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Item 1. Business

2023-08-15 compared with 2022-07-27 · 229 added, 356 removed, 167 unchanged (78% of the section changed)

Neogen Corporation and subsidiaries develop, manufacture and market a diverse line of products and services dedicated to food and animal safety.

Our Food Safety segment consists primarily of diagnostic test kits and complementary products (e.g., culture media) sold to food producers and processors to detect dangerous and/or unintended substances in human food and animal feed, such as foodborne pathogens, spoilage organisms, natural toxins, food allergens, genetic modifications, ruminant by-products,

meat speciation, drug residues, pesticide residues and general sanitation concerns.

Neogen Corporation and its subsidiaries develop, manufacture, and market a diverse line of products and services dedicated to food and animal safety.

Our diagnostic test kits are generally easier to use and provide greater accuracy and speed than conventional diagnostic methods.

The majority of the test kits are disposable, single-use,

immunoassay and DNA detection products that rely on proprietary antibodies and RNA and DNA testing methodologies to produce rapid and accurate test results.

The majority of these test kits are disposable, single-use, immunoassay and DNA detection products that rely on proprietary antibodies and RNA and DNA testing methodologies to produce rapid and accurate test results.

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.

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.

On September 1, 2022, Neogen, 3M Company (“3M”) and Neogen Food Safety Corporation (“Neogen Food Safety Corporation”), a subsidiary created to carve out 3M’s Food Safety Division (“3M FSD”, “FSD”), closed on a transaction combining 3M’s FSD with Neogen in a Reverse Morris Trust transaction and Neogen Food Safety Corporation became a wholly owned subsidiary of Neogen (“FSD transaction”, the "Transaction").

Following the FSD transaction, pre-merger Neogen Food Safety Corporation stockholders own, in the aggregate, approximately 50.1% of the issued and outstanding shares of Neogen common stock, and pre-merger Neogen shareholders own, in the aggregate, approximately 49.9% of the issued and outstanding shares of Neogen common stock.

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.

FSD products are reported in the Food Safety segment.

Neogen’s Animal Safety segment is engaged in the development, manufacture, marketing, and distribution of veterinary instruments, pharmaceuticals, vaccines, topicals, parasiticides, diagnostic products, rodent control products, cleaners, disinfectants, insect control products 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.

Our line of drug detection products is sold worldwide for the detection of abused and therapeutic drugs in animals and animal products, and has expanded into the workplace and human forensic markets.

Neogen’s products are marketed by our sales personnel in the U.S., Canada, Mexico, Central America, Brazil, Argentina, Uruguay, Chile, the United Kingdom, the European Union, China, India and Australia, and by distributors throughout the rest of the world.

Neogen’s products are marketed by our sales personnel and distributors throughout the world.

Our mission is to be the leading company in the development and marketing of solutions for food and animal safety.

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and (iv) acquiring businesses and forming strategic alliances.

We have historically been successful at increasing product sales organically, including international growth, and maintain an active acquisition program to identify and capitalize on opportunities to acquire new products, businesses, or technology.

We have been historically successful at increasing product sales organically, including international growth, and maintain an active acquisition program to identify and capitalize on opportunities to acquire new products, businesses or technology.

Neogen Corporation was formed as a Michigan corporation in June 1981 and operations began in 1982.

Our principal executive offices are located at 620 Lesher Place, Lansing, Michigan 48912-1595, and our telephone number is (517) 372-9200.

Neogen’s 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 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.

Neogen’s 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 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.

The content of our website or the website of any third party that may be noted herein is not incorporated by reference in this Form 10-K.

Product trademarks and registered trademarks owned by Neogen include:

, Neogen flask (logo) ®

, Neogen and flask (logo) ®

, NeoCenter ™

, AccuPoint ®

, Agri-Screen ®

, GeneQuence ®

, GENE-TRAK ®

, Harlequin ®

, Megazyme (design) ®

, NeoColumn ™

Food Safety Solutions SM

Neogen®, Neogen flask (logo)®, Neogen and flask (logo)®, NeoCenter

AccuClean®, AccuPoint®, AccuScan®, Acumedia®, Agri-Screen®, Alert®, ANSR® , Betastar®, BioLumix®, Ceralpha®, Clean-Trace®, Colitag, F.A.S.T.®, Freeze Watch®, GeneQuence®, Harlequin®, Iso-Grid®, Lab M®, Listeria Right Now, Megazyme®, Megazyme (design) ®, MonitorMark®, MPNTray, NeoColumn, NeoNet®, NeoSeek, NEO-GRID®, Penzyme®, Petrifilm®, Raptor®, Reveal®, Soleris®, µPREP®, Veratox®

LIFE SCIENCES:

Alert®, K-Blue®, K-Gold®, NeoSal®

ANIMAL SAFETY:

, AluShield ™

, AquaPrime ®

, Barnstorm ®

50, BioPhene ™

, Breeder-Sleeve ®

, Chem-Tech, Ltd.

, Chem-Tech’s CT logo (with circle) ™

, Chlor-A-Foam

, COMPANION ™

Needles, DC&R ®

, Dyne-O-Might

, ElectroJac ®

, ELISA Technologies (design) ®

, EquiSleeve ®

, Farm-Foam ™

, Farmphene ®

, Final-Fly-T

, Fura-Zone ®

, Horse Sense ®

, ImmunoRegulin ®

, Maxi Sleeve ®

Viroxide Super ™

Viroxide Super and flask (design) ®

, Paradefense ®

, ParlorMint ™

, Place Pack ®

, PolyPetite ™

, PolyShield ™

, PolySleeve ®

, Preserve International ®

, Preserve International(design) ®

, Prima Marc ™

, Prima Tech ®

, Protectus ™

, Provecta Advanced ®

, Prozap (stylized mark w/fancy Z) ™

, Safe-T-Flex

, Siloxycide ®

, Spectrasol ™

, Standguard ®

, Starlicide ®

, Swine-O-Dyne

, Synergize ®

, Tetrabase ®

, Tetradyne ®

, ThyroKare ™

, Paradefense ®

, Turbocide ®

, Turbocide Gold ®

, War Paint ®

, Genomic Profiler ™

, Genomic Insight for Personalized Care ™

, Infiniseek ™

, Early Warning ™

BioSentry barn logo ®

, BioSentry chicken logo ®

, BioSentry pig logo ®

, Circular design ®

, TurboCide ®

(stylized), D3 color mark – red ®

Acid-A-Foam, Ag-Tek®, AluShield, AquaPrime®, Assault®, Barnstorm®, BioCres 50, BioPhene, BioQuat, BotVax®, Breeder-Sleeve®, Calf Eze, Chem-Tech, Ltd., Chem-Tech’s CT logo (with circle), Chlor-A-Foam, COMPANION, CT-511®, Cykill, D3 Needles, D3X, DC&R®, DeciMax®, Di-Kill®, Dr.

