What changed in this filing

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Item 1. Business

2021-03-01 compared with 2020-03-27 · 119 added, 88 removed, 360 unchanged (37% of the section changed)

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Bruker BioSpin also manufactures and sells single and multiple modality systems using MRI, PET, SPECT, CT and MPI technologies (each as defined below).

Bruker BioSpin’s products, which have particular application

in structural proteomics, drug discovery, pharmaceutical and biotechnology research and production, and the food and materials science fields, provide customers with the ability to determine the structure, dynamics, and function of specific molecules, such as proteins, and to characterize and determine the composition of mixtures.

Bruker BioSpin’s products, which have particular application in structural proteomics, drug discovery, pharmaceutical and biotechnology research and production, and the food and materials science fields, provide customers with the ability to determine the structure, dynamics, and function of specific molecules, such as proteins, and to characterize and determine the composition of mixtures.

The majority of Bruker BioSpin’s customers are academic and government research facilities.

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and nonprofit laboratories.

During 2019, we ramped up installation and began to recognize revenue on a new class of NMR systems, which we refer to as GHz class systems.

In 2019, our GHz class system installations and customer acceptances included 1.0 GHz and 1.1 GHz NMR systems.

We also achieved major technical milestones in the manufacturing of 1.2 GHz NMR systems.

During 2019, we launched a number of new products and technologies, including a revolutionary benchtop magnetic resonance spectrometer.

We also installed a high-field 9.4 Tesla small animal MRI (described below) system with integrated in-line PET (described below).

During 2020, we successfully established a new class of NMR systems, which we refer to as GHz class systems, as a material part of our business.

We achieved customer acceptance on three 1.2 GHz systems.

We also achieved major technical milestones in the remote monitoring capabilities of our systems, enabling new services like predictive maintenance.

During 2020, we launched a number of new products and technologies, including a GxP solution for the Biopharma industry, solutions for high performance and automated solid-state NMR, and a new affordable high-resolution NMR product line.

Bruker BioSpin Group’s instruments are based on the following technology platforms:

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The magnetic particles are manipulated in a combination of oscillating magnetic fields exhibiting a field free zone.

The response of the particles allows a real time 3D data set acquisition of the whole body of an animal, showing

the contrast agent distributing in and flowing through the body.

The response of the particles allows a real time 3D data set acquisition of the whole body of an animal, showing the contrast agent distributing in and flowing through the body.

This imaging modality is used to detect cardiovascular disorders.

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CT offers the highest spatial resolution of all preclinical imaging modalities and is especially useful to generate morphological information about the object or animal under investigation.

CT is being used in a wide range of preclinical investigations such as bone-orthopedics, cardiovascular, pulmonary, oncology, metabolism and others.

CT is being used in a wide range of preclinical investigations in the fields of bone-orthopedics, cardiology, pulmonology, oncology and metabolism among others.

The Bruker BioSpin Group also offers a range of services, product lifecycle support, scientific software and workflow solutions to customers who use Bruker BioSpin products.

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Mass spectrometry-based solutions often combine advanced mass spectrometry instrumentation, automated sampling and sample preparation robots, reagent kits and other disposable products used in conducting tests, or assays, and bioinformatics software.

We offer mass spectrometry systems and integrated solutions for applications in multiple existing and emerging life science markets and chemical and applied markets, including expression proteomics, clinical proteomics, metabolic and peptide biomarker profiling, drug discovery and development, molecular diagnostics research and molecular and systems biology, as well as basic molecular medicine research.

We offer mass spectrometry systems and integrated solutions for applications in multiple existing and emerging life science markets and chemical and applied markets, including expression proteomics, clinical proteomics research, metabolic and peptide biomarker profiling, drug discovery and development, molecular diagnostics research and molecular and systems biology, as well as basic molecular medicine research.

Our timsTOF Pro mass spectrometer offers workflow solutions for proteomics research.

Our MALDI Biotyper mass spectrometry solution and test kits, DNA test strips and fluorescence-based PCR technologies are designed for in vitro diagnostic (IVD) use in clinical microbiology markets in certain configurations and certain countries, where regulatory approvals have been achieved.

