What changed in this filing

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Item 9A. Controls and Procedures

2022-03-01 compared with 2021-03-05 · 314 added, 489 removed, 835 unchanged (49% of the section changed)

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.

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;

● 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.

Disclosure Controls and Procedures

We have established disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act that are designed to provide reasonable assurance that information required to be disclosed 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 rules and forms of the SEC and to ensure that such information is accumulated and communicated to management, including our Chief Executive Officer (principal executive officer) and Chief Financial Officer (principal financial officer), to allow timely decisions regarding required disclosures.

Based on this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective at a reasonable assurance level as of December 31, 2021.

Management’s Report on Internal Control over Financial Reporting

Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as this term is defined in Rule 13a-15(f) and 15d-15(f) under the Exchange Act.

All internal control systems, no matter how well designed, have inherent limitations.

Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation.

Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting as of December 31, 2021 based on the framework set forth in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 Framework).

Based on our evaluation under the framework set forth in Internal Control-Integrated Framework , our management concluded that our internal control over financial reporting was effective at the reasonable assurance level as of December 31, 2021.

The Company’s independent registered public accounting firm, Ernst & Young LLP, has also issued an audit report on the Company’s internal controls over financial reporting, which is included elsewhere in this Annual Report on Form 10-K.

Changes in Internal Control over Financial Reporting

An evaluation was also performed under the supervision and with the participation of our management, including the principal executive officer and principal financial officer, of any change in our internal controls over financial reporting that occurred during our last fiscal quarter and that has materially affected, or is reasonably likely to affect, our internal controls over financial reporting.

There has been no change in our internal controls over financial reporting during the fiscal quarter ended December 31, 2021 that has materially affected, or is reasonably likely to materially affect, our internal controls over financial reporting.

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Shareholders and the Board of Directors of Quanterix Corporation

Opinion on Internal Control over Financial Reporting

We have audited Quanterix Corporation’s internal control over financial reporting as of December 31, 2021, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria).

In our opinion, Quanterix Corporation (the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, 2021, based on the COSO criteria.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of Quanterix Corporation as of December 31, 2021 and 2020, the related consolidated statements of operations, comprehensive loss, cash flows and stockholders’ equity for each of the three years in the period ended December 31, 2021, and the related notes and financial statement schedule listed in the Index at Item 15(2) and our report dated March 1, 2022 expressed an unqualified opinion thereon.

Basis for Opinion

The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting included in the accompanying Management’s Annual Report on Internal Control Over Financial Reporting.

Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit.

We are a public accounting firm registered with the 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 audit in accordance with the standards of the PCAOB.

Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects.

Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances.

We believe that our audit provides a reasonable basis for our opinion.

Definition and Limitations of Internal Control Over Financial Reporting

A company’s internal control over financial reporting is a process designed 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.

A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company;

(2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company;

and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s 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.

Also, 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.

/s/ Ernst & Young LLP

Boston, Massachusetts

March 1, 2022

OTHER INFORMATION

Not applicable.

DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS

Not applicable.

DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

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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 2022 Annual Meeting of Stockholders and is incorporated herein by reference.

PRINCIPAL ACCOUNTING FEES AND SERVICES

PRINCIPAL ACCOUNTANT 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 2022 Annual Meeting of Stockholders and is incorporated herein by reference.

EXHIBITS, FINANCIAL STATEMENT SCHEDULES

EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

(1) Financial Statements

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(2) Financial Statement Schedules

Schedules have been omitted since they are either not required or not applicable or the information is otherwise included herein.

Schedule II – Valuations and Qualifying Accounts

Beginning of Period

(in thousands)

to Costs and Expenses

(in thousands)

End of Period

(in thousands)

Allowance for credit losses:

Year ended December 31, 2021

Year ended December 31, 2020

Year ended December 31, 2019

The following is a list of exhibits filed as part of this Annual Report on Form 10-K:

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Form of Common Stock Certificate

Fourth Amended and Restated Stockholders Agreement, dated as of June 2, 2017, by and among the Registrant and the stockholders named therein

Fourth Amended and Restated Registration Rights Agreement, dated as of June 2, 2017, by and among the Registrant and the investors named therein

Warrant Agreement, dated as of January 30, 2018, by and between the Registrant and Azul Divinal Consultoria Unipessoal LDA

2007 Stock Option and Grant Plan, as amended

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Kevin Hrusovsky

Letter Agreement, dated February 14, 2019, between Registrant and Amol Chaubal

Employment Agreement, dated June 22, 2021, between the Registrant and Michael Doyle

Employment Agreement, dated May 10, 2021, between the Registrant and Dr.

