UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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OR
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TQUANTERIX CORPORATION
INDEX TO FORM 10-Q
2
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements (within the meaning of the U.S. Private Securities Litigation Reform Act of 1995) that involve risks and uncertainties. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q are forward-looking statements. In some cases, forward-looking statements can be identified by words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “will,” “would,” or the negative of these words, or other comparable terminology. These forward-looking statements include, but are not limited to, statements related to our financial performance, and are subject to a number of risks, uncertainties, and assumptions, including those further described elsewhere in this Quarterly Report on Form 10-Q, in the section titled “Part I, Item 1A. Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 6, 2023, or in other filings that we make with the SEC. Moreover, we operate in a very competitive and rapidly changing environment, and new risks emerge from time to time. It is not possible for us to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties, and assumptions, the forward-looking events and circumstances discussed in this Quarterly Report on Form 10-Q may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.
Readers should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in any forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance, or events and circumstances reflected in forward-looking statements will be achieved or occur. We undertake no obligation to update publicly any forward-looking statements for any reason after the date of this Quarterly Report on Form 10-Q to conform these statements to new information, actual results, or to changes in our expectations, except as required by law.
Readers should read this Quarterly Report on Form 10-Q and any documents referenced herein that we have filed with the SEC as exhibits to this Quarterly Report on Form 10-Q with the understanding that our actual future results, levels of activity, performance, and events and circumstances may be materially different from what we expect.
Service Marks, Trademarks and Trade Names
Unless the context otherwise requires, the terms “Quanterix,” the “Company,” “we,” “it,” “us,” and “our” in this Quarterly Report on Form 10-Q refer to Quanterix Corporation and its consolidated subsidiaries. “Quanterix,” “Simoa,” “Simoa HD-X,” “Simoa HD-1,” “SR-X,” “SP-X,” “HD-X,” “LucentAD,” and our logo are our trademarks. All other service marks, trademarks, and trade names appearing in this Quarterly Report on Form 10-Q are the property of their respective owners. We do not intend our use or display of other companies’ trade names, trademarks, or service marks to imply a relationship with, endorsement, or sponsorship of us by these other companies.
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PART I — FINANCIAL INFORMATION
Item 1. Financial Statements (Unaudited)
QUANTERIX CORPORATION
CONSOLIDATED BALANCE SHEETS
(amounts in thousands, except per share data)
September 30, 2023 |
| December 31, 2022 | |||
ASSETS | |||||
Current assets: |
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Cash and cash equivalents | $ | | $ | | |
Marketable securities | | — | |||
Accounts receivable (net of allowance for expected credit losses of $ |
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Inventory |
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Prepaid expenses and other current assets |
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Total current assets | |
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Restricted cash |
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Property and equipment, net |
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Intangible assets, net |
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Operating lease right-of-use assets | | | |||
Other non-current assets |
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Total assets | $ | | $ | | |
LIABILITIES AND STOCKHOLDERS' EQUITY |
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Current liabilities: |
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Accounts payable | $ | | $ | | |
Accrued compensation and benefits |
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Accrued expenses and other current liabilities |
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Deferred revenue |
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Operating lease liabilities | | | |||
Total current liabilities |
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Deferred revenue, net of current portion |
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Operating lease liabilities, net of current portion | | | |||
Other non-current liabilities |
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Total liabilities | | | |||
Commitments and contingencies (Note 13) | |||||
Stockholders’ equity: |
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Common stock, $ |
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Authorized shares: |
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Additional paid-in capital |
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Accumulated other comprehensive loss | ( | ( | |||
Accumulated deficit |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity | $ | | $ | |
The accompanying notes are an integral part of these Consolidated Financial Statements.
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QUANTERIX CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
(amounts in thousands, except per share data)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||
2023 |
| 2022 | 2023 |
| 2022 | ||||||
Revenues: | |||||||||||
Product revenue | $ | | $ | | $ | | $ | | |||
Service revenue |
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Collaboration and license revenue |
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Grant revenue | | | | | |||||||
Total revenues |
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Costs of goods sold and services: |
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Cost of product revenue |
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Cost of service and other revenue |
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Total costs of goods sold and services |
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Gross profit | | | | | |||||||
Operating expenses: |
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Research and development |
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Selling, general, and administrative |
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Other lease costs | | | | | |||||||
Impairment and restructuring | — | | ( | | |||||||
Total operating expenses |
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Loss from operations |
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Interest income, net |
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Other income (expense), net |
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Loss before income taxes | ( | ( | ( | ( | |||||||
Income tax expense | ( | ( | ( | ( | |||||||
Net loss | $ | ( | $ | ( | $ | ( | $ | ( | |||
Net loss per common share, basic and diluted | ( | ( | ( | ( | |||||||
Weighted-average common shares outstanding, basic and diluted |
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The accompanying notes are an integral part of these Consolidated Financial Statements.
5
QUANTERIX CORPORATION
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(amounts in thousands)
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||
2023 |
| 2022 | 2023 |
| 2022 | ||||||
Net loss | $ | ( | $ | ( | $ | ( | $ | ( | |||
Other comprehensive loss, net of tax: | |||||||||||
Unrealized losses on marketable securities | ( | — | ( | — | |||||||
Foreign currency translation | ( | ( | ( | ( | |||||||
Total other comprehensive loss | ( | ( | ( | ( | |||||||
Comprehensive loss | $ | ( | $ | ( | $ | ( | $ | ( |
The accompanying notes are an integral part of these Consolidated Financial Statements.
6
QUANTERIX CORPORATION
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(amounts in thousands)
Three Months Ended September 30, 2023 | ||||||||||||||||
Common stock | ||||||||||||||||
Shares |
| Value |
| 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 | — | — | — | ( | — | ( | ||||||||||
Net loss | — | — | — | — | ( | ( | ||||||||||
Balance at September 30, 2023 | |
| $ | |
| $ | |
| $ | ( | $ | ( |
| $ | | |
Three Months Ended September 30, 2022 | ||||||||||||||||
Common stock | ||||||||||||||||
Shares |
| Value |
| 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 | — | — | — | ( | — | ( | ||||||||||
Net loss | — | — | — | — | ( | ( | ||||||||||
Balance at September 30, 2022 | |
| $ | |
| $ | |
| $ | ( | $ | ( |
| $ | |
Nine Months Ended September 30, 2023 | ||||||||||||||||
Common stock | ||||||||||||||||
Shares |
| Value |
| Additional paid-in capital |
| Accumulated other comprehensive loss |
| Accumulated deficit |
| Total stockholders' equity | ||||||
Balance at December 31, 2022 | | $ | | $ | | $ | ( | $ | ( |
| $ | | ||||
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 | — | — | — | ( | — | ( | ||||||||||
Net loss | — | — | — | — | ( | ( | ||||||||||
Balance at September 30, 2023 | |
| $ | |
| $ | |
| $ | ( | $ | ( |
| $ | | |
Nine Months Ended September 30, 2022 | ||||||||||||||||
Common stock | ||||||||||||||||
Shares |
| Value |
| Additional paid-in capital |
| Accumulated other comprehensive loss |
| Accumulated deficit |
| Total stockholders' equity | ||||||
Balance at December 31, 2021 | | $ | | $ | | $ | | $ | ( |
| $ | | ||||
Issuance of common stock under stock plans, including tax effects | | — | | — | — | | ||||||||||
Stock-based compensation expense | — | — | | — | — | | ||||||||||
Foreign currency translation | — | — | — | ( | — | ( | ||||||||||
Net loss | — | — | — | — | ( | ( | ||||||||||
Balance at September 30, 2022 | |
| $ | |
| $ | |
| $ | ( | $ | ( |
| $ | |
The accompanying notes are an integral part of these Consolidated Financial Statements.
