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Table of Contents

SECURITIES AND EXCHANGE COMMISSION

Washington, D. C. 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 0R 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended      December 31, 2002

OR

o   TRANSITION REPORT PURSUANT TO SECTION 13 0R 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from                      to

Commission file number 0-18338

I-FLOW CORPORATION


(Exact Name of Registrant as Specified in Its Charter)
     
               Delaware   33-0121984

 
(State or Other Jurisdiction of
Incorporation or Organization)
  (IRS Employer Identification No.)
     
20202 Windrow Drive, Lake Forest, CA   92630

 
(Address of Principal Executive Offices)   (Zip Code)
     
Registrant’s telephone number, including area code:   (949) 206-2700

Securities registered pursuant to Section 12(b) of the Act: NONE

Securities registered pursuant to Section 12(g) of the Act: Common Stock, par value $0.001 per share

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes[X]       No[  ]

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

Indicate by check mark whether the registrant is an accelerated filer (as defined in Exchange Act Rule 12b-2).
Yes[  ]   No[X]

The aggregate market value of the common stock of the registrant held by non-affiliates as of June 28, 2002 (the last trading day of the second fiscal quarter) was $32,981,465, based on a closing price of $2.34 on the Nasdaq Stock Market on such day. The number of shares of the registrant’s common stock outstanding at March 10, 2003 was 15,507,254.

Information required by Part III of this report on Form 10-K is incorporated by reference to portions of the registrant’s definitive proxy statement for its 2003 Annual Meeting of Stockholders, which will be filed with the Securities and Exchange Commission within 120 days after the end of the registrant’s fiscal year ended December 31, 2002.


TABLE OF CONTENTS

PART I
Item 2. PROPERTIES
Item 3. LEGAL PROCEEDINGS
Item 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
PART II
Item 5. MARKET FOR REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
Item 6. SELECTED FINANCIAL DATA
Item 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Item 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
Item 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
PART III
Item 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT
Item 11. EXECUTIVE COMPENSATION
Item 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
Item 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
Item 14. CONTROLS AND PROCEDURES
PART IV
Item 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES, AND REPORTS ON FORM 8-K
SIGNATURES
INDEX TO EXHIBITS
EXHIBIT 10.12
EXHIBIT 21
EXHIBIT 23.1
EXHIBIT 99.1


Table of Contents

PART I

Item 1. BUSINESS

The Company

I-Flow Corporation (the “Company” or “I-Flow”) designs, develops, manufactures and markets technically advanced, low-cost ambulatory drug delivery systems that seek to redefine the standard of care by providing life enhancing, cost effective solutions for pain management and infusion therapy. The Company’s products are used in hospitals and other settings, including free-standing surgery centers and physicians’ offices.

Since it began in 1985, I-Flow Corporation has established a reputation in the medical and health care industry as an innovator in pain management and drug delivery technology. Through product innovation and strategic acquisitions, the Company has emerged as a leader in pain management, offering highly effective therapies for physicians and their patients. I-Flow’s suite of pain management products provides reliable and simple regional anesthesia techniques that eliminate many of the side effects customarily associated with narcotics and general anesthesia. Patients who use I-Flow’s pain management products generally recover more rapidly after surgery, which results in shorter hospital stays and reduced costs.

I-Flow currently manufactures a line of compact, portable infusion pumps, catheters, needles and pain kits that administer medication directly to the wound site as well as administer local anesthetics, chemotherapies, antibiotics, diagnostic agents, nutritional supplements and other medications. The Company has continued to introduce into the market reliable, lightweight, portable infusion pumps which enable patients to live ambulatory and, therefore, more productive lifestyles. I-Flow sells and distributes its products throughout the United States, Canada, Europe, Asia, Mexico, Brazil, Australia, New Zealand and the Middle East. InfuSystem, Inc., a wholly owned subsidiary of I-Flow Corporation, is primarily engaged in the rental of infusion pumps on a month-to-month basis for the cancer infusion therapy market. Spinal Specialties, Inc., another wholly owned subsidiary of I-Flow Corporation, is primarily engaged in the manufacturing and marketing of custom regional anesthesia kits with expanded capabilities in interventional radiology products.

