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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 


 

FORM 10-K

 


 

FOR ANNUAL AND TRANSITION REPORTS PURSUANT TO SECTIONS 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

 

(Mark One)

x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the year ended December 31, 2003

 

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

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

 

27711 Diaz Road, P.O. Box 9020

Temecula, California

  92589
(Address of Principal Executive Offices)   (Zip Code)

 

(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  ¨    Not Applicable   x

 

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.    Yes  ¨    Not Applicable  x

 

Indicate by check mark whether the Registrant is an accelerated filer (as defined in Exchange Act Rule 12b-2).    Yes   ¨    No   x

 

As of March 16, 2004 the number of shares of Common Stock, $.01 par value, outstanding (the only class of common stock of the registrant outstanding) was 10,654,293. 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

 



Table of Contents

HUDSON RESPIRATORY CARE INC. AND SUBSIDIARIES

 

Year Ended December 31, 2003

 

TABLE OF CONTENTS

 

             Page

PART I

           1
    Item 1.  

Business

   1
    Item 2.  

Properties

   7
    Item 3.  

Legal Proceedings

   8
    Item 4.  

Submissions of Matters to a Vote of Security Holders

   8

PART II

           8
    Item 5.  

Market for Registrant’s Common Equity and Related Stockholder Matters

   8
    Item 6.  

Selected Financial Data

   9
    Item 7.  

Management’s Discussion and Analysis of Financial Condition and Results of Operations

   10
    Item 7A  

Quantitative and Qualitative Disclosure About Market Risk

   22
    Item 8.  

Financial Statements and Supplementary Data

   23
    Item 9.  

Changes in and Disagreements With Accountants on Accounting and Financial Disclosure

   24
    Item 9A  

Controls and Procedures

   25

PART III

           25
    Item 10.  

Directors and Executive Officers of the Registrant

   25
    Item 11.  

Executive Compensation

   27
    Item 12.  

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

   29
    Item 13.  

Certain Relationships and Related Transactions

   31
    Item 14.  

Principal Accounting Fees and Services

   32

PART IV

           32
    Item 15.  

Exhibits, Financial Statement Schedules and Reports on Form 8-K

   32

SIGNATURES

   S-1

 


Table of Contents

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 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 Operations” include forward-looking information and may reflect certain judgments 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. and its subsidiaries 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 and other factors 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, incentive breathing exercisers, endotracheal tubes, small volume 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, home health care agencies and the pre-hospital market. Internationally, the Company sells its products to distributors that market to hospitals and other health care providers. The Company’s products are sold to nearly 1,900 distributors and alternate site service providers and shipped to over 5,400 customer locations in more than 100 countries worldwide. The Company has supplied the disposable respiratory care market for over 58 years and is known for impeccable product quality, a strong brand name and leading market positions.

 

The Company manufactures and markets approximately 2,000 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 in the United States from its extensive relationships with leading group purchasing organizations (“GPOs”) and Integrated Delivery Networks (“IDNs”), as these types of organizations play an increasingly important role in hospitals’ purchasing decisions.

 

The Company maintains two manufacturing facilities and three distribution facilities in the United States, one manufacturing facility and one assembly operation in Mexico, an assembly and distribution facility in Malaysia and sales and marketing offices in the United States, Sweden, the United Kingdom, France and Germany.

 

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 completed a number of strategic acquisitions in order to expand its product line and geographic penetration. Most significantly, the July 1999 acquisition of Hudson RCI AB (formerly Louis Gibeck AB), a Swedish company that manufactures and markets heat moisture exchangers (“HMEs”) and filters under the Gibeck brand name, the November 1999 acquisition of Tyco’s Voldyne® incentive breathing exerciser product line and the October 2000 purchase of the SHERIDAN® endotraheal tube product line from Tyco. 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.