7
QUANTERIX CORPORATION
CONSOLIDATED STATEMENTS OF CASH FLOWS
(amounts in thousands)
Nine Months Ended September 30, | |||||
2023 |
| 2022 | |||
Cash flows from operating activities: |
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Net loss | $ | ( | $ | ( | |
Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization expense |
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Credit losses on accounts receivable | | | |||
Foreign currency losses | | | |||
Unrealized losses on marketable securities | ( | — | |||
Amortization of (discount) premium on marketable securities | ( | — | |||
Operating lease right-of-use asset amortization | | | |||
Stock-based compensation expense |
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Impairment | — | | |||
Deferred income taxes | | ( | |||
Loss on disposal of fixed assets | | | |||
Changes in assets and liabilities: |
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Accounts receivable |
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Inventory |
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Prepaid expenses and other current assets |
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Other non-current assets |
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Accounts payable |
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Accrued compensation and benefits, accrued expenses, and other current liabilities |
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Deferred revenue |
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Operating lease liabilities | ( | ( | |||
Other non-current liabilities | ( | | |||
Net cash used in operating activities | ( | ( | |||
Cash flows from investing activities: |
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Purchases of marketable securities | ( | — | |||
Purchases of property and equipment |
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Proceeds from RADx grant on assets purchased | — | | |||
Net cash used in investing activities | ( | ( | |||
Cash flows from financing activities: |
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Proceeds from common stock issued under stock plans |
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Payments for employee taxes withheld on stock-based compensation awards | ( | — | |||
Net cash provided by financing activities | | | |||
Net decrease in cash, cash equivalents, and restricted cash |
| ( |
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Effect of exchange rate changes on cash, cash equivalents, and restricted cash | ( | ( | |||
Cash, cash equivalents, and restricted cash at beginning of period |
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Cash, cash equivalents, and restricted cash at end of period | $ | | $ | | |
Supplemental disclosure of cash flow information: | |||||
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) | $ | | $ | — |
The accompanying notes are an integral part of these Consolidated Financial Statements.
8
QUANTERIX CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
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 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. To date, the Company has completed over
Note 2. Significant Accounting Policies
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. GAAP”) and pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (the “SEC”) regarding interim financial reporting on Form 10-Q. Accordingly, certain information and disclosures required for complete financial statements prepared in accordance with U.S. GAAP are not included herein. The Consolidated Balance Sheet and related information as of December 31, 2022 included herein was derived from the audited Consolidated Financial Statements as of December 31, 2022, but does not include all disclosures required by U.S. 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. 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.
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
9
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. 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.
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 nine months ended September 30, 2023, and were $
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
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, | |||||
2023 |
| 2022 | |||
Cash and cash equivalents | $ | | $ | | |
Restricted cash (1) | | | |||
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. 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.
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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.
Note 3. Revenue and Related Matters
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 |
| EMEA |
| Asia Pacific |
| Total | North America |
| EMEA |
| Asia Pacific |
| Total | ||||||||||
Product revenue | |||||||||||||||||||||||
Instruments | $ | | $ | | $ | | $ | | $ | | $ | | $ | |
| $ | | ||||||
Consumable and other products | | | | | | | |
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Total | $ | | $ | | $ | | $ | | $ | |
| $ | |
| $ | |
| $ | | ||||
Service revenue | |||||||||||||||||||||||
Service-type warranties | $ | | $ | | $ | | $ | | $ | | $ | | $ | |
| $ | | ||||||
Research services | | | |
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Other services | | | | | | | |
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Total | $ | | $ | | $ | | $ | | $ | | $ | | $ | | $ | | |||||||
Collaboration and license revenue | $ | | $ | — | $ | — | $ | | $ | | $ | | $ | — | $ | | |||||||
Grant revenue | $ | | $ | — | $ | — | $ | | $ | | $ | — | $ | — | $ | | |||||||
Total revenues | $ | |
| $ | |
| $ | |
| $ | | $ | |
| $ | |
| $ | |
| $ | |
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Nine Months Ended September 30, 2023 |
| Nine Months Ended September 30, 2022 | |||||||||||||||||||||
North America |
| EMEA |
| Asia Pacific |
| Total | North America |
| EMEA |
| Asia Pacific |
| Total | ||||||||||
Product revenue | |||||||||||||||||||||||
Instruments | $ | | $ | | $ | | $ | | $ | | $ | | $ | | $ | | |||||||
Consumable and other products | | | | | | | | | |||||||||||||||
Total | $ | |
| $ | |
| $ | |
| $ | | $ | |
| $ | |
| $ | |
| $ | | |
Service revenue | |||||||||||||||||||||||
Service-type warranties | $ | | $ | | $ | | $ | | $ | | $ | | $ | | $ | | |||||||
Research services | | | |
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Other services | | | | | | | | | |||||||||||||||
Total | $ | | $ | | $ | | $ | | $ | | $ | | $ | | $ | | |||||||
Collaboration and license revenue | $ | | $ | — | $ | — | $ | | $ | | $ | | $ | | $ | | |||||||
Grant revenue | $ | | $ | — | $ | — | $ | | $ | | $ | — | $ | — | $ | | |||||||
Total revenues | $ | |
| $ | |
| $ | |
| $ | | $ | |
| $ | |
| $ | |
| $ | |
For each of the three and nine months ended September 30, 2023,
Product Revenue
UltraDx
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 $
In the second quarter of 2023, UltraDx completed the qualified preferred share financing and issued to the Company
During the three months ended September 30, 2023, revenue recognized was not material. During the nine months ended September 30, 2023, the Company recognized $
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Service Revenue
Eli Lilly and Company
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 $
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. 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 $
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 $
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
During the three and nine months ended September 30, 2023, the Company recognized
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.
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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 $
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 $
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 $
During the three and nine months ended September 30, 2023, grant revenue recognized and research and incurred were $
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 $
During the three and nine months ended September 30, 2023 and 2022, the Company recognized
Contract Assets
There were
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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 $
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 $
Of the performance obligations not yet satisfied or partially satisfied, $
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):
2023 | 2022 | ||||
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
Note 4. 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):
2023 | 2022 | ||||
Balance at December 31 of prior year | $ | | $ | | |
Provision for expected credit losses | | | |||
Write-offs and recoveries collected | ( | — | |||
Balance at September 30 | $ | | $ | |
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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 September 30, 2023 | Amortized cost |
| Unrealized Gains |
| Unrealized Losses |
| Fair Value | |||||
Commercial paper | $ | | $ | — | $ | ( | $ | | ||||
U.S. Treasuries | | | ( | | ||||||||
U.S. Government agency bonds | | | ( | | ||||||||
Corporate bonds | | — | ( | | ||||||||
Total marketable securities | $ | | $ | | $ | ( | $ | | ||||
Marketable securities are reported in the following Consolidated Balance Sheets captions: | ||||||||||||
Cash and cash equivalents | $ | | ||||||||||
Marketable securities | | |||||||||||
Total marketable securities | $ | |
The Company did
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):
Less Than 12 Months | ||||||
As of September 30, 2023 | Fair Value |
| Unrealized Losses | |||
Commercial paper | $ | | $ | ( | ||
U.S. Treasuries | | ( | ||||
U.S. Government agency bonds | | ( | ||||
Corporate bonds | | ( | ||||
Total | $ | | $ | ( |
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. 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 $
The following table summarizes the contractual maturities of the Company’s marketable securities (in thousands):
As of September 30, 2023 | Amortized cost | Fair Value | ||||
Due within one year | $ | | $ | | ||
Due in one to two years | | | ||||
Total | $ | | $ | |
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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 September 30, 2023 | Total |
| Quoted prices in active markets (Level 1) |
| Significant other observable inputs (Level 2) |
| Significant unobservable inputs (Level 3) | ||||
Financial assets: |
|
|
|
|
|
| |||||
Cash equivalents: (1) | |||||||||||
Money market funds | $ | |
| $ | | $ | — |
| $ | — | |
Commercial paper | | — | | — | |||||||
U.S. Treasuries | | — | | — | |||||||
Total cash equivalents: | | | | — | |||||||
Marketable securities: (2) | |||||||||||
Commercial paper | | — | | — | |||||||
U.S. Treasuries | | — | | — | |||||||
U.S. Government agency bonds | | — | | — | |||||||
Corporate bonds | | — | | — | |||||||
Total marketable securities | | — | | — | |||||||
Total financial assets | $ | | $ | | $ | | $ | — |
As of December 31, 2022 | Total |
| Quoted prices in active markets (Level 1) |
| Significant other observable inputs (Level 2) |
| Significant unobservable inputs (Level 3) | ||||
Financial assets: |
|
|
|
|
|
| |||||
Money market funds (1) | $ | |
| $ | | $ | — |
| $ | — | |
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. 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
On June 26, 2023, the Company received ordinary shares in UltraDx (refer to Note 3 − Revenue and Related Matters) which were valued at $
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.
