Item 9A. Controls and Procedures
ITEM 9A. CONTROLS AND PROCEDURES
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 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. 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 disclosure controls and procedures as of December 31, 2023. Based on this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were not effective at a reasonable assurance level as of December 31, 2023, due to the material weaknesses described below in Management’s Report on Internal Control over Financial Reporting.
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 Rules 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.
In Part II, Item 9A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2022, we identified four material weaknesses in our internal control over financial reporting, relating to the operating effectiveness of our internal controls associated with: (i) the accounting for inventory, including excess and obsolescence reserves (the “Inventory MW”), (ii) the accounting for salaries and commissions expense (the “Compensation MW”), (iii) the financial statement close process, including financial reporting, share-based compensation and non-recurring transactions such as impairment of assets and accounting for leases (the “Financial Statement Close Process MW”), and (iv) the accounting for property and equipment, net (the “Property and Equipment MW”).
A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of the Company's annual or interim financial statements will not be prevented or detected on a timely basis.
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Remediation of Previously-Identified Material Weaknesses
During 2023, we took a number of actions and incurred expenses of approximately $4.2 million, including the efforts outlined below, designed to improve our internal control over financial reporting to remediate the material weaknesses identified above. These efforts included:
● hired additional personnel with public company experience who have the appropriate level of expertise in the respective areas of accounting, SEC financial reporting, and associated internal controls commensurate with the type, volume, and complexity of our accounting operations and reporting requirements, including a Corporate Controller and an Assistant Controller;
● continued to supplement our team with advisory consultants to provide additional depth and breadth in our period-end closes, technical accounting, financial reporting capabilities, and internal controls compliance;
● implemented recommendations from a third-party service provider we engaged to perform an assessment of our internal control design and operation and provide us recommendations to enhance the effectiveness of such controls;
● engaged a third-party consultant to assess our current enterprise resource planning system and identify opportunities to enhance our use of the system through automating certain controls and processes, for which development of system enhancements were made and continue to be underway; and
● engaged an accounting advisory consultant who conducted additional trainings on a regular basis related to internal control over financial reporting with our team members including, but not limited to, finance and accounting personnel.
Based on the efforts above and after demonstrating the operating effectiveness of the related internal controls for a sufficient period of time, management has concluded that the Financial Statement Close Process MW and Compensation MW were remediated as of December 31, 2023.
Evaluation of Controls and Procedures
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, 2023, 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, as well as the actions outlined above, while our management concluded that the Financial Statement Close Process MW and Compensation MW were remediated as of December 31, 2023, management concluded that our internal control over financing reporting was not effective at the reasonable assurance level as of December 31, 2023 due to the material weaknesses described below.
Our management concluded that control deficiencies existed as of December 31, 2023, and that these control deficiencies constituted material weaknesses in our internal control over financial reporting. Specifically, management concluded that a portion of the Inventory MW related to the valuation of our inventory, including excess and obsolescence reserves (the “Inventory Valuation MW”) and the Property and Equipment MW continued to exist as of December 31, 2023. The primary cause of the Inventory Valuation MW is our reliance on manual processes to verify the completeness and accuracy of information used in our inventory valuation outputs, and the adequacy and documentation of reviews over these outputs. For the Property and Equipment MW, while the related internal controls were implemented and effective as of December 31, 2023, they were not in all cases in place for a sufficient period of time to demonstrate operating effectiveness as of December 31, 2023.
We have not identified any material misstatements as a result of the material weaknesses discussed above. If not remediated, or if we identify further material weaknesses in our internal control, our failure to establish and maintain effective disclosure controls and procedures and internal control over financial reporting could result in material misstatements in our consolidated financial statements or a failure to meet our reporting and financial obligations.
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The Company’s independent registered public accounting firm, Ernst & Young LLP, has also issued an audit report on the Company’s internal control over financial reporting, which is included elsewhere in this Annual Report on Form 10-K.
Continuing Remediation Efforts
Management, with oversight from the Audit Committee of our Board of Directors, is taking steps to remediate the control deficiencies that resulted in the Inventory Valuation MW and Property and Equipment MW described above by implementing changes to our internal control over financial reporting. Our plans for remediation include, but are not limited to, the efforts summarized below, which have been or are in the process of being implemented:
● we have engaged accounting advisory consultants to implement new software systems to automate manual key inventory valuation processes and outputs;
● we will strengthen, document, and implement additional compensating controls;
● we will continue to focus on effectively operating controls that did not have a sufficient period of time to demonstrate operating effectiveness as of December 31, 2023; and
● we will continue to evaluate, enhance, and add personnel in the finance organization with a focus on the requisite experience in the areas of accounting, SEC financial reporting, and associated internal controls.
We expect to continue our efforts to remediate the Inventory Valuation MW and Property and Equipment MW as described above through fiscal year 2024. We believe that the implementation of the above steps will allow us to address the deficient controls within our internal control environment, which will facilitate the remediation of the Inventory Valuation MW and Property and Equipment MW. As we continue to evaluate and work to improve our internal control over financial reporting, we will take additional measures to address control deficiencies and we may modify certain of the remediation measures described above. Following our design and implementation of our remediation efforts, we will need to demonstrate their operating effectiveness. We will not be able to consider the Inventory Valuation MW and Property and Equipment MW remediated until the applicable remedial controls operate for a sufficient period of time and our management has concluded, through testing, that our controls are operating effectively.
Changes in Internal Control over Financial Reporting
Other than related to the changes outlined above to remediate the material weaknesses described above, there have been no changes in our internal control over financial reporting during the fiscal quarter ended December 31, 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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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, 2023, 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, because of the effect of the material weaknesses described below on the achievement of the objectives of the control criteria, Quanterix Corporation (the Company) has not maintained effective internal control over financial reporting as of December 31, 2023, based on the COSO criteria.
A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the company’s annual or interim financial statements will not be prevented or detected on a timely basis. The following material weaknesses have been identified and included in management’s assessment. Management has identified material weaknesses in internal controls related to (i) the accounting for inventory valuation, including excess and obsolescence reserves, and (ii) the accounting for property and equipment, net.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2023 and December 31, 2022, the related consolidated statements of operations, comprehensive loss, stockholders' equity and cash flows for each of the three years in the period ended December 31, 2023, and the related notes. These material weaknesses were considered in determining the nature, timing and extent of audit tests applied in our audit of the 2023 consolidated financial statements, and this report does not affect our report dated February 29, 2024, which 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 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
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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. 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
February 29, 2024
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ITEM 9B. OTHER INFORMATION
Securities Trading Plans of Directors and Executive Officers
During the three months ended December 31, 2023, none of our directors or officers adopted or terminated any contract, instruction or written plan for the purchase or sale of our securities that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) or any “non-Rule 10b5-1 trading arrangement” (as defined in Item 408(c) of Regulation S-K).
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not applicable.
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PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND C ORPORATE GOVERNANCE
The information required by this Item will be set forth in our Proxy Statement for the 2024 Annual Meeting of Stockholders to be filed with the SEC within 120 days of December 31, 2023 and is incorporated into this Annual Report on Form 10-K by reference.
ITEM 11. EXECUTIVE COMPENSATION
The information required by this Item will be set forth in our Proxy Statement for the 2024 Annual Meeting of Stockholders to be filed with the SEC within 120 days of December 31, 2023 and is incorporated into this Annual Report on Form 10-K by reference.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND R ELATED STOCKHOLDER MATTERS
The information required by this Item will be set forth in our Proxy Statement for the 2024 Annual Meeting of Stockholders to be filed with the SEC within 120 days of December 31, 2023 and is incorporated into this Annual Report on Form 10-K by reference.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
The information required by this Item will be set forth in our Proxy Statement for the 2024 Annual Meeting of Stockholders to be filed with the SEC within 120 days of December 31, 2023 and is incorporated into this Annual Report on Form 10-K by reference.
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICE S
Our independent registered public accounting firm is Ernst & Young LLP, New York, NY, (PCAOB ID 42).
The other information required by this Item will be set forth in our Proxy Statement for the 2024 Annual Meeting of Stockholders to be filed with the SEC within 120 days of December 31, 2023 and is incorporated into this Annual Report on Form 10-K by reference.
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PART IV
ITEM 15. EXHIBITS AND F INANCIAL STATEMENT SCHEDULES
(1) Financial Statements
The Consolidated Financial Statements are included beginning on page F-1 attached hereto and are filed as part of this Annual Report on Form 10-K.
(2) Financial Statement Schedules
Financial statement schedules have been omitted since they either are not required, not applicable, or the information is otherwise included.
(3) Exhibits
The following is a list of exhibits filed as part of this Annual Report on Form 10-K:
Exhibit Number
Exhibit Description
Filed
Herewith
Incorporated by
Reference herein from
Form or Schedule
Filing Date
SEC File/
Reg. Number
3.1
Amended and Restated Certificate of Incorporation
8-K
12/15/2017
001-38319
3.2
Restated Bylaws
10-Q
8/8/2023
001-38319
4.1
Description of Securities
10-K
3/13/2020
001-38319
4.2
Form of Common Stock Certificate
S-1
11/9/2017
333-221475
10.1.1+
2007 Stock Option and Grant Plan, as amended
S-1
11/9/2017
333-221475
10.1.2+
Form of Incentive Stock Option Agreement under the 2007 Stock Option and Grant Plan, as amended
S-1
11/9/2017
333-221475
10.1.3+
Form of Non-qualified Stock Option Agreement under the 2007 Stock Option and Grant Plan, as amended
S-1
11/9/2017
333-221475
10.1.4+
Form of Restricted Stock Agreement under the 2007 Stock Option and Grant Plan, as amended
S-1
11/9/2017
333-221475
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Exhibit Number
Exhibit Description
Filed
Herewith
Incorporated by
Reference herein from
Form or Schedule
Filing Date
SEC File/
Reg. Number
10.2.1+
2017 Employee, Director and Consultant Equity Incentive Plan
S-1/A
11/27/2017
333-221475
10.2.2+
Form of Stock Option Agreement under the 2017 Employee, Director and Consultant Equity Incentive Plan
S-1/A
11/27/2017
333-221475
10.2.3+
Form of Restricted Stock Agreement under the 2017 Employee, Director and Consultant Equity Incentive Plan
S-1/A
11/27/2017
333-221475
10.2.4+
Form of Restricted Stock Unit Agreement under the 2017 Employee, Director and Consultant Equity Incentive Plan
X
10.3+
Employment Agreement, dated August 3, 2023, between the Registrant and Vandana Sriram
8-K
8/9/2023
001-38319
10.4+
Amended and Restated Employment Agreement, dated March 27, 2023, between the Registrant and Michael Doyle
8-K
3/27/2023
001-38319
10.5+
Amended and Restated Employment Agreement, dated April 25, 2022, between the Registrant and Dr. Masoud Toloue
8-K
4/29/2022
001-38319
10.6+
Employment Agreement, dated March 28, 2022, between the Registrant and Dan Pikora
8-K
9/8/2022
001-38319
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Exhibit Number
Exhibit Description
Filed
Herewith
Incorporated by
Reference herein from
Form or Schedule
Filing Date
SEC File/
Reg. Number
10.7.1*
Exclusive License Agreement, dated June 18, 2007, between the Registrant and Tufts University, as amended on April 29, 2013
S-1
11/9/2017
333-221475
10.7.2*
Second Amendment, dated August 22, 2017, to the Exclusive License Agreement between the Registrant and Tufts University
S-1
11/9/2017
333-221475
10.7.3@
Third Amendment, dated September 25, 2020, to the Exclusive License Agreement between the Registrant and Tufts University
10-Q
11/6/2020
001-38319
10.8.1*
Supply and Manufacturing Agreement, dated September 14, 2011, between the Registrant and STRATEC Biomedical AG
S-1
11/9/2017
333-221475
10.8.2
First Amendment to Supply and Manufacturing Agreement, dated October 17, 2013, between the Registrant and STRATEC Biomedical AG
S-1
11/9/2017
333-221475
10.9.1*
STRATEC Development Services and Equity Participation Agreement, dated August 15, 2011, between the Registrant and STRATEC Biomedical Systems AG
S-1
11/9/2017
333-221475
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Exhibit Number
Exhibit Description
Filed
Herewith
Incorporated by
Reference herein from
Form or Schedule
Filing Date
SEC File/
Reg. Number
10.9.2*
First Amendment to STRATEC Development Services and Equity Participation Agreement and Second Amendment to Supply and Manufacturing Agreement, dated November 18, 2016, between the Registrant and STRATEC Biomedical AG
S-1
11/9/2017
333-221475
10.10*
Manufacturing Services Agreement, dated November 23, 2016, between the Registrant and Paramit Corporation
S-1
11/9/2017
333-221475
10.11+
Form of Indemnification Agreement
S-1/A
11/27/2017
333-221475
10.12
Lease Agreement by and between SSI 900 Middlesex MA LP and the Registrant, dated October 2, 2018
8-K
10/5/2018
001-38319
10.13
Lease Agreement by and between the Registrant and XChange Owner LLC, dated January 28, 2022
8-K
1/31/2022
001-38319
10.14+
Amended and Restated Non-Employee Director Compensation Policy
X
21.1
Subsidiaries of Registrant
10-K
3/5/2021
001-38319
23.1
Consent of Ernst & Young LLP
X
31.1
Certification of the Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
X
31.2
Certification of the Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
X
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Exhibit Number
Exhibit Description
Filed
Herewith
Incorporated by
Reference herein from
Form or Schedule
Filing Date
SEC File/
Reg. Number
32.1
Certifications of the Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
X
97.1
Policy relating to recovery of erroneously awarded compensation
X
101.INS
Inline XBRL Instance Document
X
101.SCH
Inline XBRL Taxonomy Extension Schema Document
X
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase Document
X
101.DEF
Inline XBRL Taxonomy Extension Definition
X
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase Document
X
101.PRE
Inline XBRL Taxonomy Presentation Linkbase Document
X
104
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
+
Management contract or compensatory plan or arrangement.