In addition to culture-based microbial identification with the MALDI Biotyper platform, the Genotype and Fluorotype molecular diagnostics (MDx) kits enable a culture-free detection and analysis of microbes and viruses directly from patient sample with a special focus on tuberculosis, transplant diagnostics and sexually-transmitted diseases.

Molecular Diagnostics utilize Polymerase Chain Reaction (PCR) assays and systems to provide diagnostic solutions 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.

The GenoType portfolio has been established for over 30 years and has been successful in mycobacteria and tuberculosis detection, differentiation, and identification of antibiotic resistance markers.

The portfolio now 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.

We are applying this approach to a new portfolio of syndromic panels in development.

As a producer of extraction chemistry and instrumentation alongside integrated thermocyclers, software and a range of assays, Bruker brings complete diagnostic solutions to the Molecular Diagnostics market.

The Bruker Optics Division manufactures and distributes research, analytical and process analysis instruments and solutions based on infrared and Raman molecular spectroscopy technologies.

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Customers of our Bruker CALID Group 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 2019, we launched a number of new mass spectrometry-based product solutions and additional workflows, including the timsTOF fleX TM system featuring both electrospray ionization and MALDI on the same mass spectrometry system for the study of spatial molecular distributions and spatially resolved ‘omics’ molecular expression.

We also introduced additional analytical workflows for the timsTOF Pro TM system for proteomics and metabolomics research.

In clinical microbiology markets, we introduced the MALDI Biotyper sirius platform and our first assay in a novel Liquid Array TM format for the in-depth diagnosis of tuberculosis, on our new Fluorocycler-XT real-time PCR platform.The Bruker CALID Group’s instruments are based on the following technology platforms:

During 2020, we launched a number of new mass spectrometry-based solutions and additional workflows, including the MALDI-2 post-ionization source available as an option on the timsTOF fleX ESI/MALDI mass spectrometer.

In our microbiology and molecular diagnostics markets, we introduced the MALDI Biotyper sirius broadly into the market.

In our molecular diagnostics portfolio we launched two assays in the field of respiratory disease testing, primarily covering SARS-CoV 2 testing for the diagnosis of COVID-19 infection.

The Fluorotyper-SARS-CoV 2 plus kit allows for a real-time PCR detection of the SARS-CoV 2 virus.

It detects two viral genes in parallel as a mechanism for high sensitivity.

The additional FluoroType® SARS-CoV-2/Flu/RSV assay is a multiplex real-time PCR kit that detects four viruses of clinical significance causing respiratory disease during the winter season:

SARS-CoV 2, influenza A, influenza B and respiratory syncytial virus (RSV).

During 2020, the Bruker Optics division launched LUMOS II, a fully automated stand-alone FTIR imaging microscope.

LUMOS II provides ultrafast FTIR imaging capabilities based on modern focal plane array (FPA) detector technology.

The novel LUMOS II is designed to identify particles, to determine coatings and contaminations, and to reveal the polymeric composition of plastics.

The Bruker CALID Group’s instruments are based on the following technology platforms:

● MALDI-TOF —Matrix-assisted laser desorption ionization time-of-flight mass spectrometry, including tandem time-of-flight systems (MALDI-TOF/TOF);

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ESI-TOF mass spectrometers are particularly useful for:

identification, protein

analysis and functional complex analysis in proteomics and protein function;

identification, protein analysis and functional complex analysis in proteomics and protein function;

molecular identification in metabolomics, natural product and drug metabolite analysis;

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MRMS systems are particularly useful for:

the study of structure and function of biomolecules, including proteins, DNA and natural products;

the study of the structure and function of biomolecules, including proteins, DNA and natural products;

complex mixture analysis including body fluids or combinatorial libraries;

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BSI NANO Segment

Segment comprises the Bruker AXS, Bruker Nano Surfaces, Bruker Nano Analytics and Bruker Semiconductor Divisions.

The BSI Nano Segment comprises the Bruker AXS, Bruker Nano Analytics, Bruker Nano Surfaces and Metrology, Fluorescence Microscopy and Canopy Divisions.

The Bruker AXS Division 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.