The Company was incorporated in the State of California in July 1985. On July 30, 2001, the Company changed its state of incorporation to Delaware by merging into a wholly owned subsidiary incorporated in Delaware. The Company’s corporate offices are located at 20202 Windrow Drive, Lake Forest, California 92630. I-Flow’s telephone number is (949) 206-2700.

Acquisitions

On February 11, 1998, the Company acquired all of the outstanding stock of InfuSystems II, Inc. and Venture Medical, Inc. (collectively referred to as “InfuSystem”). InfuSystem is a leading ambulatory infusion pump management provider based in Madison Heights, Michigan. By delivering ambulatory pumps and the related disposables from a variety of manufacturers to private medical practices and clinics across the country, InfuSystem uses a distinctive approach to service the cancer infusion therapy market.

On January 14, 2000, the Company acquired all of the outstanding stock of Spinal Specialties, Inc. (“Spinal Specialties”), a designer and manufacturer of custom spinal, epidural and nerve block infusion kits based in San Antonio, Texas. Spinal Specialties provides a line of custom disposable products for chronic and acute pain management that are tailored to the specific needs of the hospital, anesthesiologist and pain clinic.

The Products

I-Flow offers health care professionals an array of cost-effective drug delivery devices designed to meet the needs of today’s managed care environment in hospital and alternate site settings. The I-Flow family of products is focused on three primary market segments – Regional Anesthesia, IV Infusion Therapy and Oncology Infusion Services.

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Regional Anesthesia

Chronic Pain Kits

This product line was created by I-Flow’s acquisition of Spinal Specialties, and it includes custom spinal, epidural, discogram and nerve block kits. These disposable products for chronic pain management are tailored to the specific needs of the anesthesiologist, hospital and pain management clinic. The spinal tray line can be combined with I-Flow’s infusion systems to create new products for managing acute and chronic pain. During 2002, Spinal Specialties introduced the OsteojectTM Bone Cement Delivery System.

Acute Pain Kits

The Acute Pain Kit product line includes the ON-Q® Post-Operative Pain Relief System, PainBuster® Pain Management System and C-blocTM Continuous Nerve Block System. I-Flow’s ON-Q and PainBuster Systems offer continuous wound site pain management, which is considered one of the most ideal treatments for post-operative pain. This approach represents a significant improvement over traditional methods of post-operative pain management. Because fewer narcotics are used, there are fewer side effects. I-Flow’s C-bloc technology combines the advantages of a custom nerve block kit with the added feature of a disposable infusion pump. Recent studies have shown that C-bloc, when used for continuous nerve block applications, significantly reduced pain scores and the use of narcotics for pain control following shoulder surgeries.

The Company’s SoakerTM Catheters (2.5” and 5” versions) were granted U.S. Food and Drug Administration permission for use for pain management of large surgical incisions in November 1999 and March 2000, respectively. The Soaker Catheter, which attaches to I-Flow’s diverse line of infusion systems, provides a continuous, even infusion of a non-narcotic, local anesthetic directly along incisions for post-operative pain management.

IV Infusion Therapy

Elastomerics

I-Flow’s product line of elastomeric pumps delivers medication from an elastic “balloon” that does not rely on gravity for proper delivery. These pumps are small enough to fit into a patient’s pocket or be clipped to a patient’s clothing. This easy-to-use technology provides the health care professional with a device that is both safe and simple enough for patients to use for self-administration of medication. These characteristics provide patients with better mobility and a quicker transition to rehabilitation. The Company’s elastomeric line of products can be used for antibiotic therapy, pain management medications, chemotherapy or other medications. Elastomeric products include the patented Homepump Eclipse®, the Homepump Eclipse “C” Series and the One-Step KVO.

