What changed in this filing

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Item 1A. Risk Factors

2026-08-24 compared with 2025-08-22 · 90 added, 39 removed, 310 unchanged (29% of the section changed)

14 unchanged sentences

If growth in the global economy or in any of the markets we serve slows for a significant period, if there is significant deterioration in the global economy or such markets or if improvements in the global economy do not benefit the markets we serve, our business and financial results can be adversely affected.

International political, compliance and business factors, including the military conflict in Ukraine, Israel’s conflict in Gaza, and trade tensions between the U.S.

and China, can negatively impact our operations and financial results.

International political, compliance and business factors, including the military conflicts and trade tensions, can negatively impact our operations and financial results.

We engage in business globally, with approximately 48% of our sales revenue in fiscal 2026 coming from outside the U.S.

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For example, Congress and the U.S.

administration have sought to impose changes to healthcare in the United States, including government negotiation/regulation of drug prices paid by government programs.

administration have sought to impose changes to healthcare in the U.S., including government negotiation/regulation of drug prices paid by government programs.

Such impacts could negatively impact certain markets we serve, resulting in an adverse impact on our sales revenue.

Political and military conflicts may disrupt our business or negatively impact global economic or business conditions.

For example, Russia’s military invasion of Ukraine, and the response by the US and European countries to that invasion, have caused severe political, humanitarian and economic crises, not only in Europe but globally.

For example, Russia’s military invasion of Ukraine, and the response by the US and European countries to that invasion, have

caused severe political, humanitarian and economic crises, not only in Europe but globally.

Restrictions on trade, particularly involving certain foods and energy supplies, have increased prices, led to widespread inflation and otherwise aggravated economic challenges.

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Changes in government reimbursement for certain diagnostic tests or reductions in overall healthcare spending could negatively impact us directly or our customers and, correspondingly, our sales to them.

For example, our Exosome Diagnostics business develops and sells novel exosome-based diagnostic tests.

While we received public payer coverage for certain indications, we have also sought expanded coverage from public payors as well as coverage decisions regarding reimbursement from additional private payers.

The process and timeline for obtaining coverage decisions is uncertain and difficult to predict, and reimbursement reductions due to changes in policy regarding coverage of tests or other requirements for payment (such as prior authorization, diagnosis code and other claims edits, or a physician or qualified practitioner’s signature on test requisitions) may be implemented from time to time.

Additionally, the U.S.

government’s plans to manage prescription drug prices, as well as its recently announced intention to regulate lab developed tests, may impact the customers and industries we serve by increasing the cost of commercializing and/or limiting the profitability of commercialized products.

government’s negotiation of most favored nation pricing on certain prescription drugs, and the potential for expansion of this program, may impact the customers and industries we serve by increasing the cost of commercializing and/or limiting the profitability of commercialized products.

In addition, the potential for expanded regulation of lab developed tests may, if such regulation were implemented, also impact the customers and industries we serve by increasing the cost of commercializing and/or limiting the profitability of commercialized products.

Payor actions and changes may have a material adverse effect on revenue and earnings associated with our diagnostics products and services.

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As part of our business strategy, we acquire businesses, make investments and enter into joint ventures and other strategic relationships in the ordinary course of business, and we also from time to time complete more significant transactions.

At the beginning of this fiscal year, we invested in Spear Bio and at the beginning of fiscal year 2024 we completed the acquisition of Lunaphore, a leading developer of fully automated spatial biology solutions.

At the beginning of fiscal 2025, we invested in Spear Bio and, at the beginning of fiscal 2024, we completed the acquisition of Lunaphore, a leading developer of fully automated spatial biology solutions.

Bio-Techne also obtained a 19.9% ownership stake in Wilson Wolf and will acquire the remaining ownership no later than the end of calendar year 2027.

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The market for highly skilled workers and leaders in our businesses, particularly in the areas of science and technology, is extremely competitive.

While retention improved in fiscal 2025, a number of our businesses and departments continued to face recruitment and retention challenges, and faced labor availability constraints and inflationary costs.

In fiscal 2026, a number of our businesses and departments continued to face recruitment and retention challenges, and faced labor availability constraints and inflationary costs.

