What changed in this filing

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Item 1. Business

2022-03-08 compared with 2021-02-25 · 115 added, 77 removed, 372 unchanged (34% of the section changed)

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

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

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

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

Our 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

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.

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.

Market Opportunity

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

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

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

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.

Key elements of our strategy include:

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

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

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

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

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

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

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

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

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

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

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

We received U.S.

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

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

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

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

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

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

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

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

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

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

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

This study is being funded by the U.S.

Department of Defense.

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

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

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.

Our primary product offerings are summarized in the table below:

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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

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

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Mass Cytometry and Imaging Mass Cytometry

Maxpar Human Immune Monitoring Panel Kit and Workflow

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

Enables identification and characterization of key immune cell populations.

The workflow includes protocol and data analysis.

Mass Cytometry

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

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Mass Cytometry

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

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.

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Mass Cytometry

Product Product Description Applications

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

Microfluidics

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

Product Product Description Applications

Analytical Instruments:

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RNA-seq library preparation for NGS

Product Product Description Applications

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

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

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.

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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

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

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

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

With our CyTOF systems, individual cells are atomized, ionized, and extracted.

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

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

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

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.

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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Assays and Reagents

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

We manufacture over 800 metal-conjugated antibodies for use with our mass cytometry and Imaging Mass Cytometry instruments to allow detection of up to 48 protein targets simultaneously in a single cell for a total of more than 50 detected cellular parameters.

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

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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.

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

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

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

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

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.

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

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

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.

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

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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 Helios system;

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.

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.

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

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

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

We launched our Hyperion Imaging System in October 2017.

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.

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

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

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

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.

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.

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

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

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

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

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.

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better established and larger scale manufacturing capability;

and greater resources and longer experience in research and development.

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.

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

Our patents have expiration dates ranging up to 2037.

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

License Agreements

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Contemporaneously with the purchase of the Patents, we entered into a license agreement with PerkinElmer pursuant to which we granted PerkinElmer a worldwide, non-exclusive, fully paid-up license to the Patents in fields other than (i) ICP-based mass analysis of atomic elements associated with a biological material, including any elements that are unnaturally bound, directly or indirectly, to such biological material (Mass Analysis) and (ii) the development, design, manufacture, and use of equipment or associated reagents for such Mass Analysis.

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

The license will terminate on the last expiration date of the Patents, currently expected to be in November 2026, unless earlier terminated pursuant to the terms of the license agreement.

InstruNor AS .

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

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

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

Included in this acquisition were certain intellectual property portfolio assets comprising patents and/or patent applications directed to

various aspects of automated cell pretreatment instruments.

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

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

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

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

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.

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

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

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.

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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.

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

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.

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

PMA reviews generally last between one and

two years, although they can take longer.

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

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

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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.

Healthcare Regulatory Requirements

Medical device companies are subject to additional healthcare regulation and enforcement by the federal government and by authorities in the states and foreign jurisdictions in which they conduct their business and may constrain the financial arrangements and relationships through which we research, as well as sell, market and distribute products for which we obtain marketing authorization.

Such laws include, without limitation, state and federal anti-kickback, fraud and abuse, false claims, data privacy and security, and transparency laws and regulations related to interactions and financial arrangements with healthcare professionals and healthcare organizations, payments and other transfers of value made to physicians and other healthcare providers, among others.

If our operations are found to be in violation of any of applicable laws or any other governmental regulations that apply, we may be subject to penalties, including, without limitation, administrative, civil and criminal penalties, damages, fines, disgorgement, the curtailment or restructuring of operations, integrity oversight and reporting obligations, exclusion from participation in federal and state healthcare programs and imprisonment.

Changes in healthcare regulations, statutes or the interpretation of existing regulations could also impact our business in the future, expose use to increased liabilities, and increase the costs of our operations.

Environmental Matters

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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) and the Waste Electrical and Electronic Equipment Directive (WEEE), both enacted in the European Union, regulate the use of certain hazardous substances in, 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 and WEEE requirements.

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.

24 unchanged sentences

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

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

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

We are a values-driven organization.

9 unchanged sentences

As of December 31, 2021, Fluidigm had 615 employees worldwide, 45% of whom were female.

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

In the United States, 38% of our employees were female as of December 31, 2021.

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

8 unchanged sentences

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

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

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.

5 unchanged sentences

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

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

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.

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

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.

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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Diversity and Inclusion

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

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

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

A t Fluidigm, 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.

Corporate and Available Information

11 unchanged sentences

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

What changed 10-K

Item 1. Business