. This system takes advantage of the direct correlation between a pediatric patients body length and the proper size of emergency supplies. This patented system, licensed to Vital Signs, consists of a tape measure having nine color zones, a corresponding series of color-coded single-patient-use emergency kits or modules and a nylon organizer bag custom-designed to hold all the supplies needed in either a trauma, cardiac or respiratory pediatric emergency. |
For fiscal 2007, 2006, and 2005, the respiratory/critical care segment contributed 22.6%, 22.1%, and 22.0%, respectively, of net revenue.
Sleep disorder
Building
upon the Companys airway-management expertise and long-term experience with
continuous positive airway pressure (CPAP) systems, the Company began providing
sleep disorder, personal ventilation products, and sleep diagnosis
services in the late 1990s. The
Company designed its sleep disorder products to deliver airflow to patients
undergoing therapy for the treatment of obstructive sleep apnea with the
objective of increasing patient comfort and acceptance of the treatment.
The
Company believes it is the only firm that both operates sleep centers to
diagnose obstructive sleep apnea as well as manufactures and sells products
designed to treat the condition. The Company offers sleep diagnostic
services exclusively in the United States through its Sleep Services of America
subsidiary. The Sleep Services of America subsidiary was created in January 2002
as a result of the merger with the sleep diagnostic service business of The
Johns Hopkins Health System Corporation. As of September 30, 2007, the Company operated 101 accounts, primarily
inclusive of 72 sleep diagnosis laboratories and centers and 22 hospital
locations serviced with mobile PSG equipment in nine states in the United
States and Washington D.C. The Companys Sleep Services of America
business is accredited by the Joint Commission on Accreditation of Healthcare
Organizations in ambulatory healthcare.
At these sleep laboratories and centers, which typically accommodate two or three patients per night, the Company conducts sleep studies to determine whether patients suffer from sleep disorders and, if so, the severity of their condition. If a patient is determined to suffer from obstructive sleep apnea, the Company offers the patient and their referring physician a comprehensive sleep program. This program includes a patient consult, diagnosis, titration procedure (this is the process of determining the optimal pressure to prescribe for the CPAP device), and therapeutic intervention, thus providing a one-stop-shop approach to service a patients needs.
Obstructive
sleep apnea, or OSA, is one of the most common sleep problems. Obstructive
sleep apnea is a condition that causes the soft tissue in the back of the
throat to narrow and repeatedly close during sleep. Oxygen deficiency, elevated
blood pressure, and increased heart rate associated with OSA are related to increased
risk of cardiovascular morbidity, stroke, and heart attack. Additionally, OSA
may result in excessive daytime sleepiness and reduced cognitive functions,
including memory loss, lack of concentration, depression, and irritability.
According to the National Heart, Lung and Blood Institute of the National
Institutes of Health, in 2006 more than 12 million people in the United States
suffered from sleep apnea. The Company
believes that a substantial portion of those with OSA remain
undiagnosed. Increased awareness
of OSA among doctors and patients in recent years is expected to continue
fueling growth of the OSA diagnostic and treatment industry.
OSA diagnosis requires monitoring a patient during sleep. During overnight testing, which usually takes place in a clinical setting, respiratory parameters and sleep patterns are monitored along with other vital signs, providing information about the quality of an individuals sleep. A report by Frost & Sullivan indicated that by 2003, there were approximately 2,800 sleep laboratories and centers in the United States. The Company believes this represents a significant expansion over the number of such laboratories and centers that previously existed in the United States.
CPAP
therapy is the primary method for treating obstructive sleep apnea, partly
because it is less invasive and more cost-effective than surgery. Unlike
surgery, which may only result in reduced snoring, CPAP therapy actually
reduces or eliminates the occurrence of obstructive sleep apnea. During CPAP
therapy, a patient sleeps with a nasal or facial mask connected by a tube to a
small portable airflow generator that delivers room air at a predetermined
continuous positive pressure. The continuous air
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pressure acts as a pneumatic splint to keep the patients upper airway open and unobstructed. As a result, the cycle of airway closures, which leads to the disruption of sleep and other symptoms that characterize obstructive sleep apnea, is prevented or dramatically reduced.
CPAP is generally not a cure but a therapy for managing the chronic condition of obstructive sleep apnea, and therefore, must be used on a daily basis as long as treatment is required. Patient compliance has been a major factor in the efficacy of CPAP treatment. Recent CPAP product innovations have improved patient comfort and compliance compared with earlier generations of CPAP units.
The
Companys principal sleep disorder products, currently marketed primarily
outside of the United States, are personal non-invasive ventilation-support
systems that are used in the treatment of obstructive sleep apnea to prevent
temporary airway closure during sleep. The Companys sleep disorder and
personal ventilation products that have been cleared for sale in the United
States in both hospitals and homes include the HA50TM, iSleep
10TM,
iSleep
20TM,
iSleep
20+TM,
HAO1TM,
VIVO 30TM,
and VIVO
40TM.
The Companys principal sleep disorder and personal ventilation products are
listed below.
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CPAP flow generators are electromechanical devices which deliver continuous positive airway pressure through a nasal or full face mask to a patient suffering from obstructive sleep apnea in order to keep the patients airway open during sleep. Given the importance of patient compliance in treating obstructive sleep apnea, the Company designed its full range of products to be easy to use, lightweight, small, and quiet, making them relatively unobtrusive at the bedside. The Breas iSleep 10TM is a basic low-cost CPAP; the Breas iSleep 20TM is an enhanced CPAP device for treatment of obstructive sleep apnea; the iSleep 20+TM is a premium CPAP device with additional refinement and features to facilitate tracking of patient compliance; and the self-adjusting Breas iSleep 20iTM is a CPAP device based on the Companys unique, patented i-technology for breathing pattern recognition. This latter device responds to subtle changes in breathing patterns, as individual pressure requirements vary over time, to proactively minimize apneic events; whereas traditional, constant CPAP devices must be set to a maximum pressure that is usually higher than required throughout the night and thus may create discomfort for the user. With the iSleep 20TM, the mean treatment pressure is lower as airway pressure is adjusted automatically. Clinical studies have demonstrated that patients prefer the lower pressure provided by these units to other available devices. |
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Bi-level CPAPs are electromechanical devices which allow inspiratory and expiratory pressures to be independently adjusted. The iSleep 22TM and premium iSleep 25TM devices treat more severe obstructive sleep apnea and are designed to be especially comfortable for the user. |
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Ventilators are electromechanical devices used to assist a patient with respiratory problems both in a clinical setting or at home. The Breas Vivo 30 and Vivo 40 bi-level ventilators are advanced devices that allow separate pressure levels for inspiratory and expiratory phases of each individual breath. Ventilation can be matched to the patients own breathing pattern by setting inspiratory and expiratory levels independently to provide a more comfortable and more natural respiratory support. These ventilators may also be operated from an external battery to be used during transportation and while traveling. The Breas PV403 is an advanced multi-mode homecare ventilator that provides volume and pressure ventilation for patients suffering from respiratory failure such as neuromuscular (e.g. Duchenes Muscular Dystrophy) or other restrictive or obstructed lung diseases. The PV403 has both internal and external battery capability and is well suited to be used for transport and traveling. |
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Humidification systems are an important factor in the comfort of many patients using CPAP devices or ventilators. The Breas HA50 and Breas HAO1TM are heated humidifiers designed to deliver humidified air efficiently at desired temperatures. The Breas HAO1TM is the Companys latest generation humidifier device, designed for complete integration with the iSleepTM and VIVOTM product lines. |
The Companys ability to sell its sleep disorder and personal ventilation products in Company sleep laboratories and centers is restricted by strict federal regulations that prohibit the medical facility from diverging from a physicians prescription. If a physician prescribes a sleep disorder or personal ventilation
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product by name other than a Company product at a Company sleep laboratory or center, the Company is prohibited by federal regulations from substituting its own product.
For fiscal 2007, 2006, and 2005, sleep disorder and personal ventilation products and services accounted for 23.8%, 21.2%, and 21.0%, respectively, of net revenue.
Interventional Cardiology/Radiology
Interventional
cardiology is a subspecialty of cardiology that deals specifically with
catheter based treatment of structural heart diseases; interventional radiology
is a subspecialty of radiology where minimally-invasive procedures are
performed using image guidance, either for diagnostic or treatment purposes.
The Company believes that the long term prospects for this business segment are
good as less-invasive procedures increase to minimize surgerys risk, cost,
trauma, aftercare, and procedure time.
The Companys interventional cardiology/radiology business provides vascular access and vascular device delivery and serves a substantial number of medical device companies on an ongoing manufacturing and R&D project basis. The business operates as a high-end OEM that designs, develops, and manufactures precision devices that facilitate access to the cardiovascular system by medical professionals in the electrophysiology, cardiology, radiology, critical care, and anesthesia markets. The products include percutaneous-valved introducers, peelaway-valved introducers, guiding sheaths, and device delivery sheaths. Other products include guide wires, needles, over-the-needle catheters, hemostasis valves, obturators, dilators, slicers, transvalvular insertion tools, and contamination shields.
Generally, the business makes finished sterile medical devices and bulk non-sterile products based on customer specifications. However, the business can also design, develop, and manufacture proprietary finished medical devices that are distributed by customers under their private label. As an OEM, the business depends on its customers for distribution of the medical devices produced by the Company. It is a highly-competitive business that can have major technology shifts. While the Company expects the business to grow over the next few years, the actual growth will vary depending on the customer base. Products are sold to other health care product providers either as a component of a kit or as a finished product. Customers include Johnson & Johnson, Bard, and Boston Scientific.
For
fiscal 2007, 2006, and 2005, interventional cardiology/radiology segment
contributed 14.0%, 12.6%, and 13.2%, respectively, of net revenue.
Pharmaceutical technology services
Pharmaceutical, diagnostic, biotechnology, and medical device companies are regulated by the United States Food and Drug Administration or FDA. The FDAs regulatory framework covers virtually every aspect of these companies operations and mandates that these companies maintain highly-detailed records to demonstrate compliance with complex requirements. FDA enforcement of its requirements has increased significantly in recent years, and the FDA has publicly stated that compliance will be more strictly scrutinized. The FDA may invoke extensive enforcement powers against companies that fail to comply with FDA regulations. These companies may be delayed or prevented from commercializing new products or product enhancements and may have existing products removed from the market.
The tasks of developing FDA compliance programs and monitoring their performance are complex and time-consuming. The Company believes that many FDA-regulated companies do not maintain the internal staff necessary to meet FDA requirements scrutiny, and these companies require consultants to help them become and remain compliant. FDA-regulated companies are under ongoing scrutiny with regard to the quality and compliance of critical computer systems and will continue to require external help to develop and implement these systems.
For more than 20 years, the Company has provided regulatory consulting services to clients, helping them develop and validate systems and processes for their manufacturing, IT infrastructure, research and development, facilities, laboratory, and quality assurance departments. In 2002, with the acquisition of Stelex, the Company expanded these services to include computer systems compliance. In addition, the Company developed and currently markets proprietary software products used in conjunction with the Companys services to help clients comply with FDA regulations. The Company delivers these technology services to FDA-regulated companies primarily in the pharmaceutical sector, as well as to medical device,
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diagnostic, and biotechnology companies. Clients include some of the largest pharmaceutical companies in the world.
At
September 30, 2007 and 2006 the pharmaceutical technology services staff
consisted of 87 and 99 professionals, respectively. In addition, the Companys
Vital Path subsidiary developed and currently markets proprietary software
products to help clients comply with FDA regulations. For fiscal 2007,
2006, and 2005, pharmaceutical technology services accounted for 5.6%, 7.6%,
and 8.7%, respectively, of net revenue. The Pharmaceutical technology services
segment was classified as discontinued operations in the first, second and
third quarters of Fiscal 2007. The Company believes that the public
announcement of this classification caused demand for the Companys
pharmaceutical technology services to decline. When the Company sought to sell
this business, the offers received were inadequate. When the Company wrote the
business down to fair value and reclassified the business to continuing
operations during the fourth quarter of fiscal 2007, the offers received formed
the basis for determining fair value.
Sales, marketing, and distribution
United States of America
Anesthesia and respiratory/critical care. The Company markets anesthesia and respiratory/critical care products primarily to hospitals and other health-care providers. Hospitals and other health care providers determine the channel through which they receive Vital Signs products, either directly from the Company or through a distributor of their choice. At September 30, 2007 and 2006, the United States sales force consisted of 53 and 55 sales representatives as well as seven and six regional sales managers, respectively. The Company trains its sales force in the need, use, application, and advantages of its products.
Many
of the Companys customers belong to group purchasing organizations that
provide their members access to medical products by negotiating discounts with
manufacturers. Unlike distributors, group purchasing organizations do not
themselves make purchases, carry inventory or physically handle product. The
Company has agreements with several leading group purchasing organizations,
including Amerinet, Broadlane, Consorta, Healthtrust, MedAssets (HSCA),
Novation, and Premier. During fiscal 2007, 2006 and 2005, 28%, 33% and 34%, respectively,
of the anesthesia and respiratory/critical care segments sales
to United States hospitals and other health care providers came through group
purchasing organization contracts.
Sleep disorder. Sales of sleep therapeutic and personal ventilation equipment in the United States has been minimal to date, due partly to the time required to obtain necessary FDA clearances and also to the dominant position that the Companys competitors have in the home-supply dealer channel. The Companys principal means of selling sleep disorder and personal ventilation products is through the introduction of those products to patients visiting the Companys sleep laboratories and centers.
The primary focus is to increase the patient volumes at existing laboratories and centers and negotiate contracts with new sleep laboratories and centers. The Company differentiates itself from its competitors by providing hospitals with a range of marketing options from direct marketing to an al la carte selection of services that increases the number of beds or improves existing-bed utilization.
Interventional
Cardiology/Radiology.
Sales of finished sterile medical devices and bulk non-sterile products are
primarily based on customer specification and also on proprietary finished
medical devices that are distributed by customers under their private label. As
an OEM, the business depends on its customers for distribution of the medical
devices the Company produces.
Pharmaceutical technology services. Sales are through a direct sales force of ten and nine at September 30, 2007 and 2006, respectively. The pharmaceutical technology services sales team in the United States and Puerto Rico sells FDA-compliance services to pharmaceutical companies, diagnostic and biotechnology companies, and medical device manufacturers.
International sales
The Company sells products in over 73 countries worldwide. For fiscal 2007, 2006, and 2005, international sales were approximately 24.6%, 23.7%, and 24.2%, respectively, of net revenues.
-9-
The Company
operates a wholly-owned subsidiary in the United Kingdom that distributes and
sells anesthesia and respiratory/critical care throughout the United Kingdom
and Ireland. It employs sixteen individuals, including six sales
representatives and one field-based sales manager. Anesthesia and
respiratory/critical care products are sold in over twenty European and other
international markets primarily through individual distribution channel.
Sales
in Asia, Latin America, Canada, India and Europe/Middle East are supervised by
six regional managers whose responsibilities include, but are not limited to,
the identification, qualification, appointment and continued training and
support of local, territory-specific distributors.
The Company sells sleep disorder and personal ventilation products through Breas direct sales force to home health care distributors in France, Germany, Scandinavia, Spain, and the United Kingdom, and through an independent distribution network in other countries. At September 30, 2007, Breas direct sales force consisted of 27 professionals.
See Managements discussion and analysis of financial condition and results of operations for additional information concerning international sales.
Research and development
Product
development and innovation is an essential part of the Companys success. As of
September 30, 2007 there were 46 engineers, scientists, and technicians in
research and development. The Company supplements its research with outside
consultants from time to time. The primary research and development activities
in fiscal 2007 were (1) developing SteeLiteTM single-use metal
laryngoscope blades, (2) completing the enFlow® IV Fluid/Blood Warming System
following the Enginivity LLC acquisition in August 2007, and (3) expanding the
line of ventilation products at the Companys Breas subsidiary.
The Company incorporates technical, manufacturing, operations, sales and marketing, and clinical expertise within its research and development processes. The research and development staff works with health care providers to respond to customer product needs and with Company sales and marketing teams to anticipate industry trends. The Company has successfully reduced new product development costs by utilizing its manufacturing capabilities to rapidly produce quantities of prototype products suitable for trial use and sale.
Manufacturing and quality control
Vital
Signs manufactures substantially all of its anesthesia breathing circuits,
bacterial/viral filters, blood pressure cuffs, pressure infusors, arterial
blood gas syringes, heated humidification circuits, nebulizers, manual
resuscitators, introducers, and sleep therapy products. Manufacturing processes
include tube extrusion, injection molding, radio frequency welding, product
assembly, product testing, packaging, and distribution. In some instances,
plastic components incorporated in certain products are molded to Company
specifications by outside custom injection molders who utilize molds that are
designed and, in substantially all instances, owned by the Company. In these
instances, Company suppliers are presented with written specifications to
assure that components are manufactured in conformity with design and other specifications.
The Company purchases resins, the primary raw material used in a variety of
anesthesia and respiratory products, in bulk.
The Companys manufacturing processes and systems provide quality products, react quickly to changes in demand, and generate manufacturing efficiencies. These capabilities allow the Company to contain costs, control quality, and maintain security of proprietary processes. The Company continually evaluates its manufacturing processes, with the objective of increasing automation, streamlining production, and enhancing efficiency to achieve cost savings and improve quality.
Because
the products are utilized in operating rooms and critical care units of
hospitals, the Company must meet the FDAs Quality System Regulations in all of
its facilities. The Company is required to maintain records of all raw
materials received and used in the manufacturing process along with complete
histories of all devices manufactured. For Europe distribution, the Companys
quality systems are third-party certified to be in compliance with ISO 13485
standards.
-10-
Key supplier relationships
The
Company had exclusive rights to an air-filled cushion anesthesia face mask
through a collaboration arrangement with Respironics. Face masks are used in
a variety of the Companys anesthesia circuits and manual resuscitators.
On February 2, 2007, the Company announced that it was ending its relationship
with Respironics and had formed a Chinese joint venture to manufacture face
masks. Respironics was the Companys sole face mask supplier until the
formation of the Chinese joint venture.
As of August 2007, Respironics sold all of its tooling, equipment, know-how and intellectual property for manufacturing air-filled cushion masks to the Company, agreed to continue manufacturing masks during the transition process, and agreed to cooperate with the startup of the Companys Chinese joint venture. The joint venture is ramping up mask production and is currently supplying 40% of the Companys mask needs.
If
the Company becomes unable to fully transition the face mask manufacture to the
joint venture or if the supply of face masks would be interrupted, the Company
would be required to find alternative suppliers. The Company believes that alternative face mask suppliers exist; however, there is
no assurance that, in the event of a face mask supply
interruption, the Company could maintain a delivery of face masks in a quantity
and at a cost that would not have a material adverse effect on the Companys
business and operating results.
Intellectual property
The Company primarily relies upon trade secrets and continuing technological innovations to develop and maintain its competitive position and seeks patent protection for inventions that provide its products a competitive advantage. When determined appropriate, the Company has enforced and plans to continue to enforce and defend its patent rights. In an effort to protect trade secrets, the Company requires certain employees, consultants, and advisors to execute confidentiality, proprietary information, and invention assignment agreements upon commencement of employment or consulting relationships.
Some
patents are for significant technologies that are utilized in the Companys
anesthesia, respiratory/critical care, and sleep disorder business segments.
The Companys ongoing success depends in part on the ability to maintain its
patents, obtain new patents, and develop new products and applications without
infringing on the patent or other proprietary rights of third parties. In the
medical industry, there has been substantial litigation involving the
intellectual property rights of medical device manufacturers, and the Company
has been involved in several legal proceedings, often at significant expense.
The Company cannot assure that any of its patents will not be circumvented or
successfully challenged, that its patents will provide competitive advantages,
or that pending or future patent applications will be granted. The Company also
cannot assure that its products or proprietary rights do not infringe upon the
rights of third parties. If an infringement were established, the Company could
be required to pay damages or enter into royalty or licensing agreements with
onerous terms, and/or be enjoined from making, using, or selling the infringing
product.
Regulation
Medical device regulation
As
a manufacturer of medical devices, the Company is subject to regulation by,
among other governmental entities, the FDA and the corresponding agencies of
the states and foreign countries in which the Company operates. The Company
must comply with a variety of regulations, including the Quality System
Regulations of the FDA, and is subject to periodic inspections by the FDA and
applicable state and foreign agencies. Enforcement of the Quality System
Regulations has increased significantly in recent years, and the FDA has
publicly stated that medical compliance will be more strictly scrutinized. If
the FDA believes that its regulations have not been fulfilled, it may invoke
extensive enforcement powers. Non-compliance with applicable regulatory
requirements can result in, among other things, warning letters, fines,
injunctions, civil penalties, recall or seizure of products, total or partial
suspension of production, failure to receive pre-market clearances, withdrawal
of clearances, and criminal prosecution. The FDA also has the authority to
require recall, repair, replacement or refund of the cost of any device
manufactured or distributed by the Company. Current FDA enforcement policy
prohibits the marketing of cleared medical devices for un-cleared uses.
-11-
After
clearance is given, the FDA or foreign regulatory agencies may withdraw
clearances or approvals or require the Company to change the device,
manufacturing process, labeling, supply additional proof of product safety and
effectiveness, or to recall, repair, replace, or refund the cost of the medical
device. The process of obtaining clearances or approvals to market products can
be costly, time consuming, and can delay the marketing and sale of the
Companys products. Federal, state, and foreign regulations regarding the
manufacture and sale of medical devices are also subject to change. The Company
cannot predict what impact, if any, such changes might have on its business.
From time to time the Company may take recall actions with respect to particular lots of a specific product. Such actions are recorded in Company records and are available to the FDA during inspections. The Company also may file notices with the FDA describing such actions.
The
FDA classifies medical devices into three classes that determine the degree of
regulatory control that the manufacturer must meet. Class I is the least
stringent, and these medical devices are subject to general controls, including
reporting certain types of device-related events to the FDA, labeling, and
adherence to the Quality System Regulations. Class II devices are customarily
subject to general and special controls including Section 510(k) clearance,
performance standards, post-market surveillance, patient registries, and FDA
guidelines. Class III is the most stringent, and these medical devices are
those that must receive pre-market approval by the FDA to ensure device safety
and efficacy. Class III includes life-sustaining, life-supporting, and certain
implantable devices, as well as new devices that have not been found to be
substantially equivalent to legally-marketed Class I or Class II devices. The
pre-market approval process may take several years and requires submitting
extensive performance and clinical information.
Most
Vital Signs products are either Class I or Class II. If the Company were to
develop any Class III medical devices, the time, effort, and expense required
to obtain the necessary approvals would be substantial.
International sales of medical devices are subject to foreign government regulations, which vary substantially from country to country. The time required to obtain approval by a foreign country may be longer or shorter than that required for FDA clearance, and the requirements may differ significantly.
The European Union has adopted legislation and Medical Device Directives that regulate the design, manufacture, clinical trials, labeling, and adverse event reporting for medical devices. This regulation establishes a Competent Authority in each member state to monitor and ensure compliance with the Directive. Each Competent Authority, in turn, then nominates a Notified Body to oversee the conformity assessment procedures set forth in the Directive, under which manufacturers demonstrate that their devices comply with the requirements of the Directive and are entitled to bear the CE marking. CE is an abbreviation for Conformité Européene, or European Conformity, and the CE marking, when placed on a product, indicates compliance with the requirements of the applicable directive. Only medical devices properly bearing the CE marking may be commercially distributed throughout the European Union.
The Company has approval to affix the CE marking on all of its major product lines. As new products are introduced, the Company intends to gain approval for CE marking. While no additional pre-market approvals in individual European Union countries are required prior to marketing of a device bearing the CE mark, practical complications with respect to marketing introduction may occur. For example, different labeling requirements among EU countries exist.
Over the last several years numerous countries, such as Australia, China, Japan, and India have imposed new regulations on the registration of medical devices which in some instances have significantly lengthened the registration process. Non-compliance with foreign regulations may carry the same or increased risks, liabilities, and exposures as non-compliance with FDA requirements. Foreign regulatory authorities also have the authority to require the Company to repair, replace, or refund the cost of any device that the Company manufactures or distributes.
