Quanterix Corporation

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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 10-K

(Mark One)
☒

ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

☐

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, 2020
OR

For the transition period from              to            

Commission file number: 001-38319

QUANTERIX CORPORATION
(Exact name of registrant as specified in its charter)

Delaware
(State or other jurisdiction of
incorporation or organization)
900 Middlesex Turnpike, Billerica, MA
(Address of principal executive offices)

20-8957988
(I.R.S. Employer Identification No.)

01821
(Zip Code)

Securities registered pursuant to Section 12(b) of the Exchange Act:

Registrant’s telephone number, including area code: (617) 301-9400

Title of each class
Common Stock, $0.001 par value per share

Trading Symbol(s)
QTRX

Name of each exchange on which registered
The Nasdaq Global Market

Securities registered pursuant to Section 12(g) of the Exchange Act: None

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ⌧ No ☐

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Exchange Act. Yes ☐  No ⌧

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the

preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past
90 days. Yes ⌧  No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T

during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ⌧  No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth
company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☐
Non-accelerated filer ☐

Accelerated filer ⌧
Smaller reporting company ☒
Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised

financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial

reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐  No ☒

As of the last business day of the registrant’s most recently completed second fiscal quarter (June 30, 2020), the aggregate market value of the voting and non-voting
common equity held by non-affiliates of the registrant, based on the last reported sales price for the registrant’s common stock, par value $0.001 per share, on The Nasdaq Global
Market on such date, was approximately $234 million.

As of March 1, 2021, the registrant had 36,267,609 shares of common stock outstanding.

DOCUMENTS INCORPORATED BY REFERENCE

Portions of the registrant’s definitive proxy statement for its 2021 Annual Meeting of Stockholders, which the registrant intends to file with the Securities and Exchange

Commission pursuant to Regulation 14A within 120 days after the end of the registrant’s fiscal year ended December 31, 2020, are incorporated by reference into Part III of this
Annual Report on Form 10-K.

    
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Business

Item 1.
Item 1A. Risk Factors
Item 1B. Unresolved Staff Comments
Item 2.
Item 3.
Item 4. Mine Safety Disclosures

Properties
Legal Proceedings

TABLE OF CONTENTS

PART I

PART II

Item 5. Market For Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity

Securities

Selected Financial Data

Item 6.
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Item 7A. Quantitative and Qualitative Disclosures about Market Risk
Financial Statements and Supplementary Data
Item 8.
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Item 9.
Item 9A. Controls and Procedures
Item 9B. Other Information

PART III

Item 10. Directors, Executive Officers and Corporate Governance
Item 11.
Item 12.
Item 13. Certain Relationships and Related Transactions, and Director Independence
Item 14.

Executive Compensation
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Principal Accountant Fees and Services

Exhibits, Financial Statement Schedules
Form 10-K Summary

Item 15.
Item 16.
Signatures
Consolidated Financial Statements

PART IV

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Special Note Regarding Forward-Looking Statements

This Annual Report on Form 10-K contains forward-looking statements that involve risks and uncertainties. All

statements other than statements of historical facts contained in this Annual Report on Form 10-K are forward-looking
statements. In some cases, you can identify forward-looking statements by words such as “anticipate,” “believe,”
“contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,”
“seek,” “should,” “target,” “will,” “would,” or the negative of these words or other comparable terminology. These
forward-looking statements include, but are not limited to, statements about:

● the implementation of our business model and strategic plans for our business, products and services;

● the potential size of the markets and fields addressable by our Simoa technology platforms;

● the commercialization and adoption of our existing products and services and the success of our new product

offerings;

● our ability to develop additional assays, including multiplexed assays;

● the accuracy of our estimates regarding expenses, future revenues, capital requirements and our needs for

additional financing;

● the ability of our Simoa technology’s sensitivity to improve existing diagnostics and to enable the

development of new diagnostic tests and tools;

● the potential of our Simoa technology in the field of companion diagnostics and its adoption by healthcare

professionals;

● the impact of our Simoa technology on proteomic research;

● the usefulness of the data generated by our Simoa technology in the life science research, diagnostic and

precision health screening fields; and

● our financial performance.

These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those

further described in “Part I, Item 1A, Risk Factors” and elsewhere in this Annual Report on Form 10-K. Moreover, we
operate in a very competitive and rapidly changing environment, and new risks emerge from time to time. It is not possible
for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which
any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-
looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and
circumstances discussed in this Annual Report on Form 10-K may not occur and actual results could differ materially and
adversely from those anticipated or implied in the forward-looking statements.

You should not rely upon forward-looking statements as predictions of future events. Although we believe that the

expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels
of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur.
We undertake no obligation to update publicly any forward-looking statements for any reason after the date of this Annual
Report on Form 10-K to conform these statements to new information, actual results or to changes in our expectations,
except as required by law.

You should read this Annual Report on Form 10-K and the documents that we reference herein and have filed

with the Securities and Exchange Commission (SEC) as exhibits to this Annual Report on Form 10-K with the

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understanding that our actual future results, levels of activity, performance, and events and circumstances may be
materially different from what we expect.

This Annual Report on Form 10-K includes statistical and other industry and market data that we obtained from

industry publications and research, surveys and studies conducted by third parties. Industry publications and third-party
research, surveys and studies generally indicate that their information has been obtained from sources believed to be
reliable, although they do not guarantee the accuracy or completeness of such information. This Annual Report on
Form 10-K also contains estimates and other statistical data from a custom market research report by an independent third-
party research firm, which was commissioned by us and was issued in January 2021, referred to herein as the Third-Party
Research Report. Such data involves a number of assumptions and limitations and contains projections and estimates of the
future performance of the markets in which we operate and intend to operate that are subject to a high degree of
uncertainty. We caution you not to give undue weight to such projections, assumptions and estimates.

Service Marks, Trademarks and Trade Names

Unless the context otherwise requires, the terms “Quanterix,” the “Company,” “we,” “us” and “our” in this
Annual Report on Form 10-K refer to Quanterix Corporation. “Quanterix,” “Simoa,” “Simoa HD-X,” “Simoa HD-1,” “SR-
X,” “SP-X”, “HD-X Analyzer”, “HD-1 Analyzer” and our logo are our trademarks. All other service marks, trademarks
and trade names appearing in this Annual Report on Form 10-K are the property of their respective owners. We do not
intend our use or display of other companies’ trade names, trademarks or service marks to imply a relationship with, or
endorsement or sponsorship of us by, these other companies.

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Item 1. BUSINESS

Overview

We are a life sciences company that has developed next generation, ultra-sensitive digital immunoassay platforms
that advance precision health for life sciences research and diagnostics. Our platforms are based on our proprietary digital
“Simoa” detection technology. Our Simoa bead-based and planar array platforms enable customers to reliably detect
protein biomarkers in extremely low concentrations in blood, serum and other fluids that, in many cases, are undetectable
using conventional, analog immunoassay technologies, and also allow researchers to define and validate the function of
novel protein biomarkers that are only present in very low concentrations and have been discovered using technologies
such as mass spectrometry. These capabilities provide our customers with insight into the role of protein biomarkers in
human health that has not been possible with other existing technologies and enable researchers to unlock unique insights
into the continuum between health and disease. We believe this greater insight will enable the development of novel
therapies and diagnostics and facilitate a paradigm shift in healthcare from an emphasis on treatment to a focus on earlier
detection, monitoring, prognosis and, ultimately, prevention. We are currently focusing on protein detection, which we
believe is an area of significant unmet need and where we have significant competitive advantages. However, in addition to
enabling new applications and insights in protein analysis, our Simoa platforms have also demonstrated applicability across
other testing applications, including detection of nucleic acids and small molecules.

We believe that our Simoa platforms are the most sensitive commercially available multiplex protein detection

platforms and significantly advance ELISA technology, which has been the industry standard for protein detection for over
40 years. Proteins are complex molecules that are required for the structure, function and regulation of the body’s tissues
and organs, and are the functional units that carry out specific tasks in every cell. The human body contains approximately
20,000 genes, each of which can produce multiple proteins. It is estimated that these 20,000 genes can produce over
100,000 different proteins, approximately 10,500 of which are known to be secreted in blood. Accordingly, while research
on nucleic acids provides valuable information about the role of genes in health and disease, proteins are more prevalent
and, we believe, more relevant to a precise understanding of the nuanced continuum between health and disease. Protein
measurement goes beyond genetic predisposition, reflecting the impact of a range of influences on health, including
environmental factors and lifestyle, providing deeper and more relevant insight into what is happening in a person’s body
in real time.

Researchers and clinicians rely extensively on protein biomarkers for use as research and clinical tools. However,

normal physiological levels of many proteins are not detectable in easily accessible blood samples using conventional,
analog immunoassay technologies, and many of these technologies can only detect proteins once they have reached levels
that reflect more advanced disease or injury. For many other low abundance proteins, these technologies cannot detect
proteins even at disease- or injury-elevated levels. We believe that Simoa’s sensitivity offers a new way to monitor healthy
individuals and detect proteins associated with nascent disease or injury early in the disease cascade, which holds the key
to intervention before disease or injury has advanced to the point where more significant clinical signs and symptoms have
appeared.

Our Simoa platforms have achieved significant scientific validation and commercial adoption. Simoa technology
has been cited in more than 1,100 scientific publications in areas of high unmet medical need and research interest such as
neurology, oncology, cardiology, infectious disease and inflammation. Our growing customer base is comprised of over
950 customers across our end markets, and includes all 20 of the 20 largest biopharmaceutical companies.

Our Products and Services

Our proprietary Simoa technology is based on traditional enzyme-linked immunosorbent assay (ELISA)

technology, which has been the most widely used method of detection of proteins for over 40 years. Given our target
customers’ familiarity with the core ELISA technology, we believe this offers us a significant competitive advantage. Our
Simoa bead-based platform differs, however, from conventional ELISA in its ability to trap single molecules in tiny
microwells, 40 trillionths of a milliliter, that are 2.5 billion times smaller than traditional ELISA wells, allowing for an

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analysis and digital readout of each individual molecule, which is not possible with conventional ELISA technology. This
ability is the key to our bead-based technology’s unprecedented sensitivity. In January 2018, we acquired Aushon
BioSystems, Inc. (Aushon) and its proprietary sensitive planar array detection technology. Leveraging our proprietary
sophisticated Simoa image analysis and data analysis algorithms, we further refined this planar array technology to provide
the same Simoa sensitivity found in our Simoa bead-based platform. We currently offer the following three Simoa
instruments, which we believe are the most sensitive multiplex protein detection platforms commercially available today:

● HD-X: We commercially launched our HD-X instrument in the second half of 2019. The HD-X is an

upgraded version of the Simoa HD-1 (which was launched in January 2014) that was designed to deliver
significant productivity and operational efficiency improvements, as well as greater user flexibility. The HD-
X is based on our bead-based technology, and assays run on the HD-X are fully automated. We believe the
full automation of the HD-X provides us with an additional significant competitive advantage with
biopharmaceutical customers.

● SR-X: We commercially launched our SR-X instrument in December 2017. The SR-X utilizes the same
Simoa bead-based technology and assay kits as the HD-X in a compact benchtop form with a lower price
point, more flexible assay preparation, and a wider range of potential applications.

● SP-X: We commercially launched our SP-X instrument in April 2019. The SP-X is based on our planar array
technology, which allows for significantly greater multiplexing capabilities, and is, we believe, ideal for
oncology and immunology applications.

The current menu of approximately 86 analyte-specific single-plex and multi-plex bead-based assay kits includes
assays for biomarkers in the areas of neurology, infectious disease, immunology, oncology and cardiology for both human
and mouse samples. The current menu of Simoa planar array reagent kits includes approximately 100 biomarkers ranging
from 1-10 analytes per assay in the areas of immunology and oncology research. We intend to continue to increase the
number of Simoa biomarker assays across our platforms. In addition, both the bead-based platform and the planar array
platform allow ease and flexibility in assay design, enabling our customers to develop their own in-house assays, called
“homebrew” assays.

We also provide contract research services for customers through our CLIA-certified Accelerator Laboratory. The
Accelerator Laboratory provides customers with access to Simoa technology, and supports multiple projects and services,
including sample testing, homebrew assay development and custom assay development. To date, we have completed over
1,300 projects for approximately 360 customers from all over the world using our Simoa platforms. In addition to being an
important source of revenue, we have also found the Accelerator Laboratory to be a significant catalyst for placing
additional instruments, as a number of customers for whom we have provided contract research services have subsequently
purchased an instrument from us.

In addition, in August 2019, we completed the acquisition of UmanDiagnostics AB (Uman), a company located in

Umeå, Sweden, that supplies neurofilament light (Nf-L) antibodies and Nf-L ELISA kits. Uman’s Nf-L antibodies are
widely recognized by researchers and biopharmaceutical and diagnostics companies world-wide as the premier solution for
the detection of Nf-L to advance the development of therapeutics and diagnostics for neurodegenerative conditions. Nf-L
has seen a dramatic growth as a neurological biomarker in the last three years since we developed the first assay that could
reliably measure Nf-L in blood using Uman’s antibodies and our Simoa technology. This innovation allowed research,
previously limited primarily to cerebrospinal fluid (CSF), to expand significantly and has led many of the world’s foremost
neurology researchers and clinicians to conclude that Nf-L may be one of the most clinically relevant brain biomarkers
available today. Despite significant efforts by us and others to identify or develop an alternative source of antibodies, the
Uman Nf-L antibodies remain the best-in-class for highly sensitive and specific Nf-L detection in serum or plasma. The
following graphic depicts the sensitivity of the Uman antibodies to detect Nf-L in blood and CSF compared to over a dozen
other antibody pairs tested by Quanterix:

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The superiority of the Uman antibodies is further evidenced by the fact that, to date, in over 380 publications

relating to the detection of Nf-L in serum or plasma, 100% used the Uman antibodies.

The Uman acquisition secures the Nf-L antibody supply critical to our industry leading ultrasensitive Simoa Nf-L
assays and services, provides us with additional revenue opportunities via the sale of the Nf-L antibodies and Nf-L ELISA
kits, and positions us to capitalize on significant growth opportunities with Nf-L applications in Alzheimer’s disease,
multiple sclerosis, and other neurodegenerative conditions.

In view of the COVID-19 pandemic, in the second quarter of 2020 we adjusted our operations to expand capacity

in our Accelerator Laboratory to support customers whose operations have been disrupted and to sustain their clinical
trials. We also determined that our cytokine assay technology could provide researchers with important and differentiated
tools to study disease progression, cytokine release syndrome, and patient-treatment response in the fight against COVID-
19, and began developing a SARS-CoV-2 semi-quantitative IgG assay and a SARS-CoV-2 antigen detection assay and
prototyping a high-definition multiplex SARS-CoV-2 serology assay. In December 2020, the U.S. Food and Drug
Administration (the FDA) issued an Emergency Use Authorization (EUA) for our Simoa Semi-Quantitative SARS-CoV-2
IgG Antibody Test that is run on our HD-X instrument. This test targets IgG antibodies that are directed against the region
of the novel coronavirus known as the spike protein. In January 2021, the FDA issued an EUA for our Simoa SARS-CoV-2
N Protein Antigen Test that is also run on our HD-X instrument. This test detects the presence of the SARS-CoV-2 virus
nucleocapsid protein (N protein), which is known to be elevated in respiratory fluids during the initial acute phase of the
infection. We currently intend to pursue authorization for additional sample types, including nasal swabs, saliva, and
capillary dried blood obtained from a fingerstick. Preliminary clinical research studies suggest the viral antigen may be
readily detectable in asymptomatic and pre-symptomatic patients, and we are exploring extending the test to screening
applications, home-based sample collection and pooling to enable larger scale testing.

We sell our instruments, consumables and services to the life science, pharmaceutical and diagnostics industries

through a direct sales force and support organizations in North America and Europe, and through distributors or sales
agents in other select markets. In addition, Uman sells Nf-L antibodies and Nf-L ELISA kits directly, and in conjunction
with a distributor worldwide (excluding certain Nordic countries). We have an extensive base of customers in world class
academic and governmental research institutions, as well as pharmaceutical, biotechnology and contract research
companies, using our technology to gather information to better understand human health.

Our Market Opportunities

Our Simoa platforms have applications across the life science research, diagnostics and precision health screening

markets. Our initial target market has been the life science research market, in particular neurology and oncology.
According to estimates in the Third-Party Research Report, we believe that our pre-COVID addressable neurology,
immunology and oncology life science research market is approximately $1 billion per year. We believe our

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recent EUA approvals will allow us to expand our life science research market focus into COVID-19, which we estimate
has a currently addressable potential of $0.2 billion. As we further expand our life science research focus in other areas of
immunology, oncology and other therapeutic areas, coupled with growing adoption of decentralized clinical trials, the life
science research addressable market is expected to expand to approximately $7 billion. As our customers continue to gain
experience with our proprietary Simoa technology, we believe the opportunity to access markets beyond research, such as
diagnostics and precision health screening, will be significant. The Third-Party Research Report also estimates that the
diagnostic and precision health screening markets have the potential to reach an aggregate of approximately $55 billion per
year, with neurology diagnostics estimated at approximately $18 billion, proteomic liquid biopsy estimated at
approximately $20 billion, COVID estimated at approximately $12 billion, and precision health screening estimated at
approximately $5 billion.

Life Science Research

Our initial target market has been the large and growing life science research market. We believe our Simoa
platforms are well-positioned to capture a significant share of this market because of superior sensitivity, automated
workflow capabilities, multiplexing and the ability to work with a broader range of sample types. By substantially lowering
the limit of detection of protein biomarkers, we believe that Simoa is penetrating the existing market for protein analysis
and holds potential to significantly grow the life science research market as researchers expand their research into the
diseases associated with the thousands of proteins that were previously undetectable. Simoa also enables earlier detection
of the proteins that are currently detectable by other technologies only after they have reached levels that reflect more
advanced disease or injury. As an indication of the market’s acceptance of our technology, biopharmaceutical researchers
are also integrating our platforms into drug development protocols to more efficiently and effectively develop drugs. In
addition to enabling new applications and insights in protein analysis, our Simoa bead-based technology can be used to
detect other analytes, such as nucleic acids and small molecules, which expands our market opportunity. We believe that
this technology has the potential to ultimately provide the same sensitivity as polymerase chain reaction (PCR), which is
the most commonly used technology for nucleic acid detection, without the distortion and bias issues associated with
amplification used in PCR.

Diagnostics

We believe the diagnostic market represents a significant commercial opportunity for our Simoa technology as
well. We believe existing diagnostics can be improved by Simoa’s sensitivity to enable earlier detection of diseases and
injuries, and that new diagnostics may be developed using protein biomarkers that are not detectable using conventional,
analog immunoassay technologies but are detectable using Simoa. We also believe that the ultra-sensitive protein detection
provided by Simoa can enable the development of a new category of non-invasive diagnostic tests and tools based on
blood, serum, saliva and other fluids that have the potential to replace current more invasive, expensive and inconvenient
diagnostic methods, including spinal tap, diagnostic imaging and biopsy.

Simoa technology also has significant potential in the emerging field of companion diagnostics. Drug developers

can use Simoa to stratify patients into categories, enabling selection of those patients for whom a drug is expected to be
most effective and safe. Not only does Simoa have the potential to be used to develop companion diagnostics to stratify
patients in clinical trials and for treatment, but Simoa’s sensitivity may also enable the development of companion
diagnostics based on protein biomarkers that can regularly monitor whether an approved drug is having the desired
biological effect, enabling doctors to quickly and efficiently adjust the course of treatment as appropriate.

Precision Health Screening

The ability of our Simoa platforms to detect and quantify normal physiological levels of proteins in low
abundance that are undetectable using conventional, analog immunoassay technologies may enable our technology to be
used to monitor protein biomarker levels of seemingly healthy, asymptomatic people, and potentially to signal and provide
earlier detection of the onset of disease. We believe there is the potential for a number of neurological, cardiovascular,
oncologic and other protein biomarkers associated with disease to be measured with a simple blood draw on a regular,
ongoing basis as part of a patient’s routine health screening, and for those results to be compared

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periodically with baseline measurements to predict or detect the early onset of disease, prior to the appearance of
symptoms.

Simoa products sold or used in the diagnostics and precision health screening markets will be subject to regulation

by the FDA or comparable international agencies, including requirements for regulatory clearance or approval of such
products before they can be marketed. To date, other than our EUAs for our COVID assays, we have not received or
applied for regulatory approvals for Simoa products. See “Risk Factors—Risks Related to Governmental Regulation and
Diagnostic Product Reimbursement” and “—Government Regulation” for a more detailed discussion regarding the
regulatory approvals that may be required.

Our Competitive Strengths

We believe that our competitive strengths include the following:

● Proprietary ultra-sensitive Simoa digital immunoassay technology platforms, that enable researchers and
clinicians to obtain information from less invasive procedures in smaller sample sizes. We believe our
Simoa platforms are the most sensitive commercially available protein detection platforms, and can detect
and quantify proteins of clinical interest that are undetectable using conventional, analog immunoassay
technologies. This sensitivity allows researchers to measure critical protein biomarkers at earlier stages in the
progression of a disease or injury, which we believe will enable the development of novel therapies and
diagnostics and facilitate a paradigm shift in healthcare from an emphasis on treatment to a focus on earlier
detection, monitoring, prognosis and, ultimately, prevention. The sensitivity of our Simoa technology also
allows researchers to gather biomarker information from smaller samples that can be collected less invasively
than samples required by other assay technologies. We believe that sensitivity is so important that we have
published an approach to increase the sensitivity of our Simoa technology 100-fold.

● Technology platforms that leverage and improve upon industry standard ELISA technology. Simoa uses
the basic principles of conventional bead-based ELISA immunoassay technology. Adding digital capability
to this industry standard platform has resulted in expanded capabilities and improved performance. Given our
target customers’ familiarity with the core 000ELISA technology, our Simoa platforms are easily integrated
with existing customer workflows including data analysis.

● Deep and expanding scientific validation. Our Simoa technology has been cited in more than 1,100

scientific publications, including JAMA Neurology and Nature, and is becoming a vital tool in cutting edge
life sciences research. We have established relationships with key opinion leaders, and our growing base of
over 950 customers includes some of the world’s leading academic and government research institutions as
well as all 20 of the 20 largest biopharmaceutical companies.

● Leading position in market solidified by robust customization capabilities, assay design flexibility and

automation of our HD-X instrument. Our technical capabilities and expertise allow our customers to design
high-quality, customized assays utilizing our Simoa platforms. The needs of our customers vary widely, and
the flexibility of the Simoa detection technology utilized across both our bead-based and planar array
platforms allows us to provide innovative, low cost solutions for customers in multiple markets across
various applications. In addition, the HD-X instrument provides fully automated analysis from sample
introduction to analytical results, and our proprietary approach to ELISA digitization enables rapid digital
data acquisition and assay results. This automation and speed provides customers high research and
development productivity through greater throughput and lab efficiency.

● Highly attractive business model that leverages growing installed base of instruments. As we continue to
grow our installed instrument base, optimize workflows and expand our assay menu, we expect to increase
our revenues derived from consumables. The integration of our technology in our customers’ projects also
provides ongoing sales of assays and consumables, resulting in a growing revenue stream. Our

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consumables revenue increased to $27.4 million in 2020 from $25.6 million in 2019 and $13.8 million in
2018, and represented approximately 32% of our total revenue in 2020.

● Our highly experienced senior management team. We are led by a dedicated and highly experienced senior
management team with significant industry experience and proven ability to develop novel solutions. Each of
the members of our senior management has more than 20 years of relevant experience.

Our Strategy

Our goal is to enable new research into biomarkers to allow greater insight into their role in human health in ways

that have not been possible with any other current research and diagnostic technology. We believe this greater insight will
facilitate a paradigm shift in healthcare from an emphasis on treatment to a focus on earlier detection, monitoring,
prognosis and, ultimately, prevention.

Our strategy to achieve this includes:

● Focus on the highly attractive, expanding market for protein detection and analysis. Our focus on the
detection of protein biomarkers is driven by a growing understanding of the essential role and impact of
proteins on human health. While genomic research provides valuable information about the role of genes in
health and disease, proteins are both more prevalent than nucleic acids and, we believe, more relevant to a
precise understanding of the nuanced continuum between health and disease. Protein measurement goes
beyond genetic predisposition, indicating the impact of a range of influences on health, including
environmental factors and lifestyle, providing deeper and more relevant insight into what is happening in a
person’s body in real time. Our technology provides a unique bridge between understanding the human
genotype and phenotype, which we believe addresses a large unmet need in life science research,
translational medicine and drug development.

● Continue to drive adoption of our Simoa technology in the life science research market in the near-term,
and the diagnostics and precision health screening markets in the long-term. We believe our Simoa
technology has the potential to significantly expand the life science research market because of its unrivaled
sensitivity, in particular by enabling researchers to perform studies on protein biomarkers that they were
previously unable to perform. We believe Simoa technology has the capability to enable the development of a
new category of less-invasive diagnostic tests and tools based on blood, serum, saliva and other fluids that
could replace current invasive, expensive and inconvenient diagnostic methods, including spinal tap,
diagnostic imaging and biopsy. We have recently had two EUAs approved for our COVID assays. In the
precision health screening market, we believe that Simoa technology has the potential to someday be used to
monitor biomarker levels of seemingly healthy, asymptomatic people, and potentially to signal and provide
earlier detection and monitoring of the onset of disease.

● Leverage the growing importance of Nf-L as a biomarker to advance the development of therapeutics and
diagnostics for neurodegenerative conditions. The importance of Nf-L as a neuro biomarker has increased
significantly since we developed the first assay that could reliably measure Nf-L in blood. This allowed
research of neurological disorders, previously limited primarily to CSF, to expand significantly, and many of
the world’s foremost neurology researchers and clinicians believe that Nf-L may be one of the most clinically
relevant brain biomarkers available today. To capitalize on the growing importance of this biomarker, in mid-
2019, we acquired Uman and its proprietary Nf-L antibodies, which we believe are the best-in-class for
highly sensitive and specific Nf-L detection in serum or plasma. We believe that this acquisition positions us
to capitalize on significant growth opportunities with Nf-L applications in neurodegenerative conditions.

● Grow into new markets organically with our customers and through strategic collaborations. Our

customers have access to a large breadth of diverse markets, spanning research and clinical settings. As these
customers continue to gain experience with our proprietary Simoa technology and further appreciate its
potential, we believe moving into diagnostics and ultimately precision health is a natural extension of

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some of the work that our customers are doing today in the research market. For example, Simoa’s
unprecedented sensitivity has the potential to uncover research insights that could identify novel biomarkers,
which could help stratify patients in clinical trials potentially leading to a companion diagnostic, and
ultimately a precision health test that could monitor and identify early disease. We believe this progression
with our customers will help us move into new markets organically in a cost effective manner, while also
retaining significant upside. In addition, we have entered into, and will continue to explore, partnerships that
will help us access these markets. For example, following our acquisition of Uman, we entered into a
licensing and supply arrangement with Siemens Healthineers for access to Uman’s proprietary Nf-L
antibodies, which will allow Siemens Healthineers to begin developing blood-based Nf-L clinical tests for
future commercialization. Additionally, in September 2020, we entered into a Non-exclusive License
Agreement (the Abbott License Agreement) with Abbott Laboratories (Abbott), pursuant to which we
granted Abbott a non-exclusive, worldwide, royalty-bearing license, without the right to sublicense, under
our bead-based single molecule detection patents in the field of in vitro diagnostics (IVD).

● Grow through strategic acquisitions. We intend to strategically acquire businesses and technologies to
expand our operations and strengthen our market position. For example, in January 2018, we acquired
Aushon and its proprietary sensitive planar array detection technology, which led to the development of our
SP-X instrument. In mid-2019, we also acquired Uman, securing the Nf-L antibody supply critical to our
industry leading ultrasensitive Simoa Nf-L assays and services and positioning us to capitalize on the
growing significance of Nf-L as a neurological biomarker. We expect that acquisitions will continue to be an
important part of our strategy to increase scale, and we intend to pursue acquisitions to expand product
offerings, strengthen domestic or international distribution, add technologies, and/or provide access to
complementary or strategic growth areas.

Industry Background

We intend to pursue the application of our Simoa technology to the life science research, diagnostics and precision

health screening markets. Our initial commercial strategy targets the large and growing life science research market, and
we believe that the diagnostic market and the precision health screening market represent significant future commercial
opportunities for Simoa. According to estimates in the Third-Party Research Report, we believe the aggregate commercial
opportunity across these markets has the potential to expand to up to $62 billion.

Proteins are versatile macromolecules and serve critical functions in nearly all biological processes. They are

complex molecules that organisms require for the structure, function and regulation of the body’s tissues and organs. For
example, proteins provide immune protection, generate movement, transmit nerve impulses and control cell growth and
differentiation. Understanding an organism’s proteome, the complete set of proteins and their expression levels, can
provide a powerful and unique window into its health, a window that other types of research, such as genomics, cannot
provide.

The human body contains approximately 20,000 genes. One of the core functions of genes, which are comprised
of DNA, is to regulate protein production—which ones are produced, the volume of each, and for how long—influenced
by both biological and environmental factors. These 20,000 genes help govern the expression of over 100,000 proteins,
approximately 10,500 of which are known to be secreted in blood, and fewer than 1,300 of which can be consistently
detected in healthy individuals using conventional immunoassay technologies. Accordingly, the study of much of the
proteome has not been practical given the limited level of sensitivity of existing technologies. To date, across our
platforms, we have commercialized assays that address approximately 178 protein biomarkers secreted or released in blood
and CSF.

While genomic research provides valuable information about the role of genes in health and disease, proteins are

both more prevalent than nucleic acids and, we believe, more relevant to understand precisely the nuanced continuum
between health and disease. Genes may indicate the risk of developing a certain disease later in life, but they are not able to
account for the impact of environmental factors and lifestyle, such as diet and exercise, or provide insight

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into what is happening in a patient’s body in real time. For example, identical twins have the same genotype, but may
develop different diseases over the course of their lifetime, largely due to environmental factors.

Much like the sequencing of the human genome with the Human Genome Project and the development of both
PCR and next generation sequencing technologies to detect nucleic acids, both of which accelerated biomedical genomic
research, we believe the ability to study more of the proteome enabled by our more sensitive protein detection technology
will have a profound impact on proteomic research. With our ultra-sensitive Simoa detection technology, researchers can
assess the symptoms of disease or injury and compare them to the presence and levels of relevant proteins that are not
detectable using conventional technologies, leading to a better understanding of how proteins individually and/or
collectively impact and influence important biological processes and the health and well-being of individuals. We believe
this research into understanding the individual characteristics and functioning of proteins will be central to earlier
detection, monitoring, prognosis and, ultimately, prevention, by providing researchers with the ability to assess the impact
of particular proteins on the progress of disease and injury from the time of early onset of symptoms.

Existing Technologies and Their Limitations

Protein Analysis

ELISA has been the most widely used method of sensitive detection of proteins for over 40 years. In simple terms,
in ELISA, an unknown amount of antigen (e.g., protein, peptide, antibody, hormone) is affixed to a solid surface, usually a
polystyrene multiwell plate, either directly, or indirectly through use of a conjugated secondary or “capture” antibody
(sandwich ELISA). A specific “detection” antibody is applied over the surface to bind to the antigen. This detection
antibody is linked to an enzyme, and in the final step, a substance called an enzyme substrate is added, and the enzyme
converts to colored or fluorescent product molecules, which are detected by a plate reader. Sandwich ELISA is depicted in
the graphic below:

Aside from ELISA, there are other technologies available for protein analysis today, such as Western blotting,
mass spectrometry, chromatography, surface plasmon resonance, Raman-enhanced signal detection, immuno-PCR, and
biobarcode assay. However, the proteins detectable by these conventional, analog immunoassay technologies represent a
mere fraction of what is estimated to be approximately 10,500 secreted proteins in circulation in human blood. While a
number of techniques have been used to attempt to increase sensitivity of detection, we believe all of these approaches
have limitations, including:

● dilution of colored or fluorescent product molecules due to large volume of liquid in traditional-sized wells,

limiting sensitivity;

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● narrow dynamic range (i.e., the range of concentration of proteins being detected), that may require sample
dilution, diluting molecules and increasing sample volume requiring additional enzymes to reach detection
limit;

● low detection limit of readers restrict sensitivity and ability to detect low abundance proteins, particularly

when proteins are at normal physiological levels; and

● limited success in increasing sensitivity of detection due to procedural complexity and length.

Genomic Analysis

Over the past few decades, scientists have developed a variety of genomic analysis methods to measure an
increasing number of genomic biomarkers aimed at more effectively detecting diseases. The most widely used method for
genetic testing is PCR, which involves amplifying, or generating billions of copies of, the DNA sequence in question and
then detecting the DNA with the use of fluorescent dyes. PCR is used to amplify the nucleic acid through the use of
enzymes and repeated heating and cooling cycles, with fluorescent dyes incorporated during each amplification cycle. The
expression of the nucleic acid is then inferred based on the number of amplification cycles required for the target to
become detectable. PCR is sometimes referred to as an analog technology because the number of cycles of amplification,
rather than a direct measure, is used to infer the level of gene expression. The wide availability of PCR chemistry makes it
a popular approach for measuring the expression of nucleic acids, but the use of enzymes in numerous cycles of
amplification can introduce distortion and bias into the data, potentially compromising the reliability of results, particularly
at low concentrations.

Our Simoa Technology

Our Simoa technology significantly advances conventional sandwich ELISA technology and is capable of

unprecedented protein detection sensitivity.

Simoa Bead-Based Technology

Simoa bead-based digital immunoassays utilize the basic principles of conventional bead-based sandwich ELISA

and require two antibodies: one for capture, which is applied to the beads, and one for detection. Unlike ELISA, which runs
the enzyme-substrate reaction on all molecules in one well, Simoa bead-based reactions are run on individual molecules in
tiny microwells, 40 trillionths of a milliliter that are 2.5 billion times smaller than traditional ELISA wells. Traditional
ELISA analog measurements increase in intensity only as the concentration of a sample increases. Simoa bead-based
digital technology measurements, however, are independent of sample concentration intensity and rely on a binary
signal/no signal readout, enabling detection sensitivity that was not previously possible.

Our Simoa bead-based platform is highly flexible, designed to enable practical high-sensitivity protein analysis

for academic researchers looking at novel proteins all the way through to high throughput analysis performed by large
biopharmaceutical organizations. The following chart describes the steps through which our Simoa bead-based technology
detects proteins:

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Simoa Bead-Based Analytic Process

Sample Preparation of ELISA Sandwich

Simoa bead-based technology uses beads coated with capture
antibodies that bind specifically to the protein being
measured. After an enzyme-linked detection antibody binds
to the protein, the enzyme substrate is added (as depicted by
the white star in the graphic on the left). The enzyme
associated with the enzyme-linked detection antibody then
reacts with the enzyme substrate causing the enzyme
substrate to become fluorescent (as depicted by the change in
color of the star in the graphic).

Injection of Bead/Substrate Solution into Simoa Disk This mixture of beads and enzyme substrate is then injected
into our proprietary Simoa disk, which contains 24 arrays of
microwells arranged radially. Each 3 × 4 millimeter array
contains approximately 239,000 microwells, each of which is
large enough to accommodate only a single bead.

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Bead/Substrate Solution Settles and Wells are Sealed The bead/substrate solution is drawn across the array and the

beads settle by gravity onto the surface of the array, and a
fraction of them fall into the microwells. The remainder lie
on the surface, and oil is introduced into the channel to
displace the substrate solution and excess beads, and to seal
the wells.

Simoa Readout

The entire array is then imaged using ultrasensitive digital
imaging, and the sealed wells that contain beads associated
with captured and enzyme labeled protein molecules are
identified.

Our Simoa bead-based technology offers unprecedented protein detection sensitivity and enables detection of low

abundance and previously undetectable biomarkers. This sensitivity allows researchers to measure critical protein
biomarkers at earlier stages in the progression of a disease or injury, which we believe will enable the development of
novel therapies and diagnostics and facilitate a paradigm shift in healthcare from an emphasis on treatment to a focus on
earlier detection, monitoring, prognosis and, ultimately, prevention. We have published an approach to increase the
sensitivity of our Simoa technology 100-fold.

The ability to multiplex, or simultaneously measure multiple proteins (or other biomarkers) in a single assay, can
be important to researchers to maximize the biological information from a sample, and to develop more specific diagnostic
tests. However, one of the main issues with multiplexing can be the loss of sensitivity. Our Simoa platforms maintain single
plex precision, while competitive platforms lose sensitivity when multiplexing is used. Multiplexing is achieved with our
Simoa bead-based technology by using beads labeled with different fluorescent dyes specific to the biomarker being
analyzed. After the assay is run, the array of microwells is imaged across the wavelengths of the different labeled beads.
The results are measured for each protein captured by each of the different beads. While we have demonstrated the ability
to identify and differentiate up to 35 different bead subpopulations on the HD-X, which is a prerequisite to our ability to
develop assays with the capacity to detect an equivalent number of proteins in a single sample, we believe that the ability to
multiplex above a 6-plex and maintain single-plex sensitivity and precision may be limited using bead-based technology
due to constraints in the number of bead-containing wells for each plex that are imaged on the Simoa disk. In 2017, we
commercially launched a Simoa neurology 4-plex assay (Nf-L, tau, GFAP and UCH-L1) for the study of
neurodegenerative conditions and traumatic brain injury. Whereas other assay technologies

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require CSF to detect all four of these markers, or are limited to only single-plex measurement in serum and plasma, due to
Simoa’s sensitivity, this is the only assay that can detect all of these biomarkers directly from serum and plasma samples in
a multiplex assay format. This is a significant advantage in terms of ease of use, patient comfort, speed and cost-
effectiveness. In the first quarter of 2020, we launched a new Simoa 6-plex human cytokine Simoa bead-based assay for
the HD-X and SR-X instrument platforms. This assay is the only commercially available product supporting quantitative
multiplex measurement of six key immunomodulatory cytokines (IFNg, IL-6, IL-10, IL-12p70, IL-17A and TNFa) at
baseline levels in both normal healthy individuals and patient cohorts in therapeutic areas spanning cancer, autoimmune
disease, neurodegeneration and infectious disease.

Simoa Planar Array Technology

Simoa planar array immunoassays utilize the basic principles of conventional microplate-based sandwich ELISA

and require two antibodies: one for capture, which is applied to the beads, and one for detection. Unlike ELISA, which runs
the enzyme-substrate reaction on all molecules coating the entire bottom surface in one well, Simoa planar array reactions
are run on spatially segregated micro-spots within the bottom of microtiter plate wells that concentrate the signal to a
surface area 1,000 times smaller than a traditional ELISA. The small spot size and spatial segregation of each spot enables
multiplexing up to 12 different assays within a single sample well.

Our Simoa planar array platform is highly flexible, designed to enable practical high-sensitivity multiplex protein
analysis for drug discovery and development applications as well as translational biomarker research. The following chart
describes the steps through which our Simoa planar array technology detects proteins:

Simoa Planar Array Analytic Process

A)

B)

C)

Analyte-specific capture antibodies are printed in microspots (100 microns) in a circular pattern in the bottom of a 96-well
microtiter plate. Each microspot contains capture antibodies that are specific for different analytes. Up to 12 spatially resolved
microspots can be printed in each well.

Samples are added to the plate and incubated with a benchtop plate shaker to bind the target analyte molecules to the
microspots. Unbound molecules are removed by washing the plate with a benchtop plate washer or manual wash manifold.

A mixture of biotinylated detection antibodies are added to the plate to form the antibody sandwich. Excess detection
antibodies are removed by washing.

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D)

E)

F)

Streptavidin-HRP (horseradish peroxidase enzyme) conjugated is added to the plate to bind to the biotin groups forming the
complete immunocomplex followed by a washing step.

A high-sensitivity chemiluminescent substate reagent is added to each well. The enzyme associated with the enzyme linked
detection antibody then reacts with the enzyme substrate causing the enzyme substrate to emit light.

The plate is placed into the Quanterix SP-X imaging system. A scientific-grade CCD camera images the entire plate and all
micro-spots simultaneously. The low background of the plate surface and the high-sensitivity of the camera enable detection of
very low levels of light with a high dynamic range. The SP-X imaging software utilizes algorithms to optimize exposure time
and combine multiple images in the image analysis. Protein concentrations are determined by comparing the intensity of
microspots to known analytical standards.

Below is an image of a 96-well Simoa planar array plate containing 12 microspots. Each microspot represents a

different analyte measured in each sample well.

We believe the Simoa planar array technology is well-suited for researchers who value the ability to measure
critical immunomodulatory biomarkers in patient serum and plasma with ultra-sensitive detection in a multiplex assay
format. The figure below demonstrates 10-plex detection of key cytokines in human serum from normal healthy donors
with corresponding assay Limit of Detection (LoD) listed in femtogram per ml.

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Nucleic Acid Testing

Our initial focus has been on the use of Simoa technology to detect protein biomarkers. However, our Simoa bead-

based technology has also been used to detect nucleic acids in biological samples. While methods for measuring nucleic
acid molecules have advanced substantially, currently available techniques still have drawbacks. For example, PCR is a
sensitive method that is widely used for measuring gene expression. However, PCR carries the potential for data distortion
and bias from the repeated addition of enzymes, and heating and cooling cycles needed to amplify a copy of the nucleic
acid being measured. In nucleic acid analysis, we believe that Simoa has the potential to provide the same sensitivity as
traditional PCR-based assays with the following benefits:

● no need for amplification of the targeted nucleic acid, which can result in amplification distortion and bias;

● reduced cross-contamination because of direct detection of single molecules vs. the detection of a large

number of copies of the nucleic acid; and

● the ability to detect some samples without requiring purification of the nucleic acid, such as in environmental

water or serum samples.

For detection of nucleic acids with our Simoa bead-based technology, instead of coating the beads with capture

antibodies as is done for detecting proteins, the beads are coated with nucleic acid capture probes. Samples with the target
nucleic acid molecules are then added and are captured by the beads. Nucleic acid detection probes (instead of detection
antibodies) are then added and attach to the target nucleic acid molecules which are then labeled using an enzyme substrate
that is detected and counted using the Simoa disk and instrument. This assay is pictured below:

Simoa has been used to detect short sequences of RNA, known as microRNA, that are important in a number of
biological systems, and are widely used in innovative therapeutic and gene editing technologies. For example, the assay
was used to detect microRNA-122 (miR-122), a marker of liver toxicity, from the serum of patients who had overdosed

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with acetaminophen. As shown in the graph below, these patients had elevated miR-122 levels compared to healthy
controls.

This approach suggests potential for applications for measuring drug-induced liver injury for both safety testing of

drugs in development and for monitoring of approved drugs.

Our Market Opportunities

Our commercial strategy is to pursue the application of our Simoa technology to the life science research,

diagnostics and precision health screening markets.

Life Science Research

Our initial target market is the large and growing life science research market. We believe our Simoa platforms are

well-positioned to capture a significant share of this market because of superior sensitivity, automated workflow
capabilities, multiplexing and the ability to work with a broader range of sample types.

Proteomics, the study of the proteins produced by the body, is important to understanding disease, and researchers

study proteins to understand the biological basis for disease and how to improve diagnosis and treatment. The proteins
detectable by conventional, analog immunoassay technologies represent a mere fraction of the proteins that can be detected
by Simoa technology, and we believe that Simoa can inspire a new level of research into these previously undetectable
proteins and their role in disease. By substantially lowering the limit of detection of protein biomarkers, our Simoa
platforms hold significant potential to expand research into the diseases associated with the thousands of proteins that were
previously undetectable, as well as into earlier detection of the proteins currently detectable by other technologies only
after they have reached levels that reflect more advanced disease or injury. Simoa technology provides researchers the
ability to see the nuanced continuum of health to disease more efficiently and effectively than any other technology
commercially available today, offering the potential for the first time to better understand the onset of disease cascades and
catalyzing a new era of medical and life science research, drug discovery and disease prevention.

As an indication of the market’s acceptance of our Simoa technology, researchers at pharmaceutical and
biotechnology companies are integrating our platforms into drug development protocols to more efficiently and effectively
develop drugs. Using Simoa’s unprecedented sensitivity to measure previously undetectable levels of target biomarkers
prior to and following administration of a drug, drug developers can non-invasively and objectively determine whether a
drug candidate is having a desired impact on the target biomarker. In addition, researchers can also use Simoa to monitor a
drug candidate’s unwanted effect on “off-target” biomarkers and predict side effects, addressing the significant issue of
drug toxicity, which is a leading cause of death in the United States. We estimate that our Simoa technology has been
utilized in projects for over 800 clinical trials to date.

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According to estimates in the Third-Party Research Report, we believe that our pre-COVID addressable
neurology, immunology and oncology life science research market was approximately $1 billion per year. Our recent EUA
approvals expand our life science research market focus into COVID-19, which we estimate has currently addressable
potential of $0.2 billion. As we further expand our life science research focus in other areas of immunology, oncology and
other therapeutic areas, coupled with growing adoption of decentralized clinical trials, the life science research addressable
market is expected to expand to approximately $7 billion.

Diagnostics

The diagnostic market represents a significant future commercial opportunity for our Simoa technology as well.
We believe existing biomarker diagnostics can be improved by Simoa’s sensitivity to enable earlier detection of diseases
and injuries, and that new diagnostics may be developed using protein biomarkers that are not detectable using
conventional, analog immunoassay technologies but are detectable using Simoa technology. We also believe that the ultra-
sensitive protein detection provided by our Simoa platforms can enable the development of a new category of non-invasive
diagnostic tests and tools based on blood, serum and other fluids that have the potential to replace current more invasive,
expensive and inconvenient diagnostic methods, including spinal tap, diagnostic imaging and biopsy.

For example, researchers have conducted studies using Simoa that indicate that neurological biomarkers,
including tau and Nf-L, may someday be able to replace diagnostic imaging to diagnose traumatic brain injury (TBI). Our
Simoa assays for tau and Nf-L are 3,500-fold and 840-fold more sensitive, respectively, than conventional ELISA
technologies. Almost 90% of patients who visit U.S. hospital emergency rooms and receive a computerized tomography
(CT) scan show no structural brain injury. In addition, CT scans have approximately 100 times more radiation than a chest
x-ray, and are suspected of causing cancer in up to 29,000 people per year, underscoring the need for development of a safe
and accurate blood-based diagnostic test for TBI, which we believe may be enabled by our Simoa technology.

Simoa technology also has significant potential in the emerging field of companion diagnostics. A companion
diagnostic test is a biomarker test that is specifically linked to a therapeutic drug that can help predict how a patient will
respond to the drug. Drug developers can use companion diagnostics to stratify patients and select only those patients to
study for whom a drug is expected to be most effective and safe. Companion diagnostics have demonstrated the ability to
both improve the probability of approval and accelerate approval of new drugs. Not only could Simoa be used to develop
companion diagnostics to stratify patients in clinical trials and for treatment, but Simoa’s sensitivity can also enable the
development of companion diagnostics based on protein biomarkers that can actively and regularly monitor whether an
approved drug is having the desired biological effect. This would quickly and efficiently enable doctors to adjust the course
of treatment as appropriate by increasing or decreasing dosages or even switching therapies.

There has been significant interest from third parties to use our technology to develop applications for the

diagnostic market.

Precision Health Screening

The ability of our Simoa platforms to detect and quantify normal physiological levels of low abundance proteins

that are undetectable using conventional, analog immunoassay technologies could enable our technology to be used to
monitor protein biomarker levels of seemingly healthy, asymptomatic people, and potentially to signal and provide earlier
detection of the onset of disease. This has the potential to facilitate a paradigm shift in healthcare, from an emphasis on
treatment to a focus on earlier detection, monitoring, prognosis and, ultimately, prevention, enabling a “precision health”
revolution.

We believe there is the potential for a number of neurological, cardiovascular, oncologic and other protein
biomarkers associated with disease to be measured with a simple blood draw on a regular, ongoing basis as part of a
patient’s routine health screening, and for those results to be compared periodically with baseline measurements to predict
or detect the early onset of disease, prior to the appearance of symptoms.

The Third-Party Research Report estimates that the diagnostic and precision health screening markets have the

potential to reach an aggregate of approximately $55 billion per year, with neurology diagnostics estimated at

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approximately $18 billion, proteomic liquid biopsy estimated at approximately $20 billion, COVID estimated at
approximately $12 billion, and precision health screening estimated at approximately $5 billion, which would be
addressable upon receipt of any required regulatory approvals.

Our Key Focus Areas

We have focused the application of our Simoa technology on areas of high growth and high unmet need and where

existing platforms have significant shortcomings that our technology addresses. In particular, we have focused on
neurology and oncology, as well as COVID, cardiology, infectious disease and inflammation.

Neurology

We believe that the ability of our Simoa technology to detect neurological biomarkers in blood at ultra-low levels,
which have traditionally only been detectable in cerebrospinal fluid (CSF), has the potential to rapidly advance neurology
research and drug development, and transform the way brain injuries and diseases are diagnosed and treated. To our
knowledge, the brain is the only organ in the body for which there is not currently a blood-based diagnostic test. The
challenge with developing blood-based tests for the brain is that the blood-brain barrier, which is formed by endothelial
cells lining the cerebral microvasculature, is very tight and severely restricts the movement of proteins and other substances
between these endothelial cells and into blood circulation. Accordingly, diagnosis of brain disease and injury has
traditionally required either an MRI scan of the brain or a spinal tap to collect CSF, both of which are costly and highly
invasive for the patient. The sensitivity of the Simoa technology has enabled researchers to discover that extremely small
amounts of critical neural biomarkers diffuse through the blood-brain barrier, and are released into the blood during injury
and in connection with many neurodegenerative brain diseases. However, the concentrations of these neural biomarkers in
the blood are so low that they are undetectable by conventional, analog immunoassay technologies. In 2017, we
commercially launched a Simoa neurology 4-plex assay (Nf-L, tau, GFAP and UCH-L1) for the study of
neurodegenerative conditions and traumatic brain injury. Whereas other assay technologies require CSF to detect all four of
these markers, or are limited to only single-plex measurement in serum and plasma, due to Simoa’s sensitivity, this is the
only assay that can detect all of these biomarkers directly from serum and plasma samples in a multiplex assay format. This
is a significant advantage in terms of ease of use, patient comfort, speed and cost-effectiveness.

To date, there have been over 670 neurology-related scientific publications using our Simoa technologies, and we
believe that ultra-sensitive digital detection of neural related biomarkers in the blood is becoming an essential research and
development tool for an increasing range of neurological disorders, including multiple sclerosis, Alzheimer’s disease,
dementia, Parkinson’s disease, and TBI. The goal of this research is to eventually develop accurate diagnostic tools,
predictive health screens and, ultimately, more effective treatments.

