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1
+ Item 1. Business
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+ General
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+ NIKE, Inc. was
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+ incorporated in 1968 under the laws of the state of Oregon. As used in this report, the terms “we”, “us”, “NIKE” and the “Company” refer to NIKE, Inc. and its predecessors, subsidiaries and affiliates, unless
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+ the context indicates otherwise. Our Internet address is www.nike.com . On our NIKE Corporate web site, located at www.nikebiz.com , we post the following filings as soon as reasonably practicable after they are electronically filed with
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+ or furnished to the Securities and Exchange Commission: our annual report on Form 10-K, our quarterly reports on Form 10-Q, our current reports on Form 8-K and any amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of
7
+ the Securities and Exchange Act of 1934. All such filings on our NIKE Corporate web site are available free of charge. Also available on the NIKE Corporate web site are the charters of the committees of our board of directors, as well as our
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+ corporate governance guidelines and code of ethics; copies of any of these documents will be provided in print to any shareholder who submits a request in writing to NIKE Investor Relations, One Bowerman Drive, Beaverton, Oregon 97005-6453.
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+ Our principal business activity is the design, development and
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+ worldwide marketing of high quality footwear, apparel, equipment, and accessory products. NIKE is the largest seller of athletic footwear and athletic apparel in the world. We sell our products to retail accounts and through a mix of independent
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+ distributors, licensees and subsidiaries in over 120 countries around the world. Virtually all of our products are manufactured by independent contractors. Virtually all footwear and apparel products are produced outside the United States, while
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+ equipment products are produced both in the United States and abroad.
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+ Products
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+ NIKE’s athletic
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+ footwear products are designed primarily for specific athletic use, although a large percentage of the products are worn for casual or leisure purposes. We place considerable emphasis on high quality construction and innovative design for men, women
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+ and children. Running, basketball, children’s, cross-training and women’s shoes are currently our top-selling product categories and we expect them to continue to lead in product sales in the near future. However, we also market shoes
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+ designed for outdoor activities, tennis, golf, soccer, baseball, football, bicycling, volleyball, wrestling, cheerleading, aquatic activities, hiking, and other athletic and recreational uses.
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+ We sell active sports apparel covering most of the above categories,
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+ athletically inspired lifestyle apparel, as well as athletic bags and accessory items. NIKE apparel and accessories are designed to complement our athletic footwear products, feature the same trademarks and are sold through the same marketing and
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+ distribution channels. We often market footwear, apparel and accessories in “collections” of similar design or for specific purposes. We also market apparel with licensed college and professional team and league logos.
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+ We sell a line of performance equipment under the NIKE ® brand name, including sport balls, eyewear, skates,
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+ bats, gloves, and other equipment designed for sports activities. We also have agreements for licensees to produce and sell NIKE brand swimwear, women’s sports bras, cycling apparel, maternity exercise wear, children’s clothing, school
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+ supplies, timepieces, and electronic media devices. We also sell small amounts of various plastic products to other manufacturers through our wholly-owned subsidiary, NIKE IHM, Inc. and plastic injected and metal products to other manufacturers
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+ through our wholly-owned subsidiary, BAUER Italia S.p.A.
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+ We
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+ sell a line of dress and casual footwear, apparel and accessories for men and women under the brand names Cole Haan ® , g Series © , and Bragano © through our wholly-owned subsidiary, Cole Haan Holdings Incorporated, headquartered in Yarmouth, Maine.
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+ 2
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+ Table of Contents
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+ Our wholly-owned subsidiary, Bauer NIKE Hockey Inc., headquartered in Greenland, New Hampshire,
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+ manufactures and distributes ice skates, skate blades, in-line roller skates, protective gear, hockey sticks, hockey jerseys, licensed apparel and accessories under the Bauer ® and NIKE ® brand names. Bauer also offers a full selection of products for street and roller hockey.
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+ Our wholly-owned subsidiary Hurley International LLC, headquartered in Costa Mesa, California, designs and distributes a
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+ line of action sports apparel for surfing, skateboarding, and snowboarding, and youth lifestyle apparel and footwear under the Hurley ® brand name.
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+ On September 4, 2003, the Company purchased Converse Inc., headquartered in North Andover, Massachusetts, which designs and distributes athletic and
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+ casual footwear, apparel, and accessories under the Converse ® , Chuck Taylor ® , All
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+ Star ® , One Star ® , and Jack Purcell ® brand names.
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+ Sales and Marketing
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+ Financial
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+ information about geographic and segment operations appears in Note 17 of the consolidated financial statements on page 57.
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+ We experience moderate fluctuations in aggregate sales volume during the year. However, the mix of product sales may vary considerably from time to time
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+ as a result of changes in seasonal and geographic demand for particular types of footwear, apparel, and equipment.
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+ Because NIKE is a consumer products company, the relative popularity of various sports and fitness activities and changing design trends affect the demand
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+ for our products. We must therefore respond to trends and shifts in consumer preferences by adjusting the mix of existing product offerings, developing new products, styles and categories, and influencing sports and fitness preferences through
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+ aggressive marketing. This is a continuing risk. Failure to timely and adequately respond could have a material adverse affect on our sales and profitability.
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+ United States Market
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+ During
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+ fiscal 2004, sales in the United States (including U.S. sales of Cole Haan, Bauer NIKE Hockey, Hurley, NIKE Golf, and Converse) accounted for approximately 47 percent of total revenues, compared to 49 percent in fiscal 2003 and 53 percent in fiscal
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+ 2002. We sell to approximately 28,000 retail accounts in the United States. The NIKE brand domestic retail account base includes a mix of footwear stores, sporting goods stores, athletic specialty stores, department stores, skate, tennis and golf
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+ shops, and other retail accounts. During fiscal year 2004, our three largest customers accounted for approximately 26 percent of NIKE brand sales in the United States excluding sales from NIKE Golf and Bauer NIKE Hockey, and 23 percent of total
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+ sales in the United States.
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+ We make substantial use of our
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+ “futures” ordering program, which allows retailers to order five to six months in advance of delivery with the commitment that 90 percent of their orders will be delivered within a set time period at a fixed price. In fiscal year 2004, 90
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+ percent of our U.S. wholesale footwear shipments (excluding Cole Haan, Bauer NIKE Hockey, Hurley, NIKE Golf, and Converse) were made under the futures program, compared to 91 percent in fiscal 2003 and 92 percent in fiscal 2002. In fiscal 2004 and
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+ 2003, 67 percent of our U.S. wholesale apparel shipments (excluding U.S. licensed team apparel, Cole Haan, Bauer NIKE Hockey, Hurley, NIKE Golf and Converse) were made under the futures program, compared to 69 percent in 2002.
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+ 3
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+ Table of Contents
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+ We utilize 21 NIKE sales offices to solicit sales in the United States. We also utilize 10 independent
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+ sales representatives to sell specialty products for golf, cycling, water sports and outdoor activities. In addition, we operate the following retail outlets in the United States:
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+ U.S. Retail Stores
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+ Number
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+ NIKE factory stores (which carry primarily B-grade and closeout merchandise)
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+ 78
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+ NIKE stores (including NIKE Women Stores)
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+ 5
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+ NIKETOWNs (designed to showcase NIKE products)
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+ 13
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+ Employee-only stores
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+ 4
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+ Cole Haan stores (including factory and employee stores)
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+ 65
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+ Total
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+ 165
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+ NIKE’s domestic
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+ distribution centers for footwear are located in Wilsonville, Oregon, Memphis, Tennessee, and Greenland, New Hampshire. Apparel and equipment products are shipped from our Memphis, Tennessee, Tigard, Oregon, and Foothill Ranch, California
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+ distribution centers. Cole Haan and Bauer NIKE Hockey products are distributed primarily from Greenland, New Hampshire, Converse products are shipped from Ontario and Fontana, California, and Hurley products are shipped from Costa Mesa, California.
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+ International Markets
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+ We sell our
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+ products in over 120 countries outside of the United States through retail accounts, independent distributors, licensees, subsidiaries and branch offices. Non-U.S. sales (including Non-U.S. sales of Cole Haan, Bauer NIKE Hockey, Hurley, NIKE Golf,
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+ and Converse) accounted for 53 percent of total revenues in fiscal 2004, compared to 51 percent in fiscal 2003 and 47 percent in fiscal 2002. We operate 23 distribution centers in Europe, Asia, Australia, Latin America, Africa and Canada, and also
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+ distribute through independent distributors and licensees. We estimate that we sell to more than 23,000 retail accounts outside the United States, excluding sales by independent distributors and licensees. In many countries and regions, including
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+ Japan, Canada, Asia, some Latin American countries, and Europe, we have a futures ordering program for retailers similar to the United States futures program described above. NIKE’s three largest customers outside of the U.S. accounted for
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+ approximately 13 percent of non-U.S. sales.
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+ We operate the
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+ following retail outlets outside the United States:
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+ Non-U.S. Retail Stores
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+ Number
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+ NIKE factory stores
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+ 126
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+ NIKE stores and employee-only stores
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+ 2
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+ NIKETOWNs
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+ 2
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+ Cole Haan stores (including factory and employee stores)
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+ 35
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+ Total
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+ 165
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+ International branch
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+ offices and subsidiaries of NIKE are located in Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, Indonesia, India, Ireland, Israel, Italy, Japan,
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+ Korea, Lebanon, Malaysia, Mexico, New Zealand, The Netherlands, Norway, Peoples Republic of China, The Philippines, Poland, Portugal, Russia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand,
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+ Turkey, the United Kingdom, and Vietnam.
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+ 4
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+ Table of Contents
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+ Orders
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+ Worldwide futures orders
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+ for NIKE brand athletic footwear and apparel, scheduled for delivery from June through November 2004, were $5.6 billion compared to $5.0 billion for the same period last year. Based upon historical data, we expect that approximately 95 percent of
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+ these orders will be filled in that time period, although some orders may be cancelled. Futures orders are not necessarily indicative of future sales trends. This is because the mix of orders can shift between advance/futures and at-once orders. In
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+ addition, exchange rate fluctuations as well as differing levels of order cancellations can cause differences in the comparisons between futures orders and actual revenues. Moreover, a significant portion of our revenue is not derived from futures
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+ orders, including wholesale sales of equipment, U.S. licensed team apparel, Bauer NIKE Hockey, Cole Haan, Converse, NIKE Golf, Hurley, and retail sales across all brands.
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+ Product Research and Development
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+ We believe that our research and development efforts are a key factor in our past and future success. Technical innovation in the design of footwear, apparel, and athletic equipment receive continued emphasis as NIKE strives to produce
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+ products that reduce injury, aid athletic performance and maximize comfort.
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+ In addition to NIKE’s own staff of specialists in the areas of biomechanics, exercise physiology, engineering, industrial design and related fields, we also utilize research committees and advisory boards made up
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+ of athletes, coaches, trainers, equipment managers, orthopedists, podiatrists and other experts who consult with us and review designs, materials and concepts for product improvement. Employee athletes wear-test and evaluate products during the
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+ design and development process.
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+ Manufacturing
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+ Virtually all of
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+ our footwear is produced outside of the United States. In fiscal 2004, contract suppliers in China, Indonesia, Vietnam, and Thailand manufactured 36 percent, 24 percent, 22 percent, and 16 percent of total NIKE brand footwear, respectively. We also
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+ have manufacturing agreements with independent factories in Argentina, Brazil, India, Mexico, and South Africa to manufacture footwear for sale primarily within those countries. Our largest single footwear supplier accounted for approximately 7
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+ percent of total fiscal 2004 footwear production.
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+ Almost all
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+ of NIKE brand apparel production for sale to the United States market was manufactured outside of the United States by independent contract manufacturers located in 37 countries. Most of this apparel production occurred in Bangladesh, China, Greece,
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+ Honduras, India, Indonesia, Malaysia, Mexico, Pakistan, The Philippines, Sri Lanka, Taiwan, Thailand, and Turkey. All of our apparel production for sale to the international market was manufactured outside the U.S. Our largest single apparel
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+ supplier accounted for approximately 5 percent of total fiscal 2004 apparel production.
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+ The principal materials used in our footwear products are natural and synthetic rubber, plastic compounds, foam cushioning materials, nylon, leather, canvas, and polyurethane films used to make AIR-SOLE cushioning
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+ components. NIKE IHM, Inc., a wholly-owned subsidiary of NIKE, is our sole supplier of the AIR-SOLE cushioning components used in footwear. The principal materials used in our apparel products are natural and synthetic fabrics and threads, plastic
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+ and metal hardware, and specialized performance fabrics designed to repel rain, retain heat, or efficiently transport body moisture. NIKE and its contractors and suppliers buy raw materials in bulk. Most raw materials are available in the countries
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+ where manufacturing takes place. We have thus far experienced little difficulty in satisfying our raw material requirements.
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+ Since 1972, Sojitz Corporation of America (“Sojitz America”) and its predecessor, Nissho Iwai American Corporation, a subsidiary of Nissho Iwai
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+ Corporation, a large Japanese trading company that recently merged with Nichimen Corporation, have performed significant import-export financing services for us. Currently, Sojitz
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+ 5
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+ Table of Contents
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+ America provides such financing services with respect to at least 80% of the NIKE products sold outside of the United States, Europe and Japan. Approximately
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+ 12% of NIKE products are sold outside of the United States, Europe and Japan. Any failure of Sojitz America to provide these services or any failure of Sojitz America’s banks could disrupt our ability to acquire products from our suppliers and
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+ to deliver products to our customers outside of the United States, Europe and Japan. Such a disruption could result in cancelled orders that would adversely affect sales and profitability. However, we believe that any such disruption would be short
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+ term in duration due to the ready availability of alternative sources of financing at competitive rates. Our current agreements with Sojitz America expire on May 31, 2005.
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+ International Operations and Trade
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+ Our international operations and sources of supply are subject to the usual risks of doing business abroad, such as possible revaluation of currencies, export duties, anti-dumping duties, quotas, safeguard measures, trade restrictions,
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+ restrictions on the transfer of funds and, in certain parts of the world, political instability and terrorism. We have not, to date, been materially affected by any such risk, but cannot predict the likelihood of such developments occurring. We
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+ believe that we have the ability to develop, over a period of time, adequate alternative sources of supply for the products obtained from our present suppliers outside of the United States. If events prevented us from acquiring products from our
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+ suppliers in a particular country, our operations could be temporarily disrupted and we could experience an adverse financial impact. However, we believe that we could abate any such disruption within a period of no more than 12 months, and that
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+ much of the adverse impact on supply would, therefore, be of a short-term nature. We believe that our principal competitors are subject to similar risks.
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+ As a result of the Trade Act of 2003, the United States has implemented significant new Federal requirements for cargo security, focused on imports of
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+ containerized cargo. We are a significant importer of containerized cargo. Accordingly, we participate actively in appropriate governmental programs, such as the Customs Trade Partnership Against Terrorism (“C-TPAT”), to reduce risks of
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+ possible supply disruptions caused by U.S. and international cargo security mandates and terrorism.
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+ All of our products manufactured overseas and imported into the United States and other countries are subject to customs duties collected by customs
145
+ authorities. Customs information submitted by us is routinely subject to review by customs authorities. We are unable to predict whether additional customs duties, anti-dumping duties, quotas, safeguard measures, or other trade restrictions may be
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+ imposed on the importation of our products in the future. Such actions could result in increases in the cost of our products generally and might adversely affect the sales or profitability of NIKE and the imported footwear and apparel industry as a
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+ whole. Accordingly, we are actively monitoring the developments described below.
148
+ Imports into the European Union
149
+ In 1994, the European Commission (“EU”) imposed quotas on certain types of footwear manufactured in China. These quotas replaced national quotas that had previously been in effect in several European Member States. Footwear
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+ designed for use in sporting activities, meeting certain technical criteria and having a CIF (cost, insurance and freight) price above 9 euros (“Special Technology Athletic Footwear” or “STAF”), has been excluded from the quotas.
151
+ As a result of the STAF exclusion, and the amount of quota made available to us, the quotas have not, to date, had a material effect on our business. In addition, the EU has confirmed that footwear quotas will be eliminated globally beginning
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+ January 1, 2005. However, as part of China’s 2001 accession to the World Trade Organization (“WTO”), China entered into an agreement with the EU and other WTO members to abide by a special safeguard arrangement whereby quotas could be
153
+ imposed on any product sourced in China, including footwear, if there was a surge in imports from China into another WTO country, and after a legal proceeding it was determined that such imports were injuring a domestic producer. Additionally, under
154
+ longstanding WTO rules, all WTO member countries reserve the right to impose (1) safeguard measures
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+ 6
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+ Table of Contents
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+ (temporary quotas) if it can be demonstrated in a legal proceeding that increased imports are injuring another WTO member’s domestic industry; and (2)
158
+ anti-dumping measures if it can be demonstrated in a legal proceeding that imports are being sold at an unfair low price in another WTO member’s home market.
159
+ Accordingly, with the phase-out of the quotas at the beginning of 2005, and the expiration of a separate EU anti-dumping
160
+ case in 2003 against footwear made in China, Indonesia and Thailand, there may be renewed pressure from some sectors within Europe to re-impose some level of trade protection on imported footwear. While it is unlikely that the EU will pursue any
161
+ such action, we will monitor the circumstances closely and if action is initiated, we will work to mitigate any significant business risks. We believe that our major competitors stand in much the same position of risk regarding these potential trade
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+ measures.
163
+ On May 1, 2004 ten new countries joined the EU and
164
+ the EU single market. An agreement was reached to increase the current EU quotas on footwear to account for the enlarged EU market. NIKE and other manufacturers do not expect this expansion of the EU single market to present any significant
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+ challenges to the importation into the EU of sports footwear produced in China, since the EU increased quotas take into account the enlarged consumer and market demand.
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+ If EU trade measures become substantially more restrictive we would consider shifting, to the extent possible, the
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+ production of our sports footwear to other countries in order to maintain competitive pricing and access to these markets. We believe that we are prepared to deal effectively with any such change of circumstances and that any adverse impact would be
168
+ of a temporary nature. We continue to closely monitor international restrictions and maintain our multi-country sourcing strategy and contingency plans. We believe that our principal competitors are subject to similar risks regarding these trade
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+ measures.
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+ Imports into the United States
171
+ We currently source a portion of our footwear and apparel products from
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+ factories in Vietnam. In 2001, the United States Congress and the Vietnamese National Assembly approved a comprehensive bilateral trade agreement, which, among other things, provides reciprocal, non-discriminatory Normal Trade Relations
173
+ (“NTR”) between the U.S. and Vietnam. Following that approval, the U.S. granted an annual extension of NTR to Vietnam. The U.S. President must renew this grant annually with the opportunity for review by Congress. In June 2004, President
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+ Bush renewed NTR for Vietnam for an additional year and we anticipate Congress will support this decision. We currently believe that, absent unforeseen circumstances, the President will continue his annual extensions of NTR to Vietnam and that
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+ Congress will support the President’s decisions. The annual extensions on NTR will remain in place until Vietnam enters the WTO, at which time the U.S. must grant Vietnam permanent NTR. Vietnam’s WTO accession negotiations are ongoing, and
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+ may conclude as early as the end of 2005. Ongoing NTR trading status for Vietnam will allow us to expand our production and marketing opportunities in Vietnam and allow for Vietnamese-sourced product to continue to enter the United States at NTR
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+ tariff rates.
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+ Expiration of the Textile and Apparel
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+ Multi-Fiber Arrangement
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+ Under the WTO, the Multi-Fiber
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+ Arrangement, a four-decade old agreement that allows WTO countries to impose quotas on the import of textile and apparel products, will expire on January 1, 2005. This effectively means that all trade of textile and apparel products between WTO
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+ members will be free from quotas at the end of the 2004 calendar year. Elimination of textile and apparel quotas is significant for NIKE and other textile and apparel companies as it provides these companies greater flexibility in their global
183
+ sourcing decisions. At the same time, we are monitoring closely actions by textile and apparel importing countries to ensure that they do not unilaterally attempt to re-impose restrictions through some other legal mechanism, such as safeguards,
184
+ anti-dumping measures, or in the case of China (as part of the agreement reached in China’s 2001 WTO accession), through the short-term re-imposition of quotas on certain categories of textile and apparel products in order to
185
+ 7
186
+ Table of Contents
187
+ protect a domestic market from surging Chinese imports. In the event of any significant protectionist trade actions, we will evaluate alternative sourcing
188
+ options and will work to mitigate any significant business risks. We believe that our principal competitors are subject to similar risks regarding these potential trade measures.
189
+ Competition
190
+ The athletic
191
+ footwear, apparel and equipment industry is keenly competitive in the United States and on a worldwide basis. We compete internationally with an increasing number of athletic and leisure shoe companies, athletic and leisure apparel companies, sports
192
+ equipment companies, and large companies having diversified lines of athletic and leisure shoes, apparel and equipment, including Reebok, Adidas and others. The intense competition and the rapid changes in technology and consumer preferences in the
193
+ markets for athletic and leisure footwear and apparel, and athletic equipment, constitute significant risk factors in our operations.
194
+ NIKE is the largest seller of athletic footwear and athletic apparel in the world. Performance and reliability of shoes, apparel, and equipment, new
195
+ product development, price, product identity through marketing and promotion, and customer support and service are important aspects of competition in the athletic footwear, apparel and equipment industry. To help market our products, we contract
196
+ with prominent and influential athletes, coaches, teams, colleges, and sports leagues to endorse our brands and use our products, and we actively sponsor sporting events and clinics. We believe that we are competitive in all of these areas.
197
+ Trademarks and Patents
198
+ We
199
+ utilize trademarks on nearly all of our products and believe that having distinctive marks that are readily identifiable is an important factor in creating a market for our goods, in identifying the Company, and in distinguishing our goods from the
200
+ goods of others. We consider our NIKE ® and Swoosh Design ®
201
+ trademarks to be among our most valuable assets and we have registered these trademarks in over 100 countries. In addition, we own many other trademarks that we utilize in marketing our products. We continue to vigorously protect our trademarks
202
+ against infringement.
203
+ NIKE has an exclusive, worldwide license
204
+ to make and sell footwear using patented “Air” technology. The process utilizes pressurized gas encapsulated in polyurethane. Some of the early NIKE AIR ®
205
+ patents have expired, which may enable competitors to use certain types of similar technology. Subsequent NIKE AIR patents will not expire for several years. We also have hundreds of U.S. and foreign patents covering components, features, and
206
+ designs used in various athletic and leisure shoes, apparel, and equipment. These patents expire at various times, and have a remaining duration of from now to at least 2024, although the duration of patents varies by country. We believe that our
207
+ success depends primarily upon skills in design, research and development, production and marketing rather than upon our patent position. However, we have followed a policy of filing applications for United States and foreign patents on inventions,
208
+ designs and improvements that we deem valuable.
209
+ Employees
210
+ We had approximately
211
+ 24,667 employees at May 31, 2004. Management considers its relationship with employees to be excellent. None of our employees are represented by a union, with the exception of Bauer NIKE Hockey Inc. Of Bauer NIKE Hockey’s North American
212
+ employees, approximately 47 percent, or approximately 232, are covered by three union collective bargaining agreements with three separate bargaining units, and all of Bauer NIKE Hockey’s approximately 130 non-immigrant employees in Italy are
213
+ covered by three collective bargaining agreements. The collective bargaining agreements expire on various dates from 2005 through 2007. There has never been a material interruption of operations due to labor disagreements.
214
+ 8
215
+ Table of Contents
216
+ Executive Officers of the Registrant
217
+ The executive officers of NIKE as of July 25, 2004 are as follows:
218
+ Philip H. Knight, Chief Executive Officer, Chairman of the Board, and President — Mr. Knight, 66, a director since 1968, is a co-founder of NIKE and, except for the period from June 1983 through September
219
+ 1984, served as its President from 1968 to 1990, and from June 2000 to present. Prior to 1968, Mr. Knight was a certified public accountant with Price Waterhouse and Coopers & Lybrand and was an Assistant Professor of Business Administration at
220
+ Portland State University.
221
+ Donald W. Blair, Vice
222
+ President and Chief Financial Officer — Mr. Blair, 46, joined NIKE in November 1999. Prior to joining NIKE, he held a number of financial management positions with Pepsico, Inc., including Vice President, Finance of Pepsi-Cola Asia, Vice
223
+ President, Planning of PepsiCo’s Pizza Hut Division, and Senior Vice President, Finance of The Pepsi Bottling Group, Inc. Prior to joining Pepsico, Mr. Blair was a certified public accountant with Deloitte, Haskins, and Sells.
224
+ Thomas E. Clarke, President of New Ventures — Dr. Clarke, 53, a
225
+ director since 1994, joined the Company in 1980. He was appointed divisional Vice President in charge of marketing in 1987, elected corporate Vice President in 1989, appointed General Manager in 1990, and served as President and Chief Operating
226
+ Officer from 1994 to 2000. Dr. Clarke previously held various positions with the Company, primarily in research, design, development and marketing. Dr. Clarke holds a doctorate degree in biomechanics.
227
+ Wesley A. Coleman , Vice President, Global Human Resources — Mr.
228
+ Coleman, 54, has been employed by Nike since 2002 in his current role. Prior to joining NIKE, he held a number of Human Resource positions over a 20-year period with S.C. Johnson and Sons, Inc., including Vice President HR, North America and Vice
229
+ President HR, Asia/Pacific.
230
+ Charles D. Denson,
231
+ President of the NIKE Brand — Mr. Denson, 48, has been employed by NIKE since February 1979. Mr. Denson held several positions within the Company, including his appointments as Director of USA Apparel Sales in 1994, divisional Vice
232
+ President, US Sales in 1994, divisional Vice President European Sales in 1997, divisional Vice President and General Manager, NIKE Europe in 1998, Vice President and General Manager of NIKE USA in June 2000, and President of the NIKE Brand in March
233
+ 2001.
234
+ Gary M. DeStefano, President of USA Operations
235
+ — Mr. DeStefano, 47, has been employed by NIKE since 1982, with primary responsibilities in sales and regional administration. Mr. DeStefano was appointed Director of Domestic Sales in 1990, divisional Vice President in charge of domestic sales
236
+ in 1992, Vice President of Global Sales in 1996, Vice President and General Manager of Asia Pacific in March 1997, and President of USA Operations in March 2001.
237
+ Trevor Edwards , Vice President, Global Brand Management — Mr. Edwards, 41, joined the Company in 1992. He was
238
+ appointed Marketing Manager, Strategic Accounts, Foot Locker in 1993, Director of Marketing, the Americas in 1995, Director of Marketing, Europe in 1997, Vice President, Marketing for Europe, Middle East and Africa in 1999, and Vice President, US
239
+ Brand Marketing in 2000. Mr. Edwards was appointed corporate Vice President, Global Brand Management in November 2002.
240
+ Mindy F. Grossman, Vice President of Global Apparel — Ms. Grossman, 46, joined NIKE in October 2000. Prior to joining NIKE, she was President
241
+ and Chief Executive Officer of Polo Jeans Company/Ralph Lauren, a division of Jones Apparel Group, Inc. from 1995 to 2000. Prior to that, Ms. Grossman was Vice President of New Business Development at Polo Ralph Lauren Corp. from 1994 to 1995,
242
+ President of The Warnaco Group Inc. Chaps Ralph Lauren division, and Senior Vice President of The Warnaco Group Inc. Menswear division from 1991 to 1994.
243
+ 9
244
+ Table of Contents
245
+ Adam S. Helfant , Vice President, Global Sports Marketing — Mr. Helfant, 39, joined NIKE in
246
+ 1995 in the Company’s legal department, and was appointed Director of Business Affairs for Global Sports Marketing in 1997, Director of Global Sports Marketing in 1998, Director of US Sports Marketing in 2001, Vice President of US Sports
247
+ Marketing in 2003, and corporate Vice President, Global Sports Marketing effective August 2004. Prior to joining NIKE, he was in private practice and an attorney for NHL Enterprises, Inc.
248
+ P. Eunan McLaughlin, Vice President, Europe, Middle East & Africa — Mr. McLaughlin, 46, joined NIKE as
249
+ Director of Sales, NIKE Europe in February 1999, and was appointed Vice President Commercial Sales and Retail in 2000, Vice President, Asia Pacific in 2001, and Vice President, Europe, Middle East & Africa in May 2004. Prior to joining NIKE, he
250
+ was Partner and Vice President of Consumer & Retail Practices Division, Korn/Ferry International from 1996 to 1999. From 1983 to 1996 Mr. McLaughlin held various positions with Mars, Inc. in Finance, Sales, Marketing and General Management.
251
+ D. Scott Olivet, Vice President, NIKE Subsidiaries and
252
+ New Business Development — Mr. Olivet, 42, joined NIKE in August 2001. Prior to joining NIKE, he was a Senior Vice President of Gap Inc., responsible for real estate, store design, and construction across Gap, Banana Republic, and Old Navy
253
+ brands from 1998 to 2001. Prior to that, Mr. Olivet was employed by Bain & Company, an international strategic consulting firm from 1984 to 1998 (a Partner from 1993 to 1998). In addition to direct client work, Mr. Olivet was the leader of the
254
+ firm’s worldwide practice in organizational effectiveness and change management.
255
+ Mark G. Parker, President of the NIKE Brand — Mr. Parker, 48, has been employed by NIKE since 1979 with primary responsibilities in product research, design and development, marketing, and brand
256
+ management. Mr. Parker was appointed divisional Vice President in charge of development in 1987, corporate Vice President in 1989, General Manager in 1993, Vice President of Global Footwear in 1998, and President of the NIKE Brand in March 2001.
257
+ Eric D. Sprunk, Vice President, Global Footwear —
258
+ Mr. Sprunk, 40, joined the Company in 1993. He was appointed Finance Director and General Manager of the Americas in 1994, Finance Director, NIKE Europe in 1995, Regional General Manager, NIKE Europe Footwear in 1998, and Vice President &
259
+ General Manager of the Americas in 2000. Mr. Sprunk was appointed corporate Vice President, Global Footwear in June 2001.
260
+ Lindsay D. Stewart, Vice President and Chief of Staff, and Secretary — Mr. Stewart, 57, joined NIKE as Assistant Corporate Counsel in 1981.
261
+ Mr. Stewart became Corporate Counsel in 1983. He was appointed Vice President and General Counsel in 1991, and Chief of Staff in March 2001. Prior to joining NIKE, Mr. Stewart was in private practice and an attorney for Georgia-Pacific Corporation.
262
+ Roland P. Wolfram, Vice President and General Manager,
263
+ Asia Pacific — Mr. Wolfram, 44, joined NIKE as Vice President, Strategic Planning in November 1998, and was appointed Vice President, Global Operations & Technology in 2002, and Vice President, Asia Pacific in April 2004. Prior to NIKE, Mr.
264
+ Wolfram was Vice President and General Manager at Pacific Bell Video Services.
265
+ 10
266
+ Table of Contents
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1
+ Item 13. Certain Relationships and Related Transactions
2
+ The information required by this Item is included under “Certain Transactions and Business Relationships” in the definitive Proxy Statement for
3
+ our 2004 Annual Meeting of Shareholders and is incorporated herein by reference.
raw/filings/0000320187/2003/0001193125-04-128270/item9a.txt ADDED
@@ -0,0 +1,15 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
+ Item 9A. Controls and Procedures
2
+ The Company maintains disclosure controls and procedures that are designed to ensure that information required to be disclosed in the Company’s
3
+ Exchange Act reports is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms and that such information is accumulated and communicated to the Company’s
4
+ management, including its Chief Executive Officer and Chief Financial Officer, as appropriate, to allow for timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes
5
+ that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management is required to apply its judgment in evaluating the cost-benefit
6
+ relationship of possible controls and procedures.
7
+ The Company
8
+ carries out a variety of on-going procedures, under the supervision and with the participation of the Company’s management, including the Company’s Chief Executive Officer and Chief Financial Officer, to evaluate the effectiveness of the
9
+ design and operation of the Company’s disclosure controls and procedures. Based on the foregoing, the Company’s Chief Executive Officer and Chief Financial Officer concluded that the Company’s disclosure controls and procedures were
10
+ effective at the reasonable assurance level as of May 31, 2004.
11
+ There has been no change in the Company’s internal controls over financial reporting during the Company’s most recent fiscal quarter that has materially affected, or is reasonable likely to materially affect, the Company’s
12
+ internal controls over financial reporting.
13
+ 60
14
+ Table of Contents
15
+ PART III
raw/filings/0000320187/2003/0001193125-04-128270/rp_note.txt ADDED
File without changes
raw/filings/0000320187/2003/0001193125-04-128270/rpt_disclosure.txt ADDED
File without changes
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2
+ 0000320187,NKE,"NIKE, Inc.",10-K,2005-07-29,2005-05-31,2005-07-30T01:12:55.000Z,0000950124-05-004551,v10583e10vk.htm,FORM 10-K,950848,0,0,https://www.sec.gov/Archives/edgar/data/320187/000095012405004551/v10583e10vk.htm,https://www.sec.gov/Archives/edgar/data/320187/000095012405004551/,2004,2004,1
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1
+ Item 1.
2
+ Business
3
+ General
4
+ NIKE, Inc. was incorporated in 1968 under the laws of the state
5
+ of Oregon. As used in this report, the terms “we”,
6
+ “us”, “NIKE” and the “Company”
7
+ refer to NIKE, Inc. and its predecessors, subsidiaries and
8
+ affiliates, unless the context indicates otherwise. Our Internet
9
+ address is www.nike.com. On our NIKE Corporate web site,
10
+ located at www.nikebiz.com, we post the following filings
11
+ as soon as reasonably practicable after they are electronically
12
+ filed with or furnished to the Securities and Exchange
13
+ Commission: our annual report on Form 10-K, our quarterly
14
+ reports on Form 10-Q, our current reports on Form 8-K
15
+ and any amendments to those reports filed or furnished pursuant
16
+ to Section 13(a) or 15(d) of the Securities and Exchange
17
+ Act of 1934. All such filings on our NIKE Corporate web site are
18
+ available free of charge. Also available on the NIKE Corporate
19
+ web site are the charters of the committees of our board of
20
+ directors, as well as our corporate governance guidelines and
21
+ code of ethics; copies of any of these documents will be
22
+ provided in print to any shareholder who submits a request in
23
+ writing to NIKE Investor Relations, One Bowerman Drive,
24
+ Beaverton, Oregon 97005-6453.
25
+ Our principal business activity is the design, development and
26
+ worldwide marketing of high quality footwear, apparel,
27
+ equipment, and accessory products. NIKE is the largest seller of
28
+ athletic footwear and athletic apparel in the world. We sell our
29
+ products to retail accounts, through NIKE-owned retail stores,
30
+ and through a mix of independent distributors and licensees, in
31
+ over 160 countries around the world. Virtually all of our
32
+ products are manufactured by independent contractors. Virtually
33
+ all footwear and apparel products are produced outside the
34
+ United States, while equipment products are produced both in the
35
+ United States and abroad.
36
+ Products
37
+ NIKE’s athletic footwear products are designed primarily
38
+ for specific athletic use, although a large percentage of the
39
+ products are worn for casual or leisure purposes. We place
40
+ considerable emphasis on high quality construction and
41
+ innovation in products designed for men, women and children.
42
+ Running, cross-training, basketball, soccer, sport-inspired
43
+ urban shoes, and children’s shoes are currently our
44
+ top-selling product categories and we expect them to continue to
45
+ lead in product sales in the near future. We also market shoes
46
+ designed for tennis, golf, baseball, football, bicycling,
47
+ volleyball, wrestling, cheerleading, aquatic activities, hiking,
48
+ outdoor activities and other athletic and recreational uses.
49
+ We sell sports apparel covering most of the above categories,
50
+ sports inspired lifestyle apparel, as well as athletic bags and
51
+ accessory items. NIKE apparel and accessories are designed to
52
+ complement our athletic footwear products, feature the same
53
+ trademarks and are sold through the same marketing and
54
+ distribution channels. We often market footwear, apparel and
55
+ accessories in “collections” of similar design or for
56
+ specific purposes. We also market apparel with licensed college
57
+ and professional team and league logos.
58
+ We sell a line of performance equipment under the NIKE®
59
+ brand name, including golf clubs, sport balls, eyewear,
60
+ timepieces, electronic media devices, skates, bats, gloves, and
61
+ other equipment designed for sports activities. We also have
62
+ agreements for licensees to produce and sell NIKE brand
63
+ swimwear, cycling apparel, children’s clothing, school
64
+ supplies and eyewear. We also sell small amounts of various
65
+ plastic products to other manufacturers through our wholly-owned
66
+ subsidiary, NIKE IHM, Inc.
67
+ Our wholly-owned subsidiary Converse Inc., headquartered in
68
+ North Andover, Massachusetts, designs and distributes athletic
69
+ and casual footwear, apparel and accessories under the
70
+ Converse®, Chuck Taylor®, All Star®, One
71
+ Star® and Jack Purcell® trademarks.
72
+ We sell a line of dress and casual footwear, apparel and
73
+ accessories for men and women under the brand names Cole
74
+ Haan®, g Series© and Bragano© through our
75
+ wholly-owned subsidiary, Cole Haan Holdings Incorporated,
76
+ headquartered in Yarmouth, Maine.
77
+ 2
78
+ Table of Contents
79
+ Our wholly-owned subsidiary Hurley International LLC,
80
+ headquartered in Costa Mesa, California, designs and distributes
81
+ a line of action sports apparel for surfing, skateboarding, and
82
+ snowboarding, and youth lifestyle apparel and footwear under the
83
+ Hurley® brand name.
84
+ Our wholly-owned subsidiary, Bauer NIKE Hockey Inc.,
85
+ headquartered in Greenland, New Hampshire, manufactures and
86
+ distributes ice skates, skate blades, protective gear, hockey
87
+ sticks, licensed apparel and accessories under the Bauer®
88
+ and NIKE® brand names. Bauer also offers a full selection
89
+ of products for street and roller hockey.
90
+ In the fiscal quarter ended August 31, 2004 the Company
91
+ formed Exeter Brands Group LLC, a wholly-owned subsidiary of the
92
+ Company, to develop the Company’s athletic footwear and
93
+ apparel business in retail channels for value-conscious
94
+ consumers, and to market and license athletic footwear and
95
+ apparel under the Starter®, Shaq® and Asphalt®
96
+ brand names, which we purchased during that quarter.
97
+ Sales and Marketing
98
+ Financial information about geographic and segment operations
99
+ appears in Note 17 of the consolidated financial statements
100
+ on page 60.
101
+ We experience moderate fluctuations in aggregate sales volume
102
+ during the year. Historically, revenues in the first and fourth
103
+ fiscal quarters have slightly exceeded those in the second and
104
+ third quarters. However, the mix of product sales may vary
105
+ considerably from time to time as a result of changes in
106
+ seasonal and geographic demand for particular types of footwear,
107
+ apparel and equipment.
108
+ Because NIKE is a consumer products company, the relative
109
+ popularity of various sports and fitness activities and changing
110
+ design trends affect the demand for our products. We must
111
+ therefore respond to trends and shifts in consumer preferences
112
+ by adjusting the mix of existing product offerings, developing
113
+ new products, styles and categories, and influencing sports and
114
+ fitness preferences through aggressive marketing. This is a
115
+ continuing risk. Failure to respond in a timely and adequate
116
+ manner could have a material adverse effect on our sales and
117
+ profitability.
