QTRX 10-K & 10-Q changes, risk factors and insider trading
Quanterix Corp · Nasdaq · Laboratory Analytical Instruments · CIK 1503274 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “Our quarterly and annual operating results and cash flows have fluctuated in the past, and our operating results may continue to fluctuate, which could cause the value of our common stock to fluctuate or decline significantly.”
New heading “We have incurred annual losses since our formation, and we expect to incur losses in the future. We cannot be certain that we will achieve or sustain profitability.”
New heading “Inherent limitations associated with, our internal control over financial reporting could result in material misstatements in our financial statements.”
New heading “We may fail to achieve the remaining expected cost savings and related benefits from our cost reduction actions, and the consequences of those actions may adversely impact our business.”
New heading “Recent transitions in our board of directors and management could result in changes in our strategic plan, product focus, and investment priorities, and we might not realize the anticipated benefits from any such changes.”
New heading “Changes in U.S. government policies, including reductions in federal research funding and the impacts of tariffs, are adversely affecting our business, though the full extent of the impact is uncertain. Similarly, there is substantial uncertainty regarding how the current administration’s initiatives might impact the FDA, its implementations of laws, regulations, policies and guidance and its personnel, which could prevent, limit or delay development and regulatory approval of our future diagnostic products.”
New heading “Inability to adapt to and effectively incorporate potential advantages of artificial intelligence (“AI”) could negatively impact our ability to compete, and inability to manage the risks of AI could expose us to liability or put us at a disadvantage.”
New heading “We depend heavily on intellectual property licensed from third parties, including our license agreements with Tufts University for our Simoa bead-based technology, Stanford University for our PhenoCycler product, and the University of Washington and Revvity (formerly Perkin Elmer, Inc.) for our PhenoImager product, and our licensors may not always act in our best interest. If such owners do not properly or successfully obtain, maintain or enforce the patents underlying such licenses, or if they retain or license to others any competing rights, our competitive position and business prospects may be adversely affected.”
New heading “Our rights to develop and commercialize our products and technologies are subject, in part, to the terms and conditions of licenses granted to us by others.”
Removed heading “Risks Related to the Merger and the Combined Company”
Removed heading “Risks Related to Our Business”
Removed heading “Risks Relating to the Merger”
Removed heading “The Merger may not be completed and the Merger Agreement may be terminated in accordance with its terms.”
Removed heading “Failure to complete the Merger could negatively impact our future business and financial results and the trading price of our common stock.”
Removed heading “Actions of activist or dissident stockholders could delay or prevent the approval of the Merger and negatively affect our business and operations.”
Removed heading “The issuance of shares of our common stock to Akoya stockholders in connection with the Merger may cause the market price of our common stock to decline.”
Removed heading “After the Merger, our stockholders will have a reduced ownership and voting interest in the Combined Company and may not realize a benefit from the Merger commensurate with their ownership dilution.”
Removed heading “Until the completion of the Merger or the termination of the Merger Agreement pursuant to our terms, we are prohibited from entering into certain transactions and taking certain actions that might otherwise be beneficial to us and our stockholders.”
Removed heading “Obtaining required approvals and satisfying closing conditions may prevent or delay completion of the Merger, and regulatory approvals may not be received, may take longer than expected or may impose conditions that are not presently anticipated or cannot be met.”
Removed heading “Failure to attract, motivate and retain executives and other key employees could diminish the anticipated benefits of the Merger.”
Removed heading “The Merger, and uncertainty regarding the Merger, may cause our customers, service providers, partners, vendors, suppliers and other business relationships to delay or defer decisions and adversely affect our ability to effectively manage our business, which could adversely affect our business, operating results and financial position and, following the completion of the Merger, the Combined Company’s business, operating results and financial position.”
Removed heading “Whether or not the Merger is completed, the announcement and pendency of the Merger could cause disruptions in our business, which could have an adverse effect on our business and financial results.”
Removed heading “The Merger Agreement contains provisions that could discourage a potential competing acquirer that might be willing to pay more to acquire or merge with us.”
Removed heading “We expect to incur substantial costs related to the Merger and integration.”
Removed heading “Lawsuits or other legal proceedings may be filed against us, Akoya, the Combined Company and members of their respective boards of directors, in connection with the Merger, and an adverse ruling in any such lawsuit may prevent the Merger from becoming effective or from becoming effective within the expected time frame, or have an adverse impact on the Combined Company’s business and operations.”
Removed heading “Certain customers may seek to modify contractual relationships with the Combined Company, which could have an adverse effect on the Combined Company’s business and operations.”
Removed heading “Completion of the Merger may trigger change in control, assignment or other provisions in certain agreements to which Akoya is a party, which may have an adverse impact on the Combined Company’s business and results of operations.”
Removed heading “Failure to remediate material weaknesses in, or inherent limitations associated with, our internal control over financial reporting have resulted in, and in the future could result in, material misstatements in our financial statements.”
Removed heading “The Restatement of our financial statements may affect stockholder and investor confidence in us or harm our reputation, and may subject us to additional risks and uncertainties, including increased costs and the increased possibility of legal proceedings and regulatory inquiries, sanctions or investigations.”
Removed heading “Our quarterly and annual operating results and cash flows have fluctuated in the past and might continue to fluctuate, which could cause the value of our common stock to fluctuate or decline significantly.”
Removed heading “We have incurred annual losses since we were formed and expect to incur losses in the future. We cannot be certain that we will achieve or sustain profitability.”
Removed heading “Risks Related to our Business”
Removed heading “Changes in U.S. government policies, including increased tariffs and potential reductions in federal research funding, could adversely affect our business.”
Removed heading “Our Simoa bead-based technology is licensed to us by Tufts. Any loss of our rights to this technology or other technologies we license could prevent us from selling our products.”