Evidence of the potential clinical utility of Nf-L as a biomarker in neurological disease is progressing rapidly, in
particular with respect to multiple sclerosis. At the 35th Congress of the European Committee for Treatment and Research
in Multiple Sclerosis (ECTRIMS) in September 2019, there were nearly 50 presentations in which our Simoa Nf-L assay
was used. In one presentation, Novartis presented positive data from its Phase III ASCLEPIOS I and II studies of its
multiple sclerosis drug candidate, ofatumumab. One of the secondary endpoints included serum levels of Nf-L as measured
using our Simoa Nf-L assay. Novartis presented data that showed that, starting at three months after initiation of
ofatumumab treatment, and then at 12 and 24 months timepoints, patients given ofatumumab had significantly lower blood
levels of Nf-L, compared to those in the comparator arm of teriflunomide treated patients.

In another ECTRIMS presentation, Roche presented retrospective data from its Phase III OPERA I, OPERA, II

AND ORATORIO trials of its approved multiple sclerosis drug OCREVUS (ocrelizumab). OCREVUS was only approved
in 2017, but it has already become the multiple sclerosis market leader in its class, recording sales of $1.72 billion in the
first half of 2019. By 2025, annual sales of the drug are estimated to reach $6.8 billion. In the data presented at ECTRIMS,
it was shown that treatment with OCREVUS lowered blood Nf-L levels and increased proportion of patients reaching
healthy donor range for Nf-L in both relapsing multiple sclerosis and primary progressive multiple sclerosis. Roche
believes that this data helps advance the understanding of Nf-L as a potential biomarker of disease activity and for
treatment monitoring, and may provide insight into the neuroprotective effects of the drug.

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In an article published by Bjornevik et al in JAMA Neurology in September 2019, researchers presented data that
showed that levels of serum Nf-L, as measured by the Simoa Nf-L assay, were increased six years before the clinical onset
of multiple sclerosis. The researchers concluded that these data indicate that MS may have a prodromal phase lasting
several years and that neuroaxonal damage occurs during this phase, emphasizing the importance of early diagnosis and
treatment.

In 2017, researchers using Simoa technology published a paper in JAMA Neurology demonstrating that a simple

blood test for the neurological biomarker Nf-L exhibited the same level of diagnostic accuracy for diagnosing Alzheimer’s
disease as currently established CSF biomarkers. The study was a major study of almost 600 patients from the Alzheimer’s
Disease Neuroimaging Initiative. The graph below depicts the diagnostic accuracy of plasma Simoa Nf-L measurements
compared with traditional CSF biomarkers. The diagnostic accuracy of the plasma Simoa Nf-L results approached 90%, in
line with the CSF biomarkers on the same patients.

Diagnostic Accuracy

In addition, Simoa plasma Nf-L values were associated with cognitive deficits and neuroimaging hallmarks of

Alzheimer’s disease at baseline and during follow-up. High plasma Nf-L correlated with poor cognition and Alzheimer’s
disease -related brain atrophy and with brain hypometabolism (lower neural energy). These data suggest a simple Simoa
blood test for Nf-L may have clinical utility as a noninvasive biomarker in Alzheimer’s disease.

TBIs lead to approximately five million individuals visiting emergency rooms per year in the United States alone,

often with broad and inconclusive diagnosis. Current methods of TBI diagnosis involve CT scans that fail to diagnose
approximately 90% of mild TBI. Simoa technology has demonstrated the sensitivity to identify relevant neurological
biomarkers, such as Nf-L, tau, GFAP and UCH-L1, to more adequately address diagnosis of TBIs and overall brain health.

Leading researchers in neurology have used Simoa technology to study biomarkers in the blood of athletes after

concussion in many high-impact sports. Simoa can measure critical neural biomarkers in blood that correlate repeated head
trauma from both concussions and subconcussive events with poor patient outcomes, including the potential development
of Chronic Traumatic Encephalopathy (CTE), which currently can only be diagnosed after death via a brain autopsy. A
recent publication by a National Institute of Health researcher indicates that measuring tau in the blood with Simoa may
help identify concussed individuals requiring additional rest before they can safely return to play. Eventually, we believe it
may be possible to develop a mobile screen enabling clinicians to quickly and accurately determine whether it is safe for
concussed athletes to return to play.

In 2016, Fast Company named Quanterix one of the “World’s Most Innovative Companies” for our work in

concussion detection. We also were awarded two competitive grants from the NFL-GE Head Health Challenge to advance
this work in the detection and quantification of mild TBI.

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Oncology

Our ultra-sensitive Simoa technology has the potential to detect increased levels of oncology biomarkers during
the very early stages in disease development. Biomarkers can be useful tools for diagnostics, prognostics and predictive
cancer detection. However, many traditional assay technologies can only detect these biomarkers after the disease has
progressed and the patient has become symptomatic. Simoa’s highly sensitive detection capability may result in earlier
detection, better monitoring and treatment and improved prognoses for patients. Additionally, Simoa technology has shown
early promise as a liquid biopsy alternative to more invasive diagnostic procedures.

Simoa technology was used in an unpublished scientific study that indicates it may be possible to eventually

replace routine mammograms with a very sensitive, more accurate, low cost, non-invasive blood test. In this retrospective
study, researchers found that Simoa assays resulted in significantly fewer false positives and false negatives than
mammography. Inaccurate mammography can result in unnecessary stress, additional health care costs from follow up
diagnostic mammograms, unnecessary biopsies and increased lifetime exposure to radiation. Researchers are also
developing ultrasensitive assays for lung and pancreatic cancer biomarkers using Simoa technology, potentially replacing
the need for imaging and biopsy. We believe our Simoa technology has the potential to lead to rapid, cost effective,
accurate blood-based health screens, further enabling the liquid biopsy market.

Cancer immunotherapy is a promising new area that is significantly affecting cancer remission rates. One

challenge of immunotherapy approaches is that the elicited immune responses are not always predictable and can vary
from person to person and protocol to protocol. There exists a significant need to develop biomarker tools to monitor these
drugs and their effects. Circulating (serum and plasma) protein biomarkers have the potential to be used in the field of
immuno-oncology to stratify patients, predict response, predict recurrence, reveal mechanism of action and monitor for
adverse effects. One technical challenge facing the immuno-oncology drug development process has been the availability
of immunoassays with sufficient sensitivity to measure immunomodulatory biomarkers directly in serum and plasma. We
have developed a set of over 100 tumor biomarker and immune modulation assays (cytokines and chemokines) that can be
used to monitor tumor proliferation and host immune response. In particular key immune regulatory cells (T-regs, dendritic
cells, macrophages) secrete very low amounts of the protein Interferon gamma (IFN-gamma) and these levels cannot be
reliably measured in serum and plasma using conventional, immunoassay technology, however they can be tracked with
our Simoa IFN-gamma assay. Additionally, we have developed an ultra-sensitive assay for IL-6, which is one of the
cytokines commonly measured for monitoring cytokine release syndrome as an adverse effect in immunotherapies. Several
studies have shown that our ultrasensitive assays can be valuable tools for monitoring immuno-oncology drugs and
protocols.

We also believe residual cancer cell detection post-surgery or post-treatment may significantly improve outcomes
for a variety of cancer types, by helping identify and segment patients at a greater risk of reoccurrence post-surgery due to
residual cancer. For example, we have developed an ultra-sensitive biomarker assay for Prostate Specific Antigen (PSA)
that is over 1,000-fold more sensitive than conventional ELISA assays. This assay is the only currently available
technology that can detect levels of PSA in blood samples of prostate cancer patients shortly following radical
prostatectomy, and we and researchers from Johns Hopkins and NYU conducted a pilot study on the utility of this assay to
predict recurrence of prostate cancer after this procedure. In this study, the blood of prostate cancer patients taken three to
six months following a radical prostatectomy at least five years earlier was analyzed with Simoa. The majority of samples
had PSA levels below the detectable limits of traditional PSA assays. Our Simoa technology, however, was able to detect
and quantify PSA levels in all samples. As shown in the following graph, the study demonstrated that the PSA assay using
our Simoa technology has the potential to be highly predictive of prostate cancer recurrence over a five-year period. This
has the potential to be a powerful prognostic tool, and allowing adjuvant radiation treatment to be targeted only to the men
who actually would benefit.

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COVID-19

In view of the COVID-19 pandemic, in the second quarter of 2020 we determined that our cytokine assay
technology could provide researchers with important and differentiated tools to study disease progression, cytokine release
syndrome, and patient-treatment response in the fight against COVID-19, and began developing a SARS-CoV-2 semi-
quantitative IgG assay and a SARS-CoV-2 antigen detection assay and prototyping a high-definition multiplex SARS-CoV-
2 serology assay.

In December 2020, the FDA issued an EUA for our Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test

that is run on our HD-X instrument. This test targets antibodies that are directed against the region of the novel coronavirus
known as the spike protein. The spike protein contains multiple subunits which together mediate entry of the virus into
human cells, and for this reason, many candidate and authorized COVID-19 vaccines are designed to elicit an antibody
response to the spike protein. Accordingly, we believe that this test may be useful for measuring the antibody response to
vaccine therapy. The assay may also be used for measurement of IgG antibodies in patients suspected of previous infection
or recent SARS-CoV-2 exposure. The test provides a numerical result representing the concentration of antibodies from
0.21 to 250 mg/mL. In clinical studies, the test demonstrated a 100% positive percent agreement (sensitivity) and 99.2%
negative percent agreement (specificity) 15 or more days following a positive PCR test.

In January 2021, the FDA issued an EUA for our Simoa SARS-CoV-2 N Protein Antigen Test that is also run on

our HD-X instrument. This test detects the presence of the SARS-CoV-2 virus nucleocapsid protein (or N protein) which is
known to be elevated in respiratory fluids during the initial acute phase of the infection. We believe that direct detection of
antigen proteins from the virus may be a more meaningful measure of infection status than detection of RNA by rRT-PCR
because genetic material can linger even after the virus has left the body, resulting in increased risk of false positives. In
clinical studies, this test demonstrated a sensitivity of 97.7% and specificity of 100% up to 14 days following onset of
symptoms. Under the current EUA, the test is intended for use with nasopharyngeal (NP) samples in individuals suspected
of COVID-19 infection by their healthcare providers. We currently intend to pursue authorization for additional sample
types, including nasal swabs, saliva, and capillary dried blood obtained from a fingerstick. Preliminary clinical research
studies suggest the viral antigen may be readily detectable in asymptomatic and pre-symptomatic patients, and we are
exploring extending the test to screening applications, home-based sample collection and pooling to enable larger scale
testing.

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Inflammation

Inflammation underlies the response of the body to injury in a variety of diseases. Simoa assays can measure

inflammatory and anti-inflammatory molecules in serum and plasma with unprecedented sensitivity. This has the potential
to enable new discoveries into the role of inflammation in the biology of health and disease. Our Simoa technology
measures low levels of inflammatory proteins, including cytokines and chemokines, that characterize a range of
inflammatory diseases, including Crohn’s disease, asthma, rheumatoid arthritis and neuro-inflammation. We believe the
sensitivity of Simoa technology can provide a clearer picture of the underlying state of the immune response and disease
progression.

Our Simoa technology also has the potential to be used by companies developing anti-inflammatory drugs to

quantify the effect a drug has on a particular inflammatory cytokine and to monitor therapeutic efficacy. For example, we
conducted a study in conjunction with the Mayo Clinic using our Simoa technology on patients with clinically active
Crohn’s disease undergoing anti-TNF-α therapy with Remicade, Humira or Enbrel. As shown in the graph below,
researchers were able to detect and quantify the TNF-α levels of the patients before and after treatment. These levels were
all below the LoD of traditional immunoassays.

We believe that a better understanding of the inflammatory response will be critical to future opportunities for
wellness screening and disease response monitoring. Anti-inflammatory drugs are expensive and can have serious side
effects, such as increased risk of infection. By monitoring biomarkers indicative of response, clinicians may be able to
adjust dose to reduce side effects or increase efficacy.

Cardiology

Heart disease and related cardiovascular ailments remain the leading cause of death in the United States,

contributing to nearly 1 in 4 deaths in the United States, according to the CDC. A significant need remains for early
prediction of heart attacks and other cardiac events. Simoa’s highly sensitive digital measurement capabilities have the
potential to be used to predict early cardiac disease.

Infectious Disease

The ability to detect infectious disease biomarkers before the onset of an immune response, where a virus is most
contagious and multiplying rapidly, is critical for controlling the spread of disease. We believe that our Simoa technology
has the potential to have a significant impact in reducing the spread of infectious diseases by making early stage detection
more specific and widely available.

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Today, early detection of infectious disease is conducted using nucleic acid testing to detect the nucleic acid of the
viral or bacterial organism because the levels of infectious disease specific antigens are too low in the early stage of disease
to be detected by traditional immunoassay technology. However, the sensitivity of our single molecule detection
capabilities enables the detection of extremely low levels of infectious disease specific antigens with sensitivity that can
rival the use of nucleic acid testing in this application, without the potential biases inherent in amplification technologies,
such as PCR.

For example, we have developed a simple Simoa assay with more than 4,000-fold greater sensitivity than

conventional ELISA assays capable of detecting the HIV-specific antigen, p24. This Simoa p24 sensitivity matches the
sensitivity of more expensive and complex nucleic acid testing methods. The following graph shows a comparison that we
conducted in 2011 of the Simoa p24 assay with a commercially available nucleic acid testing method, as well as two
commercially available p24 immunoassay methods for early detection of HIV infection. The Simoa p24 assay detects
infection as early as the nucleic acid testing method (11 days from initial blood draw), and a full week before the earliest
signs of infection by the conventional p24 immunoassay methods. This early detection of acute HIV infection can be
critical for controlling the spread of HIV, as HIV is ten times more infectious in the acute phase.

In addition, we believe the detection of a specific protein is more relevant to the determination of the pathogenic
effect than detection of the organism itself because someone may carry a pathogenic organism with no pathogenic effect.
Researchers have demonstrated that Simoa technology can detect Clostridium difficile (C. diff) toxins A and B with
sensitivities similar to the PCR detection of the C. diff organism itself. Because the C. diff organism does not always
produce toxins, PCR methods that detect the C. diff organism suffer from very high false positive rates, which may result in
incorrect diagnoses and the overuse of antibiotics. We believe that using Simoa to detect the toxins rather than the organism
has the potential to provide a higher level of sensitivity and specificity, greatly reducing false positives.

We will continue to develop Simoa assays for pathogenic antigens that are competitive in sensitivity to PCR but
more specific to the pathogenicity of the offending organism. We believe that these Simoa assays could also be invaluable
tools for the development of anti-infective drugs and treatment monitoring of anti-viral and anti-bacterial drugs.

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Our Products and Services

Our Quanterix commercial portfolio includes research use only (ROU) instruments, assay kits and other

consumables, and contract research services offered through our Accelerator Laboratory, as follows:

Product
HD-X

SR-X

SP-X

Key attributes
● commercially launched the next-generation HD-X in the second

half of 2019 to replace the HD-1 launched in 2014

● Simoa bead-based platform technology
● most widely referenced ultra-sensitive multiplex immunoassay

platform on market

● fully automated, floor-standing instrument
● wide dynamic range
● multiplexing capability (up to 6-plex) with small sample

volume

● up to 400 samples per eight-hour shift
● homebrew capabilities

● commercially launched in December 2017
● Simoa bead-based platform technology
● reader only, benchtop instrument with lower price point
● same sensitivity, dynamic range and homebrew capabilities as

HD-X

● multiplexing capability: SR-X currently has up to 6-plex

capability

● sample prep and assay protocol flexibility

● commercially launched in April 2019
● Simoa planar array platform technology
● reader only, benchtop instrument with lower price point
● similar sensitivity, dynamic range and homebrew capabilities as

HD-X

● multiplexing capability: SP-X currently has up to 10-plex

capability

● sample prep and assay protocol flexibility

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Product
Simoa assays and other consumables

Key attributes
● menu of approximately 87 single-plex and multi-plex bead-based

assay kits includes assays for biomarkers in the areas of
neurology, infectious disease, immunology and oncology

● Two EUA approved SARS-CoV-2 assays
● menu of Simoa planar array reagent kits includes approximately
120 biomarkers ranging from 1-10 analytes per assay in the areas
of immunology and oncology research

● homebrew kits containing reagents and supporting user guides

enabling customers to develop custom assays

● proprietary Simoa disk with 24 arrays, each containing

approximately 239,000 microwells for Simoa bead-based assays

Nf-L antibodies and Nf-L ELISA kits

● sold through our wholly-owned subsidiary, Uman, which we

acquired in 2019

● Nf-L capture/detection antibodies with unparalleled sensitivity

and specificity

● Nf-L ELISA kits for CSF; CE-certified in Europe; RUO outside

of Europe

● licensing and supply arrangement with Siemens Healthineers that

will allow Siemens to begin developing blood-based Nf-L
clinical tests for future commercialization

Services

● contract research services provided through our Accelerator

Laboratory

● over 1,300 projects completed to date
● extended warranty and service contracts
● CLIA-certified lab available

Instruments and Consumables

HD-X

We commercially launched our HD-X instrument in the second half of 2019. The HD-X is an upgraded version of

the Simoa HD-1, our very first instrument, which was launched in January 2014. The HD-X was designed to deliver
significant productivity and operational efficiency improvements, as well as greater user flexibility. The HD-X uses our
Simoa bead-based technology and is the most sensitive automated multiplex protein detection platform commercially
available. Assays for the HD-X are fully automated (i.e. sample in to result out), and results for up to 66 samples are
available in approximately one hour. We believe that this automation provides us an additional significant competitive
advantage with pharmaceutical and biotechnology customers. Samples can be input into the instrument via 96-well
microtiter plates or sample tubes where the system can multiplex and process tests in a variety of assay protocol
configurations.

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Specialized software controls the Simoa instrumentation, analyzes the digital images produced, and provides

customers with detailed analysis of their samples, such as the concentration of multiple biological molecules. The HD-X
software automates the processes for running the instrument and analyzing data from the user-defined protocols.
Proprietary image analysis software is embedded in the system, which converts the raw images into signals for each
biological molecule being analyzed within a sample. Data reduction software automatically converts those signals to
concentrations for the different biological molecules.

Following commercial launch of the HD-X, we initiated a trade-in program for installed HD-1 instruments that

has been exceeding expectations. By the end of 2020, approximately 48% of the HD installed base was HD-X instruments.

SR-X

We commercially launched the SR-X instrument in the fourth quarter of 2017. The SR-X utilizes the same Simoa

bead-based technology and assay kits as the HD-X in a compact benchtop form with a lower price point designed to
address the needs of researchers who value the ultra-sensitive detection capabilities enabled by Simoa.

In contrast to the fully automated workflow of the HD-X, the assay incubation and washing steps for the SR-X are

performed outside of the instruments using conventional liquid handling methods. The offline sample prep provides
additional flexibility to enable researchers to apply Simoa detection in an expanded range of applications including direct
detection of nucleic acids. The SR-X system automates the steps loading Simoa beads onto Simoa disks with subsequent
imaging, detection and data reduction. Processing time for imaging a 96 well plate is approximately 2.5 hours.

SP-X

We commercially launched the SP-X instrument in April 2019. The SP-X uses the Simoa planar array technology

developed initially by Aushon for multiplex chemiluminescent immunoassay measurement, which we refined by
leveraging our proprietary sophisticated Simoa image analysis and data analysis algorithms to provide the same Simoa
sensitivity found in our Simoa bead-based platform. The Simoa planar array technology utilizes a 96-well microtiter plate
with up to 10 different assay measurements performed in each well of the plate from as little as 12.5 microliters of sample.

Similar to the SR-X, the assay prep workflow utilized for the SP-X involves assay incubation and washing steps

performed outside of the instrument using the same conventional liquid handling methods as the SR-X. The SP-X
instrument automates the imaging, detection and data reduction process. Processing time for imaging a 96 well plate is less
than five minutes.

Simoa Assays and Consumables

Recurring revenue is derived through the sale of consumables used to run assays on our instruments, and from our

growing menu of Simoa digital biomarker assays. The current menu of approximately 87 analyte-specific single-plex and
multi-plex assay kits for our bead-based instruments includes assays for biomarkers in the areas of neurology, infectious
disease, immunology and oncology for both human and mouse samples. The current menu of assay kits for the planar array
instrument includes approximately 120 biomarkers ranging from 1-10 analytes per assay in the areas of immunology and
oncology research.

In addition to these assays we have developed, both of the Simoa platforms allow ease and flexibility in assay

design, enabling our customers to develop their own proprietary in-house assays, called homebrew assays, using our
homebrew assay kits. These kits include all components required for customers to run tests using their own antibodies. Our
consumables portfolio for our bead-based platform also includes our proprietary Simoa disks that are unique to our bead-
based platform, as well as cuvettes, and disposable tips. Our goal is to continue to add to our assay kits to extend our
application base.

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We have staffed our assay development and manufacturing teams to do the upfront work of antibody sourcing,

assay development and optimization, sample testing and validation, transfer to manufacturing and final documentation. We
outsource some of our assay development activities to other antibody and/or assay development providers and expect to
continue to do so to achieve our aggressive menu expansion goals.

Nf-L Antibodies and Nf-L ELISA Kits

In August 2019, we completed our acquisition of Uman. Uman supplies neurofilament light (Nf-L) antibodies and

ELISA kits for Nf-L detection in CSF. Uman’s Nf-L antibodies are widely recognized by researchers and
biopharmaceutical and diagnostics companies world-wide as the premier solution for the detection of Nf-L to advance the
development of therapeutics and diagnostics for neurodegenerative conditions. Through Uman we sell proprietary Nf-L
capture and detection antibodies, as well as two Nf-L ELISA kits for CSF, one of which is CE-certified in Europe. 

Services

Through our Accelerator Laboratory, which includes a CLIA-certified laboratory, we provide customers a contract

research option. Researchers, academics and principal investigators can work with our scientists to test specimens with
existing Simoa assays, or prototype, develop and optimize new assays. The Accelerator Laboratory supports multiple
projects and services, including:

● Sample testing. Utilizing commercially available Simoa kits, we have run large studies for customers with

thousands of specimens and small experiments with just a few samples. The sample protocol can be tailored
precisely to the customer’s needs and even large studies can be run quickly. We have extensive experience
testing many different sample types where biomarkers may be present at very low levels.

● Homebrew assay development. Utilizing proprietary or commercially available reagents in combination with
our Homebrew Assay Development Kit, we can rapidly develop a prototype assay exhibiting improved
sensitivity compared to traditional ELISA. The Accelerator Laboratory can also be used to screen reagents to
identify the optimal assay format or expand prototype efforts for further assay optimization or validation to
ultimately deliver the highest level of performance.

● Custom development. After identifying the optimal assay and conditions, the Accelerator Laboratory can be
used to generate qualified bulk reagents or custom assay kits, providing customer access to validated kits for
assays not yet commercially available on the Simoa platform.

To date, we have completed over 1,300 projects for approximately 360 customers from all over the world using
our Simoa platforms, including over 130 projects for clinical studies. In addition to being an important source of revenue,
we have also found the Accelerator Laboratory to be a significant catalyst for placing additional instruments, as a number
of customers for whom we have provided contract research services have subsequently purchased an instrument from us.

We also generate revenues through extended-warranty and service contracts for our installed base of instruments.

Research and Development

We continually seek to improve our platform and technology to enable more sensitive detection and measurement

of biological molecules. This evaluation includes examining new assay formats and instrumentation improvements and
upgrades to increase the performance of our Simoa assays and instruments. We have published an approach to increase the
sensitivity of our Simoa technology 100-fold. We are also focused on expanding our assay menu to extend the scope of
applications for our platform and grow our customer base. Our assay menu expansion is driven by a number of factors,
including input from key opinion leaders, customer feedback, homebrew projects, Accelerator Laboratory projects, new
publications on biomarkers of industry interest, and feedback from our sales and

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marketing team. We also intend to continue to develop and market new instruments with different and/or improved
capabilities in order to further broaden our market reach.

Sales and Marketing

We distribute our Simoa instruments and consumables via direct field sales and support organizations located in

North America and Europe and through a combination of our own sales force and third-party distributors in additional
major markets, including Australia, Brazil, China, Czech Republic, India, Israel, Japan, Lebanon, Mexico, Qatar, Saudi
Arabia, Singapore, South Korea and Taiwan. In addition, Uman sells Nf-L antibodies and Nf-L ELISA kits directly, and in
conjunction with a distributor worldwide (excluding certain Nordic countries). Our domestic and international sales force
informs our current and potential customers of current product offerings, new product and new assay introductions, and
technological advances in Simoa systems, workflows, and notable research being performed by our customers or ourselves.
As our primary point of contact in the marketplace, our sales force focuses on delivering a consistent marketing message
and high level of customer service, while also attempting to help us better understand evolving market and customer needs.

As of December 31, 2020, we had approximately 118 people employed in sales, sales support and marketing,

including technical field application scientists and field service personnel. This staff is primarily located in North America
and Europe. We intend to significantly expand our sales, support, and marketing efforts in the future by expanding our
direct footprint in Europe as well as developing a comprehensive distribution and support network in China where
significant new market opportunities exist. Additionally, we believe that there is significant opportunity in other Asia-
Pacific region countries such as South Korea and Australia as well as in South America. We plan to expand into these
regions via initial penetration with distributors and then subsequent support with Quanterix-employed sales and support
personnel.

Our sales and marketing efforts are targeted at key opinion leaders, laboratory directors and principal investigators

at leading biotechnology and pharmaceutical companies and governmental research institutions.

In addition to our selling activities, we align with key opinion leaders at leading institutions and clinical research
laboratories to help increase scientific and commercial awareness of our technologies, demonstrate the benefits relative to
existing technologies and accelerate adoption. We also seek to increase awareness of our products through participation at
trade shows, academic conferences, online webinars and dedicated scientific events attended by prominent users and
prospective customers.

To develop a thought leadership position in the precision health arena, we have been a Platinum Sponsor of the

annual Powering Precision Health (PPH) Summit since 2016. PPH is an organization founded in 2016 by our President and
Chief Executive Officer, Kevin Hrusovsky, that aims to gather many of the world’s top innovators, scientists, physicians,
medical professionals, patient advocates, government officials, regulators and investors to debate and collaborate around
crucial issues from neurology, oncology and cardiology to inflammation and infectious disease. We believe that sponsoring
this event provides Quanterix significant marketing benefits.

Our systems are relatively new to the life science marketplace and require a capital investment by our customers.

The sales process typically involves numerous interactions and demonstrations with multiple people within an
organization. Some potential customers conduct in-depth evaluations of the system including running experiments in the
Accelerator Laboratory and comparing results from competing systems. In addition, in most countries, sales to academic or
governmental institutions require participation in a tender process involving preparation of extensive documentation and a
lengthy review process. As a result of these factors and the budget cycles of our customers, our sales cycle, the time from
initial contact with a customer to our receipt of a purchase order, can often be six to 12 months, or longer.

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Manufacturing and Supply

Our manufacturing strategy has two components: to outsource the Simoa bead-based instrument development and

manufacturing with industry leaders, and to internally develop and manufacture our planar array instrument and all assay
kits in our own facilities.

Instruments

The HD-X instrument is manufactured by STRATEC Biomedical AG (STRATEC), based in Birkenfeld, Germany,

and is manufactured and shipped from their Birkenfeld and Beringen, Switzerland facilities. See “—Key Agreements—
Development Agreement and Supply Agreement with STRATEC” for a description of our agreement with STRATEC. The
SR-X is manufactured by Paramit Corporation (Paramit), based in Morgan Hill, California, and is shipped to our global
customers by Paramit. See “—Key Agreements—Paramit Manufacturing Services Agreement” for a description of our
agreement with Paramit. Installation of, and training on, our instruments is provided by our employees in the markets
where we conduct direct sales, and by distributors in those markets where we operate with distributors.

We believe this manufacturing strategy is efficient and conserves capital. However, in the event it becomes

necessary to utilize a different contract manufacturer for the HD-X or the SR-X, we would experience additional costs,
delays and difficulties in doing so, and our business would be harmed.

The SP-X instruments are manufactured, tested, shipped and supported by us from our Billerica, Massachusetts

facility. All internal components are sourced domestically except one significant component is sourced in Germany. These
components are sourced from a limited number of suppliers, including certain single-source suppliers. Although we believe
that alternatives would be available, it would take time to identify and validate replacement components, which could
negatively affect our ability to supply instruments on a timely basis. To mitigate this risk, we typically carry significant
inventory of critical components.

Consumables

We assemble our assay kits for our bead-based platform in our Billerica, Massachusetts facility. Reagents for our

bead-based assays include all components required to run an enzyme based immunoassay, such as beads, capture and
detector reagents, enzyme reagents and enzyme substrate. These reagents are sourced from a limited number of suppliers,
including certain single-source suppliers. Although we believe that alternatives would be available, it would take time to
identify and validate replacement reagents for our assay kits, which could negatively affect our ability to supply assay kits
on a timely basis. In an effort to mitigate this risk through inventory control, we have increased the shelf life of the vast
majority of our bead-based assays from six months to 12 months or more.

Simoa disks for our bead-based platform are supplied through a single source supplier pursuant to a long-term
supply agreement with STRATEC Consumables, a subsidiary of STRATEC Biomedical. This agreement provides for a
sufficient notification period to allow for supply continuity and the identification and tech transfer to a new supplier in the
event either party wishes to terminate the relationship. Our cuvettes for our bead-based platform are single sourced through
STRATEC Biomedical, and the disposable tips used in our bead-based platform are commercially available.

We assemble our 96 well sample plate kits for our planar array platform in our Billerica, Massachusetts facility.

Reagents for our planar array assays include all components required to run an enzyme-based chemiluminescent
immunoassay, such as capture antibody printed plates and detector reagents, enzyme reagents and enzyme substrate. These
reagents are sourced from a limited number of suppliers, including certain single-source suppliers. Although we believe
that alternatives would be available, it would take time to identify and validate replacement reagents for our assay kits,
which could negatively affect our ability to supply assay kits on a timely basis. Because our planar array assays have a
shelf life of 12 months, we believe we are able to mitigate this risk through inventory control.

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Nf-L antibodies and Nf-L ELISA Kits

The storage of Uman’s proprietary Nf-L antibody producing hybridomas as well as the cultivation and purification

of the antibodies is outsourced to a contract manufacturer, and bulk material of purified antibodies is delivered to Uman’s
site in Umeå, Sweden. Functional testing and verification of concentration are performed at Uman before the material is
approved for use in production activities. The antibodies can be aliquoted and sold as single reagents or used for the
production of Uman’s Nf-L ELISA kits. The antibody reagents are labeled and released to market after testing. The
contract manufacturer of antibodies is audited regularly, and we have entered into a written supply agreement with the
contract manufacturer. The current shelf-life of the antibodies is 18 months.

All components in Uman’s Nf-L ELISA kits are manufactured in-house at Uman from starting materials sourced

from suppliers that have been evaluated and approved. Uman has entered into supply agreements with critical suppliers.
All incoming goods are subject to receipt control and any deviations related to quality deficiencies are registered. The kit
components include buffers (sample diluent and wash solution), an ELISA 96-well plate coated with a capture antibody,
detector antibody, streptavidine conjugate, substrate (TMB) and stop reagent. The kit components are labeled (either
“RUO” or “CE”) and assembled. The final ELISA kit product is subject to quality control which include testing of human
CSF quality control samples to assure a high batch consistency. After testing and batch record review, the material is
released to market. The current shelf-life of the kits is 18 months.

Key Agreements

Development Agreement and Supply Agreement with STRATEC

In August 2011, we entered into a Strategic Development Services and Equity Participation Agreement (the

STRATEC Development Agreement) with STRATEC, pursuant to which STRATEC undertook the development of the
Simoa HD instrument. Under the STRATEC Development Agreement, we were required to pay a fee and issue to
STRATEC warrants to purchase our equity securities, all of which have been exercised as of December 31, 2017. These
fees and warrants were subject to a milestone based payment schedule. The STRATEC Development Agreement was
amended in November 2016. The Amendment reduced our obligation to satisfy a minimum purchase commitment under
the STRATEC Supply Agreement described below. Additionally, the parties agreed on additional development services for
an additional fee, which is payable when the additional development is completed. This fee includes the final milestone
payment that was associated with the final milestone due under the terms of the STRATEC Development Agreement. The
services were completed in and the final milestone payment was paid in the fourth quarter of 2019. The STRATEC
Development Agreement may be terminated on the insolvency of a party, for an uncured material breach, or, by us, on a
change of control of our company (subject to certain obligations to compensate STRATEC on such termination) or if we
and STRATEC are unable to agree on pricing of the instrument, within certain parameters.

In September 2011, we also entered into a Supply and Manufacturing Agreement with STRATEC (the STRATEC
Supply Agreement), pursuant to which STRATEC agreed to supply HD instruments to us, and we agreed to procure those
instruments exclusively from STRATEC, subject to STRATEC’s ability to supply the instruments. We are responsible for
obtaining any regulatory approval necessary to sell the instruments. We agreed to purchase a certain number of instruments
in the seven years following the acceptance of the first validation instrument. The STRATEC Supply Agreement was
amended in November 2016 to reduce the number of HD instruments we are committed to procure from STRATEC, and
this commitment has been met. The instrument price stipulated in the STRATEC Supply Agreement was established based
on certain specified assumptions and is subject to certain adjustments.

The STRATEC Supply Agreement is terminable by either party on 12 months’ notice to the other party, provided

that neither party may terminate the STRATEC Supply Agreement prior to the later of the seven year anniversary of the
acceptance of the first prototype instrument and the purchase of the minimum number of instruments which we were
committed to procure. The STRATEC Supply Agreement may also be terminated on the insolvency of a party or the
uncured material breach of a party, or, by us, on a change of control of our company (subject to certain obligations to
compensate STRATEC on such termination). On termination by us for STRATEC’s insolvency or uncured material breach
or termination by STRATEC for convenience, we are granted a nonexclusive royalty free

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license of STRATEC intellectual property to manufacture the instruments. In certain of these circumstances, we could be
obligated to issue warrants to purchase common stock.

Paramit Manufacturing Services Agreement

In November 2016, we entered into a Manufacturing Services Agreement (the Paramit Agreement) with Paramit.
Under the terms of the Paramit Agreement, we engaged Paramit to produce and test our SR-X instrument on an as-ordered
basis. We also engaged Paramit to supply spare parts. Paramit has no obligation to manufacture our instrument without a
purchase order and no obligation to maintain inventory in excess of any open purchase orders or materials in excess of the
amount Paramit reasonably determines will be consumed within 90 days or within the lead time of manufacturing our
instrument, whichever is greater. We have an obligation to purchase any material or instruments deemed in excess pursuant
to the Paramit Agreement. The price is determined according to a mutually agreed-upon pricing formula. The parties
agreed to review the pricing methodology yearly or upon a material change in cost.

The Paramit Agreement has an initial three-year term with automatic one year extensions. It is terminable by

either party for convenience with written notice to the other party given at least nine months prior to the end of the then-
current term. The agreement may also be terminated by us with three months’ notice to Paramit upon the occurrence of
(i) a failure of Paramit to obtain any necessary governmental licenses, registrations or approvals required to manufacture
our instrument or (ii) an assignment by Paramit of its rights or obligations under the agreement without our consent. The
Paramit Agreement is terminable by Paramit with 30 days’ notice to us in the event of a material breach after written notice
and a 60-day opportunity to cure the breach.

Non-Exclusive License Agreement with Abbott Laboratories

In September 2020, we entered into a Non-Exclusive License Agreement with Abbott. Pursuant to the terms of the

License Agreement, we granted Abbott a non-exclusive, worldwide, royalty-bearing license, without the right to
sublicense, under our bead-based single molecule detection patents in the field of IVD. Abbott paid us an initial license fee
of $10.0 million in connection with the execution of the License Agreement. Abbott has also agreed to pay us milestone
fees subject to the achievement by Abbott of certain development, regulatory and commercialization milestones and low
single digit royalties on net sales of licensed products.

The License Agreement includes customary representations and warranties, covenants and indemnification

obligations for a transaction of this nature. The License Agreement became effective upon signing and will continue until
expiration of the last-to-expire licensed patent, or the agreement is earlier terminated. Under the terms of the License
Agreement, each party has the right to terminate the agreement for uncured material breach by, or insolvency of, the other
party. Abbott may also terminate the License Agreement at any time without cause upon sixty (60) days’ notice.

Contracts with the NIH under RADx

In September 2020, we entered into the Rapid Acceleration of Diagnostics (RADx) workplan 2 award (WP2) with

the National Institute of Health (NIH) under the RADx program. This contract, which has a total award value of $18.2
million, is intended to accelerate the continued development, scale-up and deployment of our novel SARS-CoV-2 antigen
test. Initial early feasibility of this test was funded in part through the RADx workplan 1 award (WP1) we were granted in
June 2020. WP2 supports clinical validation of the test in support of the EUA submissions with the FDA, and provides
funding to expand assay kit manufacturing capacity and commercial deployment readiness. Contract funding is subject to
achievement of pre-defined milestones and the contract period runs through September 2021.

Competition

We compete with both established and development-stage life science companies that design, manufacture and

market instruments for protein detection, nucleic acid detection and additional applications. For example, companies such
as Bio-Techne, Luminex, MesoScale Discovery, Gyros, Nanostring, and others, have products for protein detection

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that compete in certain segments of the market in which we sell our products. Our Accelerator Laboratory competes with
other research laboratories such as Covance, Q2 Solutions, Myriad RBM, Monogram Biosciences, PPD Laboratories, and
others, some of whom are customers of ours. In addition, as we or our partners expand the applications for our products to
include diagnostics and precision health screening, we expect to compete with companies such as Siemens, Abbott, Roche,
Ortho Clinical Diagnostics and Thermo Fisher Scientific. Furthermore, our technology and products are showing promise
for non-invasive early disease detection, and in the future, we could experience competition from companies that develop
and market imaging and other molecular detection technologies. In addition, a number of other companies and academic
groups are in the process of developing novel technologies for the life science research, diagnostic and precision health
screening markets. Many of the companies with which we compete or will compete have substantially greater resources
than we have.

The life science instrumentation and lab services industries are highly competitive and expected to grow more

competitive with the increasing knowledge gained from ongoing research and development. We believe the principal
competitive factors in our target markets include:

● sensitivity;

● cost of instruments and consumables;

● assay menu;

● reputation among customers and key opinion leaders;

● innovation in product offerings;

● accuracy and reproducibility of results; and

● customer support infrastructure.

We believe that we are well positioned with respect to these competitive factors and expect to enhance our

position through ongoing global expansion, innovative new product introductions and ongoing collaborations and
partnerships with key opinion leaders.

Intellectual Property

Our core Simoa bead-based technology, directed to general methods and devices for single molecule detection,
originated at Tufts University (Tufts), in the laboratory of Professor David Walt, who is the founder of Quanterix and a
current member of our Board of Directors. Prof. Walt and his students pioneered the single molecule array technology,
including technologies that enabled the detection of single enzyme labels in arrays of microwells, thereby facilitating the
ultra-sensitive detection of proteins, nucleic acids, and cells. We have exclusively licensed from Tufts the relevant patent
filings related to these technologies. (See “—License Agreement with Tufts University” below). In addition to licensed
patents, we have developed our own portfolio of issued patents and patent applications directed to commercial products
and technologies for potential development. Our portfolio also includes issued patents and patent applications acquired as
part of our 2017 acquisition of Aushon Biosystems. We believe our proprietary platforms are a core strength of our
business and our strategy includes the continued development of our patent portfolio.

Our patent strategy is multilayered, providing coverage of aspects of the core technology as well as specific uses

and applications, some of which are reflected in our current products and some of which are not. The first layer is based on
protecting the fundamental methods for detecting single molecules independent of the specific analyte to be detected. The
second layer covers embodiments of the core technology directed to the detection of specific analytes. The third layer
protects novel instrumentation, consumables, and manufacturing processes used in applying the invention to certain
commercial products or future product opportunities. The fourth layer is concerned with specific uses of the core

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technology (e.g., biomarkers and diagnostics). Our patent strategy is both offensive and defensive in nature; seeking to
protect not only technology we currently practice but also alternative, related embodiments.

Simoa and Related Technology

As of February 1, 2021, we had exclusively licensed 18 patents and two patent applications from Tufts. These
patents and patent applications include nine issued U.S. patents and two pending U.S. patent applications, three granted
European patents, three granted Japanese patents, two granted Canadian patents and one granted Australian patent.

A first patent family licensed from Tufts is directed to methods for detecting single molecules. This patent family

includes six granted U.S. patents, one pending U.S. patent application, three granted European patents (each nationalized
and active in seven or eight countries), three granted Japanese patents, two granted Canadian patents and one granted
Australian patent. The standard patent expiration date for U.S. patents in this family is February 16, 2027, and for the non-
U.S. patents is February 20, 2027 or August 30, 2027.

A second patent family licensed from Tufts is directed to methods for detecting the presence of target analytes in

multiple samples. This patent family includes one granted U.S. patent. The standard patent expiration date for the U.S.
patent in this family is August 22, 2025.

A third patent family licensed from Tufts is directed to methods for analyzing analytes using a sensor system with

cross-reactive elements. This patent family includes one granted U.S. patent. The standard patent expiration date for the
U.S. patent in this family is March 14, 2021.

A fourth patent family licensed from Tufts is directed to electro-optical systems including an array and a plurality
of electrodes. This patent family includes one granted U.S. patent. The standard patent expiration date for the U.S. patent in
this family is February 14, 2023.

A fifth patent family licensed from Tufts is directed to methods for detecting short nucleic acids. This patent

family includes one pending U.S. patent application. The standard patent expiration date for the U.S. patent in this family is
May 29, 2039.

As of February 1, 2021, we owned 24 issued U.S. patents and 22 pending U.S. patent applications, eight granted

European patents and three pending European patent applications, nine granted Japanese patents, four granted Chinese
patents and one pending Chinese patent application, five granted Canadian patents and one pending Canadian patent
application, one granted Australian patent, and two registered Hong Kong patent applications.

A first patent family owned by us is directed to methods for determining a measure of the concentration of analyte
molecules or particles in a fluid sample, and in particular to methods for analyte capture on beads, including multiplexing.
This patent family includes four granted U.S. patents and two pending U.S. patent applications, two granted European
patent (nationalized and active in eight countries) and one pending European application, two granted Japanese patents,
two granted Chinese patents, and one granted Canadian patent. The standard patent expiration date for the U.S. patents in
this family is March 24, 2030, and for the non-U.S. patents is March 1, 2031.

A second patent family owned by us is directed to methods and systems for determining a measure of the
concentration of analyte molecules or particles in a fluid sample, and in particular to methods or systems for determining
concentration based on either counting or measured intensity (extending the dynamic range). This patent family includes
four granted U.S. patents and one pending U.S. patent application, one granted European patent (nationalized and active in
seven countries), two granted Japanese patents, one granted Chinese patent, and one granted Canadian patent. The standard
patent expiration date for the U.S. patents in this family is March 24, 2030, and for the non-U.S. patents is March 1, 2031.

A third patent family owned by us is directed to methods for determining a measure of the concentration of

analyte molecules or particles in a fluid sample, and in particular to methods for analyte capture on beads with or without

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dissociation. This patent family includes two granted U.S. patents. The standard patent expiration date for the U.S. patents
in this family is September 28, 2028.

A fourth patent family owned by us is directed to methods for determining a measure of the concentration of

analyte molecules or particles in a fluid sample, and in particular to methods for determining concentration using multiple
binding ligands for the same analyte molecule. This patent family includes one granted U.S. patent. The standard patent
expiration date for the U.S. patent in this family is March 24, 2030.

A fifth patent family owned by us is directed to instruments and consumables. This patent family includes one

granted U.S. patent and one pending U.S. patent application, two granted Japanese patents, one granted Chinese patent and
one pending Chinese patent applications, one registered Hong Kong patent application and one pending patent application
in each of Europe, and Canada. The standard patent expiration date for any U.S. patents that may issue from this family is
February 25, 2031, and for any non-U.S. patents is January 27, 2032.

A sixth patent family owned by us is directed to methods and materials for covalently associating a molecular
species with a surface. This patent family includes two pending U.S. patent applications. The standard patent expiration
date for any U.S. patents that may issue from this family is May 9, 2034.

A seventh patent family owned by us is directed to methods for improving the accuracy of capture based assays.
This patent family includes one pending U.S. patent application. The standard patent expiration date for any U.S. patents
that may issue from this family is January 13, 2036.

An eighth patent family owned by us is directed to methods and systems for reducing and/or preventing signal
decay. This patent family includes one pending U.S. patent application. The standard patent expiration date for any U.S.
patents that may issue from this family is September 20, 2038.

We own or co-own nine patent families directed to the measurement of particular types of analytes, including

prostate specific antigen (PSA), β-amyloid peptide, tau protein, toxin B of C. difficile, neurofilament light, glial fibrillary
acidic protein, ubiquitin carboxyl-terminal hydrolase L1, and DNA or RNA molecules. These families include one granted
U.S. patent directed to methods for determining treatment protocols and/or a prognosis of a patient’s recovery from a brain
injury based on measurements of tau protein in blood and one granted European patent (nationalized and active in three
countries) directed to detection of C. difficile. Any patents that may issue from these patent applications would have
standard expiration dates between 2032 and 2039.

With the acquisition of Aushon in January 2017, we acquired their patent portfolio for our planar array

technology. As of February 1, 2021, the acquired patent portfolio includes at least nine issued U.S. patents and one pending
U.S. patent application, one granted Australian patent, three granted Canadian patents, four granted European patents (each
nationalized and active in between eight and 14 countries) and one pending European patent application, three granted
Japanese patents, and one registered Hong Kong patent.

We have licensed additional patents and patent applications from third parties.

In addition to pursuing patents on our technology, 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 advisors.

License Agreement with Tufts University

In June 2007, as amended in April 2013, August 2017, and September 2020, we entered into a license agreement

with Tufts, pursuant to which we obtained an exclusive, worldwide license to research, develop, commercialize, use, make,
or have made, import or have imported, distribute or have distributed, offer or have offered, and sell or have sold products
and services covered by patent rights to the Simoa bead-based technology owned by Tufts, as well as a non-exclusive
license to related know-how. The rights licensed to us are for all fields of use and are sublicensable for a fee.

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Under the terms of the agreement, as amended, we paid a one-time, non-refundable upfront fee and issued Tufts

shares of our common stock. In addition, in connection with the April 2013 amendment, we issued Tufts shares of our
Series C-1 Preferred Stock, which converted into shares of our common stock in connection with our initial public offering.
We are required to pay Tufts low single-digit royalties on all net sales of products and services that use the licensed
technology, as well as a portion of any sublicensing revenues. We are also obligated to pay annual maintenance fees, which
are fully creditable against any royalty payments made by us, and a milestone payment upon any sublicense by us. We
were also required to reimburse Tufts for all patent prosecution cost incurred prior to the agreement and for all future patent
prosecution costs.

The term of the license agreement will continue on a country-by-country basis so long as there is a valid claim of

a licensed patent in such country. Tufts may terminate the agreement or convert to a non-exclusive license in the event
(1) we fail to pay any undisputed amount when required and fail to cure such non-payment within 60 days after receipt of
notice from Tufts, (2) we are in breach of any material provision of the agreement and fail to remedy such breach within
60 days after receipt of notice from Tufts, (3) we do not demonstrate diligent efforts to develop a product incorporating the
licensed technology, (4) we are found on five separate audits to have underpaid pursuant to the terms of the agreement,
(5) we cease to carry on the business related to the licensed technology either directly or indirectly, or (6) we are adjudged
insolvent, make an assignment for the benefit of creditors or have a petition in bankruptcy filed for or against us that is not
removed within 60 days. We may terminate the agreement at any time upon at least 60 days’ written notice. Upon
termination of the agreement, all rights revert to Tufts.

Government Regulation

Other than the COVID assays for which we have received EUAs, our products are currently intended for research
use only (RUO) applications, although our customers may use our products to develop their own products that are subject
to regulation by the FDA or the Center for Medicare and Medicaid Services (CMS). Although most products intended for
RUO are not currently subject to clearance or approval by the FDA, RUO products are subject to FDA’s premarket review
requirements if they are determined to be intended for use for clinical rather than research purposes. Consequently, our
products (other than the COVID assays for which we have received EUAs) are labeled “For Research Use Only.”

On November 25, 2013, the FDA issued Final Guidance for Industry and Food and Drug Administration Staff on

“Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only” (RUO/IUO
Guidance). The purpose of an FDA guidance document is to provide the FDA’s current thinking on when IVD products are
properly labeled for RUO or for IUO, but as with all FDA guidance documents, this guidance does not establish legally
enforceable responsibilities and should be viewed as recommendations unless specific regulatory or statutory requirements
are cited. The RUO/IUO Guidance explains that the FDA will review the totality of the circumstances when evaluating
whether equipment and testing components are properly labeled as RUO. Merely including a labeling statement that a
product is intended for research use only will not necessarily exempt the device from the FDA’s 510(k) clearance,
premarket approval, or other requirements, if the circumstances surrounding the distribution of the product indicate that the
manufacturer intends its product to be used for clinical diagnostic use. These circumstances may include written or verbal
marketing claims or links to articles regarding a product’s performance in clinical applications, a manufacturer’s provision
of technical support for clinical validation or clinical applications, or solicitation of business from clinical laboratories, all
of which could be considered evidence of intended uses that conflict with RUO labeling. Although the RUO/IUO Guidance
is a statement of the FDA’s thinking with respect to certain RUOs and IUOs in 2013 and was not intended as a compliance
requirement, we believe that our labeling and promotion of our products, including the custom assay RUO products
developed by the Accelerator Laboratory, is consistent with the RUO/IUO Guidance because we have not promoted our
products for clinical use in humans. We also are not promoting or using our products in the development or promotion of
laboratory developed test (LDT) services. When we develop products for clinical use, we will do so in accordance with
FDA requirements applicable to those products at that time. Separately, when we become aware that accredited or licensed
clinical laboratories may be using our RUO products either for research or clinical uses, such as part of LDT services, in
accordance with the regulations that apply to clinical laboratories, we will continue to review the labeling and promotion of
our products for consistency with the RUO/IUO Guidance.

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When our products are marketed for clinical diagnostic use, our products will be regulated by the FDA as medical
devices. The FDA defines a medical device in part as an instrument, apparatus, implement, machine, contrivance, implant,
in vitro reagent, or other similar or related article which is intended for the diagnosis of disease or other conditions or in the
cure, mitigation, treatment, or prevention of disease in man. This means that the FDA will regulate the development,
testing, manufacturing, marketing, post-market surveillance, distribution, advertising and labeling of our clinical products
and we will be required to register as a medical device manufacturer and list our marketed products.

The FDA classifies medical devices into one of three classes on the basis of the intended use of the device, the

risk associated with the use of the device for that indication, as determined by the FDA, and on the controls deemed by the
FDA to be necessary to reasonably ensure their safety and effectiveness. Class I devices, which have the lowest level of
risk associated with them, are subject to general controls. Class II devices are subject to general controls and special
controls, including performance standards. Class III devices, which have the highest level of risk associated with them, are
subject to general controls and premarket approval. Most Class I devices and some Class II devices are exempt from a
requirement that the manufacturer submit a premarket notification (510(k)) and receive clearance from the FDA which is
otherwise a premarketing requirement for a Class II device. Class III devices may not be commercialized until a premarket
approval application (PMA) is submitted to and approved by the FDA.

