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Item 1. Business

2023-03-14 compared with 2022-03-08 · 246 added, 312 removed, 175 unchanged (76% of the section changed)

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 systems (legacy Helios™ and newly introduced revolutionary CyTOF XT) deeply profiles cell phenotype and function.

Referenced by more than fifteen hundred 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 at a single cellular level 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 (NGS) 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 for diagnostics and research applications.

Recent Key Developments

Standard BioTools Inc.

is driven by a bold purpose – unleashing tools to accelerate breakthroughs in human health.

We develop, manufacture and sell technologies that help biomedical researchers in their search for developing medicines faster and better.

Our tools provide insights in health and disease using our proprietary mass cytometry and microfluidics technologies, which serve applications in proteomics and genomics, respectively.

Within proteomics our mass cytometry technology is embodied in two analytical platforms:

flow cytometry and tissue imaging or spatial biology.

Our flow cytometry systems (Helios™ and CyTOF XT) deeply profile cell phenotype and function.

Referenced by more than 2,200 peer-reviewed publications around the world, our CyTOF technology has set a new standard in human immune profiling with our proprietary digital readout.

Our spatial biology systems (Hyperion™ Imaging System and Hyperion+ TM Imaging System) enable highly multiplexed protein biomarker detection at a single cellular level in tissues and tumors while still preserving tissue architecture and cellular morphology information and without any autofluorescence artifacts by using our Imaging Mass Cytometry™ (IMC™) technology.

Within genomics, our microfluidics technology with our proprietary Integrated Fluidic Circuits (IFCs) provides high throughput and automated workflows for quantitative polymerase chain reaction (PCR), gene expression, copy number variation analysis, and next-generation sequencing (NGS) library preparation.

These automated systems are used to detect somatic and genomic variations from a range of different sample types which provide cost efficiencies, flexibility and proven analytical performance that customers need to meet the increasing demands of molecular biomarker analysis for diagnostics and research applications.

Strategic Investment Transaction

On January 23, 2022, we entered into (i) a Loan Agreement (the Casdin Loan Agreement) with Casdin Private Growth Equity Fund II, L.P.

On January 23, 2022, we entered into two transactions.

First, we entered into (i) a Loan Agreement (the Casdin Loan Agreement) with Casdin Private Growth Equity Fund II, L.P.

and Casdin Partners Master Fund, L.P.

(collectively, Casdin) and (ii) a Loan Agreement (the Viking Loan Agreement, and together with the Casdin Loan Agreement, the Bridge Loan Agreements) with Viking Global Opportunities Illiquid Investments Sub-Master LP and Viking Global Opportunities Drawdown (Aggregator) LP (collectively, Viking and, together with Casdin, the Purchasers and each, a Purchaser).

Each Bridge Loan Agreement provides for a $12.5 million term loan to us (each, a Bridge Loan and collectively, the Bridge Loans).

Subject to approval by our stockholders, upon the issuance of the shares of Series B Preferred Stock (as defined below) pursuant to the Purchase Agreements (as defined below), the Bridge Loans will be automatically converted into shares of Series B-1 Preferred Stock (as defined below) or Series B-2 Preferred Stock (as defined below), as applicable, in accordance with the terms of the Bridge Loan Agreements.

The Bridge Loans were fully drawn on January 24, 2022.

The proceeds of the Bridge Loans may be used for working capital and general corporate purposes.

Also on January 23, 2022, we entered into separate Series B Convertible Preferred Stock Purchase Agreements (the Purchase Agreements) with each of the Purchasers pursuant to which, among other things, at the closing of the transactions contemplated thereby, and on the terms and subject to the conditions set forth therein, including the approval of our stockholders, we will issue and sell an aggregate of $225 million of convertible preferred stock, consisting of:

(i) 112,500 shares of our Series B-1 Convertible Preferred Stock, par value $0.001 per share (the Series B-1 Preferred Stock), at a purchase price of $1,000.00 per share to Casdin, and (ii) 112,500 shares of our Series B-2 Convertible Preferred Stock, par value $0.001 per share (the Series B-2 Preferred Stock, and together with the Series B-1 Preferred Stock, the Series B Preferred Stock) at a purchase price of $1,000.00 per share to Viking (clauses (i) and (ii), the Preferred Equity Financing, and together with the issuance of shares of Series B Preferred Stock in connection with the conversion of the Bridge Loans, the Private Placement Issuance).

The Series B Preferred Stock to be purchased by Casdin and Viking pursuant to the Purchase Agreements is in addition to any Series B Preferred Stock to be issued upon conversion of outstanding amounts under the Bridge Loan Agreements.

The proceeds of the Preferred Equity Transactions will be used by us for expenses related to the Preferred Equity Transactions, as well as working capital, general corporate purposes and merger and acquisition opportunities that we may identify from time to time.

In connection with the Private Placement Issuance, we will change our name to “Standard BioTools Inc.” and Dr.

Michael Egholm will be appointed as the Company’s President and Chief Executive Officer and as a member of our Board of Directors (the Board), each occurring upon the closing of the transactions contemplated by the Purchase Agreements (Closing).

Egholm will succeed Chris Linthwaite, who will continue as our Chief Executive Officer until the earlier of the Closing or May 15, 2022.

The Closing is subject to customary closing conditions for a transaction of this nature, including approval by our stockholders of the issuance of the Series B Preferred Stock in connection with the Private Placement Issuance.

Each Private Placement Issuance is also conditioned on the substantially contemporaneous consummation of the other Private Placement Issuance.

Our Board has called a special meeting to be held on March 25, 2022 (the Special Meeting) to ask our stockholders to consider, vote upon and approve (i) a proposal to amend our Eighth Amended and Restated Certificate of Incorporation (the Charter) to, among other things, increase the number of shares of our common stock, par value $0.001 per share, (the Common Stock) that we are authorized to issue from two hundred million (200,000,000) shares to four hundred million (400,000,000) shares and to change our name to Standard BioTools Inc.

