10 unchanged sentences
By delivering the highest quality products and services possible, we are committed to protecting the communities we serve.
−Removed: Our revenues come from product sales, which include consumables and hardware;
−Removed: as well as services, which include discrete and ongoing maintenance, calibration, and testing services.
+Added: Our revenues come from product sales, which include consumables and hardware, and services, which include discrete and ongoing maintenance, calibration, and testing services.
We grow our revenues organically by expanding our customer base and our product offerings, increasing sales volumes, and implementing price increases, as well as inorganically through acquisitions.
17 unchanged sentences
Sterilization and Disinfection Control
−Removed: Our Sterilization and Disinfection Control division manufactures and sells biological, chemical and cleaning indicators used to assess the effectiveness of sterilization, decontamination, disinfection and cleaning processes, including steam, hydrogen peroxide, ethylene oxide, radiation, and other processes in the pharmaceutical, medical device, and healthcare industries.
+Added: Our Sterilization and Disinfection Control division manufactures and sells biological, chemical and cleaning indicators used to assess the effectiveness of sterilization, decontamination, disinfection and cleaning processes in the pharmaceutical, medical device, and healthcare industries.
The division also provides testing and laboratory services, mainly to the dental and pharmaceutical industries.
4 unchanged sentences
We offer a variety of product formats which allow our biological indicators to be used in many types of processes and environments.
−Removed: Our biological indicator products include inoculated carriers such as spore strips or discs which require post-processing transfer to a growth media;
+Added: Our biological indicator products include:
+Added: inoculated carriers such as spore strips or discs which require post-processing transfer to a growth media;
self-contained indicators, which have the growth media already pre-packaged in crushable ampoules;
15 unchanged sentences
Our cleaning indicator products are manufactured either by inoculating a test soil onto a stainless-steel coupon or printing an ink, imitating a test soil, onto a plastic substrate.
−Removed: Test soils and inks are designed to mimic the challenge of removing blood and tissue from surgical instruments and evaluates the effectiveness of our customers' cleaning processes.
−Removed: Our Bozeman, Montana and Waldems and Munich, Germany locations manufacture our Sterilization and Disinfection Control division products, which include, among others, our EZTest®, Apex®, GKE Clean-Record® Indicators, Simicon cleaning and disinfecting indicators, PCDs and other products.
−Removed: Our Bozeman, Montana facility provides sterility assurance testing services to dental offices in the United States and Canada.
−Removed: Sterilization and disinfection control products are disposable and are used on a routine basis, thus product sales are less sensitive to general economic conditions.
+Added: Test soils and inks are designed to mimic the challenge of removing blood and tissue from surgical instruments and evaluate the effectiveness of our customers' cleaning processes.
+Added: Our facilities in Bozeman, Montana and in Waldems, Germany and Munich, Germany manufacture our Sterilization and Disinfection Control division products, which include, among others, our GKE Clean-Record® Indicators, Apex® biological indicators, EZTest® self-contained biological indicators, and PCDs.
+Added: Our Sterilization and Disinfection Control division provides sterility assurance testing services to dental offices in the United States, Europe and Canada.
+Added: Sterilization and disinfection control products are disposable and are used on a routine basis, making product sales less sensitive to general economic conditions than certain other products and services we offer.
We generate sales to end users through our direct sales personnel and independent distributors.
5 unchanged sentences
The MassARRAY® system couples mass spectrometry with end-point polymerase chain reaction ("PCR") methods, enabling highly multiplexed reactions under universal cycling conditions to provide accurate, sensitive, rapid genetic analysis.
−Removed: The MassARRAY® system is differentiated in the market by its ability to target up to 50 specific DNA variants in a single PCR reaction and run up to 384 samples on one SpectroCHIP® array, up to eight times in a full workday, with the flexibility to process additional samples overnight.
−Removed: The system allows for the testing of hundreds of mutations, including SNPs, insertions, deletions, translocations, copy number variation, and methylation makers, all in a single, efficient workflow.
−Removed: Using time-of-flight mass spectrometry, genetic variants are distinguished by analysis of their individual mass, eliminating the need for fluorescence.
−Removed: The system's integrated software provides a user-friendly interface to generate reports that identify targets and review spectra.
+Added: The MassARRAY® system is differentiated in the market by its ability to target up to 50 specific DNA variants in a single PCR reaction and run up to 384 samples on one SpectroCHIP® array, multiple times a day, with the flexibility to process additional samples overnight.