Our growth by acquisition also creates challenges in retaining employees.

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Security breaches of systems provided or enabled by us, regardless of whether the breach is attributable to a vulnerability in our products or services, or security breaches of third party systems we rely on to process, store or transmit electronic information, can result in the misappropriation, destruction or unauthorized disclosure of confidential information or personal data belonging to us or to our employees, partners, customers, patients or suppliers.

These attacks, breaches, misappropriations and other disruptions and damage can interrupt our operations or the operations of our customers and partners, delay production and shipments, result in theft of our and our customers’ intellectual property and trade secrets, result in disclosure of personally identifiable information, damage customer, patient, business partner and employee relationships and our reputation and result in defective products or services, legal claims and proceedings, liability and penalties under privacy laws and increased costs for security and remediation, in each case resulting in an adverse effect on our business and financial results.

These attacks, breaches, misappropriations and other disruptions and damage can interrupt

our operations or the operations of our customers and partners, delay production and shipments, result in theft of our and our customers’ intellectual property and trade secrets, result in disclosure of personally identifiable information, damage customer, patient, business partner and employee relationships and our reputation and result in defective products or services, legal claims and proceedings, liability and penalties under privacy laws and increased costs for security and remediation, in each case resulting in an adverse effect on our business and financial results.

In addition, our information technology systems require an ongoing commitment of significant resources to maintain and enhance existing systems and develop or integrate new systems to keep pace with continuing changes in information processing technology, evolving legal and regulatory standards, evolving customer expectations, changes in the techniques used to obtain unauthorized access to data and information systems, and the information technology needs associated with our changing products and services.

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As a global organization, we are subject to data privacy and security laws, regulations, and customer-imposed controls in numerous jurisdictions as a result of having access to and processing confidential, personal and/or sensitive data in the course of our business.

For example, in the United States, a small number of our businesses are subject to HIPAA.

Entities that violate HIPAA due to a breach of unsecured patient health information, or that arise from a complaint about privacy practices or an audit by the HHS, may be subject to significant civil, criminal and administrative fines and penalties and/or additional reporting and oversight obligations if required to enter into a resolution agreement and corrective action plan with HHS to settle allegations of HIPAA non-compliance.

Individual states regulate data breach and security requirements, and multiple governmental bodies assert authority over aspects of the protection of personal privacy.

Most notably, in the last several years, some states, including California, Virginia, Utah, Colorado and Connecticut, have passed broad privacy legislation that could result in more material impacts as implementing regulations are issued.

Most notably, an increasing number of states, including California, Virginia, Utah, Colorado and Connecticut, have passed broad privacy legislation that could result in more material impacts as implementing regulations are issued.

European laws require us to have an approved legal mechanism to transfer personal data out of Europe.

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The third-party insurance coverage that we maintain varies from time to time in both type and amount depending on cost, availability and our decisions regarding risk retention, and may be unavailable or insufficient to protect us against such losses.

The manufacture of many of our products is a complex process, and if we directly or indirectly encounter problems manufacturing products, our business and financial results could suffer.

The manufacture of many of our products is a complex process, and in many cases subject to complex regulations, and if we directly or indirectly encounter problems manufacturing products, our business and financial results could suffer.

The manufacture of many of our products is a complex process, due in part to strict regulatory requirements for some of our products.

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Any of these manufacturing problems could result in significant adverse impacts to our business and financial results.

For instance, our use of animal-derived materials in certain products and manufacturing processes subjects us to regulatory, supply chain, quality, and reputational risks that could adversely affect our business.

The sourcing, processing, importation, exportation, handling, storage, transportation and use of animal-derived materials are subject to complex and evolving laws, regulations and governmental oversight, including requirements administered by the USDA, APHIS, and the FDA, as well as customs authorities and comparable regulatory agencies in foreign jurisdictions.

Changes in applicable regulations, guidance, interpretations, permitting requirements, certification standards or enforcement priorities could increase our compliance costs, restrict our ability to source or distribute affected products, delay shipments, interrupt manufacturing activities or adversely affect customer demand.

If we cannot adjust our manufacturing capacity or the purchases required for our manufacturing activities to reflect changes in market conditions or customer demand, our business and financial results may suffer.

