10-K
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-K
☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT of 1934
For the fiscal year ended December 31, 2025
or
☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from _________ to __________
Commission File Number 000-30833
BRUKER CORPORATION
(Exact name of registrant as specified in its charter)
40 Manning Road, Billerica, MA 01821
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number, including area code:
(978) 663-3660
Securities registered pursuant to Section 12(b) of the Act:
Title of each class Trading Symbols(s) Name of each exchange on which registered
Common Stock, $0.01 par value per share BRKR Nasdaq Global Select Market
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes☒ No ☐
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐No☒
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☒ Accelerated filer ☐
Non-accelerated filer ☐ Smaller reporting company ☐
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☒
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒
The aggregate market value of the voting and non-voting stock held by non-affiliates of the registrant as of June 30, 2025 (the last business day of the registrant’s most recently completed second fiscal quarter) was $4,251,097,535 based on the reported last sale price on the Nasdaq Global Select Market. As of February 20, 2026, there were 152,219,250 of the registrant’s common stock outstanding and 2,760,000 of the registrant’s Series A mandatory convertible preferred stock outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the information required by Part III of this report (Items 10, 11, 12, 13 and 14) are incorporated by reference from the registrant’s Definitive Proxy Statement on Schedule 14A for its 2026 Annual Meeting of Shareholders to be filed within 120 days of the close of the registrant’s fiscal year.
Table of Contents
BRUKER CORPORATION
ANNUAL REPORT ON FORM 10-K
TABLE OF CONTENTS
Page
Part I
Item 1 Business 3
Item 1A Risk Factors 21
Item 1B Unresolved Staff Comments 38
Item 1C Cybersecurity 38
Item 2 Properties 40
Item 3 Legal Proceedings 40
Item 4 Mine Safety Disclosures 40
Part II
Item 6 Reserved 42
Item 7A Quantitative and Qualitative Disclosures About Market Risk 55
Item 8 Financial Statements and Supplementary Data 58
Item 9A Controls and Procedures 126
Item 9B Other Information 126
Item 9C Disclosure Regarding Foreign Jurisdictions That Prevent Inspections 126
Part III
Item 10 Directors, Executive Officers and Corporate Governance 127
Item 11 Executive Compensation 127
Item 14 Principal Accountant Fees and Services 127
Part IV
Item 15 Exhibits, Financial Statements and Schedules 128
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Any statements contained in this Annual Report on Form 10-K that are not statements of historical fact may be deemed to be forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. Without limiting the foregoing, the words “believe,” “anticipate,” “plan,” “expect,” “seek,” “may,” “will,” “intend,” “estimate,” “should,” and similar expressions are intended to identify forward-looking statements. Forward-looking statements include, but are not limited to, statements regarding:
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the impact of supply chain challenges on our business and operations, including inventory supply problems, global supply chain challenges, changes to trade policies, financial market volatility and disruption, and other macroeconomic issues, including uncertain economic conditions in the United States and abroad;
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expectations regarding the global economy, inflation, the potential for recession and geopolitical tensions and any resulting sanctions, or wars;
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our intentions regarding our intellectual property;
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the impact of government contracts and government regulation;
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the uncertainties with respect to tariffs that have been imposed and the related impact;
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the impact of government funding decisions;
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our cost savings initiatives;
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our working capital requirements and sufficiency of cash to fund our operations and investment activities;
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our competition;
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the seasonality of our business;
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the sufficiency of our facilities;
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our employee relations and ability to attract, hire, and retain qualified employees;
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the impact of legal or intellectual property proceedings;
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the impact of changes to tax and accounting rules and changes in law, including the One Big Beautiful Bill Act (the “OBBBA”);
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our anticipated effective income tax rate;
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our expectations regarding cash dividends, share repurchases, interest expense, cross currency swap agreements, expenses, and capital expenditures;
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the impact of foreign currency exchange rates and changes in commodity prices;
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the impact of our restructuring initiatives;
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our ability to successfully complete significant acquisitions on a timely basis, including the receipt of required regulatory approvals and the satisfaction of required conditions to the completion of prospective acquisitions;
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the level and impact of our M&A activity and our ability to integrate acquired companies;
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our expectations regarding backlog and revenue; and
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any other statements that address events or developments that the Company intends or believes will or may occur in the future.
Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties, and the Company’s actual results may differ significantly from the results discussed in the forward-looking statements. Factors that might cause such differences include, but are not limited to, continued volatility in the capital markets, the impact of increased interest rates, our ability to raise capital to support our operations on favorable terms, product development and market acceptance of our products, competition, rapidly changing technologies and product obsolescence, the effects of climate change, including natural disasters, catastrophic events and other events beyond our control, and those discussed in Part I, Item 1A of this Annual Report on Form 10-K under the heading “Risk Factors.” While we may elect to update forward-looking statements in the future, we specifically disclaim any obligation to do so, even if our estimates change, and readers should not rely on those forward-looking statements as representing our views as of any date subsequent to the date of the filing of this report. References to “we,” “us,” “our,” “management” or the “Company” refer to Bruker Corporation and, in some cases, its subsidiaries, as well as all predecessor entities.
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Our principal executive offices are located at 40 Manning Road, Billerica, MA 01821, and our telephone number is (978) 663-3660. Information about Bruker Corporation is available at www.bruker.com. The information on our website is not incorporated by reference into and does not form a part of this report. All trademarks, trade names or copyrights referred to in this report are the property of their respective owners.
PART I
ITEM 1 BUSINESS
Our Business
We are a developer, manufacturer, and distributor of high-performance scientific instruments and analytical and diagnostic solutions that enable our customers to explore life and materials at microscopic, molecular and cellular levels. Many of our products are used to detect, measure and visualize structural characteristics of chemical, biological and industrial material samples. Our products and solutions address the rapidly evolving needs of a diverse array of customers in life and materials science research, biopharmaceuticals, applied markets, microbiology, in-vitro diagnostics, and nanotechnology. Our technology platforms include magnetic resonance, mass spectrometry, gas and liquid chromatography, X-ray, microscopy, metrology, and molecular spectroscopy technologies. We are enabling innovation, improved productivity, and customer success in post-genomic life science molecular and cell biology research and offer differentiated, high value life science and diagnostics systems and solutions in preclinical imaging, clinical phenomics research, proteomics and multiomics, spatial and single-cell biology, functional structural and condensate biology, as well as in clinical microbiology and molecular diagnostics. Our corporate headquarters are located in Billerica, Massachusetts. We maintain major technical and manufacturing centers in Europe and North America and have sales offices located throughout the world.
Business Segments
We have four reportable segments, Bruker Scientific Instruments (“BSI”) BioSpin, BSI CALID (Chemicals, Applied Markets, Life Science, In Vitro Diagnostics, Detection), BSI NANO, and Bruker Energy & Supercon Technologies (“BEST”), which each comprise several divisions as disclosed below. Our products, which have a particular application in structural proteomics, drug discovery, pharmaceutical and biotechnology research and production, and the food and materials science fields, primarily provide customers with the ability to determine the structure, dynamics, and function of specific molecules, such as proteins, and thus allows them to understand fundamental biological processes including the formation and progression of diseases.
BSI BioSpin Segment
The BSI BioSpin Segment comprises the following divisions:
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Magnetic Resonance Spectroscopy: Offers innovative nuclear magnetic resonance (“NMR”) and electron paramagnetic resonance (EPR) products, ranging from benchtop to ultra-high field systems. Magnetic resonance is a natural phenomenon occurring when a molecule placed in a magnetic field emits a signature radio frequency. The signature radio frequency is characteristic of the particular molecule and provides a multitude of precise chemical and structural information.
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Preclinical Imaging: Manufactures and markets solutions for in-vivo processes and drug discovery in fields including oncology, neurology, cardiology, inflammation, infectious diseases, cancer research, functional and anatomical neuroimaging, orthopedics, cardiac imaging, and stroke models. Our imaging portfolio includes single and multiple modality solutions using MRI, PET, SPECT, CT and MPI Technologies (each as defined below).
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Biopharma and Applied: Focuses on innovative solutions for emerging and applied market segments and markets comprehensive services across the entire value chain, from raw materials to finished products, and from innovation to disease prevention in pharma-biotech, cleantech, industrial, and other applied markets, as well as in the clinical market.
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Services and Lifecycle Support: Dedicated to delivering service and aftermarket solutions that complement our advanced instruments.
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Integrated Data Solution: Accelerates scientific results by automating and digitizing workflows. The vendor-agnostic platform integrates across laboratory and manufacturing ecosystems, supporting digital transformation. It offers comprehensive software solutions for workflow integration, automation, and artificial intelligence readiness, adhering to Findability, Accessibility, Interoperability, and Reusability (“FAIR”) data principles.
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Automation: Provides solutions for lab automation and digitalization in Research & Development and Quality Control. The vendor-agnostic automation complements Bruker BioSpin’s platforms in the pharma-biotech, cleantech, industrial, and other applied markets by automating and digitally transforming laboratories.
The majority of BSI BioSpin’s customers are academic and government research facilities. Other customers include pharmaceutical and biotechnology companies, battery, chemical, food and beverage, clinical and polymer companies, and nonprofit laboratories.
During 2025, we continued our focus on enhancing customer relationships and driving innovation with our key initiatives, which include expanding into high-potential markets, leveraging core strengths, and driving recurring revenue through aftermarket and connected services. With two additional successful installations of 1.2 GHz NMR systems, we continue to advance ultra-high field access, supporting studies in structural biology, pharmacology, and cellular biology, aligning with Bruker's mission to provide cutting-edge technology for scientific research.
Furthermore, during 2025, we completed certain minority investments which align with the segment’s goals of expanding its technological capabilities, entering new markets, and enhancing its product portfolio.
BSI BioSpin Segment’s instruments are based on the following technology platforms:
Instrument Name Description Market/Uses
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Instrument Name Description Market/Uses
The BSI BioSpin Segment also offers a range of services, product lifecycle support, scientific software, and workflow solutions to customers who use BSI BioSpin products.
BSI CALID Segment
The BSI CALID Segment comprises the following divisions:
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Bruker Life Sciences Mass Spectrometry: Primarily designs, manufactures, and distributes life science mass spectrometry, or MS, instruments that can be integrated and used along with sample preparation or chromatography instruments to design an analytical workflow and mass spectrometry-based solutions including informatics software. Bruker Life Science Mass Spectrometry products are used in research, pharmaceutical and biotechnology development.
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Bruker Applied Mass Spectrometry: Primarily designs solutions based on mass spectrometry for the food, environmental, forensics, clinical research, and industrial markets. Analytical areas such as toxicology, safety, authenticity, adulteration, quality control of starting and finished goods are amongst the applications covered and are used across industrial, government and academic institutes. Mass spectrometers are sophisticated devices that measure the mass or weight of a molecule, and with the addition of trapped ion mobility spectrometry (“TIMS”) and collision cross section (“CCS”), can provide accurate information on the identity, quantity, and primary structure of a molecule. We offer advanced mass spectrometry solutions combining automated robotics for sample preparation and handling, reagent kits and other disposable products used in conducting tests, or assays, with applications specific software packages.
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Bruker Microbiology and Infection Diagnostics: Develops, manufactures, and distributes innovative solutions for microbial identification, antibiotic resistance and susceptibility testing, polymerase chain reaction (“PCR”) based molecular diagnostic solutions for culture-free infectious disease diagnostics, histology, cellular staining, osmolarity testing as well as monoclonal antibodies and recombinant proteins as raw materials for diagnostic assays. Bruker Microbiology and Diagnostics solutions are used primarily in clinical microbiology, food microbiology, pharma microbiology, veterinary medicine, and infectious disease testing. In accordance with the respective market segments the products are either labeled for in-vitro diagnostic (“IVD”) use, general purpose (“GP”) or research-use only (RUO”). Our mass spectrometry solution and test kits, DNA test strips and fluorescence-based PCR technologies are designed for IVD use in clinical microbiology markets in certain configurations and certain countries, where regulatory approvals have been achieved. Our Genotype and Fluorotype molecular diagnostics (“MDx”) kits enable a culture-free detection and analysis of microbes and viruses directly from patient samples with a special focus on tuberculosis, HIV viral load, viral hepatitis and sexually transmitted diseases. Molecular Diagnostics utilize PCR assays and systems to provide diagnostic solutions
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for a number of different disease states, including respiratory, mycobacteria (including tuberculosis), virology, safety of immunocompromised patients, sexually transmitted infections, gastroenteric diseases as well as other microbiology tests. Depending on the assay being used, the technology enables users to ascertain basic identification of a certain infection, distinguish infections which can cause similar symptoms and detect specific microbial resistance, all from a single sample. Our portfolio includes FluoroType®, using fluorescence-based real-time PCR technology, and more recently we have also developed LiquidArray® assays based on melt curve analysis for optimized asymmetrical PCR technology. LiquidArray® uses light-on-off probes, providing a powerful technology to identify a broad number of indicators for different infections or resistance markers from a single sample, providing greater depth of information. Following the acquisition of ELITechGroup in 2024, our portfolio now includes InGenius and BeGenius systems which are integrated sample-to-answer PCR systems that perform automated nucleic acid extraction, specific PCR reaction and data interpretation without user interaction.