Masoud Toloue

Letter Agreement, dated May 31, 2019, by and between the Registrant and John Fry

4 unchanged sentences

Second Amendment, dated August 22, 2017, to the Exclusive License Agreement between the Registrant and Tufts University

Third Amendment, dated September 25, 2020, to the Exclusive License Agreement between the Registrant and Tufts University

Exhibit Number

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Form or Schedule

Third Amendment, dated September 25, 2020, to the Exclusive License Agreement between the Registrant and Tufts University

Supply and Manufacturing Agreement, dated September 14, 2011, between the Registrant and STRATEC Biomedical AG

3 unchanged sentences

Manufacturing Services Agreement, dated November 23, 2016, between the Registrant and Paramit Corporation

Loan and Security Agreement, dated April 14, 2014, by and between the Registrant and Hercules Capital, Inc.

(formerly known as Hercules Technology Growth Capital, Inc.)

Amendment No.

1 to Loan and Security Agreement, dated March 4, 2015, by and between the Registrant and Hercules Capital, Inc.

(formerly known as Hercules Technology Growth Capital, Inc.)

Exhibit Number

Exhibit Description

Incorporated by

Reference herein from

Form or Schedule

Amendment No.

2 to Loan and Security Agreement, dated January 29, 2016, by and between the Registrant and Hercules Capital, Inc.

(formerly known as Hercules Technology Growth Capital, Inc.)

Amendment No.

3 to Loan and Security Agreement, dated March 31, 2017, by and between the Registrant and Hercules Capital, Inc.

(formerly known as Hercules Technology Growth Capital, Inc.)

Amendment No.

4 to Loan and Security Agreement, dated July 24, 2017, by and between the Registrant and Hercules Capital, Inc.

(formerly known as Hercules Technology Growth Capital, Inc.)

Amendment No.

5 to Loan and Security Agreement, dated August 30, 2018, by and between the Registrant and Hercules Capital, Inc.

(formerly known as Hercules Technology Growth Capital, Inc.)

Amendment No.

6 to Loan and Security Agreement, dated September 28, 2018, by and between the Registrant and Hercules Capital, Inc.

(formerly known as Hercules Technology Growth Capital, Inc.)

Amendment No.

7 to Loan and Security Agreement, dated April 15, 2019, by and between the Registrant and Hercules Capital, Inc.

(formerly known as Hercules Technology Growth Capital, Inc.)

Form of Indemnification Agreement

Lease Agreement by and between SSI 900 Middlesex MA LP and the Registrant, dated October 2, 2018.

Lease Agreement by and between the Registrant and XChange Owner LLC, dated January 28, 2022 .

Exhibit Number

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Form or Schedule

Lease Agreement between SSI 900 Middlesex MA LP and the Registrant, dated October 2, 2018.

Non-Exclusive License Agreement, dated September 29, 2020, by and between Abbott Laboratories and Quanterix Corporation.

Employment Agreement between Will Geist and the Company dated November 9, 2020.

2018 Non-Employee Director Compensation Policy

Non-Exclusive License Agreement, dated September 29, 2020, by and between Abbott Laboratories and the Registrant.

Separation Agreement dated November 11, 2021 by and between the Registrant and William Geist.

Amended and Restated 2018 Non-Employee Director Compensation Policy

Subsidiaries of Registrant

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Inline XBRL Taxonomy Extension Label Linkbase Document.

Exhibit Number

Exhibit Description

Incorporated by

Reference herein from

Form or Schedule

Inline XBRL Taxonomy Presentation Linkbase Document.

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Kevin Hrusovsky

Chairman, President and Chief Executive Officer

Chairman 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.

KEVIN HRUSOVSKY

Chairman, President and Chief Executive Officer and Director (principal executive officer)

Chairman and Chief Executive Officer and Director (principal executive officer)

March 1, 2022

Kevin Hrusovsky

/s/ AMOL CHAUBAL

/s/ MICHAEL A.

Chief Financial Officer

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March 1, 2022

/s/MARIJN DEKKERS

March 1, 2022

Marijn Dekkers, Ph.D.

/s/ SARAH HLAVINKA

/s/ MARTIN D.

MADAUS, PH.D.

March 1, 2022

Sarah Hlavinka

/s/ MARTIN MADAUS, PH.D.