Syringe Delivery Systems

I-Flow’s Syringe Delivery Systems are mechanical infusion devices designed to provide accurate intravenous push delivery from a syringe. The systems are cost-effective for both single and multiple doses and provide health care professionals with a safe and accurate alternative to gravity or IV push methods with a relatively easy learning curve for patients. I-Flow’s products in this class include the Medi-SIS 20™ and Medi-SIS 60™ Syringe Infusion Systems.

Non-Electric IV Bag Delivery Systems

I-Flow’s non-electric products provide a safe and easy-to-use system for controlled infusion. Pumps in this category are drug delivery systems that consist of a reusable mechanical infuser and specially designed administration sets. The pumps can provide precise delivery of medications requiring slow and continuous infusions. I-Flow’s products in this class include the Paragon® and Sidekick® ambulatory infusion pumps and the Rely-A-Flow® Gravity Set.

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Electronic Pumps

The Company’s ambulatory electronic infusion products include I-Flow VIP, with barcode features which can be used with VOICELINK® Remote Programming System. The VOICELINK System enables caregivers to monitor and program the devices for their patients with a touch-tone phone. The system is designed to provide accurate and safe remote programming and delivery of up to four individually customized protocols.

Oncology Infusion Services

InfuSystem provides ambulatory infusion pump systems and supplies to oncology offices and chemotherapy clinics. Pumps from a variety of manufacturers are offered to customers primarily on a rental basis. InfuSystem’s revenues are primarily derived from billings to third party insurers.

The Markets

The Company participates in three market segments: Regional Anesthesia, IV Infusion Therapy, and Oncology Infusion Services. Over the last three years, I-Flow significantly expanded its product line and distribution capabilities to establish itself as a leading participant in the regional anesthesia arena. Management believes that this expansion, coupled with the Company’s innovations in pain management and infusion technologies, has placed I-Flow in a position for future potential growth. The Company operates in two business segments: manufacturing and marketing medical infusion pumps; and rentals of medical infusion pumps. The rental business segment principally consists of the activities of InfuSystem, Inc. within the Oncology Infusion Services market segment. See Note 9 in Notes to Consolidated Financial Statements.

The hospital market for I-Flow’s simple, portable regional anesthesia technologies is currently virtually untapped. There are more than 60 million operative procedures performed in the U.S. every year. I-Flow estimates that its ON-Q® and PainBuster® systems could be used in at least 15 million of those procedures.

The alternate site health care industry has supported the need for ambulatory infusion devices. An ambulatory pump enables a patient to leave the hospital earlier, making it very attractive to cost-conscious hospitals and to patients who favor home treatment. I-Flow’s sales in the IV Infusion Therapy market include the Company’s intravenous elastomeric pumps, mechanical infusion devices and electronic infusion pumps and disposables.

The Company participates in the Oncology Infusion Services market through the activities of InfuSystem which provides infusion pump rentals and related disposable products, primarily for chemotherapy.

The following table sets forth a summary of the Company’s revenues by market segment, expressed as percentages of the total net revenues:

                         
Revenues by Market Segment   2002   2001   2000

 
 
 
Regional Anesthesia
    32 %     25 %     26 %
IV Infusion Therapy
    41 %     44 %     48 %
Oncology Infusion Services
    27 %     31 %     26 %

Competition

The drug infusion industry is highly competitive. The Company competes in this industry primarily based on price, service and product performance. Some of the competitors have significantly greater resources than the Company for research and development, manufacturing, marketing, and sales. As a result, they may be better able to compete for market share, even in areas in which the Company’s products may be superior. The industry is subject to technological changes and there can be no assurance that the Company will be able to maintain any existing technological advantage long enough to establish its products and to sustain profitability.

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The number of current competitors and the Company’s current estimated competitive position in terms of revenue for each of its product lines is noted in the table below.

