What changed in this filing

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Item 1. Business

2022-07-27 compared with 2021-07-30 · 82 added, 62 removed, 441 unchanged (25% of the section changed)

6 unchanged sentences

Our expanding line of food safety products also includes genomics-based diagnostic technology, and advanced software systems that help testers to objectively analyze and store their results and perform analysis on the results from multiple locations over extended periods.

Neogen’s Animal Safety segment is engaged in the development, manufacture, marketing and distribution of veterinary instruments, pharmaceuticals, vaccines, topicals, diagnostic products, rodenticides, cleaners, disinfectants, insecticides and genomics testing services for the worldwide animal safety market.

On December 13, 2021, Neogen and 3M announced plans to merge 3M’s Food Safety business with Neogen in a Reverse Morris Trust transaction.

The transaction is expected to close by the end of the third calendar quarter of 2022.

See Note 3, Business Combinations, to the consolidated financial statements for further discussion.

Neogen’s Animal Safety segment is engaged in the development, manufacture, marketing and distribution of veterinary instruments, pharmaceuticals, vaccines, topicals, parasiticides, diagnostic products, rodenticides, cleaners, disinfectants, insecticides and genomics testing services for the worldwide animal safety market.

The majority of these consumable products are marketed through veterinarians, retailers, livestock producers and animal health product distributors.

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, Neogen and flask (logo) ®

, NeoCenter ™

, AccuPoint ®

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ANIMAL SAFETY:

, Aero-ssault ™

, AluShield ™

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, Dyne-O-Might

, Earth City Resources (design) ®

, ElectroJac ®

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, Maxi Sleeve ®

, MycAseptic ™

, NeedleGard ™

Viroxide Super ™

Viroxide Super and flask (design) ®

, Paradefense ®

, ParlorMint ™

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, Prima Marc ™

, Prima-Shot ™

, Prima Tech ®

, Protectus ™

, Provecta Advanced ®

, Prozap (stylized mark w/fancy Z) ™

, Rat & Mouse-A-Rest

, Rodent Elimination Station ™

, Safe-T-Flex

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, Spectrasol ™

, Spec-Tuss ™

, Standguard ®

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, ThyroKare ™

, Paradefense ®

, Turbocide ®

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, Genomic Insight for Personalized Care ™

, SeekTrace ™

, Infiniseek ™

, Early Warning ™

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and Campylobacter

Neogen’s ANSR pathogen detection system is an isothermal amplification reaction test method which exponentially amplifies the DNA of any bacteria present in food and environmental samples to detectable levels in 10 minutes.

Neogen’s ANSR pathogen detection system is an isothermal amplification reaction test method that exponentially amplifies the DNA of any bacteria present in food and environmental samples to detectable levels in 10 minutes.

Combined with ANSR’s single enrichment step, Neogen’s pathogen detection method provides DNA-definitive

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and shellfish toxins.

Neogen’s Reveal lateral flow tests for shellfish toxins include rapid tests to detect the toxins that cause amnesic shellfish poisoning (ASP), diarrhetic shellfish poisoning (DSP) and paralytic shellfish poisoning (PSP).

Neogen’s Reveal lateral

flow tests for shellfish toxins include rapid tests to detect the toxins that cause amnesic shellfish poisoning (ASP), diarrhetic shellfish poisoning (DSP) and paralytic shellfish poisoning (PSP).

Waterborne microorganisms.

Neogen offers the food and beverage industries, including water companies, several platforms for performing the microbial analysis of water.

This includes Neogen’s filter tests, which are a combination of Neogen Filter membrane filtration and Neogen Culture Media ampouled media, and easy-to-use

This includes Neogen’s filter tests, which are a combination of Neogen Filter membrane filtration and Neogen Culture Media ampouled media, and an easy-to-use

Colitag product.

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Digital services.

Our new food safety and risk management software as a service, Neogen Analytics, delivers a comprehensive Environmental Monitoring Program (EMP) automation solution for food companies.

Our food safety and risk management software-as-a-service,

Neogen Analytics, delivers a comprehensive Environmental Monitoring Program (EMP) automation solution for food companies.

The software reduces risk by increasing visibility to food safety testing results, elevating the ability to enforce and improve food safety standards.