-12-
Health care regulation
Some
of the services provided in the Companys sleep disorder business segment are
subject to additional regulation from various state and local regulatory
authorities. A trend is developing in the United States to require the
licensing of technical personnel to perform sleep disorder diagnostic testing
procedures. Licensed personnel are more highly compensated than unlicensed
personnel.
Sleep diagnostic service providers are subject to regulation by United States federal and state authorities aimed at combating fraud and abuse in the health care industry. The federal government has enacted statutes and corresponding regulations addressing, among other things, kickbacks, self-referral, the submission of false claims for reimbursement, and the failure to follow physician prescriptions. Many states have enacted similar statutes. The federal laws apply in any case where the Company may provide a product or service that is reimbursable under the Medicare or Medicaid programs, or where the Company is requesting reimbursement from Medicare or Medicaid.
The Companys ability to sell its Breas products in Company sleep laboratories and centers is restricted by federal regulations that prohibit the Company from diverging from a physicians prescription. If a physician prescribes a CPAP product by name other than a Breas product, at one of the Companys sleep laboratories and centers, the Company is prohibited from substituting a Breas product.
The federal government is authorized to impose criminal, civil, and administrative penalties on a health-care provider who files a false claim for reimbursement from Medicare or Medicaid. Even where a claim has not been submitted to Medicare or Medicaid, criminal penalties may be imposed against the provider if the government can show that the claims constitute mail fraud or wire fraud. The government has increasingly been applying penalties in a broadening range of circumstances, for example, in instances where reimbursement has been made or sought for medically unnecessary services or for services that fall below clinical standards for quality care. The federal anti-kickback law prohibits the offering, solicitation, payment or receipt of anything of value which is intended to induce the referral of Medicare or Medicaid patients, or to induce the ordering of items or services that are reimbursable under those programs. The federal anti-kickback law has been interpreted to apply where one purpose of an arrangement is to induce referrals, even if it is not the primary purpose of the arrangement. Arrangements that meet certain so-called safe harbors are deemed not to violate the federal anti-kickback law, but the failure of a particular arrangement to meet a safe harbor also does not necessarily mean that such an arrangement is illegal.
The federal self-referral law, commonly referred to as the Stark Law, prohibits a physician from referring a patient to another health care provider for certain designated health products and services reimbursable by Medicare or Medicaid if the referring physician has a financial relationship with that provider. Financial relationship has been broadly defined in the applicable regulations to include both direct and indirect relationships, and includes both ownership interests and compensation as forms of financial relationships. As with the federal anti-kickback laws safe harbors, the Stark Law and its regulations exclude certain arrangements from the general prohibition, provided that specific criteria applicable to each arrangement are met.
The penalties for violating these federal laws include criminal sanctions and fines, potential treble damages, and civil and administrative penalties, which may include, but not be limited to, exclusion from the Medicare and Medicaid programs, and the repayment to the federal government of any reimbursement that the provider received in violation of the law.
Many states have enacted laws similar to the federal fraud and abuse laws. There is a great degree of variability among these states in terms of the applicability and requirements of each of their laws. For instance, some states laws are applicable only to services or products reimbursable under Medicaid, while others apply to all health care services regardless of the source of payment. By way of further example, some states do not prohibit referrals to a provider with which the referring physician has a financial relationship, but only require that the patient be informed of the relationship before the referral is made.
In
addition, the Company is also subject to numerous foreign, federal, state, and
local laws and regulations relating to such matters as safe working conditions,
environmental protection, and fire hazard control.
-13-
Privacy regulation
Some of the Companys business activities require that it collect and/or use information about individuals and their medical conditions. As a result, the Company is subject to regulation by both United States and foreign authorities to protect individual privacy by requiring confidentiality of patient information.
In 1996, the United States Congress enacted the Health Insurance Portability and Accountability Act, which mandated, among other things, the promulgation of regulations to address the privacy of health information and to reduce many of the costs and administrative burdens of the health care industry. These regulations have been developed by the United States Department of Health and Human Services and address three general areas: standardization of electronic transactions, security of health information systems, and privacy of protected health information. Collectively, these regulations are intended to establish federal standards concerning the use, disclosure, and protection of health information which, by its nature, can be linked to specific individuals. In addition to limited access to protected health information of Company employees, the Companys Sleep Services of America subsidiary collects protected health information of its clients.
The Health Insurance Portability and Accountability Act also establishes civil and criminal fines and penalties for the improper use and disclosure of individually identifiable health information. The regulations continue to evolve as the United States Department of Health and Human Services continues to receive public comment and revise certain of the regulations, most notably those addressing privacy. There is no meaningful history of enforcement efforts by the federal government at this time. It is, therefore, not possible to ascertain the likelihood of enforcement efforts in connection with the Health Insurance Portability and Accountability Act regulations or the potential fines and penalties that may result from the violation thereof.
Foreign governments are increasingly addressing concerns related to the privacy of information collected about their citizens with laws and regulations designed to protect the confidentiality of such information.
Third party reimbursement
The cost of medical care in the United States and many other countries is funded substantially by government and private insurance programs. Although the Company does not generally receive payment for its products or services directly from these payors (other than in connection with the Companys sleep diagnostic services), the Companys continued success is dependent upon the ability of patients, hospitals, and home care distributors to obtain adequate reimbursement for Company products and sleep services. In most major markets, Vital Signs products are purchased primarily by hospitals and medical centers that are generally either government funded, invoice third-party payors directly, or invoice patients that receive reimbursement from third-party payors. Other than direct hospital sales (and the Companys sleep diagnostic services and resulting sales of CPAP equipment), the Companys remaining sales are to distributors and manufacturers of other medical products that then sell to these customers.
Sleep-diagnostic services provided in Company sleep laboratories and centers to patients are generally covered by private insurance. In those instances, the patient is responsible for their co-payment portion of the fee, and the Company invoices the patients insurance company for the balance. The Company contracts with hospitals on a fee for service basis, and the hospital assumes the billing risk.
In the United States, third-party payors include Medicare, Medicaid, and private health insurance providers. These payors may deny reimbursement if they determine that a device has not received appropriate FDA clearance, is not used in accordance with approved applications, or is experimental, medically unnecessary, or inappropriate. Third-party payors are also increasingly challenging prices charged for medical products and services, and certain private insurers have initiated reimbursement systems designed to reduce health care costs. The trend towards managed health care and the growth of health maintenance organizations that control and significantly influence health care service and product purchases, as well as ongoing legislative proposals to reform health care, may all result in lower prices for the Companys products and services. The Company cannot assure that its products and services will be considered cost-effective by third-party payors, reimbursement will be available or continue to be available,
-14-
or that payors reimbursement policies will not adversely affect the Companys ability to sell its products and services on a profitable basis, if at all.
Competition
The
Companys markets are highly competitive. The principal bases for competition
include product features, price, quality, customer service, technique,
performance, market reputation, breadth of product offerings, and effectiveness
of sales and marketing. The Company believes that its products compete
favorably with respect to these factors.
The
Company competes on a product-by-product bases with various companies, many of
which have greater financial and marketing resources, broader business
segments, or both. The Companys primary competitors in each of its product and
service categories include the following entities and their affiliates:
|
|
|
Product/service category |
|
Primary competitors |
|
|
|
Anesthesia |
|
Bespak |
|
|
|
Respiratory/critical care |
|
Ambu
International A/S |
|
|
|
Sleep disorder |
|
Fisher &
Paykel Healthcare |
|
|
|
Interventional cardiology/radiology |
|
Enpath
Medical |
|
|
|
Pharmaceutical technology services |
|
Day &
Zimmerman |
-15-
Employees
The
Company believes that its relations with its employees are good. None of the
Companys employees are members of unions, although certain employees outside
of the United States have statutory benefits comparable to collective
bargaining agreements. As of September 30, 2007, the Company had 1,257
full-time employees shown as follows:
|
|
|
|
|
Department |
|
Number of |
|
|
|
|
|
|
|
Manufacturing and quality control |
|
|
653 |
|
Sales and marketing |
|
|
159 |
|
Sleep center technical personnel |
|
|
157 |
|
Regulatory consultants |
|
|
66 |
|
Research and development |
|
|
46 |
|
Administration |
|
|
176 |
|
|
|
|
|
|
Total |
|
|
1,257 |
|
|
|
|
|
|
Website
The Company maintains a website at www.vital-signs.com that provides proxy statements, press releases, and SEC reports on Forms 3, 4, 5, 8-K, 10-K, and 10-Q (and any amendments to those reports) that are filed with the SEC. These reports and other materials are made available as soon as reasonably practicable after such material is electronically filed with or furnished to the SEC. Press releases are also issued via electronic transmission to provide access to Company financial and product news. In addition, the Company provides notification of and access to voice and Internet broadcasts of its quarterly and annual results.
-16-
The reader should carefully consider the risks described below and all other information contained in this Annual Report. If any of the following risks, as well as other risks and uncertainties that are not yet identified or that the Company currently thinks are immaterial, actually occur, the Companys business, financial condition, and results of operations could be materially and adversely affected. In that event, the trading price of the Companys shares could decline, and shareholders may lose all or a substantial part of their investment.
Risks related to the Companys industry
Public and private sector health care organizations continue to exert substantial cost containment pressures that could adversely impact the Companys selling prices and profitability.
In recent years,
both the public and private sectors have made widespread efforts to control
health care costs, including the prices of products sold by the Company. Such
efforts may have a material adverse effect on the pricing of, and the demand
for, Company products. Health care organizations are evaluating approaches to
reduce costs by decreasing the frequency with which a treatment, device, or
product is used and by making more diagnostic procedures available for
home-based testing as opposed to laboratory or hospital based testing. Cost
containment also has caused the health-care purchasing decision-making function
to shift from the physician to the administrator at the health care
institution, resulting in an increased emphasis on reduced price, as opposed to
product features and clinical benefits. Efforts by U.S. governmental and
private payors to contain costs will likely continue, and the Company expects
that international health care markets will follow a similar trend toward cost
containment.
The time and expense needed to obtain regulatory approval and respond to changes in regulatory requirements could adversely affect the Companys ability to commercially distribute its products and services and generate sales revenue.
The Company is
subject to extensive worldwide regulation with respect to product clearance and
enforcement activities. This results in long product approval cycles,
uncertainty with respect to the timing of the introduction of new or modified
products, uncertain regulatory approvals, and substantial expenses. The
Companys products are subject to extensive regulation by the United States
Food and Drug Administration (the FDA) and certain similar foreign regulatory
agencies. Additionally, some of the Companys sleep disorder services are
subject to additional regulation from various local regulatory agencies.
The
FDA regulates the pre-clinical and clinical testing, manufacturing, labeling,
distribution, and promotion of medical devices. It can take several years to
receive the appropriate clearances from the FDA, and the Company cannot assure
that it will always obtain such clearances. If the Company decides to develop
any products that are categorized by the FDA as Class III medical devices, the
time, effort and expense required to obtain the necessary clearances will
increase significantly. In addition, the products that the Company manufactures
or distributes pursuant to FDA clearances are subject to pervasive and
continuing regulations by the FDA. Non-compliance with applicable requirements
can result in, among other things, warning letters, fines, injunctions, civil
penalties, recalls or seizures of products, total or partial suspension of
production, failure of the government to grant pre-market clearance for
devices, withdrawal of marketing clearances, and criminal prosecution. The FDA
also has the authority to require the Company to repair, replace, or refund the
cost of any device that it manufactures or distributes.
International sales of medical devices are subject to foreign government regulations, which vary substantially from country to country. The time required to obtain approval by a foreign country may be longer or shorter than that required for FDA clearance, and the requirements may differ significantly. Over the last several years several countries, such as Australia, China, Japan, and India have imposed new regulations on the registration of medical devices which in some instances have significantly lengthened the registration process. Non-compliance with foreign regulations may carry the same or increased risks, liabilities, and exposures as non-compliance with FDA requirements. Foreign regulatory authorities also have the authority to require the Company to repair, replace, or refund the cost of any device that the Company manufactures or distributes.
-17-
Certain business activities require that the Company collect and/or use information about individuals and their medical conditions. As a result, the Company is subject to complex regulations by both United States and foreign authorities to protect individual privacy by requiring that the Company maintain the confidentiality of patient information. Implementation and compliance with these regulations are costly.
Even after receiving FDA and foreign regulatory clearance or approval, the Companys products may be subject to product recalls, which may harm the Company.
The FDA and similar governmental authorities in other countries have the authority to make a mandatory recall or order the market removal of the Companys products in the event of material deficiencies or defects in medical device design, manufacture, or labeling. Any recall of Company products may materially adversely affect the Companys profitability, divert managerial resources, and harm the Companys reputation.
The Company may lose significant customers as a result of substantial consolidation within the health care industry.
Over the past several years, the health care industry, including many of the Companys customers, has undergone significant consolidation, and the Company expects this trend to continue. The Company is subject to risks and uncertainties that result from mergers and acquisitions involving its customers. If, as a result of such mergers or combinations, the Companys customers lose control of the purchasing function, decide to use one of the Companys competitors or reduce their orders for Company products, the Companys revenues may be materially adversely affected.
Government and private insurance plans may not reimburse the Companys customers for the Companys products, which could result in reductions in sales or selling prices for Company products.
The cost of medical care in the United States and many other countries is funded substantially by government and private insurance programs. If such funding becomes limited or unavailable to the Companys customers, the Companys business may be adversely affected. Although the Company does not generally receive payment for its products or services directly from these payors other than for its sleep diagnostic services, the Companys continued success is dependent upon the ability of patients or the Companys customers to obtain adequate reimbursement for Company products and services. In most major markets, Company products are purchased primarily by hospitals which in turn bill third-party payors or bill patients directly who then seek reimbursement from third-party payors.
In the United States, third-party payors include Medicare, Medicaid, and private health insurance providers. These payors may deny reimbursement if they determine that a device has not received appropriate FDA clearance, is not used in accordance with approved indications, or is experimental, unnecessary, or deemed to be inappropriate treatment for the patient. Third-party payors are also increasingly challenging prices charged for medical products and services. The Company cannot assure that its products will be considered cost-effective by third-party payors, reimbursement will be available, or that payors reimbursement policies will not adversely affect the Companys ability to sell its products on a profitable basis, if at all.
Health care reimbursement systems vary from country to country and, accordingly, the Company cannot assure that third-party reimbursement available under one system will be available for procedures utilizing Company products under any other reimbursement system. Lack of, or inadequate reimbursement by, government and other third-party payors for Company products would have a material adverse effect on the Companys business, financial condition, and results of operations.
Health care reform proposals are gaining substantial support in the United States Congress and state legislatures and could impact the profitability of the Companys business.
The United States health care industry is subject to several reform proposals, including more stringent regulations. It is uncertain whether and when such proposals would become legal requirements affecting the Companys business, but the Company cannot assure that any such changes will not have a material adverse effect on the Companys business. Changes in the law or new interpretations of existing laws may have a dramatic effect on the costs associated with doing business and the amount of reimbursement the Companys customers receive from both government and third-party payors. Federal, state and local
-18-
government representatives will, in all likelihood, continue to review and assess alternative regulations and payment methodologies.
Health care legislation and regulation by state legislatures regarding licensure requirements for healthcare professionals could impact the profitability of the Companys business.
Several states in which the Companys Sleep Services of America business operates have taken steps to improve licensure requirements for polysomnographic sleep technicians that monitor patients during sleep diagnostic procedures. As licensing requirements are imposed, the pool of qualified personnel tends to shrink leading to a drive for higher salaries. The Company cannot assure that these changes in the pool of available qualified employees will not have an impact on the Companys ability to maintain its profit margins at historic levels.
The Company incurs
expenses to comply with environmental, health and safety laws and regulations.
The
Company is subject to numerous environmental, health and safety laws and
regulations, including those governing the use and disposal of hazardous
materials. The Company incurs expenses to comply with such laws and regulations
and any violation of these laws and regulations could have a material adverse
effect on the Companys business, financial condition, and results of
operations.
Risks related to the Companys business
The markets for the Companys products and services are highly competitive, and the Company competes against substantially larger companies.
Competition among medical device companies is intense. If the Company is unable to compete effectively with existing or future competitors, it may be prevented from retaining the Companys existing customers or from attracting new customers, which could materially impair the Companys business. There are a number of companies that currently offer, or are in the process of developing, products that compete with products that the Company offers. The Company cannot assure that some of these competitors will not succeed in developing products that are more effective and/or less expensive than those currently used or produced by the Company or that would render some products offered by the Company obsolete or non-competitive. Many of the Companys competitors have greater financial, research and development, manufacturing, and marketing resources than the Company has and may be in a better position than the Company is to withstand the adverse effects on gross margins and profitability caused by price decreases prevalent in this competitive environment.
The presence of group purchasing organizations may affect the Companys competitive position, pricing and ultimately profits.
The Companys ability to sell its products to hospitals depends on the Companys relationships with group purchasing organizations. In fiscal 2007, Company sales of anesthesia and respiratory/critical care products related to group purchasing arrangements amounted to $27.3 million, representing 28% of total net revenue from United States hospital sales. In 2008, Company contracts with several of the group purchasing organizations will terminate unless the parties mutually agree to renew them. In fiscal 2007, the Company had net revenues of $5.0 million under the contracts subject to termination or renewal in 2008. The Company cannot assure that it will be able to renew these contracts at the current or substantially similar terms. If the Company is unable to keep its relationships and develop new relationships with group purchasing organizations, the Companys competitive position would likely suffer. In addition, some group purchasing organizations have tested the use of new internet bidding procedures in order to maximize their abilities to negotiate lower prices with suppliers. Movement to these bidding modalities has been implemented by some organizations and has resulted in lower pricing in some instances. The Company cannot assure that continued movement to these bidding modalities will not increase. This may result in lower pricing or failure to secure contracts with these organizations.
The Company could lose customers and its business could be adversely affected if its competitors implement new technologies before the Company does.
The market for Company products is characterized by frequent product improvements and evolving technology. The Companys revenue and profitability could be adversely affected by technological change.
-19-
To compete effectively, the Company must anticipate and adapt to technological changes and offer, on a timely basis, competitively priced products with new and improved features that meet evolving industry standards and customer preferences. The Company may choose to develop or invest in new technologies that prove to be ineffective, do not gain market acceptance, or are incompatible with technologies of the Companys customers. As new technologies develop, the Company may be forced to implement these new technologies at a substantial cost in order to remain competitive. In addition, competitors may implement new technologies which allow them to offer lower-priced and/or superior quality products which may render Company products obsolete or uncompetitive.
The Company is dependent on a single supplier for one of its key products.
Face masks are used
in a variety of the Companys anesthesia circuits and manual resuscitators. On
February 2, 2007, the Company announced that it was ending its relationship
with Respironics. In the first quarter of 2007, the Company formed a Chinese
joint venture to manufacture face masks. Respironics was the Companys sole
face mask supplier until the formation of the Chinese joint venture.
Respironics has continued to provide products to the Company during the
transition to the joint venture, and Respironics has sold substantial
manufacturing assets to the Company.
If the Company becomes unable to fully transition the face mask manufacture to the joint venture or if the supply of face masks would be interrupted, the Company would find alternative suppliers. The Company believes that alternative face mask suppliers exist; however, there is no assurance that, in the event of a face mask supply interruption, the Company could maintain a delivery of face masks in a quantity and at a cost that would not have a material adverse effect on the Companys business and operating results.
The Company is dependent on a limited number of suppliers for key components of some of its products and delivery delays or the loss of vendors could adversely affect the Companys business.
The Company relies on vendors to supply the key components of some of its products. The Company is dependent on petroleum-based resins for most of its products. The fluctuations in petroleum prices due to market conditions or international events and the limited number of resin suppliers could result in increased production costs or the interruption of raw materials.
The Company cannot assure that it will not experience delays from resin suppliers or vendors of key components in the future. In the event the Company is unable to obtain components for any of its products, or is unable to obtain components on commercially reasonable terms, the Company may not be able to manufacture or distribute its products on a timely and competitive basis, or at all. If the Company experiences any delays in component availability, the cost incurred in switching business to alternate suppliers could have a material adverse effect on the Companys business, financial condition, and results of operations.
If the Company loses key personnel, or is unable to attract and retain additional highly skilled personnel required to lead the Company and to enable the Company to grow its activities, the Companys business would likely suffer.
To successfully expand the Companys operations, it will need to attract and retain additional, highly skilled individuals, particularly in the areas of sales, marketing, manufacturing, and finance. If the Company cannot attract sufficient skilled individuals, it may not be able to successfully grow its business, and the Companys business, financial condition, and results of operations would be materially adversely affected.
The Companys success depends upon developing new products and product enhancements, which entails considerable time and expense.
The Company places a high priority on developing new products to add to its product portfolio and on the development of enhancements to its existing products. Product development involves substantial expense, and the Company cannot be certain that a completed product will generate sufficient revenue to justify the resources that the Company devotes to research and development. The time and expense required to develop new products and product enhancements is difficult to predict, and the Company cannot assure that it will succeed in developing, introducing, and marketing new products and product
-20-
enhancements. The Companys inability to successfully develop and introduce new or enhanced products on a timely basis, at all, or to achieve market acceptance of such products, could materially impair the Companys business.
Price changes in the raw materials the Company uses could have a material adverse effect on its financial condition and results of operations.
The principal raw material used to produce Company products is plastic resin, a petro-chemical compound. The Company has elected to purchase plastic resin under short-term contracts rather than entering into long-term contracts, commodity futures, or derivative instrument transactions. The Company is, therefore, subject to fluctuations in the price of plastic resin that may result from changes in the price of petroleum-based products, increases or decreases in demand during a given period, or for other reasons. As a result of price competition, the Company may be unable to pass on to customers the higher manufacturing costs incurred if there were a significant increase in the price of plastic resin or other raw materials, which would negatively impact the Companys profit margins and results of operations.
If the Company is unable to identify, complete, and integrate future acquisitions, its business may suffer.
The Company has supplemented internal growth with product, technology, and business acquisitions in the past, and intends to do so in the future. The Companys acquisition strategy is subject to inherent risks, including the following:
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viable acquisition candidates may not be available to the Company on price and other terms that are satisfactory; |
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the Company may be unable to integrate acquired companies effectively into its business; |
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the Company may be unsuccessful in commercializing products that it manufactures pursuant to acquired or licensed patents; |
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acquired companies may require more capital resources and/or management attention than the Company anticipates at the time of acquisition; |
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the Company may have limited or no direct prior experience in new markets or countries that it enters; |
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the Company may be unable to retain the key employees of the acquired business who are necessary to manage these businesses; |
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the Company may suffer adverse customer reaction to the business combination; |
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the Companys due diligence may fail to identify liabilities and exposures which, once discovered, materially adversely affect its ability to operate the newly acquired business profitably; and |
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management focus on the Companys existing businesses may be diverted. |
In addition, an acquisition could materially impair the Companys operating results by causing it to incur debt or requiring it to amortize acquisition expenses and acquired assets.
The Company cannot be certain that its product liability insurance will be sufficient to protect it against significant exposure to product liability risks.
The Company is
exposed to potential product liability resulting from the use of its products.
The Company presently maintains product liability insurance coverage of $15.0
million in the aggregate. This product liability policy generally protects the
Company against claims of bodily injury or property damage arising out of any
products manufactured, sold or distributed by the Company. If a judgment in a
product liability suit were entered against the Company or the Company entered
into a settlement agreement in excess of a policy limit or outside the scope of
coverage, including punitive damages, the Companys
-21-
profitability and financial condition may be materially adversely affected. The
Company cannot assure that its current level of insurance will be sufficient to
cover product liability claims or that such coverage will remain available to
the Company on satisfactory terms, if at all. The Company maintains a
professional errors and omissions policy for potential claims arising from the
pharmaceutical technologies business segment and for Sleep Services of America.
The Company manufactures and sells a significant portion of its products in markets outside the United States, subjecting the Company to various risks relating to international activities.
