Neogen Corporation and subsidiaries (Neogen or the Company) develop, manufacture, and market a diverse
line of products dedicated to food and animal safety. The Companys food safety segment consists primarily of diagnostic test kits and complementary products (e.g., dehydrated culture media) marketed by company sales personnel in the United
States, Canada, the United Kingdom and other parts of Europe and by distributors elsewhere to food producers and processors to detect dangerous and/or unintended substances in human food and animal feed, such as foodborne pathogens, natural toxins,
food allergens, genetic modifications, ruminant by-products, drug residues, pesticide residues and general sanitation concerns. The diagnostic test kits are generally less expensive, easier to use and provide greater accuracy and speed than
conventional diagnostic methods. The majority of the tests are disposable, single-use, immunoassay and gene probe products that rely on the Companys proprietary antibodies and RNA and DNA probes to produce rapid and accurate test results. The
Companys expanding line of food safety products also includes bioluminescence-based diagnostic technology.
Neogens animal safety segment is
engaged in the development, manufacture and marketing of pharmaceuticals, rodenticides, disinfectants, vaccines, veterinary instruments, topicals and diagnostic products for the worldwide animal safety market. The majority of these consumable
products are marketed through a network of national and international distributors, as well as a number of large farm supply retail chains in the United States and Canada. The Companys USDA-licensed facility in Tampa, Fla., produces
immunostimulant products for horses and dogs, and its unique equine botulism vaccine. The Companys line of drug detection products are sold worldwide for the detection of abused and therapeutic drugs in animals and animal products.
Managements vision is for Neogen to become a world leader in development and marketing of products dedicated to food and animal safety. To meet this vision, a
growth strategy consisting of the following elements has been developed: (i) increasing sales of existing products; (ii) introducing new products and product lines; (iii) expanding international sales; and (iv) acquiring
businesses and forming strategic alliances. While the elements of the strategy are stated in order of importance over the long term, management understands and believes that strategic acquisitions will provide the best opportunity for more rapid
growth in the short term. For that reason, an active acquisition program is maintained and financial and other resources are maintained to capitalize on opportunities as they arise.
Neogen Corporation was formed as a Michigan corporation in June 1981 and actual operations began in 1982. The Companys principal executive offices are located at 620 Lesher Place, Lansing, Michigan 48912-1595
and its telephone number is (517) 372-9200.
Neogens Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K,
and amendments to those reports are available free of charge via our Internet website ( www.neogen.com ) as soon as reasonably practicable after such information is filed with, or furnished to, the United States Securities and Exchange
Commission.
Trademarks and registered trademarks Neogen markets its products under include: Corporate: Neogen ® , Neogen flask ® ; Food Safety: AccuScan, AccuPoint ® , Acumedia ® and logo ® , Agri-Scan ® , Agri-Screen ® ,
Agri-Screen Ticket ® , Alert ® , BetaStar ® , Centrus, GeneQuence ® , Gene-Trak ® , ISO-GRID, Reveal ® , Revive ® , Soleris, Veratox ® ; Animal Safety: AluShield, AmVet ® , BottomHoof, BotVax ® , Calf Eze, D3 Needles, DC&R ® , Dr. Franks ® , ElectroJac ® , ELISA Technologies ® , EqStim ® ,
EquiMax, Fura-Zone ® , Gnat-Away,
GNatural, Gold Nugget ® and logo ® , Gold Wrap, Ideal ® , ImmunoRegulin ® , ImmunoVet ® , Injecto-Stik, Insight ® , Iso-Prine, K-Blue ® , K-Gold ® , MegaShot, Mini-Shot ® , MycAseptic ® , NFZ, NeogenVet, NeedleGard ® , Paddock & Pasture ® , PanaKare, Penzyme ® , Poridon ® ,
Pro-Pistol, Pro-Shot, Prozap ® ,
Pyril-Pam ® , Ramik ® , RenaKare, Shine N Glo, Spec-Tuss, Squire ® , Stam-N-Aid, Stress-Dex ® , TCA Paint, ThrushCrusher, ThyroKare,
TopHoof, Tri-Hist ® , Tri-Seal, Triple
Block, Triple Cast, Triple Crown and Logo ® , Triple Heat, Tri-Soxsuprine, UriKare, UriCon, Vita-15.
PRODUCTS
Neogen
operates in two primary business areas: products for the detection of pathogens, natural toxins and other unwanted substances in food and feed products, the Food Safety segment, and products dedicated to animal health, the Animal Safety segment. See
Notes to Consolidated Financial Statements elsewhere in this Form 10-K for financial information about the Companys business segments and international operations.