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Although most of our raw materials are available from a number of potential suppliers, our operations also depend upon our ability to obtain raw materials at reasonable prices.

If we are unable to obtain the materials we need at a reasonable price, we may not be able to produce certain of our products or we may not be able to produce certain of these products at a marketable price, which could have an adverse effect on our results of operations.

we are unable to obtain the materials we need at a reasonable price, we may not be able to produce certain of our products or we may not be able to produce certain of these products at a marketable price, which could have an adverse effect on our results of operations.

Climate change and/or related environmental risks, or legal or regulatory measures to address climate change and/or related environmental risks, may negatively affect us.

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For example, we have significant operations in California, where serious drought has made water less available and more costly and has increased the risk of wildfires.

Changes in climate patterns leading to extreme heat waves or unusual cold weather at some of our locations can lead to increased energy usage and costs, or otherwise adversely impact our facilities and operations and disrupt our supply chains and distribution systems.

Changes in climate patterns leading to extreme heat waves or unusually cold weather at some of our locations can lead to increased energy usage and costs, or otherwise adversely impact our facilities and operations and disrupt our supply chains and distribution systems.

Concern over climate change can also result in new or additional legal or regulatory requirements designed to reduce greenhouse gas emissions or mitigate the effects of climate change on the environment.

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In addition, if one or more of these third-party package-delivery providers were to increase prices, and we were not able to find comparable alternatives or make adjustments in our delivery network, our profitability could be adversely affected.

The proposed acquisition of the Company by Merck KGaA, Darmstadt, Germany may disrupt or adversely affect our business, prospects, financial condition and results of operations.

On June 25, 2026, the Company entered into the Merger Agreement with Parent and Merger Sub.

The Merger Agreement provides that, on the terms and subject to the conditions set forth therein, Merger Sub will merge with and into the Company, with the Company surviving the Merger as a wholly-owned subsidiary of Parent.

At the Effective Time, each share of the Company’s common stock, other than Company Restricted Stock (as defined in the Merger Agreement), issued and outstanding immediately prior to the Effective Time, other than Excluded Shares (as defined in the Merger Agreement), will be converted into the right to receive $73.00 in cash, without interest and less any required tax withholdings.

The completion of the Merger remains subject to the satisfaction or waiver of the conditions set forth in the Merger Agreement, including receipt of required regulatory approvals and approval by the Company’s shareholders.

The announcement and pendency of the Merger could cause disruptions in and create uncertainty surrounding our business, which could have an adverse effect on our business, prospects, financial condition and results of operations, regardless of whether the Merger is completed.

During the period from the execution of the Merger Agreement until the earlier of the Effective Time and the termination of the Merger Agreement, we are required to use commercially reasonable efforts to conduct our operations in all material respects in the ordinary course of business and to maintain our existing relations and goodwill with governmental entities, customers, suppliers, distributors, creditors, lessors and employees.

Subject to specified exceptions, the Merger Agreement also restricts us from taking certain actions without Parent’s prior written consent, which consent may not be unreasonably withheld, delayed or conditioned.

These restrictions could affect our ability to execute our business strategies, pursue acquisitions or other business opportunities, make capital investments, incur indebtedness, manage our workforce and compensation arrangements, enter into or modify material contracts, respond effectively to competitive pressures and industry developments, and attain our financial and other goals, and these restrictions may impact our financial condition, results of operations and cash flows.

Employee retention and recruitment may be challenging before completion of the Merger, as employees and prospective employees may experience uncertainty regarding their future roles, responsibilities, compensation or employment with the Company following the Merger.

Although we have entered into retention arrangements with each of our current executive officers, these arrangements may not be sufficient to retain such officers or other key employees through the completion of the Merger or thereafter.

If, despite our retention and recruiting efforts, key employees depart or prospective key employees fail to accept employment with the Company because of issues relating to the uncertainty surrounding the Merger, anticipated organizational changes or a desire not to remain with the combined company, our business, financial condition and results of operations could be adversely affected.

The announcement and pendency of the Merger could also disrupt our business relationships.