118
+ United States Market
119
+ In fiscal 2005, sales in the United States (including
120
+ U.S. sales of Bauer NIKE Hockey, Cole Haan, Converse,
121
+ Exeter Brands Group, Hurley and NIKE Golf) accounted for
122
+ approximately 46 percent of total revenues, compared to
123
+ 47 percent in fiscal 2004 and 49 percent in fiscal
124
+ 2003. We sell to approximately 22,000 retail accounts in the
125
+ United States. The NIKE brand domestic retail account base
126
+ includes a mix of footwear stores, sporting goods stores,
127
+ athletic specialty stores, department stores, skate, tennis and
128
+ golf shops, and other retail accounts. During fiscal year 2005,
129
+ our three largest customers accounted for approximately
130
+ 31 percent of NIKE brand sales in the United States
131
+ excluding sales from NIKE Golf and Bauer NIKE Hockey, and
132
+ 26 percent of total sales in the United States.
133
+ We make substantial use of our “futures” ordering
134
+ program, which allows retailers to order five to six months in
135
+ advance of delivery with the commitment that 90 percent of
136
+ their orders will be delivered within a set time period at a
137
+ fixed price. In fiscal year 2005, 91 percent of our
138
+ U.S. wholesale footwear shipments (excluding Bauer NIKE
139
+ Hockey, Cole Haan, Converse, Exeter Brands Group, Hurley and
140
+ NIKE Golf) were made under the futures program, compared to
141
+ 90 percent in fiscal 2004 and 91 percent in fiscal
142
+ 2003. In fiscal 2005 and 2004, 71 percent of our
143
+ U.S. wholesale apparel shipments (excluding
144
+ U.S. licensed team apparel, Bauer NIKE Hockey, Cole Haan,
145
+ Converse, Exeter Brands Group, Hurley and NIKE Golf) were made
146
+ under the futures program, compared to 67 percent in 2004
147
+ and 2003.
148
+ 3
149
+ Table of Contents
150
+ We utilize 22 NIKE sales offices to solicit sales in the United
151
+ States. We also utilize 9 independent sales representatives to
152
+ sell specialty products for golf and outdoor activities. In
153
+ addition, we sell NIKE brand products through our internet
154
+ website, www.niketown.com , and we operate the following
155
+ retail outlets in the United States:
156
+ U.S. Retail Stores
157
+ Number
158
+ NIKE factory stores (which carry primarily overstock and
159
+ closeout merchandise)
160
+ 77
161
+ NIKE stores (including NIKE Women Stores)
162
+ 11
163
+ NIKETOWNs (designed to showcase NIKE products)
164
+ 12
165
+ NIKE employee-only stores
166
+ 4
167
+ Cole Haan, Converse, and Hurley stores (including factory and
168
+ employee stores)
169
+ 80
170
+ Total
171
+ 184
172
+ NIKE’s domestic distribution centers for footwear are
173
+ located in Wilsonville, Oregon, and Memphis, Tennessee. Apparel
174
+ and equipment products are shipped from our Memphis, Tennessee,
175
+ Tigard, Oregon, and Foothill Ranch, California distribution
176
+ centers. Cole Haan and Bauer NIKE Hockey products are
177
+ distributed primarily from Greenland, New Hampshire, Converse
178
+ products are shipped from Ontario and Fontana, California, and
179
+ Hurley products are shipped from Costa Mesa, California.
180
+ International Markets
181
+ We sell our products to retail accounts, through NIKE-owned
182
+ retail stores, and through a mix of independent distributors and
183
+ licensees, in over 160 countries around the world.
184
+ Non-U.S. sales (including non-U.S. sales of Bauer NIKE
185
+ Hockey, Cole Haan, Converse, Exeter Brands Group, Hurley and
186
+ NIKE Golf) accounted for 54 percent of total revenues in
187
+ fiscal 2005, compared to 53 percent in fiscal 2004 and
188
+ 51 percent in fiscal 2003. We estimate that we sell to more
189
+ than 37,000 retail accounts outside the United States, excluding
190
+ sales by independent distributors and licensees. We operate 21
191
+ distribution centers in Europe, Asia, Australia, Latin America,
192
+ Africa and Canada. In many countries and regions, including
193
+ Canada, Asia, some Latin American countries, and Europe, we have
194
+ a futures ordering program for retailers similar to the United
195
+ States futures program described above. NIKE’s three
196
+ largest customers outside of the U.S. accounted for
197
+ approximately 12 percent of non-U.S. sales.
198
+ We operate the following retail outlets outside the United
199
+ States:
200
+ Non-U.S. Retail Stores
201
+ Number
202
+ NIKE factory stores
203
+ 129
204
+ NIKE stores and employee-only stores
205
+ 8
206
+ NIKETOWNs
207
+ 2
208
+ Cole Haan stores (including factory and employee stores)
209
+ 51
210
+ Total
211
+ 190
212
+ International branch offices and subsidiaries of NIKE are
213
+ located in Argentina, Australia, Austria, Belgium, Brazil,
214
+ Bulgaria, Canada, Chile, Croatia, Czech Republic, Denmark,
215
+ Finland, France, Germany, Greece, Hong Kong, Hungary, Indonesia,
216
+ India, Ireland, Israel, Italy, Japan, Korea, Lebanon, Malaysia,
217
+ Mexico, New Zealand, The Netherlands, Norway, People’s
218
+ Republic of China, The Philippines, Poland, Portugal, Russia,
219
+ Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka,
220
+ Sweden, Switzerland, Taiwan, Thailand, Turkey, the United
221
+ Kingdom and Vietnam.
222
+ Significant Customer
223
+ Foot Locker Inc., which operates a chain of retail stores
224
+ specializing in athletic footwear and apparel, accounted for
225
+ approximately 11 percent of global net sales of NIKE, Inc.
226
+ during fiscal 2005. No other customer accounted for
227
+ 10 percent or more of our net sales during fiscal 2005.
228
+ 4
229
+ Table of Contents
230
+ Orders
231
+ Worldwide futures orders for NIKE brand athletic footwear and
232
+ apparel, scheduled for delivery from June through November 2005,
233
+ were $6.3 billion compared to $5.7 billion for the
234
+ same period last year. Based upon historical data, we expect
235
+ that approximately 95 percent of these orders will be
236
+ filled in that time period, although some orders may be
237
+ cancelled. Reported futures orders are not necessarily
238
+ indicative of our expectation of revenues for this period. This
239
+ is because the mix of orders can shift between advance/futures
240
+ and at-once orders. In addition, foreign currency exchange rate
241
+ fluctuations as well as differing levels of order cancellations
242
+ can cause differences in the comparisons between futures orders
243
+ and actual revenues. Moreover, a significant portion of our
244
+ revenue is not derived from futures orders, including wholesale
245
+ sales of equipment, U.S. licensed team apparel, Bauer NIKE
246
+ Hockey, Cole Haan, Converse, Exeter Brands Group, Hurley, NIKE
247
+ Golf, and retail sales across all brands.
248
+ Product Research and Development
249
+ We believe that our research and development efforts are a key
250
+ factor in our past and future success. Technical innovation in
251
+ the design of footwear, apparel, and athletic equipment receive
252
+ continued emphasis as NIKE strives to produce products that help
253
+ to reduce injury, aid athletic performance and maximize comfort.
254
+ In addition to NIKE’s own staff of specialists in the areas
255
+ of biomechanics, exercise physiology, engineering, industrial
256
+ design and related fields, we also utilize research committees
257
+ and advisory boards made up of athletes, coaches, trainers,
258
+ equipment managers, orthopedists, podiatrists and other experts
259
+ who consult with us and review designs, materials and concepts
260
+ for product improvement. Employee athletes and other athletes
261
+ wear-test and evaluate products during the design and
262
+ development process.
263
+ Manufacturing
264
+ Virtually all of our footwear is produced outside of the United
265
+ States. In fiscal 2005, contract suppliers in China, Vietnam,
266
+ Indonesia and Thailand manufactured 36 percent,
267
+ 26 percent, 22 percent and 15 percent of total
268
+ NIKE brand footwear, respectively. We also have manufacturing
269
+ agreements with independent factories in Argentina, Brazil,
270
+ India, Italy, Mexico and South Africa to manufacture footwear
271
+ for sale primarily within those countries. Our largest single
272
+ footwear supplier accounted for approximately 7 percent of
273
+ total fiscal 2005 footwear production.
274
+ Almost all of NIKE brand apparel production for sale to the
275
+ United States market, and all of our apparel production for sale
276
+ to the international market, was manufactured outside of the
277
+ United States by independent contract manufacturers located in
278
+ 38 countries. Most of this apparel production occurred in
279
+ Bangladesh, China, Honduras, India, Indonesia, Malaysia, Mexico,
280
+ Pakistan, Sri Lanka, Taiwan, Thailand, Turkey and Vietnam. Our
281
+ largest single apparel supplier accounted for approximately
282
+ 5 percent of total fiscal 2005 apparel production.
283
+ The principal materials used in our footwear products are
284
+ natural and synthetic rubber, plastic compounds, foam cushioning
285
+ materials, nylon, leather, canvas and polyurethane films used to
286
+ make AIR-SOLE cushioning components. NIKE IHM, Inc., a
287
+ wholly-owned subsidiary of NIKE, is our sole supplier of the
288
+ AIR-SOLE cushioning components used in footwear. The principal
289
+ materials used in our apparel products are natural and synthetic
290
+ fabrics and threads, plastic and metal hardware, and specialized
291
+ performance fabrics designed to repel rain, retain heat, or
292
+ efficiently transport body moisture. NIKE and its contractors
293
+ and suppliers buy raw materials in bulk. Most raw materials are
294
+ available in the countries where manufacturing takes place. We
295
+ have thus far experienced little difficulty in satisfying our
296
+ raw material requirements.
297
+ Since 1972, Sojitz Corporation of America (“Sojitz
298
+ America”) and its predecessor, Nissho Iwai American
299
+ Corporation, a subsidiary of Nissho Iwai Corporation, a large
300
+ Japanese trading company, have performed significant
301
+ import-export financing services for us. During fiscal 2005,
302
+ Sojitz America provided such financing services for nearly all
303
+ of the NIKE brand products sold outside of the United States,
304
+ Europe, Middle East, Africa and Japan, excluding products
305
+ produced and sold in the same country. However, less
306
+ 5
307
+ Table of Contents
308
+ than 11 percent of NIKE brand products, excluding products
309
+ produced and sold in the same country, were sold outside of the
310
+ United States, Europe, Middle East, Africa and Japan in fiscal
311
+ 2005. Any failure of Sojitz America to provide these services or
312
+ any failure of Sojitz America’s banks could disrupt our
313
+ ability to acquire products from our suppliers and to deliver
314
+ products to our customers outside of the United States, Europe,
315
+ Middle East, Africa and Japan. Such a disruption could result in
316
+ cancelled orders that would adversely affect sales and
317
+ profitability. However, we believe that any such disruption
318
+ would be short term in duration due to the ready availability of
319
+ alternative sources of financing at competitive rates. Our
320
+ current agreements with Sojitz America expire on May 31,
321
+ 2008.
322
+ International Operations and Trade
323
+ Our international operations and sources of supply are subject
324
+ to the usual risks of doing business abroad, such as possible
325
+ revaluation of currencies, export duties, anti-dumping duties,
326
+ quotas, safeguard measures, trade restrictions, restrictions on
327
+ the transfer of funds and, in certain parts of the world,
328
+ political instability and terrorism. We have not, to date, been
329
+ materially affected by any such risk, but cannot predict the
330
+ likelihood of such developments occurring. We believe that we
331
+ have the ability to develop, over a period of time, adequate
332
+ alternative sources of supply for the products obtained from our
333
+ present suppliers outside of the United States. If events
334
+ prevented us from acquiring products from our suppliers in a
335
+ particular country, our operations could be temporarily
336
+ disrupted and we could experience an adverse financial impact.
337
+ However, we believe that we could abate any such disruption
338
+ within a period of no more than 12 months, and that much of
339
+ the adverse impact on supply would, therefore, be of a
340
+ short-term nature. We believe that our principal competitors are
341
+ subject to similar risks.
342
+ As a result of the Trade Act of 2003, the United States
343
+ implemented significant new Federal requirements for cargo
344
+ security, focused on imports of containerized cargo. We are a
345
+ significant importer of containerized cargo. Accordingly, we
346
+ participate actively in appropriate governmental programs, such
347
+ as the Customs Trade Partnership Against Terrorism
348
+ (“C-TPAT”), to reduce risks of possible supply
349
+ disruptions caused by U.S. and international cargo security
350
+ mandates and terrorism.
351
+ All of our products manufactured overseas and imported into the
352
+ United States, the European Union and other countries are
353
+ subject to customs duties collected by customs authorities.
354
+ Customs information submitted by us is routinely subject to
355
+ review by customs authorities. We are unable to predict whether
356
+ additional customs duties, anti-dumping duties, quotas,
357
+ safeguard measures, or other trade restrictions may be imposed
358
+ on the importation of our products in the future. Such actions
359
+ could result in increases in the cost of our products generally
360
+ and might adversely affect the sales or profitability of NIKE
361
+ and the imported footwear and apparel industry as a whole.
362
+ Accordingly, we are actively monitoring the developments
363
+ described below.
364
+ Footwear Imports into the European Union
365
+ From 1994 through January 1, 2005, the European Union
366
+ (“EU”) imposed limits (or “quotas”) on the
367
+ import of certain types of footwear manufactured in China.
368
+ Footwear designed for use in sporting activities, meeting
369
+ certain technical criteria and having a CIF (cost, insurance and
370
+ freight) price above 9 euros (“Special Technology Athletic
371
+ Footwear” or “STAF”), was excluded from the
372
+ quotas. As a result of the STAF exclusion, and the amount of
373
+ quota made available to us, the quotas did not have a material
374
+ effect on our business. However, as part of China’s 2001
375
+ accession to the World Trade Organization (“WTO”),
376
+ China entered into an agreement with the EU and other WTO
377
+ members to abide by a special safeguard arrangement whereby
378
+ quotas could be imposed on any product sourced in China,
379
+ including footwear, if there was a surge in imports from China
380
+ into another WTO country, and after a legal proceeding it was
381
+ determined that such imports were injuring a domestic producer.
382
+ Additionally, under longstanding WTO rules, all WTO member
383
+ countries reserved the right to impose (1) safeguard
384
+ measures (temporary quotas) if it can be demonstrated in a legal
385
+ proceeding that increased imports are injuring another WTO
386
+ member’s domestic industry; and (2) anti-dumping
387
+ measures if it can be demonstrated in a legal proceeding that
388
+ imports are being sold at an unfair low price in another WTO
389
+ member’s home market, and those imports were causing or
390
+ threatening to cause material injury to the domestic industry.
391
+ 6
392
+ Table of Contents
393
+ Accordingly, with the phase-out of the quotas at the beginning
394
+ of 2005, and the expiration of a separate EU anti-dumping case
395
+ in 2003 against footwear made in China, Indonesia, and Thailand,
396
+ there has been renewed pressure from some parts of the EU
397
+ footwear manufacturing sector to re-impose some level of trade
398
+ protection on imported footwear from China, India, Vietnam, and
399
+ other exporting countries. In mid-2005 the European Commission,
400
+ at the request of the European domestic footwear industry,
401
+ initiated investigations into leather footwear imported from
402
+ China and Vietnam. NIKE and all other major athletic footwear
403
+ manufacturers are currently participating actively as
404
+ respondents in this investigation and are taking the position
405
+ that athletic footwear (i) should not be within the product
406
+ scope of this investigation and (ii) does not meet the
407
+ legal requirements of injury and price in an anti-dumping
408
+ investigation. We believe that our major competitors stand in
409
+ much the same position of risk regarding these potential trade
410
+ measures.
411
+ Expiration of the Textile and Apparel Multi-Fiber
412
+ Arrangement
413
+ Under the WTO, the Multi-Fiber Arrangement, a four-decade old
414
+ agreement that allows WTO countries to impose quotas on the
415
+ import of textile and apparel products, expired on
416
+ January 1, 2005. This effectively meant that absent some
417
+ other form of trade restrictions (see China discussion below)
418
+ all trade of textile and apparel products between WTO members is
419
+ free from quotas as of the end of the 2004 calendar year.
420
+ Elimination of textile and apparel quotas is significant for
421
+ NIKE and other textile and apparel companies as it provides
422
+ these companies greater flexibility in their global sourcing
423
+ decisions. At the same time, we are monitoring closely actions
424
+ by textile and apparel importing countries to ensure that they
425
+ do not unilaterally attempt to re-impose restrictions through
426
+ some other legal mechanism, such as safeguards, anti-dumping
427
+ measures, or in the case of China (as part of the agreement
428
+ reached in China’s 2001 WTO accession), through the
429
+ short-term re-imposition of quotas on certain categories of
430
+ textile and apparel products in order to protect a domestic
431
+ market from rising Chinese imports.
432
+ We are currently monitoring potential restrictions by the United
433
+ States and the European Union. In early 2005 the EU began
434
+ consultations with China over imposition of quotas. However, as
435
+ a result of those negotiations, in June of 2005, the EU and
436
+ China reached an agreement which voluntarily limits the amount
437
+ of apparel product China can export to the EU in particular
438
+ categories until January 1, 2008. NIKE monitored these
439
+ negotiations closely, adjusted its sourcing and distribution
440
+ strategy, and as a result, the agreement has not had a material
441
+ effect on our business.
442
+ In early 2005 the United States launched provisional safeguard
443
+ measures on several categories of apparel products from China.
444
+ In May of 2005, the U.S. found that imports from China of
445
+ certain apparel categories were causing market disruption to the
446
+ U.S. industry and the United States reimposed quota on
447
+ certain apparel categories. NIKE monitored these negotiations
448
+ closely, adjusted its sourcing and distribution strategy, and as
449
+ a result, the actions have not had a material effect on our
450
+ business. We believe that our principal competitors face the
451
+ same risks regarding these trade measures.
452
+ Vietnam Imports into the United States
453
+ We currently source a portion of our footwear and apparel
454
+ products from factories in Vietnam. In 2001, the United States
455
+ Congress and the Vietnamese National Assembly approved a
456
+ comprehensive bilateral trade agreement, which, among other
457
+ things, provides reciprocal, non-discriminatory Normal Trade
458
+ Relations (“NTR”) between the U.S. and Vietnam.
459
+ Following that approval, the U.S. granted an annual
460
+ extension of NTR to Vietnam. The U.S. President must renew
461
+ this grant annually with the opportunity for review by Congress.
462
+ In June 2005, President Bush renewed NTR for Vietnam for an
463
+ additional year and we anticipate Congress will support this
464
+ decision, as it has done for the past four years. We currently
465
+ believe that, absent unforeseen circumstances, the President
466
+ will continue his annual extensions of NTR to Vietnam and that
467
+ Congress will support the President’s decisions. The annual
468
+ extensions on NTR will remain in place until Vietnam enters the
469
+ WTO, at which time the U.S. must grant Vietnam permanent
470
+ NTR. Vietnam’s WTO accession negotiations are ongoing, and
471
+ may conclude as early as the end of 2005. Ongoing NTR trading
472
+ status for Vietnam will allow us to expand our production and
473
+ marketing opportunities in Vietnam and allow for
474
+ Vietnamese-sourced product to continue to enter the United
475
+ States at NTR tariff rates.
476
+ 7
477
+ Table of Contents
478
+ Competition
479
+ The athletic footwear, apparel and equipment industry is keenly
480
+ competitive in the United States and on a worldwide basis. We
481
+ compete internationally with an increasing number of athletic
482
+ and leisure shoe companies, athletic and leisure apparel
483
+ companies, sports equipment companies, and large companies
484
+ having diversified lines of athletic and leisure shoes, apparel
485
+ and equipment, including Reebok, Adidas and others. The intense
486
+ competition and the rapid changes in technology and consumer
487
+ preferences in the markets for athletic and leisure footwear and
488
+ apparel, and athletic equipment, constitute significant risk
489
+ factors in our operations.
490
+ NIKE is the largest seller of athletic footwear and athletic
491
+ apparel in the world. Performance and reliability of shoes,
492
+ apparel, and equipment, new product development, price, product
493
+ identity through marketing and promotion, and customer support
494
+ and service are important aspects of competition in the athletic
495
+ footwear, apparel and equipment industry. To help market our
496
+ products, we contract with prominent and influential athletes,
497
+ coaches, teams, colleges and sports leagues to endorse our
498
+ brands and use our products, and we actively sponsor sporting
499
+ events and clinics. We believe that we are competitive in all of
500
+ these areas.
501
+ Trademarks and Patents
502
+ We utilize trademarks on nearly all of our products and believe
503
+ that having distinctive marks that are readily identifiable is
504
+ an important factor in creating a market for our goods, in
505
+ identifying the Company, and in distinguishing our goods from
506
+ the goods of others. We consider our NIKE® and Swoosh
507
+ Design® trademarks to be among our most valuable assets and
508
+ we have registered these trademarks in over 100 countries.
509
+ In addition, we own many other trademarks that we utilize in
510
+ marketing our products. We continue to vigorously protect our
511
+ trademarks against infringement.
512
+ NIKE has an exclusive, worldwide license to make and sell
513
+ footwear using patented “Air” technology. The process
514
+ utilizes pressurized gas encapsulated in polyurethane. Some of
515
+ the early NIKE AIR® patents have expired, which may enable
516
+ competitors to use certain types of similar technology.
517
+ Subsequent NIKE AIR patents will not expire for several years.
518
+ We also have hundreds of U.S. and foreign patents covering
519
+ components, features, and designs used in various athletic and
520
+ leisure shoes, apparel and equipment. These patents expire at
521
+ various times, and have a remaining duration of from now to at
522
+ least 2025, although the duration of patents varies by country.
523
+ We believe that our success depends primarily upon skills in
524
+ design, research and development, production and marketing
525
+ rather than upon our patent position. However, we have followed
526
+ a policy of filing applications for United States and foreign
527
+ patents on inventions, designs and improvements that we deem
528
+ valuable.
529
+ Employees
530
+ We had approximately 26,000 employees at May 31, 2005.
531
+ Management considers its relationship with employees to be
532
+ excellent. None of our employees is represented by a union, with
533
+ the exception of Bauer NIKE Hockey Inc. Of Bauer NIKE
534
+ Hockey’s employees, approximately 33 percent, or
535
+ approximately 157, are covered by two union collective
536
+ bargaining agreements with two separate bargaining units. The
537
+ collective bargaining agreements expire on various dates from
538
+ 2005 through 2007. There has never been a material interruption
539
+ of operations due to labor disagreements.
540
+ Executive Officers of the Registrant
541
+ The executive officers of NIKE as of July 25, 2005 are as
542
+ follows:
543
+ Philip H. Knight, Chairman of the Board —
544
+ Mr. Knight, 67, a director since 1968, is a co-founder of
545
+ NIKE and, except for the period from June 1983 through September
546
+ 1984, served as its President from 1968 to 1990, and from June
547
+ 2000 to December 2004. Prior to 1968, Mr. Knight was a
548
+ certified public accountant with Price Waterhouse and
549
+ Coopers & Lybrand and was an Assistant Professor of
550
+ Business Administration at Portland State University.
551
+ 8
552
+ Table of Contents
553
+ William D. Perez, Chief Executive Officer and
554
+ President — Mr. Perez, 57, joined NIKE in
555
+ December 2004 as CEO and President. Immediately prior to joining
556
+ NIKE, he was President and Chief Executive Officer of S. C.
557
+ Johnson & Son, Inc., a household consumer products
558
+ company in Racine, Wisconsin, a position he held since 1997.
559
+ Mr. Perez joined S. C. Johnson & Son, Inc. in
560
+ 1970, where he held a number of senior positions in marketing,
561
+ regional management, and global management, becoming President
562
+ and Chief Operating Officer of Worldwide Consumer Products in
563
+ 1993. Mr. Perez is also a director of Kellogg Company,
564
+ where he serves on the Audit Committee and the Consumer
565
+ Marketing Committee.
566
+ Donald W. Blair, Vice President and Chief Financial
567
+ Officer — Mr. Blair, 47, joined NIKE in November
568
+ 1999. Prior to joining NIKE, he held a number of financial
569
+ management positions with Pepsico, Inc., including Vice
570
+ President, Finance of Pepsi-Cola Asia, Vice President, Planning
571
+ of PepsiCo’s Pizza Hut Division, and Senior Vice President,
572
+ Finance of The Pepsi Bottling Group, Inc. Prior to joining
573
+ Pepsico, Mr. Blair was a certified public accountant with
574
+ Deloitte, Haskins, and Sells.
575
+ Thomas E. Clarke, President of New Ventures —
576
+ Dr. Clarke, 54, a director from 1994 to 2004, joined NIKE
577
+ in 1980. He was appointed divisional Vice President in charge of
578
+ marketing in 1987, elected corporate Vice President in 1989,
579
+ appointed General Manager in 1990, and served as President and
580
+ Chief Operating Officer from 1994 to 2000. Dr. Clarke
581
+ previously held various positions with the Company, primarily in
582
+ research, design, development and marketing. Dr. Clarke
583
+ holds a doctorate degree in biomechanics.
584
+ Wesley A. Coleman, Vice President, Global Human
585
+ Resources — Mr. Coleman, 55, has been employed by
586
+ NIKE since 2002 in his current role. Prior to joining NIKE, he
587
+ held a number of Human Resource positions over a 20-year period
588
+ with S. C. Johnson & Son, Inc., including Vice
589
+ President HR, North America and Vice President HR, Asia/ Pacific.
590
+ Charles D. Denson, President of the NIKE
591
+ Brand — Mr. Denson, 49, has been employed by NIKE
592
+ since 1979. Mr. Denson held several positions within the
593
+ Company, including his appointments as Director of USA Apparel
594
+ Sales in 1994, divisional Vice President, US Sales in 1994,
595
+ divisional Vice President European Sales in 1997, divisional
596
+ Vice President and General Manager, NIKE Europe in 1998, Vice
597
+ President and General Manager of NIKE USA in 2000, and President
598
+ of the NIKE Brand in 2001.
599
+ Gary M. DeStefano, President of USA
600
+ Operations — Mr. DeStefano, 48, has been employed
601
+ by NIKE since 1982, with primary responsibilities in sales and
602
+ regional administration. Mr. DeStefano was appointed
603
+ Director of Domestic Sales in 1990, divisional Vice President in
604
+ charge of domestic sales in 1992, Vice President of Global Sales
605
+ in 1996, Vice President and General Manager of Asia Pacific in
606
+ 1997, and President of USA Operations in 2001.
607
+ Trevor Edwards, Vice President, Global Brand
608
+ Management — Mr. Edwards, 42, joined NIKE in
609
+ 1992. He was appointed Marketing Manager, Strategic Accounts,
610
+ Foot Locker in 1993, Director of Marketing, the Americas in
611
+ 1995, Director of Marketing, Europe in 1997, Vice President,
612
+ Marketing for Europe, Middle East and Africa in 1999, and Vice
613
+ President, US Brand Marketing in 2000. Mr. Edwards was
614
+ appointed corporate Vice President, Global Brand Management in
615
+ 2002.
616
+ Mindy F. Grossman, Vice President of Global
617
+ Apparel — Ms. Grossman, 47, joined NIKE in 2000.
618
+ Prior to joining NIKE, she was President and Chief Executive
619
+ Officer of Polo Jeans Company/ Ralph Lauren, a division of Jones
620
+ Apparel Group, Inc. from 1995 to 2000. Prior to that,
621
+ Ms. Grossman was Vice President of New Business Development
622
+ at Polo Ralph Lauren Corp. from 1994 to 1995, President of The
623
+ Warnaco Group Inc. Chaps Ralph Lauren division, and Senior Vice
624
+ President of The Warnaco Group Inc. Menswear division from 1991
625
+ to 1994.
626
+ Adam S. Helfant, Vice President, Global Sports
627
+ Marketing — Mr. Helfant, 40, joined NIKE in 1995
628
+ in the Company’s legal department, and was appointed
629
+ Director of Business Affairs for Global Sports Marketing in
630
+ 1997, Director of Global Sports Marketing in 1998, Director of
631
+ US Sports Marketing in 2001, Vice President of US Sports
632
+ Marketing in 2003, and corporate Vice President, Global Sports
633
+ Marketing in August 2004. Prior to joining NIKE, he was in
634
+ private practice and an attorney for NHL Enterprises, Inc.
635
+ 9
636
+ Table of Contents
637
+ P. Eunan McLaughlin, Vice President, Europe, Middle
638
+ East & Africa — Mr. McLaughlin, 47, joined
639
+ NIKE as Director of Sales, NIKE Europe in 1999, and was
640
+ appointed Vice President Commercial Sales and Retail in 2000,
641
+ Vice President, Asia Pacific in 2001, and Vice President,
642
+ Europe, Middle East & Africa in May 2004. Prior to
643
+ joining NIKE, he was Partner and Vice President of
644
+ Consumer & Retail Practices Division, Korn/ Ferry
645
+ International from 1996 to 1999. From 1983 to 1996
646
+ Mr. McLaughlin held various positions with Mars, Inc. in
647
+ finance, sales, marketing and general management.
648
+ D. Scott Olivet, Vice President, NIKE Subsidiaries
649
+ and New Business Development — Mr. Olivet, 43,
650
+ joined NIKE in 2001. Prior to joining NIKE, he was a Senior Vice
651
+ President of Gap Inc., responsible for real estate, store
652
+ design, and construction across Gap, Banana Republic, and Old
653
+ Navy brands from 1998 to 2001. Prior to that, Mr. Olivet
654
+ was employed by Bain & Company, an international
655
+ strategic consulting firm from 1984 to 1998 (a Partner from 1993
656
+ to 1998).
657
+ Mark G. Parker, President of the NIKE Brand —
658
+ Mr. Parker, 49, has been employed by NIKE since 1979 with
659
+ primary responsibilities in product research, design and
660
+ development, marketing, and brand management. Mr. Parker
661
+ was appointed divisional Vice President in charge of development
662
+ in 1987, corporate Vice President in 1989, General Manager in
663
+ 1993, Vice President of Global Footwear in 1998, and President
664
+ of the NIKE Brand in 2001.
665
+ Eric D. Sprunk, Vice President, Global
666
+ Footwear — Mr. Sprunk, 41, joined NIKE in 1993.
667
+ He was appointed Finance Director and General Manager of the
668
+ Americas in 1994, Finance Director, NIKE Europe in 1995,
669
+ Regional General Manager, NIKE Europe Footwear in 1998, and Vice
670
+ President & General Manager of the Americas in 2000.
671
+ Mr. Sprunk was appointed corporate Vice President, Global
672
+ Footwear in 2001. Prior to joining NIKE, Mr. Sprunk was a
673
+ certified public accountant with Pricewaterhouse from 1987 to
674
+ 1993.
675
+ Lindsay D. Stewart, Vice President and Chief of Staff,
676
+ and Secretary — Mr. Stewart, 58, joined NIKE as
677
+ Assistant Corporate Counsel in 1981. Mr. Stewart became
678
+ Corporate Counsel in 1983. He was appointed Vice President and
679
+ General Counsel in 1991, and Chief of Staff in 2001. Prior to
680
+ joining NIKE, Mr. Stewart was in private practice and an
681
+ attorney for Georgia-Pacific Corporation.
682
+ Roland P. Wolfram, Vice President and General Manager,
683
+ Asia Pacific — Mr. Wolfram, 45, joined NIKE as Vice
684
+ President, Strategic Planning in 1998, and was appointed Vice
685
+ President, Global Operations & Technology in 2002, and
686
+ Corporate Vice President, Asia Pacific in April 2004. Prior to
687
+ NIKE, Mr. Wolfram was Vice President and General Manager at
688
+ Pacific Bell Video Services.
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@@ -0,0 +1,6 @@
 
 
 
 
 
 
 
1
+ Item 13.
2
+ Certain Relationships and Related Transactions
3
+ The information required by this Item is included under
4
+ “Certain Transactions and Business Relationships” in
5
+ the definitive Proxy Statement for our 2005 Annual Meeting of
6
+ Shareholders and is incorporated herein by reference.
raw/filings/0000320187/2004/0000950124-05-004551/item9a.txt ADDED
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1
+ Item 9A.
2
+ Controls and Procedures
3
+ The Company maintains disclosure controls and procedures that
4
+ are designed to ensure that information required to be disclosed
5
+ in the Company’s Exchange Act reports is recorded,
6
+ processed, summarized and reported within the time periods
7
+ specified in the Securities and Exchange Commission’s rules
8
+ and forms and that such information is accumulated and
9
+ communicated to the Company’s management, including its
10
+ Chief Executive Officer and Chief Financial Officer, as
11
+ appropriate, to allow for timely decisions regarding required
12
+ disclosure. In designing and evaluating the disclosure controls
13
+ and procedures, management recognizes that any controls and
14
+ procedures, no matter how well designed and operated, can
15
+ provide only reasonable assurance of achieving the desired
16
+ control objectives, and management is required to apply its
17
+ judgment in evaluating the cost-benefit relationship of possible
18
+ controls and procedures.
19
+ The Company carries out a variety of on-going procedures, under
20
+ the supervision and with the participation of the Company’s
21
+ management, including the Company’s Chief Executive Officer
22
+ and Chief Financial Officer, to evaluate the effectiveness of
23
+ the design and operation of the Company’s disclosure
24
+ controls and procedures. Based on the foregoing, the
25
+ Company’s Chief Executive Officer and Chief Financial
26
+ Officer concluded that the Company’s disclosure controls
27
+ and procedures were effective at the reasonable assurance level
28
+ as of May 31, 2005.
29
+ Management’s report on internal control over financial
30
+ reporting and the related attestation report of
31
+ PricewaterhouseCoopers LLP are included in Item 8 on
32
+ pages 34-36 of this Report.
33
+ There has been no change in the Company’s internal control
34
+ over financial reporting during the Company’s most recent
35
+ fiscal quarter that has materially affected, or is reasonable
36
+ likely to materially affect, the Company’s internal control
37
+ over financial reporting.
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raw/filings/0000320187/2004/0000950124-05-004551/rpt_disclosure.txt ADDED
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raw/filings/0000320187/2005/0001193125-06-156152/filing.txt ADDED
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2
+ 0000320187,NKE,"NIKE, Inc.",10-K,2006-07-28,2006-05-31,2006-07-29T01:04:57.000Z,0001193125-06-156152,d10k.htm,FORM 10-K,1265560,0,0,https://www.sec.gov/Archives/edgar/data/320187/000119312506156152/d10k.htm,https://www.sec.gov/Archives/edgar/data/320187/000119312506156152/,2005,2005,1
raw/filings/0000320187/2005/0001193125-06-156152/item1.txt ADDED
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1
+ Item 1. Business
2
+ General
3
+ NIKE, Inc. was incorporated in 1968 under the laws of the state of Oregon. As used in this report, the
4
+ terms “we”, “us”, “NIKE” and the “Company” refer to NIKE, Inc. and its predecessors, subsidiaries and affiliates, unless the context indicates otherwise. Our Internet address is www.nike.com. On our
5
+ NIKE Corporate web site, located at www.nikebiz.com, we post the following filings as soon as reasonably practicable after they are electronically filed with or furnished to the Securities and Exchange Commission: our annual report on Form
6
+ 10-K, our quarterly reports on Form 10-Q, our current reports on Form 8-K and any amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities and Exchange Act of 1934. All such filings on our NIKE
7
+ Corporate web site are available free of charge. Also available on the NIKE Corporate web site are the charters of the committees of our board of directors, as well as our corporate governance guidelines and code of ethics; copies of any of these
8
+ documents will be provided in print to any shareholder who submits a request in writing to NIKE Investor Relations, One Bowerman Drive, Beaverton, Oregon 97005-6453.
9
+ Our principal business activity is the design, development and worldwide marketing of high quality footwear, apparel, equipment, and accessory products. NIKE is the largest seller of athletic footwear and athletic
10
+ apparel in the world. We sell our products to retail accounts, through NIKE-owned retail stores, and through a mix of independent distributors and licensees, in over 160 countries around the world. Virtually all of our products are manufactured by
11
+ independent contractors. Virtually all footwear and apparel products are produced outside the United States, while equipment products are produced both in the United States and abroad.
12
+ Products
13
+ NIKE’s athletic footwear products are designed primarily for specific athletic use, although a
14
+ large percentage of the products are worn for casual or leisure purposes. We place considerable emphasis on high quality construction and innovation in products designed for men, women and children. Running, cross-training, basketball, soccer,
15
+ sport-inspired urban shoes, and children’s shoes are currently our top-selling product categories and we expect them to continue to lead in product sales in the near future. We also market shoes designed for tennis, golf, baseball, football,
16
+ walking, hiking, outdoor activities, skateboarding, bicycling, volleyball, wrestling, cheerleading, aquatic activities and other athletic and recreational uses.
17
+ We sell sports apparel and accessories covering most of the above categories, sports inspired lifestyle apparel, as well as athletic bags and accessory items. NIKE apparel and accessories are designed to complement
18
+ our athletic footwear products, feature the same trademarks and are sold through the same marketing and distribution channels. We often market footwear, apparel and accessories in “collections” of similar design or for specific purposes.
19
+ We also market apparel with licensed college and professional team and league logos.
20
+ We sell a line of performance equipment under the
21
+ NIKE brand name, including golf clubs and balls, sport balls, eyewear, timepieces, electronic devices, bats, gloves, protective equipment, and other equipment designed for sports activities. We also have agreements for licensees to produce and sell
22
+ NIKE brand swimwear, cycling apparel, children’s clothing, school supplies, electronic devices, eyewear, golf accessories, and belts. We also sell small amounts of various plastic products to other manufacturers through our wholly-owned
23
+ subsidiary, NIKE IHM, Inc.
24
+ Our wholly-owned subsidiary Converse Inc. (“Converse”), headquartered in North Andover,
25
+ Massachusetts, designs and distributes athletic and casual footwear, apparel and accessories under the Converse ® , Chuck Taylor ® , All Star ® , One
26
+ Star ® and Jack Purcell ® trademarks, and footwear under the Hurley ® trademark.
27
+ We sell a line of dress and casual footwear, apparel and accessories for men and women under the brand names Cole Haan ® , G Series ® and Bragano ® through our wholly-owned subsidiary, Cole Haan Holdings Incorporated (“Cole Haan”), headquartered in Yarmouth, Maine.
28
+ 2
29
+ Table of Contents
30
+ Our wholly-owned subsidiary Hurley International LLC (“Hurley”), headquartered in Costa Mesa,
31
+ California, designs and distributes a line of action sports apparel for surfing, skateboarding, and snowboarding, and youth lifestyle apparel, and accessories under the Hurley ® trademark.
32
+ Our wholly-owned subsidiary, NIKE Bauer Hockey Inc. (“NIKE Bauer Hockey”), headquartered in Greenland, New Hampshire, manufactures and distributes ice skates, skate blades, protective gear, hockey sticks, licensed apparel and
33
+ accessories under the NIKE Bauer ® , Bauer ® , and NIKE ® trademarks. NIKE Bauer ™ also offers a full selection of products for street and roller hockey.
34
+ Our wholly-owned subsidiary, Exeter Brands Group LLC (“Exeter Brands Group”), headquartered in New York City, New York, sells athletic footwear
35
+ and apparel in retail channels for value-conscious consumers, and markets and licenses athletic footwear and apparel under the Starter logo ® and Shaq ® brand names.
36
+ Sales and Marketing
37
+ Financial information about geographic and segment operations appears in Note 17 of the
38
+ consolidated financial statements on page 68.
39
+ We experience moderate fluctuations in aggregate sales volume during the year. Historically,
40
+ revenues in the first and fourth fiscal quarters have slightly exceeded those in the second and third quarters. However, the mix of product sales may vary considerably from time to time as a result of changes in seasonal and geographic demand for
41
+ particular types of footwear, apparel and equipment.
42
+ Because NIKE is a consumer products company, the relative popularity of various
43
+ sports and fitness activities and changing design trends affect the demand for our products. We must therefore respond to trends and shifts in consumer preferences by adjusting the mix of existing product offerings, developing new products, styles
44
+ and categories, and influencing sports and fitness preferences through aggressive marketing. This is a continuing risk. Failure to respond in a timely and adequate manner could have a material adverse effect on our sales and profitability.