In addition to the MassARRAY® system and related consumable products, Clinical Genomics also sells services, including equipment maintenance contracts and custom laboratory services.
−Removed: About 70% of our Clinical Genomics revenues are from consumables used on a routine basis;
−Removed: sales of these products are less sensitive to general economic conditions.
−Removed: Approximately 20% of our Clinical Genomics revenues are from more discretionary hardware products that are more sensitive to general economic conditions.
+Added: Approximately 75% of our Clinical Genomics revenues are from consumables used on a routine basis;
+Added: sales of these products are less sensitive to general economic conditions and typically have higher gross margins than hardware products.
+Added: Approximately 15% of our Clinical Genomics revenues are from hardware products that may be purchased by customers on a discretionary basis and are therefore more sensitive to general economic conditions.
The remainder of Clinical Genomics revenues relate to services and support agreements.
4 unchanged sentences
Biopharmaceutical Development
−Removed: Our Biopharmaceutical Development division develops, manufactures, and sells automated systems for protein analysis (immunoassays) and peptide synthesis solutions.
−Removed: Protein analysis and peptide synthesis solutions accelerate the discovery, development, and manufacture of biological therapies, among other applications.
+Added: Our Biopharmaceutical Development division develops, manufactures, sells and services automated systems for protein analysis (immunoassays) and peptide synthesis solutions.
+Added: Immunoassays and peptide synthesis solutions accelerate the discovery, development, and manufacture of biologic therapies, among other applications.
Customers include biopharmaceutical research, development, and manufacturing teams at biopharmaceutical companies and their contract research organization partners, as well as academic research and development laboratories.
−Removed: The Biopharmaceutical Development division sells two types of products:
+Added: The Biopharmaceutical Development division sells two major categories of instruments and consumables:
(1) protein analysis solutions, which are used to test for the existence or concentration of specific proteins in a sample, and (2) peptide synthesis solutions, which automate the synthesis of peptides from amino acids;
1 unchanged sentence
The division also sells service agreements to maintain instruments sold by the division.
−Removed: Our Biopharmaceutical Development division develops and manufactures Gyrolab® xPand and Gyrolab xPlore™ hardware and software, as well as Gyrolab Bioaffy® consumable microfluidic disks (“CDs”), and Gyrolab kits and Rexxip® buffers for protein analysis in Uppsala, Sweden, while PurePep® Chorus and Symphony® instruments for peptide synthesis are developed and manufactured in Tucson, Arizona.
+Added: Our Biopharmaceutical Development division develops and manufactures Gyrolab® xPand and Gyrolab xPlore™ hardware and software, as well as Gyrolab Bioaffy® consumable microfluidic disks (“CDs”) and Gyrolab kits and Rexxip® buffers for protein analysis, in Uppsala, Sweden, while PurePep® Symphony and Chorus instruments for peptide synthesis are developed and manufactured in Tucson, Arizona.
Our PurePep® EasyClean products, a green chemistry solution to purify peptides, is a consumables product line within our peptide synthesis business.
−Removed: Most of the products manufactured in Sweden are typically invoiced in U.S.
−Removed: dollars or euros, whereas the costs to produce the products are incurred in Swedish krona.
−Removed: As a result, the Biopharmaceutical Development segment is susceptible to changes in foreign currency.
+Added: Most of the products manufactured in Sweden are sold in United States "U.S." dollars or euros, whereas the costs to produce the products are incurred in Swedish krona.
+Added: As a result, the Biopharmaceutical Development segment is more susceptible to changes in foreign currency than our other divisions.
For a discussion of risks related to our non-U.S.
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The remainder of the division's sales relate to service and support agreements.
−Removed: Historically, hardware has comprised a greater portion of the division's revenues;
−Removed: softening demand for capital equipment across the biopharmaceutical industry resulted in a mix weighted more heavily toward our consumables during fiscal year 2024.
+Added: Historically, hardware has comprised a smaller portion of the division's revenues;
+Added: in fiscal year 2025, the division had higher hardware sales as it began recovering from the prior fiscal year's soft demand for capital equipment across the biopharmaceutical industry, resulting in a mix weighted more heavily toward our hardware during fiscal year 2025.
We generate sales to end users through direct sales as well as through independent foreign distributors.