Largest changes
“The Restatement of our financial statements may affect stockholder and investor confidence in us or harm our reputation, and may subject us to additional risks and uncertainties, including increased costs and the increased possibility of legal proceedings and regulatory inquiries, sanctions or investigations.”see in full comparison
“In our Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 6, 2023, we identified four material weaknesses in our internal control over financial reporting relating to the operating effectiveness of our internal controls, including a material weakness associated with (i) the accounting for inventory, including excess and obsolescence reserves (the “Inventory MW”), (ii) the accounting for salaries and commissions expense (the “Compensation MW”), (iii) the financial statement close process, including financial reporting, share-based compensation and …”see in full comparison
“We have incurred, and may continue to incur, substantial unanticipated costs for accounting and legal fees in connection with, or related to, the Restatement. The Restatement could also subject us to other risks and uncertainties, including the increased possibility of legal proceedings and inquiries, sanctions, or investigations by the SEC or other regulatory authorities relating to the Restatement. …”see in full comparison
“Our efforts to remediate outstanding material weaknesses, and to maintain effective internal control over financial reporting, are ongoing; however, there are inherent limitations in all control systems and no evaluation of controls can provide absolute assurance that all deficiencies have been detected. We cannot assure you that additional material weaknesses in our internal control over financial reporting will not arise or be identified in the future. …”see in full comparison
“Our efforts to maintain effective internal control over financial reporting, are ongoing; however, there are inherent limitations in all control systems and no evaluation of controls can provide absolute assurance that all deficiencies have been detected. We cannot assure you that additional material weaknesses in our internal control over financial reporting will not arise or be identified in the future. …”see in full comparison
“•The restatement of our financial statements as of December 31, 2023 and 2022 and for each of the three years in the period ended December, 31 2023 and for the quarterly and year-to-date (as applicable) periods ended March 31, 2022, June 30, 2022, September 30, 2022, March 31, 2023, June 30, 2023, September 30, 2023, March 31, 2024, and June 30, 2024 (the “Restatement”) may affect stockholder and investor confidence in us or harm our reputation, and may subject us to additional risks and uncertainties, including increased costs and the increased possibility of legal proceedings and regulatory …”see in full comparison
Full comparison: every changed paragraph (228)
The following risk factors and other information included in this Annual Report on Form 10-K should be carefully considered. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties not presently known to us or that we presently deem less significant may also impair our business operations. Please see page ii of this Annual Report on Form 10-K for a discussion of some of the forward-looking statements that are qualified by these risk factors. If any of the following risks occur, our business, financial condition, results of operationsoperations, and future growth prospects could be materially and adversely affected.
Risks Related to the Merger and the Combined Company
•The Merger may not be completed and the Merger Agreement may be terminated in accordance with its terms.
•The market price for shares of our common stock may be affected by factors different from, or in addition to, those that historically have affected or currently affect the market price of shares of Akoya common stock.
•Actions of activist or dissident stockholders could delay or prevent the approval of the Merger and negatively affect our business and operations.
•The issuance of shares of our common stock to Akoya stockholders in connection with the Merger may cause the market price of our common stock to decline.
•The Merger, and uncertainty regarding the Merger, may cause our customers, service providers, partners, vendors, suppliers and other business relationships to delay or defer decisions concerning us and adversely affect our ability to effectively manage our business, which could adversely affect our operating results and financial position and, following the completion of the Merger, the business, operating results and financial position of us and Akoya as a combined company (the “Combined Company”).
•Whether or not the Merger is completed, the announcement and pendency of the Merger could cause disruptions in our business, which could have an adverse effect on our business and financial results.
•The Merger Agreement contains provisions that could discourage a potential acquirer from acquiring or merging with us.
•We expect to incur substantial costs related to the Merger and integration.
•Combining our business and the business of Akoya may be more difficult, costly or time-consuming than expected and the Combined Company may fail to realize the anticipated benefits of the Merger, which may adversely affect the Combined Company’s business results and negatively affect the value of our common stock following completion of the Merger.
Risks Related to Our Business
•Failure to remediate material weaknesses in, or inherent limitations associated with, our internal control over financial reporting have resulted in, and in the future could result in, material misstatements in our financial statements.
•The restatement of our financial statements as of December 31, 2023 and 2022 and for each of the three years in the period ended December, 31 2023 and for the quarterly and year-to-date (as applicable) periods ended March 31, 2022, June 30, 2022, September 30, 2022, March 31, 2023, June 30, 2023, September 30, 2023, March 31, 2024, and June 30, 2024 (the “Restatement”) may affect stockholder and investor confidence in us or harm our reputation, and may subject us to additional risks and uncertainties, including increased costs and the increased possibility of legal proceedings and regulatory inquiries, sanctions or investigations.
•Inherent limitations associated with our internal control over financial reporting could result in material misstatements in our financial statements.
•Integrating our business with that of Akoya may be more difficult, costly or time-consuming than expected and we may fail to realize the remaining anticipated benefits of the acquisition, which may adversely affect our business results and negatively affect the value of our common stock.
•We may not achieve the remaining expected cost savings and related benefits from our cost reduction actions, and the consequences of those actions may adversely impact our business.
•Recent turnover in our board of directors and management could result in changes in our strategic plan, product focus, and investment priorities, and we might not realize the anticipated benefits from any such changes.
•Sales of our Simoa-based assays for neurological indications have become increasingly important to our business, and anythere significantcan decreasebe inno salesassurance that we will be able to continue to generate meaningful revenue from the sale of such assays could have a material adverse effect on our business.products.
•The sales cycle for our instruments can be lengthy and variable, which makes it difficult for us to forecast revenue and other operating results.
•Purchase of our instruments by our customers requires a significant capital investment which can impact sales in times of constrained spending.
•Our long-term results depend upon our ability to improve existing products, develop or acquire new technology,products and develop, introduce and market new products successfully.
•We may experience delays in launching and commercializing our next-generation instrument, Simoa ONE,instruments, on our anticipated timeline, which could adversely affect our business, financial condition, and results of operations.
•We generate a substantial portion of our revenue internationally and we expect this will continue in the future; as a result, our business is subject to various risks relating to our international activities, which could adversely affect our business, operating results, and financial condition.
•Our reliance on distributors for sales of our products outside of the United States could impact our revenue.
•We rely on a single contract manufacturermanufacturers for ourcertain Simoakey HD-X instrument and on a different single contract manufacturer for our Simoa SR-X instrument, and we expect to rely on a different single contract manufacturer for our new Simoa ONE instrument.instruments. If any of these manufacturers should fail to perform, or not perform satisfactorily, our ability to supply these instruments would be negatively and adversely affected.affected, which could have a material adverse effect on our business, financial condition, results of operations, and reputation.