45
+ United States Market
46
+ In fiscal 2006, sales in the United States (including U.S. sales of Cole Haan, Converse,
47
+ Exeter Brands Group, Hurley, NIKE Bauer Hockey and NIKE Golf) accounted for approximately 47 percent of total revenues, compared to 46 percent in fiscal 2005 and 47 percent in fiscal 2004. We sell to approximately 24,000 retail accounts in the
48
+ United States. The NIKE brand domestic retail account base includes a mix of footwear stores, sporting goods stores, athletic specialty stores, department stores, skate, tennis and golf shops, and other retail accounts. During fiscal year 2006, our
49
+ three largest customers accounted for approximately 30 percent of NIKE brand sales in the United States excluding sales from NIKE Bauer Hockey and NIKE Golf, and 25 percent of total sales in the United States.
50
+ We make substantial use of our “futures” ordering program, which allows retailers to order five to six months in advance of delivery with the
51
+ commitment that 90 percent of their orders will be delivered within a set time period at a fixed price. In fiscal year 2006, 90 percent of our U.S. wholesale footwear shipments (excluding Cole Haan, Converse, Exeter Brands Group, Hurley, NIKE Bauer
52
+ Hockey and NIKE Golf) were made under the futures program, compared to 91 percent in fiscal 2005 and 90 percent in fiscal 2004. In fiscal 2006, 69 percent of our U.S. wholesale apparel shipments (excluding U.S. licensed team apparel, Cole Haan,
53
+ Converse, Exeter Brands Group, Hurley, NIKE Bauer Hockey and NIKE Golf) were made under the futures program, compared to 71 percent in fiscal 2005, and 67 percent in fiscal 2004.
54
+ 3
55
+ Table of Contents
56
+ We utilize 20 NIKE sales offices to solicit sales in the United States. We also utilize 10 independent
57
+ sales representatives to sell specialty products for golf and outdoor activities. In addition, we sell NIKE brand products through our internet website, www.niketown.com , and we operate the following retail outlets in the United States:
58
+ U.S. Retail Stores
59
+ Number
60
+ NIKE factory stores (which carry primarily overstock and closeout merchandise)
61
+ 87
62
+ NIKE stores (including NIKE Women Stores)
63
+ 14
64
+ NIKETOWNs (designed to showcase NIKE products)
65
+ 12
66
+ NIKE employee-only stores
67
+ 4
68
+ Cole Haan stores (including factory and employee stores)
69
+ 83
70
+ Converse stores (including factory and employee stores)
71
+ 9
72
+ Hurley stores
73
+ 3
74
+ Total
75
+ 212
76
+ NIKE’s domestic distribution centers for footwear are located in Wilsonville, Oregon, and
77
+ Memphis, Tennessee. Apparel and equipment products are shipped from our Memphis, Tennessee, Tigard, Oregon, and Foothill Ranch, California distribution centers. Cole Haan and NIKE Bauer Hockey products are distributed primarily from Greenland, New
78
+ Hampshire, Converse products are shipped from Ontario and Fontana, California, and Hurley products are shipped from Irvine, California.
79
+ International Markets
80
+ We sell our products to retail accounts, through NIKE-owned retail stores, and through a
81
+ mix of independent distributors and licensees, in over 160 countries around the world. Non-U.S. sales (including non-U.S. sales of Cole Haan, Converse, Exeter Brands Group, Hurley, NIKE Bauer Hockey and NIKE Golf) accounted for 53 percent of total
82
+ revenues in fiscal 2006, compared to 54 percent in fiscal 2005 and 53 percent in fiscal 2004. We estimate that we sell to more than 27,000 retail accounts outside the United States, excluding sales by independent distributors and licensees. We
83
+ operate 21 distribution centers in Europe, Asia, Australia, Africa and Canada. In many countries and regions, including Canada, Asia, some Latin American countries, and Europe, we have a futures ordering program for retailers similar to the United
84
+ States futures program described above. NIKE’s three largest customers outside of the U.S. accounted for approximately 11 percent of NIKE brand sales outside the United States excluding sales from NIKE Bauer Hockey and NIKE Golf, and
85
+ approximately 10 percent of total non-U.S. sales.
86
+ We operate the following retail outlets outside the United States:
87
+ Non-U.S. Retail Stores
88
+ Number
89
+ NIKE factory stores
90
+ 106
91
+ NIKE stores and employee-only stores
92
+ 38
93
+ NIKETOWNs
94
+ 2
95
+ Cole Haan stores (including factory and employee stores)
96
+ 59
97
+ Hurley stores
98
+ 1
99
+ Total
100
+ 206
101
+ International branch offices and subsidiaries of NIKE are located in Argentina, Australia,
102
+ Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Indonesia, India, Ireland, Israel, Italy, Japan, Korea, Lebanon, Malaysia, Mexico, New Zealand, The
103
+ Netherlands, Norway, People’s Republic of China, The Philippines, Poland, Portugal, Russia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, the United Kingdom, Uruguay and Vietnam.
104
+ 4
105
+ Table of Contents
106
+ Significant Customer
107
+ Foot Locker Inc., which operates a chain of retail stores specializing in athletic
108
+ footwear and apparel, accounted for approximately 10 percent of global net sales of NIKE, Inc. during fiscal 2006. No other customer accounted for 10 percent or more of our net sales during fiscal 2006.
109
+ Orders
110
+ Worldwide futures and advance orders for NIKE brand athletic footwear and apparel, scheduled for
111
+ delivery from June through November 2006, were $6.6 billion compared to $6.3 billion for the same period last year. This futures and advance order amount is calculated based upon our forecast of the actual exchange rates under which our revenues
112
+ will be translated during this period, which approximate current spot rates. Based upon historical data, we expect that approximately 95 percent of these orders will be filled in that time period, although some orders may be cancelled. Reported
113
+ futures and advance orders are not necessarily indicative of our expectation of revenues for this period. This is because the mix of orders can shift between advance/futures and at-once orders. In addition, foreign currency exchange rate
114
+ fluctuations as well as differing levels of order cancellations and discounts can cause differences in the comparisons between futures and advance orders and actual revenues. Moreover, a significant portion of our revenue is not derived from futures
115
+ and advance orders, including at-once and closeout sales of NIKE footwear and apparel, wholesale sales of equipment, U.S. licensed team apparel, Cole Haan, Converse, Exeter Brands Group, Hurley, NIKE Bauer Hockey, NIKE Golf, and retail sales across
116
+ all brands.
117
+ Product Research and Development
118
+ We believe that our research and development efforts are a key factor in our
119
+ past and future success. Technical innovation in the design of footwear, apparel, and athletic equipment receive continued emphasis as NIKE strives to produce products that help to reduce injury, enhance athletic performance and maximize comfort.
120
+ In addition to NIKE’s own staff of specialists in the areas of biomechanics, exercise physiology, engineering, industrial design and
121
+ related fields, we also utilize research committees and advisory boards made up of athletes, coaches, trainers, equipment managers, orthopedists, podiatrists and other experts who consult with us and review designs, materials and concepts for
122
+ product improvement. Employee athletes and other athletes wear-test and evaluate products during the design and development process.
123
+ Manufacturing
124
+ Virtually all of our footwear is produced outside of the United States. In fiscal 2006, contract
125
+ suppliers in China, Vietnam, Indonesia and Thailand manufactured 35 percent, 29 percent, 21 percent and 13 percent of total NIKE brand footwear, respectively. We also have manufacturing agreements with independent factories in Argentina, Brazil,
126
+ India, Italy, and South Africa to manufacture footwear for sale primarily within those countries. Our largest single footwear factory accounted for approximately 6 percent of total fiscal 2006 footwear production.
127
+ Almost all of NIKE brand apparel production for sale to the United States market, and all of our apparel production for sale to the international market,
128
+ was manufactured outside of the United States by independent contract manufacturers located in 40 countries. Most of this apparel production occurred in Bangladesh, China, Honduras, India, Indonesia, Malaysia, Mexico, Pakistan, Sri Lanka, Taiwan,
129
+ Thailand, Turkey and Vietnam. Our largest single apparel factory accounted for approximately 5 percent of total fiscal 2006 apparel production.
130
+ The principal materials used in our footwear products are natural and synthetic rubber, plastic compounds, foam cushioning materials, nylon, leather, canvas and polyurethane films used to make Air-Sole cushioning components. NIKE IHM, Inc.
131
+ and NIKE (Suzhou) Sports Company, Ltd., wholly-owned subsidiaries of NIKE, are our largest suppliers of the Air-Sole cushioning components used in footwear. The principal materials used in our apparel products are natural and synthetic fabrics and
132
+ threads, plastic and metal hardware, and specialized
133
+ 5
134
+ Table of Contents
135
+ performance fabrics designed to repel rain, retain heat, or efficiently transport body moisture. NIKE and its contractors and suppliers buy raw materials in
136
+ bulk. Most raw materials are available in the countries where manufacturing takes place. We have thus far experienced little difficulty in satisfying our raw material requirements.
137
+ Since 1972, Sojitz Corporation of America (“Sojitz America”) and its predecessor, Nissho Iwai American Corporation, a subsidiary of Nissho Iwai
138
+ Corporation, a large Japanese trading company, have performed significant import-export financing services for us. During fiscal 2006, Sojitz America provided such financing services for most of the NIKE brand products sold outside of the United
139
+ States, Europe, Middle East, Africa and Japan, excluding products produced and sold in the same country. However, less than 13 percent of NIKE brand products, excluding products produced and sold in the same country, were sold outside of the United
140
+ States, Europe, Middle East, Africa and Japan in fiscal 2006. Any failure of Sojitz America to provide these services or any failure of Sojitz America’s banks could disrupt our ability to acquire products from our suppliers and to deliver
141
+ products to our customers outside of the United States, Europe, Middle East, Africa and Japan. Such a disruption could result in cancelled orders that would adversely affect sales and profitability. However, we believe that any such disruption would
142
+ be short term in duration due to the ready availability of alternative sources of financing at competitive rates. Our current agreements with Sojitz America expire on May 31, 2008.
143
+ International Operations and Trade
144
+ Our international operations and sources of supply are subject to the usual
145
+ risks of doing business abroad, such as possible revaluation of currencies, export duties, anti-dumping duties, quotas, safeguard measures, trade restrictions, restrictions on the transfer of funds and, in certain parts of the world, political
146
+ instability and terrorism. We have not, to date, been materially affected by any such risk, but cannot predict the likelihood of such developments occurring. We believe that we have the ability to develop, over a period of time, adequate alternative
147
+ sources of supply for the products obtained from our present suppliers outside of the United States. If events prevented us from acquiring products from our suppliers in a particular country, our operations could be temporarily disrupted and we
148
+ could experience an adverse financial impact. However, we believe that we could abate any such disruption within a period of no more than 12 months, and that much of the adverse impact on supply would, therefore, be of a short-term nature. We
149
+ believe that our principal competitors are subject to similar risks.
150
+ As a result of the Trade Act of 2003, the United States implemented
151
+ significant new Federal requirements for cargo security, focused on imports of containerized cargo. We are a significant importer of containerized cargo. Accordingly, we participate actively in appropriate governmental programs, such as the Customs
152
+ Trade Partnership Against Terrorism, to reduce risks of possible supply disruptions caused by U.S. and international cargo security mandates and terrorism. Additionally in 2006, we and a broad coalition of businesses have been actively working with
153
+ the United States Congress as it considers legislation to make U.S. ports more secure. We are actively following this proposed legislation and believe that any legislation, if passed, will not have a significant impact on our supply chain. We
154
+ believe that our major competitors stand in much the same position of risk regarding this potential legislation.
155
+ All of our products
156
+ manufactured overseas and imported into the United States, the European Union and other countries are subject to customs duties collected by customs authorities. Customs information submitted by us is routinely subject to review by customs
157
+ authorities. We are unable to predict whether additional customs duties, anti-dumping duties, quotas, safeguard measures, or other trade restrictions may be imposed on the importation of our products in the future. Such actions could result in
158
+ increases in the cost of our products generally and might adversely affect the sales or profitability of NIKE and the imported footwear and apparel industry as a whole. Accordingly, we are actively monitoring the developments described below.
159
+ Footwear Imports into the European Union
160
+ From 1994 through January 1, 2005, the European Union (“EU”) imposed limits (or “quotas”) on the import of certain types of footwear manufactured in China. Footwear designed for use in
161
+ sporting activities, meeting
162
+ 6
163
+ Table of Contents
164
+ certain technical criteria and having a CIF (cost, insurance and freight) price above nine euros (“Special Technology Athletic Footwear” or
165
+ “STAF”), was excluded from the quotas. As a result of the STAF exclusion, and the amount of quota made available to us, the quotas did not have a material effect on our business. However, as part of China’s 2001 accession to the World
166
+ Trade Organization (“WTO”), China entered into an agreement with the EU and other WTO members to abide by a special safeguard arrangement whereby quotas could be imposed on any product sourced in China, including footwear, if there was a
167
+ surge in imports from China into another WTO country, and after a legal proceeding it was determined that such imports were injuring a domestic producer. Additionally, under longstanding WTO rules, all WTO member countries reserved the right to
168
+ impose (1) safeguard measures (temporary quotas) if it can be demonstrated in a legal proceeding that increased imports are injuring another WTO member’s domestic industry; and (2) anti-dumping measures if it can be demonstrated in a
169
+ legal proceeding that imports are being sold at an unfair low price in another WTO member’s home market, and those imports were causing or threatening to cause material injury to the domestic industry.
170
+ Accordingly, with the phase-out of the quotas at the beginning of 2005, and the expiration of a separate EU anti-dumping case in 2003 against footwear
171
+ made in China, Indonesia, and Thailand, there has been renewed pressure from some parts of the EU footwear manufacturing sector to re-impose some level of trade protection on imported footwear from China, India, Vietnam, and other exporting
172
+ countries. In July 2005, the European Commission, at the request of the European domestic footwear industry, initiated investigations into leather footwear imported from China and Vietnam. NIKE and all other major athletic footwear manufacturers are
173
+ currently participating actively as respondents in this investigation and are taking the position that athletic footwear (i) should not be within the product scope of this investigation and (ii) does not meet the legal requirements of
174
+ injury and price in an anti-dumping investigation. The EU agreed on provisional anti-dumping duties in March 2006 but excluded STAF from the measures. We anticipate that the definitive anti-dumping duties will be adopted by early October 2006 and we
175
+ expect STAF to be excluded from the final measures. We believe that our major competitors stand in much the same position regarding these potential trade measures.
176
+ Vietnam Imports into the United States
177
+ We currently source a portion of our footwear and apparel
178
+ products from factories in Vietnam. In 2001, the United States Congress and the Vietnamese National Assembly approved a comprehensive bilateral trade agreement, which, among other things, provides reciprocal, non-discriminatory Normal Trade
179
+ Relations (“NTR”) between the U.S. and Vietnam. Following that approval, the U.S. granted an annual extension of NTR to Vietnam. The U.S. President must renew this grant annually with the opportunity for review by Congress. In June 2006,
180
+ President Bush renewed NTR for Vietnam for an additional year and we anticipate Congress will support this decision, as it has done for the past five years. Additionally, in the spring of 2006 Vietnam finished its WTO accession negotiations with
181
+ several WTO countries and has embarked on entering the WTO as a full member. Legislation has been introduced within Congress to provide Vietnam Permanent Normal Trade Relations (“PNTR”) and we anticipate Congressional approval of this
182
+ legislation in 2006. Vietnam’s entry into the WTO and the U.S. providing Vietnam PNTR will provide us greater certainty about our business within Vietnam. It will likewise enable us to further expand our production and marketing opportunities
183
+ in Vietnam and allow for Vietnamese-sourced products to continue to enter the United States at NTR tariff rates.
184
+ Competition
185
+ The athletic footwear, apparel and equipment industry is keenly competitive in the United States
186
+ and on a worldwide basis. We compete internationally with an increasing number of athletic and leisure shoe companies, athletic and leisure apparel companies, sports equipment companies, and large companies having diversified lines of athletic and
187
+ leisure shoes, apparel and equipment, including Adidas and others. The intense competition and the rapid changes in technology and consumer preferences in the markets for athletic and leisure footwear and apparel, and athletic equipment, constitute
188
+ significant risk factors in our operations.
189
+ 7
190
+ Table of Contents
191
+ NIKE is the largest seller of athletic footwear and athletic apparel in the world. Performance and
192
+ reliability of shoes, apparel, and equipment, new product development, price, product identity through marketing and promotion, and customer support and service are important aspects of competition in the athletic footwear, apparel and equipment
193
+ industry. To help market our products, we contract with prominent and influential athletes, coaches, teams, colleges and sports leagues to endorse our brands and use our products, and we actively sponsor sporting events and clinics. We believe that
194
+ we are competitive in all of these areas.
195
+ Trademarks and Patents
196
+ We utilize trademarks on nearly all of our products and believe that having distinctive
197
+ marks that are readily identifiable is an important factor in creating a market for our goods, in identifying the Company, and in distinguishing our goods from the goods of others. We consider our NIKE ® and Swoosh Design ® trademarks to be among our most valuable assets and we have registered these trademarks in over 100 countries. In
198
+ addition, we own many other trademarks that we utilize in marketing our products. We continue to vigorously protect our trademarks against infringement.
199
+ NIKE has an exclusive, worldwide license to make and sell footwear using patented “Air” technology. The process utilizes pressurized gas encapsulated in polyurethane. Some of the early NIKE AIR ® patents have expired, which may enable competitors to
200
+ use certain types of similar technology. Subsequent NIKE AIR ® patents will not expire for several years. We also have hundreds of U.S. and foreign patents covering components, features, and designs used in various athletic and leisure shoes, apparel and equipment. These patents
201
+ expire at various times, and have a remaining duration of from now to at least 2026, although the duration of patents varies by country. We believe that our success depends primarily upon skills in design, research and development, production and
202
+ marketing rather than upon our patent position. However, we have followed a policy of filing applications for United States and foreign patents on inventions, designs and improvements that we deem valuable.
203
+ Employees
204
+ We had approximately 28,000 employees at May 31, 2006. Management considers its relationship
205
+ with employees to be excellent. None of our employees is represented by a union, with the exception of NIKE Bauer Hockey Inc. Of NIKE Bauer Hockey’s employees, approximately 37 percent, or approximately 183, are covered by three union
206
+ collective bargaining agreements with three separate bargaining units. The collective bargaining agreements expire on various dates from 2007 through 2008. There has never been a material interruption of operations due to labor disagreements.
207
+ Executive Officers of the Registrant
208
+ The executive officers of NIKE as of July 25, 2006 are as follows:
209
+ Philip H. Knight, Chairman of the Board — Mr. Knight, 68, a director since 1968, is a co-founder of NIKE and, except for
210
+ the period from June 1983 through September 1984, served as its President from 1968 to 1990, and from June 2000 to December 2004. Prior to 1968, Mr. Knight was a certified public accountant with Price Waterhouse and Coopers & Lybrand
211
+ and was an Assistant Professor of Business Administration at Portland State University.
212
+ Mark G. Parker, Chief Executive Officer and
213
+ President — Mr. Parker, 50, was appointed CEO and President in January 2006. He has been employed by NIKE since 1979 with primary responsibilities in product research, design and development, marketing, and brand management.
214
+ Mr. Parker was appointed divisional Vice President in charge of development in 1987, corporate Vice President in 1989, General Manager in 1993, Vice President of Global Footwear in 1998, and President of the NIKE Brand in 2001.
215
+ Lewis L. Bird III, President, Subsidiaries — Mr. Bird, 42, joined NIKE as President, Subsidiaries in July 2006. Prior to joining NIKE,
216
+ he held a number of management positions within multinational companies with
217
+ 8
218
+ Table of Contents
219
+ diverse brand portfolios. He was Executive Vice President of New Business Development for Gap Inc. from September 2005 to March 2006. Prior to that,
220
+ Mr. Bird served as Chief Operating Officer of Gap Inc.’s North American division from March 2003 to September 2005, Chief Financial Officer of Gap Inc.’s Old Navy division from 2001 to 2003, Vice President Finance &
221
+ Operations of Gateway, Inc. from 1999 to 2001, Director of business Analysis & Planning at AlliedSignal Inc. from 1998 to 1999, and prior to that held financial management positions with AlliedSignal, Ford Motor Company and BayBanks, Inc.
222
+ Donald W. Blair, Vice President and Chief Financial Officer — Mr. Blair, 48, joined NIKE in November 1999. Prior to
223
+ joining NIKE, he held a number of financial management positions with Pepsico, Inc., including Vice President, Finance of Pepsi-Cola Asia, Vice President, Planning of PepsiCo’s Pizza Hut Division, and Senior Vice President, Finance of The Pepsi
224
+ Bottling Group, Inc. Prior to joining Pepsico, Mr. Blair was a certified public accountant with Deloitte, Haskins, and Sells.
225
+ Mary
226
+ Kate Buckley, Vice President/General Manager, Americas and NIKE Bauer Hockey — Ms. Buckley, 46, has been employed by NIKE since 1998. She was appointed Director of New Business Development in 1998, Director of nike.com in 1998,
227
+ divisional Vice President of nike.com in 1999, and divisional Vice President and General Manger, Americas Region in 2001. Ms. Buckley was appointed corporate Vice President and General Manager, Americas and NIKE Bauer Hockey in July 2006. Prior
228
+ to joining NIKE, Ms. Buckley worked in several positions in finance, marketing and strategic planning for The Walt Disney Company.
229
+ Thomas E. Clarke, President of New Ventures — Dr. Clarke, 55, a director from 1994 to 2004, joined NIKE in 1980. He was appointed divisional Vice President in charge of marketing in 1987, elected corporate Vice President in
230
+ 1989, appointed General Manager in 1990, and served as President and Chief Operating Officer from 1994 to 2000. Dr. Clarke previously held various positions with the Company, primarily in research, design, development and marketing.
231
+ Dr. Clarke holds a doctorate degree in biomechanics.
232
+ Wesley A. Coleman, Vice President, Global Human Resources —
233
+ Mr. Coleman, 56, has been employed by NIKE since 2002 in his current role. Prior to joining NIKE, he held a number of Human Resource positions over a 20-year period with S. C. Johnson & Son, Inc., including Vice President HR, North
234
+ America and Vice President HR, Asia/Pacific.
235
+ Charles D. Denson, President of the NIKE Brand — Mr. Denson, 50, has been
236
+ employed by NIKE since 1979. Mr. Denson held several management positions within the Company, including his appointments as Director of USA Apparel Sales in 1994, divisional Vice President, U.S. Sales in 1994, divisional Vice President European
237
+ Sales in 1997, divisional Vice President and General Manager, NIKE Europe in 1998, Vice President and General Manager of NIKE USA in 2000, and President of the NIKE Brand in 2001.
238
+ Gary M. DeStefano, President of USA Operations — Mr. DeStefano, 49, has been employed by NIKE since 1982, with primary responsibilities
239
+ in sales and regional administration. Mr. DeStefano was appointed Director of Domestic Sales in 1990, divisional Vice President in charge of domestic sales in 1992, Vice President of Global Sales in 1996, Vice President and General Manager of
240
+ Asia Pacific in 1997, and President of USA Operations in 2001.
241
+ Trevor Edwards, Vice President, Global Brand Management —
242
+ Mr. Edwards, 43, joined NIKE in 1992. He was appointed Marketing Manager, Strategic Accounts, Foot Locker in 1993, Director of Marketing, the Americas in 1995, Director of Marketing, Europe in 1997, Vice President, Marketing for Europe, Middle
243
+ East and Africa in 1999, and Vice President, U.S. Brand Marketing in 2000. Mr. Edwards was appointed corporate Vice President, Global Brand Management in 2002.
244
+ Adam S. Helfant, Vice President, Global Sports Marketing — Mr. Helfant, 41, joined NIKE in 1995 in the Company’s legal department, and was appointed Director of Business Affairs for Global Sports
245
+ Marketing in 1997, Director of Global Sports Marketing in 1998, Director of U.S. Sports Marketing in 2001, Vice President of U.S. Sports Marketing in 2003, and corporate Vice President, Global Sports Marketing in August 2004. Prior to joining NIKE,
246
+ he was in private practice and an attorney for NHL Enterprises, Inc.
247
+ 9
248
+ Table of Contents
249
+ P. Eunan McLaughlin, Vice President, Europe, Middle East & Africa —
250
+ Mr. McLaughlin, 48, joined NIKE as Director of Sales, NIKE Europe in 1999, and was appointed Vice President Commercial Sales and Retail in 2000, Vice President, Asia Pacific in 2001, and Vice President, Europe, Middle East & Africa in
251
+ May 2004. Prior to joining NIKE, he was Partner and Vice President of Consumer & Retail Practices Division, Korn/Ferry International from 1996 to 1999. From 1983 to 1996 Mr. McLaughlin held various positions with Mars, Inc. in finance,
252
+ sales, marketing and general management.
253
+ Eric D. Sprunk, Vice President, Global Footwear — Mr. Sprunk, 42, joined NIKE in
254
+ 1993. He was appointed Finance Director and General Manager of the Americas in 1994, Finance Director, NIKE Europe in 1995, Regional General Manager, NIKE Europe Footwear in 1998, and Vice President & General Manager of the Americas in
255
+ 2000. Mr. Sprunk was appointed corporate Vice President, Global Footwear in 2001. Prior to joining NIKE, Mr. Sprunk was a certified public accountant with Price Waterhouse from 1987 to 1993.
256
+ Lindsay D. Stewart, Vice President and Chief of Staff — Mr. Stewart, 59, joined NIKE as Assistant Corporate Counsel in 1981.
257
+ Mr. Stewart became Corporate Counsel in 1983. He was appointed Vice President and General Counsel in 1991, and Chief of Staff in 2001. Prior to joining NIKE, Mr. Stewart was in private practice and an attorney for Georgia-Pacific
258
+ Corporation.
259
+ Hans van Alebeek, Vice President, Global Operations & Technology — Mr. van Alebeek, 40, joined NIKE
260
+ as Director of Operations of Europe in 1999, and was appointed Vice President, Operations & Administration in EMEA in 2001, Vice President, Global Operations in 2003, Vice President, Global Operations & Technology in 2004, and
261
+ Corporate Vice President in November 2005. Prior to joining NIKE, Mr. van Alebeek worked for McKinsey & Company as a management consultant, and at N.V. Indivers in business development.
262
+ Roland P. Wolfram, Vice President and General Manager, Asia Pacific — Mr. Wolfram, 46, joined NIKE as Vice President, Strategic Planning
263
+ in 1998, and was appointed Vice President, Global Operations & Technology in 2002, and Corporate Vice President, Asia Pacific in April 2004. Prior to NIKE, Mr. Wolfram was Vice President and General Manager at Pacific Bell Video
264
+ Services.
265
+ Roger S. Wyett, Vice President, Global Apparel — Mr. Wyett, 49, returned to NIKE in April 2005 as President and
266
+ Chief Operating Officer of the Company’s Hurley brand and was appointed Vice President, Global Apparel in 2006. Mr. Wyett first joined NIKE in 1994, holding a number of management positions in soccer and NIKE Team Sports. In 2000,
267
+ Mr. Wyett joined The Walt Disney Company where he was Senior Vice President for Global Apparel, Accessories and Footwear, and later promoted to Executive Vice President for Global Sales and Marketing for Consumer Products.
raw/filings/0000320187/2005/0001193125-06-156152/item13.txt ADDED
@@ -0,0 +1,3 @@
 
 
 
 
1
+ Item 13. Certain Relationships and Related Transactions
2
+ The
3
+ information required by this Item is included under “Certain Transactions and Business Relationships” in the definitive Proxy Statement for our 2006 Annual Meeting of Shareholders and is incorporated herein by reference.
raw/filings/0000320187/2005/0001193125-06-156152/item9a.txt ADDED
@@ -0,0 +1,13 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
+ Item 9A. Controls and Procedures
2
+ We maintain disclosure
3
+ controls and procedures that are designed to ensure that information required to be disclosed in our Exchange Act reports is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange
4
+ Commission’s rules and forms and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow for timely decisions regarding required
5
+ disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control
6
+ objectives, and management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
7
+ We carry out a variety of on-going procedures, under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, to evaluate the effectiveness of the design and operation
8
+ of our disclosure controls and procedures. Based on the foregoing, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of May 31,
9
+ 2006.
10
+ “Management’s Report on Internal Control Over Financial Reporting” and the related attestation report of
11
+ PricewaterhouseCoopers LLP are included in Item 8 on pages 43-45 of this Report.
12
+ There has been no change in our internal control
13
+ over financial reporting during our most recent fiscal quarter that has materially affected, or is reasonable likely to materially affect, our internal control over financial reporting.
raw/filings/0000320187/2005/0001193125-06-156152/rp_note.txt ADDED
File without changes
raw/filings/0000320187/2005/0001193125-06-156152/rpt_disclosure.txt ADDED
File without changes
raw/filings/0000320187/2007/0001193125-08-159004/filing_metadata.csv ADDED
@@ -0,0 +1,2 @@
 
 
 
1
+ cik,ticker,company_name,form,filing_date,report_date,acceptance_datetime,accession_number,primary_document,primary_doc_description,size,is_xbrl,is_inline_xbrl,document_url,filing_index_url,year,fiscal_year,is_primary_filing
2
+ 0000320187,NKE,"NIKE, Inc.",10-K,2008-07-28,2008-05-31,2008-07-29T00:08:06.000Z,0001193125-08-159004,d10k.htm,FORM 10-K,1502118,0,0,https://www.sec.gov/Archives/edgar/data/320187/000119312508159004/d10k.htm,https://www.sec.gov/Archives/edgar/data/320187/000119312508159004/,2007,2007,1
raw/filings/0000320187/2007/0001193125-08-159004/item1.txt ADDED
@@ -0,0 +1,259 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
+ Item 1. Business
2
+ General
3
+ NIKE, Inc. was incorporated in 1968 under the laws of the state of Oregon. As used in this
4
+ report, the terms “we”, “us”, “NIKE” and the “Company” refer to NIKE, Inc. and its predecessors, subsidiaries and affiliates, unless the context indicates otherwise. Our Internet address is
5
+ www.nike.com. On our NIKE Corporate web site, located at www.nikebiz.com, we post the following filings as soon as reasonably practicable after they are electronically filed with or furnished to the Securities and Exchange Commission:
6
+ our annual report on Form 10-K, our quarterly reports on Form 10-Q, our current reports on Form 8-K and any amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities and Exchange Act of 1934, as
7
+ amended. All such filings on our NIKE Corporate web site are available free of charge. Also available on the NIKE Corporate web site are the charters of the committees of our board of directors, as well as our corporate governance guidelines and
8
+ code of ethics; copies of any of these documents will be provided in print to any shareholder who submits a request in writing to NIKE Investor Relations, One Bowerman Drive, Beaverton, Oregon 97005-6453.
9
+ Our principal business activity is the design, development and worldwide marketing of high quality footwear, apparel, equipment, and accessory products.
10
+ NIKE is the largest seller of athletic footwear and athletic apparel in the world. We sell our products to retail accounts, through NIKE-owned retail including stores and internet sales, and through a mix of independent distributors and licensees,
11
+ in over 180 countries around the world. Virtually all of our products are manufactured by independent contractors. Virtually all footwear and apparel products are produced outside the United States, while equipment products are produced both in the
12
+ United States and abroad.
13
+ Products
14
+ NIKE’s athletic footwear products are designed primarily for specific athletic use, although a large percentage of the products are worn for casual or leisure purposes. We place considerable emphasis on high
15
+ quality construction and innovation in products designed for men, women and children. Running, training, basketball, soccer, sport-inspired urban shoes, and children’s shoes are currently our top-selling footwear categories and we expect them
16
+ to continue to lead in product sales in the near future. We also market shoes designed for aquatic activities, baseball, bicycling, cheerleading, football, golf, lacrosse, outdoor activities, skateboarding, tennis, volleyball, walking, wrestling,
17
+ and other athletic and recreational uses.
18
+ We sell sports apparel and accessories covering most of the above categories, sports-inspired
19
+ lifestyle apparel, as well as athletic bags and accessory items. NIKE apparel and accessories are designed to complement our athletic footwear products, feature the same trademarks and are sold through the same marketing and distribution channels.
20
+ We often market footwear, apparel and accessories in “collections” of similar design or for specific purposes. We also market apparel with licensed college and professional team and league logos.
21
+ We sell a line of performance equipment under the NIKE brand name, including bags, socks, sport balls, eyewear, timepieces, electronic devices, bats,
22
+ gloves, protective equipment, golf clubs, and other equipment designed for sports activities. We also have agreements for licensees to produce and sell NIKE brand swimwear, team sports apparel, training equipment, children’s clothing,
23
+ electronic devices, eyewear, golf accessories, and belts. We also sell small amounts of various plastic products to other manufacturers through our wholly-owned subsidiary, NIKE IHM, Inc.
24
+ Our wholly-owned subsidiary, Cole Haan (“Cole Haan”), headquartered in Yarmouth, Maine,
25
+ designs and distributes dress and casual footwear, apparel and accessories for men and women under the brand names Cole Haan ® and Bragano ® .
26
+ 2
27
+ Table of Contents
28
+ Our wholly-owned subsidiary, Converse Inc.
29
+ (“Converse”), headquartered in North Andover, Massachusetts, designs, distributes, and licenses athletic and casual footwear, apparel and accessories under the Converse ® , Chuck
30
+ Taylor ® , All Star ® , One Star ® , John Varvatos ® , and Jack Purcell ® trademarks and footwear under the Hurley ® trademark.
31
+ Our wholly-owned subsidiary, Hurley International LLC (“Hurley”),
32
+ headquartered in Costa Mesa, California, designs and distributes a line of action sports apparel for surfing, skateboarding, and snowboarding, youth lifestyle apparel, and accessories under the Hurley ® trademark.
33
+ On March 3, 2008, we acquired all of the capital stock of Umbro Ltd. (“Umbro”).
34
+ Headquartered in Manchester, England. Umbro designs, distributes, and licenses athletic and casual footwear, apparel and equipment, primarily for the sport of soccer, under the Umbro trademarks.
35
+ Sales and Marketing
36
+ Financial information about geographic and segment operations appears in Note 17 of the consolidated financial statements on page 75.
37
+ We experience moderate fluctuations in aggregate sales volume during the year. Historically, revenues in the first and fourth fiscal quarters have slightly exceeded those in the second and third quarters. However, the mix of product sales
38
+ may vary considerably from time to time as a result of changes in seasonal and geographic demand for particular types of footwear, apparel and equipment.
39
+ Because NIKE is a consumer products company, the relative popularity of various sports and fitness activities and changing design trends affect the demand for our products. We must therefore respond to trends and
40
+ shifts in consumer preferences by adjusting the mix of existing product offerings, developing new products, styles and categories, and influencing sports and fitness preferences through aggressive marketing. Failure to respond in a timely and
41
+ adequate manner could have a material adverse effect on our sales and profitability. This is a continuing risk.
42
+ United States
43
+ Market
44
+ In fiscal 2008, sales in the United States including U.S. sales of Cole Haan, Converse, Exeter Brands Group (which we sold
45
+ in December, 2007), Hurley, Umbro, NIKE Bauer Hockey (which we sold in April, 2008) and NIKE Golf accounted for approximately 43 percent of total revenues, compared to 47 percent in fiscal 2007 and 47 percent in fiscal 2006. We estimate that we sell
46
+ to more than 25,000 retail accounts in the United States. The NIKE brand domestic retail account base includes a mix of footwear stores, sporting goods stores, athletic specialty stores, department stores, skate, tennis and golf shops, and other
47
+ retail accounts. During fiscal year 2008, our three largest customers accounted for approximately 24 percent of NIKE brand sales in the United States.
48
+ We make substantial use of our “futures” ordering program, which allows retailers to order five to six months in advance of delivery with the commitment that their orders will be delivered within a set
49
+ time period at a fixed price. In fiscal year 2008, 86 percent of our U.S. wholesale footwear shipments (excluding Cole Haan, Converse, Exeter Brands Group, Hurley, NIKE Golf, Umbro, and NIKE Bauer Hockey) were made under the futures program,
50
+ compared to 94 percent in fiscal 2007 and 90 percent in fiscal 2006. In fiscal 2008, 62 percent of our U.S. wholesale apparel shipments (excluding Cole Haan, Converse, Exeter Brands Group, Hurley, NIKE Golf, Umbro, and NIKE Bauer Hockey) were made
51
+ under the futures program, compared to 65 percent in fiscal 2007 and 2006.
52
+ 3
53
+ Table of Contents
54
+ We utilize 18 NIKE sales offices to solicit sales in the United States. We also utilize 4 independent
55
+ sales representatives to sell specialty products for golf, and 2 for skating and outdoor products. In addition, we sell NIKE brand products through our internet website, www.nikestore.com , and we operate the following retail outlets in the
56
+ United States:
57
+ U.S. Retail Stores
58
+ Number
59
+ NIKE factory stores (which carry primarily overstock and close-out merchandise)
60
+ 121
61
+ NIKE stores (including one NIKE Women store)
62
+ 14
63
+ NIKETOWNs (designed to showcase NIKE products)
64
+ 12
65
+ NIKE employee-only stores
66
+ 3
67
+ Cole Haan stores (including factory and employee stores)
68
+ 102
69
+ Converse stores (including factory and employee stores)
70
+ 35
71
+ Hurley stores
72
+ 9
73
+ Total
74
+ 296
75
+ NIKE’s United States distribution centers for footwear are located in Wilsonville, Oregon,
76
+ and Memphis, Tennessee. Apparel and equipment products are shipped from our Memphis, Tennessee, Tigard, Oregon, and Foothill Ranch, California distribution centers. Cole Haan products are distributed primarily from Greenland, New Hampshire, Converse
77
+ products are shipped from Ontario, California, and Hurley products are distributed from Irvine, California.
78
+ International
79
+ Markets
80
+ In fiscal 2008, non-U.S. sales (including non-U.S. sales of Cole Haan, Converse, Exeter Brands Group, Hurley, NIKE Bauer
81
+ Hockey, Umbro, and NIKE Golf) accounted for 57 percent of total revenues, compared to 53 percent in fiscal 2007 and 53 percent in fiscal 2006. We sell our products to retail accounts, through NIKE-owned retail stores, and through a mix of
82
+ independent distributors and licensees around the world. We estimate that we sell to more than 27,000 retail accounts outside the United States, excluding sales by independent distributors and licensees. We operate 11 distribution centers outside of
83
+ the United States. In many countries and regions, including Canada, Asia, some Latin American countries, and Europe, we have a futures ordering program for retailers similar to the United States futures program described above. NIKE’s three
84
+ largest customers outside of the U.S. accounted for approximately 9 percent of total non-U.S. sales.
85
+ We operate the following retail
86
+ outlets outside the United States:
87
+ Non-U.S. Retail Stores
88
+ Number
89
+ NIKE factory stores
90
+ 141
91
+ NIKE stores
92
+ 46
93
+ NIKETOWNs
94
+ 3
95
+ NIKE employee-only stores
96
+ 12
97
+ Cole Haan stores
98
+ 57
99
+ Hurley stores
100
+ 1
101
+ Total
102
+ 260
103
+ International branch offices and subsidiaries of NIKE are located in Argentina, Australia,
104
+ Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Indonesia, India, Ireland, Israel, Italy, Japan, Korea, Lebanon, Macau, Malaysia, Mexico,
105
+ New Zealand, the Netherlands, Norway, People’s Republic of China, the Philippines, Poland, Portugal, Russia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, the United Arab
106
+ Emirates, the United Kingdom, Uruguay and Vietnam.
107
+ 4
108
+ Table of Contents
109
+ Significant Customer
110
+ No customer accounted for 10 percent or more of our net sales during fiscal 2008.