FOOD SAFETY SEGMENT
The products of Neogens food safety segment consist primarily of diagnostic test kits and
complementary products marketed to food and feed producers and processors to detect dangerous and/or unintended substances in food and animal feed, such as foodborne pathogens, natural toxins, food allergens, genetic modifications, ruminant
by-products, drug residues, pesticide residues and general sanitation concerns.
Most of the Neogens food safety test kits use immunoassay technology
to rapidly detect target substances. The Companys ability to produce superior antibodies, the most sensitive and specific available, sets its products apart from immunoassay test kits produced and sold by other companies. The Companys
test kits are available in microwell formats, which allow for the rapid processing of a large number of samples and automated procedures, and lateral flow and other similar devices that provide distinct visual results. Most test kits use
antibody-coated test devices and chemical reagents to produce a color change to indicate a positive or negative result for the presence of a target substance in a test sample. The simplicity of the tests, similar in technology to home pregnancy
tests, make them accessible to all levels of food producers, processors and handlers with minimal equipment and training.
Neogens test kits are used
to detect potential hazards in food and animal feed by testers ranging from small local grain elevators to the largest, best-known food and feed processors in the world, and numerous regulatory agencies.
Meat and poultry processors, seafood processors, fruit and vegetable producers and many other market segments are the primary users of the Neogens Reveal ® and Alert ® tests for foodborne bacteria, including E. coli O157:H7, Salmonella ,
Listeria and Campylobacter . Grain producers and processors of all types and sizes use the Companys Veratox ® , Agri-Screen ® and Reveal ® tests for mycotoxins, including aflatoxin, deoxynivalenol, fumonisin, ochratoxin, zearalenone and T-2 toxin, to help ensure product safety and quality. The worlds largest producers of cookies, crackers, candy,
ice cream, and many other foods, use the Companys market-best Veratox ® , Alert ® and
Reveal ® testing products for food allergens to
protect their food-allergenic customers from the inadvertent contamination of products with food allergens, such as peanut, milk, egg, almond, wheat, soy, and hazelnut residues.
Dairies are primary users of Neogens Beta Star and Penzyme diagnostic tests to detect the presence of Beta Lactam antibiotics in milk. The presence of these drugs in milk is an economic risk to processors as it
limits further processing and is also a public health hazard.
Neogen developed the first rapid immunoassay test kits to detect ruminant by-products in
animal feed ingredients and finished feed. The Reveal ® tests were designed to help prevent ruminants (cattle, sheep and goats) from being fed rendered materials containing ruminant by-products in an effort to prevent the spread of BSE (a.k.a., mad cow disease)
from animal to animal. The Companys specialty products for the seafood market include tests for histamine, a highly allergenic substance that occurs when certain species of fish begin to decay; chloramphenicol, a banned antibiotic in most of
the world, but still used by some shrimp farmers to improve the yield of their product; and sulfites, an effective but potentially allergenic shrimp preservative.
Neogen also offers other test methods and products to complement its immunoassay tests. The Companys line of Gene-Trak ® and GeneQuence ® assays utilize DNA probe hybridization technology to create exceptionally sensitive and specific tests to detect foodborne bacteria. Instead of using antibodies as in an immunoassay to
capture a target pathogen that may be present in a sample, this technology uses a portion of the target pathogens unique ribosomal RNA (rRNA) sequence to bind to complementary rRNA strands of the pathogen in a sample. The result is
a test with the ease and speed of a rapid test method, but the specificity of a time-consuming conventional laboratory method (specificity is a tests ability to distinguish between a target pathogen, and a closely-related but innocuous
bacterium).
Neogens Soleris product is used by food processors to identify the presence of spoilage organisms and other
microbiological contamination.
Neogens Acumedia ® subsidiary offers dehydrated culture media for varied purposes, including traditional bacterial testing, and growing beneficial bacteria, such as
cultures for sausages and beer. The Companys customers for dehydrated culture media also include commercial and research laboratories and producers of pharmaceuticals, cosmetics and veterinary vaccines.
Neogen manufactures and markets its AccuPoint ® rapid sanitation test for adenosine triphosphate (ATP), a chemical found in all living cells. This easy to use and relatively inexpensive test uses
bioluminescence to quickly (in less than 10 seconds) determine if a food contact surface has been sanitized completely. When ATP comes into contact with the firefly reagent luciferin luciferase contained in the test device, a reaction takes place
that produces light. The more light, the more present ATP and the greater the need for more thorough sanitation. The Companys worldwide customer base for its ATP sanitation testing products includes food and beverage processors, the
foodservice industry, as well as many other users.
Revenues from Neogens Food Safety Division accounted for 48.3%, 44.9%, and 49.7% of the
Companys total revenues for fiscal years ended May 31, 2006, 2005 and 2004, respectively.
ANIMAL SAFETY SEGMENT
Neogens animal safety segment is primarily engaged in the development, manufacture and marketing of pharmaceuticals, rodenticides, disinfectants, vaccines,
veterinary instruments, topicals and diagnostic products to the worldwide animal safety market.