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Bruker Optics: Primarily designs, manufactures, and distributes research, analytical and process analysis instruments and solutions based on infrared and Raman molecular spectroscopy and imaging technologies. These products are utilized in industry, government, and academia for a wide range of applications and solutions for life science, pharmaceutical, food and agricultural analysis, quality control, and process analysis applications. Infrared and Raman spectroscopies are widely used in both remote sensing setups for environmental control, as well as research and industry as simple, rapid, nondestructive, and reliable techniques for applications ranging from basic sample identification and quality control to advanced research. The technologies and instruments of the division are also used for military and civil purposes in the field of detection of chemical, biological, radioactive, nuclear substances and explosives (“CBRNE”). The Bruker Optics division also utilizes Fourier transform and dispersive Raman measurement techniques on an extensive range of laboratory and process spectrometers. The Bruker Optics division’s products are complemented by a wide range of sampling accessories and techniques, which include, among others, microanalysis and high-throughput screening to help users find suitable solutions to analyze their samples effectively.
Customers of our BSI CALID Segment include pharmaceutical, biotechnology and diagnostics companies, contract research organizations, academic institutions, medical schools, nonprofit or for-profit forensic laboratories, agriculture, food and beverage safety, environmental and clinical microbiology laboratories, hospitals, and government departments and agencies.
During 2025, we continued our focus on enhancing customer relationships and driving innovation through the launch of our MOVE-T solution for the dairy markets as well as the launch of the VERTEX NEO R FTIR research spectrometer. We also introduced several other new technologies and workflows advancing proteomics and multiomics in Mass Spectrometry such as: timsOmni a novel instrument type which ushers an era of functional proteomics and proteoformanalysis; timsMetabo a benchtop 4D-Metabolomics instrument for unprecedented annotation confidence with high sensitivity; the timsUltra Athena Ion Processor (“AIP”) our instrument for ultra-high sensitivity 4D single-cell proteomics and immunopeptidomics based on the AIP technology; and the proteoElute our new nanoflow liquid chromatography system for robust, ultra-sensitive proteomics with real-time monitoring.
Furthermore, during 2025, we completed our acquisition of Recipe Chemicals + Instruments GmbH (“Recipe”), AST Revolution, LLC, as well as certain other acquisitions and minority investments.
The acquisition of Recipe, a provider of vendor-agnostic therapeutic drug monitoring and other clinical in vitro diagnostic kits for Liquid chromatography-mass spectrometry systems utilizing triple-quadrupole time-of-flight mass spectrometry, High Performance Liquid Chromatography, and Inductively coupled plasma mass spectrometry assays, enhances our capabilities in small molecule clinical diagnostic assays for our liquid chromatography triple-quadrupole mass spectrometers. The acquisition of AST Revolution, LLC, an in vitro diagnostics company supporting rapid antimicrobial susceptibility testing, further enhances and complements our product portfolio.
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The BSI CALID Segment’s instruments are based on the following technology platforms:
Instrument Name Description Market/Uses
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Instrument Name Description Market/Uses
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Instrument Name Description Market/Uses
Additionally, the Bruker Detection product line offers a wide range of portable analytical and bioanalytical detection systems and related products for CBRNE detection. Our customers use these devices for nuclear, biological agent and chemical agent defense applications, anti-terrorism, law enforcement, and process and facilities monitoring. Our CBRNE detection products use many of the same technology platforms as our life science products, as well as additional technologies, including infrared stand-off detection and ion mobility spectrometry, for handheld chemical detectors. We also provide integrated, comprehensive detection suites that include our multiple detection systems, consumables, training and simulators.
BSI NANO Segment
The BSI NANO Segment comprises of the following:
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Bruker AXS: Designs, manufactures, and distributes advanced X-ray instruments that use electromagnetic radiation with extremely short wavelengths to determine the characteristics of matter and the three-dimensional structure of molecules. The product portfolio includes instruments based on X-ray fluorescence (“XRF”), micro-X-ray fluorescence (“μXRF”) and total reflection X-ray fluorescence (“TXRF”) spectroscopy, X-ray diffraction (“XRD”), X-ray micro computed tomography (“μCT”), also called X-ray microscopy, as well as spark optical emission spectroscopy systems (“OES”) used to analyze the concentration of elements in metallic samples. The Bruker AXS Division also offers high-end scanning
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transmission electron microscopes (“STEM”) and a range of analytical tools for electron microscopes, including energy-dispersive X-ray spectrometers (“EDS”) and electron backscatter diffraction systems (“EBSD”).
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Bruker Nano Surfaces and Metrology: This division's products include atomic force microscopy instrumentation (“AFM). Such instruments provide atomic or near atomic resolution of surface topography and nanoscale, mechanical, electrical, and chemical information using nano scale probes. The Bruker Nano Surfaces and Metrology division also provides non-contact nanometer resolution solution topography through white light interferometry and stylus profilometry. In addition, the division manufacturers and markets automated X-ray metrology, automated AFM defect-detection, and photomask repair and cleaning equipment for semiconductor process control.
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Bruker Spatial Biology: Provides the CosMx Spatial Molecular Imager and GeoMx Digital Spatial Profiler technologies for interrogating spatial transcriptomics, the nCounter technology for quantitation of gene expression, the Cellscape technology for precision spatial proteomics, and the PaintScape technology for single-cell 3D visualization of genome architecture and organization. These technologies allow researchers to elucidate genomic structure and gene and protein expression in a spatial context, which is useful for characterizing the underlying biology of organs and tissues, as well as for deriving deep biological insight for the development of biomarkers. In addition, Bruker Spatial Biology offers a variety of services for transcriptional profiling and multiomic analysis, spanning the spectrum from early discovery research to translational research and clinical trials.
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The Consolidated Fluorescence Microscopy Business Unit: Provides advanced optical fluorescence microscopy instruments with multi-photon, multipoint scanning confocal, miniature head-mount, 3D super-resolution, light-sheet modalities for studies in life science applications.
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The Bruker Cellular Analysis Business Unit: Provides single-cell biology research tools to deliver deep insights into cellular function and new perspectives on phenomes and genotype-to-phenotype.
Customers of our BSI NANO Segment include academic institutions, governmental customers, nanotechnology companies, semiconductor companies, raw material manufacturers, industrial companies, biotechnology and pharmaceutical companies, and other businesses involved in materials analysis.
During 2025, we completed certain minority investments which align with the segment’s goals of expanding its technological capabilities, entering new markets, and enhancing its product portfolio.
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The BSI NANO Segment systems are based on the following technology platforms:
Instrument Name Description Market/Uses
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Instrument Name Description Market/Uses
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Instrument Name Description Market/Uses
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Instrument Name Description Market/Uses
BEST Segment
The BEST Segment designs, manufactures, and distributes superconducting materials, such as metallic low temperature superconductors (“LTS”) and high temperature superconductors (“HTS”), for use in magnetic resonance imaging, nuclear magnetic resonance, fusion energy research, and other applications in medical, clinical, pharmaceutical, high-energy physics, renewable energy, and environmental research.
BEST Segment offers a range of multifilament round and rectangular LTS wires in both monolithic and wire-in-channel formats, as well as customization to precise specifications for individual applications including radio frequency accelerator cavities and modules, power couplers, and linear accelerators. The Bruker Rod-Restack Process (“RRP®”) conductor portfolio is designed for fusion and high-energy physics applications that demand the highest magnetic fields. The BEST Segment HTS solutions support high field and ultra-high field applications using round cross-section conductor design and solenoid applications for the electrical and healthcare industries.
Additionally, BEST designs and manufactures CuponalTM which is an engineered alternative to copper wire and busbar. Cuponal high conductivity copper-clad aluminum (“CCA”) retains all the surface properties of copper and provides a cost-effective and weight-saving alternative to solid copper primarily in the aerospace industry providing weight savings and improved fuel efficiency.
BEST also manufactures and sells non-superconducting high technology tools, such as synchrotron and beamline instrumentation, principally to customers engaged in materials research and high energy physics research.
Sales and Marketing
We maintain direct sales forces throughout North America, Europe, China, Japan, and elsewhere in the Asia Pacific region, and in certain countries in Africa and South America. We also utilize indirect sales channels to reach customers. We have various
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international distributors and independent sales representatives in parts of Asia, Latin America, Africa, the Middle East, and Eastern Europe. These entities augment our direct sales force and provide coverage in areas where we do not have direct sales personnel. The sales cycle for our products is dependent on the size and complexity of the system and budgeting cycles of our customers. Our sales cycle is typically three to twenty-four months for academic and high-end research products and two weeks to six months for industrial products. The sales cycle of our low temperature superconducting materials is typically four to twelve months, with cycles of certain high-end materials exceeding one year. Sales of our high-end NMR and superconducting devices typically take more than one year and certain large, complex contracts can take more than two years to complete.
We have well-equipped applications and demonstration facilities and qualified application personnel who assist customers and provide product demonstrations in specific application areas. We maintain our primary demonstration facilities at our production facilities, as well as in other key market locations.
Seasonal Nature of Business
Historically, we have higher levels of revenue in the fourth quarter and lower levels of revenues in the first quarter of the year, which we believe is influenced by our customers’ budgeting cycles.
Major Customers
We have a broad and diversified customer base, and we do not depend on any single customer. No single customer accounted for more than 10% of revenue in any of the last three fiscal years through December 31, 2025, nor more than 10% of accounts receivable as of December 31, 2025, and 2024.
Competition
Our existing products and solutions and any products and solutions that we develop in the future may compete in multiple, highly competitive markets. In addition, there has been a trend towards consolidation in our industries and some of our competitors have substantially greater financial, technical, and marketing resources than we do. Our competitors may succeed in developing and offering products that could render our products or those of our strategic partners obsolete or noncompetitive. Our competitors may also have cost and price advantages based upon the value of their currencies compared with the U.S. Dollar or Euro. In addition, some of these competitors have significantly more experience in the life sciences, chemical, and materials markets. Our ability to compete successfully will depend on our ability to develop proprietary products that reach our target markets in a timely manner and are technologically superior to and/or less expensive, or more cost effective, than products marketed by our competitors. Current competitors or other companies may possess or develop technologies and products that are more effective than ours. Our technologies and products may be rendered obsolete or uneconomical by technological advances or by entirely different approaches developed by one or more of our competitors.
We also compete with companies that provide analytical, or automation tools based on technologies other than those we offer. These technologies may prove to be more successful in meeting demands in the markets that our products and solutions are intended to serve. In addition, other companies may choose to enter our fields in the future. We believe that the principal competitive factors in our markets are technology-based applications expertise, product specifications, functionality, reliability, marketing expertise, distribution capability, proprietary patent portfolios, and cost effectiveness.
Our significant competitors (by segment) are as follows:
BSI BioSpin
The BSI BioSpin Segment competes with companies that offer magnetic resonance spectrometers, mainly JEOL, QOne Instruments, Quad, Ciqtek, Magritek, Nanalysis, and Oxford Instruments. In the field of preclinical imaging, BioSpin competes with PerkinElmer Inc., Mediso, Trifoil, MR Solutions, and others.
BSI CALID
The BSI CALID Segment competes with a variety of companies that offer mass spectrometry-based and molecular spectrometry-based systems. BSI CALID’s competitors in the life science markets and chemical and applied markets include Danaher, Agilent, GE-Healthcare, Waters, Thermo Fisher Scientific, Shimadzu, Hitachi, and JEOL. In the microbiology market, CALID competes with Biomerieux.
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In molecular diagnostics, CALID competes with a number of companies offering products for infectious disease diagnostics. CALID’s competitors in molecular spectrometry-based systems include Thermo Fisher Scientific, PerkinElmer, Agilent, Foss, ABB Bomem, Buchi, Shimadzu, Horiba, Rigaku, and Jasco.
CALID’s CBRNE detection customers are highly fragmented, and it competes with a number of companies in this area, of which the most significant competitor is Smiths Detection.
BSI NANO
The BSI NANO Segment competes with companies that offer analytical X-ray solutions, OES systems, AFM and SOM systems, optical fluorescence systems, and genomics tools, primarily Rigaku, Oxford Instruments, Agilent, Thermo Fisher Scientific, Ametek’s Spectro and Edax divisions, PANalytical, Park Systems, Olympus, Nikon, Zeiss, 10x Genomics, Thorlabs, Bio-Techne, and Danaher’s Leica business.
BEST
BEST competes with Western Superconducting Technologies Co., Ltd., Luvata, and Jastec Co., Ltd. in low temperature superconducting materials, with Zanon, Mitsubishi Electric, and AES in the development and supply of accelerator cavities, with Thales, Toshiba, and CPI International in the development and supply of radio frequency couplers, with Mitsubishi Heavy Industries in the development and supply of superconducting accelerator modules, and with AES and Thales for electron linear accelerators.