This includes a product portfolio of instruments based on X-ray fluorescence spectroscopy (XRF), X-ray diffraction (XRD) and X-ray micro computed tomography (µCT), as well as spark optical emission spectroscopy systems (S-OES) used to analyze the concentration of elements in metallic samples.

Bruker Nano Surfaces Division’s products include atomic force microscopy instrumentation (AFM).

Such instruments provide atomic or near atomic resolution of surface topography and mechanical, electrical and chemical information using nano scale probes.

In addition, the Bruker Nano Surfaces Division provides advanced fluorescence optical microscopy instruments for multi-photon, multipoint scanning confocal and high-speed 3D super-resolution studies in life science applications.

The Bruker Nano Surfaces Division also provides non-contact nanometer resolution topography through white light interferometry and stylus profilometry.

This includes a product portfolio of instruments based on X-ray fluorescence spectroscopy (XRF), X-ray diffraction (XRD) and X-ray micro computed tomography (µCT), or X-ray microscopy, as well as spark optical emission spectroscopy systems (S-OES) used to analyze the concentration of elements in metallic samples.

The Bruker Nano Analytics Division manufactures and markets analytical tools for electron microscopes, including energy-dispersive X-ray spectrometers (EDS), electron backscatter diffraction systems (EBSD) and µCT accessories, as well as mobile and bench top micro X-ray fluorescence (µXRF), total reflection X-ray fluorescence spectrometers (TXRF) and handheld, portable and mobile X-ray fluorescence (HMP-XRF) spectrometry instruments.

The Bruker Semiconductor Division manufactures and markets X-ray metrology, automated AFM defect-detection and photomask repair and cleaning equipment for semiconductor process control.

The Bruker Nano Surfaces and Metrology 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.

The Fluorescence Microscopy Division provides advanced optical fluorescence microscopy instruments with multi-photon, multipoint scanning confocal 3D super-resolution, light-sheet modalities for studies in life science applications.

The Canopy Division provides products and services to support the multi-omics needs of researchers in translational research, drug and biomarker discovery.

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 2019, we launched several new products for the life science research market, including an advanced high-speed Bio-AFM system the Nano Wizard® ULTRA speed 2 and a new large-format high-resolution Bio-AFM system for nanoscale life science applications.

In addition, we launched the TrueLive 3D light-sheet microscope for multiplex live 3D cell culture imaging (the first ever tailorable next generation lattice light sheet), the InVi SPIM Lattice Pro (a light sheet clearing module), the InVi LCS for Neuroscience, and a next generation Ultima 2Pplus multiphoton system.

Addressing materials science applications, we launched the S8 JaguarTM versatile WDXRF spectrometer, the SKYSCANTM 1273 3D benchtop X-ray microscope, the G6 LEONARDOTM gas fusion analyzer, and the new Dimension XR state-of-the-art large-sample scanning AFM.

We acquired RAVE, LLC, a provider of nanomachining and laser photomask repair and cleaning equipment for semiconductor process control.

We also acquired Anasys Instruments Corp., a developer and manufacturer of nanoscale infrared spectroscopy and thermal measurement instruments, JPK Instruments AG, which adds in-depth expertise in live-cell imaging, cellular mechanics, adhesion, and molecular force measurements, optical trapping, and biological stimulus-response characterization to Bruker’s capabilities and Alicona Imaging GmbH, a provider of optical based dimensional metrology products.

During 2020, we launched several new products for the life science research market, including Vutura VXL, S2 PUMA II and Contour SP.

We acquired Canopy Biosciences LLC, a manufacturer of high multiplex biomarker imaging tools for immunology, immune-oncology, cell therapy and targeted proteomics research.

The BSI NANO Segment systems are based on the following technology platforms:

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● SC-XRD— Single crystal X-ray diffraction, often referred to as X-ray crystallography;

● µCT —X-ray micro computed tomography;

● µCT— X-ray micro computed tomography, X-ray microscopy;

● EDS— Energy dispersive X-ray spectroscopy on electron microscopes;

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● Alicona —Focus variation optical technology for non-contact dimensional metrology;

● Canopy – Multiplexed fluorescence-based single cell imaging for suspended cells and tissues as well as multi-omics sample characterization.