(together, the Charter Amendment Proposal);

and (ii) to approve the issuance of (A) the Series B-1 Preferred Stock and the Series B-2 Preferred Stock pursuant to the Purchase Agreements, (B) the Series B-1 Preferred Stock and the Series B-2 Preferred Stock issuable pursuant to the terms of the Bridge Loan Agreements and (C) the Common Stock issuable upon the conversion of the Series B Preferred Stock.

clauses (A) through (C), the Private Placement Issuance Proposal).

The Private Placement Issuance Proposal is conditioned on the approval of the Charter Amendment Proposal.

The Charter Amendment Proposal is conditioned on the approval of the Private Placement Issuance Proposal.

If both proposals do not receive the requisite vote for approval, neither the Charter Amendment Proposal nor the Private Placement Issuance Proposal will take effect.

The parties have agreed that they will not be obligated to close the Preferred Equity Financing if the Charter Amendment Proposal has not been approved at the Special Meeting.

If the Charter Amendment Proposal and the Private Placement Issuance Proposal are not approved by our stockholders at the Special Meeting or the Purchase Agreements are otherwise terminated, then the Bridge Loans will become convertible, at each lender’s option, into Common Stock at an initial conversion rate of 352.1126 shares of Common Stock per $1,000 of conversion amount, subject to the cap set forth in the Bridge Loan Agreements.

The conversion rate is subject to customary adjustments as set forth in the Bridge Loan Agreements.

The Bridge Loans bear interest (i) from and including the effective date of the Bridge Loan Agreements to but excluding March 1, 2022, at 10%, (ii) from and including March 1, 2022 to but excluding June 1, 2022, at 12%, (iii) from and including June 1, 2022 to but excluding September 1, 2022, at 14%, and (iv) from and including September 1, 2022 and thereafter, at 16%.

Interest accrues daily and is payable in kind by adding the accrued interest to the outstanding principal amount on the last date of each month.

The Bridge Loans mature on the 91st calendar day after the latest maturity date of the loans borrowed under our Loan and Security Agreement, dated as of August 2, 2018, with Silicon Valley Bank, and the principal, together with accrued and unpaid interest, is due on the maturity date.

Each Bridge Loan Agreement provided for a $12.5 million term loan to us.

Secondly, we entered into separate Series B Convertible Preferred Stock Purchase Agreements (the Purchase Agreements), including subject to the approval of our stockholders that we issue and sell an aggregate of $225 million of convertible preferred stock, consisting of:

(i) 112,500 shares of the Company’s Series B-1 Convertible Preferred Stock, par value $0.001 per share (the Series B-1 Preferred Stock), at a purchase price of $1,000 per share to Casdin;

and (ii) 112,500 shares of the Company’s Series B-2 Convertible Preferred Stock, par value $0.001 per share (the Series B-2 Preferred Stock, and together with the Series B-1 Preferred Stock, the Series B Preferred Stock) at a purchase price of $1,000 per share to Viking (collectively, the Private Placement Issuance).

On April 1, 2022, our stockholders approved the closing of the Private Placement Issuance.

On the closing date, April 4, 2022, we sold an aggregate of $225 million worth of Series B-1 Convertible Preferred Stock and Series B-2 Convertible Preferred Stock pursuant to Series B Convertible Preferred Stock Purchase Agreements.

In addition, the Bridge Loans were automatically converted into shares of Series B-1 Preferred Stock and Series B-2 Preferred Stock.

The $250 million proceeds from the Bridge Loans and Private Placement Issuance are being used for working capital and general corporate purposes.

On the closing date, the stockholders also approved the name change of our company to “Standard BioTools Inc.”

Our new leadership team has identified three strategic priorities:

revenue growth, improving operating discipline through the Standard BioTools Business Systems (SBS) and strategic capital allocation.

Revenue Growth

One of our top priorities is to grow our instrument, consumables and service revenue.

We established new growth strategies for our product lines.

We continue to invest in research and development (R&D) to create and launch new products and have adopted best practice approaches to improve our lead generation and funnel management growth, among other things.

Improving Operating Discipline Through SBS

Our second priority is to improve our operating discipline through the implementation of SBS.

We are leveraging SBS with a set of organizing principles, rigorous standard work processes, and a continuous improvement mindset to build more efficient operations and commercial execution and reduce costs.

A phased restructuring plan, including a reduction in force, was substantially completed in 2022 to improve efficiency, reduce operating costs and better align our workforce with the current needs of our business.

As part of the restructuring plan, the following actions have been taken:

• Reducing General and Administrative Expenses.

We have significantly lowered general and administrative spend through a reduction in headcount and a decrease in office space in order to better align our spending with more streamlined operations.

Specifically, we reduced our real estate footprint, including our headquarters location in South San Francisco while fostering remote work for certain employees.

In August 2022, we entered into a 39-month term sublease agreement for approximately 25% of our corporate headquarters location that commenced in October 2022.

We expect to recognize sublease rental income of $4.8 million over the lease term.

• Right Sizing Our Microfluidics Business.

We have significantly reduced our expenses in microfluidics research and development and marketing while narrowing our commercial focus on high value niche markets for specialized applications.

• Portfolio Rationalization.

We discontinued certain products including Laser Capture Microdissection (LCM), Flow Conductor, and COVID-19 diagnostic offerings.

We recognized $4.2 million in severance related restructuring expenses and $1.2 million of consulting and legal expenses for the twelve months ended December 31, 2022.

Based on actions taken to date, we realized operating expense reductions of approximately $5.5 million in 2022.

See Note 16 Restructuring and Other Related Costs within our consolidated financial statements for further details.

Strategic Capital Allocation

Our third priority is strategic capital allocation.

We are actively pursuing business development opportunities in the life sciences industry with consolidation and synergies expected to be a key growth driver to sustain the longer-term value proposition of the Company.

Market Opportunity

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 indicate a potential opportunity in the respiratory and COVID-19 molecular diagnostics markets.