*
Confidential treatment has been granted for portions of this Exhibit. Redacted portions have been filed separately with the SEC.
@
Portions of this document (indicated by “[***]”) have been omitted because such information is not material and is the type of information that the Registrant treats as private or confidential.
ITEM 16. FORM 10-K S UMMARY
Not applicable.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
QUANTERIX CORPORATION
Date: February 29, 2024
By:
/s/ MASOUD TOLOUE, PH.D.
Masoud Toloue, Ph. D.
President and Chief Executive Officer
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
Signature
Title
Date
/s/ MASOUD TOLOUE, PH.D.
President and Chief Executive Officer and Director (Principal Executive Officer)
February 29, 2024
Masoud Toloue, Ph.D.
/s/ VANDANA SRIRAM
Chief Financial Officer
February 29, 2024
Vandana Sriram
(Principal Financial Officer and Principal Accounting Officer)
/s/ MARTIN D. MADAUS, PH.D.
Chairman
February 29, 2024
Martin D. Madaus, Ph.D.
/s/ BRIAN J. BLASER
Director
February 29, 2024
Brian J. Blaser
/s/ WILLIAM DONNELLY
Director
February 29, 2024
William Donnelly
/s/ KAREN A. FLYNN
Director
February 29, 2024
Karen A. Flynn
/s/ SARAH E. HLAVINKA
Director
February 29, 2024
Sarah E. Hlavinka
/s/ PAUL M. MEISTER
Director
February 29, 2024
Paul M. Meister
/s/ LAURIE J. OLSON
Director
February 29, 2024
Laurie J. Olson
/s/ DAVID R. WALT, PH.D.
Director
February 29, 2024
David R. Walt, Ph.D.
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QUANTERIX CORPORATION
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Page
Report of Independent Registered Public Accounting Firm (PCAOB ID: 42 )
F-2
Consolidated Balance Sheets as of December 31, 2023 and 2022
F-3
Consolidated Statements of Operations for the years ended December 31, 2023, 2022, and 2021
F-4
Consolidated Statements of Comprehensive Loss for the years ended December 31, 2023, 2022, and 2021
F-5
Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2023, 2022, and 2021
F-6
Consolidated Statements of Cash Flows for the years ended December 31, 2023, 2022, and 2021
F-7
Notes to Consolidated Financial Statements
F-8
F-1
Table of Contents
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
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, 2023 and 2022, the related consolidated statements of operations, comprehensive loss, stockholders' equity and cash flows for each of the three years in the period ended December 31, 2023, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2023 and 2022, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2023, in conformity with U.S. generally accepted accounting principles.
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, 2023, 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 February 29, 2024 expressed an adverse opinion thereon.
Basis for Opinion
These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
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 of December 31, 2023, the Company had recognized inventory of $22.4 million. As discussed in Note 2 to the consolidated financial statements, the Company analyzes its inventory levels at each reporting date for slow moving, excess or obsolete inventory and inventory expected to expire prior to being used. In the event that the Company identifies adverse conditions, the carrying value of the inventory is reduced to its estimated net realizable value.
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 supporting the Company’s estimate. 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 evaluated inventory levels compared to forecasted demand, historical sales and specific product considerations. We performed inquiries with appropriate non-financial personnel, including supply chain employees, regarding obsolete or discontinued inventory items and other factors as well as obtained supporting evidence to corroborate management's assertions regarding qualitative judgments about discontinued, slow moving and obsolete inventories. We also evaluated management's ability to accurately forecast demand by comparing actual demand to management's prior estimates.
/s/ Ernst & Young LLP
We have served as the Company’s auditor since 2008.
Boston, Massachusetts
February 29, 2024
F-2
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QUANTERIX CORPORATION
CONSOLIDATED BALANCE SHEETS
(amounts in thousands, except per share data)
December 31, 2023
December 31, 2022
ASSETS
Current assets:
Cash and cash equivalents
$
174,422
$
338,740
Marketable securities
146,902
—
Accounts receivable, net of allowance for expected credit losses
25,414
19,017
Inventory
22,365
16,786
Prepaid expenses and other current assets
9,291
6,860
Total current assets
378,394
381,403
Restricted cash
2,604
2,597
Property and equipment, net
17,926
20,162
Intangible assets, net
6,034
7,516
Operating lease right-of-use assets
18,251
21,223
Other non-current assets
1,802
1,298
Total assets
$
425,011
$
434,199
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable
$
5,048
$
3,836
Accrued compensation and benefits
13,659
10,658
Accrued expenses and other current liabilities
6,041
5,133
Deferred revenue
9,468
8,644
Operating lease liabilities
4,241
2,687
Total current liabilities
38,457
30,958
Deferred revenue, net of current portion
1,227
1,415
Operating lease liabilities, net of current portion
37,223
41,417
Other non-current liabilities
1,177
1,469
Total liabilities
78,084
75,259
Commitments and contingencies (Note 15)
Stockholders’ equity:
Common stock, $ 0.001 par value per share:
Authorized: 120,000 shares; issued and outstanding : 38,014 and 37,280 shares at December 31, 2023 and 2022, respectively
38
37
Additional paid-in capital
783,142
763,688
Accumulated other comprehensive loss
( 1,757 )
( 2,623 )
Accumulated deficit
( 434,496 )
( 402,162 )
Total stockholders’ equity
346,927
358,940
Total liabilities and stockholders’ equity
$
425,011
$
434,199
The accompanying notes are an integral part of these Consolidated Financial Statements.
F-3
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QUANTERIX CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
(amounts in thousands, except per share data)
Year Ended December 31,
2023
2022
2021
Revenues:
Product revenue
$
79,460
$
69,808
$
81,062
Service and other revenue
40,299
34,495
23,629
Collaboration and license revenue
1,380
649
648
Grant revenue
1,229
570
5,217
Total revenues
122,368
105,522
110,556
Costs of goods sold and services:
Cost of product revenue
32,636
40,809
34,149
Cost of service and other revenue
19,086
17,907
14,679
Total costs of goods sold and services
51,722
58,716
48,828
Gross profit
70,646
46,806
61,728
Operating expenses:
Research and development
24,857
25,890
27,978
Selling, general and administrative
90,241
91,995
92,336
Other lease costs
3,712
1,278
—
Impairment and restructuring
1,537
29,347
—
Total operating expenses
120,347
148,510
120,314
Loss from operations
( 49,701 )
( 101,704 )
( 58,586 )
Interest income (expense), net
15,839
5,131
( 403 )
Other income (expense), net
2,247
( 62 )
1,265
Loss before income taxes
( 31,615 )
( 96,635 )
( 57,724 )
Income tax (expense) benefit
( 719 )
( 65 )
36
Net loss
$
( 32,334 )
$
( 96,700 )
$
( 57,688 )
Net loss per common share, basic and diluted
$
( 0.86 )
$
( 2.61 )
$
( 1.60 )
Weighted-average common shares outstanding, basic and diluted
37,594
36,991
35,997
The accompanying notes are an integral part of these Consolidated Financial Statements.
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Table of Contents
QUANTERIX CORPORATION
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(amounts in thousands)
Year Ended December 31,
2023
2022
2021
Net loss
$
( 32,334 )
$
( 96,700 )
$
( 57,688 )
Other comprehensive loss, net of tax:
Unrealized gains on marketable securities
325
—
—
Foreign currency translation
541
( 3,064 )
( 1,993 )
Total other comprehensive income (loss)
866
( 3,064 )
( 1,993 )
Comprehensive loss
$
( 31,468 )
$
( 99,764 )
$
( 59,681 )
The accompanying notes are an integral part of these Consolidated Financial Statements.
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Table of Contents
QUANTERIX CORPORATION
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(amounts in thousands)
Year ended December 31, 2023
Common Stock
Shares
Amount
Additional paid-in capital
Accumulated other comprehensive loss
Accumulated
deficit
Total shareholders' equity
Balance at December 31, 2022
37,280
$
37
$
763,688
$
( 2,623 )
$
( 402,162 )
$
358,940
Issuance of common stock under stock plans, including tax effects
734
1
2,690
—
—
2,691
Stock-based compensation expense
—
—
16,764
—
—
16,764
Unrealized gains on marketable securities, net of tax
—
—
—
325
—
325
Foreign currency translation
—
—
—
541
—
541
Net loss
—
—
—
—
( 32,334 )
( 32,334 )
Balance at December 31, 2023
38,014
$
38
$
783,142
$
( 1,757 )
$
( 434,496 )
$
346,927
Year ended December 31, 2022
Common Stock
Shares
Amount
Additional paid-in capital
Accumulated other comprehensive loss
Accumulated
deficit
Total shareholders' equity
Balance at December 31, 2021
36,768
$
37
$
745,936
$
441
$
( 305,462 )
$
440,952
Issuance of common stock under stock plans, including tax effects
512
—
2,310
—
—
2,310
Stock-based compensation expense
—
—
15,442
—
—
15,442
Foreign currency translation
—
—
—
( 3,064 )
—
( 3,064 )
Net loss
—
—
—
—
( 96,700 )
( 96,700 )
Balance at December 31, 2022
37,280
$
37
$
763,688
$
( 2,623 )
$
( 402,162 )
$
358,940
Year ended December 31, 2021
Common Stock
Shares
Amount
Additional paid-in capital
Accumulated other comprehensive loss
Accumulated
deficit
Total shareholders' equity
Balance at December 31, 2020
31,797
$
32
$
451,433
$
2,434
$
( 247,774 )
$
206,125
Issuance of common stock under stock plans, including tax effects
864
1
8,814
—
—
8,815
Sale of common stock in underwritten public offering, net
4,107
4
269,714
—
—
269,718
Stock-based compensation expense
—
—
15,975
—
—
15,975
Foreign currency translation
—
—
—
( 1,993 )
—
( 1,993 )
Net loss
—
—
—
—
( 57,688 )
( 57,688 )
Balance at December 31, 2021
36,768
$
37
$
745,936
$
441
$
( 305,462 )
$
440,952
The accompanying notes are an integral part of these Consolidated Financial Statements.
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QUANTERIX CORPORATION
CONSOLIDATED STATEMENTS OF CASH FLOWS
(amounts in thousands)
Year Ended December 31,
2023
2022
2021
Cash flows from operating activities:
Net loss
$
( 32,334 )
$
( 96,700 )
$
( 57,688 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization expense
6,364
5,349
4,851
Credit losses (gains) on accounts receivable
336
( 301 )
213
Accretion of marketable securities
( 1,964 )
—
—
Operating lease right-of-use asset amortization
2,015
715
499
Stock-based compensation expense
16,764
15,442
15,975
Impairment
1,570
25,592
—
Other operating activity
150
( 439 )
692
Changes in assets and liabilities:
Accounts receivable
( 6,695 )
5,156
( 6,853 )
Inventory
( 5,364 )
5,386
( 8,090 )
Prepaid expenses and other current assets
( 2,371 )
( 568 )
( 393 )
Other non-current assets
( 775 )
( 909 )
( 2 )
Accounts payable
1,189
( 5,362 )
2,414
Accrued compensation and benefits, accrued expenses, and other current liabilities
4,276
( 3,976 )
606
Deferred revenue
635
2,599
1,462
Operating lease liabilities
( 2,645 )
( 266 )
( 1,230 )
Other non-current liabilities
( 53 )
10
( 363 )
Net cash used in operating activities
( 18,902 )
( 48,272 )
( 47,907 )
Cash flows from investing activities:
Purchases of marketable debt securities
( 175,613 )
—
—
Proceeds from marketable debt securities
31,000
—
—
Purchases of property and equipment
( 3,788 )
( 11,726 )
( 13,616 )
Proceeds from RADx grant on assets purchased
—
520
7,278
Net cash used in investing activities
( 148,401 )
( 11,206 )
( 6,338 )
Cash flows from financing activities:
Proceeds from common stock issued under stock plans
2,889
2,311
8,815
Payments for employee taxes withheld on stock-based compensation awards
( 198 )
—
—
Sale of common stock in underwritten public offering, net
—
—
269,718
Payments on notes payable
—
—
( 7,738 )
Net cash provided by financing activities
2,691
2,311
270,795
Net increase (decrease) in cash, cash equivalents, and restricted cash
( 164,612 )
( 57,167 )
216,550
Effect of exchange rate changes on cash, cash equivalents, and restricted cash
301
( 538 )
( 92 )
Cash, cash equivalents, and restricted cash at beginning of period
341,337
399,042
182,584
Cash, cash equivalents, and restricted cash at end of period
$
177,026
$
341,337
$
399,042
Supplemental disclosure of cash flow information:
Cash paid for taxes
$
808
$
684
$
—
Cash paid for interest
$
—
$
—
$
389
Purchases of property and equipment in accounts payable and accruals
$
419
$
152
$
229
Operating lease right-of-use assets obtained in exchange for lease liabilities
$
—
$
22,494
$
—
Non-cash consideration received under product sales agreement (Note 3, 6)
$
775
$
—
$
—
The accompanying notes are an integral part of these Consolidated Financial Statements.