Neogens AmVet ® product line provides innovative, value-added, high quality products to the veterinary
market. Top AmVet products include PanaKare, a digestive aid that serves as a replacement therapy where digestion of protein, carbohydrate and fat is inadequate due to exocrine pancreatic insufficiency; Natural Vitamin E-AD, which aids in the
prevention and treatment of vitamin deficiencies in swine, cattle and sheep; and RenaKare, a supplement for potassium deficiency in cats and dogs. Products sold under the NeogenVet brand include Vita-15 and Liver 7, which are used
in the treatment and prevention of nutritional deficiencies in horses.
On November 21, 2003, Neogen acquired Hacco, Inc., a manufacturer of
rodenticides, including the brands Ramik ® ,
Havoc ® and Prozap ® . On the same date, it also acquired Hess & Clark, Inc.
Hess & Clarks principal products are disinfectants, such as DC& ® , used in animal and food production facilities and proprietary anti- bacterials for animals.
Neogens
in-house equine protozoal myeloencephalitis (EPM) testing service offers veterinarians accurate, timely results for early diagnosis of the disease that can devastate a horses central nervous system. In addition, the Companys BotVax ® B vaccine has successfully protected hundreds of
thousands of horses and foals against type B botulism, commonly known as Shaker Foal Syndrome. The Companys product is the only USDA-approved vaccine for the prevention of Type B botulism in horses.
Years of research and many thousands of doses have proven Neogens EqStim ® immunostimulant to be safe and effective as a veterinarian-administered adjunct to conventional treatment of equine
bacterial and viral respiratory infections. The Companys ImmunoRegulin ® product uses similar immunostimulant technology to aid in the treatment of pyoderma (a bacterial skin inflammation) in dogs.
Neogen markets a complete line of veterinary instruments and animal health delivery systems under the Ideal product brand name. Approximately 250 different products are offered, many of which are used to deliver animal health products, such
as antibiotics and vaccines. Ideals D3 Needles are three times stronger than conventional veterinary needles, and are uniquely detectable by common meat processing facility metal detectorsa big market advantage in the
safety-conscious beef and swine industries.
Animal safety products offered by Neogen to the retail over-the-counter market include many of the Ideal brand veterinary
instruments and products sold under the Squire ® and
Gold Nugget ® brands. Squire products include
Stress-Dex ® , the No. 1 oral electrolyte for
performance horses for more than 30 years, and Fura-Zone, for the prevention and treatment of surface bacterial infections in wounds, burns and cutaneous ulcers. Gold Nugget OTC products include GNatural Spray, to protect horses from biting
insects, and Poridon ® , a pour-on insecticide for
horses.
Neogens line of 80 drug detection immunoassay test kits are sold worldwide for the detection of approximately 200 abused and therapeutic
drugs in racing animals, such as horses, greyhounds and camels, as well as for testing fair animals and drug residues in meat and meat products. The test kits are also used for human forensic toxicology drug screening applications. This line
includes tests for narcotics, analgesics, stimulants, depressants, tranquilizers, anesthetics, steroids and diuretics.
Neogen also has several products
used by researchers for the detection of biologically-active substances. These products include tests for cyclic nucleotides, hormones, leukotrienes, prostaglandins and steroids. Marketed under the trademarks of K-Blue and K-Gold, Neogen offers
certain test kit components it uses in its own testing products to other diagnostic test kit manufacturers.
Revenues from Neogens Animal Safety
Division accounted for 51.7%, 55.1%, and 50.3% of the Companys total revenues for fiscal years ended May 31, 2006, 2005 and 2004 respectively.
GENERAL SALES AND MARKETING
Neogens domestic sales efforts are organized by market segments, rather than by products or geography.
During the fiscal year that ended May 31, 2006, the Company had more than 5,000 customers for its products. Since many customers for animal safety products are distributors, and certain animal safety products are offered to the general retail
market, the total number of end users of the Companys products is considerably greater than 5,000. A total of 119 employees are assigned to sales and marketing functions within the Company. No single distributor or customer accounted for 10%
or more of the Companys revenues in any of the past three years.
FOOD SAFETY SALES AND MARKETING
To reach each customer and prospect with expertise and experience, Neogen has a staff of specialized food safety sales representatives assigned to specific markets. This
staff sells Company products directly to end users, and also handles technical support issues that arise with customers.
