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Item 1. Business

2021-02-25 compared with 2020-02-27 · 207 added, 151 removed, 242 unchanged (60% of the section changed)

Fluidigm is a global company that improves life through comprehensive health insight.

Our innovative patented technologies and multi-omic tools are used by researchers to reveal meaningful insights into health and disease, identify biomarkers to inform decisions, and accelerate the development of more effective therapies.

We create, manufacture, and market a range of products and services, including instruments, reagents and software that are used by researchers worldwide.

Our focus is on the most pressing needs in translational and clinical research, including cancer, immunology and immunotherapy.

We use proprietary CyTOF® and microfluidics technologies to develop innovative end-to-end solutions that have the flexibility required to meet the needs of translational research and the robustness to support high-impact clinical research studies.

Fluidigm improves life by driving meaningful insights in health and disease.

Our innovative technologies explore the biological complexities of disease to advance human health through research, diagnostics and clinical applications.

We create, manufacture, and market a range of products and services, including instruments, consumables, reagents and software that are used by researchers and clinical labs worldwide.

Our customers are leading academic and government laboratories, as well as pharmaceutical, biotechnology, plant and animal research organizations, and clinical laboratories worldwide.

Together with our customers, we strive to increase the quality of life for all.

Our mass cytometry Helios™ system deeply profiles cell phenotype and function.

Referenced by hundreds of peer-reviewed publications around the world, mass cytometry is setting a new standard in human immune profiling.

Referenced by more than one thousand peer-reviewed publications around the world, mass cytometry has set a new standard in human immune profiling.

Transforming biological imaging, our Hyperion™ Imaging System enables highly multiplexed protein biomarker detection in tissues and tumors while still preserving tissue architecture and cellular morphology information using Imaging Mass Cytometry™ (IMC™).

Our microfluidic systems complement our mass cytometry offerings by providing highly scalable and automated workflows for quantitative polymerase chain reaction (PCR), gene expression, copy number variation analysis, and next-generation sequencing library preparation.

Used to detect somatic and genomic variations from a range of different sample types, these automated systems provide the cost efficiencies, flexibility and proven analytical performance that customers need to meet the increasing demands of molecular biomarker analysis.

We are a trusted partner of leading academic, government, pharmaceutical, biotechnology, contract research organizations and plant and animal research laboratories worldwide and we strive to increase the quality of life for all.

Market Opportunity

We believe that the Immunome market is a large, under-penetrated multibillion dollar market opportunity.

Through our work with outside consultants and internal market analysis, we believe that our potential market is approximately $3 billion, growing at a compound annual growth rate in the teens.

The current markets for our products address a broad range of biological analysis approaches, including the genome, proteome, transcriptome, epigenome and microbiome used by academic life science research customers, as well as applied markets customers, including clinical research laboratories, biopharmaceutical companies, biorepositories and agricultural biotechnology entities.

Our markets are increasingly looking to study data sets spanning these approaches in a concerted manner to answer pressing questions about immune function across cancer, immunology and immunotherapy.

We believe that we have large, multi-billion-dollar market opportunities for our products.

We are a leader in the high-growth cytometry market for high parameter applications and high-plex imaging.

Through our work with outside consultants and internal market analysis, we believe that the current potential market for mass cytometry high-parameter applications and addressable markets for spatial imaging is just under $1 billion, but expected to be approximately $3 billion by 2025, growing at a compound annual growth rate of approximately 27% over the next five years.

We believe we will gain greater access to this market as use of our products expands beyond research to translational and clinical use.

For our microfluidics products, our work with outside consultants and market analysis reflect a large potential respiratory and COVID-19 molecular diagnostics market opportunity.

We believe that our differentiated PCR microfluidics products are well-suited to serve the needs of the diagnostics market and our participation in COVID-19 testing provides an entry point for Fluidigm to build a long-term durable diagnostics business.

The current markets for our products address a broad range of biological analysis approaches, including the genome, proteome, transcriptome, epigenome and microbiome used by academic life science research customers, as well as applied markets customers, including diagnostic and clinical research laboratories, biopharmaceutical companies, biorepositories and agricultural biotechnology entities.

Our markets are increasingly looking to study data sets spanning these approaches in a concerted manner to reveal, understand, and address the biological complexities of disease.

Key elements of our strategy include:

Offering innovative, differentiated products to researchers based on our mass cytometry and microfluidic technologies.

Mass cytometry is a leading, high multiplex solution to analyze many cell-surface and intracellular proteins simultaneously in cell suspensions including blood and disassociated tissues.

• Mass cytometry is a leading, highly multiplexed solution to analyze many cell-surface and intracellular proteins simultaneously in cell suspensions including blood and disassociated tissues.

Our products enable innovative methods to characterize cells and other sample types not commonly achieved with other conventional technologies.

IMC™ is a pioneering technology allowing for high multiplexed imaging to understand the composition of tissue microenvironments at a subcellular 1-micron resolution.

• IMC™ is a pioneering technology allowing for highly multiplexed imaging to understand the composition of tissue microenvironments at a subcellular 1-micron resolution.

Together with Mass Cytometry, these products provide researchers the capabilities to gain deeper insights into immune function.

• Our microfluidic technologies enable a scalable and sensitive solution in fields requiring high-throughput molecular biomarker analysis, whether it be for the analysis of gene expression profiles, genotyping, analysis of proteomic biomarkers, or library preparation in advance of gene sequencing.

Expanding addressable markets through attention to assay content, workflow efficiency, software improvements, desirable strategic partnerships and inorganic growth opportunities .

Our strategy addresses expanded and enhanced applications, workflows and analytics to allow our customers better productivity, increasing the value of our toolsets across our mass cytometry and microfluidics products.

We have developed a sample-to-answer workflow for comprehensive human immune profiling for use with our Helios system, that puts pre-titrated antibodies in dry format in a single tube, with automated software that provides data analysis in as few as five minutes.

This assay is reproducible from site-to-site and lot-to-lot, which is important for translational and pharma/biotech research work.

• With the COVID-19 pandemic, key aspects of our microfluidic technologies make such technologies competitive in the global COVID-19 testing market.

This has created a new market opportunity that has been incorporated in our 2021 strategy.

Expanding addressable markets through assay content development, workflow efficiency, software improvements, desirable strategic partnerships and inorganic growth opportunities .