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Table of Contents
QUANTERIX CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 1. Organization and Nature of Business
Quanterix Corporation (“Quanterix” or the “Company”) is a life sciences company that has developed next-generation, ultra-sensitive digital immunoassay platforms that advance life sciences research and diagnostics. The Company’s platforms are based on its proprietary digital “Simoa” detection technology and enable customers to reliably detect protein biomarkers in ultra- low concentrations in blood, serum, and other fluids that, in many cases, are undetectable using conventional, analog immunoassay technologies. The ability of the Company’s Simoa platforms to detect proteins in the femtomolar range is enabling the development of novel therapies and diagnostics and has the potential to facilitate a paradigm shift in healthcare from an emphasis on treatment to a focus on earlier detection, monitoring, prognosis, and, ultimately, prevention.
The Company also provides contract research services for customers and Laboratory Developed Test (“LDT”) services through its CLIA-certified Accelerator Laboratory (the “Accelerator Laboratory”). The Accelerator Laboratory provides customers with access to Simoa technology and supports multiple projects and services, including sample testing, homebrew assay development, custom assay development, and blood-based biomarker testing. To date, the Company has completed over 2,200 projects for more than 480 customers from all over the world using its Simoa platforms.
Liquidity
The Company has recognized annual losses from operations since inception and has an accumulated deficit of $ 434.5 million as of December 31, 2023. The Company incurred net losses of $ 32.3 million, $ 96.7 million, and $ 57.7 million for the years ended December 31, 2023, 2022, and 2021, respectively. As of December 31, 2023, the Company had cash and cash equivalents of $ 174.4 million and marketable securities of $ 146.9 million. The Company expects that its current cash, cash equivalents, and marketable securities will be sufficient to fund its operations for a period of at least one year from the date the Consolidated Financial Statements are issued.
Note 2. Significant Accounting Policies
Basis of Presentation
The accompanying Consolidated Financial Statements and notes herein have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) and pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) regarding annual financial reporting on Form 10-K.
The Company’s fiscal year is the twelve-month period from January 1 through December 31, and all references to “2023,” “2022,” and “2021,” refer to the fiscal year unless otherwise noted. Certain amounts in the prior years’ Consolidated Financial Statements have been reclassified to conform to the current year’s presentation.
Use of Estimates
The preparation of the Consolidated Financial Statements and Notes to Consolidated Financial Statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the dates of the Consolidated Financial Statements, and the reported amounts of revenues and expenses during each fiscal year. Such estimates include, but are not limited to, revenue recognition, valuation of inventory, leases, valuation and impairment of long-lived assets, recoverability of deferred tax assets, and stock-based compensation expense. The Company bases its estimates on historical experience, known trends, worldwide economic conditions, both general and specific to the life sciences industry, and other relevant factors it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates and changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates.
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Table of Contents
Principles of Consolidation
The Consolidated Financial Statements include the accounts of Quanterix and its wholly-owned subsidiaries. All intercompany transactions have been eliminated in consolidation.
In accordance with Accounting Standards Codification (“ASC”) 810 – Consolidation , the Company assesses the terms of its non-marketable equity investments in entities to determine if any meet the definition of a variable interest entity (“VIE”) and require consolidation into its Consolidated Financial Statements. Refer to Note 19 − Variable Interest Entities for further discussion.
Foreign Currency
The functional currency of the Company’s subsidiaries is their respective local currencies. These subsidiary financial statements are translated into U.S. dollars using the period-end exchange rates for assets and liabilities, average exchange rates during the corresponding period for revenue and expenses, and historical rates for equity. The effects of foreign currency translation adjustments are recorded in accumulated other comprehensive income (loss), a component of stockholders’ equity on the Consolidated Balance Sheets.
Foreign currency transaction gains (losses) are included in other income (expense), net on the Consolidated Statements of Operations. Foreign exchange losses were not material during the year ended December 31, 2023, and were $ 0.8 million and $ 0.4 million during the years ended December 31, 2022 and 2021, respectively.
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 (“CODM”), in deciding how to allocate resources and assess performance. The Company’s CODM is the chief executive officer, who reviews the Company's operations and manages its business as a single operating segment as of December 31, 2023.
Revenue from Contracts with Customers
The Company generates the majority of its revenues from contracts with customers and accounts for them pursuant to the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification Topic 606 - Revenue from Contracts with Customers (“ASC 606”). Refer to the section titled “Grant Revenue” below for discussion the Company’s accounting policy for revenue generated from grant awards.
For contracts with customers, the Company recognizes revenue when a customer obtains control of promised products or services, for an amount that reflects the consideration expected to be received in exchange for those products or services. The Company follows the five step revenue model prescribed by ASC 606 to determine revenue recognition: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price, including variable consideration, if any; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. Revenues are presented net of any sales, value added, or similar taxes collected from customers and remitted to the government.
The Company accounts for a contract when it has approval and commitment from both parties, the fees, payment terms and rights of the parties regarding the products or services to be transferred are identified, the contract has commercial substance, and it is probable that substantially all of the consideration for the products and services expected to be transferred is collectible. The Company applies judgment in determining the customer’s ability and intention to pay for services expected to be transferred, which is based on factors including the customer’s payment history, management’s ability to mitigate exposure to credit risk (for example, requiring payment in advance of the transfer of products or services, or the ability to stop transferring promised products or services in the event a customer fails to pay consideration when due), and experience selling to similarly situated customers.
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Table of Contents
The Company’s contracts may include either a single promise (referred to as a performance obligation) to transfer a product or service, or a combination of multiple performance obligations to transfer products or services. The Company evaluates the existence of multiple performance obligations within its contracts by using judgment to determine if (1) the customer can benefit from each contractual promise on its own or together with readily available resources and (2) the transfer of each contractual promise is separately identifiable from other promises in a contract. When both criteria are met, each promise is accounted for as a separate performance obligation. Additionally, the Company has elected the practical expedient under ASC 606 to account for shipping and handling as an activity to fulfill a promise to transfer a product, and therefore does not evaluate whether shipping and handling activities are promised services to its customers.
Contracts that include rights to additional products or services that are exercisable at a customer’s discretion are generally considered options. The Company assesses if these options provide a material right to the customer and if so, the material right is considered a performance obligation. The identification of material rights requires judgment to determine the value of the option to purchase additional products and services in relation to options that may be provided to, and prices paid by, customers in the normal course of business. Material rights are recognized when exercised by a customer or upon expiration of the right.
The Company determines the transaction price of its contracts based on the amount of consideration it expects to be entitled to, which is generally equal to the contract amount. In some cases, contracts contain variable consideration which primarily relates to (1) sales- and usage-based royalties related to the license of intellectual property in collaboration and license contracts and (2) contracts with minimum purchase commitments. For sales and usage-based royalties, ASC 606 provides an exception to estimating variable consideration. Under this exception, the Company recognizes revenues from sales- or usage-based royalty revenue at the later of when the sales or usage occurs or the satisfaction (or partial satisfaction) of the performance obligation to which the royalty has been allocated. All other variable amounts are constrained to the minimum guaranteed contract amount so that a reversal of cumulative revenue does not occur in future periods. Once there is no longer uncertainty over a variable amount, any incremental fees the Company is entitled to are allocated to the related performance obligation(s).
For contracts that contain multiple performance obligations, the Company allocates the transaction price among the performance obligations on a relative basis according to their standalone selling prices (“SSP”). Determining the SSP for performance obligations requires judgment and is based on factors including prices charged to customers in observable transactions, internal pricing objectives and list prices, and pricing of similar products. The Company uses a range of amounts to estimate SSP and has more than one range for certain products and services based on the geographic location of customers and sales channel.
Product Revenue
The Company’s product revenues are composed of instruments, assay kits, replacement parts, and other consumables such as reagents and antibodies. Products are sold directly to customers and are also sold through distributors in EMEA and Asia Pacific regions. Direct instrument sales include installation and an initial year of implied service-type warranties. The Company has determined that the instrument and installation are a combined performance obligation as the customer cannot benefit from the instrument without the installation and no other vendors can provide the installation of the Company’s specialized instruments. The implied service-type warranty is considered a separate performance obligation since a customer could benefit from it independently with readily available resources and is capable of being sold on its own. Sales of instruments to distributors include a license to import and resell the instruments. The Company has determined these distributor licenses are part of a combined performance obligation with the instrument as the distributor only benefits from the combination of the instrument and ability to resell it.
Instrument sales may also be bundled with assays and other consumables, training, and/or an extended service warranty, each of which is considered a separate performance obligation.
Product revenues for direct instrument sales to customers are recognized upon completion of the instrument’s installation. For instrument sales to distributors, revenue is recognized based on the agreed upon shipping terms (either upon shipment or delivery) as that is when title passes to the customer.
F-10
Table of Contents
Service Revenue
Service revenues are composed of contract research services, initial year of implied service-type warranties, extended services warranty contracts, repair services, and other services such as training. Contract research services are provided through the Company’s Accelerator Laboratory and generally consist of fixed fee contracts.
Revenues from contract research services are recognized at the point in time when the Company completes and delivers its research results on each individually completed study, or over time if the contractual provisions allow for the collection of transaction consideration for costs incurred plus a reasonable margin through the period of performance of the services. For contract research services recognized over time, the Company uses the output method based on the number of completed results. Revenues from other services are recognized at the point in time when the training or other services are delivered as the customer simultaneously receives and benefits from the services. Revenues from service-type warranties are recognized ratably over the contract service period.
Collaboration and License Revenue
Collaboration and license revenues are composed of revenue associated with licensing to third parties the Company’s technology, intellectual property, and know-how associated with our instruments and for related services. License arrangements consist of sales or usage-based fees and/or future royalties. Revenues are recognized at the point in time the license is delivered as the underlying license is considered functional intellectual property. Royalty revenues that are sales- or usage- based are recognized at the later of when the sales or usage occurs and the satisfaction (or partial satisfaction) of the performance obligation to which the royalty has been allocated.
Contract Assets and Liabilities
Accounts Receivable and Allowance for Credit Losses
The Company is exposed to credit losses primarily through accounts receivable from sales of its products and services. Accounts receivable includes amounts billed and currently due from customers. Since the only condition for payment of the Company’s invoices is the passage of time, the Company records a receivable on the date the invoice is issued. Also included in accounts receivable are unbilled amounts resulting from revenue exceeding the amount billed to the customer, where the right to payment is unconditional. If the right to payment for services performed was conditional on something other than the passage of time, the unbilled amount would be recorded as a separate contract asset.
The Company’s expected loss allowance methodology is developed using historical collection experience, current and future economic and market conditions, and a review of the current status of customers’ accounts receivable. 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 collection efforts have been exhausted.
Generally, the Company’s contracts are non-cancellable. For contracts that are cancellable by the customer, the Company does not record a receivable when it issues an invoice. The Company records accounts receivable on these contracts only up to the amount of revenue recognized but not yet collected.
The Company’s payment terms vary by the type and location of the customer and the products or services offered. Payment from customers is generally required 30 to 45 days from date of shipment or satisfaction of the performance obligation. The Company does not provide financing arrangements to its customers.
The Company refers to contract liabilities as deferred revenue on the Consolidated Balance Sheets. For deferred revenue, the Company applies the practical expedient under ASC 606 that allows for the exclusion of (1) contracts with original expected length of one year or less and (2) contracts for which revenue is recognized at the amount to which the Company has the right to invoice for services performed from the amount of remaining performance obligations disclosed.
F-11
Table of Contents
Costs to Obtain Contracts
The Company capitalizes commissions paid to its sales representatives and related fringe benefit costs that are incremental to obtaining customer contracts. Capitalized commissions are recorded in prepaid expenses and other current assets and other non-current assets on the Consolidated Balance Sheets. These commissions are amortized over the life of the contract and are recorded in cost of goods sold and selling, general and administrative expense on the Consolidated Statements of Operations. The Company has elected the practical expedient allowing commissions with an amortization period of one year or less to be expensed as incurred.
Commissions associated with instrument sales are generally earned when installation is complete and title to the instrument has transferred. Commissions associated with consumables sales are earned when title to the product transfers. Commissions associated with warranty and extended service contracts are earned upon booking.
Warranties
The Company provides an initial year of warranty and maintenance service related to its instruments sold directly to customers and sells extended warranty contracts for additional periods. The Company defers revenue associated with these warranty services and recognizes them ratably over the service period.