International sales accounted for approximately 24.6% of total net revenue during fiscal 2007. Such sales are subject to several risks that are separate and distinct from those the Company faces in its United States operations, including:
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difficulties in enforcing agreements and collecting receivables through certain foreign legal systems; |
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foreign customers who may have longer payment cycles than customers in the United States; |
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difficulties in enforcing intellectual property rights; |
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currency losses that may arise as a result of the fact that not all of the Companys sales are denominated in United States dollars; |
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compliance with foreign medical device manufacturing and sales regulations in the countries in which the Company sells and/or manufactures its products; |
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changes in trade policies and in domestic and foreign tax policies in the countries in which the Company sells and/or manufactures its products; |
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possible changes in export or import restrictions in the countries in which the Company sells and/or manufactures its products; |
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the modification or introduction of other governmental policies or regulations in the countries in which the Company sells and/or manufactures its products; and |
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political uncertainties in countries that the Company sells and/or manufactures its products, in particular in the Peoples Republic of China, where the Company manufactures anesthesia face masks. |
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Any such factor may affect the Companys international operations and its potential for growth in markets outside of the United States and may have a significant adverse effect on the sales of Company products and its profitability.
If the Company is unable to maintain relationships with distributors, the Companys business may be adversely affected.
Certain hospitals
require the Company to sell products through distributors. For fiscal 2007,
approximately 22.6% of the Companys net revenue was distributed through
Cardinal Health Corporation and Owens & Minor, Inc. There has also been consolidation
in the hospital distribution business with Owens & Minor having recently
purchased McKesson-General Medical. If the Companys relationships with
these distributors were damaged and the Company was unable to develop relationships
with other distributors, the Companys business, financial condition, and
results of operations could be materially adversely affected. The Company has
been disputing with Cardinal Health over inappropriate and unauthorized cash
payment discounts that Cardinal Health continues to deduct from payments. If
the Company is unable to resolve this dispute through negotiation, it may initiate
legal action against Cardinal Health. The Company cannot assure that Cardinal
Health will not attempt to terminate business relationships with the Company
should the Company sue Cardinal Health.
The Company may not be able to obtain new patents or protect its existing patents, which could enable third-parties to use the Companys technology.
-22-
The Companys
ability to compete effectively depends in part on the Companys ability to
maintain the proprietary nature of its technologies and manufacturing
processes, which includes the ability to obtain, protect, and enforce patents
on its technology and products. If the Company is unable to obtain new patents
and protect its existing patents, the Companys competitive position may
suffer. The Company owns or has licensed patents that cover several aspects of
its anesthesia, respiratory/critical care, and sleep disorder segments. Others
may challenge the Companys patents and, as a result, the Companys patents
could be narrowed, invalidated, or rendered unenforceable. Competitors may
develop products similar to the Companys products, which the Companys patents
do not cover. In addition, the Companys current and future patent applications
may not result in the issuance of patents in the United States or foreign
countries. Further, there is a substantial backlog of patent applications at
the United States Patent and Trademark Office, and the approval or rejection of
patent applications may take several years. Additionally, many of the Companys
products are not protected by patents, but rather are distinguished by product
features that others may seek to copy. As some of the Companys older patents
expire, the Company has explored new inventions to add to those products. In
certain instances when a patent expires, the Company may rely on its trademarks
to provide protection for the Company.
The Companys competitive position is dependent in part upon unpatented trade secrets that the Company may not be able to protect.
The Companys competitive position is also dependent upon unpatented trade secrets. Trade secrets are difficult to protect, and the Company cannot assure that others will not independently develop substantially equivalent proprietary information and techniques or otherwise gain access to the Companys trade secrets. If other companies are successful in copying the Companys trade secrets and developing products similar to the Companys, the Company may lose its competitive position and revenue may be significantly impacted.
The Company seeks to protect its trade secrets, know-how, and other unpatented proprietary technology, in part, with confidentiality agreements with select employees. The Company cannot assure, however, that:
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these agreements will not be breached; |
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the Company will have adequate remedies for any breach; or |
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trade secrets, know-how, and other unpatented proprietary technology will not otherwise become known to or independently developed by the Companys competitors. |
The Company holds licenses with third parties that are necessary to produce some of the Companys products. The loss of such licenses would prevent the Company from manufacturing, marketing, and selling these products, which could harm the Companys business.
The Companys success is dependent in part on its ability to operate without infringing or misappropriating the proprietary rights of others.
The Company has been sued in the past and may be sued again in the future, for infringing the intellectual property rights of others. In addition, the Company may find it necessary, if threatened, to initiate a lawsuit seeking a declaration from a court that the Company does not infringe the proprietary rights of others or that others rights are invalid or unenforceable. Even if the Company prevails in such litigation, infringement proceedings can be very expensive and time-consuming. If the Company does not prevail in infringement litigation, it may be required to pay damages and expenses, and would be required to stop the infringing activity or obtain a license. Any required license may not be available on acceptable terms, or at all. In addition, some licenses may be nonexclusive, and, therefore, the Companys competitors may have access to the same technology. If the Company fails to obtain a required license or is unable to design around a patent, the Company may be unable to sell some of its products, which could have a material adverse effect on the Companys business. The Company may decide not to introduce a product in the United States or a foreign country based on potential risk of patent infringement litigation.
-23-
Government regulation restricts the manner in which the Company may sell its obstructive sleep apnea products to customers of the Companys sleep centers and the manner in which the Company relates to referring physicians.
The Company
operates sleep centers and laboratories in the United States that diagnose
obstructive sleep apnea and other sleep disorders. The Companys ability to
sell its Breas products in Company sleep centers and laboratories is restricted
by strict regulations which prohibit the Company from diverging from a
physicians prescription. If a physician prescribes a continuous positive
airway pressure, or CPAP, product other than a Breas product at one of the
Companys sleep centers and laboratories, the Company is generally prohibited
by federal regulations from substituting a Breas product. Federal anti-kickback
and anti-referral regulations strictly limit the extent to which the Company
may provide anything of value to physicians who refer Medicare or Medicaid
patients to Company sleep centers and laboratories. Any failure by the Company
to comply with these regulations may result in significant regulatory actions,
including criminal prosecution and large fines, which could have a material
adverse effect upon the Companys business, financial condition, and results of
operations.
If the Company is unable to support its continued growth, the Companys business may suffer.
As the Company grows, the complexity of its operations increases, placing greater demands on the Companys management. The Companys ability to manage its growth effectively depends in part upon its ability to implement and improve its financial and management information systems on a timely basis and to affect other changes in its business. If the Company fails to manage its growth effectively, its business could suffer. Unexpected difficulties during expansion, the failure to attract and retain qualified employees, the failure to successfully replace or upgrade its management information systems, the failure to manage costs, the inability to respond effectively to growth opportunities, or the inability to plan for future expansion could cause the Companys growth to slow down or could require the Company to reduce its size.
A significant shift in technologies or methods used in the treatment of sleep apnea could make the Companys sleep centers and products obsolete or less attractive.
The development of new technologies or methods could reduce the demand for Company sleep centers and laboratories and its sleep disorder products. For example, pharmaceutical advances could result in different methods of treating sleep apnea and a reduced need for the Companys CPAP therapy products. The emergence of a low-invasive cost effective surgery to treat sleep apnea could also diminish the demand for the Companys sleep products and its sleep centers and laboratories. Regulatory and/or insurance reimbursement changes to current standards on reimbursement for home-based sleep disorder diagnostic testing may adversely impact the Companys revenues.
If a natural or man-made
disaster strikes one or more of the Companys manufacturing facilities, the
Company may be unable to manufacture certain products for a substantial amount
of time and the Companys revenue and profitability could decline.
The Company has four manufacturing facilities located in the United States and one manufacturing facility located in Sweden. The Company is also a partner in a joint venture manufacturing facility in China. These facilities, the manufacturing equipment, and personnel know-how that the Company uses to produce its products would be difficult to replace and could require substantial lead-time to repair or replace. The Companys facilities may be affected by natural or man-made disasters. In the event that one of the Companys facilities was affected by a disaster, the Company would attempt to shift production to its other manufacturing facilities or rely on third-party manufacturers. The Companys other facilities or a third-party manufacturer may not have the capability to effectively supply the affected products. Although the Company has insurance for property damage and business interruption, this insurance may not be sufficient in scope or amount to cover all of the potential losses and may not continue to be available to the Company on acceptable terms, or at all.
-24-
Requirements associated with the evaluation of internal controls required by Section 404 of the Sarbanes-Oxley Act of 2002 have required and will require significant Company resources and management attention.
Although the
Company believes that it is currently in compliance with Section 404 of the
Sarbanes-Oxley Act, the Company may in the future identify material
deficiencies that it may not be able to remediate on a timely basis. If the
Company is not able to continue to comply with the requirements of Section 404
in a timely manner, the Company could become subject to scrutiny by regulatory
authorities, such as the Securities and Exchange Commission, or SEC, or the
NASDAQ Global Select Market, and the trading price of the Companys stock could
decline. Moreover, effective internal controls, particularly those related to
revenue recognition, are necessary for the Company to produce reliable
financial reports and are important in helping the Company prevent financial
fraud. If the Company cannot provide reliable financial reports or prevent
fraud, its business and operating results could be harmed, investors could lose
confidence in the Companys reported financial information, and the trading
price of the Companys stock could drop significantly.
Risks related to purchasing the Companys common stock
The Companys quarterly operating results are subject to fluctuation which may impact its stock price.
The Companys operating results have, from time to time, fluctuated on a quarterly basis and may be subject to similar fluctuations in the future. These fluctuations may result from a number of factors, including:
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the introduction of new products by the Company or its competitors; |
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acquisitions; |
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actions taken by group purchasing organizations; |
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timing of orders by the Companys customers; |
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the mix of Company product sales; |
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competitive pricing in different regions in which the Company sells its products; |
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timing and cost of regulatory clearances and approvals of Company products; |
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the cost, effect, and success of the Companys promotional and marketing programs; |
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the effect of the flu season on the Companys respiratory/critical care business; |
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loss of any of the Companys key management or technical personnel; |
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product liability lawsuits against the Company; |
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changes in health care policy in the United States and internationally; |
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conditions in the financial markets in general or changes in general economic conditions; |
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changes in stock market analyst recommendations regarding the Companys common stock, other comparable companies or the medical device industry generally, or lack of analyst coverage of the Companys common stock; |
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changes in accounting principles and/or critical accounting estimates; |
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expenditures incurred by the Company for research and development; and |
-25-
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expenditures incurred by the Company to comply with enhanced regulatory obligations and internal control requirements. |
Any of these factors may cause the price for the Companys common stock to fluctuate and therefore decrease the value of any investment in the Company.
A substantial portion of the Companys assets includes goodwill and an impairment in the value of goodwill would have the effect of decreasing the Companys earnings or increasing its losses.
As of September 30,
2007, goodwill represented 24.8% of total assets. If the Company is required
to record an impairment charge to earnings relating to goodwill, it will decrease
earnings or increase losses. Goodwill represents the excess of the total
purchase price of acquisitions over the fair value of the net assets acquired.
The accounting standards on goodwill and other intangible assets that the
Company adopted as of October 1, 2001 require goodwill to be reviewed at least
annually for impairment, and does not permit amortization. In the event that
impairment is identified, a charge to earnings will be recorded and the
Companys stock price may decline as a result. For fiscal 2007, the Company
recorded $15.1 million of impairment charges related to its Stelex subsidiary
and an acquisition made by Sleep Services of America.
A large percentage of the Companys outstanding common stock is held by insiders, and, as a result, the trading market for the Companys common stock is less liquid and the Companys stock price can be volatile.
As of December 14,
2007, the Company had 13,286,050 shares of common stock outstanding.
Approximately 16.7% of these shares are beneficially owned by Terry D. Wall,
chief executive officer, and his wife, an additional 11.8% of these shares are
beneficially owned by trusts established for the benefit of the Walls
children, and an additional 9.6% of these shares are beneficially owned by an
estate planning trust established by Terry D. Wall. Such trusts are
administered by trustees who have no current or prior relationship with Vital
Signs. Companies like Vital Signs, with a relatively small percentage of shares
held by the public, can be subject to a more volatile stock price. The Companys
stock price, and therefore shareholders investments in the Company, may be
volatile.
The Companys major shareholders exercise significant influence on the Company and they may pursue policies with which other shareholders disagree.
As stated above,
Mr. Wall has a significant influence in electing Company directors, appointing
new management, and approving any action requiring shareholder approval,
including any amendment to the Companys certificate of incorporation and
approval of mergers or sales of substantially all assets. This influence may
also have the effect of delaying or preventing a change in control of the
Company or discouraging others from making tender offers for the Companys
shares, which could prevent stockholders from receiving a premium for their
shares.
The Companys
certificate of incorporation, by-laws, and New Jersey law contain provisions
that could discourage another company from acquiring the Company and may
prevent attempts by its stockholders to replace or remove the Companys current
management.
Anti-takeover provisions in the Companys certificate of incorporation make it more difficult for a third-party to acquire the Company, even if doing so would be beneficial to shareholders. These provisions include:
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the authorization of the issuance of up to 10,000,000 shares of the Companys preferred stock without further approval of shareholders; |
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the election of directors on a staggered term basis; and |
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the elimination of shareholder action by written consent. |
Similarly, the Companys by-laws establish procedures, including advance notification procedures, with regard to the nomination, other than by or at the direction of the Companys board of directors, of candidates for election as directors or for shareholder proposals to be submitted at shareholder meetings.
-26-
The Company is also subject to the New Jersey Shareholders Protection Act, an anti-takeover provision, that prevents a shareholder owning 10% or more of a New Jersey public corporations outstanding voting stock from engaging in business combinations with that corporation for five years following the date the shareholder acquired 10% or more of the corporations outstanding voting stock, unless board approval is obtained prior to the time that the shareholder reaches the 10% threshold.
These provisions are expected to discourage different types of coercive takeover practices and inadequate takeover bids and to encourage persons seeking to acquire control of the Company to first negotiate with the Companys board of directors. At the same time, however, these provisions make it more difficult for a third-party to successfully acquire the Company, even if the acquisition were beneficial to the Companys shareholders, and thus could prevent shareholders from receiving a premium for their shares.
Item 1B. Unresolved Staff Comments
Not applicable
The Company believes that its properties are adequate for its current needs. In addition, the Company believes that adequate space can be obtained to meet its foreseeable business needs. The following chart identifies the principal properties which the Company owns or leases. The properties listed below relate to the anesthesia and respiratory/critical care business segments, except for the Molnlyke, Sweden, Glen Burnie, Maryland and Atlanta, Georgia properties which relate to the Companys sleep segment; Malvern, Pennsylvania, which relates to the Companys interventional cardiology/radiology business segment; and Bensalem, Pennsylvania, which relates to the Companys pharmaceutical technology services business segment.
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Location |
Square Feet |
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Totowa, New Jersey* (executive offices, principal manufacturing, and warehouse) |
158,000 |
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Englewood, Colorado* (manufacturing, warehouse, and office space) |
88,000 |
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Burnsville, Minnesota (manufacturing, warehouse, and office space) |
38,862 |
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Molnlyke, Sweden* (Breasmanufacturing, warehouse, and office space) |
27,000 |
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Malvern, Pennsylvania (Thomas Medicalmanufacturing, warehouse, and office space) |
32,691 |
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Bensalem, Pennsylvania (Stelexoffice space) |
16,516 |
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Glen Burnie, Maryland (Sleep Services of Americaoffice space) |
9,980 |
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Atlanta, Georgia (SSA office space and sleep laboratories) |
27,652 |
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Littlehampton, United Kingdom (Vital Signs, Ltdwarehouse and office space) |
12,000 |
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* The Company Owns this Facility. |
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Vital Pharma shareholder litigation
On December 6,
1999, a complaint was filed against the Company on behalf of former
shareholders of the Companys Vital Pharma subsidiary alleging breach of
contract for failure to pay earnout payments allegedly due under the stock
purchase agreement executed in connection with the acquisition of Vital Pharma
in January 1996. In response to the lawsuit, the Company filed a seven-count
counterclaim against the plaintiffs. In August 2000, the court ordered the
plaintiffs to submit their claims relating to the earnout calculation to
binding arbitration and stayed all other proceedings pending the outcome of the
arbitration. The arbitration hearing commenced on January 26, 2004. In August
2006, the arbitrator issued a decision awarding the plaintiffs $915,000.
Plaintiffs originally claimed damages in the pre-interest amount of
approximately $8.0 million. Subsequently, in the plaintiffs post-arbitration
brief to the arbitrator, plaintiffs argued that the final calculation of their
damages could be in excess of $14 million. The Company established a reserve in
connection with this proceeding in the amount of $915,000, included in other
liabilities in the consolidated balance sheet.
The
lawsuit was stayed during the pendency of the arbitration. On October 20, 2006,
the stay was lifted and the Companys counterclaim was restored to the courts
calendar. While the plaintiffs assert that several of their claims were also
restored, the Company believes that, except for one limited claim by one
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of the named plaintiffs, all of plaintiffs original claims were adjudicated through the arbitration proceedings.
On November 11, 2006, plaintiffs filed their motion in the Federal Court to confirm the arbitrators award which was granted. However, the Company is not obligated to pay the award until resolution of the entire case. Plaintiff has told the Company of his intention to seek judicial relief for payment of the award prior to that final resolution.
Do You Snore, LLC Litigation
On
December 10, 2007 Sleep Services of America filed a lawsuit in the Superior
Court, Fulton County, Georgia against Renee McPhee and others relating to Sleep
Service of Americas acquisition in April 2007 of the assets of Do You Snore,
LLC, Southern Medical Equipment and Advanced Sleep Technologies of Georgia. The
complaint assert causes of action in breach of the acquisition agreement,
fraud, breach of non-competition agreement, misappropriation of intellectual
property and other causes of action. Ms. McPhee is the sole shareholder of Do
You Snore, LLC and a significant shareholder of the other entities. Sleep
Services of America believes that Ms. McPhee in concert with others is
violating her non-competition agreement and misappropriating business which but
for her action would have gone to Sleep Services of America.
Other litigation
The Company is also
involved in other legal proceedings arising in the ordinary course of business.
The Company cannot predict the outcome of its legal proceedings with certainty,
but based upon the Companys review of pending legal proceedings, the Company
does not believe the ultimate disposition of pending legal proceedings brought
against the Company will be material to its financial condition. Predictions
regarding the impact of pending legal proceedings constitute forward-looking
statements. The actual results and impact of such proceedings could differ
materially from the impact anticipated, primarily as a result of uncertainties
involved in the proof of facts in legal proceedings.
Item 4. Submission of Matters to a Vote of Security Holders
Not Applicable
Item 4A. Executive Officers of the Registrant
The Companys executive officers are as follows:
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Name |
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Age* |
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Positions With the Company |
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Terry D. Wall |
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66 |
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President, Chief Executive Officer and Director |
Mark D. Mishler |
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49 |
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Executive Vice President and Chief Financial Officer |
Alex Chanin |
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39 |
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Executive Vice President and Chief Information Officer |
John R. Easom |
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49 |
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Executive Vice President, Global Business Development |
Anthony P. Martino |
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61 |
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Vice President, Quality and Regulatory Affairs |
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* |
As of September 30, 2007. |
Terry D. Wall founded Vital Signs in 1972 and has been President, Chief Executive Officer, and a director of Vital Signs since that time. He received a Bachelor of Science degree in 1963 from the University of Maryland and a Master of Business Administration degree from Pace University in 1975.
Mark
D. Mishler joined Vital Signs as Executive Vice President and Chief
Financial Officer in November 2007. Prior to joining the Company, he was
Corporate Controller of Fedders Corporation, a publicly-traded manufacturer
of air management equipment firm, from November 2005 to November 2007. Prior
to that was Corporate Controller of Amcast Industrial Corporation a publicly-traded
manufacturer of technology-intensive metal products, from April 1998 to April
2005. Previously, Mr. Mishler was Division Controller for Siemens Medical Systems.
He earned Bachelors degrees in both Chemistry and Biology from Indiana University
and his MBA from The University of Michigan. Mr. Mishler is a Certified Public
Accountant and a Certified Management Accountant.
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Alex Chanin has served as Executive Vice President and Chief Information Officer for Vital Signs since January 2004. He served as President of the Companys Stelex, Inc. subsidiary from 2003 to 2004 and Vice President of Stelex from April 2002 to 2003. In 1991, Mr. Chanin was one of the founding partners of Stelex, prior to the Companys acquisition of Stelex. Mr. Chanin holds Bachelor of Science degrees in Computer Science and Electrical Engineering from Drexel University and a Master of Science in Computer Engineering from Princeton University.
John R. Easom has served as Executive Vice President of Global Business Development since January of 2007. He joined Vital Signs in October 2002 and has held various senior management positions responsible for marketing, product development, business planning and development. Prior to joining Vital Signs, Mr. Easom held management positions within Hackensack and Mountainside Hospitals before joining Foster Medical (currently Apria), Glassrock Home Health Care a division of BOC, and Affinity Ventures an M&A firm. He is a degreed and credentialed Respiratory Care Practitioner, and has a BS in Allied Health from Montclair State University.
Anthony P. Martino joined Vital Signs as Vice President, Research and Development in 1996. He has served as Vice President, Quality and Regulatory Affairs since December 1996. Prior to joining the Company, Mr. Martino spent 26 years with Becton Dickinson, a medical products manufacturer holding management positions in research and development, engineering, and quality assurance and regulatory affairs. He holds a BSME degree from the New Jersey Institute of Technology.
Each of the
Companys executive officers serves as such at the pleasure of the Board.
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|
Market for the Registrants Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities |
The Companys Common Stock (the Common Stock) is traded on the over-the-counter market and quoted on the Global Select Market of the National Association of Securities Dealers Automated Quotation System (NASDAQ) under the symbol VITL. The following table sets forth the high and low closing sales prices of the Common Stock on the NASDAQ Global Select Market, and the cash dividends declared per share of Common Stock, for the periods indicated:
|
|
|
|
|
|
|
|
|
|
|
|
|
High |
|
Low |
|
Dividend |
|
|||
|
|
|
|
|
|
|
|
|||
Fiscal Year Ended September 30, 2006: |
|
|
|
|
|
|
|
|
|
|
Quarter ended December 31, 2005 |
|
$ |
48.50 |
|
$ |
42.52 |
|
$ |
0.07 |
|
Quarter ended March 31, 2006 |
|
|
55.40 |
|
|
42.29 |
|
|
0.07 |
|
Quarter ended June 30, 2006 |
|
|
55.33 |
|
|
47.62 |
|
|
0.09 |
|
Quarter ended September 30, 2006 |
|
|
57.50 |
|
|
47.33 |
|
|
0.09 |
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Year Ended September 30, 2007: |
|
|
|
|
|
|
|
|
|
|
Quarter ended December 31, 2006 |
|
$ |
59.00 |
|
$ |
48.82 |
|
$ |
0.09 |
|
Quarter ended March 31, 2007 |
|
|
55.15 |
|
|
48.05 |
|
|
0.09 |
|
Quarter ended June 30, 2007 |
|
|
60.49 |
|
|
51.16 |
|
|
0.10 |
|
Quarter ended September 30, 2007 |
|
|
57.90 |
|
|
47.99 |
|
|
0.10 |
|
As of December 1, 2007, there were approximately 250 holders of record of the Common Stock. This figure does not represent the actual number of beneficial owners of shares of the Companys Common Stock because shares are frequently held in street name by securities dealers and others for the benefit of individual owners who have the right to vote their shares.
During fiscal 2007, the Company declared and paid cash dividends of $0.38 per share. The Company expects to continue to pay dividends on its Common Stock. However, the dividend declarations are subject to the discretion of the Companys board of directors and will depend upon various factors, including the Companys financial condition, capital requirements, loan agreement restrictions, and earnings, as well as such other factors as the Companys board may deem relevant.
