Item 1A. Risk Factors
ITEM 1A. RISK FACTORS
Investing in our securities involves a variety of risks and uncertainties, known and unknown, including, among others, those discussed below. Each of the following risks should be considered carefully, together with all the other information included in this Annual Report on Form 10-K, including our consolidated financial statements and the related notes and in our other filings with the SEC. Furthermore, additional risks and uncertainty not presently known to us or that we currently believe to be immaterial also could adversely affect our business. Our business, results of operations, financial condition and cash flow could be materially and adversely affected by any of these risks or uncertainties.
RISKS RELATING TO THE TRANSACTION WITH 3M CORPORATION
We may not realize the anticipated financial and other benefits, including growth opportunities, expected from the 3M Food Safety merger transaction.
On September 1, 2022, Neogen, 3M Company (“3M”) and Neogen Food Safety Corporation, formerly named Garden SpinCo, a subsidiary created to carve out 3M’s Food Safety Division (“3M 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”, or the "Transaction"). We have realized, and expect to continue to realize synergies, growth opportunities and other financial and operating benefits as a result of the Transaction. Our success in realizing the anticipated benefits of the Transaction depends, in part, on the successful transition of Petrifilm manufacturing from 3M to Neogen. We cannot
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predict with certainty if or when the remaining synergies, growth opportunities, and other benefits will be realized, or the extent to which they will be achieved. Delays, disruptions, or higher-than-expected costs associated with the manufacturing transition could reduce or defer these benefits. Substantial completion of the manufacturing transition is currently expected to occur in fiscal year 2027, and the Company expects to continue incurring duplicative costs during the transition period.
The transition of Petrifilm manufacturing operations from 3M to Neogen presents challenges, and the failure to successfully complete the transition and integrate the 3M FSD with Neogen could have a material adverse effect on our business, financial condition and results of operations. .
Although significant progress has been made in the integration of the 3M FSD with Neogen, substantial work remains to complete the transition of Petrifilm manufacturing operations from 3M to Neogen. The successful execution of this manufacturing transition is complex and involves significant operational, technical and regulatory activities while continuing to support ongoing business operations. Challenges include:
• transferring and validating manufacturing processes, equipment and capabilities;
• maintaining product quality, supply continuity and customer service throughout the transition;
• obtaining necessary regulatory approvals and completing required product validations;
• managing duplicative manufacturing activities and associated costs during the transition period; and
• integrating the manufacturing operations with Neogen's quality, supply chain, information technology and other supporting systems.
The successful completion of the Petrifilm manufacturing transition cannot be assured. Delays, disruptions, cost overruns or other challenges associated with the transition could adversely affect our ability to realize the anticipated benefits of the Transaction and could have a material adverse effect on our business, financial condition and results of operations.
Built-in gains related to the FSD Transaction may continue to constrain our ability to restructure our Swiss operations and could result in significant tax liability
In connection with the Transaction, we executed a Tax Matters Agreement that imposed specific requirements on Neogen Food Safety Switzerland GmbH through September 1, 2025, including commitments to (i) substantially continue to conduct its business activities within Switzerland, (ii) ensure that either the entity or the associated built-in gains remain fully subject to Swiss taxation, (iii) maintain arm’s length remuneration and required staffing levels in accordance with the applicable Swiss tax ruling, and (iv) refrain from certain restructuring transactions (including mergers) absent advance tax rulings confirming no adverse Swiss tax consequences.
Although those requirements associated with the Tax Matters Agreement expired on September 1, 2025, the underlying built-in gains related to the Transaction continue to create potential tax exposure. As a result, these built-in gains may continue to constrain Neogen’s ability to modify or restructure its Swiss operations without incurring significant tax liability.
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The legacy 3M Food Safety business may be negatively impacted if we are unable to provide benefits and services, or access to equivalent financial strength and resources, to legacy 3M Food Safety business that historically have been provided by 3M.
The legacy 3M Food Safety business had historically received benefits and services from 3M and benefited from 3M’s financial strength and corporate support services. After the Transaction, the legacy 3M Food Safety business as part of Neogen, no longer benefits from 3M’s services, financial strength or business relationships to the extent not otherwise addressed in the other transaction documents entered into in connection with the Transaction. While 3M has agreed to provide certain transition services to the legacy 3M Food Safety business for a period of time following the consummation of the Transactions, it cannot be assured that we will be able to adequately replace or provide resources formerly provided by 3M or replace them at the same or lower cost. If we are not able to replace the resources provided by 3M or are unable to replace them without incurring significant additional costs, or are delayed in replacing the resources provided by 3M, our results of operations may be negatively impacted.
RISKS RELATING TO OUR BUSINESS AND INDUSTRY
Tariffs and other trade measures could adversely affect our results of operations, financial position and cash flows.
Our international operations subject us to a multitude of different tariffs and trade policies, some of which may be discriminatory or conflicting. As a result of the current administration's trade policy, tariffs have increased and may continue to increase our material input costs. We do not expect to be able to fully mitigate the impact of these increased costs or pass price increases on to our customers. In addition, new and increased tariffs as well as uncertainty regarding global trade policies generally have also contributed to softened demand for certain of our products. These factors are expected to continue to negatively impact our results of operations and financial condition in the near term, and continued and/or increasing trade restrictions, retaliatory trade measures and additional tariffs could further exacerbate the problem.
While tariffs and other trade measures imposed by other countries on U.S. goods have not yet had a significant impact on our business or results of operations, we cannot predict further developments, and such existing or future tariffs could have a material adverse effect on our results of operations, financial position and cash flows.
The pending sale of our Genomics business is subject to risks and uncertainties that could affect our results.