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We believe we are one of the leading world-wide suppliers of protein analysis and peptide synthesis equipment to the biologics discovery and development markets.
−Removed: We further believe that enhancements of our product offerings and new product development driven by our research and development team, the recognized quality of our products and support, and the ability to continue to bring novel, cutting edge products and solutions to the market will allow us to remain competitive in the growing markets we serve.
+Added: We further believe that enhancements of our product offerings and new product development driven by our research and development team, as well as the recognized quality of our products and support, and our ability to continue to bring novel, cutting edge products and solutions to the market allows us to remain competitive in the growing markets we serve.
Protein Analysis
−Removed: We develop, manufacture, and market protein analysis equipment and consumable CDs, kits, and buffers that enable the detection and quantification of a target protein in a biological or bioprocess sample.
+Added: We develop, manufacture, and market protein analysis equipment and consumable CDs, kits, and buffers that enable the detection and quantification of target proteins in biological or bioprocess samples.
Gyrolab technology is widely used across human and non-human applications, mainly for therapy development and bioprocess design.
1 unchanged sentence
The CDs and reagents are loaded into one of our instruments for processing and analysis.
−Removed: Our proprietary software then facilitates the design of experiments, interprets results, provides useful data analysis for assay optimization and decision making, and supports end user regulatory compliance.
−Removed: Our protein analysis products accelerate the development and processing of assays to obtain accurate results for pre-clinical and clinical studies as well as for upstream and downstream bioprocessing of biological therapies, thus meeting critical data and time requirements.
+Added: Our proprietary software then facilitates the design of experiments, interprets results, provides useful data analysis for assay optimization, and supports end user regulatory compliance.
+Added: Our protein analysis products accelerate the development and processing of assays to obtain accurate results for pre-clinical and clinical studies as well as for upstream and downstream bioprocessing of biological therapies, thus enabling customers to meet critical data and time requirements.
Our analytical protein technologies provide superior data consistency and accuracy while reducing labor and the attendant variability of more manual analysis methods.
1 unchanged sentence
Our peptide synthesis solutions enable customers to automate the chemical synthesis of peptides used in the creation of peptide therapies, biomaterials, cosmetics, and general research.
−Removed: Our peptide synthesizers and related consumables, including our peptide purification consumables line, facilitate the ability to efficiently produce more complex and longer peptides with higher purity.
+Added: Our peptide synthesizers and related consumables, including our peptide purification consumables line, facilitate the efficient production of more complex and longer peptides with higher purity.
Our synthesizers are designed to support regulatory compliance for end users.
1 unchanged sentence
Calibration Solutions
−Removed: Our Calibration Solutions division develops, manufactures, sells and services quality control products using principles of advanced metrology to enable customers to measure and calibrate critical parameters in applications such as environmental and process monitoring, dialysis, gas flow, air quality, and torque testing, primarily in medical device manufacturing, pharmaceutical manufacturing, laboratory, and hospital environments.
+Added: Our Calibration Solutions division develops, manufactures, sells and services quality control products using principles of advanced metrology to enable customers to measure and calibrate critical parameters in applications such as renal care, environmental and process monitoring, gas flow, air quality and torque testing, primarily in medical device manufacturing, pharmaceutical manufacturing, laboratory and hospital environments.
Generally, our Calibration Solutions products are used for quality control, safety validation, and regulatory compliance.
1 unchanged sentence
Our Calibration Solutions products are manufactured by assembling the products from purchased components and calibrating the final products.
+Added: We also install certain of our products at customer sites.
Service demand is driven by customers’ quality control and regulatory environments, which require products to be recalibrated or recertified periodically.
We generate sales through our direct sales personnel and independent distributors.
+Added: Renal Care Dialysate Meters and Consumables
+Added: Our renal care medical meters are used to test various parameters of dialysis fluid (dialysate) and the proper calibration and operation of dialysis machines.
+Added: Each meter measures some combination of temperature, pressure, pH, conductivity and flow to ensure that the dialysate has the proper composition to promote the transfer of waste products from the blood to the dialysate.
+Added: The meters provide a digital readout verifying whether a dialysis machine is working within prescribed limits and delivering properly prepared dialysate.
+Added: We manufacture two styles of medical meters;
+Added: those designed for use by dialysis machine manufacturers and biomedical technicians, and those used primarily by dialysis clinicians.