The following table gives information about the Companys Common Stock that may be issued upon the exercise of options, warrants and rights under all of the Companys existing equity compensation plans as of September 30, 2007. These plans include the Companys 2003 Investment Plan, prior Investment Plan, as amended and restated as of May 30, 2001, 1991 Director Stock Option Plan, 1990 Employee Stock Option Plan, as amended and restated as of December 1, 1997, and the 2002 Stock Incentive Plan. No warrants or rights are outstanding under the foregoing plans:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Plan Category |
|
(a) |
|
(b) |
|
(c) |
|
|||||||||
|
|
|
|
|
|
|
|
|||||||||
|
||||||||||||||||
Equity Compensation Plans Approved by Shareholders |
|
|
|
504,734 |
|
|
|
$ |
40.74 |
|
|
|
|
1,387,296 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity Compensation Plans Not Approved by Shareholders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total: |
|
|
|
504,734 |
|
|
|
$ |
40.74 |
|
|
|
|
1,387,296 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-30-
Item 6. Selected Financial Data
-31-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Year ended September 30, |
|
2007 |
|
2006 |
|
2005 |
|
2004 |
|
2003 |
|
|||||
|
||||||||||||||||
Consolidated statement of income data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenue (4) (5) |
|
$ |
205,257 |
|
$ |
202,124 |
|
$ |
193,180 |
|
$ |
183,131 |
|
$ |
181,662 |
|
Cost of goods sold and services performed |
|
|
101,438 |
|
|
100,027 |
|
|
95,507 |
|
|
91,374 |
|
|
90,054 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
103,819 |
|
|
102,097 |
|
|
97,673 |
|
|
91,757 |
|
|
90,054 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative (5) |
|
|
57,135 |
|
|
52,182 |
|
|
51,025 |
|
|
50,115 |
|
|
51,338 |
|
Research and development |
|
|
7,511 |
|
|
7,034 |
|
|
7,011 |
|
|
7,036 |
|
|
5,871 |
|
Other (income) expense, net |
|
|
527 |
|
|
880 |
|
|
(78 |
) |
|
612 |
|
|
717 |
|
Impairment (1) (5) |
|
|
15,121 |
|
|
|
|
|
|
|
|
|
|
|
133 |
|
Restructuring charge |
|
|
|
|
|
|
|
|
213 |
|
|
539 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
80,294 |
|
|
60,096 |
|
|
58,171 |
|
|
58,302 |
|
|
58,059 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income (4) |
|
|
23,525 |
|
|
42,001 |
|
|
39,502 |
|
|
33,455 |
|
|
31,995 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
(4,909 |
) |
|
(3,294 |
) |
|
(1,697 |
) |
|
(1,254 |
) |
|
(904 |
) |
Interest expense |
|
|
56 |
|
|
|
|
|
36 |
|
|
26 |
|
|
910 |
|
Income unconsolidated investment |
|
|
(1,498 |
) |
|
(1,728 |
) |
|
(832 |
) |
|
(430 |
) |
|
(251 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other (income) expense |
|
|
(6,351 |
) |
|
(5,022 |
) |
|
(2,493 |
) |
|
(1,658 |
) |
|
(245 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from continuing operations before provision for income taxes and non-controlling interest (4) |
|
|
29,876 |
|
|
47,023 |
|
|
41,995 |
|
|
35,113 |
|
|
32,240 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision for income taxes |
|
|
9,985 |
|
|
15,828 |
|
|
15,093 |
|
|
12,498 |
|
|
12,802 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from continuing operations before non-controlling interest (4) |
|
|
19,891 |
|
|
31,195 |
|
|
26,902 |
|
|
22,615 |
|
|
19,438 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-controlling interest in net income of subsidiary |
|
|
683 |
|
|
911 |
|
|
602 |
|
|
447 |
|
|
248 |
|
Income from continuing operations (2) (3) (4) |
|
|
19,208 |
|
|
30,284 |
|
|
26,300 |
|
|
22,168 |
|
|
19,190 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings from continuing operations per common share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic (4) |
|
$ |
1.45 |
|
$ |
2.34 |
|
$ |
2.08 |
|
$ |
1.73 |
|
$ |
1.49 |
|
Diluted (4) |
|
|
1.45 |
|
|
2.32 |
|
|
2.06 |
|
|
1.72 |
|
|
1.48 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic weighted-average number of shares outstanding |
|
|
13,238 |
|
|
12,966 |
|
|
12,616 |
|
|
12,793 |
|
|
12,905 |
|
Diluted weighted-average number of shares outstanding |
|
|
13,277 |
|
|
13,040 |
|
|
12,789 |
|
|
12,907 |
|
|
12,985 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividends declared and paid per common share |
|
$ |
0.38 |
|
$ |
0.32 |
|
$ |
0.27 |
|
$ |
0.24 |
|
$ |
0.19 |
|
|
|
(1) |
In fiscal 2007, the Company recorded an impairment of $13.2 million for the Companys Stelex, Inc. subsidiary and a $1.9 million impairment of long lived assets pertaining to the acquisition of Do You Snore, LLC, Advanced Sleep Technologies of Georgia, Inc. and Southern Medical Equipment, Inc. (See Note 13) |
|
|
|
|
(2) |
In fiscal 2003, the Company reclassified its Vital Pharma business as a discontinued operation. |
-32-
|
|
|
Accordingly, the results of Vital Pharma are not included in continuing operations. |
|
|
|
|
(3) |
The Pharmaceutical technology services segment was classified as discontinued operations in the first, second and third quarters of Fiscal 2007. The Company believes that the public announcement of this classification caused demand for the Companys pharmaceutical technology services to decline. When the Company sought to sell this business, the offers received were inadequate. When the Company wrote the business down to fair value and reclassified the business to continuing operations during the fourth quarter of fiscal 2007, the offers received formed the basis for determining fair value. |
|
|
(4) |
The historical financial information presented in this Annual Report has been reclassified with respect to the income from unconsolidated investment in our sleep disorder segment. |
|
|
(5) |
The Company recognized several, non-cash charges in 2007 which directly impacted the Companys results of operations. The Company increased its distributor rebate allowance by an additional $4.7 million which reduced sales and gross profit. Operating expenses included goodwill impairment charges of $13.2 million for the Stelex business and a $1.9 million impairment of long lived assets pertaining to the Companys April 2007 acquisition of Do You Snore, LLC. Additionally, operating expenses included an increase in the allowance for unauthorized customer discounts of $1.2 million. Combined, these items reduced operating income by $21.0 million. Net income was reduced by $13.7 million, or $1.02 per diluted share. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
At September 30, |
|
2007 |
|
2006 |
|
2005 |
|
2004 |
|
2003 |
|
|||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Consolidated balance sheet data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
48,920 |
|
$ |
41,242 |
|
$ |
18,412 |
|
$ |
15,700 |
|
$ |
18,260 |
|
Short term investments |
|
|
86,671 |
|
|
85,565 |
|
|
63,355 |
|
|
60,768 |
|
|
37,400 |
|
Working capital |
|
|
183,440 |
|
|
169,791 |
|
|
119,555 |
|
|
112,853 |
|
|
98,469 |
|
Total assets |
|
|
330,944 |
|
|
305,854 |
|
|
253,702 |
|
|
236,064 |
|
|
223,078 |
|
Total long term debt including current portion |
|
|
1,354 |
|
|
|
|
|
|
|
|
|
|
|
1,690 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Total shareholders equity |
|
$ |
306,581 |
|
$ |
285,813 |
|
$ |
232,706 |
|
$ |
216,223 |
|
$ |
202,222 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For information regarding acquisitions affected during the past five years, see Managements discussion and analysis of financial condition and results of operations - Overview.
Item 7. Managements Discussion and Analysis of Financial Condition and Results of Operations
Forward Looking Statements
This Annual Report contains forward-looking statements (as such term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934) that are based on the Companys managements beliefs and assumptions and on information currently available to the Company. These statements may be found throughout this Annual Report, particularly in Items 1, 1A, and this Item 7. These sections contain discussions of some of the factors that could cause actual results to differ materially from the results projected in the Companys forward-looking statements. When used in this Annual Report, the words or phrases will likely result, expects, intends, will continue, is anticipated, estimates, projects, management believes, we believe, and similar expressions are intended to identify forward-looking statements within the meaning of the Exchange Act and the Securities Act. Forward-looking statements include plans and objectives of management for future operations. These forward-looking statements involve risks and uncertainties and are based on assumptions that may not be realized. Actual results and outcomes may differ materially from those discussed or anticipated.
-33-
All forward-looking statements are subject to known and unknown risks and uncertainties, including those discussed in Item 1A, that could cause actual results to differ materially from historical results and those presently anticipated or projected. No forward-looking statement is a guarantee of future performance. The Company wishes to caution readers not to place undue reliance on any such forward-looking statements, which speak only as of the date made. The reader should view the Companys cautionary statements as being applicable to all related forward-looking statements whenever they appear in:
|
|
|
|
|
this Annual Report and materials referred to in this Annual Report; and |
|
|
|
|
|
the Companys press releases. |
Overview
Anesthesia
Anesthesia segment revenues are driven primarily by hospitals performing general surgeries and by the aging of the populations in the geographical markets that the Company serves. In addition, because substantially all of the Companys anesthesia products are single-patient-use products, the Company benefits when hospitals undertake programs to reduce the frequency of nosocomial infections, which originate or occur within the hospital. Revenues in this segment are negatively impacted by the trend among hospitals to allow group purchasing organizations to negotiate long-term contracts with medical device manufacturers. See Item 1 - Business - Sales, marketing and distribution - United States sales. Expenses in the Companys anesthesia segment are driven primarily by the cost of raw materials, labor costs, and freight expenses. During recent periods, the Companys petrochemical based raw materials, such as resin, have been impacted by high gas prices and gas shortages.
In March 2005, the Company acquired the disposable airway management device business from a subsidiary of Baxter International, Inc. for approximately $10.1 million, including related transaction costs. This acquisition was structured as an asset purchase, and the Company acquired disposable airway management device manufacturing assets valued at approximately $1.3 million and inventory of anesthesia circuits, face masks, heat and moisture exchanger filters, and other associated anesthesia components valued at approximately $1.2 million. The excess of the purchase price over the fair value of the net assets acquired of approximately $7.7 million was allocated to goodwill. The results of operations of this business, including revenues of approximately $4.5 million, are included in the Companys results of operations for the anesthesia segment from March 2, 2005.
-34-
Respiratory/critical care
The Companys primary respiratory/critical care products are arterial blood gas syringes and kits, manual resuscitators, and blood pressure cuffs. The Companys respiratory/critical care segment responds to the growing needs of hospitals to provide respiratory relief and emergency care. The Company believes that there is an increasing incidence of respiratory illnesses, such as asthma and emphysema, due in part to an increasingly susceptible aging population, environmental pollution, smoking-related illnesses, as well as communicable diseases with significant respiratory impact, such as tuberculosis, HIV, and influenza. These trends, together with concerns regarding the spread of nosocomial infections, drive the Companys sales of respiratory products. As in the Companys anesthesia segment, revenues in this segment have been negatively impacted by the emergence of group purchasing organizations and expenses in this segment are driven principally by raw material, labor, and freight costs.
Sleep Disorders
On April 2, 2007 the Companys Sleep Services of America subsidiary acquired the assets of Do You Snore, LLC, Southern Medical Equipment, Inc. and Advanced Sleep Technologies of Georgia, Inc. each of which is located in Atlanta, Georgia. Do You Snore, LLC and Advanced Sleep Technologies of Georgia Inc. primarily provide sleep diagnostic services in both free standing and hospital owned sleep laboratories, and Southern Medical Equipment is a provider primarily of CPAP equipment to sleep apnea patients. These acquisitions allow Sleep Services of America to expand its geographic reach along the South East Coast, as well as expand its strategy of providing the patient with the complete range of sleep services.
On June 28, 2007, the Companys Sleep Services of America subsidiary acquired the assets of Southern Sleep Technologies, LLC and Southern Home Respiratory Care, LLC. Southern Sleep Technologies, LLC primarily provides sleep diagnostic services in both free standing and hospital owned sleep laboratories, and Southern Home Respiratory Care, LLC is a provider primarily of CPAP equipment to sleep apnea patients.
-35-
Interventional cardiology/radiology
While this business benefits from the overall development of less-invasive procedures in healthcare, it is highly dependent upon the conversion of development concepts to commercial products by its customers. The customer base is, in turn, subject to regulatory approval considerations as well as competitive pressures.
Pharmaceutical technology services
Summary
The Company recognized several one-time, non-cash charges in 2007. The Company increased its distributor rebate allowance by an additional $4.7 million which reduced sales and gross profit. Operating expenses included goodwill impairment charges of $13.2 million for the Stelex business and a $1.9 million impairment of long lived assets pertaining to the Companys April 2007 acquisition of Do You Snore, LLC. Additionally, operating expenses included an increase in the allowance for unauthorized customer discounts of $1.2 million. Combined, these items reduced operating income by $21.0 million. Net income was reduced by $13.6 million, or $1.02 per diluted share.
-36-
Net revenues
The amount and percentage of the Companys net revenue by business segment follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal year ended September 30, |
|
2007 |
|
2006 |
|
2005 |
|
||||||||||||
|
|
Net |
|
|
|
|
Net |
|
|
|
|
Net |
|
|
|
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
Anesthesia |
|
$ |
74,800 |
|
|
36.4 |
% |
$ |
73,794 |
|
|
36.5 |
% |
$ |
67,896 |
|
|
35.1 |
% |
Respiratory/critical care |
|
|
46,296 |
|
|
22.5 |
|
|
44,571 |
|
|
22.1 |
|
|
42,423 |
|
|
22.0 |
|
Sleep disorder |
|
|
48,770 |
|
|
23.8 |
|
|
42,850 |
|
|
21.2 |
|
|
40,660 |
|
|
21.0 |
|
Interventional cardiology/radiology |
|
|
28,637 |
|
|
14.0 |
|
|
25,538 |
|
|
12.6 |
|
|
25,441 |
|
|
13.2 |
|
Pharmaceutical technology services |
|
|
11,487 |
|
|
5.6 |
|
|
15,371 |
|
|
7.6 |
|
|
16,760 |
|
|
8.7 |
|
Rebate allowance adjustment (Note 18) |
|
|
(4,733 |
) |
|
(2.3 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
Total (1) |
|
$ |
205,257 |
|
100.0 |
% |
$ |
202,124 |
|
100.0 |
% |
$ |
193,180 |
|
100.0 |
% |
|
|
(1) |
The historical financial information presented in this Annual Report has been reclassified with respect to the income from unconsolidated investment in our sleep disorder segment. |
For
product sales, revenue is recognized when title to the product passes to the
customer. Except for certain domestic distributors, title passes when the
Company ships the product. For sales through certain domestic distributors,
title passes when the product is received by the distributor. For service
revenue in the sleep disorder and pharmaceutical technology services segments,
revenue is recognized when the service is performed.
Gross revenues associated with the Companys anesthesia and respiratory/critical care products are reduced by the amount of rebates due on sales to distributors. See -Critical accounting policies - Revenue recognition for a description of how the Company calculates those rebates. Sales to distributors represented 28.9%, 28.3%, and 26.2% of the Companys net sales during the fiscal years ended September 30, 2007, 2006, and 2005, respectively.
A reconciliation of gross to net product sales and a comparison with service revenues follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal year ended September 30, |
|
2007 |
|
2006 |
|
2005 |
|
|||
|
|
|
|
|
|
|
|
|||
Gross sales |
|
$ |
250,166 |
|
$ |
238,020 |
|
$ |
220,504 |
|
Rebates (1) |
|
|
(74,798 |
) |
|
(64,643 |
) |
|
(55,917 |
) |
Other deductions (2) |
|
|
(3,309 |
) |
|
(4,415 |
) |
|
(4,006 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net sales |
|
|
172,059 |
|
|
168,962 |
|
|
160,581 |
|
Service revenues |
|
|
33,198 |
|
|
33,162 |
|
|
32,599 |
|
|
|
|
|
|
|
|
|
|
|
|
Total net revenues (3) |
|
$ |
205,257 |
|
$ |
202,124 |
|
$ |
193,180 |
|
|
|
(1) |
See Critical accounting policies - Revenue recognition for information regarding rebate calculations. (See Notes 1 and 18) |
|
|
(2) |
Other deductions consist of discounts, returns, and allowances for credits. |
|
|
(3) |
The historical financial information presented in this Annual Report has been reclassified with respect to the income from unconsolidated investment in our sleep disorder segment. |
|
Research and development
-37-
International sales
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal year ended September 30, |
|
2007 |
|
2006 |
|
2005 |
|
||||||||||||
|
|
|
|
|
|
|
|
||||||||||||
|
Net |
Percent of |
Net |
Percent of |
|
Net |
|
Percent of |
|
||||||||||
|
|
|
|
|
|
||||||||||||||
Anesthesia |
$ |
10,907 |
5.3 |
% |
$ |
9,999 |
4.9 |
% |
$ |
8,357 |
4.3 |
% |
|||||||
Respiratory/critical care |
|
12,461 |
6.0 |
|
|
12,888 |
6.4 |
|
|
|
13,617 |
|
7.1 |
|
|||||
Sleep disorder |
|
27,059 |
13.2 |
|
|
25,059 |
12.4 |
|
|
|
24,820 |
12.8 |
|
||||||
Interventional cardiology/radiology |
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
|
|
|
|
|
|
|
|
|
||||||||||
Pharmaceutical technology services |
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
|
|
|
|
|
|
|
|
|
||||||||||
Total |
$ |
50,427 |
24.6 |
% |
$ |
47,946 |
23.7 |
% |
$ |
46,794 |
24.2 |
% |
|||||||
|
For international sales other than in the United Kingdom, where the Company operates its own sales and distribution office, the Company relies primarily on third-party distributors. International sales in anesthesia and respiratory/critical care segments increased $482,000 (2.1%) for the twelve months ended September 30, 2007 over the comparable period last fiscal year.
Foreign currency exchange risks
Acquisitions
As part of the Companys growth strategy, the Company pursued licensing agreements, strategic acquisitions and the purchase of technology. During the five-year period ended September 30, 2007, the Company made the following acquisitions:
|
|
|
|
|
The Company acquired a disposable airway management device business from a subsidiary of Baxter International, Inc. in March 2005 to improve its market share in the anesthesia segment. |
|
|
|
|
|
|
|
|
The Company acquired the assets of Futall AB, a Swedish company holding the rights to certain carbon dioxide detection technology of the type used by the Company in its C-CO2 product on November 14, 2005. The assets consisted of intellectual property rights including patents and trade secrets, manufacturing equipment, customer lists, and office equipment. |
|
|
|
|
|
The Companys Sleep Services of America subsidiary acquired the assets of Do You Snore, LLC, Southern Medical Equipment, Inc. and Advanced Sleep Technologies of Georgia, Inc. each of which is located in Atlanta, Georgia on April 2, 2007. Do You Snore, LLC and Advanced Sleep Technologies of Georgia, Inc. primarily provide sleep diagnostic services in both free standing and hospital owned sleep laboratories, and Southern Medical Equipment is a provider primarily of CPAP equipment to sleep apnea patients. These acquisitions allow Sleep |
|
|
-38-
|
|
|
|
|
Services of America to expand its geographic reach along the South East Coast, as well as expanding its strategy of providing the patient with the complete range of sleep services. Sleep Services of America is uniquely positioned to address the patients needs, by guiding them through the diagnostic procedure, through the set up and use of CPAP treatment devices and through the follow-up services. Subsequent to the acquisition, Sleep Services determined that it had been defrauded by a selling shareholder and others. Sleep Services has initiated litigation against these individuals. (See Note 2) |
|
|
|
|
|
The Companys Sleep Services of America subsidiary acquired the assets of Southern Sleep Technologies, LLC and Southern Home Respiratory Care, LLC on June 28, 2007. Southern Sleep Technologies, LLC primarily provides sleep diagnostic services in both free standing and hospital owned sleep laboratories, and Southern Home Respiratory Care, LLC is a provider primarily of CPAP equipment to sleep apnea patients. |
|
|
|
|
|
The Company acquired the assets of Enginivity, LLC and its enFlow® IV fluid and blood warmer patented technology on August 15, 2007. The assets consisted of intellectual property rights including patents and trade secrets. Since the acquisition of Enginivity, LLC is immaterial, no pro forma information has been presented. |
|
|
|
| These acquisitions have been accounted for as purchases and, accordingly, are included in the Companys consolidated financial statements from the respective dates of acquisition. | |
|
|
|
|
|
In the first quarter of fiscal 2007, the Company formed a Chinese joint venture to manufacture face masks. Respironics was the Companys sole face mask supplier until the formation of the Chinese joint venture. Respironics has continued to provide products to the Company during the transition to the joint venture, and Respironics has sold substantial manufacturing assets to the Company. |
Results of operations
The following table sets forth, for the periods indicated, certain statement of income data as a percentage of the Companys net revenue.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal years ended September 30, |
|
2007 |
|
2006 |
|
2005 |
|
|||
|
|
|
|
|
|
|
|
|||
Consolidated statement of income data: |
|
|
|
|
|
|
|
|||
Net revenue |
|
|
100 |
% |
|
100.0 |
% |
|
100.0 |
% |
Cost of goods sold |
|
|
49.4 |
|
|
49.5 |
|
|
49.4 |
|
Gross profit: |
|
|
|
|
|
|
|
|
|
|
Anesthesia |
|
|
51.7 |
|
|
51.2 |
|
|
53.2 |
|
Respiratory/critical care |
|
|
54.8 |
|
|
52.7 |
|
|
52.7 |
|
Sleep disorder |
|
|
52.0 |
|
|
51.9 |
|
|
46.2 |
|
Interventional cardiology/radiology |
|
|
56.3 |
|
|
52.3 |
|
|
54.9 |
|
Pharmaceutical technology services |
|
|
26.4 |
|
|
34.1 |
|
|
38.6 |
|
Total |
|
|
50.6 |
|
|
50.5 |
|
|
50.6 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
|
27.8 |
|
|
25.8 |
|
|
26.4 |
|
Research and development |
|
|
3.7 |
|
|
3.5 |
|
|
3.6 |
|
Impairment charge |
|
|
7.3 |
|
|
|
|
|
|
|
Restructuring charge |
|
|
|
|
|
|
|
|
0.1 |
|
Other (income) expense, net |
|
|
0.3 |
|
|
0.4 |
|
|
0.0 |
|
Total operating expenses |
|
|
39.1 |
|
|
29.7 |
|
|
30.1 |
|
Interest income, net |
|
|
(2.4 |
) |
|
(1.6 |
) |
|
(0.9 |
) |
Non-controlling interest in net income of subsidiary |
|
|
(0.3 |
) |
|
(0.4 |
) |
|
(0.4 |
) |
Provision for income taxes |
|
|
4.9 |
|
|
7.8 |
|
|
7.8 |
|
Income from continuing operations |
|
|
9.4 |
|
|
15.0 |
|
|
13.6 |
|
Net income |
|
|
9.3 |
|
|
14.9 |
|
|
13.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-39-
Comparison of results for the year ended September 30, 2007 to the year ended September 30, 2006
Net revenues
Of
the Companys total net revenue, $154.9 million, or 75.4%, were domestic sales,
and $50.4 million, or 24.6%, were international sales. Domestic revenues
increased by 0.4%, from $154.2 million for fiscal 2006 to $154.9 million for
fiscal 2007. Excluding the one-time rebate adjustment, the domestic sales
increase would have been 3.5%. International sales increased by 5.2%, from
$47.9 million for fiscal 2006 to $50.4 million for fiscal 2007. The
international sales increase would have been a 0.1% without the impact of
favorable foreign currency exchange within the Companys sleep disorder
segment. All other segments international sales are in U.S. dollars.
Net revenues by business segment for fiscal 2007 compared with fiscal 2006 are shown below:
Net revenue by business segment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the year ended September 30, |
|
2007 |
|
2006 |
|
Percent |
|
|||
|
|
|
|
|
|
|
|
|||
Consolidated statement of income data: |
|
|
|
|
|
|
|
|
|
|
Anesthesia |
|
$ |
74,800 |
|
$ |
73,794 |
|
|
1.4 |
% |
Respiratory/critical care |
|
|
46,296 |
|
|
44,571 |
|
|
3.9 |
|
Sleep disorder |
|
|
48,770 |
|
|
42,850 |
|
|
13.8 |
|
Interventional cardiology/radiology |
|
|
28,637 |
|
|
25,538 |
|
|
12.1 |
|
Pharmaceutical technology services |
|
|
11,487 |
|
|
15,371 |
|
|
(25.3 |
) |
Rebate allowance adjustment (Note 18) |
|
|
(4,733 |
) |
|
|
|
|
(100.0 |
) |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
205,257 |
|
$ |
202,124 |
|
|
1.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
The historical financial information presented in this Annual Report has been reclassified with respect to the income from unconsolidated investment in our sleep disorder segment. |
|
Anesthesia. Sales of anesthesia products increased by 1.4% from $73.8 million for fiscal 2006 to $74.8 million for fiscal 2007. This increase was due to broad based growth led by Limb-q and Infusors. Domestic sales of anesthesia products increased 0.2%, from $63.8 million to $63.9 million. International sales of anesthesia products increased 9.0%, from $10.0 million to $10.9 million.