March 1, 2022

Martin Madaus, Ph.

/s/ PAUL MEISTER

/s/ LAURIE J.

March 1, 2022

/s/ DAVID WALT, PH.D.

March 1, 2022

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Years ended December 31, 2021, 2020, and 2019

Report of Independent Registered Public Accounting Firm

Report of Independent Registered Public Accounting Firm (PCAOB ID:

Consolidated Balance Sheets

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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Stockholders and the Board of Directors of Quanterix Corporation

To the Shareholders 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”).

We have audited the accompanying consolidated balance sheets of Quanterix Corporation (the Company) as of December 31, 2021 and 2020, the related consolidated statements of operations, comprehensive loss, cash flows and stockholders' equity for each of the three years in the period ended December 31, 2021, and the related notes and financial statement schedule listed in the Index at Item 15(2) (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, 2021 and 2020, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2021, in conformity with U.S.

generally accepted accounting principles.

Adoption of ASU No.

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.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company's internal control over financial reporting as of December 31, 2021, based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework), and our report dated March 1, 2022 expressed an unqualified opinion thereon.

Basis for Opinion

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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.

We are a public accounting firm registered with the 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.

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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.

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We believe that our audits provide a reasonable basis for our opinion.

Critical Audit Matter

The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that:

(1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments.

The communication of the critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the account or disclosure to which it relates.

Excess Inventory

Description of the Matter

As discussed in Note 2 to the consolidated financial statements, the Company analyzes its inventory levels at each reporting date to identify inventory that is in excess of expected future demand.

In the event that the Company identifies excess inventory, the Company recognizes a reduction in the carrying value of inventory.

Auditing management’s valuation of inventory involved judgement in evaluating management’s analysis and significant assumptions related to projections of future demand which is dependent on market factors.

How We Addressed the Matter in Our Audit

To audit the Company’s valuation of inventory, we performed audit procedures that included, among others, performing inquiries of management and testing the completeness and accuracy of the underlying data used in the estimation of future demand.

To evaluate the Company’s estimate of future demand, we independently assessed the sensitivity and impact of reasonably possible changes in forecasted demand and the impact on the Company’s calculation of excess inventory.

We also evaluated management's ability to accurately forecast demand by comparing actual demand to management's prior estimates.

/s/ Ernst & Young LLP

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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)

Accounts receivable (less allowance for credit losses of $ 419 and $ 370 as of December 31, 2021 and December 31, 2020, respectively;

including $ 200 and $ 172 due from related parties as of December 31, 2021 and December 31, 2020, respectively)

Prepaid expenses and other current assets

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Deferred revenue, net of current portion

Long term debt, net of current portion

Long term lease liabilities

Other non-current liabilities

Deferred tax liabilities

Total liabilities

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Additional paid-in capital

Accumulated other comprehensive income (loss)

Accumulated other comprehensive income

Accumulated deficit

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Service and other revenue (including related party activity of $ 114 , $ 202 , and $ 118 for the years ended December 31, 2021, 2020, and 2019, 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)

Collaboration revenue

Grant revenue

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Cost of product revenue (including related party activity of $ 1,936 , $ 205 , and $ 234 for the years ended December 31, 2021, 2020, and 2019, 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 service and other revenue (including related party activity of $ 74 , $ 52 , and $ 0 for the years ended December 31, 2021, 2020, and 2019, respectively)

Cost of collaboration and license revenue (including related party activity of $ 0 , $ 1,000 , and $ 0 for the years ended December 31, 2021, 2020, and 2019, respectively)

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Research and development (including related party activity of $ 565 , $ 235 , and $ 152 for the years ended December 31, 2021, 2020, and 2019, respectively)

Selling, general, and administrative (including related party activity of $ 36 , $ 0 , and $ 0 for the years ended December 31, 2020, 2019, and 2018)

Selling, general and administrative (including related party activity of $ 89 , $ 37 , and $ 180 for the years ended December 31, 2021, 2020, and 2019, respectively)

Total operating expenses

Loss from operations

Interest income (expense), net

Other expense, net

Interest (expense) income, net

Other income (expense), net

Loss before income taxes

Income tax benefit (provision)

Income tax benefit

Net loss per share, basic and diluted

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Years Ended December 31,

Other comprehensive income (loss):

Other comprehensive (loss) income:

Cumulative translation adjustment

Total other comprehensive income (loss)