Neogens food safety markets
are comprised of: feed and agriculture, including grain elevators, feed mills, pet food manufacturers, and grain inspection companies; meat and poultry, including meat and poultry processors, producers of ready-to-eat meat and poultry products; and
the USDAs Food Safety Inspection Service (FSIS); milling and grocery, including flour millers, malters, bakeries, candy and confection manufacturers, manufacturers of prepared meals, nuts, spices, cookies, crackers and other snack foods;
fruits and vegetables, including growers and processors of juice and packaged fresh cut grocery items; seafood, including harvesters and processors of a wide variety of seafood products; dairy and beverage, including milk processors and soft drink
bottlers; and Acumedia dehydrated culture media, including commercial and research laboratories and producers of pharmaceuticals, cosmetics and veterinary vaccines.
ANIMAL SAFETY SALES AND MARKETING
Neogen markets a broad range of pharmaceuticals, vitamin injectibles, wound care
products, topicals, instruments, testing services and a vaccine to the veterinary market. The product range is focused on the food (cattle and pigs) and companion (horses, dogs, and cats) animal markets. Neogens sales group works directly with
key horse veterinarians, clinics and universities while supporting the efforts of over 500 domestic distributor sales representatives calling on 35,000 plus veterinarians. Neogen supports its veterinary distribution channel through product training,
field support, promotions and technical service.
The over-the-counter (OTC) animal health market is larger than the veterinary market and offers significant growth
opportunities for Neogen and its products. Neogen again offers a broad range of animal health products including well recognized brands of rodenticides, disinfectants, instruments, electrolytes and horse care products. To reach the OTC market,
Neogens sales team works with a large network of animal health distributors including marketing groups, like Durvet, Universal Cooperative and AgriLabs, traditional two-step distributors, catalogers and large retail chains. Some of the retail
chains include Tractor Supply Company (TSCO:Nasdaq), PETsMART (PETM:Nasdaq) and Orschelns Farm & Home. Support includes product training, field support, planogram solutions, promotions and advertising.
INTERNATIONAL SALES AND MARKETING
FOOD SAFETY:
Internationally, Neogen uses its own sales managers to work closely with and coordinate the efforts of a network of more than 100
distributors in 65 countries. The distributors provide local training and technical support, perform market research, and promote Company products around the world.
Neogens March 2003 acquisition of Adgen Ltd., (now Neogen Europe, Ltd.), provides the Company better access to the European Union, and allows it to better serve its network of customers and distributors
throughout the EU. Customers in United Kingdom, France and Germany are served by Company employees. Other European region customers are serviced by distributors managed by Neogen Europe personnel. Prior to the acquisition, Adgen was a major
distributor of Neogen products in Europe, and a producer and marketer of its own agricultural diagnostic testing products. Adding Adgens experienced research and development team continues to be a strong asset in the development of products
tailored to meet unique requirements of the European market.
Neogens dairy antibiotics diagnostic products are distributed outside of North America
by Denmark based Chr. Hansen, an international supplier of natural ingredient solutions for the food and health and nutritional industries.
Distribution
of Soleris products is shared worldwide by Neogen personnel and Denmark based Foss Analytical.
Since 2002, Neogen has continued to maintain a presence in
Shanghai, China, to better serve the expanding food safety market, as well as more closely manage its Chinese animal safety manufacturing. Neogen intends to use local distributors to introduce the Companys products in the Chinese market.
ANIMAL SAFETY:
The Animal
Safetys international sales group has established a strong presence in several key markets with rodenticides, disinfectants, instruments and veterinary products. Primary utilizing in-country distributors and US-based exporters, these markets
include Mexico, Canada, Australia, EU, South America, and the Caribbean. Diagnostic products are sold around the world through an extensive distributor network.
GENERAL:
Revenues from Neogens
international sales accounted for 28.6%, 27.1%, and 24.8% of the Companys total revenues for fiscal years ended May 31, 2006, 2005 and 2004, respectively.
Risks associated with foreign operations include the need for additional regulatory approvals, possible disruptions of product delivery, the differing product needs of foreign customers, difficulties in building and
managing foreign operations, fluctuations in the value of foreign currencies, import/export duties and quotas, and unexpected regulatory, economic or political changes in foreign markets. The level of foreign activities does not currently require
hedging to reduce the effect of currency fluctuations.
RESEARCH AND DEVELOPMENT
Management maintains a strong commitment to Neogens research and development activities. The Companys product development efforts are focused on the enhancement of existing product lines and in development of new products that
fit its business strategy. The Company employs 27 individuals in its research and development department, including immunologists, chemists, engineers and microbiologists. Research and development expenditures were approximately $3.0 million, $2.7
million and $2.9 million, representing 4%, 4% and 5% of total revenues in fiscal 2006, 2005 and 2004, respectively. Management currently intends to maintain the Companys research and development expenditures at approximately 4% to 6% of total
revenues.
Neogen has ongoing development projects for new immunoassay diagnostic tests for the food safety, animal safety and pharmacologics markets, as
well as engineering projects for new and improved veterinary instruments. Management expects that these products will be available for marketing in fiscal years 2007 to 2009.