510(k) Clearance Pathway

To obtain 510(k) clearance, a sponsor must submit to the FDA a premarket notification demonstrating that the
device is substantially equivalent (SE), to a device legally marketed in the U.S. for which a PMA was not required. The
FDA is supposed to make a SE determination within 90 days of FDA’s receipt of the 510(k), but it often takes longer if the
FDA requests additional information. Most 510(k)s do not require supporting data from clinical trials, but the FDA may
request such data. After a device receives 510(k) clearance, any modification that could significantly affect its safety or
effectiveness, or that would constitute a major change in its intended use, will require a new clearance or possibly a pre-
market approval.

De Novo Classification

Medical device types that the FDA has not previously classified as Class I, II or III are automatically classified

into Class III regardless of the level of risk they pose. The Food and Drug Administration Modernization Act of 1997
established a new route to market for low to moderate risk medical devices that are automatically placed into Class III due
to the absence of a predicate device, called the “Request for Evaluation of Automatic Class III Designation,” or the de novo
classification procedure.

This procedure allows a manufacturer whose novel device is automatically classified into Class III to request

down-classification of its medical device into Class I or Class II on the basis that the device presents low or moderate risk,
rather than requiring the submission and approval of a PMA application. Prior to the enactment of the Food and Drug
Administration Safety and Innovation Act of 2012 (FDASIA), a medical device could only be eligible for de novo
classification if the manufacturer first submitted a 510(k) premarket notification and received a determination from the
FDA that the device was not substantially equivalent. FDASIA streamlined the de novo classification pathway by
permitting manufacturers to request de novo classification directly without first submitting a 510(k) premarket notification
to the FDA and receiving a not substantially equivalent determination. Under FDASIA, the FDA is required to classify the
device within 120 days following receipt of the de novo application. If the manufacturer seeks reclassification into Class II,
the manufacturer must include a draft proposal for special controls that are necessary to provide a reasonable assurance of
the safety and effectiveness of the medical device. In addition, the FDA may reject the reclassification petition if it
identifies a legally marketed predicate device that would be appropriate for a 510(k) or determines that the device is not
low to moderate risk or that general controls would be inadequate to control the risks and special controls cannot be
developed.

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Premarket Approval Pathway

A PMA must be submitted if a new device cannot be cleared through the 510(k) process. The PMA process is

generally more complex, costly and time consuming than the 510(k) process. A PMA must be supported by extensive data
including, but not limited to, technical, preclinical, clinical trials, manufacturing and labeling to demonstrate to the FDA’s
satisfaction the safety and effectiveness of the device for its intended use. After a PMA is sufficiently complete, the FDA
will accept the application for filing and begin an in-depth review of the submitted information. By statute, the FDA has
180 days to review the accepted application, although review of the application generally can take between one and
three years. During this review period, the FDA may request additional information or clarification of information already
provided. Also, during the review period, an advisory panel of experts from outside the FDA may be convened to review
and evaluate the application and provide recommendations to the FDA as to the approvability of the device. Although the
FDA is not bound by the advisory panel decision, the panel’s recommendations are important to the FDA’s overall decision
making process. In addition, the FDA will conduct a preapproval inspection of the manufacturing facility to ensure
compliance with its quality system regulations (QSRs). New premarket approval applications or premarket approval
application supplements are also required for product modifications that affect the safety and efficacy of the device.

Emergency Use Authorization

In emergency situations, such as a pandemic, the FDA has the authority to allow unapproved medical products or
unapproved uses of cleared or approved medical products to be used in an emergency to diagnose, treat or prevent serious
or life-threatening diseases or conditions caused by chemical, biological, radiological or nuclear warfare threat agents
when there are no adequate, approved, and available alternatives.

Under this authority, the FDA may issue an EUA for an unapproved device if the following four statutory criteria

have been met: (1) a serious or life-threatening condition exists; (2) evidence of effectiveness of the device exists; (3) a
risk-benefit analysis shows that the benefits of the product outweigh the risks; and (4) no other alternatives exist for
diagnosing, preventing or treating the disease or condition. Evidence of effectiveness includes medical devices that “may
be effective” to prevent, diagnose, or treat the disease or condition identified in a declaration of emergency issued by the
Secretary of the Department of Health and Human Services (HHS). The “may be effective” standard for EUAs requires a
lower level of evidence than the “effectiveness” standard that FDA uses for product clearances or approvals in non-
emergency situations. The FDA assesses the potential effectiveness of a possible EUA product on a case-by-case basis
using a risk-benefit analysis. In determining whether the known and potential benefits of the product outweigh the known
and potential risks, the FDA examines the totality of the scientific evidence to make an overall risk-benefit determination.
Such evidence, which could arise from a variety of sources, may include (but is not limited to) results of domestic and
foreign clinical trials, in vivo efficacy data from animal models, in vitro data, as well as the quality and quantity of the
available evidence.

Once granted, an EUA will remain in effect and generally terminate on the earlier of (1) the determination by the

Secretary of HHS that the public health emergency has ceased or (2) a change in the approval status of the product such
that the authorized use(s) of the product are no longer unapproved. After the EUA is no longer valid, the product is no
longer considered to be legally marketed and one of the FDA’s non-emergency premarket pathways would be necessary to
resume or continue distribution of the subject product.

The FDA also may revise or revoke an EUA if the circumstances justifying its issuance no longer exist, the

criteria for its issuance are no longer met, or other circumstances make a revision or revocation appropriate to protect the
public health or safety. 

On January 31, 2020, the Secretary of HHS issued a declaration of a public health emergency related to COVID-

19. On February 4, 2020, HHS determined that COVID-19 represents a public health emergency that has a significant
potential to affect national security or the health and security of U.S. citizens living abroad and, subsequently, declared on
March 24, 2020, that circumstances exist to justify the authorization of emergency use of medical devices, including
alternative products used as medical devices, during the COVID-19 pandemic, subject to the terms of any authorization as
issued by the FDA. On February 29, 2020, the FDA issued an immediately in effect

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guidance with policy specific to development of IVD tests during the COVID-19 public health emergency. This guidance
was updated on March 16, 2020, May 4, 2020 and May 11, 2020.

Clinical Trials

Clinical trials are usually required to support a PMA and are sometimes required for a 510(k). In the U.S., if the

device is determined to present a “significant risk,” the manufacturer may not begin a clinical trial until it submits an
investigational device exemption application (IDE) and obtains approval of the IDE from the FDA. These clinical trials are
also subject to the review, approval and oversight of an institutional review board (IRB) at each clinical trial site. The
clinical trials must be conducted in accordance with the FDA’s IDE regulations and good clinical practices. A clinical trial
may be suspended by FDA, the sponsor or an IRB at its institution at any time for various reasons, including a belief that
the risks to the study participants outweigh the benefits of participation in the trial. Even if a clinical trial is completed, the
results may not demonstrate the safety and efficacy of a device to the satisfaction of the FDA, or may be equivocal or
otherwise not be sufficient to obtain approval of a device.

FDA Enforcement

After a medical device is placed on the market, numerous regulatory requirements apply. These include among

other things:

● establishment registration and device listing;

● the QSR, which requires manufacturers, including third-party manufacturers, to follow stringent design,

testing, control, documentation and other quality assurance procedures during all aspects of the
manufacturing process;

● labeling regulations and the FDA prohibitions against the promotion of products for uncleared, unapproved

or “off-label” uses and other requirements related to promotional activities;

● medical device reporting regulations, which require that manufacturers report to the FDA if their device may
have caused or contributed to a death or serious injury, or if their device malfunctioned and the device or a
similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious
injury if the malfunction were to recur;

● corrections and removal reporting regulations, which require that manufacture’s report to the FDA field

corrections or removals if undertaken to reduce a risk to health posed by a device or to remedy a violation of
the Federal Food, Drug, and Cosmetics Act that may present a risk to health; and

● post market surveillance regulations, which apply to certain Class II or III devices when necessary to protect

the public health or to provide additional safety and effectiveness data for the device.

To ensure compliance with regulatory requirements, medical device manufacturers are subject to market

surveillance and periodic, pre-scheduled and unannounced inspections by the FDA. Failure to comply with applicable
regulatory requirements can result in enforcement action by the FDA, which may include sanctions, including but not
limited to, warning letters; fines, injunctions, consent decrees and civil penalties; recall or seizure of the device; operating
restrictions, partial suspension or total shutdown of production; refusal to grant 510(k) clearance or PMA approvals of new
devices; withdrawal of 510(k) clearance or PMA approvals; and civil or criminal prosecution.

Clinical Laboratory Improvement Amendments of 1988, Regulation of LDTs and State Regulation

Since our acquisition of Aushon in January 2018, we own and operate a CLIA certified laboratory. The Clinical

Laboratory Improvement Amendments of 1988 (CLIA) are federal regulatory standards that apply to all clinical laboratory
testing performed on humans in the United States (with the exception of clinical trials and basic research). A

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clinical laboratory is defined by CLIA as any facility that performs laboratory testing on specimens obtained from humans
for the purpose of providing information for health assessment and for the diagnosis, prevention, or treatment of disease.
CLIA requires such laboratories to be certified by the federal government and mandates compliance with various
operational, personnel, facilities administration, quality and proficiency testing requirements intended to ensure that testing
services are accurate, reliable and timely. CLIA certification also is a prerequisite to be eligible to bill state and federal
health care programs, as well as many private insurers, for laboratory testing services.

In addition, CLIA requires certified laboratories to enroll in an approved proficiency testing program if
performing testing in any category for which proficiency testing is required. If a laboratory fails to achieve a passing score
on a proficiency test, then it loses its right to perform testing.

As a condition of CLIA certification, laboratories are subject to survey and inspection every other year, in addition

to being subject to additional random inspections. The biennial survey is conducted by the Centers for Medicare &
Medicaid Services (“CMS”), a CMS agent (typically a state agency), or, a CMS-approved accreditation organization.

High complexity, CLIA-certified laboratories, such as ours, frequently develop testing procedures to provide

diagnostic results to customers. These tests have been traditionally offered by nearly all complex laboratories for the last
few decades as LDTs, which are subject to CMS oversight through its enforcement of CLIA. The FDA also has claimed
that it has regulatory authority over LDTs, but has not exercised enforcement with respect to most LDTs offered by high
complexity laboratories, and not sought to require these laboratories to comply with FDA regulations regarding medical
devices. During 2010, the FDA publicly announced that it had decided to exercise regulatory authority over these LDTs,
and that it planned to issue guidance to the industry regarding its regulatory approach. At that time, the FDA indicated that
it would use a risk-based approach to regulation and would direct more resources to tests with wider distribution and with
the highest risk of injury, but that it would be sensitive to the need to not adversely impact patient care or innovation. In
September 2014, the FDA announced its framework and timetable for implementing this guidance. On November 18,
2016, the FDA announced it would not release final guidance at that time and instead would continue to work with
stakeholders, the new administration and Congress to determine the right approach. On January 3, 2017, the FDA released
a discussion paper outlining a possible risk-based approach for FDA and CMS oversight of LDTs. Later in 2017, the FDA
indicated that Congress should enact legislation to address improved oversight of diagnostics, including LTDs, rather than
the FDA addressing the issue through administrative proposals. We cannot predict the ultimate timing or form of any such
guidance or regulation or their potential impact. If adopted, such a regulatory approach by the FDA may lead to an
increased regulatory burden, including additional costs and delays in introducing new tests. While the ultimate impact of
the FDA’s approach is unknown, it may be extensive and may result in significant change.

In addition, some states require that any laboratory be licensed by the appropriate state agency in the state in

which it operates. Laboratories must also hold state licenses or permits, as applicable, from various states including, but not
limited to, California, Florida, New York, Pennsylvania, Rhode Island and Maryland, to the extent that they accept
specimens from one or more of these states, each of which requires out-of-state laboratories to obtain licensure.

If a laboratory is out of compliance with state laws or regulations governing licensed laboratories or with CLIA, it

may be subject to enforcement actions that may include suspension, limitation or revocation of the license or CLIA
certificate, assessment of financial penalties or fines, or imprisonment. Loss of a laboratory’s CLIA certificate or state
license may also result in the inability to receive payments from state and federal health care programs as well as private
third party payors.

If, in the future, we perform clinical diagnostic testing, we would also become subject to the Health Insurance

Portability and Accountability Act of 1996 (HIPAA), as well as additional federal and state laws that impose a variety of
fraud and abuse prohibitions on healthcare providers, including clinical laboratories.

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Europe/Rest of World Government Regulation

Whether or not we obtain FDA approval for a product, we must obtain the requisite approvals from regulatory

authorities in non-U.S. countries prior to the commencement of clinical trials or marketing of our product for clinical
diagnostic use in those countries. The regulations in other jurisdictions vary from those in the U.S. and may be easier or
more difficult to satisfy and are subject to change. For example, the European Union (the EU) recently published new
regulations that will result in greater regulation of medical devices and IVDs. This new IVD regulation (new IVD
Regulation) is significantly different from the European directive for In vitro diagnostic products (IVD Directive) that it
replaces in that it will ensure that the new requirements apply uniformly and on the same schedule across the member
states, include a risk-based classification system and increase the requirements for conformity assessment.

The CE registration for Uman’s Nf-L ELISA assay kit was approved in March 2014 under the IVD Directive.
Under the IVD Directive the assay is classified as a general IVD product, class I and required self-certification with no
involvement of a notified body/authority. Under the new IVD Regulation, which must be fully implemented by May 2022,
the requirements increase and involve assessment by a notified body. Uman’s Nf-L ELISA assay kit is classified as class B
product. The new requirements include an ISO 13485 certification of the quality system (which Uman received July 2018)
and increased technical evidence and follow-up of performance of the specific product (e.g. clinical evidence and post-
market activities). The work to meet the new technical requirements is on-going. An internal GAP-analysis is to be
performed and work to eliminate the GAPs performed. When completed, the available technical documentation will be
assessed by an external consultant. When all requirements are met, a notified body will be contracted and the certification
initiated.

Other Governmental Regulation

We are subject to laws and regulations related to the protection of the environment, the health and safety of
employees and the handling, transportation and disposal of medical specimens, infectious and hazardous waste and
radioactive materials. For example, the U.S. Occupational Safety and Health Administration (OSHA), has established
extensive requirements relating specifically to workplace safety for healthcare employers in the U.S. This includes
requirements to develop and implement multi-faceted programs to protect workers from exposure to blood-borne
pathogens, including preventing or minimizing any exposure through needle stick injuries. For purposes of transportation,
some biological materials and laboratory supplies are classified as hazardous materials and are subject to regulation by one
or more of the following agencies: the U.S. Department of Transportation, the U.S. Public Health Service, the United
States Postal Service and the International Air Transport Association. We generally use third-party vendors to dispose of
regulated medical waste, hazardous waste and radioactive materials that we may use during our research.

Employees and Human Capital

As of December 31, 2020, we had 314 full-time employees, of which 118 work in sales, sales support, field

service, and marketing, 74 work in engineering and research and development, 72 work in manufacturing and operations
and 50 work in general and administration. Of our 314 full-time employees, 273 were located in the United States and 41
were located in ten foreign countries. None of our employees are represented by a labor union or subject to a collective
bargaining agreement. Historically, we have experienced a turnover rate that is lower than the industry average and
attribute that to our unique culture that stresses the impact our work has on the eradication of human diseases including
Alzheimer’s, cancer and COVID. We invest in creating a diverse, inclusive and safe work environment where our
employees can deliver their workplace best every day.

Our success depends upon our ability to attract and retain highly qualified management and technical employees.

Talent management is critical to our ability to execute our long-term growth strategy, including providing career growth,
on-the-job learning opportunities and competitive compensation. We are committed to an inclusive culture which values
equality, opportunity and respect. In support of our inclusive culture, we sponsor an internal Diversity, Equity and Inclusion
Committee comprised of employees and executives, provide respectful workplace training to strengthen employee
understanding and consciously strive to recruit a diverse talent pool across all levels of the organization. As of December
31, 2020, approximately 45% of our employees were women and approximately 30%

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were non-white. We are focused on the engagement and empowerment of our employees through the demonstration of our
foundational values, which we refer to as AT&T3: Accountability, Trust, Teamwork and Transparency.

Workforce Compensation and Pay Equity

We provide robust compensation and benefits programs to help meet the needs of our employees. We provide our

full-time employees with highly competitive salaries, as well a bonus and/or commission plan, a matching 401(k) Plan,
healthcare and insurance benefits, paid time off and family leave. We also provide all of our employees with targeted
equity-based grants with vesting conditions designed to facilitate retention through the opportunity to benefit financially
from our growth and profitability.

Company Culture

We expect all of our employees and contractors to observe the highest levels of business ethics, integrity, mutual

respect, tolerance and inclusivity. Our employee handbook and Corporate Code of Conduct and Ethics set forth policies
reflecting these values and also provides direction for registering complaints in the event of any violation of our policies.
An “open door” policy is maintained at all levels of the organization and any form of retaliation against an employee is
strictly prohibited.

Employee Engagement and Wellness

The success of our business is fundamentally connected to the physical and mental well-being of our people.

Accordingly, we are committed to the health, safety and wellness of our employees and contractors. We provide our
employees with a wide range of benefits, including benefits directed to their health, safety and long-term financial security.
In response to the COVID-19 pandemic, we have implemented significant changes that we determined were in the best
interest of our employees, as well as the communities in which we operate, and which comply with government
regulations. This includes allowing our employees to work remotely as appropriate, while implementing significant safety
measures designed to protect the health of all those working in and entering our facilities.

Corporate Information

We were incorporated under the laws of the State of Delaware in April 2007 under the name “Digital
Genomics, Inc.” In August 2007, we changed our name to “Quanterix Corporation.” Our principal executive offices are
located at 900 Middlesex Turnpike, Billerica, Massachusetts 01821, and our telephone number is (617) 301-9400.

Information Available on the Internet

Our Internet website address is www.quanterix.com. The information contained on, or that can be accessed

through, our website is not a part of or incorporated by reference in this Annual Report on Form 10-K. We have included
our website address in this Annual Report on Form 10-K solely as an inactive textual reference. We make available free of
charge through our website our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on
Form 8-K and amendments to those reports filed or furnished pursuant to Sections 13(a) and 15(d) of the Securities
Exchange Act of 1934, as amended (Exchange Act). We make these reports available through the “Investors—Financial
Information—SEC Filings” section of our website as soon as reasonably practicable after we electronically file such
reports with, or furnish such reports to, the SEC. We also make available, free of charge on our website, the reports filed
with the SEC by our executive officers, directors and 10% stockholders pursuant to Section 16 under the Exchange Act as
soon as reasonably practicable after copies of those filings are provided to us by those persons. You can also review our
electronically filed reports and other information that we file with the SEC on the SEC’s website at http://www.sec.gov.

Item 1A. RISK FACTORS

The following risk factors and other information included in this Annual Report on Form 10-K should be carefully

considered. The risks and uncertainties described below are not the only ones we face. Additional risks and

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uncertainties not presently known to us or that we presently deem less significant may also impair our business operations.
Please see page ii of this Annual Report on Form 10-K for a discussion of some of the forward-looking statements that are
qualified by these risk factors. If any of the following risks occur, our business, financial condition, results of operations
and future growth prospects could be materially and adversely affected.

Risk Factor Summary

Our business is subject to numerous risks and uncertainties. The following summary highlights some of the risks
you should consider with respect to our business and prospects. This summary is not complete and the risks summarized
below are not the only risks we face. You should review and carefully consider the risks and uncertainties described in
more detail below, which includes a more complete discussion of these risks.

● We have incurred annual losses since we were formed and expect to incur losses in the future. We cannot

be certain that we will achieve or sustain profitability.

● Our quarterly and annual operating results and cash flows have fluctuated in the past and might continue

to fluctuate, causing the value of our common stock to decline substantially.

● We are an early, commercial-stage company and have a limited commercial history, which may make it

difficult to evaluate our current business and predict our future performance.

● If our products fail to achieve and sustain sufficient market acceptance, our revenue will be adversely

affected.

● Sales of our assay for the neurological biomarker Nf-L have become increasingly important to our

business, and any significant decrease in sales of that assay could have a material adverse effect on our
business.

● We are subject to extensive regulatory requirements in connection with the EUAs that we have received

from the FDA for our COVID-19 antibody and antigen tests. If we fail to comply with these
requirements, or if the FDA otherwise determines that the conditions no longer warrant such
authorization, we will be unable to market these products pursuant to this authorization and our business
may be harmed.

● The termination of an EUA, the failure of our tests to gain market acceptance or our inability to match

advances in competing products for COVID-19 could adversely impact our business.

● Epidemic diseases, such as COVID-19, could negatively affect various aspects of our business, make it

more difficult to meet our obligations to our customers, and result in reduced demand from our
customers, which could have a material adverse effect on our business, financial condition, results of
operations, or cash flows.

● Release of the remaining funding under the contract with the NIH under the RADx program is based on

the achievement of certain milestones, and there is no assurance that we can meet all of the milestones on
a timely basis, if at all.

● Our long-term results depend upon our ability to improve existing products and introduce and market new

products successfully.

● Undetected errors or defects in our products could harm our reputation, decrease market acceptance of

our products or expose us to product liability claims.

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● We may seek to enter into strategic collaborations and licensing arrangements with third parties, but we

may not be successful in establishing or maintaining such arrangements.

● We expect to generate a substantial portion of our revenue internationally in the future and can become
further subject to various risks relating to our international activities, which could adversely affect our
business, operating results and financial condition.

● We have limited experience in marketing and selling our products, and if we are unable to successfully

commercialize our products, our business and operating results will be adversely affected.

● We may experience manufacturing problems or delays, or backlogs in deliveries, that could limit the

growth of our revenue or increase our losses.

● We rely on a single contract manufacturer to manufacture and supply our Simoa HD instruments and rely
on a different single contract manufacturer to manufacture and supply our Simoa SR-X. If either of these
manufacturers should fail or not perform satisfactorily, our ability to supply these instruments would be
negatively and adversely affected.

● If the FDA determines that our products are medical devices or if we seek to market our products for
clinical diagnostic or health screening use, we will be required to obtain regulatory clearance(s) or
approval(s) and may be required to cease or limit sales of our then marketed products, which could
materially and adversely affect our business, financial condition and results of operations. Any such
regulatory process would be expensive, time-consuming and uncertain both in timing and in outcome.

● If we do not comply with governmental regulations applicable to our CLIA-certified laboratory, we may

not be able to continue our operations.

● If we are unable to protect our intellectual property, it may reduce our ability to maintain any

technological or competitive advantage over our competitors and potential competitors, and our business
may be harmed.

● The measures that we use to protect the security of our intellectual property and other proprietary rights

may not be adequate, which could result in the loss of legal protection for, and thereby diminish the value
of, such intellectual property and other rights.

● If we or any of our partners are sued for infringing intellectual property rights of third parties, it would be

costly and time-consuming, and an unfavorable outcome in that litigation could have a material adverse
effect on our business.

Risks Related to Our Financial Condition

We have incurred annual losses since we were formed and expect to incur losses in the future. We cannot be certain that
we will achieve or sustain profitability.

We incurred net losses of $31.5 million, $40.8 million and $31.5 million for the years ended December 31, 2020,

2019, and 2018, respectively. As of December 31, 2020, we had an accumulated deficit of $247.8 million. We cannot
predict if we will achieve sustained profitability in the near future or at all. We expect that our losses will continue at least
through the next 24 months as we plan to invest significant additional funds toward expansion of our commercial
organization and the development of our technology. In addition, as a public company, we incur significant legal,
accounting, and other expenses that we would not incur as a private company. These expenses make it harder for us to
achieve and sustain future profitability. We may incur significant losses in the future for a number of reasons, many of
which are beyond our control, including the other risks described in this Annual Report on Form 10-K, the market
acceptance of our products, future product development and our market penetration and margins.

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Our quarterly and annual operating results and cash flows have fluctuated in the past and might continue to fluctuate,
causing the value of our common stock to decline substantially.

Numerous factors, many of which are outside our control, may cause or contribute to significant fluctuations in
our quarterly and annual operating results. These fluctuations may make financial planning and forecasting difficult. In
addition, these fluctuations may result in unanticipated decreases in our available cash, which could negatively affect our
business and prospects. In addition, one or more of such factors may cause our revenue or operating expenses in one period
to be disproportionately higher or lower relative to the others. As a result, comparing our operating results on a period-to-
period basis might not be meaningful. You should not rely on our past results as indicative of our future performance.
Moreover, our stock price might be based on expectations of future performance that are unrealistic or that we might not
meet and, if our revenue or operating results fall below the expectations of investors or securities analysts, the price of our
common stock could decline substantially.

Our operating results have varied in the past. In addition to other risk factors listed in this section, some of the

important factors that may cause fluctuations in our quarterly and annual operating results include:

● adoption of our Simoa technology platforms and products by customers;

● the timing of customer orders to purchase our products and services;

● the rate of utilization of consumables by our customers;

● receipt and timing of revenue for services provided in our Simoa Accelerator Laboratory;

● the timing of the introduction of new products, product enhancements and services; and

● the receipt and timing of revenue from collaborations, if any.

In addition, a significant portion of our operating expenses is relatively fixed in nature, and planned expenditures
are based in part on expectations regarding future revenue. Accordingly, unexpected revenue shortfalls might decrease our
gross margins and could cause significant changes in our operating results from quarter to quarter. If this occurs, the trading
price of our common stock could fall substantially.

If we are unable to maintain adequate revenue growth or do not successfully manage such growth, our business and
growth prospects will be harmed.

We have experienced significant revenue growth in a short period of time. We may not achieve similar growth

rates in future periods. Investors should not rely on our operating results for any prior periods as an indication of our future
operating performance. To effectively manage our anticipated future growth, we must continue to maintain and enhance
our financial, accounting, manufacturing, customer support and sales administration systems, processes and controls.
Failure to effectively manage our anticipated growth could lead us to over-invest or under-invest in development,
operational, and administrative infrastructure; result in weaknesses in our infrastructure, systems, or controls; give rise to
operational mistakes, losses, loss of customers, productivity or business opportunities; and result in loss of employees and
reduced productivity of remaining employees.

Our continued growth could require significant capital expenditures and might divert financial resources from

other projects such as the development of new products and services. As additional products are commercialized, we may
need to incorporate new equipment, implement new technology systems, or hire new personnel with different
qualifications. Failure to manage this growth or transition could result in turnaround time delays, higher product costs,
declining product quality, deteriorating customer service, and slower responses to competitive challenges. A failure in any
one of these areas could make it difficult for us to meet market expectations for our products, and could damage our
reputation and the prospects for our business.

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If our management is unable to effectively manage our anticipated growth, our expenses may increase more than
expected, our revenue could decline or grow more slowly than expected and we may be unable to implement our business
strategy. In addition, the quality of our products and services may suffer, which could negatively affect our reputation and
harm our ability to retain and attract customers.

Our future capital needs are uncertain and we may need to raise additional funds in the future.

We believe that our existing cash and cash equivalents as of December 31, 2020, together with our cash generated
from commercial sales, will enable us to fund our operating expenses and capital expenditure requirements for at least the
next 24 months. However, we may need to raise substantial additional capital to:

● expand our sales and marketing efforts to further commercialize our products;

● strategically acquire companies or technologies that may be complementary to our business;

● expand our research and development efforts to improve our existing products and develop and launch new
products, particularly if any of our products are deemed by the FDA to be medical devices or otherwise
subject to additional regulation by the FDA;

● seek PMA or 510(k) clearance from the FDA for our existing products or new products if or when we decide
to market products for use in the prevention, diagnosis or treatment of a disease or other condition (see “Risk
Factors—If the FDA determines that our products are medical devices or if we seek to market our products
for clinical diagnostic or health screening use, we will be required to obtain regulatory clearance(s) or
approval(s) and may be required to cease or limit sales of our then marketed products, which could materially
and adversely affect our business, financial condition and results of operations. Any such regulatory process
would be expensive, time-consuming and uncertain both in timing and in outcome.” and “Business—
Government Regulation” for further information about the FDA approvals that we may be required to seek
and obtain in that circumstance);

● hire additional personnel and continue to expand our employee headcount;

● enter into collaboration arrangements, if any, or in-license other products and technologies;

● add operational, financial and management information systems; and

● continue to incur increased costs as a result of operating as a public company.

Our future funding requirements will depend on many factors, including:

● market acceptance of our products;

● the cost and timing of establishing additional sales, marketing and distribution capabilities;

● the cost of our research and development activities;

● our ability to enter into collaborations in the future, and the success of any such collaborations;

● the cost and timing of potential regulatory clearances or approvals that may be required in the future for our

products; and

● the effect of competing technological and market developments.

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We cannot assure you that we will be able to obtain additional funds on acceptable terms, or at all. If we raise

additional funds by issuing equity or equity-linked securities, our stockholders may experience dilution. Future debt
financing, if available, may involve covenants restricting our operations or our ability to incur additional debt. Any debt or
equity financing may contain terms that are not favorable to us or our stockholders. If we raise additional funds through
collaboration and licensing arrangements with third parties, it may be necessary to relinquish some rights to our
technologies or our products, or grant licenses on terms that are not favorable to us. If we do not have, or are not able to
obtain, sufficient funds, we may have to delay development or commercialization of our products. We also may have to
reduce marketing, customer support or other resources devoted to our products or cease operations. Any of these factors
could have a material adverse effect on our financial condition, operating results and business.

Our ability to use net operating losses to offset future income may be subject to certain limitations.

As of December 31, 2020, we had federal net operating loss (NOLs) carryforwards to offset future taxable income

of approximately $199.3 million, which begin to expire in 2021, if not utilized. A lack of future taxable income would
adversely affect our ability to utilize these NOLs. In addition, under Section 382 of the Internal Revenue Code of 1986, as
amended (the Code), a corporation that undergoes an “ownership change” is subject to limitations on its ability to utilize its
NOLs to offset future taxable income. We have already experienced ownership changes as defined under Section 382 of the
Code. Depending on the timing of any future utilization of our NOLs, we may be limited as to the amount that can be
utilized each year as a result of such previous ownership changes. In addition, future changes in our stock ownership,
including changes that may be outside of our control, could result in additional ownership changes under Section 382 of the
Code. Our NOLs may also be impaired under similar provisions of state law. We have recorded a full valuation allowance
related to our NOLs and other deferred tax assets due to the uncertainty of the ultimate realization of the future benefits of
those assets.

U.S. taxation of international business activities or the adoption of tax reform policies could materially impact our
future financial position and results of operations.

Limitations on the ability of taxpayers to claim and utilize foreign tax credits and the deferral of certain tax

deductions until earnings outside of the United States are repatriated to the United States, as well as changes to U.S. tax
laws that may be enacted in the future, could impact the tax treatment of future foreign earnings. Should the scale of our
international business activities expand, any changes in the U.S. taxation of such activities could increase our worldwide
effective tax rate and harm our future financial position and results of operations.

Risks Related to Our Business

If our products fail to achieve and sustain sufficient market acceptance, our revenue will be adversely affected.

Our success depends on our ability to develop and market products that are recognized and accepted as reliable,

enabling and cost-effective. Continued market acceptance of our Simoa technology platforms will depend on many factors,
including our ability to convince potential customers that our technology is an attractive alternative to other available
technologies. Historically, a significant part of our sales and marketing efforts has been directed at demonstrating the
advantages of our technology to industry leaders and encouraging such leaders to publish or present the results of their
evaluation of our system. If we are unable to continue to motivate leading researchers to use Simoa technology, or if such
researchers are unable to achieve or unwilling to publish or present significant experimental results using our systems,
acceptance and adoption of our systems may be slowed and our ability to increase our revenue would be adversely
affected.

Our future success is dependent upon our ability to further penetrate our existing customer base and attract new
customers.

Our current customer base is primarily composed of academic and governmental research institutions, as well as
biopharmaceutical and contract research companies. Our success will depend upon our ability to respond to the evolving
needs of, and increase our market share among, existing customers and adding new customers. Identifying,

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engaging and marketing to customers requires substantial time, expertise and expense and involves a number of risks,
including:

● our ability to attract, retain and manage the sales, marketing and service personnel necessary to expand

market acceptance for our Simoa technology platforms;

● the time and cost of maintaining and growing a specialized sales, marketing and service force; and

● our sales, marketing and service force may be unable to execute successful commercial activities.

We have utilized third parties to assist with sales, distribution and customer support in certain regions of the

world. There is no guarantee, when we enter into such arrangements, that we will be successful in attracting desirable sales
and distribution partners. There is also no guarantee that we will be able to enter into such arrangements on favorable
terms. Any failure of our sales and marketing efforts, or those of any third-party sales and distribution partners, would
adversely affect our business.

Sales of our assay for the neurological biomarker Nf-L have become increasingly important to our business, and any
significant decrease in sales of that assay could have a material adverse effect on our business.

Neurology has been one of our primary focus areas for commercialization of our Simoa technology and the

services that we provide to our customers. Sales from neurological-related biomarkers, Nf-L in particular, have become an
increasingly important part of our business. We estimate that revenue from services and sales of consumables relating to
Nf-L represented approximately 8% of our total revenue for the fiscal year ended December 31, 2020. There can be no
assurance that we will continue to derive meaningful revenues from the sale of our Nf-L assay, from services related to that
assay or from sales of instruments driven by customers desiring access to the Nf-L assay. The adoption by our customers of
competitive technologies for detecting biomarkers of neurodegenerative conditions, could negatively impact our revenues
and have a material adverse effect on our business.

WP2 with the NIH under the RADx program could expose us to unique risks and costs.

The NIH launched the RADx program to expedite development, commercialization, and implementation of

technologies for COVID-19 testing to help increase testing in the United States. On September 29, 2020, we entered into
WP2 with the NIH under the RADx program. The contract, which has a total award value of $18.2 million, will accelerate
the continued development, scale-up and deployment of our novel SARS-CoV-2 antigen test. Initial early feasibility of this
test was funded in part through WP1, in which we were granted approximately $2.0 million in June 2020. The contract
provides funding to expand assay kit manufacturing capacity and commercial deployment readiness. Release of the $18.2
million of funding under WP2 is based on the achievement of certain milestones, and there is no assurance that we can
meet all the milestones on a timely basis, if at all. If we do not meet all the milestones, we will not be able access the full
$18.2 million in funding under the contract.

In addition, other factors that could materially adversely affect our revenue stemming from WP2 include:

●
●

●
●
●
●
●
●

budgetary constraints affecting U.S. government spending generally, or the NIH in particular;
changes in U.S. government or the NIH fiscal policies or available funding, including due to
Congressional appropriations;
changes in U.S. government or the NIH programs, requirements or priorities;
adoption of new laws or regulations;
technological developments;
U.S. government shutdowns, threatened shutdowns or budget delays;
competition and consolidation in our industry; and
general economic conditions.

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These or other factors could cause the NIH to reduce its funding or future activities under WP2, which could have

a material adverse effect on the revenue generated by this contract.

WP2 also contains certain provisions from the Federal Acquisition Regulations (FAR), some of which are
customary or legally required, that give the U.S. government substantial rights and remedies, many of which are not
typically found in commercial contracts. For example, WP2 contains provisions permitting unilateral termination or
modification, in whole or in part, at the U.S. government’s convenience. In addition, WP2 contains additional requirements
that may increase our costs of doing business, reduce our profits, and expose us to liability for failure to comply with these
terms and conditions. These requirements include mandatory internal control systems and policies, mandatory
socioeconomic compliance requirements, environmental compliance requirements and intellectual property provisions. If
we fail to maintain compliance with these requirements, we may be subject to potential contract or False Claims Act
liability and to termination of the contract.

In addition, we may be required to enter into agreements with third parties, including suppliers, consultants and

other third-party contractors in order to satisfy our contractual obligations pursuant to this contract with the NIH.
Negotiating and entering into such arrangements can be time-consuming and we may not be able to reach agreement with
such third parties. Any such agreement must also be compliant with the terms of WP2. Any delay or inability to enter into
such arrangements or entering into such arrangements in a manner that is non-compliant with the terms of our contract,
may result in violations of our contract and/or delays in the release of funding.

Epidemic diseases, such as COVID-19, could negatively affect various aspects of our business, make it more difficult to
meet our obligations to our customers, and result in reduced demand from our customers, which could have a material
adverse effect on our business, financial condition, results of operations, or cash flows.

Our business could be adversely affected by the effects of a widespread outbreak of contagious disease, such as
COVID-19. Potential impacts to our business include disruptions or restrictions on our employees’ and customers’ ability
to travel, temporary closures of the facilities of our suppliers or customers, delays in installation of instruments, and delays
in shipments to and from affected countries. Any such travel restrictions and business closures could adversely impact our
operations  locally  and  worldwide,  including  our  ability  to  manufacture,  sell  or  distribute  our  products,  as  well  as  cause
temporary closures of our foreign distributors, or the facilities of suppliers or customers. Any material disruption of our
employees, distributors, suppliers or customers in impacted countries could impact our global sales and operating results.
In addition, a significant outbreak of contagious diseases in the human population could result in a widespread health crisis
that could adversely affect the economies and financial markets of many countries, resulting in an economic downturn that
could affect demand for our products and likely impact our operating results.

Some of the components used in our products are labeled for “research use only” and may have to undergo additional
testing before they could be used in a product intended for clinical use.

Some of the materials that are used in our consumable products, including certain reagents, are purchased from

suppliers with a restriction that they be used for RUO. While we have focused initially on the life sciences research market,
part of our future business strategy is to expand our product line, either alone or in collaboration with third parties, to
encompass systems and products that can be used for clinical purposes. Whether or not we continue to use the same RUO
materials that we currently use, or obtain similar materials that are not labeled with the RUO restriction, we or a
collaborator may be required to demonstrate that the use of our system and products as a clinical test complies with all
applicable requirements. In addition, if the supplier of any material or component used in a clinical test were changed, it
would require confirmation through additional testing that the change does not adversely affect the reliability of the test.
Any such additional testing may be expensive and time-consuming and delay the introduction of new products based on
our technology.

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The sales cycle for our Simoa instruments can be lengthy and variable, which makes it difficult for us to forecast
revenue and other operating results.

The sales process for our Simoa instruments generally involves numerous interactions with multiple individuals
within an organization, and often includes in-depth analysis by potential customers of our technology and products and a
lengthy review process. Our customers’ evaluation processes often involve a number of factors, many of which are beyond
our control. As a result of these factors, the capital investment required to purchase our systems, and the budget cycles of
our customers, the time from initial contact with a customer to our receipt of a purchase order can vary significantly. Given
the length and uncertainty of our sales cycle, we have in the past experienced, and expect to in the future experience,
fluctuations in our sales on a period-to-period basis. In addition, any failure to meet customer expectations could result in
customers choosing to retain their existing systems, use existing assays not requiring capital equipment or purchase
systems other than ours.

Our long-term results depend upon our ability to improve existing products and introduce and market new products
successfully.

Our business is dependent on the continued improvement of our existing Simoa products and our development of
new products utilizing our Simoa or other potential future technology. As we introduce new products or refine, improve or
upgrade versions of existing products, we cannot predict the level of market acceptance or the amount of market share
these products will achieve, if any. We cannot assure you that we will not experience material delays in the introduction of
new products in the future. In addition, introducing new products could result in a decrease in revenues from our existing
products. Consistent with our strategy of offering new products and product refinements, we expect to continue to use a
substantial amount of capital for product development and refinement. We may need more capital for product development
and refinement than is available on terms favorable to us, if at all, which could adversely affect our business, financial
condition or results of operations.

We generally sell our products in industries that are characterized by rapid technological changes, frequent new

product introductions and changing industry standards. If we do not develop new products and product enhancements
based on technological innovation on a timely basis, our products may become obsolete over time and our revenues, cash
flow, profitability and competitive position will suffer. Our success will depend on several factors, including our ability to:

● correctly identify customer needs and preferences and predict future needs and preferences;

● allocate our research and development funding to products with higher growth prospects;

● anticipate and respond to our competitors’ development of new products and technological innovations;

● innovate and develop new technologies and applications, and acquire or obtain rights to third-party

technologies that may have valuable applications in the markets we serve;

● successfully commercialize new technologies in a timely manner, price them competitively and manufacture

and deliver sufficient volumes of new products of appropriate quality on time; and

● convince customers to adopt new technologies.

In addition, if we fail to accurately predict future customer needs and preferences or fail to produce viable
technologies, we may invest heavily in research and development of products that do not lead to significant revenue. Even
if we successfully innovate and develop new products and product enhancements, we may incur substantial costs in doing
so, and our profitability may suffer.

Our ability to develop new products based on innovation can affect our competitive position and often requires the

investment of significant resources. Difficulties or delays in research, development or production of new products

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and services or failure to gain market acceptance of new products and technologies may reduce future revenues and
adversely affect our competitive position.

If we do not successfully develop and introduce new assays for our technology, we may not generate new sources of
revenue and may not be able to successfully implement our growth strategy.

Our business strategy includes the development of new assays for our Simoa instruments. New assays require
significant research and development and a commitment of significant resources prior to their commercialization. Our
technology is complex, and we cannot be sure that any assays we may intend to develop will be developed successfully, be
proven to be effective, offer improvements over currently available tests, meet applicable standards, be produced in
commercial quantities at acceptable costs or be successfully marketed. Moreover, development of particular assays may
require licenses or access to third-party intellectual property which may not be available on commercially reasonable
terms, or at all. In addition, we believe that our future success will depend, in part, on our ability to develop and
commercialize multiplex assays that can simultaneously measure multiple biomarkers, particularly for oncology
indications. While we have developed, validated and commercialize a 10-plex assay for the SP-X using our Simoa planar
array technology, the most robust multiplex assay that we have commercially launched to date using our Simoa bead-based
technology is a 6-plex assay. If we do not successfully develop new assays for our Simoa instruments, including multiplex
assays with the ability to detect an increased number of biomarkers in a single sample, we could lose revenue opportunities
with existing or future customers.

If we do not successfully manage the development and launch of new products, our financial results could be adversely
affected.

We face risks associated with launching new products. If we encounter development or manufacturing challenges

or discover errors during our product development cycle, the product launch dates of new products may be delayed. The
expenses or losses associated with unsuccessful product development or launch activities or lack of market acceptance of
our new products could adversely affect our business or financial condition.

Undetected errors or defects in our products could harm our reputation, decrease market acceptance of our products or
expose us to product liability claims.

Our Simoa products may contain undetected errors or defects when first introduced or as new versions or new

products are released. Disruptions affecting the introduction or release of, or other performance problems with, our
products may damage our customers’ businesses and could harm their and our reputation. If that occurs, we may incur
significant costs, the attention of our key personnel could be diverted, or other significant customer relations problems may
arise. We may also be subject to warranty and liability claims for damages related to errors or defects in our products. In
addition, if we do not meet industry or quality standards, if applicable, our products may be subject to recall. A material
liability claim, recall or other occurrence that harms our reputation or decreases market acceptance of our products could
harm our business and operating results.

Although we do not, and cannot currently, promote the use of our products, or services based on our products, for

diagnostic purposes, if our customers develop or use them for diagnostic purposes, someone could file a product liability
claim alleging that one of our products contained a design or manufacturing defect that resulted in the failure to adequately
perform, leading to death or injury. A product liability claim could result in substantial damages and be costly and time-
consuming to defend, either of which could materially harm our business or financial condition. We cannot assure you that
our product liability insurance would adequately protect our assets from the financial impact of defending a product
liability claim. Any product liability claim brought against us, with or without merit, could increase our product liability
insurance rates or prevent us from securing insurance coverage in the future.

We may seek to enter into additional strategic collaborations and licensing arrangements with third parties, but we may
not be successful in establishing or maintaining such arrangements.

We may seek to enter into additional strategic collaborations and licensing agreements with third parties to

develop products based on our Simoa technology, such as for certain IVD purposes. However, there is no assurance that

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we will be successful in doing so. Establishing collaborations and licensing arrangements is difficult and time-consuming,
and discussions may not lead to collaborations or licenses on favorable terms, if at all. Even if we establish such
relationships, such as our license agreement with Abbott, if our partners do not prioritize and commit sufficient resources
to develop and sell products based on our Simoa technology, they may never result in the successful development or
commercialization of products based on our Simoa technology.

Our reliance on distributors for sales of our products outside of the United States could limit or prevent us from selling
our products and could impact our revenue.

We have established exclusive distribution agreements for our Simoa instruments and related consumable
products within certain foreign countries, including Australia, Brazil, China, Czech Republic, India, Israel, Japan, Lebanon,
Mexico, Qatar, Saudi Arabia, Singapore, South Korea and Taiwan. We intend to continue to grow our business
internationally, and to do so we must attract additional distributors and retain existing distributors to maximize the
commercial opportunity for our products. There is no guarantee that we will be successful in attracting or retaining
desirable sales and distribution partners or that we will be able to enter into such arrangements on favorable terms.
Distributors may not commit the necessary resources to market and sell our products to the level of our expectations or
may choose to favor marketing the products of our competitors. If current or future distributors do not perform adequately,
or we are unable to enter into effective arrangements with distributors in particular geographic areas, we may not realize
long-term international revenue growth. In addition, if our distributors fail to comply with applicable laws and ethical
standards, including anti-bribery laws, this could damage our reputation and could have a significant adverse effect on our
business and our revenues.

We expect to generate a substantial portion of our revenue internationally in the future and can become further subject
to various risks relating to our international activities, which could adversely affect our business, operating results and
financial condition.

For the years ended December 31, 2020, 2019, and 2018, approximately 48%, 50% and 43%, respectively, of our
product revenue was generated from customers located outside of North America. We believe that a substantial percentage
of our future revenue will come from international sources as we expand our overseas operations and develop opportunities
in additional areas. We have limited experience operating internationally and engaging in international business involves a
number of difficulties and risks, including:

● required compliance with existing and changing U.S. or foreign regulatory requirements and laws;

● difficulties and costs of staffing and managing foreign operations;

● a shortage of high-quality salespeople and distributors;

● pricing pressure that we may experience internationally;

● difficulties in maintaining consistency with our internal guidelines;

● difficulties in enforcing our intellectual property rights and in defending against third-party threats and

intellectual property enforcement actions against us or any of our distributors, suppliers or collaborators;

● reduced or varied protection for intellectual property rights in some countries;

● required compliance with anti-bribery laws, such as the U.S. Foreign Corrupt Practices Act, data privacy

requirements, such as the General Data Protection Regulation (the GDPR), labor laws and anti-competition
regulations;

● export or import restrictions;

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● laws and business practices favoring local companies;

● longer payment cycles and difficulties in enforcing agreements and collecting receivables through certain

foreign legal systems;

● the imposition of restrictions on the activities of foreign agents, representatives and distributors;

● foreign currency exchange rate fluctuations;

● the imposition of U.S. or international sanctions against a country, company, person or entity with whom we
do business that would restrict or prohibit continued business with the sanctioned country, company, person
or entity; and

● political and economic instability;

● scrutiny of foreign tax authorities which could result in significant fines, penalties and additional taxes being

imposed on us;

● the imposition of new trade restrictions; and

● potentially adverse tax consequences, tariffs, customs charges, bureaucratic requirements and other trade

barriers.

Historically, most of our revenue has been denominated in U.S. dollars. In the future, we may sell our products

and services in local currency outside of the United States. As our operations in countries outside of the United States
grow, our results of operations and cash flows may be subject to fluctuations due to changes in foreign currency exchange
rates, which could harm our business in the future. For example, if the value of the U.S. dollar increases relative to foreign
currencies, in the absence of a corresponding change in local currency prices, our revenue could be adversely affected as
we convert revenue from local currencies to U.S. dollars. If we dedicate significant resources to our international
operations and are unable to manage these risks effectively, our business, operating results and financial condition will
suffer.

We could be adversely affected by violations of the U.S. Foreign Corrupt Practices Act and other worldwide anti-bribery
laws by us or our agents.

We are subject to the U.S. Foreign Corrupt Practices Act (the FCPA), which prohibits companies and their
intermediaries from making payments in violation of law to non-U.S. government officials for the purpose of obtaining or
retaining business or securing any other improper advantage. Our reliance on independent distributors to sell our products
internationally demands a high degree of vigilance in maintaining our policy against participation in corrupt activity,
because these distributors could be deemed to be our agents, and we could be held responsible for their actions. Other U.S.
companies in the medical device and pharmaceutical fields have faced criminal penalties under the FCPA for allowing their
agents to deviate from appropriate practices in doing business with these individuals. We are also subject to similar
antibribery laws in the jurisdictions in which we operate, including the United Kingdom’s Bribery Act of 2010, which also
prohibits commercial bribery and makes it a crime for companies to fail to prevent bribery. We have limited experience in
complying with these laws and in developing procedures to monitor compliance with these laws by our agents. These laws
are complex and far-reaching in nature, and, as a result, we cannot assure you that we would not be required in the future to
alter one or more of our practices to be in compliance with these laws or any changes in these laws or the interpretation
thereof. Any violations of these laws, or allegations of such violations, could disrupt our operations, involve significant
management distraction, involve significant costs and expenses, including legal fees, and could result in a material adverse
effect on our business, prospects, financial condition, or results of operations. We could also incur severe penalties,
including criminal and civil penalties, disgorgement, and other remedial measures.

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If we are unable to attract, recruit, train, retain, motivate and integrate key personnel, we may not achieve our goals.

Our future success depends on our ability to attract, recruit, train, retain, motivate and integrate key personnel,
including our recently expanded senior management team, as well as our research and development, manufacturing and
sales and marketing personnel. Competition for qualified personnel is intense. Our growth depends, in particular, on
attracting and retaining highly-trained sales personnel with the necessary scientific background and ability to understand
our systems at a technical level to effectively identify and sell to potential new customers. Because of the complex and
technical nature of our products and the dynamic market in which we compete, any failure to attract, recruit, train, retain,
motivate and integrate qualified personnel could materially harm our operating results and growth prospects.

We have limited experience in marketing and selling our products, and if we are unable to successfully commercialize
our products, our business and operating results will be adversely affected.

We have limited experience marketing and selling our products. We currently sell all our products for research use

only, through our direct field sales and support organizations located in North America and Europe and through a
combination of our own sales force and third-party distributors in additional major foreign markets. The future sales of our
products will depend in large part on our ability to effectively market and sell our products, successfully manage and
expand our sales force, and increase the scope of our marketing efforts. We may also enter into additional distribution
arrangements in the future. Because we have limited experience in marketing and selling our products, our ability to
forecast demand, the infrastructure required to support such demand and the sales cycle to customers is unproven. If we do
not build an efficient and effective sales force, our business and operating results will be adversely affected.

We rely on a single contract manufacturer to manufacture and supply our Simoa HD-X instrument and rely on a
different single contract manufacturer to manufacture and supply our Simoa SR-X instrument. If either of these
manufacturers should fail or not perform satisfactorily, our ability to supply these instruments would be negatively and
adversely affected.

We currently rely on a single contract manufacturer, STRATEC, an analytical and diagnostic systems

manufacturer located in Germany, to manufacture and supply all of our Simoa HD-X instruments. In addition, we currently
rely on a single contract manufacturer, Paramit, a contract manufacturer located in California, to manufacture and supply
all of our SR-X instruments. Since our contract with STRATEC does not commit them to supply quantities beyond the
amounts included in our forecasts and our contract with Paramit does not commit them to carry inventory or make
available any particular quantities, these contract manufacturers may give other customers’ needs higher priority than ours,
and we may not be able to obtain adequate supplies in a timely manner or on commercially reasonable terms. If either of
these manufacturers were not able to supply instruments, our business would be harmed.