Grant Revenue
Accounting for grants does not fall under ASC 606, as the grantor will not benefit directly from the Company’s expansion or product development, and no products or services are transferred to the grantor. As there is no authoritative guidance under U.S. GAAP on accounting for grants to for profit business entities from government entities, the Company accounts for grants by analogy to International Accounting Standards Topic 20, Accounting for Government Grants and Disclosure of Government Assistance (“IAS 20”) and ASC Topic 958, Not for-Profit Entities (“ASC 958”). The decision to account for a grant under IAS 20 or ASC 958 is based on whether the grantor is a government entity.
The Company records grants related to assets as a deduction in calculating the carrying value of the asset, and to record grants related to income separately on the Consolidated Statements of Operations on a gross basis as grant revenue. The related expenses are recorded on a gross basis within operating expenses. These methods are elections an entity can make under both IAS 20 and ASC 958.
The Company recognizes grant revenue as the Company performs services under the arrangement when the funding is committed and as each grant’s activities are performed. The timing of revenue recognition and receipt of funding varies by grant and can be independent from performance of the related activities, such as an upfront payment of the award value, or subsequent to the Company’s requests for reimbursement for already performed activities (subject to the approval of the granting organization).
Cost of Goods Sold and Services
Cost of Product Revenue
Cost of product revenue consists of manufacturing and assembly costs for instruments, related reagents, other consumables, contract manufacturer costs, personnel costs, royalties, overhead, and other direct costs related to product sales. Raw material part costs include inbound freight, shipping and handling costs associated with purchased goods, contract manufacturer costs, personnel costs, royalties, overhead and other direct costs related to product sales. Additionally included in cost of product revenue are royalty fees due to third parties from revenue generated by collaboration or license deals.
Cost of Service and Other Revenue
Cost of services and other revenue consists of direct costs associated with operating the Company’s Accelerator Laboratory on behalf of its customers, including raw materials, personnel costs, royalties, allocated overhead costs that include facility and other related costs, and other direct costs. Additional costs include costs related to warranties, and other costs of servicing equipment at customer sites.
F-12
Table of Contents
Research and Development Expenses
Research and development expense consists primarily of personnel costs, research supplies, third-party development costs for new products, materials for prototypes, quality assurance, and allocated overhead costs that include facility and other related costs. The Company accounts for nonrefundable advance payments for products and services that will be used in future research and development activities as expense when the service has been performed or when the products have been received.
For arrangements in which the Company receives funding from third parties for research and development activities (excluding the government sponsored arrangements), the Company assesses whether the arrangement is within the scope of ASC 730 – Research and Development . When the Company is entitled to receive reimbursements, does not have an obligation to repay, does not transfer products or services, and is the primary beneficiary of the activities, the Company records the reimbursable amounts as a reduction to research and development expense. Amounts reimbursed in excess of the cost incurred by the Company are recorded within other income (expense), net on the Consolidated Statements of Operations.
Reimbursable amounts recorded as a reduction to research and development expenses were not material during the years ended December 31, 2023, 2022, and 2021. Amounts reimbursed in excess of costs incurred by the Company related to activities funded by third parties were $ 0.4 million during the year ended December 31, 2023. No reimbursable amounts were received during the years ended December 31, 2022, and 2021.
Selling, General and Administrative Expenses
Selling, general and administrative expense consists primarily of personnel costs for our sales and marketing, finance, legal, human resources, and general management teams, shipping and handling for product sales, other general and administrative costs, as well as professional services costs, such as marketing, advertising, legal and accounting services, and allocated overhead costs that include facility and other related costs. The classification of shipping and handling costs for product sales as selling, general and administrative expenses varies from company to company with some companies recording these as selling, general and administrative expenses and others recording such expenses within costs of goods sold for products. To the extent the classification of its shipping and handling costs differs from the reporting approach used by other companies, the Company’s gross margins may not be comparable with those reported by such other companies.
Net Loss Per Share
Basic net loss per common share attributable to common stockholders is calculated by dividing the loss attributable to common stockholders by the weighted-average number of common shares outstanding. Diluted net loss per common share attributable to common stockholders is calculated under the treasury stock method by dividing the loss attributable to common stockholders by the diluted weighted-average number of common shares outstanding. Diluted weighted-average shares outstanding reflect the dilutive effect, if any, of potential common shares issued, such as unvested common stock, unvested restricted stock units (“RSUs”), common stock options, and shares estimated to be purchased under the Company’s employee stock purchase plan (“ESPP”). During periods when the Company is in a net loss position, these potential common shares are excluded from the diluted net loss per common share attributable to common stockholders because their effect would be anti-dilutive. Accordingly, basic and diluted net loss per common share attributable to common stockholders were the same for all periods presented.
Cash and Cash Equivalents
Cash and cash equivalents consist of cash deposits and short-term, highly liquid marketable securities that are readily convertible into cash, with original maturities of three months or less. Cash and cash equivalents consist of the following (in thousands):
As of December 31,
2023
2022
Cash
$
12,162
$
32,643
Money market funds
155,367
306,097
Marketable securities
6,893
—
Total cash and cash equivalents
$
174,422
$
338,740
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Table of Contents
Restricted Cash
The following table summarizes the period ending cash and cash equivalents as presented on the Consolidated Balance Sheets and the total cash, cash equivalents, and restricted cash as presented on the Consolidated Statements of Cash Flows (in thousands):
As of December 31,
2023
2022
Cash and cash equivalents
$
174,422
$
338,740
Restricted cash
2,604
2,597
Cash, cash equivalents, and restricted cash
$
177,026
$
341,337
Restricted cash consists of collateral for a letter of credit issued as security for two of the Company’s leased facilities and to secure the Company’s corporate credit card program. The short-term or long-term classification is determined in accordance with the expiration of the underlying letter of credit and security.
Marketable Securities
The Company’s current portfolio of marketable securities is entirely debt securities and may at any time include commercial paper, U.S. Treasuries, corporate notes and bonds, U.S. Government agency bonds, certificates of deposit, and similar types of debt securities. Marketable debt securities with original maturities of three months or less at the time of purchase are recorded in cash equivalents on the Consolidated Balance Sheets as they are considered highly liquid and readily convertible into cash. All other marketable securities, including those with maturities beyond one year, are recorded as current assets on the Consolidated Balance Sheets based on their highly liquid nature and because such securities are available for use in current operations.
The Company classifies its marketable securities as either held to maturity, available-for-sale, or trading at the time of purchase and re-evaluates such classification at each balance sheet date. All of the Company’s marketable securities are currently classified as available-for-sale as it may use them in current operations. Available-for-sale securities are recorded at fair value (refer to Note 6 − Fair Value of Financial Instruments ).
Unrealized gains and losses (other than impairment or credit related losses) are recorded in accumulated other comprehensive income (loss), a component of stockholders’ equity on the Consolidated Balance Sheets. Realized gains and losses are determined using the specific identification method and are recorded in other income (expense), net on the Consolidated Statements of Operations.
Quarterly, or more frequently if circumstances warrant, the Company monitors its marketable securities for impairment. In the event a security’s fair value is less than its amortized cost basis, the Company evaluates whether an impairment exists and if the impairment is a result of credit loss or other factors. For a security in an unrealized loss position, if the Company intends to sell the security in an unrealized loss position, or it is more likely than not that the Company will be required to sell the security before recovery of its amortized cost basis, an impairment loss equal to the difference between the security’s fair value and amortized cost basis is recorded in other income (expense), net. Additionally, the Company determines if a credit loss exists by considering information about the collectability of the security, current market conditions, and the issuer’s financial condition. If a decline in fair value is a result of a credit loss, an allowance for credit losses is recorded in other income (expense), net on the Consolidated Statement of Operations, limited to the portion attributed to the credit loss.
The Company has also elected the practical expedient to separately present accrued interest receivable from its marketable securities balance. Such accrued interest is recorded in prepaid expenses and other current assets on the Consolidated Balance Sheets and is not included in the assessment and measurement of impairment of its marketable securities.
Inventory
Inventory consists of instruments, assays, and the materials required to manufacture instruments and assays.
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Inventory is stated at the lower of cost or net realizable value on a first-in, first-out (“FIFO”) basis and includes the cost of materials, labor, and manufacturing overhead. The Company analyzes its inventory levels on each reporting date for slow-moving, excess, and obsolete inventory, and inventory expected to expire prior to being used. These analyses require judgment and are based on factors including, but not limited to, recent historical activity, anticipated or forecasted demand for the Company’s products (developed through its planning and sales and marketing inputs, and market conditions). If the Company identifies adverse conditions exist, the carrying value of the inventory is reduced to its estimated net realizable value by providing estimated reserves for excess or obsolete inventory.
The Company adjusts the reserves for excess or obsolete inventory and records additional inventory write downs based on unfavorable changes in estimated customer demand or actual market conditions that may differ from its projections.
Property and Equipment
Property and equipment, including leasehold improvements, are stated at cost, net of accumulated depreciation. These assets are depreciated over their estimated useful lives using the straight-line method. Expenditures for maintenance and repairs are charged to expense as incurred, whereas significant expenditures that extend the useful lives of existing assets are capitalized as additions to property and equipment.
Depreciation is calculated based upon the following estimated useful lives:
Estimated Useful Life
Laboratory and manufacturing equipment
5 Years
Office furniture and equipment
7 Years
Computers and software
3 Years
Leasehold improvements
Shorter of asset's life or remaining lease term
Leases
The Company enters into operating leases for office, laboratory, and manufacturing spaces, as well as office equipment, and determines whether an arrangement is a lease at inception of the arrangement. The Company accounts for a lease when it has the right to control the leased asset for a period of time, while obtaining substantially all of the assets’ economic benefits. Leases are recorded on the Consolidated Balance Sheets as operating lease right-of-use (“ROU”) assets and current or non-current operating lease liabilities, as applicable. All of the Company’s leases are classified as operating leases. Additionally, the Company does not separate lease and non-lease components.
Operating lease ROU assets and lease liabilities are recognized at the lease commencement date based on the estimated present value of the future minimum lease payments over the lease term and any initial direct costs incurred. Initial direct costs are incremental costs of a lease that would not have been incurred had the lease not been executed. The discount rate used to determine the present value of the lease payments is the Company’s incremental borrowing rate on a collateralized basis for a similar term and amount, as generally an implicit rate in the lease is not readily determinable. 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 an agency-based credit rating.
The Company’s lease agreements can contain lease and non-lease components. The Company accounts for the lease and fixed payments for non-lease components as a single lease component under ASC 842– Leases , which increases the amount of the ROU assets and lease liabilities. Most of the Company’s lease agreements also contain variable payments, primarily maintenance, utility, and other-related costs, which are expensed as incurred and not included in the measurement of the ROU assets and lease liabilities.
Some of the Company’s leases contain options to extend or terminate the lease. When determining the lease term, these options are included in the measurement and recognition of the Company’s ROU assets and lease liabilities when it is reasonably certain that the Company will exercise the option(s). The Company considers various economic factors when making this determination, including, but not limited to, the significance of leasehold improvements incurred in the leased space, the difficulty in replacing the asset, underlying contractual obligations, and specific characteristics unique to a particular lease. Subsequent to
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entering into a lease arrangement, the Company reassesses the certainty of exercising options to extend or terminate a lease. When it becomes reasonably certain that the Company will exercise an option that was not included in the lease term, the Company accounts for the change in circumstances as a lease modification, which results in the remeasurement of the ROU asset and lease liability as of the modification date.
Leases with a term of 12 months or less upon commencement are not recorded on the Consolidated Balance Sheets and are recorded to expense on a straight-line basis over the lease term.
Impairment of Goodwill
The Company assesses goodwill for impairment at the reporting unit level annually and whenever events occur or circumstances change that would more likely than not reduce the fair value of a reporting unit below its carrying amount. Such events or circumstances could include the occurrence of operating losses, a significant decline in earnings, or significant changes in or restructuring of the business. The impairment test is first performed at the reporting unit level using a qualitative assessment to determine whether it is more likely than not that the fair value of the reporting unit is less than the carrying value. If the reporting unit does not pass the qualitative assessment, the reporting unit’s carrying value is compared to its fair value, using estimates including forecasts of discounted future cash flows and peer market multiples. An impairment charge is recorded equal to the excess of the reporting unit’s carrying value over its fair value.
Impairment of Long-Lived Assets
The Company’s long-lived assets consist of operating lease ROU assets, property and equipment, and intangible assets. The Company reviews the carrying amount of its long-lived assets for impairment whenever events or circumstances indicate that the estimated useful lives may warrant revision, or that the carrying amount of the assets may not be fully recoverable. To assess whether a long-lived asset or group of assets has been impaired, the estimated undiscounted and discounted future cash flows for the estimated remaining useful life or estimated lease term of the asset (or the primary asset in the asset group) are compared to their carrying values. Significant judgment is required to estimate future cash flows, including, but not limited to, the expected use of the asset (group), historical customer retention rates, technology roadmaps, customer awareness, trademark and trade name history, contractual provisions that could limit or extend an asset's useful life, market data, discount rates, potential sublease opportunities including rent and rent escalation rates, time to sublease, and free rent periods. To the extent that the future cash flows are less than the carrying value, the asset(s) are impaired and written down to its estimated fair value.