Sleep disorder. Sleep disorder segment revenues increased by 13.8% from $42.9 million for fiscal 2006 to $48.8 million for fiscal 2007. The percentage increase would have been 7.7% excluding the impact of foreign currency exchange rates.
Net revenues at Sleep Services of America (SSA), the Companys domestic sleep disorder diagnostic business, increased 22.0%, from $17.8 million to $21.7 million, resulting primarily from the acquisitions of Do You Snore, LLC and Southern Sleep Technologies, Inc.
At Breas, the Companys European manufacturer of personal ventilators and CPAP devices, revenue increased 8.0%, from $25.1 million during fiscal 2006 to $27.1 million during fiscal 2007.
Interventional cardiology/radiology. Interventional cardiology/radiology segment revenues increased by
-40-
12.1% from $25.5 million for fiscal 2006 to $28.6 million for fiscal 2007.
Gross profit
The Companys gross profit dollars and margins by segment are shown below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the year ended September 30, |
|
2007 |
|
2006 |
|
||||||||
|
|
|
|
|
|
||||||||
|
|
Gross |
|
Gross |
|
Gross |
|
Gross |
|
||||
Anesthesia |
|
$ |
38,678 |
|
|
51.7 |
% |
$ |
37,784 |
|
|
51.2 |
% |
Respiratory/critical care |
|
|
25,370 |
|
|
54.8 |
|
|
23,485 |
|
|
52.7 |
|
Sleep disorder |
|
|
25,343 |
|
|
52.0 |
|
|
22,231 |
|
|
51.9 |
|
Interventional cardiology/radiology |
|
|
16,131 |
|
|
56.3 |
|
|
13,356 |
|
|
52.3 |
|
Pharmaceutical technology services |
|
|
3,030 |
|
|
26.4 |
|
|
5,241 |
|
|
34.1 |
|
Rebate allowance adjustment (Note 18) |
|
|
(4,733 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
103,819 |
|
|
50.6 |
% |
$ |
102,097 |
|
|
50.5 |
% |
|
|
|
|
|
|
|
|
|
|
Gross profit dollar and margin improvements in the Companys anesthesia and respiratory/critical care segments are due to increased sales as well as improved labor productivity and manufacturing cost controls.
The gross profit dollar increase in the interventional cardiology/radiology segment resulted primarily from a richer mix of cardiac rhythm management and electrophysiology devices combined with lean enterprise and six sigma manufacturing improvements. The gross margin in interventional cardiology/radiology products increased from 52.3% in fiscal 2006 to 56.3% in fiscal 2007.
Operating expenses
Research and development. Research and development expenses increased by 6.8%, from $7.0 million for fiscal 2006 to $7.5 million for fiscal 2007, primarily as a result of the Companys focus on the development of SteeLiteTM single-patient-use metal laryngoscope blades, expanding the Companys line of ventilation products, and completing the enFlow® IV Fluid/Blood Warming System.
-41-
Other items
Interest income, net. Interest income increased $1.6 million from $3.3 million for fiscal 2006 to $4.9 million for fiscal 2007, resulting from increased cash and cash equivalents being invested and higher interest rates.
Discontinued operations. The net loss from the Companys Vital Pharma discontinued operation was almost zero for fiscal 2007 (consisting of litigation expenses), compared with $(0.2) million for fiscal 2006. (See Note 2)
Comparison of results for the year ended September 30, 2006 to the year ended September 30, 2005
Net revenues
Net revenues by business segment for fiscal 2006 compared with fiscal 2005 are shown below.
Net revenue by business segment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the year ended September 30, |
|
2006 |
|
2005 |
|
Percent |
|
|||
|
|
|
|
|
|
|
|
|||
Consolidated statement of income data: |
|
|
|
|
|
|
|
|
|
|
Anesthesia |
|
$ |
73,794 |
|
$ |
67,896 |
|
|
8.7 |
% |
Respiratory/critical care |
|
|
44,571 |
|
|
42,423 |
|
|
5.1 |
|
Sleep disorder |
|
|
42,850 |
|
|
40,660 |
|
|
5.4 |
|
Interventional cardiology/radiology |
|
|
25,538 |
|
|
25,441 |
|
|
0.4 |
|
Pharmaceutical technology services |
|
|
15,371 |
|
|
16,760 |
|
|
(8.3 |
) |
Total (1) |
|
$ |
202,124 |
|
$ |
193,180 |
|
|
4.6 |
% |
|
|
(1) |
The historical financial information presented in this Annual Report has been reclassified with respect to the income from unconsolidated investment in our sleep disorder segment. |
Respiratory/critical care. Sales of respiratory/critical care products increased by 5.1% from $42.4 million for fiscal 2005 to $44.6 million for fiscal 2006, primarily resulting from increased sales of blood pressure cuffs and resuscitation products. Domestic sales of respiratory/critical care products increased by 10.0% from $28.8 million to $31.7 million. International sales of respiratory/critical care products decreased by 5.4% from $13.6 million for fiscal 2005 to $12.9 million for fiscal 2006, primarily reflecting declines in sales of ABG products.
Sleep disorder. Sleep disorder segment revenues increased by 5.4% from $40.7 million for fiscal 2005 to $42.9 million for fiscal 2006. The percentage increase would have been 8.75% excluding the impact of foreign currency exchange rates.
-42-
The net revenues at Sleep Services of America (SSA), the Companys domestic sleep disorder diagnostic business, increased by 12.7% from $15.8 million to $17.8 million primarily from improved utilization at existing laboratories and sleep centers.
At Breas, the Companys European manufacturer of personal ventilators and CPAP devices, revenue increased by 1.0% from $24.8 million during fiscal 2005 to $25.1 million during fiscal 2006. During fiscal 2005, a Breas component vendor did not deliver a sufficient quantity of a key component which delayed introducing a new sleep disorder and personal ventilation product line. The Company pre-announced the new product line availability, but without delivery, customers cancelled orders both for the new products and for pre-existing products. Limited shipments of the new product line began during the fourth quarter of fiscal 2005.
Interventional cardiology/radiology. The Companys interventional cardiology/radiology segment revenues increased by 0.4% from $25.4 million for fiscal 2005 to $25.5 million for fiscal 2006. The flat revenues were primarily the result of one major customer discontinuing a division to which Thomas Medical supplied two types of vascular closing devices.
Pharmaceutical technology services. Service revenues in the pharmaceutical technology services segment decreased by 8.3% from $16.8 million for fiscal 2005 to $15.4 million for fiscal 2006 due in part from a decrease in spending within its customer base comprising major pharmaceutical companies.
Gross profit
The Companys gross profit dollars and margins by segment are shown below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the year ended September 30, |
|
2006 |
|
2005 |
|
||||||||
|
|
|
|
|
|
||||||||
|
|
Gross |
|
Gross |
|
Gross |
|
Gross |
|
||||
|
|||||||||||||
Anesthesia |
|
$ |
37,784 |
|
|
51.2 |
% |
$ |
36,106 |
|
|
53.2 |
% |
Respiratory/critical care |
|
|
23,485 |
|
|
52.7 |
|
|
22,357 |
|
|
52.7 |
|
Sleep disorder |
|
|
22,231 |
|
|
51.9 |
|
|
18,770 |
|
|
46.2 |
|
Interventional cardiology/radiology |
|
|
13,356 |
|
|
52.3 |
|
|
13,976 |
|
|
54.9 |
|
Pharmaceutical technology services |
|
|
5,241 |
|
|
34.1 |
|
|
6,464 |
|
|
38.6 |
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
102,097 |
|
|
50.5 |
% |
$ |
97,673 |
|
|
50.6 |
% |
|
|
|
|
|
|
|
|
|
|
The gross profit dollar increase in the sleep disorder segment resulted from the sales volume increases in diagnostic services and introducing new sleep disorder/personal ventilation products. The gross profit margin increased from 50.6% in fiscal 2005 to 53.5% in fiscal 2006. The gross profit at Breas increased from 43.4% in fiscal 2005 to 50.7% in fiscal 2006 as the sales mix changed to include an increased percentage of higher margin new personal ventilation products.
The gross profit dollar decreased in the Companys interventional cardiology/radiology segment resulted primarily from one major customer discontinuing a division that Thomas Medical supplied two types of vascular closing devices. The gross margin in interventional cardiology/radiology products decreased from 54.9% in fiscal 2005 to 52.3% in fiscal 2006.
The gross dollar decreases in the pharmaceutical technology services segment resulted from the sales volume decrease in spending within its customer base. The gross profit margin decreased from 38.6% in fiscal 2005 to 34.1% in fiscal 2006, reflecting difficulties in leveraging certain costs over a declining revenue base.
-43-
Operating Expenses
Selling, general and administrative expenses. Selling, general and administrative expenses increased by 2.3% from $51.0 million for fiscal 2005 to $52.2 million for fiscal 2006. The increase resulted primarily from option expenses of $1.1 million due to implementing of SFAS 123(R) for stock option accounting.
Research and development. Research and development expenses remained consistent at $7.0 million for fiscal 2005 and fiscal 2006. The Company reduced its spending at Breas, where the research and development efforts in designing the new family of CPAP and ventilation equipment have been substantially completed, offset by an increase of $0.4 million from stock option expenses.
Other items
Interest income, net. Interest income increased $1.6 million from $1.7 million for fiscal 2005 to $3.3 million for fiscal 2006, resulting from an increase in cash and cash equivalents being invested (reflecting, in part, the Companys February 2006 public offering of common stock) and an increase in interest rates.
Liquidity and capital resources
The Company believes that the funds generated from operations, along with the Companys current working capital position, will be sufficient to satisfy the Companys capital requirements for at least the next twelve months.
Cash flows
-44-
Cash and working capital
Debt
Working capital and capital expenditures
Dividend and stock buybacks
Commitments and contingencies
At September 30, 2007, future payments due under the Companys operating leases and other long-term obligations are described below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
(In thousands of dollars) |
|
Total |
|
Less than |
|
One year |
|
Three |
|
More than |
|
|||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
Operating leases |
|
$ |
6,662 |
|
$ |
2,023 |
|
$ |
3,133 |
|
$ |
1,155 |
|
|
$ |
352 |
|
|
Long-term debt |
|
|
1,354 |
|
|
868 |
|
|
486 |
|
|
|
|
|
|
|
|
|
Capital leases |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fin 48 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase obligations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
8,016 |
|
$ |
2,891 |
|
$ |
3,619 |
|
$ |
1,155 |
|
|
$ |
352 |
|
|
Other
-45-
The following critical accounting estimates affect significant judgments used in the preparation of the Companys consolidated financial statements. The Companys consolidated financial statements are prepared in conformity with generally accepted accounting principles, which require the Company to make estimates and judgments that affect the Companys reported amount of assets, liabilities, revenues, and expenses, as well as related disclosures of contingent assets and liabilities. On an ongoing basis, the Company evaluates its estimates, including those related to asset impairment, revenue recognition, allowance for doubtful accounts, and contingencies and litigation. These estimates are based on the information that is currently available to the Company and on various other assumptions that the Company believes to be reasonable under the circumstances. Actual results could vary from these estimates under different assumptions or conditions.
Revenue recognition
On a monthly basis, each distributor provides the Company with documentation of shipments to particular end-users and computes a rebate claim on such shipments. Once the distributor has provided the Company with this claim, the distributor will deduct the computed rebate from its net remittance.
The amount of the estimated rebate that has not yet been taken by the distributor through the reduction of a payment is included in the allowance for rebates, which reduces the accounts receivable on the Companys balance sheet. This allowance is calculated by adding the amount of rebates claimed by the distributors through documentation but not yet reimbursed plus an estimate by the Company of the amount of future rebates due on any inventory that the distributors are holding at the end of each period.
The allowance for rebates was $10.5 million, $8.1 million, and $7.3 million at September 30, 2007, 2006, and 2005 respectively. Rebate expense was $74.8 million, $64.6 million, and $55.9 million for the years ended September 30, 2007, 2006, and 2005 respectively.
-46-
Allowance for doubtful accounts
Claims and proceedings
The Company is subject to various claims and legal actions in the ordinary course of its business. These matters frequently arise in disputes regarding the rights to intellectual property, where it is difficult to assess the likelihood of success and even more difficult to assess the probable ranges of recovery. Although the Company currently is not aware of any legal proceeding that is reasonably likely to have a material adverse effect on its financial position and results of operations other than legal proceedings for which accruals have been provided, if the Company becomes aware of any such claims against itself, the Company will evaluate the probability of an adverse outcome and provide accruals for such contingencies to the extent that such contingencies are measurable.
Inventory obsolescence
The Company establishes an allowance for inventory obsolescence. The allowance is determined by performing an aging analysis of the inventory; based upon this allowance, inventory is stated at the lower of cost, using the first in, first out method, or its net realizable value. The Companys inventory allowance for obsolescence was $0.6 million, $0.5 million, and $0.7 million at September 30, 2007, 2006, and 2005.
Recent accounting pronouncements
The Company is exposed to market risks, including the impact of material price changes and changes in the market value of its investments and, to a lesser extent, interest rate changes and foreign currency fluctuations. In the normal course of business, the Company seeks to limit the impact of market risks on earnings and cash flows.
The impact of interest rate changes is not material to the Companys financial condition. The Company does not enter into interest rate transactions for speculative purposes.
For fiscal 2007, the Companys international net revenue represented approximately 24.6% of its total net revenues. The Companys Breas subsidiary, located in Sweden, represented 53.7% of its total international net revenues during fiscal 2007. The Company does not enter into any derivative transactions, including foreign currency transactions, for speculative purposes. The Company has not entered into any derivative instrument transactions, such as foreign currency exchange forward or option contracts, as of September 30, 2007.
-47-
Item 8. Financial Statements and Supplementary Data
-48-
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We have audited the accompanying consolidated balance sheets of Vital Signs, Inc. and Subsidiaries as of September 30, 2007 and 2006 and the related consolidated statements of income, stockholders equity and other comprehensive income and cash flows for each of the three years in the period ended September 30, 2007. These consolidated financial statements are the responsibility of the Companys management. Our responsibility is to express an opinion on these consolidated financial statements based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the consolidated financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall consolidated 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 Vital Signs, Inc. and Subsidiaries as of September 30, 2007 and 2006, and the results of their operations and their cash flows for each of the three years in the period ended September 30, 2007, in conformity with United States generally accepted accounting principles.
GOLDSTEIN GOLUB
KESSLER LLP
New York, New York
F-1
|
|
|
|
|
|
|
|
|
|
September 30, |
|
||||
|
|
|
|
||||
|
|
2007 |
|
2006 |
|
||
|
|
|
|
|
|
||
|
|||||||
|
|
(In thousands of dollars) |
|
||||
ASSETS |
|
|
|
|
|
|
|
Current Assets: |
|
|
|
|
|
|
|
Cash and cash equivalents (Note 1) |
|
$ |
48,920 |
|
$ |
41,242 |
|
Short term investments (Note 1 and 3) |
|
|
86,671 |
|
|
85,565 |
|
Accounts receivable, less allowances for rebates and doubtful accounts of $14,979 and $8,526, respectively (Notes 1, 18 and 19) |
|
|
36,915 |
|
|
34,284 |
|
Inventory (Notes 1 and 4) |
|
|
19,778 |
|
|
19,006 |
|
Prepaid expenses (Note 5) |
|
|
4,140 |
|
|
4,453 |
|
Deferred income taxes (Notes 1 and 17) |
|
|
192 |
|
|
|
|
Other current assets (Note 6) |
|
|
4,650 |
|
|
596 |
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
201,266 |
|
|
185,146 |
|
|
|
|
|
|
|
|
|
Property, plant and equipmentnet (Notes 1 and 7) |
|
|
32,383 |
|
|
33,129 |
|
Goodwillnet (Notes 1 and 2) |
|
|
81,984 |
|
|
79,272 |
|
Deferred income taxes (Notes 1 and 17) |
|
|
4,732 |
|
|
801 |
|
Other assets (Notes 1 and 8) |
|
|
10,579 |
|
|
7,506 |
|
|
|
|
|
|
|
|
|
Total Assets |
|
$ |
330,944 |
|
$ |
305,854 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
|
|
|
|
|
|
|
Current Liabilities: |
|
|
|
|
|
|
|
Accounts payable |
|
$ |
7,120 |
|
$ |
5,488 |
|
Current portion of long-term debt (Note 9) |
|
|
868 |
|
|
|
|
Accrued expenses (Note 10) |
|
|
9,453 |
|
|
9,136 |
|
Income taxes payable (Note 17) |
|
|
385 |
|
|
731 |
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
17,826 |
|
|
15,355 |
|
Long-term debt (Note 9) |
|
|
486 |
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
18,312 |
|
|
15,355 |
|
|
|
|
|
|
|
|
|
Non-controlling share in subsidiary |
|
|
6,051 |
|
|
4,686 |
|
|
|
|
|
|
|
|
|
Commitments and contingencies (Notes 2, 14 and 15) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders Equity (Note 16): |
|
|
|
|
|
|
|
Common stockno par value; authorized 40,000,000 shares, issued and outstanding 13,286,050 and 13,218,850, respectively |
|
|
48,922 |
|
|
44,798 |
|
Accumulated other comprehensive income (Note 1) |
|
|
5,696 |
|
|
3,181 |
|
Retained earnings |
|
|
251,963 |
|
|
237,834 |
|
|
|
|
|
|
|
|
|
Stockholders equity |
|
|
306,581 |
|
|
285,813 |
|
|
|
|
|
|
|
|
|
Total Liabilities and Stockholders Equity |
|
$ |
330,944 |
|
$ |
305,854 |
|
|
|
|
|
|
|
|
|
F-2
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Year Ended September 30, |
|
|||||||
|
|
|
|
|||||||
|
|
2007 |
|
2006 |
|
2005 |
|
|||
|
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
|
|||
|
|
(In thousands of dollars, except |
|
|||||||
Revenue: (Note 1) |
|
|
|
|
|
|
|
|
|
|
Net sales |
|
$ |
172,059 |
|
$ |
168,962 |
|
$ |
160,581 |
|
Service revenue |
|
|
33,198 |
|
|
33,162 |
|
|
32,599 |
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
|
205,257 |
|
|
202,124 |
|
|
193,180 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold and services performed: |
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
|
83,139 |
|
|
81,632 |
|
|
77,381 |
|
Cost of services performed |
|
|
18,299 |
|
|
18,395 |
|
|
18,126 |
|
|
|
|
|
|
|
|
|
|
|
|
Total cost of services performed |
|
|
101,438 |
|
|
100,027 |
|
|
95,507 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
103,819 |
|
|
102,097 |
|
|
97,673 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
|
57,135 |
|
|
52,182 |
|
|
51,025 |
|
Research and development |
|
|
7,511 |
|
|
7,034 |
|
|
7,011 |
|
Other (income) expense, net (Note 12) |
|
|
527 |
|
|
880 |
|
|
(78 |
) |
Impairment charges (Notes 2 and 13) |
|
|
15,121 |
|
|
|
|
|
|
|
Restructuring charge (Note 11) |
|
|
|
|
|
|
|
|
213 |
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
80,294 |
|
|
60,096 |
|
|
58,171 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
23,525 |
|
|
42,001 |
|
|
39,502 |
|
|
|
|
|
|
|
|
|
|
|
|
Other (income)/expense: |
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
(4,909 |
) |
|
(3,294 |
) |
|
(1,697 |
) |
Interest expense |
|
|
56 |
|
|
|
|
|
36 |
|
Income from unconsolidated investment |
|
|
(1,498 |
) |
|
(1,728 |
) |
|
(832 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6,351 |
) |
|
(5,022 |
) |
|
(2,493 |
) |
|
|
|
|
|
|
|
|
|
|
|
Income from continuing operations before provision for income taxes, non-controlling interest and discontinued operations |
|
|
29,876 |
|
|
47,023 |
|
|
41,995 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision for income taxes (Note 17) |
|
|
9,985 |
|
|
15,828 |
|
|
15,093 |
|
|
|
|
|
|
|
|
|
|
|
|
Income from continuing operations before non-controlling interest |
|
|
19,891 |
|
|
31,195 |
|
|
26,902 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-controlling share in net income of subsidiary |
|
|
683 |
|
|
911 |
|
|
602 |
|
|
|
|
|
|
|
|
|
|
|
|
Income from continuing operations |
|
|
19,208 |
|
|
30,284 |
|
|
26,300 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income/(loss) from discontinued operations: |
|
|
(49 |
) |
|
(167 |
) |
|
89 |
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
19,159 |
|
$ |
30,117 |
|
$ |
26,389 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings (loss) per common share: |
|
|
|
|
|
|
|
|
|
|
Basic income per share from continuing operations |
|
$ |
1.45 |
|
$ |
2.34 |
|
$ |
2.08 |
|
Discontinued operations |
|
|
(0.01 |
) |
|
(0.01 |
) |
|
0.01 |
|
|
|
|
|
|
|
|
|
|
|
|
Basic net earnings per share |
|
$ |
1.44 |
|
$ |
2.33 |
|
$ |
2.09 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted income per share from continuing operations |
|
$ |
1.45 |
|
$ |
2.32 |
|
$ |
2.06 |
|
Discontinued operations |
|
|
(0.01 |
) |
|
(0.01 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net earnings per share |
|
$ |
1.44 |
|
$ |
2.31 |
|
$ |
2.06 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic weighted-average number of shares outstanding |
|
|
13,238 |
|
|
12,966 |
|
|
12,616 |
|
|
|
|
|
|
|
|
|
|
|
|
Diluted weighted-average number of shares outstanding |
|
|
13,277 |
|
|
13,040 |
|
|
12,789 |
|
|
|
|
|
|
|
|
|
|
|
|
Dividends declared and paid per common share |
|
$ |
0.38 |
|
$ |
0.32 |
|
$ |
