What changed in this filing

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Item 1. Financial Statements

2024-05-08 compared with 2023-11-08 · 214 added, 331 removed, 298 unchanged (65% of the section changed)

3 unchanged sentences

(amounts in thousands, except per share data)

September 30, 2023

March 31, 2024

December 31, 2023

2 unchanged sentences

Marketable securities

Accounts receivable (net of allowance for expected credit losses of $ 429 and $ 118 as of September 30, 2023 and December 31, 2022, respectively)

Accounts receivable, net of allowance for expected credit losses

Prepaid expenses and other current assets

20 unchanged sentences

Common stock, $ 0.001 par value per share:

Authorized shares:

120,000 shares;

issued and outstanding:

37,839 and 37,280 shares at September 30, 2023 and December 31, 2022 , respectively

38,353 and 38,014 shares at March 31, 2024 and December 31, 2023 , respectively

Additional paid-in capital

7 unchanged sentences

(amounts in thousands, except per share data)

Three Months Ended September 30,

Nine Months Ended September 30,

Three Months Ended March 31,

Product revenue

Service revenue

Service and other revenue

Collaboration and license revenue

9 unchanged sentences

Other lease costs

Impairment and restructuring

Total operating expenses

Loss from operations

Interest income, net

Other income (expense), net

Interest income

Other income, net

Loss before income taxes

6 unchanged sentences

(amounts in thousands)

Three Months Ended September 30,

Nine Months Ended September 30,

Three Months Ended March 31,

Other comprehensive loss, net of tax:

1 unchanged sentence

Foreign currency translation

Total other comprehensive loss

Total other comprehensive income (loss)

Comprehensive loss

3 unchanged sentences

(amounts in thousands)

Three Months Ended September 30, 2023

Additional paid-in capital

Accumulated other comprehensive loss

Accumulated deficit

Total stockholders' equity

Balance at June 30, 2023

Issuance of common stock under stock plans, including tax effects

Stock-based compensation expense

Unrealized loss on marketable securities, net of tax

Foreign currency translation

Balance at September 30, 2023

Three Months Ended September 30, 2022

Additional paid-in capital

Accumulated other comprehensive loss

Accumulated deficit

Total stockholders' equity

Balance at June 30, 2022

Issuance of common stock under stock plans, including tax effects

Stock-based compensation expense

Foreign currency translation

Balance at September 30, 2022

Nine Months Ended September 30, 2023

Three Months Ended March 31, 2024

Additional paid-in capital

7 unchanged sentences

Foreign currency translation

Balance at September 30, 2023

Nine Months Ended September 30, 2022

Balance at March 31, 2024

Three Months Ended March 31, 2023

Additional paid-in capital

Accumulated other comprehensive loss

Accumulated other comprehensive income (loss)

Accumulated deficit

4 unchanged sentences

Foreign currency translation

Balance at September 30, 2022

Balance at March 31, 2023

The accompanying notes are an integral part of these Consolidated Financial Statements.

2 unchanged sentences

(amounts in thousands)

Nine Months Ended September 30,

Three Months Ended March 31,

Cash flows from operating activities:

2 unchanged sentences

Credit losses on accounts receivable

Foreign currency losses

Unrealized losses on marketable securities

Amortization of (discount) premium on marketable securities

Accretion of marketable securities

Operating lease right-of-use asset amortization

Stock-based compensation expense

Deferred income taxes

Loss on disposal of fixed assets

Other operating activity

Changes in assets and liabilities:

10 unchanged sentences

Purchases of marketable securities

Proceeds from maturities of marketable securities

Purchases of property and equipment

Proceeds from RADx grant on assets purchased

Net cash used in investing activities

9 unchanged sentences

Cash paid for taxes

Operating lease right-of-use assets obtained in exchange for lease liabilities

Shares received as consideration under product sales agreement (Note 3, 6)

Purchases of property and equipment in accounts payable and accrued expenses

The accompanying notes are an integral part of these Consolidated Financial Statements.

2 unchanged sentences

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 precision health for life sciences research and diagnostics.

The Company’s platforms are based on its proprietary digital “Simoa” detection technology.

The Company’s Simoa bead-based and planar array platforms enable customers to reliably detect protein biomarkers in extremely low concentrations in blood, serum, and other fluids that, in many cases, are undetectable using conventional, analog immunoassay technologies, and also allow researchers to define and validate the function of novel protein biomarkers that are only present in very low concentrations.

The Company is currently focusing on protein detection, but its Simoa platforms have also demonstrated applicability across other testing applications, including detection of nucleic acids and small molecules.