•We rely on a limited number of suppliers or, in some cases, one supplier, for some of our materials and components used in our consumable products and certain of our SP-X instrument,instruments, and we may not be able to find replacements or immediately transition to alternative suppliers if any of these suppliers fail to perform, which could have a material adverse effect on our business, financial condition, results of operationsoperations, and reputation.
•Changes in U.S. government policies, including the impacts of tariffs and potential reductions in federal research funding, could adversely affect our business. Similarly, there is substantial uncertainty regarding how the administration’s initiatives might impact the FDA, its implementations of laws, regulations, policies and guidance and its personnel, which could prevent, limit or delay development and regulatory approval of our future diagnostic products.
•Changes in U.S. government policies, including increased tariffs and potential reductions in federal research funding, could adversely affect our business.
•If the FDA determines that our products are subject to regulation as medical devices, if theCongress enacts new laws that subject our LDT to FDA modifies its regulations to require that our LDTs are subject to regulation as devices, orregulation, if we seek to market our products for clinical diagnostic or health screening use, or if we will be requiredcontinue to complyexpand withour medicalproduct, devicetechnology law,and includingservice inofferings someand casesthe aapplications requirementand uses of our products into new fields, we expect to obtainbecome subject to additional government regulations, and the regulatory clearance(s)approval orand approval(s). Any such regulatorymaintenance process would be expensive, time-consuming and uncertain both in timing and in outcome.
•Our products may in the future be subject to product recalls that could harm our reputation, business, and financial results.
•U.S. legislative, FDA, or global regulatory reforms may make it more difficult and costly for us to obtain any required regulatory approval of our product candidates and to manufacture, market, and distribute our products after approval is obtained.
•If we do not comply with governmental regulations applicable to our CLIA-certified laboratory, we may not be able to continue our laboratory operations or continue offering our LDTs.
•We expect to rely on third parties in conducting any required future studies of diagnostic products that may be required by the FDA or other regulatory authorities, and those third parties may not perform satisfactorily.
•If diagnostic procedures that are enabled by our technology are subject to unfavorable pricing regulations or third-party coverage and reimbursement policies, our business could be harmed.
•We depend on our information technology systems, and any failure of these systems could harm our business.
•Cybersecurity breaches, loss of data and other disruptions could compromise sensitive information related to our business or prevent us from accessing critical information and expose us to liability, which could adversely affect our business and our reputation.
•Inability to adapt to and effectively incorporate potential advantages of artificial intelligence ("AI") could negatively impact our ability to compete, and inability to manage the risks of AI could expose us to liability or put us at a disadvantage.
Our quarterly and annual operating results and cash flows have fluctuated in the past, and our operating results may continue to fluctuate, which could cause the value of our common stock to fluctuate or decline significantly.
We have incurred annual losses since our formation, and we expect to incur losses in the future. We cannot be certain that we will achieve or sustain profitability.
Quanterix incurred net losses of $107.2 million, $38.5 million, and $28.4 million for the years ended December 31, 2025, 2024, and 2023, respectively. Akoya incurred net losses of $55.4 million, and $63.3 million for the years ended December 31, 2024, and 2023, respectively. We cannot predict if or when we will achieve profitability or if we will be able to sustain profitability once achieved. We expect that our operating losses will continue into 2026 as we execute our growth strategy. We may incur significant losses in the future for a number of reasons, many of which are beyond our control, including any need for incremental investments to fund our strategic objectives, unanticipated delays or obstacles in the integration of Akoya’s business with ours, the market acceptance of our products, competitive products, future product development and our market penetration and margins, and other risks described in this Annual Report on Form 10-K and our other reports filed with the SEC.
Inherent limitations associated with, our internal control over financial reporting could result in material misstatements in our financial statements.
In our Annual Reports on Form 10-K for the years ended December 31, 2022, 2023 and 2024, we disclosed certain material weaknesses in our internal control over financial reporting relating to the operating effectiveness of our internal controls. We have remediated these previously disclosed material weaknesses.
Our efforts to maintain effective internal control over financial reporting, are ongoing; however, there are inherent limitations in all control systems and no evaluation of controls can provide absolute assurance that all deficiencies have been detected. We cannot assure you that additional material weaknesses in our internal control over financial reporting will not arise or be identified in the future. If we are unable to maintain the effectiveness of our internal control over financial reporting or our disclosure controls and procedures, we could lose investor confidence in the accuracy and completeness of our financial reports, the market price of our common stock could decline, and we could be subject to regulatory scrutiny, civil, or criminal penalties, or litigation. Future failure to maintain effective internal control over financial reporting could also result in financial statements that do not accurately reflect our financial condition or results of operations, may result in material misstatements in our financial statements, and may also restrict our future access to the capital markets.
We have incurred significant expense and dedicated significant internal resources to address the previously disclosed material weaknesses, and our remediation efforts and activities have required attention and focus from management. There can be no assurance that we will not identify additional significant deficiencies or material weaknesses that will impair our ability to report our financial condition and results of operations accurately or on a timely basis.
As of December 31, 2025, we had forecasted federal net operating loss (“NOLs”) carryforwards to offset future taxable income of approximately $597.7 million, of which approximately $111.1 million begin to expire in 2026. A lack of future taxable income would adversely affect our ability to utilize these NOLs. In addition, under Section 382 of the Internal Revenue Code of 1986, as amended (the “Code”), a corporation that undergoes an “ownership change” is subject to limitations on our ability to utilize our NOLs to offset future taxable income. We may have already experienced ownership changes as defined under Section 382 of the Code. Depending on the timing of any future utilization of our NOLs, the amount that can be utilized each year may be limited as a result of such previous ownership changes. In addition, future changes in our stock ownership, including changes that may be outside of our control, could result in additional ownership changes under Section 382 of the Code. Our NOLs may also be impaired under similar provisions of state law. We have recorded a full valuation allowance related to our NOLs and other deferred tax assets due to the uncertainty of the ultimate realization of the future benefits of those assets.
Risks Relating to the Merger
The Merger may not be completed and the Merger Agreement may be terminated in accordance with its terms.