XRD systems investigate polycrystalline samples or thin films with single wavelength X-rays.

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Our XRD systems contribute to a reduction in the development cycles for new products in the catalyst, polymer, electronic, optical material and semiconductor industries.

Customers also use our XRD systems academic and government research facilities, as well as a variety of other fields, including forensics, art and archaeology.

Customers also use our XRD systems in academic and government research, as well as in a variety of other fields, including forensics, art and archaeology.

XRF systems determine the elemental composition of a material and provide a full qualitative and quantitative analysis.

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µCT is X-ray imaging in 3D, by the same method used in hospital CT scans, but on a small scale with massively increased resolution.

3D microscopy allows users to image the internal structure of objects

non-destructively on a very fine scale.

3D microscopy allows users to image the internal structure of objects non-destructively on a very fine scale.

Bruker µCT is available in a range of easy-to-use desktop instruments, which generate 3D images of the sample’s morphology and internal microstructure with resolution down to the sub-micron level.

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S-OES instruments are used for analyzing metals.

S-OES covers a broad range of applications for metals analysis from pure metals trace analysis to high alloyed grades, and allow for analysis of a complete range of relevant elements simultaneously.

S-OES covers a broad range of applications for metals analysis from pure metals trace analysis to high alloyed grades and allows for analysis of a complete range of relevant elements simultaneously.

S-OES instruments pass an electric spark onto a sample, which burns the surface of the sample and causes atoms to jump to a higher orbit.

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FM products use fluorescence microscopy to determine the structure and composition of life science samples.

Our products include two-photon microscopes, multipoint scanning confocal microscopes, laser illumination sources, photoactivation, photostimulation and photoablation accessories and synchronization and analysis software.

Our products include two-photon microscopes, multipoint scanning confocal microscopes, super-resolution microscopes, light-sheet microscopes, laser illumination sources, photoactivation, photostimulation and photoablation accessories and synchronization and analysis software.

Two-photon microscopes allow imaging deep into tissues and cells and are used widely in neuroscience.

Multipoint scanning confocal systems allow live cell imaging with rapid acquisition of images for structural and composition analysis.

We also offer super-resolution and single-molecule localization microscopy products which can break the optical diffraction limit by an order of magnitude.

Super-resolution and single-molecule localization microscopy products allow imaging below the optical diffraction limit by an order of magnitude.

Light-sheet based products allow fast 3D volume imaging with very low phototoxicity and photo-damage effects enabling live cell and large volume imaging.

SOM systems provide atomic or near-atomic two dimensional and three-dimensional surface resolution using white light interferometry, confocal optical and stylus profilometry methods.

SOM profilers range from low-cost manual tools for single measurements to advanced, highly automated systems for production line quality assurance and quality control applications where the combination of throughput, repeatability and reproducibility is essential.

SOM profilers support a range of applications in research, product development, tribology, quality

control and failure analysis related to materials and machining in the automotive, orthopedic, ophthalmic, high brightness LED, semiconductor, data storage, optics and other markets.

SOM profilers support a range of applications in research, product development, tribology, quality control and failure analysis related to materials and machining in the automotive, orthopedic, ophthalmic, high brightness LED, semiconductor, data storage, optics and other markets.

TMT systems provide a platform for all types of common mechanical, friction, durability, scratch and indentation tests for a wide spectrum of materials.

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Our systems use nanoprobe technology similar to what is used in our atomic force microscopes to deliver quantitative chemical information from the nanoscale to the sub-micron and macro scales.

The NanoIR measurement gives the user varying physical and chemical properties with nanoscale spatial resolution in a diverse range of fields, including polymers, 2D materials, materials science, life science and micro-electronics industry.

Our systems allow nanoscale IR absorption spectroscopy with interpretable IR spectra that directly correlates to FTIR as well as the complementary technique of nanoscale s-SNOM.

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These systems serve many quality assurance application areas requiring precision measurement and dimensional metrology, including aerospace, automotive, precision medical products, additive manufacturing, and micro precision manufacturing.

BEST designs, manufactures and distributes superconducting materials, primarily metallic low temperature superconductors, for use in magnetic resonance imaging, nuclear magnetic resonance, fusion energy research and other applications.