Our strategy is to provide expanded and enhanced applications, workflows and analytics to allow our customers better productivity, increasing the value of our mass cytometry and microfluidics product lines.

• In response to the need for testing to detect SARS-CoV-2, we developed our Advanta Dx SARS-CoV-2 RT-PCR Assay for use by authorized laboratories with Fluidigm microfluidics instruments.

We received U.S.

Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for this assay in August 2020, and we also supported customer efforts to develop their own laboratory developed tests and respiratory panels using our microfluidics-based products.

• Our customers have been using our award winning sample-to-answer workflow for comprehensive human immune profiling, for use with our Helios system, has played an important role in immune profiling of COVID-19 patient samples.

Our spatial imaging mass cytometry capabilities are also used for immune profiling of lung tissue samples that may inform research and development of new treatment approaches for COVID-19.

This workflow and our products are already being used by our customers in ongoing research for cancer, chronic inflammatory conditions, autoimmune and infectious diseases with inclusion in over 1,380 publications and use in 127 clinical trials as of December 31, 2020.

• We have collaborated with industry partners to enable workflows and software for both the Helios and Hyperion systems.

In 2019, we added seven new metal antibody labels, becoming the first company to enable 50-plex cytometry panels, launched three Imaging Mass Cytometry Panel Kits and Advanced CyTOF software, as well as Maxpar Direct Immune Profiling Assay, a sample-to-answer workflow that received the 2019 Life Science Industry Gold Award for Most Innovative New Cell Biology Product.

We have developed and collaborated with industry partners to build our applications, software and assays on our microfluidic platforms for gene expression, genotyping and sequencing library preparations as well as single-cell applications for our C1 system.

Our future development will leverage both in-house development as well as externally-partnered solutions to drive new applications and sample-to-answer functionality across all our platforms.

In 2019, we launched the Advanta RNA-Seq NGS Library Preparation product targeting a large potential market opportunity, in line with this strategy.

We also announced a collaboration with Icahn School of Medicine at Mount Sinai for a single-cell study of the human epigenome.

In 2020, we also launched our Therapeutic Insights Services and opened a Japan service lab, expanding accessibility of sample-to-answer mass cytometry and Imaging Mass Cytometry services for a broad range of translational and clinical research needs.

• We have leveraged both in-house development as well as externally partnered solutions to drive new applications and sample-to-answer functionality across all our platforms.

In 2020, we developed and collaborated with strategic partners to build our applications, software and assays on our microfluidic platforms for diagnostics, as well as gene expression, genotyping and sequencing library preparations.

• We executed a definitive contract with the National Institutes of Health (NIH) for a project under the NIH Rapid Acceleration of Diagnostics (RADx) program.

The project encompasses expanding our production capacity and throughput capabilities for COVID-19 tests, with funding of up to $34.0 million upon achievement of certain milestones.

• We expanded an existing collaboration with Icahn School of Medicine at Mount Sinai to include COVID-19-related diagnostics and research work.

This study is being funded by the U.S.

Department of Defense.

• We entered into an original equipment manufacturer (OEM) development agreement with a customer to develop products based on our microfluidics technology with payments of up to $11.7 million during the development stage, with some of these payments recognized in 2020.

We market innovative technologies and life science tools, including preparatory and analytical instruments for Mass Cytometry, PCR, Library Prep, Single Cell Genomics, and consumables, including integrated fluidic circuits (IFCs), assays, and reagents.

Our primary product offerings are summarized in the table below:

Product Description

Product Product Description Applications

Mass Cytometry

Analytical Systems:

Helios™, a CyTOF system

The Helios mass cytometry system performs high-parameter single-cell analysis using antibodies conjugated to metal isotopes.

Helios™, a CyTOF system The Helios mass cytometry system performs high-parameter (>50) single-cell analysis using antibodies conjugated to metal isotopes.

Mass Cytometry

Hyperion™ Imaging System

The Hyperion Imaging System brings together imaging capability with proven high-parameter CyTOF technology to enable the simultaneous detection of up to 37 protein markers in the spatial context of the tissue microenvironment.

Hyperion™ Imaging System The Hyperion Imaging System brings together imaging capability with proven high-parameter CyTOF technology to enable the simultaneous detection of up to 38 protein markers in the spatial context of the tissue microenvironment.

Imaging Mass Cytometry

Hyperion™ Tissue Imager

The Hyperion Tissue Imager scans tissues at 1 micron resolution.

Hyperion™ Tissue Imager The Hyperion Tissue Imager scans tissues at 1 micron resolution.

It can be purchased as an upgrade for the Helios system to enable imaging capability, then referred to as Hyperion Imaging System.

Imaging Mass Cytometry

Flow Conductor Flow Conductor is an integrated sample preparation system for flow or mass cytometry assays.

Mass Cytometry

Assays and Reagents:

Maxpar® Reagents

Maxpar® reagents are included in multiple product lines addressing needs in functional and phenotypic profiling of single cells, as well as nucleic acid detection.

The product lines include pre-conjugated antibodies, application-specific kits, and custom antibody labeling services.

Maxpar® Reagents Maxpar® reagents are included in multiple product lines addressing needs in functional and phenotypic profiling of single cells, as well as nucleic acid detection.

The product lines include more than 800 pre-conjugated antibodies, application-specific kits, and custom antibody labeling services.

Mass Cytometry and Imaging Mass Cytometry

Maxpar Human Immune

Monitoring Panel Kit and Workflow

Maxpar Human Immune Monitoring Panel Kit and Workflow

The kit contains 29 pre-titrated antibodies designed and optimized for deep immune profiling of human peripheral blood mononuclear cells.

Enables comprehensive identification and characterization of key immune cell populations.

Enables identification and characterization of key immune cell populations.

The workflow includes protocol and data analysis.

Mass Cytometry

Maxpar Direct Immune Profiling Assay

The assay enables comprehensive identification and characterization of 37 immune cell populations.

With automated software and as little as five minutes of data analysis.

The kit contains 30 pre-titrated antibodies provided in a dry single-tube format.

Maxpar Direct Immune Profiling Assay The assay enables identification and characterization of 37 immune cell populations with automated software.

The kit contains 30 pre-titrated antibodies provided in a dry single-tube format and is also compatible with additional expansion panels focusing on specific cell populations.

Mass Cytometry

Maxpar IMC Panel Kits for Immuno-oncology

Contains a mix of non-overlapping metal-conjugated antibodies to deeply profile tumor-infiltrating lymphocytes, immunce cell activation states or tissue architecture.