The Merger is subject to a number of conditions that must be satisfied (or waived, to the extent permitted), including (i) receipt of the approval of the issuance of shares of our common stock in the Merger by our stockholders; (ii) receipt of the approval of the Merger by Akoya stockholders; (iii) the effectiveness of the registration statement on Form S-4 filed with the SEC in connection with the Merger; (iv) the absence of any order issued or entered, or any law enacted or promulgated having the effect of restraining, enjoining, making illegal or otherwise prohibiting the consummation of the Merger; (v) the submission by us to Nasdaq of a notification of shares of our common stock to be issued in connection with the Merger; (vi) performance by each party of its respective obligations under the Merger Agreement; and (vii) the absence of a material adverse effect with respect to each of Akoya and us. These conditions to the completion of the Merger, some of which are beyond our control, may not be satisfied or waived in a timely manner or at all, and, accordingly, the Merger may be delayed or not completed. Additionally, either we or Akoya may terminate the Merger Agreement under certain circumstances, subject to the payment of a termination fee of $9 million by us to Akoya or $7 million by Akoya to us in certain cases. These termination fees may have the effect of discouraging alternative transaction proposals. We have incurred and will incur costs in connection with entering into the Merger Agreement and consummating the Merger, many of which will be payable by us whether or not the Merger is completed. Even if the Merger Agreement is terminated under circumstances that would require Akoya to pay us a $7 million termination fee, it may not cover all of the expenses and costs we have incurred.
Failure to complete the Merger could negatively impact our future business and financial results and the trading price of our common stock.
If the Merger is not completed for any reason, our ongoing business may be adversely affected and, without realizing any of the expected benefits of having completed the Merger, we would be subject to a number of risks, including the following:
•we may experience negative reactions from the financial markets, including negative impacts on our stock price;
•we may experience negative reactions from our customers, service providers, partners, vendors, suppliers and employees;
•it could negatively impact our ability to achieve future growth, expand our addressable market and achieve scale and profitability on expected timelines;
•we will have incurred substantial costs towards completion of the Merger and will generally be required to pay our costs relating to the Merger, such as financial advisory, legal, strategic advisory, accounting costs and associated fees and expenses, whether or not the Merger is completed;
•we may provide up to $30 million in bridge financing to Akoya, which would be subordinated to Akoya’s existing credit facility, and if the Merger is not completed for any reason, Akoya may not have the financial resources to repay the bridge financing when due, or at all; and
•we will have committed substantial time and resources to matters relating to the Merger (including integration planning) which would otherwise have been devoted to day-to-day operations and other opportunities that may have been beneficial to us as an independent company.
Actions of activist or dissident stockholders could delay or prevent the approval of the Merger and negatively affect our business and operations.
Recently one of our stockholders has indicated that it intends to oppose the Merger. In addition, on March 3, 2025, the same stockholder announced that it is nominating three directors for election to the Board at our 2025 annual meeting of stockholders. As a result of these actions, we will incur significant expenses even if we are successful in completing the Merger or are successful in a potential proxy contest.
In addition, perceived uncertainties as to our future direction, strategy, or leadership, and the diversion of management's and our board of director's attention and resources from our business, created by such activism may result in the loss of business opportunities and make it more difficult to complete strategic transactions or attract and retain investors, customers, employees, and other business partners. Such stockholder activism may also cause significant fluctuation in our stock price based on temporary or speculative market perceptions or other factors that do not necessarily reflect the underlying fundamentals and prospects of our business. We cannot predict the outcome or timing of any matters relating to stockholder activism or potential proxy contests or the ultimate impact that such matters may have on our business, liquidity, financial condition, or results of operations.
Management's Discussion & Analysis (MD&A)
New heading “Akoya Biosciences, Inc.”
New heading “FDA 510(k) Submission for a Multi-Analyte Algorithmic Blood Test for Alzheimer’s Disease Detection”
New heading “LucentAD Complete Medicare Pricing”
New heading “Goodwill Impairment”
New heading “Restructuring Costs”
New heading “PKI/Revvity License Agreement”
New heading “Acquired Goodwill, Intangible Assets, and Contingent Liabilities”
New heading “Impairment of Long-Lived Assets”
Removed heading “ISO 13485 Certification”
Removed heading “Agreement to Acquire Akoya Biosciences, Inc.”
Removed heading “Assay Redevelopment Program”
Removed heading “Interest Income”
Removed heading “Other Income (Expense), Net”
Removed heading “Income Tax Expense”
Removed heading “Interest Income”
Removed heading “Other Income (Expense), Net”
Removed heading “Inventory Reserves”
Removed heading “Reconciliation of Gross Profit, Gross Margin, Total Operating Expenses and Loss from Operations to”
Largest changes
“Selling, general and administrative expense increased $12.5 million, or 14% to $101.6 million for the year ended December 31, 2024, compared to $89.1 million for the year ended December 31, 2023. …”see in full comparison
“During 2025, we assessed several events and circumstances, including a larger than expected decline in the Company's revenue and bookings primarily due to the rapidly changing macro-economic conditions resulting from reductions in U.S. federal research funding, reductions in research and development spending by larger pharmaceutical customers, and new import tariffs. …”see in full comparison
Wesee in full comparisondid not incur anyrecorded impairment and restructuring costsforofthe year ended December 31, 2024, compared to $1.3$15.7 million for the year ended December 31,2023.2025Duringrelating2023,toweaincurred long-lived assetgoodwill impairmentchargescharge,associatedseverancewithand related benefit expenses from the 2025 restructuring actions, and impairment of leased facilities acquired in the Akoya acquisition that wewereare not using. No such costs were recorded in the year ended December 31, 2024.
“Acquired Goodwill, Intangible Assets, and Contingent Liabilities”see in full comparison
Full comparison: every changed paragraph (155)
The discussion and analysis of our financial condition as of, and results of operations for the year ended December 31, 20232024 as compared to the year ended December 31, 20222023 is included in the section titled “Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Amendment No. 1 to our Annual Report on Form 10-K/A for the year ended December 31, 2023,2024, as filed with the U.S Securities and Exchange Commission (the "SEC") on DecemberMarch 23,17, 2024.2025.