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laboratories offer a variety of fee-for-service

tests for the food and feed industry.

tests for the food and feed industries.

The majority of Neogen’s food safety test kits use immunoassay technology to rapidly detect target substances.

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the simplicity of the tests makes them accessible to all levels of food producers, processors and handlers.

Neogen also offers other test methods and products to complement its immunoassay tests.

Our test kits are generally based on internally developed technology, licensed technology, or technology that is acquired in connection with acquisitions.

Neogen also offers other testing methods and products to complement its immunoassay tests.

Our test kits are generally based on internally developed technology, licensed technology, or technology that is acquired as a result of acquisitions.

In fiscal 2022, the Food Safety segment incurred expense totaling $1,779,000 for royalties for licensed technology used in our products, including expense of $800,000 for allergen products and $494,000 for the pathogen product line.

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and involve technology licensed to multiple licensees.

Neogen’s international operations in the U.K., Mexico, Brazil, China and India originally focused on food safety products, and each of these units reports through the Food Safety segment.

Neogen’s international operations in the U.K., Mexico, Guatemala, Brazil, Argentina, Uruguay, Chile, China and India originally focused on food safety products, and each of these units reports through the Food Safety segment.

In recent years, these operations have expanded to offer our complete line of products and services, including those usually associated with the Animal Safety segment such as cleaners, disinfectants, rodenticides, insecticides, veterinary instruments and genomics services.

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ANIMAL SAFETY SEGMENT

Neogen’s Animal Safety segment is primarily engaged in the development, manufacture, marketing and distribution of veterinary instruments, pharmaceuticals, vaccines, topicals, diagnostic products, a full suite of agricultural biosecurity products such as rodenticides, cleaners, disinfectants and insecticides, and genomics services.

Neogen’s Animal Safety segment is primarily engaged in the development, manufacture, marketing and distribution of veterinary instruments, pharmaceuticals, vaccines, topicals, parasiticides, diagnostic products, a full suite of agricultural biosecurity products such as rodenticides, cleaners, disinfectants and insecticides, and genomics services.

Veterinary instruments.

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Neogen’s Prima Tech product line consists of highly accurate devices used by farmers, ranchers and veterinarians to inject animals, provide topical applications and to use for oral administration.

Prima Tech is also a supplier of products used in artificial insemination in the swine industry.

Other products include animal identification and handling equipment.

The Prima Tech line also includes products used in artificial insemination in the swine industry, animal identification products and handling equipment.

Veterinary pharmaceuticals.

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and Liver 7, which are used in the treatment and prevention of nutritional deficiencies.

We also manufacture and market Uniprim, a veterinary antibiotic.

Neogen also markets Uniprim, a veterinary antibiotic, and, through the Company’s September 2021 acquisition of CAPInnoVet, Inc., several companion animal parasiticides.

Veterinary biologics.

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Years of research and many thousands of doses have proven Neogen’s EqStim immunostimulant to be safe and effective as a veterinarian-administered adjunct to conventional treatment of equine bacterial and viral respiratory infections.

Our ImmunoRegulin product uses similar immunostimulant technology to aid in the treatment of pyoderma (a bacterial skin inflammation) in dogs.

The Company’s ImmunoRegulin product uses similar immunostimulant technology to aid in the treatment of pyoderma (a bacterial skin inflammation) in dogs.

Veterinary OTC products.

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Used in animal and food production facilities, Neogen’s cleaners and disinfectants, including 904 Disinfectant, Acid-A-Foam,

Synergize, BioPhene, Neogen Viroxide Super, and Companion, can stop a disease outbreak before it starts.

Synergize, BioPhene, Neogen Viroxide Super, and Companion, prevent disease outbreaks.

The products are also used in the veterinary clinic market to maintain sanitary conditions and limit the potential hazards of bacteria, fungi and viruses.

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This information has helped livestock producers increase the speed of genetic improvement in their herds and overall performance and quality of their animals.

Neogen’s December 2021 acquisition of Genetic Veterinary Sciences, Inc.

expanded the Company’s portfolio through the addition of a number of genetic tests for companion animals, including dogs, cats and birds.

Life sciences.

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Many of the products and services in the Animal Safety segment use licensed technology.