                   
      Number of   Company's
      Known   Estimated Competitive
U.S. Market Description   Competitors   Position

 
 
Regional Anesthesia
               
 
Acute Pain Kits (Wound Site Pain Management)
    8       1  
 
Chronic Pain Kits
    10       7  
IV Infusion Therapy
               
 
Elastomerics
  3       1  
 
Non-electric Syringe Delivery Systems
    2       2  
 
Non-electric IV Bag Delivery Systems
    4       2  
 
Electronic Pumps
    7       7  

Sales and Distribution

The Company currently distributes its products in the United States through its internal sales force as well as through a number of national and regional medical product distributors. The Company relies on regional U.S. medical product distributors for approximately 7% of its revenue. There are no complete integrated contracts for the entire I-Flow product line with any of these distributors.

During 1998, the Company entered into an agreement with B. Braun Celsa SA (France), a manufacturer and distributor of pharmaceuticals and infusion products, to distribute I-Flow’s elastomeric infusion pumps in Western Europe, Eastern Europe, the Middle East, Asia Pacific, South America and Africa. For the years ended December 31, 2002, 2001 and 2000, sales to B. Braun Celsa SA accounted for 12%, 9%, and 7% of the Company’s total revenues, respectively. The Company entered into a separate agreement with B. Braun Medical, Inc., a national U.S. distributor, to distribute I-Flow’s elastomeric pumps to B. Braun Medical, Inc.’s full line IV Infusion Therapy customers in the United States. For each of the years ended December 31, 2002, 2001 and 2000, sales to B. Braun Medical, Inc., accounted for 6%, 9%, and 11% of the Company’s total revenues, respectively.

In May 1999, the Company entered into an agreement with dj Orthopedics LLC (formerly DonJoy, a division of Smith & Nephew, Inc.), a leading provider of orthopedic braces, to distribute the Company’s PainBuster® pain management system exclusively in the United States and Canada for orthopedic surgery applications. I-Flow’s PainBuster pain management system provides continuous infusion of a non-narcotic, local anesthetic directly into the intraoperative site for post-operative pain management. The agreement, as amended, called for dj Orthopedics to make minimum purchases through 2001 in order to maintain exclusive distribution rights. Under the terms of the agreement, dj Orthopedics’ exclusive right to sell into the orthopedic post-operative wound site pain management market converted into a non-exclusive right to sell into this market as of January 1, 2002. The agreement expires as of December 31, 2003.

In June 1999, the Company signed a distribution agreement with Ethicon Endo-Surgery, Inc., a Johnson & Johnson subsidiary, under which Ethicon Endo-Surgery became the exclusive distributor of I-Flow’s ON-Q® Post-Operative Pain Relief System for all surgical applications excluding orthopedics. The ON-Q® Post-Operative Pain Relief System infuses non-narcotic local anesthetics directly into the operative site, the patient’s primary source of post-operative pain. This multi-year agreement required Ethicon Endo-Surgery to meet minimum purchase commitments to maintain exclusive distribution rights. The agreement was terminated by mutual agreement in October 2001. Under the terms of the termination agreement, Ethicon Endo-Surgery ceased selling the ON-Q® Post-Operative Pain Relief System effective January 1, 2002. At that time, the Company regained exclusive U.S. distribution rights to the ON-Q® Post-Operative Pain Relief System, and began selling the products on a direct basis through I-Flow’s direct sales organization.

The Company sells several of its products into the international market and has signed agreements with distributors in various countries. Currently, the Company is selling its products through distributors in Canada, Brazil, the Benelux Countries, Germany, England, Ireland, Italy, Mexico, Spain, Korea, Australia, New Zealand and Israel.

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Aggregate revenues from countries outside of the United States represented approximately 24%, 22% and 22% of the Company’s total revenues for the years ended December 31, 2002, 2001 and 2000, respectively. The Company does not have any capital investments in any foreign operations except for its manufacturing plant in Mexico.

Total revenues attributable to each geographic area in which the Company has sales is as follows:

                         
Sales to unaffiliated customers:   2002   2001   2000

 
 
 
United States
  $ 29,117,000     $ 25,890,000     $ 24,870,000  
Europe
    7,236,000       5,897,000       5,153,000  
Asia
    1,095,000       987,000       1,295,000  
Other
    669,000       531,000       648,000  
All Foreign Countries in the Aggregate
    9,000,000       7,415,000       7,096,000  

The Company did not have a significant backlog of unfilled orders as of December 31, 2002 or December 31, 2001.