In the event it becomes necessary to utilize a different contract manufacturer for the HD-X instrument or the SR-
X, we would experience additional costs, delays and difficulties in doing so as a result of identifying and entering into an
agreement with a new supplier as well as preparing such new supplier to meet the logistical requirements associated with
manufacturing our units, and our business would suffer. We may also experience additional costs and delays in the event
we need access to or rights under any intellectual property of STRATEC.

In addition, certain of the components used in our instruments are sourced from limited or sole suppliers. If we

were to lose such suppliers, there can be no assurance that we will be able to identify or enter into agreements with
alternative suppliers on a timely basis on acceptable terms, if at all. An interruption in our ability to sell and deliver
instruments to customers could occur if we encounter delays or difficulties in securing these components, or if the quality
of the components supplied do not meet specifications, or if we cannot then obtain an acceptable substitute. If any of these
events occur, our business and operating results could be harmed.

We may experience manufacturing problems or delays, or backlogs in deliveries, that could limit the growth of our
revenue or increase our losses.

We may encounter unforeseen situations that would result in delays or shortfalls in our production, backlogs in
deliveries, or delays or shortfalls caused by our outsourced manufacturing suppliers, by other third-party suppliers who

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manufacture components for our products or because of a significant unforecasted increase in demand for our products. If
we are unable to keep up with demand for our products, our revenue could be impaired, market acceptance for our products
could be adversely affected and our customers might instead purchase our competitors’ products. Our inability to
successfully manufacture our products would have a material adverse effect on our operating results.

We rely on a limited number of suppliers or, in some cases, one supplier, for some of our materials and components
used in our consumable products and our SP-X instrument, and may not be able to find replacements or immediately
transition to alternative suppliers, which could have a material adverse effect on our business, financial condition,
results of operations and reputation.

We rely on limited or sole suppliers for certain reagents and other materials and components that are used in our
consumable products and in our SP-X instrument. While we periodically forecast our needs for such materials and enter
into standard purchase orders with them, we do not have long-term contracts with many of these suppliers. If we were to
lose such suppliers, there can be no assurance that we will be able to identify or enter into agreements with alternative
suppliers on a timely basis on acceptable terms, if at all. An interruption in our operations could occur if we encounter
delays or difficulties in securing these materials, or if the quality of the materials supplied do not meet our requirements, or
if we cannot then obtain an acceptable substitute. The time and effort required to qualify a new supplier and ensure that the
new materials provide the same or better quality results could result in significant additional costs. Any such interruption
could significantly affect our business, financial condition, results of operations and reputation.

If we cannot provide quality technical and applications support, we could lose customers and our business and
prospects will suffer.

The placement of our products at new customer sites, the introduction of our technology into our customers’

existing laboratory workflows and ongoing customer support can be complex. Accordingly, we need highly trained
technical support personnel. Hiring technical support personnel is very competitive in our industry due to the limited
number of people available with the necessary scientific and technical backgrounds and ability to understand our Simoa
technology at a technical level. To effectively support potential new customers and the expanding needs of current
customers, we will need to substantially expand our technical support staff. If we are unable to attract, train or retain the
number of highly qualified technical services personnel that our business needs, our business and prospects will suffer.

The life sciences research and diagnostic markets are highly competitive. If we fail to effectively compete, our business,
financial condition and operating results will suffer.

We face significant competition in the life sciences research and diagnostic markets. We currently compete with

both established and early stage companies that design, manufacture and market systems and consumable supplies. We
believe our principal competitors in the life sciences research and diagnostic markets include Bio-Techne, Luminex
Corporation, MesoScale Diagnostics, Singulex, Gyros Corporation and Nanostring Technologies, Inc. As we expand the
applications for our products to include health screening, we expect to compete with companies such as Siemens, Abbott,
Roche, Ortho Clinical Diagnostics and Thermo Fisher Scientific. In addition, there are a number of new market entrants in
the process of developing novel technologies for the life sciences research, diagnostic and screening markets.

Many of our current competitors have competitive advantages over us, including:

● greater name and brand recognition;

● substantially greater financial and human resources;

● broader product lines;

● larger sales forces and more established distributor networks;

● substantial intellectual property portfolios;

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● larger and more established customer bases and relationships; and

● better established, larger scale, and lower cost manufacturing capabilities.

We believe that the principal competitive factors in all of our target markets include:

● accuracy, including sensitivity and specificity, and reproducibility of results;

● cost of instruments and consumables;

● reputation among customers;

● innovation in product offerings;

● flexibility and ease of use; and

● compatibility with existing laboratory processes, tools and methods.

We cannot assure you that our products will compete favorably or that we will be successful in the face of

increasing competition from new products and technologies introduced by our existing competitors or new companies
entering our markets. In addition, we cannot assure you that our competitors do not have or will not develop products or
technologies that currently or in the future will enable them to produce competitive products with greater capabilities or at
lower costs than ours. Any failure to compete effectively could materially and adversely affect our business, financial
condition and operating results.

Integrating any business, product or technology we acquire can be expensive and time-consuming and can disrupt and
adversely affect our ongoing business, including product sales, and distract our management.

We may acquire other businesses, products or technologies as well as pursue strategic alliances, joint ventures,
technology licenses or investments in complementary businesses, such as our 2018 acquisition of Aushon and our 2019
acquisition of Uman. Our ability to successfully integrate any business, product or technology we acquire depends on a
number of factors, including, but not limited to, our ability to:

● minimize the disruption and distraction of our management and other employees, including our sales force,

in connection with the integration of any acquired business, product or technology;

● minimize disruption in relationships with customers, distributors or suppliers as a result of such a transaction;

● avoid acquisition of unanticipated liabilities related to acquired companies;

● maintain and increase sales of our existing products;

● establish or manage the transition of the manufacture and supply of any acquired product;

● identify and add the necessary sales, marketing, manufacturing, regulatory and other related personnel,

capabilities and infrastructure that are required to successfully integrate any acquired business, product or
technology;

● manage the transition and migration of acquired personnel and all commercial, financial, legal, regulatory

and other pertinent information relating to any acquired business, product or technology;

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● comply with legal, regulatory and contractual requirements applicable to any acquired business, product or

technology; and

● maintain and extend intellectual property protection for any acquired product or technology.

If we are unable to perform the above functions or otherwise effectively integrate any acquired businesses,

products or technologies, our business, financial condition and operating results will suffer.

Foreign acquisitions (such as our acquisition of Uman) involve unique risks in addition to those mentioned above,
including those related to integration of operations across different cultures and languages, currency risks and the particular
economic, political and regulatory risks associated with specific countries.

Also, the anticipated benefit of any acquisition may not materialize. Future acquisitions or dispositions could

result in potentially dilutive issuances of our equity securities, the incurrence of debt, contingent liabilities or amortization
expenses or write-offs of goodwill, any of which could harm our financial condition. We cannot predict the number, timing
or size of future joint ventures or acquisitions, or the effect that any such transactions might have on our operating results.

Risks Related to Government Regulation and Diagnostic Product Reimbursement

If the FDA determines that our products are medical devices or if we seek to market our products for clinical diagnostic
or health screening use, we will be required to obtain regulatory clearance(s) or approval(s) and may be required to
cease or limit sales of our then marketed products, which could materially and adversely affect our business, financial
condition and results of operations. Any such regulatory process would be expensive, time-consuming and uncertain
both in timing and in outcome.

We have focused initially on the life sciences research market. This includes offering products for use by

laboratories associated with academic and governmental research institutions, as well as pharmaceutical, biotechnology
and contract research companies. Accordingly, other than our COVID assays for which we have received EUAs, our
products are labeled as “Research Use Only” and are not intended for diagnostic uses. While we have focused initially on
the life sciences research market and RUO products only, our future strategy includes expanding our product line to
encompass products that are intended to be used for the diagnosis of disease, either alone or in collaboration with third
parties. Such IVD products, once developed and offered, will be subject to regulation by the FDA, or comparable
international agencies, as medical devices including requirements for regulatory clearance or approval of such products
before they can be marketed.

The process of obtaining regulatory clearances to market a medical device can be costly and time consuming, and

we or our collaborators may not be able to obtain these clearances or approvals on a timely basis, if at all. In general, the
FDA permits commercial distribution of a new medical device only after the device has received clearance under
Section 510(k) of the Federal Food, Drug and Cosmetic Act, or is the subject of an approved PMA, unless the device is
specifically exempt from those requirements. The FDA will clear marketing of a lower risk medical device through the
510(k) process if the manufacturer demonstrates that the new product is substantially equivalent to other pre-amendment,
510(k)-exempt, 510(k) cleared products, or PMA-approved products that have subsequently been down-classified. If the
FDA determines that the device is not “substantially equivalent” to a predicate device, or if the device is automatically
classified into Class III, the device sponsor must then fulfill the much more rigorous premarketing requirements of the
PMA approval process, or seek reclassification of the device through the de novo process. Pursuant to amendments to the
statute in 2012, a manufacturer can also submit a petition for a direct de novo review if the manufacturer is unable to
identify an appropriate predicate device and the new device or new use of the device presents a moderate or low risk.

High risk devices deemed to pose the greatest risk, such as life-sustaining, life-supporting, or implantable devices,

or devices not deemed substantially equivalent to a previously cleared device, require the approval of a PMA. The PMA
process is more costly, lengthy and uncertain than the 510(k) clearance process. A PMA application must be

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supported by extensive data, including, but not limited to, technical, preclinical, clinical trial, manufacturing and labeling
data, to demonstrate to the FDA’s satisfaction the safety and efficacy of the device for its intended use.

Foreign governmental authorities that regulate the manufacture and sale of medical devices have become
increasingly stringent and, to the extent we market and sell our products internationally for such uses, we may be subject to
rigorous international regulation in the future. In these circumstances, we may rely significantly on our foreign independent
distributors or collaborators to comply with the varying regulations, and any failures on their part could result in
restrictions on the sale of our products in foreign countries.

If we or our collaborators are required to obtain a PMA or 510(k) clearance for products based on our technology,

we or they would be subject to a substantial number of additional requirements for medical devices, including
establishment registration, device listing, Quality Systems Regulations (QSRs), which cover the design, testing,
production, control, quality assurance, labeling, packaging, servicing, sterilization (if required), and storage and shipping of
medical devices (among other activities), product labeling, advertising, recordkeeping, post-market surveillance, post-
approval studies, adverse event reporting, and correction and removal (recall) regulations. One or more of the products we
or a collaborator may develop using our technology may also require clinical trials in order to generate the data required for
a PMA. Complying with these requirements may be time-consuming and expensive. We or our collaborators may be
required to expend significant resources to ensure ongoing compliance with the FDA regulations and/or take satisfactory
corrective action in response to enforcement action, which may have a material adverse effect on the ability to design,
develop, and commercialize products using our technology as planned. Failure to comply with these requirements may
subject us or a collaborator to a range of enforcement actions, such as warning letters, injunctions, civil monetary penalties,
criminal prosecution, recall and/or seizure of products, and revocation of marketing authorization, as well as significant
adverse publicity. If we or our collaborators fail to obtain, or experience significant delays in obtaining, regulatory
approvals for IVD products, such products may not be able to be launched or successfully commercialized in a timely
manner, or at all.

LDTs are a subset of IVD tests that are designed, manufactured and offered as services by high complexity
clinical laboratories and used within a single laboratory. The FDA maintains that LDTs are medical devices and has for the
most part exercised enforcement discretion for most LDTs. A significant change in the way that the FDA regulates any
LDTs that we, our collaborators or our customers develop using our technology could affect our business. The FDA has
considered the appropriate way to regulate such tests, but after publishing several draft guidances and holding a number of
public hearings and workshops, no final guidance has been issued. However, if the FDA requires laboratories to undergo
premarket review and comply with other applicable FDA requirements in the future, the cost and time required to
commercialize an LDT will increase substantially, and may reduce the financial incentive for laboratories to develop LDTs,
which could reduce demand for our instruments and our other products.

Foreign jurisdictions have laws and regulations similar to those described above, which may adversely affect our

ability to market our products as planned in such countries. The number and scope of these requirements are increasing. As
in the United States, the cost and time required to comply with regulatory requirements may be substantial, and there is no
guarantee that we will obtain the necessary authorization(s) required to make our products commercially viable. As a
result, the imposition of foreign requirements may also have a material adverse effect on the commercial viability of our
operations.

We are subject to extensive regulatory requirements in connection with the EUAs that we have received from the FDA
for our COVID-19 antibody and antigen tests. If we fail to comply with these requirements, or if the FDA otherwise
determines that the conditions no longer warrant such authorization, we will be unable to market these products
pursuant to this authorization and our business may be harmed.

We have received EUAs from the FDA authorizing us to market our Simoa Semi-Quantitative SARS-CoV-2 IgG
Antibody Test and our Simoa SARS-CoV-2 N Protein Antigen Test, each of which is run on our HD-X instrument. These
EUAs allow us to market and sell these products without the need to obtain premarket clearance or approval under the
FDA’s standard review pathways for the duration of the COVID-19 public health emergency. The FDA has also established
certain conditions which must be met in order to maintain authorization under these EUAs. The requirements can be
unclear and are subject to change.

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The FDA has the authority to issue an EUA during a public health emergency if it determines, based on the

totality of the scientific evidence, that it is reasonable to believe that the product may be effective, that the known and
potential benefits of a product outweigh the known and potential risks, that there is no adequate, approved and available
alternative, and if certain other regulatory criteria are met. These standards for marketing authorization are lower than if the
FDA had reviewed these tests under its traditional marketing authorization pathways, and we cannot assure you that our
tests would be cleared or approved under those more extensive clearance and approval standards. Moreover, the FDA’s
policies regarding EUAs can change unexpectedly, and the FDA may revoke an EUA when it determines that the
underlying health emergency no longer exists or warrants such authorization or if problems are identified with the
authorized product. We cannot predict how long our authorizations will remain in place. FDA policies regarding diagnostic
tests, therapies and other products used to diagnose, treat or mitigate COVID-19 remain in flux as the FDA responds to
new and evolving public health information and clinical evidence. Changes to FDA regulations or requirements could
require changes to our authorized tests, necessitate additional measures or make it impractical or impossible for us to
market our tests at all.

In addition, even though we have received these EUAs, these tests may not gain broad market acceptance among

customers, including physicians, healthcare payors, users and others in the medical community. The commercial success of
our COVID-19 tests will initially be dependent upon physicians and healthcare providers adopting our test kits, which will
be informed, in part, by the convenience and accuracy of our tests. Furthermore, the COVID-19 diagnostic testing market
is susceptible to rapid technological developments and we may not be able to match new technological advances, which
might render our COVID-19 test kits uncompetitive or obsolete. If we are unable to match technological improvements in
competitive products or effectively respond to the needs of our customers and users, the demand for our COVID-19 test
kits could be reduced.

The termination of the emergency conditions under which EUAs are permitted, the rescission of an EUA, the
failure of our tests to gain market acceptance or our inability to match advances in competing products could adversely
impact our business.

Our products may in the future be subject to product recalls that could harm our reputation, business and financial
results.

The FDA and similar foreign governmental authorities have the authority to require the recall of commercialized
products, including RUO products, in the event of material deficiencies or defects in design or manufacture. In the case of
the FDA, the authority to require a recall must be based on an FDA finding that there is a reasonable probability that the
device would cause serious injury or death. Manufacturers may, under their own initiative, recall a product if any material
deficiency in a device is found. A government-mandated or voluntary recall by us or one of our distributors could occur as
a result of component failures, manufacturing errors, design or labeling defects or other deficiencies and issues. Recalls of
any of our products would divert managerial and financial resources and have an adverse effect on our financial condition
and results of operations. The FDA requires that certain classifications of recalls be reported to FDA within 10
working days after the recall is initiated. Companies are required to maintain certain records of recalls, even if they are not
reportable to the FDA. We may initiate voluntary recalls involving our products in the future that we determine do not
require notification of the FDA. If the FDA disagrees with our determinations, they could require us to report those actions
as recalls. A future recall announcement could harm our reputation with customers and negatively affect our sales. In
addition, the FDA could take enforcement action for failing to report the recalls when they were conducted.

U.S. legislative, FDA or global regulatory reforms may make it more difficult and costly for us to obtain any required
regulatory approval of our product candidates and to manufacture, market and distribute our products after approval is
obtained.

From time to time, legislation is drafted and introduced in Congress that could significantly change the statutory

provisions governing the regulatory approval, manufacture and marketing of regulated products or the reimbursement
thereof. Any new regulations or revisions or reinterpretations of existing regulations may impose additional costs or
lengthen review times of future products. In addition, FDA regulations and guidance are often revised or reinterpreted by

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the agency in ways that may significantly affect our business and our products. It is impossible to predict whether
legislative changes will be enacted or FDA regulations, guidance or interpretations changed, and what the impact of such
changes, if any, may be.

Moreover, leadership, personnel and structural changes within the FDA as well as recent and future federal

election outcomes could result in significant legislative and regulatory reforms impacting the FDA’s regulation of our
products. Any change in the laws or regulations that govern the clearance and approval processes relating to our current
and future products could make it more difficult and costly to obtain clearance or approval for new products, or to produce,
market and distribute existing products. Significant delays in receiving clearance or approval, or the failure to receive
clearance or approval for our new products would have an adverse effect on our ability to expand our business.

In addition, on May 25, 2017, the Medical Devices Regulation (2017/745 or “MDR”) entered into force.

Following its entry into application on May 26, 2020, the MDR introduced substantial changes to the obligations with
which medical device manufacturers must comply in the EU. High risk medical devices will be subject to additional
scrutiny during the conformity assessment procedure. Specifically, the EU Medical Devices Regulation repeals and
replaces the EU Medical Devices Directive. Unlike directives, which must be implemented into the national laws of the
European Economic Area (EEA) Member States, the regulations are directly applicable, i.e., without the need for adoption
of EEA member state laws implementing them, in all EEA Member States and are intended to eliminate current differences
in regulation of medical devices among EEA Member States. The EU MDR, among other things, is intended to establish a
uniform, transparent, predictable and sustainable regulatory framework across the EEA for medical devices to ensure a
high level of safety and health while supporting innovation. The new regulations among other things:

● strengthen the rules on placing devices on the market and reinforce surveillance once they are available;

● establish explicit provisions on manufacturers’ responsibilities for the follow-up of the quality, performance

and safety of devices placed on the market;

● improve the traceability of medical devices throughout the supply chain to the end-user or patient through a

unique identification number;

● set up a central database to provide patients, healthcare professionals and the public with comprehensive

information on products available in the EU; and

● strengthen rules for the assessment of certain high-risk devices which may have to undergo an additional

check by experts before they are placed on the market.

The MDR may impose increased compliance obligations for us to access the EU market.

In order to continue to sell our products in Europe, we must maintain our CE marks and continue to comply with

certain EU directives and, in the future with the MDR. Our failure to continue to comply with applicable foreign regulatory
requirements, including those administered by authorities of the EEA countries, could result in enforcement actions against
us, including refusal, suspension or withdrawal of our CE Certificates of Conformity by our Notified Body, which could
impair our ability to market products in the EEA in the future. Any changes to the membership of the European Union,
such as the departure of the United Kingdom (Brexit), may impact the regulatory requirements for the impacted countries
and impair our business operations and our ability to market products in such countries.

If we do not comply with governmental regulations applicable to our CLIA-certified laboratory, we may not be able to
continue our operations.

The operation of our Clinical Laboratory Improvement Amendments (CLIA) certified laboratory is subject to

regulation by numerous federal, state and local governmental authorities in the United States. This laboratory holds a CLIA
certificate of compliance and is licensed by the Commonwealth of Massachusetts and the State of Maryland, and we may
obtain other state licenses if required in the future. Failure to comply with federal or state regulations or changes

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in those regulatory requirements could result in a substantial curtailment or even prohibition of the operations of our
laboratory and could have an adverse effect on our business. CLIA is a federal law that regulates clinical laboratories that
perform testing on human specimens for the purpose of providing information for the diagnosis, prevention or treatment of
disease. To maintain CLIA certification, laboratories are subject to survey and inspection every two years. Moreover, CLIA
inspectors may make unannounced inspections of these laboratories. If we were to lose our CLIA certification or any
required state licenses, whether as a result of a revocation, suspension or limitation, it could have a material adverse effect
on our business.

We expect to rely on third parties in conducting any required future studies of diagnostic products that may be required
by the FDA or other regulatory authorities, and those third parties may not perform satisfactorily.

We do not have the ability to independently conduct clinical trials or other studies that may be required to obtain
FDA and other regulatory clearance or approval for future diagnostic products. Accordingly, we expect that we would rely
on third parties, such as clinical investigators, consultants, and collaborators to conduct such studies if needed. Our reliance
on these third parties for clinical and other development activities would reduce our control over these activities. If these
third parties do not successfully carry out their contractual duties or regulatory obligations or meet expected deadlines, if
the third parties need to be replaced or if the quality or accuracy of the data they obtain is compromised, we may not be
able to obtain regulatory clearance or approval.

If diagnostic procedures that are enabled by our technology are subject to unfavorable pricing regulations or third-party
coverage and reimbursement policies, our business could be harmed.

The ability of us, our customers or our collaborators to commercialize diagnostic tests based on our technology
will depend in part on the extent to which coverage and reimbursement for these tests will be available from government
health programs, private health insurers and other third-party payors. In the United States, the principal decisions about
reimbursement for new technologies are often made by the Centers for Medicare and Medicaid Services (CMS). Private
payors often follow CMS to a substantial degree. It is difficult to predict what CMS will decide with respect to
reimbursement. A primary trend in the U.S. healthcare industry and elsewhere is cost containment. Government authorities
and third-party payors have attempted to control costs by limiting coverage and the amount of payments for particular
products and procedures. We cannot be sure that coverage will be available for any diagnostic tests based on our
technology, and, if coverage is available, the level of payments. Reimbursement may impact the demand for those tests. If
reimbursement is not available or is available only to limited levels, any tests for which marketing authorization is received
may not be able to be successfully commercialized.

Current and future legislation may increase the difficulty and cost to obtain marketing approval of and commercialize
any products based on our technology and affect the prices that may be obtained.

In March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education
Affordability Reconciliation Act, collectively, the ACA, became law. The ACA is a sweeping law intended to broaden
access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against fraud and
abuse, add new transparency requirements for the healthcare and health insurance industries, impose new taxes and fees on
the health industry and impose additional health policy reforms. Since its enactment, there have been judicial and
Congressional challenges to certain aspects of the ACA. Both Congress and former President Trump expressed their
intention to repeal or repeal and replace the ACA, and as a result certain sections of the ACA have not been fully
implemented or were effectively repealed. The uncertainty around the future of the ACA, and in particular the impact to
reimbursement levels and the number of insured individuals, may lead to uncertainty or delay in the purchasing decisions
of our customers, which may in turn negatively impact our product sales. If there are not adequate reimbursement levels,
our business and results of operations could be adversely affected.

In addition, other legislative changes have been proposed and adopted since the ACA was enacted. We expect that

the ACA, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous
coverage criteria and in additional downward pressure on the price that we or our collaborators will receive for any cleared
or approved product. Any reduction in payments from Medicare or other government programs may result in a similar
reduction in payments from private payors. The implementation of cost containment measures or other healthcare

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reforms may prevent us from being able to generate revenue, attain profitability, or commercialize any of our products for
which we receive marketing approval.

In addition, sales of our tests outside of the United States will subject us to foreign regulatory requirements, which

may also change over time.

We cannot predict whether future healthcare initiatives will be implemented at the federal or state level or in

countries outside of the United States in which we may do business, or the effect any future legislation or regulation will
have on us. The expansion in government’s effect on the United States healthcare industry may result in decreased profits
to us, lower reimbursements by payors for our products or reduced medical procedure volumes, all of which may adversely
affect our business, financial condition and results of operations.

Risks Related to Our Operations

We depend on our information technology systems, and any failure of these systems could harm our business.

We depend on information technology and telecommunications systems to operate our business. We have
installed, and expect to expand, a number of enterprise software systems that affect a broad range of business processes and
functional areas, including, for example, systems handling human resources, accounting, manufacturing, inventory control,
financial controls and reporting, sales administration, and other infrastructure operations. In addition to the aforementioned
business systems, we intend to extend the capabilities of both our preventative and detective security controls by
augmenting the monitoring and alerting functions, network design, and automatic countermeasure operations of our
technical systems. These information technology and telecommunications systems support a variety of functions, including
manufacturing operations, quality control, customer service support, and general administrative activities.

Information technology and telecommunications systems are vulnerable to damage from a variety of sources,

including telecommunications or network failures, malicious human acts and natural disasters. Moreover, despite network
security and back-up measures, some of our servers are potentially vulnerable to physical or electronic break-ins, computer
viruses, and similar disruptive problems. Despite the precautionary measures we have taken to prevent unanticipated
problems that could affect our information technology and telecommunications systems, failures or significant downtime of
our information technology or telecommunications systems or those used by our third-party suppliers could prevent us
from operating our business and managing the administrative aspects of our business. Any disruption or loss of information
technology or telecommunications systems on which critical aspects of our operations depend could have an adverse effect
on our business.

Security breaches, loss of data and other disruptions could compromise sensitive information related to our business or
prevent us from accessing critical information and expose us to liability, which could adversely affect our business and
our reputation.

In the ordinary course of our business, we collect and store sensitive data, and intellectual property and proprietary

business information owned or controlled by ourselves or our customers. This data encompasses a wide variety of
business-critical information including research and development information, commercial information, and business and
financial information. We face four primary risks relative to protecting this critical information: loss of access;
inappropriate disclosure; inappropriate modification; and inadequate monitoring of our controls over the first three risks.

The secure processing, storage, maintenance, and transmission of this critical information is vital to our operations

and business strategy, and we devote significant resources to protecting such information. Although we take measures to
protect sensitive information from unauthorized access or disclosure, our information technology and infrastructure may be
vulnerable to attacks by hackers or viruses, breaches, interruptions due to employee error, malfeasance, lapses in
compliance with privacy and security mandates, or other disruptions. Any such breach or interruption could compromise
our networks and the information stored there could be accessed by unauthorized parties, publicly disclosed, lost, or stolen.

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Any such security breach or interruption, as well as any action by us or our employees or contractors that might be

inconsistent with the rapidly evolving data privacy and security laws and regulations applicable within the United States
and elsewhere where we conduct business, could result in enforcement actions by U.S. states, the U.S. federal government
or foreign governments, liability or sanctions under data privacy laws that protect personally identifiable information,
regulatory penalties, other legal proceedings such as but not limited to private litigation, the incurrence of significant
remediation costs, disruptions to our development programs, business operations and collaborations, diversion of
management efforts and damage to our reputation, which could harm our business and operations. Because of the rapidly
moving nature of technology and the increasing sophistication of cybersecurity threats, our measures to prevent, respond to
and minimize such risks may be unsuccessful.

In addition, the European Parliament and the Council of the European Union adopted the GDPR in 2016 to

replace the current European Union Data Protection Directive and related country-specific legislation. The GDPR took
effect in May 2018 and governs the collection and use of personal data in the European Union. The GDPR, which is wide-
ranging in scope, imposes several requirements relating to the consent of the individuals to whom the personal data relates,
the information provided to the individuals, the security and confidentiality of the personal data, data breach notification
and the use of third party processors in connection with the processing of the personal data. The GDPR also imposes strict
rules on the transfer of personal data out of the European Union to the United States, enhances enforcement authority and
imposes large penalties for noncompliance, including the potential for fines of up to €20 million or 4% of the annual global
revenues of the infringer, whichever is greater. While we have taken steps to comply with the GDPR, including such as
reviewing our security procedures and entering into data processing agreements with relevant contractors, we cannot assure
you that our efforts to remain in compliance will be fully successful.

Further, unauthorized access, loss or dissemination of sensitive information could also disrupt our operations,

including our ability to conduct research and development activities, process and prepare company financial information,
manage various general and administrative aspects of our business and damage our reputation, any of which could
adversely affect our reputation and our business. In addition, there can be no assurance that we will promptly detect any
such disruption or security breach, if at all. To the extent that any disruption or security breach were to result in a loss of or
damage to our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur
liability and the further development of our products could be delayed.

We face risks related to handling of hazardous materials and other regulations governing environmental safety.

Our operations are subject to complex and stringent environmental, health, safety and other governmental laws

and regulations that both public officials and private individuals may seek to enforce. Our activities that are subject to these
regulations include, among other things, our use of hazardous materials and the generation, transportation and storage of
waste. Although we have secured clearance from the EPA historically, and currently are operating in compliance with
applicable EPA rules and regulations, our business could be adversely affected if we discover that we or an acquired
business is not in material compliance with these rules and regulations. In the future, we may pursue the use of other
surfactant substances that will require clearance from the EPA, and we may fail to obtain such clearance. Existing laws and
regulations may also be revised or reinterpreted, or new laws and regulations may become applicable to us, whether
retroactively or prospectively, that may have a negative effect on our business and results of operations. It is also
impossible to eliminate completely the risk of accidental environmental contamination or injury to individuals. In such an
event, we could be liable for any damages that result, which could adversely affect our business.

Risks Related to Intellectual Property

If we are unable to protect our intellectual property, it may reduce our ability to maintain any technological or
competitive advantage over our competitors and potential competitors, and our business may be harmed.

We rely on patent protection as well as trademark, copyright, trade secret and other intellectual property rights

protection and contractual restrictions to protect our proprietary technologies, all of which provide limited protection and
may not adequately protect our rights or permit us to gain or keep any competitive advantage. If we fail to protect our
intellectual property, third parties may be able to compete more effectively against us, we may lose our technological or

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competitive advantage, or we may incur substantial litigation costs in our attempts to recover or restrict use of our
intellectual property.

We cannot assure investors that any of our currently pending or future patent applications will result in granted

patents, and we cannot predict how long it will take for such patents to be granted. It is possible that, for any of our patents
that have granted or that may grant in the future, others will design around our patented technologies. Further, we cannot
assure investors that other parties will not challenge any patents granted to us or that courts or regulatory agencies will hold
our patents to be valid or enforceable. We cannot guarantee investors that we will be successful in defending challenges
made against our patents and patent applications. Any successful third-party challenge to our patents could result in the
unenforceability or invalidity of such patents, or to such patents being interpreted narrowly or otherwise in a manner
adverse to our interests. Our ability to establish or maintain a technological or competitive advantage over our competitors
may be diminished because of these uncertainties. For these and other reasons, our intellectual property may not provide us
with any competitive advantage. For example:

● We or our licensors might not have been the first to make the inventions covered by each of our pending

patent applications or granted patents;

● We or our licensors might not have been the first to file patent applications for these inventions. To determine

the priority of these inventions, we may have to participate in interference proceedings or derivation
proceedings declared by the United States Patent and Trademark Office (USPTO) that could result in
substantial cost to us. No assurance can be given that our patent applications or granted patents (or those of
our licensors) will have priority over any other patent or patent application involved in such a proceeding;

● Others may independently develop similar or alternative products and technologies or duplicate any of our

products and technologies;

● It is possible that our owned or licensed pending patent applications will not result in granted patents, and
even if such pending patent applications grant as patents, they may not provide a basis for intellectual
property protection of commercially viable products, may not provide us with any competitive advantages, or
may be challenged and invalidated by third parties;

● We may not develop additional proprietary products and technologies that are patentable;

● The patents of others may have an adverse effect on our business; and

● While we apply for patents covering our products and technologies and uses thereof, as we deem appropriate,
we may fail to apply for patents on important products and technologies in a timely fashion or at all, or we
may fail to apply for patents in potentially relevant jurisdictions.

To the extent our intellectual property offers inadequate protection, or is found to be invalid or unenforceable, we

would be exposed to a greater risk of direct competition. If our intellectual property does not provide adequate coverage
over our products and protection against our competitors’ products, our competitive position could be adversely affected,
as could our business.

Software is a critical component of our instruments. To the extent such software is not protected by our patents,

we depend on trade secret protection and non-disclosure agreements with our employees, strategic partners and
consultants, which may not provide adequate protection.

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The measures that we use to protect the security of our intellectual property and other proprietary rights may not be
adequate, which could result in the loss of legal protection for, and thereby diminish the value of, such intellectual
property and other rights.

In addition to pursuing patents on our technology, we also rely upon trademarks, trade secrets, copyrights and

unfair competition laws, as well as license agreements and other contractual provisions, to protect our intellectual property
and other proprietary rights. Despite these measures, any of our intellectual property rights could be challenged,
invalidated, circumvented or misappropriated. In addition, we take 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 advisors. Such agreements may not be enforceable or
may not provide meaningful protection for our trade secrets or other proprietary information in the event of unauthorized
use or disclosure or other breaches of the agreements, and we may not be able to prevent such unauthorized disclosure.
Moreover, if a party having an agreement with us has an overlapping or conflicting obligation to a third party, our rights in
and to certain intellectual property could be undermined. Monitoring unauthorized disclosure is difficult, and we do not
know whether the steps we have taken to prevent such disclosure are, or will be, adequate. If we were to enforce a claim
that a third party had illegally obtained and was using our trade secrets, it would be expensive and time-consuming, the
outcome would be unpredictable, and any remedy may be inadequate. In addition, courts outside the United States may be
less willing to protect trade secrets.

In addition, competitors could purchase our products and attempt to replicate some or all of the competitive

advantages we derive from our development efforts, willfully infringe our intellectual property rights, design around our
protected technology or develop their own competitive technologies that fall outside of our intellectual property rights. If
our intellectual property does not adequately protect our market share against competitors’ products and methods, our
competitive position could be adversely affected, as could our business.

Some of our owned and in-licensed intellectual property has been discovered through government funded programs and
thus is subject to federal regulations such as “march-in” rights, certain reporting requirements, and a preference for
U.S. industry. Compliance with such regulations may limit our exclusive rights, subject us to expenditure of resources
with respect to reporting requirements, and limit our ability to contract with non-U.S. manufacturers.

Some of the intellectual property rights we own and have in-licensed have been generated through the use of U.S.

government funding and are therefore subject to certain federal regulations. For example, some of the issued U.S. patents
we own and all of the intellectual property rights licensed to us under our license agreement with Tufts have been generated
using U.S. government funds. As a result, the U.S. government has certain rights to intellectual property embodied in our
current or future products pursuant to the Bayh-Dole Act of 1980 (the Bayh-Dole Act). These U.S. government rights in
certain inventions developed under a government-funded program include a non-exclusive, non-transferable, irrevocable
worldwide license to use inventions for any governmental purpose. In addition, the U.S. government has the right to
require us to grant exclusive, partially exclusive, or non-exclusive licenses to any of these inventions to a third party if the
government determines that: (i) adequate steps have not been taken to commercialize the invention; (ii) government action
is necessary to meet public health or safety needs; or (iii) government action is necessary to meet requirements for public
use under federal regulations (also referred to as “march-in rights”). The U.S. government also has the right to take title to
these inventions if we fail, or the applicable licensor fails, to disclose the invention to the government, elect title, and file
an application to register the intellectual property within specified time limits. In addition, the U.S. government may
acquire title to these inventions in any country in which a patent application is not filed within specified time limits.
Intellectual property generated under a government funded program is also subject to certain reporting requirements,
compliance with which may require us, or the applicable licensor, to expend substantial resources. In addition, the U.S.
government requires that any products embodying the subject invention or produced through the use of the subject
invention be manufactured substantially in the U.S. The manufacturing preference requirement can be waived if the owner
of the intellectual property can show that reasonable but unsuccessful efforts have been made to grant licenses on similar
terms to potential licensees that would be likely to manufacture substantially in the U.S. or that under the circumstances
domestic manufacture is not commercially feasible. This preference for U.S. manufacturing may limit our ability to license
the applicable patent rights on an exclusive basis under certain circumstances.

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If we enter into future arrangements involving government funding, and we make inventions as a result of such

funding, intellectual property rights to such discoveries may be subject to the applicable provisions of the Bayh-Dole Act.
To the extent any of our current or future intellectual property is generated through the use of U.S. government funding, the
provisions of the Bayh-Dole Act may similarly apply. Any exercise by the government of certain of its rights could harm
our competitive position, business, financial condition, results of operations and prospects.

Our Simoa bead-based technology is licensed to us by Tufts University. Any loss of our rights to this technology could
prevent us from selling our products.

Our Simoa bead-based technology is licensed exclusively to us from Tufts University. We do not own the patents

that underlie this license. Our rights to use this technology and employ the inventions claimed in the licensed patents are
subject to the continuation of and compliance with the terms of the license. Our principal obligations under our license
agreement with Tufts are as follows:

● royalty payments;

● milestone payments;

● annual maintenance fees;

● using commercially reasonable efforts to develop and sell a product using the licensed technology and

developing a market for such product;

● paying and/or reimbursing fees related to prosecution, maintenance and enforcement of patent rights; and

● providing certain reports.

If we breach any of these obligations, Tufts may have the right to terminate the license, which could result in our
being unable to develop, manufacture and sell products using our Simoa bead-based technology or a competitor’s gaining
access to the Simoa technology. Termination of our license agreement with Tufts would have a material adverse effect on
our business.

In addition, we are a party to a number of other agreements that include licenses to intellectual property, including
non-exclusive licenses. We expect that we may need to enter into additional license agreements in the future. Our business
could suffer, for example, if any current or future licenses terminate, if the licensors fail to abide by the terms of the
license, if the licensed patents or other rights are found to be invalid or unenforceable, or if we are unable to enter into
necessary licenses on acceptable terms.

We may need or may choose to obtain licenses from third parties to advance our research or allow commercialization of
our current or future products, and we cannot provide any assurances that we would be able to do so.

We may need or may choose to obtain licenses from third parties to advance our research or allow

commercialization of our current or future products, and we cannot provide any assurances that third-party patents do not
exist that might be enforced against our current or future products in the absence of such a license. We may fail to obtain
any of these licenses on commercially reasonable terms, if at all. Even if we are able to obtain a license, it may be non-
exclusive, thereby giving our competitors access to the same technologies licensed to us. If we could not obtain a license,
we may be required to expend significant time and resources to develop or license replacement technology. If we are
unable to do so, we may be unable to develop or commercialize the affected products, which could materially harm our
business and the third parties owning such intellectual property rights could seek either an injunction prohibiting our sales,
or, with respect to our sales, an obligation on our part to pay royalties and/or other forms of compensation.

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Licensing of intellectual property involves complex legal, business and scientific issues. Disputes may arise

between us and our licensors regarding intellectual property subject to a license agreement, including:

● the scope of rights granted under the license agreement and other interpretation-related issues;

● whether and the extent to which our technology and processes infringe on intellectual property of the licensor

that is not subject to the licensing agreement;

● our right to sublicense patent and other rights to third parties under collaborative development relationships;

● our diligence obligations with respect to the use of the licensed technology in relation to our development

and commercialization of our products, and what activities satisfy those diligence obligations; and

● the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by

our licensors and us and our partners.

If disputes over intellectual property that we have licensed prevent or impair our ability to maintain the licensing
arrangements on acceptable terms, we may be unable to successfully develop and commercialize the affected product, or
the dispute may have an adverse effect on our results of operation.

In addition to agreements pursuant to which we in-license intellectual property, we have in the past and expect to
in the future to grant licenses under our intellectual property. Like in-licenses, out-licenses are complex, and disputes may
arise between us and our licensees, such as the types of disputes described above. Moreover, our licensees may breach their
obligations, or we may be exposed to liability due to our failure or alleged failure to satisfy our obligations. Any such
occurrence could have an adverse effect on our business.

If we or any of our partners are sued for infringing intellectual property rights of third parties, it would be costly and
time-consuming, and an unfavorable outcome in that litigation could have a material adverse effect on our business.

Our success also depends on our ability to develop, manufacture, market and sell our products and perform our

services without infringing upon the proprietary rights of third parties. Numerous U.S. and foreign-issued patents and
pending patent applications owned by third parties exist in the fields in which we are developing products and services. As
part of a business strategy to impede our successful commercialization and entry into new markets, competitors have
claimed, and may claim in the future, that our products and/or services infringe their intellectual property rights and have
suggested, and may suggest in the future, that we enter into license agreements. Any such claims made to date are, we
believe, without merit.

Even if such claims are without merit, we could incur substantial costs and divert the attention of our management
and technical personnel in defending ourselves against claims of infringement made by third parties or settling such claims.
Any adverse ruling by a court or administrative body, or perception of an adverse ruling, may have a material adverse
impact on our ability to conduct our business and our finances. Moreover, third parties making claims against us may be
able to obtain injunctive relief against us, which could block our ability to offer one or more products or services and could
result in a substantial award of damages against us. In addition, since we sometimes indemnify customers, collaborators or
licensees, we may have additional liability in connection with any infringement or alleged infringement of third-party
intellectual property.

Because patent applications can take many years to issue, there may be pending applications, some of which are

unknown to us, that may result in issued patents upon which our products or proprietary technologies may infringe.
Moreover, we may fail to identify issued patents of relevance or incorrectly conclude that an issued patent is invalid or not
infringed by our technology or any of our products. There is a substantial amount of litigation involving patent and

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other intellectual property rights in our industry. If a third party claims that we or any of our licensors, customers or
collaboration partners infringe upon a third party’s intellectual property rights, we may have to:

● seek to obtain licenses that may not be available on commercially reasonable terms, if at all;

● abandon any infringing product or redesign our products or processes to avoid infringement;

● pay substantial damages including, in an exceptional case, treble damages and attorneys’ fees, which we may
have to pay if a court decides that the product or proprietary technology at issue infringes upon or violates
the third-party’s rights;

● pay substantial royalties or fees or grant cross-licenses to our technology; or

● defend litigation or administrative proceedings that may be costly whether we win or lose, and which could

result in a substantial diversion of our financial and management resources.

We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be
expensive, time-consuming and unsuccessful.

Competitors may infringe our patents or the patents that we license. In the event of infringement or unauthorized

use, we may file one or more infringement lawsuits, which can be expensive and time-consuming. An adverse result in any
such litigation proceedings could put one or more of our patents at risk of being invalidated, being found to be
unenforceable or being interpreted narrowly and could put our patent applications at risk of not issuing. Furthermore,
because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk
that some of our confidential information could be compromised by disclosure during this type of litigation.

Many of our competitors are larger than we are and have substantially greater resources. They are, therefore,

likely to be able to sustain the costs of complex patent litigation longer than we could. In addition, the uncertainties
associated with litigation could have a material adverse effect on our ability to raise any funds necessary to continue our
operations, continue our internal research programs, in-license needed technology, or enter into development partnerships
that would help us bring our products to market.

In addition, patent litigation can be very costly and time-consuming. An adverse outcome in such litigation or
proceedings may expose us or any of our future development partners to loss of our proprietary position, expose us to
significant liabilities, or require us to seek licenses that may not be available on commercially acceptable terms, if at all.

Our issued patents could be found invalid or unenforceable if challenged in court, which could have a material adverse
impact on our business.

If we or any of our partners were to initiate legal proceedings against a third party to enforce a patent covering one

of our products or services, the defendant in such litigation could counterclaim that our patent is invalid and/or
unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity and/or unenforceability
are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory
requirements, including lack of novelty, obviousness or non-enablement, or failure to claim patent eligible subject matter.
Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent
withheld relevant information from the USPTO, or made a misleading statement, during prosecution. Third parties may
also raise similar claims before the USPTO even outside the context of litigation. The outcome following legal assertions
of invalidity and unenforceability is unpredictable. With respect to the validity question, for example, we cannot be certain
that there is no invalidating prior art of which we and the patent examiner were unaware during prosecution. If a defendant
were to prevail on a legal assertion of invalidity and/or unenforceability, we would lose at least part, and perhaps all, of the
challenged patent. Such a loss of patent protection would have a material adverse impact on our business.

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We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or
disclosed alleged trade secrets of their other clients or former employers to us, which could subject us to costly litigation.

As is common in the life sciences industry, we engage the services of consultants and independent contractors to

assist us in the development of our products. Many of these consultants and independent contractors were previously
employed at, or may have previously or may be currently providing consulting or other services to, universities or other
technology, biotechnology or pharmaceutical companies, including our competitors or potential competitors. We may
become subject to claims that our company, a consultant or an independent contractor inadvertently or otherwise used or
disclosed trade secrets or other information proprietary to their former employers or their former or current clients. We may
similarly be subject to claims stemming from similar actions of an employee, such as one who was previously employed by
another company, including a competitor or potential competitor. Litigation may be necessary to defend against these
claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a
distraction to our management team. If we were not successful we could lose access or exclusive access to valuable
intellectual property.

We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.

We generally enter into confidentiality and intellectual property assignment agreements with our employees,

consultants, and contractors. These agreements generally provide that inventions conceived by the party in the course of
rendering services to us will be our exclusive property. However, those agreements may not be honored and may not
effectively assign intellectual property rights to us. For example, even if we have a consulting agreement in place with an
academic advisor pursuant to which such academic advisor is required to assign any inventions developed in connection
with providing services to us, such academic advisor may not have the right to assign such inventions to us, as it may
conflict with his or her obligations to assign all such intellectual property to his or her employing institution.

In addition, we sometimes enter into agreements where we provide services to third parties, such as customers.

Under such circumstances, our agreements may provide that certain intellectual property that we conceive in the course of
providing those services is assigned to the customer. In those cases, we would not be able to use that particular intellectual
property in, for example, our work for other customers without a license.

We may not be able to protect our intellectual property rights throughout the world, which could materially, negatively
affect our business.

Filing, prosecuting and defending patents on current and future products in all countries throughout the world

would be prohibitively expensive, and our intellectual property rights in some countries outside the United States can be
less extensive than those in the United States. In addition, the laws of some foreign countries do not protect intellectual
property rights to the same extent as federal and state laws in the United States. Consequently, regardless of whether we are
able to prevent third parties from practicing our inventions in the United States, we may not be able to prevent third parties
from practicing our inventions in all countries outside the United States, or from selling or importing products made using
our inventions in and into the United States or other jurisdictions. Competitors may use our technologies in jurisdictions
where we have not pursued and obtained patent protection to develop their own products, and further, may export
otherwise infringing products to territories where we have patent protection, but enforcement is not as strong as it is in the
United States. These products may compete with our products and our patents or other intellectual property rights may not
be effective or sufficient to prevent them from competing. Even if we pursue and obtain issued patents in particular
jurisdictions, our patent claims or other intellectual property rights may not be effective or sufficient to prevent third parties
from competing. Patent protection must ultimately be sought on a country-by-country basis, which is an expensive and
time-consuming process with uncertain outcomes. Accordingly, we may choose not to seek patent protection in certain
countries, and we will not have the benefit of patent protection in such countries.

Many companies have encountered significant problems in protecting and defending intellectual property rights in

foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the
enforcement of patents and other intellectual property protection, particularly those relating to biotechnology, which could
make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of

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our proprietary rights generally. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial
costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being
invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to
assert claims against us. We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded, if
any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around the
world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or
license and may adversely impact our business.

In addition, we and our partners also face the risk that our products are imported or reimported into markets with

relatively higher prices from markets with relatively lower prices, which would result in a decrease of sales and any
payments we receive from the affected market. Recent developments in U.S. patent law have made it more difficult to stop
these and related practices based on theories of patent infringement.

Changes in patent laws or patent jurisprudence could diminish the value of patents in general, thereby impairing our
ability to protect our products.

The America Invents Act (the AIA) was signed into law on September 16, 2011, and many of the substantive

changes became effective on March 16, 2013. An important change introduced by the AIA is that, as of March 16, 2013,
the United States transitioned to a “first-to-file” system for deciding which party should be granted a patent when two or
more patent applications are filed by different parties claiming the same invention. A third party that files a patent
application in the USPTO after that date but before us could therefore be awarded a patent covering an invention of ours
even if we had made the invention before it was made by the third party. This will require us to be cognizant going forward
of the time from invention to filing of a patent application, but circumstances could prevent us from promptly filing patent
applications on our inventions.

Among some of the other changes introduced by the AIA are changes that limit where a patent holder may file a

patent infringement suit and providing additional opportunities for third parties to challenge any issued patent in the
USPTO. This applies to all of our owned and in-licensed U.S. patents, even those issued before March 16, 2013. Because
of a lower evidentiary standard in USPTO proceedings compared to the evidentiary standard in U.S. federal courts
necessary to invalidate a patent claim, a third party could potentially provide evidence in a USPTO proceeding sufficient
for the USPTO to hold a claim invalid even though the same evidence would be insufficient to invalidate the claim if first
presented in a district court action. Accordingly, a third party may attempt to use the USPTO procedures to invalidate our
patent claims that would not have been invalidated if first challenged by the third party as a defendant in a district court
action. The AIA and its implementation could increase the uncertainties and costs surrounding the prosecution of our
patent applications and the enforcement or defense of our issued patents.

Additionally, the U.S. Supreme Court has ruled on several patent cases in recent years, such as Impression
Products, Inc. v. Lexmark International, Inc., Association for Molecular Pathology v. Myriad Genetics, Inc., Mayo
Collaborative Services v. Prometheus Laboratories, Inc. and Alice Corporation Pty. Ltd. v. CLS Bank International, either
narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in
certain situations. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this
combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on decisions
by the U.S. Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in
unpredictable ways that could weaken our ability to obtain new patents or to enforce our existing patents and patents that
we might obtain in the future.

Obtaining and maintaining our patent protection depends on compliance with various procedural, document
submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection
could be reduced or eliminated for non-compliance with these requirements.

The USPTO and various foreign governmental patent agencies require compliance with a number of procedural,

documentary, fee payment and other provisions during the patent process. There are situations in which noncompliance can
result in abandonment or lapse of a patent or patent application, resulting in partial or complete loss of patent rights in the
relevant jurisdiction. In such an event, competitors might be able to enter the market earlier than

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would otherwise have been the case. In some cases, our licensors may be responsible for, for example, these payments,
thereby decreasing our control over compliance with these requirements.

If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in
our markets of interest and our business may be adversely affected.

Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared

generic or determined to be infringing on other marks. We may not be able to protect our rights to these trademarks and
trade names, which we need to build name recognition by potential partners or customers in our markets of interest. At
times, competitors may adopt trade names or trademarks similar to ours, thereby impeding our ability to build brand
identity and possibly leading to market confusion. In addition, there could be potential trade name or trademark
infringement claims brought by owners of other registered trademarks. Over the long term, if we are unable to establish
name recognition based on our trademarks and trade names, then we may not be able to compete effectively and our
business may be adversely affected.

We may use third-party open source software components in future products, and failure to comply with the terms of the
underlying open source software licenses could restrict our ability to sell such products.

While our current products do not contain any software tools licensed by third-party authors under “open source”
licenses, we may choose to use open source software in future products. Use and distribution of open source software may
entail greater risks than use of third-party commercial software, as open source licensors generally do not provide
warranties or other contractual protections regarding infringement claims or the quality of the code. Some open source
licenses may contain requirements that we make available source code for modifications or derivative works we create
based upon the type of open source software we use. If we combine our proprietary software with open source software in
a certain manner, we could, under certain open source licenses, be required to release the source code of our proprietary
software to the public. This would allow our competitors to create similar products with less development effort and time
and ultimately could result in a loss of product sales.