On March 2, 2026, we announced that we had entered into a definitive agreement to sell our Genomics business to Zoetis, Inc. for $160.0 million. The transaction is subject to customary closing conditions and regulatory approvals, and the parties continue to work toward a closing by the end of the first half of fiscal year 2027. In July 2026, the Australian Competition and Consumer Commission (ACCC) and the New Zealand Commerce Commission (NZCC) each announced that they are moving their respective reviews of the Company’s proposed genomics divestiture into the second phase of review. The Company will continue to cooperate with the ACCC and the NZCC as they complete their respective review processes. There can be no assurance that the transaction will be completed on the anticipated timeline or at all. If the transaction fails to close, or if closing is significantly delayed, we may not realize the anticipated benefits of the sale, and may experience management distraction, employee uncertainty, customer disruption, and reputational harm. Additionally, if the Genomics business is not divested, we would need to continue to invest in and support that business, which could divert resources from other strategic priorities. The pendency of the transaction may also create uncertainties that could affect our ability to retain key employees associated with the Genomics business, maintain relationships with customers and suppliers, and conduct business in the ordinary course during the pre-closing period. Any transitional services arrangements following closing could require significant management attention and involve execution risks.
We are subject to risks relating to existing international operations and expansion into new geographical markets.
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Expanding sales globally is part of our overall growth strategy, and we expect sales from outside the U.S. to continue to represent a significant portion of our revenue. In fiscal year 2026, sales to customers outside of the U.S. accounted for 51.2% of our total revenue, compared to 50.2% and 49.7% of our total revenues in fiscal year 2025 and 2024, respectively. Our international operations are subject to general risks related to such operations, including:
• political, social and economic instability and disruptions, including social unrest, geopolitical tensions, inflation and interest rate uncertainties;
• government export controls, economic sanctions, embargoes or trade restrictions;
• the imposition of duties and tariffs and other trade barriers;
• limitations on ownership and on repatriation or dividend of earnings;
• transportation delays and interruptions;
• labor unrest and current and changing employment and labor regulatory environments;
• increased compliance costs, including costs associated with disclosure requirements and related due diligence;
• difficulties in staffing and managing multi-national operations;
• limitations on our ability to enforce legal rights and remedies;
• the ability of our current products to comply with product standards established by foreign regulatory bodies;
• differing regulatory and legal systems and environments;
• diminished protection of intellectual property in some countries;
• access to or control of networks and confidential information due to local government controls and vulnerability of local networks to cyber risks; and
• fluctuations in foreign currency exchange rates.
If we are unable to successfully manage the risks associated with expanding our global business or adequately manage operational risks of our existing international operations, these risks could have a material adverse effect on our growth strategy into new geographical markets, reputation, business, results of operations, financial condition and cash flows. In addition, the impact of such risks could be outside of our control and could decrease our ability to sell products internationally, which could adversely affect our business, financial condition, results of operations and cash flows. We continue to monitor the impact of the conflict between Russia and Ukraine and conflict in the Middle East. While it is difficult to anticipate the effect the sanctions related to these conflicts that have been implemented to date could have on us, they have contributed to volatility in global energy markets, including increases in oil prices, which may increase our transportation and shipping cost. In addition, any further sanctions imposed or actions taken by the U.S. or other countries could affect the global price and availability of raw materials, reduce our sales and earnings or otherwise have an adverse effect on our business and results of operations.
We must continue to maintain an effective system of internal control over financial reporting and disclosure controls and procedures.
Although we successfully remediated previously identified material weaknesses in internal control over financial reporting as of May 31, 2026 (as discussed in Item 9A of this report), maintaining effective controls remains critical as our business continues to evolve. Maintaining an effective system of internal control over financial reporting and disclosure controls and procedures is essential to the timely and accurate reporting of our financial results and compliance with applicable laws and regulations. As our business continues to evolve through acquisitions, organizational changes, system implementations and increasing operational complexity, maintaining an effective control environment requires significant management attention and resources. If we are unable to maintain effective internal controls, we could experience errors in our financial reporting, delays in our SEC filings, increased regulatory scrutiny or remediation costs, and a loss of investor confidence, any of
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which could materially adversely affect our business, financial condition, results of operations and the market price of our common stock.
Our business strategy is dependent on successfully promoting internal growth and identifying and integrating acquisitions.
Our business has grown significantly over the past several years as a result of both internal growth and acquisitions of existing businesses and their products. Management initiatives may be attempted to augment internal growth, such as strengthening our presence in select markets, reallocating research and development funds to products with higher growth potential, development of new applications for our technologies, enhancing our service offerings, continuing key customer efforts, and finding new markets for our products. Failure of these management initiatives may have a material adverse effect on our operating results and financial condition.
Identifying and pursuing acquisition opportunities, integrating these acquisitions into our business and managing their growth requires a significant amount of management’s time and skill. We cannot assure that we will be effective in identifying, integrating or managing future acquisition targets. Our failure to successfully integrate and manage a future acquisition could have a material adverse effect on our operating results and financial condition.
We may not be able to effectively manage our future growth, and if we fail to do so, our business, financial condition and results of operations could be adversely affected.
We rely significantly on our information systems’ infrastructure to support our operations and a failure of these systems and infrastructure and/or a security breach of our information systems could damage our reputation and have an adverse effect on operations and results.
We rely on our information systems’ infrastructure to integrate departments and functions, enhance our ability to service customers, improve our control environment, and manage our cost reduction initiatives. If a security breach or cyberattack of our information technology ("IT") networks and systems occurs, our operations could be interrupted. Any issues involving our critical business applications and infrastructure could adversely impact our ability to manage our operations and the customers we serve. Although we have controls and security measures in place to prevent such attacks, experienced computer hackers are increasingly organized and sophisticated. Malicious attack efforts operate on a large scale and sometimes offer targeted attacks as a paid-for service. In addition, the techniques used to access or sabotage networks change frequently and generally are not recognized until launched against a target.
