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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
FORM 10-K
(Mark One)
[X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934
For the fiscal year ended December 31, 1999
OR
[_] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the transition period from ________ to________.
Commission file number 333-56097
HUDSON RESPIRATORY CARE INC.
(Exact name of registrant as specified in its charter)
California 95-1867330
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
27711 Diaz Road, P.O. Box 9020 92589
Temecula, California (Zip Code)
(Address of Principal Executive Offices)
(909) 676-5611
(Registrant's telephone number, including area code)
Securities Registered Pursuant to Section 12(b) of the Act: None
Securities Registered Pursuant to Section 12(g) of the Act: None
Indicate by check mark whether the registrant (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the
registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days.
Yes [_] No [X]
Indicate by check mark if disclosure of delinquent filers pursuant to Item
405 of Regulation S-K ('229.405 of this chapter) is not contained herein, and
will not be contained, to the best of registrant's knowledge, in definitive
proxy or information statements incorporated by reference in Part III of this
Form 10-K or any amendment to this Form 10-K. [_] Not Applicable.
As of March 30, 2000, the number of shares of Common Stock, $.01 par value,
outstanding (the only class of common stock of the registrant outstanding) was
10,044,291. The registrant's Common Stock is not traded in a public market.
Aggregate market value of the registrant's voting and nonvoting Common
Stock: Not Applicable.
Documents Incorporated by Reference: None
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HUDSON RESPIRATORY CARE INC. AND SUBSIDIARIES
Fiscal Year Ended December 31, 1999
TABLE OF CONTENTS
Page
----
PART I............................................................................................... 1
Item 1. Business............................................................................... 1
Item 2. Properties............................................................................. 8
Item 3. Legal Proceedings...................................................................... 8
Item 4. Submissions of Matters to a Vote of Security Holders................................... 8
PART II.............................................................................................. 10
Item 5. Market for Registrant's Common Equity and Related Stockholder Matters.................. 10
Item 6. Selected Financial Data................................................................ 10
Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operation... 11
Item 7A. Quantitative and Qualitative Disclosure About Market Risk.............................. 24
Item 8. Financial Statements................................................................... 25
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure... 25
PART III............................................................................................. 26
Item 10. Directors and Executive Officers of the Registrant.................................... 26
Item 11. Executive Compensation................................................................ 27
Item 12. Security Ownership of Certain Beneficial Owners and Management........................ 30
Item 13. Certain Relationships and Related Transactions........................................ 31
PART IV.............................................................................................. 32
Item 14. Exhibits, Financial Statement Schedules and Reports on Form 8-K........................ 32
SIGNATURES........................................................................................... S-1
PART I
Item 1. Business.
This Annual Report on Form 10-K contains "forward-looking statements"
within the meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended. These
statements include without limitation the words "believes," "anticipates,"
"estimates," "intends," "expects," and words of similar import. All statements
other than statements of historical fact included in statements under "Item 1.
Business," "Item 2. Properties," "Item 3. Legal Proceedings" and "Item 7.
Management's Discussion and Analysis of Financial Condition and Results of
Operation" include forward-looking information and may reflect certain
judgements by management. Such forward-looking statements involve known and
unknown risks, uncertainties and other factors that may cause the actual
results, performance or achievements of Hudson Respiratory Care Inc. or the
respiratory care and anesthesia products industries to be materially different
from any future results, performance or achievements expressed or implied by
such forward-looking statements. These potential risks, uncertainties include,
but are not limited to, those identified in the "Risk Factors" section of this
Form 10-K located at the end of "Item 7. Management's Discussion and Analysis
of Financial Condition and Results of Operations." The Company disclaims any
obligation to update any such factors or to publicly announce the results of any
revisions to any of the forward-looking statements contained herein to reflect
future events or developments.
General
Hudson Respiratory Care Inc. ("Hudson RCI" or the "Company") is a leading
manufacturer and marketer of disposable medical products utilized in the
respiratory care and anesthesia segments of the domestic and international
health care markets. The Company offers one of the broadest respiratory care
and anesthesia product lines in the industry, including such products as oxygen
masks, humidification systems, nebulizers, cannulae and tubing. In the United
States, the Company markets its products to a variety of health care providers,
including hospitals and alternate site service providers such as outpatient
surgery centers, long-term care facilities, physician offices and home health
care agencies. Internationally, the Company sells its products to distributors
that market to hospitals and other health care providers. The Company's
products are sold to over 3,000 distributors and alternate site service
providers throughout the United States and in more than 75 countries worldwide.
The Company has supplied the disposable respiratory care market for over 50
years and enjoys strong brand name recognition and leading market positions.
The Company manufactures and markets over 2,300 respiratory care and
anesthesia products. The Company believes that its broad product offering
represents a competitive advantage over suppliers with more limited product
offerings, as health care providers seek to reduce medical supply costs and
concentrate purchases among fewer vendors. The Company also benefits
competitively from its extensive relationships with leading group purchasing
organizations or GPOs, as large purchasing organizations play an increasingly
important role in hospitals' purchasing decisions.
The Company maintains two manufacturing facilities and two distribution
facilities in the United States, assembly operations in Mexico and Malaysia and
sales and marketing offices in the United States, Sweden and Germany. The
Company has reduced its manufacturing and assembly costs through cost reduction
programs, process improvement, equipment automation and upgrades and increased
utilization of its Ensenada, Mexico facility for labor-intensive operations.
Hudson Oxygen Therapy Sales Company ("Hudson Oxygen"), Hudson RCI's
predecessor, was founded in 1945. In 1988, Hudson Oxygen formed Industrias
Hudson, a subsidiary that oversees the Company's assembly operation in Mexico.
In 1989, Hudson Oxygen merged with Respiratory Care Inc. to form Hudson RCI. In
April 1998, the Company consummated a recapitalization, pursuant to which it
became a majority-owned subsidiary of River Holding Corp. ("Holding"). In the
past five years, the Company has pursued a number of strategic acquisitions in
order to expand its product line and geographic penetration, most significantly
with the July 1999 acquisition of Louis Gibeck AB ("LGAB"), a Swedish company
that manufactures and markets medical devices. Hudson RCI's principal executive
offices are located at 27711 Diaz Road, P.O. Box 9020, Temecula, California
92589, and its telephone number is (909) 676-5611.
1
Industry Overview
The worldwide market for disposable respiratory care and anesthesia
products consists of the domestic hospital market, the alternate site market and
the international market. Respiratory care and anesthesia principally involve
the delivery of oxygen and anesthesia from a gas source, such as a mechanical
ventilator or respirator, to the patient's pulmonary system. The gas is
typically delivered to the patient through specialized tubing connecting to a
cannula, mask or endotracheal tube. In addition, it is often necessary to
humidify or medicate the gas. The market for respiratory care and anesthesia
products, including disposable products, is expected to be positively impacted
by demographic trends, both domestically and internationally. In the United
States, changes in demographics, including an aging population, increased
incidence and awareness of respiratory illnesses and heightened focus on cost-
efficient treatment, have had a positive impact on the domestic respiratory care
and anesthesia markets. There has been 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
and communicable diseases with significant respiratory impact, such as
tuberculosis, HIV and influenza. The Company believes that the international
respiratory care and anesthesia markets will experience many of the trends
currently affecting domestic markets. In addition, many international markets
have high incidences of communicable respiratory diseases and are becoming
increasingly aware of the value of single-use, disposable products.
The market for respiratory care and anesthesia products is also affected by
trends involving the health care market generally. In particular, the overall
trend towards cost containment has increased the desirability of disposable
products relative to reusable products, and has influenced pricing, distribution
channels, purchasing decisions and health care delivery methods.
Efforts to contain rising health care costs have increased the preference
for disposable medical products that improve the productivity of health care
professionals and reduce overall provider costs. Health care organizations are
evaluating modes of treatment that are less labor and/or technology intensive as
a means of decreasing the cost of care, which can often result in increased
disposable usage. In particular, increased utilization of disposable products
can decrease labor and other costs associated with sterilizing reusable
products. In addition, the risks of transmission of infectious diseases such as
HIV, hepatitis and tuberculosis, and related concerns about the occupational
safety of health care professionals, have also contributed to an increased
preference for disposable single-use medical products.
Cost containment has caused consolidation throughout the health care
product supply channel, which has favored manufacturers with large product
offerings and competitive pricing. In an effort to contain costs, service
providers have consolidated to form GPOs, which take advantage of group buying
power to obtain lower supply prices. This, in turn, has led to consolidation
among distributors, who seek to provide "one-stop shopping" for these large
buying groups. Distributors have also sought to concentrate purchases among
fewer vendors in an effort to reduce supply costs. Since selection as a GPO
provider and strong relationships with distributors are critical to many health
care manufacturers, they have responded to these trends by providing a broad
range of integrated products, combined with reliable delivery and strong after-
sales support.
Cost containment has also caused a migration of the decision making
function with respect to supply acquisition from the clinician to the
administrator. As clinicians lose influence and purchasing agents, materials
managers and upper level management become more involved in the purchasing
decision, a greater emphasis is placed on price relative to product features and
clinical benefits.
As a result of cost containment, health care is increasingly provided
outside of traditional hospital settings through alternate health care sites,
such as outpatient surgery centers, long-term care facilities, physician offices
and patients' homes. Growth of the alternate site market is also attributable
to advances in technology that have facilitated the delivery of care outside of
the hospital, an increased number of illnesses and diseases considered to be
treatable outside of the hospital and increased acceptance by the medical
community of, and patient preference for, non-hospital treatment.
2
Products
The Company manufactures and markets products for use in respiratory care
and anesthesia. The products for each market are similar and often overlap, as
do the distribution channels.
The Company groups its products into nine categories: (i) oxygen delivery;
(ii) aerosol therapy; (iii) active and passive humidification; (iv) ventilatory
support; (v) adaptors, connectors and filters; (vi) resuscitation; (vii) airway
management; (viii) electronic monitoring; and (ix) durable equipment.