111
+ Orders
112
+ Worldwide futures and advance orders for NIKE brand athletic footwear
113
+ and apparel, scheduled for delivery from June through November 2008, were $8.8 billion compared to $7.7 billion for the same period last year. This futures and advance order amount is calculated based upon our forecast of the actual exchange rates
114
+ under which our revenues will be translated during this period, which approximate current spot rates. Based upon historical data, we expect that approximately 95 percent of these orders will be filled in that time period, although some orders may be
115
+ cancelled. Reported futures and advance orders are not necessarily indicative of our expectation of revenues for this period. This is because the mix of orders can shift between advance/futures and at-once orders. In addition, foreign currency
116
+ exchange rate fluctuations as well as differing levels of order cancellations and discounts can cause differences in the comparisons between futures and advance orders and actual revenues. Moreover, a significant portion of our revenue is not
117
+ derived from futures and advance orders, including at-once and close-out sales of NIKE footwear and apparel, wholesale sales of equipment, Cole Haan, Converse, Hurley, Umbro, NIKE Golf, and retail sales across all brands.
118
+ Product Research and Development
119
+ We believe that our research and development efforts are a key factor in our past and future success. Technical innovation in the design of footwear, apparel, and athletic equipment receive continued emphasis as NIKE strives to produce
120
+ products that help to reduce injury, enhance athletic performance and maximize comfort.
121
+ In addition to NIKE’s own staff of
122
+ specialists in the areas of biomechanics, exercise physiology, engineering, industrial design and related fields, we also utilize research committees and advisory boards made up of athletes, coaches, trainers, equipment managers, orthopedists,
123
+ podiatrists and other experts who consult with us and review designs, materials and concepts for product improvement. Employee athletes and other athletes wear-test and evaluate products during the design and development process.
124
+ Manufacturing
125
+ Virtually all
126
+ of our footwear is produced outside of the United States. In fiscal 2008, contract suppliers in China, Vietnam, Indonesia and Thailand manufactured 36 percent, 33 percent, 21 percent and 9 percent of total NIKE brand footwear, respectively. We also
127
+ have manufacturing agreements with independent factories in Argentina, Brazil, India, Italy, and South Africa to manufacture footwear for sale primarily within those countries. Our largest single footwear factory accounted for approximately 6
128
+ percent of total fiscal 2008 footwear production.
129
+ Almost all of NIKE brand apparel production was manufactured outside of the United
130
+ States by independent contract manufacturers located in 34 countries. Most of this apparel production occurred in China, Thailand, Indonesia, Malaysia, Vietnam, Turkey, Sri Lanka, Honduras, Mexico, Taiwan, Israel, Cambodia, India and Bangladesh. Our
131
+ largest single apparel factory accounted for approximately 8 percent of total fiscal 2008 apparel production.
132
+ The principal materials used
133
+ in our footwear products are natural and synthetic rubber, plastic compounds, foam cushioning materials, nylon, leather, canvas and polyurethane films used to make Air-Sole cushioning components. NIKE IHM, Inc., and NIKE (Suzhou) Sports Company,
134
+ Ltd., both wholly-owned subsidiaries of NIKE, and independent contractors in China and Taiwan, are our largest suppliers of the Air-Sole cushioning components used in footwear. The principal materials used in our apparel products are natural and
135
+ synthetic
136
+ 5
137
+ Table of Contents
138
+ fabrics and threads, plastic and metal hardware, and specialized performance fabrics designed to repel rain, retain heat, or efficiently transport body
139
+ moisture. NIKE’s contractors and suppliers buy raw materials in bulk. Most raw materials are available in the countries where manufacturing takes place. We have thus far experienced little difficulty in satisfying our raw material requirements.
140
+ Since 1972, Sojitz Corporation of America (“Sojitz America”), a large Japanese trading company, has performed significant
141
+ import-export financing services for us. During fiscal 2008, Sojitz America provided financing and purchasing services for NIKE Brand products sold in Argentina, Uruguay, Canada, Chile, Brazil, India, Indonesia, The Philippines, Malaysia, South
142
+ Africa, China, Korea, and Thailand excluding products produced and sold in the same country. Approximately 14 percent of NIKE brand sales occurred in those countries. Any failure of Sojitz America to provide these services or any failure of Sojitz
143
+ America’s banks could disrupt our ability to acquire products from our suppliers and to deliver products to our customers outside of the United States, Europe, Middle East, Africa and Japan. Such a disruption could result in cancelled orders
144
+ that would adversely affect sales and profitability. However, we believe that any such disruption would be short term in duration due to the ready availability of alternative sources of financing at competitive rates. Our current agreements with
145
+ Sojitz America expire in 2011.
146
+ International Operations and Trade
147
+ Our international operations and sources of supply are subject to the usual risks of doing business abroad, such as possible revaluation of currencies,
148
+ export duties, anti-dumping duties, quotas, safeguard measures, trade restrictions, restrictions on the transfer of funds and, in certain parts of the world, political instability and terrorism. We have not, to date, been materially affected by any
149
+ such risk, but cannot predict the likelihood of such developments occurring. We believe that we have the ability to develop, over a period of time, adequate alternative sources of supply for the products obtained from our present suppliers outside
150
+ of the United States. If events prevented us from acquiring products from our suppliers in a particular country, our operations could be temporarily disrupted and we could experience an adverse financial impact. However, we believe that we could
151
+ abate any such disruption within a period of no more than 12 months, and that much of the adverse impact on supply would, therefore, be of a short-term nature. We believe that our principal competitors are subject to similar risks.
152
+ All of our products manufactured overseas and imported into the United States, the European Union (“EU”) and other countries are subject to
153
+ customs duties collected by customs authorities. Customs information submitted by us is routinely subject to review by customs authorities. We are unable to predict whether additional customs duties, anti-dumping duties, quotas, safeguard measures,
154
+ or other trade restrictions may be imposed on the importation of our products in the future. Such actions could result in increases in the cost of our products generally which might adversely affect the sales or profitability of NIKE and the
155
+ imported footwear and apparel industry as a whole. Accordingly, we are actively monitoring the developments described below.
156
+ Footwear
157
+ Imports into the European Union
158
+ From 1994 through January 1, 2005, the EU imposed limits (or “quotas”) on the import of
159
+ certain types of footwear manufactured in China. Footwear designed for use in sporting activities, meeting certain technical criteria and having a CIF (cost, insurance and freight) price above nine euros (“Special Technology Athletic
160
+ Footwear” or “STAF”), was excluded from the quotas. As a result of the STAF exclusion, and the amount of quota made available to us, the quotas did not have a material effect on our business. However, as part of China’s 2001
161
+ accession to the World Trade Organization (“WTO”), China entered into an agreement with the EU and other WTO members to abide by a special safeguard arrangement whereby quotas could be imposed on any product sourced in China, including
162
+ footwear, if there was a surge in imports from China into another WTO country, and after a legal proceeding it was determined that such imports were injuring a domestic producer. Additionally, under longstanding WTO rules, all WTO member countries
163
+ reserved the right to impose (1) safeguard measures (temporary quotas) if it can be demonstrated in a legal proceeding that increased imports
164
+ 6
165
+ Table of Contents
166
+ are injuring another WTO member’s domestic industry; and (2) anti-dumping measures if it can be demonstrated in a legal proceeding that imports are
167
+ being sold at an unfair low price in another WTO member’s home market, and those imports were causing or threatening to cause material injury to the domestic industry.
168
+ Accordingly, with the phase-out of the quotas at the beginning of 2005, and the expiration of a separate EU anti-dumping case in 2003 against footwear
169
+ made in China, Indonesia, and Thailand, there has been renewed pressure from some parts of the EU footwear manufacturing sector to re-impose some level of trade protection on imported footwear from China, India, Vietnam, and other exporting
170
+ countries. In July 2005, the European Commission (“EC”), at the request of the European domestic footwear industry, initiated investigations into leather footwear imported from China and Vietnam. NIKE and all other major athletic footwear
171
+ manufacturers participated actively as respondents in this investigation and took the position that athletic footwear (i) should not be within the product scope of the investigation, and (ii) does not meet the legal requirements of injury
172
+ and price in an anti-dumping investigation. Our arguments were successful and the EU agreed in October 2006 on definitive duties of 16.5% for China and 10% for Vietnam, but excluded STAF from the measures, and also agreed to implement the duties for
173
+ two years rather than the normal five-year period. As a result, these measures did not significantly impact our business and we believe that our major competitors stand in much the same position regarding these trade measures.
174
+ We understand that since the anti-dumping duties on non-STAF leather footwear imposed in 2006 will expire on October 8, 2008 the EU domestic
175
+ footwear industry has requested that the EC initiate a review of those measures. The EC will scrutinize the request closely, and make a decision by early October 2008 whether to initiate a review, and if so, the scope of that review. If the EC
176
+ conducts a review, the current definitive anti-dumping duties will remain in force for an additional 15 months until the conclusion of the review in late 2009 or early 2010. It is also possible that the EC could initiate a so-called
177
+ “interim” review of the anti-dumping measures, in which case the EC may review the scope of the STAF exemption and the level of the duties, among other things.
178
+ Trade Relations with China
179
+ China represents an important sourcing and marketing country for us. Many
180
+ governments around the world are concerned about China’s growing and fast-paced economy, compliance with WTO rules, currency valuation, and high trade deficits. As a result there is a wide range of legislative proposals that have been
181
+ introduced to address these concerns. While some of these concerns are justified, we are working with broad coalitions of global businesses and trade associations representing a wide variety of sectors (e.g. services, manufacturing, agriculture) to
182
+ help ensure that any legislation enacted and implemented (i) addresses legitimate and core concerns, (ii) is consistent with international trade rules, and (iii) is reflective and considerate of China’s domestic economy and
183
+ important role in the global economic community. We believe that our major competitors as well as most other multi-national companies stand in much the same position regarding these trade measures.
184
+ Competition
185
+ The athletic
186
+ footwear, apparel and equipment industry is keenly competitive in the United States and on a worldwide basis. We compete internationally with an increasing number of athletic and leisure shoe companies, athletic and leisure apparel companies, sports
187
+ equipment companies, and large companies having diversified lines of athletic and leisure shoes, apparel and equipment, including Adidas, Puma, and others. The intense competition and the rapid changes in technology and consumer preferences in the
188
+ markets for athletic and leisure footwear and apparel, and athletic equipment, constitute significant risk factors in our operations.
189
+ NIKE
190
+ is the largest seller of athletic footwear and athletic apparel in the world. Performance and reliability of shoes, apparel, and equipment, new product development, price, product identity through marketing and promotion, and customer support and
191
+ service are important aspects of competition in the athletic footwear, apparel and equipment industry. To help market our products, we contract with prominent and influential athletes, coaches, teams, colleges and sports leagues to endorse our
192
+ brands and use our products, and we actively sponsor sporting events and clinics. We believe that we are competitive in all of these areas.
193
+ 7
194
+ Table of Contents
195
+ Trademarks and Patents
196
+ We utilize trademarks on nearly all of our products and believe that having distinctive marks that
197
+ are readily identifiable is an important factor in creating a market for our goods, in identifying the Company, and in distinguishing our goods from the goods of others. We consider our NIKE ® and Swoosh Design ® trademarks to be among our most valuable assets and we have registered these trademarks in over 100 countries. In addition, we own many
198
+ other trademarks that we utilize in marketing our products. We continue to vigorously protect our trademarks against infringement.
199
+ NIKE has an exclusive, worldwide license to make and sell footwear using patented “Air”
200
+ technology. The process utilizes pressurized gas encapsulated in polyurethane. Some of the early NIKE AIR ® patents have expired, which may enable competitors to use certain types of similar
201
+ technology. Subsequent NIKE AIR ® patents will not expire for several years. We also have hundreds of U.S. and foreign utility patents, and thousands of U.S. and foreign design patents
202
+ covering components and features used in various athletic and leisure shoes, apparel, and equipment. These patents expire at various times, and patents issued for applications filed this year will have a remaining duration of from now to 2022 for
203
+ design patents, and from now to 2028 for utility patents. We believe that our success depends primarily upon skills in design, research and development, production and marketing rather than upon our patent position. However, we have followed a
204
+ policy of filing applications for United States and foreign patents on inventions, designs and improvements that we deem valuable.
205
+ Employees
206
+ We had approximately 32,500 employees at May 31, 2008. Management considers its relationship with employees to be
207
+ excellent. None of our employees is represented by a union, with the exception of 23 employees in Mexico, the collective bargaining agreement for which expires in 2009. Also, in some countries outside of the United States, local laws require
208
+ representation for employees by works councils (such as in the EU, in which they are entitled to information and consultation on certain Company decisions) or other representation by an organization similar to a union, although collective bargaining
209
+ agreements are not involved. There has never been a material interruption of operations due to labor disagreements.
210
+ Executive
211
+ Officers of the Registrant
212
+ The executive officers of NIKE as of July 25, 2008 are as follows:
213
+ Philip H. Knight, Chairman of the Board — Mr. Knight, 70, a director since 1968, is a co-founder of NIKE and, except for the period from
214
+ June 1983 through September 1984, served as its President from 1968 to 1990, and from June 2000 to December 2004. Prior to 1968, Mr. Knight was a certified public accountant with Price Waterhouse and Coopers & Lybrand and was an
215
+ Assistant Professor of Business Administration at Portland State University.
216
+ Mark G. Parker, Chief Executive Officer and President
217
+ — Mr. Parker, 52, was appointed CEO and President in January 2006. He has been employed by NIKE since 1979 with primary responsibilities in product research, design and development, marketing, and brand management. Mr. Parker was
218
+ appointed divisional Vice President in charge of development in 1987, corporate Vice President in 1989, General Manager in 1993, Vice President of Global Footwear in 1998, and President of the NIKE Brand in 2001.
219
+ David J. Ayre, Vice President, Global Human Resources — Mr. Ayre, 48, joined NIKE as Vice President, Global Human Resources in July
220
+ 2007. Prior to joining NIKE, he held a number of senior human resource positions with Pepsico, Inc. since 1990, most recently as head of Talent and Performance Rewards.
221
+ Lewis L. Bird III, President, Affliates — Mr. Bird, 44, joined NIKE in July 2006 as President, Affiliates, which currently includes the businesses of Cole Haan, Converse, Hurley, and Umbro. Prior to
222
+ joining NIKE, he held a number of management positions within multinational companies with diverse brand portfolios. He was
223
+ 8
224
+ Table of Contents
225
+ Executive Vice President of New Business Development for Gap Inc. from September 2005 to March 2006. Prior to that, Mr. Bird served as Chief Operating
226
+ Officer of Gap Inc.’s North American division from March 2003 to September 2005, Chief Financial Officer of Gap Inc.’s Old Navy division from 2001 to 2003, Vice President Finance & Operations of Gateway, Inc. from 1999 to
227
+ 2001, Director of Business Analysis & Planning at AlliedSignal Inc. from 1998 to 1999, and prior to that held financial management positions with AlliedSignal, Ford Motor Company and BayBanks, Inc.
228
+ Donald W. Blair, Vice President and Chief Financial Officer — Mr. Blair, 50, joined NIKE in November 1999. Prior to joining NIKE, he
229
+ held a number of financial management positions with Pepsico, Inc., including Vice President, Finance of Pepsi-Cola Asia, Vice President, Planning of PepsiCo’s Pizza Hut Division, and Senior Vice President, Finance of The Pepsi Bottling Group,
230
+ Inc. Prior to joining Pepsico, Mr. Blair was a certified public accountant with Deloitte, Haskins, and Sells.
231
+ Charles D. Denson,
232
+ President of the NIKE Brand — Mr. Denson, 52, has been employed by NIKE since 1979. Mr. Denson held several management positions within the Company, including his appointments as Director of USA Apparel Sales in 1994, divisional
233
+ Vice President, U.S. Sales in 1994, divisional Vice President European Sales in 1997, divisional Vice President and General Manager, NIKE Europe in 1998, Vice President and General Manager of NIKE USA in 2000, and President of the NIKE Brand in
234
+ 2001.
235
+ Gary M. DeStefano, President of Global Operations — Mr. DeStefano, 51, has been employed by NIKE since 1982, with
236
+ primary responsibilities in sales and regional administration. Mr. DeStefano was appointed Director of Domestic Sales in 1990, divisional Vice President in charge of domestic sales in 1992, Vice President of Global Sales in 1996, Vice President
237
+ and General Manager of Asia Pacific in 1997, President of USA Operations in 2001 and President of Global Operations in 2006.
238
+ Trevor
239
+ Edwards, Vice President, Global Brand and Category Management — Mr. Edwards, 45, joined NIKE in 1992. He was appointed Marketing Manager, Strategic Accounts, Foot Locker in 1993, Director of Marketing, the Americas in 1995, Director of
240
+ Marketing, Europe in 1997, Vice President, Marketing for Europe, Middle East and Africa in 1999, and Vice President, U.S. Brand Marketing in 2000. Mr. Edwards was appointed corporate Vice President, Global Brand Management in 2002 and Vice
241
+ President, Global Brand and Category Management in 2006.
242
+ Ronald D. McCray, Vice President, Chief Administrative Officer —
243
+ Mr. McCray, 51, joined NIKE as Vice President, Chief Administrative Officer in August 2007. Prior to joining NIKE, he held a number of positions at Kimberly-Clark Corporation since 1987, most recently as Senior Vice President, Law and
244
+ Government Affairs and Chief Compliance Officer. Mr. McCray is a member of the Council of Foreign Relations.
245
+ Bernard F.
246
+ Pliska, Vice President, Corporate Controller — Mr. Pliska, 46, joined NIKE as Corporate Controller in 1995. He was appointed Vice President, Corporate Controller in 2003. Prior to NIKE, Mr. Pliska was with Price Waterhouse from
247
+ 1984 to 1995. Mr. Pliska is a certified public accountant.
248
+ John F. Slusher, Vice President, Global Sports Marketing —
249
+ Mr. Slusher, 39, has been employed by NIKE since 1998 with primary responsibilities in global sports marketing. Mr. Slusher was appointed Director of Sports Marketing for the Asia Pacific and Americas regions in 2006, divisional Vice
250
+ President, Asia Pacific & Americas Sports Marketing in September 2007 and Vice President, Global Sports Marketing in November 2007. Prior to joining NIKE, Mr. Slusher was an attorney at the law firm of O’Melveny & Myers
251
+ from 1995 to 1998.
252
+ Eric D. Sprunk, Vice President, Global Footwear — Mr. Sprunk, 44, joined NIKE in 1993. He was
253
+ appointed Finance Director and General Manager of the Americas in 1994, Finance Director, NIKE Europe in 1995, Regional General Manager, NIKE Europe Footwear in 1998, and Vice President & General Manager of the Americas in 2000.
254
+ Mr. Sprunk was appointed corporate Vice President, Global Footwear in 2001. Prior to joining NIKE, Mr. Sprunk was a certified public accountant with Price Waterhouse from 1987 to 1993.
255
+ 9
256
+ Table of Contents
257
+ Hans van Alebeek, Vice President, Global Operations & Technology — Mr. van
258
+ Alebeek, 42, joined NIKE as Director of Operations of Europe in 1999, and was appointed Vice President, Operations & Administration in EMEA in 2001, Vice President, Global Operations in 2003, Vice President, Global Operations &
259
+ Technology in 2004, and Corporate Vice President in November 2005. Prior to joining NIKE, Mr. van Alebeek worked for McKinsey & Company as a management consultant, and at N.V. Indivers in business development.
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1
+ Item 13. Certain Relationships and Related Transactions, and Director Independence
2
+ The information required by Item 404 and 407(a) of Regulation S-K is included under “Transactions with Related Persons” and “Board of Directors and Committees” in the definitive Proxy Statement for our 2008 Annual
3
+ Meeting of Shareholders and is incorporated herein by reference.
raw/filings/0000320187/2007/0001193125-08-159004/item9a.txt ADDED
@@ -0,0 +1,13 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
+ Item 9A. Controls and Procedures
2
+ We maintain
3
+ disclosure controls and procedures that are designed to ensure that information required to be disclosed in our Exchange Act reports is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange
4
+ Commission’s rules and forms and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow for timely decisions regarding required
5
+ disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control
6
+ objectives, and management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
7
+ We carry out a variety of on-going procedures, under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, to evaluate the effectiveness of the design and operation
8
+ of our disclosure controls and procedures. Based on the foregoing, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of May 31,
9
+ 2008.
10
+ “Management’s Annual Report on Internal Control Over Financial Reporting” is included in Item 8 on pages 45-48
11
+ of this Report.
12
+ There has been no change in our internal control over financial reporting during our most recent fiscal quarter that has
13
+ materially affected, or is reasonable likely to materially affect, our internal control over financial reporting.
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+ 0000320187,NKE,"NIKE, Inc.",10-K,2013-07-23,2013-05-31,2013-07-24T00:32:32.000Z,0000320187-13-000092,nke-5312013x10k.htm,10-K,26524396,1,0,https://www.sec.gov/Archives/edgar/data/320187/000032018713000092/nke-5312013x10k.htm,https://www.sec.gov/Archives/edgar/data/320187/000032018713000092/,2012,2012,1
raw/filings/0000320187/2012/0000320187-13-000092/item1.txt ADDED
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1
+ ITEM 1. Business
2
+ General
3
+ NIKE, Inc. was incorporated in 1968 under the laws of the state of Oregon. As used in this report, the terms “we,” “us,” “NIKE” and the “Company” refer to NIKE, Inc. and its predecessors, subsidiaries and affiliates, collectively, unless the context indicates otherwise. Our internet address is www.nike.com. On our NIKE Corporate website, located at www.nikeinc.com, we post the following filings as soon as reasonably practicable after they are electronically filed with or furnished to the Securities and Exchange Commission: our annual report on Form 10-K, our quarterly reports on Form 10-Q, our current reports on Form 8-K and any amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities and Exchange Act of 1934, as amended. All such filings on our NIKE Corporate website are available free of charge. Also available on the NIKE Corporate website are the charters of the committees of our board of directors, as well as our corporate governance guidelines and code of ethics; copies of any of these documents will be provided in print to any shareholder who submits a request in writing to NIKE Investor Relations, One Bowerman Drive, Beaverton, Oregon 97005-6453.
4
+ Our principal business activity is the design, development and worldwide marketing and selling of athletic footwear, apparel, equipment, accessories and services. NIKE is the largest seller of athletic footwear and athletic apparel in the world. We sell our products to retail accounts, through NIKE-owned retail stores and internet websites (which we refer to as our “Direct to Consumer” operations) and through a mix of independent distributors and licensees, in virtually all countries around the world. Virtually all of our products are manufactured by independent contractors. Virtually all footwear and apparel products are produced outside the United States, while equipment products are produced both in the United States and abroad.
5
+ Products
6
+ We focus our NIKE Brand and Brand Jordan product offerings in seven key categories: Running, Basketball, Football (Soccer), Men’s Training, Women’s Training, NIKE Sportswear (our sports-inspired lifestyle products), and Action Sports. We also market products designed for kids, as well as for other athletic and recreational uses such as baseball, cricket, golf, lacrosse, outdoor activities, football, tennis, volleyball, walking, and wrestling.
7
+ NIKE’s athletic footwear products are designed primarily for specific athletic use, although a large percentage of the products are worn for casual or leisure purposes. We place considerable emphasis on high quality construction and innovation in our products. NIKE Sportswear, Running, Basketball, Football (Soccer), and kids’ shoes are currently our top-selling footwear categories and we expect them to continue to lead in product sales in the near future.
8
+ We sell sports apparel and accessories covering most of the above-mentioned categories, which feature the same trademarks and are sold predominantly through the same marketing and distribution channels as athletic footwear. We often market footwear, apparel and accessories in “collections” of similar use or by category. We also market apparel with licensed college and professional team and league logos.
9
+ We sell a line of performance equipment under the NIKE Brand name, including bags, socks, sport balls, eyewear, timepieces, digital devices, bats, gloves, protective equipment, golf clubs, and other equipment designed for sports activities. We also sell small amounts of various plastic products to other manufacturers through our wholly-owned subsidiary, NIKE IHM, Inc.
10
+ Our wholly-owned subsidiary, Converse Inc. (“Converse”), headquartered in North Andover, Massachusetts, designs, distributes and licenses athletic and casual footwear, apparel and accessories under the Converse ® , Chuck Taylor ® , All Star ® , One Star ® , Star Chevron ® and Jack Purcell ® trademarks.
11
+ Our wholly-owned subsidiary, Hurley International LLC (“Hurley”), headquartered in Costa Mesa, California, designs and distributes a line of action sports and youth lifestyle apparel and accessories under the Hurley ® trademark.
12
+ In addition to the products we sell to our wholesale customers and directly to consumers through our Direct to Consumer operations, we have also entered into license agreements that permit unaffiliated parties to manufacture and sell certain apparel, digital devices and applications and other equipment designed for sports activities.
13
+ As part of our long-term growth strategy, we continually evaluate our portfolio of businesses to ensure we are investing in those businesses that are accretive to the NIKE Brand with the largest growth potential and highest returns. On February 1, 2013, and November 30, 2012, we completed the divestitures of the Cole Haan and Umbro businesses, respectively, allowing us to better focus our resources on driving growth in the NIKE, Jordan, Converse and Hurley brands.
14
+ Sales and Marketing
15
+ Financial information about geographic and segment operations appears in Note 18 — Operating Segments and Related Information of the accompanying Notes to the Consolidated Financial Statements.
16
+ We experience moderate fluctuations in aggregate sales volume during the year. Historically, revenues in the first and fourth fiscal quarters have slightly exceeded those in the second and third quarters. However, the mix of product sales may vary considerably as a result of changes in seasonal and geographic demand for particular types of footwear, apparel, and equipment.
17
+ Because NIKE is a consumer products company, the relative popularity of various sports and fitness activities and changing design trends affect the demand for our products. We must, therefore, respond to trends and shifts in consumer preferences by adjusting the mix of existing product offerings, developing new products, styles and categories, and influencing sports and fitness preferences through extensive marketing. Failure to respond in a timely and adequate manner could have a material adverse effect on our sales and profitability. This is a continuing risk.
18
+ We report our NIKE Brand operations based on our internal geographic organization. Each NIKE Brand geography operates predominantly in one industry: the design, development, marketing and selling of athletic footwear, apparel, equipment, accessories, and services. Our reportable operating
19
+ 1
20
+ Table of Contents
21
+ segments for the NIKE Brand are: North America, Western Europe, Central & Eastern Europe, Greater China, Japan, and Emerging Markets. Our NIKE Brand Direct to Consumer operations are managed within each geographic segment.
22
+ United States Market
23
+ In fiscal 2013, sales in the United States, including U.S. sales of our Other Businesses, accounted for approximately 45% of total revenues, compared to 42% in both fiscal 2012 and fiscal 2011. Converse and Hurley, our affiliate brands, and NIKE Golf comprise our Other Businesses. We sell to thousands of retail accounts in the United States, including a mix of footwear stores, sporting goods stores, athletic specialty stores, department stores, skate, tennis and golf shops, and other retail accounts. During fiscal 2013, our three largest customers accounted for approximately 25% of sales in the United States.
24
+ We make substantial use of our futures ordering program, which allows retailers to order five to six months in advance of delivery with the commitment that their orders will be delivered within a set time period at a fixed price. In fiscal 2013, 87% of our U.S. wholesale footwear shipments (excluding our Other Businesses) were made under the futures program, compared to 86% in fiscal 2012 and 87% in fiscal 2011. In fiscal 2013, 67% of our U.S. wholesale apparel shipments (excluding our Other Businesses) were made under the futures program, compared to 64% in fiscal 2012 and 60% in fiscal 2011.
25
+ We utilize NIKE sales offices to solicit sales in the United States as well as independent sales representatives to sell specialty products for golf, skateboarding, and snowboarding. In addition, our Direct to Consumer operations sell NIKE Brand products to consumers through our internet website, www.nike.com , and through the following number of retail stores in the United States:
26
+ U.S. Retail Stores
27
+ Number
28
+ NIKE Brand factory stores
29
+ 171
30
+ NIKE Brand in-line stores, including NIKETOWNs and employee-only stores
31
+ 33
32
+ Converse stores (including factory stores)
33
+ 72
34
+ Hurley stores (including factory and employee stores)
35
+ 27
36
+ TOTAL
37
+ 303
38
+ NIKE has five primary distribution centers in the United States located in Memphis, Tennessee, three of which are leased. NIKE Brand apparel and equipment products are also shipped from our Foothill Ranch, California distribution center. Converse and Hurley products are shipped primarily from Ontario, California.
39
+ International Markets
40
+ In fiscal 2013, non-U.S. sales including non-U.S. sales of our Other Businesses accounted for 55% of total revenues, compared to 58% in both fiscal 2012 and fiscal 2011. We sell our products to retail accounts, through our own Direct to Consumer operations, and through a mix of independent distributors, licensees, and sales representatives around the world. We sell to thousands of retail accounts and operate 16 distribution centers outside of the United States. In many countries and regions, including Canada, Asia, some Latin American countries, and Europe, we have a futures ordering program for retailers similar to the United States futures ordering program described above. During fiscal 2013, NIKE’s three largest customers outside of the U.S. accounted for approximately 6% of total non-U.S. sales.
41
+ Our Direct to Consumer business operates the following number of retail stores outside the United States:
42
+ Non-U.S. Retail Stores
43
+ Number
44
+ NIKE Brand factory stores
45
+ 388
46
+ NIKE Brand in-line stores, including NIKETOWNs and employee-only stores
47
+ 59
48
+ Converse stores (including factory stores)
49
+ 3
50
+ TOTAL
51
+ 450
52
+ International branch offices and subsidiaries of NIKE are located in Argentina, Australia, Austria, Belgium, Bermuda, Brazil, Canada, Chile, China, Costa Rica, Croatia, Cyprus, the Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Malaysia, Mexico, New Zealand, the Netherlands, Norway, the Philippines, Poland, Portugal, Russia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, the United Arab Emirates, the United Kingdom, Uruguay and Vietnam.
53
+ Significant Customer
54
+ No customer accounted for 10% or more of our worldwide net sales during fiscal 2013.
55
+ Orders
56
+ Worldwide futures orders for NIKE Brand athletic footwear and apparel, scheduled for delivery from June through November 2013, were $12.1 billion compared to $11.2 billion for the same period last year. This futures orders amount is calculated based upon our forecast of the actual exchange rates under which our revenues will be translated during this period. Reported futures orders are not necessarily indicative of our expectation of revenues for this period. This is because the mix of orders can shift between futures and at-once orders and the fulfillment of certain of these futures orders may fall outside of the scheduled time period noted above. In addition, foreign currency exchange rate fluctuations as well as differing levels of discounts, order cancellations and returns can cause differences in the comparisons between futures orders and actual revenues. Moreover, a significant portion of our revenue is not derived from futures orders, including at-once and close-out sales of NIKE Brand footwear and apparel, sales of NIKE Brand equipment, sales from our Direct to Consumer operations, and sales from our Other Businesses.
57
+ Product Research and Development
58
+ We believe our research and development efforts are a key factor in our success. Technical innovation in the design and manufacturing process of footwear, apparel, and athletic equipment receive continued emphasis as NIKE strives to produce products that help to reduce injury, enhance athletic performance and maximize comfort.
59
+ In addition to NIKE’s own staff of specialists in the areas of biomechanics, chemistry, exercise physiology, engineering, industrial design, sustainability, and related fields, we also utilize research committees and advisory boards made up of athletes, coaches, trainers, equipment managers, orthopedists, podiatrists, and other experts who consult with us and review designs, materials, concepts for product and manufacturing process improvements and compliance with product safety regulations around the world. Employee athletes, athletes engaged under sports marketing contracts and other athletes wear-test and evaluate products during the design and development process.
60
+ Manufacturing
61
+ Virtually all of our footwear is manufactured outside of the United States by independent contract manufacturers. In fiscal 2013, contract factories in Vietnam, China and Indonesia manufactured approximately 42%, 30%, and 26% of total NIKE Brand footwear, respectively. We also have manufacturing agreements with independent factories in Argentina, Brazil, India, and Mexico to manufacture footwear for sale primarily within those countries. The largest single footwear factory with which we have contracted accounted for approximately 6% of total fiscal 2013 NIKE Brand footwear production. Almost all of NIKE Brand apparel is manufactured outside of the United States by independent contract manufacturers located in 28 countries. Most of this apparel production occurred in China, Vietnam, Thailand, Indonesia, Sri Lanka, Pakistan, Malaysia, Turkey, Mexico, and Cambodia. The largest single apparel factory that we have contracted with accounted for approximately 6% of total fiscal 2013 apparel production.
62
+ The principal materials used in our footwear products are natural and synthetic rubber, plastic compounds, foam cushioning materials, nylon, leather, canvas, and polyurethane films used to make Air-Sole cushioning components. During fiscal 2013, NIKE IHM, Inc., a wholly-owned subsidiary of NIKE, Inc., with facilities in Beaverton, Oregon and St. Louis, Missouri, as well as independent contractors in China and Vietnam, were our largest suppliers of the Air-Sole cushioning components used in footwear. The principal materials used in our apparel products are natural and synthetic fabrics and threads, plastic and metal hardware, and specialized performance fabrics designed to repel rain and snow, retain heat, or efficiently wick moisture away from the body. NIKE’s independent contractors and suppliers buy raw materials in bulk for the manufacturing of our footwear, apparel and equipment products. Most raw materials are available and purchased by those independent contractors and suppliers in the countries where manufacturing takes place. We have thus far experienced little difficulty in satisfying our raw material requirements.
63
+ Since 1972, Sojitz Corporation of America (“Sojitz America”), a large Japanese trading company and the sole owner of our redeemable preferred stock, has performed significant import-export financing services for us. During fiscal 2013, Sojitz America provided financing and purchasing services for NIKE Brand products sold in Argentina, Uruguay, Canada, Brazil, India, Indonesia, the Philippines, Malaysia, South Africa, Korea, and Thailand, excluding products produced and sold in the same country. Approximately 13% of NIKE Brand sales occurred in those countries. Any failure of Sojitz America to provide these services or any failure of Sojitz America’s banks could disrupt our ability to acquire products from our suppliers and to deliver products to our customers in those markets. Such a disruption could result in canceled orders that would adversely affect sales and profitability. However, we believe that any such disruption would be short-term in duration due to the ready availability of alternative sources of financing at competitive rates. Our current agreements with Sojitz America expire on May 31, 2014.
64
+ International Operations and Trade
65
+ Our international operations and sources of supply are subject to the usual risks of doing business abroad, such as possible revaluation of currencies, export and import duties, anti-dumping measures, quotas, safeguard measures, trade restrictions, restrictions on the transfer of funds and, in certain parts of the world, political instability and terrorism. We have not, to date, been materially affected by any such risk, but cannot predict the likelihood of such material effects occurring in the future.
66
+ In recent years, uncertain global and regional economic conditions have affected international trade and caused a rise in protectionist actions around the world. These trends are affecting many global manufacturing and service sectors, and the footwear and apparel industries, as a whole, are not immune. Companies in our industry are facing trade protectionism in many different regions, and in nearly all cases we are working together with industry groups to address trade issues and reduce the impact to the industry, while observing applicable competition laws. Notwithstanding our efforts, such protectionist measures, if implemented, could result in increases in the cost of our products, which may in turn adversely affect our sales or profitability as well as the imported footwear and apparel industry as a whole.
67
+ We monitor protectionist trends and developments throughout the world that may materially impact our industry and engage in administrative and judicial processes to mitigate trade restrictions. In Brazil, we are actively monitoring for dumping investigations against products from China and other countries that may result in additional anti-dumping measures and could affect our industry. We are also monitoring for and advocating against other impediments that may increase customs clearance times for imports of footwear, apparel and equipment. Moreover, with respect to trade restrictions targeting China, which represents an important sourcing and consumer marketing country for us, we are working with a broad coalition of global businesses and trade associations representing a wide variety of sectors to help ensure that any legislation enacted and implemented (i) addresses legitimate and core concerns, (ii) is consistent with international trade rules, and (iii) reflects and considers China's domestic economy and the important role it has in the global economic community.
68
+ Where trade protection measures are implemented, we believe that we have the ability to develop, over a period of time, adequate alternative sources of supply for the products obtained from our present suppliers. If events prevented us from acquiring products from our suppliers in a particular country, our operations could be temporarily disrupted and we could experience an adverse financial impact. However, we believe we could abate any such disruption, and that much of the adverse impact on supply would, therefore, be of a short-term nature, although alternate sources of supply might not be as cost effective and could have an ongoing adverse impact on profitability.
69
+ 2
70
+ Table of Contents
71
+ Competition
72
+ The athletic footwear, apparel, and equipment industry is highly competitive in the United States and on a worldwide basis. We compete internationally with a significant number of athletic and leisure footwear companies, athletic and leisure apparel companies, sports equipment companies, and large companies having diversified lines of athletic and leisure footwear, apparel, and equipment, including adidas, V.F. Corp., Puma, Li Ning and Under Armour, among others. We also compete with a number of vertical retailers such as Lululemon and Uniqlo. The intense competition and the rapid changes in technology and consumer preferences in the markets for athletic and leisure footwear and apparel, and athletic equipment, constitute significant risk factors in our operations.
73
+ NIKE is the largest seller of athletic footwear, apparel, and equipment in the world. Important aspects of competition in this industry are:
74
+ •
75
+ Product quality; performance and reliability; new product innovation and development; and consumer price/value;
76
+ •
77
+ Consumer connection and affinity for brands and products, developed through marketing and promotion; customer support and service; identification with prominent and influential athletes, coaches, teams, colleges and sports leagues who endorse our brands and use our products; and active engagement through sponsored sporting events and clinics; and
78
+ •
79
+ Effective distribution of products, with attractive merchandising and presentation at retail, in store and online.
80
+ We believe that we are competitive in all of these areas.
81
+ Trademarks and Patents
82
+ We utilize trademarks on nearly all of our products and believe having distinctive marks that are readily identifiable is an important factor in creating a market for our goods, in identifying our brands and the Company, and in distinguishing our goods from the goods of others. We consider our NIKE® and Swoosh Design® trademarks to be among our most valuable assets and we have registered these trademarks in almost 170 jurisdictions. In addition, we own many other trademarks that we utilize in marketing our products. We continue to vigorously protect our trademarks against infringement.
83
+ NIKE has an exclusive, worldwide license to make and sell footwear using patented “Air” technology. The process utilizes pressurized gas encapsulated in polyurethane. Some of the early NIKE AIR® patents have expired, which may enable competitors to use certain types of similar technology. Subsequent NIKE AIR® patents will not expire for several years.
84
+ We also file and maintain many U.S. and foreign utility patents, as well as many U.S. and foreign design patents covering components, manufacturing techniques and features used in various athletic and leisure footwear, apparel, athletic equipment, digital devices and golf products. These patents expire at various times, and patents issued for applications filed this year in the U.S. will last until 2027 for design patents and until 2033 for utility patents.
85
+ We believe our success depends primarily upon our capabilities in design, research and development, production, and marketing rather than exclusively upon our patent position. However, we have followed a policy of filing patent applications for the United States and foreign patents on inventions, designs, and improvements that we deem valuable.
86
+ Employees
87
+ As of May 31, 2013, we had approximately 48,000 employees worldwide, including retail and part-time employees. Management considers its relationship with employees to be excellent. None of our employees are represented by a union, except for certain employees in the Emerging Markets geography, where local law requires those employees to be represented by a trade union. Also, in some countries outside of the United States, local laws require employee representation by works councils (which may be entitled to information and consultation on certain Company decisions) or by organizations similar to a union. In certain European countries, we are required by local law to enter into and/or comply with industry-wide or national collective bargaining agreements. NIKE has never experienced a material interruption of operations due to labor disagreements.