We rely on several information systems throughout our company, as well as those of our third-party business partners, to provide access to our web-based products and services, keep financial records, analyze results of operations, process customer orders, manage inventory, process shipments to customers, store confidential or proprietary information and operate other critical functions. We also rely on third-party cloud infrastructure providers, software-as-a service (SaaS) platforms, and other hosted solutions for certain business-critical applications. An outage, service disruption, or security incident at one of these third-party providers could interrupt our operations, compromise our data, or impair our ability to serve customers, regardless of whether our own systems are directly affected. Although we employ system backup measures and engage in information system redundancy planning and processes, such measures, as well as our current disaster recovery plan, may be ineffective or inadequate to address all vulnerabilities, including those arising from our dependence on third-party cloud and SaaS providers over whom we have limited control. Further, our information systems and our business partners’ and suppliers’ information systems may be vulnerable to attacks by hackers and other security breaches, including computer viruses and malware, through the internet (including via devices and applications connected to the internet), email attachments and persons with access to these information systems, such as our employees or third parties with whom we do business. As information systems and the use of software and related applications by us, our business partners, suppliers and customers become more cloud-based, there has been an increase in global cybersecurity vulnerabilities and threats, including more sophisticated and targeted cyber-related attacks that pose a risk to the security of our information systems and networks and the confidentiality, availability and integrity of data and information.
While we have implemented network security and internal control measures, including for the purpose of protecting our connected products and services from cyberattacks, and invested in our data and IT
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infrastructure, there can be no assurance that these efforts will prevent a system disruption, attack, or security breach and, as such, the risk of system disruptions and security breaches from a cyberattack remains.
If our security and information systems are compromised, interrupted or destroyed, or employees fail to comply with the applicable laws and regulations, or the information we maintain is obtained by unauthorized persons or used inappropriately, it could adversely affect our business and reputation, as well as our results of operations, and could result in litigation, the imposition of regulatory sanctions or penalties, or significant expenditures to remediate any damage to persons whose personal information has been compromised.
We are currently undertaking additional phases of enterprise resource planning (ERP) harmonization and related systems integration activities across our operations. These initiatives are complex and require significant financial investment, management focus, and coordination of internal and external resources. While we believe these efforts will enhance operational efficiency and data consistency over the long term, there can be no assurance that the implementation and harmonization activities will be completed successfully or on the anticipated timeline. Any delays, disruptions, or failure of these systems to perform as expected could adversely impact our business operations, including our ability to process transactions effectively and report accurate and timely financial results.
Rapid developments in artificial intelligence and other emerging technologies may disrupt our markets, affect our competitive position and create new risks for our business.
The food and animal safety industries in which we operate are increasingly influenced by artificial intelligence ("AI"), machine learning and other emerging technologies. Our ability to compete effectively may depend, in part, on our ability to develop, acquire and effectively integrate these technologies into our products and operations. In addition, the use of AI presents operational, cybersecurity, data privacy and regulatory risks, including the risk that AI-generated outputs may be inaccurate or unreliable and that evolving laws and regulations may increase compliance costs or restrict our use of AI. If we are unable to effectively manage these risks or adapt to technological developments, our business, results of operations and financial condition could be materially and adversely affected.
Disruption of our manufacturing and service operations could have an adverse effect on our financial condition and results of operations.
Our facilities and our distribution systems are subject to catastrophic loss due to fire, flood, terrorism or other natural or man-made disasters. If any of our facilities were to experience a catastrophic loss, it could disrupt our operations, delay production, shipments and revenue and result in significant expenses to repair or replace the facility and/or distribution system. If such a disruption were to occur, we could breach agreements, our reputation could be harmed, and our business and operating results could be adversely affected. Although we carry insurance for property damage and business interruption, we do not carry insurance or financial reserves for interruptions or potential losses arising from terrorism. Economic conditions and uncertainties in global markets could adversely affect the cost and other terms upon which we are able to obtain third party insurance. If we are unable to obtain sufficient and cost-effective third-party insurance coverage, or to the extent we have elected to self-insure, we could be at greater risk that our operations will be harmed by a catastrophic loss.
We rely heavily on third-party package delivery services, and a significant disruption in these services or significant increases in prices could disrupt our ability to ship products, increase our costs and lower our profitability.
We ship a significant portion of our products to customers through independent package delivery companies, such as UPS, Federal Express and DHL. We also ship our products through other carriers, including national and regional trucking firms, overnight carrier services and the U.S. Postal Service. If one or more of these third-party package delivery providers were to experience a major work stoppage or other event that prevented our products from being delivered in a timely fashion or caused us to incur additional shipping costs we could not pass on to our customers, our costs could increase and our relationships with some of our customers could be adversely affected. In addition, if one or more of our third-party package delivery providers were to increase prices, and we were not able to find comparable alternatives or make adjustments within our delivery network, our profitability could be adversely affected. Even if we are able to pass through increased shipping costs to our customers through increased pricing, it may impact the demand for many of our products, which could adversely affect our profitability.
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Our dependence on suppliers could limit our ability to sell certain products or negatively affect our operating results.
We rely on third-party suppliers to provide raw materials and other components in our products, manufacture products that we do not manufacture ourselves and perform services that we do not provide ourselves. Because these suppliers are independent third parties with their own financial objectives, actions taken by them could have a negative effect on our results of operations. The risks of relying on suppliers include our inability to enter into contracts with third party suppliers on reasonable terms, inconsistent or inadequate quality control, relocation of supplier facilities, supplier work stoppages and suppliers’ failure to comply with their contractual obligations. In addition, we currently purchase some raw materials and products from sole or single sources. Some of the products that we purchase from these sources are proprietary and, therefore, cannot be readily or easily replaced by alternative sources. Problems with suppliers and the supply chain could negatively impact our ability to supply the market, substantially decrease sales, lead to higher costs and damage our reputation with our customers.
We sell many products through distributors, which presents risks that could negatively affect our operating results.