+Added: The meters for technicians are characterized by exceptional accuracy, stability and flexibility, and are used by the industry as the primary standard for the calibration of dialysis machines.
+Added: The meters designed for use by dialysis clinicians are known primarily for their ease of use, and they incorporate a built-in syringe sampling system.
+Added: These meters are used as the final quality control check on the dialysate just prior to starting treatment.
+Added: In addition to dialysate meters, we market a line of standard consumable solutions for use in dialysis clinics for calibration of our meters.
+Added: These standard solutions are regularly consumed by dialysis clinics, and thus, like the calibration services we also provide, are less impacted by general economic conditions than sales of meters.
+Added: Customers that utilize our renal care products include dialysis facilities, medical device manufacturers, and biomedical service companies.
+Added: With technological advancements in dialysis machines that include built-in calibrators, our meters designed for clinicians are subject to considerable competition in the market.
+Added: Refer to Item 1A.
+Added: Risk Factors, “Changes to dialysis methods and equipment capabilities may decrease demand for our renal care products and negatively impact our financial statements.”
Continuous Monitoring
9 unchanged sentences
We also offer support agreements and provide annual sensor recalibrations.
−Removed: We have a strong competitive position in North America but do not yet have meaningful presence in international markets.
+Added: We have a strong competitive position in North America but do not yet have a meaningful presence in markets outside of the U.S.
Key markets for our continuous monitoring systems are hospitals, pharmaceutical and medical device manufacturers, blood banks, pharmacies, and laboratory environments.
−Removed: Dialysate Meters and Consumables
−Removed: Our dialysis medical meters are used to test various parameters of dialysis fluid (dialysate) and the proper calibration and operation of dialysis machines.
−Removed: Each meter measures some combination of temperature, pressure, pH, conductivity and flow to ensure that the dialysate has the proper composition to promote the transfer of waste products from the blood to the dialysate.
−Removed: The meters provide a digital readout verifying whether a dialysis machine is working within prescribed limits and delivering properly prepared dialysate.
−Removed: We manufacture two styles of medical meters;
−Removed: those designed for use by dialysis machine manufacturers and biomedical technicians, and those used primarily by dialysis clinicians.
−Removed: The meters for technicians are characterized by exceptional accuracy, stability and flexibility, and are used by the industry as the primary standard for the calibration of dialysis machines.
−Removed: The meters designed for use by dialysis clinicians are known primarily for their ease of use, and they incorporate a built-in syringe sampling system.
−Removed: These meters are used as the final quality control check on the dialysate just prior to starting treatment.
−Removed: In addition to dialysate meters, we market a line of standard consumable solutions for use in dialysis clinics for calibration of our meters.
−Removed: These standard solutions are regularly consumed by dialysis clinics, and thus, along with the calibration services that we also provide, are less impacted by general economic conditions than sales of meters.
−Removed: Customers that utilize our dialysate products include dialysis facilities, medical device manufacturers, and biomedical service companies.
−Removed: With technological advancements in dialysis machines that include built-in calibrators, our meters designed for clinicians are subject to considerable competition in the market.
−Removed: Refer to Item 1A.
−Removed: Risk Factors, “Changes to dialysis methods and equipment capabilities may decrease demand for our dialysis products and negatively impact our financial statements.”
Our data loggers are self-contained, wireless, high precision instruments used in critical manufacturing and quality control processes in the pharmaceutical, medical device, food, and tool industries.
1 unchanged sentence
In addition, data loggers can be used to validate the proper operation of laboratory or manufacturing equipment, either during installation or for annual re-certifications.
−Removed: The products consist of individual data loggers, a personal computer (“PC”) interface, software, and various accessories.
−Removed: Customers typically purchase a large number of data loggers along with a single PC interface and software package.
−Removed: In practice, the user programs the loggers to collect environmental data at pre-determined time intervals, places the data loggers into the product or process to be tested, and then collects stored process data from the data logger either through the PC interface or wirelessly via a radio link.
+Added: The products consist of individual data loggers, software, and various accessories.
+Added: Customers typically purchase a large number of data loggers along with a single interface and software package.
+Added: In practice, the user programs the loggers to collect environmental data at pre-determined time intervals, places the data loggers into the product or process to be tested, and then collects stored process data from the data logger.
The user can then prepare tabular and graphical reports using the software.