Although we intend to monitor any use of open source software to avoid subjecting our products to conditions we
do not intend, the terms of many open source licenses have not been interpreted by U.S. courts, and there is a risk that any
such licenses could be construed in a way that could impose unanticipated conditions or restrictions on our ability to
commercialize our products. Moreover, we cannot assure investors that our processes for controlling our use of open
source software in our products will be effective. If we are held to have breached the terms of an open source software
license, we could be required to seek licenses from third parties to continue offering our products on terms that are not
economically feasible, to re-engineer our products, to discontinue the sale of our products if re-engineering could not be
accomplished on a timely basis, or to make generally available, in source code form, our proprietary code, any of which
could adversely affect our business, operating results, and financial condition.

We use third-party software that may be difficult to replace or may cause errors or failures of our products that could
lead to lost customers or harm to our reputation.

We use software licensed from third parties in our products. In the future, this software may not be available to us

on commercially reasonable terms, or at all. Any loss of the right to use any of this software could result in delays in the
production of our products until equivalent technology is either developed by us, or, if available, is identified, obtained and
integrated, which could harm our business. In addition, any errors or defects in third-party software or other third-party
software failures could result in errors, defects or cause our products to fail, which could harm our business and be costly
to correct. Many of these providers attempt to impose limitations on their liability for such errors, defects or failures, and if
enforceable, we may have additional liability to our customers or third-party providers that could harm our reputation and
increase our operating costs.

We will need to maintain our relationships with third-party software providers and to obtain software from such

providers that does not contain any errors or defects. Any failure to do so could adversely impact our ability to deliver
reliable products to our customers and could harm our reputation and results of operations.

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Numerous factors may limit any potential competitive advantage provided by our intellectual property rights.

The degree of future protection afforded by our intellectual property rights is uncertain because intellectual
property rights have limitations, and may not adequately protect our business, provide a barrier to entry against our
competitors or potential competitors, or permit us to maintain our competitive advantage. Moreover, if a third party has
intellectual property rights that cover the practice of our technology, we may not be able to fully exercise or extract value
from our intellectual property rights. The following examples are illustrative:

● others may be able to develop and/or practice technology that is similar to our technology or aspects of our
technology but that is not covered by the claims of any patents that have issued, or may issue, from our
owned or in-licensed patent applications;

● we might not have been the first to make the inventions covered by a pending patent application that we own

or license;

● we might not have been the first to file patent applications covering an invention;

● others may independently develop similar or alternative technologies without infringing our intellectual

property rights;

● pending patent applications that we own or license may not lead to issued patents;

● patents, if issued, that we own or license may not provide us with any competitive advantages, or may be

held invalid or unenforceable, as a result of legal challenges by our competitors;

● third parties may compete with us in jurisdictions where we do not pursue and obtain patent protection;

● we may not be able to obtain and/or maintain necessary or useful licenses on reasonable terms or at all;

● third parties may assert an ownership interest in our intellectual property and, if successful, such disputes

may preclude us from exercising exclusive rights over that intellectual property;

● we may not be able to maintain the confidentiality of our trade secrets or other proprietary information;

● we may not develop or in-license additional proprietary technologies that are patentable; and

● the patents of others may have an adverse effect on our business.

Should any of these events occur, they could significantly harm our business and results of operations.

Risks Related to Our Common Stock and Being a Public Company

We expect that our stock price may fluctuate significantly.

The market price of shares of our common stock has been and could continue to be subject to wide fluctuations in

response to many risk factors listed in this section, and others beyond our control, including:

● actual or anticipated fluctuations in our financial condition and operating results;

● announcements by us, our partners or our competitors of new products, significant contracts, strategic

partnerships, joint ventures, collaborations, acquisitions, commercial relationships or capital commitments;

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● competition from existing products or new products that may emerge;

● failure to meet or exceed financial estimates and projections of the investment community or that we may

provide to the public;

● issuance of new or updated research or reports by securities analysts or recommendations for our stock;

● positive or adverse regulatory announcements;

● disputes or other developments related to proprietary rights, including patents, litigation matters, and our

ability to obtain patent protection for our technologies;

● commencement of, or our involvement in, litigation;

● fluctuations in the valuation of companies perceived by investors to be comparable to us;

● conditions in our markets;

● manufacturing disputes or delays;

● any future sales of our common stock or other securities;

● any change to the composition of our board of directors or key personnel;

● general economic conditions and slow or negative growth of our markets;

● share price and volume fluctuations attributable to inconsistent trading volume levels of our shares;

● announcement or expectation of additional debt or equity financing efforts; and

● other factors described in this Risk Factors section of this Annual Report on Form 10-K.

These and other market and industry factors may cause the market price and demand for our common stock to

fluctuate substantially, regardless of our actual operating performance, which may limit or prevent investors from readily
selling their shares of common stock and may otherwise negatively affect the liquidity of our common stock. In addition,
the stock market in general, and life science companies in particular, have experienced extreme price and volume
fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. In the
past, when the market price of a stock has been volatile, holders of that stock have on occasion instituted securities class
action litigation against the company that issued the stock. If any of our stockholders were to bring a lawsuit against us, the
defense and disposition of the lawsuit could be costly and divert the time and attention of our management and harm our
operating results.

If securities or industry analysts do not publish research reports about our business, or if they issue an adverse opinion
about our business, our stock price and trading volume could decline.

The trading market for our common stock will be influenced by the research and reports that industry or securities

analysts publish about us or our business. If one or more of the analysts who cover us issues an adverse opinion about our
company, our stock price would likely decline. If one or more of these analysts ceases coverage of us or fails to regularly
publish reports on us, we could lose visibility in the public markets, which could cause our stock price or trading volume to
decline.

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Our principal stockholders and management own a significant percentage of our stock and will be able to exercise
significant influence over matters subject to stockholder approval.

As of December 31, 2020, our executive officers and directors, and entities affiliated with our executive officers

and directors, owned or controlled approximately 17.4% of our outstanding common stock. Accordingly, our executive
officers, directors and principal stockholders have significant influence over our operations. This concentration of
ownership could have the effect of delaying or preventing a change in our control or otherwise discouraging a potential
acquirer from attempting to obtain control of us, which in turn could have a material adverse effect on our stock price and
may prevent attempts by our stockholders to replace or remove the board of directors or management.

We have never paid dividends on our capital stock, and we do not anticipate paying any dividends in the foreseeable
future. Consequently, any gains from an investment in our common stock will likely depend on whether the price of our
common stock increases.

We have not paid dividends on any of our classes of capital stock to date and we currently intend to retain our

future earnings, if any, to fund the development and growth of our business. In addition, the terms of our indebtedness with
Hercules Capital Inc. (Hercules) (formally known as Hercules Technology Growth Capital, Inc.) prohibit us from paying
dividends. As a result, capital appreciation, if any, of our common stock will be your sole source of gain for the foreseeable
future. Consequently, in the foreseeable future, you will likely only experience a gain from an investment in our common
stock if the price of our common stock increases.

Anti-takeover provisions contained in our restated certificate of incorporation and restated by-laws, as well as
provisions of Delaware law, could impair a takeover attempt.

Our restated certificate of incorporation, restated by-laws and Delaware law contain provisions which could have
the effect of rendering more difficult, delaying or preventing an acquisition deemed undesirable by our board of directors.
Our corporate governance documents include provisions:

● authorizing our board of directors to issue up to 5,000,000 shares of preferred stock without stockholder
approval upon the terms and conditions and with the rights, privileges and preferences as our board of
directors may determine;

● specifying that special meetings of our stockholders can be called only by our board of directors and that our

stockholders may not act by written consent;

● establishing an advance notice procedure for stockholder proposals to be brought before an annual meeting
of our stockholders, including proposed nominations of persons for election to our board of directors;

● providing that directors may be removed only for cause;

● providing that our board of directors may create new directorships and that vacancies on our board of
directors may be filled only by a majority of directors then in office, even though less than a quorum;

● establishing that our board of directors is divided into three classes—Class I, Class II, and Class III—with

each class serving staggered three-year terms;

● providing that our board of directors may amend our restated by-laws without stockholder approval; and

● requiring a super-majority of votes to amend certain of the above-mentioned provisions.

These provisions, alone or together, could delay or prevent hostile takeovers and changes in control or changes in

our management.

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As a Delaware corporation, we are also subject to provisions of Delaware law, including Section 203 of the
Delaware General Corporation law, which prevents some stockholders holding more than 15% of our outstanding common
stock from engaging in certain business combinations without approval of the holders of substantially all of our
outstanding common stock.

Any provision of our restated certificate of incorporation, restated by-laws or Delaware law that has the effect of

delaying or deterring a change in control could limit the opportunity for our stockholders to receive a premium for their
shares of our common stock, and could also affect the price that some investors are willing to pay for our common stock.

We are an “emerging growth company” and are able to avail ourselves of reduced disclosure requirements applicable to
emerging growth companies, and we plan to avail ourselves of the ability to adopt new accounting standards on the
timeline permitted for private companies, which could make our common stock less attractive to investors and our
financial statements less comparable to other companies who are complying with new accounting standards on public
company timelines.

We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012, as
amended (the JOBS Act), and we intend to take advantage of certain exemptions from various reporting requirements that
are applicable to other public companies that are not “emerging growth companies,” including not being required to
comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act, reduced disclosure
obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from the
requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden
parachute payments not previously approved. In addition, Section 107 of the JOBS Act also provides that an emerging
growth company can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act
for complying with new or revised accounting standards. In other words, an emerging growth company can delay the
adoption of certain accounting standards until those standards would otherwise apply to private companies. We have
elected to take advantage of the extended transition period afforded by the JOBS Act for the implementation of new or
revised accounting standards and, as a result, will comply with new or revised accounting standards not later than the
relevant dates on which adoption of such standards is required for non-public companies. As a result of this election, the
timeline to comply with certain accounting standards will in many cases be delayed as compared to other public companies
who are not eligible to have made or have not made this election. As a result, investors may view our financial statements
as not comparable to other public companies. We cannot predict if investors will find our common stock less attractive
because we may rely on these exemptions. If some investors find our common stock less attractive as a result, there may be
a less active trading market for our common stock and our stock price may be more volatile. We may take advantage of
these reporting exemptions until we are no longer an emerging growth company. We will remain an emerging growth
company until the earliest of (i) the last day of the fiscal year in which we have total annual gross revenue of $1.07 billion
or more; (ii) December 31, 2022; (iii) the date on which we have issued more than $1.0 billion in nonconvertible debt
during the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under the rules of
the SEC.

We incur increased costs and devote substantial management time as a result of operating as a public company.

As a public company, we incur significant legal, accounting and other expenses that we did not incur as a private

company, and these expenses may increase even more after we are no longer an “emerging growth company.” We are
subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform
and Protection Act, as well as rules adopted, and to be adopted, by the SEC and The Nasdaq Global Market. Our
management and other personnel devote a substantial amount of time to these compliance initiatives. Moreover, these
rules and regulations substantially increase our legal and financial compliance costs and make some activities more time-
consuming and costly. The increased costs increase our net loss. For example, we expect these rules and regulations to
make it more difficult and more expensive for us to obtain director and officer liability insurance and we may be required
to incur substantial costs to maintain the sufficient coverage. We cannot predict or estimate the amount or timing of
additional costs we may incur to respond to these requirements. The impact of these requirements could also make it more
difficult for us to attract and retain qualified persons to serve on our board of directors, our board committees or as
executive officers.

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In addition, as a public company we incur additional costs and obligations in order to comply with SEC rules that
implement Section 404 of the Sarbanes-Oxley Act. Under these rules, we are required to make a formal assessment of the
effectiveness of our internal control over financial reporting, and once we cease to be an emerging growth company, which
we expect to occur during our current fiscal year, we will be required to include an attestation report on internal control
over financial reporting issued by our independent registered public accounting firm, effective with our Annual Report for
the fiscal year ending December 31, 2021. To achieve timely compliance with Section 404, we engaged in a process to
document and evaluate our internal control over financial reporting, which was both costly and challenging. The process of
obtaining the attestation report from our independent registered public accounting firm will be significantly more costly
and will require the devotion of significant management attention and resources. We will need to continue to dedicate
internal resources, engage outside consultants and adopt a detailed work plan to assess and document the adequacy of our
internal control over financial reporting, continue steps to improve control processes as appropriate, validate through
testing that controls are designed and operating effectively, and implement a continuous reporting and improvement
process for internal control over financial reporting. If we identify one or more material weaknesses, it could result in an
adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial statements.

Item 1B. UNRESOLVED STAFF COMMENTS

Not applicable.

Item 2. PROPERTIES

We currently lease approximately 91,600 square feet of office, laboratory, and manufacturing space at our

headquarters in Billerica, Massachusetts. The premises covered by this lease serve as our principal office and laboratory
space. The initial term of the lease is 11 years and five months beginning on April 1, 2019, and we have the option to
extend the lease for two additional five-year periods. We believe that this office, laboratory and manufacturing space will
be sufficient to meet our needs for the foreseeable future.

In addition, our subsidiary, Uman, leases a total of approximately 6,500 square feet of office, laboratory,

manufacturing and storage space in Umeå, Sweden. These leases expire at various dates between May 31, 2020 and
February 28, 2023.

Item 3. LEGAL PROCEEDINGS

We are not currently a party to any material legal proceedings.

Item 4. MINE SAFETY DISCLOSURES

Not applicable.

PART II

Item 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND
ISSUER PURCHASES OF EQUITY SECURITIES

Market Information

Our common stock is traded on The Nasdaq Global Market under the symbol “QTRX.”

Stockholders

As of March 1, 2021, there were approximately 39 stockholders of record of the 36,267,609 outstanding shares of

common stock.

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Unregistered Sales of Securities

There were no unregistered sales of equity securities during the fourth quarter ended December 31, 2020.

Issuer Purchases of Equity Securities

Not applicable.

Item 6. SELECTED FINANCIAL DATA

You should read the following selected financial data together with our consolidated financial statements and the

related notes and the information under the caption “Management’s Discussion and Analysis of Financial Condition and
Results of Operations” included elsewhere in this Annual Report on Form 10-K. We have derived the statement of
operations data for the years ended December 31, 2020, 2019, and 2018 and the balance sheet data as of December 31,
2020 and 2019 from our audited consolidated financial statements included elsewhere in this Annual Report on Form 10-K.
Note that the results for the year ended December 31, 2018 include activity related to the acquisition of Aushon, which
occurred on January 1, 2018, and the results for the year ended December 31, 2019 include activity from the acquisition of
Uman, which was finalized on August 1, 2019. The statement of operations data for the years ended December 31, 2017
and 2016, and the selected balance sheet data as of December 31, 2018, 2017, and 2016 is derived from audited financial
statements that are not included in this Annual Report on Form 10-K. Our historical results are not necessarily indicative of
the results that should be expected in the future.

Consolidated statement of operations data (in thousands, except per share data)

Total revenue
Cost of revenue
Gross profit
Research and development
Selling, general and administrative
Total operating expenses
Loss from operations
Interest income (expense), net
Other expense, net
Loss before income taxes
Income tax benefit (provision)
Net loss
Accretion and accrued dividends on redeemable convertible
preferred stock
Net loss attributable to common stockholders
Net loss per share attributable to common stockholders,
basic and diluted
Weighted-average common shares outstanding

Consolidated balance sheet data (in thousands)

Cash and cash equivalents
Total assets
Total long term debt
Total redeemable convertible preferred stock
Total stockholders’ deficit

2020
$  86,377
 38,195
 48,182
 20,174
 59,592
 79,766
   (31,584)
 (273)
 (49)
   (31,906)
 376
   (31,530)

Year Ended December 31, 
2018
$  37,632
 19,684
 17,948
 15,805
 33,693
 49,498
   (31,550)
 46
 (7)
   (31,511)
 (25)
   (31,536)

2019
$  56,734
 29,898
 26,836
 16,190
 52,246
 68,436
   (41,600)
 627
 (10)
   (40,983)
 187
   (40,796)

2017
$  22,874
 12,887
 9,987
 16,304
 19,688
 35,992
   (26,005)
 (951)
 (63)
   (27,019)

   (27,019)

 —  

2016
$  17,585
 9,837
 7,748
 16,993
 12,466
 29,459
   (21,711)
 (1,298)
 (164)
   (23,173)
 —
   (23,173)

 —  

 (4,445)
$ (31,530) $ (40,796) $ (31,536) $ (31,185) $  (27,618)

 (4,166)

 —  

 —  

$

 (1.07) $

 (1.63) $

 (1.43) $

 29,589

 25,091

 21,994

 (8.30) $  (12.89)
 2,143
 3,757

As of December 31, 
2018

2019

2020
$ 181,584
$ 271,045
$
 7,673
$
$ 206,125

$  109,155 $ 44,429
$  169,951 $ 67,611
 7,587 $  7,623
$
 — $

 — $
$  128,658 $ 41,065

2017
$  79,682 $
$  91,779 $
$  9,382 $

2016
 29,671
 37,117
 10,243
 — $  128,585
$  65,866 $  (115,109)

 — $

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Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS

The following discussion and analysis of our financial condition and results of operations should be read in
conjunction with our consolidated financial statements and related notes included elsewhere in this Annual Report on
Form 10-K. In addition to historical consolidated financial information, the following discussion contains forward-looking
statements that reflect our plans, estimates and beliefs. Our actual results could differ materially from those discussed in
the forward-looking statements. See “Special Note Regarding Forward-Looking Statements.” Factors that could cause or
contribute to these differences include those discussed below and elsewhere in this Annual Report on Form 10-K,
particularly in “Risk Factors.”

Overview

We are a life sciences company that has developed next generation, ultra-sensitive digital immunoassay platforms
that advance precision health for life sciences research and diagnostics. Our platforms are based on our proprietary digital
“Simoa” detection technology. Our Simoa bead-based and planar array platforms enable customers to reliably detect
protein biomarkers in extremely low concentrations in blood, serum and other fluids that, in many cases, are undetectable
using conventional, analog immunoassay technologies, and also allow researchers to define and validate the function of
novel protein biomarkers that are only present in very low concentrations and have been discovered using technologies
such as mass spectrometry. These capabilities provide our customers with insight into the role of protein biomarkers in
human health that has not been possible with other existing technologies and enable researchers to unlock unique insights
into the continuum between health and disease. We believe this greater insight will enable the development of novel
therapies and diagnostics and facilitate a paradigm shift in healthcare from an emphasis on treatment to a focus on earlier
detection, monitoring, prognosis and, ultimately, prevention. We are currently focusing on protein detection, which we
believe is an area of significant unmet need and where we have significant competitive advantages. However, in addition to
enabling new applications and insights in protein analysis, our Simoa platforms have also demonstrated applicability across
other testing applications, including detection of nucleic acids and small molecules.

We currently sell most of our products for life science research, primarily to laboratories associated with academic
and governmental research institutions, as well as pharmaceutical, biotechnology and contract research companies, through
a direct sales force and support organizations in North America and Europe, and through distributors or sales agents in
other select markets, including Australia, Brazil, China, Czech Republic, India, Israel, Japan, Lebanon, Mexico, Qatar,
Saudi Arabia, Singapore, South Korea and Taiwan.

Our instruments are designed to be used either with assays fully developed by us, including all antibodies and

supplies required to run the tests, or with “homebrew” kits where we supply some of the components required for testing,
and the customer supplies the remaining required elements. Accordingly, our installed instruments generate a recurring
revenue stream. We believe that our recurring consumable revenue is driven by our customers’ ability to extract more
valuable data using our platform and to process a large number of samples quickly with little hands-on preparation.

We commercially launched our first immunoassay platform, the Simoa HD-1, in January 2014. The HD-1 is based
on our bead-based technology, and assays run on the HD-1 are fully automated. We initiated commercial launch of the SR-
X instrument in December 2017. The SR-X utilizes the same Simoa bead-based technology and assay kits as the HD-1 in a
compact benchtop form with a lower price point, more flexible assay preparation, and a wider range of applications. In July
2019, we launched the Simoa HD-X, an upgraded version of the Simoa HD-1, which replaces the HD-1. The HD-X has
been designed to deliver significant productivity and operational efficiency improvements, as well as greater user
flexibility. We began shipping and installing HD-X instruments at customer locations in 2019. As the installed base of the
Simoa instruments increases, total consumables revenue overall is expected to increase. We believe that consumables
revenue should be subject to less period-to-period fluctuation than our instrument sales revenue, and will become an
increasingly important contributor to our overall revenue.

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On January 30, 2018, we acquired Aushon for $3.2 million in cash, with an additional payment of $0.8 million
made in July 2018, six months after the acquisition date. With the acquisition of Aushon, we acquired a CLIA certified
laboratory, as well as Aushon’s proprietary sensitive planar array detection technology. Leveraging our proprietary
sophisticated Simoa image analysis and data analysis algorithms, we further refined this planar array technology to develop
the SP-X instrument to provide the same Simoa sensitivity found in our Simoa bead-based platform. We initiated an early-
access program for the SP-X instrument in January 2019, with the full commercial launch commenced in April 2019.

On August 1, 2019, we completed our acquisition of Uman for an aggregate purchase price of $21.2 million,

comprised of (i) $15.7 million in cash plus (ii) 191,152 shares of our common stock (representing $5.5 million based on the
closing prices of our common stock on the Nasdaq Global Market on July 1, 2019 and August 1, 2019, the dates of
issuance). The acquisition closed with respect to 95% of the outstanding shares of capital stock of Uman on July 1, 2019
and with respect to the remaining 5% of the outstanding shares of capital stock of Uman on August 1, 2019. Uman supplies
neurofilament light (Nf-L) antibodies and ELISA kits, which are widely recognized by researchers and biopharmaceutical
and diagnostics companies world-wide as the premier solution for the detection of Nf-L to advance the development of
therapeutics and diagnostics for neurodegenerative conditions.

On September 29, 2020, we entered the Abbott License Agreement with Abbott. Pursuant to the terms of the

Abbott License Agreement, we granted Abbott a non-exclusive, worldwide, royalty-bearing license, without the right to
sublicense, under our bead-based single molecule detection patents in the field of IVD. Abbott paid an initial license fee of
$10.0 million in connection with the execution of the Abbott License Agreement, which was recognized as license revenue
for the year ended December 31, 2020. Abbott has also agreed to pay us milestone fees subject to the achievement by
Abbott of certain development, regulatory and commercialization milestones and low single digit royalties on net sales of
licensed products.

We are subject to ongoing uncertainty concerning the COVID-19 pandemic, including its length and severity and

its effect on our business. During the first and second quarters of 2020, we implemented a resiliency plan focused on the
health and safety of our employees and maintaining continuity of our operations. We have seen an impact on instrument
revenue due to limitations on our ability to access certain customer sites and complete instrument installations, as well as
an impact on consumables revenue from interruptions in certain customer laboratories. We expect these COVID-19 related
challenges to continue until these customers return to normal operations.

In view of the pandemic, we have adjusted our operations to expand capacity in our Accelerator Laboratory to

support customers whose operations have been disrupted and to sustain clinical trials. We also determined that our cytokine
assay technology provides researchers with important and differentiated tools to study disease progression, cytokine release
syndrome, and patient-treatment response in the fight against COVID-19, and began developing a SARS- CoV-2 semi-
quantitative IgG assay and a SARS-CoV-2 antigen detection assay, and prototyping a high-definition multiplex SARS-
CoV-2 serology assay. In December 2020, the FDA issued an EUA for our Simoa Semi-Quantitative SARS-CoV-2 IgG
Antibody Test, and in January 2021, the FDA issued an EUA for our Simoa SARS-CoV-2 N Protein Antigen Test, each of
which is run on our HD-X instrument. We currently intend to pursue authorization for additional sample types, including
nasal swabs, saliva, and capillary dried blood obtained from a fingerstick. Preliminary clinical research studies suggest the
viral antigen may be readily detectable in asymptomatic and pre-symptomatic patients, and we are exploring extending the
test to screening applications, home-based sample collection and pooling to enable larger scale testing.

In September 2020, we entered into WP2 with the NIH under the RADx program. This contract, which has a total

award value of $18.2 million, is intended to accelerate the continued development, scale-up and deployment of our novel
SARS-CoV-2 antigen test. Initial early feasibility of this test was funded in part through WP1 we were granted in June
2020. WP2 supports clinical validation of the test in support of the EUA submissions with the FDA, and provides funding
to expand assay kit manufacturing capacity and commercial deployment readiness. Contract funding is subject to
achievement of pre-defined milestones and the contract period runs through September 2021.

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The COVID-19 situation remains dynamic and there remains significant uncertainty as to the length and severity
of the pandemic, the actions that may be taken by government authorities, the impact to the business of our customers and
suppliers, the long-term economic implications and other factors identified in “Part I, Item 1A, Risk Factors” of this
Annual Report on Form 10-K. We will continue to evaluate the nature and extent of the impact to our business, financial
condition, and operating results.

As of December 31, 2020, we had cash and cash equivalents of $181.6 million. Since inception, we have incurred
annual net losses. Our net loss was $31.5 million, $40.8 million, and $31.5 million for the years ended December 31, 2020,
2019, and 2018, respectively. As of December 31, 2020, we had an accumulated deficit of $247.8 million and stockholders'
equity of $206.1 million. We expect to continue to incur significant expenses and operating losses at least through the next
24 months. We expect our expenses will increase substantially as we:

●
●
●

●

●
●
●
●

expand our sales and marketing efforts to further commercialize our products;
strategically acquire companies or technologies that may be complementary to our business;
expand our research and development efforts to improve our existing products and develop and launch
new products, particularly if any of our products are deemed by the FDA to be medical devices or
otherwise subject to additional regulation by the FDA;
seek PMA or 510(k) clearance from the FDA for our existing products or new products if or when we
decide to market products for use in the prevention, diagnosis or treatment of a disease or other
condition;
hire additional personnel and continue to grow our employee headcount;
enter into collaboration arrangements, if any, or in-license other products and technologies;
add operational, financial and management information systems; and
continue to incur increased costs as a result of operating as a public company.

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Financial Operations Overview

Revenue

Under Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) Topic 606 -
Revenue from Contracts with Customers (ASC 606), an entity recognizes revenue when its customer obtains control of
promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for
those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope
of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the
performance obligations in the contract; (iii) determine the transaction price, including variable consideration, if any; (iv)
allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the
entity satisfies a performance obligation. We only apply the five-step model to contracts when it is probable that the entity
will collect the consideration to which it is entitled in exchange for the goods or services it transfers to the customer.

Once a contract is determined to be within the scope of ASC 606, we assess the goods or services promised within
each contract and determine those that are performance obligations. Arrangements that include rights to additional goods or
services that are exercisable at a customer’s discretion are generally considered options. We assess if these options provide
a material right to the customer and if so, they are considered performance obligations. The identification of material rights
requires judgments related to the determination of the value of the underlying license relative to the option exercise price,
including assumptions about technical feasibility and the probability of developing a candidate that would be subject to the
option rights. The exercise of a material right is accounted for as a contract modification for accounting purposes.

The transaction price is then determined and allocated to the identified performance obligations in proportion to
their standalone selling prices (SSP) on a relative SSP basis. SSP is determined at contract inception and is not updated to
reflect changes between contract inception and when the performance obligations are satisfied. Determining the SSP for
performance obligations requires significant judgment. In developing the SSP for a performance obligation, we consider
applicable market conditions and relevant entity-specific factors, including factors that were contemplated in negotiating
the agreement with the customer and estimated costs. We validate the SSP for performance obligations by evaluating
whether changes in the key assumptions used to determine the SSP will have a significant effect on the allocation of
arrangement consideration between multiple performance obligations.

We generate product revenue primarily from sales of our HD-X, HD-1, SR-X, and SP-X instruments and related

reagents and other consumables. We currently sell our products for RUO applications and our customers are primarily
laboratories associated with academic and governmental research institutions, as well as pharmaceutical, biotechnology
and contract research companies. Sales of our consumables have consistently increased due to an increasing number of
instruments being installed in the field, all of which require certain of our consumables to run customers’ specific tests.
Consumable revenue consists of sales of complete assays which are developed internally by us, plus sales of “homebrew”
kits which contain all the elements necessary to run tests with the exception of the specific antibodies utilized which are
separately provided by the customer.

Service and other revenue consists of testing services provided by us in our Accelerator Laboratory on behalf of
certain research customers, in addition to warranty and other service-based revenue. Services provided in our Accelerator
Laboratory include sample testing, homebrew assay development and custom assay development.

Collaboration and license revenue consists of revenue associated with licensing our technology to third parties and

for related services.

Grants received by us that do not require the transfer of goods or services to a customer are accounted for by

analogy to International Accounting Standards (IAS) 20, Accounting for Government Grants and Disclosure of
Government Assistance (IAS 20). Under IAS 20, we recognize revenue as the matching expense or asset is incurred or
capitalized.

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Cost of Products, Services and Collaboration Revenue

Cost of goods sold for products consists of HD-X, HD-1, and SR-X instrument costs from the manufacturer. Cost

of goods sold for SP-X consists of costs based on the internal assembly of this item. Raw material part costs, associated
freight, shipping and handling costs, contract manufacturer costs, salaries, personnel costs, royalties, stock-based
compensation, overhead and other direct costs related to those sales are classified as cost of goods sold for products.

Cost of goods sold for services consists of salaries and other personnel costs, royalties, stock-based compensation
and facility costs associated with operating the Accelerator Laboratory on behalf of customers, in addition to costs related
to warranties and other costs of servicing equipment at customer sites. Additionally, we incur costs related to cost of goods
sold under the NIH RADx program.

Cost of collaboration revenue consists of royalty expense due to third parties from revenue generated by

collaboration or license deals.

Research and Development Expenses

Research and development expenses consist of salaries and other personnel costs, stock-based compensation,

research supplies, third-party development costs for new products, materials for prototypes, and allocated overhead costs
that include facility and other overhead costs. We have made substantial investments in research and development since our
inception, and plan to continue to make substantial investments in the future. Our research and development efforts have
focused primarily on the tasks required to support development and commercialization of new and existing products. We
believe that our continued investment in research and development is essential to our long-term competitive position and
expect these expenses to increase in future periods. Additionally, costs incurred related to grant revenue are recorded as
research and development expenses.

Selling, General and Administrative Expenses

Selling, general and administrative expenses consist primarily of salaries and other personnel costs, and stock-

based compensation for our sales and marketing, finance, legal, human resources and general management, as well as
professional services, such as legal and accounting services. We expect selling, general and administrative expenses to
increase in future periods as the number of sales, technical support and marketing and administrative personnel grows and
we continue to introduce new products, broaden our customer base and grow our business. We also expect to incur
additional expenses as a public company, including expenses related to compliance with the rules and regulations of the
SEC and the Nasdaq Stock Market, additional insurance expenses, and expenses related to investor relations activities and
other administrative and professional services.

Critical Accounting Policies, Significant Judgments and Estimates

Our consolidated financial statements and the related notes included elsewhere in this Annual Report on Form 10-

K are prepared in accordance with accounting principles generally accepted in the United States. The preparation of these
consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets,
liabilities, revenue, costs and expenses and related disclosures. We base our estimates on historical experience and on
various other assumptions that we believe to be reasonable under the circumstances. Changes in accounting estimates may
occur from period to period. Accordingly, actual results could differ significantly from the estimates made by our
management. We evaluate our estimates and assumptions on an ongoing basis. To the extent that there are material
differences between these estimates and actual results, our future financial statement presentation, financial condition,
results of operations and cash flows will be affected.

We believe that the following critical accounting policies involve a greater degree of judgment and complexity

than our other significant accounting policies. Accordingly, these are the policies we believe are the most critical to
understanding and evaluating our consolidated financial condition and results of operations. Our significant accounting

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policies are more fully described in “Significant Accounting Policies” (Note 2) in the notes to our consolidated financial
statements included elsewhere in this Annual Report on Form 10-K.

Revenue Recognition

We recognize revenue when a customer obtains control of a promised good or service. The amount of revenue

recognized reflects consideration that we expect to be entitled to receive in exchange for these goods and services,
incentives and taxes collected from customers, that are subsequently remitted to governmental authorities.

We adopted ASC 606 on January 1, 2019, using the modified retrospective method for all contracts not completed

as of the date of adoption. The reported results for 2020 and 2019 reflect the application of ASC 606 guidance.

Product Revenue

Our products are composed of analyzer instruments, assay kits and other consumables such as reagents. Products
are sold directly to biopharmaceutical and academic research organizations or are sold through distributors in EMEA and
Asia Pacific regions. The sales of instruments are generally accompanied by an initial year of implied service-type
warranties and may be bundled with assays and other consumables and may also include other items such as training and
installation of the instrument and/or an extended service warranty. Revenues from the sale of products are recognized at a
point in time when we transfer control of the product to the customer, which is upon installation for instruments sold to
direct customers, and based upon shipping terms for assay kits and other consumables. Revenue for instruments sold to
distributors is generally recognized based upon shipping terms (either upon shipment or delivery).

Service and Other Revenue

Service revenues are composed of contract research services, initial implied one-year service-type warranties,

extended services contracts and other services such as training. Contract research services are provided through our
Accelerator Laboratory and generally consist of fixed fee contracts. Revenues from contract research services are
recognized at a point in time when we complete and deliver our research report on each individually completed study, or
over time if the contractual provisions allow for the collection of transaction consideration for costs incurred plus a
reasonable margin through the period of performance of the services. Revenues from service-type warranties are
recognized ratably over the contract service period. Revenues from other services are immaterial.

Collaboration and License Revenue

We may enter into agreements to license the intellectual property and know-how associated with its instruments in

exchange for license fees and future royalties (as described below). The license agreements provide the licensee with a
right to use the intellectual property with the license fee revenues recognized at a point in time as the underlying license is
considered functional intellectual property. We have recognized revenues from a sales- or usage based royalties related to
our licensing technology and intellectual property.

Payment Terms

Our payment terms vary by the type and location of customer and the products or services offered. Payment from

customers is generally required in a term ranging from 30 to 45 days from date of shipment or satisfaction of the
performance obligation with no discounts for early payment. Occasionally we do provide extended payment terms or
financing arrangements to customers.

Disaggregated Revenue

When disaggregating revenue, we considered all of the economic factors that may affect revenues. The following

tables disaggregate our revenue from contracts with customers by revenue type:

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(in thousands)
Product revenues
Instruments
Consumable and other products
Totals

Service and other revenues
Service-type warranties
Research services
Other services
Totals

Collaboration and license revenue
Collaboration and license revenue
Totals

(in thousands)
Product revenues
Instruments
Consumable and other products
Totals

Service and other revenues
Service-type warranties
Research services
Other services
Totals

Collaboration and license revenue
Collaboration and license revenue
Totals

Year Ended
December 31, 2020

 NA

 EMEA       Asia Pacific     

 Total

  $

 8,680
 14,305

$

 4,332
 10,854

$

  $  22,985   $  15,186   $

$  16,606
 3,594
 2,252
 27,411
 5,846   $  44,017

  $

 3,171
 15,011
 700
$  18,882

$

$

 1,543
 2,225
 435
 4,203

$

$

 207
 737  
 100
 1,044

$

 4,921
 17,973
 1,235
$  24,129

$  11,685
$
  $  11,685   $

 124
$
 124   $

 — $  11,809
 —   $  11,809

Year Ended
December 31, 2019

 NA

 EMEA       Asia Pacific     

 Total

  $

 6,250   $

 14,148  

 5,243   $
 9,674  

  $  20,398   $  14,917   $

 3,393   $  14,886
 1,783  
 25,605
 5,176   $  40,491

  $

 3,139   $
 8,845  
 825  

$  12,809

$

 1,323   $
 704  
 565  

 2,592

$

 171   $
 456  
 31  
 658

 4,633
 10,005
 1,421
$  16,059

$
  $

 167
$
 167   $

 17
$
 17   $

 — $
 —   $

 184
 184

Our contracts with customers may include promises to transfer multiple products and services to a customer. In

accordance with ASC 606, we combine any performance obligations that are immaterial with one or more other
performance obligations that are material to the contract. For arrangements with multiple performance obligations, we
allocate the contract transaction price, including discounts, to each performance obligation based on its relative standalone
selling price. Judgment is required to determine the standalone selling price for each distinct performance obligation. We
determine standalone selling prices based on prices charged to customers in observable transactions, and use a range of
amounts to estimate standalone selling prices for each performance obligation. We may have more than one range of
standalone selling price for certain products and services based on the pricing for different customer classes.

Variable consideration in our contracts primarily relates to (i) sales- and usage-based royalties related to the
license of intellectual property in collaboration and license contracts and (ii) certain non-fixed fee research services
contracts. ASC 606 provides for an exception to estimating the variable consideration for sales- and usage-based royalties
related to the license of intellectual property, such that the sales- or usage-based royalty will be recognized in the period the
underlying transaction occurs. We have recorded sales- or usage-based royalty revenue for the year ended December 31,
2020 and 2019 related to the intellectual property licensed by Uman. We recognize revenues from sales-

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or usage based royalty revenue at the later of when the sales or usage occurs; and the satisfaction or partial satisfaction of
the performance obligation to which the royalty has been allocated.

The aggregate amount of transaction price that is allocated to performance obligations that have not yet been

satisfied or are partially satisfied as of December 31, 2020 is $6.0 million. Of the performance obligations not yet satisfied
or are partially satisfied, $5.4 million is expected to be recognized as revenue in the next 12 months, with the remainder to
be recognized within the 24 months thereafter. The $5.4 million principally consists of amounts billed for undelivered
services related to initial and extended service-type warranties and research services, as well as $0.5 million related to
undelivered licenses of intellectual property for a diagnostics company. During the year ended December 31, 2020, we
recognized $1.2 million of previously deferred revenue as a result of entering into a license agreement with a diagnostics
company (see Note 13).

We have classified the balance of capitalized costs to obtain a contract as a component of prepaid expenses and

other current assets as of December 31, 2020 and classified the expense as a component of cost of goods sold and selling,
general and administrative expense over the estimated life of the contract. We consider potential impairment in these
amounts each period.

ASC 606 provides entities with certain practical expedients and accounting policy elections to minimize the cost

and burden of adoption.

We exclude from the transaction price any amounts collected from customers related to sales and other similar

taxes.

When determining the transaction price of a contract, an adjustment is made if payment from a customer occurs

either significantly before or significantly after performance, resulting in a significant financing component. We do not
assess whether a significant financing component exists if the period between when we perform our obligations under the
contract and when the customer pays is one year or less. None of our contracts contained a significant financing component
for the years ended December 31, 2020 and 2019.

We have elected to account for the shipping and handling as an activity to fulfill the promise to transfer the

product, and therefore will not evaluate whether shipping and handling activities are promised services to its customers.

Grant Revenue

We recognize grant revenue as we perform services under the arrangement when the funding is committed.

Revenues and related research and development expenses are presented gross in the consolidated statements of operations
as we have determined we are the primary obligor under the arrangement relative to the research and development services.

Accounting for grants does not fall under ASC 606, as the grantor will not benefit directly from our expansion or

product development. As there is no authoritative guidance under U.S. GAAP on accounting for grants to for-profit
business entities, we have accounted for grants by analogy to IAS 20.

Our grants contain both monetary amounts granted related to assets and monetary amounts granted related to

income, which are grants other than those related to assets. The grants related to assets are for the expansion and increase
of manufacturing capacity. The grants related to income are for additional research and development, as well as other non-
asset related scale up costs. We determined it was appropriate to account for each monetary grant amount under the
appropriate accounting treatment outlined in IAS 20.

Under IAS 20, grants related to assets shall be presented in the consolidated balance sheets either by recognizing
the grant as deferred income (which is recognized in the consolidated statements of operations on a systematic basis over
the useful life of the asset), or by deducting the grant in calculating the carrying amount of the asset (which is recognized in
the consolidated statements of operations over the life of the depreciable asset as a reduced

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depreciation expense). Both methods are acceptable under IAS 20. We have elected to record grants related to assets as a
deduction in calculating the carrying value of the asset.

Under IAS 20, grants related to income are presented as part of the consolidated statements of operations, either

separately or under a general heading. Both methods are acceptable under IAS 20. We have elected to record grants related
to income separately on the consolidated statements of operations as grant revenue. The related expenses are recorded
within operating expenses and not deducted.

On June 22, 2020, we entered into WP1 under the NIH’s RADx program to assess the feasibility of a novel
SARS-CoV-2 antigen detection test using our Simoa technology. During the year ended December 31, 2020 we recognized
$2.0 million of grant revenue and incurred $1.0 million in research and development expense related to WP1. WP1 is
complete as of December 31, 2020.

On September 29, 2020, we entered into WP2 with the NIH under its RADx program. The contract, which has a
total award value of $18.2 million, accelerates the continued development, scale-up, and deployment of the novel SARS-
CoV-2 antigen detection test using our Simoa technology. The contract provides funding to expand assay kit manufacturing
capacity and commercial deployment readiness. Release of the $18.2 million of funding under WP2 is based on the
achievement of certain milestones, and there is no assurance that we can meet all the milestones on a timely basis, if at all.
If we do not meet all the milestones, we will not be able access the full $18.2 million in funding under the contract. During
the year ended December 31, 2020 we recognized $4.4 million in grant revenue and incurred $2.6 million in research and
development expense related to WP2.

The following table summarizes the activity under WP2 as of December 31, 2020 (in thousands):

Total grant revenue from research and development activities
Total proceeds used for assets
Total deferred proceeds for assets
Total deferred grant revenue
Total recognized

Total recognized
Total amount accrued
Total cash received

Total proceeds received
Total proceeds reasonably assured
Total WP2 grant amount

Stock-Based Compensation

$

$

$

$

$

$

 4,362
 826
 2,478
 304
 7,970

 7,970
 (2,968)
 5,002

 5,002
 13,198
 18,200

We account for stock-based compensation awards in accordance with ASC 718, Compensation—Stock
Compensation (ASC 718). ASC 718 requires all stock-based payments to employees, including grants of employee stock
options, to be recognized in the statement of operations based on their fair values. Stock-based compensation awards have
historically consisted of stock options and restricted stock. Prior to the adoption of Accounting Standards Update (ASU)
No. 2018-07, Compensation - Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment
Accounting (ASU 2018-07), the measurement date for non-employee awards was generally the date the services were
completed, resulting in financial reporting period adjustments to stock-based compensation during the vesting period for
changes in the fair value of the awards. We adopted ASU 2018-07 on January 1, 2020. After the adoption of ASU 2018-07,
the measurement date for non-employee awards is the date of grant without changes in the fair value of the award. Stock-
based compensation costs for non-employees are recognized as expense over the vesting period on a straight-line basis.
There were no material non-employee awards outstanding during the years ended December 31, 2020, 2019, and 2018.

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We estimate the grant date fair value, and the resulting stock-based compensation expense, using the Black-
Scholes option-pricing model. The grant date fair value of the stock-based awards is generally recognized on a straight-line
basis over the requisite service period, which is generally the vesting period of the respective awards.

The fair value of stock options granted to employees and non-employees is estimated on the grant date using the

Black-Scholes option-pricing model, based on the assumptions noted in the following table:

Risk-free interest rate
Expected dividend yield
Expected term (in years)
Expected volatility

2020

Year Ended December 31, 
2019
0.4% - 1.7%    1.4% - 2.6%    2.6% - 3.0%  
None
6.0
  43.9% - 49.2%   33.5% - 39.7% 32.4% - 36.8%  

None
5.9

None
6.0

2018

Using the Black-Scholes option-pricing model, the weighted-average grant date fair value of options granted for

the years ended December 31, 2020, 2019, and 2018 was $12.66, $9.09, and $7.19 per share, respectively. Expected
volatility was calculated based on proportional weighting of reported volatility data for a representative group of guideline
publicly traded companies for which historical information was available, as well as our stock. The risk-free interest rate is
based on the U.S. Treasury yield curve in effect at the time of grant, commensurate with the expected life assumption. We
estimate the expected life of options granted to employees utilizing the simplified method which calculates the expected
life of an option as the average of the time to vesting and contractual life of the options. The expected life is applied to the
stock option grant group as a whole, as we do not expect substantially different exercise or post-vesting termination
behavior among our employee population. We use the simplified method due to the lack of historical exercise data and the
plain nature of the stock options. We use the remaining contractual term for the expected life of non-employee awards. The
expected dividend yield is assumed to be zero as we have never paid dividends and have no current plans to pay any
dividends on common stock.

For the years ended December 31, 2020, 2019, and 2018 stock-based compensation expense was $10.1 million,

$6.4 million, and $4.9 million, respectively.

The table below summarizes the stock-based compensation expense recognized in our statements of operations by

classification (in thousands):

Cost of product revenue
Cost of service and other revenue
Research and development
General and administrative
Total

Year Ended December 31, 
2019

2018

2020

$

 189
 311
 1,129
 8,470
$  10,099

$

$

 86
 238
 718
 5,346
 6,388

$

$

 55
 173
 513
 4,143
 4,884

As of December 31, 2020, we had $21.3 million of total unrecognized stock-based compensation costs which we

expect to recognize over a weighted-average period of 4.7 years.

Prior to our initial public offering (IPO) in December 2017, the fair value of our common stock underlying our

stock options was estimated on each grant date by our board of directors. In order to determine the fair value of our
common stock underlying granted stock options, our board of directors considered, among other things, the most recent
valuations of our common stock prepared by an unrelated third-party valuation firm in accordance with the guidance
provided by the American Institute of Certified Public Accountants Practice Guide, Valuation of Privately-Held-Company
Equity Securities Issued as Compensation.

Given the absence of a public trading market for our common stock, our board of directors exercised reasonable

judgment and considered a number of objective and subjective factors to determine the best estimate of the fair value of our
common stock, including (1) our business, financial condition and results of operations, including related industry

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trends affecting our operations; (2) our forecasted operating performance and projected future cash flows discounted to
present value using our estimated weighted average cost of capital; (3) the illiquid nature of our common stock;
(4) liquidation preferences and other rights and privileges of our preferred stock over our common stock; (5) likeliness and
estimated timing of the potential option to have our stock become publicly traded; (6) market multiples of our most
comparable public peers; (7) recently completed equity financing transactions; and (8) market conditions affecting our
industry.

Since the completion of our IPO, we have determined the fair value of each common share underlying share-based

awards based on the closing price of our common shares as reported by Nasdaq on the date of grant.

Results of Operations

Comparison of the Years Ended December 31, 2020 and December 31, 2019 (dollars in thousands):

Product revenue
Service and other revenue
Collaboration and license revenue
Grant revenue

Total revenue
Cost of goods sold:
Cost of product revenue
Cost of service revenue
Cost of collaboration and license revenue
Total costs of goods sold, services, and licenses
Gross profit
Operating expenses:
Research and development
Selling, general, and administrative

Total operating expense
Loss from operations
Interest income (expense), net
Other expense, net
Loss before income taxes
Income tax benefit
Net loss

Revenue

Year Ended     

$

December 31, 
2020
 44,017  
 24,129  
 11,809  
 6,422

% of
revenue
 52 %    $
 28 %   
 14 %   
 6 %  

     Year Ended     
% of
December 31, 
revenue
2019
 72 %    $  3,526  
 40,491  
 8,070  
 28 %   
 16,059  
   11,625  
 184  
 — %   
 6,422
 —  — %  

$
change

%
change
 9 %
 50 %
 6,318 %
 100 %  

 86,377  

100 %   

 56,734  

100 %   

   29,643  

 52 %

 25,950  
 11,245  
 1,000
 38,195  
 48,182  

 30 %   
 13 %   
 1 %  
 44 %   
 56 %   

 20,900  
 8,998  

 37 %   
 16 %   
 —  — %  
 53 %   
 47 %   

 29,898  
 26,836  

 5,050  
 2,247  
 1,000
 8,297  
   21,346  

 24 %
 25 %
 100 %  
 28 %
 80 %

 20,174  
 59,592  

 23 %   
 69 %   

 16,190  
 52,246  

 29 %   
 92 %   

 3,984  
 7,346  

 25 %
 14 %

 79,766  
 (31,584) 
 (273) 
 (49) 
 (31,906) 
 376  
$  (31,530) 

 68,436  
 92 %   
 (41,600) 
 (37)%   
 627  
 — %   
 (10) 
 — %   
 (40,983) 
 (37)%   
 — %   
 187  
 (37)%    $  (40,796) 

   11,330  
121 %   
   10,016  
 (73)%   
 (900) 
 1 %  `
 (39) 
 — %   
 9,077  
 (72)%   
 — %   
 189  
 (72)%    $  9,266  

 17 %
 24 %
 (144)%
 (390)%
 22 %
 101 %
 23 %

Revenue increased by $29.6 million, or 52%, to $86.4 million for the year ended December 31, 2020 as compared

to $56.7 million for the year ended December 31, 2019. Product revenue consisted of sales of instruments totaling
$16.6 million and sales of consumables and other products of $27.4 million for the year ended December 31, 2020. Product
revenue consisted of sales of instruments totaling $14.9 million and sales of consumables and other products totaling
$25.6 million for the year ended December 31, 2019. Average sales prices of instruments and consumables did not change
materially for the year ended December 31, 2020 as compared with the year ended December 31, 2019. The increase in
product revenue of $3.5 million was due to the sale of more instruments for the year ended December 31, 2020 and
increased sales of consumables. The installed base of instruments increased from December 31, 2019 to December 31,
2020, and as these additional instruments were used by customers, the consumables sales increased. The increase in service
and other revenue of $8.1 million was primarily due to increased services performed in our Accelerator Laboratory; more
customers use these services, and existing customers use these services more frequently. In addition, an increase in
purchased warranties contributed to the service and other revenue increase. Collaboration and license revenue for the year
ended December 31, 2020 of $11.8 million was related to entering into

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the Abbott License Agreement, and from existing contracts related to licensing technology and intellectual property.
Collaboration and license revenue for the year ended December 31, 2019 of $0.2 million was related to licensing
technology and intellectual property. Grant revenue of $6.4 million for the year ended December 31, 2020 consisted of
revenue related to WP1 and WP2. We did not have any grant revenue during the year ended December 31, 2019.

Cost of Goods Sold and Services

Cost of product revenue increased by $5.1 million, or 24%, to $26.0 million for the year ended December 31,

2020 as compared to $20.9 million for the year ended December 31, 2019. The increase was primarily due to our product
revenue increase, as well as a full year of costs incurred from the amortization of the Uman acquisition-related inventory
valuation adjustment and acquired intangibles for the year ended December 31, 2020, as compared to only six months of
these costs during the year ended December 31, 2019. Cost of service revenue increased to $11.2 million for the year ended
December 31, 2020 from $9.0 million for the year ended December 31, 2019. The increase was primarily due to higher
utilization of the Accelerator Laboratory, plus increased personnel costs from the build out of our field service and
Accelerator organization. Cost of collaboration and license revenue of $1.0 million resulted from the licensing of certain
technology and intellectual property to Abbott during the year ended December 31, 2020. No cost of collaboration and
license revenue was incurred during the year ended December 31, 2019. Overall cost of goods sold and services as
a percentage of revenue decreased to 44% of total revenue for the year ended December 31, 2020 as compared to 53% for
the year ended December 31, 2019, primarily as a result of the significant increase in collaboration and license revenue.