Portions of certain technologies utilized in some products marketed by Neogen were acquired from or developed in collaboration with affiliated partnerships, independent scientists, governmental units, universities and
other third parties. The Company has entered into agreements with these parties that provide for the payment of royalties based upon sales of products that utilize the pertinent technology. For fiscal 2006, 2005 and 2004, royalty expense under these
agreements amounted to $911,000, $742,000 and $900,000, respectively.
PROPRIETARY PROTECTION AND APPROVALS
Patents and trademarks are applied for whenever appropriate. Since its inception, Neogen has acquired and received more than 50 patents and trademarks, and has several
pending patents and trademarks. The patents expire at various times over the next 20 years.
Management believes that Neogen has adequate protection as to
proprietary rights for its products. However, it is aware that substantial research has taken place at universities, governmental agencies and other companies throughout the world and that numerous patent applications have been filed and that
numerous patents have been issued. To the extent some of the Companys products may now, or in the future, embody technologies protected by patents, copyrights or trade secrets of others, licenses to use such technologies may need to be
obtained in order to continue to sell the products. These licenses may not be available on commercially reasonable terms. Failure to obtain any such licenses may delay or prevent the sale of certain new or existing products. In addition, patent
litigation is not uncommon. Accordingly, there can be no assurance that the Companys existing patents will be sufficient to completely protect its proprietary rights.
Neogen uses trade secrets as proprietary protection in numerous of its food and animal safety products. In many cases, the Company has developed unique antibodies capable of detecting microorganisms and residues at
minute levels. The supply of these antibodies, and the proprietary techniques utilized for their development, may offer better protection than the filing of patents. Such proprietary reagents are maintained in secure facilities and stored in more
than one location to reduce exposure to complete destruction by natural disaster or other means.
One of the major areas affecting the success of
biotechnology development involves the time, costs and uncertainty surrounding regulatory approvals. Currently, Neogen products requiring regulatory approval include BotVax B, EqStim and ImmunoRegulin. The Companys general strategy is to
select technical and proprietary products that do not require mandatory approval to be marketed. In China three of the Companys immunoassay based test kits are listed in the GB, or National Standard. Listings of these products are expected
assist to generate future sales into Government and other laboratories in China.
Neogen utilizes third party validations on many of its disposable test
kits as a marketing tool to provide its customers with the proper assurances. These include validation by the Association of Official Analytical Chemists, independently administered third-party, multi-laboratory collaborative studies and approvals
by the U.S. Federal Grain Inspection Service and the U.S. Food Safety Inspection Service for the use of Company products in their operations.
PRODUCTION AND SUPPLY
Neogen manufactures its products in Lansing, Michigan; Lexington, Kentucky; Randolph, Wisconsin; Tampa, Florida; and Ayr, Scotland. There are currently approximately 184 full-time employees assigned to manufacturing in these five locations.
Most locations operate on a one-shift basis, but could be increased to a two-shift basis. Management believes it could increase the current output of its primary product lines by more than 50% using the current space available with a minimum of
additional capital equipment.
Manufacturing of diagnostic tests for detection of natural toxins, pathogens, food allergen and pesticides, final kit
assembly, quality assurance and shipping takes place from the Companys facilities in Lansing. Proprietary monoclonal and polyclonal antibodies for the Neogens diagnostic kits are produced on a regular schedule in the Companys
immunology laboratories. Other reagents are similarly prepared by the chemistry group.
Manufacturing of diagnostic tests for the presence of dairy
antibiotics in milk is completed in the Companys Lansing facilities. Generally, final assembly and shipment to customers are performed in the Companys Ayr, Scotland facility.
Assembly and shipment of electronic readers and disposable single-use samplers takes place in the Companys facilities in Lansing.
Dehydrated culture media products are manufactured in a FDA monitored facility in Lansing. Products are blended following strict formulations or custom blended to customer specification and shipped directly to
customers from Lansing.
Soleris single-use samplers and equipment are produced and shipped to customers by third party vendors.
Manufacture of pharmacological diagnostic test kits, test kits for drug residues and of animal health products takes place from the Companys facility in Lexington.
In general, manufacturing operations including reagent manufacturing, quality assurance, final kit assembly and packaging are performed by Neogen personnel. Certain animal health products that are purchased finished or that are toll manufactured by
third party vendors and veterinary instruments are warehoused and shipped from the Companys Lexington, facility. Other veterinary instruments are produced in the Companys facilities in Lansing, and are generally then shipped to
Lexington, for distribution to customers.
Manufacture of rodenticides and disinfectants takes place in Randolph. Manufacturing consists of blending
technical material (active ingredient) with bait consisting principally of various grains.