Frank’s®, Dy-Fly®, DX3, Dyne-O-Might®, ElectroJac®, ELISA Technologies (design)®, EqStim®, EquiSleeve, E-Z Catch®, Farm-Foam, Final-Fly-T®, Fly-Die Defense, Fly-Die Ultra, Fura-Zone®, Gene-Trak®, Horse Sense®, Ideal®, ImmunoRegulin®, Iodis®, Jolt®, LD-44T, LD-44Z, MACLEOD®, Maxi Sleeve®, MegaShot, Viroxide Super, Neogen® Viroxide Super and flask (design)®, NFZ, Nu Dyne®, PanaKare, Paradefense®, Parvosol®, Peraside, Place Pack®, PolyPetite, PolyShield, PolySleeve®, Preserve®, Preserve International®, Preserve International(design)®, Prima®, Prima Marc, Prima-Shot, Prima Tech®, Pro-Fix®, Pro-Flex®,Pro-Shot, Protectus, Provecta®, Provecta Advanced®, Prozap®, Prozap (stylized mark w/fancy Z), PY-75, Ramik®, RenaKare, Rodex, Safe-T-Flex, Siloxycide®, Squire®, Standguard®, Stress-Dex®, SureBond®, SureKill®, Swine-O-Dyne®, Synergize®, Tetrabase®, Tetracid®, Tetradyne®, ThyroKare,Tri-Hist®, Triplox, Paradefense®, Turbocide®, Turbocide Gold®, Uniprim®, VAP-5, VAP-20, Vet-Tie, Vita-15, War Paint®, X-185

Aviandx and Design®, Canine HealthCheck®, Canine HealthCheck and Design®, CatScan and Design®, EarlyBird Sex Identification®, Envigor, GeneSeek®, Genomic Profiler, Genomic Insight for Personalized Care, Igenity®, Infiniseek, Paw Print Genetics®, Paw Print Pedigrees®, SeekGain, SeekSire, Skimseek®, Early Warning

BioSentry barn logo®, BioSentry chicken logo®, BioSentry pig logo®, Circular design®, TurboCide® (stylized), D3 color mark –

Neogen operates in two business areas:

the Food Safety and the Animal Safety segments.

See the “Notes to Consolidated Financial Statements” section of this Form 10-K

for financial information about our business segments and international operations.

the Food Safety and Animal Safety segments.

See the “Notes to Consolidated Financial Statements”

section of this Form 10-K for financial information about our business segments and international operations.

Food Safety Segment

Neogen’s Food Safety segment is primarily engaged in the production and marketing 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, spoilage organisms, natural toxins, food allergens, genetic modifications, ruminant by-products,

meat speciation, drug residues, pesticide residues and general sanitation concerns.

Neogen’s Food Safety segment primarily is engaged in the production and marketing 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, spoilage organisms, natural toxins, food allergens, genetic modifications and general sanitation concerns.

Our test kits are used to detect potential hazards or unintended substances 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.

Neogen’s products include tests for:

Grain producers and processors of all types and sizes use our Veratox, Agri-Screen, Reveal, Reveal Q+ and Reveal Q+ MAX tests to detect the presence of mycotoxins, including aflatoxin, aflatoxin M1, deoxynivalenol, fumonisin, ochratoxin, zearalenone, T-2/HT-2

toxin and ergot alkaloid, to help ensure product safety and quality in food and animal feed.

Along with detection of contaminants in foods, we also detect beneficial components in foods such as dietary fiber and carbohydrates.

Neogen’s products include tests for:

Food allergens.

The world’s largest producers of cookies, crackers, candy, ice cream and many other processed foods use our Veratox, Alert, Reveal, Reveal 3-D

and BioKits testing products to help protect their food-allergic customers from the inadvertent contamination of products with food allergens, including but not limited to peanut, milk, egg, almond, gliadin (gluten), soy, hazelnut and coconut residues.

Dairy antibiotics.

Dairy processors are the primary users of Neogen’s BetaStar diagnostic tests to detect the presence of veterinary antibiotics in milk.

The presence of these drugs above a certain level in milk is a public health hazard and an economic risk to producers as it limits the milk’s further processing.

The world’s largest producers of cookies, crackers, candy, ice cream and many other betaprocessed foods use our Veratox, Alert, Reveal, Reveal 3-D and BioKits testing products to help protect their food-allergic customers from the inadvertent contamination of products with food allergens, including but not limited to peanut, milk, egg, almond, gliadin (gluten), soy, hazelnut and coconut residues.

Also included in our food allergen testing portfolio are Allergen Protein Rapid Kits and Allergen Protein ELISA Kits, acquired as part of the FSD transaction in September of 2022.

Foodborne pathogens.

Meat and poultry processors, seafood processors, fruit and vegetable producers and many other market segments are the primary users of Neogen’s ANSR and Reveal tests for foodborne bacteria, including E.

O157:H7, Salmonella

and Campylobacter

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

results in a fraction of the time of other molecular detection methods.

Right Now test detects the pathogen in less than 60 minutes without sample enrichment.

Reveal’s lateral flow device combines an immunoassay with chromatography for a rapid and accurate one-step

coli O157:H7, Salmonella , Listeria and Campylobacter .

Combined with ANSR’s single enrichment step, Neogen’s pathogen detection method provides DNA-definitive results in a fraction of the time of other molecular detection methods.

The Molecular Detection System, an isothermal DNA detection and bioluminescence device, and unique Molecular Detection Assays provide a total solution for fast and accurate pathogen detection, acquired as part of the FSD transaction in September 2022.

Our Listeria Right Now test detects the pathogen in less than 60 minutes without sample enrichment.

Reveal’s lateral flow device combines an immunoassay with chromatography for a rapid and accurate one-step result.

Spoilage microorganisms.

Neogen’s Soleris products are used by food processors to identify the presence of spoilage organisms (e.g., yeast and mold) and other microbiological contamination in food.

The systems measure microbial growth by monitoring biochemical reactions that generate a color change in the media as microorganisms grow.