The Company also provides contract research services for customers and Laboratory Developed Test (“LDT”) services through its CLIA-certified Accelerator Laboratory (the “Accleerator 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.

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 Accelerator Laboratory provides customers with access to its Simoa technology and its Lucent Diagnostics clinical testing services (launched in July 2023) 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 2,300 projects for more than 480 customers from all over the world using its Simoa platforms.

1 unchanged sentence

Basis of Presentation

The Consolidated Financial Statements have been prepared in accordance with the generally accepted accounting principles in the United States of America (“U.S.

The accompanying Consolidated Financial Statements and Notes to Consolidated Financial Statements 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.

4 unchanged sentences

GAAP on an annual reporting basis.

Certain prior period amounts have been reclassified to conform to the current period presentation.

These Consolidated Financial Statements should be read in conjunction with the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the SEC on March 6, 2023.

Certain amounts in the prior years’ Consolidated Financial Statements have been reclassified to conform to the current year’s presentation.

These Consolidated Financial Statements should be read in conjunction with the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the SEC on February 29, 2024.

Since the date of that filing, there have been no changes or updates to the Company’s significant accounting policies, other than those described below.

In the opinion of management, the Consolidated Financial Statements contain all normal, recurring adjustments necessary for a fair statement of financial position, results of operations, comprehensive loss, and cash flows as of the dates and for the interim periods presented.

The results of operations for the three and nine months ended September 30, 2023 may not be indicative of the results for the full year ended December 31, 2023 or any other period.

The Company’s fiscal year is the twelve-month period from January 1 through December 31.

In the opinion of management, the Consolidated Financial Statements and Notes to Consolidated Financial Statements contain all normal, recurring adjustments necessary for a fair statement of financial position, results of operations, comprehensive loss, and cash flows as of the dates and for the interim periods presented.

The results of operations for the three months ended March 31, 2024 may not be indicative of the results for the full year ended December 31, 2024, or any other period.

The Company’s fiscal year is the twelve-month period from January 1 through December 31, and all references to “2024,” “2023,” and the like refer to the fiscal year unless otherwise noted.

Use of Estimates

The preparation of the Consolidated Financial Statements in conformity with U.S.

GAAP requires management to make estimates and assumptions that affect the amounts of assets, liabilities, revenues, and expenses reported and disclosures in the financial statements and accompanying notes.

Such estimates include, but are not limited to, revenue recognition, valuation of inventory, leases, valuation of intangible and other long-lived assets, recoverability of deferred

tax assets, ongoing impairment reviews, and stock-based compensation expense.

The Company bases its estimates on historical experience, known trends, market specific information, or other relevant factors it believes to be reasonable.

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 end of each fiscal period, and the reported amounts of revenues and expenses during each fiscal period.

Such estimates include, but are not limited to, revenue recognition, valuation of inventory, leases, valuation and impairment of intangible and 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 may differ from these estimates.

Actual results could differ from those estimates.

Principles of Consolidation

The Consolidated Financial Statements and Notes to 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 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 14 − Variable Interest Entities for further discussion.

Foreign Currency

3 unchanged sentences

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 nine months ended September 30, 2023, and were $ 0.8 million during the nine months ended September 30, 2022.

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 investment interests 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 16 − Variable Interest Entities for further discussion.

Presentation of Restricted Cash

Foreign currency transaction gains (losses) are included in other income, net on the Consolidated Statements of Operations and were not material for the three months ended March 31, 2024 and 2023.

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 September 30,

As of March 31,

Cash and cash equivalents

1 unchanged sentence

Cash, cash equivalents, and restricted cash

(1) Restricted cash consists of collateral for a letter of credit issued as security for several of the Company’s leased facilities and to secure the Company’s corporate credit card program.

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), net of tax, 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, limited to the portion attributed to the credit loss.

Recent Accounting Pronouncements

There are no new accounting pronouncements issued or effective in the current or future periods that are expected to have a material impact on the Company’s Consolidated Financial Statements or accompanying notes.

Recently Adopted Accounting Pronouncements

In June 2022, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No.

2022-03, Fair Value Measurement (Topic 820):

Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions (“ASU 2022-03”).

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 became effective for the Company on January 1, 2024.

The Company adopted this standard on a prospective basis and such adoption did not have a material impact on the Company’s Consolidated Financial Statements or related disclosures.

Recent Accounting Standards to be Adopted

In November 2023, the FASB issued ASU No.

2023-07, Segment Reporting (Topic 280):

Improvements to Reportable Segment Disclosures .