Unique aspects of our data loggers are their ability to operate at elevated temperatures and in explosive environments, which are important differentiating factors in the marketplace.
−Removed: We face competition in data logger sales from several other companies, some of which have well-established commercial organizations, particularly in Europe.
+Added: We face competition in data logger sales from several other companies, particularly in Europe.
Gas Flow Calibration and Air Sampling Equipment
We manufacture a variety of instruments and equipment for gas flow calibration and environmental air sampling.
−Removed: Our gas flow calibration instruments provide the precise standards required by laboratories and industry for the design, development, manufacture, installation and calibration of various gas flow meters and air sampling devices.
+Added: Our gas flow calibration instruments meet the precise standards required by laboratories and industry for the design, development, manufacture, installation and calibration of various gas flow meters and air sampling devices.
Our flow calibrators are used by professionals in many industries, including (1) industrial hygienists and environmental technicians, (2) calibration and research laboratories, (3) manufacturers who design, develop and manufacture gas flow metering devices, and (4) industrial engineering and manufacturing companies that utilize gas flow metering devices.
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Year ended March 31, 2024 Acquisition
−Removed: We acquired 100% of the outstanding shares of GKE GmbH and SAL GmbH on October 16, 2023, and upon approval by applicable Chinese regulators, we acquired 100% of the outstanding shares of Beijing GKE Science & Technology Co.
−Removed: (“GKE China,” and, together with GKE GmbH and SAL GmbH, “GKE”), effective December 31, 2023 ( the "GKE acquisition").
−Removed: Total consideration for the acquisition was $87,187, net of cash and financial liabilities but inclusive of working capital adjustments.
−Removed: Of the total acquisition price, approximately $9,300, at March 31, 2024 exchange rates, will be held back for a period of 18 months from the acquisition closing date as security against potential indemnification losses.
−Removed: GKE develops, manufactures and sells a highly competitive portfolio of chemical sterilization indicators, biologics, and process challenge devices to protect patient safety across global healthcare markets.
−Removed: GKE is included in our Sterilization and Disinfection Control ("SDC") division, and GKE's strengths in biologic indicators are complementary to SDC's strengths in biologic indicators, as chemical and biologic indicators are used in the same sterility validation workflows.
+Added: We acquired 100% of the outstanding shares of GKE GmbH and SAL GmbH on October 16, 2023, and effective December 31, 2023, we acquired 100% of the outstanding shares of Beijing GKE Science & Technology Co.
+Added: (“GKE China” and together with GKE GmbH and SAL GmbH, “GKE” or the "GKE acquisition.") Total consideration for the acquisition was $87,187, net of cash acquired and financial liabilities assumed, but inclusive of working capital adjustments.
+Added: In April 2025, we paid the GKE sellers $9,555 to settle in full the portion of the transaction price that was held back against potential indemnification losses upon acquisition.
+Added: GKE develops, manufactures and sells a portfolio of chemical sterilization indicators, biologics, and process challenge devices to protect patient safety across global healthcare markets.
+Added: GKE is included in our Sterilization and Disinfection Control ("SDC") division, and GKE's strengths in chemical indicators are complementary to SDC's strengths in biologic indicators, as chemical and biologic indicators may be used in the same sterility validation workflows.
Additionally, GKE’s healthcare-focused commercial capabilities in Europe and Asia greatly expand our reach in the healthcare markets in those geographies.
2 unchanged sentences
Financial Statements and Supplementary Data for further information.
−Removed: Year ended March 31, 2023 Acquisition
−Removed: On November 17, 2022, we acquired substantially all of the assets and certain liabilities of Belyntic GmbH’s peptide purification business (“Belyntic” or the “Belyntic acquisition”) for a total cash price of $6,450, of which $4,950 was paid on the date of acquisition.
−Removed: The remaining $1,500 is due to the Belyntic sellers as patent applications are approved (see Note 13.
−Removed: "Commitments and Contingencies" in Item 8.
−Removed: Financial Statements and Supplementary Data ).
−Removed: The business complements our existing peptide synthesis business, part of the Biopharmaceutical Development segment, by adding a consumables line that can be used with the instruments we sell.
−Removed: These PurePep® EasyClean products are an environmentally conscious chemistry solution to purify peptides.
−Removed: Year Ended March 31, 2022 Acquisition
−Removed: On October 20, 2021, we completed the acquisition of 100% of the outstanding shares of Agena Bioscience, Inc.