Total other comprehensive (loss) income

Comprehensive loss

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Inventory step-up amortization

Credit loss expense on accounts receivable

Reduction in the carrying amounts of right-of-use assets

1 unchanged sentence

Non-cash interest expense

Loss (gain) on disposal of fixed assets

Loss on disposal of fixed assets

Changes in operating assets and liabilities:

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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

3 unchanged sentences

Payments on notes payable

Net cash provided by (used in) financing activities

Net increase (decrease) in cash and cash equivalents

Net cash provided by financing activities

Net increase in cash and cash equivalents

Effect of foreign currency exchange rate on cash

3 unchanged sentences

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

Purchases of property and equipment included in accounts payable and other accrued expenses

Purchase of property and equipment included in other non-current liabilities

Common stock issued in connection with the acquisition of UmanDiagnostics AB

Reconciliation of cash, cash equivalents, and restricted cash:

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Balance at December 31, 2018

Exercise of common stock warrants

Exercise of common stock options and vesting of restricted stock

Common stock issuance offering costs

Stock-based compensation expense

Balance at December 31, 2018

Cumulative effect of adoption of Accounting Standards Codification Topic 606

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Balance at December 31, 2020

Exercise of common stock warrants

Exercise of common stock options and vesting of restricted stock

Issuance of common stock

Sale of common stock in underwritten public offering, net

ESPP stock purchase

Stock-based compensation expense

Cumulative translation adjustment

Balance at December 31, 2021

See accompanying notes.

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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.

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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.

Morgan Securities LLC (J.P.

Morgan) and SVB Securities LLC (f/k/a SVB Leerink) (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.

On August 6, 2020, the Company entered into an underwriting agreement with Leerink and Cowen and Company, LLC (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.

On February 3, 2021, the Company entered into an underwriting agreement with Goldman Sachs & Co.

LLC (Goldman Sachs), Leerink, and Cowen, as representatives of the several underwriters, relating to an underwritten public offering of approximately 4.1 million 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 $ 17.8 million in issuance costs associated with the underwritten public offering, resulting in net proceeds to the Company of $ 269.7 million.

The Company has recognized annual losses from operations since inception and has an accumulated deficit of $ 305.5 million at December 31, 2021 and the Company incurred a net loss of $ 57.7 million, $31.5 million, and $40.8 million for the years ended December 31, 2021, 2020, and 2019, 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, 2021, the Company had $ 396.5 million of unrestricted cash and cash equivalents.

10 unchanged sentences

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.

Reclassifications

Certain amounts in the prior years’ consolidated financial statements have been reclassified to conform to the current year’s presentation.

Segment information

Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision-maker, the Company’s Chief Executive Officer, in deciding how to allocate resources and assess performance.

The Company and the Company's chief operating decision-maker reviews the Company's operations and manages its business as a single operating segment.

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

goods and services, incentives and taxes collected from customers, that are subsequently remitted to governmental authorities.

The amount of revenue recognized reflects consideration that the Company expects 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.

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 .

The reported results for 2021, 2020, and 2019 reflect the application of ASC 606 guidance.

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 statement of operations, as a result of adopting the provisions of ASC 606, was as follows (in thousands):

For the Year Ended December 31, 2019

Under ASC 606

Product revenue

Service revenue

Costs of goods sold and services

Selling general and administrative expenses

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.

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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:

The following tables disaggregate the Company's revenue from contracts with customers based on their location by revenue type:

December 31, 2021

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Collaboration and license revenue

December 31, 2019

(in thousands)

Product revenues:

Consumable and other products

Service and other revenues:

Service-type warranties

Research services

Other services

Collaboration and license revenue:

Collaboration and license revenue

The Company’s contracts with customers may include promises to transfer multiple products and services to a customer.

2 unchanged sentences

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

transactions, and uses a range of amounts to estimate standalone selling prices for each performance obligation.

The Company determines standalone selling prices based on prices charged to customers in observable 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 aggregate amount of transaction price that is allocated to performance obligations that have not yet been satisfied or that are partially satisfied as of December 31, 2021 is $ 7.5 million.

Of the performance obligations not yet satisfied or that are partially satisfied, $ 6.4 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 $ 7.5 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):

16 unchanged sentences

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.

The Company has elected to account for 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.

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.

1 unchanged sentence

None of the Company’s contracts contained a significant financing component for the years ended December 31, 2021, 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

12 unchanged sentences

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.

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.

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.

WP1 was complete as of December 31, 2020.