We are a life sciences company thattransforming developshealthcare andinnovation commercializesby next-generation,accelerating biomarker breakthroughs from discovery to diagnostics using our ultra-sensitive digital immunoassay platforms that advance life sciencestranslational research and diagnostics.spatial Ourbiology platformsinstruments, are based on our proprietary digital “Simoa” detection technologyconsumables, and enableservices. customersWe continue to reliably detect protein biomarkers at ultra-low concentrationsinvest in blood, serum and other fluids that, in many cases, are undetectable using conventional, analog immunoassay technologies. The ability of our Simoa platforms to detect proteins in the femtomolar range enables the development of novel therapies and diagnostics and has the potential to identify early-stage disease markers before symptoms appear to facilitatepushing a paradigm shift in healthcare from an emphasis on later-stage treatment to a focus on earlier detection, monitoring, prognosis, and, ultimately, prevention. Our Simoacombined platforms have achieved significant commercial adoption with an installed base of over 1,0002,500 instruments,instruments and scientific validation with citations in more than 3,2006,200 scientific publications in areas of high unmet medical need and research interest such as neurology, oncology andoncology, immunology, and inflammation.
Our proprietary digital “Simoa” detection technology enables customers to reliably detect protein biomarkers at ultra-low concentrations in blood, serum and other fluids that, in many cases, are undetectable using conventional, analog immunoassay technologies. Multi-plexing biomarker analysis in tissue samples with our “Spatial Biology” platforms enables scientists to understand the localized interactions occurring on the cellular level. We believe our combination of technologies will enable scientists to help drive diagnostic innovation in the evolving healthcare landscape with data across the tissue to fluid continuum. Currently, the ability of our Simoa platforms to detect proteins in the femtomolar range is enabling the development of novel therapies and diagnostics and has the potential to identify early-stage disease markers before symptoms appear.
Our instruments are designed to be used either with assays fully developed by us, including all antibodies and supplies required to run the assays, or with “"homebrew”" assay 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 Simoaour instruments increases, we expect total consumables revenue to increase.
We commercially launched our HD-X instrument in the second half of 2019. The HD-X is an upgraded version of the Simoa HD-1 (our first Simoa instrument, launched in January 2014), collectively “HD Instruments”, that is designed to deliver significant productivity and operational efficiency improvements, as well as greater user flexibility. The HD-X uses our bead-based technology and assays run on the HD-X are fully automated. At December 31, 2024, approximately 84% of the HD Instrument installed base were HD-X instruments.
Further, we launched our SR-X instrument in 2017 as a compact desktop instrument with a lower price point, more flexible assay preparation, and a wider range of applications. The SR-X utilizes the same Simoa bead-based technology and assay kits as the HD-X.
With our acquisition of Aushon BioSystems, Inc. in 2018, we acquired their CLIA certified laboratory and their proprietary sensitive planar array detection technology. The Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) are federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States (with the exception of research testing that does not report patient specific results). 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 (“NfL”), antibodies, and enzyme-linked immunoassay (“ELISA”) kits, which are used by researchers and biopharmaceutical and diagnostics companies world-wide in the detection of NfL to advance the development of therapeutics and diagnostics for neurodegenerative conditions.
We also provide contract research services forand customersclinical andlaboratory testing services, including four Laboratory Developed TestTests (“"LDT”"), servicesusing our proprietary Simoa and Spatial Biology technology through our CLIA-certified Accelerator Laboratory. The Accelerator Laboratory provideswhich customersis withcertified accessunder tothe SimoaClinical technology,Laboratory andImprovement supportsAmendments multipleof projects1988 and("CLIA") services,(the including"Accelerator sample testing, homebrew assay development, custom assay development, and blood-based biomarker testing.Laboratory"). To date, we have completed over 2,4002,600 projects for more than 500 customers from all over the world using our Simoa platforms.
We have an extensive base of worldwide customers including pharmaceutical,research biotechnology,laboratories, contract research organizations,organizations ("CROs"), academic institutions, and governmentalbio-pharmaceutical research institutions.companies. We sell our instruments, consumables, and services through a direct field sales and support organizations in North America and Europe, and through our own sales force and distributors in additional countries, 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.
We expect to incur operating losses into 2026 as we incur costs related to:
We expect to incur significant expenses and operating losses at least through the next 24 months, and we expect our expenses to increase substantially as we:
•expand our sales and marketing efforts to further commercialize our products;
•expandexpanding our research and development efforts to improve our existing, or to develop and launch, new assays and instruments, including Simoa ONE.instruments. These expenses could be particularly significant if any of itsour products become subject to additional or more burdensome regulation by the U.S Food and Drug Administration (the "FDA");
•investinvesting in Lucent Diagnostics, additional LDTs,laboratory developed tests ("LDTs"), and other diagnostics initiatives including entry into translational pharma and clinical diagnostic markets;
•seekseeking Premarket Approval (“"PMA”"), de novo classification, or 510(k) clearance from the FDA for our existing products or new products, including new assays and instruments, 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 acquireacquiring and integrateintegrating companies or technologies that may be complementary to our business;
•making required earnout payments under the Emission, Inc. ("Emission") acquisition agreement, which are contingent upon the achievement of certain performance milestones;
•enterentering into collaboration arrangements, or in-license other products and technologies; and
•addadding or enhanceenhancing operational, financial, and management information systems.
As further described in the section titled "Recent Business Developments - Restructuring Costs", in 2025 we implemented actions to realize many of the synergies of the acquisition of Akoya Biosciences, Inc. ("Akoya"). As a result of these actions and our continued integration activities, we expect to be cash flow breakeven in 2026, although our ability to achieve this goal is dependent on our success in meeting both revenue and expense objectives.
ISO 13485 Certification
On January 31, 2025, we received ISO 13485 certification for our operations in Billerica, Massachusetts. ISO 13485 certification indicates that a company has implemented a quality management system that meets international requirements for medical device manufacturing.
Agreement to Acquire Akoya Biosciences, Inc.
On January 9, 2025, we entered into an Agreement and Plan of Merger (the “Merger Agreement”) to acquire Akoya Biosciences, Inc. (“Akoya”), a life sciences technology company based in Marlborough, Massachusetts delivering spatial biology solutions through the power of spatial phenotyping. Spatial phenotyping refers to a rapidly evolving technology that enables academic and biopharma scientists to detect and map the distribution of cell types and biomarkers across whole tissue samples at single-cell resolution, enabling advancements in their understanding of disease progression and patient response to therapy. Akoya commercializes proprietary instrument platforms, reagents, software, and services that offer end-to-end solutions to perform tissue analysis and spatial phenotyping from discovery through translational and clinical research and diagnostics. The transaction is part of our plans to establish the first fully integrated technology ecosystem to identify and measure biomarkers across tissue and blood, expand our technology offerings into oncology and immunology, and expand our portfolio of lab service offerings.