In fiscal year 2021, the Animal Safety segment incurred expense totaling $331,000 for royalties for licensed technology used in our products and services, including expense of $213,000 related to the genomics services line.

In fiscal 2022, the Animal Safety segment incurred expense totaling $220,000 for royalties for licensed technology used in our products and services, including expense of $122,000 related to genomics services.

Neogen’s operation in Australia originally focused on providing genomics services and sales of animal safety products and reports through the Animal Safety segment.

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To reach each customer and prospect with expertise and experience, Neogen has a staff of specialized food safety sales and technical service representatives assigned to specific markets or geographies.

This staff sells our products directly to end users, and also handles technical support issues that arise with customers in the United States.

This staff sells our products directly to end users, and also handles technical support issues that arise with customers.

Neogen’s food safety markets are primarily comprised of:

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ANIMAL SAFETY

Neogen’s staff of specialized animal safety sales, marketing, customer and technical service representatives sell our products and services directly to consumers, dealers, veterinarians, distributors and other manufacturers and also handle domestic technical support issues.

Neogen further supports its distribution channels through product training, field support, various promotions and advertising.

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INTERNATIONAL SALES AND MARKETING

Neogen maintains 16 Company-owned locations outside of the United States to provide a direct presence in regions of particular importance to us;

Neogen maintains Company-owned locations outside of the United States in 14 countries to provide a direct presence in regions of particular importance to us;

we maintain an extensive network of distributors to reach countries where we do not have a direct presence.

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Neogen Europe, Ltd., headquartered in Ayr, Scotland, sells products and services to our network of customers and distributors throughout the United Kingdom (U.K.), Europe, the Middle East and Africa.

Customers in the U.K., France, Germany, Italy and the Netherlands are served by our employees.

Customers in the U.K., France, Germany, Italy, the Netherlands and the United Arab Emirates (U.A.E.) are served by our employees.

In other regions, customers are generally serviced by distributors managed by Neogen Europe personnel.

Neogen Europe management is also responsible for Neogen’s other European operations, which include:

Quat-Chem, Ltd., a Rochdale, England-based chemical company that specializes in the development, manufacture and sale of agricultural, industrial, and food processing biocidal hygiene products, including cleaners and disinfectants.

Quat-Chem, Ltd.,

a Rochdale, England-based chemical company that specializes in the development, manufacture and sale of agricultural, industrial and food processing biocidal hygiene products, including cleaners and disinfectants.

Quat-Chem sells its products on a global basis, with a focus on markets in the U.K., Europe, Middle East, Africa and Asia.

Neogen Italia, a Milan, Italy-based business, which directly markets and sells Neogen’s products in Italy.

Megazyme, Ltd., a Bray, Ireland-based food quality diagnostics company, acquired in December 2020, which develops and refines the analytical methods used to measure the carbohydrates and enzymes in food and feed products that affect quality.

Neogen Italia

, a Milan, Italy-based business, which directly markets Neogen’s products in Italy.

Megazyme, Ltd

., a Bray, Ireland-based food quality diagnostics company, acquired in December 2020, which develops and refines the analytical methods used to measure the carbohydrates and enzymes in food and feed products that affect quality.

., a Liverpool, England-based manufacturer and supplier of animal hygiene and industrial cleaning products, acquired in November 2021.

Abbott Analytical, Ltd.

, a Liverpool, England-based service provider, acquired in November 2021.

Neogen Europe has two additional manufacturing locations in:

Heywood, England, which manufactures an extensive range of microbiological culture media, supplements and immunomagnetic separation techniques.

Liverpool, England, a developer and supplier of culture media supplements and microbiology technologies.

Liverpool, England, which manufacturers culture media supplements and microbiology technologies.

Neogen Latinoam

Neogen Latinoamérica is headquartered near Mexico City and distributes Neogen’s products throughout Mexico and Central America.

Neogen Latinoamérica manages our business activities throughout the region by marketing to animal and crop producers and food processors, utilizing our direct sales representatives to sell Food Safety products and genomics services, while marketing cleaners, disinfectants and other Animal Safety products primarily through distributors.

rica and Neogen Guatemala.