On September 29, 2020, the Company 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 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.

Release of the $ 18.2 million of funding under WP2 is based on the achievement of certain milestones.

Contract funding was subject to achievement of these pre-defined milestones and the contract period ran through September 2021, with one milestone extended to March 31, 2022.

As of December 31, 2021, the Company had received $ 17.7 million out of the full $ 18.2 million under WP2 .

During the year ended December 31, 2021, the Company recognized $ 5.2 million in grant revenue and incurred $ 3.4 million in research and development expense related to WP2.

The following table summarizes the activity under WP2 as of December 31, 2020 (in thousands):

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.

The following table summarizes the cumulative activity under WP2 as of December 31, 2021 and December 31, 2020 (in thousands):

December 31, 2021

December 31, 2020

Total grant revenue from research and development activities

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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.

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.

1 unchanged sentence

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 service and other revenue consists of personnel, facility costs associated with operating the Accelerator Laboratory 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.

1 unchanged sentence

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

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.

The Company accounts 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.

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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.

For purposes of the diluted net loss per share calculations, unvested restricted common stock, restricted stock units, 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):

3 unchanged sentences

Outstanding common stock warrants

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

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Restricted cash and deposits

Restricted cash represents collateral for a letter of credit issued as security for the lease for the Company’s new headquarters.

Restricted cash primarily represents collateral for a letter of credit issued as security for the lease for the Company’s headquarters in Billerica, Massachusetts, and additional space in Bedford, Massachusetts, and to secure the Company’s corporate credit card program.

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, 2021.

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

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

December 31, 2018

December 31, 2019

December 31, 2020

Allowance for credit losses

The Company is exposed to credit losses primarily through sales of products and services.

The Company’s expected loss allowance methodology for accounts receivable is developed using historical collection experience, current and future economic and market conditions, and a review of the current status of customers’ trade accounts receivable.

Due to the short-term nature of such receivables, the estimated accounts receivable that may not be collected is based on aging of the accounts receivable balances.

Customers are assessed for credit worthiness upfront through a credit review, which includes assessment based on the Company’s analysis of customers’ financial statements when a credit rating is not available.

The Company evaluates contract terms and conditions, country, and political risk, and may require prepayment to mitigate risk of loss.

Specific allowance amounts are established to record the appropriate provision for customers that have a higher probability of default.

The Company monitors changes to the receivables balance on a timely basis, and balances are written off as they are determined to be uncollectable after all collection efforts have been exhausted.

Inventory is stated at the lower of cost or market on a first-in, first-out (FIFO) basis.

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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.

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.

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Shorter of the useful life of the asset or the remaining term of the lease

The Company accounts for leases in accordance with ASC Topic 842, Leases (ASC 842), which was adopted on January 1, 2020, using the optional transition method allowing entities to recognize a cumulative effect adjustment to the opening balance sheet without restating comparative prior periods presented.

At adoption the Company elected the package of practical expedients which was 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.

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 are differentiated between finance leases and operating leases, and classification impacts expense recognition.

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 does not 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 does not separate lease and non-lease 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.

Software development costs

1 unchanged sentence

Software development costs are expensed as incurred until the point the Company establishes technological feasibility.

Company’s product development process, technological feasibility is established upon the completion of a working model.

Based on the 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.

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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.

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.

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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):

Fair value measurements are as follows (in thousands):

Quoted prices

Significant other

December 31, 2021

inputs (Level 2)

1 unchanged sentence

Cash equivalents

Fair value measurements as of December 31, 2019 are as follows (in thousands):

Quoted prices

Significant other

December 31, 2020

inputs (Level 2)

4 unchanged sentences

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.

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.

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As of December 31, 2021, one customer represented 18 % 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.

As of December 31, 2020, one customer represented 19 % of the Company’s aggregate accounts receivable.

During the years ended December 31, 2021 and 2019, no individual customer represented 10 % of the Company’s total revenue.

During the year ended December 31, 2020, one company represented 13 % of the Company’s total revenue.

Stock-based compensation

9 unchanged sentences

There were no material non-employee awards outstanding during the years ended December 31, 2021, 2020, and 2019.

Effective January 1, 2017, the Company ceased utilizing an estimated forfeiture rate and began recognizing forfeitures as they occur.

The Company recognizes 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.

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33.5 % - 39.7 %

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.

Weighted-average grant date fair value

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.

Treasury yield curve in effect at the time of grant, commensurate with the expected term assumption.