Software Development Costs
The Company develops and modifies software related to the operation of some of its instruments and internal use software supporting the Company’s operations. Certain costs incurred during the application development stage including external direct costs of services used in the development or internal personnel costs for employees directly associated with the development, are capitalized. The Company begins depreciating these costs over the life of the related asset upon completion of a working model or when it is ready for its intended use. Capitalized software development costs related to software owned or developed by the Company are recorded in property and equipment on the Consolidated Balance Sheets. Capitalized software development costs related to software hosted by a vendor (i.e. cloud computing) are recorded in prepaid expenses and other current assets, and other non-current assets on the Consolidated Balance Sheets.
Costs incurred during the preliminary project stage and post-configuration stages are expensed as incurred.
Fair Value of Financial Instruments
The carrying amount reflected in the Consolidated Balance Sheets for cash, restricted cash, accounts receivable, prepaid expenses and other current assets, accounts payable, accrued compensation and benefits, and accrued expenses and other current liabilities approximate their fair values due to their short-term nature.
Additionally, the Company has certain financial assets that are required to be measured at fair value on a recurring basis including cash equivalents and marketable securities. Pursuant to the accounting standards for fair value measurements, the fair values of these financial assets are classified as Level 1, 2, or 3 within the fair value hierarchy as follows:
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● Level 1: Observable inputs based on unadjusted quoted prices in active markets for identical assets.
● Level 2: Inputs, other than Level 1 inputs, that are observable either directly or indirectly, such as quoted prices for similar assets, quoted prices in markets that are not active, other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets.
● Level 3: Unobservable inputs for which there is little or no market data and such inputs are significant to the fair value of the assets. These inputs reflect the Company’s assumptions about the inputs that market participants would use in pricing the asset.
To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment.
Income Taxes
The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the Consolidated Financial Statements or tax returns. Deferred tax assets and liabilities are determined based on differences between the carrying amount and the tax basis of the assets and liabilities using the enacted tax rates in effect in the years in which the differences are expected to reverse. A valuation allowance against deferred tax assets is recorded if, based on the weight of the available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized.
The Company accounts for uncertain tax positions using a more likely than not threshold for recognizing uncertain tax positions, in accordance with ASC 740 – Income Taxes . The evaluation of uncertain tax positions is based on factors that include, but are not limited to, changes in tax law, the measurement of tax positions taken or expected to be taken in tax returns, the effective settlement of matters subject to audit, new audit activity, and changes in facts or circumstances related to a tax position. The Company evaluates uncertain tax positions on an ongoing basis and adjusts any liability recorded to reflect subsequent changes in the relevant facts surrounding the uncertain positions. Amounts recorded for uncertain tax positions, including interest and penalties, are recorded in income tax (expense) benefit on the Consolidated Statement of Operations.
Credit, Product, and Supplier Concentrations and Off-Balance-Sheet Risk
Financial instruments that potentially expose the Company to concentrations of credit risk primarily consist of cash, cash equivalents, marketable securities, and accounts receivable. The Company limits its risk exposure by having its cash, cash equivalents, and marketable securities held at large commercial banks.
Customers outside the United States represented 38 % and 41 % of the Company’s gross trade accounts receivable balance as of December 31, 2023 and 2022, respectively.
For the year ended December 31, 2023, one customer of approximately $ 14.0 million revenue accounted for greater than 10 % of the Company’s total revenue. For the year ended December 31, 2022, one customer of approximately $ 13.7 million revenue accounted for greater than 10 % of the Company’s total revenue. For the year ended December 31, 2021, no customer individually accounted for greater than 10 % of the Company’s total revenue.
The Company is also subject to supply chain risks related to outsourced manufacturing of its instruments. Although there are a limited number of manufacturers for its instruments, the Company believes that other suppliers could provide similar manufacturing on comparable terms. A change in suppliers, however, could cause a delay in manufacturing and a possible loss of sales, which would adversely affect operating results. In addition to outsourced manufacturing of its instruments, the Company also purchases antibodies through a number of different suppliers. Although a disruption in service from any one of its antibody suppliers is possible, the Company believes that it would be able to find an adequate supply from alternative suppliers.
Stock-Based Compensation
The Company measures and recognizes stock-based compensation expense by calculating the estimated fair value of stock options, RSUs, or purchase rights issued under the Company’s ESPP on the grant date. The Company generally issues new common
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shares upon exercise of options and vesting of RSUs. Awards granted by the Company are routine in nature including new hire, annual, and promotion grants.
The fair value of stock options and purchase rights under the ESPP is estimated using the Black-Scholes option-pricing model. The Black-Scholes model requires the Company to make assumptions about the expected or contractual term of the option or purchase right, the expected volatility, risk-free interest rates, and expected dividend yield. The Company estimates the expected term of options granted to employees utilizing historical exercise data. 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. During 2023, the expected volatility was based on the Company’s historical volatility. Prior to 2023, the expected volatility was estimated based on both the Company’s volatility and the average volatility for comparable publicly traded companies over a period equal to the expected term of the related stock-based awards. 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 term. The expected dividend yield is zero as the Company has never paid dividends and has no current plans to pay any dividends on common stock.
The fair value of RSUs is determined using the closing market price of the Company’s common stock on the grant date.
The Company recognizes stock-based compensation expense on a straight-line basis over the award’s requisite service period, which is the vesting period for stock options and RSUs, and the offering period for purchase rights under the ESPP. The Company recognizes forfeitures as they occur.
Advertising
The Company expenses the cost of advertising as incurred and records them in selling, general and administrative expense in the Consolidated Statements of Operations. Advertising expense was $ 0.3 million, $ 0.3 million, and $ 0.5 million for the years ended December 31, 2023, 2022, and 2021, respectively.
Recent Accounting Pronouncements
Recent Accounting Standards To Be Adopted
In June 2022, the FASB issued ASC Update No. 2022-03, Fair Value Measurement (Topic 820): Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions . This update clarifies the guidance in Topic 820 related to measuring the fair value of an equity security subject to contractual restrictions that prohibit the sale of an equity security, as well as introduces new disclosure requirements for these types of equity securities. The new standard will be effective for the Company on January 1, 2024. The adoption of this standard is not expected to have a material impact on the Company’s financial position or results of operations.
In November 2023, the FASB issued ASC Update No. 2023-07, Segment Reporting (Topic 280): Improvement to Reportable Segment Disclosures. This update enhances reportable segment disclosure requirements by requiring public entities to provide disclosures of significant segment expenses and other segment items, as well as disclosures about a reportable segment’s profit or loss and assets that are currently required annually in interim periods. The new standard will be effective for the Company’s annual financial statements for the period beginning on January 1, 2024. The adoption of this standard is not expected to have a material impact on the Company’s disclosures.
In December 2023, the FASB issued ASC Update No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This update enhances income tax disclosure requirements by requiring public entities to provide additional information in its tax rate reconciliation and additional disclosures about income taxes paid. The update is effective for annual periods beginning after December 15, 2024. Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance and the amendments in this update should be applied prospectively, but entities have the option to apply it retrospectively. The Company is currently evaluating the impact that the standard will have on its Consolidated Financial Statements.
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Note 3. Revenue and Related Matters
Revenue from Contracts with Customers
The Company’s customers primarily consist of entities engaged in the life sciences research that pursue the discovery and development of new drugs for a variety of neurologic, oncologic, cardiovascular, infectious disease, and other protein biomarkers associated with diseases. The Company’s customer base includes pharmaceutical, biotechnology, contract research organizations, academic, and government institutions.
Disaggregated Revenue
When disaggregating revenue, the Company considers all of the economic factors that may affect its revenues. The following tables disaggregate the Company’s revenue from contracts with customers by geography, based on the location products and services are consumed, and revenue type (in thousands):
Year Ended December 31, 2023
(in thousands)
North America
EMEA
Asia Pacific
Total
Product revenue:
Instruments
$
6,374
$
4,384
$
4,947
$
15,705
Consumable and other products
35,018
21,128
7,609
63,755
Total
$
41,392
$
25,512
$
12,556
$
79,460
Service revenue:
Service-type warranties
$
6,369
$
3,089
$
631
$
10,089
Research services
24,706
2,000
1,122
27,828
Other services
1,436
951
( 5 )
2,382
Total
$
32,511
$
6,040
$
1,748
$
40,299
Collaboration and license revenue:
1,380
—
—
1,380
Total
$
1,380
$
—
$
—
$
1,380
Year Ended December 31, 2022
(in thousands)
North America
EMEA
Asia Pacific
Total
Product revenue:
Instruments
$
9,254
$
8,362
$
7,388
$
25,004
Consumable and other products
25,894
14,514
4,396
44,804
Total
$
35,148
$
22,876
$
11,784
$
69,808
Service and other revenues:
Service-type warranties
$
5,581
$
2,779
$
480
$
8,840
Research services
22,493
1,013
147
23,653
Other services
1,144
722
136
2,002
Total
$
29,218
$
4,514
$
763
$
34,495
Collaboration and license revenue:
Total
$
274
$
323
$
52
$
649
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Year Ended December 31, 2021
(in thousands)
North America
EMEA
Asia Pacific
Total
Product revenue:
Instruments
$
12,138
$
8,178
$
5,657
$
25,973
Consumable and other products
34,997
16,122
3,970
55,089
Total
$
47,135
$
24,300
$
9,627
$
81,062
Service and other revenue:
Service-type warranties
$
4,334
$
2,039
$
255
$
6,628
Research services
12,101
2,600
124
14,825
Other services
1,372
695
109
2,176
Total
$
17,807
$
5,334
$
488
$
23,629
Collaboration and license revenue:
Total
$
360
$
288
$
—
$
648
UltraDx Product Sales Agreement
On May 26, 2022, the Company and UltraDx Limited (“UltraDx”), a company formed by ARCH Venture Partners (“ARCH”), entered into an agreement (the “UltraDx Agreement”). Under the UltraDx Agreement, the Company agreed to supply UltraDx with HD-X instruments (both fully assembled and disassembled), assays and assay components, and granted a co-exclusive license to manufacture, seek Chinese regulatory approval of (including performance of any necessary research and development activities), and commercialize, HD-X instruments assembled in China and related assays in the Chinese in vitro diagnostic (“IVD”) market. Refer to Note 16 − Related Party Transactions for a discussion of the related party relationships between Quanterix and these entities.
The Company determined that the instruments, components, and licenses formed a single, combined performance obligation. The consideration due to the Company included (1) cash proceeds of $ 1.9 million, which was received and recognized as revenue in the third quarter of 2022 when the instruments, components, and licenses were delivered to and paid for by UltraDx, and (2) contingent, non-cash consideration in the form of ordinary shares of UltraDx with a deemed fair value of $ 1.0 million. The issuance of the shares was contingent on UltraDx completing a preferred share financing under the terms and conditions in the UltraDx Agreement. Given the uncertainty of the completion of the preferred share financing, the Company concluded that the non-cash consideration related to the ordinary shares was variable consideration that was fully constrained at contract inception.
In the second quarter of 2023, UltraDx completed the qualified preferred share financing and issued to the Company one million ordinary shares. Refer to Note 6 − Fair Value of Financial Instruments for the Company’s disclosures related to determining the fair value of the shares received. Also refer to Note 19 − Variable Interest Entities for additional information on the Company’s investment in UltraDx as a result of the share issuance.
During the year ended December 31, 2023, the Company recognized $ 1.8 million of revenue from UltraDx, which includes the one-time revenue from the receipt of the UltraDx shares in the second quarter of 2023. During the year ended December 31, 2022, the Company recognized $ 1.9 million of revenue from UltraDx.
Eli Lilly and Company Service Revenue Agreements
On February 25, 2022, the Company entered into a Master Collaboration Agreement with Eli Lilly and Company (“Lilly”) establishing a framework for future projects focused on the development of Simoa immunoassays (the “Lilly Collaboration Agreement”). The Company also entered into a statement of work under the Lilly Collaboration Agreement to perform assay research and development services within the field of Alzheimer’s disease. In connection with the Lilly Collaboration Agreement, the Company received a non-refundable up-front payment of $ 5.0 million during the first quarter of 2022, which was recognized over a one-year period. In addition, under the statement of work, the Company receives $ 1.5 million per calendar quarter, which began in the first quarter of 2022. The statement of work automatically renews on a quarterly basis until Lilly provides a termination notice in accordance with the terms of the Lilly Collaboration Agreement. As of December 31, 2023, the Lilly Collaboration Agreement and the statement of work were still in effect.
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Concurrent with the execution of the Lilly Collaboration Agreement, the Company entered into a Technology License Agreement (the “Lilly License”) under which Lilly granted the Company a non-exclusive license to Lilly’s proprietary p-Tau 217 antibody technology for use in research use only products and services and future IVD applications within the field of Alzheimer’s disease. In consideration of the Lilly License, the Company paid an upfront fee, is required to make milestone payments based on the achievement of predetermined regulatory and commercial events, and will pay royalties on net sales of licensed products.
The Company recognized revenue from the Lilly Collaboration Agreement of $ 6.0 million during the year ended December 31, 2023, and $ 10.9 million during the year ended December 31, 2022.