Maxpar IMC Panel Kits for Immuno-oncology Contains a mix of non-overlapping metal-conjugated antibodies to deeply profile tumor-infiltrating lymphocytes, immune cell activation states or tissue architecture.

These new panels can be easily mixed and matched or combined as an 18-marker panel to broadly profile immune infiltrates.

Mass Cytometry

Advanced CyTOF Software 7.0

Streamlines the selection and acquisition of multiple regions of interest from each slide with an enhanced user experience.

Remotely annotate each ROI using bright field reference images to guide automated batch acquisition of highly multiplexed images on the Hyperion Imaging System.

CyTOF Software v7.0 Streamlines the selection and acquisition of multiple Regions of Interest (ROI) from each slide.

Mass Cytometry

Product Product Description Applications

Microfluidics

Preparatory Instruments:

Access Array System

A modular, flexible system that automates amplicon-based library preparation of up to 480 amplicons across 48 unique samples per processing run.

The resulting barcoded libraries are ready for targeted DNA sequencing on next-generation sequencing (NGS) platforms from Illumina® and Ion Torrent®.

Library preparation for targeted DNA sequencing on NGS systems

An integrated system that automates the preparation of amplicon-based libraries for targeted next-generation DNA sequencing.

Additionally, Juno automates microfluidic workflows for PCR-based gene expression, genotyping, digital PCR, and copy number variant analysis by processing IFCs prior to analysis on Biomark HD or EP1 platforms.

Library preparation for targeted DNA sequencing on NGS systems.

End-Point PCR, SNP Genotyping, sample identification, Gene Expression, and digital PCR

Juno System An integrated system that automates the preparation of RNA-seq and amplicon-based libraries for next-generation sequencing (NGS).

Additionally, Juno automates microfluidic-based PCR workflows by processing IFCs prior to analysis on Biomark HD or EP1 platforms.

Library preparation for RNA-seq and targeted NGS.

PCR applications include sequence detection, sample identification, genotyping, gene expression, and real-time digital PCR

Analytical Instruments:

Biomark HD System

Real-time PCR analytical instrument for microfluidics-based analysis of gene expression, single-cell targeted gene expression, microRNA expression, sample identification, SNP genotyping, and real-time digital PCR.

SNP Genotyping, sample identification, Digital PCR, and Gene Expression, including Single-Cell Targeted Gene Expression

End-point PCR analytical instrument for microfluidics-based analysis of SNP genotyping and end-point digital PCR.

SNP Genotyping, sample identification, and Digital PCR

Biomark HD System Real-time PCR analytical instrument for microfluidics-based workflows using Fluidigm IFCs.

Sequence detection, sample identification, genotyping, gene expression, and real-time digital PCR Expression

EP1 System End-point PCR analytical instrument for microfluidics-based workflows using Fluidigm IFCs.

Genotyping, sample identification, and digital PCR

Integrated Fluidic Circuits (IFCs):

Library Preparation IFCs to support targeted DNA sequencing of 48 or 192 samples on NGS instruments.

Library preparation for targeted next-generation DNA sequencing

Juno Genotyping IFC

IFC that incorporates preamplification for genotyping of 96 samples and 96 markers on a single run.

Library Preparation (LP) IFCs LP and 48.Atlas IFCs for NGS LP supporting RNA-Seq and targeted amplicon-based sequencing.

Library preparation for RNA-seq and targeted NGS

Juno Genotyping IFC IFC that incorporates preamplification for genotyping of 96 samples and 96 markers in a single run.

Genotyping, sample identification

Dynamic Array IFCs

IFCs based on matrix architecture, allowing users to (i) individually assay up to 24 samples against up to 192 assays, (ii) individually assay up to 48 samples against up to 48 assays, (iii) individually assay up to 96 samples against up to 96 assays, or (iv) individually assay up to 192 samples against up to 24 assays.

Real-time qPCR, End-Point PCR, SNP Genotyping and Gene Expression, including Single-Cell Targeted Gene Expression, sample identification, copy number variant analysis

Digital Array IFCs

IFCs based on partitioning architecture allowing users to (i) individually assay up to 12 samples or panels across 765 chambers, or to (ii) individually assay up to 48 samples across 770 chambers per IFC.

Digital PCR, Copy Number Variation and

Variant Detection

IFC that incorporates six 12 X 12 partitions that can be organized in any configuration, in up to six separate experimental runs.

Dynamic Array IFCs IFCs based on matrix architecture, allowing users to (i) individually assay up to 24 samples against up to 192 assays, (ii) individually assay up to 48 samples against up to 48 assays, (iii) individually assay up to 96 samples against up to 96 assays, or (iv) individually assay up to 192 samples against up to 24 assays.

Real-time and end-point PCR;

Sequence detection, sample identification, genotyping, gene expression, and real-time digital PCR

Digital Array IFCs IFCs based on partitioning architecture allowing users to (i) individually assay up to 12 samples or panels across 765 chambers, or to (ii) individually assay up to 48 samples across 770 chambers per IFC.

Real-time and end-point digital PCR, Copy Number Variation and variant detection

Flex Six IFC IFC that incorporates six 12 X 12 partitions that can be organized in any configuration, in up to six separate experimental runs.

Gene Expression and SNP Genotyping

Assays and Reagents:

Advanta RNA-Seq NGS Library Prep Kit

Integrated solution for automated NGS library prep.

Used with The Juno system with the Advanta RNA-Seq reagents and 48.Atlas integrated fluidic circuit, supports simultaneous processing of up to 48 total RNA samples.

Library preparation for next-generation DNA sequencing

Delta Gene and SNP Type Assays

Custom designed assays targeted to genomic regions of interest for genotyping and gene expression.

Advanta RNA-Seq NGS Library Prep Kit Integrated solution for automated NGS library prep.

Used with the Juno system with the Advanta RNA-Seq reagents and 48.Atlas IFCs, supports simultaneous processing of up to 48 total RNA samples.

RNA-seq library preparation for NGS

Product Product Description Applications

Advanta™ Dx SARS-CoV-2 RT-PCR Assay qPCR-based test that takes advantage of Fluidigm proprietary microfluidics technology and the Juno™ and Biomark™ HD systems.

Enables reliable, high-capacity testing of saliva samples from patients suspected by their health care providers of COVID-19 (coronavirus) infection to support diagnostic decision making

Delta Gene and SNP Type Assays Custom designed assays targeted to genomic regions of interest for genotyping and gene expression.