0.27 |
|
|
|
|
|
|
|
|
|
|
|
|
F-3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
|
|
Common Stock |
|
|
Retained |
|
Stockholders |
|
Comprehensive |
|
|||||||||
|
|
Shares |
|
Amount |
|
|
|
|
|
||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(In thousands of dollars, except per share amounts) |
|
||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2004 |
|
$ |
12,715,243 |
|
$ |
24,279 |
|
$ |
3,059 |
|
$ |
188,885 |
|
$ |
216,223 |
|
|
|
|
Net income |
|
|
|
|
|
|
|
|
|
|
|
26,389 |
|
|
26,389 |
|
$ |
26,389 |
|
Repurchase of common stock |
|
|
(238,400 |
) |
|
(9,084 |
) |
|
|
|
|
|
|
|
(9,084 |
) |
|
|
|
Common stock issued under various incentive plans |
|
|
116,736 |
|
|
3,101 |
|
|
|
|
|
|
|
|
3,101 |
|
|
|
|
Tax benefit from employees and directors stock option plans (Note 16) |
|
|
|
|
|
536 |
|
|
|
|
|
|
|
|
536 |
|
|
|
|
Foreign currency translation gain/(loss) |
|
|
|
|
|
|
|
|
(1,047 |
) |
|
|
|
|
(1,047 |
) |
|
(1,047 |
) |
Dividends paid ($.27 per share) |
|
|
|
|
|
|
|
|
|
|
|
(3,412 |
) |
|
(3,412 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2005: |
|
|
12,593,579 |
|
|
18,832 |
|
|
2,012 |
|
|
211,862 |
|
|
232,706 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
25,342 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
|
|
|
|
|
|
|
|
|
30,117 |
|
|
30,117 |
|
$ |
30,117 |
|
Repurchase of common stock |
|
|
(5,000 |
) |
|
(217 |
) |
|
|
|
|
|
|
|
(217 |
) |
|
|
|
Common stock issued under various incentive plans |
|
|
196,271 |
|
|
4,192 |
|
|
|
|
|
|
|
|
4,192 |
|
|
|
|
Tax benefit from employees and directors stock option plans (Note 16) |
|
|
|
|
|
2,013 |
|
|
|
|
|
|
|
|
2,013 |
|
|
|
|
Foreign currency translation gain/(loss) |
|
|
|
|
|
|
|
|
1,169 |
|
|
|
|
|
1,169 |
|
|
1,169 |
|
Secondary offering |
|
|
434,000 |
|
|
18,490 |
|
|
|
|
|
|
|
|
18,490 |
|
|
|
|
Dividends paid ($.32 per share) |
|
|
|
|
|
|
|
|
|
|
|
(4,145 |
) |
|
(4,145 |
) |
|
|
|
Option compensation expense |
|
|
|
|
|
1,488 |
|
|
|
|
|
|
|
|
1,488 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2006 |
|
|
13,218,850 |
|
|
44,798 |
|
|
3,181 |
|
|
237,834 |
|
|
285,813 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
31,286 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
|
|
|
|
|
|
|
|
|
19,159 |
|
|
19,159 |
|
|
19,159 |
|
Common stock issued under various incentive plans |
|
|
67,200 |
|
|
1,891 |
|
|
|
|
|
|
|
|
1,891 |
|
|
|
|
Tax benefit from employees and directors stock option plans (Note 16) |
|
|
|
|
|
670 |
|
|
|
|
|
|
|
|
670 |
|
|
|
|
Foreign currency translation gain/(loss) |
|
|
|
|
|
|
|
|
2,515 |
|
|
|
|
|
2,515 |
|
|
2,515 |
|
Dividends paid ($.38 Per share) |
|
|
|
|
|
|
|
|
|
|
|
(5,030 |
) |
|
(5,030 |
) |
|
|
|
Option compensation expense |
|
|
|
|
|
1,563 |
|
|
|
|
|
|
|
|
1,563 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Balance at September 30, 2007 |
|
|
13,286,050 |
|
$ |
48,922 |
|
$ |
5,696 |
|
$ |
251,963 |
|
$ |
306,581 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
21,674 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-4
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Year Ended September 30, |
|
|||||||
|
|
|
|
|||||||
|
|
2007 |
|
2006 |
|
2005 |
|
|||
|
|
|
|
|
|
|
|
|||
|
|
(In thousands of dollars) |
|
|||||||
|
|
|
|
|
|
|
|
|
|
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
19,159 |
|
$ |
30,117 |
|
$ |
26,389 |
|
Add (income) loss from discontinued operations |
|
|
49 |
|
|
167 |
|
|
(89 |
) |
|
|
|
|
|
|
|
|
|
|
|
Income from continuing operations |
|
|
19,208 |
|
|
30,284 |
|
|
26,300 |
|
Adjustments to reconcile income from continuing operations to net cash provided by continuing operations: |
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
6,537 |
|
|
5,817 |
|
|
5,816 |
|
Deferred income taxes |
|
|
(4,460 |
) |
|
519 |
|
|
1,126 |
|
Impairment charge |
|
|
15,122 |
|
|
|
|
|
|
|
Non-cash compensation expense |
|
|
1,563 |
|
|
1,488 |
|
|
|
|
Non-controlling interest in income of subsidiary |
|
|
683 |
|
|
911 |
|
|
602 |
|
Tax benefit for stock options |
|
|
|
|
|
|
|
|
536 |
|
Changes in operating assets and liabilities: Net of assets acquired and liabilities assumed: |
|
|
|
|
|
|
|
|
|
|
(Increase)/in short term investments |
|
|
(1,106 |
) |
|
(22,210 |
) |
|
(2,587 |
) |
(Increase)/decrease in accounts receivable |
|
|
(479 |
) |
|
417 |
|
|
(2,810 |
) |
(Increase)/decrease in inventory |
|
|
438 |
|
|
(2,139 |
) |
|
1,063 |
|
(Increase)/in prepaid expenses and other current assets |
|
|
(3,546 |
) |
|
(1,068 |
) |
|
(479 |
) |
(Increase)/decrease in other assets |
|
|
(2,749 |
) |
|
1,431 |
|
|
(2,395 |
) |
Increase/(decrease) in accounts payable |
|
|
(1,181 |
) |
|
(1,659 |
) |
|
1,910 |
|
(Decrease)/increase in accrued expenses |
|
|
846 |
|
|
989 |
|
|
(46 |
) |
(Decrease) in income taxes payable |
|
|
(346 |
) |
|
(2,245 |
) |
|
(716 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by continuing operations |
|
|
30,530 |
|
|
12,535 |
|
|
28,320 |
|
Net cash provided by (used in) discontinued operations |
|
|
(49 |
) |
|
(167 |
) |
|
89 |
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by operating activities |
|
|
30,481 |
|
|
12,368 |
|
|
28,409 |
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
|
|
Acquisition of property, plant and equipment |
|
|
(3,450 |
) |
|
(7,411 |
) |
|
(3,493 |
) |
Capitalization of software development costs |
|
|
(1,491 |
) |
|
(1,314 |
) |
|
(1,880 |
) |
Capitalization of patent costs |
|
|
(202 |
) |
|
(343 |
) |
|
(206 |
) |
Acquisition of Do You Snore LLC, Southern Medical Equipment, Inc and Advanced Sleep Technologies of Georgia, Inc, Net of Cash Acquired of $148.8 |
|
|
(9,785 |
) |
|
|
|
|
|
|
Acquisition of Southern Sleep Technologies, LLC and Southern Home Respiratory Care LLC |
|
|
(2,255 |
) |
|
|
|
|
|
|
Acquisition of Enginivity, Net of Cash Acquired $6.4 |
|
|
(5,869 |
) |
|
|
|
|
|
|
Acquisition of Futall AB |
|
|
|
|
|
(2,273 |
) |
|
|
|
Acquisition of Baxter disposable airways product line |
|
|
|
|
|
|
|
|
(9,932 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net cash from investing activities |
|
|
(23,052 |
) |
|
(11,341 |
) |
|
(15,511 |
) |
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
|
|
Net proceeds from sale of common stock |
|
|
|
|
|
18,491 |
|
|
|
|
Dividends paid |
|
|
(5,030 |
) |
|
(4,145 |
) |
|
(3,412 |
) |
Tax benefit on stock options in excess of benefit provided |
|
|
670 |
|
|
2,013 |
|
|
|
|
Proceeds from exercise of stock options |
|
|
1,891 |
|
|
4,192 |
|
|
3,101 |
|
Repurchase of common stock |
|
|
|
|
|
(217 |
) |
|
(9,084 |
) |
Payments on debt |
|
|
(366 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash (used in) provided by financing activities |
|
|
(2,835 |
) |
|
20,334 |
|
|
(9,395 |
) |
Effect of foreign currency translation |
|
|
3,084 |
|
|
1,469 |
|
|
(791 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net increase in cash and cash equivalents |
|
|
7,678 |
|
|
22,830 |
|
|
2,712 |
|
Cash and cash equivalents at beginning of year |
|
|
41,242 |
|
|
18,412 |
|
|
15,700 |
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of year |
|
$ |
48,920 |
|
$ |
41,242 |
|
$ |
18,412 |
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosures of cash flow information: |
|
|
|
|
|
|
|
|
|
|
Cash paid during the year for: |
|
|
|
|
|
|
|
|
|
|
Interest |
|
$ |
56 |
|
$ |
|
|
$ |
36 |
|
Income taxes |
|
|
11,169 |
|
|
15,127 |
|
|
12,457 |
|
Supplemental schedule of non-cash financing activities: |
|
|
|
|
|
|
|
|
|
|
Fair value of common stock received as payment for exercise of stock options |
|
|
|
|
|
1,586 |
|
|
|
|
F-5
Note 1Summary of Significant Accounting Policies and Principal Business Activities
Business Activities
Principles of Consolidation
Accounts Receivable
Inventory
Inventory, net of allowances for obsolete and slow-moving goods, is stated at the lower of cost (first-in, first-out method) or market.
Depreciation
Depreciation and amortization of property, plant and equipment is provided for by the straight-line method over the estimated useful lives of the related assets.
Income Taxes
Revenue Recognition
For product sales to all customers except for certain domestic distributors (where revenue, net of allowances, is recognized upon delivery of goods to that customer), revenue, net of allowances, is recognized upon shipment to the customer, when title passes. The Company establishes allowances for rebates and sales returns. Substantially all of the Companys sales returns relate to shipping errors or damaged goods. For service revenue, revenue is recorded when the service is performed.
F-6
Shipping and Handling
Goodwill and Other Intangibles
The Company reviews the carrying value of long-lived assets, including goodwill, on a periodic basis, or whenever events or changes in circumstances indicate that the amounts may not be recoverable. If the events or circumstances indicate that the carrying amount of an asset may not be recoverable, the Company estimates the future undiscounted cash flows expected to result from the use of the asset and its eventual disposition. An impairment loss will be recognized if the carrying value of the assets exceeds the estimated future undiscounted cash flows of those assets.
The Company performs an annual impairment analysis based upon discounted cash flows to assess the recoverability of the goodwill, in accordance with the provisions of SFAS No. 142. The Company completed this annual impairment test during the period ended March 31, 2007 and found no impairment at the time.
Goodwill consists of the following:
|
|
|
|
|
|
|
|
|
|
For the Year Ended |
|
||||
|
|
|
|
||||
|
|
2007 |
|
2006 |
|
||
|
|
|
|
|
|
||
|
|
(In thousands of dollars) |
|
||||
Beginning balance: |
|
$ |
79,272 |
|
$ |
77,167 |
|
Goodwill resulting from an increase in non-controlling interest in SSA |
|
|
682 |
|
|
|
|
Goodwill acquired: Futall |
|
|
|
|
|
2,105 |
|
Goodwill acquired: Enginivity |
|
|
5,655 |
|
|
|
|
Goodwill acquired: Do You Snore, LLC & Advanced Sleep Technologies of Georgia, Inc and Southern Medical Equipment, Inc |
|
|
7,758 |
|
|
|
|
Goodwill acquired: Southern Sleep Technologies, LLC and Southern Home Respiratory Care, LLC |
|
|
1,798 |
|
|
|
|
Impairment of Stelex Goodwill |
|
|
(13,181 |
) |
|
|
|
|
|
|
|
|
|
|
|
Ending balance |
|
$ |
81,984 |
|
$ |
79,272 |
|
|
|
|
|
|
|
|
|
Other Intangibles consists of the following and are included in Other Assets on the balance sheet:
|
|
|
|
|
|||
|
|
For the Year Ended |
|||||
|
|
|
|||||
|
|
2007 |
|
2006 |
|||
|
|
|
|
||||
|
|
(In thousands of dollars) |
|||||
Trademark, provider numbers, and customer lists: |
|
|
|
|
|||
Southern Sleep Technologies, LLC and Southern Home Respiratory Care, LLC |
|
$ |
200 |
|
$ |
— |
|
Amortization |
|
|
(3 |
) |
— |
||
|
|
|
|
||||
Ending Balance |
|
$ |
197 |
|
$ | 0 |
|
|
|
|
|
F-7
Cash and Cash Equivalents
The Company considers all highly-liquid investments with a maturity of three months or less when purchased to be cash equivalents. The Company believes it is not exposed to any significant credit risk with respect to its highly-liquid investments in money market securities and its commercial banking facilities.
Short Term Investments
Management determines the appropriate classification of securities at the time of purchase pursuant to the Vital Signs, Inc. Investment Policy.
Net Income per Share of Common Stock
Basic net income per common share is computed using the weighted-average number of shares outstanding. Diluted net income per common share is computed using the weighted-average number of shares outstanding adjusted for the incremental shares attributed to outstanding options to purchase common stock.
The following table sets forth the computation of basic and diluted net income per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Year Ended September 30, |
|
|||||||
|
|
|
|
|||||||
|
|
2007 |
|
2006 |
|
2005 |
|
|||
|
|
|
|
|
|
|
|
|||
|
|
(In thousands of dollars, except |
|
|||||||
Income applicable to common shares: |
|
|
|
|
|
|
|
|
|
|
Income from continuing operations |
|
$ |
19,208 |
|
$ |
30,284 |
|
$ |
26,300 |
|
Income/(loss) from discontinued operations |
|
|
(49 |
) |
|
(167 |
) |
|
89 |
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
19,159 |
|
$ |
30,117 |
|
$ |
26,389 |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares outstanding: |
|
|
|
|
|
|
|
|
|
|
Basic weighted-average common shares outstanding |
|
|
13,238 |
|
|
12,966 |
|
|
12,616 |
|
Dilutive effect of employee stock options |
|
|
39 |
|
|
74 |
|
|
173 |
|
|
|
|
|
|
|
|
|
|
|
|
Diluted weighted-average outstanding shares |
|
|
13,277 |
|
|
13,040 |
|
|
12,789 |
|
|
|
|
|
|
|
|
|
|
|
|
Earnings/(loss) per common share: |
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
|
|
|
|
|
|
|
|
Income per share from continuing operations |
|
$ |
1.45 |
|
$ |
2.34 |
|
$ |
2.08 |
|
Income/(loss) per share from discontinued operations |
|
|
(0.01 |
) |
|
(0.01 |
) |
|
0.01 |
|
|
|
|
|
|
|
|
|
|
|
|
Net earnings |
|
$ |
1.44 |
|
$ |
2.33 |
|
$ |
2.09 |
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
|
|
|
|
|
|
|
|
|
Income per share from continuing operations |
|
$ |
1.45 |
|
$ |
2.32 |
|
$ |
2.06 |
|
Income/(loss) per share from discontinued operations |
|
|
(0.01 |
) |
|
(0.01 |
) |
|
0.00 |
|
|
|
|
|
|
|
|
|
|
|
|
Net earnings |
|
$ |
1.44 |
|
$ |
2.31 |
|
$ |
2.06 |
|
|
|
|
|
|
|
|
|
|
|
|
Capitalized Software
F-8
Estimates
The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect reported amounts in the financial statements. Actual results could differ from those estimates.
Accounting for Stock-Based Compensation
Recent Accounting Pronouncements
In July 2006, the Financial Accounting Standards Board (FASB) issued FASB Interpretation No. 48, Accounting for Uncertainty in Income Taxes, an interpretation of FASB Statement No. 109 (FIN 48), which provides criteria for the recognition, measurement, presentation, and disclosure of uncertain tax positions. A tax benefit from an uncertain position may be recognized only if it is more likely than not that the position is sustainable based on its technical merits. The FIN 48 is effective for fiscal years beginning after December 15, 2006, which is October 1, 2007 for the Company. Preliminary estimates are that the Company may recognize liability of $2.0 - $3.0 million, with the offset being to the opening balance of retained earnings.
The Company does not believe that any other recently issued but not yet effective accounting standards will have a material effect on the Companys consolidated financial position or results of operations.
F-9
Translation of Foreign Currency Financial Statements
The financial position and results of operations of the Companys foreign subsidiaries are measured using local currency as the functional currency. Assets and liabilities of these subsidiaries are translated at current exchange rates, and related revenue and expenses are translated at average monthly exchange rates. The aggregate effect of translation adjustments is reflected as a separate component of stockholders equity (accumulated other comprehensive income/(loss)) until there is a sale or liquidation of the underlying foreign subsidiary.
Note 2Acquisitions/Dispositions
Do You Snore, LLC, Southern Medical Equipment, Inc. and Advanced Sleep Technologies of Georgia, Inc.
Southern Sleep Technologies, LLC and Southern Home Respiratory Care, LLC
F-10
The results of operations of Southern Sleep Technologies, LLC and Southern Home Respiratory Care, LLC have been included in the sleep disorder segment since June 28, 2007.
F-11
|
|
|
|
|
|
|
|
|
|
|
|||
In thousands of dollars, except per share amounts |
|
Fiscal Year |
|
|||
|
|
|
|
|||
|
|
2005 |
|
|||
|
|
|
|
|||
Net sales |
|
|
$ |
199,118 |
|
|
|
|
|
|
|
|
|
Net income |
|
|
|
27,391 |
|
|
|
|
|
|
|
|
|
Basic net income per common share |
|
|
$ |
2.17 |
|
|
|
|
|
|
|
|
|
Diluted net income per common share |
|
|
$ |
2.14 |
|
|
Vital Pharma, Inc.Discontinued Operations
On October 30, 2003, the Company sold its Vital Pharma subsidiary to ProClinical, Inc. The Company received $0.5 million in cash and a three-year note receivable from ProClinical for $2.0 million. The note accrues interest at 8%, 10%, and 12% in the first, second and third years of the note, respectively. Interest is payable quarterly. ProClinical has defaulted on the payment of the note and the Company has brought foreclosure action in connection with its security interests on the assets sold to ProClinical. No gain or further loss was recorded on the sale.
Summarized selected financial information for the discontinued operations is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Year Ended September 30, |
|
|||||||
|
|
|
|
|
|||||||
|
|
|
2007 |
|
2006 |
|
2005 |
|
|||
|
|
|
|
|
|
|
|
|
|||
|
|
|
(In thousands of dollars) |
|
|||||||
|
Revenue |
|
$ |
|
|
$ |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income/(loss) before income tax benefit |
|
|
(74 |
) |
|
(253 |
) |
|
135 |
|
|
Income tax (provision) benefit |
|
|
25 |
|
|
86 |
|
|
(46 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income/(loss) from discontinued operations |
|
$ |
(49 |
) |
$ |
(167 |
) |
$ |
89 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows of the discontinued operations consisted of the following for the years ended September 30, 2007, 2006, and 2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007 |
|
2006 |
|
2005 |
|
|||
|
|
|
|
|
|
|
|
|
|||
|
|
|
(In thousands of dollars) |
|
|||||||
|
Income/(loss) from discontinued operations |
|
$ |
(49 |
) |
$ |
(167 |
) |
$ |
89 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by/(used in) discontinued operations |
|
$ |
(49 |
) |
$ |
(167 |
) |
$ |
89 |
|
|
|
|
|
|
|
|
|
|
|
|
|
F-12
Note 3Short-Term Investments
The following is a summary of Trading Securities:
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
||||
|
|
|
|
|
||||
|
|
|
2007 |
|
2006 |
|
||
|
|
|
|
|
|
|
||
|
|
|
(In thousands of dollars) |
|
||||
|
Trading Securities |
|
$ |
86,671 |
|
$ |
85,565 |
|
|
|
|
|
|
|
|
|
|
|
Total Short-Term Investment |
|
$ |
86,671 |
|
$ |
85,565 |
|
|
|
|
|
|
|
|
|
|
Note 4Inventory
Inventory consists of the following:
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
||||
|
|
|
|
|
||||
|
|
|
2007 |
|
2006 |
|
||
|
|
|
|
|
|
|
||
|
|
|
(In thousands of dollars) |
|
||||
|
Raw materials |
|
$ |
13,177 |
|
$ |
13,045 |
|
|
Finished goods |
|
|
7,230 |
|
|
6,456 |
|
|
Allowance for obsolete inventory |
|
|
(629 |
) |
|
(495 |
) |
|
|
|
|
|
|
|
|
|
|
Inventory |
|
$ |
19,778 |
|
$ |
19,006 |
|
|
|
|
|
|
|
|
|
|
Allowance for obsolete and slow moving goods at September 30, 2007 and 2006 were $629,000 and $495,000, respectively. Provisions charged to expense were $231,000, $168,000, and $127,000 for fiscal 2007, 2006, and 2005, respectively. Amounts written off against the allowance were $97,000, $409,000, and $542,000 for fiscal 2007, 2006, and 2005, respectively.
Note 5Prepaid Expenses
Prepaid expenses consist of the following:
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
||||
|
|
|
|
|
||||
|
|
|
2007 |
|
2006 |
|
||
|
|
|
|
|
|
|
||
|
|
|
(In thousands of dollars) |
|
||||
|
Prepaid Income taxes |
|
$ |
1,436 |
|
$ |
1,362 |
|
|
Prepaid taxes other |
|
|
215 |
|
|
527 |
|
|
Prepaid insurance |
|
|
818 |
|
|
1,515 |
|
|
Other |
|
|
1,671 |
|
|
1,049 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
4,140 |
|
$ |
4,453 |
|
|
|
|
|
|
|
|
|
|
Note 6Other Current Assets
Other current assets consist of the following:
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
||||
|
|
|
|
|
||||
|
|
|
2007 |
|
2006 |
|
||
|
|
|
|
|
|
|
||
|
|
|
(In thousands of dollars) |
|
||||
|
Non-trade receivables |
|
$ |
456 |
|
$ |
286 |
|
|
Restricted cash |
|
|
2,800 |
|
|
|
|
|
Other |
|
|
1,394 |
|
|
310 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
4,650 |
|
$ |
596 |
|
|
|
|
|
|
|
|
|
|
F-13
Note 7Property, Plant and Equipment
Property, plant and equipment, at cost, consists of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|||||
|
|
|
|
|
Estimated |
|
|||||
|
|
|
2007 |
|
2006 |
|
Useful Life |
|
|||
|
|
|
|
|
|
|
|
|
|||
|
|
|
(In thousands of dollars) |
|
|
|
|
||||
|
|
|
|
|
|
|
|
||||
|
Land |
|
$ |
2,395 |
|
$ |
2,364 |
|
|
|
|
|
Building and building improvements |
|
|
19,363 |
|
|
18,937 |
|
|
30 to 40 years |
|
|
Equipment and molds |
|
|
35,417 |
|
|
33,394 |
|
|
5 to 20 years |
|
|
Fixtures and office equipment |
|
|
5,180 |
|
|
4,920 |
|
|
5 to 15 years |
|
|
Transportation equipment |
|
|
140 |
|
|
143 |
|
|
5 years |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
62,495 |
|
|
59,758 |
|
|
|
|
|
Less accumulated depreciation and amortization |
|
|
(30,112 |
) |
|
(26,629 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
32,383 |
|
$ |
33,129 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation expense for fiscal year end 2007 and 2006 was $5.3 million and $4.6 million, respectively.
Note 8Other Assets
Other assets consist of the following:
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
||||
|
|
|
|
|
||||
|
|
|
2007 |
|
2006 |
|
||
|
|
|
|
|
|
|
||
|
|
|
(In thousands of dollars) |
|
||||
|
|
|
|
|
||||
|
Deposits on equipment |
|
$ |
3,872 |
|
$ |
1,586 |
|
|
Capitalized software |
|
|
3,305 |
|
|
3,262 |
|
|
Prepaid royalties |
|
|
391 |
|
|
470 |
|
|
Equity interest at cost |
|
|
432 |
|
|
432 |
|
|
Other |
|
|
2,579 |
|
|
1,756 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
10,579 |
|
$ |
7,506 |
|
|
|
|
|
|
|
|
|
|
Capitalized software, inclusive primarily of personnel and consulting costs, consists of the following:
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
||||
|
|
|
|
|
||||
|
|
|
2007 |
|
2006 |
|
||
|
|
|
|
|
|
|
||
|
|
|
(In thousands of dollars) |
|
||||
|
|
|
|
|
||||
|
Software development costsStelex Inc |
|
$ |
156 |
|
$ |
|
|
|
Software development costsVital Path |
|
|
1,626 |
|
|
1,452 |
|
|
Software development costsBreas SA |
|
|
5,340 |
|
|
4,677 |
|
|
Accumulated amortization |
|
|
(3,817 |
) |
|
(2,867 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
$ |
3,305 |
|
$ |
3,262 |
|
|
|
|
|
|
|
|
|
|
For fiscal years 2007, 2006, and 2005 amortization was $1,447,000, $1,074,000, and $1,429,000, respectively.