The sensitivity of the system allows detection in a fraction of the time needed for traditional methods, with less labor and handling time.

In July 2020, we launched Soleris NG, a next generation version of the platform, which features enhanced hardware and software for results that are easier to analyze and audit.

Our NeoSeek genomics services utilize a novel application of metagenomics to determine all bacteria in a sample, without introducing biases from culture media, and without the need to generate a bacterial isolate for each possible microbe in a sample.

The Microbial Luminescence System (MLS II), acquired in the September 2022 FSD transaction, is designed for the rapid detection of microbial contamination in dairy and dairy-related products, utilizing adenosine triphosphate ("ATP") bioluminescence technology.

Sanitation monitoring.

Neogen manufactures and markets our AccuPoint Advanced rapid sanitation test to detect the presence of adenosine triphosphate (ATP), a chemical found in all living cells.

This easy-to-use

and inexpensive test uses bioluminescence to quickly determine if a contact surface has been completely sanitized.

Neogen manufactures and markets our AccuPoint Advanced rapid sanitation test to detect the presence of ATP, a chemical found in all living cells.

Also included in our ATP sanitation monitoring portfolio is the Clean-Trace hygiene monitoring system, acquired as part of the FSD transaction in September 2022.

These easy-to-use and inexpensive tests use bioluminescence to quickly determine if a contact surface has been completely sanitized.

When ATP comes into contact with reagents contained in the test device, a reaction takes place that produces light.

More light is indicative of higher levels of ATP and a need for more thorough sanitation.

In May 2021, we launched AccuPoint Advanced NG, a next generation version, designed to be simpler to use, and provide results that are easier to analyze.

Our worldwide customer base for ATP sanitation testing products includes food and beverage processors, the food service and healthcare industries, as well as many other users.

Seafood contaminants.

Neogen’s specialty products for the seafood market include tests for histamine, a highly allergenic substance that occurs when certain species of fish begin to decay;

sulfite, an effective but potentially allergenic shrimp preservative;

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 specialty products for the seafood market include tests for histamine, a highly allergenic substance that occurs when certain species of fish begin to decay;

and sulfite, an effective but potentially allergenic shrimp preservative.

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 an easy-to-use

Colitag product.

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.

With Colitag, after an incubation period, the sample changes color in the presence of coliforms and fluoresces in the presence of E.

Culture media.

Neogen Culture Media, formerly Neogen’s Acumedia and Lab M products, offers culture media and prepared media for varied purposes, including traditional bacterial testing and the growth of beneficial bacteria, such as cultures for sausages and beer.

Also included under Neogen Culture Media is the Petrifilm solution, acquired as part of the FSD transaction in September 2022.

Petrifilm standard and rapid plates are all-in-one plating systems that serve as an efficient method for the detection and enumeration of various microorganisms.

Our customers for culture media also include commercial and research laboratories and producers of pharmaceuticals, cosmetics and veterinary vaccines.

Food quality diagnostics.

Through the December 2020 acquisition of Ireland-based Megazyme, Ltd., Neogen supplies diagnostic kits and specialty enzymes used worldwide by quality control laboratories in the food, animal feed and beverage industries.

Megazyme’s validated assays and reagents are used across various food industries such as the grain, wine and dairy markets, to measure dietary fibers, complex carbohydrates, simple sugars and organic acids, such as lactose.

Through the Ireland-based Megazyme, Ltd., Neogen supplies diagnostic kits and specialty enzymes used worldwide by quality control laboratories in the food, animal feed and beverage industries.

Sample handling.

Neogen offers a range of sample handling products, acquired through the September 2022 FSD transaction.

These innovative solutions are designed to make environmental and carcass sample collection and preparation more reliable and convenient than traditional methods.

These products are manufactured to meet the highest quality standards and government regulations, maximizing accuracy, consistency and efficiency, while remaining cost efficient.

Digital services.

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.

Neogen Analytics builds upon innovative technologies like our AccuPoint Advanced Next Generation and ANSR systems, offering floor plan mapping, smart test scheduling, easily filtered and auditable data management, and corrective actions.

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 the visibility of food safety testing results, elevating the ability to comply with and improve food safety standards.

With the Corvium acquisition in February 2023, Neogen's capabilities expanded with additional services and modules to include data aggregation and digitalized workflow services for product testing and sanitation programs.

Laboratory services.

Neogen offers food safety analysis services in the U.S., United Kingdom (U.K.) and India.

These ISO-accredited

laboratories offer a variety of fee-for-service

tests for the food and feed industries.

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

Neogen offers food safety analysis services in the United States ("U.S."), United Kingdom ("U.K.") and India.

These ISO-accredited laboratories offer a variety of fee-for-service tests for the food and feed industries.

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

Our ability to produce high-quality antibodies sets our products apart from immunoassay test kits produced and sold by other companies.

Our kits are available in microwell formats, which allow for automated and rapid processing of a large number of samples, and lateral flow and other similar devices that provide distinct visual results.

Our kits are available in microwell formats, which allow for automated and rapid processing of a large number of samples, as well as lateral flow and other similar devices that provide distinct visual results.

Typically, test kits use antibody-coated test devices and chemical reagents to indicate a positive or negative result for the presence of a target substance in a test sample.

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Generally, royalty rates are in the range of 2% to 10% of revenues on products containing the licensed technology.

Some licenses involve technology that is exclusive to Neogen’s use, while others are non-exclusive

and involve technology licensed to multiple licensees.

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.

Some licenses involve technology that is exclusive to Neogen’s use, while others are non-exclusive and involve technology licensed to multiple licensees.

Neogen’s international operations in the U.K., Europe, 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, rodent control, insect control, veterinary instruments and genomics services.

These additional products and services are managed and directed by existing management at our international operations and report through the Food Safety segment.

Revenues from Neogen’s Food Safety segment accounted for 49.3%, 50.0%, and 50.9% of our total revenues for fiscal years ended May 31, 2022, 2021 and 2020, respectively.

Revenues from Neogen’s Food Safety segment accounted for 66.5%, 49.3%, and 50.0% of our total revenues for fiscal years ended May 31, 2023, 2022 and 2021, respectively.

ANIMAL SAFETY SEGMENT

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.

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 rodent control, cleaners, disinfectants and insect control, and genomics services.

Veterinary instruments.

Neogen markets a broad line of veterinary instruments and animal health delivery systems under the Ideal brand name.

Neogen markets a broad line of veterinary instruments and animal health delivery systems primarily under the Ideal brand name.