The Tampa facility is an USDA-approved manufacturing plant
devoted to the production of the biologic products EqStim ® and ImmunoRegulin ® .
P. acnes seed cultures are added to media and then subjected to several stages of further processing resulting in a product that is filled and packaged within the Tampa facility. The Companys BotVax B vaccine is also produced in the
Tampa facility utilizing Type B botulism seed cultures and a traditional fermentation process. All completed product is then shipped to Neogens Lexington, facilities for inventory and distribution to customers.
Neogen purchases component parts and raw materials from more than 200 suppliers. Though many of these supplies are purchased from a single source in order to achieve the
greatest volume discounts, the Company believes it has identified acceptable alternative suppliers for all of its components and raw materials.
Shipments
of products are generally accomplished within a 48-hour turnaround time. As a result of this quick response time, Neogens backlog of unshipped orders at any given time is not significant.
COMPETITION
Although
competitors vary in individual markets, management knows of no competitor that is pursuing Neogens fundamental strategy of developing a full line of products, ranging from disposable tests and dehydrated culture media to veterinary
pharmaceuticals and veterinary instruments for a large number of food safety and animal safety concerns. For each of its individual products, the Company faces intense competition from companies ranging from ses to divisions of large
international companies. Some of these organizations have substantially greater financial resources than the Company. The Company competes primarily on the basis of ease of use, speed, accuracy, and other similar performance characteristics of its
products. The breadth of the Companys product line, the effectiveness of its sales and customer service organizations and pricing are also components in managements competitive plan. Management is not aware of any factors within its
product lines that place the Company in a negative competitive position relative to its competitors.
Future competition may become even more intense,
including the development of changing technologies, which could affect the marketability of the Neogens products. The Companys competitive position also will depend on managements ability to develop proprietary products, attract
and retain qualified scientific and other personnel, develop and implement production and marketing plans and obtain patent protection and adequate capital resources.
FOOD SAFETY
Neogens Food Safety
Division has strong distribution of its products using Company employees domestically and from an active and aggressive distributor group outside of North America. With one of the largest professional sales organizations in the industry, management
believes that it maintains a general competitive advantage as sales personnel are in a position to be with customers and prospects more frequently than those of its competitors. Additionally, as an agriculturally based company, Neogen has what is
believed to be a unique insight into the food industry as opposed to its clinically based competition.
Competition for pathogen detection products
includes traditional methods and antibody and genetic based platforms. Neogens product offerings compete across the entire spectrum of methods. Competition for natural toxins and allergen detection products include instrumentation and antibody
based tests. Generally, the Companys products fall within the non-instrument category. While for these and other food safety products the Companys offerings will not always compete on all platforms in all markets, the products that are
offered provide tests that can be well utilized by most customers to meet their testing needs.
Besides its strong product offerings and its superior
distribution, the Company focuses its competitive advantage in the areas of customer service and speed and ease of use of its products. Additionally, by aggressively maintaining itself as a low cost producer, Neogen assures that it can be
competitive with new market entrants that may choose a low pricing strategy in an attempt to gain market share.
ANIMAL
SAFETY
Neogens Animal Safety Division faces no one competitor across the products and markets it serves. In the racing industry market, the Company
holds the position of dominant market share, facing only one other significant company in the marketplace. In the Life Sciences market, the Company competes against a few other diagnostic and reagent companies but none with the same breadth of
product offering.
In the veterinary market, Neogen markets BotVax B, the only USDA approved vaccine for the prevention of botulism Type B in horses. The
Company competes on other key products through differentiated product performance and superior customer and technical support. With some of its products, the Company provides solutions as a lower cost alternative and offers a private label option
for its distributors.
Competition in the rodenticide market includes several companies of comparable size that offer products into similar market
segments. The rodenticide retail market is dominated by a single brand. While the technical materials used by the competing companies are similar, Neogen uses techniques to better draw rodents to the product and thereby improve the objectives of the
product.
Neogen competes in the retail market by providing solutions to common retail problems stock outs, wasted floor
space, and inconsistent brand identity. The Company offers plan-o-grams and reordering systems to maximize turns and profitability for its customers.
GOVERNMENT REGULATION
A significant portion of the Neogens products and revenues are affected by the regulations of various domestic
and foreign government agencies, including the U.S. Department of Agriculture and the U.S. Food and Drug Administration. Changes in these regulations could affect revenues and/or costs or production and distribution.
Neogens development and manufacturing processes involve the use of certain hazardous material, chemicals and compounds. Management believes that the Companys
safety features for handling and disposing of such commodities comply with the standards prescribed by local, state and federal regulations. The Companys cost to comply with these regulations is not significant and the Company has no reason to
believe that any such future legislation or rules would be materially adverse to its business.
The Companys rodenticide products generally require
registration with U.S. governmental agencies at federal and state levels and with foreign governments.