Category/Products
- ------------------------------------------------------------------------------
Oxygen Delivery: Oxygen Masks, Oxygen Cannulae, Oxygen Tubing
Aerosol Therapy: AQUAPAK(R) Large Volume, Prefilled Nebulizers; Non-Prefilled
Large Volume Nebulizer; UPDRAFT(R), UPDRAFT II(R), AVA-NEB(R) and MICRO MIST(R)
Small Volume, Medication Nebulizers; Aerosol Tubing; AQUATHERM(R) and
THERMAGARD(R) Nebulizer Heaters; AQUAPAK Prefilled Ultrasonic Cups; ADDIPAK(R)
Prefilled Unit Dose Solutions; POCKETPEAK(R) Peak Flow Meter
Active and Passive Humidification: CONCHATHERM(R) Heated Humidifiers, AQUA+(R)
Hygroscopic Condenser Humidifiers, AQUAPAK Prefilled Humidifiers, Non-Prefilled,
Reusable Humidifier, Non-Prefilled Disposable Humidifier, HUMID-HEAT(R) Heat-
Moisture Exchangers
Ventilatory Support: Conventional Ventilator Circuits, Heated-Wire Ventilator
Circuits, Anesthesia Breathing Circuits, Air Cushion Anesthesia Masks, Infant
CPAP Systems
Adaptors, Connectors and Filters: A wide variety of adaptors and connectors;
Main Flow Bacterial/Viral Filters; Pulmonary Function Filter
Description
- --------------------------------------------------------------------------------
Used to deliver therapeutic, supplemental oxygen to a patient. Oxygen masks
cover the nose and mouth. Nasal cannulae fit inside the nostrils. Both masks and
cannulae are connected to an oxygen source via small diameter tubing through
which oxygen flows.
Used to create and deliver aerosolized particles of liquid water, sodium
chloride or medication to the patient's airways to dilute and mobilize
secretions and/or dilate constricted breathing passages. The peak flow meter is
used to monitor the patient's respiratory status before and after an aerosolized
medication treatment.
Heated humidification systems actively heat and humidify oxygen/air mixtures or
anesthetic gases provided by a mechanical ventilator or anesthesia gas machine.
Hygroscopic condenser humidifiers passively conserve the heat and humidity in
the patient's exhaled breath for use during inspiration. Prefilled and non-
prefilled humidifiers are used to add water vapor to oxygen being provided to a
patient via a mask or cannula.
Used to convey an oxygen/air mixture and/or anesthetic gas from a mechanical
ventilator or anesthesia gas machine to a patient during the temporary or long-
term support of ventilation. The infant CPAP system provides non-invasive
respiratory support to premature infants with under-developed, immature lungs.
The adaptors and connectors are frequently used in respiratory care and
anesthesia to add accessories, modify configurations, and/or customize other
related products to meet specific needs. Filters are used to protect patients,
3
Category/Products
- --------------------------------------------------------------------------------
Resuscitation: LIFESAVER(R) Reusable and Disposable Resuscitation Bags,
Isolation Valves and Kits, LIFESAVER Tubes and Kits
Airway Management: SOFTECH(R) Cuffed and Uncuffed Endotracheal Tubes; CATH-
GUIDE(R), Color-Coded and DUAL-CHANNEL Oral Pharyngeal Airways; BITEGARD(TM)
Oral Bite Block; CATH-GUIDE Closed Suction Catheters; VOLDYNE(R) and TRI-FLO(R)
Incentive Breathing Exercisers
Electronic Monitoring: Replacement oxygen sensors, Oxygen Monitors and
Analyzers, VENTILARM II(R) Low-Pressure Alarms
Durable Equipment: Oxygen Regulators; Cylinder Carts, Trucks and Stands;
Portable Oxygen Units
Description
- --------------------------------------------------------------------------------
caregivers, and medical equipment from cross-contamination with bacteria and
viruses.
Used during cardiopulmonary resuscitation ("CPR") to adequately support and/or
maintain the patient's ventilatory function.
Assist in securing and maintaining an open airway and unobstructed breathing
passage. They also can assure that the patient's ventilation can be maintained
and that respiratory secretions can be adequately removed from the lungs.
The oxygen sensors, monitors and analyzers are used to analyze and monitor the
amount of oxygen being administered to a patient. The low-pressure alarm is used
to detect a patient disconnect or a leak in the breathing circuit during
mechanical ventilation.
Used to regulate oxygen flow from cylinders, stabilize or transport oxygen or
other gas cylinders, and provide a portable oxygen supply for emergency use.
Sales, Marketing and Distribution
The Company has sales offices in Temecula, Sweden and Germany. While
substantially all of the Company's domestic hospital sales are made to
distributors, the Company's marketing efforts are focused on the health care
service provider. In the alternate site market, the Company both sells and
markets directly to the service provider. The Company's five largest alternate
site accounts are Gulf South Medical Supply, Inc., Medline Industries, Inc.,
Moore Medical Corp., Redline Healthcare Corp. and VGM & Associates.
Internationally, the Company sells its products to distributors that market to
hospitals and other health care providers. See Note 12 to "Item 8. Financial
Statements" for information with respect to international sales. The Company's
sales personnel currently call on approximately 2,800 health care providers, 50
hospital distributors and 1,500 alternate site customers. Due to consolidation
and cost pressures among the Company's customer base, the Company's target call
point at the health care provider has been moving away from the clinician to
include a purchasing manager or corporate executive. As of December 31, 1999,
the Company had a sales backlog of approximately $2.6 million.
In the current market environment, GPO relationships are an essential part
of access to the Company's target markets and the Company has entered into
preferred supplier arrangements with 11 national GPOs. The Company is typically
positioned as either a sole supplier of respiratory care disposables to the GPO,
or as one of two suppliers. While these arrangements set forth pricing and terms
for various levels of purchasing, they do not obligate either party to purchase
or sell a specific amount of product. In addition, GPO affiliated hospitals
often purchase products from other
4
suppliers notwithstanding the existence of sole or dual source GPO arrangements.
Further, these arrangements are terminable at any time, but in practice usually
run for two to three years. The Company enjoys longer terms with two of its
major GPOs, Novation LLC (which represents the 1998 consolidation of VHA, Inc.
and University HealthSystem Consortium) and Columbia/HCA Healthcare Corporation.
The Company's most significant GPO relationships are with AmeriNet Inc.,
Columbia/HCA Healthcare Corporation, Health Services Corporation of America,
MedEcon Medical Services, Novation LLC and Purchase Connection Limited.
Health care providers have responded to pressures to reduce their costs by
merging with other members of their industry. The acquisition of a customer of
the Company often results in the renegotiation of contracts, the granting of
price concessions or in the loss of the customer. Alternatively, to the extent
a customer of the Company grows through acquisition activity, the Company may
benefit from increased sales to the larger entity.
The Company markets its products primarily through consultative dialogue
with health care providers, targeted print advertising, trade shows, selective
promotional arrangements with distributors and the Company's heater lease
program. To support sales of the entire line of humidification and ventilation
products, the Company leases heaters to domestic customers without charge. The
revenues from the sale of products used in connection with the operation of the
heaters covers the amortization of the heater cost under the leases. The
Company has heaters with a net book value of approximately $1.1 million placed
at service provider locations under this program.
The Company utilizes a network of over 3,000 hospital distributors, as well
as additional alternate site distributors, to reach its markets. A number of
these distributors carry competing product lines, but many are moving to select
single supply sources for particular product groups. The Company has been
selected as the FOCUS preferred vendor of respiratory disposables for Owens &
Minor Inc. Such status gives preference to the shipping of the Company's
products versus competing lines. Owens & Minor Inc. is the Company's largest
distributor, accounting for approximately $24.5 million or approximately 19.0%
of total fiscal 1999 net sales. The Company is seeking FOCUS status with its
second largest distributor, McKesson General Medical, Inc. ("McKesson").
McKesson accounted for approximately $14.8 million or approximately 11.5% of
total fiscal 1999 net sales. The Company provides a price list to its
distributors which details base acquisition prices. Distributors receive orders
from the service providers and charge the contract pricing (which is determined
by their GPO affiliation or individual contract price) plus a service margin.
As is customary within the industry, the Company rebates the difference between
base acquisition price and the specific contract price to the distributor. The
Company offers select large health care providers a reward for purchasing a
broader selection of the Company's product lines. The program allows a rebate
in the form of merchandise credit for purchasing minimum volumes from a selected
group of products. The Company's international distributors place their orders
directly with dedicated international customer service representatives based in
Temecula. Customer orders are shipped from one of two warehouse locations.
Sales strategies and marketing plans are tailored to each market with
involvement of the distributor. Region and territory sales managers are
responsible for the launch of products into their regions, including related
support and training. The Company utilizes a network of 100 international
distributors, typically on an exclusive basis within each market.
Manufacturing and Assembly
The Company operates two manufacturing facilities and two distribution
facilities in the United States and assembly facilities in Ensenada, Mexico and
Kuala-Lumpur, Malaysia. While the Company believes that it is operating at a
high utilization rate, existing facilities could support increased capacity with
additional machinery and workers.
The Company's manufacturing facility in Temecula, California houses 76
injection molding machines, 67 of which are automated. During the past five
years, 38 out of the 76 machines have been replaced with more efficient models,
which has increased capacity. Tubing is produced on 11 extrusion lines: 6
corrugated, 4 oxygen or "spaghetti," and 1 repellitizer/regrinder. The Temecula
facility uses 12-14 million pounds of over 30 different kinds of resin annually;
the most prominent are PVC, polyethylene and polypropylene. Sterile prefilled
humidification and nebulization products and electronics are manufactured using
9 blow/fill/seal machines in the Company's facility in Arlington Heights,
Illinois.
5
The Company's facility located in Ensenada, Mexico is primarily used for
the assembly of certain products molded at the Temecula facility. The facility
is a maquiladora, and therefore there are minimal tariffs associated with the
transport of products and components across the United States-Mexico border.
The Company's facility located in Kuala-Lumpur, Malaysia assembles virtually all
of the products marketed by the LGAB operation. The components assembled by the
Malaysian operation are generally molded by outside vendors in Malaysia.
The Company occasionally outsources production of certain products while it
establishes its ability to penetrate a target market. Having achieved an
acceptable level of penetration, the Company internalizes the manufacturing
function in order to increase margins and improve quality control.
The Company monitors the quality of its products at the Temecula, Arlington
Heights, Ensenada and Malaysia facilities by statistical sampling and visual and
dimensional inspection. The Company also inspects incoming raw materials for
inconsistencies, rating its vendors on quality and delivery time. The Company
is routinely audited by the FDA and has received no significant regulatory
actions. The Company is in substantial compliance with the GMP/QSR regulations
of the FDA and the United States and Mexico operations have qualified for an
"advanced notification" program allowing the Company to be informed of FDA
inspections in advance. The Company utilizes outside facilities for
sterilization of products produced in Temecula and Ensenada. The Arlington
Heights products are manufactured in a sterile environment and are certified
sterile as a result of the production process. The Ensenada and Arlington
Heights facilities are certified as ISO 9002 compliant and the Temecula facility
is certified as ISO 9001 compliant.
Suppliers and Raw Materials
The Company's primary raw materials are various resins, which are formed
into the Company's products. The top 10 purchased products in 1999 were Tubing
Grade PVC, Clear PVC, LDPE-EVA, Polypropylene, Aluminum Cylinder, Pre-Cut
Elastic, Non-Tubing Grade PVC, Cannula Blanks, Acrylic Resin and Hose-End Grade
PVC. The Company believes that it is able to purchase materials at a cost no
higher than its competitors. The Company does not have long-term supply
contracts for any of its purchased raw materials. The Company believes that
sufficient availability exists for its raw materials, as they consist of mainly
readily available plastic resins.