Customers, suppliers, distributors, collaborators, service providers, creditors and other business partners may experience uncertainty as to the future of such relationships and may delay or defer certain business decisions, seek alternative relationships with third parties, reduce or discontinue their business with us, or seek to alter their present business with us.

Parties with whom we otherwise may have sought to establish business relationships may seek alternative relationships with third parties.

The pursuit of the Merger and preparation for the potential integration of the Company with Parent may place a significant burden on management and our internal resources.

The diversion of management’s attention away from our day-to-day business operations could adversely affect our business, financial condition and results of operations.

We may also become subject to shareholder litigation or other legal proceedings relating to the Merger or the other transactions contemplated by the Merger Agreement.

Such litigation may name the Company, members of our Board of Directors or our officers as defendants and could seek, among other things, to enjoin or otherwise prevent or delay completion of the Merger.

We cannot predict whether any such proceeding will be brought or the outcome of any such proceeding, including the amount of costs associated with defending or resolving such claims or any other liabilities that may be incurred.

If a plaintiff were successful in obtaining an injunction prohibiting the parties from completing the Merger on the agreed-upon terms, such an injunction could delay completion of the Merger or prevent the Merger from being completed.

Whether or not any claim is successful, transaction-related litigation could result in significant costs and divert management’s attention and resources, which could adversely affect our business, financial condition and results of operations.

We have incurred and expect to continue to incur substantial transaction-related fees and costs in connection with the Merger.

We have incurred and expect to continue to incur significant costs, expenses and fees for professional services, such as legal, financial and accounting fees, and other transaction costs in connection with the Merger.

A material portion of these expenses are payable by us whether or not the Merger is completed and may relate to activities that we would not have undertaken other than to complete the Merger.

If the Merger is not completed, we will have received little or no benefit from such expenses.

Further, although we have assumed that a certain amount of transaction expenses will be incurred, factors beyond our control could affect the total amount or the timing of these expenses.

Many of the expenses that will be incurred, by their nature, are difficult to estimate accurately.

These costs could adversely affect our business, financial condition and results of operations.

The Merger may not be completed within the expected timeframe, or at all, and a significant delay in or the failure to complete the Merger could adversely affect our business and the market price of our common stock.

The consummation of the Merger is subject to customary and other closing conditions, including:

● the approval of the Merger Agreement (including the “plan of merger” for purposes of the Minnesota Business Corporation Act) by the affirmative vote of the holders of a majority of the voting power of all of the Shares outstanding and entitled to vote thereon at the meeting of the Company’s shareholders held for the purpose of voting upon the approval of the Merger Agreement;

● the expiration or termination of the required waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and all other scheduled antitrust or investment screening law approvals having been obtained (or the applicable waiting periods having expired or terminated) (such approvals in this bullet, collectively, the “Required Approvals”);

● no governmental entity of competent jurisdiction having issued or entered any order, injunction or decree or enacted, enforced, issued, promulgated, entered or adopted any law, in each case, that is continuing in effect and that prohibits, enjoins or otherwise prevents the consummation of the Merger;

● accuracy of the other party’s representations and warranties, subject to certain customary materiality or de minimis standards set forth in the Merger Agreement;

● the other party’s compliance with its obligations and covenants required under the Merger Agreement, subject to certain materiality standards;

● with respect to the obligations of Parent and Merger Sub, the Required Approvals not containing, individually or in the aggregate, a Burdensome Condition, as defined in the Merger Agreement.

Many of the conditions to the consummation of the Merger are not within our control or the control of Parent or Merger Sub, and we cannot predict when or if these conditions will be satisfied.

There can be no assurance that our business, our relationships or our financial condition will not be adversely affected, as compared to the condition prior to the announcement of the Merger, if the Merger is not consummated within the expected timeframe or at all.

Failure to complete the Merger within the expected timeframe, or at all, could adversely affect our business and the market price of our common stock in a number of ways, including the following:

● if the Merger is not completed within the expected timeframe, or at all, the share price of our common stock will change to the extent that the current market price of our stock reflects assumptions regarding the completion of the Merger;

● we have incurred, and will continue to incur, significant costs, expenses and fees for professional services and other costs in connection with the Merger, for which we may receive little or no benefit if the Merger is not completed.

