What changed in this filing

/stocks — the workspaceLOADING

Item 1A. Risk Factors

2025-08-22 compared with 2024-08-22 · 26 added, 19 removed, 323 unchanged (12% of the section changed)

52 unchanged sentences

Research and development spending by our customers and the availability of government research funding can fluctuate due to changes in available resources, mergers of pharmaceutical and biotechnology companies, spending priorities, general economic conditions and institutional and governmental budgetary policies.

Our Diagnostics and Genomics segment products include applications in the medical diagnostics market, which relies largely on government healthcare-related policies and funding.

Our Diagnostics and Spatial Biology segment products include applications in the medical diagnostics market, which relies largely on government healthcare-related policies and funding.

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 uses, we are currently seeking expanded coverage from public payors as well as coverage decisions regarding reimbursement from additional private payers.

However, the process and timeline for obtaining coverage decisions is uncertain and difficult to predict.

Further, 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.

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.

All of these payor actions and changes may have a material adverse effect on revenue and earnings associated with our diagnostics products.

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

Acquisition and Investment Risks

7 unchanged sentences

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 completed the acquisition of Lunaphore SA, a leading developer of fully automated spatial biology solutions.

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.

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.

137 unchanged sentences

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 China and the UK, and approximately 43% of our revenue in fiscal 2024 was from outside 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.

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

39 unchanged sentences

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, including tax reform under the Tax Cuts and Jobs Act which became effective in late 2017, which included broad and complex changes

to the United States tax code.

Interpretations, assumptions and guidance regarding the Tax Act that have been issued subsequently have had a material impact on our effective tax rate, and we anticipate that there may be additional changes to the U.S.

tax code under a new Administration.

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 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.

3 unchanged sentences

For many years, our Board has declared quarterly dividends.

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

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.

Legal, Regulatory, Compliance and Reputational Risks

37 unchanged sentences

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.

For example, the previous U.S.

administration increased tariffs on certain goods imported into the United States and trade tensions between the United States and China escalated, with each country imposing significant additional tariffs on a wide range of goods imported from the other country.

That trade tension has not diminished under the current U.S.

administration.

and China could impose other types of restrictions such as limitations on government procurement or technology export restrictions, which could affect our access to markets.

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.

Beginning in early April 2025, the U.S.

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

Many of these tariffs and announcements underwent continued revision, with certain tariff levels increasing while others decreased.

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.

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.

As a result of any surcharge or price increase, there may be an adverse impact on the demand for our products, as well as an adverse impact as to our ability to serve the market in certain countries.

The increased cost of importing raw materials and components from certain countries may disrupt our supply chains, with related impacts to our operations.

In addition, whenever we are unable to fully recover higher costs, or whenever there is a time delay between the increase in costs and our ability to recover these costs, our margins and profitability can decline.

and/or other countries may implement additional tariffs and/or other responsive or retaliatory measures, and which would exacerbate the risks and adverse effects noted above.

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.

27 unchanged sentences

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 resting services.

If the Company does not comply with existing or new laws and regulations related to protecting the privacy and security of personal or health information, it could be subject to monetary fines, civil penalties or criminal sanctions.

In the U.S., the Health Insurance Portability and Accountability Act of 1996 (HIPAA) privacy and security regulations, including the expanded requirements under U.S.

3 unchanged sentences

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