Manufacturing and Suppliers
Several of our manufacturing facilities are certified under ISO 9001:2015 international quality standards. Manufacturing processes at our facilities in Europe, Israel and California, U.S.A. include all phases of manufacturing, such as machining, fabrication, subassembly, system assembly, and final testing. Our other facilities primarily perform high-level assembly, system integration, and final testing. We typically manufacture critical components in-house to ensure key competence and outsource to third party manufacturers non-critical components. Refer to Item 2, Properties in this Annual Report on Form 10-K for further detail on our principal locations and products they manufacture.
We purchase materials and components from various suppliers that are either standard products or built to our specifications. We obtain some of the components included in our products from a limited group of suppliers or from a single-source supplier for items such as ceramics, charge coupled device area detectors, X-ray tubes, robotics, infrared optics, and others. BEST has an ongoing collaboration and a joint technology development agreement with Allegheny Technologies Incorporated to advance state-of-the-art niobium-based superconductors, including those used in MRI magnets for the medical industry, and preclinical MRI magnets used in the life-science tools industry.
Research and Development
We are committed to ongoing innovation as a core element of our strategy to drive scientific research, develop new markets, enhance our product and service offerings, and to maintain our leadership position and relevance in the various industries in which we compete. To support these efforts, we commit substantial resources to internal and collaborative research and development projects. This level of investment in research and development has historically exceeded the industry average and reflects our commitment to scientific research and technological advancement to provide innovative products and solutions to our customers and maintain our competitive advantage. We conduct research primarily to enhance system performance and improve the reliability of existing products, develop revolutionary new products and solutions, and to maintain technical competencies in our core technology platforms. Our research and development efforts are conducted for the relevant products within each of the operating segments, as well as in collaboration with others on areas such as microfluidics, automation and workflow management software. We have been the recipient of government grants within the European Union, Switzerland, and the United States for various projects related to research and development. We have generally retained, at a minimum, non-exclusive rights to any items or enhancements we develop under these grants. We have also accepted some sponsored research contracts from private sources. Additionally, the Company has been able to gain access to research and development capabilities through acquisitions, acquiring the intellectual property, technology, and expertise of the acquired companies. Refer to Item 2, Properties in this Annual Report on Form 10-K for further detail on our principal locations that are also used for research and development activities.
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Our significant research and development activities (by segment) are as follows:
BSI BioSpin
The BSI BioSpin Segment’s most recent technological innovations included Bruker’s ultra-high-field class (1GHz and above) in the NMR and MRI product lines and the benchtop Fourier NMR platform. As part of our continuous development of systems and software, we have achieved many major milestones to make NMR and MRI technologies accessible to more labs, such as reduced sitting requirements.
BSI CALID
The BSI CALID Segment’s recent projects include the innovative timsTOF mass spectrometer for separation and analysis of unresolved compounds and conformations, and further enhanced instrument sensitivity. In addition, new sample preparation and automation workflows were developed for deep plasma proteomics (Biognosys P2 workflow and Preomics ENRICHplus kit).
BSI NANO
The BSI NANO Segment’s recent innovations include an EBSD detector based on direct electron detection for ultra-fast and ultra-sensitive characterization of crystalline materials in electron microscopes, transmission electron microscopes for investigations under non-ambient conditions, an X-ray μCT system that delivers functionality of a floor standing system in a compact bench-top design, high-performance fully automated uXRD and uXRF X-ray systems for AI semiconductor chip yield management and automated AFM metrology systems used in the production of High Bandwidth Memory (“HBM”) for AI applications, advancements to imaging-based or digital readout platforms for spatial biology applications, including spatial proteomics and spatial transcriptomics, spatial 3D genome and multiomic capabilities, single-cell live functional analysis, high-speed neural imaging, deep organoid imaging, and expanded field of view for connectivity studies in multiphoton microscopy.
BEST
BEST has had unique innovations in the production and development of low and high temperature superconducting materials and devices.
Intellectual Property
Our intellectual property consists of patents, copyrights, trade secrets, know-how, and trademarks. Protection of our intellectual property is a strategic priority for our businesses because of the length of time and expense associated with bringing new products through the development process and to the marketplace. We have a substantial patent portfolio, and we intend to file additional patent applications as appropriate. We believe our owned and licensed patent portfolio provides us with a competitive advantage. This portfolio permits us to maintain access to a number of key technologies. We license our owned patent rights where appropriate. We intend to enforce our patent rights against infringers, if necessary. The patent positions of life sciences tools companies involve complex legal and factual questions. As a result, we cannot predict the enforceability of our patents with certainty. In addition, we are aware of the existence from time to time of patents in certain countries, which, if valid, could impair our ability to manufacture and sell products in these countries.
We also rely upon trade secrets, know-how, trademarks, copyright protection, and licensing to develop and maintain our competitive position. We generally require the execution of confidentiality agreements by our employees, consultants, and other scientific advisors. These agreements provide that all confidential information made known during the course of a relationship with us will be held in confidence and used only for our benefit. In addition, these agreements provide that we own all inventions generated during the course of the relationship.
Government Contracts
We are a party to various government contracts. Under some of these government contracts, the government may receive a license or similar rights to intellectual property developed under the contract. However, under the government contracts we enter, we generally receive at least non-exclusive rights to any items or technologies we develop. Although we transact business with various government agencies, we believe that no government contract is of such magnitude that a renegotiation of profits or termination of the contract or subcontracts at the election of the government would have a material adverse effect on our financial results.
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Government Regulation
We are required to comply with international and U.S. federal, state, and local environmental protection regulations. We do not expect this compliance to have a significant impact on our capital spending, earnings or competitive position.
Certain of our products are subject to the U.S. Food and Drug Administration’s, or the FDA’s, requirements for electronic radiation emitting products, which include requirements related to record-keeping and reporting; labeling; notification; product repairs, replacements and refunds; importation; and performance standards. For example, prior to introducing a product in the United States, our Bruker AXS subsidiary provides notice to the FDA in the form of a Radiation Safety Initial Product Abbreviated Report, which provides identification information and operating characteristics of the product. If the FDA finds that the report is complete, it provides approval in the form of what is known as an accession number. Bruker AXS may not market a product in the U.S. until it has received an accession number. In addition, Bruker AXS submits an annual report to the FDA that includes the radiation safety history of all products it sells in the United States. Bruker AXS is required to report to the FDA incidents of accidental exposure to radiation arising from the manufacture, testing, or use of any of its products. Bruker AXS also reports installations of its products to state government regulatory agencies responsible for the regulation of radiation emitting devices. For sales in Germany, Bruker AXS registers each product with the local authorities. In some countries where Bruker AXS sells systems, Bruker AXS uses the certificate that Bruker AXS obtained from the federal authorities in Germany to assist it in obtaining a license, registration or certificate, as applicable, from the country or its relevant authorities in which the sale occurs. The U.S. Nuclear Regulatory Commission also has regulations concerning the exposure of our employees to radiation.
Certain of our products are subject to regulation as medical devices in the United States by the FDA and by similar regulatory bodies in other countries where such products are sold. The regulatory requirements imposed by the FDA and other regulatory bodies govern a wide variety of product-related activities, from quality management, design and development to labeling, manufacturing, promotion, sales, and distribution. As such, we continually invest in our manufacturing infrastructure to gain and maintain certifications and registrations necessary for the relevant level of regulatory clearance. We also are required to maintain processes and systems for medical device product submissions. For example, our MALDI BioTyper CA system is subject to regulation by the FDA as a medical device and requires FDA premarket review and clearance via the 510(k) premarket notification process and our IVD-CE Certified MALDI BioTyper system is subject to regulation in the European Union under the provisions of Directive 98/79/EC and Regulation (EU) 2017/746. In addition, certain product changes, including changes to the product indications or label claims, could trigger the requirement for a new 510(k) or other FDA or foreign regulatory premarket submission. The process of preparing a premarket submission to, and obtaining marketing approval, authorization, or clearance from the FDA and comparable foreign regulatory authorities (including notified bodies in the EU) for new products, or for enhancements or modifications to existing products, could take a significant amount of time, require the expenditure of substantial financial and other resources, and require rigorous and expensive pre-clinical and clinical testing. Additionally, the FDA or comparable foreign regulatory authorities could impose limitations on the indications for use of our products. Should we pursue an FDA or comparable foreign regulatory authority clearance, authorization, or approval for a new device or device modification, we cannot be certain that we will receive required clearance, authorization, or approval on a timely basis or at all. The failure to receive clearance, authorization, or approval for significant new products or modifications to existing products on a timely basis or at all could have a material, adverse effect on our financial condition and results of operations.
Both before and after a medical device product is commercially released, we have ongoing responsibilities under FDA and foreign regulations. For example, we are required to comply with the FDA’s Quality System Regulation, which sets forth the good manufacturing requirements for medical devices. These include requirements related to design controls, production and process controls, process validation, purchasing controls, supplier oversight, complaint handling and investigation, corrective and preventative actions, and record-keeping. In addition, the FDA’s medical device reporting regulation requires us to provide information to the FDA whenever we become aware that there is evidence that reasonably suggests that a device may have caused or contributed to a death or serious injury or, that a malfunction occurred which would be likely to cause or contribute to a death or serious injury upon recurrence. We are also required to report to the FDA if we initiate a device removal (recall) or correction to reduce a risk to health posed by the device or to remedy a violation which may present a risk to health. The FDA and comparable foreign regulatory authorities also regulate the promotion and marketing of medical devices and require that manufacturers only make promotional claims or statements that are consistent with the indications and labeling cleared, authorized, or approved by the FDA or other regulatory authorities. The FDA and comparable foreign regulatory authorities may take enforcement action against us, should the FDA determine we have engaged in “off-label” promotion or other violative marketing activities. In addition, FDA and comparable foreign regulatory authorities may take enforcement action should they determine that we have marketed any of our other (non-medical device) products for FDA-regulated purposes without obtaining the required regulatory clearances, authorizations, or approvals or ensuring such products comply with other FDA and comparable foreign regulatory requirements.
The European Union Directive 98/97/EC (IVDD) was replaced by the Regulation (EU) 2017/746 of April 5, 2017, on in vitro diagnostic medical devices (“IVDR”). The IVDR became applicable in May 2022. The regime changes significantly with the IVDR. In comparison to the IVDD, the IVDR requires, among other things, more clinical evidence to demonstrate the claimed benefits and safety of the device in relation to its stated purpose, stricter classification and CE-marking requirements and ongoing post-market
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follow-up to ensure conformity. The IVDR also requires new databases to be set up to track which devices are CE marked and to register clinical studies and post-market monitoring. In addition, tracing is enhanced by a Unique Device Identification (“UDI”) System and through requirements on other economic operators in the supply chain. Our products that are currently approved under the IVDD and not already placed on the market or put into service, must be recertified under the IVDR.
Backlog
Our backlog consists of firm orders (also referred to as bookings) under non-cancelable purchase orders received from customers for instruments and services. Total remaining performance obligations as of December 31, 2025, and 2024 were approximately $2,569.4 million and $2,090.4 million, respectively. The increase in our backlog in 2025 compared to 2024 was primarily driven by higher BEST order bookings. We generally experience varying revenue levels in the first three quarters of the year, while our fourth quarter revenues have historically been stronger than the rest of the year. As a result, backlog on any particular date is not necessarily a reliable indicator of long-term revenue performance.
Human Capital
We are committed to enabling scientists to make breakthrough discoveries and develop new applications that improve the quality of human life. Our employees are a critical component of that mission. We endeavor to attract, hire, and retain top talent by offering our employees a challenging but rewarding work experience, as well as competitive compensation and benefits. Further, we strive to create a work environment that promotes integrity, respect, and trust among our employees.
Workforce Composition
As of December 31, 2025, Bruker had approximately 11,085 employees worldwide. Approximately 20.2% of our employees were located in the United States. Additionally, approximately 45.8% of our employees were in production and distribution, 23.5% in selling and marketing, 17.6% in research and development and 13.1% in general and administrative functions.
Talent, Development and Workforce Strategy
Bruker is committed to providing a variety of learning opportunities to advance the personal and professional goals of our global teams. Our talent and development programs cover a variety of topics including those focused on technical expertise, leadership, and communication skills.
A global performance management process promotes regular feedback and coaching by managers to develop employees. Throughout the year, managers and employees engage in annual objective setting, mid-year reviews of performance, as well as a year-end performance evaluation. Managers and employees also participate in career conversations throughout the year. These discussions are critical tools that reinforce the alignment of employee activities and career goals throughout the year and provide employees opportunities to grow. Performance assessments also support the identification of our high performers and high potential employees based on merit. These employees are encouraged to continue their professional development with additional coaching and on the job learning opportunities to enhance their readiness for future advancement.
In 2025, we continued with several supervisor and leadership training programs for eligible participants. These programs provide a consistent foundation of knowledge and expectations for our leaders across Bruker.
Employee Engagement
Bruker is committed to fostering a culture of continuous learning and knowledge sharing to support development and retention and also recognizes the importance of a culture of belonging. A strong sense of belonging is crucial to the dynamic, entrepreneurial working environment our employees thrive in, and aligns with our mission to innovate responsibly and with integrity.
We support several initiatives that promote belonging at Bruker:
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Cross-functional collaboration and teamwork, encouraging employees to build relationships across different business units and geographies.
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Employee engagement programs including professional networking opportunities, internal mentorship, and knowledge sharing platforms.