Research and Development Expense

Research and development expense increased by $4.0 million, or 25%, to $20.2 million for the year ended
December 31, 2020 as compared to $16.2 million for the year ended December 31, 2019. The increase was primarily due to
compensation, development, materials, and other expenses related to work under WP1 and WP2 incurred during the year
ended December 31, 2020.

Selling, General and Administrative Expense

Selling, general and administrative expense increased by $7.3 million, or 14%, to $59.6 million for the year ended
December 31, 2020 as compared to $52.2 million for the year ended December 31, 2019. The increase was primarily due to
headcount additions in various departments as we build out our organization to support growth.

Interest Income (Expense), Net and Other Expense, Net

Interest income (expense), net and other expense, net decreased by $0.9 million for the year ended December 31,
2020 as compared to the same period in 2019, primarily due to the unfavorable impact of COVID-19 on the interest rates
of our cash equivalents during the year ended December 31, 2020.

Income Tax Benefit

Income tax benefit was $0.4 million for the year ended December 31, 2020 as compared to $0.2 million for the

same period in 2019. The change is primarily due to the increase in the tax benefit recorded on the operating results of our
foreign subsidiaries.

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Comparison of the Years Ended December 31, 2019 and December 31, 2018 (dollars in thousands):

Product revenue
Service and other revenue
Collaboration and license revenue
Grant revenue

Year Ended     

$

December 31, 
2019
 40,491  
 16,059  
 184  
 —  — %

% of
revenue
 72 %    $
 28 %   
 — %   

     Year Ended     
December 31, 
2018
 23,365  
 12,117  
 2,150  

$
change

% of
revenue
 62 %    $  17,126  
 32 %   
 3,942  
 (1,966) 
 6 %   
 —

%
change

 73 %
 33 %
 (91)%
 — %

 —  — %

Total revenue
Cost of goods sold:
Cost of product revenue
Cost of service revenue
Total costs of goods sold, services, and licenses
Gross profit
Operating expenses:
Research and development
Selling, general, and administrative

 56,734  

100 %   

 37,632  

100 %   

 19,102  

 51 %

 20,900  
 8,998  
 29,898  
 26,836  

 37 %   
 16 %   
 53 %   
 47 %   

 12,729  
 6,955  
 19,684  
 17,948  

 34 %   
 18 %   
 52 %   
 48 %   

 8,171  
 2,043  
 10,214  
 8,888  

 16,190  
 52,246  

 29 %   
 92 %   

 15,805  
 33,693  

 42 %   
 90 %   

 385  
 18,553  

 64 %
 29 %
 52 %
 50 %

 2 %
 55 %

Total operating expense
Loss from operations
Interest income, net
Other expense, net
Loss before income taxes
Income tax benefit (provision)
Net loss

Revenue

 68,436  
 (41,600) 
 627  
 (10) 
 (40,983) 
 187  
$  (40,796) 

 49,498  
121 %   
 (31,550) 
 (73)%   
 46  
 — %   
 (7) 
 — %   
 (31,511) 
 (72)%   
 — %   
 (25) 
 (72)%    $  (31,536) 

 18,938  
132 %   
   (10,050) 
 (84)%   
 581  
 — %  `
 (3) 
 — %   
 (9,472) 
 (84)%   
 — %   
 212  
 (84)%    $  (9,260) 

 38 %
 (32)%
 1,263 %
 (43)%
 (30)%
 848 %
 (29)%

Revenue increased by $19.1 million, or 51%, to $56.7 million for the year ended December 31, 2019 as compared

to $37.6 million for the year ended December 31, 2018. Product revenue consisted of sales of instruments totaling
$14.9 million and sales of consumables and other products of $25.6 million for the year ended December 31, 2019. Product
revenue consisted of sales of instruments totaling $9.6 million and sales of consumables and other products totaling
$13.8 million for the year ended December 31, 2018. Average sales prices of instruments and consumables did not change
materially for the year ended December 31, 2019 as compared with the year ended December 31, 2018. The increase in
product revenue of $17.1 million was primarily due to the sale of more instruments for the year ended December 31, 2019
and increased sales of consumables. The installed base of instruments increased from December 31, 2018 to December 31,
2019, and as these additional instruments were used by customers, the consumables sales increased. The increase in service
and other revenue of $3.9 million was primarily due to increased services performed in our Accelerator Laboratory; more
customers use these services, and existing customers use these services more frequently. In addition, an increase in
purchased warranties contributed to the service and other revenue increase. Collaboration and license revenue for the year
ended December 31, 2019 of $0.2 million was related to licensing technology and intellectual property. Collaboration and
license revenue for the year ended December 31, 2018 of $2.2 million was related to the termination of the collaboration
arrangement with bioMérieux.

Cost of Goods Sold and Services

Cost of product revenue increased by $8.2 million, or 64%, to $20.9 million for the year ended December 31,

2019 as compared to $12.7 million for the year ended December 31, 2018. The increase was primarily due to an increase in
sales of consumables and instruments, along with costs incurred from the amortization of the Uman acquisition-related
inventory valuation adjustment and acquired intangibles. Cost of service revenue increased to $9.0 million for the year
ended December 31, 2019 from $7.0 million for the year ended December 31, 2018. The increase was primarily due to
higher utilization of the Accelerator Laboratory, plus increased personnel costs from the build out of our field service and
Accelerator organization. Overall cost of goods sold and services as a percentage of revenue increased slightly to 53% of
total revenue for the year ended December 31, 2019 as compared to 52% for the year ended

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December 31, 2018, primarily as a result of the impact of the collaboration arrangement with bioMérieux during the year
ended December 31, 2018 and the impact of the Uman acquisition-related charges during the year ended December 31,
2019.

Research and Development Expense

Research and development expense increased slightly by $0.4 million, or 2%, to $16.2 million for the year ended

December 31, 2019 as compared to $15.8 million for the year ended December 31, 2018. The increase was primarily due to
the development of the SP-X and HD-X and increased headcount in research and development.

Selling, General and Administrative Expense

Selling, general and administrative expense increased by $18.6 million, or 55%, to $52.2 million for the year

ended December 31, 2019 as compared to $33.7 million for the year ended December 31, 2018. The increase was primarily
due to headcount additions in various departments as we build out our organization to support future growth, public
company costs, the lease for the new headquarters, and stock-based compensation expense. In addition, we incurred
approximately $1.9 million in costs associated with the acquisition of Uman during the year ended December 31, 2019.

Interest Income, Net and Other Expense, Net

Interest income, net and other expense, net increased by $0.6 million for the year ended December 31, 2019 as

compared to the same period in 2018, primarily due to the interest income earned on cash equivalents, which increased due
to our “at-the-market” and underwritten public offerings completed during 2019.

Income Tax Benefit (Provision)

Income tax benefit was $0.2 million for the year ended December 31, 2019 as compared to a provision of less than

$0.1 million for the same period in 2018. The increase is primarily due to certain state and international taxes in 2019,
which we did not have in the prior year.

Liquidity and Capital Resources

Since our inception, we have incurred annual net losses and negative cash flows from operations. We incurred net

losses of $31.5 million, $40.8 million and $31.5 million and used $23.4 million, $26.2 million and $28.7 million of cash
from our operating activities for the years ended December 31, 2020, 2019, and 2018, respectively. As of December 31,
2020, we had an accumulated deficit of $247.8 million.

As of December 2020, we had cash and cash equivalents of $181.6 million and no additional amounts were

available to borrow under our debt facility.

On February 3, 2021, we received approximately $269.6 million in net proceeds related to an underwritten public

offering.

Sources of Liquidity

To date, we have financed our operations principally through equity offerings, borrowings from credit facilities

and revenue from our commercial operations.

Equity Offerings

In December 2017, we completed our IPO in which we sold 4,916,480 shares of common stock at an initial public

offering price of $15.00 per share. The aggregate net proceeds received by us from the offering, net of

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underwriting discounts and commissions and offering expenses, were $65.6 million. Prior to the IPO, we had raised capital
through the sale of redeemable convertible preferred stock in private placement transactions.

On March 19, 2019, we entered into a Sales Agreement for an “at-the-market offering” arrangement with Cowen

and Company, LLC (Cowen), which allowed us to issue and sell shares of common stock pursuant to a shelf registration
statement for total gross sales proceeds of up to $50.0 million from time to time through Cowen, acting as our agent.
During the year ended December 31, 2019, we sold an aggregate of 2,186,163 shares of common stock pursuant to this
agreement resulting in $49.7 million in gross proceeds and $48.0 million in net proceeds. On August 6, 2020, we delivered
written notice to Cowen to terminate the Sales Agreement, which termination the parties agreed to make immediately
effective.

On August 8, 2019, we entered into an underwriting agreement with J.P. Morgan Securities LLC and SVB Leerink

LLC, or Leerink, as representatives of the several underwriters, relating to an underwritten public offering of 2,732,673
shares of common stock at a public offering price of $25.25 per share. We received $69.0 million in gross proceeds and
$64.5 million in net proceeds.

On August 6, 2020, we entered into an underwriting agreement with Leerink and Cowen, as representatives of the

several underwriters, relating to an underwritten public offering of 3,048,774 shares of common stock at a public offering
price of $32.00 per share. We received $97.6 million in gross proceeds and $91.4 million in net proceeds.

On February 3, 2021, we entered into an underwriting agreement with Goldman Sachs & Co. LLC, Leerink and
Cowen, as representatives of the several underwriters, relating to an underwritten public offering of 4,107,142 shares of
common stock at a public offering price of $70.00 per share. We received $287.5 million in gross proceeds and
approximately $269.6 million in net proceeds.

Loan Facility with Hercules

On April 14, 2014, we executed a Loan Agreement with Hercules, as subsequently amended, most recently in

April 2019. The Loan Agreement provided a total debt facility of $10.0 million, which is secured by substantially all of our
assets. At closing, we borrowed $5.0 million in principal and had the ability to draw the additional $5.0 million over the
period from November 1, 2014 to March 31, 2015. The interest rate on this term loan was variable based on a calculation
of 8% plus the prime rate less 5.25%, with a minimum interest rate of 8%. Interest was to be paid monthly beginning
the month following the borrowing date. Principal payments were scheduled to begin on September 1, 2015, unless we
achieved certain milestones which would have extended this date to December 1, 2015 or March 1, 2016. In connection
with the execution of the Loan Agreement, we issued Hercules a warrant to purchase up to 173,428 shares of our Series C
Preferred Stock at an exercise price of $3.3299 per share. Upon closing of the IPO, this warrant was automatically
converted into a warrant to purchase up to 53,960 shares of our common stock at an exercise price of $10.70 per share.

In August 2018, we signed Amendment 5 to the Loan Agreement, which extended the interest only payment

period through March 1, 2020 and also extended the loan maturity date to March 1, 2020. We accounted for the
August 2018 amendment as a modification pursuant to ASC 470-50 and determined that no material change occurred as a
result of the modification. In addition, the amendment deferred the payment of principal until the maturity date. We paid
$0.1 million in end of term payments related to Amendment 5 during the year ended December 31, 2020.

In October 2018, we signed Amendment 6 to the Loan Agreement, which amended the Loan Agreement's
collateral clause to exclude the $1 million certificate of deposit associated with the lease on our new headquarters in
Billerica, Massachusetts. The Loan Agreement and amendments contain end of term payments and are recorded in the debt
accounts. We paid $0.5 million in end of term payments related to Amendment 6 during the year ended December 31,
2018.

On April 15, 2019, we entered into Amendment 7 to the Loan Agreement, which extended the interest only
payment period through July 1, 2021 and also extended the loan maturity date to October 1, 2021. We are required to

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pay the loan principal in five equal monthly installments starting July 1, 2021 with the final principal payment to be made
on October 1, 2021.

On July 2, 2019, 66,041 warrants were exercised by Hercules on a net, non-cash, basis. Per the terms of the

warrant agreement, we issued 45,690 shares of common stock as a result of the net exercise. The Loan Agreement and
amendments contain end of term payments and are recorded in the debt accounts. No end of term payments were paid in
the year ended December 31, 2019. We paid $0.1 million in end of term payments related to Amendment 5 during the year
ended December 31, 2020.

The Loan Agreement contains negative covenants restricting our activities, including limitations on dispositions,

mergers or acquisitions, incurring indebtedness or liens, paying dividends or making investments and certain other business
transactions. There are no financial covenants associated with the Loan Agreement. The obligations under the Loan
Agreement are subject to acceleration upon the occurrence of specified events of default, including a material adverse
change in our business, operations or financial or other condition, which is subjective in nature. We have determined that
the risk of subjective acceleration under the material adverse events clause is not probable and therefore have classified the
outstanding principal in current and long-term liabilities based on scheduled principal payments.

Debt principal repayments, including the end of term fees, due as of December 31, 2020 are (in thousands):

Years ending December 31, 
2021

Uman Acquisition

$
$

 7,738
 7,738

In August 2019, we completed the acquisition of Uman, in which we paid $15.7 million in cash to the
shareholders of Uman. We funded this payment through our existing cash balances. In addition, we issued $5.5 million in
stock in connection with the purchase of Uman. The acquisition closed with respect to 95% of the outstanding shares of
capital stock of Uman on July 1, 2019 and with respect to the remaining 5% of the outstanding shares of capital stock of
Uman on August 1, 2019.

Cash Flows

The following table presents our cash flows for each period presented (in thousands):

Net cash used in operating activities
Net cash used in investing activities
Net cash provided by (used in) financing activities
Net increase (decrease) in cash and cash equivalents

Net Cash Used in Operating Activities

2020
$  (23,365)
 (626)
 96,236
$  72,245

Year Ended December 31, 
2019
$  (26,187)
 (25,376)
 116,197
$  64,634

2018
$  (28,721)
 (5,454)
 (78)
$  (34,253)

We derive cash flows from operations primarily from the sale of our products and services. Our cash flows from

operating activities are also significantly influenced by our use of cash for operating expenses to support the growth of our
business. We have historically experienced negative cash flows from operating activities as we have developed our
technology, expanded our business and built our infrastructure and this may continue in the future.

Net cash used in operating activities was $23.4 million during the year ended December 31, 2020. Net cash used
in operating activities primarily consisted of net loss of $31.5 million offset by non-cash charges of $10.1 million of stock-
based compensation expense and $4.3 million of depreciation and amortization expense. Cash used as a result of changes
in operating assets and liabilities of $7.5 million was primarily due to an increase in an increase in accounts

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receivable of $6.2 million, an increase in inventory of $5.1 million, and an increase in prepaid expenses and other assets of
$3.9 million, offset by a decrease in accrued compensation and benefits and other accrued expenses of $6.2 million.

Net cash used in operating activities was $26.2 million during the year ended December 31, 2019. Net cash used
in operating activities primarily consisted of net loss of $40.8 million offset by non-cash charges of $6.4 million of stock-
based compensation expense, $3.0 million of depreciation and amortization expense, and $0.6 of inventory valuation
adjustment amortization. Cash provided as a result of changes in operating assets and liabilities of $4.4 million was
primarily due to a $9.8 million increase in other non-current liabilities related to our lease, offset by an increase in accounts
receivable of $3.4 million, and an increase in inventory of $3.4 million.

Net cash used in operating activities was $28.7 million during the year ended December 31, 2018. Net cash used

in operating activities primarily consisted of net loss of $31.5 million, a decrease of $1.9 million in deferred revenue and an
increase of $1.6 million in inventory, primarily offset by non-cash stock compensation expense of $4.9 million and an
increase of $1.3 million in accounts payable.

Net Cash Used in Investing Activities

Historically, our primary investing activities have consisted of capital expenditures for the purchase of capital
equipment to support our expanding infrastructure and work force. We expect to continue to incur additional costs for
capital expenditures related to these efforts in future periods.

We used $0.6 million of cash in investing activities during the year ended December 31, 2020 consisting of $3.9

million in additions to property and equipment, offset by $3.3 million in grant proceeds related to assets acquired under
WP2.

We used $25.4 million of cash in investing activities during the year ended December 31, 2019. The significant

increase was related to the cash portion of the Uman acquisition, as well as the leasehold improvements for our
headquarters, which is a component of our lease agreement.

We used $5.5 million of cash in investing activities during the year ended December 31, 2018 consisting of cash

paid in the acquisition of Aushon, net of cash acquired, and for purchases of capital equipment to support our
infrastructure.

Net Cash Provided by (Used in) Financing Activities

Historically, we have financed our operations principally through private placements of our convertible preferred

stock and borrowings from credit facilities, the sale of shares of our common stock in our IPO or other offerings and
revenues from our commercial operations.

Financing activities provided $96.2 million of cash during the year ended December 31, 2020, primarily from net

proceeds of our underwritten public offering during the third quarter of 2020.

Financing activities provided $116.2 million of cash during the year ended December 31, 2019, primarily from

proceeds of our “at-the-market” offering during the second quarter of 2019 and our underwritten public offering during the
third quarter of 2019.

We used $0.1 million cash in financing activities during the year ended December 31, 2018, which primarily was

from payments on debt of $1.9 million offset by cash generated by the exercise of stock options.

Capital Resources

We have not achieved profitability on an annual basis since our inception, and we expect to continue to incur net

losses in the future. We also expect that our operating expenses will increase as we continue to increase our marketing
efforts to drive adoption of our commercial products. Additionally, as a public company, we have incurred

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and will continue to incur significant audit, legal and other expenses that we did not incur as a private company. Our
liquidity requirements have historically consisted, and we expect that they will continue to consist, of sales and marketing
expenses, research and development expenses, working capital, debt service and general corporate expenses.

We believe cash generated from commercial sales, our current cash and cash equivalents, and interest income we

earn on these balances will be sufficient to meet our anticipated operating cash requirements for at least the next 12
months. In the future, we expect our operating and capital expenditures to increase as we increase headcount, expand our
sales and marketing activities and grow our customer base. Our estimates of the period of time through which our financial
resources will be adequate to support our operations and the costs to support research and development and our sales and
marketing activities are forward-looking statements and involve risks and uncertainties and actual results could vary
materially and negatively as a result of a number of factors, including the factors discussed in Item 1A, “Risk Factors” of
this Annual Report on Form 10-K. We have based our estimates on assumptions that may prove to be wrong and we could
utilize our available capital resources sooner than we currently expect. Our future funding requirements will depend on
many factors, including:

● market acceptance of our products;
● the cost and timing of establishing additional sales, marketing and distribution capabilities;
● the cost of our research and development activities;
● our ability to enter into collaborations in the future, and the success of any such collaborations;
● the cost and timing of potential regulatory clearances or approvals that may be required in the future for our

products; and

● the effect of competing technological and market developments.

We cannot assure you that we will be able to obtain additional funds on acceptable terms, or at all. If we raise

additional funds by issuing equity or equity-linked securities, our stockholders may experience dilution. Future debt
financing, if available, may involve covenants restricting our operations or our ability to incur additional debt. Any debt or
equity financing that we raise may contain terms that are not favorable to us or our stockholders. If we raise additional
funds through collaboration and licensing arrangements with third parties, it may be necessary to relinquish some rights to
our technologies or our products, or grant licenses on terms that are not favorable to us. If we do not have or are not able to
obtain sufficient funds, we may have to delay development or commercialization of our products. We also may have to
reduce marketing, customer support or other resources devoted to our products or cease operations.

If the conditions for raising capital are favorable, we may seek to finance future cash needs through public or

private equity or debt offerings or other financings. On November 6, 2020, we filed an automatically effective shelf
registration statement with the SEC. Each issuance of securities under the shelf registration statement will require the filing
of a prospectus supplement identifying the amount and terms of securities to be issued.  The registration statement does not
limit the amount of securities that may be issued thereunder. Our ability to issue securities is subject to market conditions
and other factors. This registration statement will expire on November 6, 2023, three years after its date of effectiveness.

Off-Balance Sheet Arrangements

We did not have, during the periods presented, and we do not currently have, any off-balance sheet arrangements,

as defined under applicable SEC rules.

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Contractual Obligations, Commitments and Contingencies

The following table summarizes our contractual obligations as of December 31, 2020 (in thousands):

(in thousands)
Contractual Obligations:(1)
Operating lease obligations
Principal payments and end of term fees on the term loan
Total

Payments due by period

2022

2024

     through      through     

2021

2023

2025

2026
and
thereafter

Total

$  3,388
 7,738
$  11,126

$  6,981
 —
$  6,981

$  7,212
 —
$  7,212

$

$

 18,548
 —
 18,548

$  36,129
 7,738
$  43,867

(1)

See “Development and Supply Agreement” for additional contractual obligations.

We also have ongoing obligations related to license agreements which contain immaterial minimum annual

payments that are credited against the actual royalty expense.

Purchase orders or contracts for the purchase of supplies and other goods and services are not included in the table
above. We are not able to determine the aggregate amount of such purchase orders that represent contractual obligations, as
purchase orders may represent authorizations to purchase rather than binding agreements. Our purchase orders are based on
our current procurement or development needs and are fulfilled by our vendors within short time horizons.

Loan Facility with Hercules

On April 14, 2014, we executed a Loan Agreement with Hercules, as subsequently amended, most recently in

April 2019. The Loan Agreement provided a total debt facility of $10.0 million, which is secured by substantially all of our
assets. At closing, we borrowed $5.0 million in principal and had the ability to draw the additional $5.0 million over the
period from November 1, 2014 to March 31, 2015. The interest rate on this term loan was variable based on a calculation
of 8% plus the prime rate less 5.25%, with a minimum interest rate of 8%. Interest was to be paid monthly beginning the
month following the borrowing date. Principal payments were scheduled to begin on September 1, 2015, unless we
achieved certain milestones which would have extended this date to December 1, 2015 or March 1, 2016. In connection
with the execution of the Loan Agreement, we issued Hercules a warrant to purchase up to 173,428 shares of our Series C
Preferred Stock at an exercise price of $3.3299 per share. Upon closing of the IPO, this warrant was automatically
converted into a warrant to purchase up to 53,960 shares of our common stock at an exercise price of $10.70 per share.

Leases

On January 1, 2020, we adopted ASC Topic 842 – Leases (ASC 842) using the optional transition method

allowing entities to recognize a cumulative effect adjustment to the opening balance sheet without restating comparative
prior periods presented. ASC 842 requires a lessee to recognize assets and liabilities on the balance sheet for most leases
and changes many key definitions, including the definition of a lease. Lessees will continue to differentiate between
finance leases and operating, and classification will impact expense recognition.

We elected the following practical expedients for all lease asset classes, which must be elected as a package and

applied consistently to all of its leases at the transition date: i) we did not reassess whether any expired or existing contracts
are or contain leases; ii) we did not reassess the lease classification for any expired or existing leases (that is, all existing
leases that were classified as operating leases in accordance with ASC 840, Leases (ASC 840), are classified as operating
leases); and iii) we did not reassess initial direct costs for any existing leases.

At the inception of an arrangement, we determine whether the arrangement is or contains a lease based on the

facts and circumstances present in the arrangement. Leases with a term greater than one year are recognized on the

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balance sheet as right-of-use (ROU) assets and short-term and long-term lease liabilities, as applicable. We have elected the
practical expedient not to recognize leases on the balance sheet with a term of twelve months or less. Our leases consist of
office and lab space and office equipment. All of our leases are classified as operating, and options to renew a lease are
only included in the lease term to the extent those options are reasonably certain to be exercised. Additionally, we elected
to apply the practical expedient not to separate lease and nonlease components for all leases.

Operating lease liabilities and their corresponding ROU assets are initially recorded based on the present value of

lease payments over the expected remaining lease term. The rate implicit in lease contracts is typically not readily
determinable and, as a result, we utilize its incremental borrowing rate to discount lease payments, which reflects the fixed
rate at which we could borrow on a collateralized basis the amount of the lease payments, for a similar term, in a similar
economic environment. To estimate its incremental borrowing rate, a credit rating applicable to us is estimated using a
synthetic credit rating analysis since we do not currently have a rating agency-based credit rating.

The adoption of ASC 842 resulted in the recognition of operating lease ROU assets and operating lease liabilities
of $12.2 million and $22.8 million, respectively, on our consolidated balance sheet, with the difference between the ROU
asset and lease liability primarily attributable to unamortized lease incentives and deferred rent related to the lease for our
corporate headquarters at 900 Middlesex Turnpike in Billerica, Massachusetts (the 900 Middlesex Turnpike Lease).

We currently lease approximately 91,600 square feet of office, laboratory, and manufacturing space at our

headquarters in Billerica, Massachusetts. The premises covered by this lease serves as our principal office and laboratory
space effective the second quarter of 2019. The initial term of the lease is 11 years and five months beginning on April 1,
2019, and we have the option to extend the lease for two additional five-year periods.

We previously leased approximately 30,655 square feet of office, laboratory, and manufacturing space as our

headquarters in Lexington, Massachusetts, which was to expire on June 30, 2020; however in November 2018, we agreed
to terminate the lease with the lessor effective May 2019. The termination of the lease was connected to us signing the new
lease in October 2018 for our new headquarters in Billerica. In addition, pursuant to our acquisition of Aushon in
January 2018, we assumed a lease of approximately 21,500 square feet of office, laboratory, and manufacturing space in
Billerica, Massachusetts, under a lease that was to expire on February 28, 2021; however, in August 2018, we exercised an
option to terminate the lease effective as of September 1, 2019. We paid a termination fee of $75,000 in February 2019 in
consideration for the early termination.

In addition, our subsidiary, Uman, leases a total of approximately 6,500 square feet of office, laboratory,

manufacturing and storage space in Umeå, Sweden. These leases expire at various dates between May 31, 2020 and
February 28, 2023.

Development and Supply Agreement

We do not have significant agreements, with the exception of the supply agreement with STRATEC for the
purchase of supplies or other goods specifying minimum quantities or set prices that exceed our expected requirements for
the next three to six months. STRATEC manufactured our HD-1 instrument and manufactures the HD-X that we
commercialized in the second half of 2019. In 2013, we entered into the Supply Agreement with STRATEC which requires
us to purchase a minimum number of commercial units over a seven-year period ending in May 2021. We could be
obligated to pay a fee based on the shortfall of commercial units purchased compared to the required number. Based on the
commercial units purchased as of December 31, 2020, we have satisfied our required minimum purchase amount per the
supply agreement.

Also, if we terminate the Supply Agreement under certain circumstances and do not purchase up to a required

number of commercial units, we would be required to issue warrants to purchase 93,341 shares of common stock at
$0.003214 per share. We believe that we will not issue such warrants and therefore have not recorded any amounts related
to the potential equity consideration.

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In August 2011, we entered into the Development Agreement with STRATEC, pursuant to which STRATEC

undertook the development of the HD-1 for manufacture and sale to us or a partner whom we designate. During the year
ended December 31, 2016, the Development Agreement was amended to modify the deliverables related to the final
milestone, to agree on instrument design changes to be implemented, and to reduce the minimum purchase commitment in
the Supply Agreement. Additionally, the parties agreed on additional development services for a total fee of $1.5 million,
which was payable when development is completed and of which $0.9 million was paid in 2018 and $0.6 million was paid
in 2019. The total amount included the final milestone payment that was due under the terms of the original agreement.

Backlog

We generally expect to ship all instrument and consumable orders received in a given period with the exception of

orders received near the end of a fiscal quarter; and as a result, our backlog at the end of any period is typically
insignificant.

Item 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Market risk represents the risk of loss that may impact our financial position due to adverse changes in financial
market prices and rates. Our market risk exposure is primarily a result of fluctuations in foreign currency exchange rates
and interest rates. We do not hold or issue financial instruments for trading purposes.

Foreign Currency Exchange Risk

As we expand internationally our results of operations and cash flows will become increasingly subject to

fluctuations due to changes in foreign currency exchange rates. Historically, the substantial majority of our revenue has
been denominated in U.S. dollars. Our expenses are generally denominated in the currencies in which our operations are
located, which is primarily in the United States, with a portion of expenses incurred in Canada, Europe, Japan and China.
Our results of operations and cash flows are, therefore, subject to fluctuations due to changes in foreign currency exchange
rates. Fluctuations in currency exchange rates could harm our business in the future. The effect of a 10% adverse change in
exchange rates on foreign denominated cash, receivables and payables as of December 31, 2020 would not have been
material.

To date, we have not entered into any material foreign currency hedging contracts although we may do so in the

future.

Interest Rate Sensitivity

We had cash and cash equivalents of $181.6 million as of December 31, 2020. These amounts were held primarily

in cash on deposit with banks. Due to the short-term nature of these investments, we believe that we do not have any
material exposure to changes in the fair value of our investment portfolio as a result of changes in interest rates. Declines in
interest rates, however, will reduce future investment income. If overall interest rates had decreased by 10% during the
periods presented, our interest income would not have been materially affected.

As of December 31, 2020, the principal amount of our term debt outstanding with Hercules was $7.7 million. If

overall interest rates had increased by 10% during the periods presented, our interest expense would have increased by
approximately $0.1 million on an annualized basis.

Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

The financial statements required to be filed pursuant to this Item 8 are appended to this Annual Report on

Form 10-K beginning on page F-1.

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Item 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL
DISCLOSURE

Not applicable.

Item 9A. CONTROLS AND PROCEDURES

(a)

Evaluation of Disclosure Controls and Procedures. Our principal executive officer and principal financial
officer, after evaluating the effectiveness of our disclosure controls and procedures (as defined in Exchange Act Rules 13a-
15(e) and 15d-15(e)) as of the end of the period covered by this Form 10-K, have concluded that, based on such evaluation,
our disclosure controls and procedures were effective to ensure that information required to be disclosed by us in the
reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported, within the time
periods specified in the SEC’s rules and forms, and is accumulated and communicated to our management, including our
principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely
decisions regarding required disclosure.

(b)

Changes in Internal Controls. There were no changes in our internal control over financial reporting,

identified in connection with the evaluation of such internal control that occurred during the fourth quarter of our last
fiscal year that have materially affected, or are reasonably likely to materially affect, our internal control over financial
reporting.

(c)

Management’s Annual Report on Internal Control Over Financial Reporting. Our management is
responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over
financial reporting is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act, as a process designed by, or under
the supervision of, our principal executive officer and principal financial officer and effected by our board of directors,
management and other personnel to provide reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with generally accepted accounting principles. Our
internal control over financial reporting includes those policies and procedures that:

● pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions

and dispositions of our assets;

● provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial

statements in accordance with generally accepted accounting principles, and that our receipts and
expenditures are being made only in accordance with authorizations of management and our directors; and
● provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or

disposition of our assets that could have a material effect on the financial statements.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect
misstatements. Projections of any evaluation of effectiveness to future periods are subject to the risk that controls may
become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may
deteriorate.

Under the supervision and with the participation of our management, including our principal executive officer and

principal financial officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting
based on the 2013 framework in Internal Control—Integrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission. Based on our evaluation under that framework, our management concluded
that our internal controls over financial reporting were effective as of December 31, 2020.

(d)

Attestation Report on Internal Control over Financial Reporting. This Annual Report on Form 10-K does

not include an attestation report of our independent registered public accounting firm on internal control over financial
reporting due to the deferral allowed under the JOBS Act for emerging growth companies.

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Table of Contents

Item 9B. OTHER INFORMATION

Not applicable.

PART III

Item 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

The information required by this Item 10 will be included in our definitive proxy statement to be filed with the

SEC with respect to our 2021 Annual Meeting of Stockholders and is incorporated herein by reference.

Item 11. EXECUTIVE COMPENSATION

The information required by this Item 11 will be included in our definitive proxy statement to be filed with the

SEC with respect to our 2021 Annual Meeting of Stockholders and is incorporated herein by reference.

Item 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND
RELATED STOCKHOLDER MATTERS

The information required by this Item 12 will be included in our definitive proxy statement to be filed with the

SEC with respect to our 2021 Annual Meeting of Stockholders and is incorporated herein by reference.

Item 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

The information required by this Item 13 will be included in our definitive proxy statement to be filed with the

SEC with respect to our 2021 Annual Meeting of Stockholders and is incorporated herein by reference.

Item 14. PRINCIPAL ACCOUNTING FEES AND SERVICES

The information required by this Item 14 will be included in our definitive proxy statement to be filed with the

SEC with respect to our 2021 Annual Meeting of Stockholders and is incorporated herein by reference.

Item 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES

(1)

Financial Statements

PART IV

The consolidated financial statements are included beginning on page F-1 attached hereto and are filed as part of

this Annual Report on Form 10-K.

(2)

Financial Statement Schedules

Schedules have been omitted since they are either not required or not applicable or the information is otherwise

included herein.

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(3)

Exhibits

The following is a list of exhibits filed as part of this Annual Report on Form 10-K:

Exhibit Number     

Exhibit Description

Filed

Herewith     

Incorporated by
Reference herein from
Form or Schedule

3.1 Amended and Restated

Certificate of Incorporation

3.2 Restated Bylaws

4.1 Description of Securities

4.2 Form of Common Stock

Certificate

4.3 Fourth Amended and Restated
Stockholders Agreement,
dated as of June 2, 2017, by
and among the Registrant and
the stockholders named
therein

8-K

8-K

10-K

S-1

S-1

Filing Date

12/15/17

12/15/17

3/13/20

11/9/17

SEC File/
Reg. Number

001-38319

001-38319

001-38319

333-221475

11/9/17

333-221475

4.4 Fourth Amended and Restated

S-1

11/9/17

333-221475

Registration Rights
Agreement, dated as of June 2,
2017, by and among the
Registrant and the investors
named therein

4.5 Warrant Agreement, dated as
of January 30, 2018, by and
between the Registrant and
Azul Divinal Consultoria
Unipessoal LDA

10.1.1+ 2007 Stock Option and Grant
Plan, as amended

10.1.2+ Form of Incentive Stock

Option Agreement under the
2007 Stock Option and Grant
Plan, as amended

10.1.3+ Form of Non-qualified Stock
Option Agreement under the
2007 Stock Option and Grant
Plan, as amended

10.1.4+ Form of Restricted Stock

Agreement under the 2007
Stock Option and Grant Plan,
as amended

10-K

3/19/18

001-38319

S-1

S-1

S-1

S-1

11/9/17

333-221475

11/9/17

333-221475

11/9/17

333-221475

11/9/17

333-221475

10.2.1+ 2017 Employee, Director and

S-1/A

11/27/17

333-221475

Consultant Equity Incentive
Plan

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Exhibit Number     

Exhibit Description

10.2.2+ Form of Stock Option

Agreement under the 2017
Employee, Director and
Consultant Equity Incentive
Plan

Filed

Herewith     

Incorporated by
Reference herein from
Form or Schedule

S-1/A

Filing Date

11/27/17

SEC File/
Reg. Number

333-221475

10.2.3+ Form of Restricted Stock

S-1/A

11/27/17

333-221475

Agreement under the 2017
Employee, Director and
Consultant Equity Incentive
Plan

10.2.4+ Form of Restricted Stock Unit

S-1/A

11/27/17

333-221475

Agreement under the 2017
Employee, Director and
Consultant Equity Incentive
Plan

10.3+ Employment Agreement,

S-1

11/9/17

333-221475

dated January 1, 2015, by and
between the Registrant and E.
Kevin Hrusovsky

10.4+ Letter Agreement, dated

February 14, 2019, between
Registrant and Amol Chaubal

10.5+ Letter Agreement, dated May
31, 2019, by and between the
Registrant and John Fry

10.6+ Letter Agreement, dated
August 8, 2014, by and
between the Registrant and
Mark T. Roskey, Ph.D.

10-Q

10-Q

5/10/19

001-38319

8/6/19

001-38319

S-1

11/9/17

333-221475

10.7+ Letter Agreement, effective as

10-Q

5/15/18

001-38319

February 5, 2018, by and
between the Registrant and
Dawn Mattoon

10.8.1* Exclusive License Agreement,
dated June 18, 2007, between
the Registrant and Tufts
University, as amended on
April 29, 2013

10.8.2* Second Amendment, dated

August 22, 2017, to the
Exclusive License Agreement
between the Registrant and
Tufts University

S-1

11/9/17

333-221475

S-1

11/9/17

333-221475

10.8.3@Third Amendment, dated

10-Q

11/6/20

001-38319

September 25, 2020, to the
Exclusive License Agreement
between the Registrant and
Tufts University

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Table of Contents

Exhibit Number     

Exhibit Description

10.9.1* Supply and Manufacturing
Agreement, dated
September 14, 2011, between
the Registrant and STRATEC
Biomedical AG

10.9.2 First Amendment to Supply
and Manufacturing
Agreement, dated October 17,
2013, between the Registrant
and STRATEC
Biomedical AG

Filed

Herewith     

Incorporated by
Reference herein from
Form or Schedule

S-1

Filing Date

11/9/17

SEC File/
Reg. Number

333-221475

S-1

11/9/17

333-221475

10.10.1* STRATEC Development

S-1

11/9/17

333-221475

Services and Equity
Participation Agreement,
dated August 15, 2011,
between the Registrant and
STRATEC Biomedical
Systems AG

10.10.2* First Amendment to

S-1

11/9/17

333-221475

STRATEC Development
Services and Equity
Participation Agreement and
Second Amendment to Supply
and Manufacturing
Agreement, dated
November 18, 2016, between
the Registrant and STRATEC
Biomedical AG

10.11* Manufacturing Services

S-1

11/9/17

333-221475

Agreement, dated
November 23, 2016, between
the Registrant and Paramit
Corporation

10.12.1 Loan and Security Agreement,

S-1

11/9/17

333-221475

dated April 14, 2014, by and
between the Registrant and
Hercules Capital, Inc.
(formerly known as Hercules
Technology Growth
Capital, Inc.)

10.12.2 Amendment No. 1 to Loan

S-1

11/9/17

333-221475

and Security Agreement,
dated March 4, 2015, by and
between the Registrant and
Hercules Capital, Inc.
(formerly known as Hercules
Technology Growth
Capital, Inc.)

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Exhibit Number     

Exhibit Description

Filed

Herewith     

Incorporated by
Reference herein from
Form or Schedule

10.12.3 Amendment No. 2 to Loan

S-1

Filing Date

11/9/17

SEC File/
Reg. Number

333-221475

and Security Agreement,
dated January 29, 2016, by
and between the Registrant
and Hercules Capital, Inc.
(formerly known as Hercules
Technology Growth
Capital, Inc.)

10.12.4 Amendment No. 3 to Loan

S-1

11/9/17

333-221475

and Security Agreement,
dated March 31, 2017, by and
between the Registrant and
Hercules Capital, Inc.
(formerly known as Hercules
Technology Growth
Capital, Inc.)

10.12.5 Amendment No. 4 to Loan

10-Q

11/7/18

001-38319

and Security Agreement,
dated July 24, 2017, by and
between the Registrant and
Hercules Capital, Inc.
(formerly known as Hercules
Technology Growth
Capital, Inc.)

10.12.6 Amendment No. 5 to Loan

10-Q

11/7/18

001-38319

and Security Agreement,
dated August 30, 2018, by and
between the Registrant and
Hercules Capital, Inc.
(formerly known as Hercules
Technology Growth
Capital, Inc.)

10.12.7 Amendment No. 6 to Loan

10-Q

11/7/18

001-38319

and Security Agreement,
dated September 28, 2018, by
and between the Registrant
and Hercules Capital, Inc.
(formerly known as Hercules
Technology Growth
Capital, Inc.)

10.12.8 Amendment No. 7 to Loan

8-K

4/15/19

001-38319

and Security Agreement,
dated April 15, 2019, by and
between the Registrant and
Hercules Capital, Inc.
(formerly known as Hercules
Technology Growth
Capital, Inc.)

10.13+ Form of Indemnification

S-1/A

11/27/17

333-221475

Agreement

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Exhibit Number     

Exhibit Description

Filed

Herewith     

Incorporated by
Reference herein from
Form or Schedule

10.14 Lease Agreement between SSI

8-K

Filing Date

10/5/18

SEC File/
Reg. Number

001-38319

900 Middlesex MA LP and
the Registrant, dated
October 2, 2018.

10.15@Non-Exclusive License

8-K

10/5/20

001-38319

Agreement, dated September
29, 2020, by and between
Abbott Laboratories and
Quanterix Corporation.

10.16+ Employment Agreement

8-K

11/18/20

001-38319

10-K

3/18/19

001-38319

between Will Geist and the
Company dated November 9,
2020.

10.17+ 2018 Non-Employee Director
Compensation Policy

21.1 Subsidiaries of Registrant

23.1 Consent of Ernst & Young

LLP

31.1 Certification of the Principal
Executive Officer pursuant to
Section 302 of the Sarbanes-
Oxley Act of 2002

31.2 Certification of the Principal
Financial Officer pursuant to
Section 302 of the Sarbanes-
Oxley Act of 2002

X

X

X

X

32.1 Certifications of the Chief

X

Executive Officer and Chief
Financial Officer pursuant to
Section 906 of the Sarbanes-
Oxley Act of 2002.

101.INS Inline XBRL Instance
Document.

101.SCH Inline XBRL Taxonomy

Extension Schema Document.

101.CAL Inline XBRL Taxonomy

Extension Calculation
Linkbase Document.

101.DEF Inline XBRL Taxonomy

Extension Definition.

101.LAB Inline XBRL Taxonomy

Extension Label Linkbase
Document.

X

X

X

X

X

103

    
    
    
Table of Contents

Exhibit Number     

Exhibit Description

Filed

Herewith     

Incorporated by
Reference herein from
Form or Schedule

Filing Date

SEC File/
Reg. Number

101.PRE Inline XBRL Taxonomy

X

Presentation Linkbase
Document.

104 Cover Page Interactive Data
File (formatted as Inline
XBRL and contained in
Exhibit 101)

+

*

@

Management contract or compensatory plan or arrangement.

Confidential treatment has been granted for portions of this Exhibit. Redacted portions have been filed separately
with the SEC.

Certain confidential portions of this exhibit have been omitted and replaced with “[***]”. Such identified
information has been excluded from this exhibit because it is (i) not material and (ii) would likely cause
competitive harm to the company if disclosed

Item 16. FORM 10-K SUMMARY

Not applicable.

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SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly

caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

QUANTERIX CORPORATION

Date: March 5, 2021

By:

/s/ E. KEVIN HRUSOVSKY
E. Kevin Hrusovsky
Chairman, President and Chief Executive Officer

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the

following persons on behalf of the registrant and in the capacities and on the dates indicated.

Signature

Title

Date

/s/ E. KEVIN HRUSOVSKY
E. Kevin Hrusovsky

/s/ AMOL CHAUBAL
Amol Chaubal

/s/ KEITH L. CRANDELL
Keith L. Crandell

/s/MARIJN DEKKERS
Marijn Dekkers, Ph.D.

/s/ SARAH HLAVINKA
Sarah Hlavinka

/s/ MARTIN MADAUS, PH.D.
Martin Madaus, Ph. D.

/s/ PAUL MEISTER
Paul M. Meister

/s/ DAVID WALT, PH.D.
David R. Walt, Ph.D.

Chairman, President and Chief
Executive Officer and Director
(principal executive officer)

Chief Financial Officer

(principal financial officer and
principal accounting officer)

Director

Director

Director

Director

Director

Director

105

March 5, 2021

March 5, 2021

March 5, 2021

March 5, 2021

March 5, 2021

March 5, 2021

March 5, 2021

March 5, 2021

    
    
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INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
QUANTERIX CORPORATION
Years ended December 31, 2020, 2019, and 2018

Report of Independent Registered Public Accounting Firm
Consolidated Balance Sheets
Consolidated Statements of Operations
Consolidated Statements of Comprehensive Loss
Consolidated Statements of Cash Flows
Consolidated Statements of Stockholders’ Equity
Notes to Consolidated Financial Statements

F-1

Page

F-2
F-3
F-4
F-5
F-6
F-7
F-8

Table of Contents

Report of Independent Registered Public Accounting Firm

To the Stockholders and the Board of Directors of Quanterix Corporation

Opinion on the Financial Statements

We have audited the accompanying consolidated balance sheets of Quanterix Corporation (the Company) as of December
31,  2020  and  2019,  the  related  consolidated  statements  of  operations,  comprehensive  loss,  and  stockholders’  (deficit)
equity and cash flows for each of the three years in the period ended December 31, 2020, and the related notes (collectively
referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly,
in  all  material  respects,  the  financial  position  of  the  Company  at  December  31,  2020  and  2019,  and  the  results  of  its
operations and its cash flows for each of the three years in the period ended December 31, 2020, in conformity with U.S.
generally accepted accounting principles.

Adoption of ASU No. 2016-02

As discussed in Note 2 to the consolidated financial statements, the Company changed its method of accounting for leases
in the year ended December 31, 2020 due to the adoption of Accounting Standards Update No. 2016-02, Leases, and the
related amendments, using the modified retrospective method.

Basis for Opinion

These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion
on  the  Company’s  financial  statements  based  on  our  audits.  We  are  a  public  accounting  firm  registered  with  the  Public
Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the
Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and
Exchange Commission and the PCAOB.

We  conducted  our  audits  in  accordance  with  the  standards  of  the  PCAOB.  Those  standards  require  that  we  plan  and
perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement,
whether  due  to  error  or  fraud.  The  Company  is  not  required  to  have,  nor  were  we  engaged  to  perform,  an  audit  of  its
internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control
over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal
control over financial reporting. Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether
due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test
basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the
accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of
the financial statements. We believe that our audits provide a reasonable basis for our opinion.

/s/ Ernst & Young LLP

We have served as the Company’s auditor since 2008.
Boston, Massachusetts
March 5, 2021

F-2

Table of Contents

Quanterix Corporation
Consolidated Balance Sheets
(amounts in thousands, except share and per share data)

Assets
Current assets:

Cash and cash equivalents
Accounts receivable (less allowance for doubtful accounts of $370 and $162 as of
December 31, 2020 and December 31, 2019, respectively; including $172 and $186 from
related parties as of December 31, 2020 and December 31, 2019, respectively)
Inventory
Prepaid expenses and other current assets

Total current assets

Restricted cash
Property and equipment, net
Intangible assets, net
Goodwill
Right-of-use assets
Other non-current assets

Total assets

Liabilities and stockholders’ equity
Current liabilities:

Accounts payable (including $14 and $36 to related parties as of December 31, 2020 and
December 31, 2019, respectively)
Accrued compensation and benefits
Other accrued expenses (including $1,377 and $0 to related parties as of December 31, 2020
and December 31, 2019, respectively)
Deferred revenue (including $90 and $55 with related parties as of December 31, 2020 and
December 31, 2019, respectively)
Current portion of long term debt
Short term lease liabilities
Other current liabilities

Total current liabilities

Deferred revenue, net of current portion
Long term debt, net of current portion
Long term lease liabilities
Other non-current liabilities

Total liabilities

Commitments and contingencies (Note 9)
Stockholders’ equity:

Common stock, $0.001 par value:

Authorized—120,000,000 shares as of December 31, 2020 and December 31, 2019;
issued and outstanding — 31,796,544 and 28,112,201 shares as of December 31, 2020
and December 31, 2019, respectively

Additional paid-in capital
Accumulated other comprehensive income (loss)
Accumulated deficit
Total stockholders’ equity
Total liabilities and stockholders’ equity

See accompanying notes.

F-3

     December 31, 2020      December 31, 2019

$

181,584

$

109,155

17,184
14,856
5,981
219,605
1,000
13,912
13,716
10,460
11,995
357
271,045

6,799
10,777

4,845

$

$

5,421
7,673
1,234
3,054
39,803
577
—  

21,891
2,649
64,920

10,906
10,463
2,137
132,661
1,026
12,047
14,307
9,353
—
557
169,951

5,777
6,570

2,498

4,697
75
—
216
19,833
466
7,587
—
13,407
41,293

32
451,433
2,434
(247,774)
206,125
271,045

$

28
345,027
(153)
(216,244)
128,658
169,951

$

$

$

    
    
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
  
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
  
 
  
 
  
 
 
 
 
 
 
 
 
 
 
Table of Contents

Quanterix Corporation
Consolidated Statements of Operations
(amounts in thousands, except share and per share data)

Product revenue (including related party activity of $580, $720, and $294 for
the years ended December 31, 2020, 2019, and 2018, respectively)
Service and other revenue (including related party activity of $202, $118, and
$149 for the years ended December 31, 2020, 2019, and 2018, respectively)
Collaboration and license revenue (including related party activity of $0, $0,
and $2,150 for the years ended December 31, 2020, 2019, and 2018,
respectively)
Grant revenue
Total revenue
Costs of goods sold:

Cost of product revenue (including related party activity of $205, $234, and
$191 for the years ended December 31, 2020, 2019, and 2018, respectively)  
Cost of services and other revenue (including related party activity of $52,
$0, and $0 for the years ended December 31, 2020, 2019, and 2018,
respectively)
Cost of collaboration and license revenue (including related party activity
of $1,000, $0, and $0 for the years ended December 31, 2020, 2019, and
2018, respectively)

Total costs of goods sold, services, and licenses
Gross profit
Operating expenses:

Research and development (including related party activity of $268, $0, and
$0 for the years ended December 31, 2020, 2019, and 2018, respectively)
Selling, general, and administrative (including related party activity of $36,
$0, and $0 for the years ended December 31, 2020, 2019, and 2018)

Total operating expenses
Loss from operations
Interest income (expense), net
Other expense, net
Loss before income taxes
Income tax benefit (provision)
Net loss
Net loss per share, basic and diluted
Weighted-average common shares outstanding, basic and diluted

Years Ended
December 31, 
2019

2018

2020

$

44,017

$

40,491

$

23,365

24,129

16,059

12,117

11,809
6,422
86,377

184
—
56,734

2,150
—
37,632

25,950

20,900

12,729

11,245

8,998

6,955

1,000
38,195
48,182

—
29,898
26,836

—
19,684
17,948

20,174

16,190

15,805

59,592
79,766
(31,584)
(273)
(49)
(31,906)
376
(31,530) $
(1.07) $

$
$
  29,589,132

52,246
68,436
(41,600)
627
(10)
(40,983)
187
(40,796) $
(1.63) $

33,693
49,498
(31,550)
46
(7)
(31,511)
(25)
(31,536)
(1.43)
  21,994,317

  25,090,708

See accompanying notes.

F-4

    
    
 
 
 
 
 
 
 
 
 
 
  
 
  
 
  
 
 
 
 
 
 
 
 
 
  
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table of Contents

Quanterix Corporation
Consolidated Statements of Comprehensive Loss
(amounts in thousands)

Net loss
Other comprehensive income (loss):

Cumulative translation adjustment
Total other comprehensive income (loss)

Comprehensive loss

$

$

Years Ended December 31,

2020

2019

2018

(31,530)

$

(40,796)

$

(31,536)

2,587
2,587
(28,943)

$

(153)
(153)
(40,949)

$

—
—
(31,536)

See accompanying notes.