Neogen Latinoamérica is headquartered near Mexico City and Neogen Guatemala is located in Guatemala City.

Combined, the two businesses distribute Neogen’s products throughout Mexico and Central America.

Neogen Latinoamérica manages our business activities throughout the region by marketing to animal and crop producers and food processors, utilizing our direct sales representatives to sell food safety products and genomics services, while marketing cleaners, disinfectants, rodenticides and other animal safety products primarily through distributors.

Neogen Argentina, Neogen Uruguay and Neogen Chile.

In January 2020, Neogen acquired Productos Quimicos Magiar and Lakenord S.A.

(Magiar Uruguay), distributors of Neogen’s food safety diagnostics products for the past 20 years, with operations in Argentina and Uruguay, respectively.

In March 2020, Neogen acquired the assets of Chile-based Magiar Chilena, a distributor of food, animal, and plant diagnostics, including Neogen products.

With the acquisitions, the former Magiar operations remain in the three countries and provide Neogen with a physical presence in the important agricultural Southern Cone region of South America, which has large beef and dairy populations with significant export markets.

These three countries provide Neogen with a physical presence in the important agricultural Southern Cone region of South America, which has large beef and dairy populations with significant export markets.

The operations are managed through Neogen’s Latin American operations and offer direct sales of Neogen food safety, animal safety and genomics products into Argentina, Uruguay and Chile.

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Research and development costs were approximately $17.0 million, $16.2 million, and $14.8 million representing 3.2%, 3.5%, and 3.5% of total revenues in fiscal years 2022, 2021 and 2020, respectively.

Management currently expects our future research and development expenditures to approximate 3% of total revenues annually.

Management currently expects our future research and development expenditures to approximate 3% to 4% of total revenues annually.

Neogen has ongoing development projects for several new and improved diagnostic tests and other complementary products for both the Food Safety and Animal Safety markets.

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Natural Toxins, Allergens, & Drug Residues

Bacterial & General Sanitation

Life Sciences

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PRODUCTION AND SUPPLY

Neogen manufactures our products in Michigan, Kentucky, Wisconsin, North Carolina, Iowa, Tennessee, California, Ireland, the United Kingdom and Brazil and provides genomics services in Nebraska, Scotland, Brazil, Australia, China and Canada.

As of May 31, 2022, there were approximately 1,039 full-time employees assigned to manufacturing operations and providing of services in these locations, operating on multiple shift schedules;

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Generally, final assembly and shipment of diagnostic test kits to customers in Europe is performed in our Ayr, Scotland facility.

Most of the Company’s food safety diagnostic instruments and readers are produced by third-party vendors to our specifications, quality tested in Lansing, and then shipped to customers.

Most of the Company’s food safety

diagnostic instruments and readers are produced by third-party vendors to our specifications, quality tested in Lansing, and then shipped to customers.

Culture media products are manufactured in an ISO-approved

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Certain animal health products and veterinary instruments that are purchased finished or that are toll manufactured by third party vendors are warehoused and shipped from our Lexington facilities.

Other veterinary instruments are produced in our facilities in Lansing, and are generally then shipped to Lexington for distribution to customers.

Some veterinary instruments are produced in our facilities in Lansing, and are generally then shipped to Lexington for distribution to customers.

Manufacturing and shipment of devices used for animal injections, topical applications and oral administration occurs in Kenansville, North Carolina.

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Agricultural genomics services.

Neogen offers agricultural genomics laboratory services and bioinformatics at our locations in Nebraska, Scotland, Brazil, Australia, China and Canada.

Neogen offers agricultural genomics laboratory services and bioinformatics at our locations in Nebraska, Washington, Scotland, Brazil, Australia, China and Canada.

Through our laboratory services and bioinformatics (primarily in beef and dairy cattle, pigs, sheep, poultry, horses and dogs), Neogen Genomics allows our customers to speed genetic improvement efforts, as well as identify economically important diseases.

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Manufacturing of rodenticides and/or cleaners and disinfectants takes place in the following locations:

Randolph, Wisconsin;

Memphis, Tennessee;

Turlock, California;

Rochdale, England;

and Pindamonhangaba, Brazil.

Wisconsin, Tennessee, California, England and Brazil.