88
+ Executive Officers of the Registrant
89
+ The executive officers of NIKE, Inc. as of July 19, 2013 are as follows:
90
+ Philip H. Knight, Chairman of the Board of Directors — Mr. Knight, 75, a director since 1968, is a co-founder of NIKE and, except for the period from June 1983 through September 1984, served as its President from 1968 to 1990 and from June 2000 to December 2004. Prior to 1968, Mr. Knight was a certified public accountant with Price Waterhouse and Coopers & Lybrand and was an Assistant Professor of Business Administration at Portland State University.
91
+ Mark G. Parker, President and Chief Executive Officer — Mr. Parker, 57, was appointed President and Chief Executive Officer in January 2006. He has been employed by NIKE since 1979 with primary responsibilities in product research, design and development, marketing, and brand management. Mr. Parker was appointed divisional Vice President in charge of product development in 1987, corporate Vice President in 1989, General Manager in 1993, Vice President of Global Footwear in 1998, and President of the NIKE Brand in 2001.
92
+ David J. Ayre, Executive Vice President, Global Human Resources — Mr. Ayre, 53, joined NIKE as Vice President, Global Human Resources in 2007. Prior to joining NIKE, he held a number of senior human resource positions with PepsiCo, Inc. since 1990, most recently as head of Talent and Performance Rewards.
93
+ Donald W. Blair, Executive Vice President and Chief Financial Officer — Mr. Blair, 55, joined NIKE in November 1999. Prior to joining NIKE, he held a number of financial management positions with PepsiCo, Inc., including Vice President, Finance of Pepsi-Cola Asia, Vice President, Planning of PepsiCo’s Pizza Hut Division, and Senior Vice President, Finance of The Pepsi Bottling Group, Inc. Prior to joining PepsiCo, Mr. Blair was a certified public accountant with Deloitte, Haskins, and Sells.
94
+ Trevor A. Edwards, President, NIKE Brand — Mr. Edwards, 50, joined NIKE in 1992. He was appointed Marketing Manager, Strategic Accounts for Foot Locker in 1993, Director of Marketing for the Americas Region in 1995, Director of Marketing for Europe in 1997, Vice President, Marketing for the Europe, Middle East and Africa Region in 1999, and Vice President, U.S. Brand Marketing in 2000. Mr. Edwards was appointed corporate
95
+ 3
96
+ Table of Contents
97
+ Vice President, Global Brand Management in 2002, Vice President, Global Brand and Category Management in 2006 and President, NIKE Brand in 2013. Prior to NIKE, Mr. Edwards was with the Colgate-Palmolive Company.
98
+ Jeanne P. Jackson, President, Product and Merchandising — Ms. Jackson, 61, joined NIKE in 2009. She was appointed President, Direct to Consumer in 2009 and President, Product and Merchandising in 2013. Ms. Jackson also served as a member of the NIKE, Inc. Board of Directors from 2001 through 2009. She founded and served as Chief Executive Officer of MSP Capital, a private investment company, from 2002 to 2009. Ms. Jackson was Chief Executive Officer of Walmart.com from March 2000 to January 2002. She was with Gap, Inc., as President and Chief Executive Officer of Banana Republic from 1995 to 2000, also serving as Chief Executive Officer of Gap, Inc. Direct from 1998 to 2000. Since 1978, she has held various retail management positions with Victoria’s Secret, The Walt Disney Company, Saks Fifth Avenue, and Federated Department Stores.
99
+ Hilary K. Krane, Executive Vice President, Chief Administrative Officer and General Counsel — Ms. Krane, 49, joined NIKE as Vice President and General Counsel in April 2010. In 2011, her responsibilities expanded and she became Vice President, General Counsel and Corporate Affairs. Ms. Krane was appointed to Executive Vice President, Chief Administrative Officer and General Counsel in 2013. Prior to joining NIKE, Ms. Krane was General Counsel and Senior Vice President for Corporate Affairs at Levi Strauss & Co. from 2006 to 2010. From 1996 to 2006, she was a partner and assistant general counsel at PricewaterhouseCoopers LLP.
100
+ Bernard F. Pliska, Vice President, Corporate Controller — Mr. Pliska, 51, joined NIKE as Corporate Controller in 1995. He was appointed Vice President, Corporate Controller in 2003. Prior to NIKE, Mr. Pliska was with Price Waterhouse from 1984 to 1995. Mr. Pliska is a certified public accountant.
101
+ John F. Slusher, Executive Vice President, Global Sports Marketing — Mr. Slusher, 44, has been employed by NIKE since 1998 with primary responsibilities in global sports marketing. Mr. Slusher was appointed Director of Sports Marketing for the Asia Pacific and Americas Regions in 2006, divisional Vice President of Asia Pacific & Americas Sports Marketing in September 2007 and Vice President, Global Sports Marketing in November 2007. Prior to joining NIKE, Mr. Slusher was an attorney at the law firm of O’Melveny & Myers from 1995 to 1998.
102
+ Eric D. Sprunk, Chief Operating Officer — Mr. Sprunk, 49, joined NIKE in 1993. He was appointed Finance Director and General Manager of the Americas Region in 1994, Finance Director for NIKE Europe in 1995, Regional General Manager of NIKE Europe Footwear in 1998, and Vice President & General Manager of the Americas Region in 2000. Mr. Sprunk was appointed corporate Vice President of Global Footwear in 2001, Vice President of Merchandising and Product in 2009 and Chief Operating Officer in 2013. Prior to joining NIKE, Mr. Sprunk was a certified public accountant with Price Waterhouse from 1987 to 1993.
103
+ 4
104
+ Table of Contents
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1
+ ITEM 13. Certain Relationships and Related Transactions, and Director Independence
2
+ The information required by Items 404 and 407(a) of Regulation S-K is included under “Election of Directors — Transactions with Related Persons” and “Corporate Governance — Director Independence” in the definitive Proxy Statement for our 2013 Annual Meeting of Shareholders and is incorporated herein by reference.
raw/filings/0000320187/2012/0000320187-13-000092/item9a.txt ADDED
@@ -0,0 +1,5 @@
 
 
 
 
 
 
1
+ ITEM 9A. Controls and Procedures
2
+ We maintain disclosure controls and procedures that are designed to ensure information required to be disclosed in our Exchange Act reports is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow for timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
3
+ We carry out a variety of on-going procedures, under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, to evaluate the effectiveness of the design and operation of our disclosure controls and procedures. Based on the foregoing, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of May 31, 2013 .
4
+ “Management’s Annual Report on Internal Control Over Financial Reporting” is included in Item 8 of this Report.
5
+ There has been no change in our internal control over financial reporting during our most recent fiscal quarter that has materially affected, or is reasonable likely to materially affect, our internal control over financial reporting.
raw/filings/0000320187/2012/0000320187-13-000092/rp_note.txt ADDED
File without changes
raw/filings/0000320187/2012/0000320187-13-000092/rpt_disclosure.txt ADDED
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1
+ Transactions with Related Persons
2
+ Effective July 1, 2013, Mr. Knight terminated an arrangement whereby he made his airplane available to the Company for business use for no charge. During the course of the arrangement NIKE operated and maintained the aircraft. Mr. Knight reimbursed the Company $96,835 for NIKE’s operating costs related to his personal use of this aircraft during fiscal 2014, determined based on the cost of fuel and other variable costs associated with the flights under FAR 91-501(d). In connection with the termination of the airplane arrangement, the Company sold a tug and power cart, purchased for Mr. Knight's plane, to a company owned by Mr. Knight for $110,000.
3
+ Mr. Howard S. Slusher, the father of John Slusher, Executive Vice President of Sports Marketing, and the Company are parties to a Consulting Agreement pursuant to which Howard Slusher manages the planning, design, and construction of new buildings at, and improvements to, NIKE's World Headquarters. Howard Slusher was selected due to his deep history and experience with the Company, as he has managed several significant construction projects for the Company, including the original World Headquarters construction and later expansions. In addition, Howard Slusher's previous engagement with the Company garnered the trust of management and makes him uniquely qualified to oversee the project. During fiscal 2014, the Company paid Howard Slusher $1,525,000 for these services.
4
+ Pursuant to the terms of a past consulting agreement with the Company, the Company agreed to pay for health and life insurance policies for Howard Slusher following expiration of the agreement. During fiscal 2014, the Company paid $129,801 for health and life insurance premiums.
5
+ Three of Mr. Parker’s siblings are employed by the Company in non-executive roles. Bob Parker is a Marketplace Director, and has been employed by the Company for over 30 years; Stephen Parker is Vice President & General Manager, Converse Asia-Pacific, and has been employed by the Company for over 26 years; and Ann Parker is an Executive Talent Scout, and has been employed by the Company for over 24 years. During fiscal year 2014, the Company paid aggregate compensation to each of Bob Parker, Stephen Parker and Ann Parker in the amounts of $384,637, $514,215, $277,678, respectively. The compensation was consistent with compensation paid to other employees holding similar positions, and was composed of salary, bonuses, the grant date fair value of stock options granted during the fiscal year estimated using the Black-Scholes pricing model, profit sharing and matching contributions to Company-sponsored retirement plans.
6
+ Mr. Thompson’s son, John Thompson III, head basketball coach at Georgetown University, and the Company are parties to a contract pursuant to which Mr. Thompson III provides certain endorsement and consulting services to the Company. The terms of this agreement, effective August 2014 through August 2019, provide for annual base compensation of $200,000, and up to $112,000 per year of product and merchandise, for use by him, the basketball staff and team. In addition, there are annual incentive payments based upon his team's performance of up to $100,000.
7
+ Compensation Committee Interlocks and Insider Participation
8
+ The members of the Compensation Committee of the Board of Directors during the fiscal year ended May 31, 2014 were Timothy D. Cook, Elizabeth J. Comstock, John C. Lechleiter, and Johnathan A. Rodgers. The Committee is composed solely of independent, non-employee directors. No member of the Compensation Committee has been an executive officer of the Company, and no member of the Compensation
9
+ NIKE, INC. Ÿ 2014 Notice of Annual Meeting 14
raw/filings/0000794172/2000/0000950152-00-008668/filing.txt ADDED
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1
+ 10-K
2
+ 1
3
+ l85672ae10-k.txt
4
+ MERIDIAN DIAGNOSTICS, INC. FORM 10-K
5
+ 1
6
+ SECURITIES AND EXCHANGE COMMISSION
7
+ Washington, D.C. 20549
8
+ FORM 10-K
9
+ X ANNUAL REPORT PURSUANT TO SECTION 13 OF THE SECURITIES EXCHANGE ACT OF 1934
10
+ FOR THE FISCAL YEAR ENDED SEPTEMBER 30, 2000.
11
+ [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES
12
+ EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ______________
13
+ TO__________________.
14
+ MERIDIAN DIAGNOSTICS, INC.
15
+ Incorporated under 3471 River Hills Drive IRS Employer ID
16
+ the Laws of Ohio Cincinnati, Ohio 45244 No. 31-0888197
17
+ Phone: (513) 271-3700
18
+ Securities Registered Pursuant to Section 12(b) of the Act:
19
+ None
20
+ Securities Registered Pursuant to Section 12(g) of the Act:
21
+ Common Stock
22
+ Indicate by check mark whether the Registrant (1) has filed all reports required
23
+ to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
24
+ the preceding 12 months, and (2) has been subject to such filing requirements
25
+ for the past 90 days.
26
+ YES NO
27
+ --- --
28
+ X
29
+ ----- ------
30
+ Indicate by check mark if disclosure of delinquent filers pursuant to Item 405
31
+ of Regulation S-K (Section 229.405 of this Chapter) is not contained herein, and
32
+ will not be contained, to the best of registrant's knowledge, in definitive
33
+ proxy or information statements incorporated by reference in Part III of this
34
+ Form 10-K or any amendment to this Form 10-K. [ ]
35
+ The aggregate market value of Common Stock held by non-affiliates is $53,641,941
36
+ based on a closing sale price of $5.56 per share on December 8, 2000. As of
37
+ December 8, 2000, 14,597,614 shares of no par value Common Stock were issued and
38
+ outstanding.
39
+ Documents Incorporated by Reference
40
+ Portions of the Registrant's Annual Report to Shareholders for 2000 furnished to
41
+ the Commission pursuant to Rule 14a-3(b) as specified and portions of the
42
+ Registrant's Proxy Statement filed with the Commission for its 2001 Annual
43
+ Meeting as specified are incorporated by reference in Parts II and III as
44
+ specified.
45
+ 2
46
+ MERIDIAN DIAGNOSTICS, INC.
47
+ INDEX TO ANNUAL REPORT
48
+ ON FORM 10-K
49
+ Part I Page
50
+ Item 1 Business ................................................................................ 1
51
+ Item 2 Properties ..............................................................................12
52
+ Item 3 Legal Proceedings .......................................................................13
53
+ Item 4 Submission of Matters to a Vote of Security Holders .....................................14
54
+ Part II
55
+ Item 5 Market for Registrant's Common Equity and Related Stockholder Matters ...................14
56
+ Item 6 Selected Financial Data .................................................................14
57
+ Item 7 Management's Discussion and Analysis of Financial Condition and Results of Operations ...15
58
+ Item 7A Quantitative and Qualitative Disclosures about Market Risk .............................15
59
+ Item 8 Financial Statements and Supplementary Data .............................................15
60
+ Item 9 Disagreements on Accounting and Financial Disclosure ....................................16
61
+ Part III
62
+ Item 10 Directors and Executive Officers of the Registrant. ....................................16
63
+ Item 11 Executive Compensation .................................................................16
64
+ Item 12 Security Ownership of Certain Beneficial Owners and Management .........................16
65
+ Item 13 Certain Relationships and Related Transactions .........................................16
66
+ Part IV
67
+ Item 14 Exhibits, Financial Statement Schedules, and Reports on Form 8-K .......................16
68
+ i
69
+ 3
70
+ PART I.
71
+ ITEM 1.
72
+ BUSINESS
73
+ --------
74
+ GENERAL
75
+ Meridian is a fully integrated life sciences company that develops, manufactures
76
+ and markets a broad range of innovative, disposable diagnostic test kits and
77
+ related diagnostic products used for the rapid diagnosis of infectious diseases,
78
+ and also offers biopharmaceutical capabilities. Meridian's diagnostics products
79
+ provide accuracy, simplicity, and speed, and enable early diagnosis and
80
+ treatment of common medical conditions such as gastrointestinal, viral, urinary
81
+ tract and respiratory infections. All of Meridian's diagnostics products are
82
+ used in procedures performed in vitro (outside the body) and enhance patient
83
+ well-being while reducing total outcome costs of healthcare. In addition to the
84
+ diagnostic business, Meridian is expanding further into the area of life
85
+ sciences. Through recent acquisitions, Meridian has the technical expertise to
86
+ enable research efforts of genomics scientists in drug and vaccine development.
87
+ The expansion into life sciences prompted the Company's decision to change its
88
+ official name to Meridian Bioscience, Inc., subject to shareholder approval in
89
+ January 2001.
90
+ Meridian's product development strategy is to combine existing technologies with
91
+ new product designs both through internal or joint product development and
92
+ through product acquisitions, licensing or supply arrangements. Internal and
93
+ joint product development activities focus on the development or enhancement of
94
+ immunodiagnostic technologies and applications to simplify, accelerate or
95
+ increase the accuracy of diagnoses of certain infectious diseases. Since 1991,
96
+ Meridian has also acquired or obtained rights to distribute a number of products
97
+ and technologies.
98
+ Meridian utilizes its resources to serve each of the strategic domestic and
99
+ international medical markets it has targeted: hospital networks and clinical
100
+ and hospital laboratories; alternate site markets, including physicians'
101
+ offices, outpatient clinics, nursing homes and health maintenance organizations
102
+ (HMOs); and new markets, including veterinary laboratories and water treatment
103
+ facilities. Meridian markets over 200 products representing four major disease
104
+ states through a direct sales force in the United States, Italy, France, Belgium
105
+ and the Netherlands, supplemented by a network of national and international
106
+ distributors. International sales in more than 60 countries were 31% of total
107
+ fiscal 2000 sales.
108
+ During the fourth quarter of fiscal 2000, a plan was implemented to restructure
109
+ European distribution operations and eliminate the Company's direct presence in
110
+ Germany. This plan involves (i) the shutdown of the German distribution center,
111
+ (ii) the transfer of the export business from Germany to the Company's Belgian
112
+ operations and (iii) movement of the German in-country business to an
113
+ independent distributor. This plan was adopted as a means to improve operating
114
+ results in Europe.
115
+ 1
116
+ 4
117
+ ACQUISITIONS AND ALLIANCES
118
+ An important facet of Meridian's long-term business strategy is the expansion
119
+ into life sciences, as well as the acquisition, licensing or entrance into
120
+ supply arrangements to obtain innovative diagnostic testing technologies,
121
+ product formats and products that complement its existing operations and address
122
+ the needs of Meridian's existing and targeted customer base. Prior to fiscal
123
+ 2000, Meridian's management had pursued the acquisition and licensing of
124
+ products and technologies that fit Meridian's niche diagnostic test markets,
125
+ which are characterized by a large number of users. Examples of this included
126
+ the acquisition of Gull Laboratories, Inc. in fiscal 1999, the acquisition of
127
+ the enteric product line of Cambridge Biotech Corporation in fiscal 1996, the
128
+ acquisitions of the infections disease and mononucleosis product lines of
129
+ Johnson & Johnson in fiscal 1994 and 1993, respectively, and numerous smaller
130
+ product acquisitions and licensing arrangements.
131
+ In the late fiscal 2000, Meridian completed its acquisition of Viral Antigens,
132
+ Inc. VAI further expands Meridian's life sciences capabilities through VAI's
133
+ protein expression lab which provides Meridian the opportunity to serve as an
134
+ enabler to biopharmaceutical companies in the development of new drugs and
135
+ vaccines. VAI also manufactures infectious disease antigens that are used in
136
+ immunodiagnostics testing, and a Pseudorabies Virus antibody test kit and equine
137
+ infectious anemia antibody test kit for the veterinary market.
138
+ The purchase price for VAI was $9 million in cash, and was funded with bank debt
139
+ from the Company's existing credit facilities. The purchase agreement provides
140
+ for additional consideration, up to $8.25 million, contingent upon VAI's future
141
+ earnings though September 30, 2006. See Note 2 to the consolidated financial
142
+ statements for further information. On September 29, 2000, Meridian filed on
143
+ Form 8-K/A certain financial statements and pro forma financial information
144
+ relating to this acquisition.
145
+ Also during fiscal 2000, Meridian executed a Research and Development Agreement
146
+ and an Exclusive Supply Agreement with OraSure Technologies, Inc. to
147
+ commercialize the Uplink technology. Meridian believes that this technology will
148
+ offer competitive advantages including the elimination of background
149
+ interference, simultaneous detection of multiple biological markers and improved
150
+ sensitivity. These agreements require Meridian to make future payments to
151
+ OraSure to fund research and development costs and to obtain an exclusive
152
+ license to market and sell related products on a global basis.
153
+ In early fiscal 1999, Meridian acquired Gull Laboratories, Inc. for $19 million
154
+ in cash. Gull develops, manufactures and markets diagnostic test kits and
155
+ materials designed to detect past or present infection caused by certain
156
+ microbial agents such as viruses, bacteria and protozoa and to detect certain
157
+ autoimmune disorders. The products are based on established immunological assay
158
+ methods including indirect immunofluorescent antibody assay (IFA), enzyme-linked
159
+ immunosorbent assay (EIA), immunodiffusion and Western Blot. Gull's products are
160
+ used by private laboratories and hospital clinical laboratories worldwide.
161
+ Included in the Gull acquisition was its subsidiary, BIODESIGN International,
162
+ which manufactures and markets antigens and
163
+ 2
164
+ 5
165
+ antibodies to diagnostic and pharmaceutical manufacturers as well as academic
166
+ researchers.
167
+ During fiscal 2000, Meridian completed the transfer of Gull's Salt Lake City
168
+ production to the Company's Cincinnati facilities, and the sale of the Salt Lake
169
+ City facilities and real estate. During fiscal 1999, Meridian shut down Gull's
170
+ European manufacturing activities. See Note 2 to the consolidated financial
171
+ statements for further information.
172
+ A key component in the success of Meridian's acquisition and licensing of new
173
+ products and technologies has been the ability of Meridian's management to
174
+ respond quickly to acquisition and licensing opportunities as they arise in the
175
+ marketplace. The success of this strategy has also been due in part to
176
+ management's selective acquisition and licensing philosophy as well as the
177
+ availability of cash on hand and available lines of credit.
178
+ IMMUNODIAGNOSTICS OVERVIEW
179
+ In vitro diagnostic testing is the process of analyzing constituents of blood,
180
+ urine, stool, other body fluids or tissue for the presence of specific
181
+ infectious diseases. Immunodiagnostic testing, which is the leading method of in
182
+ vitro testing for infectious diseases, tests for antigens and antibodies. When
183
+ an infectious disease caused by pathogens, such as bacteria, viruses and fungi,
184
+ and their related antigens are present, the body responds by producing an
185
+ antibody. The antibody binds specifically with the antigen in a lock-and-key
186
+ fashion and initiates a biochemical reaction to attempt to neutralize and,
187
+ ultimately, to eliminate the antigen. The ability of an antibody to bind with a
188
+ specific antigen provides the basis for immunodiagnostic testing.
189
+ Immunodiagnostic testing detects the presence of specific infectious diseases
190
+ through "visualization", such as color changes or the formation of visible
191
+ aggregates, of the biochemical reactions caused by the antigen/antibody. Most
192
+ immunodiagnostic tests utilize one of two alternative methods to determine the
193
+ presence of a specific disease in a patient specimen. In one method, the test
194
+ employs the antibody to detect directly the presence of an antigen.
195
+ Alternatively, certain tests employ the antigen to detect the presence of an
196
+ antibody. In addition to the diagnosis of infectious diseases, immunodiagnostic
197
+ testing is also used to monitor the status of various patient therapy programs.
198
+ MARKET TRENDS
199
+ The global market for infectious disease tests continues to expand as new
200
+ disease states are identified, new therapies become available and worldwide
201
+ standards of living and access to health care improve. More importantly, within
202
+ this market there is a continuing shift from conventional testing, which
203
+ requires highly trained personnel and lengthy turnaround times for test results,
204
+ to more technologically advanced testing which can be performed by less highly
205
+ trained personnel and completed in minutes or hours.
206
+ 3
207
+ 6
208
+ Technological advances permitting accurate testing to occur outside the
209
+ traditional hospital or laboratory setting have also affected the market for
210
+ diagnostic products. These technological developments have contributed to the
211
+ emergence of alternate site markets, such as physicians' offices, outpatient
212
+ clinics, nursing homes and HMOs, as important diagnostic market segments. These
213
+ technological advances should also contribute to the development of new markets
214
+ for Meridian's products, including food testing, veterinary laboratories and
215
+ water treatment facilities.
216
+ The increasing pressures to contain total health care costs have accelerated the
217
+ increased use of diagnostic testing and the market shift to alternate sites.
218
+ With rapid and accurate diagnoses of infectious diseases, physicians can
219
+ pinpoint appropriate therapies quickly, leading to faster recovery, shorter
220
+ hospital stays and less treatment expense. In addition, these pressures have led
221
+ to a major consolidation among reference laboratories and the formation of
222
+ multi-hospital alliances that have reduced the number of institutional customers
223
+ for diagnostic products and resulted in changes in buying practices.
224
+ Specifically, multi-year exclusive or primary source marketing or distribution
225
+ contracts with institutional customers have become more common, replacing less
226
+ formal distribution arrangements of shorter duration and involving lower product
227
+ volumes. In Europe, the reexamination of health care costs, access and funding
228
+ is causing similar pressures.
229
+ BUSINESS STRATEGY
230
+ Meridian continues to execute its long-term strategy consisting of the following
231
+ elements:
232
+ Developing New Product Applications from Core Technologies - Meridian employs a
233
+ market-driven product development strategy to adapt or enhance diagnostic
234
+ testing technologies and product formats in response to newly identified disease
235
+ states and customer demands for improvements in product accuracy, simplicity,
236
+ speed and cost-efficiency. Meridian accomplishes this by monitoring existing
237
+ markets, interacting closely with its customers and recognizing emerging
238
+ diseases and therapies. In the last ten years, Meridian has developed 35 new
239
+ products, including one new product in fiscal 2000.
240
+ Acquiring and Licensing Products and Technology - Meridian intends to acquire,
241
+ license or enter into supply arrangements to obtain innovative diagnostic
242
+ testing technologies, product formats and products that complement its existing
243
+ operations and address the needs of Meridian's existing and targeted customer
244
+ base. Management regularly identifies and reviews opportunities through its
245
+ broad industry contacts and recognized position in the industry. In the last ten
246
+ years, Meridian has acquired, licensed or entered into supply arrangements
247
+ relating to approximately 100 products. The Gull acquisition accounted for 65 of
248
+ the 100 products.
249
+ Enabling Biomedical Research and Early Stage Biopharmaceutical Development -
250
+ Meridian intends to leverage its skills and capabilities in the life sciences
251
+ market. Meridian has an established position in this market through its
252
+ BIODESIGN subsidiary. BIODESIGN manufactures and distributes essential antigen
253
+ and antibody reagents to diagnostic and
254
+ 4
255
+ 7
256
+ pharmaceutical manufacturers as well as academic researchers. These reagents are
257
+ essential to the development of assay systems, control standards and new drug
258
+ development research.
259
+ During fiscal 2000, Meridian further improved its skills and capabilities in the
260
+ life sciences market through the acquisition of VAI and the expansion of outside
261
+ collaborations with academic and government research laboratories. VAI recently
262
+ completed the installation of a pharmaceutical quality proteomics laboratory
263
+ that will be used to produce drug and vaccine proteins through gene expression
264
+ techniques. These proteins will be used by biopharmaceutical companies in the
265
+ development of drugs and vaccines for Phase I, II and III clinical trials.
266
+ In September 2000, Meridian expanded its relationship with Texas Tech University
267
+ Health Sciences Center for the development of highly specific, gene-mediated
268
+ antigen and antibody systems. Texas Tech's capabilities utilize gene
269
+ manipulation technologies to produce proteins that are reproducible and specific
270
+ for a variety of disease states.
271
+ Increasing International Sales - Meridian has targeted international sales as an
272
+ attractive source of growth. Meridian has developed a strong presence in Italy
273
+ through its Italian subsidiary, Meridian Diagnostics Europe s.r.l., and with the
274
+ acquisition of Gull has an established sales force in Belgium, France and the
275
+ Netherlands. Meridian has added management to expand its ability to serve Latin
276
+ American markets and has expanded its international distributor base to include
277
+ distributors in Argentina and Asia. Over the last six years, Meridian's
278
+ international sales have grown from $2.1 million in fiscal 1993 to $17.7 million
279
+ in fiscal 2000 and represented 31% of total consolidated sales in fiscal 2000.
280
+ Strengthening Partnerships With Consolidated Health Care Organizations -
281
+ Meridian seeks to develop strategic partnerships with the major reference
282
+ laboratories and other consolidated health care providers. Meridian believes it
283
+ is in a position to develop partnerships because it is an integrated
284
+ manufacturer, has a broad product line, offers tests in multiple formats and is
285
+ willing to invest resources in building relationships and facilitating open
286
+ communications with those large customers. During fiscal 1999 and 1998, several
287
+ exclusive multiple-year contracts were signed with consolidated health care
288
+ providers. In the fall of 1998, a major national reference laboratory added
289
+ Premier Platinum HpSA to its test menu and actively markets HpSA to its client
290
+ list of primary care physicians and specialists. During fiscal 2000 and 1999,
291
+ Meridian extended or renewed supply agreements with several major reference
292
+ laboratories and other consolidated health care providers.
293
+ Global Sales Excellence - Meridian has launched an initiative to improve its
294
+ worldwide excellence in customer service, sales support and technical
295
+ assistance. Meridian believes that its customers have rewarded it for the high
296
+ level of customer service and support it has provided in the past. However,
297
+ Meridian desires to provide a level of service that exceeds the current
298
+ standards of the health care industry and, most importantly, the customer's
299
+ expectations. Meridian is implementing several customer satisfaction training
300
+ programs and information system improvements in order to achieve global sales
301
+ excellence.
302
+ 5
303
+ 8
304
+ PRODUCTS AND MARKETS
305
+ Meridian has expertise in the development and manufacture of products based on
306
+ multiple core diagnostic technologies, each of which enables the visualization
307
+ and identification of antigen/antibody reactions for specific pathogens. As a
308
+ result, Meridian is able to develop and manufacture diagnostic tests in a
309
+ variety of formats that satisfy customer needs and preferences, whether in a
310
+ hospital, commercial or reference laboratory or alternate site location. These
311
+ technologies include enzyme immunoassay, immunofluorescence, particle
312
+ agglutination, membrane filtration/concentration, immunodiffusion, complement
313
+ fixation and chemical stains.
314
+ Enzyme Immunoassay (EIA) - Products incorporating the EIA technology achieve
315
+ extremely high levels of accuracy in detecting disease-related antigens or
316
+ antibodies through the use of special color-based enzyme-substrate reactions.
317
+ Meridian utilizes this technology in its multiple test format, the Premier(TM)
318
+ product for large volume users, and in its single test formats, the
319
+ ImmunoCard(R) and Monolert(R) products, for single physician users.
320
+ Immunofluorescence - When the microscopic visualization of an antigen/antibody
321
+ reaction is necessary or desired, immunofluorescence technology is frequently
322
+ utilized. Fluorescing immunochemicals, in the presence of the target antigen or
323
+ antibody, can be viewed via a fluorescent microscope. Meridian utilizes this
324
+ technology in its Merifluor(R) products.
325
+ Particle Agglutination - This technology utilizes microparticles (e.g., latex,
326
+ red blood cells) coated with specific antigens or antibodies that form visible
327
+ aggregates in the presence of a specimen containing the complementary antigen or
328
+ antibody. This technology is rapid and economical and is used in Meridian's
329
+ Meritec(TM), MeriStar(R) and MonoSpot(R) products.
330
+ Membrane Filtration/Concentration - Meridian utilizes this technology to detect
331
+ infection-causing bacteria present in human urine. These bacteria are
332
+ concentrated on a unique filter membrane for detection via the addition of a
333
+ special dye solution. This technology is utilized in Meridian's proprietary
334
+ rapid, single-unit FiltraCheck-UTI(R) test format.
335
+ Other Technologies - Meridian utilizes other technologies that include
336
+ immunodiffusion, complement fixation and chemical stains. Meridian also
337
+ manufactures and markets specimen collection, transportation, preservation and
338
+ concentration products, such as Para-Pak(R), Macro-CON(R) and Spin-CON.
339
+ Meridian's product line, including products acquired in the VAI and Gull
340
+ acquisitions, consists of over 250 medical diagnostic products representing four
341
+ major disease states. Currently, the most important product lines from the
342
+ perspective of sales are products to diagnose gastrointestinal, viral and
343
+ parasitic diseases. Meridian's products generally range in list price from $1
344
+ per test to $33 per test. A discussion of Company's key products and their
345
+ competitive advantage follows.
346
+ Parasitic Diseases - Meridian manufactures products for the diagnosis and
347
+ collection, preservation, transportation and concentration of parasites.
348
+ Parasitic diseases include Giardiasis,
349
+ 6
350
+ 9
351
+ Cryptosporidiosis, Amebiasis and Lyme disease. The markets for these products
352
+ are hospital, reference and veterinary laboratoties.
353
+ Gastrointestinal Diseases - Meridian manufactures products for the rapid
354
+ diagnosis of stomach ulcers, toxigenic E.coli, antibiotic associated diarrhea
355
+ (C. difficile) and pediatric diarrhea (Rotavirus and Adenovirus). The markets
356
+ for these products are hospital, reference, veterinary and state health
357
+ laboratories.
358
+ Respiratory Diseases - Meridian manufactures a broad range of diagnostic
359
+ reagents for detecting respiratory diseases including pneumonia (mycoplasma
360
+ pneumoniae) and valley fever (coccidioides immittis). The markets for these
361
+ products are hospital, reference, veterinary and state health laboratories.
362
+ Urogenital Diseases - Meridian manufactures products for the rapid detection of
363
+ urinary tract infection and Chlamydia. The markets for these products are
364
+ hospital, reference, physicians' office and public health laboratories.
365
+ Viral Diseases - Meridian manufactures a broad range of products for the
366
+ detection of various viruses including Epstein -Barr (mononucleosis), Herpes
367
+ simplex, Cytomegalovirus (organ transplant infections) and Varicella -Zoster
368
+ (chicken pox and shingles). The markets for these products are hospital,
369
+ reference, physicians' office and public health laboratories.
370
+ MARKETING AND SALES
371
+ Meridian's marketing efforts are focused on a continual process of seeking ways
372
+ to assist health care providers in improving outcomes for patients exposed to
373
+ serious infectious diseases. Rapid, accurate diagnosis can mean faster recovery,
374
+ shorter hospital stays and less expense, both for the patient and the health
375
+ care system.
376
+ Meridian believes that its marketing goals are best served by forming
377
+ partnerships with key customers to develop concepts for future products and
378
+ technology applications. These partnerships facilitate close customer
379
+ interaction, including product strategy sessions and co-marketing programs.
380
+ Marketing utilizes its strong industry contacts, plus key customer focus
381
+ sessions, to identify new products and other opportunities. Through the use of
382
+ cross-functional teams that include marketing, research and development and
383
+ manufacturing personnel, marketing guides the development process to meet
384
+ customers' needs with products that are easier to use, require less technical
385
+ expertise, and yield faster results--often in minutes or hours rather than days.
386
+ Changes in the health care delivery system have resulted in major consolidation
387
+ among reference laboratories and the formation of multi-hospital alliances.
388
+ Meridian has structured its marketing, selling and customer service to
389
+ anticipate and respond to these changes. This involved the
390
+ 7
391
+ 10
392
+ addition of sales and marketing personnel; the expansion of technical services
393
+ staff to support Meridian's customers and distribution network through a
394
+ toll-free service hotline; and the implementation of major marketing programs to
395
+ target key customers.
396
+ Meridian markets products through direct sales forces, both domestically and in
397
+ Italy, France, Belgium and the Netherlands, and through national and
398
+ international independent distributors. In the United States, Meridian's direct
399
+ sales force consists of three regional sales managers, one Corporate Health
400
+ System Manager, three inside sales representatives and 18 technical sales
401
+ representatives. In Europe, Meridian's sales force consists of a vice president
402
+ of sales and marketing, six sales and marketing managers, two product managers,
403
+ five product specialists and 20 technical sales representatives. Where Meridian
404
+ utilizes distributors, Meridian participates in selling efforts involving key
405
+ customers. Meridian has nearly 80 independent distributors in more than 60
406
+ foreign countries including key distributor relationships in Canada, Central and
407
+ South America, Mexico, Australia, New Zealand and the Pacific Rim, which are
408
+ managed directly from the United States by an international manager. Meridian's
409
+ sales in Europe, North Africa and the Middle East are shipped from Meridian
410
+ Diagnostics Europe (MDE) distribution centers in Milan, Italy and Nivelle,
411
+ Belgium.
412
+ RESEARCH AND DEVELOPMENT
413
+ Meridian's research and development activities focus on developing new and
414
+ improved diagnostic solutions. Working in conjunction with the marketing
415
+ department, Meridian's research and development department focuses its
416
+ activities on enhancements to, and new applications for, Meridian's
417
+ technologies. Over the past ten years, Meridian has developed internally 35 new
418
+ products. Meridian has patent protection on a limited number of its products
419
+ including Premier Platinum HpSA(TM). The research and development department is
420
+ proficient in a number of diagnostic technologies, each of which can be applied
421
+ to meet new product specifications that marketing has established. Meridian's
422
+ product development staffs are experts in binding various biological materials
423
+ to numerous solid phases, including plastics, membranes, latex beads,
424
+ immunofluorescent dyes and immunogold, to develop testing formats. Meridian
425
+ believes that its proprietary know-how and technologies in these areas enable it
426
+ to develop products that have longer shelf-lives and provide improved
427
+ performance and quicker test results.
428
+ The research and development department initiates Meridian's quality process
429
+ through its design control mechanism which establishes manufacturing standards
430
+ and specifications. By working closely with the manufacturing department, the
431
+ same standards and specifications ensure consistent high-quality products.
432
+ Meridian estimates that it takes approximately 18 to 24 months from the
433
+ conceptualization of a product to its marketing.
434
+ The research and development department includes the Vice President of Research
435
+ and Development and 14 research scientists. The disciplines represented in the
436
+ group include biochemistry, immunology, mycology, bacteriology, virology and
437
+ parasitology. In fiscal 1998, fiscal 1999 and fiscal 2000, Meridian spent $2.0
438
+ million, $2.0 million, and $2.3 million
439
+ 8
440
+ 11
441
+ respectively, on its research and development activities.
442
+ CUSTOMERS
443
+ The principal customers for Meridian's products are hospitals, commercial and
444
+ reference laboratories, alternate site markets, such as physicians' offices,
445
+ outpatient clinics, nursing homes and HMOs, and new markets, such as veterinary
446
+ laboratories and water treatment facilities. Meridian also serves as an original
447
+ equipment manufacturer for other diagnostic companies. Two distributors together
448
+ accounted for more than 25% of Meridian's fiscal 2000 sales. However, Meridian
449
+ does not believe that the loss of either of these distributors would have a
450
+ material adverse effect on Meridian because of its ability to sell to the
451
+ end-use customers served by these distributors through alternative means.
452
+ MANUFACTURING
453
+ During fiscal 2000, substantially all of Meridian's manufacturing was performed
454
+ at its Cincinnati, Ohio facility. Meridian's acquisition of VAI has added
455
+ additional manufacturing capacity in Memphis, Tennessee. VAI's manufacturing of
456
+ veterinary products is regulated by the USDA and VAI's proteomics laboratory is
457
+ regulated by CBER (see Government Regulation). VAI's manufacturing facilities
458
+ are also subject to audit by certain customers. To maintain the highest quality
459
+ standards, Meridian utilizes both external and internal quality auditors who
460
+ routinely evaluate Meridian's manufacturing processes. Meridian strives to
461
+ quickly evaluate, remedy and review the implementation of corrective actions to
462
+ further assure compliance with medical device regulation.
463
+ Meridian is required to comply with, among other regulations, the FDA's Quality
464
+ System Regulation and is subject to periodic audits by the FDA. In response to
465
+ audits conducted in fiscal 2000, the Company implemented various programs to
466
+ address necessary corrective actions which it identified and increased its
467
+ quality assurance and control staffing. The costs attributable to the additional
468
+ staff and consulting assistance for fiscal 2000 were approximately $800,000. The
469
+ FDA is currently conducting a follow-up audit and is reviewing certain
470
+ validation procedures for certain products. The Company is fully cooperating
471
+ with the FDA in an effort to complete this process. While the outcome of the
472
+ audit is unknown at this time, if the FDA requires that validation procedures be
473
+ re-performed, the Company estimates that the lost revenue impact, while the
474
+ product is being re-validated and not available for sale, and the potential
475
+ work-in-process inventory that is not saleable, could be significant.
476
+ Meridian's immunodiagnostic products require the production of highly specific
477
+ and sensitive antigens and antibodies. Meridian produces substantially all of
478
+ its own requirements including monoclonal antibodies and polyclonal antibodies,
479
+ plus a variety of fungal, bacterial and viral antigens. For many of its key raw
480
+ materials acquired from third parties, Meridian has developed dual sources. As a
481
+ result, Meridian believes it has access to sufficient raw materials for its
482
+ 9
483
+ 12
484
+ products. Meridian believes it has sufficient manufacturing capacity for
485
+ anticipated growth. Meridian Diagnostics Europe s.r.l. achieved ISO 9002
486
+ certification in fiscal 1998, BIODESIGN achieved ISO 9001 certification in
487
+ fiscal 2000 and Meridian is working towards achieving ISO 9000 certification in
488
+ Cincinnati in fiscal 2001.