The Company estimates the expected term of options granted to employees utilizing the simplified method which calculates the expected term of an option as the average of the time to vesting and contractual life of the options.

The expected term 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 Company uses the remaining contractual term for the expected term 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.

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;

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 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.

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):

Adjusted under

December 31, 2018

January 1, 2019

Accounts receivable

Prepaid expenses and other current assets

Other non-current assets

Deferred revenue

Deferred revenue, net of current portion

Stockholders’ equity:

Accumulated deficit

For the year Ended December 31, 2019

Under ASC 606

Product revenue

Service revenue

Costs of goods sold and services

Selling general and administrative expenses

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 June 2016, the Financial Accounting Standards Board (FASB) established Topic 326 , Financial Instruments — Credit Losses:

Measurement of Credit Losses on Financial Instruments (ASC 326) by issuing ASU No.

2016-13 (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 Company early adopted ASU 2016-13 on January 1, 2021 using the modified retrospective approach.

The Company’s consolidated financial statements for prior-year periods have not been revised and are reflective of the credit loss requirements which were in effect for that period.

The adoption of ASU 2016-13 did not have a material impact on the Company’s consolidated financial statements.

In August 2018, the FASB issued ASU No.

3 unchanged sentences

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.

The Company adopted ASU 2018-15 on January 1, 2021 using the prospective method.

The adoption of ASU 2018-15 did not have a material impact on the Company’s consolidated financial statements.

In December 2019, the FASB issued ASU No.

2019-12, Simplifying the Accounting for Income Taxes (ASU 2019-12), which is intended to simplify various areas related to ASC 740, Income Taxes (ASC 740).

ASU 2019-12 removes certain exceptions for performing intra period tax allocations and calculating income taxes in interim periods.

The guidance also simplifies the accounting for transactions that result in a step-up in the tax basis of goodwill and the effect of enacted changes in tax laws or rates in interim periods.

The Company early adopted ASU 2019-12 on January 1, 2021.

The adoption of ASU 2019-12 did not have a material impact on the Company’s consolidated financial statements.

Inventory consists of the following (in thousands):

As of December 31,

Raw materials

4 unchanged sentences

Property and equipment consists of the following (in thousands):

As of December 31,

Laboratory and manufacturing equipment

3 unchanged sentences

accumulated depreciation

The Company incurred depreciation expense of $ 2.2 million and $ 1.6 million for the years ended December 31, 2020 and 2019, respectively.

Property and equipment, net

The Company incurred depreciation expense of $ 2.8 million, $ 2.2 million and $ 1.6 million for the years ended December 31, 2021 2020, and 2019, respectively.

The Company has instruments included in laboratory and manufacturing equipment, which are used internally by the Company.

3 unchanged sentences

Other accrued expenses consist of the following (in thousands):

As of December 31,

Accrued inventory purchases

Accrued property and equipment purchases

Accrued royalties

1 unchanged sentence

Accrued development costs

Accrued tax liabilities

Accrued other

Total accrued expenses

Other non-current liabilities consist of the following (in thousands):

Leasehold obligation incentive

Deferred rent

Deferred tax liabilities

Total other non-current liabilities

The following table presents the components of loss before income taxes (in thousands):

1 unchanged sentence

United States

The following table summarizes income tax benefit (provision) (in thousands):

Total loss before income taxes

The following table summarizes income tax benefit (in thousands):

Year Ended December 31,

United States

1 unchanged sentence

United States

Total deferred income tax benefit (provision)

Total income tax benefit (provision)

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.

Total deferred income tax benefit

Total income tax benefit

A reconciliation of the federal statutory income tax rate to the effective tax rate is as follows:

8 unchanged sentences

Effective income tax rate

The effective tax rate of 1.2 % differs from the U.S.

The effective income tax rate of 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.

6 unchanged sentences

Stock-based compensation

Deferred rent

Lease incentive obligation

Lease liability

12 unchanged sentences

Balance, end of year

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.

The valuation allowance increased during the year ended December 31, 2021 as compared to the year ended December 31, 2020, primarily as a result of the U.S.

operating losses incurred, stock-based compensation windfall benefits 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.

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federal NOLs generated in the tax years beginning after December 31, 2017 of approximately $ 158.7 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, 2021, the Company had $ 17 8.8 million of state NOLs, approximately $168.8 million expire at various dates through 2041, and certain state NOLs of approximately $10.0 million do not expire.