We believe that our differentiated PCR microfluidics products could be well-suited to serve the needs of the diagnostics market.

Our participation in COVID-19 testing provides an entry point if we choose to explore the diagnostics opportunity.

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.

In 2020, we were awarded the NIH Contract under the RADx program to support the expansion of our production capacity and throughput capabilities for COVID-19 testing with our microfluidics technology.

As of December 31, 2021, we have achieved the required milestones and have received the total NIH Contract value of $34.0 million.

Proceeds from the NIH Contract have been primarily used for capital expenditures to expand production capacity and, to a lesser extent, to offset applicable operating costs.

With the funding from the NIH Contract, integrated fluidic circuit (IFC) manufacturing capacity increased from 12,000 IFCs per month to 36,000 IFCs per month in our Singapore facility.

One of the milestones under the NIH Contract was submitting a request with the FDA for Emergency Use Authorization (EUA) of the Advanta Dx COVID-19 EASE Assay.

We were granted an EUA for this assay in February

This test is authorized for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swab, oropharyngeal swab, mid-turbinate nasal swab, and anterior nasal swab specimens from individuals suspected of COVID-19 by their healthcare provider.

• Fluidigm made significant strides in product innovation in the form of two new, world-class instrument systems, CyTOF® XT and Biomark™ X.

Biomark X is our next generation qPCR platform, integrating the Fluidigm Juno and Biomark HD instruments into a single platform while adding sample-to-answer capabilities.

CyTOF XT is the fourth-generation CyTOF instrument, designed to simplify the design and execution of deep cell profiling studies, standardize sample analysis with reproducible workflows and automation and accelerate novel therapeutic development.

Both new instrument platforms provide customers with significant value at more economical price points relative to prior generation instruments and include significant enhancements that positively impact instrument operating efficiency and productivity.

• We delivered the Signature Q100 microfluidics platform to our OEM partner, Olink®, showcasing how strategic partnerships support our Vision 2025 growth plan and ability to expand Fluidigm’s customer base for instruments and consumables usage.

• The Company focused on partnership and collaboration to accelerate customer adoption of its technology, innovate products or penetrate new markets.

Fluidigm completed the milestones under its agreement with the National Institutes of Health, National Institute of Biomedical Imaging and Bioengineering, under the agency’s Rapid Acceleration of Diagnostics (RADx) initiative.

In addition, the Company completed all milestones in its collaboration with the Defense Advanced Research Projects Agency (DARPA) and its Epigenetic Characterization and Observation program that supports development of innovative programs based on our microfluidics technology.

• As of year-end 2021, 188 clinical trials were underway using CyTOF technology.

Total publications and preprints involving CyTOF technology exceeded 1,846, including 179 publications and preprints for Imaging Mass Cytometry.

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 IFCs, assays, and reagents.

We participate in growing and emerging market segments within the broader proteomics and genomics markets.

The market for Proteomics is broadly defined as instruments, consumables and reagents, software, and services for all technologies used in the identification of proteins.

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.

The proteome varies and is dynamic.

Every cell in an individual organism has the same set of genes, but the set of proteins produced in different tissues differ from one another and are dependent on gene expression.

Protein analysis is required to profile and understand cellular function as well as the interaction in tissues and other complex microenvironments.

Within the Proteomics market, we focus on Flow Cytometry and Spatial Biology.

Flow Cytometry is a method to detect and measure physical and chemical characteristics of cells or particles.

With our CyTOF technology, we focus in a smaller sub-segment of Flow Cytometry for high-parameter analysis defined as greater than 20 parameters.

• Traditional flow cytometry utilizes a suspension of cells in a stream of fluid and passes them through an electronic detection apparatus to allow simultaneous multi-parameter analysis of the physical and chemical characteristics of up to thousands of cells per second.

Although traditional flow cytometry technologies are high-throughput with single-cell analysis capabilities, a key limitation is the use of fluorescent dyes to label antibodies for detection.

These fluorescent labels have emission spectra that typically overlap, making it challenging to optimize reagents to analyze many protein markers at once.

In general, the number of protein targets for conventional flow cytometry is less than about 10 with significant reagent optimization often involved.

• Our CyTOF technology 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.

Spatial Biology, which itself is a sub-segment of the broader Tissue Image Analysis market that includes immunohistochemistry and in-situ hybridization, is the study of single cells in its spatial context to understand the role of heterogeneity in cell function and assess complex phenotypes and tumor-immune interactions in the tissue and tumor microenvironment.

• Immunohistochemistry is a method by which cells in a tissue section are stained with antibodies and then imaged with a conventional or fluorescent microscope.

Antibodies selected to bind to proteins of interest can be conjugated with either chromogenic or fluorescent labels, allowing cellular proteins to be visualized in spatial context.

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.

• Cyclic immunofluorescence is a method using an iterative process in which tissue slides are repeatedly stained and imaged with a fluorescent microscope, and then antibody stripping using denaturants.

This method allows higher parameter analysis versus immunohistochemistry.

• Imaging mass cytometry is similar to immunohistochemistry but is based primarily on antibodies using heavy metal isotope labels rather than fluorescent or chromogenic labels for detection of proteins.

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.

This method also eliminates issues of using fluorescent technology to image highly auto-fluorescent tissues.

The market for genomics is broadly defined as instruments, consumables and reagents, software, and services for all technologies used in the identification of genes (DNA, RNA) and their function.

The hereditary material or nucleic acid of an organism is often referred to as its genome, the protein-encoding regions of which are commonly known as genes.

Analysis of variations in genomes, genes and gene activity in and between organisms can provide insights into their health and functioning.

Within the genomics market, we focus on two sub-segments:

qPCR analysis and NGS library preparation.

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.

There are multiple forms of variants, including single nucleotide polymorphism (SNPs), insertion-deletions and copy number variation.