The new standard enhances the disclosures of reportable segment information, primarily with regards to significant segment expenses, and applies to entities with a single reportable segment.

The new standard is effective for the Company for annual periods beginning January 1, 2024, and for interim periods beginning January 1, 2025, with early adoption permitted.

Upon adoption, the guidance should be applied retrospectively to all prior periods presented in the financial statements.

The Company is currently evaluating the impact of adoption of the standard on its Consolidated Financial Statements disclosures.

In December 2023, the FASB issued ASU No.

2023-09, Income Taxes (Topic 740):

Improvements to Income Tax Disclosures .

The new standard enhances income tax disclosure requirements by requiring specified categories and greater disaggregation within the tax rate reconciliation table, disclosure of income taxes paid by jurisdiction, and providing clarification on uncertain tax positions and related financial statement impacts.

The new standard is effective for the Company for annual periods beginning January 1, 2025, with early adoption permitted.

The Company is currently evaluating the impact of adoption of the standard on its Consolidated Financial Statements disclosures.

Revenue and Related Matters

Revenue from Contracts with Customers

The Company’s customers primarily consist of entities engaged in 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

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):

Three Months Ended September 30, 2023

Three Months Ended September 30, 2022

North America

Product revenue

Consumable and other products

Service revenue

Service-type warranties

Research services

Other services

Collaboration and license revenue

Grant revenue

Total revenues

Nine Months Ended September 30, 2023

Nine Months Ended September 30, 2022

When disaggregating revenue, the Company considers all of the economic factors that may affect its revenues.

The following table disaggregates the Company’s revenue from contracts with customers by geography, based on the location products and services are consumed, and revenue type (in thousands):

Three Months Ended March 31, 2024

Three Months Ended March 31, 2023

North America

7 unchanged sentences

Collaboration and license revenue:

Grant revenue

Total revenues

For each of the three and nine months ended September 30, 2023, one customer accounted for more than 10 % of the Company’s total revenues.

At September 30, 2023, one customer accounted for more than 10 % of the Company’s gross accounts receivable.

Product Revenue

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 neurological in vitro diagnostic market.

Refer to Note 14 − 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 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 16 − Variable Interest Entities for additional information on the Company’s investment interests in UltraDx as a result of the share issuance.

During the three months ended September 30, 2023, revenue recognized was not material.

During the nine months ended September 30, 2023, the Company recognized $ 1.6 million of revenue, which includes the one-time revenue from the receipt of the UltraDx shares in the second quarter of 2023.

During the three and nine months ended September 30, 2022, the Company recognized $ 1.9 million of revenue.

Service Revenue

Eli Lilly and Company

For the three months ended March 31, 2024, no customer accounted for more than 10 % of the Company’s total revenues and for the three months ended March 31, 2023, one customer accounted for more than 10 % of the Company’s total revenues.

At March 31, 2024 and December 31, 2023, one customer accounted for more than 10 % of the Company’s gross accounts receivable.

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.

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 September 30, 2023, the Lilly Collaboration Agreement and the statement of work were still in effect.

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 pTau217 antibody technology for use in research use only products and services and future in vitro diagnostics applications within the field of Alzheimer’s disease.

As of March 31, 2024, the Lilly Collaboration Agreement and the statement of work were still in effect.

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 in vitro diagnostics (“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 $ 1.5 million and $ 4.5 million during the three and nine months ended September 30, 2023, respectively, and $ 2.7 million and $ 8.1 million during the three and nine months ended September 30, 2022, respectively.

Collaboration and License Revenue

Abbott Laboratories

On September 29, 2020, the Company and Abbott Laboratories (“Abbott”) entered into a Non-Exclusive License Agreement (the “Abbott License Agreement”) under which the Company granted Abbott a non-exclusive, worldwide, royalty-bearing license, without the right to sublicense, to the Company’s bead-based single molecule detection patent (the “Licensed Patents”) in the field of in vitro diagnostics.

Abbott paid the Company an initial license fee of $ 10.0 million, which was recognized as license revenue during 2020.

Abbott also agreed to pay the Company milestone fees, subject to the achievement by Abbott of certain development, regulatory, and commercialization milestones and low single-digit royalties on net sales of licensed products.

The Abbott License Agreement will continue until expiration of the last-to-expire licensed patent, or the agreement is earlier terminated.

Under the terms of the Abbott License Agreement, the Company and Abbott each have the right to terminate the agreement for uncured material breach by, or insolvency of, the other party.

Abbott may also terminate the Abbott License Agreement at any time, without cause, upon 60 days ’ notice.