Canopy provides digital spatial profiling services and instruments which include both our ChipCytometry profiling instrument and ChipCytometry (single cell and spatial targeted proteomics) and other services.

These technologies, along with Canopy's more basic IHC and FISH services, allow researchers to elucidate gene and protein expression in a spatial context, which is useful for deep biological insight into gene expression and for the development of biomarkers.

Canopy also provides transcriptional profiling services covering a variety of assays, including RNASeq and qPCR.

Our multi-omic services provide data elucidating gene expression, signaling pathways, and differential expression trends on customer provided biological samples.

These services generally incorporate a data analysis service as well and can be utilized with multiple types of samples from very early discovery research through clinical trials.

The BEST Segment designs, manufactures and distributes superconducting materials, primarily metallic low temperature superconductors, for use in magnetic resonance imaging, nuclear magnetic resonance, fusion energy research and other applications.

Additionally, BEST develops, manufactures and markets sophisticated devices and complex tools based primarily on metallic low temperature superconductors that have applications in “big science” research, including radio frequency accelerator cavities and modules, power couplers and linear accelerators.

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In the microbiology market, Bruker CALID competes with Biomerieux.

In molecular diagnostics, Bruker CALID competes with a number of companies offering products for infectious disease diagnostics.

Bruker CALID also competes with a variety of companies that offer molecular spectrometry-based systems, including Thermo Fisher Scientific, PerkinElmer, Agilent, Foss, ABB Bomem, Buchi, Shimadzu and Jasco.

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in low temperature superconducting materials.

In addition, BEST competes with Fujikura, SuperPower (a Furukawa company), Superconductor Technologies Inc.

and SuNam Co., Ltd.

in the market for second generation high temperature superconducting materials.

BEST further competes 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.

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BSI Life Science Segment Research and Development

The research and development performed in the Bruker BioSpin Group and in the CALID Group is primarily conducted at our facilities in Bremen, Ettlingen, Germany;

The research and development performed in the Bruker BioSpin Group and in the CALID Group is primarily conducted at our facilities in Bremen and Ettlingen, Germany;

Faellanden, Switzerland and Wissembourg, France.

The Bruker BioSpin Group maintains technical competencies in core magnetic resonance technologies and

single- and multimodal imaging technologies and capabilities, including NMR, EPR, MRI, MPI, PET and CT.

The most recent technological innovations included Bruker’s ultra-high field NMR GHz-class product line now enabling novel research in functional structural biology of proteins and protein complexes and was followed by the delivery of the world’s first for Avance TM NEO 1.2 GHz NMR.

These ultra-high field trends in NMR are complemented by preclinical MRI magnet developments of up to 18 Tesla.

NMR probe technology now offers low temperature magic angle spinning (MAS) probes for dynamic nuclear polarization NMR for analysis of complex biomolecules and materials as well as new CP/MAS CryoProbes for material science research.

Bruker is incorporating artificial intelligence Deep Learning capabilities into its software to improve signal detection and the research instruments are further enhanced by advanced software tools for automated workflows on analytical data and 3D conformational and configurational analysis.

Remote monitoring of labs and systems now increases system protection and can provide expert supervision.

The next-generation, high-performance 80 MHz FT-NMR benchtop spectrometer allows new capabilities for organic or medicinal chemistry research, teaching or synthesis verification.

The Bruker BioSpin Group maintains technical competencies in core magnetic resonance technologies and single- and multimodal imaging technologies and capabilities, including NMR, EPR, MRI, MPI, PET and CT.

The most recent technological innovations included Bruker’s GHz-class ultra-high field NMR product line, enabling novel research in functional structural biology of proteins and protein complexes.

In 2020, we delivered and successfully installed our first NMR systems at the 1.2 GHz magnetic strength, the Avance TM NEO 1.2 GHz NMR.

In addition to ultra-high field NMR, we are also developing preclinical MRI magnets of up to 18 Tesla.

We have developed and introduced various new NMR probes, including low temperature magic angle spinning (MAS) probes for the analysis of complex biomolecules and materials, as well as new CP/MAS CryoProbes for material science research.