Research and Development
The Company's research and development department consists of 17 people,
including 11 engineers. The Company's research and development efforts are
split between developing new products and process improvements to its
manufacturing operations. The Company develops new products to expand its
product line in anticipation of changes in demand. The Company has invested
heavily in the anesthesia product line, as the Company continues to penetrate
this market. The Company makes several new product introductions every year.
Significant products introduced in the last five years include the line of heat-
moisture exchangers, POCKETPEAK peak flow meter, SOFTECH endotracheal tubes,
MICRO MIST small volume nebulizer and CONCHA IV heated humidification system.
The Company constantly works to reduce costs through improved continued process
improvements. The Company incurred research and development expenses of
approximately $1.1 million, $1.0 million and $2.0 million in fiscal 1997, 1998
and 1999, respectively.
Competition
The medical supply industry is characterized by intense competition. The
Company's primary competitor in the respiratory care sector is Allegiance
Corporation and its primary competitors in the anesthesia sector include
Allegiance Corporation, The Kendall Company, Smiths Industries Medical Systems,
Inc. and Vital Signs, Inc. Many of the products manufactured by the Company are
available from several sources, and many of the Company's customers tend to have
relationships with several manufacturers. The Company competes on the basis of
brand name, product quality, breadth of product line, service and price.
Patents and Trademarks
6
The Company has historically relied primarily on its technological and
engineering abilities and on its design and production capabilities to gain
competitive business advantages, rather than on patents or other intellectual
property rights. However, the Company does file patent applications on concepts
and processes developed by the Company's personnel. The Company has 20 patents
in the U.S. Many of the U.S. patents have corresponding patents issued in
Canada, Europe and various Asian countries. The Company's success will depend
in part on its ability to maintain its patents, add to them where appropriate,
and develop new products and applications without infringing the patent and
other proprietary rights of third parties and without breaching or otherwise
losing rights in technology licenses obtained by the Company for other products.
There can be no assurance that any patent owned by the Company will not be
circumvented or challenged, that the rights granted thereunder will provide
competitive advantages to the Company or that any of the Company's pending or
future patent applications will be issued with claims of the scope sought by the
Company, if at all. If challenged, there can be no assurance that the Company's
patents (or patents under which it licenses technology) will be held valid or
enforceable. In addition, there can be no assurance that the Company's products
or proprietary rights do not infringe the rights of third parties. If such
infringement were established, the Company could be required to pay damages,
enter into royalty or licensing agreements on onerous terms and/or be enjoined
from making, using or selling the infringing product. Any of the foregoing
could have a material adverse effect upon the Company's business, financial
condition or results of operations.
Government Regulation and Environmental Matters
The Company and its customers and suppliers are subject to extensive
Federal and state regulation in the United States, as well as regulation by
foreign governments, and the Company cannot predict the extent to which future
legislative and regulatory developments concerning its practices and products
for the health care industry may affect the Company. Most of the Company's
products are subject to government regulation in the United States and other
countries. In the United States, the FDC Act and other statutes and regulations
govern or influence the testing, manufacture, safety, labeling, storage, record
keeping, marketing, advertising and promotion of such products. Failure to
comply with applicable requirements can result in fines, recall or seizure of
products, total or partial suspension of production, withdrawal of existing
product approvals or clearances, refusal to approve or clear new applications or
notices and criminal prosecution. Under the FDC Act and similar foreign laws,
the Company, as a marketer, distributor and manufacturer of health care
products, is required to obtain the clearance or approval of Federal and foreign
governmental agencies, including the FDA, prior to marketing, distributing and
manufacturing certain of those products. The Company may also need to obtain
FDA clearance before modifying marketed products or making new promotional
claims. Delays in receipt of or failure to receive required approvals or
clearances, the loss of previously received approvals or clearances, or failures
to comply with existing or future regulatory requirements in the United States
or in foreign countries could have a material adverse effect on the Company's
business. Foreign sales are subject to similar requirements.
The Company is required to comply with the FDA's GMP/QSR Regulations, which
set forth requirements for, among other things, the Company's manufacturing
process, design control and associated record keeping, including testing and
sterility. Further, the Company's plants and operations are subject to review
and inspection by local, state, Federal and foreign governmental entities. The
distribution of the Company's products may also be subject to state regulation.
The impact of FDA regulation on the Company has increased in recent years as the
Company has increased its manufacturing operations. The Company's suppliers,
including the sterilizer facilities, are also subject to similar governmental
requirements. There can be no assurance that changes to current regulations or
additional regulations imposed by the FDA will not have an adverse impact on the
Company's business and financial condition in the future. The FDA also has the
authority to issue special controls for devices manufactured by the Company,
which it has not done to date. In the event that such special controls were
issued, the Company's products would be required to conform, which could result
in significant additional expenditures for the Company.
The Company is also subject to numerous federal, state and local laws and
regulations relating to such matters as safe working conditions, manufacturing
practices, fire hazard control and the handling and disposal of hazardous or
infectious materials or substances and emissions of air pollutants. The Company
owns and leases properties which are subject to environmental laws and
regulations. There can be no assurance that the Company will not be required to
incur significant costs to comply with such laws and regulations in the future
or that such laws or regulations will not have a
7
material adverse effect upon the Company's business, financial condition or
results of operations. In addition, the Company cannot predict the extent to
which future legislative and regulatory developments concerning its practices
and products for the health care industry may affect the Company.
Employees
As of March 15, 2000, the Company employed approximately [2,700] employees,
substantially all of whom were full-time employees. None of the Company's
employees is represented by unions and the Company considers its employee
relations to be good.
Item 2. Properties.
The Company owns approximately 30 acres of land in Temecula, California on
which its headquarters, one of two principal manufacturing centers and three
other buildings totaling approximately 245,000 square feet are located. Plastic
and vinyl components and corrugated tubing are manufactured in Temecula and
assembled into finished goods at a 77,000 square foot facility in Ensenada,
Mexico. The Company owns the Ensenada facility and the underlying land is held
in a 30-year trust that expires in 2019. The Company leases an 86,000 square
foot manufacturing facility in Arlington Heights, Illinois under a lease that
expires in 2000. Prefilled sterile solutions and electronics are manufactured
in Arlington Heights. The Company also leases a 73,000 square foot distribution
warehouse in Elk Grove, Illinois under a lease that expires in 2000, and a
25,375 square foot distribution facility in Atlanta, Georgia under a lease that
expires in April 2001. The Company leases sales and marketing offices in
Stockholm, Sweden and Lohman, Germany under leases that expire in April 2001 and
April 2002, respectively. The Company also leases a 33,260 square foot facility
in Kuala-Lumpur, Malaysia, under a lease that expires in July 2001. This
facility primarily assembles finished products for the Swedish operation.
The Company believes that its current facilities are adequate for its
present level of operations. Management expects that the Arlington Heights and
Elk Grove leases will be renewed on favorable terms.
Item 3. Legal Proceedings.
The Company is party to lawsuits and other proceedings, including suits
relating to product liability and patent infringement. While the results of
such lawsuits and other proceedings cannot be predicted with certainty,
management does not expect that the ultimate liabilities, if any, will have a
material adverse effect on the financial position or results of operations of
the Company.
Item 4. Submissions of Matters to a Vote of Security Holders.
None.
8
PART II
Item 5. Market for Registrant's Common Equity and Related Stockholder Matters.
There is no established public trading market for the Company's Common
Stock. All of the Common Stock of the Company is held by Holding and the
shareholder of the Company prior to the Recapitalization, described below. See
"Item 7. Management's Discussion and Analysis of Financial Condition and Results
of Operations--Recapitalization."
The Company has not paid cash dividends to Holding in the past two years,
and does not intend to pay cash dividends to Holding in the foreseeable future.
See "Item 7. Management's Discussion and Analysis of Financial Condition and
Results of Operations--Liquidity and Capital Resources" for a discussion of
restrictions on the Company's ability to pay cash dividends.
Item 6. Selected Financial Data.
The selected fiscal year end historical financial data has been derived
from the audited financial statements of the Company. The information contained
in this table should be read in conjunction with the Company's audited
consolidated financial statements and notes thereto included elsewhere in this
Report.