During the three and nine months ended September 30, 2023, the Company recognized zero and $ 0.5 million of one-time revenue, respectively, related to the expiration of a previously paid for option to expand the scope of the Abbott License Agreement.

The Company recognized $ 1.5 million of revenue from the Lilly Collaboration Agreement during the three months ended March 31, 2024 and 2023.

Contract Assets

There were no contract assets as of March 31, 2024 or December 31, 2023.

Deferred Revenue

During the three months ended March 31, 2024 and 2023, the Company recognized $ 2.7 million and $ 2.4 million of revenue, respectively, related to its deferred revenue balance at January 1 of each such period.

Remaining Performance Obligations

As of March 31, 2024, the aggregate amount of transaction prices allocated to performance obligations that were not yet satisfied, or were partially satisfied, was $ 11.2 million.

Of this amount, $ 10.2 million is expected to be recognized as revenue in the next 12 months , with the remainder expected to be recognized thereafter.

The $ 11.2 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):

Balance at December 31 of prior year

Capitalization of costs to obtain a contract

Recognition of costs to obtain a contract

Balance at March 31

The Company evaluates potential impairment of these amounts at each balance sheet date, and no related impairments were recorded during the three months ended March 31, 2024 and 2023.

Grant Revenue

The Company recognizes grant revenue after funding is committed and as each grant’s related 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), as further described below.

All of the Company's grant revenue is generated within North America.

On September 21, 2022, the Company and the National Institutes of Health (the “NIH”), an agency of the U.S.

3 unchanged sentences

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 September 30, 2023, the Company had received $ 0.5 million of the award value.

During the three months ended September 30, 2023, grant revenue recognized and research and development expenses incurred were not material.

During the nine months ended September 30, 2023, grant revenue recognized and research and development expenses incurred were $ 0.5 million and $ 0.4 million, respectively.

During the three and nine months ended September 30, 2022, grant revenue recognized and research and development expenses incurred were not material.

As of March 31, 2024, the Company had received $ 0.8 million of the total award value.

During the three months ended March 31, 2024 and 2023, grant revenue recognized and research and development expenses incurred were not material.

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 in vitro diagnostic test for early detection of Alzheimer's disease.

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 September 30, 2023, the Company had received the total funding value of $ 2.3 million.

During the three and nine months ended September 30, 2023, grant revenue recognized and research and development expenses incurred were $ 0.3 million and $ 0.4 million, respectively.

During the three and nine months ended September 30, 2022, grant revenue recognized and research and development expenses incurred were $ 0.3 million and $ 0.4 million, respectively.

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 three and nine months ended September 30, 2023 and 2022, the Company recognized no grant revenue and incurred no research and development expenses.

As of September 30, 2023, the Company had no future obligations under the RADx Grant.

Contract Assets

There were no contract assets of as September 30, 2023 or December 31, 2022.

Deferred Revenue

The Company refers to contract liabilities as deferred revenue on the Consolidated Balance Sheets.

During the nine months ended September 30, 2023 and 2022, the Company recognized $ 6.4 million and $ 4.7 million of revenue, respectively, related to its deferred revenue balance at January 1 of each such period.

Remaining Performance Obligations

As of September 30, 2023, the aggregate amount of transaction prices allocated to performance obligations that have not yet been satisfied, or are partially satisfied, was $ 11.0 million.

Of the performance obligations not yet satisfied or partially satisfied, $ 9.8 million is expected to be recognized as revenue in the next 12 months , with the remainder expected to be recognized thereafter.

The $ 9.8 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

The Company capitalizes commissions paid to its sales representatives and related fringe benefits costs that are incremental to obtaining customer contracts.

These costs are included in prepaid expenses and other current assets on the Consolidated Balance Sheets.

Changes in costs to obtain a contract were as follows (in thousands):

Balance at December 31 of prior year

Deferral of costs to obtain a contract

Amortization of costs to obtain a contract

Balance at September 30

Costs to obtain a contract are amortized to earnings 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 evaluates potential impairment of these amounts at each balance sheet date, and no related impairments were recorded during the nine months ended September 30, 2023 and 2022.

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 three months ended March 31, 2024 and 2023 grant revenue recognized and research and development expenses incurred were not material.

As of March 31, 2024, the Company had $ 1.0 million of deferred revenue related to the ADDF Grant.

Allowance for Credit Losses

The Company is exposed to credit losses primarily through accounts receivable from sales of its products and services.