Contract Assets
There were no contract assets as of December 31, 2023.
Deferred Revenue
During the years ended December 31, 2023 and 2022, the Company recognized $ 7.7 million and $ 5.5 million of revenue, respectively, related to its deferred revenue balance at January 1 of each such period.
Remaining Performance Obligations
As of December 31, 2023, the aggregate amount of transaction prices allocated to performance obligations that were not yet satisfied, or were partially satisfied, was $ 10.7 million. Of the performance obligations not yet satisfied or partially satisfied, $ 9.5 million is expected to be recognized as revenue in the next 12 months , with the remainder expected to be recognized thereafter. The $ 10.7 million primarily consists of amounts billed for undelivered services related to initial and extended service-type warranties and research services.
Costs to Obtain a Contract
Changes in costs to obtain a contract were as follows (in thousands):
2023
2022
2021
Balance at December 31 of prior year
$
377
$
440
$
248
Capitalization of costs to obtain a contract
528
1,387
905
Recognition of costs to obtain a contract
( 617 )
( 1,450 )
( 713 )
Balance at December 31
$
288
$
377
$
440
The Company evaluates potential impairment of these amounts at each balance sheet date, and no related impairments were recorded during the years ended December 31, 2023, 2022, and 2021, respectively.
Grant Revenue
All of the Company's grant revenue is generated within North America. Grant revenue for the years ended December 31, 2023, 2022, and 2021 was $ 1.2 million, $ 0.6 million, and $ 5.2 million, respectively.
NIH Grant
On September 21, 2022, the Company and the National Institutes of Health (the “NIH”), an agency of the U.S. Department of Health and Human Services, entered into a contract (the “NIH Grant”) with a total award value of $ 1.7 million. The NIH granted the Company funding in support of the development of certain point-of-care diagnostic technologies through collaborative efforts. Grant funding is to be used solely for activities related to the point-of-care diagnostic device development project and the contract period runs through August 2025. Receipt of the award value occurs throughout the term of the contract period and after the Company submits for reimbursement of activities related to the grant. As of December 31, 2023, the Company had received $ 0.6 million of the award value.
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During the year ended December 31, 2023, grant revenue recognized and research and development expenses incurred were $ 0.7 million a nd $ 0.6 million, respectively . During the year ended December 31, 2022, grant revenue recognized and research and development expenses incurred were not material.
ADDF Grant
On March 24, 2022, the Company and the Alzheimer’s Drug Discovery Foundation (the “ADDF”) entered into a contract (the “ADDF Grant”) with a total funding value of $ 2.3 million. The ADDF is a charitable venture philanthropy entity that granted the Company funding in support of certain activities for the development of an IVD test for early detection of Alzheimer's disease. The ADDF Grant restricts the Company’s use of the granted funds solely for activities related to the Company’s Alzheimer’s diagnostic test development project and the contract period runs through June 2024. Receipt of the contract funding was subject to achievement of pre-defined milestones, and as of December 31, 2023, the Company had received the total funding value of $ 2.3 million.
During the year ended December 31, 2023, grant revenue recognized and research and development expenses incurred was $ 0.5 million a nd $ 0.5 million, respectively . During the year ended December 31, 2022, grant revenue recognized and research and development expenses incurred was $ 0.6 million and $ 0.6 million, respectively. As of December 31, 2023, the Company had $ 1.1 million of deferred revenue related to the ADDF Grant.
RADx Grant
On September 29, 2020, the Company entered into a contract with the NIH under its Rapid Acceleration of Diagnostics (“RADx”) program (the “RADx Grant”), with a total award value of $ 18.2 million. The RADx Grant was to accelerate the continued development, scale-up, and deployment of the novel SARS-CoV-2 antigen detection test using the Company’s Simoa technology. Grant funding was used to expand assay kit manufacturing capacity and commercial deployment readiness, and the contract ran through the final milestone on May 31, 2022. Receipt of the award value occurred throughout the term of the contract period and after the Company submitted for reimbursement of activities related to the grant. During the first half of 2022, the Company received $ 0.5 million which represented the final and total funding value of the $ 18.2 million award.
During the years ended December 31, 2023 and 2022, the Company recognized no grant revenue and incurred no research and development expenses. 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 expenses. As of December 31, 2023, the Company had no future obligations under the RADx Grant.
Note 4. Allowance for Credit Losses
The change in the allowance for credit losses on accounts receivable is summarized as follows (in thousands):
2023
2022
2021
Balance at December 31 of prior year
$
118
$
419
$
370
Provision for expected credit losses
729
752
213
Write-offs and recoveries collected
( 393 )
( 1,053 )
( 164 )
Balance at December 31
$
454
$
118
$
419
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Note 5. Marketable Securities
The amortized cost, gross unrealized gains, gross unrealized losses, and fair value of the Company’s marketable securities by major security type were as follows (in thousands):
As of December 31, 2023
Amortized cost
Unrealized Gains
Unrealized Losses
Fair Value
Commercial paper
$
53,482
$
23
$
( 12 )
$
53,493
U.S. Treasuries
4,896
1
—
4,897
U.S. Government agency bonds
28,366
39
( 7 )
28,398
Corporate bonds
66,726
289
( 8 )
67,007
Total marketable securities
$
153,470
$
352
$
( 27 )
$
153,795
Marketable securities are reported in the following Consolidated Balance Sheets captions:
Cash and cash equivalents
$
6,893
Marketable securities
146,902
Total marketable securities
$
153,795
The Company did no t have any marketable securities as of December 31, 2022.
The following table shows the fair value and gross unrealized losses of the Company’s available-for-sale securities with unrealized losses that are not deemed to be other-than-temporary, aggregated by major security type and length of time that the individual securities have been in a continuous unrealized loss position (in thousands):
Less Than 12 Months
As of December 31, 2023
Fair Value
Unrealized Losses
Commercial paper
$
32,137
$
( 12 )
U.S. Government agency bonds
15,861
( 7 )
Corporate bonds
8,367
( 8 )
Total
$
56,365
$
( 27 )
The Company did not have any individual securities in a continuous loss position for greater than 12 months, and there were no individual securities that were in a significant unrealized loss position as of December 31, 2023. For marketable securities in an unrealized loss position, the Company does not intend to sell them before recovery of their amortized cost bases, it is not more likely than not that the Company will be required to sell them before recovery of their amortized cost bases, and the unrealized losses are not credit related. Accordingly, the Company has not recorded any impairment losses or a credit loss allowance.
The Company did not sell any marketable securities or record any realized gains or losses for the year ended December 31, 2023. At December 31, 2023, the Company had $ 1.0 million of accrued interest receivable on its marketable securities.
The following table summarizes the contractual maturities of the Company’s marketable securities (in thousands):
As of December 31, 2023
Amortized cost
Fair Value
Due within one year
$
95,188
$
95,232
Due in one to two years
58,282
58,563
Total
$
153,470
$
153,795
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Note 6. Fair Value of Financial Instruments
Recurring Fair Value Measurements
The following tables present the Company’s fair value hierarchy for its financial assets that are measured at fair value on a recurring basis (in thousands):
As of December 31, 2023
Total
Level 1
Level 2
Level 3
Financial assets:
Cash equivalents: (1)
Money market funds
$
155,367
$
155,367
$
—
$
—
Commercial paper
1,996
—
1,996
—
U.S. Treasuries
4,897
—
4,897
—
Total cash equivalents
162,260
155,367
6,893
—
Marketable securities: (2)
Commercial paper
51,498
—
51,498
—
U.S. Treasuries
—
—
—
—
U.S. Government agency bonds
28,398
—
28,398
—
Corporate bonds
67,006
—
67,006
—
Total marketable securities
146,902
—
146,902
—
Total financial assets
$
309,162
$
155,367
$
153,795
$
—
As of December 31, 2022
Total
Level 1
Level 2
Level 3
Financial assets:
Money market funds (1)
$
306,097
$
306,097
$
—
$
—
Total financial assets
$
306,097
$
306,097
$
—
$
—
(1) Included in cash and cash equivalents on the Consolidated Balance Sheets.
(2) Marketable securities are initially valued at their purchase price and subsequently fair valued at the end of each reporting period utilizing third party pricing services or other observable data. The pricing services utilize industry standard valuation methods, including both income and market-based approaches and observable market inputs to determine the fair value. These observable market inputs include reportable trades, benchmark yields, credit spreads, broker/dealer quotes, bids, offers, current spot rates, and other industry and economic events.
Nonrecurring Fair Value Measurements
The Company has several non-marketable equity investments in entities that are evaluated under the VIE guidance (refer to Note 19 - Variable Interest Entities for further discussion). Pursuant to ASC 321 – Investments – Equity Securities , the Company uses the measurement alternative for equity investments without readily determinable fair values and recognizes its non-marketable equity investments at cost, less any impairment, and adjusted for any observable price changes in orderly transactions.
On June 26, 2023, the Company received ordinary shares in UltraDx (refer to Note 3 − Revenue and Related Matters ) which were valued at $ 1.0 million upon receipt, primarily using the third-party purchase price of similar interests issued during UltraDx’s financing event that closed in the second quarter of 2023. As UltraDx is a recently formed, privately held entity, there was minimal market activity or other financial information available to determine the fair value of UltraDx’s shares and therefore this investment is considered a Level 3 financial asset. Changes in the inputs and assumptions used to determine the fair value would have resulted in a higher or lower fair value measurement.
During the year ended December 31, 2023, the Company recorded $ 0.5 million in adjustments to the fair value of its non-marketable equity investments. As of December 31, 2023 and December 31, 2022, the carrying value of the Company’s Level 3 financial assets was $ 0.8 million and $ 0.3 million, respectively, and is included in other non-current assets on the Consolidated Balance Sheets.
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Table of Contents
Other Fair Value Disclosures
During the years ended December 31, 2023 and 2022, the Company did not transfer financial assets between levels of the fair value hierarchy. Additionally, there have been no changes to the valuation techniques for Level 2 or Level 3 financial assets.
Note 7. Inventory
Inventory, net of inventory reserves, consisted of the following (in thousands):
As of December 31,
2023
2022
Raw materials
$
5,114
$
5,509
Work in process
4,466
3,362
Finished goods
12,785
7,915
Total inventory
$
22,365
$
16,786
Note 8. Property and Equipment
Property and equipment consisted of the following (in thousands):
As of December 31,
2023
2022
Laboratory and manufacturing equipment
$
13,141
$
11,806
Office furniture and equipment
1,905
1,798
Computers and software
3,927
3,831
Leasehold improvements
13,074
13,688
Total cost
$
32,047
$
31,123
Less: accumulated depreciation
( 14,121 )
( 10,961 )
Property and equipment, net
$
17,926
$
20,162
The Company incurred depreciation expense of $ 4.7 million, $ 3.5 million, and $ 2.8 million for the years ended December 31, 2023, 2022, and 2021, respectively. Substantially all of the Company’s property and equipment is located in North America.
During the year ended December 31, 2023, the Company had $0.8 million of disposals related to equipment no longer being used by the Company. There were no material disposals during the years ended December 31, 2022, and 2021.
For the years ended December 31, 2023, and 2022, the Company recorded impairments related to leasehold improvements associated with two leased facilities not being used. Refer to Note 14 − Leases for further discussion. There were no material impairments relating to property and equipment during the year ended December 31, 2021.
As of December 31, 2023, the Company capitalized $ 1.1 million of software development costs, all of which are included in the computers and software category above. Amounts capitalized as of December 31, 2022 and 2021 were no t material. Depreciation of capitalized software costs for the years ended December 31, 2023, 2022, and 2021 was no t material.
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Note 9. Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following (in thousands):
As of December 31,
2023
2022
Accrued professional services
$
1,596
$
1,409
Accrued royalties
1,689
815
Accrued tax liabilities
808
172
Other accrued expenses
1,948
2,737
Total accrued expenses and other current liabilities
$
6,041
$
5,133
Note 10. Stock-Based Compensation
Stock-Based Compensation Plans
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, RSUs, and other stock-based awards. As of December 31, 2017, the 2017 Plan allowed for the issuance of (1) up to 1.0 million shares of common stock and (2) up to 2.5 million shares of common stock represented by awards granted under the 2007 Stock Option and Grant Plan (which was terminated upon completion of the Company’s initial public offering) that were forfeited, expired, or 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. The 2017 Plan contains an “evergreen” provision, which allows for an annual increase in the number of shares of common stock available for issuance under the 2017 Plan on the first day of each fiscal year during the period beginning in 2019 and ending in 2027. The annual increase is equal to the lowest of (1) 4 % of the number of shares of common stock outstanding as of such date and (2) an amount determined by the Company’s Board of Directors or Compensation Committee. As of December 31, 2023, 4.0 million shares were outstanding and there were 2.0 million shares available for grant under the 2017 Plan.
In December 2017, the Company adopted the 2017 Employee Stock Purchase Plan (the “2017 ESPP”). As of December 31, 2019, the 2017 ESPP allowed for the issuance of up to 0.6 million shares of common stock. The 2017 ESPP contains an “evergreen” provision, which allows for an increase in the number of shares under the plan on the first day of each fiscal year beginning with 2018 and ending in 2027. The increase is equal to the lowest of: (1) 1 % of the number of shares of common stock outstanding on the last day of the immediately preceding fiscal year and (2) an amount determined by the Company’s Board of Directors or Compensation Committee. As of December 31, 2023, 1.7 million shares were available for grant under the 2017 ESPP.