Manufacturing and Operations

A substantial portion of the Company’s products are manufactured by its Mexican subsidiary, Block Medical de Mexico, S.A. de C.V. (“Block”). This plant has been in operation since 1994 and has historically manufactured, and is currently manufacturing, all of the Company’s disposable IV Infusion Therapy devices and tubing sets. The Company currently intends to maintain the plant in Mexico and to manufacture a substantial portion of its products there. The Company regularly reviews the use of outside vendors for production versus internal manufacturing, analyzing factors such as the quality of the products received from vendors, the costs of the products, timely delivery and employee utilization.

Product Development

The Company has focused its product development efforts on products in pain relief and ambulatory infusion systems markets and, with the majority of its new products, it is expanding its market to include hospitals. In each of the years ended December 31, 2002, 2001 and 2000, the Company incurred expenses of approximately $2,104,000, $2,238,000 and $2,001,000, respectively, for product research and development.

Patents and Trademarks

The Company has filed U.S. patent applications for substantially all of its products. The total number of patents now held by the Company is approximately 40 and includes patents relating to both the On-Q Pain Relief System and Soaker catheter. The Company’s patents generally expire between 2009 to 2015, with the most significant patents expiring in 2009. The Company has also filed for intellectual property right protection in all foreign countries from which it derives significant revenue. In the opinion of management, there are no limitations on the Company’s intellectual property that would have a material adverse effect on the Company.

Copyrights have been obtained for the Vivus 4000® programming software. All of the Company’s product names are either registered trademarks or have trademark applications pending. There can be no assurance that pending patent or trademark applications will be approved or that any patents will provide competitive advantages for the Company’s products or will not be challenged or circumvented by competitors.

Regulations Governing the Company’s Products and Manufacturing Operations

I-Flow’s activities are regulated by the Food, Drug and Cosmetic Act (the “Act”). Under the Act, the Company is required, among other matters, to register its facilities and list its devices with the U.S. Food and Drug Administration (the “FDA”), to file notice of its intent to market new products under Section 510(K) of the Act, to track the location of certain of its products, and to report any incidents of death or serious injury relating to its products. To date, there have been no reportable conditions found during any FDA inspections. Failure to comply

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with any of these regulations can result in civil and criminal penalties being imposed upon the Company and/or the recall, seizure or injunction of products.

The State of California also has similar regulations. Each year the Company is subject to production-site inspections in order to maintain its manufacturing license. State regulations also specify the standards for the storage and handling of certain chemicals and disposal of their wastes.

The Company is required to comply with federal, state and local environmental laws. To date, there has been no significant environmental issue affecting the Company’s capital expenditures, earnings or competitive position and there is currently no significant use of hazardous materials in the manufacture of its products.

Products intended for export are subject to additional regulations, including compliance with ISO 9000. In May 1995, the Company received ISO 9001 certification, which indicates that I-Flow’s products meet specified uniform standards of quality and testing. The Company was also granted permission to use the CE mark on its products, which reflects approval of the Company’s products for export into 18 member countries of the European Community. In December 1996, the Block operations, including its Mexico facility, were added to the Company’s ISO certification and permission was granted to use the CE mark on the Block products.

Employees

As of March 1, 2003, the Company and its subsidiaries had a total of 188 full-time employees in the United States and an additional 194 employees in Mexico. None of the Company’s employees in the United States or Mexico are covered by a collective bargaining agreement. The Company considers its relationship with its employees to be good. From time to time, the Company also uses temporary employees. These temporary employees are usually engaged to manufacture the Company’s products.