F-5

    
Table of Contents

Quanterix Corporation
Consolidated Statements of Cash Flows
(amounts in thousands)

Operating activities

Net loss

Adjustments to reconcile net loss to net cash used in operating activities:

Depreciation and amortization expense

Inventory step-up amortization

Reduction in the carrying amounts of right-of-use assets

Stock-based compensation expense

Non-cash interest expense

Loss (gain) on disposal of fixed assets

Changes in operating assets and liabilities:

Accounts receivable

Prepaid expenses and other assets

Inventory

Other non-current assets

Accounts payable

Accrued compensation and benefits, other accrued expenses and other current liabilities

Contract acquisition costs

Operating lease liabilities

Other non-current liabilities

Deferred revenue

Net cash used in operating activities

Investing activities

Purchases of property and equipment

Acquisitions, net of cash acquired

Proceeds from RADx grant on assets purchased

Purchase of investments

Proceeds from sale of assets

Net cash used in investing activities

Financing activities

Proceeds from sale of common stock, net of issuance costs

Proceeds from stock options exercised

Sale of common stock in at-the-market offering, net

Sale of common stock in underwritten public offering, net

Proceeds from ESPP purchase

Payments on notes payable

Net cash provided by (used in) financing activities

Net increase (decrease) in cash and cash equivalents

Effect of foreign currency exchange rate on cash

Cash, restricted cash, and cash equivalents at beginning of period

Cash, restricted cash, and cash equivalents at end of period

Supplemental cash flow information

Cash paid for interest

Purchases of property and equipment included in accounts payable

Purchases of property and equipment included in other non-current liabilities
191,152 shares of common stock issued in connection with the acquisition of
UmanDiagnostics AB

$

$

$

$

$

Fair value of common stock warrants exercised and reclassified as shares of common stock $

Reconciliation of cash, cash equivalents, and restricted cash:

Cash and cash equivalents

Restricted cash

Total cash, cash equivalents, and restricted cash

$

$

$

181,584

1,000

182,584

$

$

$

See accompanying notes.

F-6

Year Ended December 31, 

2020

2019

2018

$

(31,530)

$

(40,796) $

(31,536)

4,312

722

245

10,099

86

171

(6,240)

(3,927)

(5,119)

198

649

6,219

87

316

(488)

835

(23,365)

(3,930)

—  

3,304

—  

—  

(626)

3,009

611

—

6,388

89

140

(3,365)

289

(3,447)

(21)

621

822

336

—

9,845

(708)

(26,187)

(10,847)

(14,529)

—
—  
—  

(25,376)

—  

—  

4,019

—

91,404

888

(75)

96,236

72,245

158

110,181

182,584

625

1,029

$

$

$

— $

— $

— $

2,820

48,019

64,529

879

(50)

116,197

64,634

118

45,429

110,181

656

164

7,572

$

$
$
$

5,468

$
— $

109,155

1,026

110,181

$
$
$

1,352

—

—

4,884

170

(14)

(983)

(1,828)

(1,603)

267

1,318

1,101

—

—

—

(1,849)

(28,721)

(1,518)

(3,801)

—

(150)

15

(5,454)

(20)

1,871

—

—

—

(1,929)

(78)

(34,253)

—

79,682

45,429

606

78

—

—

196

44,429

1,000

45,429

    
    
 
  
 
  
 
  
 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
  
 
  
 
 
 
 
 
 
 
 
  
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
  
 
  
Table of Contents

Quanterix Corporation
Consolidated Statements of Stockholders’ Equity

Balance at December 31, 2017
Exercise of common stock warrants
Exercise of common stock options and vesting of restricted stock
Common stock issuance offering costs
Stock-based compensation expense
Net loss
Balance at December 31, 2018
Cumulative effect of adoption of Accounting Standards Codification Topic
606
Exercise of common stock warrants
Exercise of common stock options and vesting of restricted stock
Sale of common stock in "at-the-market" offering, net
Sale of common stock in underwritten public offering, net
Issuance of shares for the acquisition of UmanDiagnostics AB
Stock-based compensation expense
Employee stock purchase plan
Accumulated other comprehensive income
Net loss
Balance at December 31, 2019
Exercise of common stock options and vesting of restricted stock
Sale of common stock in underwritten public offering, net
ESPP stock purchase
Stock-based compensation expense
Cumulative translation adjustment
Net loss
Balance at December 31, 2020

Common 
stock 
shares
21,707,041
16,718
645,277

$

—  
—  
—  
$

22,369,036

—  

45,690
550,734
2,186,163
2,732,673
191,152
—
36,753
—
—  
$

28,112,201
589,723
3,048,774
45,846
—
—
—
31,796,544

$

Common 
 stock 
value

Additional 
 paid-in
capital

Accumulated
other

     comprehensive
income (loss)

 Accumulated 
 deficit

Total
 stockholders’
equity

22
$
—  
—  
—  
—  
—  
$
22

—  
—  
—  
2
3
1
—
—
—
—  
28
$
1
3
—
—
—
—
32

$

210,196

$
—  

1,871
(20)
4,884

—  
$

216,931

—  
—  

2,820
48,017
64,526
5,467
6,388
878
—
—  
$

345,027
4,018
91,401
888
10,099
—
—
451,433

$

— $
—
—
—
—
—
— $

—
—
—
—
—
—
—
—
(153)
—
(153)
—
—
—
—
2,587
—
2,434

$

$

(144,352)
—
—
—
—
(31,536)
(175,888)

440
—
—
—
—
—
—
—
—
(40,796)
(216,244)
—
—
—
—
—
(31,530)
(247,774)

$

$

$

$

65,866
—
1,871
(20)
4,884
(31,536)
41,065

440
—
2,820
48,019
64,529
5,468
6,388
878
(153)
(40,796)
128,658
4,019
91,404
888
10,099
2,587
(31,530)
206,125

See accompanying notes.

F-7

  
    
    
    
  
    
    
    
    
    
 
 
 
 
 
 
 
 
 
 
 
Table of Contents

Quanterix Corporation
Notes to Consolidated Financial Statements

1. Organization and operations

Quanterix Corporation (NASDAQ: QTRX) (the Company) is a life sciences company that has developed next

generation, ultra-sensitive digital immunoassay platforms that advance precision health for life sciences research and
diagnostics. The Company’s platforms are based on its proprietary digital “Simoa” detection technology. The Company’s
Simoa bead-based and planar array platforms enable customers to reliably detect protein biomarkers in extremely low
concentrations in blood, serum and other fluids that, in many cases, are undetectable using conventional, analog
immunoassay technologies, and also allow researchers to define and validate the function of novel protein biomarkers that
are only present in very low concentrations and have been discovered using technologies such as mass spectrometry. These
capabilities provide the Company’s customers with insight into the role of protein biomarkers in human health that has not
been possible with other existing technologies and enable researchers to unlock unique insights into the continuum between
health and disease. The Company is currently focusing on protein detection, but the Company’s Simoa platforms have also
demonstrated applicability across other testing applications, including detection of nucleic acids and small molecules.

The Company launched its first immunoassay platform, the Simoa HD-1, in 2014. The HD-1 is a fully automated

immunoassay bead-based platform with multiplexing and custom assay capability, and related assay test kits and
consumable materials. The Company launched a second bead-based immunoassay platform (SR-X) in the fourth quarter of
2017 with a more compact footprint than the Simoa HD-1 and less automation designed for lower volume requirements
while still allowing multiplexing and custom assay capability. The Company initiated an early-access program for its third
instrument (SP-X) on the new Simoa planar array platform in January 2019, with the full commercial launch commencing
in April 2019. In July 2019, the Company launched the Simoa HD-X, an upgraded version of the Simoa HD-1 which
replaces the HD-1. The HD-X has been designed to deliver significant productivity and operational efficiency
improvements, as well as greater user flexibility. The Company began shipping and installing HD-X instruments at
customer locations in the third quarter of 2019. The Company also performs research services on behalf of customers to
apply the Simoa technology to specific customer needs. The Company's customers are primarily in the research use only
market, which includes academic and governmental research institutions, the research and development laboratories of
pharmaceutical manufacturers, contract research organizations, and specialty research laboratories.

The Company acquired Aushon Biosystems, Inc. (Aushon) in January 2018. With the acquisition of Aushon, the

Company acquired a CLIA certified laboratory, as well as Aushon’s proprietary sensitive planar array detection technology.
Leveraging its proprietary sophisticated Simoa image analysis and data analysis algorithms, the Company further refined
this planar array technology to develop the SP-X instrument to provide the same Simoa sensitivity found in its bead-based
platform.

The Company acquired UmanDiagnostics AB (Uman), a Swedish company located in Umeå, Sweden, in August

2019. The acquisition closed with respect to 95% of the outstanding shares of capital stock of Uman on July 1, 2019 and
with respect to the remaining 5% of the outstanding shares of capital stock of Uman on August 1, 2019. Uman supplies
neurofilament light (Nf-L) antibodies and ELISA kits, which are widely recognized by researchers and biopharmaceutical
and diagnostics companies world-wide as the premier solution for the detection of Nf-L to advance the development of
therapeutics and diagnostics for neurodegenerative conditions. With the acquisition of Uman, the Company has secured a
long-term source of supply for a critical technology.

“At-the-market offering”

On March 19, 2019, the Company entered into a Sales Agreement (the Sales Agreement) with Cowen and

Company, LLC (Cowen) with respect to an “at-the-market” offering program under which the Company could offer and
sell, from time to time at its sole discretion, shares of its common stock, par value $0.001 per share, having an aggregate
offering price of up to $50.0 million through Cowen as its sales agent.

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Table of Contents

On June 5, 2019, the Company issued approximately 2.2 million shares of common stock at an average stock
price of $22.73 per share pursuant to the terms of the Sales Agreement. The “at-the-market” offering resulted in gross
proceeds of $49.7 million. The Company incurred $1.7 million in issuance costs associated with the “at-the-market”
offering, resulting in net proceeds to the Company of $48.0 million. On August 6, 2020, the Company delivered written
notice to Cowen to terminate the Sales Agreement, which termination the parties agreed to make immediately effective.

Underwritten public offering

On August 8, 2019, the Company entered into an underwriting agreement with J.P. Morgan Securities LLC and
SVB Leerink LLC (Leerink), as representatives of the several underwriters, relating to an underwritten public offering of
approximately 2.7 million shares of the Company’s common stock, par value $0.001 per share. The underwritten public
offering resulted in gross proceeds of $69.0 million. The Company incurred $4.5 million in issuance costs associated with
the underwritten public offering, resulting in net proceeds to the Company of $64.5 million.

On August 6, 2020, the Company entered into an underwriting agreement with Leerink and Cowen, as
representatives of the several underwriters, relating to an underwritten public offering of approximately 3.0 million shares
of the Company’s common stock, par value $0.001 per share. The underwritten public offering resulted in gross proceeds
of $97.6 million. The Company incurred $6.2 million in issuance costs associated with the underwritten public offering,
resulting in net proceeds to the Company of $91.4 million.

Liquidity

The  Company  has  recognized  annual  losses  from  operations  since  inception  and  has  an  accumulated  deficit  of
$247.8  million  at  December  31,  2020  and  the  Company  incurred  a  net  loss  of  $31.5  million,  $40.8  million,  and  $31.5
million  for  the  years  ended  December  31,  2020,  2019,  and  2018,  respectively.  Prior  to  the  Company’s  Initial  Public
Offering (IPO) in December 2017, the Company had funded its operations principally from issuances of preferred stock,
debt  financings,  grants,  product  and  service  sales  and  development  and  license  agreements.  At  December  31,  2020,  the
Company had $181.6 million of unrestricted cash and cash equivalents. The Company expects the current cash balance will
be  sufficient  to  fund  operations  for  a  period  of  at  least  one  year  from  the  date  the  consolidated  financial  statements  are
issued. There can be no assurances, however, that no additional funding will be required or that additional funding will be
available on terms acceptable to the Company, or at all.

2. Significant accounting policies

Principles of consolidation

The consolidated financial statements have been prepared in accordance with U.S. GAAP and include the
accounts of Quanterix Corporation, and its wholly-owned subsidiaries. All material intercompany transactions and
balances have been eliminated in consolidation.

Use of estimates

The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to

make estimates and assumptions that affect the amounts reported in the consolidated financial statements and
accompanying notes. In making those estimates and assumptions, the Company bases its estimates on historical experience
and on various other assumptions believed to be reasonable. The Company’s significant estimates included in the
preparation of the consolidated financial statements are related to revenue recognition, fair value of assets acquired and
liabilities assumed in acquisitions, valuation allowances recorded against deferred tax assets, and valuation of inventory.
Actual results could differ from those estimates.

Revenue recognition

The Company recognizes revenue when a customer obtains control of a promised good or service. The amount of

revenue recognized reflects consideration that the Company expects to be entitled to receive in exchange for these

F-9

Table of Contents

goods and services, incentives and taxes collected from customers, that are subsequently remitted to governmental
authorities.

The Company adopted Accounting Standards Codification (ASC) Topic 606 Revenue from Contracts with

Customers (ASC 606), on January 1, 2019, using the modified retrospective method for all contracts not completed as of
the date of adoption. The reported results for 2020 and 2019 reflect the application of ASC 606 guidance, while the
reported results for 2018 were prepared under ASC 605, Revenue Recognition.

Customers

The Company’s customers primarily consist of entities engaged in the life sciences research market that pursue the

discovery and development of new drugs for a variety of neurologic, cardiovascular, oncologic and other protein
biomarkers associated with diseases. The Company’s customer base includes several of the largest biopharmaceutical
companies, academic research organizations and distributors who serve certain geographic markets.

Product revenue

The Company’s products are composed of analyzer instruments, assay kits and other consumables such as

reagents. Products are sold directly to biopharmaceutical and academic research organizations or are sold through
distributors in EMEA and Asia Pacific regions. The sales of instruments are generally accompanied by an initial year of
implied service-type warranties and may be bundled with assays and other consumables and may also include other items
such as training and installation of the instrument and/or an extended service warranty. Revenues from the sale of products
are recognized at a point in time when the Company transfers control of the product to the customer, which is upon
installation for instruments sold to direct customers, and based upon shipping terms for assay kits and other consumables.
Revenue for instruments sold to distributors is generally recognized based upon shipping terms (either upon shipment or
delivery).

Service and other revenue

Service revenues are composed of contract research services, initial implied one-year service-type warranties,

extended services contracts and other services such as training. Contract research services are provided through the
Company’s Accelerator Laboratory and generally consist of fixed fee contracts. Revenues from contract research services
are recognized at a point in time when the Company completes and delivers its research report on each individually
completed study, or over time if the contractual provisions allow for the collection of transaction consideration for costs
incurred plus a reasonable margin through the period of performance of the services. Revenues from service-type
warranties are recognized ratably over the contract service period. Revenues from other services are immaterial.

Collaboration and license revenue

The Company may enter into agreements to license the intellectual property and know-how associated with its

instruments in exchange for license fees and future royalties (as described below). The license agreements provide the
licensee with a right to use the intellectual property with the license fee revenues recognized at a point in time as the
underlying license is considered functional intellectual property. The Company has recognized revenues from sales- or
usage based royalties related to the Company’s licensing technology and intellectual property. ASC 606 provides for an
exception to estimating the variable consideration for sales- and usage-based royalties related to the license of intellectual
property, such that the sales- or usage-based royalty will be recognized in the period the underlying transaction occurs. The
Company has recorded sales- or usage-based royalty revenue for the years ended December 31, 2020 and 2019 related to
the intellectual property licensed by Uman. The Company recognizes revenues from sales- or usage based royalty revenue
at the later of when the sales or usage occurs; and the satisfaction or partial satisfaction of the performance obligation to
which the royalty has been allocated.

F-10

Table of Contents

Payment terms

The Company’s payment terms vary by the type and location of customer and the products or services offered.

Payment from customers is generally required in a term ranging from 30 to 45 days from date of shipment or satisfaction of
the performance obligation with no discounts for early payment. Occasionally the Company provides extended payment
terms or financing arrangements to customers.

Disaggregated revenue

When disaggregating revenue, the Company considered all of the economic factors that may affect its revenues.

The following tables disaggregate the Company's revenue from contracts with customers by revenue type:

(in thousands)
Product revenues
Instruments
Consumable and other products
Totals

Service and other revenues
Service-type warranties
Research services
Other services
Totals

Collaboration and license revenue
Collaboration and license revenue
Totals

(in thousands)
Product revenues
Instruments
Consumable and other products
Totals

Service and other revenues
Service-type warranties
Research services
Other services
Totals

Collaboration and license revenue
Collaboration and license revenue
Totals

Year Ended
December 31, 2020

 NA

 EMEA       Asia Pacific     

 Total

$

8,680
14,305
22,985   $

$

4,332
10,854
15,186   $

$

3,594
2,252
5,846   $

16,606
27,411
44,017

3,171
15,011
700
18,882

$

$

1,543
2,225
435
4,203

$

$

207
737  
100
1,044

$

$

4,921
17,973
1,235
24,129

  $

  $

  $

$

$
  $

$
11,685
11,685   $

$
124
124   $

— $
—   $

11,809
11,809

Year Ended
December 31, 2019

 NA

 EMEA       Asia Pacific     

 Total

6,250   $
14,148  
20,398   $

5,243   $
9,674  
14,917   $

3,393   $
1,783  
5,176   $

14,886
25,605
40,491

3,139   $
8,845  
825  

$

12,809

$

1,323   $
704  
565  

2,592

$

171   $
456  
31  
658

$

4,633
10,005
1,421
16,059

  $

  $

  $

$
  $

167
$
167   $

17
$
17   $

— $
—   $

184
184

The Company’s contracts with customers may include promises to transfer multiple products and services to a
customer. The Company combines any performance obligations that are immaterial with one or more other performance
obligations that are material to the contract. For arrangements with multiple performance obligations, the Company
allocates the contract transaction price, including discounts, to each performance obligation based on its relative standalone
selling price. Judgment is required to determine the standalone selling price for each distinct performance obligation. The
Company determines standalone selling prices based on prices charged to customers in observable

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transactions, and uses a range of amounts to estimate standalone selling prices for each performance obligation. The
Company may have more than one range of standalone selling price for certain products and services based on the pricing
for different customer classes.

Variable consideration in the Company’s contracts primarily relates to (i) sales- and usage-based royalties related
to the license of intellectual property in collaboration and license contracts and (ii) certain non-fixed fee research services
contracts. 

The aggregate amount of transaction price that is allocated to performance obligations that have not yet been

satisfied or are partially satisfied as of December 31, 2020 is $6.0 million. Of the performance obligations not yet satisfied
or are partially satisfied, $5.4 million is expected to be recognized as revenue in the next 12 months, with the remainder to
be recognized within the 24 months thereafter. The $5.4 million principally consists of amounts billed for undelivered
services related to initial and extended service-type warranties and research services, as well as $0.5 million related to
undelivered licenses of intellectual property for a diagnostics company. During the year ended December 31, 2020, the
Company recognized $1.2 million of previously deferred revenue as a result of entering into a license agreement with a
diagnostics company (see Note 13).

Changes in deferred revenue from contracts with customers were as follows (in thousands):

Balance at December 31, 2019
Deferral of revenue
Recognition of deferred revenue
Balance at December 31, 2020

Costs to obtain a contract

  $

  $

Year Ended December 31, 2020

5,163
6,955
(6,120)
5,998

The Company’s sales commissions are generally based on revenues of the Company. The Company has

determined that certain commissions paid under its sales incentive programs meet the requirements to be capitalized as
they are incremental and would not have occurred absent a customer contract. The changes in the balance of costs to obtain
a contract are as follows (in thousands):

Balance at December 31, 2019
Deferral of costs to obtain a contract
Recognition of costs to obtain a contract
Balance at December 31, 2020

Year Ended December 31, 2020

335
506
(593)
248

  $

  $

The Company has classified the balance of capitalized costs to obtain a contract as a component of prepaid
expenses and other current assets as of December 31, 2020 and classifies the expense as a component of cost of goods sold
and selling, general and administrative expense over the estimated life of the contract. The Company considers potential
impairment in these amounts each period.

ASC 606 provides entities with certain practical expedients and accounting policy elections to minimize the cost

and burden of adoption.

The Company does not disclose the value of unsatisfied performance obligations for (i) contracts with original

expected length of one year or less and (ii) contracts for which revenue is recognized at the amount to which the Company
has the right to invoice for services performed.

The Company will exclude from its transaction price any amounts collected from customers related to sales and

other similar taxes.

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When determining the transaction price of a contract, an adjustment is made if payment from a customer occurs

either significantly before or significantly after performance, resulting in a significant financing component. The Company
does not assess whether a significant financing component exists if the period between when the Company performs its
obligations under the contract and when the customer pays is one year or less. None of the Company’s contracts contained
a significant financing component for the years ended December 31, 2020 and 2019.

The Company has elected to account for the shipping and handling as an activity to fulfill the promise to transfer

the product, and therefore will not evaluate whether shipping and handling activities are promised services to its customers.

Grant revenue

The Company recognizes grant revenue as it performs services under the arrangement when the funding is
committed. Revenues and related research and development expenses are presented gross in the consolidated statements of
operations as the Company has determined it is the primary obligor under the arrangement relative to the research and
development services.

Accounting for grants does not fall under ASC 606, as the grantor will not benefit directly from the Company’s

expansion or product development. As there is no authoritative guidance under U.S. GAAP on accounting for government
assistance to for-profit business entities, the Company has accounted for grants by analogy to International Accounting
Standards (IAS) 20, Accounting for Government Grants and Disclosure of Government Assistance (IAS 20).

Grants to the Company contain both monetary amounts granted related to assets and monetary amounts granted

related to income, which are grants other than those related to assets. The grants related to assets are for the expansion and
increase of manufacturing capacity. The grants related to income are for additional research and development, as well as
other non-asset related scale up costs.

Under IAS 20, grants related to assets shall be presented in the consolidated balance sheets either by recognizing
the grant as deferred income (which is recognized in the consolidated statements of operations on a systematic basis over
the useful life of the asset), or by deducting the grant in calculating the carrying amount of the asset (which is recognized in
the consolidated statements of operations over the life of the depreciable asset as a reduced depreciation expense). Both
methods are acceptable under IAS 20. The Company has elected to record grants related to assets as a deduction in
calculating the carrying value of the asset.

Under IAS 20, grants related to income are presented as part of the consolidated statements of operations, either

separately or under a general heading. Both methods are acceptable under IAS 20. The Company has elected to record
grants related to income separately on the consolidated statements of operations as grant revenue. The related expenses are
recorded within operating expenses and not deducted.

On June 22, 2020, the Company entered into a workplan 1 award (WP1) with the National Institute of Health
(NIH), under the Rapid Acceleration of Diagnostics (RADx) program to assess the feasibility of a novel SARS-CoV-2
antigen detection test using the Company’s Simoa technology. During the year ended December 31, 2020, the Company
recognized $2.0 million of grant revenue and incurred $1.0 million in research and development expense related to WP1.
WP1 is complete as of December 31, 2020.

On September 29, 2020, the Company entered into a workplan 2 award (WP2) with the NIH under its RADx
program. WP2, which has a total award value of $18.2 million, accelerates the continued development, scale-up, and
deployment of the novel SARS-CoV-2 antigen detection test using the Company’s Simoa technology. The contract
provides funding to expand assay kit manufacturing capacity and commercial deployment readiness. Release of the $18.2
million of funding under WP2 is based on the achievement of certain milestones, and there is no assurance that the
Company can meet all the milestones on a timely basis, if at all. If the Company does not meet all of the milestones, it will
not be able access the full $18.2 million in funding under the contract. During the year ended December 31, 2020 the
Company recognized $4.4 million in grant revenue and incurred $2.6 million in research and development expense related
to WP2.

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Table of Contents

The following table summarizes the activity under WP2 as of December 31, 2020 (in thousands):

Total grant revenue from research and development activities
Total proceeds used for assets
Total deferred proceeds for assets
Total deferred grant revenue
Total recognized

Total recognized
Total amount accrued
Total cash received

Total proceeds received
Total proceeds reasonably assured
Total WP2 grant amount

Business combinations

$

$

$

$

$

$

4,362
826
2,478
304
7,970

7,970
(2,968)
5,002

5,002
13,198
18,200

Under the acquisition method of accounting, the Company generally recognizes the tangible and identifiable

intangible assets acquired and liabilities assumed based on their estimated fair values on the date of acquisition. The fair
values recognized, defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly
transaction between willing market participants, are based on estimates and assumptions determined by management. The
excess consideration over the aggregate value of acquired tangible and intangible assets, net of liabilities recognized, is
recorded as goodwill. These valuations require significant estimates and assumptions, especially with respect to intangible
assets.

The Company typically uses the discounted cash flow method to value acquired intangible assets. This method

requires significant management judgment to forecast future operating results and establish residual growth rates and
discount factors. The estimates used to value and amortize intangible assets are consistent with the plans and estimates that
are used to manage the business and are based on available historical information. If the subsequent actual results and
updated projections of the underlying business activity change compared with the assumptions and projections used to
develop these values, the Company could experience impairment charges. In addition, the Company has estimated the
economic lives of certain acquired assets and these lives are used to calculate depreciation and amortization expense. If
estimates of the economic lives change, depreciation or amortization expenses could be accelerated or slowed.

Cost of revenue

Cost of product revenue consists of raw materials, parts costs and associated freight, shipping and handling costs,
contract manufacturer costs, personnel costs, yield loss, in-license payments and royalties, stock-based compensation, other
direct costs and overhead.

Cost of service and other revenue consists of personnel, facility costs associated with operating the Accelerator

Labs on behalf of the customers, costs related to instrument maintenance and servicing equipment at customer sites, other
direct and overhead.

Cost of license revenue consists of license fees that are the direct results of cash payments received related to

license agreements.

Research and development expenses

Research and development expenses, including personnel costs, allocated facility costs, lab supplies, outside

services, contract laboratory costs are charged to research and development expense as incurred. The Company accounts

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for nonrefundable advance payments for goods and services that will be used in future research and development activities
as expense when the service has been performed or when the goods have been received. Expenses incurred related to grant
funded activities are recorded in research and development expense.

Selling, general, and administrative expenses

Selling, general, and administrative expenses are primarily composed of compensation and benefits associated
with sales and marketing, finance, human resources, and other administrative personnel, outside marketing, advertising,
allocated facilities costs, legal expenses, and other general and administrative costs.

Net loss per share

Basic net loss per common share attributable to common stockholders is calculated by dividing the loss
attributable to common stockholders by the weighted-average number of common shares. For purposes of the diluted net
loss per share calculations, unvested restricted common stock, common stock options, and warrants are considered to be
potentially dilutive securities, but are excluded from the diluted net loss per share because their effect would be anti-
dilutive and therefore basic and diluted net loss per share were the same for all periods presented.

The following table sets forth the outstanding potentially dilutive securities that have been excluded in the

calculation of diluted net loss per share because to do so would be anti-dilutive (in common stock equivalent shares):

Unvested restricted common stock and restricted stock units
Outstanding stock options
Outstanding common stock warrants
Total

2020
518,387  
  2,494,045  
10,000  
  3,022,432  

Year Ended December 31, 
2019
409,929  
2,507,062  
10,000  
2,926,991  

2018
361,468
2,476,911
76,041
2,914,420

As of December 31, 2020, 2019, and 2018 the Company had an obligation to issue warrants to purchase an
additional 93,341 shares of common stock to a vendor if a contract is terminated prior to a minimum purchase commitment
being met. No amounts are presented in the table above for this obligation to issue a warrant as the issuance of the warrant
is not considered probable.

Cash and cash equivalents

Cash and cash equivalents consist of cash deposits and short-term, highly liquid investments that are readily

convertible into cash, with original maturities of three months or less. Cash equivalents are carried at fair value based on
quoted prices for identical assets. Cash and cash equivalents consist of the following (in thousands):

Cash
Money market funds invested in U.S. Treasury obligations
Total cash and cash equivalents

Restricted cash and deposits

As of
December 31, 

2020
19,535
162,049
181,584

$

$

2019

6,406
102,749
109,155

$

$

Restricted cash represents collateral for a letter of credit issued as security for the lease for the Company’s new
headquarters. The restricted cash is long term in nature as the Company will not have access to the funds until more than
one year from December 31, 2020.

As of both December 31, 2020 and 2019, the Company had $1.1 million in restricted cash and deposits related to

amounts held for a line of credit, amounts held as a security deposit for the Company’s facility lease obligation, and a

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Table of Contents

business registration application. As of both December 31, 2020 and 2019, $1.0 million of the $1.1 million was recorded 
on a separate line item as restricted cash. The remaining $0.1 million was included in noncurrent assets as of both 
December 31, 2020 and 2019.

Accounts receivable and allowance for doubtful accounts

The Company provides credit, in the normal course of business, to customers and does not require collateral.

Accounts receivable consist of amounts due to the Company for sales to customers and are recorded net of an allowance
for doubtful accounts. The Company reviews accounts receivable on a regular basis to determine if any receivable will
potentially be uncollectable and to estimate the amount of allowance for doubtful accounts necessary. Once a receivable is
deemed uncollectible, such balance is written off and charged against the allowance for doubtful accounts. The Company
has not incurred material write offs in any of the periods presented.

The Company’s allowance for doubtful accounts activity for the years ended December 31, 2020, 2019, and 2018

was as follows (in thousands):

December 31, 2017
Additions
Deductions
December 31, 2018
Additions
Deductions
December 31, 2019
Additions
Deductions
December 31, 2020

Inventory

$

$

$

$

—
36
—
36
160
(34)
162
493
(285)
370

Inventory is stated at the lower of cost or market on a first-in, first-out (FIFO) basis. The Company analyzes its

inventory levels on each reporting date and writes down inventory that is expected to expire prior to being sold and
inventory in excess of expected sales requirements. In the event that the Company identifies these conditions exist in its
inventory, the carrying value is reduced to its estimated net realizable value.

Property and equipment

Property and equipment, including leasehold improvements, are stated at cost and are depreciated, or amortized in

the case of leasehold improvements, over their estimated useful lives using the straight-line method. Expenditures for
maintenance and repairs are charged to expense as incurred, whereas major betterments are capitalized as additions to
property and equipment. The Company reviews its property and equipment whenever events or changes in circumstances
indicate that the carrying value of certain assets might not be recoverable and recognizes an impairment loss when it is
probable that an asset’s realizable value is less than the carrying value. To date, no such impairment losses have been
recorded. Depreciation is calculated based upon the following estimated useful lives of the assets:

Laboratory and manufacturing equipment
Computers and software
Office furniture and equipment

    Five years
  Three years
  Seven years

Leasehold improvements

Software development costs

Shorter of the useful life of the asset or
the remaining term of the lease

The Company develops and modifies software related to the operation of the instrument. Software development

costs are expensed as incurred until the point the Company establishes technological feasibility. Based on the

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Company’s product development process, technological feasibility is established upon the completion of a working model.
The Company does not incur material costs between the completion of the working model and the point at which the
product is ready for release. Therefore, software development costs are charged to the statement of operations as incurred
as research and development expense.

Fair value of financial instruments

ASC Topic 820, Fair Value Measurement (ASC 820), establishes a fair value hierarchy for instruments measured

at fair value that distinguishes between assumptions based on market data (observable inputs) and the Company’s own
assumptions (unobservable inputs). Observable inputs are inputs that market participants would use in pricing the asset or
liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that
reflect the Company’s assumptions about the inputs that market participants would use in pricing the asset or liability, and
are developed based on the best information available in the circumstances.

ASC 820 identifies fair value as the exchange price, or exit price, representing the amount that would be received

to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As a basis for
considering market participant assumptions in fair value measurements, ASC 820 establishes a three-tier fair value
hierarchy that distinguishes between the following:

Level 1 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities.

Level 2 inputs are inputs other than quoted prices that are observable for the asset or liability, either directly or

indirectly; and

Level 3 inputs are unobservable inputs that reflect the Company’s own assumptions about the assumptions market

participants would use in pricing the asset or liability.

To the extent that the valuation is based on models or inputs that are less observable or unobservable in the

market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the
Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within
the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement.

The carrying amount reflected on the balance sheets for cash and cash equivalents, accounts receivable, prepaid

expenses and other current assets, accounts payable and accrued liabilities approximated their fair values, due to the short-
term nature of these instruments. The carrying value of the long-term debt approximates its fair value as the debt
arrangement is based on interest rates the Company believes it could obtain for borrowings with similar terms. The
Company has an investment in the preferred stock of a privately held company which is recorded within other non-current
assets on a cost basis. This cost method investment’s fair value has not been estimated as there are no identified events or
changes in circumstances that would indicate a significant adverse effect on the fair value of the investment and to do so
would be impractical.

Fair value measurements as of December 31, 2020 are as follows (in thousands):

Description
Financial assets
Cash equivalents

Quoted prices
in active
markets
(Level 1)

Significant

Significant other unobservable

observable
     inputs (Level 2)     

inputs
(Level 3)

Total

  $ 162,048   $ 162,048
$ 162,048

$ 162,048

$
$

—   $
— $

—
—

Fair value measurements as of December 31, 2019 are as follows (in thousands):

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Description
Financial assets
Cash equivalents

Warranties

Quoted prices
in active
markets
(Level 1)

Significant

Significant other unobservable

observable
     inputs (Level 2)     

inputs
(Level 3)

Total

  $ 102,749   $ 102,749
  $ 102,749   $ 102,749

$
$

—   $
—   $

—
—

The Company provides a one-year warranty and maintenance service related to its instruments and sells extended
warranty contracts for additional periods. The Company defers revenue associated with these services and recognizes them
on a pro-rata basis over the period of service.

Income taxes

The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that

have been recognized in the Company’s consolidated financial statements or tax returns. Under this method, deferred tax
assets and liabilities are determined based on differences between the consolidated financial statement carrying amounts
and the tax bases of the assets and liabilities using the enacted tax rates in effect in the years in which the differences are
expected to reverse. A valuation allowance against deferred tax assets is recorded if, based on the weight of the available
evidence, it is more likely than not that some or all of the deferred tax assets will not be realized.

The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740 Income
Taxes (ASC 740). When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent
that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than
not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and
circumstances. As of December 31, 2020 and 2019, the Company did not have any significant uncertain tax positions.

Credit, product and supplier concentrations and off-balance-sheet risk

The Company has no significant off-balance-sheet risk, such as foreign exchange contracts, option contracts, or

other hedging arrangements. Financial instruments that potentially expose the Company to concentrations of credit risk
primarily consist of cash and cash equivalents and a cost method investment. The Company places its cash and cash
equivalents principally in depository accounts with a bank.

The Company is also subject to supply chain risks related to the outsourcing of the manufacturing of its
instruments. Although there are a limited number of manufacturers for instruments of this type, the Company believes that
other suppliers could provide similar products on comparable terms. A change in suppliers, however, could cause a delay in
manufacturing and a possible loss of sales, which would adversely affect operating results. In addition to outsourcing the
manufacturing of its instruments, the Company also purchases antibodies through a number of different suppliers.
Although a disruption in service from any one of its antibody suppliers is possible, the Company believes that it would be
able to find an adequate supply from alternative suppliers.

Customers outside the United States represented 29% and 50% of the Company’s gross trade accounts receivable

balance as of December 31, 2020 and 2019, respectively.

As of December 31, 2020, one customer represented 19% of the Company’s aggregate accounts receivable. As of

December 31, 2019, and 2018, no single customer represented 10% of the Company’s aggregate accounts receivable.
During the year ended December 31, 2020 one customer represented 13% of the Company’s total revenue. For the years
ended December 31, 2019 and 2018, no single customer represented 10% of the Company’s total revenue.

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Stock-based compensation

The Company accounts for stock-based compensation awards in accordance with ASC 718, Compensation—Stock

Compensation (ASC 718). ASC 718 requires all stock-based payments to employees including grants of employee stock
options, to be recognized in the statement of operations based on their fair values. Stock-based compensation awards have
historically consisted of stock options and restricted stock. Prior to the adoption of Accounting Standards Update (ASU)
No. 2018-07, Compensation - Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment
Accounting (ASU 2018-07), the measurement date for non-employee awards was generally the date the services were
completed, resulting in financial reporting period adjustments to stock-based compensation during the vesting period for
changes in the fair value of the awards. The Company adopted ASU 2018-07 on January 1, 2020. After the adoption of
ASU 2018-07, the measurement date for non-employee awards is the date of grant without changes in the fair value of the
award. Stock-based compensation costs for non-employees are recognized as expense over the vesting period on a straight-
line basis. There were no material non-employee awards outstanding during the years ended December 31, 2020, 2019, and
2018.

Effective January 1, 2017, the Company ceased utilizing an estimated forfeiture rate and began recognizing

forfeitures as they occur. The Company estimates the grant date fair value, and the resulting stock-based compensation
expense, using the Black-Scholes option-pricing model. The grant date fair value of the stock-based awards is generally
recognized on a straight-line basis over the requisite service period, which is generally the vesting period of the respective
awards.

The fair value of stock options granted to employees and non-employees is estimated on the grant date using the

Black-Scholes option-pricing model, based on the assumptions noted in the following table:

Year Ended December 31, 

Risk-free interest rate
Expected dividend yield
Expected term (in years)
Expected volatility

2020
0.4% - 1.7%
None
6

2019
1.4% - 2.6%
None
6.0
  43.9% - 49.2% 33.5% - 39.7% 32.4% - 36.8%  

2018
2.6% - 3.0%  
None
5.9

Using the Black-Scholes option-pricing model, the weighted-average grant date fair value of options granted for

the years ended December 31, 2020, 2019, and 2018 was $12.66, $9.09, and $7.19 per share, respectively. Expected
volatility was calculated based a proportional weighting of reported volatility data for a representative group of guideline
publicly traded companies for which historical information was available, as well as the Company’s stock. The risk-free
interest rate is based on the U.S. Treasury yield curve in effect at the time of grant, commensurate with the expected life
assumption. The Company estimates the expected life of options granted to employees utilizing the simplified method
which calculates the expected life of an option as the average of the time to vesting and contractual life of the options. The
expected life is applied to the stock option grant group as a whole, as the Company does not expect substantially different
exercise or post-vesting termination behavior among its employee population. The Company uses the simplified method
due to the lack of historical exercise data and the plain nature of the stock options. The Company uses the remaining
contractual term for the expected life of non-employee awards. The expected dividend yield is assumed to be zero as the
Company has never paid dividends and has no current plans to pay any dividends on common stock.

Recent accounting pronouncements

The Company is considered to be an “emerging growth company” as defined in the Jumpstart Our Business

Startups Act of 2012, as amended (JOBS Act). The JOBS Act provides that an emerging growth company can take
advantage of an extended transition period for complying with new or revised accounting standards. Thus, an emerging
growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to
private companies. The Company has elected to avail itself of this extended transition period and, as a result, the Company
will not be required to adopt new or revised accounting standards on the relevant dates on which adoption of such
standards is required for other public companies so long as the Company remains an emerging growth company.

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Recently Adopted

On January 1, 2020, the Company adopted ASC Topic 842, Leases (ASC 842) using the optional transition
method allowing entities to recognize a cumulative effect adjustment to the opening balance sheet without restating
comparative prior periods presented. ASC 842 requires a lessee to recognize assets and liabilities on the balance sheet for
most leases and changes many key definitions, including the definition of a lease. Lessees will continue to differentiate
between finance leases and operating, and classification will impact expense recognition.

The Company elected the following practical expedients for all lease asset classes, which must be

elected as a package and applied consistently to all of its leases at the transition date: i) the Company did not
reassess whether any expired or existing contracts are or contain leases; ii) the Company did not reassess the
lease classification for any expired or existing leases (that is, all existing leases that were classified as operating
leases in accordance with ASC 840, Leases (ASC 840), are classified as operating leases); and iii) the Company
did not reassess initial direct costs for any existing leases.

At the inception of an arrangement, the Company determines whether the arrangement is or contains

a lease based on the facts and circumstances present in the arrangement. Leases with a term greater than one
year are recognized on the balance sheet as right-of-use (ROU) assets and short-term and long-term lease
liabilities, as applicable. The Company has elected the practical expedient not to recognize leases on the
balance sheet with a term of twelve months or less. The Company’s leases consist of office and lab space and
office equipment. All of the Company’s leases are classified as operating, and options to renew a lease are only
included in the lease term to the extent those options are reasonably certain to be exercised. Additionally, the
Company elected to apply the practical expedient not to separate lease and nonlease components for all leases.

Operating lease liabilities and their corresponding ROU assets are initially recorded based on the

present value of lease payments over the expected remaining lease term. The rate implicit in lease contracts is
typically not readily determinable and, as a result, the Company utilizes its incremental borrowing rate to
discount lease payments, which reflects the fixed rate at which the Company could borrow on a collateralized
basis the amount of the lease payments, for a similar term, in a similar economic environment. To estimate its
incremental borrowing rate, a credit rating applicable to the Company is estimated using a synthetic credit rating
analysis since the Company does not currently have a rating agency-based credit rating.

The adoption of ASC 842 resulted in the recognition of operating lease ROU assets and operating lease

liabilities of $12.2 million and $22.8 million, respectively, on the Company’s condensed consolidated balance
sheet, with the difference between the ROU asset and lease liability primarily attributable to unamortized lease
incentives and deferred rent related to its lease for its corporate headquarters at 900 Middlesex Turnpike in
Billerica, Massachusetts (the 900 Middlesex Turnpike Lease).

On January 1, 2020, the Company adopted ASU 2017-04, “Intangibles – Goodwill and Other (Topic

350): Simplifying the Test for Goodwill Impairment” (ASU 2017-04). This ASU eliminates Step 2 from the
goodwill impairment test. In addition, income tax effects from any tax deductible goodwill on the carrying
amount of the reporting unit should be considered when measuring the goodwill impairment loss, if applicable.
The amendments also eliminate the requirements for any reporting unit with a zero or negative carrying amount
to perform a qualitative assessment and, if it fails that qualitative test, to perform Step 2 of the goodwill
impairment test. An entity still has the option to perform the qualitative assessment for a reporting unit to
determine if the quantitative impairment test is necessary. The adoption of ASU 2017-04 resulted in no material
effect to the Company’s financial statements.

On January 1, 2020 the Company adopted ASU 2018-07. This standard simplifies the accounting for share-based

payments to non-employees by aligning it with the accounting for share-based payments to employees, with certain
exceptions. The adoption of ASU 2018-07 did not have a material effect on the Company’s consolidated financial
statements.

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Table of Contents

On January 1, 2020, the Company adopted ASU No. 2018-13, “Fair Value Measurement (Topic 820), Disclosure

Framework—Changes to the Disclosure Requirements for Fair Value Measurement”. This ASU removed the following
disclosure requirements: (1) the amount of and reasons for transfers between Level 1 and Level 2 of the fair value
hierarchy; (2) the policy for timing of transfers between levels; and (3) the valuation processes for Level 3 fair value
measurements. Additionally, this update added the following disclosure requirements: (1) the changes in unrealized gains
and losses for the period included in other comprehensive income for recurring Level 3 fair value measurements held at the
end of the reporting period; and (2) the range and weighted average of significant unobservable inputs used to develop
Level 3 fair value measurements. For certain unobservable inputs, an entity may disclose other quantitative information
(such as the median or arithmetic average) in lieu of the weighted average if the entity determines that other quantitative
information would be a more reasonable and rational method to reflect the distribution of unobservable inputs used to
develop Level 3 fair value measurements. The adoption of this standard did not have a material effect on the Company’s
consolidated financial statements.

On January 1, 2019, the Company adopted ASC 606 using the modified retrospective method. Under ASC 606,

revenue is recognized upon the transfer of control of goods or services to customers and reflects the amount of
consideration to which an entity expects to be entitled in exchange for those goods or services. The adoption of ASC 606
has been applied to customer contracts that were not completed as of January 1, 2019, and did not materially change the
pattern of revenue recognition for its current customer contracts.

The Company's consolidated financial statements for the prior-year period have not been revised and are reflective

of the revenue recognition requirements which were in effect for that period.

The Company recorded an adjustment to the accumulated deficit of $0.4 million as of January 1, 2019 for the

cumulative effect primarily related to the deferral of sales commissions.

In accordance with the reporting requirements of ASC 606, the disclosure of the impact on the Company's

consolidated balance sheet and statement of operations, as a result of adopting the provisions of ASC 606, was as follows
(in thousands):

Assets:
Accounts receivable
Prepaid expenses and other
current assets
Other non-current assets

Liabilities:
Deferred revenue
Deferred revenue, net of current
portion

Stockholders’ equity:
Accumulated deficit

As
reported

Adjusted under
ASC 606

    December 31, 2018    Adjustments    January 1, 2019    

As reported
December 31, 
2019

Prior to
adoption of
ASC 606

  December 31, 

    Adjustments     

2019

  $

6,792   $

47   $

6,839   $

10,906   $

—   $

10,906

2,330
536

5,437

520

288
19

43

43

2,618
555

2,137
557

335
—  

1,802
557

5,394

4,697

(209)

4,488

477

466

14

480

  $

(175,888)  $

(440)  $

(175,448)  $ (216,244)  $

(140)  $ (216,104)

F-21

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table of Contents

Product revenue
Service revenue
Costs of goods sold and services
Gross profit
Selling general and administrative expenses
Net loss

For the year Ended December 31, 2019

     Under ASC 606     Adjustment
40,491   $
  $
16,059
29,898
26,836
52,246
(40,796)  $

55   $
273
1
327
27
300   $

  $

Under ASC
 605
40,546
16,332
29,899
27,163
52,273
(40,496)

In January of 2019, the Company adopted ASU 2016-01, which requires equity investments (except those
accounted for under the equity method of accounting or those that result in consolidation of the investee) to be measured at
fair value with changes in fair value recognized in net income. For equity investments without readily determinable fair
values that do not qualify for the practical expedient to estimate fair value using the net asset value per share or its
equivalent, the Company has elected to measure these investments at cost minus impairment, if any, plus or minus changes
resulting from observable price changes in orderly transactions for the identical or similar investment of the same issuer.
This election is made for each investment separately and is reassessed at each reporting period as to whether the investment
continues to qualify for this election. Additionally, at each reporting period, the Company makes a qualitative assessment
considering impairment indicators to evaluate whether the investment is impaired. The adoption of this standard did not
have a material effect on the Company’s consolidated financial statements.

Not Yet Adopted

In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments — Credit Losses: Measurement of Credit

Losses on Financial Instruments (ASU 2016-13), which amends the impairment model by requiring entities to use a
forward-looking approach based on expected losses to estimate credit losses on certain types of financial instruments,
including trade receivables and available-for-sale debt securities. The standard is effective for the Company beginning in
the first quarter of 2022, with early adoption permitted. The Company does not expect impact of ASU 2016-13 to be
material on its consolidated financial statements.

In August 2018, the FASB issued ASU No. 2018-15, Intangibles - Goodwill and Other - Internal-Use Software

(Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is
a Service Contract (ASU 2018-15). This ASU addresses the accounting for implementation, setup and other upfront costs
paid by a customer in a cloud computing or hosting arrangement. The guidance aligns the accounting treatment of these
costs incurred in a hosting arrangement treated as a service contract with the requirements for capitalization and
amortization costs to develop or obtain internal-use software. This guidance is effective for fiscal years beginning after
December 15, 2020 and early adoption is permitted. The guidance can be adopted either retrospectively or prospectively.
The Company is currently evaluating the expected impacts of ASU 2018-15.

In December 2019, the FASB issued ASU 2019-12, Income Taxes (ASC 740): Simplifying the Accounting for

Income Taxes, which is intended to simplify various areas related to accounting for income taxes. ASU 2019-12 removes
certain exceptions to the general principles in ASC 740 and also clarifies and amends existing guidance to improve
consistent application. ASU 2019-12 is effective for the Company beginning in fiscal year 2022, with early adoption
permitted. The Company is currently evaluating the impact of this standard on its consolidated financial statements and
disclosures.

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3. Inventory

Inventory consists of the following (in thousands):

Raw materials
Work in process
Finished goods

Total

December 31,

2020

5,265
3,306
6,285
14,856

$

$

$

$

2019

4,717
2,573
3,173
10,463

Inventory comprises commercial instruments, assays, and the materials required to manufacture assays.

4. Property and equipment

Property and equipment consists of the following (in thousands):

Laboratory and manufacturing equipment
Office furniture and equipment
Computers and software
Leasehold improvements

Total

Less: accumulated depreciation

Total

As of
December 31, 

2020

8,523
1,556
1,504
8,765
20,348

(6,436)
13,912

$

$

$

2019

5,391
1,403
1,103
8,489
16,386

(4,339)
12,047

$

$

$

The Company incurred depreciation expense of $2.2 million and $1.6 million for the years ended
December 31, 2020 and 2019, respectively. The Company has instruments included in laboratory and manufacturing
equipment, which are used internally by the Company. As of December 31, 2020, the laboratory and manufacturing
equipment balance includes $3.4 million of cost and $1.8 million of accumulated depreciation related to these instruments.
As of December 31, 2019, the laboratory and manufacturing equipment balance includes $2.8 million of cost and $1.2
million of accumulated depreciation related to these instruments.

5. Other accrued expenses

Other accrued expenses consist of the following (in thousands):

Accrued inventory purchases
Accrued royalties
Accrued professional services
Accrued development costs
Accrued other

Total accrued expenses

F-23

December 31, 
2020

December 31, 
2019

$

$

527
1,845
797
323
1,353
4,845

$

$

459
476
655
151
757
2,498

    
    
 
 
 
 
    
    
 
 
 
 
 
 
 
 
 
 
    
    
 
 
 
 
 
 
 
 
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Other non-current liabilities consist of the following (in thousands):

Leasehold obligation incentive
Deferred rent
Deferred tax liabilities
Other

Total other non-current liabilities

6. Income taxes

December 31, 
2020

December 31, 
2019

— $
—
2,649
—
2,649

$

7,572
3,009
2,825
1
13,407

$

$

The following table presents the components of loss before income taxes (in thousands):

United States
Foreign

2020

Year Ended December 31, 
2019
$ (29,896) $ (40,010) $ (31,436)
(75)
$ (31,906) $ (40,983) $ (31,511)

(2,010)

(973)

2018

The following table summarizes income tax benefit (provision) (in thousands):

Current:

United States

Federal
State
Foreign

Total current income tax provision
Deferred

United States

Federal
State
Foreign

Total deferred income tax benefit (provision)
Total income tax benefit (provision)

Year Ended
December 31, 
2019

2018

2020

  $

—   $
(13)
(102)
(115)

—   $
(20)
(93)
(113)

(8)
(3)
502
491
376

$

(3)
(1)
304
300
187

$

  $

—
(18)
—
(18)

(2)
(5)
—
(7)
(25)

During the years ended December 31, 2020, 2019, and 2018, the Company recorded an income tax benefit

(provision) of $0.4 million, $0.2 million, and $(0.0) million, respectively.