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Global team-building events, providing employees with opportunities to interact and strengthen connections.
Our employees play active roles in these initiatives, often creating and facilitating them directly. We encourage these activities to help employees develop their skills, expand their networks, and contribute meaningfully to our business objectives. They also
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provide critical connections for new hires and establish internal networks across functions for employees who may not otherwise have opportunity to interact.
Employee Health and Safety
Bruker prioritizes the safety and wellbeing of its employees. Bruker accomplishes this through compliance with applicable laws and regulations regarding workplace safety, including recognition and control of workplace hazards, the elimination of unsafe manufacturing and workplace practices, tracking injury and illness rates, utilizing a global travel health program, and maintaining detailed emergency and disaster recovery plans. We are committed to reducing safety risks across our business groups and at our corporate and manufacturing sites worldwide. The following are examples of initiatives and programs designed with employee health and safety in mind:
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A confidential Employee Assistance Program has been implemented at several new sites providing no-cost support to employees and offering assistance on several personal topic areas.
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Many locations throughout the globe encourage employees to be mindful of a healthy lifestyle, including by offering group exercise activities. These activities aim to enhance employee physical health, emotional and mental, as well to increase camaraderie among colleagues.
Available Information
We maintain a website at www.bruker.com. We make available on our website documents describing our corporate governance and our Code of Conduct. We are not including the information contained on our website as a part of, or incorporating it by reference into, this Annual Report on Form 10-K. We make available free of charge through our website our annual reports on Form 10-K, our proxy statements, quarterly reports on Form 10-Q, current reports on Form 8-K, and amendments to these reports filed with or furnished to the SEC pursuant to Sections 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, as soon as reasonably practicable after they are electronically filed with or furnished to the SEC. The SEC also maintains a website site that contains periodic reports, proxy and information statements and other information regarding our filings at www.sec.gov.
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ITEM 1A RISK FACTORS
The following risk factors should be considered in conjunction with the other information included in this Annual Report on Form 10-K, including “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our audited consolidated financial statements and related notes. This report may include forward-looking statements that involve risks and uncertainties. In addition to those risk factors discussed elsewhere in this report, we identify the following risk factors, which could affect our actual results and cause actual results to differ materially from those in the forward-looking statements.
Risk Factor Summary
Our business is subject to numerous risks and uncertainties that include, but are not limited to, the following:
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Supply chain issues, including increasing demand for certain components used in our products and production delays, have and could continue to result in significant additional costs and manufacturing inefficiencies, which could adversely impact our revenue, increase our manufacturing costs and have a material adverse effect on our operating results;
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Adverse global economic conditions, and geopolitical tensions, including in Ukraine, the Middle East, China and other regions, and other conditions that impact our increasingly global operations could have a negative effect on our business, results of operations and financial condition and liquidity;
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New U.S. and reciprocal tariffs that have been imposed, and remain subject to potential change and other uncertainties, including as a result of the recent U.S. Supreme Court decision, have had a material adverse effect on our business, results of operations and financial condition, and may continue to do so in the foreseeable future;
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A meaningful portion of our revenue is derived from U.S. academic institutions, research organizations and other entities that rely in part on U.S. academic and government funding including grants from the U.S. National Institutes of Health (“NIH”), the National Science Foundation (“NSF”), and the Department of Energy (“DOE”). The current reduction in the level of funding and delay in such research funding, has had a material adverse effect on our U.S. academic and governmental customers, and our business, results of operations and financial condition, and may continue to do so in the foreseeable future;
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Delays in the release of Chinese government stimulus spending have had a material adverse effect on our business, results of operations and financial condition, and may continue to do so for the foreseeable future;
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We derive a significant portion of our revenue from international sales and are subject to the operational risks of doing business in foreign countries due to potential macroeconomic effects, including financial market volatility and disruption, inflationary concerns, changes in tax laws and regulations, volatility in interest and currency exchange rates, uncertain economic conditions in the United States and abroad, the impact of the recent U.S. government shutdown, and additional tariffs, including those imposed or that may be imposed by the current administration in the U.S.;
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Our competitive position and reported financial results may be adversely affected when we exchange foreign currency received from international sales into U.S. Dollars and by fluctuations in currency exchange rates;
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Goodwill, intangible assets and other long-lived assets are subject to impairment which has had and could continue to negatively impact our operating results;
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Our products compete in markets that are subject to rapid technological change, and one or more of the technologies underlying our products could be made obsolete by new technology;
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We face substantial competition in our industries and expect that such competition will continue. If we fail to compete effectively, it could harm our business results and materially impact the value of our company;
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If investment in life and material science research spending declines, our ability to generate revenue may suffer;
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Any reduction or shift in the capital resources, including as a result of changes to governmental policies and programs, or government funding imposed by the current U.S. administration, of our customers could reduce our sales and impede our ability to generate revenue;
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Disruptions at any of our manufacturing facilities could adversely affect our business;
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In addition to the risks applicable to our life science and materials analysis products, our CBRNE detection products are subject to a number of additional risks, including lengthy product development and contract negotiation periods and certain risks inherent in long-term government contracts;
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We rely on information technology to support our operations and reporting environments. A security failure of that technology, including with respect to cybersecurity risks and cyber incidents, could impact our ability to operate our businesses effectively, adversely affect our financial results, damage our reputation and expose us to potential liability or litigation;
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Our debt may adversely affect our cash flow and may restrict our investment opportunities or limit our activities;
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Changes in our effective income tax rate could adversely affect our results of operations;
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Various international tax risks could adversely affect our earnings and cash flows;
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The unpredictability and fluctuation of our quarterly results may adversely affect the trading price of our common stock;
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The ownership of our shares is highly concentrated, which could cause or exacerbate volatility in our share price as well as have significant influence over us;
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The loss of key personnel or an inability to attract and retain additional personnel could affect our ability to successfully grow our business;
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Our common stock ranks junior to our Series A Mandatory Convertible Preferred Stock with respect to dividends and amounts payable in the event of our liquidation, winding-up or dissolution;
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We face risks related to sales through distributors and other third parties that we do not control, which could harm our business;
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Our operations are dependent upon a limited number of suppliers and contract manufacturers;
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Supply shortages and increasing prices of raw materials could adversely affect the gross profit;
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If we are unable to effectively protect our intellectual property, third parties may use our technology, which would impair our ability to compete in our markets;
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We may be involved in lawsuits to protect or enforce our patents that are brought by us which could be expensive and time consuming and, if determined adversely, could adversely affect our patent position;
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Our manufacture and sale of products could lead to product liability claims for which we could have substantial liability;
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We are subject to environmental laws and regulations, which may impose significant compliance or other costs on us;
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Failure to maintain effective internal controls may cause a loss of investor confidence in the reliability of our financial statements or cause us to delay filing our periodic reports with the SEC and adversely affect our stock price;
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We operate as an entrepreneurial, decentralized company, which presents certain risks. In particular, significant growth in a decentralized operating model may put strain on certain business group resources and our corporate functions, which could materially and adversely affect our business, financial condition and results of operations; and
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If we are not able to successfully integrate the businesses we acquire through mergers, acquisitions or strategic alliances, we may not be able to realize all of the cost savings and other benefits that we expect to result from the transactions, and our financial results may be different than expected.
If any of the risks described above actually occur, our business, revenues, profitability, results of operations, financial condition, cash flows, reputation and stock price could be materially adversely affected. Additional risks and uncertainties not currently known to us or that we currently do not view as material may also become materially adverse to our business in future periods or if circumstances change.
Risks Related to Our Business and Industry
Supply chain issues, including increasing demand for certain components used in our products and production delays, have and could continue to result in significant additional costs and manufacturing inefficiencies, which could adversely impact our revenue, increase our manufacturing costs and have a material adverse effect on our operating results.
We have experienced supply chain interruptions or increased costs as a result of general global economic conditions, including economic instability, changes to governmental policies and programs, changes in tax laws and regulations, export controls, economic sanctions and trade restrictions, including those related to the ongoing conflict between Russia and Ukraine or conflict in the Middle East and surrounding areas, changes to trade policies, including higher tariff rates and customs duties imposed or that may be imposed
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by the current presidential administration in the U.S., continued threat of terrorism and heightened security and military action in response thereto, or any other current or future acts of terrorism, war (such as the ongoing geopolitical tensions and military conflicts between Russia and Ukraine, the ongoing conflict in the Middle East and its regional effects, and increased tensions between the U.S. and China and other regions ), a tight labor market and other factors, including natural events and disasters. Various factors, including increased demand for certain components and production delays, are contributing to shortages of certain components used in our products including microelectronic components and increased difficulties in our ability to obtain a consistent supply of materials at stable pricing levels. Supply shortages and longer lead times for components used in our products, including limited source components, have and can result in significant additional costs and inefficiencies in manufacturing. A shortage of key components have in the past and may in the future cause a significant disruption to our production activities, which could have a substantial adverse effect on our financial condition or results of operations. If we are unsuccessful in resolving any such component shortages in a timely manner, we could experience a significant adverse impact on the timing of our revenue, a possible loss of revenue, or an increase in manufacturing costs, any of which could have a material adverse impact on our operating results.
Adverse global economic conditions, and geopolitical tensions, including in Ukraine, the Middle East, China and other regions, and other conditions that impact our increasingly global operations could have a negative effect on our business, results of operations and financial condition and liquidity.
As a global company, our performance is affected by global economic conditions as well as geopolitical tensions and other conditions with global reach. In recent years, concerns about the global economic outlook have adversely affected market and business conditions in general. Macroeconomic weakness and uncertainty make it more difficult for us to manage our operations and accurately forecast revenue, gross margin and expenses. Geopolitical tensions, including the conflict between Russia and Ukraine and related economic sanctions, the conflict in the Middle East and surrounding areas, the possible expansion of such conflicts and potential geopolitical consequences, the ongoing tensions between the United States and China, tariff and trade policy changes, and increasing potential of conflict involving countries in Asia that are significant to the Company’s supply chain operations, such as Taiwan and China, have resulted in increasing global tensions and create uncertainty for global commerce. As a result of the adverse economic impacts resulting from the conflict between Russia and Ukraine, such as increased prices for and a reduced supply of key metals used in our products, the Company has ceased its Russian operations. Sustained or worsening of global economic conditions and increasing geopolitical tensions may increase our cost of doing business, materially disrupt our supply chain operations, cause our customers to reduce or delay spending and intensify pricing pressures. We have recently experienced an increase in inflationary pressures in many of the jurisdictions in which we operate. We have and may continue to offset the effect of these inflationary pressures by increasing the prices of our products to customers. However, we may not be fully able to pass additional costs on to our customers, which could have a negative impact on our results of operations and financial condition. If the economic conditions of the general economy or markets in which we operate worsen from present levels, these factors could negatively affect demand for our products and our business, financial condition and result of operations.
Our revenue from U.S. operations represented approximately 26% and 28% of total consolidated revenue for fiscal 2025 and 2024, respectively. Our revenue from operations in Europe represented approximately 36% and 35% of total consolidated revenue for fiscal years 2025 and 2024, respectively. Our revenue from operations in the Asia Pacific region represented approximately 30% and 29% of total consolidated revenue for fiscal years 2025 and 2024, respectively. Economic factors that could adversely influence demand for our products include the impact of geopolitical tensions and any related sanctions implemented, continued uncertainty about global economic conditions, including as a result of any natural disasters, pandemics, or epidemics, leading to ongoing reductions in investment, changes in government spending levels and/or priorities, the size and availability of government budgets, customers’ and suppliers’ access to credit and other macroeconomic factors affecting government, academic or industrial spending behavior. Slower economic growth or a deterioration in economic conditions could result in a decrease in government funding for scientific research, a delay in orders from current or potential customers or a reduction in purchases of our products.
We cannot predict how changes in economic conditions or political instability will affect our customers and suppliers or how any negative impact on our customers and suppliers might adversely impact our business results or financial condition.
New U.S. and reciprocal tariffs that have been imposed, and remain subject to potential change and other uncertainties, have had a material adverse effect on our business, results of operations and financial condition, and may continue to do so in the foreseeable future.
Recently, the U.S. government has indicated its intent to modify U.S. trade policy and, in some cases, to renegotiate, or potentially terminate, certain existing bilateral or multi-lateral trade agreements. It has also imposed or increased tariffs on foreign imports into the United States from key trading partners, including Germany and Switzerland.
The tariff increases adopted in 2025, and the uncertainty associated with them in global markets, have resulted in lower than anticipated bookings and revenues and contributed to reduced gross margins, operating margins, and profitability, and may continue to
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adversely affect our business, results of operations and financial condition for the foreseeable future. For example, during the year ended December 31, 2025, our results of operations were adversely impacted by an increase in cost of goods sold as a result of increased tariffs. Changes to tariffs and trade policies between the United States and foreign countries, such as what occurred during 2025, could reduce the purchasing power of our customers by increasing costs in their operations, which in turn may lead to decreased demand for our products or services. The magnitude and duration of any reduction in customer purchasing ability is difficult to reliably predict and quantify.