Approximately 250 different products are offered, many of which are used to deliver animal health products, such as antibiotics and vaccines.

Ideal’s D3 Needles are stronger than conventional veterinary needles and are uniquely detectable by metal detectors at meat processing facilities — a potential market advantage in the safety-conscious beef and swine industries.

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.

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

Ideal’s D3 and D3X Needles are stronger than conventional veterinary needles and are detectable by metal detectors at meat processing facilities —

a potential market advantage in the safety-conscious beef and swine industries.

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

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

Veterinary pharmaceuticals.

Animal Safety’s NeogenVet product line provides innovative, value-added, high quality products to the veterinary market.

Top NeogenVet 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;

Natural Vitamin E-AD, which aids in the prevention and treatment of vitamin deficiencies in swine, cattle and sheep;

RenaKare, a supplement for potassium deficiency in cats and dogs;

and ThryroKare, a supplement used as replacement therapy for dogs with diminished thyroid function.

Other products sold under the NeogenVet brand include Vita-15

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

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

and ThyroKare, a supplement used as replacement therapy for dogs with diminished thyroid function.

Neogen also markets Uniprim, a veterinary antibiotic, and several companion animal parasiticides.

Veterinary biologics.

Neogen’s BotVax B vaccine has successfully protected thousands of horses and foals against Type B botulism, commonly known as Shaker Foal Syndrome.

Our 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 Neogen’s EqStim immunostimulant to be safe and effective as a veterinarian-administered adjunct to conventional treatment of equine bacterial and viral respiratory infections.

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.

Animal Safety products offered by Neogen to the retail over-the-counter

(OTC) market include Ideal brand veterinary instruments packaged for the retail market.

OTC products also include Stress-Dex,

an oral electrolyte replacer for performance horses, and Fura-Zone, for the prevention and treatment of surface bacterial infections in wounds, burns and cutaneous ulcers.

Animal Safety products offered by Neogen to the retail over-the-counter (OTC) market include Ideal brand veterinary instruments packaged for the retail market.

OTC products also include Stress-Dex, an oral electrolyte replacer for performance horses, and Fura-Zone, for the prevention and treatment of surface bacterial infections in wounds, burns and cutaneous ulcers.

Hoof care, disposables and artificial insemination supplies are marketed to the dairy and veterinary industries.

Rodenticides.

Neogen’s comprehensive line of proven rodenticides, sold under brand names such as Ramik and Havoc, effectively address rodent problems of any size and serve as a critical component of an overall biosecurity plan for animal protein production operations.

Neogen offers several rodenticide active ingredients including diphacinone, bromethalin, brodifacoum and zinc phosphide, formulated with food grade ingredients to generate the highest acceptance and most palatable bait possible.

Rodent control products.

Neogen’s comprehensive line of proven rodent control products, sold under brand names such as Ramik, CyKill and Havoc, effectively address rodent problems of any size and serve as a critical component of an overall biosecurity plan for animal protein production operations.

Neogen offers several active ingredients, including diphacinone, bromethalin, brodifacoum and zinc phosphide, formulated with food-grade ingredients to generate the highest acceptance and most palatable bait possible.

Cleaners and disinfectants.

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, prevent disease outbreaks.

Used in animal and food production facilities, Neogen’s cleaners and disinfectants, including Synergize, 904 Disinfectant, Acid-A-Foam, BioPhene, Neogen Viroxide Super, and Companion, can 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.

Neogen’s water line cleaner and disinfectant products, including Peraside, NeoKlor, AquaPrime and Siloxycide, are used to clean water lines and provide continuous disinfection of a livestock facility’s water supply.

Insecticides.

Neogen’s highly effective insecticides utilize environmentally friendly technical formulas, and several are approved for use in food establishments and by pest control professionals in a wide range of environments.

The Company’s Prozap insecticide brand is used in the large animal production industry, particularly with dairy and equine producers.

Neogen’s SureKill line of products is used by professionals to control a variety of insects and the Company’s StandGuard Pour-on

solution, acquired in July 2020, is used for horn fly and lice control in beef cattle.

Insect control products.

Neogen’s highly effective insect control products utilize environmentally friendly technical formulas, and several are approved for use in food establishments and by pest control professionals in a wide range of environments.

The Company’s Prozap insect control brand is used in the large animal production industry, particularly with dairy and equine producers.

Neogen’s SureKill line of products is used by professionals to control a variety of insects, and the Company’s StandGuard Pour-on solution is used for horn fly and lice control in beef cattle.

Animal genomics services.

Neogen Genomics, formerly known as GeneSeek, provides value-added services to leading agricultural genetics providers, large national cattle associations, companion animal breed registries and direct to consumer canine genetic test providers, university researchers, and numerous commercial beef and dairy cattle, swine, sheep and poultry producers.

With state-of-the-art

genomics laboratories and the comprehensive bioinformatics to interpret genomics test results, Neogen Genomics offers identity and trait determination and analysis.

Neogen Genomics provides value-added services to leading agricultural genetics providers, large national cattle associations, companion animal breed registries and direct-to-consumer canine genetic test providers, university researchers, and numerous commercial beef and dairy cattle, swine, sheep and poultry producers.

With state-of-the-art genomics laboratories and comprehensive bioinformatics to interpret genomics test results, Neogen Genomics offers identity and trait determination and analysis.

Our technology employs high-density DNA genotyping and genomic sequencing for identity and trait analysis in a variety of important animal and agricultural plant species.

Our extensive bioinformatics database identifies and predicts an animal’s positive or negative traits based on DNA test results.

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.

Our extensive bioinformatics database identifies and predicts an animal’s positive or negative traits based on DNA test results.

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

Neogen’s line of approximately 100 drug detection immunoassay test kits is sold worldwide for the detection of approximately 300 abused and therapeutic drugs in farm animals and racing animals, and for the detection of 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.

Neogen’s Life Science/Toxicology line of products include reagents and test kits for immunoassay production, life science research, and forensic and animal toxicology.

Product offering includes a wide range of tests to provide solutions for drugs of abuse, including designer drugs and emerging drugs.

The drug detection assays include over 100 test kits used to screen more than 300 drugs and their metabolites in various forensic matrices, including oral fluid, whole blood, urine, serum, plasma, meconium, and others.

Our portfolio for life science research includes assays for detecting levels of hormones, steroids, lipoxins, and histamine in a wide range of samples and species types.

Additionally, we offer reagents and unique colorimetric and chemiluminescent substrates for immunoassay production and research applications.