We sell many of our products, both within and outside of the U.S., through independent distributors. As a result, we are dependent on distributors to sell our products and assist us in promoting and creating demand for our products. Our distributors may offer products from several different companies, and those distributors may carry our competitors’ products and promote our competitors’ products over our own. We have limited ability to cause our distributors to devote adequate resources to promoting, marketing, selling and supporting our products. We cannot assure that we will be successful in maintaining and strengthening our relationships with our distributors or establishing relationships with new distributors who have the ability to market, sell, and support our products effectively. We may rely on one or more key distributors for a product or region, and the loss of one or more of these distributors could reduce our revenue. Distributors could face financial difficulties, including bankruptcy, which could impact our ability to collect our accounts receivable and negatively impact our financial results. In addition, violations of anti-bribery and anti-corruption or similar laws by our distributors could have a material impact on our business. Further, termination of a distributor relationship could result in increased competition in the applicable jurisdiction. Failing to manage the risks associated with our use of distributors could reduce sales, increase expenses and weaken our competitive position, which could have a negative impact on our operating results.
If we are unable to develop new products and technologies, our competitive position could be impaired, which could materially and adversely affect our sales and market share.
The markets in which we operate are characterized by rapidly changing technologies and the frequent introduction of new products. As a result, our success is dependent upon our ability to develop or acquire new products and services on a cost-effective basis, to introduce them into the marketplace in a timely manner and to protect and maintain critical intellectual property assets related to these developments. Difficulties or delays in research, development or production of new products and technologies, or failure to gain market acceptance of new products and technologies, could significantly reduce future revenue and materially and adversely affect our competitive position. While we intend to continue to commit financial resources and effort to the development of new products and services, we may not be able to successfully differentiate our products and services from those of our competitors. Our customers may not consider our proposed products and services to be of value to them or may not view them as superior to our competitors’ products and services. In addition, our competitors or customers could develop new technologies or products which reflect similar or improved solutions to our existing technologies. Further, we may not be able to adapt to evolving markets and technologies, develop new products, achieve and maintain technological advantages or protect technological advantages through intellectual property rights. If we do not successfully compete through the development and introduction of new products and technologies, our business, results of operations, financial condition and cash flows could be materially adversely affected.
If we fail to maintain a positive reputation or are unable to conduct effective sales and marketing, our prospects and financial condition could be adversely affected.
We believe that market awareness and recognition of our brands have contributed significantly to the success of our business. We also believe that maintaining and enhancing these brands, especially market perceptions of the quality of our products, is critical to maintaining our competitive advantage. If any of our products are
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subject to recall or are proven to be, or are claimed to be, ineffective or inaccurate for their stated purpose, then this could have a material adverse effect on our business, financial condition and results of operations. Also, because we are dependent on market perceptions, negative publicity associated with product quality or other adverse effects resulting from, or perceived to be resulting from, our products could have a material adverse impact on our business, financial condition and results of operations.
Our sales and marketing efforts are anchored by promoting our products to potential customers. Therefore, our sales and marketing force, whether in-house sales representatives or third-party commercial partners, must possess an up-to-date understanding of industry trends and products, as well as promotion and communication skills.
While we will continue to promote our brands to remain competitive, we may not be successful in doing so. If we are unable to increase or maintain the effectiveness and efficiency of our sales and marketing activities, or if we incur excessive sales expenses to do so, our business, financial condition and results of operations may be materially and adversely affected.
We could lose customers or generate lower revenue, operating profits and cash flows if there are significant increases in the cost of raw materials or if we are unable to obtain such raw materials or other components of our products.
We purchase raw materials and components for use in our products, which exposes us to volatility in prices for certain raw materials and products. Prices and availability of these raw materials are subject to substantial fluctuations that are beyond our control due to factors such as changing economic conditions, inflation, currency and commodity price fluctuations, tariffs, resource availability, transportation costs, weather conditions and natural disasters, political unrest and instability, and other factors impacting supply and demand pressures. Significant price increases for these supplies could adversely affect our operating profits. Current and future inflationary effects may be driven by, among other things, supply chain disruptions and governmental stimulus or fiscal policies. The COVID-19 pandemic, for example, resulted in raw material price inflation as well as supply chain constraints and disruptions. While we will generally attempt to mitigate the impact of increased raw material prices by endeavoring to make strategic purchasing decisions, broadening our supplier base and passing along increased costs to customers, there may be a time delay between the increased raw material prices, and our mitigation efforts. Additionally, we may be unable to increase the prices of products due to a competitor’s pricing pressure or other factors, or may be unable to raise the price of our products in a manner that is proportional to the level of inflation in our input costs, which would materially and adversely affect our results of operations.
Certain of our food safety product lines depend on a sole or single source supplier or vendor. The ability of these third parties to deliver raw materials and products may be affected by events beyond our control. In addition, public health threats, such as COVID-19, severe influenza and other highly communicable viruses or diseases could affect our supply of raw materials, by limiting our ability to transport raw materials from our vendors or increasing demand and competition for supplies, which could adversely affect our ability to obtain necessary raw materials for certain of our products. Any sustained interruption in our receipt of adequate raw materials, supply chain disruptions impacting the receipt or distribution of products, or disruption to key manufacturing sites’ operations due to natural and other disasters or events or other legal or regulatory requirements, could result in a significant price increase in raw materials, or their unavailability, which could result in a loss of customers or otherwise adversely impact our business, results of operations, financial condition and cash flows.
Our reputation, ability to do business and results of operations could be impaired by improper conduct by or disputes with any of our employees, agents or business partners and we have a compliance burden with respect to, and risk of violations of, anti-bribery, trade control, trade sanctions, anti-corruption and similar laws.