Fiscal Year
-------------------------------------------------------------------------------
1998(As
Restated;
1995 1996 1997 See Note 15 1999(a)
to the
Audited
Financial
Statements)
--------- --------- --------- ------------ ----------
Operating Data: (dollars in thousands)
Net sales.......................................... $ 86,825 $ 93,842 $ 99,509 $100,498 $128,803
Cost of sales...................................... 49,896 52,189 54,575 56,802 75,418
-------- -------- -------- -------- --------
Gross profit....................................... 36,929 41,653 44,934 43,696 53,385
Operating expenses:
Selling expenses................................... 8,283 8,961 9,643 10,350 13,122
Distribution expenses.............................. 3,088 3,114 3,170 3,336 4,647
General and administrative expenses................ 9,769 11,277 11,456 10,284 14,732
Research and development expenses.................. 1,257 1,184 1,072 976 2,031
Provision for equity participation plan............ 11,415 8,249 6,954 63,939 --
Provision for retention payments................... -- -- -- 4,754(b) --
-------- -------- -------- -------- --------
Operating income (loss)............................ 3,117 8,868 12,639 (49,943) 18,853
Other (income) and expenses:
Interest expense................................... 2,424 2,177 1,834 11,327 17,263
Other (income) expense............................. 811 (463) (638) 406 1,232
-------- -------- -------- -------- --------
Total other expense................................ 3,235 1,714 1,196 11,733 18,495
-------- -------- -------- -------- --------
Income (loss) before provision (benefit) for
income taxes....................................... (118) 7,154 11,443 (61,676) 358
Provision (benefit) for income taxes............... 280 73 150 8,405 1,586
-------- -------- -------- -------- --------
Income (loss) before extraordinary item............ (398) 7,081 11,293 (70,081) (1,228)
Extraordinary item (loss on extinguishment of debt) -- -- -- 104(c) --
-------- -------- -------- -------- --------
Net income (loss).................................. $ (398) $ 7,081 $ 11,293 $(70,185) $ (1,228)
======== ======== ======== ======== ========
continued on following page
Other Financial Data: (dollars in thousands)
Net cash provided by (used in) operating
activities........................................ $ 15,939 $ 16,133 $ 19,269 $(83,024) $ 7,097
Net cash used in investing activities.............. $ (6,088) $(11,354) $ (3,673) $ (6,444) $(75,818)
Net cash provided by (used in) financing
activities........................................ $(11,880) $ (3,668) $(16,398) $ 89,624 $ 71,529
Adjusted EBITDA(d)................................. $ 21,205 $ 23,194 $ 25,440 $ 24,851 $ 29,993
Adjusted EBITDA margin(e).......................... 24.4% 24.7% 25.6% 24.7% 23.3%
9
Fiscal Year
-------------------------------------------------------------------------------
1998(As
Restated;
1995 1996 1997 See Note 15 1999(a)
to the
Audited
Financial
Statements)
--------- --------- --------- ------------ ----------
Operating margin before EPP and Retention
Payments(f)....................................... 16.7% 18.2% 19.7% 18.7% 14.6%
Depreciation and amortization(g)................... $ 6,820 $ 6,133 $ 5,847 $ 6,101 $ 8,315
Capital expenditures............................... $ 5,850 $ 6,395 $ 4,659 $ 3,111 $ 10,973
Ratio of Adjusted EBITDA to cash interest expense.. 8.7x 10.7x 13.9x 2.3x 2.1x
Ratio of total debt to Adjusted EBITDA............. 1.2x 1.2x 0.8x 6.4x 7.1x
Ratio of earnings to fixed charges(h).............. 1.0x 3.7x 6.0x -- 1.0x
Deficiency of earnings to cover fixed charges...... -- -- -- $(61,676) --
Ratio of earnings to fixed charges and preferred
stock dividends(i)................................ 1.0x 3.7x 6.0x -- --
Deficiency of earnings to cover fixed charges and
preferred stock dividends......................... -- -- -- $(65,863) $ (6,160)
Balance Sheet Data:
Working capital.................................... $ 18,641 $ 24,188 $ 6,430 $ 29,533 $ 35,971
Working capital as adjusted(j)..................... 22,461 26,768 29,960 32,026 39,727
Total assets....................................... 64,387 76,910 77,554 165,321 251,819
Total debt......................................... 25,364 28,146 20,250 159,000 211,694
Shareholders' equity (deficit)..................... 19,112 19,872 22,515 (37,735) (14,649)
______________________
(a) Includes results of operations for (i) LGAB, since it was acquired in July
1999, (ii) Medimex, since certain of its assets were acquired in October
1999 and (iii) Tyco, since certain of its assets were acquired in November
1999. See "Item 7. Management's Discussion and Analysis of Financial
Condition and Results of Operations C Recent Developments."
(b) Reflects retention payments made to substantially every employee of the
Company in connection with the Recapitalization. These payments were
intended to ensure the continued employment of all employees after the
Recapitalization and no future payments are anticipated.
(c) Reflects the write-off of deferred financing fees related to the payoff of
outstanding debt under the Company's previous credit agreement.
(d) Adjusted EBITDA represents income before depreciation and amortization,
interest expense, income tax expense, charges related to the Equity
Participation Plan, which was terminated upon consummation of the
Recapitalization, and recognition of the portion of purchase price
allocation related to acquired inventories. The Company has excluded
payments under the Equity Participation Plan to present comparable figures
for all historical periods presented. Adjusted EBITDA is not a measure of
performance under generally accepted accounting principles, and should not
be considered as a substitute for net income, cash flows from operating
activities and other income or cash flow statement data prepared in
accordance with generally accepted accounting principles, or as a measure of
profitability or liquidity. The Company has included information concerning
Adjusted EBITDA as one measure of an issuer's historical ability to service
debt. In addition, certain covenants in the Indenture are based upon a
calculation analogous to Adjusted EBITDA. Adjusted EBITDA should not be
considered as an alternative to, or more meaningful than, income from
operations or cash flow as an indication of the Hudson RCI's operating
performance. For purposes of compliance with the Indenture, the Company's
Consolidated Net Income and EBITDA will not be reduced by retention
payments, payments made pursuant to the Equity Participation Plan or by the
amount of any contingent payments made by the Company to former participants
in the Equity Participation Plan. See "Certain Relationships and Related
Transactions."
(e) Represents ratio of Adjusted EBITDA to net sales.
(f) Represents ratio of operating income before EPP and retention payments to
net sales.
(g) Includes amortization of deferred financing fees of $0.1 million in 1995 and
$0.1 million in 1996, which should be excluded from depreciation and
amortization in calculating Adjusted EBITDA since such fees are reflected
below the operating income line.
(h) For the purpose of determining the ratio of earnings to fixed charges,
earnings consist of earnings before income taxes and fixed charges. Fixed
charges consist of interest on indebtedness, the amortization of debt issue
costs and that portion of operating rental expense representative of the
interest factor.
10
(i) For the purpose of determining the ratio of earnings to fixed charges and
preferred stock dividends, earnings consist of earnings before income taxes
and fixed charges. Fixed charges consist of interest on indebtedness, the
amortization of debt issue costs and that portion of operating rental
expense representative of the interest factor. Preferred stock dividends,
consisting of amounts to be paid-in-kind, are also included in the pro forma
fixed charge amounts. Preferred stock dividends have been "grossed up" to a
pre-income tax basis to provide comparability to other components of the
ratio.
(j) Working capital as adjusted represents current assets, excluding cash, less
current liabilities, excluding the current portion of long-term debt.
Item 7. Management's Discussion and Analysis of Financial Condition and Results
of Operation.
The following discussion of the Company's consolidated historical results
of operations and financial condition should be read in conjunction with the
consolidated financial statements of the Company and the notes thereto included
elsewhere in this Form 10-K. The following discussion and analysis includes
periods before completion of the Recapitalization.
General
The Company has increased its net sales and improved its position within
the disposable health care products market in recent years by increasing its
respiratory care product offering, introducing disposable products for the
anesthesia health care market, expanding its presence in international markets
and establishing a position in the growing alternate site market.
The Company's results of operations may fluctuate significantly from
quarter to quarter as a result of a number of factors, including, among others,
the buying patterns of the Company's distributors, GPOs and other purchasers of
the Company's products, forecasts regarding the severity of the annual cold and
flu season, announcements of new product introductions by the Company or its
competitors, changes in the Company's pricing of its products and the prices
offered by the Company's competitors, rate of overhead absorption due to
variability in production levels and variability in the number of shipping days
in a given quarter.
Recent Developments
On November 8, 1999, the Company acquired certain assets of Tyco Healthcare
Group LP ("Tyco"), including Tyco's incentive breathing exerciser and pulmonary
function monitor product lines, for a cash purchase price of approximately $23.8
million. The Tyco acquisition was funded principally with proceeds from the
Company's $60.0 million revolving line of credit.
On October 8, 1999, the Company acquired certain assets of Medimex, a
German distribution company that had previously distributed products for both
the Company and LGAB, for a cash purchase price of $2.2 million. The assets
were acquired through the Company's wholly-owned, non-guarantor subsidiary,
HRCDAC Inc., and was funded with cash on hand.
On July 22, 1999, the Company, through its indirect, wholly-owned
subsidiary Steamer Holding AB, a company organized under the laws of Sweden
("Steamer"), acquired a majority of the outstanding capital stock of LGAB, a
company organized under the laws of Sweden. Pursuant to a series of private
purchases and a tender offer consummated pursuant to Swedish law, Steamer
acquired 604,000 shares of Class A stock and 2,452,838 shares of Class B stock
representing approximately 82.0% of the capital and 62.8% of the voting power of
LGAB at a price of 115 Swedish krona (approximately $13.60 at the July 22
exchange rate) per share of Class A stock and Class B stock for an aggregate
cash purchase price of approximately $45.5 million. In addition, on August 4,
1999, Steamer acquired an additional 483,750 shares of Class A stock of LGAB
from River Holding Corp., a Delaware corporation and the parent of Steamer and
the Company ("Holding"), which shares Holding acquired in a private transaction
in exchange for 525,042 shares of common stock of Holding ("Holding Common
Stock"). The exchange ratio for the Class A stock was the same as the effective
price per share of the shares acquired in the tender offer. After giving effect
to this exchange and the conversion of the Series A stock acquired by Steamer in
the tender offer into Series B stock, Steamer holds approximately 99.0%
11
of the capital and 100.0% of the voting power of LGAB. The Company intends that
Steamer, through continuing purchases and a statutory freezeout and appraisal
procedure under Swedish law, will acquire the remaining outstanding shares of
LGAB as soon as practicable.
The cash for the purchase price and certain related transaction costs was
funded with (i) $22.0 million in gross proceeds from the sale of Holding Common
Stock to the majority stockholder of Holding, (ii) a $22.0 million loan from the
majority stockholder of Holding to Steamer's parent, HRC Holding Inc., a
Delaware corporation and a wholly-owned subsidiary of the Company, and (iii) the
funding of 50 million Swedish krona (approximately $5.9 million) pursuant to the
terms of a loan facility agreement between Steamer and Svenska Handelsbanken AB.
Founded in 1954, LGAB develops, manufactures and markets medical device
products which humidify, heat and filter a patient's breathing gases during
anesthesia and intensive care. LGAB is a market leader in the area of "heat
moisture exchange" ("HME") products, with approximately 25% share of the world
market. Following completion of the acquisition, the Company intends to
continue LGAB's operations in substantially the same manner as conducted prior
to the acquisition.
In September 1998, the Company acquired certain assets of Gibeck, Inc., a
subsidiary of LGAB, for approximately $3.35 million. Prior to the transaction,
Gibeck, Inc. was engaged primarily in the business of manufacturing, marketing
and selling disposable anesthesia supplies. In conjunction with that
transaction, the Company became the exclusive North American distributor of
LGAB's HME product line. In fiscal year 1997, Gibeck, Inc. reported net sales
of approximately $12.3 million.
The Company established a sales office located in Germany in the second
quarter of 1999. It is anticipated that this operation will better equip the
Company to more aggressively pursue the German market. The German operation had
a negative impact on the Company's results of approximately $1.3 million in
fiscal 1999. It is anticipated that the Company's earnings will be positively
impacted for fiscal 2000 and beyond.
The Recapitalization
On April 7, 1998, Hudson RCI consummated its Recapitalization pursuant to
an Agreement and Plan of Merger pursuant to which River Acquisition Corp., a
wholly-owned subsidiary of Holding merged with and into Hudson RCI, with Hudson
RCI surviving as a majority-owned subsidiary of Holding (the "Merger").
Pursuant to the Recapitalization, Holding contributed approximately $93.0
million in equity capital into Hudson RCI (the "Holding Equity Investment") and
a shareholder of Hudson RCI (the "Continuing Shareholder") retained common stock
of Hudson RCI ("HCRI Common Stock") with a value of approximately $15.0 million
(the "Rollover Equity"), based on the valuation of Hudson RCI used in the
Recapitalization. In the Merger, a portion of the HRCI Common Stock was
converted into the right to receive approximately $131.1 million in cash, and
management received $88.3 million pursuant to the Company's Equity Participation
Plan (the "Equity Participation Plan" or "EPP"). Following the Holding Equity
Investment, Holding owned 80.8% of the outstanding HRCI Common Stock and the
Continuing Shareholder owned the remaining 19.2%.