Moreover, tariffs and international trade arrangements may continue to change, potentially without warning, and to an extent that is difficult to predict. On February 20, 2026, the U.S. Supreme Court issued a ruling striking down certain tariffs previously imposed under the International Emergency Economic Powers Act (“IEEPA”). The ultimate availability, timing, and amount of any potential refunds of such tariffs remain highly uncertain and are subject to further legal, regulatory, and administrative developments. Following the Supreme Court’s decision, the U.S. presidential administration announced its intention to invoke other laws to collect tariffs and announced new tariffs on imports from all countries, in addition to any existing non-IEEPA tariffs.
There remains substantial uncertainty regarding the duration of existing and newly announced tariffs, potential changes or pauses to such tariffs, tariff levels, and whether further additional tariffs or other retaliatory actions may be imposed, modified, or suspended, and the impacts of such actions on our business. We are continuing to monitor and evaluate these “developments” and assess their potential impact on our business, financial condition, and results of operations.
A meaningful portion of our revenue is derived from U.S. academic institutions, research organizations and other entities that rely in part on U.S. academic and government funding, including NIH, NSF and DOE grants. The current reduction in the level of funding and delay in such research funding, has had a material adverse effect on our U.S. academic and governmental customers, and our business, results of operations and financial condition, and may continue to do so in the foreseeable future.
A substantial portion of our revenue in the United States is derived from academic and governmental institutions, research organizations and other entities that may rely in part or in whole on academic and government funding, including grants from the NIH, NSF and DOE, and other U.S. government agencies. However, during fiscal year 2025, under the current U.S. administration there has been significant disruption in U.S. academic funding for high-end research instrumentation used in academic and medical research. U.S. academic and governmental researchers experiencing material reductions or delays in government funding, or modifications of the terms or conditions of funding, including allowable overhead rates, have reduced or delayed their purchases of our products and services, which has adversely affected our business and results of operations. While the recent dispute settlements between a limited number of major universities and the U.S. federal government may allow for the resumption of certain grants for scientific and medical research, we expect the reduced level of funding may continue for the foreseeable future, which could continue to have a material adverse effect on our business, results of operations and financial condition.
Delays in the release of Chinese government stimulus spending have had a material adverse effect on our business, results of operations and financial condition, and may continue to do so for the foreseeable future.
A significant portion of our revenue is derived from sales into China, some of which are directly funded through Chinese government stimulus programs for high-end medical and industrial research instrumentation. In 2025, the release of such Chinese government stimulus spending was delayed, which has negatively affected our sales growth into China and consequently has had an adverse effect on our business, results of operations, and financial condition in 2025. Our revenue in China for the year ended December 31, 2025, was $475.8 million and remained flat compared to $471.2 million for the year ended December 31, 2024. If the release of the Chinese government’s stimulus spending continues to be delayed or recurs, our sales into China may continue to be negatively affected and our business, results of operations, and financial condition may be adversely affected in the foreseeable future. Furthermore, we are subject to significant risks associated with the trading relationship between the U.S. and China, which is currently characterized by significant uncertainty. In addition to tariffs newly imposed by the U.S. and China, which have fluctuated and remain volatile, and may increase our costs, there may be additional import, export, tax, or other regulatory changes effected by the U.S. and Chinese governments in the future that could also adversely affect our business and results of operations.
We derive a significant portion of our revenue from international sales and are subject to the operational risks of doing business in foreign countries due to potential macroeconomic effects, including financial market volatility and disruption, inflationary concerns, changes in tax laws and regulations, volatility in interest and currency exchange rates, uncertain economic conditions in the United States and abroad, the impact of the recent U.S. government shutdown, and additional tariffs, including those imposed or that may be imposed by the current administration in the U.S.
International sales account, and are expected to continue to account, for a significant portion of our total revenues. Our revenue from non-U.S. operations represented approximately 74% and 72%, of our total consolidated revenue for fiscal 2025 and 2024,
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respectively. Our international operations are, and will continue to be, subject to a variety of risks associated with conducting business internationally, many of which are beyond our control. These risks, which may adversely affect our ability to achieve and maintain profitability and our ability to sell our products internationally, include:
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changes and volatility in foreign currency translation rates;
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changes in regulatory requirements;
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legislation and regulation, including tariffs imposed or that may be imposed by the current presidential administration in the U.S., relating to the import or export of high technology products, which legislation and regulation may conflict with U.S. law and may have an adverse impact on our business results;
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the impact of the recent U.S. government shutdown and its potentially adverse impact on the global economy;
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the imposition of government controls;
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political and economic instability, the possibility of an economic recession in certain key markets such as Germany, international hostilities and resulting sanctions, acts of terrorism and governmental restrictions, inflation, trade relationships and military and political alliances;
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costs and risks of deploying systems in foreign countries;
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compliance with export laws and controls and trade embargoes in multiple jurisdictions, which may conflict with U.S. law and may have an adverse impact on our business results;
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limited intellectual property rights;
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the burden of complying with a wide variety of complex foreign laws and treaties, including unfavorable labor regulations, specifically those applicable to our European operations; and
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compliance with U.S. and local laws affecting the activities of U.S. companies abroad, including the United States Foreign Corrupt Practices Act, or FCPA, and local anti-bribery laws.
We must also comply with the European Union General Data Protection Regulation (“GDPR”) and other similar regulations in other countries, including the UK Data Protection Act 2018. These laws include strong protections for individual privacy rights of residents of the European Economic Area (“EEA”) and UK. GDPR purports to apply extraterritorially such that it can apply to businesses that are not established within the EEA, but that process personal data of individuals located within the European Union in connection with the offering of goods and services within the EEA. There are significant fines associated with non-compliance. In 2020, the Court of Justice of the European Union invalidated the EU-U.S. Privacy Shield Framework, a key mechanism for transfers of personal data from the European Union to the United States and altered the international data transfer under GDPR. Even though Bruker did not rely on the EU-U.S. Privacy Shield for its transfers to the United States, Bruker has conducted a transfer impact assessment to understand the risks of its EU-U.S. persona data transfers and implemented the new EU Standard Contractual Clauses (including the UK addendum). More recently, the European Commission and United States have agreed on a new EU-U.S. Transatlantic Data Privacy Framework that may stabilize rules for transfers of personal data from the EU to the United States. However, ongoing litigation and challenges relating to such transfers could cause disruption of data transfers and have a material adverse effect on our business.
While the impact of these factors is difficult to predict, any one or more of these factors could adversely affect our operations in the future.
Our competitive position and reported financial results may be adversely affected when we exchange foreign currency received from international sales into U.S. Dollars and by fluctuations in currency exchange rates.
A significant portion of our business is conducted in currencies other than the U.S. Dollar, which is our reporting currency. As a result, currency fluctuations among the U.S. Dollar and the currencies in which we do business could cause the price of our products to be more or less competitive than our principal competitors’ products. Currency fluctuations will increase or decrease our cost structure relative to those of our competitors, which could lessen the demand for our products and affect our competitive position. From time to time, we enter into certain hedging transactions and/or option and foreign currency exchange contracts which are intended to offset some of the market risk associated with our sales denominated in foreign currencies. We cannot predict the effectiveness of these transactions or their impact upon our future operating results, and from time to time they may negatively affect our quarterly earnings.
In addition to the foreign currency exposure associated with differences between where our products are manufactured and sold by us and our competitors, our exposure to currency exchange rate fluctuations results from the currency translation exposure
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associated with the preparation of our consolidated financial statements, as well as from the exposure associated with transactions of our subsidiaries that are denominated in a currency other than the respective subsidiary’s functional currency. While our financial results are reported in U.S. Dollars, the financial statements of many of our subsidiaries outside the U.S. are prepared using the local currency as the functional currency. During consolidation, these results are translated into U.S. Dollars by applying appropriate exchange rates. As a result, fluctuations in the exchange rate of the U.S. Dollar relative to the local currencies in which our foreign subsidiaries report could cause significant fluctuations in our reported results. Moreover, as exchange rates vary, revenue and other operating results may differ materially from our expectations. The effects of changes in currency exchange rates increased our 2025 revenue by approximately $77.6 million, or 2.3%, decreased our 2024 revenue by approximately $13.1 million, or 0.4%, and increased our 2023 revenue by approximately $11.2 million, or 0.4%. Adjustments resulting from financial statement translations are included as a separate component of shareholders' equity. We recorded net gains from currency translation adjustments of $115.1 million for the year ended December 31, 2025, and net losses of $79.6 million during the year ended December 31, 2024.
Additionally, to the extent monetary assets and liabilities, including cash and debt, are held in a different currency than the reporting subsidiary’s functional currency, fluctuations in currency exchange rates may have a significant impact on our reported financial results, and may lead to increased earnings volatility. We may record significant gains or losses related to both the translation of assets and liabilities held by our subsidiaries into local currencies and the re-measurement of inter-company receivables and loan balances.
Goodwill, intangible assets and other long-lived assets are subject to impairment which has had and could continue to negatively impact our operating results.
We have recorded goodwill, intangible assets and other long-lived assets that must be periodically evaluated for potential impairment. We assess the realizability of the reported goodwill, intangible assets and other long-lived assets annually, as well as whenever events or changes in circumstances indicate that the assets may be impaired. These events or circumstances generally include operating losses or a significant decline in the earnings associated with the reporting unit these assets are reported within. A decline in our stock price and market capitalization may also cause us to consider whether goodwill, intangible assets and other long-lived assets may require an impairment assessment. Our ability to realize the value of these assets will depend on the future cash flows of the reporting unit in addition to how well we integrate the businesses we acquire. During the year ended December 31, 2025, the Company recorded impairment losses for certain goodwill and intangible assets as disclosed in Note 6, Goodwill and Intangible Assets to our consolidated financial statements included in Item 8 of this Annual Report on Form 10-K. The Company recorded no goodwill impairment for the years ended December 31, 2024, and 2023.
If our products fail to achieve and sustain sufficient market acceptance across their broad intended range of applications, we will not generate expected revenue.
Our business strategy depends on our ability to successfully commercialize a broad range of products based on our technology platforms, including magnetic resonance technology, pre-clinical imaging technology, mass spectrometry technology, X-ray technology, atomic force microscopy technology, spatial biology technologies, stylus and optical metrology technology, fluorescence microscopy technology, infrared technology and superconducting magnet technologies for use in a variety of life science, chemistry and materials analysis applications. Some of our products have only recently been commercially launched and have achieved only limited sales to date. The commercial success of our products depends on obtaining and expanding market acceptance by a diverse array of industrial, academic, clinical, pharmaceutical, biotechnology, applied, medical research and governmental customers around the world. We may fail to achieve or sustain substantial market acceptance for our products across the full range of our intended applications or in one or more of our principal intended applications. Any such failure could decrease our sales and revenue. To succeed, we must convince substantial numbers of potential customers to invest in new systems or replace their existing techniques with techniques employing our systems. Limited funding available for capital acquisitions by our customers, as well as our customers’ own internal purchasing approval policies, could hinder market acceptance of our products. Our intended customers may be reluctant to make the substantial capital investment generally needed to acquire our products or to incur the training and other costs involved with replacing their existing systems with our products. We also may not be able to convince our intended customers that our systems are an attractive and cost-effective alternative to other technologies and systems for the acquisition, analysis and management of molecular, cellular and microscopic information. Because of these and other factors, our products may fail to gain or sustain market acceptance.
Our products compete in markets that are subject to rapid technological change, and one or more of the technologies underlying our products could be made obsolete by new technology.
The market for discovery and analysis tools is characterized by rapid technological change and frequent new product introductions. Rapidly changing technology could make some or all of our product lines obsolete unless we are able to continually improve our existing products and develop new products. Because substantially all of our products are based on our technology
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platforms, including magnetic resonance technology, mass spectrometry technology, X-ray technology, atomic force microscopy technology, fluorescence microscopy technology, spatial biology technologies, stylus and optical metrology technology and infrared technology, we are particularly vulnerable to any technological advances that would make these techniques obsolete as the basis for analytical systems in any of our markets. To meet the evolving needs of our customers, we must rapidly and continually enhance our current and planned products and services and develop and introduce new products and services. In addition, our product lines are based on complex technologies that are subject to rapid change as new technologies are developed and introduced in the marketplace. We may have difficulty in keeping abreast of the rapid changes affecting each of the different markets we serve or intend to serve. If we fail to develop and introduce products in a timely manner in response to changing technology, market demands or the requirements of our customers, our product sales may decline, and we could experience significant losses.
We face substantial competition in our industries and expect that such competition will continue. If we fail to compete effectively, it could harm our business results and materially impact the value of our company.
We face substantial competition in our industries, and we expect that competition in all of our markets will increase further. Currently, our principal competition comes from established companies providing products using existing technologies that perform many of the same functions for which we market our products. A number of our competitors have expanded their market share in recent years through business combinations. Other companies also may choose to enter our fields in the future. Our competitors may develop or market products that are more effective or commercially attractive than our current or future products or that may render our products obsolete. Competition has in the past subjected, and is likely in the future to subject, our products to pricing pressure. Certain competitors have more experience in the market and substantially greater financial, operational, marketing and technical resources than we do, which could give them a competitive advantage in areas such as research and development, production, marketing and distribution. Our ability to compete successfully will depend, in part, on our ability to develop proprietary products that reach the market in a timely manner and are technologically superior to, less expensive than, or more cost-effective than, other currently marketed products.
