What changed in this filing

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Item 1. Business

2026-08-24 compared with 2025-08-22 · 61 added, 56 removed, 257 unchanged (31% of the section changed)

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This segment also includes proteomic analytical tools, both manual and automated, that offer researchers and pharmaceutical manufacturers efficient and streamlined options for protein analysis, automated western blot, and multiplexed ELISA workflows.

Our Diagnostics and Spatial Biology segment develops and manufactures diagnostic products, including controls, calibrators, and diagnostic assays for the regulated diagnostics market, exosome-based molecular diagnostic assays, advanced tissue-based in-situ hybridization assays and instrumentation for spatial genomic and tissue biopsy analysis, and genetic and oncology kits for research and clinical applications.

Our Diagnostics and Spatial Biology segment develops and manufactures diagnostic products, including controls, calibrators, and diagnostic assays for the regulated diagnostics market, advanced tissue-based in-situ hybridization assays and instrumentation for spatial genomic and tissue biopsy analysis, and genetic and oncology kits for research and clinical applications.

We are a Minnesota corporation with our global headquarters in Minneapolis, Minnesota.

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We have implemented a disciplined strategy to accelerate growth in part by acquiring businesses and product portfolios that leveraged and diversified our existing product lines, filled portfolio gaps with differentiated high growth businesses, and expanded our geographic scope.

Recent examples include the investment in Spear Bio at the beginning of fiscal 2025 and the acquisition of Lunaphore SA (“Lunaphore”) at the beginning of fiscal 2024.

A recent example includes the acquisition of Lunaphore SA (“Lunaphore”) at the beginning of fiscal 2024.

We also completed a 19.9% investment in Wilson Wolf Corporation (“Wilson Wolf”) in fiscal 2023, and will acquire the remaining ownership in Wilson Wolf by the end of calendar year 2027, if not earlier due to its achievement of revenue or earnings before interest, taxes, depreciation, and amortization (“EBITDA”) targets.

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We aim to deeply understand customers’ wants and needs while simultaneously offering high-quality service at every touchpoint.

Develop People Through a Transofrmative Culture.

Develop People Through a Transformative Culture.

As we continue to grow both organically and through acquisition, we are intentionally fostering an “EPIC” culture based on the ideals of Empowerment, Passion, Innovation and Collaboration.

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Key product brands include R&D Systems, Tocris Biosciences and Novus Biologicals.

Our combined chemical and biological reagents portfolio provides high quality tools that customers can use in solving complex biological pathways and glean knowledge that may lead to a more complete understanding of biological processes, and, ultimately, to the development of novel therapeutic strategies to address different pathologies.

Our combined chemical and biological reagents portfolio provides high quality tools that customers can use in solving complex biological pathways and to glean knowledge that may lead to a more complete understanding of biological processes, and, ultimately, to the development of novel therapeutic strategies to address different pathologies.

In recent years, we have made several acquisitions and investments that have expanded our product offerings for the cell and gene therapy market.

These include a significant investment in state-of-the art facilities for production of both proteins and small molecules in large quantities manufactured in accordance with cGMP, as well as a 19.9% investment in, and eventual acquisition of, Wilson Wolf, a leading provider of cell culture devices for cell-based therapies.

Through a collaborative marketing venture with Wilson Wolf and another company, we have leveraged the products we have or are developing to provide a more complete offering for the cell and gene therapy market.

Through a collaborative marketing venture with Wilson Wolf, we have leveraged the products we have or are developing to provide a more complete offering for the cell and gene therapy market.

The Analytical Solutions division includes manual and automated protein analysis instruments and immunoassays that are used in quantifying proteins in a variety of biological fluids.

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This segment also sells to diagnostic/companion diagnostic and therapeutic customers, including those engaged in the development of cell- and gene-based therapies.

Our biologics line of products in the Analytical Solutions division is used chiefly by production and quality control departments at biotech and pharmaceutical companies.

Our biologics line of products in the Analytical Solutions division is used chiefly by production and quality control departments at biotech

and pharmaceutical companies.

We sell our products directly to customers who are primarily located in North America, Europe and China, as well as through a distribution agreement with Thermo Fisher Scientific.