A common application of genotyping focuses on analyzing SNPs to determine whether a SNP or group of SNPs are associated with a particular genetic trait, such as propensity for a disease.

• Gene expression analysis involves measuring the levels of particular ribonucleic acid sequences known as messenger RNAs (mRNAs), which have been transcribed from genes.

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.

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

These platforms often rely on PCR amplification to generate exponential copies of a DNA sample to provide sufficient signal to facilitate detection.

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.

• 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.

We also utilize our proprietary microfluidics technology to collaborate with OEM providers to pursue market opportunities outside our core markets.

These OEM markets are highly varied, and we believe represent significant expansion opportunities for our technology.

We market life science tools, including preparatory and analytical instruments, consumables, and software for single cell proteomics analysis via mass cytometry and tissue imaging and for genomics analysis via real-time PCR and NGS library preparation.

Our primary product offerings are summarized in the table below:

Product Product Description Applications

Mass Cytometry

Single Cell Proteomics

Analytical Systems:

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

Mass Cytometry

CyTOF system, XT, a CyTOF system The CyTOF XT mass cytometry system performs highly automated 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 38 protein markers in the spatial context of the tissue microenvironment.

Imaging Mass Cytometry

Product Product Description Applications

Flow Cytometry

CyTOF XT™ System The CyTOF XT mass cytometry system performs highly automated high-parameter (>50) single-cell analysis using antibodies conjugated to metal isotopes.

Flow Cytometry

Hyperion™ Imaging System The Hyperion Imaging System brings together imaging capability with proven high-parameter mass cytometry technology to enable the simultaneous detection of up to 40 protein markers in the spatial context of the tissue microenvironment.

Tissue Imaging

Hyperion+™ Imaging System The Hyperion+ Imaging System provides lower limits of detection and twice the speed to results as compared to the Hyperion Imaging System.

Tissue Imaging

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

Tissue Imaging

Hyperion+™ Tissue Imager The Hyperion+ Tissue Imager scans tissues at twice the speed of the Hyperion.

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

Tissue Imaging

Assays and Reagents:

Product Product Description Applications

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

Flow Cytometry and Tissue Imaging

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 On Demand Reagents Made to order conjugated antibodies, pre-verified and available with seven-day turn-around Mass Cytometry

Flow Cytometry

Maxpar On Demand Reagents Made to order conjugated antibodies, pre-verified and available with seven-day turn-around.

Flow Cytometry and Tissue Imaging

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

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

Mass Cytometry

CyTOF Software 8.0 Streamlines and automates the sample acquisition for CyTOF XT to measure 50+ markers for single-cell cytometry Mass Cytometry

Microfluidics

Tissue Imaging

Preparatory Instruments:

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.

Juno TM 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 the Biomark HD System.

Library preparation for RNA-seq and targeted NGS.

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

Product Product Description Applications

IFC preparation for analysis on Biomark HD System.

IFC Controllers (HX, MX, and RX) Each controller is designed to work with specific IFC formats:

(i) IFC Controller MX- for priming and loading the 48.48 Dynamic Array TM IFC, the 12.765 Digital Array TM, IFC, the 48.770 Digital Array IFC, and qdPCR 37K TM , (ii) IFC Controller HX- for priming and loading the Flex Six TM Gene Expression IFC and Flex Six Genotyping IFC, 96.96 Dynamic Array IFC, (iii) IFC Controller RX- for loading the 192.24 Gene Expression IFC, 192.24 Genotyping IFC, and the 24.192 Dynamic Array IFC for gene expression.

Real-time PCR analysis

Analytical Instruments:

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

Product Product Description Applications

Biomark TM HD System

Real-time PCR analytical instrument for microfluidics-based workflows using prepared IFCs.

Real-time PCR analysis

X9 TM Real-Time PCR System

Real-time PCR analytical instrument, including pre-processing steps for microfluidics-based workflows using IFCs.

This system is designed to deliver the functionality of both the Juno and Biomark HD systems.

Real-time PCR analysis

Integrated Fluidic Circuits (IFCs):

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

Library Preparation (LP) IFCs LP and 48.Atlas TM 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.

Juno Genotyping IFC IFC designed for use with Juno 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.

96.96 GT Preamp IFC-X IFC designed for use with X9 that incorporates preamplification for genotyping of 96 samples and 96 markers in single run.

Genotyping, sample identification

Dynamic Array TM 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.

Sample identification, genotyping, gene expression, copy number variation (CNV) and variant detection

Digital Array TM 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

Flex Six TM 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.

Advanta TM 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

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 qualitative detection of nucleic acid from SARS-CoV-2 in saliva specimens collected without preservatives in a sterile container from individuals suspected of COVID-19 by their healthcare provider;

authorized for use with the AZOVA COVID-19 Test Collection Kit for self-collection of saliva specimens at home with or without the supervision of a healthcare provider

Product Product Description Applications

Advanta™ Dx COVID-19 EASE Assay

qPCR-based test that takes advantage of Fluidigm proprietary microfluidics technology

Enables qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swab, oropharyngeal swab, mid-turbinate nasal swab, and anterior nasal swab specimens from individuals suspected of COVID-19 by their healthcare provider

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

Delta Gene TM and SNP Type Assays

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

and genotyping.

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.

Product Product Description Applications

Access Array TM Target-Specific Primers and Targeted Sequencing Prep Primers

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

Library preparation for targeted NGS

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Library preparation for targeted NGS

Single Cell Microfluidics

Preparatory Instrument:

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:

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.

• We launched two new analytical systems, the Hyperion+ Imaging System and the X9 System.

The Hyperion+ Imaging System is a next generation imaging platform that brings twice the speed of its predecessor.

The X9 combines the functionality of the Juno and the Biomark HD with improved workflow and performance.

The Hyperion+ Imaging System is our second-generation imaging instrument, designed to clearly see the how and where of cellular interaction with fast, sample to insight from clean quality data, even when working with highly autofluorescent tissues.

• We continued to expand our Maxpar® Direct Immune Profiling Assay panels for CyTOF.