If investment in life and material science research spending declines, our ability to generate revenue may suffer.
We are dependent, both directly and indirectly, upon general investment in life science research, particularly in the research and development budgets of the pharmaceutical and biotechnology industries, and in material science research as well as upon the financial condition and funding priorities of various governments and government agencies. Since our inception, both we and our academic collaborators and customers have benefited from various government contracts and grants, such as funding from the NIH and similar government agencies. Whether we or our academic collaborators will continue to be able to attract these grants and funding from these sources depends not only on the quality of our products, but also on general spending patterns of public institutions, changes to governmental policies and programs, including loans, grants, guarantees and other subsidies, and disruptions or changes in government funding of other government agencies.
Any reduction or shift in the capital resources or government funding of our customers, including as a result of changes to governmental policies and programs, could reduce our sales and impede our ability to generate revenue.
A significant portion of our sales are capital purchases by our customers. The spending policies of our customers could have a significant effect on the demand for our products. These policies are based on a wide variety of factors, including the resources available to make purchases, the spending priorities among various types of equipment, policies regarding spending during recessionary periods, changes in the political climate, including disruptions or changes to funding of other government agencies, changes to governmental policies and programs, including loans, grants, guarantees and other subsidies, and changes to government spending policies, including shifts in funding priorities.
Any changes in capital spending or changes in the capital budgets of our customers could significantly reduce demand for our products. The capital resources of our life science and other corporate customers may be limited by the availability of equity or debt financing. Any significant decline in research and development expenditures by our life science and material science customers as a result of shifting governmental support for capital projects or disruptions or changes to funding of other government agencies could significantly decrease our sales. In addition, a substantial portion of our sales are to non-profit and government entities, which are dependent on government support for scientific research. Any decline in this support could decrease the ability of these customers to purchase our products.
Disruptions at any of our manufacturing facilities could adversely affect our business.
We have manufacturing facilities located in Austria, France, Germany, Israel, Switzerland, United States, United Kingdom and in other locations worldwide. Many of our products are developed and manufactured at single locations, with limited alternate facilities. If we experience any significant disruption of those facilities for any reason, such as war or other geopolitical conflicts,
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strikes or other labor unrest, power interruptions, fire, earthquakes, or other events beyond our control, we may be unable to manufacture the relevant products at previous levels or at all. A reduction or interruption in manufacturing could harm our customer relationships, impede our ability to generate revenues from our backlog or obtain new orders and could have a material adverse effect on our business, results of operations, financial condition and cash flows.
If employees were to engage in a strike or other work stoppage or interruption, our business, results of operations, financial condition and liquidity could be materially adversely affected.
Many of our employees are represented by workers’ councils and labor unions in certain jurisdictions, primarily in Germany and France. If disputes with these employees arise, or if our workers engage in a strike or other work stoppage or interruption, we could experience a significant disruption of, or inefficiencies in, our operations or incur higher labor costs, which could have a material adverse effect on our business, results of operations, financial condition and liquidity.
In addition to the risks applicable to our life science and materials analysis products, our CBRNE detection products are subject to a number of additional risks, including lengthy product development and contract negotiation periods and certain risks inherent in long-term government contracts.
Our CBRNE detection products are subject to many of the same risks associated with our life science products, including vulnerability to rapid technological change, dependence on mass spectrometry and other technologies and substantial competition. In addition, our CBRNE detection products are sold to government agencies under long-term contracts. These contracts generally involve lengthy pre-contract negotiations and product development. We may be required to devote substantial working capital and other resources prior to obtaining product orders. As a result, we may incur substantial costs before we recognize revenue from these products. Moreover, in return for larger, longer-term contracts, our customers for these products often demand more stringent acceptance criteria. These criteria may also cause delays in our ability to recognize revenue from sales of these products. Furthermore, we may not be able to accurately predict in advance our costs to fulfill our obligations under these long-term contracts. If we fail to accurately predict our costs, due to inflation or other factors, we could incur significant losses. Also, the presence or absence of such contracts may cause substantial variation in our results of operations between fiscal periods and, as a result, our results of operations for any given fiscal period may not be predictive of our results for subsequent fiscal periods. The resulting uncertainty may have an adverse impact on our stock price.
We rely on information technology to support our operations and reporting environments. A security failure of that technology, including with respect to cybersecurity risks and cyber incidents, could impact our ability to operate our businesses effectively, adversely affect our financial results, damage our reputation and expose us to potential liability or litigation.
We use information systems to carry out our operations and maintain our business records. Some systems are internally managed, and some are maintained by third-party service providers. Our ability to conduct business could be materially and adversely affected if these systems or resources are compromised, damaged or fail. This could be a result of a cyber-incident, social engineering scam, hacking, phishing attempts, malware, natural disaster, hardware or software corruption, failure or error, telecommunications system failure, service provider error or failure, intentional or unintentional personnel actions or other disruption.
In the ordinary course of business, we collect and store sensitive data, including intellectual property, other proprietary information and personally identifiable information. Despite our security measures, our information technology and infrastructure may be vulnerable to cyber-attacks by hackers, including intrusions designed to access and exfiltrate information and to disrupt and lock-up access to systems for the purpose of demanding ransom payments, or breached due to employee error, malfeasance, or other disruptions. Further, a breach of our security systems or infrastructure, or those of our customers, suppliers and other business partners, could result in the disclosure, misuse, corruption or loss of confidential information, including intellectual property, personally identifiable information and other critical data of the Company and our employees, customers suppliers and other business partners. There can be no guarantee that any computer system failure, cyber-attack or security breach, if any should occur, will be timely detected or sufficiently remediated. Furthermore, our remediation efforts may not be successful, and there could be interruptions, delays, or cessation of service due to cyber-attacks or other data security breaches. If any data is compromised, destroyed or inappropriately disclosed, it could have a material adverse effect, including damage to our reputation, and our relationships with our employees, customers, suppliers and other business partners, decrease the value of our investments in research, development and engineering, disrupt our manufacturing processes, result in significant expenses to address and resolve the issues, fines or litigation or other proceedings by affected individuals, customers, suppliers, business partners or regulatory authorities.
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Our debt, which is principally denominated in foreign currency, is impacted by movement in foreign currency rates which may adversely affect our operations and cash flows and may restrict our investment opportunities or limit our activities.
As of December 31, 2025, we had an outstanding aggregate principal amount of debt totaling approximately $1.9 billion and had $900.0 million available for borrowing under the 2024 Revolving Credit Agreement, subject to compliance with financial covenant ratios.
We have substantial cash funding obligations in the United States to service debt interest obligations, fund operations, capital expenditures, and our declared dividends on our common stock and our dividends on the Series A Mandatory Convertible Preferred Stock. We may also incur further obligations to finance future acquisitions or share repurchases. Our ability to satisfy our debt obligations and meet our other liquidity needs depends on our future operating performance and on economic, financial, competitive and other factors beyond our control. If we are unable to service our debt or obtain additional financing, we may be forced to delay acquisitions, capital expenditures, or research and development expenditures, or suspend our dividend payments and share repurchases. We may not be able to obtain additional financing on terms acceptable to us or at all. Furthermore, the majority of our cash and cash equivalents is generated from foreign operations and we may incur certain tax consequences relocating cash from our foreign operations to the United States. Our financial condition and results of operations could be adversely impacted if we are unable to maintain a sufficient level of cash flow in the United States to address our funding requirements through cash from operations and timely repatriation of cash from overseas or other sources obtained at an acceptable cost.
Additionally, the agreements governing our debt require that we maintain certain financial covenant ratios related to maximum leverage and minimum interest coverage and contain affirmative and negative covenants, including among others, timely provision of audited consolidated financial statements, as well as restrictions on liens, our indebtedness and the indebtedness of our subsidiaries, asset sales, dividends and transactions with affiliates. Our ability to comply with these financial covenant ratios and covenants is dependent on our operations and performance, which is subject to prevailing economic conditions and other factors, some of which are beyond our control, such as inflationary pressures, changes to trade and tariff policies, customs duties imposed or that may be imposed in the United States or other jurisdictions, government funding policies principally in the United States and China, geopolitical tensions and possible expansion of current conflicts, and increasing potential of conflict involving countries in Asia that are significant to the Company’s supply chain operations, such as Taiwan and China, as well as factors such as foreign currency translation rates, in particular the Swiss Franc and Euro, both of which have strengthened significantly against the U.S. Dollar in 2025, and interest rates, which are also beyond our control.
As of December 31, 2025, we were in compliance with all covenants under our debt agreements. Our failure to comply with any of these restrictions or covenants may result in an event of default under the applicable debt agreement, which would require waivers from participating banks and noteholders or permit acceleration of the debt under such debt agreement or a cross-default under all of our other debt agreements, and require us to prepay all of our outstanding debt before the applicable scheduled due dates, which would materially and adversely affect our financial condition.
Changes in our effective income tax rate could adversely affect our results of operations.
We are subject to income taxes in both the United States and various foreign jurisdictions, and our domestic and international tax liabilities are largely dependent upon the distribution of income among these different jurisdictions. Various factors may have favorable or unfavorable effects on our effective income tax rate. These factors include interpretations of existing tax laws, the accounting for stock options and other share-based compensation, changes in tax laws and rates, future levels of research and development spending, changes in accounting standards, changes in the mix of earnings in the various tax jurisdictions in which we operate, the outcome of examinations by the U.S. Internal Revenue Service and other tax authorities, the accuracy of our estimates for unrecognized tax benefits and realization of deferred tax assets and changes in overall levels of pre-tax earnings. A change in tax laws, treaties or regulations, or their interpretation, of any country in which we operate could result in a higher tax rate on our earnings, which could result in a significant negative impact on our earnings and cash flow from operations.
On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was enacted in the U.S. The OBBBA includes significant changes to U.S. corporate tax provisions of the Tax Cuts and Jobs Act. Notably, it allows an immediate deduction for domestic research and development expenditures, reinstates 100% bonus depreciation, and modifies the international tax framework. The legislation has multiple effective dates, with certain provisions effective starting in 2025 and others in the subsequent years. We have evaluated and reflected the OBBBA’s impact on its financial statements for the year ended December 31, 2025, which was not material. We will continue to monitor developments related to OBBBA and will update our disclosures as appropriate.
In December 2021, the Organization for Economic Co-operation and Development (“OECD”)/G20 Inclusive Framework, agreed to implement a global minimum tax regime for multinationals known as “Pillar Two”. The OECD has released the Pillar Two model rules (the Global Anti-Base Erosion Proposal, or “GloBE”) to reform international corporate taxation. The Pillar Two model rules provide guidance for a global minimum tax. This guidance lays out a common approach for adopting the global minimum tax
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and enacting local legislation codifying the provisions that all 142 countries in the Inclusive Framework agreed to by consensus. The EU member states have agreed to adopt these rules in two stages with the first component effective on January 1, 2024, while the second component became effective on January 1, 2025. Non-EU countries have enacted or are expected to enact legislation on various timelines. While certain countries in which we operate have already enacted legislation to adopt the Pillar Two framework and, several other countries are expected to implement similar legislation with varying effective dates in the future, the U.S. has withdrawn support for Pillar Two. In June 2025, the U.S. Department of the Treasury and the other G7 countries (including Canada, France, Germany, Italy, Japan, the United Kingdom and the European Union) released a joint statement announcing an understanding regarding a proposed “side-by-side” solution that would exempt U.S.-parented multinational businesses from certain provisions of the global minimum tax, and the OECD released a draft proposal, dated August 13, 2025, to exclude U.S. multinational companies from certain minimum tax enforcement measures. However, no agreement regarding implementation of the proposal has yet been reached. We will continue to monitor the implementation of the Inclusive Framework agreement by the remaining countries in which we operate or may operate in the future. We are unable to predict when and how the Inclusive Framework agreement will be enacted into law in these remaining countries; however, when and how this framework is adopted or enacted by the various countries in which we do business will increase tax complexity and may increase uncertainty and adversely affect our provision for income taxes in the U.S. and non-U.S. jurisdictions.
We also assess the impact of various international tax reform proposals and modifications to existing tax treaties in all jurisdictions where we have operations that could result in a material impact on our income taxes. However, if such proposals were enacted, or if modifications were made to certain existing treaties, the consequences could have a materially adverse impact on us, including increasing our tax burden, increasing costs of our tax compliance or otherwise adversely affecting our financial condition, results of operations and cash flows.
Various international tax risks could adversely affect our earnings and cash flows.
We are subject to international tax risks. We could be subject to double taxation on income related to operations in certain countries that do not have tax treaties with the country of the trading partner. In addition, we may have a higher effective income tax rate than that of other companies in our industry if losses incurred by one operating company are not available to offset the income of an operating company located in another country. Also, distributions of earnings and other payments received from our subsidiaries may be subject to withholding taxes imposed by the countries where they are operating or are incorporated. If these foreign countries do not have income tax treaties with the United States or the countries where our subsidiaries are incorporated, we could be subject to high rates of withholding taxes on these distributions and payments. Additionally, the amount of the credit that we may claim against our U.S. federal income tax for foreign income taxes paid or accrued is subject to many limitations which may significantly restrict our ability to claim a credit for all of the foreign taxes we pay.