We also sell through third

party distributors in China, Japan, certain eastern European countries and the rest of the world.

We also sell through third party distributors in China, Japan, certain eastern European countries and the rest of the world.

Our sales are widely distributed, and no single end-user customer accounted for more than 10% of the Protein Sciences segment’s net sales during fiscal 2026, 2025, or 2024.

DIAGNOSTICS AND SPATIAL BIOLOGY SEGMENT

The Diagnostics and Spatial Biology segment, representing approximately 28% of our net revenues in fiscal 2025, includes three divisions and is focused primarily on the diagnostic and research markets and includes spatial biology, liquid biopsy, molecular diagnostics kits and products, and diagnostics reagents.

The Diagnostics and Spatial Biology segment, representing approximately 28% of our net revenues in fiscal 2026, includes two divisions and is focused primarily on the diagnostic and research markets and includes spatial biology, liquid biopsy, molecular diagnostics kits and products, and diagnostics reagents.

Diagnostics and Spatial Biology Segment Products

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In the first quarter of fiscal 2024, we closed on the acquisition of Lunaphore, a leading developer of fully automated spatial biology solutions using precision microfluidic technology capable of revealing hyperplex proteomic and transcriptomic biomarkers in tumors and other tissues at single-cell and subcellular resolution.

Lunaphore’s COMET instrument automates ACD’s RNAscope assays and utilizies antibodies to enable simultaneous hyperplex detection of protein and RNA biomarkers on the same slide at single-cell resolution.

The Molecular Diagnostics division markets and sells products and services under the Exosome Diagnostics and Asuragen brands.

The Exosome Diagnostics brand is based on exosome-based liquid biopsy techniques that analyze genes or their transcripts.

It includes the ExoDx Prostate test, which is a urine-based assay for early detection of high-grade prostate cancer used as an aid in deciding the need for biopsy in men with grey-zone prostate specific antigen (PSA) scores.

ExoDX Prostate is offered by Exosome Diagnostics as a lab-developed test.

We have also licensed exclusively the ExoTRU kidney transplant rejection test to Thermo Fisher Scientific.

We also sell products for genetic carrier screening, oncology diagnostics, molecular controls, and research under the Asuragen brand.

The Diagnostic Reagents division consists of regulated products traditionally used as calibrators and controls in the clinical setting.

Lunaphore’s COMET instrument automates ACD’s RNAscope assays and utilizes antibodies to enable simultaneous hyperplex detection of protein and RNA biomarkers on the same slide at single-cell resolution.

The Bio-Techne Diagnostic division consists of regulated products traditionally used as calibrators and controls in the clinical setting.

Also included are instrument and process control products for hematology, blood chemistry, blood gases, coagulation controls and reagents used in various diagnostic applications.

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Most of these products are sold on an Original Equipment Manufacturer (OEM) basis to instrument manufacturers, with most products being FDA-cleared.

We also sell products for genetic carrier screening, oncology diagnostics, molecular controls, and research under the Asuragen brand.

Diagnostics and Spatial Biology Segment Customers and Distribution Methods

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In addition to being useful research tools, our DNA and RNA in situ hybridization (ISH) assays have diagnostics applications, and several are cleared or currently under review by the FDA in partnership with diagnostics instrument manufacturers and pharmaceutical companies.

In the United States, we offer the ExosomeDx Prostate test to physicians using our lab-developed non-invasive urine-based assay for prostate cancer detection.

Our diagnostic laboratory is certified under and regulated by the State of Massachusetts pursuant to the Clinical Laboratory Improvement Amendments, or CLIA.

We reach our customers through physicians prescribing such tests for their patients.

This test is also available in Europe as a CE-marked product.

The Asuragen-branded products are sold primarily to laboratories for use in lab-developed tests or in kit form as regulated diagnostic tests.

The majority of Diagnostic Reagents Division’s sales are through OEM agreements, but we sell some of our diagnostic reagent products directly to customers and, in Europe and Asia, also through distributors.

The majority of Bio-Techne Diagnostic division’s sales are through OEM agreements, but we sell some of our diagnostic reagent products directly to customers and, in Europe and Asia, also through distributors.