The 2017 ESPP provides for six-month offering periods commencing and ending on March 1 through August 31, and September 1 through February 28. During the years ended December 31, 2023, 2022, and 2021, employees purchased 121 thousand, 57 thousand, and 29 thousand shares, respectively, of the Company’s common stock pursuant to the 2017 ESPP.
Stock Options
Under the 2017 Plan, stock options may not be granted with exercise prices of less than fair market value on the date of the grant. Options generally vest ratably over a four-year period with 25 % vesting on the first anniversary and the remaining 75 % vesting ratably on a monthly basis over the remaining three years . These options expire ten years after the grant date.
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Stock option activity for the year ended December 31, 2023 is presented below (in thousands, except per share and contractual life amounts):
Weighted-average
Weighted-average remaining contractual
Aggregate
Number of options
exercise price per share
life (in years)
intrinsic value
Outstanding at December 31, 2022
2,188
$
20.69
8.1
$
4,273
Granted
1,187
16.23
Exercised
( 161 )
11.77
Forfeited/expired
( 440 )
18.65
Outstanding at December 31, 2023
2,774
$
19.62
7.9
$
26,941
Exercisable at December 31, 2023
1,117
$
22.81
6.4
$
9,176
Vested and expected to vest at December 31, 2023
2,774
$
19.62
7.9
$
26,941
The total intrinsic value of stock options exercised was $ 1.9 million in 2023, $ 3.4 million in 2022, and $ 24.3 million in 2021.
Restricted Stock Units
RSUs represent the right to receive shares of common stock upon meeting specified vesting requirements. Shares are delivered to the grantee upon vesting, less shares for the payment of withholding taxes. RSU activity for the year ended December 31, 2023 is presented below (in thousands, except per share amounts):
Weighted-average grant
Number of shares
date fair value per share
Unvested as of December 31, 2022
1,188
$
21.18
Granted
868
15.90
Vested
( 453 )
23.00
Forfeited
( 275 )
17.50
Unvested as of December 31, 2023
1,328
$
17.87
Expected to convert at December 31, 2023
1,328
$
17.87
The weighted average grant-date fair value per share of awards granted was $ 15.90 in 2023, $ 18.32 in 2022, and $ 58.20 in 2021.The total fair value of shares that vested was $ 10.4 million in 2023, $ 9.8 million in 2022 and $ 7.3 million in 2021.
Stock-Based Compensation Expense
Stock-based compensation expense was recorded in the following categories on the Consolidated Statements of Operations (in thousands):
Year Ended December 31,
2023
2022
2021
Cost of product revenue
$
826
$
608
$
471
Cost of service and other revenue
1,124
819
403
Research and development
1,704
1,639
1,807
Selling, general and administrative
13,110
12,376
13,294
Total stock-based compensation
$
16,764
$
15,442
$
15,975
As of December 31, 2023, there was $ 35.4 million of total unrecognized stock-based compensation expense related to unvested RSUs and stock options, which is expected to be recognized over the remaining weighted-average vesting period of 2.7 years.
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The fair value of the Company’s stock options granted and purchase rights to the ESPP were estimated using the Black-Scholes valuation model with the following assumptions:
Year Ended December 31,
2023
2022
2021
Stock Options:
Risk-free interest rate
3.5 % - 4.7 %
1.4 % - 4.1 %
0.4 % - 1.3 %
Expected dividend yield
None
None
None
Expected term (in years)
5.0 - 5.2
5.0 - 5.8
6.0
Expected volatility
71.1 % - 83.1 %
55.0 % - 70.8 %
49.2 % - 55.6 %
Weighted-average grant date fair value per share
$
10.63
$
9.88
$
29.96
Employee Stock Purchase Plan:
Risk-free interest rate
5.2 % - 5.5 %
0.7 % - 3.9 %
0.1 %
Expected dividend yield
None
None
None
Expected term (in years)
0.5
0.5
0.5
Expected volatility
72.8 % - 82.5 %
51.9 % - 117.3 %
46.3 % - 59.8 %
Weighted-average grant date fair value per share
$
3.19
$
3.53
$
8.06
Note 11. Net Loss Per Share
The following table presents the computation of basic and diluted net loss per share (in thousands, except per share data):
Year Ended December 31,
2023
2022
2021
Numerator:
Net loss
$
( 32,334 )
$
( 96,700 )
$
( 57,688 )
Denominator:
Weighted average common shares outstanding, basic and diluted
37,594
36,991
35,997
Net loss per share, basic and diluted
$
( 0.86 )
$
( 2.61 )
$
( 1.60 )
As the Company was in a net loss position, the following common share equivalents (calculated on a weighted average basis) were excluded from the calculation of diluted net loss per share (in thousands):
Year Ended December 31,
2023
2022
2021
Stock options
2,783
446
2,305
Common stock and RSUs
1,512
702
531
Estimated ESPP purchases
23
52
8
Total dilutive shares
4,318
1,200
2,844
Note 12. Income Taxes
The following table presents the components of loss before income taxes (in thousands):
Year Ended December 31,
2023
2022
2021
United States
$
( 34,337 )
$
( 89,590 )
$
( 56,554 )
Foreign
2,722
( 7,045 )
( 1,170 )
Total loss before income taxes
$
( 31,615 )
$
( 96,635 )
$
( 57,724 )
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The following table summarizes income tax (expense) benefit (in thousands):
Year Ended December 31,
2023
2022
2021
Current:
United States
Federal
$
—
$
—
$
—
State
( 161 )
( 77 )
( 30 )
Foreign
( 850 )
( 368 )
( 342 )
Total current income tax provision
( 1,011 )
( 445 )
( 372 )
Deferred
United States
Federal
—
10
5
State
—
13
( 6 )
Foreign
292
357
409
Total deferred income tax benefit
292
380
408
Total income tax (expense) benefit
$
( 719 )
$
( 65 )
$
36
A reconciliation of the federal statutory income tax rate to the effective tax rate is as follows:
Year Ended December 31,
2023
2022
2021
Federal statutory income tax rate
21.0
%
21.0
%
21.0
%
Non-deductible executive compensation
( 2.3 )
%
( 0.1 )
%
( 1.6 )
%
State taxes, net of federal benefit
0.8
%
2.7
%
6.5
%
Tax credits
4.3
%
1.4
%
2.0
%
Stock-based compensation
( 1.3 )
%
( 2.5 )
%
7.4
%
Permanent items
( 0.5 )
%
( 0.2 )
%
( 0.2 )
%
Deferred tax rate change
—
%
—
%
0.2
%
Change in valuation allowance
( 25.0 )
%
( 20.8 )
%
( 34.8 )
%
Impairment of goodwill
—
%
( 1.7 )
%
—
%
Other
0.7
%
—
%
( 0.4 )
%
Effective income tax rate
( 2.3 )
%
( 0.2 )
%
0.1
%
The effective income tax rate 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.
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Deferred tax assets and liabilities reflect the net tax effects of temporary differences between the carrying amount of assets and liabilities for financial reporting and the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets and liabilities were as follows (in thousands):
As of December 31,
2023
2022
Deferred tax assets:
Net operating loss carryforwards
$
78,812
$
78,191
Tax credits
8,758
7,407
Deferred revenue
2,523
2,385
Amortization
734
847
Stock-based compensation
3,217
2,773
Inventory
1,404
1,507
Capitalized R&D Costs
9,210
5,680
Lease liability
10,043
10,856
Other deferred tax assets
2,256
1,370
Total deferred tax assets
116,957
111,016
Less: valuation allowances
( 111,147 )
( 103,243 )
Net deferred tax assets
5,810
7,773
Deferred tax liabilities:
Right-of-Use Assets
( 4,414 )
( 5,219 )
Depreciation
( 1,319 )
( 2,244 )
Amortization acquired intangibles
( 1,254 )
( 1,570 )
Goodwill
—
—
Other deferred tax liabilities
—
( 209 )
Net deferred tax (liability) asset
$
( 1,177 )
$
( 1,469 )
The Company records deferred tax liabilities in other non-current liabilities on the Consolidated Balance Sheets.
The Company’s change in its valuation allowance account related to deferred tax assets was as follows (in thousands):
2023
2022
Balance at December 31 of prior year
$
103,243
$
83,121
Change in valuation allowance
7,904
20,122
Balance at December 31
$
111,147
$
103,243
The valuation allowance increased during the year ended December 31, 2023 primarily as a result of the U.S. operating losses incurred.
In determining the need for a valuation allowance, the Company considers the cumulative book income and loss positions of each of its entities as well as its worldwide cumulative loss position. The Company has assessed, on a jurisdictional basis, the available means of recovering deferred tax assets, including the ability to carryback net operating losses (“NOLs”), the existence of reversing taxable temporary differences, the availability of tax planning strategies, and forecasted future taxable income. At December 31, 2023, the Company maintained a full valuation allowance against its worldwide net deferred tax assets, as it concluded that it was more likely than not that the deferred assets will not be utilized.
As of December 31, 2023, the Company had U.S. federal net operating losses (“NOLs”) of approximately $ 313.4 million. U.S. federal NOLs generated through December 31, 2017 of approximately $ 108.5 million expire at various dates through 2037, and U.S. federal NOLs generated after December 31, 2017 of approximately $ 204.9 million do not expire. As of December 31, 2023, the Company had U.S. federal tax credit carryforwards of approximately $ 6.7 million that expire at various dates through 2043.
As of December 31, 2023, the Company had $ 214.9 million of state NOLs, approximately $ 204.3 million of which expire at various dates through 2042, and approximately $ 10.6 million of which do not expire. As of December 31, 2023, the Company had U.S. state tax credit carryforwards of approximately $ 2.6 million that expire at various dates through 2038.
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Table of Contents
Under Sections 382 and 383 of the U.S. Internal Revenue Code, if a corporation undergoes an ownership change, the corporation’s ability to use its pre-ownership change NOLs and other pre-ownership change tax attributes, such as research tax credits, to offset its post-change income and taxes may be limited. In general, an ownership change occurs if there is a cumulative change in an entity’s ownership by 5% stockholders that exceeds 50 percentage points over a rolling three-year period. Similar rules may apply under U.S. state tax laws. Under the 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. As a result, if the Company earns net taxable income, its ability to use its pre-ownership change NOLs, or other pre-ownership change tax attributes, to offset U.S. federal and state taxable income and taxes may be subject to significant limitations.
For the years ended December 31, 2023, 2022, and 2021, the Company had no tax reserves accrued for uncertain tax positions.
The Company is subject to taxation in the United States as well as the Netherlands, Sweden, and China. At December 31, 2023, the Company is generally no longer subject to examination by taxing authorities in the United States for years prior to 2020. However, NOLs and tax credits in the United States may be subject to adjustments by taxing authorities in future years in which they are utilized. The Company’s foreign subsidiaries remain open to examination by taxing authorities from 2018 onward.
As of December 31, 2023, the Company’s foreign subsidiaries had immaterial undistributed earnings and the tax payable on the earnings that are indefinitely reinvested would be immaterial.
Note 13. Goodwill and Intangible Assets
During the third quarter of 2022, the Company identified certain indicators of impairment, including the significant decline in the Company’s stock price, actions taken under the Restructuring Plan (Refer to Note 17 – Restructuring) , and a reduction of forecasted sales and profitability. As a result, the Company performed a goodwill impairment test and determined the carrying amount of the Company’s sole reporting unit exceeded its estimated fair value. The Company concluded that its entire goodwill balance was impaired and recognized an $ 8.2 million impairment charge during the third quarter of 2022. As of December 31, 2023 and December 31, 2022, the Company had no remaining goodwill balance.
Acquired intangible assets consisted of the following (in thousands, except useful life and weighted average life amounts):
As of December 31, 2023
Estimated
Cumulative
Useful
Gross Carrying
Accumulated
Translation
Net Carrying
Weighted Average
Life (in years)
Value
Amortization
Adjustment
Value
Life Remaining (in years)
Know-how
8.5
$
13,000
$
( 6,326 )
$
( 1,050 )
$
5,624
4.0
Developed technology
7
1,650
( 1,581 )
—
69
1.1
Customer relationships
8.5 - 10
1,360
( 1,067 )
( 9 )
284
4.1
Non-compete agreements
5.5
340
( 256 )
( 27 )
57
1.0
Trade names
3
50
( 50 )
—
—
—
Total
$
16,400
$
( 9,280 )
$
( 1,086 )
$
6,034
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Table of Contents
As of December 31, 2022
Estimated
Cumulative
Useful
Gross Carrying
Accumulated
Translation
Net Carrying
Weighted Average
Life (in years)
Value
Amortization
Adjustment
Value
Life Remaining (in years)
Know-how
8.5
$
13,000
$
( 4,763 )
$
( 1,433 )
$
6,804
5.0
Developed technology
7
1,650
( 1,458 )
—
192
2.1
Customer relationships
8.5 - 10
1,360
( 938 )
( 12 )
410
5.1
Non-compete agreements
5.5
340
( 193 )
( 37 )
110
2.0
Trade names
3
50
( 50 )
—
—
—
Total
$
16,400
$
( 7,402 )
$
( 1,482 )
$
7,516
The Company recorded amortization expense of $ 1.6 million, $ 1.8 million, and $ 2.0 million for the years ended December 31, 2023, 2022, and 2021, respectively. Amortization of know-how is recorded in cost of goods sold; amortization of developed technology is recorded in research and development expenses; and amortization of customer relationships, non-compete agreements and trade names are recorded in selling, general and administrative expenses on the Consolidated Statements of Operations.