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

The change in the allowance for credit losses on accounts receivable is summarized as follows (in thousands):

The change in the allowance for expected credit losses on accounts receivable is summarized as follows (in thousands):

Balance at December 31 of prior year

1 unchanged sentence

Write-offs and recoveries collected

Balance at September 30

Balance at March 31

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 September 30, 2023

As of March 31, 2024

Amortized Cost

5 unchanged sentences

Total marketable securities

Marketable securities are reported in the following Consolidated Balance Sheets captions:

Marketable securities are recorded in the following Consolidated Balance Sheets captions:

Cash and cash equivalents

1 unchanged sentence

Total marketable securities

The Company did no t have any marketable securities as of December 31, 2022.

The following table shows the gross unrealized losses and fair value 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):

As of December 31, 2023

Amortized Cost

Unrealized Gains

Unrealized Losses

Commercial paper

Government agency bonds

Corporate bonds

Total marketable securities

Marketable securities are recorded in the following Consolidated Balance Sheets captions:

Cash and cash equivalents

Marketable securities

Total marketable securities

The following tables show 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 September 30, 2023

As of March 31, 2024

Unrealized Losses

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Corporate bonds

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 September 30, 2023.

Less Than 12 Months

As of December 31, 2023

Unrealized Losses

Commercial paper

Government agency bonds

Corporate bonds

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 three and nine months ended September 30, 2023.

At September 30, 2023, the Company had $ 0.4 million of accrued interest receivable on its marketable securities, which was recorded in prepaid expenses and other current assets on the Consolidated Balance Sheets.

The Company did not sell any marketable securities or record any realized gains or losses for the three months ended March 31, 2024.

At March 31, 2024 and December 31, 2023, the Company had $ 1.2 million and $ 1.0 million, respectively, of accrued interest receivable on its marketable securities, which was recorded in prepaid expenses and other current assets on the Consolidated Balance Sheets.

The following table summarizes the contractual maturities of the Company’s marketable securities (in thousands):

As of September 30, 2023

As of March 31, 2024

As of December 31, 2023

Amortized Cost

Due within one year

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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 September 30, 2023

As of March 31, 2024

Quoted prices in active markets (Level 1)

Significant other observable inputs (Level 2)

Significant other observable inputs

Significant unobservable inputs (Level 3)

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Money market funds

Commercial paper

Total cash equivalents

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Quoted prices in active markets (Level 1)

Significant other observable inputs (Level 2)

Significant other observable inputs

Significant unobservable inputs (Level 3)

Financial assets:

Cash equivalents:

Money market funds

Commercial paper

Total cash equivalents

Marketable securities:

Commercial paper

Government agency bonds

Corporate bonds

Total marketable securities

Total financial assets

(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.

Cash equivalents and marketable securities classified as Level 2 financial assets are initially valued at their purchase price and subsequently 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.

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Nonrecurring Fair Value Measurements

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 would have resulted in a higher or lower fair value measurement.

Pursuant to ASC 321 – Investments – Equity Securities , the Company has elected the measurement alternative for equity investments without readily determinable fair values and will continue to recognize the UltraDx shares at cost, less any impairment, and adjusted for any observable price changes in orderly transactions.

During the third quarter of 2023, the Company recorded an immaterial adjustment to the fair value of the UltraDx shares.

There were no other changes in the carrying value of these assets during the three and nine months ended September 30, 2023 and 2022.

As of September 30, 2023 and December 31, 2022, the carrying value of the Company’s Level 3 financial assets was $ 1.1 million and $ 0.3 million, respectively, and are included in other non-current assets on the Consolidated Balance Sheets.

Refer to Note 16 − Variable Interest Entities for further discussion.

The Company has a non-marketable equity investment in an entity that is evaluated under the VIE guidance (refer to Note 14 - 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 investment at cost, less any impairment, and adjusted for any observable price changes in orderly transactions.

The Company’s investment is classified as a Level 3 financial asset.

Changes in the inputs and assumptions used to determine the fair value would result in a higher or lower fair value measurement.

The Company’s non-marketable equity investment contains certain restrictions related to the sale or transfer of the securities.

The restrictions are in place indefinitely and cannot lapse.

No adjustment to the fair value was required as a result of adopting ASU 2022-03 on January 1, 2024.

During the three months ended March 31, 2024 and 2023, the Company did not record any fair value adjustments to its non-marketable equity investment and to date, the cumulative fair value adjustments have not been material.

As of March 31, 2024 and December 31, 2023, the carrying value of the non-marketable equity investment was $ 0.8 million, and is recorded in other non-current assets on the Consolidated Balance Sheets.