No customer accounted for 10% or more of the reporting segment’s consolidated net sales during fiscal 2026, 2025 or 2024.

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The majority of our products are shipped within one day of receipt of the customers’ orders, other than our instruments and related cartridges, which are typically shipped within one to two weeks of receipt of an order.

There was no significant backlog of orders for our products as of the date of this Annual Report on Form 10-K or as of a comparable date.

There was no significant

backlog of orders for our products as of the date of this Annual Report on Form 10-K or as of a comparable date.

For additional discussion of risks relating to supply chain and manufacturing, refer to “Item 1A.

Risk Factors.”

Although our segments both generally operate in highly competitive markets, it is difficult to determine our competitive position, either in the aggregate or by segment, since none of our competitors offer all of the same product and service lines or serve all of the same markets as the Company, or any of its segments, does.

Because of the range of the products and services we sell, we encounter a wide variety of competitors, including a number of large, global companies or divisions of such companies with substantial capabilities and resources, as well a number of smaller, niche competitors with specialized product offerings.

Because of the range of the products and services we sell, we encounter a wide variety of competitors, including a number of large, global companies or divisions of such companies with substantial capabilities and resources, as well as a number of smaller, niche competitors with specialized product offerings.

We have seen increased competition in a number of our markets as a result of the entry of new companies into certain markets, the entry of competitors based in low-cost manufacturing locations, and increasing consolidation in particular markets.

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Bio-Techne believes there is some seasonality as a result of vacation and academic schedules of its worldwide customer base, particularly for the Protein Sciences segment.

There is also some seasonality for the ExosomeDx Prostate test, as patients tend to avoid scheduling medical appointments during the summer and other holidays.

A majority of Diagnostics Reagents division products are manufactured in large bulk lots and sold on a schedule set by the customer.

A majority of Bio-Techne Diagnostic division products are manufactured in large bulk lots and sold on a schedule set by the customer.

Consequently, sales for that division can be unpredictable, and not necessarily based on seasonality.

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GOVERNMENT CONTRACTS

Although the Company transacts business with various government entities, no government contract is of such magnitude that renegotiation of profits or termination of the contract at the election of the government entity would have a material adverse effect on the Company’s financial results.

Although the Company transacts business with various government entities, no government contract is of such magnitude that renegotiation or termination of the contract at the election of the government entity would have a material adverse effect on the Company’s financial results.

As a party to these contracts, Bio-Techne does have to comply with certain regulations that apply to companies doing business with governments.

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In fiscal 2026, we introduced over 1,900 new products.

While this is an area of focus for the Company, there is no

assurance that any of the products in the research and development phases can be successfully completed or, if completed, can be successfully introduced into the marketplace.

While this is an area of focus for the Company, there is no assurance that any of the products in the research and development phases can be successfully completed or, if completed, can be successfully introduced into the marketplace.

PENDING MERGER WITH MERCK KGAA, DARMSTADT, GERMANY

On June 25, 2026, the Company entered into the Agreement and Plan of Merger (the “Merger Agreement”), with Merck KGaA, Darmstadt, Germany, a German corporation with general partners (“Parent”) and EMD Holdings NewCo, Inc.

(“Merger Sub”), a Minnesota corporation and a wholly-owned subsidiary of Parent.

The Merger Agreement provides that, upon the terms and subject to the conditions set forth therein, Merger Sub will be merged with and into the Company (the “Merger”), with the Company surviving the Merger as a wholly-owned subsidiary of Parent.

At the effective time of the Merger (the “Effective Time”), each share of our common stock (other than Company Restricted Stock (as defined in the Merger Agreement)) that is issued and outstanding immediately prior to the Effective Time (other than Excluded Shares (as defined in the Merger Agreement)) will automatically be converted into the right to receive $73.00 in cash, without

any interest thereon and less any required tax withholdings and all of such shares of our common stock will cease to be outstanding and cease to exist.

The Merger is expected to close by late 2026 or early 2027, subject to satisfaction of customary closing conditions, including receipt of required regulatory approvals and approval by the Company’s shareholders.