 

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Industry Overview

 

The Company breaks down the worldwide market for disposable respiratory care and anesthesia products into the U.S. Hospital market, the U.S. Alternate Site market and the international market. In the respiratory and anesthesia clinical areas, oxygen or an anesthetic agent is delivered 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 clinically desirable to humidify or medicate the gas prior to delivery to the patient. 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 clinical and economic value of single-use, disposable products.

 

The market for respiratory care and anesthesia products is also affected by trends involving the health care market in general. In particular, the overall trend towards cost containment and infection control has increased the desirability of disposable products relative to reusable products, and has influenced pricing, product utilization, 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 and reprocessing 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 reliable manufacturers with large, high quality product offerings and competitive pricing. In an effort to contain costs, service providers have consolidated and affiliated with GPOs, which take advantage of group buying power to obtain lower supply costs. 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 contracted GPO provider and strong relationships with distributors are critical to many health care manufacturers, the Company has 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 to include both the clinician and the administrator. As teams of clinicians, purchasing agents, materials managers and upper level administrative management become more involved in the purchasing decision, a greater emphasis will be placed on overall value (price/product features and clinical/patient benefits).

 

As a result of U.S. cost containment measures, health care is increasingly provided outside of traditional hospital settings through lower cost alternate health care sites, such as outpatient surgery centers, long-term care facilities, physician offices and patients’ homes. Growth of the U.S. 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.

 

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.

 

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The Company categorizes its products into four clinical product groups (i) oxygen therapy; (ii) airway management; (iii) humidification; and (iv) aerosol therapy. Although the Company’s sales efforts differ depending on the clinical use of its products, management focuses on geographic segments for strategic decision making.

 

Product Group


  

Description


Oxygen Therapy: oxygen masks, cannulae, oxygen tubing, prefilled and refillable humidifiers, oxygen regulators, cylinder carts and bases, oxygen analyzers/monitors, oxygen sensors, and adaptors and connectors.    Used to transport, regulate, deliver and analyze therapeutic, supplemental oxygen to a patient. Cylinder carts and bases are used to transport and stabilize oxygen cylinders. Regulators control the pressure and flow of oxygen from the primary gas source to the patient. Oxygen masks and nasal cannulae cover the nose and mouth or fit inside the nostrils and are connected to an oxygen source via small diameter tubing through which oxygen flows. Oxygen analyzers, monitors and sensors are utilized to measure and monitor the oxygen concentration being delivered to the patient. 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.
Airway Management: oral airways, SHERIDAN® endotracheal tubes, Voldyne® incentive breathing exercisers (IBEs), disposable and re-useable resuscitation bags, hyperinflation bags, breathing bags, air cushion masks, anesthesia circuits, filters and Ventilarm® monitors.    Used to secure and maintain an open airway and unobstructed breathing passage; convey an oxygen/air mixture and/or anesthetic gas from a mechanical ventilator, anesthesia gas machine to a patient; artificially support ventilation during resuscitative efforts; and measure and monitor airway pressure.
Humidification: ConchaTherm® heated humidifiers and accessories, Humid-Heat® system and accessories, Concha® water, ConchaPak®, Aqua+® and Humid-Vent® HMEs, volume ventilator circuits, heated wire circuits, neonatal CPAP and CPAP heated humidifiers.    Heated humidification systems actively heat and humidify oxygen/air mixtures or anesthetic gases provided by a mechanical ventilator or anesthesia gas machine or other gas source. Heat Moisture Exchangers (HMEs) passively conserve the heat and humidity in the patient’s exhaled breath for use during inspiration. Breathing filters are used to protect patients, caregivers and medical equipment from cross-contamination with bacteria and viruses. The infant CPAP system provides non-invasive respiratory support to premature infants with under-developed, immature lungs.
Aerosol Therapy: AquaTherm® and ThermaGard® nebulizer heaters, aerosol masks, prefilled and refillable large volume nebulizers, aerosol tubing, unit dose solutions, small volume nebulizers, peak flow meters, spacers/changers and compressor accessories.    Used to create and deliver aerosolized particles of liquid water, sodium chloride or medication solutions 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. Spacers/Chambers are used as an adjunct to metered dose inhaler therapy to facilitate optimal treatment effectiveness.