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During the third quarter of 2023, the Company recorded an immaterial adjustment to the fair value of the UltraDx shares. There were
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. 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):
September 30, 2023 |
| December 31, 2022 | |||
Raw materials | $ | | $ | | |
Work in process |
| |
| | |
Finished goods |
| |
| | |
Total inventory | $ | | $ | |
Note 8. Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following (in thousands):
September 30, 2023 |
| December 31, 2022 | |||
Accrued professional services | $ | | $ | | |
Accrued royalties | | | |||
Accrued tax liabilities | | | |||
Other accrued expenses |
| |
| | |
Total accrued expenses and other current liabilities | $ | | $ | |
Note 9. Stock-Based Compensation
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):
Weighted-average | |||||||||
Weighted-average | remaining contractual | Aggregate | |||||||
Number of shares |
| exercise price per share |
| life (in years) |
| intrinsic value | |||
Outstanding at December 31, 2022 | |
| $ | | $ | | |||
Granted | | | |||||||
Exercised | ( | | |||||||
Cancelled | ( | | |||||||
Outstanding at September 30, 2023 | | $ | | $ | | ||||
Exercisable at September 30, 2023 | | $ | | $ | | ||||
Vested and expected to vest at September 30, 2023 | | $ | | $ | |
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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 | Weighted-average | ||||||||
grant date fair | remaining contractual | Aggregate | |||||||
Number of shares |
| value per share | life (in years) | intrinsic value | |||||
Unvested RSUs at December 31, 2022 | 1,188 |
| $ | 21.18 | 9.6 | $ | 16,455 | ||
Granted | 812 | 15.49 | |||||||
Vested | (306) | 24.52 | |||||||
Cancelled | (258) | 17.59 | |||||||
Unvested RSUs at September 30, 2023 | 1,436 | $ | 17.90 | 9.1 | $ | 38,976 | |||
Expected to convert at September 30, 2023 | 1,436 | $ | 17.90 | 9.1 | $ | 38,976 |
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)
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
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, | ||||||||||
2023 |
| 2022 |
| 2023 |
| 2022 | |||||
Cost of product revenue | $ | | $ | | $ | | $ | | |||
Cost of service and other revenue |
| |
| |
| |
| | |||
Research and development |
| |
| |
| |
| | |||
Selling, general, and administrative |
| |
| |
| |
| | |||
Total stock-based compensation | $ | | $ | | $ | | $ | |
As of September 30, 2023, there was $
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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:
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||
Stock Options: | |||||||||||
Risk-free interest rate | |||||||||||
Expected dividend yield | |||||||||||
Expected term (in years) | |||||||||||
Expected volatility | |||||||||||
Weighted-average grant date fair value | $ | | $ | | $ | | $ | | |||
Employee Stock Purchase Plan: | |||||||||||
Risk-free interest rate | |||||||||||
Expected dividend yield | |||||||||||
Expected term (in years) | |||||||||||
Expected volatility | |||||||||||
Weighted-average grant date fair value | $ | | $ | | $ | | $ | |
Note 10. 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, | ||||||||||
2023 |
| 2022 | 2023 |
| 2022 | ||||||
Numerator: | |||||||||||
Net loss | $ | ( | $ | ( | $ | ( | $ | ( | |||
Denominator: | |||||||||||
Weighted average common shares outstanding | | | | | |||||||
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, | |||||||||
2023 |
| 2022 |
| 2023 |
| 2022 | |||||
Common stock and RSUs | 1,522 |
| 902 | 1,545 |
| 807 | |||||
Stock options | 2,760 |
| 2,503 | 2,793 |
| 2,423 | |||||
Total anti-dilutive shares | 4,282 | 3,405 | 4,338 | 3,230 |
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Note 11. Income Taxes
The Company’s effective tax rates were (
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.
Note 12. Goodwill
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 $
As of September 30, 2023 and December 31, 2022, the Company had
Note 13. Commitments and Contingencies
Purchase Commitments
Stratec
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. As part of the Stratec Supply Agreement, the Company agreed to purchase a total of
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 $
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 $
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Refer to Note 14 − 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 $
Refer to Note 14 − 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.
Leases
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):
Maturity of lease liabilities | As of September 30, 2023 | ||
2023 (remainder) | $ | | |
2024 | | ||
2025 | | ||
2026 | | ||
2027 | | ||
2028 | | ||
Thereafter | | ||
Total lease payments | | ||
Less: imputed interest | | ||
Total operating lease liabilities | $ | |
The Company’s lease agreement for office and laboratory facilities in Bedford, Massachusetts included a tenant improvement allowance with the landlord that offset a portion of the Company’s construction costs. During the first quarter of 2023, the Company received the final tenant improvement allowance reimbursement of $
22
Note 14. 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 $
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. 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
Note 15. 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
During the three and nine months ended September 30, 2022, the Company incurred approximately $
Total restructuring expenses incurred in 2022 under the Restructuring Plan were $
23
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 $
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.
Note 16. 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
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 $
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited Consolidated Financial Statements and the related notes included elsewhere in this Quarterly Report on Form 10-Q and our audited Consolidated Financial Statements and Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 6, 2023 (the “Annual Report on Form 10-K”). In addition to historical information, the following discussion contains forward-looking statements that involve risks, uncertainties, and assumptions. Our actual results, performance, or experience could differ materially from what is indicated by any forward-looking statement due to various important factors, risks, and uncertainties, including, but not limited to, those set forth under the section titled “Part II, Item 1A. Risk Factors” and “Note Regarding Forward-Looking Statements” included in this Quarterly Report on Form 10-Q or under the section titled “Part I, Item 1A. Risk Factors” of our Annual Report on Form 10-K, as may be updated by Part II, Item 1A. Risk Factors in our subsequently filed Quarterly Reports on Form 10-Q. Unless the context otherwise requires, the terms “Quanterix,” the “Company,” “we,” “it,” “us, “and “our” in this Quarterly Report on Form 10-Q refer to Quanterix Corporation and its consolidated subsidiaries.
Overview
We are a life sciences company that has developed next generation, ultra-sensitive digital immunoassay platforms that advance precision health for life sciences research and diagnostics. Our platforms are based on our proprietary digital “Simoa” detection technology. Our Simoa bead-based and planar array platforms enable customers to reliably detect protein biomarkers in extremely low concentrations in blood, serum, and other fluids that, in many cases, are undetectable using conventional, analog immunoassay technologies, and also allow researchers to define and validate the function of novel protein biomarkers that are only present in very low concentrations. These capabilities provide our customers with insight into the role of protein biomarkers in human health that has not been possible with other existing technologies and enable researchers to unlock unique insights into the continuum between health and disease. We believe this greater insight will enable the development of novel therapies and diagnostics and facilitate a paradigm shift in healthcare from an emphasis on treatment to a focus on earlier detection, monitoring, prognosis and, ultimately, prevention.
Our instruments are designed to be used either with assays fully developed by us, including all antibodies and supplies required to run the tests, or with “homebrew” kits where we supply some of the components required for testing and the customer supplies the remaining required elements. Accordingly, our installed instruments generate a recurring revenue stream. As the installed base of the Simoa instruments increases, we expect total consumables revenue to increase.
We commercially launched our first immunoassay platform, the Simoa HD-1, in 2014. The HD-1 is based on our bead-based technology and assays run on the HD-1 are fully automated. We initiated commercial launch of the SR-X instrument in 2017. The SR-X utilizes the same Simoa bead-based technology and assay kits as the HD-1 in a compact benchtop form with a lower price point, more flexible assay preparation, and a wider range of applications. In 2019, we launched the Simoa HD-X, an upgraded version of the Simoa HD-1, which replaces the HD-1. The HD-X has been designed to deliver significant productivity and operational efficiency improvements, as well as greater user flexibility. By September 30, 2023, approximately 81% of the HD instrument installed base was HD-X instruments.
With our acquisition of Aushon BioSystems, Inc. in 2018, we acquired a CLIA-certified laboratory, as well as their proprietary sensitive planar array detection technology. Leveraging our proprietary sophisticated Simoa image analysis and data analysis algorithms, we further refined the planar array technology to develop the SP-X instrument to provide sensitivity similar to that found in our Simoa bead-based platform. We commercially launched the SP-X instrument in 2019.
Our wholly-owned subsidiary UmanDiagnostics AB (“Uman”), a company located in Umeå, Sweden, supplies neurofilament light (“Nf-L”), antibodies, and enzyme-linked immunoassay (“ELISA”) kits, which are used by
25
researchers and biopharmaceutical and diagnostics companies world-wide in the detection of Nf-L to advance the development of therapeutics and diagnostics for neurodegenerative conditions.
We also provide contract research services for customers and Laboratory Developed Test (“LDT”) services through our CLIA-certified Accelerator Laboratory (the “Acceleratory 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, we have completed over 2,200 projects for more than 470 customers from all over the world using our Simoa platforms.