Gene Expression, Single-Cell Targeted Gene Expression, SNP Genotyping

Access Array Target-Specific Primers and Targeted Sequencing Prep Primers

Custom designed assays for NGS library preparation using Access Array chemistry on the Access Array or Juno systems.

Library preparation for targeted next-generation DNA sequencing

Targeted DNA Seq Library Assays

Custom designed assays for NGS library preparation using Targeted DNA Sequencing Library Preparation chemistry on the Access Array or Juno systems.

Library preparation for targeted next-generation DNA sequencing

Access Array Target-Specific Primers and Targeted Sequencing Prep Primers Custom designed assays for NGS library preparation using Access Array chemistry on the Access Array or Juno systems.

Library preparation for targeted NGS

Targeted DNA Seq Library Assays Custom designed assays for NGS library preparation using Targeted DNA Sequencing Library Preparation chemistry on the Juno systems.

Library preparation for targeted NGS

Single Cell Microfluidics

Preparatory Instrument:

Sample preparation system that rapidly and reliably isolates and processes individual cells for genomic analysis.

Single-Cell Targeted Gene Expression, Single-Cell microRNA Analysis, Single-Cell mRNA Sequencing (Full Length and End-Counting), Single-Cell Targeted DNA Sequencing, Single-Cell Whole Exome Sequencing, and Single-Cell Whole Genome DNA Sequencing, Single-Cell Epigenetics, Total RNA sequencing, T-ATAC-seq, REAP-Seq (RNA and Protein)

C1 System Sample preparation system that rapidly and reliably isolates and processes individual cells for genomic analysis.

Single-Cell NGS library preparation for RNA sequencing including full-length, end-counting, and total RNA applications;

single-cell targeted gene expression by real-time PCR including microRNA analysis;

single-cell epigenetics and multi-omic applications including ATAC-seq and REAP-Seq (RNA and Protein);

single-cell NGS library preparation for DNA sequencing including targeted, whole exome and whole genome applications

Preparatory Analytical Instruments:

Polaris System

System and IFC that enables single cell contextual studies by facilitating active/live cell selection, isolation, imaging, dosing, and cell culturing workflows.

Functional Genomics Using Single-Cell mRNA Sequencing

IFCs that capture up to 800 cells between 5-25 microns in diameter and then automatically process the cells for a variety of genomic analysis using thermal and pneumatic controls at nanoliter scale.

Single-Cell Targeted Gene Expression, Single-Cell microRNA Analysis, Single-Cell mRNA Sequencing (Full Length and End-Counting), Single-Cell Targeted DNA Sequencing, Single-Cell Whole Exome DNA Sequencing, and Single-Cell Whole Genome DNA Sequencing, Total RNA sequencing, T-ATAC-seq, REAP-Seq (RNA and Protein).

Additional customer and 3 rd -party developed applications available through Fluidigm Script Hub

IFC that actively selects, captures and cultures up to 48 single-cells for up to 24 hours.

It integrates media exchange, dosing and time course studies followed by cell lysis, reverse transcriptions and library preparation for single cell mRNA sequencing.

Functional Genomics of Single Cells

C1 IFCs IFCs that capture up to 800 cells between 5-25 microns in diameter and then automatically process the cells for a variety of genomic analysis using thermal and pneumatic controls at nanoliter scale.

Single-Cell NGS library preparation for RNA sequencing including full-length, end-counting, and total RNA applications;

single-cell targeted gene expression by real-time PCR including microRNA analysis;

single-cell epigenetics and multi-omic applications including ATAC-seq and REAP-Seq (RNA and Protein);

single-cell NGS library preparation for DNA sequencing including targeted, whole exome and whole genome applications

Multi-Layer Soft Lithography

Our IFCs are manufactured using multi-layer soft lithography (MSL) technology to create valves, chambers, channels and other fluidic components on our IFCs that allow nanoliter quantities of fluids to be precisely manipulated within the IFC.

We have developed commercial manufacturing processes to fabricate valves, channels, vias, and chambers with dimensions in the ten to 100 micron range, at high density and with high yields.

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The second level of our IFC technology comprises the architectures we have designed to exploit our ability to conduct thousands of reactions on a single IFC.

The third level of our IFC technology involves the

interaction of our IFCs with the actual laboratory environment.

The third level of our IFC technology involves the interaction of our IFCs with the actual laboratory environment.

Our IFCs are built on specially designed input frames that are compatible with most commonly used laboratory systems.

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Our mass cytometry instrumentation technology includes a custom-designed inductively coupled plasma ion source, ion-optical and vacuum systems, and instrument control electronics.

With our Helios system, which is an enhanced version of our CyTOF 2 system, individual cells are atomized, ionized, and extracted.

With our Helios system, individual cells are atomized, ionized, and extracted.

A time-of-flight mass analyzer separates atomic ions of different mass-to-charge ratios, providing information on temporal distribution of ions.

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Our systems have the ability to utilize up to 135 channels to detect additional parameters to meet future market needs.

Lastly, our Flow Conductor sample preparation system provides sample preparation capabilities for both flow and mass cytometry assays.

The Flow Conductor system can process up to 100 antibodies at a time and simultaneously stain and prepare up to 18 specimens.

Our Biomark HD system includes our custom thermal cycler, the FC1 cycler, and a sophisticated fluorescence imaging system.

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They apply precise control of multiple pressures to move fluid and control valve states in a microfluidic IFC.

We have also developed specialized software to manage and analyze the unusually large amounts of data produced by our systems.

We offer Fluidigm Cytobank, our cloud-based platform of analytical tools, for use with the Helios system.

We also offer specialized software to manage and analyze the unusually large amounts of data produced by our systems.

We offer Fluidigm Cytobank, our cloud-based platform of analytical tools, FCS Express7 Flow, and Maxpar Pathsetter data analysis packages for use with the Helios system.

For our Imaging Mass Cytometry platform, Hyperion, we offer various state of the art software packages to enable data analysis from basic to translational research:

CyTOF Software 7.0, MCD Viewer, histoCAT, Visiopharm Phenomap and Indica Lab Halo.

Our bioinformatic toolset, the Singular software, facilitates the analysis and visualization of single-cell gene expression data.