 

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The Company’s percentage of sales by product group for the years ending December 31, 2003, 2002 and 2001 is as follows:

 

     Year Ended

 
    

December 31,

2003


   

December 31,

2002


   

December 31,

2001


 

Oxygen Therapy

   29.4 %   32.1 %   32.6 %

Airway Management

   25.5     28.1     29.2  

Humidification

   24.3     23.5     21.6  

Aerosol Therapy

   20.8     16.3     16.6  
    

 

 

     100.0 %   100.0 %   100.0 %
    

 

 

 

Sales, Marketing and Distribution

 

The Company’s main focus for operational management and strategic decisions is based on geographic segments. These are defined as the United States and European operations, each having their own, distinct management team.

 

The Company has sales offices in California, Sweden, Germany, France and the United Kingdom and two distribution facilities in the United States, one in Europe and one in Malaysia. Additionally, the Company contracts with a third-party distribution facility in Charlotte, North Carolina. The Company also employs sales managers in Thailand, China, Mexico, Chile and Australia. While a majority of the Company’s U.S. Hospital sales logistically moves through 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. Internationally, the Company sells its products to distributors that market to hospitals and other health care providers. See Note 9 to “Item 8. Financial Statements” for information with respect to international sales. The Company’s U.S. sales personnel currently call on approximately 5,300 hospitals and surgery centers, over 50 hospital distributors and over 1,100 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 changed to include the clinician, a purchasing manager or corporate executive.

 

In the current U.S. Hospital market environment, GPO and Integrated Delivery Network (“IDN”) relationships are an essential part of access to the Company’s target markets and the Company has entered into preferred supplier arrangements with eight 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 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 three of its major GPOs, Novation LLC, Consorta and HealthTrust Purchasing Group. The Company’s most significant GPO relationships are with Novation LLC, HealthTrust Purchasing Group, AmeriNet Inc., Consorta, Broadlane and Med Assets.

 

Health care providers have responded to pressures to reduce their costs by merging with other facilities, which make up the care continuum. Changes to the Company’s customer base may result 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 and web site 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 depreciation of the heater cost.

 

The Company utilizes a network of over 50 hospital distributors, as well as over 1,100 alternate site distributors and end-users, to reach its markets. The Company has been selected as the FOCUS preferred vendor of respiratory disposables for Owens & Minor Inc. Such status provides some competitive advantage to the Company’s products versus competing product lines. Owens & Minor Inc. is the Company’s largest distributor, accounting for approximately $35.9 million or approximately 19.4% of total 2003 net sales, $32.7 million or approximately 19.1% of total 2002 net sales and $30.4 million or 19.4% of total 2001 net sales. The Company provides a price list to its distributors which details base acquisition prices. Distributors receive orders from the healthcare 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

 

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the industry, the Company rebates the difference between base acquisition price and the specific contract price to the distributor. The Company’s international distributors outside of the European Union (“EU”), Middle East and Africa place their orders directly with dedicated international customer service representatives. Customer orders are shipped from one of two warehouse locations. Sales strategies and marketing plans are tailored to each specific country and clinical product group. Region and territory sales managers are responsible for the launch of products into their markets, including related support and training. The Company utilizes a network of approximately 120 international distributors, typically on an exclusive basis by product group or market/country. Customers within Europe, the Middle East and Africa are serviced by the Company’s Sweden office.

 

Manufacturing and Assembly

 

The Company operates two manufacturing facilities in the United States, one in Tecate, Mexico 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 operates 71 injection molding machines. During the past several years, many of the machines have been replaced with more efficient models, which have increased capacity. Tubing is produced on 11 extrusion lines: six corrugated, four vinyl and one repellitizer/regrinder. The Temecula facility uses approximately 19 million pounds of over 30 different kinds of resin annually; the most prominent are PVC, polyethylene, polypropylene and polystyrene. Sterile prefilled humidification and nebulization products are manufactured using nine blow/fill/seal machines in the Company’s facility in Arlington Heights, Illinois. The Company has planned to purchase an additional three machines to expand the capacity of the Arlington Heights facility.