Other Fair Value Disclosures

During the nine months ended September 30, 2023 and 2022, the Company did not transfer financial assets between levels of the fair value hierarchy.

During the three months ended March 31, 2024 and 2023, 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.

Inventory, net of inventory reserves, consisted of the following (in thousands):

September 30, 2023

March 31, 2024

December 31, 2023

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Accrued expenses and other current liabilities consisted of the following (in thousands):

September 30, 2023

March 31, 2024

December 31, 2023

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Stock Options

Stock option activity for the nine months ended September 30, 2023 is presented below (in thousands, except per share and contractual life amounts):

Stock option activity for the three months ended March 31, 2024 is presented below (in thousands, except per share and contractual life amounts):

Weighted-average

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remaining contractual

Number of shares

Number of options

exercise price per share

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Outstanding at December 31, 2023

Outstanding at September 30, 2023

Exercisable at September 30, 2023

Vested and expected to vest at September 30, 2023

Forfeited/expired

Outstanding at March 31, 2024

Exercisable at March 31, 2024

Vested and expected to vest at March 31, 2024

Restricted Stock Units

Restricted stock unit (“RSU”) activity for the nine months ended September 30, 2023 is presented below (in thousands, except per share and contractual life amounts):

Weighted-average

Restricted stock unit (“RSU”) activity for the three months ended March 31, 2024 is presented below (in thousands, except per share amounts):

Weighted-average

grant date fair

remaining contractual

Number of shares

value per share

life (in years)

intrinsic value

Unvested RSUs at December 31, 2022

Unvested RSUs at September 30, 2023

Expected to convert at September 30, 2023

Unvested at December 31, 2023

Unvested at March 31, 2024

Employee Stock Purchase Plan (“ESPP”)

In December 2017, the Company adopted the 2017 Employee Stock Purchase Plan (the “2017 ESPP”).

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.

The increase is equal to the lower of:

(i) 1 % of the number of shares of common stock outstanding on the last day of the immediately preceding fiscal year and (ii) an amount determined by the Company’s Board of Directors or Compensation Committee.

On January 3, 2023, the number of shares of common stock available for issuance under the 2017 ESPP was increased by 372 thousand shares.

The 2017 ESPP provides for six-month offering periods commencing and ending as follows:

March 1 through August 31, and September 1 through February 28.

During the nine months ended September 30, 2023, employees purchased 121 thousand shares of the Company’s common stock pursuant to the 2017 ESPP.

During the three months ended March 31, 2024, employees purchased 36 thousand shares of the Company’s common stock pursuant to the 2017 ESPP.

Stock-Based Compensation Expense

Stock-based compensation expense was recorded in the following categories on the Consolidated Statements of Operations (in thousands):

Three Months Ended September 30,

Nine Months Ended September 30,

Three Months Ended March 31,

Cost of product revenue

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Selling, general and administrative

Total stock-based compensation

As of September 30, 2023, there was $ 37.4 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 2.8 years.

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:

Three Months Ended September 30,

Nine Months Ended September 30,

Stock Options:

Risk-free interest rate

4.0 % − 4.4 %

2.7 % − 3.9 %

3.5 % − 4.4 %

1.4 % − 3.9 %

Expected dividend yield

Expected term (in years)

Expected volatility

82.6 % − 83.1 %

62.6 % − 69.8 %

71.1 % − 83.1 %

55.0 % − 69.8 %

Weighted-average grant date fair value

Employee Stock Purchase Plan:

Risk-free interest rate

3.3 % - 3.9 %

5.2 % - 5.5 %

0.7 % - 3.9 %

Expected dividend yield

Expected term (in years)

Expected volatility

74.7 % − 78.5 %

115.3 % − 117.3 %

72.8 % − 82.5 %

51.9 % − 117.3 %

Weighted-average grant date fair value

Total stock-based compensation expense

As of March 31, 2024, there was $ 56.0 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 3.1 years.

Net Loss Per Share

The following table presents the computation of basic and diluted net loss per share (in thousands, except per share data):

Three Months Ended September 30,

Nine Months Ended September 30,

Weighted average common shares outstanding

Three Months Ended March 31,

Weighted average common shares outstanding, basic and diluted

Net loss per share, basic and diluted

In periods when the Company is in a net loss position, dilutive securities are excluded from the computation of diluted earnings per share because their inclusion would have an anti-dilutive effect.

Therefore, basic net loss per share is the same as diluted net loss per share.