EMPLOYEES
Currently, the Company employs 393 full-time persons. None of the employees are covered by collective bargaining agreements. There have been no work stoppages or slow
downs due to labor-related problems. Management believes that its relationship with its employees is good. All employees having access to proprietary information have executed confidentiality agreements with the Company.
ITEM 1.A RISK FACTORS
An investment in our common shares involves a high degree of risk. The risks described below are not
the only ones that we face. Additional risks that are not yet known to us or that we currently think are immaterial could also impair our business, financial condition or results of operations. If any of the following risks actually occurs, our
business, financial condition or results of operations could be adversely affected.
Risks Relating to Our Business
Our business strategy is dependent on successfully identifying and integrating acquisitions as well as promoting internal growth.
Our business has grown significantly over the past several years as a result of both internal growth and acquisitions of existing businesses and their products. The
Company has no agreements or commitments in place with respect to, and is not currently engaged in any negotiations for, any acquisition. Identifying and pursuing acquisition opportunities, integrating these acquisitions into our business and
managing their growth require a significant amount of management time and skill. We cannot assure that we will be effective in identifying, integrating or managing any acquisition target in the future. Our failure to successfully integrate and
manage any future acquisition may have a material adverse effect on our operating results and financial condition.
In addition, if we continue to
experience growth in our business, our growth could place a significant strain on our management, customer service, operations, sales and administrative personnel and other resources. To serve the needs of our existing and future customers, we will
be required to train, motivate and manage qualified employees. We have incurred and will continue to incur significant costs to retain qualified management, sales and marketing, engineering, production, manufacturing and administrative personnel, as
well as expenses for marketing and promotional activities. Our ability to manage our planned growth depends upon our success in expanding our operating, management and information and financial systems, which might significantly increase our
operating expenses.
We might not be able to manage effectively our future growth, and if we fail to do so, our business, financial condition
and results of operations would be adversely affected.
The development of new products entails substantial risk of failure.
We are continually developing new products for which we believe there should be significant market demand. We cannot assure that we will successfully develop commercially
viable products, that the products will be developed on a timely basis to meet market demand or that the relevant market will be properly identified. If we expend substantial resources in developing an unsuccessful product, operating results will be
adversely affected.
Our international operations are subject to different product standards as well as other operational risks.
In fiscal 2006, international sales accounted for 29% of the Companys total revenue. We expect that our international business will continue to account for a
significant portion of our total revenue. Foreign regulatory bodies may establish product standards different from those in the U.S. and with which the Companys current products do not comply. Our inability to design products that comply with
foreign standards could have a material adverse effect on our future growth. Other risks related to our international sales include the possible disruption in transportation, difficulties in building and managing foreign distribution, fluctuation in
the value of foreign currencies, import duties and quotas and unexpected economic and political changes in foreign markets. These factors might adversely affect international sales and our overall financial performance.
The markets for our products are extremely competitive, and our competitors may be able to utilize existing resource advantages to our detriment.
The markets in which the Company competes are subject to rapid and substantial changes in technology and are characterized by extensive research and development and
intense competition. Many of our competitors and potential competitors have greater financial, technical, manufacturing, marketing, research and development and management resources than we do. These competitors might be able to use their resources,
reputations and ability to leverage existing customer relationships to give them a competitive advantage over us. They might also succeed in developing products that are at least as reliable and effective as our products that make additional
measurements, that are less costly than our products or that provide alternatives to our products.
We are dependent on the agricultural marketplace,
which is affected by factors beyond our control.
Our primary customers are in the agricultural and food production industries. Economic conditions
affecting agricultural industries are cyclical and are dependent upon many factors outside our control, including weather conditions or changes in consumption patterns. An economic downturn in the agricultural marketplace could adversely affect our
sales.
Our quarterly operating results are subject to significant fluctuations.
We have experienced, and may experience in the future, significant fluctuations in our quarterly operating results. The mix of products sold and the acceptance of new products, in addition to other factors, could
contribute to this quarterly variability. We operate with relatively little backlog and have few long-term customer contracts. Substantially all of our product revenue in each quarter results from orders received in that quarter. In addition, our
expense levels are based, in part, on expectation of future revenue levels. A shortfall in expected revenue could, therefore, result in a disproportionate decrease in our net income.
Our success is highly dependent on our ability to obtain protection for the intellectual property utilized in our
products.