 

The Company has completed the relocation of the SHERIDAN® endotracheal tubes product line from Argyle, New York to Tecate, Mexico. Furthermore, the Voldyne® IBE product line was moved from Temecula, California to Tecate, Mexico. The Tecate facility currently operates four extrusion lines, four blow molding machines, seven assembly lines and three packaging machines for the endotracheal product line. In addition, Tecate has three IBE work cells that consist of blow molding, assembly and packaging machines.

 

The Company’s facility located in Ensenada, Mexico is primarily used for the assembly of certain products molded and/or extruded at the Temecula facility. Each of the Tecate and the Ensenada facilities 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 HME and filter products marketed by the Company. The components assembled by the Malaysian operation are generally molded by outside vendors in Malaysia.

 

The Company monitors the quality of its products at its manufacturing 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 Food and Drug Administration (“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, Arlington Heights, Kuala Lumpur, Tecate and Ensenada. Certain Arlington Heights products are manufactured in a sterile environment and are certified sterile as a result of the production process. The Ensenada, Tecate, Temecula, Sweden and Arlington Heights facilities are certified as ISO 9001 and ISO 13485 compliant and the Kuala Lumpur facility is certified as ISO 9002 compliant.

 

Suppliers and Materials

 

The Company’s primary raw materials are various resins, which are formed into the Company’s products. The top 10 purchased products in 2003 were tubing grade PVC, LDPE-EVA, mask grade PVC, polystyrene, polypropylene, clear PVC, manual resuscitators, elastic, bag material and aerosol pocket chambers. The Company believes that it is able to purchase materials at a cost no higher than its competitors. The Company believes that sufficient availability exists for its raw materials, as they consist of mainly readily available plastic resins.

 

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Research and Development

 

The Company believes product development and innovation are an essential part of its continued success. The Company focuses on developing new products, design enhancements to existing products and process improvements to its manufacturing operations. Manufacturing, sales, marketing and clinical expertise is incorporated into the research and development process. This expertise is expected to continue to be performed by internal staff for the foreseeable future, however external expertise is utilized as necessary.

 

The Company develops new products to expand its product line in anticipation of changes in demand. Significant advances to humidification products introduced include; CONCHATHERM® IV Plus heated humidifier for respiratory support, CONCHATHERM® 2000 heater humidifier for the sleep apnea market, and a first of its kind active humidification system, Humid-Heat®, which incorporates the desired features of passive and active humidification for respiratory support. Complementing its new active humidifier, the Company recently introduced an enhanced line of heated wire ventilator circuits, a nebulizer adaptor (NebTee) to allow in-line nebulization of medication without contamination, the patient-ventilator system and a series of flexible adaptors and connectors for respiratory care and anesthesia.

 

As of December 31, 2003, the Company’s research and development department consisted of 20 people including engineers, scientists and technicians. The Company incurred research and development expenses of $3.2 million, $2.6 million and $2.0 million in 2003, 2002 and 2001, respectively.

 

Competition

 

The global medical supply industry is highly fragmented and characterized by intense competition. Many of the products manufactured by the Company are available from several sources and many of the Company’s customers have relationships with several manufacturers. Competition in the international market includes both local and global manufacturers. The Company’s primary competitor in the U.S. respiratory care sector is Cardinal Health (formerly, Allegiance Healthcare) and its primary competitors in the anesthesia sector include Tyco, Smiths Industries Medical Systems, Inc. (“SIMS”) and Vital Signs, Inc. The Company competes on the basis of brand name, product design, quality, breadth of product line, service and price.