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Assays and Reagents

We manufacture metal-conjugated antibodies for use with our mass cytometry instruments to allow detection of up to approximately 44 protein targets simultaneously in a single cell for a total of more than 50 detected cellular parameters.

We manufacture over 800 metal-conjugated antibodies for use with our mass cytometry and Imaging Mass Cytometry instruments to allow detection of up to approximately 44 protein targets simultaneously in a single cell for a total of more than 50 detected cellular parameters.

Our metal-conjugated antibodies are manufactured using metal-chelating polymers, which are produced using proprietary polymerization processes and subsequent post-polymerization modifications.

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We have developed a process to provide customers with validated assays for their targets of interest.

Life Science Research

Our products enable comprehensive interrogation of biological samples across a range of genomic and protein molecular biomarkers.

One primary area of focus within life science research is genetic analysis, the study of genes and their functions.

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Single-cell genomics is the study of the sequence and expression of genes and their ultimate functions at the individual cell level.

There are several forms of genetic analysis in use today, including genotyping, gene expression analysis and DNA sequencing:

There are several forms of genetic analysis in use today, including genotyping, gene expression analysis and NGS:

• Genotyping involves the analysis of DNA variations across individual genomes.

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Determining these levels is important because mRNAs are often translated by the cell into proteins and may affect the activity of the cell or the larger organism.

DNA sequencing is a process by which researchers are able to determine the particular order of nucleotide bases that comprise all or a portion of a particular gene or genome, and typically improves with target enrichment, such as complex sample preparation and tagging processes.

Researchers are increasingly using next-generation DNA sequencers to rapidly and cost-effectively sequence portions of genomes, which is important for the identification of genetic variations that correlate with particular phenotypes.

• NGS is a process by which researchers are able to determine the particular order of nucleotide bases that comprise all or a portion of a particular gene or genome (in the case of DNA sequencing) or gene transcript or sample transcriptome (in the case of RNA sequencing).

NGS is routinely used for studies across the research continuum including basic research, biomarker discovery, translational research, and clinical research.

Gene expression and genotyping are studied through a combination of various technology platforms that characterize gene function and genetic variation.

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Real-time quantitative PCR (real-time qPCR) is a more advanced form of PCR that makes it possible to quantify the number of copies of DNA present in a sample.

Another focus within life science research is protein analysis, the study of proteins and their structures and functions.

Another focus within life science research is single cell protein analysis, the study of proteins and their structures and functions.

Proteins perform a vast array of functions within living organisms, including catalyzing metabolic reactions, replicating DNA, signaling response to stimuli and transporting molecules from one location to another.

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Immunohistochemistry is used broadly throughout the life sciences industry, and in clinical research to better understand the characteristics and relationship of cancerous versus normal cells in biopsy tissue.

In general, the number of simultaneously imageable proteins is less than five, with researchers only able to achieve a higher-parameter resolution using serial sections (several adjacent sections of the same tissue) or other highly laborious, more serial staining methods.

Suspension mass cytometry is similar to traditional flow cytometry but is based primarily on antibodies using heavy metal isotope labels rather than fluorescent labels for detection of proteins, enabling the significant expansion of the number of parameters analyzed per individual cell versus conventional flow cytometry technologies.

In general, the number of simultaneously imageable proteins is less than five, with researchers only able to achieve a higher-

parameter resolution using serial sections (several adjacent sections of the same tissue) or other highly laborious, more serial staining methods.

• Suspension mass cytometry is similar to traditional flow cytometry but is based primarily on antibodies using heavy metal isotope labels rather than fluorescent labels for detection of proteins, enabling the significant expansion of the number of parameters analyzed per individual cell versus conventional flow cytometry technologies, as well as providing superior data quality.

With high-throughput, single-cell analysis capabilities and the ability to analyze more protein markers per individual cell, researchers have more granular information, which allows them to identify and characterize even finer subpopulations of cells.

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This method enables a significant expansion of the number of parameters simultaneously analyzed per tissue section rather than in adjacent sections or via serial staining protocols.

We sell our instruments for research use only to leading academic research institutions, translational research and medicine centers, cancer centers, clinical research laboratories, and biopharmaceutical, biotechnology, and plant and animal research companies.

With the exception of our Advanta™ Dx SARS-CoV-2 RT-PCR Assay (Rx Only), which is for In Vitro Diagnostic use under Emergency Use Authorization (EUA) and CE-IVD, being performed on our instruments, we sell our instruments for research use only to leading academic research institutions, translational research and medicine centers, cancer centers, clinical research laboratories, and biopharmaceutical, biotechnology, and plant and animal research companies.

No single customer represented more than 10% of our total revenue for 2020, 2019, or 2018.

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As a result of these factors and the budget cycles of our customers, our sales cycle, the time from initial contact with a customer to our receipt of a purchase order, can often be 12 months or longer.

As of December 31, 2019, we had 187 people employed in sales, technical support, and marketing.

Manufacturing

Our manufacturing operations are primarily located in Singapore and Canada.

Our facility in Singapore manufactures our IFCs and manages production of our genomics instruments, which are assembled by our contract manufacturer located within our Singapore facility.

Our facility in Singapore manufactures our IFCs and manages production of our microfluidics instruments, which are assembled by our contract manufacturer located within our Singapore facility.

All of our IFCs for commercial sale and some IFCs for our research and development purposes are also fabricated at our Singapore facility.

Our mass cytometry instruments for commercial sale, as well as for internal research and development purposes, are manufactured at our facility in Canada.

As part of our on-going efforts related to operational excellence and improving efficiencies, we consolidated our North American production of reagents for mass cytometry activities into our Canadian facility in 2019.

We rely on a limited number of suppliers for certain components and materials used in our products.

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The largest component of our current research and development effort is in the areas of new products, new applications and new content.

In the area of mass cytometry, we developed an initial prototype imaging mass cytometer instrument in 2016, and successfully launched the commercial Hyperion Imaging System in October 2017.

The imaging mass cytometer system provides spatial resolution of protein expression in complex tissue samples at the single-cell level, quantitative measurement using metal isotope tags, and analysis of up to 37 proteins.

We also developed metal-labeled antibodies compatible with formalin fixed paraffin embedded tissue samples, to be used with the Hyperion.

We also invest

significantly in research and development efforts to expand our single-cell and production genomics applications.

In the area of mass cytometry, we developed an initial prototype Imaging Mass Cytometry instrument in 2016, and successfully launched the commercial Hyperion Imaging System in October 2017.