Future estimated amortization expense is as follows (amounts in thousands):
As of December 31, 2023
2024
$
1,631
2025
1,493
2026
1,465
2027
1,443
2028
2
Thereafter
—
Total amortization expense
$
6,034
Note 14. Leases
As part of the Restructuring Plan in the third quarter of 2022 (refer to Note 17 − Restructuring ), the Company decided not to use two leased facilities in its operations and intends to sublease the vacant space to recover a portion of the total lease costs. The Company’s decision to not use the leased facilities triggered an impairment assessment and the related ROU assets and leasehold improvements became their own asset group. The impairment analysis evaluated the present value of net cash flows under the original lease and the estimated cash flows under estimated subleases to identify any impairment amount. The impairment assessment considered all industry and economic factors such as rental rates, interest rates, and recent real estate activities to estimate the net cash flows analysis and impairment amount. During 2023, the Company continued to reassess the remaining ROU assets and leasehold improvements associated with the leased facilities that remained vacant.
The above assessments resulted in the Company recording an impairment charge of $ 1.3 million and $ 16.3 million during the years ended December 31, 2023 and 2022, respectively, which was recorded in impairment and restructuring on the Consolidated Statements of Operations. For the years ended December 31, 2023 and 2022, impairment charges included $ 1.1 million and $ 12.0 million impairment of ROU assets, respectively. For the related leasehold improvements, during the year ended December 31, 2023, impairment charges were no t material and for the year ended December 31, 2022 impairment charges were $ 4.3 million. After recording impairments for the year ended December 31, 2023 and 2022, the carrying value of ROU assets and related leasehold improvements for facilities not being used were $ 10.1 million and $ 12.8 million, respectively.
There were no ROU asset or leasehold improvement impairments recorded in 2021.
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The components of the lease costs and supplemental cash flow information relating to the Company's leases were as follows (in thousands):
Year Ended December 31,
2023
2022
2021
Operating lease cost
$
5,209
$
5,488
$
2,726
Short-term and variable lease cost
3,996
3,417
2,699
Total lease cost
$
9,205
$
8,905
$
5,425
Year Ended December 31,
2023
2022
Cash paid for amounts included in the measurement of operating lease liabilities
$
8,935
$
6,539
Operating ROU assets obtained in exchange for lease obligations
$
—
$
22,494
Weighted average remaining lease term - operating leases (years)
6.8
7.8
Weighted average discount rate - operating leases
7.86 %
7.83 %
The undiscounted future lease payments for non-cancelable operating leases were as follows (in thousands):
Maturity of lease liabilities
As of December 31, 2023
2024
$
7,094
2025
7,254
2026
7,408
2027
7,641
2028
7,880
Thereafter
15,741
Total lease payments
$
53,018
Less: imputed interest
( 11,554 )
Total operating lease liabilities
$
41,464
Operating lease balances presented on the Consolidated Balance Sheets were as follows (in thousands):
As of December 31, 2023
Operating lease ROU assets
$
18,251
Operating lease liabilities
$
4,241
Operating lease liabilities, net of current portion
37,223
Total operating lease liabilities
$
41,464
Note 15. Commitments and Contingencies
Purchase Commitments
STRATEC
During 2022, the Company and STRATEC Consumables GmbH (“STRATEC”) entered into an amendment to the supply agreement with STRATEC (as amended, the “STRATEC Supply Agreement”), related to the supply of discs used in Simoa bead-based instruments. As part of the STRATEC Supply Agreement, the Company agreed to purchase a total of 515 thousand discs to be shipped at various points starting in 2022 and continuing through 2024 at an agreed purchase price per disc.
The total purchase commitment under the STRATEC Supply Agreement is $ 3.7 million, of which $ 2.1 million has been paid, and $ 1.0 million is due within one year from December 31, 2023.
In 2023 and 2022, STRATEC shipped 218 thousand and 75 thousand discs, respectively, to the Company. The Company recorded cost of product revenue related to these shipments of $ 1.6 million and $ 0.5 million for the years ended December 31, 2023 and 2022, respectively. During 2024, STRATEC is required to ship 222 thousand discs to the Company.
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Other Purchase Commitments
The Company’s other non-cancellable purchase commitments primarily consist of purchases of raw materials for manufacturing operations under annual and multi-year agreements, some of which have minimum quantity requirements. The Company’s total purchase commitments under these agreements as of December 31, 2023 was $ 3.1 million, most of which the Company expects to incur in the year ending December 31, 2024.
License Agreements
Harvard University
In August 2022, the Company and Harvard University (“Harvard”) entered into an exclusive license agreement (the “Harvard License Agreement”) for certain intellectual property owned by Harvard. Pursuant to the Harvard License Agreement, the Company paid an upfront fee of $ 0.6 million, which was recorded in research and development expenses on the Consolidated Statements of Operations. Under this license, the Company is required to pay Harvard low single-digit royalties on net sales of products and services using the licensed technology, as well as a portion of its applicable sublicense revenues. The Company incurred no royalty expense under the Harvard License Agreement for the years ended December 31, 2023 and 2022.
Refer to Note 16 − Related Party Transactions for a discussion of a related party relationship with Harvard.
Tufts University
In June 2007, the Company and Tufts University (“Tufts”) entered into a license agreement (the “Tufts License Agreement”) for certain intellectual property owned by Tufts. The Tufts License Agreement, which was subsequently amended, is exclusive and sub-licensable, and will continue in effect on a country by country basis as long as there is a valid claim of a licensed patent in a country. The Company is contractually obligated to pay license and maintenance fees that are creditable against royalties, in addition to low single-digit royalties on direct sales and services, and a royalty on sublicense income. The Company incurred royalty expenses related to the Tufts License Agreement of $ 1.7 million, $ 1.4 million, and $ 1.6 million, during the years ended December 31, 2023, 2022, and 2021, respectively, which was recorded in cost of product revenue on the Consolidated Statements of Operations.
Refer to Note 16 − Related Party Transactions for a discussion of a related party relationship with Tufts.
Legal Contingencies
The Company is subject to claims in the ordinary course of business; however, the Company is not currently a party to any pending or threatened litigation, the outcome of which would be expected to have a material adverse effect on its financial condition or results of operations. The Company accrues for contingent liabilities when losses are probable and estimable. If an estimate of a probable loss is a range and no amount within the range is more likely than any other amount in the range, the Company accrues the minimum amount of the range.
Note 16. Related Party Transactions
In June 2007, the Company entered into the Tufts License Agreement for certain intellectual property owned by Tufts (refer to Note 15 − Commitments and Contingencies ). A member of the Company’s Board of Directors was previously affiliated with Tufts. This Board member continues to receive compensation from Tufts on a formulaic basis based on royalties and license payments the Company makes to Tufts. At December 31, 2023 and 2022, open payable balances to Tufts were not material.
In August 2022, the Company entered into the Harvard License Agreement for certain intellectual property owned by Harvard (refer to Note 15 − Commitments and Contingencies ). Harvard is obligated to pay a portion of the payments received from the Company under the Harvard License Agreement to a member of the Company’s Board of Directors. A member of the Company’s Board of Directors is also affiliated with Harvard and Mass General Brigham. Revenue recorded from sales of products and services to Harvard and its affiliates and to Mass General Brigham and its affiliates totaled $ 1.3 million and $ 0.7 million for the years ended December 31, 2023 and 2022, respectively, and was not material for the year ended December 31, 2021. Cost of
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product revenue and operating expenses with Harvard and its affiliates and Mass General Brigham and its affiliates was $ 0.3 million for the year ended December 31, 2023, and was not material for the years ended December 31, 2022 and 2021. At December 31, 2023 and 2022, open payables to and receivable balances from Harvard and Mass General Brigham were not material.
As discussed in Note 3 − Revenue and Related Matters , on May 26, 2022, the Company and UltraDx, a company formed by ARCH, entered into the UltraDx Agreement to supply certain instruments and to grant certain licenses. At contract inception, the Company determined that UltraDx was a related party because a member of the Company’s Board of Directors was affiliated with ARCH and UltraDx. As of June 7, 2023, this individual was no longer a member of the Company’s Board of Directors. Cost of product revenue with UltraDx was $ 0.3 million for the year ended December 31, 2023 and $ 0.7 million for the year ended December 31, 2022. At December 31, 2023 and 2022, there were no open payable balances to UltraDx and open receivable balances from UltraDx were not material.
Note 17. Restructuring
Following a strategic review and assessment of the Company’s operations and cost structure, on August 8, 2022, the Company announced a plan of restructuring and strategic re-alignment plan (the “Restructuring Plan”). As part of the Restructuring Plan, the Company began an assay redevelopment program with the ultimate objective of improving its ability to manufacture and deliver high-quality assays at scale. The Restructuring Plan aligned the Company’s investments to best serve the needs of its customers, focused the Company’s innovation efforts on key platforms, and provided a foundation for the Company’s entry into translational pharma and clinical markets. In accordance with the Restructuring Plan, the Company implemented a workforce reduction, which was substantially completed by the end of the third quarter of 2022. The Restructuring Plan included the elimination of 119 positions and other cost-saving measures.
During the year ended December 31, 2022, the Company incurred approximately $ 3.8 million of expenses related to the Restructuring Plan, which represents the total amount expected to be incurred and the amount incurred to date. These costs were recorded in impairment and restructuring on the Consolidated Statements of Operations and were substantially for cash payments of severance and employee benefits, $ 3.5 million of which was paid by December 31, 2022.
As a result of the Restructuring Plan, the Company performed an impairment assessment of its goodwill, long-lived assets, including ROU assets and related leasehold improvements, and intangibles. The assessments resulted in the Company recording an impairment charge of $ 25.6 million during the year ended December 31, 2022, which was recorded in impairment and restructuring on the Consolidated Statements of Operations. The impairment charge included (1) $ 8.2 million of goodwill (refer to Note 13 − Goodwill and Intangible Assets ), (2) $ 16.3 million associated with the ROU assets and related leasehold improvements at two leased facilities not being used (refer to Note 14 − Leases ), and (3) $ 1.1 million for software costs related to projects that were rationalized as part of the Restructuring Plan or the related exit and disposal costs. During the year ended December 31, 2023, the Company recorded an additional impairment of $ 1.3 million associated with the ROU asset and related leasehold improvements at the leased facilities not being used (refer to Note 14 − Leases )
The following table presents the restructuring reserve and provision activity for the year ended December 31, 2023 (in thousands):
Severance and Employee Benefit Costs
Balance at December 31, 2022
$
328
Accrual adjustments
( 33 )
Cash payments
( 16 )
Foreign currency translation
8
Balance at December 31, 2023
$
287
The Company did not have any restructuring activities related to the Restructuring Plan during the year ended December 31, 2023.
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Note 18. Employee Benefit Plans
The Company sponsors a 401(k) savings plan for employees and may make discretionary contributions. During the years ended December 31, 2023, 2022, and 2021, the Company made contributions of $ 0.8 million, $ 1.2 million, and $ 1.1 million, respectively.
Note 19. Variable Interest Entities
The Company enters into relationships with, or has investments in, other entities that may be VIEs. The Company assesses the criteria in ASC 810 – Consolidation to determine if any of these entities meet the definition of a VIE and require consolidation into its financial statements. The Company’s analysis determines whether it has a controlling financial interest and also identifies the primary beneficiary of a VIE as the enterprise that has both (1) the power to direct activities of a VIE that most significantly impact the entity’s economic performance and (2) the obligation to absorb losses of, or the right to receive benefits from, the entity that could potentially be significant to that entity.
As discussed in Note 3 − Revenue and Related Matters , during the second quarter of 2023 the Company received one million ordinary shares of UltraDx under the UltraDx Agreement. Primarily due to having less than a 5 % ownership interest in UltraDx, the Company concluded that it does not have the power to direct activities impacting UltraDx’s economic performance and therefore the Company is not the primary beneficiary of the VIE.
Based on the Company’s assessments, it does not have any controlling financial interests in any VIEs, and therefore did not consolidate any VIEs into its Consolidated Financial Statements during the years ended December 31, 2023 and 2022. As of December 31, 2023 and 2022, the carrying value of the Company’s investments in VIEs was $ 0.8 million and $ 0.3 million, respectively, which were recorded in other non-current assets on the Consolidated Balance Sheets. Refer to Note 6 − Fair Value of Financial Instruments for the Company’s related valuation disclosures. Maximum exposure to losses related to these VIEs is limited to their carrying value and the Company does not have any future funding commitments to these VIEs.
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