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

In fiscal 2023, the Animal Safety segment incurred expense totaling $274 for royalties for licensed technology used in our products and services, including expense of $152 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.

With the acquisition of Cell BioSciences in February 2020, our Australian operation has expanded to offer our complete line of products and services, including those usually associated with the Food Safety segment.

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

It has expanded to offer our complete line of products and services, including those usually associated with the Food Safety segment.

These additional products are managed and directed by existing management at Neogen Australasia and report through the Animal Safety segment.

Revenues from Neogen’s Animal Safety segment accounted for 50.7%, 50.0%, and 49.1% of our total revenues for fiscal years ended May 31, 2022, 2021 and 2020, respectively.

Revenues from Neogen’s Animal Safety segment accounted for 33.5%, 50.7%, and 50.0% of our total revenues for fiscal years ended May 31, 2023, 2022 and 2021, respectively.

GENERAL SALES AND MARKETING

Neogen is organized under two segments — Food Safety and Animal Safety.

Neogen is organized under two segments —

Food Safety and Animal Safety.

Within these segments, our sales efforts are generally organized by specific markets, and/or geography.

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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:

Milling and grain

, 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 USDA’s Food Safety Inspection Service (FSIS);

Prepared foods and ingredients

, 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;

, including harvesters and processors of a wide variety of seafood products;

, including milk and yogurt processors;

, including soft drink bottlers and beer and wine producers;

including food producers, water bottlers and municipal water departments;

, including hospitals and distributors to the healthcare industry;

Traditional culture media markets

, including commercial and research laboratories and producers of pharmaceuticals, cosmetics and veterinary vaccines;

, including fast food service establishments and retail grocery market chains;

Dietary supplements

, including producers and marketers of a wide variety of nutritional and holistic consumer products.

Neogen’s food safety markets are primarily comprised of:

Milling and grain , 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 USDA’s Food Safety Inspection Service (FSIS);

Prepared foods and ingredients , 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 , including milk and yogurt processors;

Beverage , including soft drink bottlers and beer and wine producers;

Water, including food producers, water bottlers and municipal water departments;

Healthcare , including hospitals and distributors to the healthcare industry;

Traditional culture media markets , including commercial and research laboratories and producers of pharmaceuticals, cosmetics and veterinary vaccines;

Food service , including fast food service establishments and retail grocery market chains;

Dietary supplements , including producers and marketers of a wide variety of nutritional and holistic consumer products.

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 technical support issues.

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

Neogen’s animal safety markets are primarily comprised of:

Companion animal veterinarians ;

Neogen has a dedicated sales group that sells and technically supports the Company’s animal care, biosecurity and disposable products to the companion animal veterinary market.

Livestock producers, veterinarians and breed associations ;

Neogen has a dedicated group of sales professionals that sells the Company’s comprehensive suite of biosecurity and husbandry products and genomics services directly to livestock producers, and livestock veterinarians and veterinary clinics.

Retailers , including large farm and ranch retailers;

Breeding and genetics companies , including large dairy artificial insemination providers, poultry and swine genetics companies and the aquaculture industry;

Diagnostic labs and universities , including commercial and forensic testing laboratories;

Distributors.

To expand the reach of its animal safety OTC and veterinary products, Neogen has a dedicated sales team that sells the Company’s products to animal health product distributors.

Neogen offers select animal care and biosecurity products directly to large farm and ranch retailers for sale to consumers.

Breeding and genetics companies.

Neogen has sales professionals who sell directly to the large dairy artificial insemination providers, poultry and swine genetics companies and the aquaculture industry.

Diagnostic labs and universities.

Neogen has a dedicated lab, manufacturing, sales and technical service group that calls on large commercial and forensic testing laboratories and universities.

To expand the reach of its animal safety OTC and veterinary products, Neogen has a dedicated sales team that sells the Company’s products to animal health product distributors;

Other manufacturers and government agencies.

Neogen has an experienced group of professionals who work directly with other manufacturers and government agencies to provide custom solution products and services for their needs.

INTERNATIONAL SALES AND MARKETING

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.

Neogen Europe and subsidiaries.

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, 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 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 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, which manufacturers culture media supplements and microbiology technologies.

Neogen Latinoam

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.

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.

Neogen do Brasil.

Neogen do Brasil, headquartered near São Paulo, distributes Neogen’s products throughout Brazil.

Brazil is a world leader in the export of numerous food commodities, including beef, poultry, soybeans, coffee, corn, sugar and orange juice, and this operation gives us direct sales representation to these important markets.

Neogen do Brasil management is also responsible for manufacturing, marketing and sales for Rogama, located in Pindamonhangaba, Brazil.

This company operates a genomics testing laboratory (formerly named Deoxi) and develops, manufactures and markets rodenticides and insecticides.

Rogama offers more than 70 registered pest control products to Brazil’s agronomic, professional and retail markets.

Neogen China.

Our Chinese subsidiary, located in Shanghai, employs sales representatives who sell directly to Chinese customers.

China’s burgeoning middle class, with its rapidly growing demand for higher quality meat and dairy products, makes the country a growth opportunity for Neogen’s products and services — both for animal production on the country’s farms, and in processing plants throughout China’s food production and distribution channels.

The business also operates a genomics testing laboratory.

We utilize both direct sales representatives and distributors to sell our complete portfolio in this growing market.

Neogen India.

This business operates an accredited laboratory which performs food safety and water quality testing for food producers, major hotels and restaurants in its home region, as well as safety and quality analysis for the country’s expanding nutraceutical market, and growing food export businesses.

The laboratory is located in Kochi, in the state of Kerala, which is India’s leading region for the export of spices, tea, and fresh fruits and vegetables.

Neogen India is also responsible for sales of our food safety and animal safety products to customers and distributors in India and nearby countries.

Neogen Australasia.

Neogen Australasia operates a genomics testing laboratory, focusing on the sheep and cattle markets in Australia and New Zealand, and also directly markets and sells our food and animal safety products in those countries.

Neogen maintains Company-owned locations outside of the United States in 23 countries to provide a direct sales presence.

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

UK, Europe, Middle East, Africa and India.

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

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

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

Neogen Europe management also is responsible for various other manufacturing operations and service providers, including Quat-Chem, Ltd., Neogen Italia, Megazyme, Ltd., Delf, Ltd., and Abbott Analytical, Ltd.

Neogen Europe has two additional manufacturing locations in Heywood and Liverpool, England, which manufacture culture media supplements and microbiology technologies.