Many of these fees and costs will be payable by us even if the Merger is not completed and may relate to activities that we would not have undertaken other than to complete the Merger;

● failure to complete the Merger within the expected timeframe, or at all, may result in negative publicity and a negative impression of us in the investment community and may lead to subsequent offers to acquire the Company at a lower price or otherwise on less favorable terms to us and our shareholders than contemplated by the Merger;

● the impairment of our ability to attract, retain and motivate personnel, including our senior management;

● difficulties maintaining relationships with governmental entities, customers, suppliers, distributors, creditors, lessors and employees;

● upon termination of the Merger Agreement by us or Parent under specified circumstances, we would be required to pay a termination fee of approximately $230.5 million.

The Merger Agreement contains provisions that could discourage a potential competing acquirer of the Company or could result in a competing proposal being made at a lower price than it otherwise might have been.

We are subject to certain restrictions on our ability to solicit alternative acquisition proposals from third parties, to provide information to third parties and to enter into or continue discussions or negotiations with third parties regarding alternative acquisition proposals, subject to customary exceptions.

In addition, we may be required to pay Parent a termination fee of approximately $230.5 million in specified circumstances, including if the Merger Agreement is terminated in specified circumstances following our receipt of a Competing Proposal (as defined in the Merger Agreement).

These provisions could discourage a potential competing acquirer that might have an interest in acquiring all or a significant part of the Company from considering or proposing such an acquisition, including, if the Merger Agreement is terminated prior to the consummation of the Merger, after such termination of the Merger Agreement, even if it were prepared to pay a price per share higher than the price per share proposed to be paid in the Merger, or might result in a potential competing acquirer proposing to pay a lower price than it might otherwise have proposed to pay because of the added expense of the termination fee that may become payable in specified circumstances under the Merger Agreement, including, in certain circumstances, after a valid termination of the Merger Agreement in accordance with the terms thereof.

If the Merger Agreement is terminated and we decide to seek another similar transaction, we may not be able to negotiate or consummate a transaction with another party on terms comparable to, or better than, the terms of the Merger Agreement.

Intellectual Property Risks

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There can be no assurance that these agreements adequately protect our trade secrets and other proprietary rights and will not be breached, that we will have adequate remedies for any breach, that others will not independently develop substantially equivalent proprietary information or that third parties will not otherwise gain access to our trade secrets or other proprietary rights.

These risks are particularly pronounced in countries in which we do business that do not have levels of protection of corporate proprietary information, intellectual property, technology and other assets comparable to the United States.

We operate globally, with manufacturing operations in Canada, Switzerland, China and the UK, and approximately 44% of our revenue in fiscal 2025 was from outside the United States.

We operate globally, with manufacturing operations in Canada, Switzerland, China and the UK, and approximately 48% of our revenue

in fiscal 2026 was from outside the U.S.

The laws, regulations and enforcement mechanisms in other countries may in some cases be less protective of our intellectual property rights.

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These lawsuits are expensive, take significant time, and divert management’s focus from other business concerns.

If we are found to be infringing the intellectual property of others, we could be required to cease certain activities, alter

our products or processes or pay licensing fees.

If we are found to be infringing the intellectual property of others, we could be required to cease certain activities, alter our products or processes or pay licensing fees.

This could cause unexpected costs and delays which may have a material adverse effect on us.

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International markets contribute a substantial portion of our revenues, and we intend to continue expanding our presence in these regions.

The exposure to fluctuations in currency exchange rates takes on different forms.

The exposure to fluctuations in currency exchange rates takes 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.

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As a global company, we are subject to taxation in numerous countries, states and other jurisdictions.

In particular, we are affected by the impact of changes to tax laws or related authoritative interpretations in the United States.

We anticipate that there may be additional impact to us in the future from the One Big Beautiful Bill Act.

In particular, we are affected by the impact of changes to tax laws or related authoritative interpretations in the U.S.

In preparing our financial results, we record the amount of tax that is payable in each of the countries, states and other jurisdictions in which we operate.

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In the future, our Board may reduce or eliminate our common stock dividend in order to fund investments for growth, repurchase shares or conserve capital resources.