Maxpar® antibodies and cell labeling reagents are available for use in flow cytometry.

• We continued to deliver the Signature Q100 microfluidics platform to our OEM collaborator, Olink Holding AB.

Integrated Fluidic Circuits

Our IFCs incorporate several different types of technology that together enable us to use MSL technology to rapidly design and deploy new microfluidic applications.

Our IFCs incorporate several different types of technology that together enable us to use multi-layer soft lithography (MSL) technology to rapidly design and deploy new microfluidic applications with state-of-the-art commercial manufacturing processes.

The first level of our IFC technology is a library of components that perform basic microfluidic functions, such as pumps, mixers, single-cell capture chambers, separation columns, control logic, and reaction chambers.

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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.

Instrumentation and Software

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

The Hyperion Imaging System combines mass cytometry technology with imaging capability to enable simultaneous interrogation of up to 38 protein markers in the spatial context of the tissue microenvironment.

Our Imaging Mass Cytometry systems combine mass cytometry technology with imaging capability to enable simultaneous interrogation of up to 50 protein markers in the spatial context of the tissue microenvironment.

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.

Our EP1 instrument is a fluorescence reader designed for end-point imaging, suitable for genotyping and digital PCR applications.

Our C1 system combines the hardware elements of our IFC controllers and FC1 cycler with sophisticated scripting and protocol control software to enable automation of single-cell capture and preparation for subsequent analysis.

Certain capabilities of the C1 system have been used to create our Juno system, which serves as a universal controller and cycler for our Dynamic Array IFCs.

Our Polaris system combines the capabilities of all these instruments by incorporating thermal cycling, IFC control, environmental regulation, and imaging.

We have developed instrumentation technology to load samples and reagents onto our IFCs and to control and monitor reactions within our IFCs.

Our line of IFC controllers consists of commercial pneumatic components and both custom and commercial electronics.

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

Our microfluidics-based X9 Real-Time PCR system includes our custom thermal cycler, a sophisticated fluorescence imaging system, and on-board scripting and protocol control software, and utilizes our IFC technology for a wide range automated genomics applications.

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 CyTOF systems.

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

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:

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More recently, we extended the scope of the toolset to include DNA analysis tools.

We also developed the C1 Script Builder software to enable customers to take full advantage of the flexibility of C1 IFC architecture by allowing them to program their own control scripts for the C1 system.

Assays and Reagents

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

Our Delta Gene and single nucleotide polymorphism type (SNP Type) assay products consist of assay design and custom content delivery systems for gene expression and genotyping, respectively.

These offerings provide low-cost alternatives to other available chemistries and allow customers to use IFCs in more flexible ways.

PCR assay reagents need to be specific to the gene targets of interest but the process of designing a set of assays may delay the implementation experiments or require the use of expensive pre-designed assays.

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

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

The hereditary material or nucleic acid of an organism is often referred to as its genome, the protein-encoding regions of which are commonly known as genes.

Analysis of variations in genomes, genes and gene activity in and between organisms can provide valuable insight into their health and functioning.

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 NGS:

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

There are multiple forms of variants, including single nucleotide polymorphism (SNPs), insertion-deletions and copy number variation.

A common application of genotyping focuses on analyzing SNPs to determine whether a SNP or group of SNPs are associated with a particular genetic trait, such as propensity for a disease.

• Gene expression analysis involves measuring the levels of particular ribonucleic acid sequences known as messenger RNAs (mRNAs), which have been transcribed from genes.

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.

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.

These platforms often rely on PCR amplification to generate exponential copies of a DNA sample to provide sufficient signal to facilitate detection.

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 single cell protein analysis, the study of proteins and their structures and functions.

The proteome varies and is dynamic.

Every cell in an individual organism has the same set of genes, but the set of proteins produced in different tissues differ from one another and are dependent on gene expression.

Protein analysis is required to profile and understand cellular function as well as the interaction in tissues and other complex microenvironments.

There are several forms of high-throughput protein analysis in use today, including mass spectrometry, traditional flow cytometry, immunohistochemistry and both suspension and Imaging Mass Cytometry.

• Mass spectrometry is an analytical chemistry technique that measures the mass-to-charge ratio in molecules using external electric and magnetic fields.

Mass spectrometry techniques are limited to bulk samples and provide an understanding of global protein dynamics on a tissue or organism level, but do not, by themselves, enable researchers to analyze data at a single cell level.

Although traditional flow cytometry technologies are high-throughput with single-cell analysis capabilities, a key limitation is the use of fluorescent dyes to label antibodies for detection.

These fluorescent labels have emission spectra that typically overlap, making it challenging to optimize reagents to analyze many protein markers at once.

In general, the number of protein targets for conventional flow cytometry is less than about 10 with significant reagent optimization often involved.

• Immunohistochemistry is a method by which cells in a tissue section are stained with antibodies and then imaged with a conventional or fluorescent microscope.

Antibodies selected to bind to proteins of interest can be conjugated with either chromogenic or fluorescent labels, allowing cellular proteins to be visualized in spatial context.

• 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.

• Imaging mass cytometry is similar to immunohistochemistry, but is also based primarily on antibodies using heavy metal isotope labels rather than fluorescent or chromogenic labels for detection of proteins.

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.

With the exception of our Advanta™ Dx SARS-CoV-2 RT-PCR Assay (Rx Only), which has been authorized for in vitro diagnostic use by clinical laboratories under Emergency Use Authorizations (EUAs) in the United States and CE-IVD in Europe, and our Advanta™ Dx COVID-19 EASE Assay, which has been authorized for in vitro diagnostic use by clinical laboratories under Emergency Use Authorizations (EUAs) in the United States, 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 2021, 2020, or 2019.

Our genotyping and single nucleotide polymorphism type (SNP Type) assay products consist of assay design and custom content delivery systems for gene expression and genotyping, respectively.