−Removed: (“Agena” or “the Agena acquisition”) for adjusted cash consideration of $300,793.
−Removed: Agena is a leading clinical genomics tools company that develops, manufactures, markets and supports proprietary instruments and related consumables that enable genetic analysis for a broad range of research applications.
−Removed: The acquisition of Agena moved our business toward the life sciences tools sector and expanded our market opportunities, particularly in Asia.
−Removed: Agena’s operations comprise our Clinical Genomics segment.
Manufacturing and Materials
−Removed: Most of the components, raw materials, and other supplies used in our product lines are available from a number of different suppliers.
−Removed: We generally maintain multiple sources of supply, but we are dependent on sole or limited sources for certain items, particularly in our Biopharmaceutical Division.
+Added: Most of the raw materials, components, and other supplies used in our product lines are available from a number of different suppliers.
+Added: We generally maintain multiple sources of supply, but we are dependent on sole or limited sources for certain items, particularly in our Biopharmaceutical Development and Calibration Solutions divisions.
We continue to emphasize reviewing our supply base and designs for limited source suppliers that might affect our ability to supply critical products to our customers.
1 unchanged sentence
See further discussion within Item 1A.
−Removed: Risk Factors, “We face numerous manufacturing and supply chain risks.
+Added: Risk Factors, “Supply chain and manufacturing risks could adversely affect our financial results.
In addition, our reliance upon sole or limited sources of supply for certain materials, components and services could cause production interruptions, delays and inefficiencies .
4 unchanged sentences
Backlog as of March 31, 2025 and 2024 was approximately $43.2 million and $25.5 million, respectively.
−Removed: The decrease in backlog is primarily due to decreases in the Clinical Genomics division attributable to lower customer orders in the fourth quarter of fiscal year 2024 compared to the fourth quarter of fiscal year 2023 and, to a lesser extent, abated supply chain issues in our Calibration Solutions division during fiscal year 2024 which allowed us to fulfill previously outstanding orders, partially offset by the acquisition of GKE.
−Removed: Changes in our backlog are somewhat dependent upon the timing of large, recurring customer orders, which may be recognized to revenue over a period of up to twelve months, typically.
+Added: The increase in backlog is primarily due to the timing of order placements and fulfillments in our Clinical Genomics and Sterilization and Disinfection Control division in fiscal year 2025 compared to fiscal year 2024.
+Added: The majority of the backlog increase does not relate to overdue order fulfillments.
+Added: Changes in our backlog are somewhat dependent upon the timing of large, recurring customer orders, which are typically recognized to revenue over a period of up to twelve months.
Research and Development
−Removed: Research and development ("R&D") activities are primarily directed towards innovating new products and improving the quality and performance of our existing products or altering our current products to accommodate use of raw materials that are more readily available for purchase in our supply chain.
−Removed: Other R&D efforts seek to improve manufacturing efficiencies.
+Added: Research and development ("R&D") activities are primarily directed towards improving the quality and performance of our existing products or altering our current products to accommodate use of raw materials that are more readily available for purchase in our supply chain.
+Added: Other R&D efforts seek to improve manufacturing efficiencies and innovate new products.
Intellectual Property
3 unchanged sentences
In addition, the process of preparing, applying for, obtaining and protecting patents and other intellectual property can be long and expensive, with no assurance that a patent or other intellectual property will ultimately issue.
−Removed: We rely upon trade secrets, technical know-how and continuing technological innovation to develop and maintain our proprietary position.
+Added: We rely upon trade secrets, technical know-how and continuing technological innovation to develop and maintain our proprietary positions.
Our products and services are sold under various trade names, trademarks and brand names.
2 unchanged sentences
Regulatory Matters
−Removed: Our operations are global and are affected by complex state, federal and international laws relating to healthcare, environmental protection, antitrust, anti-corruption, marketing, fraud and abuse, import and export control, product safety and efficacy, employment, privacy, government contracts acquisition regulations, and other areas.
+Added: Our operations are global and are affected by complex state, federal and international laws relating to healthcare, environmental protection, antitrust, anti-corruption, marketing, fraud and abuse, import and export control, product safety and efficacy, employment, privacy, government contracts, acquisition regulations, tariffs and other areas.