We sell our instruments, consumables, and services to the life science, pharmaceutical, and diagnostics industries through a direct sales force and support organizations in North America and Europe, and through distributors and sales agents in other select markets, including Australia, Brazil, China, Czech Republic, India, Hong Kong, Israel, Japan, New Zealand, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, and the United Arab Emirates. In addition, Uman sells Nf-L antibodies and Nf-L ELISA kits directly, and in conjunction with us and another distributor, worldwide. We have an extensive base of customers in academic and governmental research institutions, as well as pharmaceutical, biotechnology, and contract research companies.
As of September 30, 2023, we had cash, cash equivalents, and marketable securities of $327.7 million. Since our inception, we have incurred annual net losses. Our net losses were $7.8 million and $19.9 million for the three and nine months ended September 30, 2023, respectively, and $35.1 million and $78.1 million for the three and nine months ended September 30, 2022, respectively. As of September 30, 2023, we had an accumulated deficit of $422.1 million and stockholders’ equity of $353.4 million.
We expect to continue to incur significant expenses and operating losses at least through the next 24 months. We expect our expenses will increase as we:
● | expand our sales and marketing efforts to further commercialize our products; |
● | expand our research and development efforts to improve our existing products and develop and launch new products, particularly if any of our products are deemed by the U.S. Food and Drug Administration (the “FDA”) to be medical devices or otherwise subject to additional regulation by the FDA; |
● | seek Premarket Approval (“PMA”) or 510(k) clearance from the FDA for our existing products or new products if or when we decide to market products for use in the prevention, diagnosis, or treatment of a disease or other condition; |
● | hire additional personnel to support our growth and research and development; |
● | strategically acquire and integrate companies or technologies that may be complementary to our business; |
● | intend to invest in our diagnostics business in support of the launch of Lucent Diagnostics, LDTs and other diagnostics initiatives; |
● | enter into collaboration arrangements, or in-license other products and technologies; and |
● | add operational, financial, and management information systems. |
Recent Business Developments
In October 2023, we entered into a license agreement with Janssen Sciences Ireland UC, a Johnson & Johnson Company (“J&J”). The agreement grants us worldwide, non-exclusive rights to J&J’s p-Tau 217 antibodies and assay designs for use in clinical research and diagnostic products, including in the production of Simoa p-Tau 217 research-use only assay kits for global distribution. Under this license, we are required to pay royalties on net sales of the licensed products and service activities.
In July 2023, we launched Lucent Diagnostics, a new healthcare provider-facing portal to meet the future needs of patients at the same time a therapy for disease becomes more widely available. In the second half of 2023, we have launched initial blood-based biomarker LDTs, LucentAD and LucentAD p-Tau 217, to assist in the evaluation of patients experiencing cognitive symptoms consistent with the early signs of Alzheimer’s disease. These tests have not been cleared or approved by the FDA. We do not expect material revenues from these tests until 2024 or later.
26
On September 21, 2022, we entered into a contract with the National Institutes of Health (the “NIH”) with a total award value of $1.7 million (the “NIH Grant”). The NIH is an agency of the U.S. Department of Health and Human Services and under the NIH Grant granted us 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 we submit for reimbursement of activities related to the grant. As of September 30, 2023, we had received $0.5 million of the award value.
During the three months ended September 30, 2023, grant revenue recognized and research and development expense incurred under the NIH Grant were not material. During the nine months ended September 30, 2023, grant revenue recognized and research and development expense incurred under the NIH Grant were $0.5 million and $0.4 million, respectively.
On March 24, 2022, we entered into a contract with the Alzheimer’s Drug Discovery Foundation (the “ADDF”) with a total funding value of $2.3 million (the “ADDF Grant”). The ADDF is a charitable venture philanthropy entity that granted us funding in support of certain activities for the development of an in vitro diagnostic test for early detection of Alzheimer's disease. The ADDF Grant restricts our use of the granted funds solely for activities related to our Alzheimer’s diagnostic test development project and the contract period runs through June 2024. Receipt of the contract funding was subject to achievement of predefined milestones and as of September 30, 2023, we 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 under the ADDF Grant were $0.3 million and $0.4 million, respectively.
On February 25, 2022, we 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”). We 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, we 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, we receive $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, we entered into a Technology License Agreement (the “Lilly License”) under which Lilly granted us 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. In consideration of the Lilly License, we paid an upfront fee, are 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.
We 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.
Restructuring and Strategic Re-Alignment
Following a strategic review and assessment of our operations and cost structure, on August 8, 2022, we announced a restructuring and strategic re-alignment plan (the “Restructuring Plan”). As part of the Restructuring Plan, we began an assay redevelopment program with the ultimate objective of improving our ability to manufacture and deliver high-quality assays at scale. The Restructuring Plan aligns our investments to best serve the needs of our customers, focuses our innovation efforts on key platforms, and provides a foundation for our entry into translational pharma and clinical markets, which we believe will be required to access new growth categories. In accordance with the Restructuring Plan, we 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.
27
During the nine months ended September 30, 2022, we incurred approximately $3.4 million of expenses related to the Restructuring Plan. These expenses were substantially for cash payments of severance and employee benefits, $3.1 million of which was paid as of September 30, 2022. Total restructuring expenses incurred in 2022 under the Restructuring Plan were $3.8 million.
As a result of the Restructuring Plan, we performed an impairment assessment of our goodwill, long-lived assets, including operating lease right-of-use assets, and intangibles. The assessments resulted in us recording an impairment charge of $16.9 million during the three and nine months ended September 30, 2022. The impairment charge included (1) $8.2 million of goodwill (refer to Note 12 − Goodwill in the Notes to Consolidated Financial Statements), (2) $7.7 million associated with the right-of-use asset and 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.
Overall, as a result of the Restructuring Plan, we expect to realize estimated annualized operating expense savings in 2023 of approximately $25.0 million.
Comparison of Results of Operations for Three Months Ended September 30, 2023 and 2022:
The following table sets forth select Consolidated Statements of Operations data, and such data as a percentage of total revenues (in thousands, except percentages):
Three Months Ended September 30, | Increase (Decrease) | ||||||||||||||||
2023 | % of revenue | 2022 | % of revenue | Amount | % | ||||||||||||
Revenues: | |||||||||||||||||
Product revenue | $ | 19,660 |
| 63 | % |
| $ | 17,693 |
| 66 | % |
| $ | 1,967 |
| 11 | % |
Service revenue |
| 10,938 |
| 35 | % |
|
| 8,370 |
| 31 | % |
|
| 2,568 |
| 31 | % |
Collaboration and license revenue |
| 237 |
| 1 | % |
|
| 301 |
| 1 | % |
|
| (64) |
| (21) | % |
Grant revenue | 499 | 2 | % | 282 | 1 | % | 217 | 77 | % | ||||||||
Total revenues |
| 31,334 |
| 100 | % |
|
| 26,646 |
| 100 | % |
|
| 4,688 |
| 18 | % |
Costs of goods sold and services: |
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||
Cost of product revenue |
| 8,342 |
| 27 | % |
|
| 10,511 |
| 39 | % |
|
| (2,169) |
| (21) | % |
Cost of service and other revenue |
| 5,209 |
| 17 | % |
|
| 5,191 |
| 19 | % |
|
| 18 |
| 0 | % |
Total costs of goods sold and services |
| 13,551 |
| 43 | % |
|
| 15,702 |
| 59 | % |
|
| (2,151) |
| (14) | % |
Gross profit |
| 17,783 |
| 57 | % |
|
| 10,944 |
| 41 | % |
|
| 6,839 |
| 62 | % |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
| ||||
Research and development |
| 7,200 |
| 23 | % |
|
| 6,631 |
| 25 | % |
|
| 569 |
| 9 | % |
Selling, general, and administrative |
| 23,595 |
| 75 | % |
|
| 19,966 |
| 75 | % |
|
| 3,629 |
| 18 | % |
Other lease costs | 758 |
| 2 | % |
|
| 609 |
| 2 | % |
|
| 149 |
| 24 | % | |
Impairment and restructuring | — |
| — | % |
|
| 20,341 |
| 76 | % |
|
| (20,341) |
| (100) | % | |
Total operating expenses | 31,553 | 101 | % | 47,547 | 178 | % | (15,994) | (34) | % | ||||||||
Loss from operations |
| (13,770) |
| (44) | % |
|
| (36,603) |
| (137) | % |
|
| (22,833) |
| (62) | % |
Interest income, net |
| 4,185 |
| 13 | % |
|
| 1,712 |
| 6 | % |
| 2,473 |
| 144 | % | |
Other income (expense), net |
| 2,030 |
| 6 | % |
|
| (101) |
| — | % |
|
| 2,131 |
| 2,110 | % |
Loss before income taxes |
| (7,555) |
| (24) | % |
|
| (34,992) |
| (131) | % |
|
| (27,437) |
| (78) | % |
Income tax expense |
| (203) |
| (1) | % |
|
| (72) |
| — | % |
|
| 131 |
| 182 | % |
Net loss | $ | (7,758) |
| (25) | % |
| $ | (35,064) |
| (131) | % |
| $ | (27,306) |
| (78) | % |
28
Revenues
Total revenues increased $4.7 million, or 18%, to $31.3 million for the three months ended September 30, 2023, compared to $26.6 million for the three months ended September 30, 2022.