Neogen also operates an accredited laboratory in India, located in Kochi, in the state of Kerala, that performs food safety and water quality testing for food producers, major hotels and restaurants in its home region, as well as safety and quality analysis for the country’s expanding nutraceutical market, and growing food export businesses.

Mexico, Central and South America.

Neogen maintains offices and distribution facilities in Mexico, Guatemala, Brazil, Argentina, Chile, Uruguay and Colombia.

Combined, the businesses distribute Neogen’s products and offer genomics services throughout Mexico, Central and South America to distributors and end customers.

Neogen do Brasil, headquartered near São Paulo, is also responsible for manufacturing, marketing and sales for Rogama, located in Pindamonhangaba, Brazil.

This company operates a genomics testing laboratory (formerly named Deoxi) and develops, manufactures and markets rodent control and insect control products.

Rogama offers registered pest control products to Brazil’s agronomic, professional and retail markets.

Asia Pacific.

Neogen maintains offices in Japan, Korea, Thailand, China, Australia and New Zealand.

Combined, the businesses distribute Neogen’s products throughout the Asia Pacific region to distributors and end customers.

Our Chinese subsidiary, located in Shanghai, also operates a genomics testing laboratory, focusing on swine, dairy and beef cattle markets.

Neogen’s Australasia subsidiary also operates a genomics testing laboratory, focusing on sheep and cattle markets in Australia and New Zealand.

Neogen Canada.

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RESEARCH AND DEVELOPMENT

Management maintains a strong commitment to Neogen’s research and development activities.

Our product development efforts are focused on the enhancement of existing products and on the development of new products that fit our business strategy.

Neogen has a strong commitment to its research and development activities.

Our product development efforts are focused on the enhancement of existing products and on the development of new products that advance our business strategy.

As of May 31, 2023, we employed 136 scientists and support staff in our worldwide research and development group, including immunologists, chemists and microbiologists.

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.

Research and development costs were approximately $26,039, $17,049, and $16,247 representing 3.2%, 3.2%, and 3.5% of total revenues in fiscal years 2023, 2022 and 2021, respectively.

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

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Management expects that a number of these products will be commercially available at various times during fiscal years 2024 and 2025.

Certain technologies used in some products manufactured and marketed by Neogen were acquired from or developed in collaboration with affiliated partners, independent scientists, governmental agencies, universities and other third parties.

We have entered into agreements with these parties that provide for the payment of royalties based upon sales of products that use the pertinent licensed technology.

Certain technologies used in some products manufactured and marketed by Neogen were acquired from or developed in collaboration with partners, independent scientists, governmental agencies, universities and other third parties.

We have entered into agreements with these parties that provide for the payment of royalties based on sales of products that use the pertinent licensed technology.

Royalties, expensed to sales and marketing, under these agreements amounted to $3,392, $1,999, and $2,129 in fiscal years 2023, 2022, and 2021, respectively.

PROPRIETARY PROTECTION AND APPROVALS

Neogen uses trade secrets as proprietary protection in many of its food and animal safety products.

In many cases, we have 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 filing 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.

Patent and trademark applications are submitted whenever appropriate.

Since its inception, Neogen has acquired and been granted numerous patents and trademarks and has numerous pending patents and trademark applications.

The patents expire at various times over the next 20 years.

A summary of patents by product categories follows:

International

Natural Toxins, Allergens, & Drug Residues

Life Sciences

Veterinary Instruments & Other

Genomics Services

Neogen uses a variety of intellectual property approaches to protect the competitive position of its offerings, including the use of patents, trademarks, trade secrets, proprietary and confidential know-how, as well as branding and trademarks.

Patent and trademark registration applications are submitted whenever appropriate.

From its inception, Neogen has acquired and been granted numerous patents and trademark registrations and has numerous pending patents and trademark applications.

Neogen’s patent portfolio includes at least 48 U.S.

patents, 404 patents in countries outside of the U.S., and 209 pending patent applications globally.

Neogen’s trademark estate includes 119 trademark registrations within the U.S., and 548 trademark registrations in countries outside of the U.S, and 24 trademark registration applications globally.

We do not expect the near-term expiration of any single patent to have a significant effect on future results of operations.

Our offerings also are protected by trade secrets and proprietary know-how when appropriate.

For example, many of our products employ unique antibodies capable of detecting microorganisms and other substances at minute levels.

In some instances, we have chosen to keep confidential the methods and techniques used to manufacture and use those antibodies when trade secret and/or proprietary know-how protections are more appropriate.

Management believes that Neogen has adequate rights to commercialize our products.

However, we are aware that substantial research is conducted at universities, governmental agencies and other companies throughout the world and that it is always possible that patents have been applied for and could be granted that are relevant to technologies that may be used in our products.

To the extent some of our products may now, or in the future, embody technologies protected by patents or trade secrets of others, we may need to obtain licenses to use such technologies to continue to sell the products.

However, we are aware that substantial research is conducted at universities, governmental agencies and other companies throughout the world, and that it always is possible that patents have been applied for and could be granted that are relevant to technologies that may be used in our products.

To the extent some of our products may now, or in the future, embody technologies protected by patents of others, we may need to obtain licenses to use such technologies to continue to sell the products.

These licenses may not be available on commercially reasonable terms.

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Accordingly, there can be no assurance that we will continue to have adequate rights to commercialize our new products or that we will avoid litigation.

One of the major areas affecting the success of biotechnology development involves the time, cost and uncertainty surrounding regulatory approvals.

Neogen products requiring regulatory approval, which we currently have in place, include BotVax B, EqStim, ImmunoRegulin, Uniprim and BetaStar.

Our general strategy is to focus on technical and proprietary products that do not require mandatory approval by regulatory bodies to be marketed.

Neogen’s rodenticide, disinfectant and insecticide products are subject to registration in the United States and internationally.

Neogen utilizes third-party validations on many of our disposable test kits to provide our customers with assurances that our products perform to specified levels.

These include validation by the AOAC International, independently administered third-party, multi-laboratory collaborative studies and approvals by the USDA Food Safety Inspection Service for the use of our products in their operations.

One of the major areas affecting the success of biotechnology and pharmaceutical development involves the time, cost and uncertainty surrounding regulatory approvals.

Neogen products requiring regulatory approval, which we currently have in place, include BotVax B, EqStim, ImmunoRegulin and Uniprim.

Neogen’s rodenticide, disinfectant, parasiticide and insecticide products are subject to registration in the United States and internationally.