 

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 seek and obtain intellectual property rights on concepts, processes and trademarks when appropriate. The Company has 17 active utility patents and several design patents in the United States with the majority of the patents maintained in other countries. One patent expires in 2007, three expire in 2008 and the remaining patents expire between 2010 and 2019. The Company has over 60 well recognized and accepted registered trademarks in the United States, which are also recognized in other countries in which the Company manufactures, distributes or sells its products.

 

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. Most of the Company’s products are subject to government regulation in the United States and other countries. In the United States, the Food, Drug and Cosmetic (“FD&C “) Act and other statutes and regulations govern or influence the testing, manufacture, safety, labeling, storage, record keeping, marketing, advertising and promotion of such products. Under the FD&C 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. Foreign sales are subject to similar requirements.

 

The Company is required to comply with pertinent sections of the Code of Federal Regulations, 21CFR GMP/QSR, 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 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

 

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the Company has increased its manufacturing operations. The Company’s suppliers, including contract sterilization facilities, are also subject to similar governmental requirements. The FDA also has the authority to issue special controls for devices manufactured by the Company.

 

The Company is also subject to numerous federal, state and local laws and regulations relating to such matters as safe working conditions, business licenses, 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.

 

Employees

 

As of March 16, 2004, the Company employed 2,174 employees in the United States and abroad, substantially all of whom were full-time employees. None of the Company’s employees are represented by unions and the Company considers its employee relations to be good.

 

Where You Can Find More Information

 

Although the Company is not subject to the reporting requirements of the Securities and Exchange Act of 1934, the Company files periodic reports with the Securities and Exchange Commission (“SEC”). You may read and copy the periodic reports that the Company has filed or may file in the future at the SEC’s public reference facility at 450 Fifth Street, NW, Washington, D.C. 20549. Please call the SEC at 1-800-SEC-0330 for further information on the public reference room. The SEC maintains a web site that contains periodic reports and other information regarding the registrants that file electronically with the SEC at http://www.sec.gov.

 

Item 2. Properties

 

The Company owns or leases its manufacturing, office and warehouse facilities. The Company’s major facilities and their primary uses are summarized below:

 

     Square Feet

   Owned/Leased

   Lease Expiration

United States:

              

Temecula, California (Headquarters, offices)

   26,000    Owned     

Temecula, California (manufacturing)

   119,000    Owned     

Temecula, California (distribution)

   99,000    Leased    November 2005

Arlington Heights, Illinois (manufacturing)

   94,000    Leased    May 2010

Elk Grove, Illinois (distribution)

   73,000    Leased    May 2010

International:

              

Ensenada, Mexico (manufacturing)

   97,000    Owned     

Tecate, Mexico (manufacturing)

   90,200    Leased    March 2005

Stockholm, Sweden (Headquarters, offices)

   16,500    Leased    October 2006

Ashby de la Zouch, U.K. (sales office)

   3,850    Leased    May 2006

Lyon, France (sales office)

   3,080    Leased    April 2005

Lohmar, Germany (sales office)

   2,255    Leased    April 2005

Kuala Lumpur, Malaysia (manufacturing)

   33,300    Leased    July 2004

 

The Company owns approximately 10 acres of land in Temecula, California on which its headquarters and a manufacturing center are located. The Company owns the Ensenada facility and the underlying land is held in a 30 year trust that expires in August 2019.

 

The Company believes that its present facilities are suitable and adequate for its current and presently anticipated future needs.

 

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Item 3. Legal Proceedings

 

The Company is not a party to any material lawsuits or other proceedings, including suits relating to product liability and/or patent infringement. While the results of the Company’s other existing legal matters and 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

 

On October 2, 2003, the holders of a majority of the outstanding 11 1/2% Senior PIK Preferred Stock of the Company (the “Senior Preferred Stock”), 12% Junior Convertible Preferred Stock of the Company (the “Junior Preferred Stock”) and Common Stock, each class voting separately, by written consent, approved an amendment to the Certificate of Determination for the Senior Preferred Stock to extend the time period in which the Company may pay dividends in kind on the Senior Preferred Stock through and including April 15, 2005. 470,307 shares of Senior Preferred Stock, all of shares of Junior Preferred Stock and 8,654,293 shares of Common Stock consented to the amendment.