Product revenue of $19.7 million for the three months ended September 30, 2023 consisted of instrument sales of $3.7 million and sales of consumables and other products of $16.0 million. This represented an increase of $2.0 million, or 11%, compared to product revenue of $17.7 million for the three months ended September 30, 2022, which consisted of $7.8 million in instrument sales and $9.9 million in sales of consumables and other products. The increase in product revenue was primarily due to a $6.1 million increase in sales of consumables and increased average selling prices. This increase was partially offset by a $4.1 million decrease in instrument sales due to reduced demand, which is a trend we expect to continue for the remainder of 2023.
Service revenue was $10.9 million for the three months ended September 30, 2023, compared to $8.4 million for the three months ended September 30, 2022, an increase of $2.6 million, or 31%. This increase was primarily due to a $3.3 million increase in Accelerator Laboratory revenue due to higher volumes of sample testing and assay development services, which was partially offset by a $1.2 million decrease in revenue recognized from the Lilly Collaboration Agreement.
Collaboration and license revenue was $0.2 million for the three months ended September 30, 2023, compared to $0.3 million for the three months ended September 30, 2022, a decrease of $0.1 million, or 21%.
Grant revenue was $0.5 million for the three months ended September 30, 2023, compared to $0.3 million for the three months ended September 30, 2022, an increase of $0.2 million, or 77%.
Cost of Goods Sold and Services
Cost of goods sold and services decreased $2.2 million, or 14%, to $13.6 million for the three months ended September 30, 2023, compared to $15.7 million for the three months ended September 30, 2022.
Cost of product revenue decreased $2.2 million, or 21%, to $8.3 million for the three months ended September 30, 2023, compared to $10.5 million for the three months ended September 30, 2022. The decrease was primarily due to improvement in inventory management and manufacturing processes and lower instrument sales. These decreases were partially offset by product revenue related increases, including compensation and benefit costs from increased headcount and an increase in royalty fees.
Cost of service revenue was consistent with the prior period at $5.2 million for each of the three months ended September 30, 2023 and September 30, 2022, primarily due to the increase in Accelerator Laboratory revenue at higher margins.
Research and Development
Research and development expense increased $0.6 million, or 9%, to $7.2 million for the three months ended September 30, 2023, compared to $6.6 million for the three months ended September 30, 2022. The increase was primarily due to professional services fees to enable product development.
29
Selling, General, and Administrative
Selling, general and administrative expense increased $3.6 million, or 18%, to $23.6 million for the three months ended September 30, 2023, compared to $20.0 million for the three months ended September 30, 2022. The increase was primarily due to (1) a $1.5 million increase in professional services and consulting fees related to our efforts to remediate the previously disclosed material weaknesses identified in 2022 and other services, (2) a $1.3 million increase in stock-based compensation expense, which was lower in the three months ended September 30, 2022 due to equity award forfeitures recorded from eliminating positions as part of the Restructuring Plan, and (3) a $0.6 million increase in shipping and handling costs for consumables and other products due to increased volume. Included within selling, general, and administrative expense are $2.6 million and $1.6 million of shipping and handling costs for product sales for the three months ended September 30, 2023 and 2022, respectively.
Other Lease Costs
Other lease costs increased $0.1 million, or 24% to $0.8 million for the three months ended September 30, 2023, compared to $0.6 million for the three months ended September 30, 2022. As part of the Restructuring Plan, we are not utilizing the leased office and laboratory facilities in Bedford, Massachusetts and are evaluating alternatives, including sub-leasing the facilities. Other lease costs include amortization of the related operating lease right-of-use assets and other leased facility operating expenses from periods after the impairment and the determination that the facilities would not be utilized. The increase is primarily due to the expenses incurred while not utilizing the space for the full third quarter of 2023, compared to the expenses incurred while not utilizing the space for one and a half months in the third quarter of 2022 after the Restructuring Plan was implemented. Expenses incurred prior to the Restructuring Plan were recorded in selling, general, and administrative on the Consolidated Statements of Operations.
Impairment and Restructuring Expense
There were no impairment and restructuring costs for the three months ended September 30, 2023 compared to $20.3 million incurred in the three months ended September 30, 2022. This decrease was due to the implementation of the Restructuring Plan in August 2022 which did not repeat in 2023. The costs incurred included (1) $8.2 million of goodwill impairment charges, (2) $7.7 million of long-lived asset impairment charges associated with the Bedford, Massachusetts facilities that we are no longer utilizing, (3) $1.0 million of software costs related to projects that were rationalized as part of the Restructuring Plan, and (4) $3.4 million of restructuring expenses primarily for severance and one-time termination benefits in connection with the elimination of 119 positions across the Company.
Interest Income, Net
Interest income, net increased $2.5 million, or 144%, to $4.2 million for the three months ended September 30, 2023, as compared to $1.7 million for the three months ended September 30, 2022, primarily due to (1) higher interest rates earned on cash and cash equivalents, and (2) higher interest rates and accretion of discounts from the purchase of marketable securities.
Other Income (Expense), Net
Other income (expense), net was $2.0 million for the three months ended September 30, 2023, as compared to ($0.1) million for the three months ended September 30, 2022. The $2.1 million increase was primarily due to the recognition of $2.4 million receivable under the Employee Retention Credit established by the Coronavirus Aid, Relief, and Economic Security Act in 2021.
Income Tax (Expense) Benefit, Net
Income tax (expense) benefit, net was consistent with the prior period with a $0.1 million increase, or 182%, to ($0.2) million for the three months ended September 30, 2023, as compared to ($0.1) million for the three months ended September 30, 2022.
30
Comparison of Results of Operations for the Nine Months Ended September 30, 2023 and 2022:
The following table sets forth select Consolidated Statements of Operations data, and such data as a percentage of total revenues (in thousands, except percentages):
Nine Months Ended September 30, | Increase (Decrease) | ||||||||||||||||
2023 | % of revenue | 2022 | % of revenue | Amount | % | ||||||||||||
Revenues: | |||||||||||||||||
Product revenue | $ | 58,639 |
| 65 | % |
| $ | 53,134 |
| 67 | % |
| $ | 5,505 |
| 10 | % |
Service revenue |
| 30,069 |
| 33 | % |
|
| 25,728 |
| 32 | % |
|
| 4,341 |
| 17 | % |
Collaboration and license revenue |
| 1,234 |
| 1 | % |
|
| 479 |
| 1 | % |
|
| 755 |
| 158 | % |
Grant revenue | 877 | 1 | % | 357 | — | % | 520 | 146 | % | ||||||||
Total revenues |
| 90,819 |
| 100 | % |
|
| 79,698 |
| 100 | % |
|
| 11,121 |
| 14 | % |
Costs of goods sold and services: |
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||
Cost of product revenue |
| 22,611 |
| 25 | % |
|
| 31,178 |
| 39 | % |
|
| (8,567) |
| (27) | % |
Cost of service and other revenue |
| 14,361 |
| 16 | % |
|
| 14,306 |
| 18 | % |
|
| 55 |
| 0 | % |
Total costs of goods sold and services |
| 36,972 |
| 41 | % |
|
| 45,484 |
| 57 | % |
|
| (8,512) |
| (19) | % |
Gross profit |
| 53,847 |
| 59 | % |
|
| 34,214 |
| 43 | % |
|
| 19,633 |
| 57 | % |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
| ||||
Research and development |
| 17,866 |
| 20 | % |
|
| 20,290 |
| 25 | % |
|
| (2,424) |
| (12) | % |
Selling, general, and administrative |
| 66,069 |
| 73 | % |
|
| 72,723 |
| 91 | % |
|
| (6,654) |
| (9) | % |
Other lease costs | 2,696 |
| 3 | % |
|
| 609 |
| 1 | % |
|
| 2,087 |
| 343 | % | |
Impairment and restructuring | (33) |
| — | % |
|
| 20,341 |
| 26 | % |
|
| (20,374) |
| (100) | % | |
Total operating expenses |
| 86,598 |
| 95 | % |
|
| 113,963 |
| 143 | % |
|
| (27,365) |
| (24) | % |
Loss from operations |
| (32,751) |
| (36) | % |
|
| (79,749) |
| (100) | % |
|
| (46,998) |
| (59) | % |
Interest income, net |
| 11,520 |
| 13 | % |
|
| 2,316 |
| 3 | % |
| 9,204 |
| 397 | % | |
Other income (expense), net |
| 1,884 |
| 2 | % |
|
| (676) |
| (1) | % |
|
| 2,560 |
| 379 | % |
Loss before income taxes |
| (19,347) |
| (21) | % |
|
| (78,109) |
| (98) | % |
|
| (58,762) |
| (75) | % |
Income tax expense |
| (578) |
| (1) | % |
|
| (10) |
| — | % |
|
| 568 |
| 5,680 | % |
Net loss | $ | (19,925) |
| (22) | % |
| $ | (78,119) |
| (98) | % |
| $ | (58,194) |
| (74) | % |
Revenues
Total revenues increased $11.1 million, or 14%, to $90.8 million for the nine months ended September 30, 2023, compared to $79.7 million for the nine months ended September 30, 2022.