Pursuant to the Merger Agreement, a newly formed, wholly owned subsidiary of Quanterix will merge with and into Akoya, with Akoya continuing as the surviving corporation and becoming a wholly owned subsidiary of Quanterix (the “Merger”). Upon completion of the Merger, each issued and outstanding share of common stock of Akoya will be converted into 0.318 of a share of our common stock. The closing of the Merger is subject to a number of conditions and obligations and we expect that, if approved, the Merger will close in the second quarter of 2025.
We and Akoya have also agreed to use our respective reasonable best efforts to cooperate in good faith to enter into one or more agreements pursuant to which we would provide Akoya with bridge financing. Any such financing would be in the form of subordinated convertible note(s) in an aggregate principal amount not to exceed $30.0 million, subject to Akoya having obtained any required consents and satisfied any other conditions under Akoya’s existing credit facility. As of the date of filing of this annual report, we are negotiating the potential terms of such financing.
Acquisition of Emission Inc.Acquisitions
Akoya Biosciences, Inc.
On July 8, 2025, we acquired Akoya, a life sciences technology company based in Marlborough, Massachusetts delivering spatial biology solutions through the power of spatial phenotyping. Spatial phenotyping refers to a rapidly evolving technology that enables academic and biopharma scientists to detect and map the distribution of cell types and biomarkers across whole tissue samples at single-cell resolution, enabling advancements in their understanding of disease progression and patient response to therapy. Akoya commercializes proprietary instrument platforms, reagents, software, and services that offer end-to-end solutions to perform tissue analysis and spatial phenotyping from discovery through translational and clinical research and diagnostics.
Pursuant to the acquisition agreement, the consideration transferred was $151.0 million, which consisted of Quanterix common stock with a fair value of $49.9 million, $18.9 million of cash to Akoya shareholders, and $82.1 million of cash to settle Akoya's debt financing arrangement with Midcap Financial Trust (the "Midcap Trust Term Loan"). The debt payment included a $75.1 million payoff of the principal outstanding and $7.0 million in early termination, legal, and prepayment fees.
Emission, Inc.
On January 8, 2025, we acquired all of the issued and outstanding shares of capital stock of Emission (the “Emission Transaction”),Emission, a life sciences manufacturing company based in Georgetown, Texas,Texas. thatEmission produces large-scale, highly-uniform dye-encapsulating magnetic beads designed for low and mid-plex assays and a mid-plex platform that reads its proprietary beads. The transaction is part of our plans to secure the use of Emission’s highly controlled beads in our next generation platforms and expansion into a new multi-plex segment targeting third-party original equipment manufacturer customers. UnderAs part of the Emissionacquisition Transaction,of Emission, we made an upfront payment of $10.0$9.0 million, with up to an additional $1.0 million payable at the end of the holdback period, and a $10.0 million payablepayment in the forth quarter of 2025 upon completion of certain technical milestones. Additionally, the selling shareholders of Emission (collectively, the “Emission Shareholders”) may receive up to an additional $50.0 million in earnout payments through December 31, 2029, contingent upon the achievement of certain performance milestones.
In connection with the closing of the Emission Transaction,acquisition, the parties entered into a call option agreement (the “"Option Agreement”"), in which the Emission Shareholders have the right to repurchase all of the outstanding capital stock of Emission for $10.0 million after five years if Emission’s revenues do not exceed $5.0 million in any one year during such five-year period. If the Emission Shareholders exercise the right to repurchase Emission under the Option Agreement and consummate the repurchase, we will retain a perpetual, fully-paid, irrevocable license to all Emission intellectual property required to continue to manufacture and commercialize our products.
For further information about the Akoya and Emission acquisitions, refer to Note 3 - Acquisitions in the Notes to Consolidated Financial Statements included in this Annual Report on Form 10-K.
FDA 510(k) Submission for a Multi-Analyte Algorithmic Blood Test for Alzheimer’s Disease Detection
On January 31, 2026, we submitted a 510(k) premarket notification to the U.S. Food and Drug Administration ("FDA") for a multi-analyte algorithmic blood test for Alzheimer’s disease.
This submission represents a significant milestone in the Company’s mission to provide superior, non-invasive, high-performance diagnostic tools to aid in the evaluation of patients with cognitive symptoms for possible Alzheimer’s disease. The multi-analyte test previously received Breakthrough Device Designation from the FDA, a program intended to accelerate the development and review of devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases. The test is intended to aid in identifying whether patients with cognitive symptoms are likely to have amyloid brain plaques—a hallmark of Alzheimer’s—providing diagnostic clarity through a non-invasive blood test.
LucentAD Complete Medicare Pricing
In November 2025, the Centers for Medicare & Medicaid Services ("CMS") approved a reimbursement rate of $897 for our LucentAD Complete multiplex test. This milestone provides a nationally recognized reference price, an important step for coverage decision with private issuers, enables broader access and supports efforts to bring this multiplex diagnostic solution to hospitals and laboratories across the country. In addition, based on available data, we believe LucentAD Complete has the potential to obtain a Local Coverage Determination, which would support more consistent reimbursement of claims.
Goodwill Impairment
During 2025, we assessed several events and circumstances, including a larger than expected decline in the Company's revenue and bookings primarily due to the rapidly changing macro-economic conditions resulting from reductions in U.S. federal research funding, reductions in research and development spending by larger pharmaceutical customers, and new import tariffs. Based on a an impairment test of our goodwill as of June 30, 2025, which estimated the implied fair value of our then single reporting unit under a market valuation approach (using inputs such as our quoted stock price), we determined our entire goodwill balance was impaired. As a result, we recorded a $6.4 million impairment charge in the second quarter of 2025.
Restructuring Costs
In 2025, we announced actions to reduce operating costs, preserve cash, and realize anticipated synergies and other benefits of the Akoya acquisition, including reductions in our workforce. The actions we implemented in 2025 reduced our annualized operating expenses by approximately $74.0 million. As we continue to integrate Akoya, we expect to take additional steps into 2026 to further reduce our operating expenses, with a goal of reducing our annualized operating expenses by a total of approximately $85.0 million.