 

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. As of March 16, 2004, all of the outstanding Common Stock of the Company is held by two holders of record, Holding and the shareholder of the Company prior to the recapitalization.

 

The Company issued non-qualified options to purchase an aggregate of 800,000 and 3,550,000 shares of Common Stock in 2003 and 2002, respectively, to its officers, directors and employees under the Company’s 2001 Nonqualified Stock Option Plan. The issuances were exempt from the registration requirements of the Securities Act either by virtue of (i) an exemption provided by Rule 701 promulgated under the Securities Act or (ii) a “no sale” theory under Section 5 of the Securities Act, since none of the optionees provided any consideration for the grants (the sale of the underlying option shares occurs only when the option is exercised and the purchase price for the shares is paid to the Company).

 

In May 2002, the Company and HRC Holding issued debt securities to certain of the Company’s shareholders for an aggregate cash consideration of $20.0 million. As additional consideration for the issuance of the debt securities, the Company issued warrants to purchase an aggregate of 20 million shares of its Common Stock to the holders of the debt securities. The Company relied on Section 4(2) of the Securities Act as a transaction by an issuer not involving a public offering in issuing the securities as the purchasers were sophisticated and shareholders of the Company or Holding.

 

In October 2002, HRC Holding issued debt securities to certain of the Company’s shareholders for an aggregate cash consideration of $2.1 million. As additional consideration for the issuance of the debt securities, the Company issued warrants to purchase an aggregate of 2.1 million shares of its Common Stock to the holders of the debt securities. The Company relied on Section 4(2) of the Securities Act as a transaction by an issuer not involving a public offering in issuing the securities as the purchasers were sophisticated and shareholders of the Company or Holding.

 

No underwriter was employed with respect to any sales of securities of the Company in the transactions described above. No commissions or fees were paid with respect to any such sales.

 

The Company has not paid cash dividends to its shareholders in the past two years, and does not intend to pay cash dividends to its shareholders 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.

 

See “Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters – Equity Compensation Plan Information.”

 

8


Table of Contents

Item 6. Selected Financial Data

 

The following table sets forth selected consolidated financial and operating data as of and for each of the five fiscal years ended December 31, 2003, 2002, 2001, 2000 and 1999. Financial data as of and for each of the five years in the period ended December 31, 2003, were derived from the Company’s audited consolidated financial statements and notes thereto. All the data should be read in conjunction with “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and the Company’s audited consolidated financial statements and notes thereto included elsewhere in this Report.

 

     Year

 
     2003

    2002

    2001

    2000

    1999

 
     (dollar amounts in thousands)  
Operating Data:         

Net sales

   $ 184,595     $ 171,959     $ 158,068     $ 159,278     $ 128,803  

Cost of sales

     102,610       102,511       109,010       84,923       75,418  
    


 


 


 


 


Gross profit

     81,985       69,448       49,058       74,355       53,385  

Operating expenses:

                                        

Selling expenses

     20,964       20,370       20,337       18,262       13,122  

Distribution expenses

     10,177       9,174       10,588       10,109       4,647  

General and administrative expenses

     19,387 (a)     18,549 (c)     30,205 (e)     27,343 (g)     14,732 (h)

Impairment of goodwill

     —         —         33,128 (f)     —         —    

Impairment of fixed assets

     —         —         4,469 (f)     —         —    

Research and development expenses

     3,236       2,578       2,043       2,387       2,031  
    


 


 


 


 


Operating income (loss)

     28,221       18,777       (51,712 )     16,254       18,853  
    


 


 


 


 


Other (income) and expenses:

                                        

Interest expense

     24,612 (b)     20,875       20,542       21,089       17,263