The unpredictability and fluctuation of our quarterly results may adversely affect the trading price of our common stock.
Our revenues and results of operations have in the past and will in the future vary from quarter to quarter due to a number of factors, many of which are outside our control and any of which may cause our stock price to fluctuate. The primary factors that may affect us include the following:
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the timing of sales of our products and services;
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the timing of recognizing revenue and deferred revenue under GAAP;
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changes in our pricing policies or the pricing policies of our competitors;
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increases in sales and marketing, product development or administration expenses;
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the mix of services provided by us and third-party contractors;
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our ability to attain and maintain quality levels for our products; and
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costs related to acquisitions of technology or businesses.
We can experience quarter to quarter fluctuations in our operating results as a result of various factors, some of which are outside our control, such as:
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the timing of governmental stimulus programs and academic research budgets;
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changes to governmental policies and programs, including loans, grants, guarantees and other subsidies;
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the time it takes between the date customer orders and deposits are received, systems are shipped and accepted by our customers and full payment is received;
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foreign currency exchange rates;
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the time it takes for us to receive critical materials to manufacture our products;
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general economic conditions, geopolitical tensions and other conditions that impact our global operations;
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the time it takes to satisfy local customs requirements and other export/import requirements;
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the time it takes for customers to construct or prepare their facilities for our products; and
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the time required to obtain governmental licenses.
These factors have in the past affected the amount and timing of revenue recognized on sales of our products and receipt of related payments and will likely continue to do so in the future. Accordingly, our operating results in any particular quarter may not necessarily be an indication of any future quarter’s operating performance.
Historically we have higher levels of revenue in the fourth quarter of the year compared to the first, second and third quarters, which we believe is primarily the result of our customers’ budgeting cycles. Quarter to quarter comparisons of our results of operations should not be relied upon as an indication of our future performance. It is likely that in some future quarters, our results of operations may be below the expectations of public market analysts and investors. In this event, the price of our common stock may fall.
Our ability to manage and grow our business successfully can be impeded by systems and other technological limitations.
Our continued success in effectively managing and growing our business depends on our ability to integrate our varied accounting, financial, information, and operational systems on a global basis. Moreover, adapting or developing the existing technology systems we use to meet our internal needs, as well as client needs, industry demands and new regulatory requirements, is also critical for our business. The introduction of new technologies presents new challenges to us. We must be proactive and prepared to implement new technology when growth opportunities present themselves, whether as a result of a business acquisition or rapidly increasing business activities in particular markets or regions. These needs could present operational issues or require significant capital spending and may require us to reevaluate the current value and/or expected useful lives of the technology we use, which could negatively impact our results of operations.
In addition, technology is subject to rapid advancements and changes, and our competitors may, from time to time, implement newer technologies or more advanced platforms for their services and products, including platforms based on artificial intelligence. If we do not effectively anticipate and timely avail ourselves of new technologies, our competitive position may suffer, and these impacts would adversely affect our business, financial condition and results of operations. In addition, our efforts to utilize technological advancements such as artificial intelligence may result in substantial integration and maintenance costs and may expose us to additional risks. In particular, personal information within any data set collected from our business is vulnerable to unauthorized acquisition or access, compromise or loss, which could lead to heightened business and security costs, reputational damage, administrative penalties, and significant legal and financial exposure. The content, analyses, or recommendations generated by artificial intelligence programs, if deficient, inaccurate, or biased, could adversely impact our business, financial condition, and operational results, as well as our reputation. Moreover, ethical concerns associated with artificial intelligence could lead to brand damage, competitive disadvantages, or legal repercussions. Any problems with our implementation or use of artificial intelligence or other technological advancements could also negatively impact our business or results of our operations.
Climate change and natural disasters, or legal, regulatory or market measures to address climate change, could adversely affect our business, financial condition or results of operations.
Climate change, allegedly resulting from increased concentrations of carbon dioxide and other greenhouse gases (“GHG”) in the atmosphere, may present risks to our business and operations. Extreme weather events and natural disasters, such as tornadoes, tsunamis, tropical storms (including hurricanes), earthquakes, volcanic eruptions, windstorms, hailstorms, heat waves, floods, droughts, severe thunderstorms, wildfires, and other fires, which may or may not result from climate change or natural disasters, could adversely impact our operations and increase volatility in our supply chain, including the availability and cost of raw materials and components required for the operation of our business. Failure to monitor, adapt, and develop solutions against the physical and transitional impacts from climate change may negatively impact our results of operations.
There has been increased focus by federal, international, state and local regulatory and legislative bodies to combat and/or limit the effects of climate change through a variety of means, including regulating GHG emissions (and requirements to disclose climate-related risks and metrics, including GHG emissions), policies mandating or promoting the use of renewable or zero-carbon energy and sustainability initiatives, and additional taxes on fuel and energy. These regulations, and changes to them, could increase our cost of
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compliance, and our failure to comply could result in the imposition of significant fines, suspension of production, alteration of product processes, cessation of operations or other actions which could materially and adversely affect our business, financial condition and results of operation.
Additionally, the impacts of climate change may further influence customer and other stockholder preferences and requirements. This includes increased demand for more sustainable products, including products with lower environmental footprints, and for companies to produce and demonstrate progress against sustainability goals and GHG reduction targets, including product-level GHG emissions data. Failure to meet stockholder expectations or our own goals or commitments relating to sustainability or GHG emissions reductions, provide sustainable products or demonstrate GHG reductions could potentially result in loss of market share, reputational impacts, or an inability to attract and retain customers.
The ownership of our shares is highly concentrated, which could cause or exacerbate volatility in our share price as well as have significant influence over us.
As of December 31, 2025, Laukien family members, including our Chairman, President and Chief Executive Officer (“CEO”) Frank Laukien and his brother, Joerg Laukien, owned, in the aggregate, approximately 32% of our outstanding common stock. We may also repurchase shares in the future, which could further increase the concentration of our share ownership. These shareholders may also exercise substantial influence over all matters requiring shareholder approval, including the election of directors and approval of significant corporate transactions. This could have the effect of delaying or preventing a change in control of our company and will make some transactions difficult to accomplish without the support of these shareholders.
The loss of key personnel or an inability to attract and retain additional personnel could affect our ability to successfully grow our business.
We are highly dependent upon the continued service and performance of our CEO and other members of senior management and key finance, technical, scientific and production personnel, any of whom may cease their employment with us at any time with minimal advance notice. Because the expertise of these individuals is highly specific and takes years to develop, we face intense competition for these individuals from many other companies. The loss of one or more of our key employees may significantly delay or prevent the achievement of our business objectives, and our failure to attract and retain suitably qualified individuals or to adequately plan for succession could have an adverse effect on our ability to implement our business plan.
Risks Related to Ownership of our Common Stock
The Series A Mandatory Convertible Preferred Stock may adversely affect the market price of our common stock.
The market price of our common stock could be influenced by outstanding Series A Mandatory Convertible Preferred Stock and could become more volatile and impacted by investors’ anticipation of the potential resale in the market of a substantial number of additional shares of common stock received upon conversion of the Series A Mandatory Convertible Preferred Stock.
Our common stock ranks junior to our Series A Mandatory Convertible Preferred Stock with respect to dividends and amounts payable in the event of our liquidation, winding-up or dissolution.
Our common stock ranks junior to our Series A Mandatory Convertible Preferred Stock with respect to the payment of dividends and amounts payable in the event of our liquidation, winding-up or dissolution. This means that, unless accumulated dividends have been paid or set aside for payment on all our outstanding Series A Mandatory Convertible Preferred Stock through the most recently completed dividend period, no dividends may be declared or paid on our common stock subject to limited exceptions. Likewise, in the event of our voluntary or involuntary liquidation, winding-up or dissolution, no distribution of our assets may be made to holders of our common stock until we have paid to holders of our Series A Mandatory Convertible Preferred Stock a liquidation preference equal to $250 per share plus accumulated and unpaid dividends.
Dividends on our common stock could be reduced or eliminated in the future.
In recent years, we have paid dividends on our common stock. In February 2026, we announced that our Board of Directors (the “Board”) had declared a quarterly dividend of $0.05 per share that will be payable in April 2026. There is no guarantee that such dividends will continue indefinitely. 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 addition, on September 8, 2025, we issued 2,760,000 shares of Series A Mandatory Convertible Preferred Stock with a dividend rate of 6.375% per annum on the liquidation preference thereof. The Series A Mandatory Convertible Preferred Stock ranks
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senior to our common stock with respect to the payment of dividends. As long as any share of Series A Mandatory Convertible Preferred Stock is outstanding, unless all accumulated and unpaid dividends on the Series A Mandatory Convertible Preferred Stock for all preceding dividend periods have been declared and paid in full or declared and set apart for payment, we may not declare, pay or set apart for payment any dividends on our common stock. Dividends on the Series A Mandatory Convertible Preferred Stock are discretionary and cumulative. Holders of Series A Mandatory Convertible Preferred Stock will only receive dividends on their shares when, as, and if declared by our Board. These dividend obligations could impact our liquidity and reduce the amount of cash flows available for working capital, capital expenditures, growth opportunities, acquisitions, and other general corporate purposes. Our obligations to the holders of our Series A Mandatory Convertible Preferred Stock could also limit our ability to obtain additional financing, which could have an adverse effect on our financial condition. The preferential rights could also result in divergent interests between the holders of our Series A Mandatory Convertible Preferred Stock and holders of our Class A common stock. Additional risks related to the Series A Mandatory Convertible Preferred Stock are contained in the prospectus supplement filed with the SEC on September 8, 2025.
Risks Related to Our Dependence on Third Parties
We face risks related to sales through distributors and other third parties that we do not control, which could harm our business.
We sell certain products through third party agents, including distributors and value-added resellers. This exposes us to various risks, including competitive pressure, concentration of sales volumes, credit risks, and compliance risks. We may rely on one or a few key distributors for a product or market, and the loss of these distributors could reduce our revenue and net earnings. Distributors may also face financial difficulties, including bankruptcy, which could harm our collection of accounts receivable. Risks related to our use of distributors may reduce sales, increase expenses, and weaken our competitive position. Moreover, violations of the FCPA or similar anti-bribery laws by distributors or other third-party agents could materially and adversely impact our business, reputation and results of operations.
Furthermore, a portion of our sales of selected products consists of sales to third parties who incorporate our products into their systems. These third parties are responsible for the marketing and sales of their systems. We have little or no control over their marketing and sales activities or how they use their resources. They may or may not purchase sufficient quantities of products from us or perform appropriate marketing and sales activities. In addition, if we are unable to maintain our relationships with these third parties, our businesses may suffer. Failures by these third parties, or our inability to maintain existing or enter into new arrangements with them for product distribution, could materially impede the growth of our businesses and our ability to generate sufficient revenue and profits.
Dependence on contract manufacturing may adversely affect our ability to bring products to market and damage our reputation.
As part of our efforts to streamline our operations and reduce our operating costs, we outsource certain aspects of our manufacturing processes and continue to evaluate additional outsourcing. If our contract manufacturers fail to perform their obligations in a timely manner or at satisfactory quality levels, our ability to bring products to market and our reputation could suffer. For example, during a market upturn, our contract manufacturers may be unable to meet our demand requirements, which may preclude us from fulfilling our customers’ orders on a timely basis. The ability of these manufacturers to perform is largely outside our control. Additionally, changing or replacing our contract manufacturers could cause disruptions or delays. Problems with outsourced manufacturing could result in lower revenues and unexecuted efficiencies and adversely affect our financial condition and results of operations.
Our operations are dependent upon a limited number of suppliers and contract manufacturers.
We currently purchase components used in our products from a limited number of outside suppliers. Our reliance on a limited number of suppliers could result in time delays associated with redesigning a product due to an inability to obtain an adequate supply of required components and reduced control over pricing, quality and timely delivery. Any of these factors could adversely affect our revenues and profitability. As an example, BSI CALID purchases detectors and power supplies from sole or limited source suppliers. Additionally, our superconducting magnets or our electronics are partially dependent on cooperation from larger manufacturers like Electronic Manufacturing Services or High Temperature Superconductors suppliers. The existence of shortages of these components or the failure of delivery with regard to these components could have a material adverse effect on our revenues and margins. In addition, price increases from these suppliers or contract manufacturers could have a material adverse effect on our gross margins.
Because of the scarcity of some components and raw material, we may be unable to obtain an adequate supply of components, or we may be required to pay higher prices or to purchase components of lesser quality. Any delay or interruption in the supply of these or other components could impair our ability to manufacture and deliver our products, harm our reputation and cause a reduction in our revenues. In addition, any increase in the cost of the components that we use in our products could make our products less competitive and decrease our gross profits. We may not be able to obtain sufficient quantities of required components on the same or
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substantially the same terms. Additionally, consolidation among our suppliers could result in other sole source suppliers for us in the future. Other events that could affect our ability to source materials, manufacture or distribute our products include fire, natural disaster or extreme weather or a pandemic and the impact of those events on our operations and our suppliers’ and contract manufacturers’ operations.