Note 9Long-Term Debt
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
||||
|
|
|
|
|
||||
|
|
|
2007 |
|
2006 |
|
||
|
|
|
|
|
|
|
||
|
|
|
(In thousands of dollars) |
|
||||
|
|
|
|
|
||||
|
Inventory financing assumed with acquisitions |
|
$ |
1,354 |
|
$ |
|
|
|
Less current portion |
|
|
(868 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
486 |
|
$ |
|
|
|
|
|
|
|
|
|
|
|
F-14
Note 10Accrued Expenses
Accrued expenses consist of the following:
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
||||
|
|
|
|
|
||||
|
|
|
2007 |
|
2006 |
|
||
|
|
|
|
|
|
|
||
|
|
|
(In thousands of |
|
||||
|
|
|
|
|
|
|
|
|
|
Payroll and related costs |
|
$ |
3,051 |
|
$ |
2,681 |
|
|
Professional fees |
|
|
1,715 |
|
|
1,857 |
|
|
Sales expenses |
|
|
72 |
|
|
40 |
|
|
Other taxes payable |
|
|
169 |
|
|
147 |
|
|
Deferred tax liability (Note 17) |
|
|
20 |
|
|
357 |
|
|
Other |
|
|
4,426 |
|
|
4,054 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
9,453 |
|
$ |
9,136 |
|
|
|
|
|
|
|
|
|
|
Note 11Restructuring Expense
Restructuring expense consists of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Year Ended |
|
|||||||
|
|
|
|
|
|||||||
|
|
|
2007 |
|
2006 |
|
2005 |
|
|||
|
|
|
|
|
|
|
|
|
|||
|
|
|
(In thousands of dollars) |
|
|||||||
|
Closing of California plant |
|
$ |
|
|
$ |
|
|
$ |
213 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
213 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Year Ended |
|
|||||||
|
|
|
|
|
|||||||
|
|
|
2007 |
|
2006 |
|
2005 |
|
|||
|
|
|
|
|
|
|
|
|
|||
|
|
|
(In thousands of dollars) |
|
|||||||
|
Legal |
|
$ |
410 |
|
$ |
296 |
|
$ |
|
|
|
Charitable contributions of inventory |
|
|
84 |
|
|
113 |
|
|
73 |
|
|
Acquisition costs |
|
|
|
|
|
298 |
|
|
|
|
|
Other |
|
|
33 |
|
|
173 |
|
|
(151 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
527 |
|
$ |
880 |
|
$ |
(78 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Note 13 Asset Impairment
F-15
Note 14Commitments
Leases
|
|
|
|
|
||
Year Ending September 30, |
|
(In
thousands of |
|
|||
2008 |
|
|
|
2,023 |
|
|
2009 |
|
|
|
1,764 |
|
|
2010 |
|
|
|
1,368 |
|
|
2011 |
|
|
|
676 |
|
|
2012 |
|
|
|
479 |
|
|
2013 and thereafter |
|
|
|
352 |
|
|
|
|
|
|
|
|
|
|
|
|
$ |
6,662 |
|
|
|
|
|
|
|
|
|
Note 15Contingent Liabilities
However, based on facts currently available, management believes that the disposition of matters that are pending or asserted will not have a materially adverse effect on the financial position of the Company.
The lawsuit was stayed during the pendency of the arbitration. On October 20, 2006, the stay was lifted and the Companys counterclaim, as well as plaintiffs remaining claim, were restored to the courts calendar. While plaintiff asserts that several of its claims were also restored, the Company believes that except for one limited claim by one of the names of plaintiffs original claims were adjudicated through the arbitration proceedings. The lawsuit is now in the discovery phase.
F-16
Beginning in the Companys 2003 fiscal year and running through the Companys 2005 fiscal year, a number of negligence and product liability lawsuits were filed against the Companys Vital Pharma, Inc. subsidiary, primarily in Palm Beach County, Florida, over an anti-adhesion product for gynecological surgery known as Intergel. Intergel was manufactured by Lifecore Biomedical, Inc. and distributed by Ethicon, Inc., a subsidiary of Johnson & Johnson. The Companys subsidiary, Vital Pharma, packaged the Intergel product into plastic containers. A global settlement was reached in all matters, and the Company paid only a token settlement amount, which was covered by its insurance. Lifecore, through its insurer, had been reimbursing a significant portion of Vital Pharmas legal fees and costs for all of the litigation relating to Intergel in which Vital Pharma had been involved. Notwithstanding this reimbursement, Vital Pharma and its insurer had incurred substantial legal fees and expenses which were not reimbursed. During November 2007 that matter was successfully settled in favor of Vital Pharma and its insurer for $149,000.
On November 11, 2006, plaintiffs filed their motion in the Federal Court to confirm the arbitrators award which was granted. However, the Company is not obligated to pay the award until resolution ofthe entire case. Plaintiff has told the Company of his intention to seek judicial relief for payment of the award prior to that final resolution
Do You Snore, LLC Litigation
On December 10, 2007 Sleep Services of America filed a lawsuit in the Superior Court, Fulton County, Georgia against Renee McPhee and others relating to Sleep Service of Americas acquisition in April 2007 of the assets of Do You Snore, LLC, Southern Medical Equipment and Advanced Sleep Technologies of Georgia. The complaint assert causes of action in breach of the acquisition agreement fraud, breach of non-competition agreement, misappropriation of intellectual property and other causes of action. Ms. McPhee is the sole shareholder of Do You Snore, LLC and a significant shareholder of the other entities. Sleep Services of America believes that Ms. McPhee in concert which others is violating her non-competition agreement and misappropriating business which but for her action would have gone to Sleep Services of America.
Note 16Stockholders Equity
Preferred Stock
The Company has authorized 10,000,000 shares of no par value preferred stock. No shares were issued or outstanding at September 30, 2007 or 2006.
Stock Options
Effective October 1, 2005, the Company began recording compensation expense associated with stock options in accordance with SFAS No. 123R, Share-Based Payment. Prior to October 1, 2005, the Company accounted for stock-based compensation related to stock options under the recognition and measurement principles of Accounting Principles Board Opinion No. 25; therefore, the Company measured compensation expense for its stock option plans using the intrinsic value method, that is, as the excess, if any, of the fair market value of the Companys stock at the grant date over the amount required to be paid to acquire the stock, and provided the disclosures required by SFAS Nos. 123 and 148. The Company has adopted the modified prospective transition method provided under SFAS No. 123R, and as a result, has not retroactively adjusted results from prior periods. Under this transition method, compensation expense associated with stock options recognized in fiscal year 2006 includes: 1) expense related to the remaining unvested portion of all stock option awards granted prior to October 1, 2005, based on the grant date fair value estimated in accordance with the original provisions of SFAS No. 123; and 2) expense related to all stock option awards granted subsequent to October 1, 2005, based on the grant date fair value estimated in accordance with the provisions of SFAS No. 123R.
At
September 30, 2007, the Company had two stock option plans. The Vital Signs
2003 Investment Plan provides for the grant of options to employees, officers
and directors to purchase the Companys common stock. The 2003 Investment
Plan is a renewal of the Companys 1994 Investment Plan, which expired in
January 2004. One million shares of the Companys common stock have been
authorized for share purchase and option grants. Options may be granted at prices
not less than fair value at the date of grant. The options have a ten-year life.
Options generally vest after a two-year period. Shares purchased by persons who
are not executive officers or directors may be financed through the Company.
The 2002 Stock Incentive Plan provides for the grant of options to employees,
officers, directors and consultants to purchase a maximum of 1,000,000 shares.
Although the 2002 Stock Incentive Plan allows for the grants of stock options
to consultants, to date no options have been granted to consultants under that
plan.
F-17
For stock option grants prior to October 1, 2005, the estimated fair value of each option award granted was determined on the date of grant using the Black-Scholes option valuation model. For stock option grants on and after October 1, 2005, the estimated fair value of each option award granted was determined on the date of grant using a lattice based option valuation model. The following weighted-average assumptions were used for option grants during the twelve month period ended September 30, 2007, 2006 and 2005.
|
|
|
|
|
|
|
|
|
|
|
|
|
Twelve Months Ended September 30, |
|
|||||||
|
|
|
|
|||||||
|
|
2007 |
|
2006 |
|
2005 |
|
|||
|
|
|
|
|
|
|
|
|||
Risk-free interest rate |
|
4.70 |
% |
|
4.70 |
% |
|
4.33 |
% |
|
Expected volatility of common stock |
|
32.33 |
% |
|
34.75 |
% |
|
33.00 |
% |
|
Dividend yield |
|
0.63 |
% |
|
0.65 |
% |
|
0.70 |
% |
|
Expected option term |
|
3.4-6.8 years |
|
3.3-6.8 years |
|
5.0-10.0 years |
|
F-18
A summary of the status of the Companys vested stock options are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number |
|
Weighted |
|
Weighted- |
|
Aggregate |
|
||||
|
|
|
|||||||||||
Options outstanding at September 30, 2004 |
|
|
554,529 |
|
$ |
25.79 |
|
|
6.35 |
|
$ |
3,432,662 |
|
Options granted |
|
|
160,082 |
|
|
39.74 |
|
|
|
|
|
|
|
Options exercised |
|
|
(116,670 |
) |
|
27.06 |
|
|
|
|
|
|
|
Options forfeited or expired |
|
|
(15,730 |
) |
|
27.76 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding at September 30, 2005 |
|
|
582,211 |
|
$ |
29.32 |
|
|
6.34 |
|
$ |
9,765,615 |
|
|
|||||||||||||
Options granted |
|
|
172,938 |
|
|
49.51 |
|
|
|
|
|
|
|
Options exercised |
|
|
(227,583 |
) |
|
25.39 |
|
|
|
|
|
|
|
Options forfeited or expired |
|
|
(14,151 |
) |
|
33.45 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding at September 30, 2006 |
|
|
513,415 |
|
$ |
37.75 |
|
|
9.11 |
|
$ |
9,684,635 |
|
|
|||||||||||||
Options granted |
|
|
62,500 |
|
|
52.10 |
|
|
|
|
|
|
|
Options exercised |
|
|
(67,200 |
) |
|
28.14 |
|
|
|
|
|
|
|
Options forfeited or expired |
|
|
(3,981 |
) |
|
45.65 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding at September 30, 2007 |
|
|
504,734 |
|
$ |
40.74 |
|
|
7.37 |
|
$ |
5,753,685 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options vested and exercisable at September 30, 2007 |
|
|
250,047 |
|
$ |
33.79 |
|
|
6.19 |
|
$ |
4,588,853 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The weighted-average fair value of each option granted during the twelve month periods ended September 30, 2007, 2006 and 2005, estimated as of the grant date using a lattice based option valuation model (2007) and (2006) and the Black-Scholes option valuation model (2005), was $14.00 per option, $13.32 per option and $20.56 per option, respectively.
A
summary of the status of the Companys non-vested shares is presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of Shares |
|
Weighted
- |
|
Weighted- |
|
|||||
|
|
|
|
|
|
|
|
|||||
Non-vested shares at September 30, 2006 |
|
|
293,324 |
|
|
$ |
44.40 |
|
|
|
7.88 |
|
Options granted |
|
|
62,500 |
|
|
|
52.10 |
|
|
|
9.45 |
|
Options vested |
|
|
(98,137 |
) |
|
|
41.04 |
|
|
|
7.55 |
|
Options forfeited or expired |
|
|
(3,000 |
) |
|
|
46.09 |
|
|
|
8.01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-vested shares at September 30, 2007 |
|
|
254,687 |
|
|
$ |
47.57 |
|
|
|
8.52 |
|
|
|
|
|
|
|
|
|
|
|
|
|
F-19
As of September 30, 2007, there was $3.0 million of unrecognized compensation cost related to non-vested stock option awards, which is expected to be recognized over a remaining weighted-average vesting period of 3.50 years.
For stock options granted prior to the adoption of SFAS No. 123R, the following table illustrates the pro forma effect on net income and earnings per common share as if the Company had applied the fair value recognition provision of SFAS No. 123, as amended by SFAS No. 148, to apply the accounting rules under APB Opinion No. 25 and related interpretations in accounting for its stock options in determining stock-based compensation for awards under the plan:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(In thousands of dollars, except share amounts) |
|
Twelve
Month |
|
|||
|
|
|
|
|
|
|
Net incomeas reported |
|
|
$ |
26,389 |
|
|
Stock compensation expense |
|
|
|
1,322 |
|
|
Net incomePro forma |
|
|
|
25,067 |
|
|
Basic net income per common shareas reported |
|
|
|
2.09 |
|
|
Diluted net income per commons shareas reported |
|
|
|
2.06 |
|
|
Basic net income per common sharepro forma |
|
|
|
1.99 |
|
|
Diluted net income per common sharepro forma |
|
|
$ |
1.96 |
|
|
|
|
|
|
|
|
In fiscal 2002, the Companys board of directors and stockholders approved the adoption of the 2002 Stock Incentive Plan, which provides for the grant of options to employees, officers, directors and consultants to purchase a maximum of 1,000,000 shares. Although the Vital Signs option plans allow for the grants of stock options to consultants, to date none have been granted to consultants. Options may be granted at prices not less than fair value at the date of grant. The options have a ten-year life.
Options generally vest ratably over a five-year period commencing on the first anniversary of the grant with respect to options granted under the 2002 Stock Incentive Plan and over two years with respect to the Companys options granted as part of its Investment Plan. The 2002 Stock Incentive Plan expires on May 31, 2012. As of September 30, 2007, 691,718 shares had been granted under this plan.
In connection with the plans described above and other plans which are no longer in force, options covering 2,090,233 shares (excluding lapsed shares) have been granted through September 30, 2007.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding |
|
Options Exercisable |
|
|||||||||||
|
|
|
|
|
|
|||||||||||
Range of |
|
Number |
|
Weighted- |
|
Weighted- |
|
Number |
|
Weighted- |
|
|||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1. $17.56$19.25 |
|
3,882 |
|
|
0.3 |
|
|
18.06 |
|
|
3,882 |
|
|
18.06 |
|
|
2. $20.75$21.25 |
|
27,202 |
|
|
2.4 |
|
|
21.25 |
|
|
27,202 |
|
|
21.25 |
|
|
3. $25.52$27.80 |
|
72,138 |
|
|
5.6 |
|
|
26.97 |
|
|
72,138 |
|
|
26.97 |
|
|
4. $28.52$32.63 |
|
47,063 |
|
|
6.0 |
|
|
30.86 |
|
|
42,664 |
|
|
31.01 |
|
|
5. $33.16$41.26 |
|
126,386 |
|
|
7.5 |
|
|
39.86 |
|
|
64,925 |
|
|
39.67 |
|
|
6. $46.09$54.75 |
|
165,563 |
|
|
8.7 |
|
|
49.66 |
|
|
39,236 |
|
|
49.86 |
|
|
7. $52.10$52.11 |
|
62,500 |
|
|
9.5 |
|
|
52.10 |
|
|
0 |
|
|
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total: |
|
504,734 |
|
|
7.4 |
|
|
40.74 |
|
|
250,047 |
|
|
33.79 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-20
Note 17Income Taxes
The provision for income taxes consists of the following components:
|
|
|
|
|
|
|
|
|
|
|
|
|
For the
Year Ended |
|
|||||||
|
|
|
|
|||||||
|
|
2007 |
|
2006 |
|
2005 |
|
|||
|
|
|
|
|
|
|
|
|||
|
|
(In thousands of dollars) |
|
|||||||
Current: |
|
|
|
|
|
|
|
|
|
|
Federal |
|
$ |
12,117 |
|
$ |
11,101 |
|
$ |
12,095 |
|
State |
|
|
1,379 |
|
|
1,418 |
|
|
1,227 |
|
Foreign |
|
|
924 |
|
|
893 |
|
|
691 |
|
Deferred: |
|
|
|
|
|
|
|
|
|
|
Federal |
|
|
(3,715 |
) |
|
2,303 |
|
|
1,598 |
|
State |
|
|
(687 |
) |
|
27 |
|
|
176 |
|
Foreign |
|
|
(58 |
) |
|
|
|
|
(648 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,960 |
|
|
15,742 |
|
|
15,139 |
|
|
|
|
|
|
|
|
|
|
|
|
Federal tax provision (benefit) from discontinued operations (Note 2) |
|
|
(25 |
) |
|
(86 |
) |
|
46 |
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense from continuing operations |
|
$ |
9,985 |
|
$ |
15,828 |
|
$ |
15,093 |
|
|
|
|
|
|
|
|
|
|
|
|
The breakdown of U.S. and foreign income from continuing operations before income taxes for the year ended September 30 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
2007 |
|
2006 |
|
2005 |
|
|||
|
|
|
|
|
|
|
|
|||
|
|
(In thousands of dollars) |
|
|||||||
|
|
|
|
|||||||
United States |
|
$ |
26,856 |
|
$ |
44,019 |
|
$ |
41,894 |
|
Foreign |
|
|
3,020 |
|
|
3,004 |
|
|
101 |
|
|
|
|
|
|
|
|
|
|
|
|
Total income from continuing operations |
|
$ |
29,876 |
|
$ |
47,023 |
|
$ |
41,995 |
|
|
|
|
|
|
|
|
|
|
|
|
The tax effect of temporary differences that give rise to the net short-term deferred tax (liability)/ assets are presented below:
|
|
|
|
|
|
|
|
|
|
September 30, |
|
||||
|
|
|
|
||||
|
|
2007 |
|
2006 |
|
||
|
|
|
|
|
|
||
|
|
(In
thousands of |
|
||||
|
|
|
|
||||
Bad debt |
|
$ |
1,089 |
|
$ |
|
|
Net operating loss carryforward from acquisition |
|
|
140 |
|
|
449 |
|
Stelex goodwill |
|
|
(324 |
) |
|
(323 |
) |
Baxter goodwill |
|
|
(189 |
) |
|
(189 |
) |
Other |
|
|
(524 |
) |
|
(294 |
) |
|
|
|
|
|
|
|
|
|
|
$ |
192 |
|
$ |
(357 |
) |
|
|
|
|
|
|
|
|
F-21
The tax effects of temporary differences that give rise to the net long-term deferred tax assets are presented below:
|
|
|
|
|
|
|
|
|
|
September 30, |
|
||||
|
|
|
|
||||
|
|
2007 |
|
2006 |
|
||
|
|
|
|
|
|
||
|
|
(In thousands of dollars) |
|
||||
|
|
|
|
||||
Net operating loss carryforward from acquisition |
|
$ |
|
|
$ |
141 |
|
Accelerated depreciation |
|
|
(1,763 |
) |
|
(568 |
) |
Stelex goodwill |
|
|
(1,280 |
) |
|
(957 |
) |
Stelex impairment |
|
|
4,877 |
|
|
|
|
DYS/SME impairment |
|
|
718 |
|
|
|
|
Baxter goodwill |
|
|
(291 |
) |
|
(102 |
) |
Loss on sales of discontinued operation (Vital Pharma) |
|
|
700 |
|
|
700 |
|
Foreign net operating loss carryforward |
|
|
1,012 |
|
|
954 |
|
State net operating loss carryforward |
|
|
878 |
|
|
878 |
|
Stock compensation expense |
|
|
952 |
|
|
627 |
|
Other |
|
|
(509 |
) |
|
(310 |
) |
|
|
|
|
|
|
|
|
|
|
$ |
5,294 |
|
$ |
1,363 |
|
|
|
|
|
|
|
|
|
Less: Valuation allowance |
|
|
(562 |
) |
|
(562 |
) |
|
|
|
|
|
|
|
|
|
|
$ |
4,732 |
|
$ |
801 |
|
|
|
|
|
|
|
|
|
At September 30, 2007, the Company has federal net operating loss carryforwards of approximately $380,000 to offset future taxable income. These net operating loss carryforwards expire through 2008. Under Section 382 of the Internal Revenue Code, the annual amount available to offset consolidated taxable income is limited to approximately $380,000 in fiscal 2008. In addition, at September 30, 2007, the Company has available approximately $10,000,000 of New Jersey net operating loss carryforwards to offset future state taxable income. The New Jersey operating loss carryforwards, as extended, expire from 2009 through 2010. Utilization of these net operating losses has been suspended for deduction carryover for privilege periods beginning during calendar years 2002 and 2003, but this suspension extends the seven-year carryforward period by two years. A full net operating loss deduction is allowed for privilege periods beginning on or after January 1, 2006. The Company has established a partial valuation allowance against the New Jersey net operating loss carryforwards, based upon managements estimate of future taxable earnings available to offset the net operating loss.
The total provision for income taxes differs from that amount which would be computed by applying the U.S. federal income tax rate to income before provision for income taxes. The reasons for these differences are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Year Ended |
|
|||||||
|
|
|
|
|||||||
|
|
2007 |
|
2006 |
|
2005 |
|
|||
|
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
|
|||
Statutory federal income tax rate |
|
|
35.0 |
% |
|
35.0 |
% |
|
35.0 |
% |
State income taxes net of federal tax benefit |
|
|
3.0 |
|
|
2.0 |
|
|
2.1 |
|
Tax exempt interest |
|
|
(3.6 |
) |
|
(1.6 |
) |
|
(1.1 |
) |
Benefit from foreign sales corporation and extraterritorial exclusion |
|
|
(0.0 |
) |
|
(0.5 |
) |
|
(0.7 |
) |
Manufacturing credit |
|
|
(1.2 |
) |
|
(0.8 |
) |
|
|
|
Other |
|
|
0.2 |
|
|
(0.4 |
) |
|
0.6 |
|
|
|
|
|
|
|
|
|
|
|
|
Effective income tax rate |
|
|
33.4 |
% |
|
33.7 |
% |
|
35.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
F-22
Income taxes payable consist of the following:
|
|
|
|
|
|
|
|
|
|
September 30, |
|
||||
|
|
|
|
||||
|
|
2007 |
|
2006 |
|
||
|
|
|
|
|
|
||
|
|
(In thousands of dollars) |
|
||||
Federal income taxes (prepaid) payable |
|
$ |
(807 |
) |
$ |
(1,227 |
) |
State income taxes (prepaid) payable |
|
|
(426 |
) |
|
264 |
|
Foreign income taxes payable |
|
|
182 |
|
|
332 |
|
|
|
|
|
|
|
|
|
|
|
$ |
(1,051 |
) (b) |
$ |
(631 |
) (a) |
|
|
|
|
|
|
|
|
(a) |
This balance consists of $1,362,000 of prepaid income taxes included in prepaid expenses on the accompanying consolidated balance sheet (see Note 5) net of income taxes payable of $731,000. |
|
|
(b) |
This balance consists of $1,436,000 of income taxes included in prepaid expenses on the accompanying consolidated balance sheet (see Note 5) net of income taxes payable of $385,000. |
Note 18Allowance for Rebates and Doubtful Accounts
Information relating to the allowance for rebates and doubtful accounts is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Beginning |
|
Charges |
|
Deductions |
|
Balance |
|
||||
|
|
|
|
|
|
|
|
|
|
||||
|
|
(In thousands of dollars) |
|
||||||||||
2005 |
|
|
|
||||||||||
Rebates |
|
$ |
8,162 |
|
$ |
55,917 |
|
$ |
56,747 |
|
$ |
7,332 |
|
Doubtful accounts |
|
|
563 |
|
|
4 |
|
|
78 |
|
|
489 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
8,725 |
|
$ |
55,921 |
|
$ |
56,825 |
|
$ |
7,821 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Rebates |
|
$ |
7,332 |
|
$ |
64,643 |
|
$ |
63,873 |
|
$ |
8,102 |
|
Doubtful accounts |
|
|
489 |
|
|
170 |
|
|
235 |
|
|
424 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
7,821 |
|
$ |
64,813 |
|
$ |
64,108 |
|
$ |
8,526 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Rebates |
|
$ |
8,102 |
|
$ |
74,798 |
|
$ |
72,387 |
|
$ |
10,513 |
|
Doubtful accounts |
|
|
424 |
|
|
4,076 |
|
|
34 |
|
|
4,466 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
8,526 |
|
$ |
78,874 |
|
$ |
72,421 |
|
$ |
14,979 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(A) |
Charges represent estimated rebates deducted from gross revenues and estimated provision for doubtful accounts. |
|
|
(B) |
Deductions represent rebates credited to the wholesaler and the write-off of uncollectible accounts. |
|
|
(C) |
In the fourth quarter of fiscal 2007, the Company increased its distributor rebate allowance by $4.7 million after obtaining new information from its two largest distributors on their inventory levels. In addition, the Company increased its reserve for bad debt $1.2 million for unauthorized customer cash payment discounts with one distributor. |
Note 19Significant Customers
A
portion of the Companys hospital customers are serviced by national and
regional medical supply distributors. During fiscal years 2007, 2006 and 2005,
respectively, 27%, 28%, and 26%, of the Companys net revenue were made in this
distribution channel. In each fiscal year 2007, 2006 and 2005, one of the large
national distributors represented approximately 13%, 11%, and 10%,
respectively, of net revenue. The same customer represented approximately 14%
and 8% of outstanding accounts receivable at September 30, 2007 and 2006,
respectively.