489
+ COMPETITION
490
+ The market for diagnostic tests is a multi-billion dollar international industry
491
+ which is highly competitive. Many of Meridian's competitors are larger with
492
+ greater financial, research, manufacturing and marketing resources. Important
493
+ competitive factors of Meridian's products include product quality, price, ease
494
+ of use, customer service, and reputation. In a broader sense, industry
495
+ competition is based upon scientific and technological capability, proprietary
496
+ know-how, access to adequate capital, the ability to develop and market products
497
+ and processes, the ability to attract and retain qualified personnel and the
498
+ availability of patent protection. To the extent that Meridian's product lines
499
+ do not reflect technological advances, Meridian's ability to compete in those
500
+ product lines could be adversely affected.
501
+ Companies competing in the diagnostic test industry generally focus on a limited
502
+ number of tests or limited segments of the market. As a result, the diagnostic
503
+ test industry is highly fragmented and segmented. Hundreds of companies in the
504
+ United States alone supply immunodiagnostic tests. These companies range from
505
+ multi-national health care companies, for which immunodiagnostics is one line of
506
+ business, to small start-up companies. Of central importance in the industry are
507
+ mid-sized medical diagnostic specialty companies, like Meridian, that offer
508
+ multiple, broad product lines and have the ability to deliver high value new
509
+ products quickly to the marketplace. Among the companies with which Meridian
510
+ competes in the marketing of one or more of its products are Abbott Laboratories
511
+ Inc., Becton, Dickinson and Company, Diagnostic Products Corporation, Quidel
512
+ Corporation and Wampole Laboratories Division of Carter-Wallace, Inc.
513
+ INTELLECTUAL PROPERTY, PATENTS AND LICENSES
514
+ Meridian owns or licenses U.S. and foreign patents for approximately 25 of its
515
+ products, including a patent for Premier Platinum HpSA(TM) issued in February
516
+ 1998. The Company's VAI subsidiary has U.S. patents for four of its
517
+ manufacturing processes. The patents or licenses for most of Meridian's products
518
+ were acquired in connection with the purchase of the products or the licensing
519
+ of the technology on which the products are based. In the absence of patent
520
+ protection, Meridian may be vulnerable to competitors who successfully replicate
521
+ Meridian's production and manufacturing techniques and processes. Meridian's
522
+ laboratory and research personnel are required to execute confidentiality
523
+ agreements designed to protect Meridian's proprietary products.
524
+ 10
525
+ 13
526
+ Meridian has no reason to believe that its products and proprietary rights
527
+ infringe the proprietary rights of any third parties. There can be no assurance,
528
+ however, that third parties will not assert infringement claims in the future.
529
+ GOVERNMENT REGULATION
530
+ FDA Regulation of Medical Devices - Meridian's products are regulated by the
531
+ Food & Drug Administration as "devices" pursuant to the Federal Food, Drug and
532
+ Cosmetic Act (FDCA). Under the FDCA, medical devices are classified into one of
533
+ three classes (i.e., Class I, II or III). Class I and II devices are not
534
+ expressly approved by the FDA, but, instead, are "cleared" for marketing. Class
535
+ III devices generally must receive "pre-market approval" from the FDA as to
536
+ safety and effectiveness.
537
+ A 510(k) clearance will be granted if the submitted data establishes that the
538
+ proposed device is "substantially equivalent" to an existing Class I or Class II
539
+ medical device or to a Class III medical device for which the FDA has not
540
+ required pre-market approval. The 510(k) clearance process for "substantially
541
+ equivalent" devices allows product sales to be made after the filing of an
542
+ application and upon acknowledgment by the FDA, typically within 90 to 120 days
543
+ after submission. If the FDA requests additional information, the product cannot
544
+ be sold until the application has been supplemented and upon acknowledgment by
545
+ the FDA within 90 to 120 days of the supplemental application. In practice, the
546
+ FDA has been granting clearance in about 30 days following submission of the
547
+ supplemental information. If there are no existing FDA-approved products or
548
+ processes comparable to a diagnostic product or process, approval by the FDA
549
+ involves the more lengthy pre-market approval procedures.
550
+ Each of the products currently marketed by Meridian has been cleared by the FDA
551
+ pursuant to the 510(k) clearance process or is exempt from such requirements.
552
+ Meridian believes that most, but not all, products under development will be
553
+ classified as Class I or II medical devices and will be eligible for 510(k)
554
+ clearance.
555
+ Other Medical Device Regulation - Sales of Meridian's products in foreign
556
+ countries are subject to foreign government regulation, the requirements of
557
+ which vary substantially from country to country. The time required to obtain
558
+ approval by a foreign country may be longer or shorter than that required for
559
+ FDA approval, and the requirements may differ. During fiscal 1999, Meridian
560
+ received approval for several new product registrations in Japan. Currently,
561
+ Meridian is supporting foreign product registrations in Mexico, Korea, Japan,
562
+ China and Argentina via the distributors in the respective countries.
563
+ VAI's veterinary products are approved and licensed by the United States
564
+ Department of Agriculture (USDA). This typically requires six months to one year
565
+ for the approval process. In addition, assays for monitoring "controlled
566
+ diseases" require testing and release of each production serial before it is
567
+ available to the market.
568
+ 11
569
+ 14
570
+ The proteins produced in VAI's proteomics laboratory are intended to be used as
571
+ "injectibles". As such they are produced under more stringent regulations under
572
+ the auspices of the Center for Biologicals Evaluation & Research (CBER).
573
+ Approval and licensing, following clinical trials, of these products will be the
574
+ responsibility of the company that owns the rights to each protein. Such
575
+ products are approved under the "pre-market approval" guidelines which requires
576
+ substantially more time than 510(k) clearance.
577
+ The Clinical Laboratory Improvement Act of 1988 prohibits laboratories from
578
+ performing in vitro tests for the purpose of providing information for the
579
+ diagnosis, prevention or treatment of any disease or impairment of, or the
580
+ assessment of, the health of human beings unless there is in effect for such
581
+ laboratories a certificate issued by the U.S. Department of Health and Human
582
+ Services applicable to the category of examination or procedure performed.
583
+ Although these certificates are required only for Meridian's laboratory
584
+ customers (but not for Meridian itself), Meridian considers the requirements of
585
+ The Clinical Laboratory Improvement Act of 1988 in the design and development of
586
+ its products.
587
+ Meridian is a conditionally exempt small quantity generator of hazardous waste
588
+ and has a U.S. Environmental Protection Agency identification number. All
589
+ hazardous waste is manifested and disposed of properly. Meridian is in
590
+ compliance with the applicable portions of the federal and state hazardous waste
591
+ regulations and has never been a party to any environmental proceeding.
592
+ EMPLOYEES
593
+ As of September 30, 2000, Meridian had 369 full-time employees, including 75 in
594
+ sales, marketing and technical support, 106 in manufacturing, 15 in research and
595
+ product development, and 35 in administration and finance. 93 of Meridian's
596
+ employees hold scientific degrees.
597
+ Meridian maintains a Savings and Investment Plan for its U.S. employees and has
598
+ established stock option plans for its officers, directors and employees. In
599
+ addition, a stock purchase plan was established on October 1, 1997 for all
600
+ employees.
601
+ None of Meridian's employees is represented by a labor organization and Meridian
602
+ is not a party to any collective bargaining agreement. Meridian has never
603
+ experienced any strike or work stoppage and considers its relationship with its
604
+ employees to be good.
605
+ ITEM 2.
606
+ PROPERTIES
607
+ ----------
608
+ Meridian's corporate offices, manufacturing facility and research and
609
+ development facility are located in three buildings totaling approximately
610
+ 94,000 square feet on 6.2 acres of land in a suburb of Cincinnati. These
611
+ properties are owned by Meridian. Meridian has approximately
612
+ 12
613
+ 15
614
+ 51,000 square feet of manufacturing space and 9,000 square feet of warehouse
615
+ space in the Cincinnati facility.
616
+ In the VAI acquisition, Meridian acquired VAI's executive offices and
617
+ manufacturing facility located in Memphis, Tennessee. This facility is comprised
618
+ of two buildings totaling approximately 31,000 square feet, including
619
+ approximately 25,000 square feet of manufacturing space.
620
+ The distribution center in Italy conducts its operations in a two-story building
621
+ in the Milan, Italy area consisting of approximately 18,000 square feet. This
622
+ facility is owned by Meridian Diagnostics Europe s.r.l.
623
+ In the Gull acquisition, Meridian acquired Gull's executive offices and
624
+ principal U.S. manufacturing facilities located in two buildings totaling 33,000
625
+ square feet on approximately five acres of land in Salt Lake City, Utah. Both
626
+ the land and the building were sold during fiscal 2000.
627
+ BIODESIGN rents a 10,000 square foot facility that houses administration,
628
+ distribution and manufacturing facilities in Saco, Maine under a lease that
629
+ expires in 2006.
630
+ Meridian rents approximately 3,000 square feet of space in Nivelle, Belgium for
631
+ sales, warehousing and distribution. The lease expires in 2009. Meridian also
632
+ rents office space in France and the Netherlands for small sales offices.
633
+ ITEM 3.
634
+ LEGAL PROCEEDINGS
635
+ -----------------
636
+ In June 2000, Meridian filed suit against a former employee and certain other
637
+ defendants for breach of an employment agreement and misappropriation of trade
638
+ secrets. The lawsuit seeks injunctive relief as well as compensatory and
639
+ punitive damages against the defendants. Meridian successfully obtained a
640
+ temporary restraining order and a preliminary injunction against its former
641
+ employee. Meridian intends to seek recovery from the defendants for its damages,
642
+ costs and expenses, including its legal fees which amounted to approximately
643
+ $450,000 at September 30, 2000. There are no assurances, however, that Meridian
644
+ will be able to recover all or some of those amounts.
645
+ Management is not aware of any other material pending or threatened litigation,
646
+ claims or assessments, asserted or unasserted, against Meridian or its
647
+ subsidiaries except those arising in the ordinary course of business.
648
+ 13
649
+ 16
650
+ ITEM 4.
651
+ SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
652
+ ---------------------------------------------------
653
+ No matters were submitted to a vote of security holders during the fourth
654
+ quarter of fiscal 2000.
655
+ PART II.
656
+ ITEM 5.
657
+ MARKET FOR REGISTRANT'S COMMON
658
+ EQUITY AND RELATED STOCKHOLDER MATTERS
659
+ --------------------------------------
660
+ "Common Stock Information" on page 27 and "Quarterly Financial Data" on page 25
661
+ of the Registrant's Annual Report to Shareholders for 2000 are incorporated
662
+ herein by reference. There are no external restrictions on cash dividend
663
+ payments.
664
+ Meridian follows a cash dividend policy consisting of regular quarterly
665
+ dividends and special year-end dividends. The Board has set a targeted payout
666
+ ratio of 45% to 55% of annual net earnings. Approximately 30% to 35% of
667
+ forecasted annual net earnings is intended to be paid in regular quarterly
668
+ dividends with any balance being paid as a year-end special dividend. All or a
669
+ portion of the year-end dividend may be paid in stock. The declaration and
670
+ amount of dividends are determined by the Board of Directors in its discretion
671
+ based upon its evaluation of earnings, cash flow requirements and future
672
+ business developments. There is no assurance that dividends will continue.
673
+ Meridian paid dividends of $0.22 per share, $0.20 per share, and $0.23 per share
674
+ in fiscal 1998, fiscal 1999, and fiscal 2000, respectively.
675
+ On November 16, 2000, the Board of Directors voted to increase the annual cash
676
+ dividend rate to $0.26 per share, an increase of 13%.
677
+ ITEM 6.
678
+ SELECTED FINANCIAL DATA
679
+ -----------------------
680
+ "Ten Year Summary" on page 26 of the Registrant's Annual Report to Shareholders
681
+ for 2000 is incorporated by reference.
682
+ 14
683
+ 17
684
+ ITEM 7.
685
+ MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL
686
+ CONDITION AND RESULTS OF OPERATIONS
687
+ -----------------------------------
688
+ "Management's Discussion and Analysis of Financial Condition and Results of
689
+ Operations" commencing on page 10 of the Registrant's Annual Report to
690
+ Shareholders for 2000 is incorporated herein by reference.
691
+ ITEM 7A.
692
+ QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
693
+ ----------------------------------------------------------
694
+ The information required by Item 7A is incorporated by reference from the
695
+ discussion of "Market Risk Exposure" contained on page 13 of the Registrants
696
+ Annual Report to Shareholders for 2000.
697
+ ITEM 8.
698
+ FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
699
+ -------------------------------------------
700
+ "Quarterly Financial Data" on page 25 of the Registrant's Annual Report to
701
+ Shareholders for 2000 along with the Consolidated Financial Statements of the
702
+ Registrant shown on pages 14 through 25 of its Annual Report to Shareholders for
703
+ 2000, are incorporated herein by reference:
704
+ Consolidated Balance Sheets as of September 30, 2000 and 1999.
705
+ Consolidated Statements of Earnings for the years ended September 30, 2000,
706
+ 1999 and 1998.
707
+ Consolidated Statements of Shareholders' Equity for the years ended
708
+ September 30, 2000, 1999 and 1998.
709
+ Consolidated Statements of Cash Flows for the years ended September 30,
710
+ 2000, 1999 and 1998.
711
+ Notes to Consolidated Financial Statements.
712
+ Report of Independent Public Accountants.
713
+ The following schedules are filed herewith:
714
+ 15
715
+ 18
716
+ Schedule
717
+ No. Description Page
718
+ --- ----------- ----
719
+ Report of Independent Public Accountants. 23
720
+ II. Valuation and Qualifying Accounts for the years ended
721
+ September 30, 2000, 1999 and 1998. 24
722
+ All other supplemental schedules are omitted due to the absence of conditions
723
+ under which they are required or because the information is shown in the
724
+ Consolidated Financial Statements or Notes thereto.
725
+ ITEM 9.
726
+ DISAGREEMENTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
727
+ ----------------------------------------------------
728
+ None.
729
+ PART III
730
+ Items 10., 11., 12., and 13. of Part III are incorporated by reference to the
731
+ Registrant's Proxy Statement for its 2001 Annual Shareholders' Meeting to be
732
+ filed with the Commission pursuant to Regulation 14A.
733
+ PART IV
734
+ ITEM 14.
735
+ EXHIBITS, FINANCIAL STATEMENT SCHEDULES, AND REPORTS ON FORM 8-K
736
+ ----------------------------------------------------------------
737
+ (a) (1) and (2) FINANCIAL STATEMENTS AND SCHEDULES.
738
+ All financial statements and schedules required to be filed by Item 8 of this
739
+ Form and included in this report have been listed previously under Item 8. No
740
+ additional financial statements or schedules are being filed since the
741
+ requirements of paragraph (d) under Item 14 are not applicable to Meridian.
742
+ (a) (3) EXHIBITS.
743
+ 16
744
+ 19
745
+ Exhibit Number Description of Exhibit Filing Status
746
+ -------------- ---------------------- -------------
747
+ 3.1 Articles of Incorporation, including amendments A
748
+ 3.2 Code of Regulations B
749
+ 4 Indenture between Meridian and Star Bank, National C
750
+ Association, as Trustee, relating to Meridian's 7%
751
+ Convertible Subordinated Debentures due 2006
752
+ 10.3 License Agreement dated October 6, 1983 with Marion B
753
+ Laboratories, Inc.
754
+ 10.5 Sublicense Agreement dated June 17, 1993 among Johnson & D
755
+ Johnson, the Scripps Research Institute and Meridian
756
+ Concerning certain Patent Rights
757
+ 10.6 Assignment dated June 17, 1993 from Ortho Diagnostic D
758
+ Systems Inc. to Meridian concerning certain Patent Rights
759
+ 10.7 Agreement dated January 24, 1994 between Meridian E
760
+ Diagnostics, Inc. and Immulok, Inc.
761
+ 10.8 Asset Purchase Agreement dated June 24, 1996 between F
762
+ Cambridge Biotech Corporation and Meridian Diagnostics,
763
+ Inc.
764
+ 10.9 Merger Agreement among Gull Laboratories, Inc., Meridian G
765
+ Diagnostics, Inc. Fresenius AG and Meridian Acquisition
766
+ Co. dated as of September 15, 1998
767
+ 10.10* Savings and Investment Plan, as amended H
768
+ 10.11* Savings and Investment Plan Trust I
769
+ 10.12* 1986 Stock Option Plan J
770
+ 10.14* 1994 Directors' Stock Option Plan K
771
+ 10.15* 1996 Stock Option Plan L
772
+ 10.16* Salary Continuation Agreement for John A. Kraeutler M
773
+ 10.17 First Amendment to Merger Agreement Among Gull N
774
+ Laboratories, Inc., Meridian Diagnostics
775
+ 17
776
+ 20
777
+ Inc. Fresenius AG and Meridian Acquisition Co.
778
+ 10.18* 1999 Directors' Stock Option Plan O
779
+ 10.19* 1996 Stock Option Plan Amended and Restated Effective O
780
+ January 22, 1999
781
+ 10.20 Dividend Reinvestment Plan Q
782
+ 10.21 Merger Agreement dated September 13, 2000 among Meridian P
783
+ and the Shareholders of Viral Antigens, Inc.
784
+ 13 2000 Annual Report to Shareholders Filed herewith(1)
785
+ 21 Subsidiaries of the Registrant Filed herewith
786
+ 23 Consent of Independent Public Accountants Filed herewith
787
+ 27 Financial Data Schedule Filed herewith
788
+ 99 Forward Looking Statements Statement Filed herewith
789
+ --------
790
+ 1 Only portions of the 2000 Annual Report to Shareholders specifically
791
+ incorporated by reference in this Form 10-K are filed herewith. A supplemental
792
+ paper copy of the 2000 Annual Report to Shareholders has been provided to the
793
+ Securities and Exchange Commission for informational purposes only.
794
+ 18
795
+ 21
796
+ *Management Compensatory Contracts
797
+ Incorporated by reference to:
798
+ A. Registration Statement No. 333-02613 on Form S-3 filed with the Securities
799
+ and Exchange Commission on April 18, 1996.
800
+ B. Registration Statement No. 33-6052 filed under the Securities Act of 1933.
801
+ C. Registration Statement No. 333-11077 on Form S-3 filed with the Securities
802
+ and Exchange Commission on August 29, 1996.
803
+ D. Meridian's Form 8-K filed with the Securities and Exchange Commission on
804
+ June 17, 1993.
805
+ E. Meridian's Forms 8-K filed with the Securities and Exchange Commission on
806
+ February 8, 1994 and April 6, 1994.
807
+ F. Meridian's Form 8-K filed with the Securities and Exchange Commission on
808
+ July 2, 1996.
809
+ G. Meridian's Form 8-K filed with the Securities and Exchange Commission on
810
+ September 17, 1998.
811
+ H. Meridian's Annual Report on Form 10-K for the Fiscal Year Ended September
812
+ 30, 1994 and to Registration Statement No. 33-65443 on Form S-8 filed with
813
+ the Securities and Exchange Commission on December 28, 1995.
814
+ I. Meridian's Annual Report on Form 10-K for the Fiscal Year Ended September
815
+ 30, 1994.
816
+ J. Registration Statement No. 33-89214 on Form S-8 filed with the Securities
817
+ and Exchange Commission on April 5, 1995.
818
+ K. Registration Statement No. 33-78868 on Form S-8 filed with the Securities
819
+ and Exchange Commission on May 12, 1994.
820
+ L. Meridian's Annual Report on Form 10-K for the Fiscal Year Ended September
821
+ 30, 1996.
822
+ M. Meridian's Annual Report on Form 10-K for the Fiscal Year Ended September
823
+ 30, 1995.
824
+ N. Company's Report on Form 8-K filed with the Securities and Exchange
825
+ Commission filed on November 13, 1998.
826
+ 19
827
+ 22
828
+ O. Meridian's Proxy Statement filed with the Securities and Exchange
829
+ Commission on December 21, 1998.
830
+ P. Meridian's Current Report on Form 8-K dated September 29, 2000.
831
+ Q. Meridian's Annual Report on Form 10-K for the Fiscal Year Ended September
832
+ 30, 1999.
833
+ (b) REPORTS ON FORM 8-K.
834
+ Meridian filed Reports on Form 8-K dated September 14, 2000 and September 29,
835
+ 2000 related to the acquisition of all of the outstanding common stock of Viral
836
+ Antigens, Inc.
837
+ 20
838
+ 23
839
+ SIGNATURES
840
+ ----------
841
+ Pursuant to the requirements of Section 13 of the Securities Exchange Act of
842
+ 1934, the Registrant has duly caused this report to be signed on its behalf by
843
+ the undersigned, thereunto duly authorized.
844
+ MERIDIAN DIAGNOSTICS, INC.
845
+ By: /s/ William J. Motto
846
+ --------------------------------------
847
+ Date: December 22, 2000 William J. Motto
848
+ Chairman of the Board of
849
+ Directors and Chief Executive
850
+ Officer (Principal Executive Officer)
851
+ 21
852
+ 24
853
+ Pursuant to the requirements of the Securities Exchange Act of 1934, this report
854
+ has been signed by the following persons on behalf of the Registrant and in the
855
+ capacities and on the dates indicated.
856
+ Signature Capacity Date
857
+ --------- -------- ----
858
+ /s/ William J. Motto Chairman of the Board of Directors and December 22, 2000
859
+ ---------------------------------------- Chief Executive Officer (Principal
860
+ William J. Motto Executive Officer)
861
+ /s/ John A. Kraeutler President and Chief Operating December 22, 2000
862
+ ---------------------------------------- Officer, Director
863
+ John A. Kraeutler
864
+ /s/ Melissa Lueke Corporate Controller December 22, 2000
865
+ ---------------------------------------- (Acting Principal Accounting Officer)
866
+ Melissa Lueke
867
+ /s/ James A. Buzard Director December 22, 2000
868
+ ----------------------------------------
869
+ James A. Buzard
870
+ /s/ Gary P. Kreider Director December 22, 2000
871
+ ----------------------------------------
872
+ Gary P. Kreider
873
+ /s/ David C. Phillips Director December 22, 2000
874
+ ----------------------------------------
875
+ David C. Phillips
876
+ /s/ Robert J. Ready Director December 22, 2000
877
+ ----------------------------------------
878
+ Robert J. Ready
879
+ 22
880
+ 25
881
+ Report of Independent Public Accountants
882
+ ----------------------------------------
883
+ To Meridian Diagnostics, Inc:
884
+ We have audited in accordance with generally accepted auditing standards, the
885
+ consolidated financial statements included in Meridian Diagnostics, Inc. and
886
+ subsidiaries' annual report to shareholders incorporated by reference in this
887
+ Form 10-K, and have issued our report thereon dated November 16, 2000. Our audit
888
+ was made for the purpose of forming an opinion on those statements taken as a
889
+ whole. The schedule listed in Item 8 is the responsibility of the Company's
890
+ management and is presented for purposes of complying with the Securities and
891
+ Exchange Commission's rules and is not part of the basic financial statements.
892
+ This schedule has been subjected to the auditing procedures applied in the audit
893
+ of the basic financial statements and, in our opinion, fairly states in all
894
+ material respects the financial data required to be set forth therein in
895
+ relation to the basic financial statements taken as a whole.
896
+ ARTHUR ANDERSEN LLP
897
+ Cincinnati, Ohio
898
+ November 16, 2000
899
+ 23
900
+ 26
901
+ SCHEDULE II
902
+ Meridian Diagnostics, Inc.
903
+ and Subsidiaries
904
+ Valuation and Qualifying Accounts
905
+ (Amounts in Thousands)
906
+ Years Ended September 30, 2000, 1999 and 1998
907
+ Balance at Charged to Charged Balance
908
+ Beginning Costs and to Other at End of
909
+ Description of Period Expenses Accounts Deductions Other(1) Period
910
+ ----------- --------- -------- -------- ---------- -------- ------
911
+ Year Ended September 30, 2000:
912
+ ------------------------------
913
+ Allowance for Doubtful Accounts $ 380 $ 122 $ - $ (45) $(19) $ 438
914
+ Inventory Reserves 1,013 568 - (806) (90) 685
915
+ Merger Integration Accounts 157 - - (157) - -
916
+ Year Ended September 30, 1999:
917
+ ------------------------------
918
+ Allowance for Doubtful Accounts $ 171 $ 150 $ 7 $ (303) $355 $ 380
919
+ Inventory Reserves 857 667 - (1,242) 731 1,013
920
+ Merger Integration Accounts - 3,415 - (3,258) - 157
921
+ Year Ended September 30, 1998:
922
+ ------------------------------
923
+ Allowance for Doubtful Accounts $ 166 $ 27 $ 7 $ (29) $ - $ 171
924
+ Inventory Reserves 416 1,029 - (588) - 857
925
+ --------
926
+ 1 Balances in fiscal 2000 reflect acquired valuation accounts related to the
927
+ Viral Antigens, Inc. acquisition ($5 for the allowance for doubtful accounts)
928
+ and the effects of currency translation. Balances in fiscal 1999 reflect the
929
+ acquired valuation accounts related to the Gull Laboratories, Inc. acquisition.
930
+ 24
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1
+ ITEM 1.
2
+ BUSINESS
3
+ --------
4
+ GENERAL
5
+ Meridian is a fully integrated life sciences company that develops, manufactures
6
+ and markets a broad range of innovative, disposable diagnostic test kits and
7
+ related diagnostic products used for the rapid diagnosis of infectious diseases,
8
+ and also offers biopharmaceutical capabilities. Meridian's diagnostics products
9
+ provide accuracy, simplicity, and speed, and enable early diagnosis and
10
+ treatment of common medical conditions such as gastrointestinal, viral, urinary
11
+ tract and respiratory infections. All of Meridian's diagnostics products are
12
+ used in procedures performed in vitro (outside the body) and enhance patient
13
+ well-being while reducing total outcome costs of healthcare. In addition to the
14
+ diagnostic business, Meridian is expanding further into the area of life
15
+ sciences. Through recent acquisitions, Meridian has the technical expertise to
16
+ enable research efforts of genomics scientists in drug and vaccine development.
17
+ The expansion into life sciences prompted the Company's decision to change its
18
+ official name to Meridian Bioscience, Inc., subject to shareholder approval in
19
+ January 2001.
20
+ Meridian's product development strategy is to combine existing technologies with
21
+ new product designs both through internal or joint product development and
22
+ through product acquisitions, licensing or supply arrangements. Internal and
23
+ joint product development activities focus on the development or enhancement of
24
+ immunodiagnostic technologies and applications to simplify, accelerate or
25
+ increase the accuracy of diagnoses of certain infectious diseases. Since 1991,
26
+ Meridian has also acquired or obtained rights to distribute a number of products
27
+ and technologies.
28
+ Meridian utilizes its resources to serve each of the strategic domestic and
29
+ international medical markets it has targeted: hospital networks and clinical
30
+ and hospital laboratories; alternate site markets, including physicians'
31
+ offices, outpatient clinics, nursing homes and health maintenance organizations
32
+ (HMOs); and new markets, including veterinary laboratories and water treatment
33
+ facilities. Meridian markets over 200 products representing four major disease
34
+ states through a direct sales force in the United States, Italy, France, Belgium
35
+ and the Netherlands, supplemented by a network of national and international
36
+ distributors. International sales in more than 60 countries were 31% of total
37
+ fiscal 2000 sales.
38
+ During the fourth quarter of fiscal 2000, a plan was implemented to restructure
39
+ European distribution operations and eliminate the Company's direct presence in
40
+ Germany. This plan involves (i) the shutdown of the German distribution center,
41
+ (ii) the transfer of the export business from Germany to the Company's Belgian
42
+ operations and (iii) movement of the German in-country business to an
43
+ independent distributor. This plan was adopted as a means to improve operating
44
+ results in Europe.
45
+ 1
46
+ 4
47
+ ACQUISITIONS AND ALLIANCES
48
+ An important facet of Meridian's long-term business strategy is the expansion
49
+ into life sciences, as well as the acquisition, licensing or entrance into
50
+ supply arrangements to obtain innovative diagnostic testing technologies,
51
+ product formats and products that complement its existing operations and address
52
+ the needs of Meridian's existing and targeted customer base. Prior to fiscal
53
+ 2000, Meridian's management had pursued the acquisition and licensing of
54
+ products and technologies that fit Meridian's niche diagnostic test markets,
55
+ which are characterized by a large number of users. Examples of this included
56
+ the acquisition of Gull Laboratories, Inc. in fiscal 1999, the acquisition of
57
+ the enteric product line of Cambridge Biotech Corporation in fiscal 1996, the
58
+ acquisitions of the infections disease and mononucleosis product lines of
59
+ Johnson & Johnson in fiscal 1994 and 1993, respectively, and numerous smaller
60
+ product acquisitions and licensing arrangements.
61
+ In the late fiscal 2000, Meridian completed its acquisition of Viral Antigens,
62
+ Inc. VAI further expands Meridian's life sciences capabilities through VAI's
63
+ protein expression lab which provides Meridian the opportunity to serve as an
64
+ enabler to biopharmaceutical companies in the development of new drugs and
65
+ vaccines. VAI also manufactures infectious disease antigens that are used in
66
+ immunodiagnostics testing, and a Pseudorabies Virus antibody test kit and equine
67
+ infectious anemia antibody test kit for the veterinary market.
68
+ The purchase price for VAI was $9 million in cash, and was funded with bank debt
69
+ from the Company's existing credit facilities. The purchase agreement provides
70
+ for additional consideration, up to $8.25 million, contingent upon VAI's future
71
+ earnings though September 30, 2006. See Note 2 to the consolidated financial
72
+ statements for further information. On September 29, 2000, Meridian filed on
73
+ Form 8-K/A certain financial statements and pro forma financial information
74
+ relating to this acquisition.
75
+ Also during fiscal 2000, Meridian executed a Research and Development Agreement
76
+ and an Exclusive Supply Agreement with OraSure Technologies, Inc. to
77
+ commercialize the Uplink technology. Meridian believes that this technology will
78
+ offer competitive advantages including the elimination of background
79
+ interference, simultaneous detection of multiple biological markers and improved
80
+ sensitivity. These agreements require Meridian to make future payments to
81
+ OraSure to fund research and development costs and to obtain an exclusive
82
+ license to market and sell related products on a global basis.
83
+ In early fiscal 1999, Meridian acquired Gull Laboratories, Inc. for $19 million
84
+ in cash. Gull develops, manufactures and markets diagnostic test kits and
85
+ materials designed to detect past or present infection caused by certain
86
+ microbial agents such as viruses, bacteria and protozoa and to detect certain
87
+ autoimmune disorders. The products are based on established immunological assay
88
+ methods including indirect immunofluorescent antibody assay (IFA), enzyme-linked
89
+ immunosorbent assay (EIA), immunodiffusion and Western Blot. Gull's products are
90
+ used by private laboratories and hospital clinical laboratories worldwide.
91
+ Included in the Gull acquisition was its subsidiary, BIODESIGN International,
92
+ which manufactures and markets antigens and
93
+ 2
94
+ 5
95
+ antibodies to diagnostic and pharmaceutical manufacturers as well as academic
96
+ researchers.
97
+ During fiscal 2000, Meridian completed the transfer of Gull's Salt Lake City
98
+ production to the Company's Cincinnati facilities, and the sale of the Salt Lake
99
+ City facilities and real estate. During fiscal 1999, Meridian shut down Gull's
100
+ European manufacturing activities. See Note 2 to the consolidated financial
101
+ statements for further information.
102
+ A key component in the success of Meridian's acquisition and licensing of new
103
+ products and technologies has been the ability of Meridian's management to
104
+ respond quickly to acquisition and licensing opportunities as they arise in the
105
+ marketplace. The success of this strategy has also been due in part to
106
+ management's selective acquisition and licensing philosophy as well as the
107
+ availability of cash on hand and available lines of credit.
108
+ IMMUNODIAGNOSTICS OVERVIEW
109
+ In vitro diagnostic testing is the process of analyzing constituents of blood,
110
+ urine, stool, other body fluids or tissue for the presence of specific
111
+ infectious diseases. Immunodiagnostic testing, which is the leading method of in
112
+ vitro testing for infectious diseases, tests for antigens and antibodies. When
113
+ an infectious disease caused by pathogens, such as bacteria, viruses and fungi,
114
+ and their related antigens are present, the body responds by producing an
115
+ antibody. The antibody binds specifically with the antigen in a lock-and-key
116
+ fashion and initiates a biochemical reaction to attempt to neutralize and,
117
+ ultimately, to eliminate the antigen. The ability of an antibody to bind with a
118
+ specific antigen provides the basis for immunodiagnostic testing.
119
+ Immunodiagnostic testing detects the presence of specific infectious diseases
120
+ through "visualization", such as color changes or the formation of visible
121
+ aggregates, of the biochemical reactions caused by the antigen/antibody. Most
122
+ immunodiagnostic tests utilize one of two alternative methods to determine the
123
+ presence of a specific disease in a patient specimen. In one method, the test
124
+ employs the antibody to detect directly the presence of an antigen.
125
+ Alternatively, certain tests employ the antigen to detect the presence of an
126
+ antibody. In addition to the diagnosis of infectious diseases, immunodiagnostic
127
+ testing is also used to monitor the status of various patient therapy programs.
128
+ MARKET TRENDS
129
+ The global market for infectious disease tests continues to expand as new
130
+ disease states are identified, new therapies become available and worldwide
131
+ standards of living and access to health care improve. More importantly, within
132
+ this market there is a continuing shift from conventional testing, which
133
+ requires highly trained personnel and lengthy turnaround times for test results,
134
+ to more technologically advanced testing which can be performed by less highly
135
+ trained personnel and completed in minutes or hours.
136
+ 3
137
+ 6
138
+ Technological advances permitting accurate testing to occur outside the
139
+ traditional hospital or laboratory setting have also affected the market for
140
+ diagnostic products. These technological developments have contributed to the
141
+ emergence of alternate site markets, such as physicians' offices, outpatient
142
+ clinics, nursing homes and HMOs, as important diagnostic market segments. These
143
+ technological advances should also contribute to the development of new markets
144
+ for Meridian's products, including food testing, veterinary laboratories and
145
+ water treatment facilities.
146
+ The increasing pressures to contain total health care costs have accelerated the
147
+ increased use of diagnostic testing and the market shift to alternate sites.
148
+ With rapid and accurate diagnoses of infectious diseases, physicians can
149
+ pinpoint appropriate therapies quickly, leading to faster recovery, shorter
150
+ hospital stays and less treatment expense. In addition, these pressures have led
151
+ to a major consolidation among reference laboratories and the formation of
152
+ multi-hospital alliances that have reduced the number of institutional customers
153
+ for diagnostic products and resulted in changes in buying practices.
154
+ Specifically, multi-year exclusive or primary source marketing or distribution
155
+ contracts with institutional customers have become more common, replacing less
156
+ formal distribution arrangements of shorter duration and involving lower product
157
+ volumes. In Europe, the reexamination of health care costs, access and funding
158
+ is causing similar pressures.
159
+ BUSINESS STRATEGY
160
+ Meridian continues to execute its long-term strategy consisting of the following
161
+ elements:
162
+ Developing New Product Applications from Core Technologies - Meridian employs a
163
+ market-driven product development strategy to adapt or enhance diagnostic
164
+ testing technologies and product formats in response to newly identified disease
165
+ states and customer demands for improvements in product accuracy, simplicity,
166
+ speed and cost-efficiency. Meridian accomplishes this by monitoring existing
167
+ markets, interacting closely with its customers and recognizing emerging
168
+ diseases and therapies. In the last ten years, Meridian has developed 35 new
169
+ products, including one new product in fiscal 2000.
170
+ Acquiring and Licensing Products and Technology - Meridian intends to acquire,
171
+ license or enter into supply arrangements to obtain innovative diagnostic
172
+ testing technologies, product formats and products that complement its existing
173
+ operations and address the needs of Meridian's existing and targeted customer
174
+ base. Management regularly identifies and reviews opportunities through its
175
+ broad industry contacts and recognized position in the industry. In the last ten
176
+ years, Meridian has acquired, licensed or entered into supply arrangements
177
+ relating to approximately 100 products. The Gull acquisition accounted for 65 of
178
+ the 100 products.
179
+ Enabling Biomedical Research and Early Stage Biopharmaceutical Development -
180
+ Meridian intends to leverage its skills and capabilities in the life sciences
181
+ market. Meridian has an established position in this market through its
182
+ BIODESIGN subsidiary. BIODESIGN manufactures and distributes essential antigen
183
+ and antibody reagents to diagnostic and
184
+ 4
185
+ 7
186
+ pharmaceutical manufacturers as well as academic researchers. These reagents are
187
+ essential to the development of assay systems, control standards and new drug
188
+ development research.
189
+ During fiscal 2000, Meridian further improved its skills and capabilities in the
190
+ life sciences market through the acquisition of VAI and the expansion of outside
191
+ collaborations with academic and government research laboratories. VAI recently
192
+ completed the installation of a pharmaceutical quality proteomics laboratory
193
+ that will be used to produce drug and vaccine proteins through gene expression
194
+ techniques. These proteins will be used by biopharmaceutical companies in the
195
+ development of drugs and vaccines for Phase I, II and III clinical trials.
196
+ In September 2000, Meridian expanded its relationship with Texas Tech University
197
+ Health Sciences Center for the development of highly specific, gene-mediated
198
+ antigen and antibody systems. Texas Tech's capabilities utilize gene
199
+ manipulation technologies to produce proteins that are reproducible and specific
200
+ for a variety of disease states.
201
+ Increasing International Sales - Meridian has targeted international sales as an
202
+ attractive source of growth. Meridian has developed a strong presence in Italy
203
+ through its Italian subsidiary, Meridian Diagnostics Europe s.r.l., and with the
204
+ acquisition of Gull has an established sales force in Belgium, France and the
205
+ Netherlands. Meridian has added management to expand its ability to serve Latin
206
+ American markets and has expanded its international distributor base to include
207
+ distributors in Argentina and Asia. Over the last six years, Meridian's
208
+ international sales have grown from $2.1 million in fiscal 1993 to $17.7 million
209
+ in fiscal 2000 and represented 31% of total consolidated sales in fiscal 2000.
210
+ Strengthening Partnerships With Consolidated Health Care Organizations -
211
+ Meridian seeks to develop strategic partnerships with the major reference
212
+ laboratories and other consolidated health care providers. Meridian believes it
213
+ is in a position to develop partnerships because it is an integrated
214
+ manufacturer, has a broad product line, offers tests in multiple formats and is
215
+ willing to invest resources in building relationships and facilitating open
216
+ communications with those large customers. During fiscal 1999 and 1998, several
217
+ exclusive multiple-year contracts were signed with consolidated health care
218
+ providers. In the fall of 1998, a major national reference laboratory added
219
+ Premier Platinum HpSA to its test menu and actively markets HpSA to its client
220
+ list of primary care physicians and specialists. During fiscal 2000 and 1999,
221
+ Meridian extended or renewed supply agreements with several major reference
222
+ laboratories and other consolidated health care providers.
223
+ Global Sales Excellence - Meridian has launched an initiative to improve its
224
+ worldwide excellence in customer service, sales support and technical
225
+ assistance. Meridian believes that its customers have rewarded it for the high
226
+ level of customer service and support it has provided in the past. However,
227
+ Meridian desires to provide a level of service that exceeds the current
228
+ standards of the health care industry and, most importantly, the customer's
229
+ expectations. Meridian is implementing several customer satisfaction training
230
+ programs and information system improvements in order to achieve global sales
231
+ excellence.