Available Information

Our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and amendments to those reports filed with or furnished to the Securities and Exchange Commission pursuant to Section 13(a) or 15(d) of the Exchange Act of 1934, as amended, are available free of charge through our web site at www.i-flowcorp.com as soon as reasonably practicable after we electronically file or furnish the reports with or to the Securities and Exchange Commission

Item 2. PROPERTIES

The Company’s headquarters are located in Lake Forest, California, where the Company leases a 51,000 square foot building. The Company entered the lease in 1997 and it has a term of 10 years. The Company has the option to extend the lease for an additional five years, which the Company currently intends to exercise. The Company also leases a plant in Northern Mexico for the manufacture of ambulatory infusion devices. The current plant lease was entered into in 2000 and has a term of five years. The plant currently operates at approximately 60% of capacity. The Company’s Infusystem subsidiary rents a building in Madison Heights, Michigan on a month-to-month basis. Finally, the Company leases a building in San Antonio, Texas to manufacture the Spinal Specialties regional anesthesia devices. The lease was entered into in 2002 and has a term of three years. Management believes that the above properties provide the Company with sufficient space to continue to operate its business as currently conducted.

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Item 3. LEGAL PROCEEDINGS

As of March 1, 2003, the Company was involved in legal proceedings in the normal course of operations. Although the outcome of the proceedings cannot be determined, in the opinion of management any resulting future liability will not have a material adverse effect on the Company and its subsidiaries, taken as a whole.

Item 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS

There were no matters submitted to a vote of security holders during the three months ended December 31, 2002.

EXECUTIVE OFFICERS OF THE REGISTRANT

The following table sets forth information concerning the executive officers of the Company as of March 1, 2003. There are no family relationships between any of the executive officers or directors of the Company. The executive officers are chosen annually at the first meeting of the board of directors following the annual meeting of stockholders and, subject to the terms of any employment agreement, serve at the will and pleasure of the board of directors.

                 
Name   Age   Position

 
 
Donald M. Earhart
    58     President, Chief Executive Officer and
 
              Chairman of the Board
Henry Tsutomu Tai, Ph.D., M.D.
    59     Secretary and Director
 
James J. Dal Porto
    49     Executive Vice President, Chief Operating
 
              Officer and Director
James R. Talevich
    52     Chief Financial Officer and Treasurer

Donald M. Earhart has been Chairman of the Board since March 1991 and Chief Executive Officer since July 1990. Mr. Earhart joined the Company as President and Chief Operating Officer in June 1990. Mr. Earhart, who holds a Bachelor of Engineering degree from Ohio State University and a Masters Degree in Business Administration from Roosevelt University, has over 25 years experience in the medical products industry. Prior to joining the Company, from 1986 to 1990, Mr. Earhart was a Corporate Officer and the President of the Optical Division of Allergan, Inc. Prior to his employment at Allergan, he was a Corporate Officer and Division President of Bausch and Lomb and was an operations manager of Abbott Laboratories. He has also served as an engineering consultant at Peat, Marwick, Mitchell & Co. and as an engineer with Eastman Kodak Company.

Henry Tsutomu Tai, Ph.D., M.D. is the initial progenitor of the Company’s product and business concept in multiple-drug infusion systems and founding director. Dr. Tai has been on the board of directors since 1985, serving as Chairman from 1985 to 1988. Dr. Tai has been the Secretary of the Company since 1990. Dr. Tai has been a consultant in hematology and oncology since 1977. Dr. Tai holds a B.A. in Molecular Biology from Harvard University and a Ph.D. in Molecular Biology and an M.D. from the University of Southern California. He has done postdoctoral research in the molecular biology of tumor virus DNA at the Weizman Institute of Science in Israel and at the California Institute of Technology.

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James J. Dal Porto joined the Company in October 1989 to serve as Controller. Mr. Dal Porto was promoted to Treasurer in October 1990, to Vice President of Finance and Administration in March 1991, to Executive Vice President and Chief Financial Officer in March 1993, and to Chief Operating Officer in February 1994. Mr. Dal Porto served as Financial Planning Manager and Manager of Property Accounting and Local Taxation at CalComp, a high technology manufacturing company, from 1984 to 1989. Mr. Dal Porto holds a B.S. in Economics from the University of California, Los Angeles, and a M.B.A. from California State University, Northridge.