As of December 31, 2021, the Company had U.S.

federal tax credit carryforwards of approximately $ 4.5 million that expire at various dates through 2040.

federal tax credit carryforwards of approximately $ 5.1 million that expire at various dates

through 2041.

As of December 31, 2021, the Company had U.S.

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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).

Under the Tax Cuts and Jobs Act of 2017 (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.

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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.

In July 2021, the Company filed for a $ 2.1 million refund under the CARES Act relating to an employee retention credit (ERC).

The ERC is a refundable payroll tax credit.

The Company expects receipt of the ERC refund during the first half of 2022, and this amount is included in prepaid expenses and other current assets on the consolidated balance sheet as of December 31, 2021.

The Company accounts for uncertain tax positions using a more likely than not threshold for recognizing uncertain tax positions.

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As of December 31, 2021, the Company’s foreign subsidiaries had immaterial undistributed earnings and the tax payable on the earnings that are indefinitely reinvested would be immaterial.

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.

As of December 31,

Common stock warrants

Common stock options and unvested restricted common stock

Shares reserved for future awards under compensation plans

The following table summarizes the Company’s outstanding warrants as of December 31, 2020, and 2019:

Exercise Price

As of December 31, 2019

As of December 31, 2020

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.

Stockholders’ equity

Stock-based compensation

Share-based compensation expense for all stock awards consists of the following (in thousands):

Stock-based compensation expense for all stock awards consists of the following (in thousands):

Cost of product revenue

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Selling, general, and administrative

Total stock-based compensation

At December 31, 2021, there was $ 35.8 million of total unrecognized compensation cost related to unvested stock options and restricted stock units which is expected to be recognized over the remaining weighted-average vesting period of 2.9 years.

Stock-based compensation plans

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.

As of December 31, 2021, 709,772 shares were outstanding.

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.

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, expired, 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, 2021, 2,026,021 shares were outstanding and there were 1,434,072 shares available for grant under the 2017 Plan.

In addition, the 2017 Plan contains an "evergreen"

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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.

The following table summarizes the Company’s outstanding warrants:

Exercise Price

As of December 31, 2020

As of December 31, 2021

Stock options

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These options expire ten years after the grant date.

Activity under the 2007 Plan and the 2017 Plan were as follows:

Option activity is as follows:

Weighted-average

Remaining contractual

Aggregate intrinsic value

intrinsic value

exercise price

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Outstanding at December 31, 2021

Vested and expected to vest at December 31, 2020

Exercisable at December 31, 2021

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.

Vested and expected to vest at December 31, 2021

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.

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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

ended December 31, 2016 and 2015 and the remaining unvested awards with performance conditions are not material.

The majority of the performance criteria were achieved during the years 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, 2021, 2020, or 2019.

As of December 31, 2021, the Company had 39,803 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:

Weighted-average

grant date fair

remaining contractual

intrinsic value

value per share

life (in years)

(in thousands)

Unvested RSUs as of December 31, 2020

Unvested RSUs as of December 31, 2021

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.

Expected to convert at December 31, 2021

The Company is a lessee under leases of offices, lab spaces, and certain office equipment.

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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

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.

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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:

The following table contains a summary of the lease costs recognized under ASC 842 and other information pertaining to the Company’s operating leases:

Year Ended December 31,

Operating leases (in thousands)

For the year ended December 31, 2020

Lease costs (1)

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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.

As of December 31, 2020, future minimum commitments under ASC 842 under the Company’s operating leases were as follows:

Therefore, the amount disclosed pertaining to the year ended December 31, 2019 is presented under previous accounting guidance and is not comparable to the amounts recorded in the 2021 and 2020 periods under ASC 842.

Future minimum commitments under ASC 842 under the Company’s operating leases in effect at December 31, 2021 were as follows:

Maturity of lease liabilities (in thousands)

As of December 31, 2021

2025 and thereafter

Total lease payments

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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.

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.

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.

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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.

The non-exclusive, non-sublicensable 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.

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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

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.

As this agreement was terminated in 2019, the Company recorded no royalty expense during the years ended December 31, 2021 and 2020.

During the year ended December 31, 2019, the Company recorded royalty expense of $ 0.8 million in cost of product revenue on the consolidated statements of operations.

Legal contingencies

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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 %.

On April 14, 2014, the Company executed a loan agreement with a lender, as subsequently amended.

As of December 31, 2021, there were no additional amounts available to borrow under the debt facility.