232
+ 5
233
+ 8
234
+ PRODUCTS AND MARKETS
235
+ Meridian has expertise in the development and manufacture of products based on
236
+ multiple core diagnostic technologies, each of which enables the visualization
237
+ and identification of antigen/antibody reactions for specific pathogens. As a
238
+ result, Meridian is able to develop and manufacture diagnostic tests in a
239
+ variety of formats that satisfy customer needs and preferences, whether in a
240
+ hospital, commercial or reference laboratory or alternate site location. These
241
+ technologies include enzyme immunoassay, immunofluorescence, particle
242
+ agglutination, membrane filtration/concentration, immunodiffusion, complement
243
+ fixation and chemical stains.
244
+ Enzyme Immunoassay (EIA) - Products incorporating the EIA technology achieve
245
+ extremely high levels of accuracy in detecting disease-related antigens or
246
+ antibodies through the use of special color-based enzyme-substrate reactions.
247
+ Meridian utilizes this technology in its multiple test format, the Premier(TM)
248
+ product for large volume users, and in its single test formats, the
249
+ ImmunoCard(R) and Monolert(R) products, for single physician users.
250
+ Immunofluorescence - When the microscopic visualization of an antigen/antibody
251
+ reaction is necessary or desired, immunofluorescence technology is frequently
252
+ utilized. Fluorescing immunochemicals, in the presence of the target antigen or
253
+ antibody, can be viewed via a fluorescent microscope. Meridian utilizes this
254
+ technology in its Merifluor(R) products.
255
+ Particle Agglutination - This technology utilizes microparticles (e.g., latex,
256
+ red blood cells) coated with specific antigens or antibodies that form visible
257
+ aggregates in the presence of a specimen containing the complementary antigen or
258
+ antibody. This technology is rapid and economical and is used in Meridian's
259
+ Meritec(TM), MeriStar(R) and MonoSpot(R) products.
260
+ Membrane Filtration/Concentration - Meridian utilizes this technology to detect
261
+ infection-causing bacteria present in human urine. These bacteria are
262
+ concentrated on a unique filter membrane for detection via the addition of a
263
+ special dye solution. This technology is utilized in Meridian's proprietary
264
+ rapid, single-unit FiltraCheck-UTI(R) test format.
265
+ Other Technologies - Meridian utilizes other technologies that include
266
+ immunodiffusion, complement fixation and chemical stains. Meridian also
267
+ manufactures and markets specimen collection, transportation, preservation and
268
+ concentration products, such as Para-Pak(R), Macro-CON(R) and Spin-CON.
269
+ Meridian's product line, including products acquired in the VAI and Gull
270
+ acquisitions, consists of over 250 medical diagnostic products representing four
271
+ major disease states. Currently, the most important product lines from the
272
+ perspective of sales are products to diagnose gastrointestinal, viral and
273
+ parasitic diseases. Meridian's products generally range in list price from $1
274
+ per test to $33 per test. A discussion of Company's key products and their
275
+ competitive advantage follows.
276
+ Parasitic Diseases - Meridian manufactures products for the diagnosis and
277
+ collection, preservation, transportation and concentration of parasites.
278
+ Parasitic diseases include Giardiasis,
279
+ 6
280
+ 9
281
+ Cryptosporidiosis, Amebiasis and Lyme disease. The markets for these products
282
+ are hospital, reference and veterinary laboratoties.
283
+ Gastrointestinal Diseases - Meridian manufactures products for the rapid
284
+ diagnosis of stomach ulcers, toxigenic E.coli, antibiotic associated diarrhea
285
+ (C. difficile) and pediatric diarrhea (Rotavirus and Adenovirus). The markets
286
+ for these products are hospital, reference, veterinary and state health
287
+ laboratories.
288
+ Respiratory Diseases - Meridian manufactures a broad range of diagnostic
289
+ reagents for detecting respiratory diseases including pneumonia (mycoplasma
290
+ pneumoniae) and valley fever (coccidioides immittis). The markets for these
291
+ products are hospital, reference, veterinary and state health laboratories.
292
+ Urogenital Diseases - Meridian manufactures products for the rapid detection of
293
+ urinary tract infection and Chlamydia. The markets for these products are
294
+ hospital, reference, physicians' office and public health laboratories.
295
+ Viral Diseases - Meridian manufactures a broad range of products for the
296
+ detection of various viruses including Epstein -Barr (mononucleosis), Herpes
297
+ simplex, Cytomegalovirus (organ transplant infections) and Varicella -Zoster
298
+ (chicken pox and shingles). The markets for these products are hospital,
299
+ reference, physicians' office and public health laboratories.
300
+ MARKETING AND SALES
301
+ Meridian's marketing efforts are focused on a continual process of seeking ways
302
+ to assist health care providers in improving outcomes for patients exposed to
303
+ serious infectious diseases. Rapid, accurate diagnosis can mean faster recovery,
304
+ shorter hospital stays and less expense, both for the patient and the health
305
+ care system.
306
+ Meridian believes that its marketing goals are best served by forming
307
+ partnerships with key customers to develop concepts for future products and
308
+ technology applications. These partnerships facilitate close customer
309
+ interaction, including product strategy sessions and co-marketing programs.
310
+ Marketing utilizes its strong industry contacts, plus key customer focus
311
+ sessions, to identify new products and other opportunities. Through the use of
312
+ cross-functional teams that include marketing, research and development and
313
+ manufacturing personnel, marketing guides the development process to meet
314
+ customers' needs with products that are easier to use, require less technical
315
+ expertise, and yield faster results--often in minutes or hours rather than days.
316
+ Changes in the health care delivery system have resulted in major consolidation
317
+ among reference laboratories and the formation of multi-hospital alliances.
318
+ Meridian has structured its marketing, selling and customer service to
319
+ anticipate and respond to these changes. This involved the
320
+ 7
321
+ 10
322
+ addition of sales and marketing personnel; the expansion of technical services
323
+ staff to support Meridian's customers and distribution network through a
324
+ toll-free service hotline; and the implementation of major marketing programs to
325
+ target key customers.
326
+ Meridian markets products through direct sales forces, both domestically and in
327
+ Italy, France, Belgium and the Netherlands, and through national and
328
+ international independent distributors. In the United States, Meridian's direct
329
+ sales force consists of three regional sales managers, one Corporate Health
330
+ System Manager, three inside sales representatives and 18 technical sales
331
+ representatives. In Europe, Meridian's sales force consists of a vice president
332
+ of sales and marketing, six sales and marketing managers, two product managers,
333
+ five product specialists and 20 technical sales representatives. Where Meridian
334
+ utilizes distributors, Meridian participates in selling efforts involving key
335
+ customers. Meridian has nearly 80 independent distributors in more than 60
336
+ foreign countries including key distributor relationships in Canada, Central and
337
+ South America, Mexico, Australia, New Zealand and the Pacific Rim, which are
338
+ managed directly from the United States by an international manager. Meridian's
339
+ sales in Europe, North Africa and the Middle East are shipped from Meridian
340
+ Diagnostics Europe (MDE) distribution centers in Milan, Italy and Nivelle,
341
+ Belgium.
342
+ RESEARCH AND DEVELOPMENT
343
+ Meridian's research and development activities focus on developing new and
344
+ improved diagnostic solutions. Working in conjunction with the marketing
345
+ department, Meridian's research and development department focuses its
346
+ activities on enhancements to, and new applications for, Meridian's
347
+ technologies. Over the past ten years, Meridian has developed internally 35 new
348
+ products. Meridian has patent protection on a limited number of its products
349
+ including Premier Platinum HpSA(TM). The research and development department is
350
+ proficient in a number of diagnostic technologies, each of which can be applied
351
+ to meet new product specifications that marketing has established. Meridian's
352
+ product development staffs are experts in binding various biological materials
353
+ to numerous solid phases, including plastics, membranes, latex beads,
354
+ immunofluorescent dyes and immunogold, to develop testing formats. Meridian
355
+ believes that its proprietary know-how and technologies in these areas enable it
356
+ to develop products that have longer shelf-lives and provide improved
357
+ performance and quicker test results.
358
+ The research and development department initiates Meridian's quality process
359
+ through its design control mechanism which establishes manufacturing standards
360
+ and specifications. By working closely with the manufacturing department, the
361
+ same standards and specifications ensure consistent high-quality products.
362
+ Meridian estimates that it takes approximately 18 to 24 months from the
363
+ conceptualization of a product to its marketing.
364
+ The research and development department includes the Vice President of Research
365
+ and Development and 14 research scientists. The disciplines represented in the
366
+ group include biochemistry, immunology, mycology, bacteriology, virology and
367
+ parasitology. In fiscal 1998, fiscal 1999 and fiscal 2000, Meridian spent $2.0
368
+ million, $2.0 million, and $2.3 million
369
+ 8
370
+ 11
371
+ respectively, on its research and development activities.
372
+ CUSTOMERS
373
+ The principal customers for Meridian's products are hospitals, commercial and
374
+ reference laboratories, alternate site markets, such as physicians' offices,
375
+ outpatient clinics, nursing homes and HMOs, and new markets, such as veterinary
376
+ laboratories and water treatment facilities. Meridian also serves as an original
377
+ equipment manufacturer for other diagnostic companies. Two distributors together
378
+ accounted for more than 25% of Meridian's fiscal 2000 sales. However, Meridian
379
+ does not believe that the loss of either of these distributors would have a
380
+ material adverse effect on Meridian because of its ability to sell to the
381
+ end-use customers served by these distributors through alternative means.
382
+ MANUFACTURING
383
+ During fiscal 2000, substantially all of Meridian's manufacturing was performed
384
+ at its Cincinnati, Ohio facility. Meridian's acquisition of VAI has added
385
+ additional manufacturing capacity in Memphis, Tennessee. VAI's manufacturing of
386
+ veterinary products is regulated by the USDA and VAI's proteomics laboratory is
387
+ regulated by CBER (see Government Regulation). VAI's manufacturing facilities
388
+ are also subject to audit by certain customers. To maintain the highest quality
389
+ standards, Meridian utilizes both external and internal quality auditors who
390
+ routinely evaluate Meridian's manufacturing processes. Meridian strives to
391
+ quickly evaluate, remedy and review the implementation of corrective actions to
392
+ further assure compliance with medical device regulation.
393
+ Meridian is required to comply with, among other regulations, the FDA's Quality
394
+ System Regulation and is subject to periodic audits by the FDA. In response to
395
+ audits conducted in fiscal 2000, the Company implemented various programs to
396
+ address necessary corrective actions which it identified and increased its
397
+ quality assurance and control staffing. The costs attributable to the additional
398
+ staff and consulting assistance for fiscal 2000 were approximately $800,000. The
399
+ FDA is currently conducting a follow-up audit and is reviewing certain
400
+ validation procedures for certain products. The Company is fully cooperating
401
+ with the FDA in an effort to complete this process. While the outcome of the
402
+ audit is unknown at this time, if the FDA requires that validation procedures be
403
+ re-performed, the Company estimates that the lost revenue impact, while the
404
+ product is being re-validated and not available for sale, and the potential
405
+ work-in-process inventory that is not saleable, could be significant.
406
+ Meridian's immunodiagnostic products require the production of highly specific
407
+ and sensitive antigens and antibodies. Meridian produces substantially all of
408
+ its own requirements including monoclonal antibodies and polyclonal antibodies,
409
+ plus a variety of fungal, bacterial and viral antigens. For many of its key raw
410
+ materials acquired from third parties, Meridian has developed dual sources. As a
411
+ result, Meridian believes it has access to sufficient raw materials for its
412
+ 9
413
+ 12
414
+ products. Meridian believes it has sufficient manufacturing capacity for
415
+ anticipated growth. Meridian Diagnostics Europe s.r.l. achieved ISO 9002
416
+ certification in fiscal 1998, BIODESIGN achieved ISO 9001 certification in
417
+ fiscal 2000 and Meridian is working towards achieving ISO 9000 certification in
418
+ Cincinnati in fiscal 2001.
419
+ COMPETITION
420
+ The market for diagnostic tests is a multi-billion dollar international industry
421
+ which is highly competitive. Many of Meridian's competitors are larger with
422
+ greater financial, research, manufacturing and marketing resources. Important
423
+ competitive factors of Meridian's products include product quality, price, ease
424
+ of use, customer service, and reputation. In a broader sense, industry
425
+ competition is based upon scientific and technological capability, proprietary
426
+ know-how, access to adequate capital, the ability to develop and market products
427
+ and processes, the ability to attract and retain qualified personnel and the
428
+ availability of patent protection. To the extent that Meridian's product lines
429
+ do not reflect technological advances, Meridian's ability to compete in those
430
+ product lines could be adversely affected.
431
+ Companies competing in the diagnostic test industry generally focus on a limited
432
+ number of tests or limited segments of the market. As a result, the diagnostic
433
+ test industry is highly fragmented and segmented. Hundreds of companies in the
434
+ United States alone supply immunodiagnostic tests. These companies range from
435
+ multi-national health care companies, for which immunodiagnostics is one line of
436
+ business, to small start-up companies. Of central importance in the industry are
437
+ mid-sized medical diagnostic specialty companies, like Meridian, that offer
438
+ multiple, broad product lines and have the ability to deliver high value new
439
+ products quickly to the marketplace. Among the companies with which Meridian
440
+ competes in the marketing of one or more of its products are Abbott Laboratories
441
+ Inc., Becton, Dickinson and Company, Diagnostic Products Corporation, Quidel
442
+ Corporation and Wampole Laboratories Division of Carter-Wallace, Inc.
443
+ INTELLECTUAL PROPERTY, PATENTS AND LICENSES
444
+ Meridian owns or licenses U.S. and foreign patents for approximately 25 of its
445
+ products, including a patent for Premier Platinum HpSA(TM) issued in February
446
+ 1998. The Company's VAI subsidiary has U.S. patents for four of its
447
+ manufacturing processes. The patents or licenses for most of Meridian's products
448
+ were acquired in connection with the purchase of the products or the licensing
449
+ of the technology on which the products are based. In the absence of patent
450
+ protection, Meridian may be vulnerable to competitors who successfully replicate
451
+ Meridian's production and manufacturing techniques and processes. Meridian's
452
+ laboratory and research personnel are required to execute confidentiality
453
+ agreements designed to protect Meridian's proprietary products.
454
+ 10
455
+ 13
456
+ Meridian has no reason to believe that its products and proprietary rights
457
+ infringe the proprietary rights of any third parties. There can be no assurance,
458
+ however, that third parties will not assert infringement claims in the future.
459
+ GOVERNMENT REGULATION
460
+ FDA Regulation of Medical Devices - Meridian's products are regulated by the
461
+ Food & Drug Administration as "devices" pursuant to the Federal Food, Drug and
462
+ Cosmetic Act (FDCA). Under the FDCA, medical devices are classified into one of
463
+ three classes (i.e., Class I, II or III). Class I and II devices are not
464
+ expressly approved by the FDA, but, instead, are "cleared" for marketing. Class
465
+ III devices generally must receive "pre-market approval" from the FDA as to
466
+ safety and effectiveness.
467
+ A 510(k) clearance will be granted if the submitted data establishes that the
468
+ proposed device is "substantially equivalent" to an existing Class I or Class II
469
+ medical device or to a Class III medical device for which the FDA has not
470
+ required pre-market approval. The 510(k) clearance process for "substantially
471
+ equivalent" devices allows product sales to be made after the filing of an
472
+ application and upon acknowledgment by the FDA, typically within 90 to 120 days
473
+ after submission. If the FDA requests additional information, the product cannot
474
+ be sold until the application has been supplemented and upon acknowledgment by
475
+ the FDA within 90 to 120 days of the supplemental application. In practice, the
476
+ FDA has been granting clearance in about 30 days following submission of the
477
+ supplemental information. If there are no existing FDA-approved products or
478
+ processes comparable to a diagnostic product or process, approval by the FDA
479
+ involves the more lengthy pre-market approval procedures.
480
+ Each of the products currently marketed by Meridian has been cleared by the FDA
481
+ pursuant to the 510(k) clearance process or is exempt from such requirements.
482
+ Meridian believes that most, but not all, products under development will be
483
+ classified as Class I or II medical devices and will be eligible for 510(k)
484
+ clearance.
485
+ Other Medical Device Regulation - Sales of Meridian's products in foreign
486
+ countries are subject to foreign government regulation, the requirements of
487
+ which vary substantially from country to country. The time required to obtain
488
+ approval by a foreign country may be longer or shorter than that required for
489
+ FDA approval, and the requirements may differ. During fiscal 1999, Meridian
490
+ received approval for several new product registrations in Japan. Currently,
491
+ Meridian is supporting foreign product registrations in Mexico, Korea, Japan,
492
+ China and Argentina via the distributors in the respective countries.
493
+ VAI's veterinary products are approved and licensed by the United States
494
+ Department of Agriculture (USDA). This typically requires six months to one year
495
+ for the approval process. In addition, assays for monitoring "controlled
496
+ diseases" require testing and release of each production serial before it is
497
+ available to the market.
498
+ 11
499
+ 14
500
+ The proteins produced in VAI's proteomics laboratory are intended to be used as
501
+ "injectibles". As such they are produced under more stringent regulations under
502
+ the auspices of the Center for Biologicals Evaluation & Research (CBER).
503
+ Approval and licensing, following clinical trials, of these products will be the
504
+ responsibility of the company that owns the rights to each protein. Such
505
+ products are approved under the "pre-market approval" guidelines which requires
506
+ substantially more time than 510(k) clearance.
507
+ The Clinical Laboratory Improvement Act of 1988 prohibits laboratories from
508
+ performing in vitro tests for the purpose of providing information for the
509
+ diagnosis, prevention or treatment of any disease or impairment of, or the
510
+ assessment of, the health of human beings unless there is in effect for such
511
+ laboratories a certificate issued by the U.S. Department of Health and Human
512
+ Services applicable to the category of examination or procedure performed.
513
+ Although these certificates are required only for Meridian's laboratory
514
+ customers (but not for Meridian itself), Meridian considers the requirements of
515
+ The Clinical Laboratory Improvement Act of 1988 in the design and development of
516
+ its products.
517
+ Meridian is a conditionally exempt small quantity generator of hazardous waste
518
+ and has a U.S. Environmental Protection Agency identification number. All
519
+ hazardous waste is manifested and disposed of properly. Meridian is in
520
+ compliance with the applicable portions of the federal and state hazardous waste
521
+ regulations and has never been a party to any environmental proceeding.
522
+ EMPLOYEES
523
+ As of September 30, 2000, Meridian had 369 full-time employees, including 75 in
524
+ sales, marketing and technical support, 106 in manufacturing, 15 in research and
525
+ product development, and 35 in administration and finance. 93 of Meridian's
526
+ employees hold scientific degrees.
527
+ Meridian maintains a Savings and Investment Plan for its U.S. employees and has
528
+ established stock option plans for its officers, directors and employees. In
529
+ addition, a stock purchase plan was established on October 1, 1997 for all
530
+ employees.
531
+ None of Meridian's employees is represented by a labor organization and Meridian
532
+ is not a party to any collective bargaining agreement. Meridian has never
533
+ experienced any strike or work stoppage and considers its relationship with its
534
+ employees to be good.
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+ Item 13 Certain Relationships and Related Transactions .........................................16
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+ 0000794172,VIVO,MERIDIAN BIOSCIENCE INC,10-K,2001-12-20,2001-09-30,2001-12-20T05:00:00.000Z,0000950109-01-505814,d10k.htm,ANNUAL REPORT,574517,0,0,https://www.sec.gov/Archives/edgar/data/794172/000095010901505814/d10k.htm,https://www.sec.gov/Archives/edgar/data/794172/000095010901505814/,2001,2001,1
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1
+ ITEM 1.
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+ BUSINESS
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+ General
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+ Meridian was incorporated in 1976 as an Ohio corporation. Meridian is a fully integrated life sciences company that develops, manufactures and markets a broad range of innovative, disposable diagnostic test kits and related
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+ diagnostic products used for the rapid diagnosis of infectious diseases. Meridian also offers biopharmaceutical capabilities and serves as an original equipment manufacturer for other diagnostics companies.
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+ Meridian’s diagnostics products provide accuracy, simplicity and speed, and enable early diagnosis and treatment of common medical conditions such as gastrointestinal, viral and respiratory infections. All of Meridian's
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+ diagnostics products are used in procedures performed in vitro (outside the body) and enhance patient well-being while reducing total outcome costs of healthcare.
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+ In addition to the diagnostic business, Meridian is expanding further into the area of life sciences. Through recent acquisitions, Meridian has the technical expertise to enable research efforts of genomics scientists in drug and
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+ vaccine development. The expansion into life sciences prompted the Meridian’s decision to change its official name to Meridian Bioscience, Inc.
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+ Meridian's diagnostic product development strategy is to combine existing technologies with new product designs, both through internal or joint product development, and through product acquisitions, licensing or supply arrangements.
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+ Internal and joint product development activities focus on the development or enhancement of immunodiagnostic technologies and applications to simplify, accelerate or increase the accuracy of diagnoses of certain infectious diseases. Since 1990,
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+ Meridian has also acquired or obtained rights to distribute numerous products and technologies.
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+ Meridian utilizes its resources to serve each of the strategic domestic and international medical markets it has targeted: hospital networks and clinical and hospital laboratories; alternate site markets, including physicians'
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+ offices, outpatient clinics, nursing homes and health maintenance organizations (HMOs); and new markets, including veterinary laboratories and water treatment facilities. Meridian markets over 200 products representing four major disease states
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+ through a direct sales force in the United States, Italy, France, Belgium and the Netherlands, supplemented by a network of national and international distributors. International sales in more than 60 countries were 30% of total fiscal 2001 sales
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+ (see Note 12 to the Consolidated Financial Statements for information regarding sales by business segment).
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+ 1
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+ During the fourth quarter of fiscal 2000, a plan was implemented to restructure European distribution operations, eliminate Meridian’s direct presence in Germany and improve operating results. Effective October 1, 2000, the
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+ European export business was transferred from Germany to Belgium. During the second quarter of fiscal 2001, Meridian completed the transfer of the German business to an independent distributor. Meridian believes that the results of the restructuring
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+ plan to date have been successful. Excluding restructuring costs, the European business segment generated operating income of $852,000 during fiscal 2001 compared to an operating loss of $566,000 in fiscal 2000. Substantial savings have been
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+ realized from the closure of the German distribution facility.
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+ Acquisitions and Alliances
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+ Important elements of Meridian's long-term business strategy are the expansion into life sciences and the acquisition, licensing or entrance into supply arrangements to obtain innovative diagnostic testing technologies, product
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+ formats and products that complement its existing operations. During the last 14 months, Meridian executed a number of supply arrangements, both domestically and internationally, that included approximately 30 products.
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+ In late fiscal 2000, Meridian completed its acquisition of Viral Antigens, Inc. VAI further expanded Meridian's life sciences capabilities through VAI’s protein expression laboratories, providing Meridian the opportunity to
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+ serve as an enabler to biopharmaceutical companies in the development of new drugs and vaccines. VAI’s facilities are currently being expanded to accommodate a larger volume of business and are expected to be operational in March 2002. VAI also
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+ manufactures infectious disease antigens that are used in immunodiagnostics testing, and a Pseudorabies Virus antibody test kit and equine infectious anemia antibody test kit for the veterinary market. See Note 3 to the Consolidated Financial
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+ Statements for further information.
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+ Also during fiscal 2000, Meridian executed a Research and Development Agreement and an Exclusive Supply Agreement with OraSure Technologies, Inc. to commercialize the Up link technology . Meridian believes that this technology will offer competitive advantages including the elimination of background interference, simultaneous detection of multiple biological markers
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+ and improved sensitivity. These agreements require Meridian to make future payments to OraSure to fund research and development costs and to obtain an exclusive license to market and sell related products on a global basis. Meridian expects to begin
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+ the commercial sale of Up link™ products in late fiscal 2002 or early fiscal 2003.
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+ In early fiscal 1999, Meridian completed its acquisition of Gull Laboratories, Inc. Gull further expanded Meridian’s diagnostic test product offerings and European distribution channels. Included in the Gull acquisition was its
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+ subsidiary, BIODESIGN International, which manufactures and markets antigens and antibodies to diagnostic and pharmaceutical manufacturers as well as academic researchers. See Note 3 to the Consolidated Financial Statements for further information.
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+ 2
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+ Prior to fiscal 2000, Meridian pursued the acquisition and licensing of products and technologies that fit Meridian's niche diagnostic test markets, which are characterized by a large number of users. Examples of this included the
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+ acquisition of Gull Laboratories, Inc. in fiscal 1999, the acquisition of the enteric product line of Cambridge Biotech Corporation in fiscal 1996, the acquisitions of the infectious disease and mononucleosis product lines of Johnson & Johnson
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+ in fiscal 1994 and 1993, respectively, and numerous smaller product acquisitions and licensing arrangements.
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+ A key component in the success of Meridian's acquisition and licensing of new products and technologies has been the ability of Meridian to respond quickly to acquisition and licensing opportunities as they arise in the marketplace.
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+ The success of this strategy has also been due in part to management's selective acquisition and licensing philosophy as well as the availability of cash on hand and available lines of credit.
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+ Immunodiagnostics Overview
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+ In vitro diagnostic testing is the process of analyzing constituents of blood, urine, stool, other body fluids or tissue for the presence of specific infectious diseases. Immunodiagnostic testing, which is
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+ the leading method of in vitro testing for infectious diseases, tests for antigens and antibodies. When an infectious disease caused by pathogens, such as bacteria, viruses and fungi, and their related
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+ antigens are present, the body responds by producing an antibody. The antibody binds specifically with the antigen in a lock-and-key fashion and initiates a biochemical reaction to attempt to neutralize and, ultimately, to eliminate the antigen. The
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+ ability of an antibody to bind with a specific antigen provides the basis for immunodiagnostic testing.
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+ Immunodiagnostic testing detects the presence of specific infectious diseases through "visualization", such as color changes or the formation of visible aggregates, of the biochemical reactions caused by the antigen/antibody. Most
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+ immunodiagnostic tests utilize one of two alternative methods to determine the presence of a specific disease in a patient specimen. In one method, the test employs the antibody to detect directly the presence of an antigen. Alternatively, certain
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+ tests employ the antigen to detect the presence of an antibody. In addition to the diagnosis of infectious diseases, immunodiagnostic testing is also used to monitor the status of various patient therapy programs.
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+ Market Trends
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+ The global market for infectious disease tests continues to expand as new disease states are identified, new therapies become available and worldwide standards of living and access to health care improve. More importantly, within
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+ this market there is a continuing shift from conventional testing, which requires highly trained personnel and lengthy turnaround times for test results, to more technologically advanced testing which can be performed by less highly trained
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+ personnel and completed in minutes or hours.
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+ 3
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+ Technological advances permitting accurate testing to occur outside the traditional hospital or laboratory setting have also affected the market for diagnostic products. These technological developments have contributed to the
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+ emergence of alternate site markets, such as physicians' offices, outpatient clinics, nursing homes and HMOs, as important diagnostic market segments. These technological advances should also contribute to the development of new markets for
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+ Meridian's products, including food testing, veterinary laboratories and water treatment facilities.
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+ The increasing pressures to contain total health care costs have accelerated the increased use of diagnostic testing and the market shift to alternate sites. With rapid and accurate diagnoses of infectious diseases, physicians can
57
+ pinpoint appropriate therapies quickly, leading to faster recovery, shorter hospital stays and less treatment expense. In addition, these pressures have led to a major consolidation among reference laboratories and the formation of multi-hospital
58
+ alliances that have reduced the number of institutional customers for diagnostic products and resulted in changes in buying practices. Specifically, multi-year exclusive or primary source marketing or distribution contracts with institutional
59
+ customers have become more common, replacing less formal distribution arrangements of shorter duration and involving lower product volumes. In Europe, the reexamination of health care costs, access and funding is causing similar pressures.
60
+ Business Strategy
61
+ Meridian continues to execute its long-term strategy consisting of the following elements:
62
+ Developing New Product Applications from Core Technologies - Meridian employs a market-driven product development strategy to adapt or enhance
63
+ diagnostic testing technologies and product formats in response to newly identified disease states and customer demands for improvements in product accuracy, simplicity, speed and cost-efficiency. Meridian accomplishes this by monitoring existing
64
+ markets, interacting closely with its customers and recognizing emerging diseases and therapies. Since 1991, Meridian has developed 35 new products.
65
+ Acquiring and Licensing Products and Technology - Meridian intends to acquire, license or enter into supply arrangements to obtain innovative diagnostic testing
66
+ technologies, product formats and products that complement its existing operations and address the needs of Meridian's existing and targeted customer base. Management regularly identifies and reviews opportunities through its broad industry contacts
67
+ and recognized position in the industry. Since 1991, Meridian has acquired, licensed or entered into supply arrangements relating to approximately 100 products.
68
+ Enabling Biomedical Research and Early Stage Biopharmaceutical Development - Meridian intends to leverage its skills and capabilities in the life
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+ sciences market. Meridian has an established position in this market through
70
+ 4
71
+ its BIODESIGN subsidiary. BIODESIGN manufactures and distributes essential antigen and antibody reagents to diagnostic and pharmaceutical manufacturers as well as academic researchers. These reagents are essential to the development
72
+ of assay systems, control standards and new drug development research.
73
+ During fiscal 2000, Meridian further improved its skills and capabilities in the life sciences market through the acquisition of VAI. VAI’s pharmaceutical quality proteomics laboratories, which are currently being expanded,
74
+ will be used to produce drug and vaccine proteins through gene expression techniques. These proteins will be used by biopharmaceutical companies in the development of drugs and vaccines for Phase I and II clinical trials.
75
+ Increasing International Sales - Meridian has targeted international sales as an attractive source of growth. Meridian has developed a strong presence in Italy
76
+ through its Italian subsidiary, Meridian Bioscience Europe s.r.l., and with the acquisition of Gull has an established sales force in Belgium, France and the Netherlands. Meridian has expanded its ability to serve Latin American markets and has
77
+ expanded its international distributor base to include distributors in Argentina and Asia. Over the last several years, Meridian's international sales have grown from $2.1 million in fiscal 1993 to $16.7 million in fiscal 2001 and represented 30% of
78
+ total consolidated sales in fiscal 2001.
79
+ Strengthening Partnerships With Consolidated Health Care Organizations - Meridian seeks to develop strategic
80
+ partnerships with the major reference laboratories and other consolidated health care providers. Meridian believes it is in a position to develop partnerships because it is an integrated manufacturer, has a broad product line, offers tests in
81
+ multiple formats and is willing to invest resources in building relationships and facilitating open communications with those large customers. During the last four years, several exclusive multiple-year contracts were signed with consolidated health
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+ care providers and Meridian also extended or renewed supply agreements with several major reference laboratories and other consolidated health care providers.
83
+ Global Sales Excellence - Meridian continues to focus on an initiative to improve its worldwide excellence in customer service, sales support and
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+ technical assistance. Meridian believes that its customers have rewarded it for the high level of customer service and support it has provided in the past. However, Meridian desires to provide a level of service that exceeds the current standards of
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+ the health care industry and, most importantly, the customer’s expectations. Meridian is implementing several customer satisfaction training programs and information system improvements in order to achieve global sales excellence.
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+ Products and Markets
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+ Meridian has expertise in the development and manufacture of products based on multiple core diagnostic technologies, each of which enables the visualization and identification of antigen/antibody reactions for specific pathogens.
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+ As a result, Meridian is able to develop and manufacture diagnostic tests in a variety of formats that satisfy customer needs and preferences, whether in a hospital, commercial or reference laboratory or alternate site
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+ 5
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+ location. These technologies include enzyme immunoassay, immunofluorescence, particle agglutination, membrane filtration/concentration, immunodiffusion, complement fixation and chemical stains.
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+ Enzyme Immunoassay (EIA) - Products incorporating the EIA technology achieve extremely high levels of accuracy in detecting disease-related antigens or antibodies through the use of special color-based
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+ enzyme-substrate reactions. Meridian utilizes this technology in its multiple test format, the Premier TM
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+ product for large volume users, and in its single test formats, the Immuno Card ®
94
+ and Monolert ®
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+ products, for single physician users.
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+ Immunofluorescence - When the microscopic visualization of an antigen/antibody reaction is necessary or desired,
97
+ immunofluorescence technology is frequently utilized. Fluorescing immunochemicals, in the presence of the target antigen or antibody, can be viewed via a fluorescent microscope. Meridian utilizes this technology in its Merifluor ®
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+ products.
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+ Particle Agglutination - This technology utilizes microparticles (e.g., latex, red blood cells) coated with specific antigens or antibodies that form visible aggregates in the presence of a specimen
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+ containing the complementary antigen or antibody. This technology is rapid and economical and is used in Meridian's Meritec TM
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+ , MeriStar ®
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+ and MonoSpot ®
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+ products.
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+ Other Technologies - Meridian utilizes other technologies that include immunodiffusion, complement fixation and chemical stains. Meridian also
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+ manufactures and markets specimen collection, transportation, preservation and concentration products, such as Para-Pak ®
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+ , Macro-CON ®
107
+ and SpinCON ®
108
+ .
109
+ Meridian's product line consists of over 200 medical diagnostic products representing four major disease states. Currently, the most important product lines from the perspective of sales are products to diagnose gastrointestinal,
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+ viral and parasitic diseases. Meridian's products generally range in list price from $1 per test to $33 per test. A discussion of Meridian's key products and their competitive advantage follows.
111
+ Parasitic Diseases - Meridian manufactures products for the diagnosis and collection, preservation, transportation and concentration of parasites. Parasitic diseases
112
+ include Giardiasis, Cryptosporidiosis, Amebiasis and Lyme disease. The markets for these products are hospital, reference and veterinary laboratories .
113
+ Gastrointestinal Diseases - Meridian manufactures products for the rapid diagnosis of stomach ulcers, toxigenic E. coli , antibiotic associated diarrhea (C. difficile ) and pediatric diarrhea ( Rotavirus and Adenovirus). The markets for these
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+ products are hospital, reference, veterinary and state health laboratories.
115
+ 6
116
+ Respiratory Diseases - Meridian manufactures a broad range of diagnostic reagents for detecting respiratory diseases including pneumonia ( mycoplasma pneumoniae ) and valley fever ( coccidioides immittis ). The markets for these products are hospital, reference, veterinary and state health laboratories.
117
+ Urogenital Diseases - Meridian manufactures a product for the rapid detection of Chlamydia . The markets for this product are hospital,
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+ reference, physicians’ office and public health laboratories.
119
+ Viral Diseases - Meridian manufactures a broad range of products for the detection of various viruses including Epstein - Barr (mononucleosis), Herpes simplex, Cytomegalovirus (organ transplant infections) and Varicella- Zoster (chicken pox and shingles). The markets for these products are hospital, reference, physicians' office and public health laboratories.
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+ Marketing and Sales
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+ Meridian's marketing efforts are focused on a continual process of seeking ways to assist health care providers in improving outcomes for patients exposed to serious infectious diseases. Rapid, accurate diagnosis can mean faster
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+ recovery, shorter hospital stays and less expense, both for the patient and the health care system.
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+ Meridian believes that its marketing goals are best served by forming partnerships with key customers to develop concepts for future products and technology applications. These partnerships facilitate close customer interaction,
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+ including product strategy sessions and co-marketing programs.
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+ Marketing utilizes its strong industry contacts, plus key customer focus sessions, to identify new products and other opportunities. Through the use of cross-functional teams that include marketing, research and development and
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+ manufacturing personnel, marketing guides the development process to meet customers' needs with products that are easier to use, require less technical expertise, and yield faster results--often in minutes or hours rather than days.
127
+ Changes in the health care delivery system have resulted in major consolidation among reference laboratories and the formation of multi-hospital alliances. Meridian has structured its marketing, selling and customer service to
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+ anticipate and respond to these changes. This involved the addition of sales and marketing personnel; the expansion of technical services staff to support Meridian's customers and distribution network through a toll-free service hotline; and the
129
+ implementation of major marketing programs to target key customers.
130
+ Meridian markets products through direct sales forces, both domestically and in Italy, France, Belgium and the Netherlands, and through national and international independent distributors. In the United States, Meridian's
131
+ 7
132
+ direct sales force consists of three regional sales managers, one corporate health system manager, two inside sales representatives and 21 technical sales representatives. In Europe, Meridian’s sales force consists of five
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+ sales and marketing managers, three product specialists and 11 technical sales representatives. Where Meridian utilizes distributors, Meridian participates in selling efforts involving key customers. Meridian has nearly 80 independent distributors
134
+ in more than 60 foreign countries including key distributor relationships in Canada, Central and South America, Mexico, Australia, New Zealand and the Pacific Rim, which are managed directly from the United States by an international manager.
135
+ Meridian's sales in Europe, North Africa and the Middle East are shipped from Meridian Bioscience Europe (MBE) distribution centers in Milan, Italy and Nivelle, Belgium.
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+ Research and Development
137
+ Meridian's research and development activities focus on developing new and improved diagnostic solutions, both internally and with collaborative partners such as OraSure. Working in conjunction with the marketing department,
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+ Meridian's research and development department focuses its activities on enhancements to, and new applications for, Meridian's technologies. Since 1990, Meridian has developed internally 35 new products. Meridian has patent protection on a limited
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+ number of its products including Premier Platinum HpSA ™ . The research and development department is proficient in a number of diagnostic technologies, each of which can be applied to meet new product specifications that
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+ marketing has established. Meridian's product development staffs are experts in binding various biological materials to numerous solid phases, including plastics, membranes, latex beads, immunofluorescent dyes and immunogold, to develop testing
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+ formats. Meridian believes that its proprietary know-how and technologies in these areas enable it to develop products that have longer shelf-lives and provide improved performance and quicker test results.
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+ The research and development department initiates Meridian's quality process through its design control mechanism which establishes manufacturing standards and specifications. By working closely with the manufacturing department,
143
+ the same standards and specifications ensure consistent high-quality products. Meridian estimates that it takes approximately 18 to 24 months from the conceptualization of a product to its marketing.
144
+ The research and development department includes the Vice President of Research and Development and nine research scientists. The disciplines represented in the group include biochemistry, immunology, mycology, bacteriology,
145
+ virology and parasitology. In fiscal 1999, fiscal 2000 and fiscal 2001, Meridian spent $2.0 million, $2.3 million, and $3.4 million, respectively, on its research and development activities.
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+ Customers
147
+ The principal customers for Meridian's products are hospitals, commercial and reference laboratories, alternate site markets, such as physicians' offices, outpatient clinics, nursing homes and HMOs, and new markets, such as
148
+ 8
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+ veterinary laboratories and water treatment facilities. Meridian also serves as an original equipment manufacturer for other diagnostic companies. Two distributors together accounted for more than 20% of Meridian's fiscal 2001
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+ sales. However, Meridian does not believe that the loss of either of these distributors would have a material adverse effect on Meridian because of its ability to sell to the end-use customers served by these distributors through alternative means.
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+ Manufacturing
152
+ During fiscal 2001, substantially all of Meridian's manufacturing was performed at its Cincinnati, Ohio facility and VAI's Memphis, Tennessee facility. To maintain the highest quality standards, Meridian utilizes both external and
153
+ internal quality auditors who routinely evaluate Meridian's manufacturing processes. Meridian strives to quickly evaluate, remedy and review the implementation of corrective actions to further assure compliance with medical device regulation.
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+ Meridian's immunodiagnostic products require the production of highly specific and sensitive antigens and antibodies. Meridian produces substantially all of its own requirements including monoclonal antibodies and polyclonal
155
+ antibodies, plus a variety of fungal, bacterial and viral antigens. Meridian believes it has sufficient manufacturing capacity for anticipated growth.