We are required to comply with certain International Standard Organization (“ISO”) standards, United States Pharmacopeia standards and Food and Drug Administration (“FDA”) requirements in order to sell some of our products.
−Removed: Our biological indicators are developed and manufactured according to ISO 11138 (Sterilization of health care products – Biological indicators) and our chemical indicators are developed and manufactured according to ISO 11140 (Sterilization of health care products – Chemical indicators), under a quality system that complies with ISO 13485:2016 (Medical devices – Quality management systems – Requirements for regulatory purposes and, as applicable, 21 CFR 820 (Quality system regulation).
+Added: Our biological indicators are developed and manufactured according to ISO 11138 (Sterilization of healthcare products – Biological indicators) and our chemical indicators are developed and manufactured according to ISO 11140 (Sterilization of healthcare products – Chemical indicators), under a quality system that complies with ISO 13485:2016 (Medical devices – Quality management systems – Requirements for regulatory purposes and, as applicable, 21 CFR 820 (Quality system regulation).
Specific Calibration Solutions products are compliant under ISO 13485:2016, ISO 17025:2017, and certain 21 CFR 820 regulations.
6 unchanged sentences
Failure to comply with these practices renders the product adulterated and could subject us to an interruption of manufacturing and sales of these products, and possible regulatory action by the FDA.
−Removed: On April 29, 2024 the FDA announced amendments to their regulations and announced a policy to phase out, over the course of four years, its general enforcement discretion approach for lab developed tests (“LDTs”).
−Removed: We are still assessing the impact the regulatory changes will have on our results of operations, which may impact certain future U.S.
−Removed: revenues in our Clinical Genomics division.
The manufacture and sale of medical devices is also regulated by some states.
6 unchanged sentences
Although we transact business with various U.S.
−Removed: government agencies, no government contract or aggregate contracts are of such magnitude that a renegotiation of profits or termination of the contracts at the election of the government would have a material adverse effect on our financial results.
−Removed: Environmental Matters
+Added: government agencies, no government contract or aggregate contracts are of such magnitude that a renegotiation of profits or termination of the contracts at the election of the government would have a material adverse effect on our consolidated financial results or on the results of any of our individual reporting segments.
+Added: Environmental Matters and Corporate Responsibility
As a global corporate citizen, we recognize the importance of the environment to a healthy, sustainable future for our business, our customers, and our communities.
We are committed to minimizing the environmental impacts of our business operations, and we actively evaluate ways to promote rigorous sustainability standards in our operations and products, including efforts to conserve water and energy and to reduce waste.
−Removed: More information about our environmental, social, and governance (“ESG”) efforts is included in our ESG brochure, which is available on our website at www.mesalabs.com/esg.
−Removed: The contents of our ESG brochure are not incorporated by reference into this annual report on Form 10-K.
−Removed: Human Capital Management
+Added: More information about our corporate responsibility efforts is included in our corporate responsibility brochure, which is available on our website at www.mesalabs.com/corporate-responsibility.
+Added: The contents of our corporate responsibility brochure are not incorporated by reference into this annual report on Form 10-K.
+Added: Recently imposed or threatened tariffs may have an impact on our operations as discussed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations – General Trends”.
+Added: Human Capital
Our people are our greatest asset, and we are proud to outline the material aspects of our human capital program.
As a company, our vision is to Protect the Vulnerable® and we believe that our vision is achieved in large part through the strength of our workforce.
−Removed: Every day, our talented employees strive to implement lean based tools to find ways to continuously improve our products and services so that we may better serve our customers and create value for all our stakeholders.
+Added: Indeed, every day, our talented employees strive to implement lean based tools to find ways to continuously improve our products and services so that we may better serve our customers and create value for all our stakeholders.
We recruit top talent from all backgrounds using a combination of industry expert recruiters and recruiting tools to reach a diverse pool of candidates across race, gender, disability, and veteran statuses.
We support employees with compensation, benefits and development programs aimed at ensuring employees are productive and engaged.
−Removed: As of March 31, 2024, we had 736 employees (approximately 500 in the U.S.), of whom 345 are employed for manufacturing and quality assurance, 103 for research and development and engineering, 196 for sales and marketing, and 92 for administration.
−Removed: As our overall headcount has grown, we have continued to attract and retain high-performing, diverse employees at all levels of the organization.