While the Merger Agreement is in effect, we are prohibited from declaring, setting aside, making or paying any dividend or other distribution with respect to our capital stock to our shareholders, whether payable in cash, stock, property or a combination thereof, other than regular quarterly cash dividends on our common stock materially consistent with our past dividend policy (including with respect to timing and record date) in quarterly amounts not to exceed those set forth in the disclosure letter delivered by Bio-Techne in connection with the Merger Agreement and with record dates consistent with the dates on which quarterly dividends have been declared.

Legal, Regulatory, Compliance and Reputational Risks

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The laws governing government contracts differ from the laws governing private contracts and government contracts may contain pricing terms and conditions that are not applicable to private contracts.

We are also subject to investigation for compliance with the regulations governing government contracts.

We are also subject to investigation for compliance with the regulations governing

government contracts.

A failure to comply with these regulations could result in suspension of these contracts, criminal, civil and administrative penalties or debarment.

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Drug Enforcement Agency (the DEA), the U.S.

Department of Health and Human Services (the DHHS), and other comparable agencies and, in the future, any changes to such laws and regulations could adversely affect us.

Department of Health and Human Services (the DHHS), the USDA, APHIS, and other comparable agencies and, in the future, any changes to such laws and regulations could adversely affect us.

In particular, we are subject to laws and regulations concerning current good manufacturing practices.

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Manufacturers of in vitro diagnostics medical devices that have been marketed and sold under the prior regulatory regime now have to comply with some of the new EU IVDR requirements, while the effective date of other requirements have been delayed.

Complying with EU IVDR, the regulation applicable to the Company, may require material modifications to our quality management systems, additional resources in certain functions, updates to technical files and additional clinical data in some cases, among other

Failure by us or by our customers to comply with the requirements of the EU IVDR, or other requirements imposed by these or similar regulatory authorities, including without limitation, remediating any inspectional observations to the satisfaction of these regulatory authorities, could result in warning letters, product recalls or seizures, monetary sanctions, injunctions to halt manufacture and distribution, restrictions on our operations, civil or criminal sanctions, or withdrawal of existing or denial of pending approvals, including those relating to products or facilities.

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Supreme Court), such as laws and policies governing foreign trade, manufacturing, and development and investment in the territories and countries where we or our customers operate, or governing the health care system and drug prices, can adversely affect our business and financial results.

Developments or changes in national laws or policies to protect or promote domestic interests and/or address foreign competition can have an adverse effect on our business and financial statements.

Developments or changes in national laws or policies to protect or promote domestic interests and/or address foreign competition, including laws and policies in areas such as trade, manufacturing, government purchasing, healthcare, intellectual property, regulatory enforcement and investment/development, can adversely affect our business and financial statements.

has announced and/or implemented new tariffs on imports from a wide range of countries, which has prompted retaliatory tariffs, or changes to existing tariffs, by a number of countries.

Developments or changes in national laws or policies to protect or promote domestic interests and/or address foreign competition, including laws and policies in areas such as trade, manufacturing, government purchasing, healthcare, intellectual property, regulatory enforcement and investment/development can have an adverse effect on our business and financial statements.

has implemented, amended, and in some cases retracted tariffs on imports from a wide range of countries, and which has in some cases prompted retaliatory tariffs, or changes to existing tariffs, by a number of countries.

Beginning in early April 2025, the U.S.

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Additionally, the U.S.

and a number of other countries have implemented a number of product- and industry- specific exclusions, though these exclusions have been subject to revision and/or announced revision as well.

As of the date of this report, a number of the recently-imposed tariffs remain in effect, including significant tariffs between the U.S.

and a number of other countries have implemented a number of product- and industry- specific

exclusions, though these exclusions have been subject to revision and/or announced revision as well.

As of the date of this report, a number of the tariffs remain in effect, including significant tariffs between the U.S.

Collectively, these tariffs have increased and will continue to increase the cost to us of supplies and components we import, as well as our cost to serve certain markets, which in turn will require us to bear significant increased costs to do business, and/or implement surcharges, and/or increase the price of certain of our products.

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Though the risks identified above in certain cases have already adversely impacted parts of our business, the full impact of these tariffs and other actions on the Company and on our business partners remains highly uncertain and subject to rapid change.