These offerings provide low-cost alternatives to other available chemistries and allow customers to use IFCs in more flexible ways with validated assays for their targets of interest

We sell our instruments and consumables 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.

One customer accounted for 11% of our total revenue for the year ended December 31, 2022.

No single customer represented more than 10% of our total revenue for 2021.

Marketing, Sales, Service and Support

We distribute our systems through our direct sales force and support organizations located in North America, Europe, and Asia-Pacific, and through distributors or sales agents in several European, Latin American, Middle Eastern, and Asia-Pacific countries.

We distribute our systems through our direct sales force and support organizations located in North America, Europe, and Asia-Pacific, and through distributors or sales agents in European, Latin American, Middle Eastern, and Asia-Pacific countries.

Our sales and marketing efforts are targeted at laboratory directors and principal investigators at leading academic, translational research, healthcare consortiums, and biopharmaceutical companies who need reliable life science automation solutions to power their disease research with the goal of providing actionable insights.

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Manufacturing

Our manufacturing operations are primarily located in Singapore and Canada.

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.

Our manufacturing operations are located in Singapore and Canada.

Our facility in Singapore manufactures IFCs and assemblies of microfluidics instruments.

In 2022, assembly of microfluidics instruments was insourced to our Singapore facility to reduce cost and improve product quality.

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 and reagents for commercial sale, as well as for internal research and development purposes, are manufactured at our facility in Canada.

Our genomics reagent manufacturing was transferred from South San Francisco to Markham, Canada in late 2022.

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

Key components in our products that are supplied by sole or limited source suppliers include a specialized polymer and other specialized materials from which our IFC cores are fabricated, specialized custom camera lenses, fiber light guides, and other components required for the reader of our Biomark system;

specialized pneumatic and electronic components for our C1, Juno, Callisto, and Polaris systems;

the electron multiplier detector included in, and certain metal isotopes used with, our CyTOF systems;

specially developed lasers used in our Hyperion Imaging System;

and certain raw materials for our Delta Gene and SNP Type assays and Access Array Target-Specific primers.

The loss of a single or sole source supplier would

require significant time and effort to locate and qualify an alternative source of supply, if at all, and could adversely impact our business.

For additional information, please see the section entitled “Risk factors” in Part I, Item 1A of this Form 10-K.

Key components in our products that are supplied by sole or limited source suppliers.

The loss of a single or sole source supplier would require significant time and effort to locate and qualify an alternative source of supply, if at all, and could adversely impact our business.

For additional information, please refer to “Item 1A.

Risk Factors.”

Research and Development

We have assembled experienced research and development teams at our South San Francisco, California, Markham, Ontario, Canada, and Singapore locations with the scientific, engineering, software, bioinformatic, and process talent that we believe is required to grow our business.

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

We have assembled experienced research and development teams at our South San Francisco, California, Markham, Ontario, Canada, and Singapore locations and have the scientific, engineering, software, bioinformatic, and process talent that we believe is required to grow our business.

The largest components of our current research and development efforts are in the areas of new products, new applications and new content.

We launched our Hyperion Imaging System in October 2017.

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

In 2019, we launched the Maxpar Direct Immune Profiling Assay, a sample-to-answer workflow for comprehensive human immune profiling for use with our CyTOF systems, 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.

In 2022 we launched the Hyperion+ Imaging System, our second-generation imaging platform.

In 2019, we launched the Maxpar Direct Immune Profiling Assay, a sample-to-answer workflow for comprehensive human immune profiling for use with our CyTOF systems, which 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.

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In May 2021, we launched the new, fourth generation cell suspension mass cytometry system, CyTOF XT.

It’s main features include automation of sample introduction and acquisition, enabling unattended operation for 23 hours at high stability, lower cost of ownership and enhanced performance in resolution of cell populations.

Its main features include automation of sample introduction and acquisition, and lower cost of ownership and enhanced performance in resolution of cell populations.

The system enables storage of pelleted samples in the cooled autosampler, automated resuspension of pellets, and addition of beads standards.

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.

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

In 2017, we successfully launched the Advanta™ Immuno-Oncology Gene Expression Assay, which is a 170-gene expression qPCR assay that enables profiling of tumor immunobiology and new biomarker identification.

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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 2020, we expanded our microfluidics franchise to develop products for the COVID-19 testing marketplace and we launched the AdvantaDx SARS-CoV-2 RT-PCR assay.

These COVID-19 related products were discontinued in 2022.

In 2022, we launched the X9 Real Time PCR System:

a next-generation system platform that integrates all the features of all our legacy platforms into one ultra-compact footprint with a simple-to-operate user interface.

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

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 $37.9 million, $36.5 million and $31.6 million in 2021, 2020, and 2019 respectively.

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

We believe that the principal competitive factors in our target markets include competition for human resources;

cost of capital equipment and supplies;

We believe that the principal competitive factors in our target markets include quality of product, cost of capital equipment and supplies;

reputation among customers;

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accuracy and reproducibility of results;

competition for human resources;

and compatibility with existing laboratory processes, tools, and methods.

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larger sales forces and e-commerce channels;

larger and more geographically dispersed customer support organization;

larger and more geographically dispersed customer support organizations;

substantial intellectual property portfolios;

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better established and larger scale manufacturing capability;

resources and longer experience in research and development.

For additional information, please see the section entitled “Risk factors” in Part I, Item 1A of this Form 10-K.

and greater resources and longer experience in research and development.

For additional information, please refer to “Item 1A.

Risk Factors.”

To successfully compete with existing products and future technologies, we need to demonstrate to potential customers that the performance of our technologies and products, the solutions we provide our customers, as well as our customer support capabilities, are superior to those of our competitors.

To differentiate our company from other, larger enterprises, we need to introduce new and innovative offerings regularly and maintain a well-staffed commercial team “in the field” to successfully communicate the advantages of our products and overcome potential obstacles to acceptance of our products.

In addition, ongoing collaborations and partnerships with key opinion leaders are desirable to demonstrate both biological innovation and applications that solve customer problems.