Product revenue of $58.6 million for the nine months ended September 30, 2023 consisted of instrument sales of $12.4 million and sales of consumables and other products of $46.2 million. This represented an increase of $5.5 million, or 10%, compared to product revenue of $53.1 million for the nine months ended September 30, 2022, which consisted of $19.6 million in instrument sales and $33.5 million in sales of consumables and other products. The increase in product revenue was primarily due to a $12.7 million increase in sales of consumables and increased average selling prices. These increases were partially offset by a $7.2 million decrease in instrument sales due to reduced demand, which is a trend we expect to continue for the remainder of 2023. Included in consumables and other product revenue for the nine months ended September 30, 2023 is $0.8 million of one-time revenue, which includes the immaterial fair value adjustment recorded during the third quarter, from the receipt of ordinary shares from UltraDx Limited (“UltraDx”) that was accounted as variable consideration under the UltraDx Agreement (as a Level 3 financial asset with minimal market activity or other data available, the fair value of the ordinary shares was determined primarily using the third-party purchase price of similar instruments issued by UltraDx).
31
Service revenue was $30.1 million for the nine months ended September 30, 2023, compared to $25.7 million for the nine months ended September 30, 2022, an increase of $4.3 million, or 17%. This increase was primarily due to a $6.7 million increase in Accelerator Laboratory revenue due to higher volumes of sample testing and assay development services and a $1.0 million increase in extended service-type warranties, which were partially offset by a $3.7 million decrease in revenue recognized from the Lilly Collaboration Agreement.
Collaboration and license revenue was $1.2 million for the nine months ended September 30, 2023, compared to $0.5 million for the nine months ended September 30, 2022, an increase of $0.8 million, or 158%. The increase was primarily due to a $0.5 million one-time increase from the expiration of a previously paid for option to expand the scope of the Abbott License Agreement.
Grant revenue was $0.9 million for the nine months ended September 30, 2023, compared to $0.4 million for the nine months ended September 30, 2022, an increase of $0.5 million or 146%. This increase was due to the receipt of a portion of the NIH Grant.
Cost of Goods Sold and Services
Cost of goods sold and services decreased $8.5 million, or 19%, to $37.0 million for the nine months ended September 30, 2023 compared to $45.5 million for the nine months ended September 30, 2022.
Cost of product revenue decreased $8.6 million, or 27%, to $22.6 million for the nine months ended September 30, 2023, compared to $31.2 million for the nine months ended September 30, 2022. The decrease was primarily due to improvement in inventory management and manufacturing processes and lower instrument sales.
Cost of service revenue was consistent with the prior period with an increase of $0.1 million, or less than 1%, to $14.4 million for the nine months ended September 30, 2023, compared to $14.3 million for the nine months ended September 30, 2022, primarily due to the increase in Accelerator Laboratory revenue at higher margins.
Research and Development
Research and development expense decreased $2.4 million, or 12%, to $17.9 million for the nine months ended September 30, 2023, compared to $20.3 million for the nine months ended September 30, 2022. This decrease was primarily due to a decrease in compensation and benefit costs related to the reduction in headcount from the Restructuring Plan, which was partially offset by an increase in license fees and professional services to enable product development.
Selling, General, and Administrative
Selling, general and administrative expense decreased $6.7 million, or 9%, to $66.1 million for the nine months ended September 30, 2023, compared to $72.7 million for the nine months ended September 30, 2022. The decrease was primarily due to a decrease in compensation and benefit costs related to the reduction in headcount in from the Restructuring Plan and a full nine months of facilities costs from the leased office and laboratory facilities we are no longer utilizing being recorded in other lease costs instead of selling, general, and administrative expenses on the Consolidated Statements of Operations. These decreases were partially offset by an increase in professional services and consulting fees related to our efforts to remediate the previously disclosed material weaknesses identified in 2022 and other services, and a increase in shipping and handling costs for consumables and other products due to higher volume. Included within selling, general and administrative expense are $6.0 million and $5.3 million of shipping and handling costs for product sales for the nine months ended September 30, 2023 and 2022, respectively.
Other Lease Costs
Other lease costs increased $2.1 million, or 343%, to $2.7 million for the nine months ended September 30, 2023, compared to $0.6 million for the nine months ended September 30, 2022. As part of the Restructuring Plan, we are not utilizing the leased office and laboratory facilities in Bedford, Massachusetts and are
32
evaluating alternatives, including sub-leasing the facilities. Other lease costs include the amortization of the related operating lease right-of-use assets and other leased facility operating expenses from periods after the impairment and the determination that the facilities would not be utilized. The increase is primarily due to the expenses incurred while not utilizing the space for the full nine months of 2023, compared to the expenses incurred while not utilizing the space for one and a half months in the third quarter of 2022 after the Restructuring Plan was implemented. Expenses incurred prior to the Restructuring Plan were recorded in selling, general, and administrative on the Consolidated Statements of Operations.
Impairment and Restructuring Expense
There were no impairment and restructuring costs for the nine months ended September 30, 2023, compared to $20.3 million for the nine months ended September 30, 2022. This decrease was due to the implementation of the Restructuring Plan in August 2022 which did not repeat in 2023. The costs incurred included (1) $8.2 million of goodwill impairment charges, (2) $7.7 million of long-lived asset impairment charges associated with the Bedford, Massachusetts facilities that we are no longer utilizing, (3) $1.0 million of software costs related to projects that were rationalized as part of the Restructuring Plan, and (4) $3.4 million of restructuring expenses primarily for severance and one-time termination benefits in connection with the elimination of 119 positions across the Company.
Interest Income, Net
Interest income, net increased $9.2 million, or 397%, to $11.5 million for the nine months ended September 30, 2023, compared to $2.3 million for the nine months ended September 30, 2022. This increase was primarily due to higher interest rates earned on cash, cash equivalents and marketable securities, and the accretion of discounts from the purchase of marketable securities.
Other Income (Expense), Net
Other income (expense), net increased $2.6 million or 379%, to $1.9 million for the nine months ended September 30, 2023, as compared to ($0.7) million for the nine months ended September 30, 2022. The increase was primarily due to recognizing $2.4 million receivable under the Employee Retention Credit established by the Coronavirus Aid, Relief, and Economic Security Act in 2021.
Income Tax Expense, Net
Income tax expense, net was ($0.6) million for the nine months ended September 30, 2023, as compared to less than ($0.1) million for the nine months ended September 30, 2022.
Liquidity and Capital Resources
Our principal sources of liquidity are cash, cash equivalents, marketable securities, and funds generated from sales of our products and services. As of September 30, 2023, we had cash and cash equivalents of $201.3 million and marketable securities of $126.4 million. Historically we have also financed our operations through equity offerings and borrowings from credit facilities.
As discussed in Note 2 − Significant Accounting Policies and Note 5 − Marketable Securities in the Notes to Consolidated Financial Statements, during the third quarter of 2023 we invested available cash and cash equivalents in a portfolio of marketable securities. These securities are currently classified as available-for-sale and recorded in current assets on the Consolidated Balance Sheets based on their highly liquid nature and because we may use them in our current operations. Our marketable securities are required to be recorded at fair value each reporting period. The fair value is determined utilizing quoted prices in active markets in cases that such information exists (i.e. Level 1 fair value inputs), or third party pricing services and other market observable data (i.e. Level 2 fair value inputs).