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+ During January 2001, the FDA completed a follow-up inspection of Meridian’s compliance with the Quality Systems Regulations that govern the manufacturing of in vitro diagnostics. This inspection included a review of,
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+ among other things, procedures for validation, document control, corrective actions and design control. In June 2001, Meridian received a Warning Letter from the FDA which summarized and reiterated certain of the observations made by the FDA during
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+ their follow-up inspection completed in January 2001. Meridian responded to the Warning Letter on July 20, 2001.
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+ In January 2001, Meridian submitted a comprehensive plan to the FDA outlining specific steps it committed to undertake to improve its quality systems. To concentrate and focus resources on QSR compliance, Meridian discontinued the
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+ manufacture and distribution of approximately 30 products. The costs to date of implementing the plan include costs for outside consultants with experience in the quality system regulations, validation and computer software and equipment. During the
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+ fiscal 2001, Meridian incurred plan implementation costs in the amount of $2,322,000, primarily related to consulting fees. On an on-going basis, Meridian has considered the effects of incremental costs of compliance with QSR in its cost structure.
162
+ Meridian believes that such incremental costs of compliance with QSR will be offset by cost reductions and efficiencies related to the restructuring of Cincinnati manufacturing operations discussed below, and consequently, gross profit margins for
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+ the diagnostics business are expected to approach 1999 - 2000 levels.
164
+ 9
165
+ Meridian continues to engage in other activities designed to reduce costs, improve operations and replace products that were discontinued. Meridian restructured its Cincinnati manufacturing operations and quality functions by, among
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+ other things, hiring a number of professionals with experience in monitoring and improving a FDA-compliant quality system. During the second quarter, Meridian entered into a three-year supply agreement (with renewal options) with Zeus Scientific,
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+ Inc., whereby Zeus will manufacture, on an OEM basis, replacement products for 27 of the 30 discontinued Meridian products.
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+ As a result of the decision to discontinue the manufacturing and distribution of approximately 30 products, Meridian could not recover the cost of certain assets, and consequently, recorded a pre-tax charge in the amount of $12.8
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+ million during fiscal 2001 (see Note 4 to the Consolidated Financial Statements for further discussion).
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+ In accordance with the FDA's directive in the Warning Letter, Meridian engaged an outside independent auditor to evaluate Meridian’s progress in implementing its corrective plan. Based on an extensive review of documents and an
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+ on-site visit, the auditors substantiated Meridian’s progress in addressing the issues raised in the FDA inspection and Warning Letter.
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+ Contingent upon the successful restructuring of operations and the acceptance of the plan by the FDA, Meridian expects cash flows from operations to be sufficient to fund working capital needs, debt service, dividends and the stock
173
+ buyback program referred to in Note 1 to the Consolidated Financial Statements during fiscal 2002. Meridian is communicating with the FDA on a periodic basis to advise it on the progress of the plan implementation. At present, it is uncertain
174
+ whether Meridian’s actions will be sufficient so that no further remedial action or enforcement action by the FDA will occur.
175
+ Competition
176
+ The market for diagnostic tests is a multi-billion dollar international industry which is highly competitive. Many of Meridian's competitors are larger with greater financial, research, manufacturing and marketing resources.
177
+ Important competitive factors of Meridian's products include product quality, price, ease of use, customer service, and reputation. In a broader sense, industry competition is based upon scientific and technological capability, proprietary know-how,
178
+ access to adequate capital, the ability to develop and market products and processes, the ability to attract and retain qualified personnel and the availability of patent protection. To the extent that Meridian's product lines do not reflect
179
+ technological advances, Meridian's ability to compete in those product lines could be adversely affected.
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+ Companies competing in the diagnostic test industry generally focus on a limited number of tests or limited segments of the market. As a result, the diagnostic test industry is highly fragmented and segmented. Hundreds of companies
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+ in the United States alone supply immunodiagnostic tests. These companies range from multi-national health care companies, for which immunodiagnostics is one line of business, to small start-up companies. Of
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+ 10
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+ central importance in the industry are mid-sized medical diagnostic specialty companies, like Meridian, that offer multiple, broad product lines and have the ability to deliver high value new products quickly to the marketplace.
184
+ Among the companies with which Meridian competes in the marketing of one or more of its products are Abbott Laboratories Inc., Becton, Dickinson and Company, Diagnostic Products Corporation, Quidel Corporation and Wampole Laboratories Division of
185
+ Carter-Wallace, Inc.
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+ Intellectual Property, Patents and Licenses
187
+ Meridian owns or licenses U.S. and foreign patents for approximately 25 of its products, including a patent for Premier Platinum HpSA TM
188
+ issued in February 1998. Meridian’s VAI subsidiary has U.S. patents for four of its manufacturing processes. The patents or licenses for most of Meridian’s products were acquired in connection with the
189
+ purchase of the products or the licensing of the technology on which the products are based. In the absence of patent protection, Meridian may be vulnerable to competitors who successfully replicate Meridian's production and manufacturing techniques
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+ and processes. All of Meridian's employees are required to execute confidentiality and non-disclosure agreements designed to protect Meridian's proprietary products.
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+ Meridian does not believe that its products and proprietary rights infringe the proprietary rights of any third parties. There can be no assurance, however, that third parties will not assert infringement claims
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+ in the future.
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+ Government Regulation
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+ FDA Regulation of Medical Devices - Meridian’s products are regulated by the Food & Drug Administration as "devices" pursuant to the Federal
195
+ Food, Drug and Cosmetic Act (FDCA). Under the FDCA, medical devices are classified into one of three classes (i.e., Class I, II or III). Class I and II devices are not expressly approved by the FDA, but, instead, are "cleared"
196
+ for marketing. Class III devices generally must receive "pre-market approval" from the FDA as to safety and effectiveness.
197
+ A 510(k) clearance will be granted if the submitted data establishes that the proposed device is "substantially equivalent" to an existing Class I or Class II medical device or to a Class III medical device for which the FDA has
198
+ not required pre-market approval. The 510(k) clearance process for "substantially equivalent" devices allows product sales to be made after the filing of an application and upon acknowledgment by the FDA, typically within 90 to 120 days after
199
+ submission. If the FDA requests additional information, the product cannot be sold until the application has been supplemented and upon acknowledgment by the FDA within 90 to 120 days of the supplemental application. In practice, the FDA has been
200
+ granting clearance in about 90 days following submission of the supplemental information. If there are no existing FDA-approved products or processes comparable to a diagnostic product or process, approval by the FDA involves the more lengthy
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+ pre-market approval procedures.
202
+ 11
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+ Each of the products currently marketed by Meridian has been cleared by the FDA pursuant to the 510(k) clearance process or is exempt from such requirements. Meridian believes that most, but not all, products under development will
204
+ be classified as Class I or II medical devices and will be eligible for 510(k) clearance.
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+ Other Medical Device Regulation - Sales of Meridian's products in foreign countries are subject to foreign government regulation, the requirements of
206
+ which vary substantially from country to country. The time required to obtain approval by a foreign country may be longer or shorter than that required for FDA approval and the requirements may differ. Currently, Meridian is
207
+ supporting foreign product registrations in Mexico, Korea, Japan, China and Argentina via the distributors in the respective countries.
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+ VAI’s veterinary products are approved and licensed by the United States Department of Agriculture (USDA). This typically requires six months to one year for the approval process. In addition, assays for monitoring
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+ “controlled diseases” require testing and release of each production serial before it is available to the market.
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+ The proteins produced in VAI’s proteomics laboratories are intended to be used as “injectibles”. As such they are produced under more stringent regulations under the auspices of the Center for Biologicals Evaluation
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+ & Research (CBER). Approval and licensing, following clinical trials, of these products will be the responsibility of Meridian that owns the rights to each protein. Such products are approved under the “pre-market approval” guidelines
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+ which requires substantially more time than 510(k) clearance.
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+ The Clinical Laboratory Improvement Act of 1988 prohibits laboratories from performing in vitro tests for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the
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+ assessment of, the health of human beings unless there is in effect for such laboratories a certificate issued by the U.S. Department of Health and Human Services applicable to the category of examination or procedure performed. Although these
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+ certificates are required only for Meridian's laboratory customers (but not for Meridian itself), Meridian considers the requirements of The Clinical Laboratory Improvement Act of 1988 in the design and development of its products.
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+ Meridian is a conditionally exempt small quantity generator of hazardous waste and has a U.S. Environmental Protection Agency identification number. All hazardous waste is manifested and disposed of properly. Meridian is in
217
+ compliance with the applicable portions of the federal and state hazardous waste regulations and has never been a party to any environmental proceeding.
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+ Employees
219
+ As of September 30, 2001, Meridian had 325 full-time employees and 9 part-time employees. None of Meridian's employees is represented by a labor organization and Meridian is not a party to any collective
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+ bargaining
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+ 12
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+ agreement. Meridian has never experienced any strike or work stoppage and considers its relationship with its employees to be good.
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+ Meridian maintains a Savings and Investment Plan for its U.S. employees and has established stock option plans for its officers, directors and employees. In addition, a stock purchase plan was established on October 1, 1997 for all
224
+ employees.
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1
+ ITEM 1.
2
+ BUSINESS
3
+ General
4
+ Meridian is a fully integrated life sciences company that develops,
5
+ manufactures, markets and distributes a broad range of innovative, disposable
6
+ diagnostic test kits and related diagnostic products used for the rapid
7
+ diagnosis of infectious diseases. Meridian also offers biopharmaceutical
8
+ capabilities through its cGMP protein production laboratory at its Viral
9
+ Antigens subsidiary.
10
+ Meridian's diagnostics products provide accuracy, simplicity and speed, and
11
+ enable early diagnosis and treatment of common medical conditions such as
12
+ gastrointestinal, viral, and respiratory infections. All of Meridian's
13
+ diagnostics products are used in procedures performed in vitro (outside the
14
+ body) and enhance patient well-being while reducing total outcome costs of
15
+ healthcare.
16
+ In addition to the diagnostic business, Meridian is expanding further into the
17
+ area of life sciences. Through recent acquisitions, Meridian has the technical
18
+ expertise to enable research efforts of genomics scientists in drug and vaccine
19
+ development. The expansion into life sciences prompted Meridian's decision to
20
+ change its official name to Meridian Bioscience, Inc. in fiscal 2001.
21
+ Meridian's diagnostic product development strategy is to combine existing
22
+ technologies with new product designs, both through internal or joint product
23
+ development, and through product acquisitions, licensing or supply arrangements.
24
+ Internal and joint product development activities focus on the development or
25
+ enhancement of immunodiagnostic technologies and applications to simplify,
26
+ accelerate or increase the accuracy of diagnoses of certain infectious diseases.
27
+ Since 1990, Meridian has acquired or obtained rights to distribute numerous
28
+ products and technologies.
29
+ Meridian utilizes its resources to serve each of the strategic domestic and
30
+ international medical markets it has targeted: hospital networks and clinical
31
+ and hospital laboratories; outpatient clinics, and health maintenance
32
+ organizations (HMOs); and new markets, including veterinary laboratories and
33
+ water treatment facilities. Meridian markets over 200 products representing four
34
+ major disease states through a direct sales force in the United States, Italy,
35
+ France, Belgium and the Netherlands, supplemented by a network of national and
36
+ international distributors. International sales in more than 60 countries were
37
+ 30% of total fiscal 2002 sales (see Note 11 to the Consolidated Financial
38
+ Statements for information regarding sales by business segment.)
39
+ During the fourth quarter of fiscal 2000, a plan was implemented to restructure
40
+ European distribution operations and improve operating results. Effective
41
+ October 1, 2000, the European export business was transferred from Germany to
42
+ Belgium. During the second quarter of fiscal 2001 Meridian completed the
43
+ transfer of the German business to an independent distributor. Meridian believes
44
+ that the results of the restructuring plan to date have been successful.
45
+ Excluding restructuring costs, the European business segment generated operating
46
+ income of $1,565,000 and $852,000 during fiscal 2002 and 2001, respectively,
47
+ compared to an operating loss of $566,000 in fiscal 2000. Substantial savings
48
+ have been realized from the closure of the German distribution facility and
49
+ further cost-cutting measures implemented in fiscal 2002.
50
+ Acquisitions
51
+ Important elements of Meridian's long-term business strategy are the expansion
52
+ into life sciences and the acquisition, licensing or entrance into supply
53
+ arrangements to obtain innovative diagnostic testing technologies, product
54
+ formats and products that complement its existing operations. Meridian has
55
+ executed a number of supply arrangements, both domestically and internationally,
56
+ that include more than 80 products. In late fiscal 2000, Meridian completed its
57
+ acquisition of Viral Antigens, Inc. VAI further expanded Meridian's life
58
+ sciences capabilities through VAI's cGMP protein production laboratory,
59
+ providing Meridian the opportunity to serve as an enabler to biopharmaceutical
60
+ companies in the development of new drugs and vaccines. VAI also manufactures
61
+ 1
62
+ infectious disease antigens that are used in immunodiagnostics testing, and a
63
+ Pseudorabies Virus antibody test kit and equine infectious anemia antibody test
64
+ kit for the veterinary market.
65
+ In early fiscal 1999, Meridian completed its acquisition of Gull Laboratories,
66
+ Inc. Gull further expanded Meridian's diagnostic test product offerings and
67
+ European distribution channels. Included in the Gull acquisition was its
68
+ subsidiary, BIODESIGN International, which manufactures, markets and distributes
69
+ antigens and antibodies to diagnostic and pharmaceutical manufacturers as well
70
+ as academic researchers.
71
+ Meridian pursues the acquisition and licensing of products and technologies that
72
+ fit Meridian's niche diagnostic test markets, which are characterized by a large
73
+ number of users. Examples of this included the acquisition of Gull Laboratories,
74
+ Inc. in fiscal 1999, the acquisition of the enteric product line of Cambridge
75
+ Biotech Corporation in fiscal 1996, the acquisitions of the infectious disease
76
+ and mononucleosis product lines of Johnson & Johnson in fiscal 1994 and 1993,
77
+ respectively, and numerous smaller product acquisitions and licensing
78
+ arrangements.
79
+ A key component in the success of Meridian's acquisition and licensing of new
80
+ products and technologies has been the ability of Meridian to respond quickly to
81
+ acquisition and licensing opportunities as they arise in the marketplace. The
82
+ success of this strategy has also been due in part to management's selective
83
+ acquisition and licensing philosophy as well as the availability of cash on hand
84
+ and available lines of credit.
85
+ Immunodiagnostics Overview
86
+ In vitro diagnostic testing is the process of analyzing constituents of blood,
87
+ urine, stool, other body fluids or tissue for the presence of specific
88
+ infectious diseases. Immunodiagnostic testing, which is the leading method of in
89
+ vitro testing for infectious diseases, tests for antigens and antibodies. When a
90
+ pathogen, such as bacteria, viruses and fungi, and its related antigens is
91
+ present, the body responds by producing an antibody. The antibody binds
92
+ specifically with the antigen in a lock-and-key fashion and initiates a
93
+ biochemical reaction to attempt to neutralize and, ultimately, to eliminate the
94
+ antigen. The ability of an antibody to bind with a specific antigen provides the
95
+ basis for immunodiagnostic testing.
96
+ Immunodiagnostic testing detects the presence of specific infectious diseases
97
+ through "visualization", such as color changes or the formation of visible
98
+ aggregates, of the biochemical reactions caused by the antigen/antibody. Most
99
+ immunodiagnostic tests utilize one of two alternative methods to determine the
100
+ presence of a specific disease in a patient specimen. In one method, the test
101
+ employs the antibody to detect directly the presence of an antigen.
102
+ Alternatively, certain tests employ the antigen to detect the presence of an
103
+ antibody. In addition to the diagnosis of infectious diseases, immunodiagnostic
104
+ testing is also used to monitor the status of various patient therapy programs.
105
+ Market Trends
106
+ The global market for infectious disease tests continues to expand as new
107
+ disease states are identified, new therapies become available and worldwide
108
+ standards of living and access to health care improve. More importantly, within
109
+ this market there is a continuing shift from conventional testing, which
110
+ requires highly trained personnel and lengthy turnaround times for test results,
111
+ to more technologically advanced testing which can be performed by less highly
112
+ trained personnel and completed in minutes or hours. These technological
113
+ advances permit accurate testing to occur outside the traditional hospital or
114
+ laboratory.
115
+ The increasing pressures to contain total health care costs have accelerated the
116
+ increased use of diagnostic testing and the market shift to alternate sites.
117
+ With rapid and accurate diagnoses of infectious diseases, physicians can
118
+ pinpoint appropriate therapies quickly, leading to faster recovery, shorter
119
+ hospital stays and less treatment expense. In addition, these pressures have led
120
+ to a major consolidation among reference laboratories and the formation of
121
+ multi-hospital alliances that have reduced the number of institutional customers
122
+ for diagnostic products and resulted in changes in buying practices.
123
+ Specifically, multi-year exclusive or primary source marketing or distribution
124
+ contracts with institutional customers have become more common, replacing less
125
+ formal distribution arrangements of shorter duration and involving lower product
126
+ volumes. In Europe, the reexamination of health care costs, access and funding
127
+ is causing similar pressures.
128
+ 2
129
+ Business Strategy
130
+ Meridian continues to execute its long-term strategy consisting of the following
131
+ elements:
132
+ Developing New Product Applications from Core Technologies - Meridian employs a
133
+ market-driven product development strategy to adapt or enhance diagnostic
134
+ testing technologies and product formats in response to newly identified disease
135
+ states and customer demands for improvements in product accuracy, simplicity,
136
+ speed and cost-efficiency. Meridian accomplishes this by monitoring existing
137
+ markets, interacting closely with its customers and recognizing emerging
138
+ diseases and therapies.
139
+ Acquiring and Licensing Products and Technology - Meridian intends to acquire,
140
+ license or enter into supply arrangements to obtain innovative diagnostic
141
+ testing technologies, product formats and products that complement its existing
142
+ operations and address the needs of Meridian's existing and targeted customer
143
+ base. Management regularly identifies and reviews opportunities through its
144
+ broad industry contacts and recognized position in the industry. Meridian has
145
+ acquired, licensed or entered into supply arrangements relating to more than 100
146
+ products.
147
+ Enabling Biomedical Research and Early Stage Biopharmaceutical Development -
148
+ Meridian intends to leverage its skills and capabilities in the life sciences
149
+ market. Meridian has an established position in this market through its
150
+ BIODESIGN subsidiary. BIODESIGN manufactures and distributes essential antigen
151
+ and antibody reagents to diagnostic and pharmaceutical manufacturers as well as
152
+ academic researchers. These reagents are essential to the development of assay
153
+ systems, control standards and new drug development research.
154
+ During fiscal 2000, Meridian further improved its skills and capabilities in the
155
+ life sciences market through the acquisition of VAI. VAI's pharmaceutical
156
+ quality proteomics laboratory will be used to produce drug and vaccine proteins
157
+ through gene expression techniques. These proteins will be used by
158
+ biopharmaceutical companies in the development of drugs and vaccines for Phase I
159
+ and II clinical trials. Meridian expects to have its first customer for the cGMP
160
+ protein production laboratory in the second quarter of fiscal 2003.
161
+ Increasing International Sales - Meridian has targeted international sales as an
162
+ attractive source of growth. Meridian has developed a strong presence in Italy
163
+ through its Italian subsidiary, Meridian Bioscience Europe s.r.l., and with the
164
+ acquisition of Gull has an established sales force in Belgium, France and the
165
+ Netherlands. Meridian has expanded its ability to serve Latin American and Asian
166
+ markets and has expanded its international distributor base. Over the last
167
+ several years, Meridian's international sales have grown from $2.1 million in
168
+ fiscal 1993 to $18.0 million in fiscal 2002 and represented 30% of total
169
+ consolidated sales in fiscal 2002.
170
+ Strengthening Partnerships With Consolidated Health Care Organizations -
171
+ Meridian seeks to develop strategic partnerships with the major reference
172
+ laboratories and other consolidated health care providers. Meridian believes it
173
+ is in a position to develop partnerships because it is an integrated
174
+ manufacturer, has a broad product line, offers tests in multiple formats and is
175
+ willing to invest resources in building relationships and facilitating open
176
+ communications with those large customers. Since 1998, several exclusive
177
+ multiple-year contracts have been signed with consolidated health care providers
178
+ and Meridian also extended or renewed supply agreements with major reference
179
+ laboratories and other consolidated health care providers.
180
+ Global Sales Excellence - Meridian continues to focus on an initiative to
181
+ improve its worldwide excellence in customer service, sales support and
182
+ technical assistance. Meridian believes that its customers have rewarded it for
183
+ the high level of customer service and support it has provided in the past.
184
+ However, Meridian desires to provide a level of service that exceeds the current
185
+ standards of the health care industry and, most importantly, the customer's
186
+ expectations. Meridian is implementing several customer satisfaction training
187
+ programs and information system improvements in order to achieve global sales
188
+ excellence.
189
+ Products and Markets
190
+ Meridian has expertise in the development and manufacture of products based on
191
+ multiple core diagnostic technologies, each of which enables the visualization
192
+ and identification of antigen/antibody reactions for specific pathogens. As a
193
+ result, Meridian is able to develop and manufacture diagnostic tests in a
194
+ variety of formats that
195
+ 3
196
+ satisfy customer needs and preferences, whether in a hospital, commercial or
197
+ reference laboratory or alternate site location. These technologies include
198
+ enzyme immunoassay, immunofluorescence, particle agglutination/aggregation,
199
+ immunodiffusion, complement fixation and chemical stains.
200
+ Enzyme Immunoassay (EIA) - Products incorporating the EIA technology achieve
201
+ extremely high levels of accuracy in detecting disease-related antigens or
202
+ antibodies through the use of special color-based enzyme-substrate reactions.
203
+ Meridian utilizes this technology in its multiple test format, the Premier(TM)
204
+ product for large volume users, and in its single test formats, the
205
+ ImmunoCard(R), ImmunoCard STAT!(R) and Monolert(R) products, for lower volume
206
+ users.
207
+ Immunofluorescence - When the microscopic visualization of an antigen/antibody
208
+ reaction is necessary or desired, immunofluorescence technology is frequently
209
+ utilized. Fluorescing immunochemicals, in the presence of the target antigen or
210
+ antibody, can be viewed via a fluorescent microscope. Meridian utilizes this
211
+ technology in its Merifluor(R) products.
212
+ Particle Agglutination/Aggregation - This technology utilizes microparticles
213
+ (e.g., latex, red blood cells) coated with specific antigens or antibodies that
214
+ form visible aggregates in the presence of a specimen containing the
215
+ complementary antigen or antibody. This technology is rapid and economical and
216
+ is used in Meridian's Meritec(TM), MeriStar(R) and MonoSpot(R) products.
217
+ Other Technologies - Meridian utilizes other technologies that include
218
+ immunodiffusion, complement fixation and chemical stains. Meridian also
219
+ manufactures and markets specimen collection, transportation, preservation and
220
+ concentration products, such as Para-Pak(R), Macro-CON(R) and Spin-CON.
221
+ Meridian's product line consists of over 200 medical diagnostic products
222
+ representing four major disease types discussed below. Currently, the most
223
+ important product lines from the perspective of sales are products to diagnose
224
+ gastrointestinal, viral and parasitic diseases. Meridian's products generally
225
+ range in list price from $1 per test to $33 per test. A discussion of Meridian's
226
+ key products and their competitive advantage follows.
227
+ Parasitic Diseases - Meridian manufactures products for the diagnosis and
228
+ collection, preservation, transportation and concentration of parasites.
229
+ Parasitic diseases include Giardiasis, Cryptosporidiosis, and Lyme disease. The
230
+ markets for these products are hospital, reference and veterinary laboratories.
231
+ Gastrointestinal Diseases - Meridian manufactures products for the rapid
232
+ diagnosis of stomach ulcers, toxigenic E.coli, antibiotic associated diarrhea
233
+ (C. difficile) and pediatric diarrhea (Rotavirus and Adenovirus). The markets
234
+ for these products are hospital, reference, veterinary and state health
235
+ laboratories.
236
+ Respiratory Diseases - Meridian manufactures a broad range of diagnostic
237
+ reagents for detecting respiratory diseases including pneumonia (Mycoplasma
238
+ pneumoniae) and valley fever (Coccidioides immittis). The markets for these
239
+ products are hospital, reference, veterinary and state health laboratories.
240
+ Viral Diseases - Meridian manufactures a broad range of products for the
241
+ detection of various viruses including Epstein-Barr (mononucleosis), Herpes
242
+ simplex, Cytomegalovirus (organ transplant infections) and Varicella -Zoster
243
+ (chicken pox and shingles). The markets for these products are hospital,
244
+ reference, physicians' office and public health laboratories.
245
+ Marketing and Sales
246
+ Meridian's marketing efforts are focused on a continual process of seeking ways
247
+ to assist health care providers in improving outcomes for patients exposed to
248
+ serious infectious diseases. Rapid, accurate diagnosis can mean faster recovery,
249
+ shorter hospital stays and less expense, both for the patient and the health
250
+ care system.
251
+ Meridian believes that its marketing goals are best served by forming
252
+ partnerships with key customers to develop concepts for future products and
253
+ technology applications. These partnerships facilitate close customer
254
+ interaction, including product strategy sessions and co-marketing programs.
255
+ 4
256
+ Marketing utilizes its strong industry contacts, plus key customer focus
257
+ sessions, to identify new products and other opportunities. Through the use of
258
+ cross-functional teams that include marketing, research and development and
259
+ manufacturing personnel, marketing guides the development process to meet
260
+ customers' needs with products that are easier to use, require less technical
261
+ expertise, and yield faster results--often in minutes or hours rather than days.
262
+ Changes in the health care delivery system have resulted in major consolidation
263
+ among reference laboratories and the formation of multi-hospital alliances.
264
+ Meridian has structured its marketing, selling and customer service to
265
+ anticipate and respond to these changes. This involved dedicating sales and
266
+ marketing personnel to these accounts; the expansion of technical services staff
267
+ to support Meridian's customers and distribution network; and the implementation
268
+ of major marketing programs to target key customers.
269
+ Meridian markets products through direct sales forces, both domestically and in
270
+ Italy, France, Belgium and the Netherlands, and through national and
271
+ international independent distributors. In the United States, Meridian's direct
272
+ sales force consists of three regional sales managers, one corporate health
273
+ system manager, two inside sales representatives and 21 technical sales
274
+ representatives. In Europe, Meridian's sales force consists of five sales and
275
+ marketing managers, three product specialists and 11 technical sales
276
+ representatives. Where Meridian utilizes distributors, Meridian participates in
277
+ selling efforts involving key customers. Meridian has nearly 80 independent
278
+ distributors in more than 60 foreign countries including key distributor
279
+ relationships in Canada, Central and South America, Mexico, Australia, New
280
+ Zealand and the Pacific Rim, which are managed directly from the United States
281
+ by an international manager. Meridian's sales in Europe, North Africa and the
282
+ Middle East are shipped from Meridian Bioscience Europe (MBE) distribution
283
+ centers in Milan, Italy and Nivelle, Belgium.
284
+ Research and Development
285
+ Meridian's research and development activities focus on developing new and
286
+ improved diagnostic solutions, both internally and with collaborative partners.
287
+ Working in conjunction with the marketing department, Meridian's research and
288
+ development department focuses its activities on enhancements to, and new
289
+ applications for, Meridian's technologies. Meridian's internally developed
290
+ products include Premier Platinum HpSA and Premier(TM) Toxins A&B. Meridian has
291
+ patent protection on certain of its products including Premier Platinum
292
+ HpSA(TM). The research and development department is proficient in a number of
293
+ diagnostic technologies, each of which can be applied to meet new product
294
+ specifications that marketing has established. Meridian's product development
295
+ staffs are experts in binding various biological materials to numerous solid
296
+ phases, including plastics, membranes, latex beads, immunofluorescent dyes and
297
+ immunogold, to develop testing formats. Meridian believes that its proprietary
298
+ know-how and technologies in these areas enable it to develop products that have
299
+ longer shelf-lives and provide improved performance and quicker test results.
300
+ The research and development department initiates Meridian's quality process
301
+ through its design control mechanism which establishes manufacturing standards
302
+ and specifications. By working closely with the manufacturing department, the
303
+ same standards and specifications ensure consistent high-quality products.
304
+ Meridian estimates that it takes approximately 18 to 24 months from the
305
+ conceptualization of a product to its marketing.
306
+ The research and development department includes the Vice President of Research
307
+ and Development and 14 research scientists, up from nine one year ago. The
308
+ disciplines represented in the group include biochemistry, immunology, mycology,
309
+ bacteriology, virology and parasitology. In fiscal 2000, fiscal 2001 and fiscal
310
+ 2002, Meridian spent $2.3 million, $3.4 million, and $2.9 million respectively,
311
+ on its research and development activities.
312
+ Customers
313
+ The principal customers for Meridian's products are hospitals, commercial and
314
+ reference laboratories and HMOs, and new markets, such as veterinary
315
+ laboratories and water treatment facilities. Two distributors together accounted
316
+ for 25% of Meridian's fiscal 2002 sales. However, Meridian does not believe that
317
+ the loss of either of these distributors would have a material adverse effect on
318
+ Meridian because of its ability to sell to the end-use customers served by these
319
+ distributors through alternative means.
320
+ 5
321
+ Manufacturing
322
+ During fiscal 2002, substantially all of Meridian's manufacturing was performed
323
+ at its Cincinnati, Ohio facility and VAI's Memphis, Tennessee facility. To
324
+ maintain the highest quality standards, Meridian utilizes both external and
325
+ internal quality auditors who routinely evaluate Meridian's manufacturing
326
+ processes. Meridian strives to quickly evaluate, remedy and review the
327
+ implementation of corrective actions to further assure compliance with medical
328
+ device regulation.
329
+ Meridian's immunodiagnostic products require the production of highly specific
330
+ and sensitive antigens and antibodies. Meridian produces substantially all of
331
+ its own requirements including monoclonal antibodies and polyclonal antibodies,
332
+ plus a variety of fungal, bacterial and viral antigens. Meridian believes it has
333
+ sufficient manufacturing capacity for anticipated growth.
334
+ During January 2001, the FDA completed a follow-up inspection of Meridian's
335
+ compliance with the Quality Systems Regulations that govern the manufacturing of
336
+ in vitro diagnostics. This inspection included a review of, among other things,
337
+ procedures for validation, document control, corrective actions and design
338
+ control. In June 2001, Meridian received a Warning Letter from the FDA which
339
+ summarized and reiterated certain of the observations made by the FDA during
340
+ their follow-up inspection completed in January 2001. Meridian responded to the
341
+ Warning Letter on July 20, 2001.
342
+ In January 2001, Meridian submitted a comprehensive plan to the FDA outlining
343
+ specific steps it committed to undertake to improve its quality systems. To
344
+ concentrate and focus resources on QSR compliance, Meridian discontinued the
345
+ manufacturing and distribution of approximately 30 products. During fiscal 2001,
346
+ Meridian incurred costs in the amount of $2,322,000, primarily for outside
347
+ consultants with experience in the quality system regulations, validation and
348
+ computer software and equipment. Meridian has considered the effects of
349
+ incremental costs of compliance with QSR in its cost structure. Meridian
350
+ continues to engage in activities designed to reduce costs, improve operations
351
+ and replace products that were discontinued.
352
+ As a result of the decision to discontinue the manufacturing and distribution of
353
+ approximately 30 products, Meridian could not recover the cost of certain
354
+ assets, and consequently, recorded a pre-tax charge in the amount of $12.8
355
+ million during fiscal 2001 (see Note 4 to the Consolidated Financial Statements
356
+ for further discussion).
357
+ In accordance with the FDA's directive in the Warning Letter, in September 2001,
358
+ Meridian engaged an independent auditor to evaluate Meridian's progress in
359
+ implementing its corrective plan. Based on an extensive review of documents and
360
+ an on-site visit, the auditors substantiated Meridian's progress in addressing
361
+ the issues raised in the FDA inspection and Warning Letter. As anticipated by
362
+ Meridian, the FDA commenced an on-site follow-up inspection during late fiscal
363
+ 2002. This follow-up inspection was completed in August 2002. The FDA issued
364
+ several observations primarily aimed at fine-tuning established quality control
365
+ systems and procedures. Meridian submitted written corrective action plans to
366
+ address these refinements and continues its periodic communications with the FDA
367
+ on the progress of its plan submitted to the FDA in January 2001 and the
368
+ observations from the recently completed inspection.
369
+ Meridian expects cash flows from operations to be sufficient to fund working
370
+ capital needs, debt service and dividends during fiscal 2003. Meridian is
371
+ communicating with the FDA on a periodic basis to advise it on the progress of
372
+ its plan. At present, it is uncertain whether Meridian's actions will be
373
+ sufficient so that no further remedial action or enforcement action by the FDA
374
+ will occur.
375
+ Competition
376
+ The market for diagnostic tests is a multi-billion dollar international industry
377
+ which is highly competitive. Many of Meridian's competitors are larger with
378
+ greater financial, research, manufacturing and marketing resources. Important
379
+ competitive factors of Meridian's products include product quality, price, ease
380
+ of use, customer service, and reputation. In a broader sense, industry
381
+ competition is based upon scientific and technological capability, proprietary
382
+ know-how, access to adequate capital, the ability to develop and market products
383
+ and processes, the ability to attract and retain qualified personnel and the
384
+ availability of patent protection. To the extent that
385
+ 6
386
+ Meridian's product lines do not reflect technological advances, Meridian's
387
+ ability to compete in those product lines could be adversely affected.
388
+ Companies competing in the diagnostic test industry generally focus on a limited
389
+ number of tests or limited segments of the market. As a result, the diagnostic
390
+ test industry is highly fragmented and segmented. Hundreds of companies in the
391
+ United States alone supply immunodiagnostic tests. These companies range from
392
+ multi-national health care companies, for which immunodiagnostics is one line of
393
+ business, to small start-up companies. Of central importance in the industry are
394
+ mid-sized medical diagnostic specialty companies, like Meridian, that offer
395
+ multiple, broad product lines and have the ability to deliver high value new
396
+ products quickly to the marketplace. Among the companies with which Meridian
397
+ competes in the marketing of one or more of its products are Abbott Laboratories
398
+ Inc., Becton, Dickinson and Company, Diagnostic Products Corporation, Quidel
399
+ Corporation and Inverness Medical.
400
+ Intellectual Property, Patents and Licenses
401
+ Meridian owns or licenses U.S. and foreign patents for approximately 25 of its
402
+ products, including a patent for Premier Platinum HpSA(TM) issued in February
403
+ 1998. Meridian's VAI subsidiary has U.S. patents for four of its manufacturing
404
+ processes. The patents or licenses for most of Meridian's products were acquired
405
+ in connection with the purchase of the products or the licensing of the
406
+ technology on which the products are based. In the absence of patent protection,
407
+ Meridian may be vulnerable to competitors who successfully replicate Meridian's
408
+ production and manufacturing techniques and processes. Meridian's employees are
409
+ required to execute confidentiality and non-disclosure agreements designed to
410
+ protect Meridian's proprietary products.
411
+ Meridian does not believe that its products and proprietary rights infringe the
412
+ proprietary rights of any third parties. There can be no assurance, however,
413
+ that third parties will not assert infringement claims in the future.
414
+ Government Regulation
415
+ FDA Regulation of Medical Devices - Meridian's products are regulated by the
416
+ Food & Drug Administration as "devices" pursuant to the Federal Food, Drug and
417
+ Cosmetic Act (FDCA). Under the FDCA, medical devices are classified into one of
418
+ three classes (i.e., Class I, II or III). Class I and II devices are not
419
+ expressly approved by the FDA, but, instead, are "cleared" for marketing. Class
420
+ III devices generally must receive "pre-market approval" from the FDA as to
421
+ safety and effectiveness.
422
+ A 510(k) clearance will be granted if the submitted data establishes that the
423
+ proposed device is "substantially equivalent" to an existing Class I or Class II
424
+ medical device or to a Class III medical device for which the FDA has not
425
+ required pre-market approval. The 510(k) clearance process for "substantially
426
+ equivalent" devices allows product sales to be made after the filing of an
427
+ application and upon acknowledgment by the FDA, typically within 90 to 120 days
428
+ after submission. If the FDA requests additional information, the product cannot
429
+ be sold until the application has been supplemented and upon acknowledgment by
430
+ the FDA within 90 to 120 days of the supplemental application. In practice, the
431
+ FDA has been granting clearance in about 90 days following submission of the
432
+ supplemental information. If there are no existing FDA-approved products or
433
+ processes comparable to a diagnostic product or process, approval by the FDA
434
+ involves the more lengthy pre-market approval procedures.
435
+ Each of the products currently marketed by Meridian in the United States has
436
+ been cleared by the FDA pursuant to the 510(k) clearance process or is exempt
437
+ from such requirements. Meridian believes that most, but not all, products under
438
+ development will be classified as Class I or II medical devices and, in the case
439
+ of Class II devices, will be eligible for 510(k) clearance.
440
+ Other Medical Device Regulation - Sales of Meridian's products in foreign
441
+ countries are subject to foreign government regulation, the requirements of
442
+ which vary substantially from country to country. The time required to obtain
443
+ approval by a foreign country may be longer or shorter than that required for
444
+ FDA approval and the requirements may differ. Currently, Meridian is supporting
445
+ foreign product registrations in Mexico, Korea, Japan, China and Argentina via
446
+ the distributors in the respective countries.
447
+ 7
448
+ VAI's veterinary products are approved and licensed by the United States
449
+ Department of Agriculture (USDA). This typically requires six months to one year
450
+ for the approval process. In addition, assays for monitoring "controlled
451
+ diseases" require testing and release of each production serial before it is
452
+ available to the market.
453
+ The proteins that will be produced in VAI's cGMP protein production laboratory
454
+ are intended to be used as "injectibles". As such they will be produced under
455
+ cGMP Regulations for Biologics and Human Drugs under the auspices of the FDA.
456
+ Approval and licensing, following clinical trials, of these products will be the
457
+ responsibility of the applicant, who owns the rights to each protein. VAI may or
458
+ may not be the applicant depending on specific circumstances with particular
459
+ customers.
460
+ The Clinical Laboratory Improvement Act of 1988 prohibits laboratories from
461
+ performing in vitro tests for the purpose of providing information for the
462
+ diagnosis, prevention or treatment of any disease or impairment of, or the
463
+ assessment of, the health of human beings unless there is in effect for such
464
+ laboratories a certificate issued by the U.S. Department of Health and Human
465
+ Services applicable to the category of examination or procedure performed.
466
+ Although these certificates are required only for Meridian's laboratory
467
+ customers (but not for Meridian itself), Meridian considers the requirements of
468
+ The Clinical Laboratory Improvement Act of 1988 in the design and development of
469
+ its products.
470
+ Meridian is a conditionally exempt small quantity generator of hazardous waste
471
+ and has a U.S. Environmental Protection Agency identification number. All
472
+ hazardous waste is manifested and disposed of properly. Meridian is in
473
+ compliance with the applicable portions of the federal and state hazardous waste
474
+ regulations and has never been a party to any environmental proceeding.
475
+ Employees
476
+ As of September 30, 2002, Meridian had 339 full-time employees and 11 part time
477
+ employees. None of Meridian's employees is represented by a labor organization
478
+ and Meridian is not a party to any collective bargaining agreement. Meridian has
479
+ never experienced any strike or work stoppage and considers its relationship
480
+ with its employees to be good.
481
+ Meridian maintains a Savings and Investment Plan for its U.S. employees and has
482
+ established stock option plans for its officers, directors and employees. In
483
+ addition, a stock purchase plan was established on October 1, 1997 for all
484
+ employees.
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+ Item 13 Certain Relationships and Related Transactions .......................................... 45