Intellectual Property

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

As of December 31, 2021, we owned or licensed more than 410 patents and we had approximately 130 pending patent applications worldwide.

Our utility patents have expiration dates ranging up to 2039, and our design patents have expiration dates ranging up to 2044.

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

As of December 31, 2022, we owned or licensed more than 400 patents and had approximately 160 pending patent applications worldwide.

Our utility patents have expiration dates ranging up to year 2039, and our design patents have expiration dates ranging up to year 2047.

License Agreements

We have entered into licenses for technologies from various companies and academic institutions.

Microfluidic Technologies.

Our core microfluidics technology originated at the California Institute of Technology (Caltech) in the laboratory of Professor Stephen Quake, who is a co-founder of Fluidigm.

We license microfluidics technology from Caltech, Harvard University, and Caliper Life Sciences, Inc.

Genomics Technologies.

Our core Genomics technology originated at the California Institute of Technology (Caltech) in the laboratory of Professor Stephen Quake, who is a co-founder of Fluidigm (now Standard BioTools Inc.).

We license genomics technology from Caltech, Harvard University, and Caliper Life Sciences, Inc.

(Caliper), now a PerkinElmer company.

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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 now and 2025.

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

issued patents we have licensed from Caltech expire between now and year 2025.

• We have entered into a co-exclusive license agreement with Harvard University for the license of relevant patent filings relating to genomics 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 now and 2027.

Mass Cytometry.

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

Some of the intellectual property rights covering our mass cytometry products were subject to a license agreement (the Original License Agreement) between Fluidigm Canada Inc.

(Fluidigm Canada), and PerkinElmer Health Sciences, Inc.

(now Standard BioTools Canada Inc.), and PerkinElmer Health Sciences, Inc.

(PerkinElmer).

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.

Under the Original License Agreement, Fluidigm Canada Inc, received an exclusive, royalty bearing, worldwide license to certain patents owned by PerkinElmer in the field of inductively coupled plasma (ICP) -based proteomics, 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.

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.

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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.

InstruNor provided automated sample preparation solutions for proteomics and flow cytometry instrument markets and became part of Standard BioTool Inc.’s proteomics business.

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

The expiration dates for the issued patents in this patent portfolio extend to March 2033.

We recognized a $3.5 million impairment charge on InstruNor’s developed technology intangible asset in the second quarter of 2022 related to our discontinued Flow Conductor product line.

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.

For additional information, please see the section entitled “Risk factors” in Part I, Item 1A of this Form 10-K.

In addition to pursuing patents and licenses on key technologies, we have taken steps to protect our intellectual property and proprietary technology by entering into confidentiality agreements and intellectual property assignment agreements with our employees, consultants, corporate partners, and, when needed, our advisers.

For additional information, please refer to “Item 1A.

Risk Factors.”

In addition to pursuing patents and licenses on key technologies, we have taken steps to protect our intellectual property and proprietary technology by entering into confidentiality agreements and intellectual property assignment agreements with our employees, consultants, OEM counterparties and collaborators and, when needed, our advisers.

Government Regulation

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 the qualitative detection of nucleic acid from SARS-CoV-2 in saliva specimens collected without preservatives in a sterile container from individuals suspected of COVID-19 by their healthcare providers.

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 COVID-19 EASE Assay authorized by the FDA under the EUA granted in February 2022 and the Advanta Dx SARS-CoV-2 RT-PCR Assay authorized by the FDA under the EUA granted in August 2020, subsequently updated for use with the AZOVA COVID-19 Test Collection Kit, among other updates, 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.

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

Our products are not intended or promoted for use in clinical practice in the diagnosis of disease or other conditions.

Accordingly, they are not subject to pre- and post-market controls for medical devices by the FDA.

In accordance with FDA regulations, our RUO products are labeled, “For Research Use Only.

Not for use in diagnostic procedures.”

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.

These circumstances may include, among other things, written or verbal marketing claims regarding a product’s performance in clinical diagnostic applications and a manufacturer’s provision of technical support for such activities.

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 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 FD&C Act.

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.

This FDA review process typically takes from four to twelve months, although it can take longer.

Most class I devices are exempted from this 510(k) premarket submission requirement.

Devices deemed by the FDA to pose the greatest risk, such as life-sustaining, life-supporting, or implantable devices, or those deemed not substantially equivalent to a legally marketed predicate device, are placed in class III.

Class III devices typically require PMA approval.

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.

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

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

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Any future legislative or administrative rule making or oversight of LDTs and LDT manufacturers if and when finalized, may impact the sales of our products and how customers use our products, and may require us to change our business model in order to maintain compliance with these laws.

We would become subject to additional FDA requirements if our products are determined to be medical devices or if we elect to seek 510(k) clearance or pre-market approval.

We would need to continue to invest significant time and other resources to ensure ongoing compliance with FDA quality system regulations and other post-market regulatory requirements.

For additional information, please see the section entitled “Risk factors” in Part I, Item 1A of this Form 10-K.

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.

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.

In February 2022, we were granted Emergency Use Authorization (EUA) for our the Advanta Dx COVID-19 EASE Assay, which was authorized for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swab, oropharyngeal swab, mid-turbinate nasal swab, and anterior nasal swab specimens from individuals suspected of COVID-19 by their healthcare provider.

Subsequently, in February 2023, the FDA granted our request to withdraw the EUA for our Advanta Dx SARS-CoV-2 RT-PCR Assay.

We submitted our request to withdraw such EUA as we had discontinued commercial distribution of the product.

Healthcare Regulatory Requirements

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We are subject to many federal, state, local, and foreign environmental regulations.

To comply with applicable regulations, we have and will continue to incur significant expense and allocate valuable internal resources to manage compliance-related issues.

To comply with applicable regulations, we have and will continue to incur significant expenses and allocate internal resources to manage compliance-related issues.