Supply shortages and increasing prices of raw materials could adversely affect our gross profit.
The last few years have seen periodic supply shortages and strong fluctuations in the prices for various raw materials, in part due to high demand from developing countries, the war between Russia and Ukraine, uncertainties regarding international trade policies, including the potential for a trade war, and other geopolitical tensions. Supply shortages may also be impacted by demand increases from green transition, military or space/aerospace industry. We rely on some of these materials for the production of our products. For example, in our superconducting magnet production, both for the horizontal and vertical magnet series, we rely on the availability of copper, and other metallic raw materials as well as niobium titanium for the production of traditional low-temperature superconducting magnets, wires and devices. Higher prices for these commodities will increase the production cost of superconducting wires and superconducting magnets and may adversely affect gross profits.
The prices of copper and certain other raw materials used for superconductors have increased significantly over the last decade. Since copper is a main constituent of low temperature superconductors, this may affect the price of superconducting wire. This type of increase would have an immediate effect on the production costs of superconducting magnets and may negatively affect the profit margins for those products.
In order to operate superconducting magnets, we and our customers rely on liquid helium. Helium is subject to price and availability volatility, and shortages of liquid helium associated with federal price controls or depleted natural reserves could drive increases in helium pricing, which could have an adverse impact on producing and operating our superconducting magnets. This could cause us to lose sales, incur additional costs, or suffer harm to our reputation, which may negatively impact our business and results of operations.
Risks Related to Our Intellectual Property Rights
Our success depends on our ability to operate without infringing or misappropriating the proprietary rights of others.
Our commercial success depends on avoiding the infringement of other parties’ patents and proprietary rights as well as avoiding the breach of any licenses relating to our technologies and products. Given that there may be patents of which we are unaware, particularly in the United States where patent applications are confidential, avoidance of patent infringement may be difficult. Various third parties hold patents which may relate to our technology, and we may be found in the future to infringe these or other patents or proprietary rights of third parties, either with products we are currently marketing or developing or with new products which we may develop in the future. If a third-party holding rights under a patent successfully asserts an infringement claim with respect to any of our current or future products, we may be prevented from manufacturing or marketing our infringing product in the country or countries covered by the patent we infringe, unless we can obtain a license from the patent holder. We may not be able to obtain such a license on commercially reasonable terms, if at all, especially if the patent holder is a competitor. In addition, even if we can obtain a license, it may be non-exclusive, which will permit others to practice the same technology licensed to us. We also may be required to pay substantial damages to the patent holder in the event of infringement. Under some circumstances in the United States these damages could include damages equal to triple the actual damages the patent holder incurs. If we have supplied infringing products to third parties for marketing by them or licensed third parties to manufacture, use or market infringing products, we may be obligated to indemnify these third parties for any damages they may be required to pay to the patent holder and for any losses the third parties may sustain themselves as the result of lost sales or license payments they are required to make to the patent holder. Any successful infringement action brought against us may also adversely affect marketing of the infringing product in other markets not covered by the infringement action, as well as our marketing of other products based on similar technology. Furthermore, we will suffer adverse consequences from a successful infringement action against us even if the action is subsequently reversed on appeal, nullified through another action or resolved by settlement with the patent holder. The damages or other remedies awarded, if any, may be significant. As a result, any successful infringement action against us may harm our business.
If we are unable to effectively protect our intellectual property, third parties may use our technology, which would impair our ability to compete in our markets.
Our continued success will depend in significant part on our ability to obtain and maintain meaningful patent protection for our products throughout the world. We rely on patents to protect a significant part of our intellectual property and to enhance our competitive position. However, our presently pending or future patent applications may not issue as patents, and any patent previously issued to us may be challenged, invalidated, held unenforceable or circumvented. Furthermore, the claims in patents which have been issued, or which may be issued to us in the future, may not be sufficiently broad to prevent third parties from producing competing
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products similar to our products. In addition, the laws of various foreign countries in which we compete may not protect our intellectual property to the same extent as do the laws of the United States. Failure to obtain adequate patent protection for our proprietary technology could materially impair our ability to be commercially competitive.
In addition to patent protection, we also rely on the protection of trade secrets, know-how and confidential and proprietary information. To maintain the confidentiality of trade secrets and proprietary information, we generally seek to enter into confidentiality agreements with our employees, consultants and strategic partners upon the commencement of a relationship with us. However, we may not obtain these agreements in all circumstances. In the event of unauthorized use or disclosure of this information, these agreements, even if obtained, may not provide meaningful protection for our trade secrets or other confidential information. In addition, adequate remedies may not exist in the event of unauthorized use or disclosure of this information. The loss or exposure of our trade secrets and other proprietary information would impair our competitive advantages and could have a material adverse effect on our operating results, financial condition and future growth prospects. Furthermore, others may have, or may in the future independently develop, substantially similar or superior know-how and technology.
We may be involved in lawsuits to protect or enforce our patents that are brought by us which could be expensive and time consuming and, if determined adversely, could adversely affect our patent position.
In order to protect or enforce our patent rights, we may initiate patent litigation against third parties, and we may be similarly sued by others. We may also become subject to interference proceedings conducted in the patent and trademark offices of various countries to determine the priority of inventions. The defense and prosecution, if necessary, of intellectual property suits, interference proceedings and related legal and administrative proceedings is costly and diverts our technical and management personnel from their normal responsibilities. We may not prevail in any of these suits. An adverse determination of any litigation or defense proceedings could put our patents at risk of being invalidated or interpreted narrowly and could put our patent applications at risk of not being issued.
Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. In addition, during the course of this kind of litigation, there could be public announcements of the results of hearings, motions or other interim proceedings or developments in the litigation. If securities analysts or investors perceive these results to be negative, it could have a substantial negative effect on the trading price of our common stock. Refer to Note 25, Commitment and Contingencies for further information on our Litigation and Related Contingencies.
Risks Related to Legal, Regulatory and Compliance
Our manufacture and sale of products could lead to product liability claims for which we could have substantial liability.
The manufacture and sale of our products expose us to product liability claims if any of our products cause injury or are found otherwise unsuitable or defective as a consequence of product design, manufacturing, marketing, sale or customer use. In particular, if one of our CBRNE detection products malfunctions, this could lead to civilian or military casualties in a time of unrest, exposing us to increased potential for high-profile liability. Additionally, the nuclear magnetic resonance, research magnetic resonance imaging, Fourier transform mass spectrometry and certain electron paramagnetic resonance magnets of BSI BioSpin utilize high magnet fields and cryogenics to operate at approximately 4 Kelvin, the temperature of liquid helium. There is an inherent risk of potential product liability due to the existence of these high magnetic fields, associated stray fields outside the magnet, and the handling of the cryogens associated with superconducting magnets. In addition, our MALDI BioTyper product has an IVD-CE mark and U.S. FDA approval and is used for the identification of microorganisms. Misidentification or a false-negative of certain viruses, bacteria, yeasts or fungi could lead to inappropriate treatment for patients and could expose us to product liability claims.
A successful product liability claim brought against us in excess of, or outside the coverage of, our insurance coverage could have a material adverse effect on our business, financial condition and results of operations. We may not be able to maintain product liability insurance on acceptable terms, if at all, and insurance may not provide adequate coverage against potential liabilities.
We are subject to environmental laws and regulations, which may impose significant compliance or other costs on us.
Our manufacturing, product development and research and development operations and processes involve the controlled use of certain hazardous materials. In addition, we own and/or lease a number of facilities, some of which have been in operation for many decades, where we or others may have used substances or generated and disposed of wastes which are considered hazardous or may be considered hazardous in the future. We also have acquired various companies which historically may have used certain hazardous materials, and which may have owned and/or leased facilities where hazardous materials have been used. Due to the foregoing reasons, we are subject to federal, state, foreign, and local laws and regulations governing the use, manufacture, storage, transportation, handling, treatment, remediation, and disposal of hazardous materials and certain waste products. We have potential liability under these laws and regulations with respect to the remediation of past contamination in certain of the facilities we now own
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or lease. Additionally, in the future our facilities and the disposal sites owned by others to which we send or have sent waste, may be identified as contaminated and require remediation. Accordingly, we may become subject to additional compliance costs or environmental liabilities which may be significant and could materially harm our results of operations or financial condition.
Specifically, we use controlled hazardous and radioactive materials in our business and generate wastes that are regulated as hazardous wastes under U.S. federal, state, and local environmental laws, including, but not limited to, the state laws of Massachusetts, California, New Jersey, Washington and Wisconsin, under atomic energy regulatory laws, and under equivalent provisions of law in those and other jurisdictions in which our research and manufacturing facilities are located. Our use of these substances and materials is subject to stringent, and periodically changing, regulation that can impose costly compliance obligations on us and has the potential to adversely affect our manufacturing activities. The risk of accidental contamination or injury from these materials cannot be completely eliminated. If an accident with these substances occurs, we could be held liable for any damages that result, in addition to incurring clean-up costs and liabilities, which can be substantial. Additionally, an accident could damage our research and manufacturing facilities resulting in delays and increased costs.
We are subject to existing and potential additional regulation and government inquiry, which can impose burdens on our operations and narrow the markets for our products.
We are subject, both directly and indirectly, to the adverse impact of existing and potential future government regulation of our operations and markets. For example, the export of our products is subject to U.S. and non-U.S. export control, sanctions, customs, import and anti-boycott laws and regulations, including, as applicable, the International Traffic in Arms Regulations, the Export Administration Regulations and the sanctions laws, regulations and executive orders administered and enforced by the U.S. Department of the Treasury’s Office of Foreign Assets Control, and other laws and regulations adopted by the governments or agencies of other countries relating to the same subject matter as the U.S. laws and regulations described above.
The failure to satisfy export control criteria or obtain necessary clearances could delay or prevent shipment of products, which could adversely affect our revenues and profitability. Failure by the Company, our employees or others working on our behalf to comply with these laws and regulations could result in administrative, civil or criminal liabilities, including suspension, debarment from bidding for or performing government contracts, or suspension of our export privileges, which could have a material adverse effect on us. We frequently team with international subcontractors and suppliers who are also exposed to similar risks. In some cases, compliance with the laws and regulations of one country could violate the laws and regulations of another country. Violations of these laws and regulations could materially adversely affect our brand, international growth efforts and business.
In addition, as a result of our international operations, we are subject to compliance with various laws and regulations, including the FCPA and local anti-bribery laws in the jurisdictions in which we do business (including some higher risk countries according to the Transparency International Corruption Index), which generally prohibit companies and their intermediaries or agents from engaging in bribery or making improper payments to foreign officials or their agents. The FCPA also requires proper record keeping and characterization of such payments in our reports filed with the SEC. Despite maintaining policies and procedures that require our employees to comply with these laws and our standards of ethical conduct, we cannot ensure that these policies and procedures will always protect us from intentional, reckless or negligent acts committed by our employees or third-party agents.
Moreover, the life sciences industry, which is the market for our principal products, has historically been heavily regulated. Given the evolving nature of this industry, legislative bodies or regulatory authorities may adopt additional regulation or governmental policies that adversely affect our market opportunities. Our business is also directly affected by a wide variety of government regulations applicable to business enterprises generally and to companies operating in the life sciences industry in particular.
Our products are subject to the FDA’s requirements for electronic radiation emitting products, which include requirements related to record-keeping and reporting; labeling; notification; product repairs, replacements, and refunds; importation; and performance standards. In addition, our clinical products are subject to regulation as medical devices in the United States by the FDA and by similar regulatory bodies in other countries where such products are sold. These regulations govern a wide variety of product related activities, from quality management, design, development, and testing to labeling, manufacturing, complaint handling, reporting, promotion, sales and distribution. Compliance with applicable regulatory requirements is subject to continual review and is monitored rigorously through periodic inspections by the FDA and other regulatory authorities, which may result in written inspectional observations. The FDA and comparable foreign regulatory authorities also monitor product promotion and marketing materials and activities. If we or any of our suppliers or distributors fail to comply with FDA or other applicable regulatory requirements, or are perceived to potentially have failed to comply, we may face, among other things, warning letters; adverse publicity affecting both us and our customers; investigations or notices of non-compliance, fines, injunctions, and civil or criminal penalties; import or export restrictions; partial suspensions or total shutdown of production facilities or the imposition of operating restrictions; increased difficulty in obtaining required FDA clearances or approvals or foreign equivalents; seizures or recalls of our products or those of our customers; or the inability to sell such products. Any such FDA or comparable foreign regulatory actions could disrupt our business and operations, lead to significant remedial costs and have a material adverse impact on our financial position and results of operations. In addition, negative publicity and product liability claims resulting from any adverse regulatory
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action could have a material, adverse effect on our financial condition and results of operations. Further, the replacement of the European Union IVD Directive by the IVD Regulation (EU) 2017/746 in May 2022 has resulted in a stricter regime for manufacturers of IVDs. In accordance with the transitional provisions of the IVDR (Regulation (EU) 2017/746), our products currently comply with the applicable grace periods. Full conformity with all IVDR requirements must be achieved by December 31, 2029, for our in vitro diagnostic devices.