F-23
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Anesthesia |
|
Respiratory/ |
|
Sleep |
|
Interventional |
|
Pharmaceutical |
|
Rebate |
|
Consolidated |
|
|||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
|
|
|
(In thousands of dollars) |
|
||||||||||||||||||
2007 |
|
|
|
|
|
|
|
|
|
|
||||||||||||
Net sales |
|
$ |
74,800 |
|
$ |
46,296 |
|
$ |
48,770 |
|
$ |
28,637 |
|
$ |
11,487 |
|
$ |
(4,733 |
) |
$ |
205,257 |
|
Gross profit |
|
|
38,678 |
|
|
25,370 |
|
|
25,343 |
|
|
16,131 |
|
|
3,030 |
|
|
(4,733 |
) |
|
103,819 |
|
Gross profit percentage |
|
|
51.7 |
% |
|
54.8 |
% |
|
52.0 |
% |
|
56.3 |
% |
|
26.4 |
% |
|
|
|
|
50.6 |
% |
Operating income |
|
|
13,489 |
|
|
8,348 |
|
|
3,046 |
|
|
12,553 |
|
|
(13,911 |
) |
|
|
|
|
23,525 |
|
Total assets |
|
|
157,897 |
|
|
97,727 |
|
|
56,658 |
|
|
13,172 |
|
|
5,490 |
|
|
|
|
|
330,944 |
|
Capital expenditures |
|
|
1,649 |
|
|
1,021 |
|
|
1,423 |
|
|
451 |
|
|
599 |
|
|
|
|
|
5,143 |
|
2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales |
|
$ |
73,794 |
|
$ |
44,571 |
|
$ |
42,850 |
|
$ |
25,538 |
|
$ |
15,371 |
|
$ |
|
|
$ |
202,124 |
|
Gross profit |
|
|
37,784 |
|
|
23,485 |
|
|
22,231 |
|
|
13,356 |
|
|
5,241 |
|
|
|
|
|
102,097 |
|
Gross profit percentage |
|
|
51.2 |
% |
|
52.7 |
% |
|
51.9 |
% |
|
52.3 |
% |
|
34.1 |
% |
|
|
|
|
50.5 |
% |
Operating income |
|
|
16,526 |
|
|
9,981 |
|
|
4,341 |
|
|
10,034 |
|
|
1,119 |
|
|
|
|
|
42,001 |
|
Total assets |
|
|
145,226 |
|
|
87,715 |
|
|
42,965 |
|
|
11,254 |
|
|
18,694 |
|
|
|
|
|
305,854 |
|
Capital expenditures |
|
|
4,218 |
|
|
2,335 |
|
|
1,684 |
|
|
497 |
|
|
334 |
|
|
|
|
|
9,068 |
|
2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales |
|
$ |
67,896 |
|
$ |
42,423 |
|
$ |
40,660 |
|
$ |
25,441 |
|
$ |
16,760 |
|
$ |
|
|
$ |
193,180 |
|
Gross profit |
|
|
36,106 |
|
|
22,357 |
|
|
18,770 |
|
|
13,976 |
|
|
6,464 |
|
|
|
|
|
97,673 |
|
Gross profit percentage |
|
|
53.2 |
% |
|
52.7 |
% |
|
46.2 |
% |
|
54.9 |
% |
|
38.6 |
% |
|
|
|
|
50.6 |
% |
Operating income |
|
|
15,471 |
|
|
11,722 |
|
|
666 |
|
|
10,319 |
|
|
1,324 |
|
|
|
|
|
39,502 |
|
Total assets |
|
|
131,050 |
|
|
54,546 |
|
|
35,518 |
|
|
13,306 |
|
|
19,282 |
|
|
|
|
|
253,702 |
|
Capital expenditures |
|
|
892 |
|
|
761 |
|
|
2,758 |
|
|
781 |
|
|
387 |
|
|
|
|
|
5,579 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table presents revenues by geographic area:
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|||||||
|
|
|
|
|||||||
|
|
2007 |
|
2006 |
|
2005 |
|
|||
|
|
|
|
|
|
|
|
|||
|
|
(In thousands of dollars) |
|
|||||||
United States |
|
$ |
154,830 |
|
$ |
154,178 |
|
$ |
146,386 |
|
Europe |
|
|
34,816 |
|
|
34,495 |
|
|
33,516 |
|
Asia |
|
|
5,242 |
|
|
5,685 |
|
|
3,716 |
|
Other |
|
|
10,369 |
|
|
7,766 |
|
|
9,562 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
205,257 |
|
$ |
202,124 |
|
$ |
193,180 |
|
|
|
|
|
|
|
|
|
|
|
|
F-24
Note 21Employee Benefit Plans
The
Company has established a savings incentive plan for substantially all
employees of the Company which is qualified under section 401(k) of the
Internal Revenue Code. The savings plan provides for contributions to an
independent trustee by both the Company and its participating employees. Under
the plan, employees may contribute up to 80% of their pretax base pay up to the
dollar limits set by law. The Company matches 25% of the first 6% of
participant contributions. Participants vest immediately for their own
contributions and for the Companys contributions. Company contributions were
approximately $409,000, $397,000, and $365,000, for the years ended September
30, 2007, 2006 and 2005, respectively.
Note 22Quarterly Financial Data (unaudited)
The following is a summary of the unaudited quarterly results of operations for the years ended September 30, 2007 and 2006:
Fiscal Year Ended September 30, 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from Continuing Operations |
|
Net Income (Loss) |
|
Balance Sheet |
|
|||||||||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||||||||||||
|
|
Total |
|
Gross |
|
Income |
|
Basic |
|
Diluted |
|
Net |
|
Basic |
|
Diluted |
|
Cash
and cash |
|
|||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
|
|
(In thousands of dollars, except EPS) |
|
|||||||||||||||||||||||||||
1st Quarter |
|
$ |
47,718 |
|
$ |
24,207 |
|
$ |
7,292 |
|
$ |
0.55 |
|
$ |
0.55 |
|
$ |
7,294 |
|
$ |
0.55 |
|
$ |
0.55 |
|
|
$ |
139,036 |
|
|
2nd Quarter |
|
|
52,648 |
|
|
27,354 |
|
|
8,622 |
|
|
0.65 |
|
|
0.65 |
|
|
8,602 |
|
|
0.65 |
|
|
0.65 |
|
|
|
139,901 |
|
|
3rd Quarter |
|
|
54,407 |
|
|
28,589 |
|
|
8,641 |
|
|
0.65 |
|
|
0.65 |
|
|
8,624 |
|
|
0.65 |
|
|
0.65 |
|
|
|
136,253 |
|
|
4th Quarter(a) |
|
|
50,484 |
|
|
23,669 |
|
|
(5,347 |
) |
|
(0.40 |
) |
|
(0.40 |
) |
|
(5,361 |
) |
|
(0.41 |
) |
|
(0.41 |
) |
|
|
135,591 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
205,257 |
|
$ |
103,819 |
|
$ |
19,208 |
|
$ |
1.45 |
|
$ |
1.45 |
|
$ |
19,159 |
|
$ |
1.44 |
|
$ |
1.44 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) |
The Company recognized several one-time, non-cash charges in 2007. The Company increased its distributor rebate allowance by an additional $4.7 million which reduced sales and gross profits. Operating expenses included goodwill impairment charge of $13.2 million for the Stelex business and a $1.9 million impairment of long-lived assets pertaining to the Companys April 2007 acquisition of Do You Snore, LLC. Additionally, operating expenses included an increase in the allowance for unauthorized customer cash payment discounts of $1.2 million. Combined, these items reduced operating income by $12.0 million. Net income was reduced by $13.6 million, or $1.02 per diluted share. |
|
|
|
|
|
Excluding these one-time, non-cash items, sales would have increased by 3.9% instead of the 1.6% increase reported, and operating income would have increased by 6.1% instead of the reported decrease. Net income would have increased by 6.7% instead of the reported decrease, and diluted EPS would have been $2.46. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Year Ended September 30, 2006 |
|
|||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from Continuing Operations |
|
Net Income (Loss) |
|
Balance Sheet |
|
|||||||||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||||||||||||
|
|
Total |
|
Gross |
|
Income |
|
Basic |
|
Diluted |
|
Net |
|
Basic |
|
Diluted |
|
Cash
and cash |
|
|||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
|
|
(In thousands of dollars, except EPS) |
|
|||||||||||||||||||||||||||
1st Quarter |
|
$ |
47,285 |
|
$ |
23,758 |
|
$ |
6,661 |
|
$ |
0.53 |
|
$ |
0.53 |
|
$ |
6,660 |
|
$ |
0.53 |
|
$ |
0.53 |
|
|
$ |
86,033 |
|
|
2nd Quarter |
|
|
50,816 |
|
|
25,584 |
|
|
7,452 |
|
|
0.58 |
|
|
0.57 |
|
|
7,468 |
|
|
0.58 |
|
|
0.57 |
|
|
|
108,254 |
|
|
3rd Quarter |
|
|
51,690 |
|
|
26,478 |
|
|
7,918 |
|
|
0.60 |
|
|
0.60 |
|
|
7,944 |
|
|
0.60 |
|
|
0.60 |
|
|
|
119,293 |
|
|
4th Quarter |
|
|
52,333 |
|
|
26,277 |
|
|
8,253 |
|
|
0.63 |
|
|
0.62 |
|
|
8,045 |
|
|
0.62 |
|
|
0.61 |
|
|
|
126,807 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
202,124 |
|
$ |
102,097 |
|
$ |
30,284 |
|
$ |
2.34 |
|
$ |
2.32 |
|
$ |
30,117 |
|
$ |
2.33 |
|
$ |
2.31 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-25
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Not applicable.
Item 9A. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
During the fourth quarter of fiscal 2007, the Companys management, including its principal executive officer and principal financial officer, evaluated its disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934) related to the recording, processing, summarizing, and reporting of information in the periodic reports that the Company files with the SEC. These disclosure controls and procedures have been designed to ensure that material information relating to Vital Signs, including the Companys subsidiaries, is made known to its management, including these officers, by other of its employees, and that this information is recorded, processed, summarized, evaluated, and reported, as applicable, within the time periods specified in the SECs rules and forms. Due to the inherent limitations of control systems, not all misstatements may be detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the control. The Companys controls and procedures can only provide reasonable, not absolute, assurance that the above objectives have been met.
Based on their evaluation as of September 30, 2007, the Companys principal executive officer and principal financial officer have concluded that the Companys disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934) are effective to ensure that the information required to be disclosed by us in the reports that the Company files or submits under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms.
Managements Report on Internal Control Over Financial Reporting
The Companys management is responsible for establishing and maintaining adequate internal control over financial reporting. The Companys internal control system is a process designed to provide reasonable assurance to its management and board of directors regarding the preparation and fair presentation of published financial statements.
The Companys internal control over financial reporting includes policies and procedures that pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect transactions and dispositions of assets; provide reasonable assurances that transactions are recorded as necessary to permit preparation of financial statements in accordance with accounting principles generally accepted in the United States of America, and that receipts and expenditures are being made only in accordance with authorizations of the Companys management and directors; and provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Companys assets that could have a material effect on its financial statements.
All internal control systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
The Companys management assessed the effectiveness of Vital Signs internal control over financial reporting as of September 30, 2007. In making this assessment, the Company used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control-Integrated Framework. Based on its assessment the Company believes that, as of September 30, 2007, Vital Signs internal control over financial reporting is effective based on those criteria.
The Companys
independent registered public accounting firm that audited the consolidated
financial statements has issued an audit report on its assessment of, and the
effective operation of, Vital Signs internal control over financial reporting
as of September 30, 2007. This report appears below.
50
Report of Independent Registered Public Accounting Firm
The Board of Directors and Stockholders
Vital Signs, Inc.
We have audited Vital Signs, Inc. and Subsidiaries internal control over financial reporting as of September 30, 2007, based on criteria established in Internal ControlIntegrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (the COSO criteria). The Companys management is responsible for maintaining effective internal control over financial reporting, and for its assessment of the effectiveness of internal control over financial reporting included in the accompanying Report on Internal Control over Financial Reporting. Our responsibility is to express an opinion on the companys internal control over financial reporting based on our audit.
We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.
A companys internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A companys internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the companys assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
In our opinion, Vital Signs, Inc. and Subsidiaries maintained, in all material respects, effective internal control over financial reporting as of September 30, 2007, based on the COSO criteria .
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the consolidated financial statements of Vital Signs, Inc. and Subsidiaries as of September 30, 2007 and 2006 and our report dated December 14, 2007 expressed an unqualified opinion thereon.
GOLDSTEIN GOLUB KESSLER LLP
New York, New York
December 14, 2007
51
Changes in Internal Controls Over Financial Reporting
There have been no changes in the Companys internal control over financial reporting that occurred during the last fiscal quarter to which this Annual Report on Form 10-K relates that have materially affected, or are reasonably likely to materially affect, the Companys internal control over financial reporting.
Not applicable.
52
Item 10. Directors, Executive Officers and Corporate Governance
The registrant incorporates by reference herein information to be set forth in
its definitive proxy statement for its 2008 annual meeting of shareholders that
is responsive to the information required with respect to this Item provided,
however, that such information shall not be incorporated herein:
|
|
|
|
|
if the information that is responsive to the information required with respect to this Item is provided by means of an amendment to this Annual Report on Form 10-K filed with the Securities and Exchange Commission prior to the filing of such definitive proxy statement; or |
|
|
|
|
|
if such proxy statement is not mailed to shareholders and filed with the Securities and Exchange Commission within 120 days after the end of the registrants most recently completed fiscal year, in which case the registrant will provide such information by means of an amendment to this Annual Report on Form 10-K. |
Item 11. Executive Compensation
The registrant incorporates by reference herein information to be set forth in its definitive proxy statement for its 2008 annual meeting of shareholders that is responsive to the information required with respect to this Item; provided, however, that such information shall not be incorporated herein:
|
|
|
|
|
if the information that is responsive to the information required with respect to this Item is provided by means of an amendment to this Annual Report on Form 10-K filed with the Securities and Exchange Commission prior to the filing of such definitive proxy statement; or |
|
|
|
|
|
if such proxy statement is not mailed to shareholders and filed with the Securities and Exchange Commission within 120 days after the end of the registrants most recently completed fiscal year, in which case the registrant will provide such information by means of an amendment to this Annual Report on Form 10-K. |
Item 12. Security Ownership of Certain Beneficial Owners,
Management and Related Stockholder Matters
The registrant incorporates by reference herein information to be set forth in its definitive proxy statement for its 2008 annual meeting of shareholders that is responsive to the information required with respect to this Item; provided, however, that such information shall not be incorporated herein:
|
|
|
|
|
if the information that is responsive to the information required with respect to this Item is provided by means of an amendment to this Annual Report on Form 10-K filed with the Securities and Exchange Commission prior to the filing of such definitive proxy statement; or |
|
|
|
|
|
if such proxy statement is not mailed to shareholders and filed with the Securities and Exchange Commission within 120 days after the end of the registrants most recently completed fiscal year, in which case the registrant will provide such information by means of an amendment to this Annual Report on Form 10-K. |
Item 13. Certain Relationships and Related Transactions, and Director Independence
The registrant incorporates by reference herein information to be set forth in its definitive proxy statement for its 2008 annual meeting of shareholders that is responsive to the information required with respect to this Item; provided, however, that such information shall not be incorporated herein:
|
|
|
|
|
if the information that is responsive to the information required with respect to this Item is provided by means of an amendment to this Annual Report on Form 10-K filed with the Securities and Exchange Commission prior to the filing of such definitive proxy statement; or |
|
|
|
|
|
if such proxy statement is not mailed to shareholders and filed with the Securities and Exchange Commission within 120 days after the end of the registrants most recently completed fiscal year, in which case the registrant will provide such information by means of an amendment to this Annual Report on Form 10-K. |
Item 14. Principal Accountant Fees and Services
The registrant incorporates by reference herein information to be set forth in its definitive proxy statement for its 2008 annual meeting of shareholders that is responsive to the information required with respect to this Item; provided, however, that such information shall not be incorporated herein:
|
|
|
|
|
if the information that is responsive to the information required with respect to this Item is provided by means of an amendment to this Annual Report on Form 10-K filed with the Securities and Exchange Commission prior to the filing of such definitive proxy statement; or |
|
|
|
|
|
if such proxy statement is not mailed to shareholders and filed with the Securities and Exchange Commission within 120 days after the end of the registrants most recently completed fiscal year, in which case the registrant will provide such information by means of an amendment to this Annual Report on Form 10-K. |
Item 15. Exhibits and Financial Statement Schedules
|
|
(a-1) |
The financial statements listed in the index set forth in Item 8 of this Annual Report on Form 10-K are filed as part of this Annual Report. |
|
|
(a-2) |
All schedules have been omitted because they are not applicable or the required information is included in the financial statements or notes thereto. |
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(a-3) |
The following exhibits are incorporated by reference herein or annexed to this Annual Report: |
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Exhibit |
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Description |
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3.1 |
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Restated Certificate of Incorporation is incorporated by reference to Exhibit 3.1 to the Companys Annual Report on Form 10-K for the year ended September 30, 2005. |
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3.2 |
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Certificate of Amendment to the Restated Certificate of Incorporation is incorporated by reference to Exhibit 3.2 to the Companys Annual Report on Form 10-K for the year ended September 30, 2006. |
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3.3 |
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By-laws, as amended and restated, are incorporated by reference to Exhibit 10.1 to the Companys Annual Report on Form 10-K for the year ended September 30, 2006. |
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10.1 |
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1990 Employee Stock Option Plan, as amended, is incorporated by reference to Exhibit 10.1 to the Companys Annual Report on Form 10-K for the year ended September 30, 1997 |
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10.2 |
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1991 Director Stock Option Plan, as amended, is incorporated by reference to Exhibit 10.2 to the Companys Annual Report on Form 10-K for the year ended September 30, 1999. |
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10.3 |
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Agreement between the Company and Respironics, Inc., dated effective as of July 1, 1993, is incorporated by reference to Exhibit 10.4 to the Companys Annual Report on Form 10-K for the year ended September 30, 1993. Amendment to Agreement between the Company and Respironics, Inc., dated September 14, 1999 is incorporated by reference to Exhibit 10.3 to the Companys Annual Report on Form 10-K for the year ended September 30, 1999. |
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10.4 |
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Forms of Option Agreements with various employees of the Company are incorporated by reference to Exhibit 10.6 to the Companys Registration Statement on Form S-1 (No. 33-39107) initially filed with the Commission on February 21, 1991. |
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10.5 |
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Vital Signs Investment Plan, as amended is incorporated by reference to Exhibit 10.5 to the Companys Annual Report on Form 10-K for the year ended September 30, 1999. |
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10.6 |
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Stock Option Grants to Terry D. Wall and Barry Wicker, replacing stock options granted to Messrs. Wall and Wicker pursuant to the 1993 Executive Stock Option Plan, is incorporated by reference to Exhibit 10.8 to the Companys Annual Report on Form 10-K for the year ended September 30, 1996. |
10.7 |
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Vital Signs 2002 Stock Incentive Plan, is incorporated by reference to the Companys Annual Report on Form 10-K for the year ended September 30, 2003 |
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10.8 |
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Vital Signs 2003 Investment Plan is incorporated by reference to the Companys proxy statement filed with the SEC on September 2, 2003. |
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14.1 |
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Code of Ethics is incorporated by reference to the Companys Annual Report on Form 10-K for the year ended September 30, 2003. |
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21.1 |
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Subsidiaries of the Registrant. |
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23.1 |
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Consent of Goldstein Golub Kessler LLP. |
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24.1 |
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Power of Attorney. |
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31.1 |
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Certification of the Chief Executive Officer under Section 302 of the Sarbanes-Oxley Act of 2002. |
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31.2 |
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Certification of the Chief Financial Officer under Section 302 of the Sarbanes-Oxley Act of 2002. |
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32.1 |
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Certification of the Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
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32.2 |
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Certification of the Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
55
SIGNATURES
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VITAL SIGNS, INC. |
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By: |
/s/ |
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Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
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Signature |
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Title |
Date |
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/s/ TERRY D. WALL* |
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President, Chief Executive Officer and Director |
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(Terry D. Wall) |
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/s/ HOWARD DONNELLY* |
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Director |
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(Howard Donnelly) |
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/s/ DAVID MACCALLUM* |
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Director |
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(David MacCallum) |
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/s/ RICHARD L. ROBBINS* |
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Director |
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(Richard L. Robbins) |
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/s/ GEORGE A. SCHAPIRO* |
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Director |
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(George A. Schapiro) |
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/s/ C. BARRY WICKER* |
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Director |
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(C. Barry Wicker) |
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/s/ MARK D. MISHLER* |
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Chief Financial and Accounting Officer |
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(Mark D. Mishler) |
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*By: |
/s/ |
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56
INDEX TO EXHIBITS
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|
Exhibit |
|
Description |
|
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|
3.1 |
|
Restated Certificate of Incorporation is incorporated by reference to Exhibit 3.1 to the Companys Annual Report on Form 10-K for the year ended September 30, 1995. |
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3.2 |
|
Certificate of Amendment to the Restated Certificate of Incorporation is incorporated by reference to Exhibit 3.2 to the Companys Annual Report on Form 10-K for the year ended September 30, 2006. |
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3.3 |
|
By-laws, as amended and restated, are incorporated by reference to Exhibit 3.3 to the Companys Annual Report on Form 10-K for the year ended September 30, 2006. |
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|
|
10.1 |
|
1990 Employee Stock Option Plan, as amended, is incorporated by reference to Exhibit 10.1 to the Companys Annual Report on Form 10-K for the year ended September 30, 1997 |
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10.2 |
|
1991 Director Stock Option Plan, as amended, is incorporated by reference to Exhibit 10.2 to the Companys Annual Report on Form 10-K for the year ended September 30, 1999. |
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|
10.3 |
|
Agreement between the Company and Respironics, Inc., dated effective as of July 1, 1993, is incorporated by reference to Exhibit 10.4 to the Companys Annual Report on Form 10-K for the year ended September 30, 1993. Amendment to Agreement between the Company and Respironics, Inc., dated September 14, 1999 is incorporated by reference to Exhibit 10.3 to the Companys Annual Report on Form 10-K for the year ended September 30, 1999. |
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|
10.4 |
|
Forms of Option Agreements with various employees of the Company are incorporated by reference to Exhibit 10.6 to the Companys Registration Statement on Form S-1 (No. 33-39107) initially filed with the Commission on February 21, 1991. |
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|
10.5 |
|
Vital Signs Investment Plan, as amended is incorporated by reference to Exhibit 10.5 to the Companys Annual Report on Form 10-K for the year ended September 30, 1999. |
|
|
|
10.6 |
|
Stock Option Grants to Terry D. Wall and Barry Wicker, replacing stock options granted to Messrs. Wall and Wicker pursuant to the 1993 Executive Stock Option Plan, is incorporated by reference to Exhibit 10.8 to the Companys Annual Report on Form 10-K for the year ended September 30, 1996. |
10.7 |
|
Vital Signs 2002 Stock Incentive Plan, is incorporated by reference to the Companys Annual Report on Form 10-K for the year ended September 30, 2003 |
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|
10.8 |
|
Vital Signs 2003 Investment Plan is incorporated by reference to the Companys proxy statement filed with the SEC on September 2, 2003. |
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|
14.1 |
|
Code of Ethics is incorporated by reference to the Companys Annual Report on Form 10-K for the year ended September 30, 2003. |
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|
|
21.1 |
|
Subsidiaries of the Registrant. |
|
|
|
23.1 |
|
Consent of Goldstein Golub Kessler LLP. |
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|
|
24.1 |
|
Power of Attorney. |
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|
|
31.1 |
|
Certification of the Chief Executive Officer under Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
31.2 |
|
Certification of the Chief Financial Officer under Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
32.1 |
|
Certification of the Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
|
|
|
32.2 |
|
Certification of the Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
57