33
Cash Flows
The following table summarizes our cash flows (in thousands):
Nine Months Ended September 30, | |||||
2023 |
| 2022 | |||
Net cash used in operating activities | $ | (12,918) | $ | (44,182) | |
Net cash used in investing activities |
| (126,772) |
| (9,611) | |
Net cash provided by financing activities |
| 2,490 |
| 1,597 | |
Net decrease in cash, cash equivalents, and restricted cash | $ | (137,200) | $ | (52,196) |
Net Cash Used in Operating Activities
We derive cash flows from operations primarily from the sale of our products and services. Our cash flows from operating activities are also significantly influenced by our use of cash for operating expenses to develop new products and services, invest in process and product improvements, and increase our sales and marketing efforts. We have historically experienced negative cash flows from operating activities as we have developed our technology, expanded our business, and built our infrastructure. We expect negative cash flows from operating activities may continue in the future.
Net cash used in operating activities was $12.9 million during the nine months ended September 30, 2023. The $31.3 million reduction in net cash used in operating activities from $44.2 million during the nine months ended September 30, 2022 was primarily driven by an overall reduction in our net loss, adjusted for non-cash items, consisting of revenue growth, a full nine months of reduced expenses resulting from the Restructuring Plan implemented in the third quarter of 2022, continued improvements in our inventory management and manufacturing processes leading to improved gross margin, and increased interest income from investing in marketable securities and rising interest rates.
Net Cash Used in Investing Activities
Our primary investing activities consist of purchases of marketable securities and capital expenditures for the purchase of equipment to support our expanding infrastructure and work force. We expect to continue to incur additional capital expenditures related to these efforts in future periods. Cash used towards capital expenditures can be partially offset by proceeds from grants with third parties to purchase assets (refer to the section titled “Grant Revenue” in Note 3 − Revenue and Related Matters in the Notes to Consolidated Financial Statements for more information).
Net cash used in investing activities was $126.8 million during the nine months ended September 30, 2023, which consisted of the purchase of $125.2 million of marketable securities and $1.6 million of purchases of property and equipment.
Net cash used in investing activities was $9.6 million during the nine months ended September 30, 2022, which consisted of $10.1 million of purchases of property and equipment which were partially offset by $0.5 million in grant proceeds under the RADx Grant.
Net Cash Provided by Financing Activities
Our primary financing activities are proceeds from sales of our common stock.
Financing activities provided $2.5 million and $1.6 million of cash during the nine months ended September 30, 2023 and 2022, respectively.
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Capital Resources
We have not achieved profitability on an annual basis since our inception, and we expect to continue to incur net losses in the future. We also expect that our operating expenses will increase as we continue to increase our marketing efforts to drive adoption of our commercial products, as well as our investment in improving the quality of, and expanding, our products and services. Our liquidity requirements have consisted, and we expect that they will continue to consist, of sales and marketing expenses, research and development expenses, working capital, and general corporate expenses.
We believe cash generated from product and services sales, along with our current cash, cash equivalents, and marketable securities, will be sufficient to meet our anticipated operating cash requirements for at least 12 months from the date of this Quarterly Report on Form 10-Q. In the future, we expect our operating and capital expenditures to increase as we increase headcount, expand our sales, marketing, and research and development activities, and grow our customer base. Our estimates of the period of time through which our financial resources will be adequate to support our operations and the costs to expand our business are forward-looking statements and involve risks and uncertainties. Actual results could vary materially and negatively as a result of a number of factors, including the factors discussed in the section titled “Part I, Item 1A. Risk Factors” of our Annual Report on Form 10-K.
We have based our estimates on assumptions that may change or not materialize and we could utilize our available capital resources sooner than we currently expect. Our future funding requirements will depend on many factors, including but not limited to:
● | continued market acceptance of our products and services and the ability of our products to meet our customers’ expectations; |
● | the cost and timing of establishing additional sales, marketing, and distribution capabilities; |
● | the extent to which we achieve revenue improvement and related benefits from our Restructuring Plan; |
● | the extent to which we are able to successfully complete our assay improvement program to enhance product quality; |
● | the cost of our research and development activities; |
● | our ability to enter into collaborations in the future, and the success of any such collaborations; |
● | potential opportunities to strategically acquire and integrate companies or technologies that may be complementary to our business; |
● | the cost and timing of potential regulatory clearances or approvals that may be required in the future for our products; and |
● | the effect of competing technological and market developments. |
We cannot guarantee that we will be able to obtain additional funds on acceptable terms, or at all. If we raise additional funds by issuing equity or equity-linked securities, our stockholders may experience dilution. Future debt financing, if available, may involve covenants restricting our operations or our ability to incur additional debt. Any debt or equity financing that we raise may contain terms that are not favorable to us or our stockholders. If we raise additional funds through collaboration and licensing arrangements with third parties, it may be necessary to relinquish some rights to our technologies or our products or grant licenses on terms that are not favorable to us. If we do not have or are not able to obtain sufficient funds, we may have to delay development or commercialization of our products and services. We also may have to reduce marketing, customer support or other resources devoted to our products, or cease operations.
If the conditions for raising capital are favorable, we may seek to finance future cash needs through public or private equity, debt offerings, or other financings.
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Contractual Obligations and Commitments
As of September 30, 2023, there have been no material changes to our contractual obligations and commitments from those described in the section titled “Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K.
In addition to these cash commitments disclosed in our Annual Report on Form 10-K, we may have other payables and liabilities that may be legally enforceable but are not considered contractual commitments.
Critical Accounting Policies and Estimates
Our critical accounting policies and significant estimates that involve a higher degree of judgment and complexity are described in the section titled “Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies, Significant Judgments and Estimates” included in our Annual Report on Form 10-K.
There have been no material changes to our critical accounting policies and estimates as previously disclosed in that report.
Related Party Transactions
Refer to Note 14 − Related Party Transactions in the Notes to Consolidated Financial Statements included in this Quarterly Report on Form 10-Q for a full description of related party transactions.
Non-GAAP Financial Measures
To supplement our financial statements presented on a U.S. GAAP basis, we present non-GAAP gross profit, non-GAAP gross margin, non-GAAP total operating expenses, and non-GAAP loss from operations, which are calculated by including shipping and handling costs for product sales within cost of goods sold instead of within selling, general, and administrative expenses. Management uses these non-GAAP measures to evaluate our operating performance in a manner that allows for meaningful period-to-period comparison and analysis of trends in our business and our competitors. Management believes that presentation of these non-GAAP measures provides useful information to investors in assessing our operating performance within our industry and in order to allow comparability to the presentation of other companies in our industry where shipping and handling costs are included in cost of goods sold for products. Management also uses these non-GAAP measures as a factor in assessing our progress against the Restructuring Plan. The non-GAAP financial information presented here should be considered in conjunction with, and not as a substitute for, the financial information presented in accordance with U.S. GAAP.
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Set forth below is a reconciliation of non-GAAP gross profit, non-GAAP gross margin, non-GAAP total operating expenses, and non-GAAP loss from operations to their most directly comparable GAAP financial measures.
Reconciliation of U.S. GAAP Financial Measures to Non-GAAP Financial Measures:
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||
GAAP gross profit | $ | 17,783 | $ | 10,944 | $ | 53,847 | $ | 34,214 | |||
Shipping and handling costs | (2,553) | (1,639) | (6,004) | (5,288) | |||||||
Non-GAAP gross profit | $ | 15,230 | $ | 9,305 | $ | 47,843 | $ | 28,926 | |||
GAAP revenue | $ | 31,334 | $ | 26,646 | $ | 90,819 | $ | 79,698 | |||
GAAP gross margin (gross profit as % of revenue) | 56.8% | 41.1% | 59.3% | 42.9% | |||||||
Non-GAAP gross margin (non-GAAP gross profit as % of revenue) | 48.6% | 34.9% | 52.7% | 36.3% | |||||||
GAAP total operating expenses | $ | 31,553 | $ | 47,547 | $ | 86,598 | $ | 113,963 | |||
Shipping and handling costs | (2,553) | (1,639) | (6,004) | (5,288) | |||||||
Non-GAAP total operating expenses | $ | 29,000 | $ | 45,908 | $ | 80,594 | $ | 108,675 | |||
GAAP loss from operations | $ | (13,770) | $ | (36,603) | $ | (32,751) | $ | (79,749) | |||
Non-GAAP loss from operations | $ | (13,770) | $ | (36,603) | $ | (32,751) | $ | (79,749) |
Recent Accounting Pronouncements
Refer to Note 2 − Significant Accounting Policies in the Notes to Consolidated Financial Statements included in this Quarterly Report on Form 10-Q for a full description of recent accounting pronouncements, including the expected dates of adoption and effects on our Consolidated Financial Statements.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
As of September 30, 2023, there have been no material changes to the market risk information from those described in the section titled “Part II, Item 7A. Quantitative and Qualitative Disclosures About Market Risk” included in our Annual Report on Form 10-K.