The Hyperion Imaging System provides spatial resolution of protein expression in complex tissue samples at the single-cell level, quantitative measurement using metal isotope tags, and analysis of up to 38 proteins.

We also developed metal-labeled antibodies compatible with formalin fixed paraffin embedded tissue samples, to be used with the Hyperion Imaging System.

We also invest significantly in research and development efforts to expand our microfluidics applications.

For example, we continue to develop and commercialize various panel sets for cancer research for use with our systems.

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Designed to drive significant improvement in the RNA-seq workflow, the Advanta RNA-Seq NGS Library Prep Kit together with the Juno™ system delivers an integrated solution for automated, cost-efficient NGS library prep.

In 2020, we expanded our microfluidics franchise to develop products for the COVID-19 testing marketplace.

We launched the AdvantaDx SARS-CoV-2 RT-PCR assay.

In addition, we secured significant development partnerships, including for development of OEM systems using our microfluidics technology.

In 2019, we launched the Maxpar Direct Immune Profiling Assay, a sample-to-answer workflow for comprehensive human immune profiling for use with our Helios system, that puts pre-titrated antibodies in dry format in a single tube, with automated software that provides data analysis in as few as five minutes.

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We have collaborated with industry partners to enable workflows and software for both the Helios and Hyperion systems.

Also in 2019, we added seven new metal antibody labels, becoming the first company to enable 50-plex cytometry panels, and launched three Imaging Mass Cytometry Panel Kits as well as CyTOF7.0, an advanced CyTOF software.

Also in 2019, we added seven new metal antibody labels, becoming the first company to enable 50-plex cytometry panels, and launched three Imaging Mass Cytometry panel kits as well as CyTOF Software v7.0, an updated CyTOF software application.

The second component of our research and development effort is to continuously develop new manufacturing processes and test methods to drive down manufacturing costs, increase manufacturing throughput, widen fabrication process capability, and support new microfluidic devices and designs.

Our research and development expenses were $36.5 million, $31.6 million and $30.0 million in 2020, 2019, and 2018 respectively.

As of December 31, 2019, 123 of our employees were engaged in research and development activities.

The life science markets are highly competitive and expected to grow more competitive with the increasing knowledge gained from ongoing research and development.

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broader product lines and product packages;

larger sales forces and eCommerce channels;

larger sales forces and e-commerce channels;

larger and more geographically dispersed customer support organization;

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We have developed a portfolio of issued patents and patent applications directed to commercial products and technologies in development.

As of December 31, 2019, we owned or licensed over 520 patents and we had approximately 158 pending patent applications worldwide.

As of December 31, 2020, we owned or licensed more than 440 patents and we had approximately 140 pending patent applications worldwide.

Our patents have expiration dates ranging up to 2037.

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The license agreement will terminate as to each country and licensed product upon expiration of the last-to-expire patent covering licensed products in each country.

issued patents we have licensed from Caltech expire between 2017 and 2030.

issued patents we have licensed from Caltech expire between now and 2030.

• We have entered into a co-exclusive license agreement with Harvard University for the license of relevant patent filings relating to microfluidic technology.

The license agreement will terminate with the last-to-expire of the licensed patents.

issued patents we have licensed from Harvard University expire between 2019 and 2027.

In May 2011, we entered into a license agreement with Caliper to license Caliper’s existing patent portfolio in certain fields.

The license agreement will terminate with the last-to-expire of the licensed patents.

As later amended, the license agreement provides for certain royalty payments until mid-2018 for our existing products at the time of amendment and their future equivalents.

Instrumentation and Digital PCR.

On June 30, 2011, we settled litigation and entered into a series of patent cross-license and sub-license agreements with Life Technologies Corporation (now part of Thermo Fisher Scientific Inc.) and its subsidiary Applied Biosystems, LLC (Life).

The agreements involve a cross-license concerning our imaging readers and other patent filings and certain of Life’s patent families relating to methods and instruments for conducting nucleic acid amplification, such as with PCR;

a sub-license that provides us access to certain of Life’s digital PCR patents;

and a sublicense that provides Life access to certain of our non-core technology patents licensed from Caltech.

In July 2011, pursuant to the terms of the agreements, we paid Life $2.0 million in connection with our exercise of an option to preclude Life from initiating litigation under its patents existing as of June 30, 2011 against our customers for two years and against our company, with respect to our current products and equivalent future products, for four years, subject to certain exceptions.

In November 2017, we settled pending litigation with Life and, pursuant to the terms of the settlement, one of the patent license agreements was amended to provide Life with a fully paid-up license under the patents covered by the agreement, subject to certain field of use restrictions.

The license agreement will terminate with the last-to-expire of the licensed patents, which is expected to be in 2028.

issued patents we have licensed from Harvard University expire between now and 2027.

Mass Cytometry.

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Under the Original License Agreement, Fluidigm Canada received an exclusive, royalty bearing, worldwide license to certain patents owned by PerkinElmer in the field of inductively coupled plasma (ICP) -based mass cytometry, including the analysis of elemental tagged materials in connection therewith (the Patents), and a non-exclusive license for reagents outside the field of ICP-based mass cytometry.

On November 4, 2015, we entered into a patent purchase agreement with PerkinElmer pursuant to which we purchased the Patents for a purchase price of $6.5 million and a patent assignment agreement pursuant to which PerkinElmer transferred and assigned to us all rights, title, privileges, and interest in and to the Patents and the Original License Agreement.

In November 2015, we entered into a patent purchase agreement with PerkinElmer pursuant to which we purchased the Patents for a purchase price of $6.5 million and a patent assignment agreement pursuant to which PerkinElmer transferred and assigned to us all rights, title, privileges, and interest in and to the Patents and the Original License Agreement.

Accordingly, we have no further financial obligations to PerkinElmer under the Original License Agreement.

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The license will terminate on the last expiration date of the Patents, currently expected to be in December 2025, unless earlier terminated pursuant to the terms of the license agreement.

InstruNor AS .

In January 2020, we completed the acquisition of InstruNor AS (InstruNor) for $7.2 million, including $5.2 million in cash and $2.0 million in stock.

InstruNor provides automated sample preparation solutions for mass cytometry and flow cytometry instrument markets and is now part of Fluidigm’s mass cytometry business.

Included in this acquisition were certain intellectual property portfolio assets comprising patents and/or patent applications directed to various aspects of automated cell pretreatment instruments.