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Table of Contents

A reconciliation of the federal statutory income tax rate to the effective tax rate is as follows:

Federal statutory income tax rate
Foreign tax rate differential
State taxes, net of federal benefit
Tax credits
Share-based compensation
Permanent items
Deferred tax rate change
Change in valuation allowance
Other

Effective income tax rate

Year Ended December 31, 

2020

2019     

2018

21.0 %   21.0 %  
0.3 %   — %  
3.2 %  
2.5 %  
2.3 %  
1.6 %  
2.3 %  
5.2 %  
(0.9)%  
(0.4)%  
(1.4)%  
0.3 %  
(29.7)%   (24.6)%  
(1.4)%  
0.5 %  

0.4 %  
1.2 %  

21.0 %  
— %  
6.0 %  
2.7 %  
1.1 %  
(1.2)%  
— %  
(29.9)%  
0.2 %  
(0.1)%  

The effective tax rate of 1.2% differs from the U.S. Federal statutory rate of 21.0% primarily as a result of the

valuation allowance maintained against the Company’s net deferred tax assets.

During 2018, the Company acquired Aushon. The Company analyzed the transaction from an income tax

perspective and adjusted the deferred tax assets and liabilities related to the Aushon acquisition. Of the total goodwill
recorded, approximately $0.3 million is amortizable related to historical tax basis that Aushon had related to a prior
acquisition.

During 2019, the Company acquired Uman, a Swedish entity. The Company analyzed the transaction from an

income tax perspective and found that there was no tax deductible goodwill or other identifiable intangible assets related to
the transaction.

Deferred tax assets and liabilities reflect the net tax effects of temporary differences between the carrying amount
of assets and liabilities for financial reporting and the amounts used for income tax purposes. Significant components of the
Company’s deferred tax assets and liabilities were as follows (in thousands):

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Deferred tax assets:

Net operating loss carryforwards
Tax credits
Deferred revenue
Amortization
Stock-based compensation
Deferred rent
Lease incentive obligation
Lease liability
Other deferred tax assets

Total deferred tax assets

Less: valuation allowances

Net deferred tax assets

Deferred tax liabilities:
Right-of-Use Assets
Depreciation
Amortization acquired intangibles
Inventory
Goodwill
Other deferred tax liabilities

Net deferred tax liabilities

December 31, 

2020

2019

$

$

50,233
5,101
2,167
1,054
1,956
—
—
5,703
2,533
68,747
(63,609)
5,138

(2,957)
(1,775)
(2,880)
(64)
(49)
(61)
(2,648)

$

$

43,814
5,518
1,247
928
973
727
1,828
—
1,325
56,360
(54,137)
2,223

—
(1,769)
(3,031)
(212)
(31)
(5)
(2,825)

The Company’s change in its valuation allowance account with respect to the deferred tax asset is as follows (in

thousands):

Balance, beginning of year
Change in valuation allowance
Balance, end of year

2020
54,137
9,472
63,609

$

$

2019
44,033
10,104
54,137

$

$

The valuation allowance increased by $9.5 million during the year ended December 31, 2020, primarily as a result

of the U.S. operating losses incurred, and research and development tax credit carryforwards generated during the year.

In determining the need for a valuation allowance, the Company has given consideration to the cumulative book
income and loss positions of each of its entities as well as its worldwide cumulative book loss position. The Company has
assessed, on a jurisdictional basis, the available means of recovering deferred tax assets, including the ability to carryback
net operating losses (NOLs), the existence of reversing taxable temporary differences, the availability of tax planning
strategies, and forecasted future taxable income. At December 31, 2020, the Company maintains a full valuation allowance
against its worldwide net deferred tax assets.

As of December 31, 2020, the Company had U.S. federal NOLs of approximately $199.3 million. U.S. federal
NOLs generated through December 31, 2017 of approximately $108.5 million expire at various dates through 2037, and
U.S. federal NOLs generated in the tax years beginning after December 31, 2017 of approximately $90.8 million do not
expire. As of December 31, 2020, the Company had $133.7 million of state NOLs, some of which are indefinite lived and
some that expire at various dates through 2040. As of December 31 2020, the Company had U.S. federal tax credit
carryforwards of approximately $4.5 million that expire at various dates through 2040. As of December 31, 2020, the
Company had U.S. state tax credit carryforwards of approximately $0.8 million that expire at various dates through 2040.

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Under Sections 382 and 383 of the U.S. Internal Revenue Code, if a corporation undergoes an ownership change,

the corporation’s ability to use its pre-change NOLs and other pre-change tax attributes, such as research tax credits, to
offset its post-change income and taxes may be limited. In general, an ownership change generally occurs if there is a
cumulative change in its ownership by 5% stockholders that exceeds 50 percentage points over a rolling three-year period.
Similar rules may apply under U.S. state tax laws. Under the TCJA, the use of federal NOLs arising in taxable years
beginning after December 31, 2017 is limited to 80% of current year taxable income and NOLs arising in taxable years
ending after December 31, 2017 may not be carried back (though any such NOLs may be carried forward indefinitely).

The Company may have experienced an ownership change in the past and may experience ownership changes in

the future as a result of future transactions in its share capital, some of which may be outside of the control of the
Company. As a result, if the Company earns net taxable income, its ability to use its pre-change NOLs, or other pre-change
tax attributes, to offset U.S. federal and state taxable income and taxes may be subject to significant limitations.

The Coronavirus Aid, Relief and Economic Security Act (the CARES Act) was enacted in the United States on
March 27, 2020. The CARES Act is an emergency economic stimulus package that includes spending and tax breaks to
strengthen the United States economy and fund a nationwide effort to curtail the effect of COVID-19. While the CARES
Act provides extensive tax changes in response to the COVID-19 pandemic, the provisions do not have a significant impact
on the Company’s financial results.

The Company accounts for uncertain tax positions using a more likely than not threshold for recognizing

uncertain tax positions. The evaluation of uncertain tax positions is based on factors that include, but are not limited to,
changes in tax law, the measurement of tax positions taken or expected to be taken in tax returns, the effective settlement of
matters subject to audit, new audit activity and changes in facts or circumstances related to a tax position. The Company
evaluates uncertain tax positions on an ongoing basis and adjusts the level of the liability to reflect any subsequent changes
in the relevant facts surrounding the uncertain positions. The Company accounts for interest and penalties related to
uncertain tax positions as a component of its benefit (provision) for income taxes. For the years ended December 31, 2020,
2019, and 2018, the Company had no tax reserves accrued for uncertain tax positions and there were no accrued interest or
penalties in the consolidated statements of operations.

The Company is subject to taxation in the United States as well as the Netherlands, Sweden, and China. At

December 31, 2020, the Company is generally no longer subject to examination by taxing authorities in the United States
for years prior to 2017. However, NOLs and credits in the United States may be subject to adjustments by taxing
authorities in future years in which they are utilized. The Company’s foreign subsidiaries remain open to examination by
taxing authorities from 2015 onward.

As of December 31, 2020, the Company’s foreign subsidiaries had immaterial undistributed earnings and the tax

payable on the earnings that are indefinitely reinvested would be immaterial.

7. Common Stock, warrants, stock-based compensation, stock options, restricted stock and restricted stock units

Common stock reserved

The Company reserved the following shares of common stock, on a common stock equivalent basis, for the

exercise of warrants, the exercise of common stock options, and the vesting of restricted common stock.

Common stock warrants
Common stock options and unvested restricted common stock
Shares reserved for future awards under compensation plans

F-27

As of December 31,

2020
10,000  
3,012,432  
1,559,108  
4,581,540  

2019
10,000
2,916,991
882,715
3,809,706

    
    
 
 
 
 
Table of Contents

Warrants

The following table summarizes the Company’s outstanding warrants as of December 31, 2020, and 2019:

As of December 31, 2019
Issued
Exercised
Cancelled
As of December 31, 2020

Weighted
Average

Issued and
exercisable
10,000

$
—  
—  
—
10,000

     Exercise Price
21.00
—
—
—
21.00

$

The Company has an agreement with a vendor (Note 9) where the Company could be obligated to issue warrants

to purchase an additional 93,341 shares of common stock to the vendor if the contract is terminated prior to a minimum
purchase commitment being met. No shares have been reserved related to these potential obligations to issue warrants in
the future. On January 30, 2018, the Company issued a warrant to purchase 10,000 of common stock to a consultation
company for services rendered.

On July 2, 2019, 66,041 warrants were exercised by a holder on a net, non-cash, basis. Per terms of the warrant

agreement, the Company issued 45,690 shares of common stock after giving effect to the holder’s net exercise.

Stock-based compensation

Share-based compensation expense for all stock awards consists of the following (in thousands):

Cost of product revenue
Cost of service and other revenue
Research and development
Selling, general, and administrative
Total

2020

$

189
311
1,129
8,470
$ 10,099

December 31, 
2019

$

$

86
238
718
5,346
6,388

2018

55
173
513
4,143
4,884

$

$

In June 2007, the Company adopted the 2007 Stock Option and Grant Plan (the 2007 Plan), under which it could

grant incentive stock options, non-qualified options, restricted stock, and stock grants. In connection with the completion of
the IPO, the Company terminated the 2007 Plan. As of December 31, 2020, 926,615 shares were outstanding and no shares
were available for future grant under the 2007 Plan.

In December 2017, the Company adopted the 2017 Employee, Director and Consultant Equity Incentive Plan (the
2017 Plan), under which it may grant incentive stock options, non-qualified stock options, restricted stock, and other stock-
based awards. As of December 31, 2017, the 2017 Plan allowed for the issuance of up to 1,042,314 shares of common
stock plus up to 2,490,290 shares of common stock represented by awards granted under the 2007 Plan that are forfeited,
expire or are cancelled without delivery of shares or which result in the forfeiture of shares of common stock back to the
Company on or after the date the 2017 Plan became effective. As of December 31, 2020 and 2019, there were shares
available for grant under the 2017 Plan of 710,839 and 270,143, respectively.

In addition, the 2017 Plan contains an "evergreen" provision, which allows for an annual increase in the number of

shares of common stock available for issuance under the 2017 Plan on the first day of each fiscal year during the period
beginning in fiscal year 2019 and ending in fiscal year 2027. The annual increase in the number of shares shall be equal to
the lowest of: 4% of the number of shares of common stock outstanding as of such date; and an amount determined by the
Company’s Board of Directors or Compensation Committee. On January 1, 2021, the number of shares of common stock
available for issuance under the 2017 plan was automatically increased by 1,273,501 shares.

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Table of Contents

In December 2017, the Company adopted the 2017 Employee Stock Purchase Plan (the 2017 ESPP). As

December 31, 2019, the 2017 ESPP allowed for the issuance of up to 612,572 shares of common stock. As of
December 31, 2020, 848,269 shares were available for grant under the 2017 ESPP.

In addition, the 2017 ESPP contains an "evergreen" provision, which allows for an increase on the first day of

each fiscal year beginning with fiscal year 2018. The increase in the number of shares shall be equal to the lowest of: 1% of
the number of shares of common stock outstanding on the last day of the immediately preceding fiscal year or an amount
determined by the Company’s Board of Directors or Compensation Committee. The number of shares available for grant
under the 2017 ESPP increased by 318,375 shares on January 1, 2021 due to this provision.

The 2017 ESPP provides for six-month option periods commencing on March 1 and ending August 31 and

commencing September 1 and ending February 28 of each calendar year. The first offering under the 2017 ESPP began on
September 1, 2018.

Stock options

Under the 2007 and 2017 Plans, stock options may not be granted with exercise prices of less than fair market

value on the date of the grant. Options generally vest ratably over a four-year period with 25% vesting on the first
anniversary and the remaining 75% vesting ratably on a monthly basis over the remaining three years. These options expire
ten years after the grant date. Activity under the 2007 Plan and the 2017 Plan were as follows:

Weighted-average Remaining contractual Aggregate intrinsic value

Outstanding at December 31, 2019

Granted
Exercised
Cancelled

Outstanding at December 31, 2020
Vested and expected to vest at
December 31, 2020
Exercisable at December 31, 2020

     Options
  2,507,062   $
550,290
$
(407,687) $
(155,620) $
$

  2,494,045

exercise price
14.41
28.39
9.85
22.58
17.73

  2,494,045
1,514,576

$
$

17.73
12.54

life (in years)

(in thousands)

7.58

$

24,870

7.27

7.27
6.42

$

$
$

71,760

71,760
51,430

Using the Black-Scholes option pricing model, the weighted-average fair value of options granted to employees

and directors during the years ended December 31, 2020, 2019, and 2018 was $12.64, $9.09, and $7.19 per share,
respectively. The expense related to stock options granted to employees was $5.4 million, $3.7 million, and $2.7 million for
the years ended December 31, 2020, 2019, and 2018, respectively. The intrinsic value of stock options exercised was $10.4
million, $6.9 million, and $5.3 million, for the years ended December 31, 2020, 2019, and 2018, respectively. On
December 7, 2020, the Company entered into an agreement with a non-employee director related to the extension of the
exercise period, resulting in $0.5 million of stock-based compensation expense recorded in selling, general and
administrative expense during the year ended December 31, 2020.

At December 31, 2020, there was $9.3 million of total unrecognized compensation cost related to unvested stock

options, which is expected to be recognized over the remaining weighted-average vesting period of 7.3 years.

Restricted stock awards

In December 2014, the Company issued 78,912 shares of restricted common stock to a director of the Company
under the 2007 Plan. Under the terms of the agreement, shares of common stock issued are subject to a four year vesting 
schedule. Vesting occurs periodically at specified time intervals and specified percentages. In January 2015, the Company 
issued 781,060 shares of restricted common stock to an executive of the Company under the 2007 Plan. The majority of 
these shares were issued subject to a four year vesting schedule with 25% vesting on the first anniversary and the 
remaining vesting 75% ratably on a monthly basis over the remaining three years, while another portion was issued subject 
to performance based vesting. The vesting of performance based awards is dependent upon achievement of specified 
financial targets of the Company. The majority of the performance criteria were achieved during the years 

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Table of Contents

ended December 31, 2016 and 2015 and the remaining unvested awards with performance conditions are not material. No 
restricted stock awards were granted during the years ended December 31, 2020, 2019, or 2018. As of December 31, 2020, 
the Company had 39,806 shares of unvested restricted common stock with a weighted average grant date fair value of 
$3.12 per share.

The expense related to restricted stock awards granted to employees and non-employees was $0.0 million,

$0.0 million, and $0.4 million for the years ended December 31, 2020, 2019, and 2018, respectively.

At December 31, 2020, there was no unrecognized compensation cost related to unvested restricted stock.

The aggregate fair value of restricted stock awards that vested during the years ended December 31, 2020, 2019,

and 2018, based on estimated fair values of the stock underlying the restricted stock awards on the day of vesting, was
$0.0 million, $0.0 million and $2.4 million, respectively.

Restricted stock units

Restricted stock units (RSUs) represent the right to receive shares of common stock upon meeting specified

vesting requirements. In the fiscal year ended December 31, 2020, the Company issued 334,665 RSUs to employees of the
Company under the 2017 Plan. Under the terms of the agreements, 268,694 of the RSUs issued are subject to a four year 
vesting schedule with 25% vesting on the first anniversary and the remaining vesting 75% ratably on a monthly basis over 
the remaining three years, 15,890 of the RSUs vested on December 31, 2020, 40,045 of the RSUs vest equally over three 
years on the anniversary of the vesting start date, 8,576 vested immediately upon grant, and 1,460 RSUs vest on May 31, 
2021. A summary of RSU activity is as follows:

Unvested RSUs as of December 31, 2019

Granted
Vested
Cancelled

Unvested RSUs as of December 31, 2020

Weighted-average
grant date
fair value
per share

20.48
31.99
20.13
26.79
28.08

Shares
370,123   $
$
334,665
$
(182,036)
$
(44,171)
478,581
$

The expense related to RSU awards granted to employees and non-employee directors was $4.2 million for the

fiscal year ended December 31, 2020.

At December 31, 2020, there was $12.0 million of total unrecognized compensation cost related to unvested
restricted stock, which is expected to be recognized over the remaining weighted-average vesting period of 2.8 years.

8. Leases

The Company is a lessee under leases of offices, lab spaces, and certain office equipment. Some of the Company’s
leases include options to extend the lease, and these options are included in the lease term to the extent they are reasonably
certain to be exercised.

900 Middlesex Turnpike Lease

The Company’s primary lease is the 900 Middlesex Turnpike Lease. On October 2, 2018, the Company entered

into a 137-month operating lease for the Company’s new headquarters in Billerica, Massachusetts. The lease is for
approximately 92,000 square feet of office and laboratory space and commenced on April 1, 2019. The lease contains a
period of free rent and escalating monthly rent payments. As part of the lease, the Company was required to enter into a
$1.0 million Letter of Credit drawable by the lessor under specifically outlined conditions, which will be subsequently
reduced throughout the lease term. Pursuant to a work letter entered into in connection with the 900 Middlesex Turnpike
Lease, the landlord contributed an aggregate of $8.2 million toward the cost of construction and tenant improvements for

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the building. Under the lease, the Company has the option to extend the lease for two successive five-year terms, and the
renewal options are not reasonably certain to be exercised.

In applying the ASC 842 transition guidance, the 900 Middlesex Turnpike Lease remained classified as an
operating lease and the Company recorded ROU assets of $12.2 million and lease liability of $22.7 million on the effective
date. The difference between the ROU and the lease liability was driven by the Company derecognizing deferred rent of
$3.0 million and the lease obligation incentive of $7.6 million. The Company is recognizing rent expense on a straight-line
basis throughout the remaining term of the leases.

48 Tvistevägen

The Company has multiple leases at 48 Tvistevägen Umeå, Sweden for laboratory spaces, manufacturing spaces,

and office space (the Uman leases). All of these Uman leases have been assessed as operating leases.

In applying the ASC 842 transition guidance, the Uman leases remained classified as operating leases and the

Company recorded ROU assets of less than $0.1 million and lease liability of less than $0.1 million on the effective date.
The Company is recognizing rent expense on a straight-line basis throughout the remaining term of the leases.

Summary of all lease costs recognized under ASC 842

The following table contains a summary of the lease costs recognized under ASC 842 and other information

pertaining to the Company’s operating leases for the year ended December 31, 2020:

Operating leases (in thousands)
Lease Costs (1)

Operating lease costs
Total lease cost

Other information

Operating cash flows used for operating leases
Weighted average remaining lease term (years)
Weighted average discount rate

For the year ended December 31, 2020

$
$

$

2,663
2,663

2,108
9.8
9.73%

(1) Short-term lease costs and variable lease costs incurred by the Company for the year ended December 31,

2020 were considered immaterial.

Rent expense is calculated on a straight-line basis over the term of the lease. Rent expense recognized under all

leases was $4.8 million, $3.3 million, and $1.6 million for the years ended December 31, 2020, 2019, and 2018,
respectively. Note that the Company adopted ASC 842 effective January 1, 2020 using the required modified retrospective
approach and utilizing the effective date as its date of initial application. Therefore, amounts disclosed pertaining to the
years ended December 31, 2019 and 2018 are presented under previous accounting guidance and are therefore not
comparable to the amounts recorded in the current period under ASC 842.

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As of December 31, 2020, future minimum commitments under ASC 842 under the Company’s operating leases

were as follows:

Maturity of lease liabilities (in thousands)
2021
2022
2023
2024
2025 and thereafter
Total lease payments
Less: imputed interest
Total operating lease liabilities

9. Commitments and contingencies

License agreements

Tufts University

$

$

$

As of December 31, 2020

3,388
3,466
3,515
3,577
22,203
36,149
13,024
23,125

In June 2007, the Company entered into a license agreement (the License Agreement) for certain

intellectual property with Tufts University (Tufts). Tufts is a related party to the Company due to Tuft’s equity
ownership in the Company and because a board member of the Company’s Board of Directors was affiliated with
Tufts. The License Agreement, which was subsequently amended, is exclusive and sub licensable, and will
continue in effect on a country by country basis as long as there is a valid claim of a licensed patent in a country.
The Company is committed to pay license and maintenance fees, prior to commercialization, in addition to low
single digit royalties on direct sales and services and a royalty on sublicense income. During the years ended
December 31, 2020, 2019, and 2018, the Company recorded royalty expense of $1.1 million, $1.0 million and
$0.7 million, respectively, in cost of product revenue on the consolidated statements of operations. During the
year ended December 31, 2020, the Company incurred $1.0 million in cost of collaboration and license revenue
owed to Tufts related to sublicensing certain technology and intellectual property to Abbott Laboratories (Abbott)
(see Note 13).

Other licenses

During the year ended December 31, 2012, the Company entered into a license agreement for certain intellectual

property with a third party. The non-exclusive, non-sublicenseable third party’s license provides the Company access to
certain patents specifically for protein detection, and shall be in effect until the expiration of the last licensed patent. In
consideration for these rights, the Company committed to certain license fees, milestone payments, minimum annual
royalties and a mid-single digit royalty. The Company is required to make mid-single digit royalty payments on net sales of
products and services which utilize the licensed technology. The Company must pay the greater of calculated royalties on
net sales or an annual minimum royalty of $50 thousand. In September 2019, all remaining patents related to the
intellectual property expired and the license agreement terminated. As this agreement was terminated in 2019, the
Company recorded no royalty expense during the year ended December 31, 2020. During the year ended December 31,
2019 and 2018, the Company recorded royalty expense of $0.8 million, and $0.4 million, respectively, in cost of product
revenue on the consolidated statements of operations.

Development and supply agreement

Through the Company’s development agreement with STRATEC Biomedical, as amended in December 2016, the
parties agreed on additional development services for an additional fee, which is payable when the additional development
is completed. A total of $11.7 million is payable to STRATEC Biomedical upon completion of the

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development activities. This amount is being recorded to research and development expense and accrued expenses as the 
services are performed. The services were completed during the year ended December 31, 2018. Substantive efforts related 
to these additional development activities started in the first quarter of 2019 and were completed in the third quarter of 
2019.

The Company’s supply agreement with STRATEC Biomedical required the Company to purchase a minimum

number of commercial units over a seven-year period ending in May 2021. If the Company were to fail to purchase a
required number of commercial units, the Company would be obligated to pay termination costs plus a fee based on the
shortfall of commercial units purchased compared to the required minimum amount. Based on the number of commercial
instruments purchased as of December 31, 2020 the Company has satisfied its required minimum purchase amount per the
supply agreement. Also, if the Company terminates the supply agreement under certain circumstances and has not
purchased a required number of commercial units, it would be obligated to issue warrants to purchase 93,341 shares of
common stock (the Supply Warrants) at $0.003214 per share. The Company believes that it will purchase sufficient units to
meet the requirements of the minimum purchase commitment and, therefore, has not accrued for any of the potential cash
consideration. The Supply Warrants are accounted for at fair value; however, the fair value of the Supply Warrants as of
December 31, 2020 and December 31, 2019 was insignificant as there was a low probability of the warrants being issued.

Legal contingencies

The Company is subject to claims in the ordinary course of business; however, the Company is not currently a

party to any pending or threatened litigation, the outcome of which would be expected to have a material adverse effect on
its financial condition or the results of its operations. The Company accrues for contingent liabilities to the extent that the
liability is probable and estimable.

10. Notes payable

Loan agreement

On April 14, 2014, the Company executed a Loan Agreement with a lender, as subsequently amended, most
recently in April 2019. As of December 31, 2020 and 2019, there were no additional amounts available to borrow under the
debt facility. The interest rate on this term loan is variable based on a calculation of the prime rate less 5.25% with a
minimum interest rate of 8%. Interest is paid monthly beginning the month following the borrowing date. At loan inception
and in connection with the amendments, the Company issued the lender warrants to purchase shares of stock. The Loan
Agreement also contains prepayment penalties and an end of term charge. Fees incurred upon execution of the agreements,
and the fair value of warrants on the date of grant were accounted for as a reduction in the book value of debt and accreted
through interest expense, using the effective interest rate method, over the term of the debt.

Amendment 5 to loan agreement

In August 2018, the Company signed Amendment 5 to the Loan Agreement (Amendment 5). Amendment 5

instituted a 2018 End of Term Charge of $0.08 million. Additionally, the Term Loan Maturity Date extended until March 1,
2020. Amendment 5 additionally, changed the due date of the End of Term Charge to, the earlier of (i) the Term Loan
Maturity Date, (ii) the date that Borrower prepays the outstanding Secured Obligations or (iii) the date that the Secured
Obligations become due and payable. The Company incurred a cost of $0.05 million in relation to the execution of
Amendment 5. In connection with the extension of the due date of the Loan, the deferral of principal payments
(Amendment 3) was further deferred until the new Term Loan Maturity Date. On March 2, 2020, the Company paid $0.1
million in end of term fees related to Amendment 5 of the loan agreement.

Amendment 6 to loan agreement

In October 2018, the Company signed Amendment 6 to the Loan agreement, which amended the Loan
Agreement’s collateral clause to exclude the $1.0 million certificate of deposit associated with the lease on the Company’s
new headquarters in Billerica, MA.

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Amendment 7 to loan agreement

On April 15, 2019, the Company signed Amendment 7 to the loan agreement, which extends the interest only

payment period through July 1, 2021 and also extends the maturity date until October 1, 2021. As part of this Amendment
7, a “2019 End of Term Charge” for $50,000 was added to the loan agreement due on the earliest to occur of (i) the term
loan maturity date, (ii) the date that the Company prepays the outstanding secured obligations and (iii) the date that the
secured obligations become due and payable. In addition, the Company is required to pay the loan principal in four equal
installments starting July 1, 2021 with the final principal payment to be made on October 1, 2021.

As of December 31, 2020, debt payment obligations due based on principal payments are as follows (in

thousands):

2021
Total

$
$

7,688
7,688

Non-cash interest expense related to debt discount amortization and accretion of end of term fees was $0.1

million, $0.1 million, and $0.2 million for the year ended December 31, 2020, 2019, and 2018, respectively.

The Company assessed all terms and features of the Loan Agreement and the subsequent amendments in order to
identify any potential embedded features that would require bifurcation. As part of this analysis, the Company assessed the
economic characteristics and risks of the debt. The Company determined that all features of the Loan Agreement and the
subsequent amendments are either clearly and closely associated with a debt host or have a de minimis fair value and, as
such, do not require separate accounting as a derivative liability. The Company assessed each amendment under ASC 470-
50 Debt – Modifications and Extinguishments and concluded that all of the amendments constituted modifications. The
Company also assessed whether the amendments represented a troubled debt restructuring and concluded they did not. The
Company accounted for each of the amendments to the Loan Agreement as a modification of its debt and the unamortized
discount and issuance costs related to the prior debt are amortized over the modified term of the new debt.

The Loan Agreement and the subsequent amendments contain negative covenants restricting the Company’s

activities, including limitations on dispositions, mergers or acquisitions, incurring indebtedness or liens, paying dividends
or making investments and certain other business transactions. There are no financial covenants associated with the Loan
Agreement and the subsequent amendments. The obligations under the Loan Agreement and subsequent amendments are
subject to acceleration upon the occurrence of specified events of default, including a material adverse change in the
Company’s business, operations or financial or other condition. The Company has determined that the risk of subjective
acceleration under the material adverse events clause is not probable and therefore has classified the outstanding principal
in current and long-term liabilities based on scheduled principal payments.

11. “At-the-market offering”

On March 19, 2019, the Company entered into the Sales Agreement with Cowen with respect to an “at-the-

market” offering program under which the Company could offer and sell, from time to time at its sole discretion, shares of
its common stock, having an aggregate offering price of up to $50.0 million through Cowen as its sales agent.

On June 5, 2019, the Company issued approximately 2.2 million shares of common stock at an average stock
price of $22.73 per share pursuant to the terms of the Sales Agreement. The “at-the-market” offering resulted in gross
proceeds of $49.7 million. The Company incurred $1.7 million in issuance costs associated with the “at-the-market”
offering, resulting in net proceeds to the Company of $48.0 million. On August 6, 2020, the Company delivered written
notice to Cowen to terminate the Sales Agreement, which termination the parties agreed to make immediately effective.

12. Underwritten public offerings

On August 8, 2019, the Company entered into an underwriting agreement with J.P. Morgan Securities LLC and

SVB Leerink LLC, as representatives of the several underwriters, relating to an underwritten public offering of

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approximately 2.7 million shares of the Company’s common stock, par value $0.001 per share. The underwritten
public offering resulted in gross proceeds of $69.0 million. The Company incurred $4.5 million in issuance costs associated
with the underwritten public offering, resulting in net proceeds to the Company of $64.5 million.

On August 6, 2020, the Company entered into an underwriting agreement with Leerink and Cowen, as
representatives of the several underwriters, relating to an underwritten public offering of approximately 3.0 million shares
of the Company’s common stock, par value $0.001 per share. The underwritten public offering resulted in gross proceeds
of $97.6 million. The Company incurred $6.2 million in issuance costs associated with the underwritten public offering,
resulting in net proceeds to the Company of $91.4 million.

13. Collaboration and license arrangements

The Company has entered into certain licenses with other companies for use of the Company’s technology. These

licenses have royalty components which the Company earns and recognizes as collaboration and license revenue
throughout the year. The Company recognized revenue of less than $0.1 million for the years ended December 31, 2020
and 2019 associated with these licenses.

During the year ended December 31, 2020, the Company recognized $1.2 million of previously deferred revenue

as a result of entering into a license agreement with a diagnostics company. As of December 31, 2020 and 2019, the
Company had $0.5 million and $1.7 million, respectively, of deferred revenue related to ongoing negotiations with a
diagnostics company.

Abbott Laboratories

On  September  29,  2020,  the  Company  entered  into  a  Non-Exclusive  License  Agreement  (the  Abbott  License
Agreement)  with  Abbott.  Pursuant  to  the  terms  of  the  Abbott  License  Agreement,  the  Company  granted  Abbott  a  non-
exclusive,  worldwide,  royalty-bearing  license,  without  the  right  to  sublicense,  under  the  Company’s  bead-based  single
molecule detection patents (Licensed Patents) in the field of in vitro diagnostics. Abbott has paid the Company an initial
license fee of $10.0 million in connection with the execution of the Abbott License Agreement, which was recognized as
license revenue for the year ended December 31, 2020. Abbott has also agreed to pay the Company milestone fees subject
to  the  achievement  by  Abbott  of  certain  development,  regulatory  and  commercialization  milestones  and  low  single-digit
royalties on net sales of licensed products.

The Abbott License Agreement includes customary representations and warranties, covenants and indemnification
obligations for a transaction of this nature. The Abbot License Agreement became effective upon signing and will continue
until expiration of the last-to-expire Licensed Patent, or the agreement is earlier terminated. Under the terms of the Abbott
License Agreement, the Company and Abbott each have the right to terminate the agreement for uncured material breach
by, or insolvency of, the other party. Abbott may also terminate the Abbott License Agreement at any time without cause
upon 60 days’ notice.

During the year ended December 31, 2020, the Company recognized $10.0 million within collaboration and

license revenue related to the initial license fee under the Abbott License Agreement.

14. Employee benefit plans

The Company sponsors a 401(k) savings plan for employees. The Company may make discretionary contributions

for each 401(k) plan year. During the years ended December 31, 2020, 2019, and 2018, the Company made contributions
of $0.7 million, $0.5 million, and $0.1 million, respectively.

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15. Business combinations

Aushon BioSystems,Inc.

On January 30, 2018, the Company completed the acquisition of Aushon pursuant to an Agreement and Plan of

Merger dated January 30, 2018. The Company acquired Aushon to complement its existing product line, improve its
existing research and development capabilities in assay development and software engineering, and expand its customer
base. The acquisition of Aushon was accounted for as a business combination and the Company has recorded the assets
acquired and liabilities assumed at their respective fair values as of the acquisition date.

In connection with the closing of the acquisition of Aushon, the Company paid $3.2 million at closing, and an

additional $0.8 million in July 2018, the six-month anniversary of the acquisition date.

The following table presents acquisition accounting as of January 30, 2018 (in thousands):

Fair value of consideration transferred:
Cash
Obligation to issue cash
Total acquisition consideration

Fair value of assets acquired and liabilities assumed:
Cash and cash equivalents
Accounts receivable
Inventory
Prepaid expenses
Property and equipment and other non-current assets
Intangible Assets
Goodwill
Total assets acquired
Contractual obligations
Accounts payable and accrued liabilities
Net assets acquired

$

$

$

$

3,200
800
4,000

199
210
828
71
180
2,950
1,308
5,746
(1,155)
(591)
4,000

The intangible assets identified in the purchase price allocation discussed above include developed technology,

tradenames and customer relationships. Tradenames are amortized over the useful life on a straight-line basis, while
developed technology and customer relationships are amortized over their respective useful lives on an accelerated basis
reflecting the period of expected derived benefits of the underlying assets. Developed technology consists of products that
have reached technological feasibility and trade names represent acquired company and product names. To value the
developed technology and trade name assets, the Company utilized a relief from royalty method. Under the methodology,
fair value is calculated as the discounted cash flow savings accruing to the owner for not having to pay the royalty. Key
assumptions included expected revenue attributable to the assets, royalty rates, discount rate and estimated asset lives.
Customer relationships represent the underlying relationships with certain customers to provide ongoing services and
continued product sale opportunities. The Company utilized excess earnings methodology to derive the fair value of the
customer relationships. Key assumptions included expected attrition of customer's rates, operating income margins and
discount rate. The Company used a risk-adjusted discount rate of 14.4% in determining the fair value of the intangible
assets.

The goodwill recorded as a result of the acquisition of Aushon represents the strategic benefits of growing the

Company's product portfolio and the expected revenue growth from increased market penetration from future products and
customers. None of the goodwill recorded is tax deductible for income tax purposes.

The Company incurred a total of $0.1 million in transaction costs in connection with the transaction, which were
included in selling, general and administrative expense within the consolidated statement of operations for the year ended
December 31, 2018.

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UmanDiagnostics AB

On August 1, 2019, the Company completed its acquisition of Uman for an aggregate purchase price of $21.2

million, comprised of (i) $15.7 million in cash plus (ii) 191,152 shares of common stock (representing $5.5 million based
on the closing prices of the Company’s common stock on the Nasdaq Global Market on July 1, 2019 and August 1, 2019,
the dates of issuance). The acquisition of Uman closed with respect to 95% of the outstanding shares of capital stock of
Uman on July 1, 2019 and with respect to the remaining 5% of the outstanding shares of capital stock of Uman on
August 1, 2019. 

Uman supplies Nf-L antibodies and ELISA kits, which are widely recognized by researchers and

biopharmaceutical and diagnostics companies world-wide as the premier solution for the detection of Nf-L to advance the
development of therapeutics and diagnostics for neurodegenerative conditions. With the acquisition of Uman, the Company
has secured a long-term source of supply for a critical technology. This acquisition was considered a business acquisition
for accounting purposes.

The Company has accounted for the acquisition of Uman as a purchase of a business under U.S. GAAP. Under the
acquisition method of accounting, the assets and liabilities of Uman are recorded as of the acquisition date of July 1, 2019,
at their respective fair values, and consolidated with those of the Company. Purchase consideration in excess of the
amounts recognized for the net assets acquired was recognized as goodwill and is not expected to be tax deductible in any
taxing jurisdiction.

The following table summarizes the acquisition accounting, net of $1.2 million in cash and cash equivalents

acquired (in thousands):

Purchase price:

Cash and stock paid
Cash and cash equivalents acquired

Purchase price, net

Assets (liabilities) acquired:
Accounts receivable
Inventory
Prepaids and other current assets
Property and equipment
Intangibles
Goodwill
Accounts payable
Accrued expense and other current liabilities
Deferred tax liabilities

Total

$

$

$

21,217
1,221
19,996

638
1,680
114
33
13,450
8,111
(20)
(871)
(3,139)
19,996

Revenue and net loss related to Uman’s operations were $1.5 million and $0.1 million, respectively for the year

ended December 31, 2020 and is included in the Company’s consolidated statement of operations. Revenue and net income
related to Uman’s operations were $1.1 million and less than $0.1 million, respectively, for the six months following the
July 1, 2019 acquisition date, and is included in the Company’s consolidated statements of operations for the year ended
December 31, 2019.

The following unaudited pro forma information presents the condensed consolidated results of operations of the

Company and Uman for the years ended December 31, 2020, 2019, and 2018 as if the acquisition of Uman had been
completed on January 1, 2018. These pro forma condensed consolidated financial results have been prepared for
comparative purposes only and include certain adjustments that reflect pro forma results of operations, such as increased
amortization for the fair value of acquired intangible assets, increased cost of sales related to the inventory valuation
adjustment, and adjustments relating to the tax effect of combining the Company and Uman businesses.

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The unaudited pro forma results do not reflect any operating efficiencies or potential cost savings which may

result from the consolidation of the operations of the Company and Uman. Accordingly, these unaudited pro forma results
are presented for informational purposes only and are not necessarily indicative of the results of operations that actually
would have been achieved had the acquisition occurred as of January 1, 2018, nor are they intended to represent or be
indicative of future results of operations (in thousands):

Revenue (unaudited)
Pre-tax loss (unaudited)

$
$

57,597
(38,636)

$
$

38,753
(33,894)

Year Ended December 31,

Year Ended December 31,

2019

2018

During the year ended December 31, 2020, the Company incurred no costs associated with the acquisition of

Uman. During the year ended December 31, 2019, the Company incurred $1.9 million in costs associated with the
acquisition of Uman. Costs associated with the acquisition of Uman are recorded as selling, general, and administrative
expenses within the consolidated statements of operations.

16. Goodwill and intangible assets

As of December 31, 2020 the carrying amount of goodwill was $10.5 million. The following is a rollforward of 

the Company’s goodwill balance (in thousands):

Balance as of December 31, 2019
Cumulative translation adjustment
Balance as of December 31, 2020

Acquired intangible assets consist of the following (dollars in thousands):

Estimated Useful

     Life (in years)

$

8.5
7
8.5 - 10
5.5
3

$

Gross 
Carrying
Value
13,000
1,650
1,360  
340
50  

$

16,400

$

December 31, 2020

Accumulated

Cumulative
Translation

      Amortization     Adjustment    

(2,296) $
(1,036)
(618)
(102)
(49)
(4,101) $

1,374
—
12  
31
—  

1,417

Goodwill

9,353
1,107
10,460

$

$

Net
Carrying
 Value
$ 12,078
614
754
269
1
$ 13,716

Weighted
Average

    Life Remaining (in years)
6.99
4.09
7.08
3.99
0.08

December 31, 2019

Estimated Useful

     Life (in years)

$

8.5
7
8.5 - 10
5.5
3

Gross 
Carrying
Value
13,000
1,650
1,360  
340
50  

$

16,400

Net
Carrying
 Value

Accumulated

Cumulative
Translation

$

      Amortization     Adjustment    
(767) $
(737)
(421)
(34)
(32)
(1,991) $

(99) $ 12,134
913
—
938
(1) 
304
(2)
18
—  
(102) $ 14,307

$

Weighted
Average

     Life Remaining (in years)
8.00
5.09
8.08
5.00
1.09

Know-how
Developed technology
Customer relationships
Non-compete agreements
Trade names
Total

Know-how
Developed technology
Customer relationships
Non-compete agreements
Trade names
Total

The Company acquired $13.5 million of intangible assets in the Uman acquisition, of which $13.0 million was

assigned to know-how, $0.4 million was assigned to non-compete agreements, and $0.1 million was assigned to customer
relationships. The know-how and customer relationships intangible assets are being amortized on a straight-line basis over
an 8.5 year amortization period, and the non-compete agreement intangible asset is being amortized on a 

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straight-line basis over a 5.5 year amortization period. In total, the weighted-average amortization period for these 
intangible assets is 8.4 years.

Know-how consists of the processes and procedures to produce Uman’s products. Customer relationships
represent the underlying relationships with certain customers to provide continued product sale opportunities. The
Company utilized excess earnings methodology to derive the fair value of the customer relationships.

The Company recorded amortization expense of $2.1 million, $1.4 million, and $0.6 million for the years ended
December 31, 2020, 2019, and 2018, respectively. Amortization of developed technology is recorded within research and
development expenses, amortization of customer relationships is recorded within selling, general, and administrative
expenses, amortization of trade names is recorded within selling, general, and administrative expenses, amortization of
non-compete agreements is recorded within selling, general, and administrative expenses, and amortization of know-how is
recorded within cost of goods sold.

Future estimated amortization expense of acquired intangible assets as of December 31, 2020 is as follows

(amounts in thousands):

For the Years Ended December 31, 
2021
2022
2023
2024
Thereafter

17. Related party transactions

Estimated Amortization Expense

2,013
1,930
1,848
1,733
6,192
13,716

$

$

As described in Note 9, in June 2007, the Company entered into a license agreement for certain intellectual

property with Tufts. Tufts is a related party to the Company due to Tufts’ equity ownership in the Company and because a
board member of the Company’s Board of Directors was affiliated with Tufts. During the years ended December 31, 2020,
2019, and 2018 the Company recorded royalty expense of $1.1 million, $1.0 million, and $0.7 million, respectively, in cost
of product revenue on the consolidated statements of operations. During the year ended December 31, 2020, the Company
also incurred $1.0 million in cost of collaboration and license revenue owed to Tufts related to sublicensing certain
technology and intellectual property to Abbott.

During the year ended December 31, 2017, Harvard University became a related party because a member of the
Company’s Board of Directors is affiliated with Harvard University. Revenue recorded from sales to Harvard University
was $0.1 million, $0.1 million, and less than $0.1 million for the years ended December 31, 2020, 2019, and 2018,
respectively.

On November 28, 2018, the Company entered into a sponsor agreement with Powering Precision Health (PPH), a

501(c)6 not-for-profit entity of which an executive of the Company is a board member, through December 31, 2018. The
agreement committed a maximum of $120,000 in funds and services to be provided to PPH for the term of the agreement.
On November 14, 2019, the Company entered into the first amendment to the PPH sponsorship agreement. The agreement
amended the $120,000 annual committed maximum amount to $200,000 for the annual committed amount. The agreement
is terminable by either party and does not bind the Company to beyond the term of the agreement. For the year ended
December 31, 2020, the company did not make any contributions. For the years ended December 31, 2019, and 2018, the
Company had total contributions $0.1 million, and less than $0.1 million, respectively.

18. Restricted cash

The Company’s restricted cash consists of cash that the Company is contractually obligated to maintain in

accordance the terms of the Letter of Credit in the lease agreement. The $1.0 million Letter of Credit drawable by the

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lessor under specifically outlined conditions within the lease, which are primarily related to rent payments. The amount of 
the Letter of Credit will be reduced at 41 and 65 months after the commencement date of the lease to $750,000 and then 
$250,000, respectively.

The Company had $1.0 million of restricted cash as of December 31, 2020 and 2019, respectively.

19. Quarterly data (unaudited)

(Amounts in thousands, except share and per share data)

2020
Product revenue
Service and other revenue
Collaboration and license revenue
Grant revenue
Total revenue
Costs of goods sold:

Cost of product revenue
Cost of services and other revenue
Cost of collaboration and license
revenue

Total costs of goods sold and services
Gross profit
Operating expenses:

Research and development
Selling, general and administrative

Total operating expenses
Income (loss) from operations
Interest income (expense), net
Other income (expense), net
Income (loss) before income taxes
Income tax benefit
Net income (loss)
Net income (loss) per share, basic
Weighted-average common shares
outstanding, basic
Net income (loss) per share, diluted
Weighted-average common shares
outstanding, diluted

$

$
$

$

$

Q1

9,833
5,762
132
—
15,727

6,186
2,728

—
8,914
6,813

$

Q2

6,790
6,317
23
—
13,130

5,416
2,501

—
7,917
5,213

4,268
14,273
18,541
(11,728)
161
(167)
(11,734)
124
(11,610) $
(0.41) $

4,312
13,102
17,414
(12,201)
(108)
(11)
(12,320)
18
(12,302) $
(0.43) $

Q3
11,662
6,552
11,246
1,929
31,389

6,387
2,896

1,000
10,283
21,106

5,377
13,451
18,828
2,278
(160)
(26)
2,092
111
2,203
0.07

$

$
$

$

Q4
15,732
5,498
408
4,493
26,131

7,961
3,120

—
11,081
15,050

6,217
18,766
24,983
(9,933)
(166)
155
(9,944)
123
(9,821) $
(0.31) $

Total Year

44,017
24,129
11,809
6,422
86,377

25,950
11,245

1,000
38,195
48,182

20,174
59,592
79,766
(31,584)
(273)
(49)
(31,906)
376
(31,530)
(1.07)

28,179,132  

28,312,925  

30,139,157  

31,696,002  

(0.41) $

(0.43) $

0.07

$

(0.31) $

29,589,132
(1.07)

28,179,132

28,312,925

31,386,439

31,696,002

29,589,132

F-40

    
    
    
    
    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table of Contents

2019
Product revenue
Service and other revenue
Collaboration and license revenue
Total revenue
Costs of goods sold:

Cost of product revenue
Cost of services and other revenue
Total costs of goods sold and services
Gross profit
Operating expenses:

Research and development
Selling, general and administrative

Total operating expenses
Loss from operations
Interest income, net
Other income (expense), net
Loss before income taxes
Income tax benefit (provision)
Net loss
Net loss per share, basic and diluted
Weighted-average common shares
outstanding, basic and diluted

20. Subsequent events

Q1

Q2

$

9,547
2,790

—  

$

8,776
4,760

—  

Q3
10,737
4,207

$

—  

12,337

13,536

14,944

4,248
2,082
6,330
6,007

3,852
11,512
15,364
(9,357)
21
(47)
(9,383)
(22)
(9,405) $
(0.42) $

4,455
2,150
6,605
6,931

4,016
13,429
17,445
(10,514)
42
(68)
(10,540)
(23)
(10,563) $
(0.46) $

5,513
2,398
7,911
7,033

3,924
13,352
17,276
(10,243)
282
(34)
(9,995)
125
(9,870) $
(0.37) $

$

Q4
11,431
4,302
184
15,917

6,684
2,368
9,052
6,865

4,398
13,953
18,351
(11,486)
282
139
(11,065)
107
(10,958) $
(0.39) $

Total Year

40,491
16,059
184
56,734

20,900
8,998
29,898
26,836

16,190
52,246
68,436
(41,600)
627
(10)
(40,983)
187
(40,796)
(1.63)

$

$
$

22,422,960  

23,213,653  

26,627,831  

28,021,957  

25,090,708

On February 3, 2021, the Company entered into an underwriting agreement with Goldman Sachs & Co. LLC,

Leerink and Cowen, as representatives of the several underwriters, relating to an underwritten public offering of
approximately 4,107,142 shares of the Company’s common stock, par value $0.001 per share. The underwritten public
offering resulted in gross proceeds of $287.5 million. The Company incurred $17.9 million in issuance costs associated
with the underwritten public offering, resulting in net proceeds to the Company of $269.6 million.

F-41

    
    
    
    
    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Company Name
Aushon Biosystems, Inc.
Quanterix Security Corporation
Quanterix Netherlands B.V.
UmanDiagnostics AB
Quanterix Holdings (Hong Kong) Limited
Quanterix Bio-tech (Shanghai) Co., Ltd

SUBSIDIARIES

Delaware
Massachusetts
The Netherlands
Sweden
Hong Kong
China

Exhibit 21.1

Jurisdiction of Incorporation

    
Exhibit 23.1

Consent of Independent Registered Public Accounting Firm

We consent to the incorporation by reference in the following Registration Statements:

(1) Registration Statement (Form S-3ASR No. 333-249925) of Quanterix Corporation,

(2) Registration  Statement  (Form  S-8  No.  333-223771)  pertaining  to  the  2007  Stock  Option  and  Grant  Plan,  as  amended,  the  2017

Employee Stock Purchase Plan, and 2017 Employee, Director and Consultant Equity Incentive Plan;

(3) Registration  Statement  (Form  S-8  No.  333-231373)  pertaining  to  the  2017  Employee  Stock  Purchase  Plan,  and  2017  Employee,

Director and Consultant Equity Incentive Plan; and

(4) Registration  Statement  (Form  S-8  No.  333-240420)  pertaining  to  the  2017  Employee  Stock  Purchase  Plan,  and  2017  Employee,

Director and Consultant Equity Incentive Plan;

of  our  report  dated  March  5,  2021,  with  respect  to  the  consolidated  financial  statements  of  Quanterix  Corporation,  included  in  this
Annual Report (Form 10-K) of Quanterix Corporation for the year ended December 31, 2020.

/s/ Ernst & Young LLP

Boston, Massachusetts

March 5, 2021

Exhibit 31.1

CERTIFICATIONS UNDER SECTION 302

I, E. Kevin Hrusovsky, certify that:

1.            I have reviewed this annual report on Form 10-K of Quanterix Corporation;

2.            Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material

fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with
respect to the period covered by this report;

3.            Based on my knowledge, the financial statements, and other financial information included in this report, fairly present

in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented
in this report;

4.            The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls

and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in
Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a)            designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be

designed under our supervision, to ensure that material information relating to the registrant, including its consolidated
subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being
prepared;

b)           designed such internal control over financial reporting, or caused such internal control over financial reporting

to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c)            evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report

our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this
report based on such evaluation; and

d)           disclosed in this report any change in the registrant’s internal control over financial reporting that occurred
during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has
materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5.            The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control
over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing
the equivalent functions):

a)            all significant deficiencies and material weaknesses in the design or operation of internal control over

financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and
report financial information; and

b)           any fraud, whether or not material, that involves management or other employees who have a significant role

in the registrant’s internal control over financial reporting.

Date: March 5, 2021

/s/ E. KEVIN HRUSOVSKY
E. Kevin Hrusovsky
Chairman, President and Chief Executive Officer (principal
executive officer)

Exhibit 31.2

CERTIFICATIONS UNDER SECTION 302

I, Amol Chaubal, certify that:

1.            I have reviewed this annual report on Form 10-K of Quanterix Corporation;

2.            Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material

fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with
respect to the period covered by this report;

3.            Based on my knowledge, the financial statements, and other financial information included in this report, fairly present

in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented
in this report;

4.            The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls

and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in
Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a)            designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be

designed under our supervision, to ensure that material information relating to the registrant, including its consolidated
subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being
prepared;

b)           designed such internal control over financial reporting, or caused such internal control over financial reporting

to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c)            evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report

our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this
report based on such evaluation; and

d)           disclosed in this report any change in the registrant’s internal control over financial reporting that occurred
during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has
materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5.            The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control
over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing
the equivalent functions):

a)            all significant deficiencies and material weaknesses in the design or operation of internal control over

financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and
report financial information; and

b)           any fraud, whether or not material, that involves management or other employees who have a significant role

in the registrant’s internal control over financial reporting.

Date: March 5, 2021

/s/ AMOL CHAUBAL
Amol Chaubal
Chief Financial Officer
(principal financial officer and principal accounting officer)

CERTIFICATIONS UNDER SECTION 906

Exhibit 32.1

Pursuant to section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350, chapter 63 of title 18,

United States Code), each of the undersigned officers of Quanterix Corporation, a Delaware corporation (the “Company”), does hereby
certify, to such officer’s knowledge, that:

The Annual Report for the year ended December 31, 2020 (the “Form 10-K”) of the Company fully complies with the
requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, and the information contained in the Form 10-K fairly
presents, in all material respects, the financial condition and results of operations of the Company.

Dated: March 5, 2021

Dated: March 5, 2021

/s/ E. KEVIN HRUSOVSKY
E. Kevin Hrusovsky
Chairman, President and Chief Executive Officer

/s/ AMOL CHAUBAL
Amol Chaubal
Chief Financial Officer