Neogen utilizes third-party validations and certifications on many of our products and associated methods to provide our customers with confidence that our products perform to specified levels.

These include validation by, among others, the AOAC International, independently administered third-party, multi-laboratory collaborative studies, and approvals by the USDA Food Safety Inspection Service.

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, Washington, 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;

with occasional 24/7 production during high demand periods.

Neogen manufactures products in the U.S., the U.K., Ireland and Brazil and provides genomics services in the U.S., Scotland, Brazil, Australia, China and Canada.

As of May 31, 2023, there were approximately 1,168 full-time employees assigned to manufacturing operations and providing services in these locations, operating on multiple shift schedules, with occasional 24/7 production during high-demand periods.

Future demand increases could be accommodated by adding shifts.

Management believes we could increase the current output of our primary product lines by more than 30% using the current space available;

Management believes we could increase the current output of our primary product lines by using the current space available.

However, to do so would require investment in additional equipment.

Food safety diagnostics.

Manufacturing of diagnostic tests for the detection of natural toxins, pathogens, food allergens, dairy antibiotics, spoilage organisms and pesticides, final kit assembly, quality assurance and shipping takes place at our facilities in Lansing, Michigan.

Proprietary monoclonal and polyclonal antibodies for Neogen’s diagnostic kits are produced on a regular schedule in our immunology laboratories in Lansing.

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.

Culture media products are manufactured in an ISO-approved

facility in Lansing and in Heywood and Liverpool, England.

Products are blended following strict formulations or custom blended to customer specifications and shipped directly to customers from Lansing and the United Kingdom.

Manufacturing of diagnostic tests for the detection of natural toxins, pathogens, food allergens and spoilage organisms, final kit assembly, quality assurance and shipping takes place at our facilities in Lansing, Michigan.

Proprietary monoclonal and polyclonal antibodies for Neogen’s diagnostic kits are produced on a regular schedule in our immunology laboratories in Lansing.

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

Many 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 facility in Lansing and in Heywood and Liverpool, England.

Products are blended following strict formulations or custom blended to customer specifications and shipped directly to customers from Lansing and the U.K.

The Heywood location produces prepared media plates, sterile liquid media, and other related products in ready-to-use format for food testing laboratories across the U.K.

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Enzyme substrates are manufactured at Megazyme in Bray, Ireland.

Our Clean-Trace product line is manufactured in Wales.

Other FSD products are currently manufactured within 3M plants in the U.S.

Animal health products.

Manufacturing of animal health products, pharmacological diagnostic test kits and test kits for drug residues takes place in our FDA-registered

facilities in Lexington, Kentucky.

Manufacturing of animal health products, pharmacological diagnostic test kits, and test kits for drug residues takes place in our FDA-registered facilities in Lexington, Kentucky.

In general, manufacturing operations including reagent manufacturing, quality assurance, final kit assembly and packaging are performed by Neogen personnel.

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.

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.

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 Kentucky facilities.

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

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

Veterinary biologics.

Neogen maintains a Lansing-based USDA-approved manufacturing facility devoted to the production of the biologic products EqStim and ImmunoRegulin.

seed cultures are added to media and then subjected to several stages of further processing resulting in a finished product that is filled and packaged within the facility.

Our BotVax B vaccine is also produced in the Lansing facility utilizing Type B botulism seed cultures and a traditional fermentation process.

All completed biologic products are then shipped to Neogen’s Lexington facilities where they are inventoried prior to distribution to customers.

P.acnes seed cultures are added to media and then subjected to several stages of further processing resulting in a finished product that is filled and packaged within the facility.

Our BotVax B vaccine also is produced in the Lansing facility using Type B botulism seed cultures and a traditional fermentation process.

All completed biologic products are then shipped to Neogen’s Lexington facilities, where they are inventoried prior to distribution to customers.

Agricultural genomics services.

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

Neogen offers agricultural genomics laboratory services and bioinformatics at our locations in the U.S., 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.

Cleaners, disinfectants and rodenticides.

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

Cleaners, disinfectants and rodent control products.

Manufacturing of rodent control products and/or cleaners and disinfectants takes place in the following locations:

Wisconsin, Tennessee, California, England and Brazil.

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

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

Certain cleaners and disinfectants are manufactured in Neogen facilities, while others are purchased from other manufacturers for resale or toll manufactured by third parties.

Insecticides.

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

Insect control products.

Neogen manufactures insect control products at its facilities in Iowa and Brazil.

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

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There can be no assurance that we would avoid a disruption of supply in the event a supplier discontinues shipment of product.

Shipments of higher volume products are generally accomplished within a 48-hour

turnaround time.

Shipments of higher volume products are generally accomplished within a 48-hour turnaround time.

Our backlog of unshipped orders at any given time has historically not been significant.

Although competitors vary in individual markets, management knows of no single competitor that is pursuing Neogen’s fundamental strategy of developing and marketing a broad line of products, ranging from disposable tests and culture media to veterinary pharmaceuticals and instruments for a large number of food safety and animal safety concerns.

For each of our individual products or product lines, we face intense competition from companies ranging from small businesses to divisions of large multinational companies.

Some of these organizations have substantially greater financial resources than Neogen.

We compete primarily on the basis of ease of use, speed, accuracy and other similar performance characteristics of our products.

The breadth of our product line, the effectiveness of our sales and customer service organizations, and pricing are also components in management’s competitive strategy.

Future competition may become even more intense, and could result from the development of new technologies, which could affect the marketability and profitability of Neogen’s products.

Our competitive position will also depend on our ability to continue to develop proprietary products, attract and retain qualified scientific and other personnel, develop and implement production and marketing plans and obtain patent protection for new products.

We compete primarily on the basis of ease of use, speed, accuracy and other performance characteristics of our products.

The breadth of our product line, the effectiveness of our sales and customer service organizations, and pricing also are components in management’s competitive strategy.

Future competition may become even more intense and could result from the development of new technologies, which could affect the marketability and profitability of Neogen’s products.

Our competitive position also depends on our ability to continue to develop proprietary products, attract and retain qualified scientific and other personnel, develop and implement production and marketing plans and protect the intellectual property for new products.

Additionally, we must continue to generate or have access to adequate capital resources to execute our strategy.

With a large professional sales organization offering a comprehensive catalog of food safety solutions, management believes we maintain a general advantage over competitors offering only limited product lines.