The following common share equivalents have been excluded from the calculation of diluted net loss per share (in thousands):

Three Months Ended September 30,

Nine Months Ended September 30,

Common stock and RSUs

As the Company was in a net loss position for all periods listed in the table below, the following common share equivalents (calculated on a weighted average basis) were excluded from the calculation of diluted net loss per share (in thousands):

Three Months Ended March 31,

Stock options

Total anti-dilutive shares

The Company’s effective tax rates were ( 2.7 )% and ( 3.0 %)% for the three and nine months ended September 30, 2023, respectively, and 0.2 % and less than 0.1 % for the three and nine months ended September 30, 2022, respectively.

Common stock and RSUs

Estimated ESPP purchases

Total dilutive shares

The Company’s effective tax rates were ( 2.6 )% and ( 2.4 )% for the three months ended March 31, 2024 and 2023, respectively.

The income tax provision and effective tax rate is driven primarily by a valuation allowance in the United States, partially offset by income taxes in foreign jurisdictions.

The Company maintains a valuation allowance on the majority of its deferred tax assets, and it has concluded that it is more likely than not that the deferred assets will not be utilized.

During the third quarter of 2022, the Company identified certain indicators of impairment, including a significant decline in the Company’s stock price, actions taken under the Restructuring Plan (refer to Note 15 − Restructuring ), and a reduction of forecasted sales and profitability.

As a result, the Company performed a goodwill impairment test and determined its goodwill was impaired as 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 September 30, 2023 and December 31, 2022, the Company had no remaining goodwill balance.

Commitments and Contingencies

Purchase Commitments

During the year ended December 31, 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.

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.

In 2022, Stratec shipped 75 thousand discs to the Company.

In 2023, Stratec is required to ship no less than 220 thousand discs, 184 thousand of which have been shipped as of September 30, 2023.

The total purchase commitment under the Stratec Supply Agreement is $ 3.7 million.

The total purchase commitment under the STRATEC Supply Agreement is $ 3.7 million, of which $ 2.1 million has been paid, and $ 1.6 million is due within one year from March 31, 2024.

During the three months ended March 31, 2024 and 2023, STRATEC shipped 35 thousand and 75 thousand discs, respectively, to the Company.

The Company recorded cost of product revenue related to these shipments of $ 0.3 million and $ 0.5 million for the three months ended March 31, 2024 and 2023, respectively.

During 2024, STRATEC is

required to ship 222 thousand discs to the Company.

During the three months ended March 31, 2024, 35 thousand discs were shipped.

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 September 30, 2023 were $ 4.7 million.

As of March 31, 2024, the Company’s total purchase commitments under these agreements were $ 3.8 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 a 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 in August 2022, which was recorded in research and development expenses on the Consolidated Statements of Operations.

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 three and nine months ended September 30, 2023 and 2022.

The Company incurred no royalty expense under the Harvard License Agreement for the three months ended March 31, 2024 and 2023.

Refer to Note 13 − Related Party Transactions for a discussion of a related party relationship with Harvard.

2 unchanged sentences

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 $ 0.5 million and $ 1.3 million during the three and nine months ended September 30, 2023, respectively and $ 0.3 million and $ 1.1 million during the three and nine months ended September 30, 2022, respectively, which are recorded in cost of product revenue on the Consolidated Statements of Operations.

The Company is required 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 $ 0.5 million and $ 0.4 million during the three months ended March 31, 2024 and 2023, respectively, which was recorded in cost of product revenue on the Consolidated Statements of Operations.

Refer to Note 13 − Related Party Transactions for a discussion of a related party relationship with Tufts.

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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.

Operating lease obligations are recorded in operating lease liabilities and operating lease liabilities, net of current portion on the Consolidated Balance Sheets.

Future minimum lease payments under non-cancellable operating leases were as follows (in thousands):

The Company records 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 records the minimum amount of the range.

The undiscounted future lease payments for non-cancelable operating leases were as follows (in thousands):

Maturity of lease liabilities

As of September 30, 2023

As of March 31, 2024

2024 (remainder)

5 unchanged sentences

Related Party Transactions

In June 2007, the Company and Tufts entered into the Tufts License Agreement for certain intellectual property owned by Tufts (refer to Note 13 − 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 September 30, 2023 and December 31, 2022, open payable balances to Tufts were not material.

A member of the Company’s Board of Directors is 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 $ 0.3 million and $ 1.0 million for the three and nine months ended September 30, 2023, respectively.

Revenue recorded from sales of products and services was no t material for the three months ended September 30, 2022, and $ 0.5 million for the nine months ended September 30, 2022.