Our operations require us to comply with a number of U.S. and international laws and regulations, including those governing payments to government officials, bribery, fraud, anti-kickbacks, false claims, unfair competition, export and import compliance, money laundering and data privacy, as well as the improper use of proprietary information or social media. In particular, our international operations are subject to the regulations imposed by the Foreign Corrupt Practices Act and the United Kingdom Bribery Act 2010 as well as anti-bribery and anti-corruption laws of various jurisdictions in which we operate. While we strive to maintain high standards, we cannot provide assurance that our internal controls and compliance systems always will protect
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us from acts committed by our employees, agents or business partners that would violate such U.S. or international laws or regulations or fail to protect our confidential information. Any such violations of law or improper actions could subject us to civil or criminal investigations in the U.S. or other jurisdictions, result in substantial monetary and non-monetary penalties and shareholder lawsuits, lead to increased costs of compliance and damage our reputation, business, results of operations, financial condition and cash flows.
Changes in domestic and foreign laws, regulations, policies, and enforcement initiatives increase our costs of compliance and subject us to increased risk.
Our domestic and international sales and operations are subject to risks associated with changes in laws, regulations and policies (including environmental and employment regulations, export/import laws, tax policies and other similar programs). Failure to comply with any of these laws, regulations and policies could result in civil and criminal as well as monetary and non-monetary penalties, and damage to our reputation. In addition, we cannot provide assurance that our costs of complying with new and evolving regulatory reporting requirements and current or future laws, including environmental protection, employment, data security, data privacy and health and safety laws, will not exceed our estimates. While these risks and the impact of these risks are difficult to predict, any one or more of them could adversely affect our business, results of operations and reputation.
Evolving data privacy and data protection laws and regulations may increase our compliance costs and exposure to liability.
We are subject to a broad and rapidly evolving set of global data privacy and data protection laws, including the European Union’s General Data Protection Regulation (GDPR), U.S. state-level privacy laws such as the California Consumer Privacy Act (CCPA), and similar regulations in other jurisdictions. These laws govern the collection, use, retention, sharing, transfer, and security of personal data and require significant and increasing compliance investment. We process personal data relating to employees, customers, and business partners across multiple jurisdictions and rely on cross-border data transfer mechanisms that may be challenged, invalidated, or require enhanced safeguards, particularly between the European Union and other regions. Failure to comply with applicable laws could result in significant fines (including penalties of up to 4% of global annual revenue under GDPR), regulatory investigations, litigation, and reputational harm, as well as material costs related to remediation, customer attrition, and constraints on our ability to use data to support commercial operations. Regulators may also impose restrictions on data processing activities, which could disrupt business operations, impair customer relationships, and limit our ability to generate insights and effectively serve key accounts. Any of these outcomes could have a material adverse effect on our business, results of operations, financial condition, and cash flows.
Differences in and changes to tax rates in the jurisdictions in which we operate and unanticipated outcomes with respect to tax audits could adversely affect our business, profitability and reputation.
We are subject to taxation in a number of jurisdictions. Accordingly, our effective tax rate is impacted by changes in the mix among earnings in countries with differing statutory tax rates. A material change in the statutory tax rate or interpretation of local law in a jurisdiction in which we have significant operations could adversely impact our effective tax rate and impact our financial results.
Our tax returns are subject to audit, and taxing authorities could challenge our operating structure, taxable presence, application of treaty benefits or transfer pricing policies. If changes in statutory tax rates or laws or audits result in assessments different from amounts estimated, our business, results of operations, financial condition and cash flows could be adversely affected. In addition, changes in tax laws could have an adverse effect on our customers, resulting in lower demand for our products and services.
A deterioration in our future expected profitability or cash flows could result in an impairment of our recorded goodwill and intangible assets.
We have significant goodwill and intangible assets recorded on our consolidated balance sheet. The valuation and classification of these assets and the assignment of useful lives to intangible assets involve significant judgments and the use of estimates. Impairment testing of goodwill and intangible assets requires significant use of judgment and assumptions, particularly as it relates to the determination of fair market value. A decrease in the long-term economic outlook and future cash flows of our business could significantly impact asset values and potentially result in the impairment of intangible assets, including goodwill.
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The markets for our products are extremely competitive, and our competitors could use existing resource advantages to our detriment.
The food and animal safety industries are subject to rapid and substantial changes in technology and are characterized by extensive research and development and intense competition. Our competitors and potential competitors may have greater financial, technical, manufacturing, marketing, research and development and management resources than us. These competitors could use their resources, reputations and ability to leverage existing customer relationships to provide a competitive advantage over us that could impact our results of operations. They might also succeed in developing products that are more reliable and effective than our products, are less costly than our products or provide alternatives to our products. If the products of a competitor are better able to meet our customers' requirements, then our operating results could be adversely affected.
We are dependent on the agricultural marketplace, which is affected by factors beyond our control.
Our primary customers are in the agricultural and food production industries. Economic conditions affecting agricultural industries are cyclical and are dependent upon many factors outside of our control, including weather conditions, changes in consumption patterns or commodity prices. Any of these factors in the agricultural marketplace could affect our sales and overall financial performance.
RISKS RELATED TO LIQUIDITY, INDEBTEDNESS AND THE CAPITAL MARKETS
We have incurred substantial indebtedness and our financial condition and operations may be adversely affected by a violation of financial or other covenants.
We have incurred substantial indebtedness and related debt service obligations, which could have important consequences, including:
• reduced flexibility in responding to changing business and economic conditions, and increased vulnerability to adverse economic and industry conditions;
• reduced flexibility in planning for, or reacting to, changes in our business, the competitive environment and the markets in which we operate, and to technological and other changes;
• reduced access to capital and increased borrowing costs generally or for any additional indebtedness to finance future operating and capital expenditures and for general corporate purposes;
• lowered credit ratings;
• reduced funds available for operations, capital expenditures and other activities;
• increased vulnerability to increases in interest rates because a substantial portion of our indebtedness bears interest at floating rates; and
• competitive disadvantages relative to other companies with lower debt levels.