+Added: As of March 31, 2025, we had 730 employees (including approximately 500 domestic employees), of whom 359 are employed for manufacturing and quality assurance, 89 for research and development and engineering, 186 for sales and marketing, and 96 for administration.
+Added: We have continued to attract and retain an inclusive team of high-performing employees at all levels of the organization in fiscal year 2025, such that we were able to realize higher revenues and adjusted operating income (a non-GAAP measure) compared to the prior year, without increasing employee headcount.
Our voluntary employee turnover decreased approximately 2.0 percentage points during fiscal year 2025 compared to fiscal year 2024, signaling improved employee satisfaction and engagement.
1 unchanged sentence
In recent years, we have invested heavily in our talent acquisition and development processes.
−Removed: We’ve implemented standardized assessment processes for candidate selection, created frameworks for formalized development and career paths, and developed mentoring systems.
+Added: We’ve implemented standardized assessment processes for candidate selection, created frameworks for formalized development and career paths, developed mentoring systems, and implemented regular leadership workshops.
We’ve also strengthened our succession planning processes with annual talent reviews and actions.
−Removed: Diversity and Inclusion
−Removed: We are committed to diversity and inclusion (“D&I”), and we are always working to improve in this area.
−Removed: We continue to evolve our talent acquisition process to focus on diversity.
−Removed: We make efforts to work with vendors and to consider candidates for employment from underrepresented categories.
−Removed: Our global cloud-based human capital management platform enables us to more accurately track employee representation and identify how we can better enhance our diversity around the world.
+Added: Inclusive Workforce
+Added: We maintain a commitment to foster an inclusive workplace.
+Added: We believe our employees should reflect the communities in which we live, work and serve.
+Added: In our hiring practices, we strive to attract and retain the most qualified individuals for open positions;
+Added: we seek inclusive slates of qualified applicants for all roles within Mesa in order to ensure that our workforce is comprised of individuals and teams who can cultivate sustainable, creative improvement, and who are capable of and committed to furthering our purpose of Protecting the Vulnerable®.
Employee Engagement
3 unchanged sentences
In addition to our engagement surveys, we utilize a variety of channels to facilitate open and direct communication with our employees, including:
−Removed: (i) quarterly town hall meetings with our executive team;
+Added: (i) town hall meetings with our executive and leadership teams;
(ii) internally maintained websites;
4 unchanged sentences
In determining merit increases, we evaluate individual performance—including measuring an individual's contribution to company goals and performing semi-annual performance reviews—to align financial incentives with individual contributions.
−Removed: Our compensation package includes market-competitive pay, cash bonuses, stock-based compensation to certain levels of employees, health care and retirement benefits, paid time off, paid caregiver leave, and 401(K) matching, among other benefits.
+Added: Our compensation package includes market-competitive pay, cash bonuses, stock-based compensation to certain levels of employees, healthcare and retirement benefits, paid time off, paid caregiver leave, and 401(k) matching, among other benefits.
Our total rewards program:
3 unchanged sentences
The health, safety and wellness of all employees is a top priority at Mesa:
−Removed: We deeply embed our environmental, health and safety functions within our operations and business teams to ensure top priority and focus.
+Added: We deeply embed environmental, health and safety functions within our operations to ensure these critical areas remain a top priority and focus.
We sponsor a variety of health and wellness programs designed to enhance the physical and mental well-being of our employees around the world;
2 unchanged sentences
We are subject to the reporting and other information requirements of the Securities Exchange Act of 1934, as amended (“Exchange Act”).
−Removed: We make available, free of charge, on or through our website at www.mesalabs.com under the link “Financials” in the Investor Relations section, our annual report on Form 10-K, our quarterly reports on Form 10-Q and our current reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act, and other information.
+Added: We make available, free of charge, on or through our website at www.mesalabs.com under the link “Financials” in the Investor Information section, our annual report on Form 10-K, our quarterly reports on Form 10-Q and our current reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act, and other information.
Information on our website is not incorporated into this annual report on Form 10-K and is not a part of this report.
The Securities and Exchange Commission (“SEC”) also maintains a website at www.sec.gov containing reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC.
−Removed: Our code of ethics and Board of Directors committee charters and policies are also posted on the Investor Relations section of our website.
+Added: Our code of ethics and Board of Directors committee charters and policies are also posted on the Investor Information section of our website.
The information on our website is not part of this or any other report Mesa files with, or furnishes to, the SEC.
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.