Our success and ability to compete depends in part upon our ability to obtain protection in the United States and other countries for our
products by establishing and maintaining intellectual property rights relating to or incorporated into our technology and products. Patent applications filed by the Company may not result in the issuance of patents or, if issued, may not be issued
in a form that will be commercially advantageous to us. Even if issued, patents may be challenged, narrowed, invalidated or circumvented, which could limit our ability to stop competitors from marketing similar products or limit the length of time
of patent protection we may have for our products. We also cannot assure that our nondisclosure agreements, together with trade secrets and other common law rights, will provide meaningful protection for the Companys trade secrets and other
proprietary information. Moreover, the laws of some foreign jurisdictions may not protect intellectual property rights to the same extent as in the United States, and many companies have encountered significant difficulties in protecting and
defending such rights in foreign jurisdictions. If we encounter such difficulties or we are otherwise precluded from effectively protecting our intellectual property rights domestically or in foreign jurisdictions, we may incur substantial costs and
our business, including our business prospects, could be substantially harmed. From time to time, the Company has received notices alleging that the Companys products infringe third party proprietary rights. Whether the manufacture, sale or
use of current products, or whether any products under development would, upon commercialization, infringe any patent claim will not be known with certainty unless and until a court interprets the patent claim in the context of litigation. If an
infringement allegation is made against us, we may seek to invalidate the asserted patent claim and/or to allege non-infringement of the asserted patent claim. In order for us to invalidate a U.S. patent claim, we would need to rebut the presumption
of validity afforded to issued patents in the United States with clear and convincing evidence of invalidity, which is a high burden of proof. The outcome of infringement litigation is subject to substantial uncertainties, and also the testimony of
experts as to technical facts upon which experts may reasonably disagree. Our defense of an infringement litigation lawsuit could result in significant expense. Regardless of the outcome, infringement litigation could significantly disrupt our
marketing, development and commercialization efforts, divert our managements attention and consume our financial resources.
In the event that we are
found to infringe any valid claim in a patent held by a third party, we may, among other things, be required to:
pay damages, including up to treble damages and the other partys attorneys fees, which may be substantial;
cease the development, manufacture, importation, use and sale of products that infringe the patent rights of others, through a court-imposed sanction called an injunction;
expend significant resources to redesign our technology so that it does not infringe others patent rights, or to develop or acquire non-infringing intellectual property, which
may not be possible;
discontinue manufacturing or other processes incorporating infringing technology; and/or
obtain licenses to the infringed intellectual property, which may not be available to us on acceptable terms, or at all.
Any development or acquisition of non-infringing products or technology or licenses could require the expenditure of substantial time and other resources and could have
a material adverse effect on our business and financial results. If we are required to, but cannot, obtain a license to valid patent rights held by a third party, we would likely be prevented from commercializing the relevant product, or from
further manufacture, sale or use of the relevant product.
We are subject to substantial governmental regulation.
A portion of our products are regulated by various domestic and foreign government agencies, including the U.S. Department of Agriculture and the U.S. Food and Drug
Administration. Although less than 10% of our revenues is currently derived from products requiring government approval prior to sale, a significant portion of our revenues is derived from products used to monitor and detect the presence of residues
that are regulated by various government agencies. Furthermore, a significant portion of the Companys growth may be affected by the implementation of new regulations.
We are dependent on key employees.
The Companys success depends, in large part, on its president and on other members of its management team. Our loss of any of these key employees could have a material adverse effect on the Company. The Company
maintains certain incentive plans for its key employees, and most of these employees have been with the Company in excess of five years. However, the Company has not executed long-term employment agreements with any of these employees and does not
expect to do so in the foreseeable future. The Companys success also depends, significantly, on its ability to continue to attract such personnel. We cannot assure that we will be able to retain our existing personnel or attract additional
qualified persons when required and on acceptable terms.
Our business may be subject to product liability claims.
The manufacturing and distribution of the Companys products involve an inherent risk of product liability claims being asserted against us. Regardless of whether we
are ultimately determined to be liable or our products are determined to be defective, we might incur significant legal expenses not covered by insurance. In addition, product liability litigation could damage our reputation and impair our ability
to market our products, regardless of the outcome. Litigation could also impair our ability to retain product liability insurance or make our insurance more expensive. Although the Company currently maintains liability insurance, we cannot assure
that we will be able to continue to obtain such insurance on acceptable terms, or that such insurance will provide adequate coverage against all potential claims. If we are subject to an uninsured or inadequately insured product liability claim, our
business, financial condition and results of operations could be adversely affected.
Market prices for securities of technology companies are highly
volatile.
The market prices for securities of technology companies have been volatile in the past and could continue to be volatile in the future.
Fluctuations in our financial performance from period to period could have a significant impact on the market price of our common shares.
ITEM 1B. UNRESOLVED STAFF COMMENTS
None
Neogen Corp (NEOG) - Description of business
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Research Report
Description
Level 2 quotes
Charts
News
Profile
Balance Sheet
Income Statement
Cash Flow Statement
Insiders
SEC Filings
Analyst Recommendation
Earnings Report
Historical Prices
Recent Material Events
Key executives
Comments