Bruker is incorporating artificial intelligence Deep Learning capabilities into its NMR software to improve signal detection and we are adding advanced software tools for automated workflows and 3D conformational and configurational analysis.

We have incorporated remote monitoring tools of labs and systems to increase system protection and support our customers with expert supervision.

We recently introduced our next-generation, high-performance 80 MHz FT-NMR benchtop spectrometer with new capabilities for organic and medicinal chemistry research, teaching and synthesis verification.

The Bruker CALID Group maintains technical competencies in core mass spectrometry technologies and capabilities, including:

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BSI NANO Segment Research and Development

The research and development performed in the BSI NANO Segment is primarily conducted at our facilities in Karlsruhe, Germany;

The research and development performed in the BSI NANO Segment is primarily conducted at our facilities in Karlsruhe, Berlin and Leipzig, Germany;

Penang, Malaysia;

Madison, Wisconsin, U.S.A.;

and San Jose and Santa Barbara, California, U.S.A.

Madison, Wisconsin, Eden Prairie, Minnesota, San Jose and Santa Barbara, California, and St.

Louis, Missouri, U.S.A.

The BSI NANO Segment maintains technical competencies in core X-ray technologies and capabilities, including detectors used to sense X-ray and X-ray diffraction patterns, X-ray sources and optics that generate and focus the X-rays, robotics and sample handling equipment that holds and manipulates the experimental material, and software that generates the structural data.

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The BSI NANO Segment also has competencies in AFM technology, which involve sub-angstrom level position and motion control, as well as sub-pico newton force control.

The BSI NANO Segment technologies also include 3D optical inference-based microscopy, stylus profilometry, tribology testing, nano-indentation, optical fluorescence two-photon microscopy, multipoint scanning microscopy and high-speed, 3D super-resolution florescence microscopy.

The BSI NANO Segment technologies also include 3D optical inference-based microscopy, stylus profilometry, tribology testing, nano-indentation, optical fluorescence two-photon microscopy, multipoint scanning microscopy, high-speed, 3D super-resolution florescence microscopy and spatial biology and single-cell targeted proteomics technologies.

Recent innovations include elemental analyzer systems for advanced applications and research and simultaneous, all-optical stimulation and imaging platforms for neuroscience applications.

BEST Segment Research and Development

The research and development performed in the BEST Segment is primarily conducted at our facilities in Hanau, Bergisch Gladbach and Alzenau, Germany;

The research and development performed in the BEST Segment is primarily conducted at our facilities in Hanau and Bergisch Gladbach, Germany;

and Carteret, New Jersey, U.S.A.

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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.

substantial patent portfolio, and we intend to file additional patent applications as appropriate.

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.

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We do not expect this compliance to have a significant impact on our capital spending, earnings or competitive position.

Prior to introducing a product in the United States, our Bruker AXS subsidiary provides notice to the U.S.

Food and Drug Administration, or FDA, in the form of a Radiation Safety Initial Product Abbreviated Report, which provides identification information and operating characteristics of the product.

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;

notification;

product repairs, replacements and refunds;

importations;

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.

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Nuclear Regulatory Commission also has regulations concerning the exposure of our employees to radiation.

Certain of our clinical products are subject to regulation in the United States by the FDA and by similar regulatory bodies in other countries where such products are sold.

For example, our MALDI Biotyper CA system is subject to regulation by the FDA and our IVD-CE Certified MALDI BioTyper system is subject to regulation in the European Union under the provisions of Directive 98/79/EC.

These, and similar local regulations elsewhere in the world, 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 necessary for the relevant level of regulatory clearance.

Certain of 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.

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.

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 obtaining marketing approval, authorization, or clearance from the FDA and comparable foreign regulatory authorities 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.

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.

The European Union Directive will be replaced in May 2022 by the IVD Regulation (EU) 2017/746.

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Our products currently approved under the Directive, and not already placed on the market or put into service, must be recertified under the Regulation by May 2024.

Working Capital Requirements

During the year ended December 31, 2019, there were no credit terms extended to customers that would have a material adverse effect on our working capital.

We recognize revenue from systems sales upon transfer of control in an amount that reflects the consideration we expect to receive.