James R. Talevich joined the Company as its Chief Financial Officer in August 2000. Prior to joining I-Flow, he was Chief Financial Officer of Gish Biomedical, Inc., a publicly held medical device company, from 1999 to 2000 and Chief Financial Officer of Tectrix Fitness Equipment, a privately held manufacturing company, from 1995 to 1999. Prior to 1996, he held financial management positions with Mallinckrodt Medical, Inc., Sorin Biomedical, Inc., a medical products subsidiary of Fiat S.p.A., Pfizer, Inc., Sensormedics Corporation, a privately held medical device company, Baxter Travenol Laboratories, Inc., and KPMG Peat Marwick. Mr. Talevich holds a B.A. in Physics from California State University, Fullerton and a M.B.A. from the University of California at Los Angeles, and is a Certified Public Accountant.

PART II

Item 5. MARKET FOR REGISTRANT’S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS

Common Stock Information

The Company’s common stock trades on The Nasdaq Small Cap Market under the symbol “IFLO.” The table below sets forth the high and low sales prices of the Company’s common stock as reported by Nasdaq.

                         
            High   Low
           
 
2001                        
 
1st
Quarter   $ 2.81     $ 1.38  
 
2nd
Quarter   $ 3.20     $ 1.45  
 
3rd
Quarter   $ 3.50     $ 1.93  
 
4th
Quarter   $ 3.30     $ 2.10  
2002                        
 
1st
Quarter   $ 3.37     $ 2.59  
 
2nd
Quarter   $ 3.12     $ 2.00  
 
3rd
Quarter   $ 2.55     $ 1.14  
 
4th
Quarter   $ 1.89     $ 1.06  

American Stock Transfer & Trust Company is the Company’s transfer agent for its common stock. As of March 12, 2003, the Company had 387 shareholders of record and, based upon information received from nominee holders, the Company believes it has approximately 6,000 total beneficial holders. The Company has not paid, and does not currently expect to pay in the foreseeable future, cash dividends on its common stock.

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Equity Compensation Plan Information

The following table provides information, as of December 31, 2002, about compensation plans under which equity securities of the registrant are authorized for issuance:

                         
    Number of           Number of Shares of
    Shares of           Common Stock
    Common   Weighted -   Remaining Available
    Stock to be   Average   for Future Issuance
    Issued Upon   Exercise   Under the Company’s
    Exercise of   Price of   Stock Option Plans
    Outstanding   Outstanding   (excluding shares
    Options   Options   reflected in column 1)
   
 
 
Equity compensation plans approved by Stockholders
    4,463,921     $ 2.18       2,149,000  (1)
Stock option grants not approved by Stockholders
    40,000 (2)   $ 2.89        
Equity compensation plans not approved by Stockholders (3)
    73,500             301,500  
 
   
     
     
 
Total
    4,577,421     $ 2.19       2,450,500  
 
   
     
     
 

(1)   All options available for future grant are authorized under the Company’s 2001 Equity Incentive Plan.
(2)   Stock options for the purchase of 40,000 shares were granted by the board of directors as inducements to new hires.
(3)   2001 Restricted Stock Plan

Material Features of Non-Stockholder Approved Plan

      On December 4, 2001, the Company adopted a Restricted Stock Plan. The term of the plan is 10 years. The plan, as amended, provides for the issuance of up to 375,000 shares. The plan provides that the Company may, from time to time, grant shares of restricted stock to employees of the Company or one of its subsidiaries. Officers and employee-directors are not eligible to receive grants under the plan. The plan, and offers and sales of securities under the plan, are intended to meet the requirements of, and qualify under, Rule 506 promulgated under the Securities Act of 1933, as amended. Upon delivery of shares of restricted stock, the stockholder generally has, subject to the restrictions contained in his or her award agreement, all rights of a stockholder, including the right to vote and receive dividends, if any. Shares granted under the plan generally vest over a period of three years subject to accelerated vesting based upon the achievement of individual performance goals. The Company also has the right to repurchase shares if an employee’s employment is terminated in some circumstances. Shares of restricted stock may not be transferred unless and until the shares have been issued and all restrictions on the shares have lapsed, and such transfer is otherwise in compliance with federal and state securities laws. See Note 5 of Notes to Consolidated Financial Statements for additional information about the plan.