In addition, such regulations could restrict our ability to expand or equip our facilities or could require us to acquire costly equipment or to incur other significant expenses to comply with the regulations.

For example, the Restriction on the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Directive (RoHS), the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) and the Waste Electrical and Electronic Equipment Directive (WEEE), enacted in the European Union, regulate the use of certain hazardous substances, notification of customers of the presence of any substances of very high concern in products, and require the collection, reuse, and recycling of waste from, products we manufacture.

Certain of our products sold in these countries are subject to RoHS, REACH and WEEE requirements.

If we fail to comply with any present and future regulations, we could be subject to future fines, penalties, and restrictions, such as the suspension of manufacturing of our products or a prohibition on the sale of products we manufacture.

For additional information, please see the section entitled “Risk factors” in Part I, Item 1A of this Form 10-K.

Additionally, our research and development and manufacturing processes involve the controlled use of hazardous materials, including flammables, toxics, corrosives, and biologics.

Certain products sold in these countries are subject to RoHS, REACH and WEEE requirements.

If we fail to comply with any present and future regulations, we could be subject to future fines,

penalties, and restrictions, such as the suspension of manufacturing of our products or a prohibition on the sale of products we manufacture.

For additional information, please refer to “Item 1A.

Risk Factors.”

Our research and development and manufacturing processes also involve the controlled use of hazardous materials, including flammables, toxics, corrosives, and biologics.

Our research and manufacturing operations produce hazardous biological and chemical waste products.

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Geographic Area Information

During the last three years, a significant portion of our revenue was generated outside of the United States.

Total revenue received from customers outside the United States equaled $70.4 million, or 54% of our total revenue, in 2021, compared to $66.2 million, or 48% of our total revenue, in 2020, and $73.9 million, or 63% of our total revenue, in 2019.

The majority of our long-lived assets are located within the United States, in Singapore and in Canada.

Please see Note 6 and Note 16 to our audited consolidated financial statements for additional information regarding geographic areas.

Our business is not subject to significant seasonality.

However, the timing of customer orders and shipments, customer budget and spending cycles, and new product releases can result in variability in our quarterly revenues.

During the last two years, a significant portion of our revenue was generated outside of the United States.

Total revenue received from customers outside the United States was $56.9 million, or 58% of our total revenue, in 2022, compared to $70.4 million, or 54% of our total revenue, in 2021.

The majority of our long-lived assets are located within the United States, Singapore and Canada.

Refer to Note 6 to our consolidated financial statements for additional information regarding geographic areas.

Our fourth quarter revenues are often the highest, primarily due to seasonality since many of our customers tend to spend budgeted money before the end of their calendar fiscal year-end.

Our revenue in the first quarter is generally sequentially lower than the prior year’s revenue in the fourth quarter.

Raw Materials

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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 Fluidigm’s most valued assets.

Our team members share our commitment to improving the human condition and, in turn, Standard BioTools 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 amongst some of Standard BioTools’ 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, 2021, Fluidigm had 615 employees worldwide, 45% of whom were female.

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

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

They help us to model respect and inclusiveness in our words and actions.

Our core values conceived and developed by our employees are:

• Customer commitment

• Continuous improvement

A Diverse Global Workforce

As of December 31, 2022, Standard BioTools had 523 employees worldwide, 45% of whom were female.

In the United States, 35% of our employees were female as of December 31, 2022.

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Total 133 180 115 95 523 287 236 523

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, legal, 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, the Occupational Safety and Health Administration, and other regional government entities.

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

One of the key learnings of the extended pandemic is that there are many ways for work to get done.

Since the early days of the global health crisis, Fluidigm colleagues around the world have stepped up to make virtual work remarkably successful across a diverse range of teams in every part of the Company.

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 the necessity 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.

this is an opportunity to make Fluidigm a place to do your very best work in a way that is safe, flexible, collaborative and right for Fluidigm.

Compensation and Benefits

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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.

Our intention is to align our compensation practices with the changing marketplace.

By doing so, we strive to provide incentives to our team members to achieve short-term 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.

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

These programs are designed to:

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• 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

A t Fluidigm, our commitment to diversity, inclusion and equity is reflective of our values.

At Standard BioTools, our commitment to diversity, inclusion and equity is reflective of our values.

We believe that we are strongest when we embrace all forms of diversity, and that it is essential to seek out diverse, innovative ideas and foster an inclusive culture where all colleagues are respected and engaged.

We apply this commitment to diversity to every aspect of the employee experience, from recruitment to development, training and advancement.

As Fluidigm evolves, we will continue to build an inclusive and diverse culture that empowers all of us.

We endeavor to apply this commitment to diversity to every aspect of the employee experience, from recruitment to development, training and advancement.

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.

On April 1, 2022, the Company changed its name from Fluidigm Corporation to Standard BioTools Inc.

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

Our telephone number is (650) 266-6000.

Our website address is www.fluidigm.com.

Our website address is www.standardbio.com.

We make available on our website, free of charge, our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and any amendments to those reports, as soon as reasonably practicable after we electronically file such material with, or furnish it to, the Securities and Exchange Commission (SEC).

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

Our SEC reports can be accessed through the investor relations page of our website located at http://investors.standardbio.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 file electronically with the SEC.

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Any reference to our website is intended to be an inactive textual reference only.

We intend to use our website, www.fluidigm.com as a means of disclosing material non-public information and for complying with our disclosure obligations under SEC Regulation FD.

Such disclosures will be included on our website under “About Us > Investors.” Accordingly, investors should monitor the “Investors” section of our website, in addition to following our press releases, SEC filings, and public conference calls and webcasts.

We intend to use our website, www.standardbio.com as a means of disclosing material non-public information and for complying with our disclosure obligations under SEC Regulation FD.

Such disclosures will be included on our website under “About> Investors.” Accordingly, investors should monitor the “Investors” section of our website, in addition to following our press releases, SEC filings, and public conference calls and webcasts.

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What changed 10-K

Item 1. Business