On June 30, 2022, Neogen Food Safety Corporation entered into a credit agreement consisting of a five-year senior secured term loan facility (“Term Loan Facility”) and a five-year senior secured revolving facility (“Revolving Credit Facility”). Our Revolving Credit Facility and Term Loan Facility contains customary affirmative and negative covenants, including financial covenants based on leverage and cash interest expense coverage ratios and limitations on our ability to make certain investments, declare or pay dividends or distributions on capital stock, redeem or repurchase capital stock and certain debt obligations, incur liens, incur indebtedness, or merge, make certain acquisitions or sales of assets. In April 2025, Neogen Food Safety Corporation entered into the Amendment No. 1 and Refinancing Amendment to Credit Agreement (the “Refinancing Amendment”), which amended the existing credit agreement, dated June 30, 2022. The Refinancing Amendment, among other things, provides for (i) a new tranche of senior secured term loans in an aggregate principal amount of $450.0 million (the “2025 Term Loans”) and (ii) a revolving credit facility in an aggregate principal amount of $250.0 million, against which $100.0 million has been drawn. The 2025 Term Loans will mature on April 4, 2030.
Our outstanding 8.625% senior notes due 2030, which were issued by Neogen Food Safety Corporation on July 20, 2022 and became guaranteed on a senior unsecured basis by the Company and certain wholly owned domestic subsidiaries upon the closing of the Transaction on September 1, 2022 (the "Senior Notes") also
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include customary events of default. A violation of any of these credit-related covenants or agreements could result in a default under one or more of these agreements, which could permit the lenders or note holders, as applicable, to accelerate repayment of any borrowings or notes outstanding at that time, levy on any collateral securing such indebtedness, and/or taking other actions designed to protect our ability to repay our indebtedness. Any such event would materially and adversely affect our ability to operate our business and our results of operations and financial condition.
The available capacity under our Revolving Facility could be limited by our covenant ratios under certain conditions. An increase in the applicable leverage ratio, as a result of decreased earnings or otherwise, could result in reduced access to capital under our Revolving Facility, which is a significant component of our total available liquidity.
The outcome of litigation, investigations, product recalls, and other legal proceedings in which we are involved is inherently uncertain; adverse developments could be costly, divert management attention, restrain insurance coverage, and materially harm our business, results of operation, financial condition, and cash flows.
From time to time, we are party to legal proceedings, including securities and shareholder litigation, product-related claims, and other commercial disputes. As disclosed in our periodic reports, we are defendants in putative shareholder class and derivative actions relating to disclosures about the integration of the 3M Food Safety business and the FSD transaction, as well as related stockholder demands, and we have received demand letters and are aware of two individual lawsuits and an uncertified class action lawsuit filed on behalf of one named plaintiff relating to Vet HyCoat® Hyaluronate Sodium Sterile Solution, a third-party manufactured product we distributed and voluntarily recalled in January 2026. Although we intend to defend these matters vigorously, litigation is subject to many uncertainties. Unfavorable outcomes – whether through judgments, injunctions, settlements, fines, penalties, or mandated changes to business practices – could result in significant costs, limit our ability to sell certain products, require increased reserves, or adversely affect access to capital markets. Insurance may be unavailable or insufficient to cover all costs and defending these matters could divert management time and attention. Additional similar claims could be filed, and developments in existing matters – such as class certification, adverse court rulings, discovery demands, settlement dynamics, or regulatory coordination – could increase our exposure. For a description of currently pending legal proceedings and related contingencies, see Part I, Item 3 “Legal Proceedings” below and Note 11 – Commitments and Contingencies below.
Our quarterly and annual operating results are subject to significant fluctuations.
We have experienced, and may experience in the future, significant fluctuations in our quarterly and annual operating results. The mix of products sold and the acceptance of new products, in addition to other factors such as cost increases, could contribute to this variability. We have few long-term customer contracts and operate primarily with purchase orders. In addition, our expense levels are based, in part, on our expectation of future revenue levels. Therefore, a shortfall in expected revenue could result in a disproportionate reduction in our net income.
The market price of our common stock could be highly volatile.
The trading price of our common stock could be volatile. Securities markets worldwide experience significant price and volume fluctuations. This market volatility, as well as other general economic, market or political conditions, could reduce the market price of our common stock rapidly and unexpectedly, despite our operating performance. Factors that could impact the market price of our common stock include the factors described in this “Risk Factors” section and elsewhere in this Annual Report on Form 10-K, as well as:
• Public announcements (including the timing of these announcements) regarding our business, financial performance, acquisitions and prospects or new products or services, product enhancements or technological advances by our competitors or us;
• Trading activity in our stock, including transactions by us, our executive officers and directors, and significant shareholders; trading activity that results from the ordinary course rebalancing of stock indices in which we may be included, such as the S&P Mid-Cap 400 Index; trading activity related to our inclusion in, or removal from, any stock indices; and short-interest in our common stock, which could be significant from time to time;
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• Investor perception of us and the industry and markets in which we operate; changes in earnings estimates or buy/sell recommendations by securities analysts; and whether or not we meet earnings estimates of securities analysts who follow us; and
• General financial, domestic, international, economic and market conditions, including overall fluctuations in the U.S. equity markets, which may experience extreme volatility that, in some cases, is unrelated or disproportionate to our operating performance.
Our business could be adversely affected by fluctuations in the global capital markets.
Our business and financial results are affected by fluctuations in the global financial markets, including interest rates and currency exchange rates. The exposure to fluctuations in currency exchange rates takes on different forms. International revenues and costs are subject to the risk that fluctuations in exchange rates could adversely affect our reported revenues and profitability when translated into U.S. dollars for financial reporting purposes. These fluctuations could also adversely affect the demand for products and services provided by us. Failure to respond timely to these fluctuations, or failure to effectively hedge these risks when possible, could lead to a material adverse impact on our results of operations and financial condition.