Additionally, in August 2022, the Company and Harvard entered into the Harvard License Agreement for certain intellectual property owned by Harvard (refer to Note 13 − 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.

Cost of product revenue and operating expenses with Harvard and its affiliates and Mass General Brigham and its affiliates for the three and nine months ended September 30, 2023 and 2022 were not material.

At September 30, 2023 and December 31, 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.

In June 2007, the Company entered into the Tufts License Agreement for certain intellectual property owned by Tufts (refer to Note 12 − Commitments and Contingencies ).

A member of the Company’s Board of Directors was previously affiliated with Tufts and continues to receive compensation from Tufts on a formulaic basis based on royalties and license payments the Company makes to Tufts.

At March 31, 2024 and December 31, 2023, 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 12 − Commitments and Contingencies ).

Harvard is required 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 was $ 0.3 million for both the three months ended March 31, 2024 and 2023.

Cost of product revenue and operating expenses with Harvard and Mass General Brigham were not material for the three months ended March 31, 2024 and 2023.

At March 31, 2024 and December 31, 2023, open payables to and receivable balances from Harvard and Mass General Brigham were not material.

In May 2022, the Company and UltraDx Limited (“UltraDx”), a company formed by ARCH Venture Partners (“ARCH”), entered into an agreement (the “UltraDx Agreement”).

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 goods sold for both the three and nine months ended September 30, 2023 were not material.

At September 30, 2023 and December 31, 2022, there were no open payable balances to UltraDx and open receivable balances from UltraDx were $ 0.4 million and zero , respectively.

Restructuring

Following a strategic review and assessment of the Company’s operations and cost structure, on August 8, 2022, the Company announced a 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 aligns the Company’s investments to best serve the needs of its customers, focuses the Company’s innovation efforts on key platforms, and provides a foundation for the Company’s entry into translational pharma and clinical markets, which it believes will be required to access new growth categories.

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 three and nine months ended September 30, 2022, the Company incurred approximately $ 3.4 million of expenses related to the Restructuring Plan, which were recorded in impairment and restructuring on the Consolidated Statements of Operations.

These expenses were substantially for cash payments of severance and employee benefits, $ 3.1 million of which was paid by September 30, 2022.

Total restructuring expenses incurred in 2022 under the Restructuring Plan were $ 3.8 million.

As a result of the Restructuring Plan, the Company performed an impairment assessment of its goodwill, long-lived assets, including operating lease right-of-use assets, and intangibles.

The assessments resulted in the Company recording an impairment charge of $ 16.9 million during the three and nine months ended September 30, 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 12 − Goodwill ), (2) $ 7.7 million associated with the operating lease right-of-use asset and related property and equipment at leased facilities no longer being utilized, and (3) $ 1.0 million for software costs related to projects that were rationalized as part of the Restructuring Plan.

During the nine months ended September 30, 2023, there were no material changes to the Restructuring Plan or the related exit and disposal costs.

The following table presents the restructuring reserve and provision activity for the nine months ended September 30, 2023 (in thousands):

Severance and Employee Benefit Costs

Balance at December 31, 2022

Accrual adjustments

Cash payments

Foreign currency translation

Balance at September 30, 2023

The Company did not have any restructuring activities or additional impairment charges related to the Restructuring Plan during the nine months ended September 30, 2023.

Revenue recorded from sales of products and services to UltraDx totaled $1.1 million for the three months ended March 31, 2024.

Cost of product revenue and services was not material for the three months ended March 31, 2024.

At March 31, 2024 there was $1.2 million in open receivable balances and no open payable balances to UltraDx.

Revenue and cost of product revenue and services for three months ended March 31, 2023 were not material.

At December 31, 2023, there were no open payable balances to UltraDx and open receivable balances from UltraDx were not material.

Variable Interest Entities

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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 three and nine months ended September 30, 2023 and 2022.

As of September 30, 2023 and December 31, 2022, the carrying value of the Company’s investment interests in VIEs was $ 1.1 million and $ 0.3 million, respectively, which are recorded in other non-current assets on the Consolidated Balance Sheets.

Based on the Company’s assessments, it does not have any controlling financial interests in any VIE, and therefore did not consolidate any VIE into its Consolidated Financial Statements during the three months ended March 31, 2024 and 2023.

As of March 31, 2024 and December 31, 2023, the carrying value of the Company’s investment in VIEs was $ 0.8 million, which was 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.

Maximum exposure to losses related to the VIE is limited to its carrying value and the Company does not have any future funding commitments to any VIE.

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

What changed 10-Q

Item 1. Financial Statements