We incurred expenses of $8.0 million related to the reductions in force in 2025, substantially all of which relate to cash expenditures for severance and related benefits. These reductions in force were completed in 2025.
LucentAD Tests
In October 2024, we launched LucentAD Complete, a confirmatory blood biomarker test capable of providing results equivalent to FDA-cleared CSF biomarkers. This test combines p-Tau 217, Amyloid beta 42, Amyloid beta 40, GFAP, and NfL biomarkers, which are recognized by the Alzheimer’s Association as core biomarkers of amyloid and tau, or biomarkers of non-specific processes involved in Alzheimer’s disease pathophysiology. The LucentAD Complete test is intended for patients being evaluated for Alzheimer’s disease. The results from the LucentAD Complete test can aid in the earlier diagnosis of Alzheimer’s disease, as well as the development of personalized treatment plans.
Additionally, our LucentAD Complete and our LucentAD p-Tau 217 blood tests were granted Breakthrough Device designation by the FDA in January 2025 and March 2024, respectively. This designation is granted to products that have the potential to offer more effective diagnosis of life-threatening diseases with an unmet medical need. Proposed indications for these blood tests include use of the test results in patients presenting with cognitive impairment who are being evaluated for Alzheimer’s disease risk to aid in diagnostic evaluation. These tests are not intended as a stand-alone diagnostic test and test results will be interpreted in conjunction with other diagnostic tools to establish a final clinical diagnosis. These tests have not been otherwise cleared or approved by the FDA and Breakthrough Device designation does not guarantee that the FDA review and approval process will be shortened or that an application will be approved.
We do not expect material revenue from these tests, or other Lucent Diagnostics tests, until 2025 or later, if at all.
Assay Redevelopment Program
During the fourth quarter of 2023, we substantially completed our six-quarter assay redevelopment program. The objective of this operational program was to improve our ability to manufacture and deliver high-quality assays at scale. Since then, and using the improved protocols resulting from the assay redevelopment program, we have launched our new Simoa Advantage PLUS assays and continue to transition existing assays to Advantage PLUS. The improved protocols leverage manufacturing efficiencies and reagent improvements to provide more consistent results and improved lot-to-lot consistency, which also enables production of larger lot sizes with extended shelf lives. Advantage PLUS assays began shipping to customers in the first quarter of 2024. We expect to continue to apply these improved protocols and manufacturing efficiencies to other existing assays, as well as assays that we may develop in the future.
During 2025, we experienced a larger than expected decline in our revenue and bookings, primarily due to rapidly changing macro-economic conditions. These macro-economic conditions, including reductions in U.S. federal research funding and new tariffs, impacted demand from academic customers and caused decreased demand from pharmaceutical customers as research and development spending and clinical trials slowed down. These conditions caused decreased revenue for our products and Accelerator Laboratory services.
We continue to see strong opportunities with our customers and expect that revenue and bookings in 2026 will be consistent with 2025.
Our product revenues are generated from sales of (1) instrumentsinstruments, including the related installation, and (2) consumables and related revenues. Our products are sold directly to customers and are also sold through distributors in EMEA and Asia Pacific regions.
Instrument revenues consist of sales of our instruments (HD-X, SR-X, and SP-X).instruments. We currently sell our products for research use only ("RUO") applications directly to customers or through distributors. Customers' purchase processes for certain of our instruments can be long and as a result, instrument revenue can vary from period-to-period and can be concentrated to a small number of customers in any given period. Instruments sold directly to customers include an initial year service-type warranty, which is recorded in services and other revenue on the Consolidated Statements of Operations. Instruments sold to distributors include a license to import and resell the instruments and an initial year assurance-type warranty. Costs related to assurance-type warranties are recorded in cost of product revenue on the Consolidated Statements of Operations. Instrument sales may also be bundled with assays and other consumables, training, installation, and/or an extended service warranty.
We expect softness in instrument sales to continue in 2025 as a result of what we believe is a constrained capital funding environment. We believe instrument sales will recover with an improvement in the capital funding environment , and further believe the introduction of our Simoa ONE instrument, which is expected to launch by the end of 2025, will help grow instrument sales in future years.
Service revenues generally consist of fixed fee contract research services through our Accelerator Laboratory, initial service-type warranties, extended service warranty contracts, repair services, and other services such as training.
Grant Revenue
Grant revenues consist of funding received to perform specific research and development services under grant arrangements.
What changed in the latest 10-Q
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 set forth in the section titled "Part I, Item 1A. Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2025 (the "Form 10-K"), as filed with the SEC on March 2, 2026. These 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 Form 10-K.
No wording changes found in this section.
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Management's Discussion & Analysis (MD&A)
New heading “Goodwill Impairment”
New heading “Impairment and Restructuring Costs”
New heading “Comparison of Results of Operations for the Six Months Ended June 30, 2026 and 2025:”
New heading “Cost of Goods Sold and Services”
New heading “Research and Development”
New heading “Selling, General and Administrative”
New heading “Impairment and Restructuring Costs”
New heading “Change in Fair Value of Contingent Liabilities”
New heading “Other Income (Expense), Net”
New heading “Income Tax (Expense) Benefit”
Removed heading “Income Tax Benefit”
Largest changes
“Impairment and Restructuring Costs”see in full comparison
“Impairment and Restructuring Costs”see in full comparison
“We recorded impairment and restructuring costs of $46.8 million during the six months ended June 30, 2026 primarily related to impairments of the remaining goodwill from the acquisition of Akoya and an in process research and development intangible asset. During the six months ended June 30, 2025, we recorded impairment and restructuring costs of $7.7 million relating to a goodwill impairment charge and severance and related benefit expenses from the May 2025 restructuring plan.”see in full comparison
“We recorded an impairment charge of $26.9 million during the three months ended June 30, 2026 related to impairment of the remaining goodwill from the acquisition of Akoya. During the three months ended June 30, 2025, we recorded impairment and restructuring costs of $7.7 million relating to a goodwill impairment charge and severance and related benefit expenses from the May 2025 restructuring plan.”see in full comparison
see in full comparisonOfThethe decrease, $7.1 million was related to the legacy Quanterix business anddecrease was primarily due to (1) a$3.2$4.0 million decrease in due diligence and other acquisition costs related to the acquisitions of Akoya and Emission in 2025, (2) a$1.9 million decrease from a non-recurring charge in 2025 associated with the contingent compensation payable under the acquisition of Emission, (3) a $1.6$2.6 million decrease in headcount and related compensation and benefitcosts,costsincludingfromstockthebasedMaycompensation,2025 restructuring plan and changes in our executive team, and (3) a $1.9 million decrease from arestructuringnon-recurringplancontingentimplementedpayment arrangement in2025,2025andassociated(4) a $1.2 million decrease in professional services and consulting fees related to our annual audit and completingwith theremediationacquisition ofthe material weaknesses in our internal control over financial reporting described in our 2025 Form 10-K.Emission. These decreases were partially offset bythe(1)acquisitionaof Akoya, which added $5.7$1.1 millionofincrease in consulting fees related to strategic initiatives and corporate matters, (2) a $1.0 million increase in professional services and technology integration costs, and (3) the selling, general and administrativeexpenses.expenses added from the acquisition of Akoya.