We have no current plans to start paying dividends in the near term.
Dividend payments to our shareholders depend upon a number of factors, including our results of operations, cash flows and financial position, contractual restrictions and other factors considered relevant by our Board of Directors. We have not historically paid dividends to our shareholders, and there is no assurance that we will declare and pay, or have the ability to declare and pay, any dividends on our common stock in the future.
OTHER RISK FACTORS RELATING TO OUR BUSINESS
Our success is highly dependent on our ability to obtain protection for the intellectual property used in our products.
Our success and ability to compete depends, in part, on our ability to establish and maintain intellectual property rights capable of protecting our technology and products in the U.S and other countries. Patent applications filed by us may not result in the issuance of patents or, if granted, may not be granted in a form that will be commercially advantageous to us. Even if granted, patents can be challenged, narrowed, invalidated, or circumvented, which could limit our ability to stop competitors from marketing similar products or limit the length of time we have patent protection for our products. We also cannot assure that our nondisclosure agreements, together with trade secrets and other common law rights, will provide meaningful protection for our trade secrets and other proprietary information. Moreover, the laws of some foreign jurisdictions may not protect intellectual property rights to the same extent as in the U.S., and many companies have encountered significant difficulties in protecting and defending such rights in foreign jurisdictions. If we encounter such difficulties or we are otherwise precluded from effectively protecting our intellectual property rights domestically or in foreign jurisdictions, we could incur substantial costs and our business, including our business prospects, could be substantially harmed.
Some of our products could be the subject of patent infringement challenges.
From time to time, we have received notices alleging that our products infringe third-party proprietary rights. Whether the manufacture, sale, or use of current products, or whether any products under development would, upon commercialization, infringe any patent claim cannot be known with certainty unless and until a court interprets a patent claim and its validity in the context of litigation. The outcome of infringement litigation is subject to substantial uncertainties, including the testimony of experts as to technical facts upon which experts may reasonably disagree. Our defense of an infringement litigation lawsuit could result in significant expense. Regardless of the outcome, infringement litigation could significantly disrupt our marketing, development and commercialization efforts, divert management’s attention and consume our financial resources. In the event that we are found to infringe any valid claim in a patent held by a third party, we could, among other things, be required to:
• Pay damages, including up to treble damages and the other party’s attorneys’ fees, which may be substantial;
• Cease the development, manufacture, importation, use and sale of products that infringe the patent rights of others, through a court-imposed injunction;
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• Expend significant resources to redesign our technology so that it does not infringe others’ patent rights, or develop or acquire non-infringing intellectual property, which may not be possible;
• Discontinue manufacturing or other processes incorporating infringing technology; and/or
• Obtain licenses to the infringed intellectual property, which may not be available to us on acceptable terms, or at all.
Any development or acquisition of non-infringing products, technology or licenses could require the expenditure of substantial time and other resources and could have a material adverse effect on our business and financial results. If we are required to, but cannot, obtain a license to valid patent rights held by a third party, we would likely be prevented from commercializing the relevant product, or from further manufacture, sale or use of the relevant product.
The industries in which we operate are subject to substantial governmental regulation.
A portion of our products and facilities are regulated by various domestic and foreign government agencies including the U.S. Department of Agriculture, the U.S. Food and Drug Administration and the Environmental Protection Agency. A significant portion of our revenue is derived from products used to monitor and detect the presence of substances that are regulated by various government agencies. Furthermore, our growth could result in substantial liability to us and be adversely affected by the implementation of new regulations. The costs of compliance or failure to comply with any obligations related to these laws or regulations could adversely impact our business, including suspension or cessation of our operations, restrictions on our ability to expand at our present locations or requirements that we make significant capital expenditures or incur other significant expenses.
Failure to attract, retain and develop personnel, including for key management positions, could have an adverse impact on our results of operations, financial condition and cash flows.
Our growth, profitability and effectiveness in conducting our operations and executing our strategic plans depend in part on our ability to attract, retain and develop qualified personnel and align them with appropriate opportunities for key management positions and support for strategic initiatives. Our loss of any of our key employees could have a material adverse effect on us. We compete with employers in various industries for sales, manufacturing, technical services and other personnel, and this competition to hire may increase and the availability of qualified personnel may be reduced. If we are unsuccessful in our efforts to attract and retain qualified personnel, our business, results of operations, financial condition, cash flows and competitive position could be adversely affected. Additionally, we could miss opportunities for growth and efficiencies. We cannot assure that we will be able to retain our existing personnel or attract additional qualified persons when required and on acceptable terms.
We have experienced significant management transitions, and our inability to successfully integrate new leadership could adversely affect our business and strategic initiatives.
During fiscal years 2025 and 2026, we experienced significant transitions in our senior leadership team, including our CEO, CFO and other members of our senior leadership team. Our ability to execute our strategic plan, including the continued integration of the 3M Food Safety business, maintenance of effective internal controls, and management of our indebtedness, depends in substantial part on the successful on boarding and performance of our new leadership team. New members of senior management may have different perspectives on strategy, operations, and risk management, which could result in changes to our business plans or strategic direction. There can be no assurance that our new leadership team will be able to work together effectively, retain the confidence of our employees, customers, and investors, or successfully execute our strategic priorities. If our new leadership team is unable to effectively manage these challenges, or if we experience unplanned departures of key personnel, our business, results of operations, financial condition, and cash flows could be materially and adversely affected.
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Our business may be subject to product or service liability claims.
The manufacturing and distribution of our products and the performance of our services involves an inherent risk of liability claims being asserted against us. Regardless of whether we are ultimately determined to be liable or whether our products are determined to be defective, we could incur significant legal expenses not covered by insurance. In addition, product or service liability litigation could damage our reputation and impair our ability to market our products and services, regardless of the outcome. Litigation also could impair our ability to retain product liability insurance or make our insurance more expensive. Although we currently maintain liability insurance, we cannot assure that we will be able to continue to obtain such insurance on acceptable terms, or that such insurance will provide adequate coverage against all potential claims. If we are subject to an uninsured or inadequately insured product or services liability claim, our business, financial condition and results of operations could be adversely affected.