Item 4. Controls and Procedures
As previously disclosed in the section titled “Part II, Item 9A. Controls and Procedures” in our Annual Report on Form 10-K, management concluded that our internal control over financial reporting was not effective at a reasonable assurance level as of December 31, 2022, due to certain deficiencies that constituted material weaknesses in our internal control over financial reporting. 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 our annual or interim financial statements will not be prevented or detected on a timely basis.
Management has been actively engaged in the implementation of remediation efforts to address the material weaknesses, as well as other identified areas of risk. For a complete description of management’s remediation plan, refer to the section titled “Part II, Item 9A. Controls and Procedures” in our Annual Report on Form 10-K, as may be updated by Part I. Item 4. “Controls and Procedures” of our subsequently filed Quarterly Reports on Form 10-Q. For updates on management’s remediation plan as of September 30, 2023, refer to the section titled “Management’s Implementation of Remediation Plan” below.
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Evaluation of 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 and principal accounting officer), to allow timely decisions regarding required disclosures. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Our disclosure controls and procedures are designed to provide a reasonable assurance of achieving their objectives. 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 September 30, 2023. Because we commenced implementing efforts to remediate the material weaknesses in our internal control over financial reporting in March 2023 and we have not had a sufficient period of time to test the operating effectiveness of our internal control over financial reporting, which we view as an integral part of our disclosure controls and procedures, 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 September 30, 2023.
Nevertheless, based on a number of factors, including the performance of additional procedures by management designed to ensure the reliability of our financial reporting, we believe that the Consolidated Financial Statements in this Quarterly Report on Form 10-Q fairly present, in all material respects, our financial position, results of operations, and cash flows as of the dates, and for the periods, presented, in conformity with U.S. GAAP.
Management’s Implementation of Remediation Plan
Management, with oversight from the Audit Committee of our Board of Directors, previously commenced implementing changes to our internal control over financial reporting in order to remediate the control deficiencies that resulted in the material weaknesses as previously disclosed in our Annual Report on Form 10-K. As of September 30, 2023, we are on track with the remediation plan disclosed therein. Our ongoing efforts for remediation include, but are not limited to, the following:
● | we have hired a Corporate Controller and an Assistant Controller and are actively continuing to hire 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. In the interim we continue 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. We will continue to utilize such consultants until we have filled vacancies with qualified personnel, with a sufficient period of overlap to ensure successful transition of responsibilities; |
● | we engaged a third-party service provider who has performed an assessment of our internal control design and operation and provided us recommendations to enhance the effectiveness of such controls, and we are currently in the process of implementing these recommendations; |
● | we have engaged a third-party consultant who assessed our current enterprise resource planning system and identified opportunities to enhance our use of the system through automating certain controls and processes, for which development of system enhancements are actively underway; and |
● | we have engaged an accounting advisory consultant who has 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, which trainings will continue throughout fiscal year 2023. |
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We will continue our efforts through fiscal year 2023 to remediate the material weaknesses described in our Annual Report on Form 10-K and expect to implement all necessary recommendations during fiscal year 2023. We are actively executing the remediation plan and are focused on implementing those recommendations deemed as high priority. 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 material weaknesses.
Given that many of the remediation efforts described above were recently implemented and continue to undergo independent testing, we will not be able to consider the material weaknesses remediated until the applicable remedial controls operate for a sufficient period of time and management has concluded, through testing, that our controls are operating effectively. We, along with our Audit Committee, will continue to monitor and evaluate the effectiveness of these remedial actions and take further actions as we deem appropriate.
Changes in Internal Control over Financial Reporting
Other than the changes outlined above to remediate the material weaknesses, there have been no changes in our internal control over financial reporting during the quarter ended September 30, 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II — OTHER INFORMATION
Item 1. Legal Proceedings
In the ordinary course of business, we are from time to time involved in lawsuits, claims, investigations, proceedings and threats of litigation consisting of intellectual property, contractual, employment, and other matters. While the outcome of any such actions or proceedings cannot be predicted with certainty, as of September 30, 2023, we were not party to any legal proceedings, the outcome of which would be expected to have a material adverse effect on our financial condition or results of operations.
Item 1A. Risk Factors
Our business is subject to risks and events that, if they occur, could adversely affect our financial condition, results of operations, or the price of our common stock. In addition to the other information set forth in this Quarterly Report on Form 10-Q, you should carefully consider the risk factors described in the section titled “Part I, Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the SEC on March 6, 2023 (the “Annual Report on Form 10-K”). Those risk factors are not the only risks we face. Additional risks and uncertainties not currently known to us or that we deem to be not material also may adversely affect our business, financial condition, and results of operations.
As of the date of this Quarterly Report on Form 10-Q, there were no material changes to the risk factors described in our Annual Report on Form 10-K.
Item 2. Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities
Not applicable.
Item 3. Defaults Upon Senior Securities
Not applicable.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
Securities Trading Plans of Directors and Executive Officers
On
On
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Item 6. Exhibits
Exhibit |
| Exhibit Description | Filed | Incorporated by from Form or Schedule | Filing Date | SEC File/ | ||||
3.1 | 8-K | 12/15/2017 | 001-38319 | |||||||
3.2 | 10-Q | 8/8/2023 | 001-38319 | |||||||
10.1 | Employment Agreement dated August 3, 2023 between Vandana Sriram and the Company. | 8-K | 8/9/2023 | 001-38319 | ||||||
31.1 | X | |||||||||
31.2 | X | |||||||||
32.1 | X | |||||||||
101.INS | XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. | X | ||||||||
101.SCH | XBRL Taxonomy Extension Schema Document. | X | ||||||||
101.CAL | XBRL Taxonomy Extension Calculation Linkbase Document. | X | ||||||||
101.DEF | XBRL Taxonomy Extension Definition. | X | ||||||||
101.LAB | XBRL Taxonomy Extension Label Linkbase Document. | X | ||||||||
101.PRE | XBRL Taxonomy Extension Presentation Linkbase Document. | X | ||||||||
104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). | X |
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SIGNATURES
Pursuant to the requirements 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 | |||
Dated: November 7, 2023 | By: | /s/ Masoud Toloue | |
Masoud Toloue | |||
President and Chief Executive Officer | |||
(principal executive officer) |
Dated: November 7, 2023 | By: | /s/ Vandana Sriram | |
Vandana Sriram | |||
Chief Financial Officer | |||
(principal financial officer and principal accounting officer) |
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Exhibit 31.1
CERTIFICATIONS UNDER SECTION 302
I, Masoud Toloue, certify that:
1. I have reviewed this quarterly report on Form 10-Q of Quanterix Corporation;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
Date: November 7, 2023
/s/ Masoud Toloue | |
Masoud Toloue | |
President and Chief Executive Officer | |
(principal executive officer) | |
Exhibit 31.2
CERTIFICATIONS UNDER SECTION 302
I, Vandana Sriram, certify that:
1. I have reviewed this quarterly report on Form 10-Q of Quanterix Corporation;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
Date: November 7, 2023
/s/ Vandana Sriram | |
Vandana Sriram | |
Chief Financial Officer | |
(principal financial officer and principal accounting officer) | |
Exhibit 32.1
CERTIFICATIONS UNDER SECTION 906
Pursuant to section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350, chapter 63 of title 18, United States Code), each of the undersigned officers of Quanterix Corporation, a Delaware corporation (the “Company”), does hereby certify, to such officer’s knowledge, that:
The Quarterly Report for the period ended September 30, 2023 (the “Form 10-Q”) of the Company fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, and the information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of the Company.
Dated: November 7, 2023 | /s/ Masoud Toloue |
| Masoud Toloue |
| President and Chief Executive Officer |
| |
| |
Dated: November 7, 2023 | /s/ Vandana Sriram |
| Vandana Sriram |
| Chief Financial Officer |