The Holding Equity Investment was comprised of $63.0 million of common
equity (the "Common Stock Investment") and $30.0 million of preferred equity
(the "Preferred Stock Investment"). The Common Stock Investment was funded with
a $55.0 million investment by affiliates of Freeman Spogli & Co. Incorporated
("Freeman Spogli"), and an $8.0 million investment by management of Hudson RCI.
The Preferred Stock Investment was funded with proceeds from the sale of 11-1/2%
Senior Exchangeable PIK Preferred Stock due 2010 (the "Holding Preferred Stock")
with an aggregate liquidation preference of $30.0 million offered by Holding
(the "Preferred Stock Offering"). Immediately following consummation of the
Recapitalization, Freeman Spogli beneficially owned approximately 87.3% of the
outstanding Holding Common Stock and management owned the remaining 12.7%.
12
In connection with the Recapitalization and concurrently with the Preferred
Stock Offering, Hudson RCI offered $115.0 million aggregate principal amount of
9-1/8% Senior Subordinated Notes due 2008 (the "Subordinated Notes") (the
"Subordinated Notes Offering," and together with the Preferred Stock Offering,
the "Offerings").
On April 7, 1998, Hudson RCI entered into an agreement (the "Credit
Facility") providing for a $40.0 million secured term loan facility (the "Term
Loan Facility"), which was funded in connection with the consummation of the
Recapitalization, and a $60.0 million revolving loan facility (the "Revolving
Loan Facility") which will be available for Hudson RCI's future capital
requirements and to finance acquisitions.
The Offerings and the application of the net proceeds therefrom, repayment
of existing Hudson RCI debt payments to the Continuing Shareholder under the
Recapitalization Agreement and to management, the Holding Equity Investment and
the related borrowings under the Credit Facility are collectively referred to
herein as the "Recapitalization."
The Company and the shareholders that received distributions in the
Recapitalization made an election under Section 338(h)(10) of the Internal
Revenue Code of 1986, as amended, to treat the Recapitalization as an asset
purchase for tax purposes, which had the effect of significantly increasing the
basis of the Company's assets, thus increasing depreciation and amortization
expenses and other deductions for tax purposes and reducing the Company's
taxable income in 1998 and subsequent years. The Recapitalization resulted in
no change in the basis of the Company's assets and liabilities for financial
reporting purposes. A deferred tax asset was recorded upon the Company's
conversion from a Subchapter S corporation to a Subchapter C corporation,
primarily resulting from the Section 338(h)(10) election.
Results of Operations
The following tables set forth, for the periods indicated, certain income
and expense items expressed in dollars and as a percentage of the Company's net
sales.
Fiscal Year
------------------------------------------------
1997 1998 1999
---------- ---------- ----------
(dollars in thousands)
Net sales.................................................................... $99,509 $100,498 $128,803
Cost of sales................................................................ 54,575 56,802 75,418
------- -------- --------
Gross profit............................................................... 44,934 43,696 53,385
------- -------- --------
Selling expenses............................................................. 9,643 10,350 13,122
Distribution expenses........................................................ 3,170 3,336 4,647
General and administrative expenses.......................................... 11,456 10,284 14,732
Research and development expenses............................................ 1,072 976 2,031
Provision for equity participation plan...................................... 6,954 63,939 --
Provision for retention payments............................................. -- 4,754 --
------- -------- --------
Total operating expenses..................................................... 35,138 96,921 34,532
------- -------- --------
Operating income (loss)...................................................... 12,639 (49,943) 18,853
Add back: Provision for equity participation plan............................ 6,954 63,939 --
Add back: Provision for retention payments................................... -- 4,754 --
------- -------- --------
Operating income before provision for equity participation plan and
provision for retention payments............................................ $19,593 $ 18,750 $ 18,853
======= ======== ========
Fiscal Year
---------------------------------------------
1997 1998 1999
------- ------ ------
13
Net sales.................................................................... 100.0% 100.0% 100.0%
Cost of sales................................................................ 54.8 56.5 58.5
------- -------- --------
Gross profit............................................................... 45.2 43.5 41.4
------- -------- --------
Selling expenses............................................................. 9.7 10.3 10.2
Distribution expenses........................................................ 3.2 3.3 3.6
General and administrative expenses.......................................... 11.5 10.2 11.4
Research and development expenses............................................ 1.1 1.0 1.6
Provision for equity participation plan...................................... 7.0 63.6 --
Provision for retention payments............................................. -- 4.7 --
------- -------- --------
Total operating expenses..................................................... 35.3 96.4 26.8
------- -------- --------
Operating income (loss)...................................................... 12.7 (49.7) 14.6
Add back: Provision for equity participation plan............................ 7.0 63.6 --
Add back: Provision for retention payments................................... -- 4.7 --
------- -------- --------
Operating income before provision for equity participation plan and
provision for retention payments............................................ 19.7% 18.7% 14.6%
======= ======== ========
Year Ended December 31, 1999 Compared to Year Ended December 25, 1998
Net sales, reported net of accrued rebates, were $128.8 million in 1999, an
increase of $28.3 million or 28.2% over 1998. Of the $28.3 million increase,
approximately $6.1 million related to the acquisition of LGAB, $2.2 million
related to the Tyco acquisition and $0.9 million related to the Medimex
acquisition. In addition, the full effect in 1999 of the Gibeck, Inc.
acquisition in September 1998 resulted in a sales increase of $7.6 million. For
the base Hudson RCI business, domestic hospital sales increased by $3.3 million
or 5.5%, due to increased demand at the hospital level, primarily the result of
increased sales through certain GPOs. Alternate site sales increased by $4.4
million or 26.5% as the Company continued to focus its efforts on this growing
market. International sales increased by $1.6 million or 9.1%, as growth in
sales continued to Japan and Europe. This growth was partially offset by
weakness in South America. Sales to customers in Southeast Asia have
stabilized, remaining virtually unchanged over 1998. Canadian sales increased
by approximately $0.3 million, due primarily to the efforts of a new distributor
in that country. Approximately 30% of the Company's 1999 total net sales were
to two distributors.
The Company's gross profit for 1999 was $53.4 million, an increase of $9.7
million or 22.2% from 1998. As a percentage of net sales, the Company's gross
profit was 41.4% for 1998 as compared to 43.5% for 1997. This decline was
primarily due to the recognition of inventory revalued as a result of the LGAB
acquisition, increased shipping costs as a result of sales of acquired Gibeck,
Inc. products, and an unfavorable mix variance caused by increased sales of
products at lower gross margins. This trend is expected to continue in the
future if the preference for passive humidification products over higher margin
active humidification products continues. This trend was partially offset by
manufacturing cost reductions realized by the Company and higher gross margins
of sales at LGAB.
Selling expenses were $13.1 million for 1999, an increase of $2.7 million
or 26.8% over 1998. This increase was due primarily to $1.2 million of costs
associated with LGAB and $1.2 million as a result of the start-up of the German
sales operation. In addition, sales and marketing expenses at Hudson RCI
increased by approximately $0.3 million. As a percentage of net sales, selling
expenses decreased to 10.2% as compared to 10.3% in 1998.
Distribution expenses were $4.6 million for 1999, an increase of $1.3
million or 39.0% over 1998. As a percentage of sales, distribution expenses
increased to 3.6% as compared to 3.3% in 1998. The increase is primarily the
result of the increased cost of freight between the Company's distribution
facilities, the start up of a distribution facility in Atlanta and increased
headcount.
14
General and administrative expenses for 1999 were $14.7 million, an
increase of $4.4 million or 43.3% over 1998. Of this increase, $2.0 million
relates to expenses incurred at LGAB and $0.2 million as a result of the German
operation. In addition, the company increased management bonuses and incurred
certain non-recurring consulting expenses. As a percentage of net sales,
general and administrative expenses were 11.4% in 1999 as compared to 10.2% in
1998.
Research and development expenses were $2.0 million in 1999, an increase of
$1.1 million or 108.2% over 1998. This increase was primarily due to the
addition of LGAB research and development expenses of $0.7 million and increases
in the Hudson RCI engineering staff.
The provision for equity participation plan consists of accrued expenses
and payments made to executives under the Equity Participation Plan. The Equity
Participation Plan was terminated upon consummation of the Recapitalization and
replaced with an executive stock purchase plan. See "Item 11. Executive
Compensation--Stock Purchase Plan." No payments under the Equity Participation
Plan were made in 1999 that were not provided for in 1998. In 1998, the
provision for equity participation plan was $63.9 million, which included
approximately $1.3 million in employer taxes relating to the distribution made
under the Equity Participation Plan.
The provision for retention payments, including related employer payroll
taxes, was $4.8 million in 1998. These payments were made to substantially
every employee in the Company and were intended to ensure the continued
employment of all employees after the Recapitalization. No payments were made
in 1999 and no future retention payments are anticipated.
Interest expense was $17.3 million for 1999, an increase of $5.9 million
over 1998. The increase was due to higher debt levels during 1999 as a result
of the LGAB and Tyco acquisitions. Interest expense is expected to increase in
2000 reflecting a full year of interest expense at the higher debt level.
Year Ended December 25, 1998 Compared to Year Ended December 26, 1997
Net sales, reported net of accrued rebates, were $100.5 million in 1998, an
increase of $1.0 million or 1.0% over 1997. Domestic hospital sales declined by
$3.1 million or 4.8%, due primarily to the decreased demand of $5.0 million from
hospitals affiliated with the Premier GPO, as the Premier contract for
respiratory supplies was awarded to a competitor in February 1997. This decline
was partially offset by Gibeck sales of approximately $2.3 million. Average
selling price of certain domestic hospital sales also declined slightly from
1997 to 1998 due to pricing terms of a contract entered into in 1997. Alternate
site sales increased by $2.1 million or 14.4% as the Company continued to focus
its efforts on this growing market. International sales increased by $1.1
million or 5.8%. Although good growth was experienced in Japan (approximately
35.0%), this was partially offset by general weakness in other parts of
Southeast Asia. There is continued uncertainty in the outlook for sales in
Southeast Asia in the near term. Sales in Europe were essentially flat as
compared to 1997. Approximately 33% of the Company's 1998 total net sales were
to two distributors.