For more information, see Note 1 to our Consolidated Financial Statements as of and for the fiscal year ended June 30, 2026 and our proxy statement filed with the SEC on August 20, 2026.

HUMAN CAPITAL

Through its subsidiaries, Bio-Techne employed approximately 3,100 full-time and part-time employees as of June 30, 2025, of whom approximately 2,300 were employed in the United States and approximately 800 outside the United States.

None of the United States employees are unionized.

Outside the United States, the Company has government-mandated collective bargaining arrangements or work councils in certain countries.

Through its subsidiaries, Bio-Techne employed approximately 3,000 full-time and part-time employees as of June 30, 2026, of whom approximately 2,200 were employed in the U.S.

and approximately 800 outside the U.S.

None of the U.S.

employees are unionized.

Outside the U.S., the Company has government-mandated collective bargaining arrangements or work councils in certain countries.

Bio-Techne is committed to attracting, developing, engaging, and retaining the best people possible from around the world to sustain and grow our leadership position in life sciences tools and diagnostics.

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We also engage more formally via an annual engagement survey that assesses our employees’ overall experience.

In 2025, two-thirds of our global workforce participated, and 75% of those who responded provided favorable feedback.

In fiscal 2026, three-fourths of our global workforce participated, and 77% of those who responded provided favorable feedback.

While these responses were positive, our management used the responses to inform and shape our future employee-focused initiatives.

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We believe a culture of belonging is central to drive innovation, fuel growth and help ensure our technologies and products effectively serve a global customer base.

The Company’s executive-sponsored Belonging initiative is focused on providing a welcoming working environment for all employees, continued education, broadening our candidate pools, and implementing and sustaining programs.

Under the guidance of our executive-sponsored Employee Resource Group

Council, ERGs offer mentorship, support and engagement to help our employees succeed and thrive.

The Company’s executive-sponsored Belonging initiative is focused on providing

a welcoming working environment for all employees, continued education, broadening our candidate pools, and implementing and sustaining programs.

Under the guidance of our executive-sponsored Employee Resource Group Council, ERGs offer mentorship, support and engagement to help our employees succeed and thrive.

As of June 30, 2026, we had 11 ERGs operating globally.

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The Company and its employees donate financially and by giving their time and energy.

Most sites or departments engage in local

charitable causes and activities.

Most sites or departments engage in local charitable causes and activities.

In some of our sites, employees are encouraged to give through regular payroll deductions and through the annual campaign week where employee contributions are matched by the Company.

In addition, United States employees receive a paid day off to participate in local opportunities to give back to the community as part of our volunteer time off benefit.

In addition, U.S.

employees receive a paid day off to participate in local opportunities to give back to the community as part of our volunteer time off benefit.

INTELLECTUAL PROPERTY

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Where we have been contacted by patent holders with certain intellectual property rights, Bio-Techne typically has entered into licensing agreements with patent holders under which it has the exclusive and/or non-exclusive right to use patented technology as well as the right to manufacture and sell certain patented products to the research and/or diagnostics markets.

All trademarks, trade names, product names, graphics, and logos of Bio-Techne contained herein are trademarks and registered trademarks of Bio-Techne or its subsidiaries, as applicable, in the United States and/or other countries.

All trademarks, trade names, product names, graphics, and logos of Bio-Techne contained herein are trademarks and registered trademarks of Bio-Techne or its subsidiaries, as applicable, in the U.S.

and/or other countries.

Solely for convenience, we may refer to trademarks in this Annual Report on Form 10-K without the ™ or ® symbols.

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Food, Drug and Cosmetic Act (the “FDCA”).

The FDCA requires these products, when sold in the United States, to be safe and effective for their intended uses and to comply with the regulations administered by the U.S.

The FDCA requires these products, when sold in the U.S., to be safe and effective for their intended uses and to comply with the regulations administered by the U.S.

Food and Drug Administration (“FDA”).

The FDA regulates the design, development, testing, manufacture, advertising, labeling, packaging, marketing, distribution, import and export and record keeping for such products.

The FDA regulates the design, development, testing, manufacture, advertising, labeling, packaging, marketing, distribution, import and export

and record keeping for such products.

Many medical device products are also regulated by comparable agencies in non-U.S.

