What changed in this filing

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Item 1A. Risk Factors

2026-07-30 compared with 2025-07-30 · 118 added, 60 removed, 256 unchanged (41% of the section changed)

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We may not realize the anticipated financial and other benefits, including growth opportunities, expected from the 3M Food Safety merger transaction.

We have realized and expect that we will continue to realize synergies, growth opportunities and other financial and operating benefits as a result of the Transaction.

Our success in realizing these benefits, and the timing of their realization, depends, among other things, on the continued successful integration of the business operations of the 3M Food Safety business with Neogen.

Even if we are able to integrate the 3M Food Safety business successfully, we cannot predict with certainty if or when the balance of these synergies, growth opportunities and other benefits will be realized, or the extent to which they will actually be achieved.

For example, the benefits from the Transaction could be offset by costs incurred in integrating the 3M Food Safety business.

Realization of any synergies, growth opportunities or other benefits could be affected by the factors described in other risk factors and a number of factors beyond our control, including, without limitation, general economic conditions, increased operating costs and regulatory developments.

The integration of the 3M Food Safety business with Neogen presents challenges, and the failure to successfully integrate the 3M Food Safety business could have a material adverse effect on our business, financial condition and results of operations.

Although significant progress has been made to date in the integration of the 3M Food Safety business with Neogen, there is much that remains to be accomplished, particularly in the integration of the manufacturing operations of the 3M Food Safety business with Neogen.

There is a significant degree of difficulty inherent in the process of integrating the 3M Food Safety business with Neogen.

The difficulties include:

• the integration of the 3M Food Safety business with Neogen’s current businesses while carrying on the ongoing operations of all businesses;

• managing a significantly larger company than before the consummation of the Transaction;

• integrating certain manufacturing, information technology, purchasing, accounting, finance, sales, billing, human resources, payroll and regulatory compliance systems.

The continued successful integration of the 3M Food Safety business cannot be assured.

The failure to do so could have a material adverse effect on our business, financial condition and results of operations.

Challenges with integrating the business contributed to impairment charges to the carrying value of our Food Safety reporting unit in the second and fourth quarters of fiscal 2025, and it is possible we may be required to record future impairment charges that relate, in whole or in part, to the successful integration of this business.

Pursuant to the terms of the Transaction, Neogen Food Safety Switzerland will be restricted from taking certain actions that could adversely affect the intended tax treatment of the Transaction, and such restrictions could impair Neogen’s ability to implement strategic initiatives that otherwise would be beneficial.

The Tax Matters Agreement executed in connection with the Transaction generally restricts Neogen Food Safety Switzerland from taking certain actions that could adversely affect the intended tax treatment of the Transaction.

In particular, until September 1, 2025,:

• Neogen Food Safety Switzerland will substantially continue the business activity of Neogen Food Safety Switzerland within Switzerland;

• either Neogen Food Safety Switzerland or the built-in gains related to Neogen Food Safety Switzerland’s business will remain fully subject to Tax in Switzerland;

• Neogen Food Safety Switzerland will (i) continue its business activity within Switzerland, (ii) earn remuneration consistent with arm’s-length transfer pricing practices, (iii) employ at least the number of full-time employee(s) set forth in the Tax Ruling issued by the competent Swiss Tax Authority at all times to carry out the business activity of Neogen Food Safety Switzerland will;

• Neogen Food Safety Switzerland will not merge into another Swiss entity unless, prior to such merger, Parent obtains a Tax ruling issued by the competent Swiss Tax Authority stating that such merger (I) will be non-taxable for Swiss Tax purposes, (II) will not affect the tax-free nature of the demerger of 3M EMEA GmbH and (III) will not result in any other adverse Tax affects to 3M EMEA GmbH.

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.

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;

• 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.

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

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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 new administration's trade policy, tariffs have increased and may continue to increase our material input costs.

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.

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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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In fiscal year 2026, sales to customers outside of the U.S.

accounted for 50.2% of our total revenue, compared to 49.7% and 48.4% of our total revenues in fiscal

year 2024 and 2023, respectively.

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:

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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 announced to date could have on us, any further sanctions imposed or actions taken by the U.S.

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 have material weaknesses in our internal control over financial reporting, and if we are unable to improve our internal controls, our financial results may not be accurately reported.

As disclosed in Item 9A, “Controls and Procedures,” we have identified additional material weaknesses in our internal control over financial reporting.

Specifically, we determined that we did not design, implement, and/or operate effective control activities across substantially all of the Company’s business and financial reporting processes to adequately achieve and complete accurate financial accounting, reporting, and disclosures based on the criteria established in the COSO Framework, and we identified deficiencies in the principles associated with the control activities component of the COSO Framework.

This contributed to a material weakness in control activities, either individually or in aggregate related to management not maintaining effective management review controls to adequately support certain assumptions applied in its goodwill valuation analysis.

The material weaknesses did not result in any material identified misstatements to the consolidated financial statements, and there were no changes to previously issued financial results.

These material weaknesses, potential new and additional material weaknesses that we conclude exist, and difficulties we may encounter in implementing new or improved controls or remediation efforts could prevent us from accurately reporting our financial results, result in material misstatements in our financial statements or cause us to fail to meet our reporting obligations.

These deficiencies could negatively affect our business, financial condition 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

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.

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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 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.

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.

In fiscal year 2024, we implemented our SAP enterprise resource planning (ERP) system for our U.S.

food safety business and at a manufacturing facility in Wales.

The first phase of this implementation also included upgrades to many of our existing operating and financial systems.

Such an implementation is a major undertaking, both financially and from a management and personnel perspective.

Should the subsequent phases of implementation not occur successfully, or if the systems do not perform in a satisfactory manner, our business and operations could be disrupted and our results of operations could be adversely affected, including our ability to report accurate and timely financial results.

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.

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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.

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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.

Our business sells many products through distributors, which presents risks that could negatively affect our operating results.

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 sometimes 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, if any, to cause our distributors to devote adequate resources to promoting, marketing, selling and supporting 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.

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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 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.

If any of our products are

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.

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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 us from acts committed by our employees, agents or business partners that would violate such U.S.

While we strive to maintain high standards, we cannot provide assurance that our internal controls and compliance systems always will protect

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.

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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 was monetary and non-monetary penalties, and damage to our reputation.

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.

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• competitive disadvantages relative to other companies with lower debt levels.

Our Term Loan, comprised of our Revolving 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.

Our outstanding Senior Notes also include customary events of default.

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

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.

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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 and other legal proceedings in which we are involved is subject to significant uncertainty, and we may incur losses in excess of what we currently anticipate, which could be material.

The Company is subject to certain legal and other proceedings, most of which are ordinary routine litigation matters incidental to our business.

We do not currently believe any pending litigation matter is reasonably likely to have a material adverse effect on our future results of operations or financial position.

However, because of the inherent uncertainty of outcomes from any litigation matter and because of the fact that certain of these litigation matters are in their early stages, it is possible we will incur losses relating to these litigation matters in excess of our current expectations, and it is possible such losses could have a material adverse effect on our future results of operations or financial condition.

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.

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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 protect, in the U.S.

and other countries, our products by establishing and maintaining intellectual property rights capable of protecting our technology and 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.

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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.

Certain of our products could be the subject of patent infringement challenges.

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, and also the testimony of experts as to technical facts upon which experts may reasonably disagree.

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.

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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.

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 our products are determined to be defective, we could incur significant legal expenses not covered by insurance.

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.

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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.

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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.

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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.

Income tax audits associated with the allocation of income and other complex issues could result in significant income tax adjustments that could negatively impact our future operating results.

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.

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 1A. Risk Factors