The Company's gross profit for 1998 was $43.7 million, a decline of $1.2
million or 2.7% from 1997. As a percentage of net sales, the Company's gross
profit was 43.5% for 1998 as compared to 45.2% for 1997. This decline was
primarily due to an unfavorable mix variance caused by increased sales of
products at lower gross margins. This trend is expected to continue in the
future if the preference for passive humidification products over higher margin
active humidification products continues. This trend was partially offset by
manufacturing cost reductions realized by the Company.
Selling expenses were $10.4 million for 1998, an increase of $0.7 million
or 7.3% over 1997. This increase is primarily the result of higher fees paid to
certain GPOs due to higher sales to their facilities. As a percentage of net
sales, selling expenses increased to 10.3% as compared to 9.7% in 1997.
Distribution expenses were $3.3 million for 1998, an increase of $0.1
million over 1997. As a percentage of sales, distribution expenses increased to
3.3% as compared to 3.2% in 1997.
15
General and administrative expenses for 1998 were $10.3 million, a decrease
of $1.2 million or 10.2% over 1997. This decrease is primarily the result of
the elimination of certain costs associated with the Recapitalization and lower
management bonuses. These declines were partially offset by legal expenses of
approximately $300,000 relating to the successful defense of a patent
infringement lawsuit. As a percentage of net sales, general and administrative
expenses were 10.2% in 1998 as compared to 11.5% in 1997.
Research and development expenses were $1.0 million in 1998 and were
virtually unchanged from 1997.
The provision for equity participation plan consists of accrued expenses
and payments made to executives under the Equity Participation Plan. The Equity
Participation Plan was terminated upon consummation of the Recapitalization and
replaced with an executive stock purchase plan. See "Item 11. Executive
CompensationCStock Purchase Plan." In 1998, the provision for equity
participation plan was $63.9 million, which included approximately $1.3 million
in employer taxes relating to the distribution made under the Equity
Participation Plan.
The provision for retention payments, including related employer payroll
taxes, was $4.8 million in 1998. These payments were made to substantially
every employee in the Company and were intended to ensure the continued
employment of all employees after the Recapitalization. No future retention
payments are anticipated.
Interest expense was $11.3 million for 1998, an increase of $9.5 million
over 1997. The increase was due to higher debt levels during 1998 as a result
of the Recapitalization. Interest expense is expected to increase in 1999
reflecting a full year of interest expense at the higher debt level.
The net effect of the Company's conversion from S to C corporation status
and the related Section 338(h)(10) election to increase the tax bases of assets
in connection with the Recapitalization of $77.1 million was previously
reflected in operations during the quarter ended June 26, 1998. This amount
should have been reflected as a direct credit to retained earnings. This
restatement has no impact on ending retained earnings for the periods presented.
The impact of the restatement on the accompanying financial statements is as
follows (amount in thousands):
As
Year Ended December 25, 1998 Originally Adjustments As Restated
Reported
- ---------------------------- --------------- --------------- ---------------
Net loss before provision for income taxes $(61,676) $ -- $(61,676)
======== ======== ========
Net income (loss) before extraordinary item $ 6,983 $(77,064) $(70,081)
======== ======== ========
Net income (loss) $ 6,879 $(77,064) $(70,185)
======== ======== ========
Seasonality
The Company's results of operations exhibit some measure of seasonality.
Generally, the Company's sales and EBITDA are higher in the first and fourth
quarters and lower in the second and third quarters. This is due primarily to
the higher incidence of breathing ailments, such as colds and flu, during the
winter months, which results in increased hospitalization and respiratory care,
especially among higher-risk individuals, such as infants and the elderly.
Fourth quarter sales are generally the Company's highest, as distributors
increase inventory in anticipation of the cold and flu seasons. First quarter
results are generally affected by the length and severity of flu seasons.
Liquidity and Capital Resources
The Company's primary sources of liquidity are cash flow from operations
and borrowings under its working capital bank facility. Cash provided by
operations totaled $19.3 million in 1997 and cash provided by operations before
EPP payments and retention bonuses totaled $(57.2) million and $8.2 million in
1998 and 1999, respectively. The decline from 1997 to 1998 is primarily
attributable to increased interest expense due to higher debt levels. The
Company
16
had operating working capital, excluding cash and short-term debt, of $30.0
million, $32.0 million and $39.7 million as of the end of fiscal 1997, 1998 and
1999, respectively. Inventories were $16.6 million, $18.0 million and $24.0
million as of the end of fiscal 1997, 1998 and 1999, respectively. In order to
meet the needs of its customers, the Company must maintain inventories
sufficient to permit same-day or next-day filling of most orders. Such
inventories are higher than those that would be required for delayed filling of
orders, thus adversely impacting liquidity. Over time, the Company expects its
level of inventories to increase as the Company's sales in the international
market increase. Accounts receivable, net of allowances, were $21.3 million,
$25.8 million and $30.4 million at the end of fiscal 1997, 1998 and 1999,
respectively. The average number of days sales in accounts receivable
outstanding was approximately 85 days for 1999, compared to 84 days for 1998 and
77 days for 1997. The Company offers 30 day credit terms to its U.S. hospital
distributors. Alternate site and international customers typically receive 60 to
90 day terms and, as a result, as the Company's alternate site and international
sales have increased, the amount and aging of its accounts receivable have
increased. The Company anticipates that the amount and aging of its accounts
receivable will continue to increase. The Company established a sales office in
Germany in the second quarter of 1999. While this will have the effect of
increasing the Company's investment in inventories, management believes that it
will also result in improved service to international customers as well as in
lower international accounts receivable than would otherwise be the case because
customers will receive products, and consequently pay for them, more quickly.
In connection with the Recapitalization, the Company made cash payments
under the Equity Participation Plan and for retention bonuses of $89.6 million
in the year ended December 25, 1998, which it funded with the proceeds of the
debt and equity transactions that were part of the Recapitalization.
Net cash used in investing activities was $3.7 million, $6.4 million and
$75.8 million in 1997, 1998 and 1999, respectively. These funds were primarily
used to finance the acquisition of the custom anesthesia circuit product line in
1998, various acquisitions of businesses and for capital expenditures. Capital
expenditures, consisting primarily of new manufacturing equipment purchases and
expansion of the Ensenada facility, totaled $4.7 million, $3.1 million and $11.0
million in 1997, 1998 and 1999, respectively. The decrease in 1997 and 1998
resulted from temporary delays in projects that the Company completed in 1998
and 1999. The Company currently estimates that capital expenditures will be
approximately $8.0 million in each of 2000 and 2001, consisting primarily of
additional and replacement manufacturing equipment and new heater placements.
Net cash used in financing activities was $16.4 million in 1997, which
consisted primarily of repayment of debt and shareholder distributions
principally to pay taxes on income passed through by the Company. Net cash
provided by financing was $89.6 million in 1998, reflecting net borrowings by
the Company. Net cash provided by financing activities was $71.5 million in
1999, which was used primarily to finance the LGAB and Tyco acquisitions.
The Company has outstanding $211.7 million of indebtedness, consisting of
$115.0 million of Subordinated Notes issued in connection with the
Recapitalization, borrowings of $71.6 million under the Company's Credit
Facility entered into in connection with the Recapitalization and $7.5 million
in notes payable to affiliates. In addition, LGAB has $17.6 million in
outstanding borrowings under its bank facility.
The Credit Facility consists of a $40.0 million Term Loan Facility (all of
which was funded in connection with the Recapitalization) and a $60.0 million
Revolving Loan Facility. The Revolving Loan Facility has a letter of credit
sublimit of $7.5 million. The Term Loan Facility matures on the sixth
anniversary of the initial borrowing and, commencing June 30, 1999, requires
quarterly principal installments of $3.0 million in 1999, $4.0 million in 2000,
$7.0 million in 2001, $9.0 million in 2002, $11.0 million in 2003, and $10.0
million in 2004. The Revolving Loan Facility matures on the sixth anniversary
of the initial borrowing. The interest rate under the Credit Facility is
based, at the option of the Company, upon either a Eurodollar rate plus 2.50%
per annum or a base rate (as defined) plus 1.50% per annum, each less an
applicable pricing adjustment (as defined). Borrowings under the Credit
Facility are required to be prepaid, subject to certain exceptions, with (i) 75%
(or 50% for years when the Company's ratio of Debt to EBITDA (as defined) is
less than 5:1) of Excess Cash Flow (as defined), (ii) 50% of the net cash
proceeds of an equity issuance by the Company in connection with an initial
public offering or 100% of the net cash proceeds of an equity issuance by the
Company other than in connection with an initial public offering, (iii) 100% of
the net cash proceeds of the sale or other disposition of any properties or
assets of Holding and its subsidiaries (subject to certain exceptions),
17
(iv) 100% of the net proceeds of certain issuances of debt obligations of Hudson
RCI and its subsidiaries and (v) 100% of the net proceeds from insurance
recoveries and condemnations. The Revolving Loan Facility must be prepaid upon
payment in full of the Term Loan Facility. As of December 31, 1999, the Company
had available credit under the Revolving Loan Facility in the amount of $23.4
million ($16.8 million of which is restricted for use on future acquisitions).
No additional borrowing is available under the Term Loan Facility.
The Credit Facility is guaranteed by Holding and all existing and
subsequently acquired or organized domestic and, to the extent no adverse tax
consequences would result, foreign subsidiaries of the Company. The Credit
Facility is secured by a first priority lien in substantially all of the
properties and assets of the Company and the guarantors now owned or acquired
later, including a pledge of all of the capital stock of the Company owned by
Holding and all of the shares held by the Company of its existing and future
subsidiaries; provided, that such pledge is limited to 65% of the shares of any
foreign subsidiary to the extent a pledge of a greater percentage would result
in adverse tax consequences to the Company.
The Credit Facility contains covenants restricting the ability of Holding,
the Company and the Company's subsidiaries to, among others, (i) incur
additional debt, (ii) declare dividends or redeem or repurchase capital stock,
(iii) prepay, redeem or purchase debt, (iv) incur liens, (v) make loans and
investments, (vi) make capital expenditures, (vii) engage in mergers,
acquisitions and asset sales, (viii) engage in transactions with affiliates.
Hudson RCI is also required to comply with financial covenants with respect to
(a) limits on annual aggregate capital expenditures (as defined), (b) a fixed
charge coverage ratio, (c) a maximum leverage ratio, (d) a minimum EBITDA test
and (e) an interest coverage ratio.
The Subordinated Notes bear interest at the rate of 9-1/8%, payable
semiannually on each April 15 and October 15, and will require no principal
repayments until maturity. The Subordinated Notes are general unsecured
obligations of the Company. The Subordinated Notes contain covenants that place
limitations on, among other things, (i) the ability of the Company, any
subsidiary guarantors and other restricted subsidiaries to incur additional
debt, (ii) the making of certain restricted payments including investments,
(iii) the creation of certain liens, (iv) the issuance and sale of capital stock
of restricted subsidiaries, (v) asset sales, (vi) payment restrictions affecting
restricted subsidiaries, (vii) transactions with affiliates, (viii) the ability
of the Company and any subsidiary guarantor to incur layered debt, (ix) the
ability of Holding to engage in any business or activity other than those
relating to ownership of capital stock of the Company and (x) certain mergers,
consolidations and transfers of assets by or involving the Company.