In most cases, Neogen sales and technical service personnel can offer unique insight into a customer’s numerous safety and quality challenges, and offer testing and other solutions to help the customer overcome those challenges.

Competition for pathogen detection products includes traditional methods and antibody and genetic-based platforms;

competition for natural toxins and allergen detection products include instrumentation and antibody-based tests.

competition for natural toxins and allergen detection products includes instrumentation and antibody-based tests.

While our offerings will not always compete on all platforms in all markets, the products we offer provide tests that can be utilized by most customers to meet their testing needs.

In addition to our extensive product offerings and robust distribution network, we focus our competitive advantage in the areas of customer service, product performance, speed, and ease of use of our products.

Additionally, by aggressively maintaining Neogen’s ability to produce at low cost, we believe that we can be competitive with new market entrants that may choose a low pricing strategy in an attempt to gain market share.

ANIMAL SAFETY:

Neogen’s Animal Safety segment faces no single competitor across the products and markets we serve.

In the racing industry market, we believe we hold a leading market share position.

In the life sciences and forensics markets, we compete against several other diagnostic and reagent companies with similar product offerings.

Neogen’s Animal Safety segment faces no single competitor across the products and markets we serve.

In the life sciences and toxicology markets, we compete against several other diagnostic and reagent companies with similar product offerings.

In the veterinary market, Neogen markets BotVax B, the only USDA-approved vaccine for the prevention of botulism Type B in horses.

We compete on other key products through differentiated product performance and superior customer and technical support.

With some of our products, we provide solutions as a lower cost alternative and also offer a private label option for our distributors.

Competition in the rodenticide market includes several companies of comparable size that offer products into similar market segments.

The retail rodenticide market is not dominated by a single brand.

While the technical materials used by competing companies are similar, Neogen uses manufacturing and bait formula techniques which we believe may better attract rodents to the product and thereby improves overall product performance.

Within the insecticide market, Chem-Tech products specifically focus on the area of insect control for food and animal safety applications.

There are several competitors offering similar products, however, we have a proprietary formulation chemistry that optimizes the delivery and safe application of insecticides at the customer’s location.

These products are currently only sold in the U.S.

With some of our products, we provide solutions as a lower cost alternative and also offer a private label option for our customers.

Competition in the rodent control market includes several companies of comparable size that offer products into similar market segments.

The retail rodent control market is not dominated by a single brand.

While the technical

materials used by competing companies are similar, Neogen uses manufacturing and bait formula techniques, which we believe may better attract rodents to the product and thereby improves overall product performance.

Within the insect control market, Chem-Tech products specifically focus on the area of insect control for food and animal safety applications.

There are several competitors offering similar products, however, we have a proprietary formulation chemistry that optimizes the delivery and safe application of insect control products at the customer’s location.

These products currently are only sold in the U.S.

through a combination of direct sales and distributors.

Numerous companies, including a number of large multinationals, compete for sales in the cleaner and disinfectant product segment.

Neogen’s broad line of products are sold through our distributor network around the world, primarily to assist in the cleaning and disinfecting of animal production facilities.

Neogen’s broad line of products is sold around the world, primarily to assist in the cleaning and disinfecting of animal production facilities.

In addition to our extensive portfolio of animal safety products, Neogen also competes in the retail market by providing solutions to common retail problems, such as stock outs, wasted floor space, and inconsistent brand identity.

We differentiate ourselves by offering planograms and convenient reordering systems to maximize turns and profitability for our retail customers.

Neogen Genomics, the leading worldwide commercial agricultural genomics laboratory in the U.S., employs cutting-edge technology in the area of genomics.

Neogen Genomics, a leading worldwide commercial animal genomics laboratory, employs cutting-edge technology in the area of genomics.

The result of this technology allows the acceleration of natural selection through parentage testing and selective breeding of traits such as disease resistance, yield improvement and meat quality.

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GOVERNMENT REGULATION

A significant portion of Neogen’s products and revenues are affected by the regulations of various domestic and foreign government agencies, including the U.S.

Department of Agriculture (USDA), the Environmental Protection Agency (EPA), and the U.S.

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Changes in these regulations could affect revenues and/or costs of production and distribution.

Neogen’s development and manufacturing processes involve the use of certain hazardous materials, chemicals and compounds.

Neogen’s development and manufacturing processes involve the use of certain hazardous materials, chemicals, and compounds.

Management believes that our safety procedures for handling and disposing of such commodities comply with the standards prescribed by federal, state and local regulations.

However, changes in such regulations or rules could involve significant costs to us and could be materially adverse to our business.

The rodenticides, insecticides, cleaners, disinfectants and sanitizers manufactured and distributed by Neogen are subject to EPA and various state regulations.

In general, any international sale of our products must also comply with similar regulatory requirements in the country of destination.

Each country has its own individual regulatory construct with specific requirements (e.g., label in the language of the importing country).

The rodent control products, insect control products, cleaners, disinfectants and sanitizers manufactured and distributed by Neogen are subject to EPA and various U.S.

state regulations as well as other analogous agencies in the markets where we sell such products.

In general, any international sale of our products also must comply with similar regulatory requirements in the country of destination.

Each country has its own individual regulatory construct with specific requirements.

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

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.

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

However, we have pursued voluntary approvals and certifications for a number of these products to enhance their marketability.

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

The vaccine products are approved by the U.S.

Department of Agriculture, Center for Veterinary Biologics (USDA-CVB)

and the pharmaceutical products are approved by the FDA.

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 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.

Department of Agriculture, Center for Veterinary Biologics (USDA-CVB) and analogous agencies in jurisdictions where sold.

The pharmaceutical products are approved by the FDA and analogous agencies in jurisdictions where sold.

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

We have no warning letters based on any review of these products or facility inspections 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.

However, Neogen’s regulatory staff routinely monitors amendments to current regulatory requirements to ensure compliance.

HUMAN CAPITAL MANAGEMENT

Our people are a critical component in our continued success.

As a team, they put Neogen’s core values into action, while executing on key growth initiatives to maintain long-term sustainable growth.

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

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and 1,196 international.

None of these employees are covered by collective bargaining agreements.

We maintain good relations with both our union and non-union employees and have not experienced any work stoppages.

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

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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

Our Code of Conduct codifies our commitment to conducting business ethically.

Equity, Diversity, Inclusion, and Belonging (EDIB).

We strive to create an environment where colleagues feel valued 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 equity, diversity, inclusion and belonging initiatives.

Talent Attraction, Development and Retention.

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

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Compensation and Benefits .

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

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.

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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