Manufacturing of rodenticides consists of blending technical material (active ingredient) with bait consisting principally of various grains.

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Insecticides.

Neogen manufactures insecticides and other pesticides at its facilities in Pleasantville, Iowa and Pindamonhangaba, Brazil.

Neogen manufactures insecticides and other pesticides at its facilities in Iowa and Brazil.

Neogen purchases component parts and raw materials from more than 1,000 suppliers.

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To the best of our knowledge, Neogen products are compliant with applicable regulations in the countries where such products are sold.

Dairy diagnostic products used in National Conference on Interstate Milk Shipments (NCIMS), a cooperative program involving FDA, state governments and the industry, must first be approved prior to commercialization.

Before products requiring NCIMS approval can be sold in the U.S., extensive product performance data must be submitted in accordance with FDA-approved

protocol administered by the AOAC Research Institute (AOAC RI).

Following approval of a product by NCIMS, the product must be reviewed by the FDA.

Our BetaStar Advanced U.S.

dairy antibiotic residue testing product has been reviewed and/or approved by the appropriate regulatory bodies.

Many of the food safety diagnostic products do not require direct government approval.

However, we have pursued AOAC approval for a number of these products to enhance their marketability.

Our BetaStar Advanced U.S.

dairy antibiotic residue testing product has been reviewed and/or approved by the appropriate regulatory bodies.

Neogen’s veterinary vaccine products and some pharmaceutical products require government approval to allow for lawful sales.

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The products, and the facilities in which they are manufactured, are in a position of good standing with both agencies.

We have no warning letters based on any review of these products or facility inspection, no recalls on any of these products, and are not aware of any reason why we could not manufacture and market such products in the future.

We have no warning letters based on any review of these products or facility inspections, no recalls on any of these products, and are not aware of any reason why we could not manufacture and market such products in the future.

Other animal safety and food safety products generally do not require additional registrations or approvals.

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We strive to create a workplace of choice to attract, retain and develop top talent to achieve our vision and deliver shareholder results.

As of May 31, 2021, we employed 1,841 full-time persons worldwide.

As of May 31, 2022, we employed 2,108 people worldwide, with 1,264 located in the U.S.

and 844 international.

None of these employees are covered by collective bargaining agreements.

We adhere to a philosophy that includes, among other things, commitments to create ongoing job opportunities, pay fair wages, and protect worker health and safety.

Fundamental to these commitments are Neogen’s Pillars of Trust, consisting of openness, honesty, credibility, respect and service.

Management considers its relations with employees to generally be positive.

The Company is committed to fostering a diverse and inclusive workplace that attracts and retains exceptional talent.

Through ongoing employee development, comprehensive compensation and benefits, and a focus on health, safety and employee wellbeing, the Company strives to help its employees in all aspects of their lives so they can do their best work.

Workplace Culture and Employee Engagement

We have established our One Neogen Pillars of Trust which are the principles that guide our decision making every day:

• Openness • Honesty • Credibility • Respect • Service.

We value responsibility, consistency and integrity.

Our Code of Conduct contains general guidelines for conducting business ethically.

Inclusion, Diversity, Equity and Belonging (IDEB)

We strive to create an environment where colleagues feel valued and cared for and understand the important role we play in embracing diversity to improve the quality of our innovation, collaboration and relationships.

We are dedicated to executing on our diversity, equity and inclusion initiatives.

Talent Recruitment, Development and Retention

We employ a variety of career development, employee benefits, policies and compensation programs designed to attract, develop and retain our colleagues.

Employee benefits and policies are designed for diverse needs.

We have internal programs designed to develop and retain talent, including career planning, leadership development programs, performance management and training programs.

Compensation and Benefits

We strive to support our colleagues’ well-being and enable them to achieve their best at work and at home.

Our compensation and benefits programs are designed to be competitive and support colleague well-being including physical and mental health, financial wellness, and family resources.

Employee Health and Safety

We are committed to ensuring a safe working environment for our colleagues.

Our sites have injury prevention programs, and we strive to build on our safety culture.

Our procedures emphasize the need for the cause of injuries to be investigated and for action plans to be implemented to mitigate potential recurrence.

Our safety programs have resulted in strong safety performance.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business