In connection with the LGAB acquisition, the Company borrowed $22.0 million
pursuant to an unsecured promissory note payable to Freeman Spogli. The note
bears interest at 12.0% per annum, matures in August 2006, and requires
semiannual interest payments. As of December 31, 1999, $7.5 million remained
outstanding on the note.
In connection with the LGAB acquisition, the Company assumed debt owed by
LGAB under its bank facility (the "LGAB Facility"), which totaled $17.6 million
as of December 31, 1999. The LGAB Facility, which is denominated in Swedish
krona, bears interest at three-month STIBOR (the interest rate at or about 11:00
a.m. Stockholm time, two banking days before a draw-down date or the relevant
interest period, quoted for deposits in krona) plus 0.75% to 1.75% (4.365% to
5.365% at December 31, 1999), matures in December 2003, and is secured by the
common stock of LGAB.
In connection with the Recapitalization, the Company issued to Holding
300,000 shares of its 11-1/2% Senior PIK Preferred Stock due 2010 with an
aggregate liquidation preference of $30.0 million, which has terms and
provisions materially similar to those of the Holding Preferred Stock. At the
election of the Company, dividends may be paid in kind until April 15, 2003 and
thereafter must be paid in cash.
The Company believes that after giving effect to the Recapitalization, the
1999 acquisitions and the incurrence of indebtedness related thereto, based on
current levels of operations and anticipated growth, its cash from operations,
together with other available sources of liquidity, including borrowings
available under the Revolving Loan Facility, will be sufficient over the next
twelve months to fund anticipated capital expenditures and acquisitions and to
make required payments of principal and interest on its debt, including payments
due on the Subordinated Notes and obligations under the Credit Facility. The
Company intends to selectively pursue strategic acquisitions, both domestically
and internationally, to
18
expand its product line, improve its market share positions and increase cash
flows. Financing for such acquisitions is available, subject to limitations,
under the Credit Facility. Any significant acquisition activity by the Company
in excess of such amounts would require additional capital, which could be
provided through capital contributions or debt financing. The Company has no
commitments for such acquisition financing and to the extent financing is
unavailable, acquisitions may be delayed or not completed.
Year 2000 Compliance
The following discussion about the implementation of the Company's Year
2000 program, the costs expected to be associated with the program and the
results the Company expects to achieve constitute forward-looking information.
As noted below, there are many uncertainties involved with the Year 2000 issue,
including the extent to which the Company will be able to adequately provide for
contingencies that may arise, as well as the broader scope of the Year 2000
issue as it may affect third parties and the Company's key trading partners.
Accordingly, the costs and results of the Company's Year 2000 program and the
extent of any impact on the Company's results of operations could vary
materially from that stated herein.
A significant percentage of software that runs on most computers relies on
two-digit date codes to perform computations and decision-making functions.
Commencing on January 1, 2000, these computer programs may fail from an
inability to interpret date codes properly, misinterpreting "00" as the year
1900 rather than 2000. The Company has completed the identification of all
necessary internal software changes to ensure that it does not experience any
loss of critical business functionality due to the Year 2000 issue. The Company
has completed an assessment of all internal software, hardware and operating
systems and has made all necessary hardware and software changes as a result of
that assessment. The Company has not encountered any material Year 2000
problems to date and does not believe that its systems will encounter any
material Year 2000 problems in the future. The Company's products are not
subject to Year 2000 problems.
The Company also relies, directly and indirectly, on the external systems
of various independent business enterprises, such as its customers, suppliers,
creditors, financial organizations, and of governments, for the accurate
exchange of data and related information. The Company could be affected as a
result of any disruption in the operation of the various third-party enterprises
with which the Company interacts. The Company has contacted its key trading
partners to assess its Year 2000 risk based upon the Year 2000 issues of its
partners, and has developed contingency plans for a substantial number of its
key trading partners. These contingency plans include the establishment of
back-up vendors and back-up plans for communications with its customers and for
the procurement of power and water at its Mexico facilities. The cost of
establishing these contingency plans was not material.
The total costs of the Year 2000 program are anticipated to be less than
$100,000, some of which has been expended to date. The costs and time estimates
of the Year 2000 project are based on the Company's best estimates. There can
be no assurance that these estimates will be achieved and that planned results
will be achieved. Risk factors include, but are not limited to, the retention
of internal resources dedicated to the project and the successful completion of
key business partners' Year 2000 projects.
Recent Accounting Pronouncements
Statement of Financial Accountings Standards ("SFAS") No. 133, "Accounting
for Derivative Instruments and Hedging Activities" was issued in June 1998.
Because the Company has no derivative instruments and does not engage in hedging
activities, SFAS No. 133 is not expected to impact the Company materially.
RISK FACTORS
Substantial Leverage; Shareholders' Deficit
As of December 31, 1999, the Company had $211.7 million of outstanding
indebtedness and a shareholders' deficit of approximately $14.6 million. This
level of indebtedness is substantially higher than the Company's historical
19
debt levels and may reduce the flexibility of the Company to respond to changing
business and economic conditions. In addition, subject to the restrictions in
the Credit Facility and the indenture governing the Subordinated Notes (the
"Indenture"), the Company may incur additional senior or other indebtedness from
time to time to finance acquisitions or capital expenditures or for other
general corporate purposes. See "Liquidity and Capital Resources." The Credit
Facility and the Indenture restrict, but do not prohibit, the payment of
dividends by the Company to Holding to finance the payment of dividends on the
Holding Preferred Stock.
The Company's high degree of leverage may have significant consequences for
the Company, including: (i) the ability of the Company to obtain additional
financing for working capital, capital expenditures, acquisitions or other
purposes, if necessary, may be impaired; (ii) a substantial portion of the
Company's cash flow will be dedicated to the payment of interest and principal
on its indebtedness and will not be available to the Company for its operations
and future business opportunities; (iii) the covenants contained in the
indenture and the Credit Facility will limit the Company's ability to, among
other things, borrow additional funds, dispose of assets or make investments and
may affect the Company's flexibility in planning for, and reacting to, changes
in business conditions; (iv) indebtedness under the Credit Facility will be at
variable rates of interest, which will cause the Company to be vulnerable to
increases in interest rates; and (v) the Company's high degree of leverage may
make it more vulnerable to a downturn in its business or the economy generally
or limit its ability to withstand competitive pressures. If the Company is
unable to generate sufficient cash flow from operations in the future to service
its indebtedness, it may be required to refinance all or a portion of its
existing debt or to obtain additional financing. There can be no assurance that
any such actions could be effected on a timely basis or on satisfactory terms or
that these actions would enable the Company to continue to satisfy its capital
requirements. The Company's ability to meet its debt service obligations and to
reduce its total indebtedness will be dependent upon the Company's future
performance, which will be subject to general economic conditions and to
financial, business and other factors affecting the operations of the Company,
many of which are beyond its control. The terms of the Company's indebtedness,
including the Credit Facility and the Indenture, also may prohibit the Company
from taking such actions.
Medical Cost Containment
In recent years, widespread efforts have been made in both the public and
private sectors to control health care costs, including the prices of products
such as those sold by the Company, in the United States and abroad. Cost
containment measures have resulted in increased customer purchasing power,
particularly through the increased presence of GPOs in the marketplace and
increased consolidation of distributors. Health care organizations are
evaluating ways in which costs can be reduced by decreasing the frequency with
which a treatment, device or product is used. Cost containment has also caused
a shift in the decision-making function with respect to supply acquisition from
the clinician to the administrator, resulting in a greater emphasis being placed
on price, as opposed to features and clinical benefits. The Company has
encountered significant pricing pressure from customers and believes that it is
likely that efforts by governmental and private payors to contain costs through
managed care and other efforts and to reform health systems will continue and
that such efforts may have an adverse effect on the pricing and demand for the
Company's products. There can be no assurance that current or future reform
initiatives will not have a material adverse effect on the Company's business,
financial conditions or results of operations.
The Company's products are sold principally to a variety of health care
providers, including hospitals and alternate site providers, that receive
reimbursement for the products and services they provide from various public and
private third party payors, including Medicare, Medicaid and private insurance
programs. As a result, while the Company does not receive payments directly
from such third party payors, the demand for the Company's products in any
specific care setting is dependent in part on the reimbursement policies of the
various payors in that setting. In order to be reimbursed, the products
generally must be found to be reasonable and necessary for the treatment of
medical conditions and must otherwise fall within the payor's list of covered
services. In light of increased controls on Medicare spending, there can be no
assurance on the outcome of future coverage or payment decisions for any of the
Company's products by governmental or private payors. If providers, suppliers
and other users of the Company's products are unable to obtain sufficient
reimbursement, a material adverse impact on the Company's business, financial
condition or operations may result.
20
The Company expects that the trend toward cost containment that has
impacted the domestic market will also be experienced in international health
care markets, impacting the Company's growth in foreign countries, particularly
where health care is socialized.
Industry Consolidation; Customer Concentration
Cost containment has resulted in significant consolidation within the
health care industry. A substantial number of the Company's customers,
including group purchasing organizations, hospitals, national nursing home
companies and national home health care agencies, have been affected by this
consolidation. The acquisition of any of the Company's significant customers
could result in the loss of such customers by the Company, thereby negatively
impacting its business, financial condition and results of operations. For
example, in 1996, three GPOs that accounted for aggregate sales of approximately
$11.0 million combined and, as a result of a decision of the combined entity to
enter into a sole distributorship arrangement in 1997 with one of the Company's
competitors, the Company has experienced some decrease in sales and may
experience additional sales decreases in the future. In addition, the
consolidation of health care providers often results in the renegotiation of
terms and in the granting of price concessions. The Company's customer
relationships, including exclusive or preferential provider relationships, are
terminable at will by either party without advance notice or penalty. Because
larger purchasers or groups of purchasers tend to have more leverage in
negotiating prices, this trend has caused the Company to reduce prices and could
have a material adverse effect on the Company's business, financial condition or
results of operations. As GPOs and integrated health care systems increase in
size, each relationship represents a greater concentration of market share and
the adverse consequences of losing a particular relationship increases
considerably. For fiscal 1999, the Company's ten largest group purchasing
arrangements accounted for approximately 34% of the Company's total net sales.