Transfer of control generally occurs upon shipment, or for certain systems, based upon customer acceptance for a system once delivered and installed at a customer facility.

For systems that include customer-specific acceptance criteria, we are required to assess when it can demonstrate the acceptance criteria has been met, which generally is upon successful factory acceptance testing or customer acceptance and evidence of installation.

Systems that have been shipped to customers, but not yet accepted by the customer, are included as finished goods in-transit.

Finished goods in-transit was $36.0 million and $38.3 million at December 31, 2019 and 2018, respectively.

We also have well-equipped applications and demonstration facilities and qualified application personnel who assist customers and provide product demonstrations in specific application areas.

In total, we held $77.5 million and $67.9 million of demonstration inventory at December 31, 2019 and 2018, respectively.

Our backlog consists of firm orders under non-cancellable purchase orders received from customers.

Total system backlog at December 31, 2020 and 2019 was approximately $2,006.7 million and $1,855.3 million, respectively.

The increase in our backlog in 2019 when compared to 2018 is due to new long-term contracts within our BEST Segment.

The increase in our backlog in 2020 when compared to 2019 is due to recovering performance in our BSI order bookings at December 31, 2020.

We anticipate that approximately 67.3% of the backlog as of December 31, 2020 will be filled in 2021.

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As a result, backlog on any particular date can be indicative of our short-term revenue performance but 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 strive to attract, develop and retain top talent by offering our employees a challenging but rewarding work experience, as well as competitive compensation and benefits.

Further, we are dedicated to creating a work environment that promotes integrity, respect and trust among our employees.

As of December 31, 2020 and 2019, we had approximately 7,400 and 7,230 full-time employees worldwide, respectively.

Of these employees, approximately 1,225 and 1,095 were located in the United States as of December 31, 2019 and 2018, respectively.

Our employees in the United States are not unionized or affiliated with any labor organizations.

Employees based outside the United States are primarily located in Europe, with worker’s councils or labor unions primarily in Germany and France.

Several of our international subsidiaries are parties to contracts with labor unions and workers’ councils.

We believe that we have good relationships with our employees and the workers’ councils.

As of December 31, 2019, we had approximately 3,505 employees in production and distribution, 1,740 employees in selling and marketing and 1,205 employees in research and development, with general and administrative employees representing the remainder.

As of December 31, 2018, we had approximately 3,290 employees in production and distribution, 1,700 employees in selling and marketing and 1,135 employees in research and development, with general and administrative employees representing the remainder.

Of these employees, approximately 1,180 and 1,225 were located in the United States at December 31, 2020 and 2019, respectively.

Our senior leadership team is 67% male and 33% female.

The table below provides our employees by functional area.

Number of Employees

Production and distribution

Selling and marketing

General and administrative

Research and development

We also devote resources to training and development, including educational assistance for career-enhancing academic and professional programs.

Further, we invest time in identifying high-potential future leaders and working with them on individual development plans.

We recognize that our success is based on the collective talents and dedication of those we employ, and we are highly invested in their success.

Additionally, we are committed to promoting diversity across our organization.

We are actively working to expand the diversity of our workforce by embracing a variety of different perspectives and fostering an inclusive work environment for all of our employees.

As part of our efforts, we seek to identify and recruit employees with diverse professional experiences, skills and backgrounds, as well employees from diverse gender, racial and ethnic backgrounds.

Available Information

We are subject to the informational requirements of the Securities Exchange Act of 1934 (Exchange Act).

Therefore, we file periodic reports, proxy statements and other information with the Securities and Exchange Commission (SEC).

Such reports, proxy statements and other information are available on the SEC’s website (http://www.sec.gov).

Our website is located at www.bruker.com .

We make available free of charge through this website our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and amendments to those reports filed with or furnished to the SEC pursuant to Sections 13(a) or 15(d) of the Exchange Act, as soon as reasonably practicable after they are electronically filed with or furnished to the SEC.

The contents of our website are not incorporated into this report.

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 Exchange Act, as soon as reasonably practicable after they are electronically filed with or furnished to the SEC.

The SEC also maintains an internet site that contains reports, proxy and information statements and other information regarding our filings at www.sec.gov .

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

What changed 10-K

Item 1. Business