Regulatory actions, product recalls, or the loss of required regulatory approvals for our products could materially harm our business and reputation.
Certain of our products are subject to regulatory approval or registration requirements in the jurisdictions in which they are marketed and sold, including approvals or registrations from the U.S. Department of Agriculture, the U.S. Food and Drug Administration, the Environmental Protection Agency, and their international equivalents. If a regulatory authority determines that any of our products does not comply with applicable requirements, or if product defects or performance failures are identified, we could be required to recall or withdraw affected products from the market, cease manufacturing or distribution, or undertake costly corrective actions. A product recall or regulatory withdrawal could expose us to significant expenses, including costs of notification, retrieval, remediation, and potential fines or penalties. Moreover, because our food safety products are relied upon by customers to detect contaminants and ensure the safety of the food supply, a failure in our products that results in undetected contamination could lead to serious public health consequences, substantial product liability claims, regulatory enforcement actions, loss of customer confidence, and significant reputational damage. Any such event could have a material adverse effect on our business, results of operations, financial condition, and cash flows.
Changing political conditions could adversely impact our business and financial results.
Changes in the political conditions in markets in which we manufacture, sell or distribute our products are difficult to predict and could affect our business and financial results adversely. In addition, results of elections, referendums or other political processes in certain markets in which our products are manufactured, sold, or distributed could create uncertainty regarding how existing governmental policies, laws and regulations may change, including with respect to sanctions, taxes, the movement of goods, services, capital and people between countries and other matters. The potential implications of such uncertainty, which include, among others, exchange rate fluctuations, trade barriers and market contraction, could adversely affect our business and financial results.
Climate change, or legal, regulatory or market measures to address climate change could materially adversely affect our financial condition and business operations.
Climate change resulting from increased concentrations of carbon dioxide and other greenhouse gases in the atmosphere could present risks to our future operations from natural disasters and extreme weather conditions, such as hurricanes, tropical storms, blizzards, tornadoes, earthquakes, wildfires or flooding. Such extreme weather conditions could pose physical risks to our facilities and disrupt our operations and impair our critical systems, and may impact raw material sourcing, manufacturing operations, the distribution of our products and our operational costs. Damage or destruction of our facilities may result in losses that exceed our insurance coverage. The impacts of climate change on global water resources may result in water scarcity, which could impact our ability to access sufficient quantities of water in certain locations and result in increased costs. Concern over climate change could result in new legal or regulatory requirements designed to mitigate the effects of climate change on the environment. If such laws or regulations are more stringent than current legal or regulatory requirements, we may experience increased compliance burdens and costs to meet the regulatory obligations.
Our business could be adversely impacted by an inability to meet the expectations of our stakeholders related to environmental, social and governance (ESG) objectives.
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Various stakeholders, including customers, suppliers, providers of debt and equity capital, regulators, and those in the workforce, are increasing their expectations of companies to do their part to combat global climate change and its impact and to conduct their operations in an environmentally sustainable and socially responsible manner with appropriate oversight by senior leadership. We have made certain public commitments to reduce emissions, conserve resources at our various facilities and further develop a diverse, equitable and inclusive culture. A failure to respond to the expectations and initiatives of our stakeholders or to achieve the commitments we have made, could result in damage to our reputation and relationships with various stakeholders, as well as adversely impact our financial condition due to volatility in the cost or availability of capital, difficultly obtaining new business, or entering into new supplier relationships, a possible loss of market share on our current product portfolio, or difficulty attracting and retaining a skilled workforce.
Tax legislation could materially adversely affect our financial results and tax liabilities.
Our business is subject to tax-related external conditions, such as tax rates, tax laws, and regulations, changing political environments in the U.S. and foreign jurisdictions that impact tax examination, assessment and enforcement approaches. In addition, changes in tax laws including further regulatory developments arising from U.S. tax reform legislation and/or regulations around the world could result in a tax expense or benefit recorded to our consolidated statement of earnings. In connection with guidance such as the Base Erosion and Profit Shifting (BEPS) Integrated Framework provided by Organization for Economic Cooperation and Development (OECD), determination of multi-jurisdictional taxation rights and the rate of tax applicable to certain types of income may be subject to potential change. In particular, the OECD’s Pillar Two framework, which establishes a global minimum effective tax rate of 15%, has been adopted or is in the process of being adopted by numerous jurisdictions in which we operate. As a result, we may face incremental tax liabilities, compliance costs, or restructuring needs as Pillar Two rules take effect in applicable jurisdictions . Due to uncertainty of the regulation changes and other tax-related factors stated above, it is currently not possible to assess the ultimate impact of these actions on our financial statements.
Additionally, U.S Congress enacted the One Big Beautiful Bill Act (“OBBBA”) which includes significant provisions, including tax cut extensions and modifications to the international tax framework. While we continue to evaluate the impact of these legislative changes as additional guidance becomes available, uncertainty remains regarding the timing and interpretation by tax authorities in affected jurisdictions. These legislative changes could have an adverse impact on our future effective tax rate, tax liabilities, and cash tax.
Although we believe that our historical tax positions are sound and consistent with applicable laws, regulations and existing precedent, there can be no assurance that our tax positions will not be challenged by relevant tax authorities or that we would be successful in any such challenge. Given the complexity of our international structure, including intercompany arrangements among our U.S. and international subsidiaries, we face heightened exposure to transfer pricing challenges and adjustments by tax authorities in multiple jurisdictions. Income tax audits associated with the allocation of income and other complex issues, including transfer pricing, could result in significant income tax adjustments that could negatively impact our future operating results.