The interest rate on this term loan is variable based on the greater of 8 % or 8 % plus the prime rate less 5.25 %.

Interest is paid monthly beginning the month following the borrowing date.

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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.

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):

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.

Under the amended agreement, the Company was required to pay the loan principal in four equal installments starting July 1, 2021, with the final payment and end of term charge to be made on October 1, 2021.

On October 1, 2021, the Company made the final principal payment, including end of term fees, of $ 2.0 million related to the loan agreement.

“At-the-market offering”

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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

approximately 2.7 million shares of the Company’s common stock, par value $ 0.001 per share.

Morgan and 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.

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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.

On February 3, 2021, the Company entered into an underwriting agreement with Goldman Sachs, Leerink, and Cowen, as representatives of the several underwriters, relating to an underwritten public offering of approximately 4.1 million 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 $ 17.8 million in issuance costs associated with the underwritten public offering, resulting in net proceeds to the Company of $ 269.7 million.

Collaboration and license arrangements

3 unchanged sentences

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.

As of December 31, 2021 and 2020, the Company had $ 0.5 million of deferred revenue related to ongoing negotiations with a diagnostics company.

Abbott Laboratories

7 unchanged sentences

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.

During the year ended December 31, 2021 and 2020, the Company recognized no revenue and $ 10.0 million, respectively, within collaboration and license revenue related to the initial license fee under the Abbott License Agreement.

Employee benefit plans

3 unchanged sentences

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:

Obligation to issue cash

Total acquisition consideration

Fair value of assets acquired and liabilities assumed:

Cash and cash equivalents

Accounts receivable

Prepaid expenses

Property and equipment and other non-current assets

Intangible Assets

Total assets acquired

Contractual obligations

Accounts payable and accrued liabilities

Net assets acquired

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.

UmanDiagnostics AB

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Deferred tax liabilities

Revenue and net income related to Uman’s operations were $ 1.8 million and $ 0.1 million, respectively for the year ended December 31, 2021, and is included in the Company’s consolidated statement of operations.

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.

The following unaudited pro forma information presents the condensed consolidated results of operations of the Company and Uman for the year ended December 31, 2019, 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.

1 unchanged sentence

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):

Year Ended December 31,

December 31, 2019

Revenue (unaudited)

Pre-tax loss (unaudited)

During the year ended December 31, 2020, the Company incurred no costs associated with the acquisition of Uman.

During the year ended December 31, 2021 and 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.

1 unchanged sentence

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):

The changes in the carrying amount of goodwill are as follows (in thousands):

Balance as of December 31, 2020

3 unchanged sentences

December 31, 2021

Estimated Useful

Gross Carrying

Weighted Average

Life (in years)

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December 31, 2020

Estimated Useful

Gross Carrying

Weighted Average

Life (in years)

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Non-compete agreements

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

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 $ 2.0 million, $ 2.1 million, and $ 1.4 million for the years ended December 31, 2021, 2020, and 2019, respectively.

1 unchanged sentence

Future estimated amortization expense of acquired intangible assets as of December 31, 2021 is as follows (amounts in thousands):

For the Years Ended December 31,

Estimated Amortization Expense

As of December 31, 2021

Total amortization expense

Related party transactions

4 unchanged sentences

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.

Revenue recorded from sales to Harvard University was $ 0.2 million, $ 0.1 million, and $ 0.1 million for the years ended December 31, 2021, 2020, and 2019, 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.

3 unchanged sentences

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.

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

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.

Quarterly data (unaudited)

(Amounts in thousands, except share and per share data)

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

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

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

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 per share, basic and diluted

Weighted-average common shares outstanding, basic and diluted

For the years ended December 31, 2021 and 2020, the Company did not make any contributions.

For the year ended December 31, 2019, the Company had total contributions of $ 0.1 million.

Subsequent events

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.

On January 28, 2022, the Company entered into a multi-year lease agreement for approximately 53,000 square feet of new principal office space and approximately 32,770 square feet of new laboratory space in Bedford, Massachusetts.

The initial lease term is eight years and nine months beginning on the earlier of the Company occupancy, or May 1, 2022.

The Company was required to provide an initial security deposit of $ 0.9 million, which was provided in a form of a letter of credit to the landlord during 2021, and is included in the Company’s restricted cash balance as of December 31, 2021.

The security deposit is scheduled to be reduced to $ 0.5 million after 60 months .

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

What changed 10-K

Item 9A. Controls and Procedures