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Complying with EU IVDR 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 changes.

One of our products under our Exosome Diagnostics brand is offered as a test by a certified laboratory under CLIA.

Our Asuragen business also maintains a CLIA certification.

Our Asuragen business maintains a CLIA certification.

Consequently, we must comply with state licensing regulations applicable to laboratories regulated under CLIA, governing laboratory practices and procedures.

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federal regulations discussed above and below, including the UK Bribery Act and similar anti-bribery laws.

● The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which prohibits knowingly and willfully (1) executing, or attempting to execute, a scheme to defraud any health care benefit program, including private payors, or (2) falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for health care benefits, items or services.

In addition, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, also restricts the use and disclosure of patient identifiable health information,

mandates the adoption of standards relating to the privacy and security of patient identifiable health information and requires the reporting of certain security breaches with respect to such information.

items or services.

In addition, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, also restricts the use and disclosure of patient identifiable health information, mandates the adoption of standards relating to the privacy and security of patient identifiable health information and requires the reporting of certain security breaches with respect to such information.

● The False Claims Act, which imposes liability on any person or entity that, among other things, knowingly presents, or causes to be presented, a false or fraudulent claim for payment by a federal health care program, knowingly makes, uses or causes to be made or used, a false record or statement material to a false or fraudulent claim, or knowingly makes a false statement to avoid, decrease or conceal an obligation to pay money to the U.S.

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Both directly and indirectly through our distributors, we must comply with such laws when interacting with those entities.

As Bio-Techne’s businesses also include export and import activities, we are subject to pertinent laws enforced by the U.S.

As Bio-Techne’s businesses also include export and import activities, including the export and import of products derived from animals, we are subject to pertinent laws enforced by the U.S.

Department of Agriculture, U.S.

Customers and Border Patrol, U.S.

Departments of Commerce, State and Treasury.

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laws and regulations, U.S.

companies and their subsidiaries and affiliates outside the United States are prohibited from participating or agreeing to participate in unsanctioned foreign boycotts in connection with certain business activities, including the sale, purchase, transfer, shipping or financing of goods or services within the United States or between the United States and countries outside of the United States.

companies and their subsidiaries and affiliates outside the U.S.

are prohibited from participating or agreeing to participate in unsanctioned foreign boycotts in connection with certain business activities, including the sale, purchase, transfer, shipping or financing of goods or services within the U.S.

between the U.S.

and countries outside of the U.S.

If we, or certain third parties through which we sell or provide goods or services, violate anti-boycott laws and regulations, we may be subject to civil or criminal enforcement action and varying degrees of liability.

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President, Protein Sciences

Matthew McManus

President, Diagnostics and Spatial Biology

Senior Vice President, General Counsel & Corp.

Senior Vice President, General Counsel & Corporate Secretary

Set forth below is information regarding the business experience of each executive officer.

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Hippel started his career with KPMG LLP.

Matthew McManus joined Bio-Techne on January 8, 2024 as President, Diagnostics and Spatial Biology.

Prior to Bio-Techne, Mr.

McManus most recently served as Chief Operating Officer for Azenta Life Sciences and served as Chief Executive Officer of Asuragen prior to the Bio-Techne acquisition.

William Geist has been President of the Protein Sciences segment since January 3, 2022.

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Geist most recently served as Chief Operating Officer for Quanterix, and before that in senior management roles at Thermo Fisher Scientific and QuantaBiosciences, a QIAGEN company

Shane Bohnen was promoted to General Counsel and Corporate Secretary on March 3, 2023, and has been an attorney on the Company’s legal team since July 2019.

Steve Crouse was promoted to President of the Diagnostics and Spatial Biology segment on March 1, 2026, and had served as the Senior Vice President of the Analytical Solutions Division since joining the Company in 2021.

Prior to Bio-Techne, Mr.

Crouse most recently served as a General Manager at Thermo Fisher Scientific.

Shane Bohnen has been General Counsel and Corporate Secretary since March 3, 2023, and has been an attorney on the Company’s legal team since July 2019.

Prior to joining Bio-Techne, Mr.

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

What changed 10-K

Item 1. Business