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Table of Contents

Item 6. SELECTED FINANCIAL DATA

The following selected consolidated financial data have been derived from the Company’s consolidated statements of operations for the years ended December 31, 2002, 2001 and 2000 and consolidated balance sheets as of December 31, 2002 and 2001 which are included herein and have been audited by Deloitte & Touche LLP, independent auditors. The Company’s consolidated statements of operations for the years ended December 31, 1999 and 1998 and the consolidated balance sheets as of December 31, 2000, 1999 and 1998 which are not included herein have also been audited by Deloitte & Touche LLP, independent auditors. The information set forth below is not necessarily indicative of the expectations of results for future operations and should be read in conjunction with the consolidated financial statements and notes thereto appearing elsewhere in this Annual Report on Form 10-K.

                                               
          Years Ended December 31,
(Amounts in thousands, except per share amounts)   2002   2001   2000   1999   1998

 
 
 
 
 
Consolidated Statements of Operations Data:(1)(2)(3)
                                       
Revenues:
                                       
 
Net product sales
  $ 27,824     $ 22,942     $ 23,497     $ 19,272     $ 17,006  
 
Rental income and other
    10,293       10,363       8,469       8,512       6,586  
 
Licensing fees
                      2,000        
 
 
   
     
     
     
     
 
   
Total revenues
    38,117       33,305       31,966       29,784       23,592  
Cost of revenues
    14,597       14,011       13,710       11,824       10,219  
 
 
   
     
     
     
     
 
Gross Profit
    23,520       19,294       18,256       17,960       13,373  
Operating expenses:
                                       
 
Selling and marketing
    12,324       5,504       5,115       4,193       4,178  
 
General and administrative
    8,336       9,385       8,150       7,604       5,834  
 
Product development
    2,104       2,238       2,001       1,710       1,507  
 
 
   
     
     
     
     
 
   
Total operating expenses
    22,764       17,127       15,266       13,507       11,519  
 
 
   
     
     
     
     
 
Operating income
    756       2,167       2,990       4,453       1,854  
 
Interest and other (income) expense, net
    (6 )     44       265       404       684  
 
 
   
     
     
     
     
 
Income before income taxes and cumulative effect of a change in accounting principle
    762       2,123       2,725       4,049       1,170  
 
Income tax provision (benefit)
    323       856       1,113       (4,763 )     69  
 
 
   
     
     
     
     
 
Net income before cumulative effect of a change in accounting principle
    439     $ 1,267       1,612       8,812       1,101  
 
 
   
     
     
     
     
 
Cumulative effect of a change in accounting principle
    (3,474 )                        
 
 
   
     
     
     
     
 
 
Net income (loss)
  $ (3,035 )     1,267     $ 1,612     $ 8,812     $ 1,101  
 
 
   
     
     
     
     
 
Net income per share before cumulative effect of a change in accounting principle:
                                       
 
Basic
  $ 0.03     $ 0.08     $ 0.11     $ 0.61     $ 0.08  
 
Diluted
  $ 0.03     $ 0.08     $ 0.10     $ 0.58     $ 0.08  
Loss per share from cumulative effect of a change in accounting principle
                                       
 
Basic
  $ (0.23 )   $     $     $     $  
 
Diluted
  $ (0.22 )   $     $     $     $  
Net income (loss) per share:
                                       
 
Basic
  $ (0.20 )   $ 0.08     $ 0.11     $ 0.61     $ 0.08  
 
Diluted
  $ (0.19 )   $ 0.08     $ 0.10     $ 0.58     $ 0.08  
 
 
   
     
     
     
     
 
 
Weighted-average common shares outstanding:
                                       
     
Basic
    15,368       15,231       15,002       14,387       13,479