In addition, changes to laws or regulations pertraining to laboratory developed tests may adversely affect our business and financial results.

In addition, changes to laws or regulations pertaining to laboratory developed tests may adversely affect our business and financial results.

These factors have adversely affected, and in the future could further adversely affect, our business and financial results.

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Foreign Corrupt Practices Act, the UK Bribery Act and similar anti-bribery laws in other jurisdictions generally prohibit companies and their intermediaries from making improper payments to government officials for the purpose of obtaining or retaining business, and we operate in many parts of the world that have experienced governmental corruption to some degree.

Any such improper actions or allegations of such acts could damage our reputation and subject us to civil or criminal investigations in the United States and in other jurisdictions and related shareholder lawsuits, could lead to substantial civil and criminal, monetary and non-monetary penalties and could cause us to incur significant legal and investigatory fees.

Any such improper actions or allegations of such acts could damage our reputation and subject us to civil or criminal investigations in the U.S.

and in other jurisdictions and related shareholder lawsuits, could lead to substantial civil and criminal, monetary and non-monetary penalties and could cause us to incur significant legal and investigatory fees.

In addition, the government may seek to hold us liable for violations committed by companies in which we invest or that we acquire.

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Government authorities may conclude that our business practices do not comply with current or future statutes, regulations, agency guidance or case law.

Failure to obtain required regulatory clearances before marketing our products (or before implementing modifications to or promoting additional indications or uses of our products), other violations of laws or regulations, failure to remediate inspectional observations to the satisfaction of these regulatory authorities, real or perceived efficacy or safety concerns or trends of adverse events with respect to our products (even after obtaining clearance for distribution) and unfavorable or inconsistent clinical data from existing or future clinical trials can lead to FDA Form 483 Inspectional Observations, warning letters, notices to customers, declining sales, loss of customers, loss of market share, remediation and increased compliance costs, recalls, seizures of adulterated or misbranded products, fines, expenses, injunctions, civil penalties, criminal penalties, consent decrees, administrative detentions, refusals to permit importations, partial or total shutdown of production facilities or the implementation of operating restrictions, narrowing of permitted uses for a product, refusal of the government to grant 510(k) clearance, suspension or withdrawal of approvals, pre-market notification rescissions and other adverse effects.

perceived efficacy or safety concerns or trends of adverse events with respect to our products (even after obtaining clearance for distribution) and unfavorable or inconsistent clinical data from existing or future clinical trials can lead to FDA Form 483 Inspectional Observations, warning letters, notices to customers, declining sales, loss of customers, loss of market share, remediation and increased compliance costs, recalls, seizures of adulterated or misbranded products, fines, expenses, injunctions, civil penalties, criminal penalties, consent decrees, administrative detentions, refusals to permit importations, partial or total shutdown of production facilities or the implementation of operating restrictions, narrowing of permitted uses for a product, refusal of the government to grant 510(k) clearance, suspension or withdrawal of approvals, pre-market notification rescissions and other adverse effects.

Further, defending against any such actions can be costly and time-consuming and may require significant personnel resources.

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Ensuring that our internal operations and business arrangements with third parties comply with applicable laws and regulations also involves substantial costs.

More specifically, as a healthcare provider, the Company’s Exosome Diagnostics’ ExoDx Prostate business is subject to extensive regulation at the federal, state, and local levels in the U.S.

and other countries where it operates.

The Company’s failure to meet governmental requirements under these regulations, including those relating to billing practices and financial relationships with physicians, hospitals, and health systems, could lead to civil and criminal penalties, exclusion from participation in Medicare and Medicaid, and possibly prohibitions or restrictions on the use of its laboratories.

While the Company believes that it is in material compliance with all statutory and regulatory requirements, there is a risk that government authorities might take a contrary position.

Such occurrences, regardless of their outcome, could damage the Company’s reputation and adversely affect important business relationships it has with third parties.

Failure to comply with privacy and security laws and regulations could result in fines, penalties and damage to the Company ’ s reputation and have a material adverse effect upon the Company ’ s business, a risk that has been elevated with recent acquisitions that use protected health information and utilize healthcare providers for laboratory testing services.

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

What changed 10-K

Item 1A. Risk Factors