The putative patent expiration dates for this patent portfolio begin in March 2033.

Any loss, termination, or adverse modification of our licensed intellectual property rights could have a material adverse effect on our business, operating results, and financial condition.

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Government Regulation

Our products are currently labeled and sold for research purposes only, and we sell them to academic institutions, life sciences and clinical research laboratories that conduct research, and biopharmaceutical and biotechnology companies for non-diagnostic and non-clinical purposes.

Our products are not intended or promoted for use in clinical practice in the diagnosis of disease or other conditions, and they are labeled for research use only, not for use in diagnostic procedures.

Accordingly, they are not subject to regulation by the U.S.

Food and Drug Administration (FDA).

Rather, while FDA regulations require that research use only products be labeled, “For Research Use Only.

Not for use in diagnostic procedures,” or RUO products, the regulations do not subject such products to the FDA’s jurisdiction or the broader pre- and post-market controls for medical devices.

Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA has authority to allow certain unapproved medical products or unapproved uses of approved medical products to be used during a public health emergency.

In issuing an EUA, the FDA will consider the totality of scientific evidence available to the FDA regarding safety, efficacy and known and potential risks of such products and availability of alternatives to the emergency use products, among others.

EUAs issued by the FDA will specify the scope of authorization and conditions of authorization, including limitations on distribution and conditions related to product advertising and promotion.

Once granted, an EUA is effective until the declaration that circumstances exist justifying the authorization of the emergency use is terminated under Section 564(b)(2) of the FD&C Act or the EUA is revoked under Section 564(g) of the FD&C Act, after which the product must be cleared or approved by the FDA under a traditional pathway in order to remain on the market or to continue commercialization of the product.

In August 2020, the FDA granted an EUA for our Advanta Dx SARS-CoV-2 RT-PCR Assay for qualitative detection of nucleic acid from SARS-CoV-2 in saliva specimens from individuals suspected by their healthcare providers of having COVID-19.

As set forth in the EUA, we are required to comply with the conditions of authorization, including certain requirements pertaining to FDA notification, distribution, printed materials, advertising and promotion.

If we, our distributors, or authorized laboratories do not comply with the EUA requirements, our business, financial condition and results of operations may be adversely impacted, and we may be subject to regulatory or enforcement actions, including the issuance of an untitled letter, a warning letter, penalties, or fines, among other adverse actions.

If the FDA’s policies and guidance change unexpectedly and/or materially or if we misinterpret them, potential sales of our Advanta Dx SARS-CoV-2 RT-PCR Assay could be adversely impacted.

In addition, the FDA will revoke an EUA where it is determined that the underlying public health emergency no longer exists or warrants such authorization, or if new evidence becomes available that indicates the test does not meet the conditions of authorization or perform as provided in the EUA application.

We cannot predict how long this EUA will remain effective.

The termination or revocation of the EUA and changing policies and regulatory requirements could adversely impact our business, financial condition and results of operations.

Given the uncertain nature of the COVID-19 pandemic and future legislation and regulation in this space, we can provide no assurance with respect to our ability to achieve or sustain profitability on a quarterly or annual basis.

Except for the Advanta Dx SARS-CoV-2 RT-PCR Assay authorized by the FDA under the EUA granted in August 2020, all of our other products are currently labeled and sold for research purposes only, and we sell them to academic institutions, life sciences and clinical research laboratories that conduct research, and biopharmaceutical and biotechnology companies for non-diagnostic and non-clinical purposes.

Our products are not intended or promoted for use in clinical practice in the diagnosis of disease or other conditions, and they are labeled, “For research use only.

Not for use in diagnostic procedures.” Accordingly, they are not subject to pre- and post-market controls for medical devices by the FDA.

The FDA regulations require that research use only products be labeled, “For Research Use Only.

Not for use in diagnostic procedures,” or RUO products.

In November 2013, the FDA issued a final guidance document stating that merely including a labeling statement that the product is for research purposes only will not necessarily render the device exempt from the FDA’s clearance, approval, or other regulatory requirements if the totality of circumstances surrounding the distribution of the product indicate that the manufacturer knows its product is being used by customers for diagnostic uses or the manufacturer intends such a use.

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In the future, certain of our products or related applications could become subject to regulation as medical devices by the FDA.

If we wish to label and market our products for use in performing clinical diagnostics, thus subjecting them to regulation by the FDA under premarket and postmarket control as medical devices, unless an exemption applies, we would be required to obtain either prior 510(k) clearance or prior pre-market approval from the FDA before commercializing the product.

If we wish to label and market our products for use in performing clinical diagnostics, thus subjecting them to regulation by the FDA under pre-market and post-market control as medical devices, unless an exemption applies, we would be required to obtain either prior 510(k) clearance or prior pre-market approval (PMA) from the FDA before commercializing the product.

The FDA classifies medical devices into one of three classes.

Devices deemed to pose lower risk to the patient are placed in either class I or II, which, unless an exemption applies, requires the manufacturer to submit a pre-market notification requesting FDA clearance for commercial distribution pursuant to Section 510(k) of the FFDCA.

This process, known as 510(k) clearance, requires that the manufacturer demonstrate that the device is substantially equivalent to a previously cleared and legally marketed 510(k) device or a “pre-amendment” class III device for which pre-market approval applications (PMAs) have not been required by the FDA.

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To obtain PMA approval, an applicant must demonstrate the reasonable safety and effectiveness of the device based, in part, on data obtained in clinical studies.

PMA reviews generally last between one and two years, although they can take longer.

PMA reviews generally last between one and

two years, although they can take longer.

Both the 510(k) and the PMA processes can be expensive and lengthy and may not result in clearance or approval.

If we are required to submit our products for pre-market review by the FDA, we may be required to delay marketing and commercialization while we obtain premarket clearance or approval from the FDA.

If we are required to submit our products for pre-market review by the FDA, we may be required to delay marketing and commercialization while we obtain pre-market clearance or approval from the FDA.

There would be no assurance that we could ever obtain such clearance or approval.

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International sales of medical devices are subject to foreign government regulations, which vary substantially from country to country.

Outside of the EU, regulatory approval needs to be sought on a country-by-country basis in order to

market medical devices.

Outside of the EU, regulatory approval needs to be sought on a country-by-country basis in order to market medical devices.

Although there is a trend towards harmonization of quality system, standards and regulations in each country may vary substantially which can affect timelines of introduction.