Distributors have also consolidated in response to cost containment. For fiscal
1999, approximately 30.5% of the Company's net sales were to two distributors,
Owens & Minor Inc. and McKesson, which accounted for 19.0% and 11.5%,
respectively, of the Company's net sales. The loss of the Company's
relationship with these distributors would have a material adverse effect on the
Company's business, financial condition and results of operations.
Government Regulation
The Company and its customers and suppliers are subject to extensive
federal and state regulation in the United States, as well as regulation by
foreign governments. Most of the Company's products are subject to government
regulation in the United States and other countries. In the United States, the
Federal Food, Drug, and Cosmetic Act, as amended (the "FDC Act"), and other
statutes and regulations govern or influence the testing, manufacture, safety,
labeling, storage, record keeping, marketing, advertising and promotion of such
products. Failure to comply with applicable requirements can result in fines,
recall or seizure of products, total or partial suspension of production,
withdrawal of existing product approvals or clearances, refusal to approve or
clear new applications or notices and criminal prosecution. Under the FDC Act
and similar foreign laws, the Company, as a marketer, distributor and
manufacturer of health care products, is required to obtain the approval of
federal and foreign governmental agencies, including the Food and Drug
Administration ("FDA"), prior to marketing, distributing and manufacturing
certain of those products, which can be time consuming and expensive. The
Company may also need to obtain FDA clearance before modifying marketed products
or making new promotional claims. Delays in receipt of or failure to receive
required approvals or clearances, the loss of previously received approvals or
clearances, or failures to comply with existing or future regulatory
requirements in the United States or in foreign countries could have a material
adverse effect on the Company's business. Foreign sales are subject to similar
requirements.
The Company is required to comply with the FDA's "Quality System
Regulations for Medical Devices," implementing "Good Manufacturing Practices"
("GMP/QSR Regulations"), which set forth requirements for, among other things,
the Company's manufacturing process, design control and associated record
keeping, including testing and sterility. Further, the Company's plants and
operations are subject to review and inspection by local, state, federal and
foreign governmental entities. The distribution of the Company's products may
also be subject to state regulation. The impact of FDA regulation on the
Company has increased in recent years as the Company has increased its
manufacturing operations. The Company's suppliers, including sterilizer
facilities, are also subject to similar governmental requirements. There can be
no assurance that changes to current regulations or additional regulations
imposed by the
21
FDA will not have an adverse impact on the Company's business and
financial condition in the future. If the FDA believes that a company is not in
compliance with applicable regulations, it can institute proceedings to detain
or seize products, issue a recall, impose operating restrictions, enjoin future
violations and assess civil and criminal penalties against the company, its
officers or its employees and can recommend criminal prosecution to the
Department of Justice. Other regulatory agencies may have similar powers. In
addition, product approvals could be withdrawn due to the failure to comply with
regulatory standards or the occurrence of unforeseen problems following initial
marketing. The FDA also has the authority to issue special controls for devices
manufactured by the Company, which it has not done to date. In the event that
such special controls were issued, the Company's products would be required to
conform, which could result in significant additional expenditures for the
Company.
The Company is subject to numerous federal, state and local laws and
regulations relating to such matters as safe working conditions, manufacturing
practices, fire hazard control and the handling and disposal of hazardous or
infectious materials or substances and emissions of air pollutants. The Company
owns and leases properties which are subject to environmental laws and
regulations. There can be no assurance that the Company will not be required to
incur significant costs to comply with such laws and regulations in the future
or that such laws or regulations will not have a material adverse effect upon
the Company's business, financial condition or results of operations. In
addition, the Company cannot predict the extent to which future legislative and
regulatory developments concerning its practices and products for the health
care industry may affect the Company.
Risks Related to International Sales; Foreign Operations
Sales made outside the United States represented approximately 22.1% of the
Company's 1999 net sales and the Company intends to increase international sales
as a percentage of total net sales. Foreign operations are subject to special
risks that can materially affect the sales, profits, cash flows and financial
position of the Company, including increased regulation, extended payment
periods, competition from firms with more local experience, currency exchange
rate fluctuations and import and export controls. The Company has operations in
Germany, Sweden, Japan and other countries where sales are made in local
currency. While the Company plans to hedge its foreign currency exposures by
attempting to purchase goods and services with the proceeds from sales in local
currencies where possible, and to purchase forward contracts to hedge
receivables denominated in foreign currency, there can be no assurance that the
Company's hedging strategies will allow the Company to successfully mitigate its
foreign exchange exposures. The Company's foreign exchange exposure has
historically not been significant, and was not considered to be significant in
fiscal 1999.
The destabilization of the economies of several Asian countries in 1997
caused a decrease in demand for the Company's products throughout Southeast
Asia, and future sales in that region are uncertain. In addition, adverse
economic conditions in Asia could result in "dumping" of products similar to
those produced by the Company by other manufacturers, both in Asian and other
markets.
The Company also maintains a manufacturing and assembly facility in
Ensenada, Mexico and an assembly facility in Kuala-Lumpur, Malaysia and, as a
result, is subject to operational risks such as changing labor trends and civil
unrest in those countries. In the event the Company were required to transfer
its foreign operations to the United States or were otherwise unable to benefit
from its lower cost foreign operations, its business, financial condition and
results of operations would be adversely affected.
Product Liability
The manufacturing and marketing of medical products entails an inherent
risk of product liability claims. Although the Company has not experienced any
significant losses due to product liability claims and currently maintains
umbrella liability insurance coverage, there can be no assurance that the amount
or scope of the coverage maintained by the Company will be adequate to protect
it in the event a significant product liability claim is successfully asserted
against the Company. In addition, the Company cannot predict the extent to
which future legislative and regulatory developments concerning its practices
and products for the health care industry may affect the Company.
22
Dependence on Key Personnel; Management of Expanding Operations
The Company's success will, to a large extent, depend upon the continued
services of its executive officers. The loss of services of any of these
executive officers could materially and adversely affect the Company. While the
Company has employment agreements with it senior management team, these
agreements may be terminated by either party, with or without cause.
The Company's plans to expand its business may place a significant strain
on the Company's operational and financial resources and systems. To manage its
expanding operations, the Company may be required to, among other things,
improve its operational, financial and management information systems. The
Company may also be required to attract, train and retain additional highly
qualified management, technical, sales and marketing and customer support
personnel. The process of locating such personnel with the combination of
skills and attributes required to implement the Company's strategy is often
lengthy. The inability to attract and retain additional qualified personnel
could materially and adversely affect the Company.
Competition
The medical supply industry is characterized by intense competition.
Certain of the Company's competitors have greater financial and other resources
than the Company and may succeed in utilizing these resources to obtain an
advantage over the Company. The general trend toward cost containment in the
health care industry has had the effect of increasing competition among
manufacturers, as health care providers and distributors consolidate and as GPOs
increase in size and importance. The Company competes on the basis of brand
name, product quality, breadth of product line, service and price.
Risks Generally Associated with Acquisitions
An element of the Company's business strategy is to pursue strategic
acquisitions that either expand or complement the Company's business.
Acquisitions involve a number of special risks, including the diversion of
management's attention to the assimilation of the operations and the
assimilation and retention of the personnel of the acquired companies, and
potential adverse effects on the Company's operating results. The Company may
require additional debt or equity financing for future acquisitions, which may
not be available on terms favorable to the Company, if at all. In addition, the
Credit Facility and the Indenture contain certain restrictions regarding
acquisitions. The Indenture restricts acquisitions to those companies in the
same line of business as the Company, and requires that all such acquired
companies be designated Restricted Subsidiaries (as defined therein). The
Credit Facility restricts all acquisitions with the exception of Permitted
Acquisitions (as defined therein), and limits, among other things, (i) the sum
that may be paid in connection with any single acquisition to $30.0 million,
(ii) the total amount outstanding of revolving credit indebtedness that can be
incurred for acquisition purposes to $40.0 million, and (iii) the line of
business of the acquired entity or assets. The inability of the Company to
successfully finance, complete and integrate strategic acquisitions in a timely
manner could have an adverse impact on the Company's ability to effect a portion
of its growth strategy.
Patents and Trademarks
The Company has historically relied primarily on its technological and
engineering abilities and on its design and production capabilities to gain
competitive business advantages, rather than on patents or other intellectual
property rights. However, the Company does file patent applications on concepts
and processes developed by the Company's personnel. The Company has 20 patents
in the U.S. Many of the U.S. patents have corresponding patents issued in
Canada, Europe and various Asian countries. The Company's success will depend
in part on its ability to maintain its patents, add to them where appropriate,
and to develop new products and applications without infringing the patent and
other proprietary rights of third parties and without breaching or otherwise
losing rights in technology licenses obtained by the Company for other products.
There can be no assurance that any patent owned by the Company will not be
circumvented or challenged, that the rights granted thereunder will provide
competitive advantages to the Company or that any of the Company's pending or
future patent applications will be issued with claims of the scope sought by the
23
Company, if at all. If challenged, there can be no assurance that the Company's
patents (or patents under which it licenses technology) will be held valid or
enforceable. In addition, there can be no assurance that the Company's products
or proprietary rights do not infringe the rights of third parties. If such
infringement were established, the Company could be required to pay damages,
enter into royalty or licensing agreements on onerous terms and/or be enjoined
from making, using or selling the infringing product. Any of the foregoing
could have a material adverse effect upon the Company's business, financial
condition or results of operations.
S Corporation Status
The Company elected to be treated as an S corporation for federal and state
income tax purposes for its taxable years beginning on or after January 1, 1987.
Unlike a C corporation, an S corporation is generally not subject to income tax
at the corporate level; instead, the S corporation's income is taxed on the
personal income tax returns of its shareholders. The Company's status as an S
corporation terminated upon consummation of the Recapitalization. If S
corporation status were denied for any periods prior to such termination by
reason of a failure to satisfy the S corporation election or eligibility
requirements of the Internal Revenue Code of 1986, as amended, the Company would
be subject to tax on its income as if it were a C corporation for these periods.
Such an occurrence would have a material adverse effect on the Company's
results.
Item 7A. Quantitative and Qualitative Disclosure About Market Risk.
Quantitative Disclosures. With the LGAB acquisition, the Company has
greater foreign currency exposure with respect to its international operations.
In the past, the Company's only international exposure was its manufacturing
operation in Mexico. All sales were previously denominated in U.S. dollars.
Currently, the Company has operations in Germany, Sweden, Japan and other
countries where sales are made in local currency. The Company plans to hedge
its foreign currency exposures by attempting to purchase goods and services with
the proceeds from sales in local currencies where possible. The Company will
also purchase forward contracts to hedge receivables denominated in foreign
currency that are expected to be collected and converted into another currency.
However, there can be no assurance that the Company's hedging strategies will
allow the Company to successfully mitigate its foreign exchange exposures.
The Company is exposed to certain market risks associated with interest
rate fluctuations on its debt. All debt arrangements