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Accordingly, backlog at any given time is not a meaningful indicator of future sales.

As of December 31, 2019, we had 566 employees, of which 123 work in research and development, 134 work in general and administrative, 122 work in manufacturing, and 187 work in sales, technical support, and marketing.

Human Resource Capital

Our team members share our commitment to improving the human condition and, in turn, Fluidigm strives to create an environment where our people can do their best work.

We know that our employees, who supply the ideas, energy, and innovation that powers our business, are our most valued assets.

We are a values-driven organization.

We believe strong shared values are essential for Fluidigm to evolve and grow and to be successful for the long-term.

Our values inform our relationships with customers, suppliers, investors and each other.

They ensure that we model respect and inclusiveness in our words and actions.

Our core values, conceived and developed by our employees, define us when we are at our best and guide us in all that we do.

Our core values are to:

• Create what customers need next

• Drive to make a difference

• Collaborate and learn

A Growing Global Workforce

As of December 31, 2020, Fluidigm had 627 employees worldwide, 44% of whom were female.

In the United State s, 35% of our employees were female as of December 31, 2020.

None of our employees are represented by a labor union nor are they subject to a collective bargaining agreement.

The table below provides an overview of our employees by function, geographic location, and gender as of December 31, 2020:

United States Canada Singapore Other Total Male Female Total

Manufacturing 16 79 88 — 183 87 96 183

Research and Development 41 65 16 1 123 81 42 123

Sales and Marketing 93 29 7 85 214 129 85 214

General and Administration 59 17 27 4 107 51 56 107

Total 209 190 138 90 627 348 279 627

Employee Safety and COVID-19

Employee safety has always been paramount at Fluidigm, a commitment very much in evidence as we continue to navigate the challenges of the COVID-19 pandemic.

At the outset of the crisis, we tasked a global, interdisciplinary team of leaders in environmental health and safety, human resources, facilities and information technology to develop guidelines and processes for new health and well-being protocols.

Also developed were new practices for cross-functional, remote teamwork, operating disciplines and training programs.

To keep our employees safe, we provide to those who can work remotely the tools and resources to do so.

Our pivot to remote work has been successful, with employees taking advantage of our technology resources.

Essential work continues not only at our facilities and labs, but also every day in home offices, living rooms, kitchens and spare rooms, made possible by our IT systems and the collective commitment of our people.

Many of our employees have worked on-site in labs and other facilities throughout the pandemic, and we have adopted a range of protocols and practices to keep them safe.

We have empowered each Fluidigm business location to adopt health and safety recommendations that address local requirements, and we have made site-specific COVID-19 prevention plans readily available for all our employees.

In addition, we provide team members practical recommendations based on guidelines from the Centers for Disease Control and Prevention, the World Health Organization, the U.S.

Department of Health and Human Services, t he Occupational Safety and Health Administration, and other regional government entities.

We are committed to updating these recommendations and communicating new pertinent information when available.

Each Fluidigm site will determine how and when more people return, based on site-specific factors related to health and safety, the needs of the business and each individual’s ability to work remotely versus needing to be onsite.

We are prepared to be flexible as new information becomes available or as conditions change.

As we consider a return to the workplace for more people, safety is our priority.

Compensation and Benefits

The primary goal of our compensation program is to ensure that we attract, hire, and retain talented and highly skilled team members who are motivated to achieve or exceed our corporate goals.

We offer competitive total reward packages comprising various elements including market-driven base pay, short- and long-term incentives in the form of performance-based cash and equity, as well as comprehensive health and welfare benefits that include medical, dental, vision, group life, disability, and accidental death and dismemberment insurance, as well as our 401(k) or comparable non-U.S.

retirement plans, subject to applicable law.

We also provide vacation and other paid holidays to all employees at levels that we believe are comparable to those provided at peer companies.

Our intention is to align our compensation practices with the changing marketplace, working to exceed our peer competitors.

By doing so, we strive to provide incentives to our team members to achieve short- and long-term business goals, ensuring they feel rewarded for their performance and contributions.

Professional Development

In addition to providing attractive and competitive total rewards packages, Fluidigm believes in fostering individual and organizational effectiveness by offering our team members a variety of professional development programs.

These programs are designed to:

• inform, educate, and inspire our people to reach their professional goals;

• provide professional growth opportunities in different, easily accessible ways to accommodate diverse learning styles, including via classroom/live instructor-led trainings, online/e-learning modules, webinar/virtual trainings, blended learning, and professional coaching;

• provide individuals and the organization with the knowledge and skills to respond effectively to customer needs as well as current and future business demands;

• provide ongoing support to the organization’s development efforts.

Our culture is one that actively supports participation in learning activities and the application of new knowledge and skills on the job.

As such, we strive to create a work environment that both challenges and supports all our team members to do their best work.

Diversity and Inclusion

At Fluidigm, our commitment to diversity, inclusion and equity is woven into our values and the belief that our global company is strongest when we embrace the full spectrum of humanity, regardless of what we look like, where we come from, or who we love.

As an equal opportunity workplace and affirmative action employer, our ongoing commitment is to recruit and reward team members based on capability and performance—regardless of race, color, gender, sexual orientation, gender identity or expression, lifestyle, genetic information, marital status, pregnancy, educational background, national origin, religion, veteran status, physical ability, or any legally protected status.

As Fluidigm evolves, we will continue to work together on building an inclusive and diverse culture that empowers all of us to connect, belong, and grow.

Corporate and Available Information

We were incorporated in California in May 1999 as Mycometrix Corporation, changed our name to Fluidigm Corporation in April 2001, and reincorporated in Delaware in July 2007.

Our principal executive offices are located at 7000 Shoreline Court, Suite 100, South San Francisco, California 94080, until March 13, 2020, and thereafter will be located at Two Tower Place, South San Francisco, California 94080.

Our principal executive offices are located at Two Tower Place, South San Francisco, California 94080.

Our telephone number is (650) 266-6000.

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Our SEC reports can be accessed through the investor relations page of our website located at http://investors.fluidigm.com.

The SEC also maintains an Internet site at www.sec.gov that contains reports, proxy and information statements, and other information regarding issuers that electronically file with the SEC.

The SEC also maintains an Internet site at www.sec.gov that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC.

The contents of our website are not a part of, and are not incorporated by reference into, this Annual Report on Form 10-K or any other report or document we file with the SEC.

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

What changed 10-K

Item 1. Business