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Our proprietary digital “"Simoa”" detection technology enables customers to reliably detect protein biomarkers at ultra-low concentrations in blood, serumserum, and other fluids that, in many cases, are undetectable using conventional, analog immunoassay technologies. Multi-plexing biomarker analysis in tissue samples with our “Spatialspatial Biology”biology platforms enables scientists to understand the localized interactions occurring on the cellular level. We believe our combination of technologies will enable scientists to help drive diagnostic innovation in the evolving healthcare landscape with data across the tissue to fluid continuum. Currently, the ability of our Simoa platforms to detect proteins in the femtomolar range is enabling the development of novel therapies and diagnostics and has the potential to identify early-stage disease markers before symptoms appear.
We also provide contract research services and clinical laboratory testing services, including four Laboratory Developed Tests ("LDT"), using our proprietary Simoa and Spatialspatial Biologybiology technology through our Accelerator Laboratory,Laboratory (the "Accelerator Laboratory"), which is certified under the Clinical Laboratory Improvement Amendments of 1988 ("CLIA") (the "Accelerator Laboratory"). To date, we have completed over 2,650 projects for more than 500 customers from all overthroughout the world using our platforms.
We have an extensive base of worldwide customers including research laboratories, contract research organizations ("CROs"), academic institutions, and bio-pharmaceutical companies. We sell our instruments, consumables, and services through a direct field sales and support organizations in North America and Europe, and through our own sales force and distributors in countries throughout Europe, Asia Pacific, Africa, Latin America, and the Middle East.
Our total revenues were $36.4$32.9 million and $30.3$69.3 million for the three and six months ended MarchJune 31,30, 20262026, respectively, and $24.5 million and $54.8 million for the three and six months ended June 30, 2025, respectively. Since our inception, we have incurred annual net losses, including net losses of $17.5$48.9 million and $20.5$66.5 million for the three and six months ended MarchJune 31,30, 20262026, respectively, and $30.0 million and $50.5 million for the three and six months ended June 30, 2025, respectively.
We expect operating losses to continue in the remainder of 2026 as we incur costs related to the following:
•seeking Premarket Approval (“PMA”), de novo classification, or 510(k) clearance from the FDA for our products, if or when we decideproducts to market productsthem for use in the prevention, diagnosis, or treatment of a disease or other condition;
•strategically acquiring and integrating companies or technologies that may be complementary to our business;
•making required earnout payments under the Emission, Inc. ("Emission") acquisition agreement, which are contingent upon completion of certain performance milestones;
Subsequent to our acquisition of Akoya Biosciences, Inc. ("Akoya") in 2025, we implemented actions to realize many of the transaction's synergies. In the second quarter of 2026, we completed the integration of Akoya with the consolidation of operational processes and financial reporting systems. As a result of the actions takenwe to date,took, on an annualized basis, we have realized approximately $85.0 million of cost synergies.
Following the appointment of our new President and Chief Executive Officer in January 2026, managementwe undertook a comprehensive review of the Company’s commercial and product strategy. Upon completion of the review, we announced in May 2026 and August 2026 several plannedsignificant changes intended to accelerate revenue growth in our research tools business and to further advance our position in the Alzheimer’s Disease diagnostics market.
To improve our commercial effectiveness, we have hired a new Chief Commercial Officer who has extensive life sciences and diagnostics business experience. Under this new leadership, we are reorganizing our commercial organization to product-based selling, adding additional experienced sales leadership within our Accelerator business, improving lead generation efforts, and investing in marketing spend. These investments are intended to strengthen sales execution and competitive positioning and to deepen our pharmaceutical partnerships.
We are also increasing our strategic focus on Alzheimer’s diagnostics, as reflected by our hiring of an experienced Senior Vice President, General Manager Diagnostics to oversee our diagnostics business and investing in laboratory infrastructure and targeted commercial programs.
To help fund these investments, we streamlined our product roadmap and commenced upgrading our HD‑X platform with the intent to pursue FDA in vitro diagnostics ("IVD") status in 2027.
We are making targeted investments to improve commercial effectiveness, including adding experienced sales leadership within our Accelerator business, improving lead generation efforts, and investing in marketing spend. These investments are intended to deepen our pharmaceutical partnerships and to strengthen sales execution and competitive positioning. We are also increasing our strategic focus on Alzheimer’s diagnostics by hiring an experienced leader to oversee our diagnostics business, upgrading our HD‑X platform with the intent to pursue FDA in vitro diagnostics ("IVD") status in 2027, and investing in laboratory infrastructure and targeted commercial programs. To fund these investments, we are streamlining our product roadmap to focus our efforts on these initiatives, which we believe can positively impact our revenues starting in 2026.
By focusing our efforts on these initiatives, we believe we can positively impact our revenues starting in the second half of 2026 and more materially in 2027. We further believe these changes, supported by sustained investment in our SP-XSP-X, SR-X, and SR-Xspatial biology platforms, will enable us to defend and extend our leadership in the early-stage research and translational markets, which remain foundational to the organization.
We continue to expect to be cash flow breakeven in the second half of 2026, although our ability to achieve this goal is dependent on our success in implementing these strategy changes and meeting revenue and expense objectives. Further, our progress could be adversely affected by external factors.
LucentAD Complete Medicare Pricing
LucentAD Complete is our multi-biomarker LDT used in assessing Alzheimer’s disease pathology. In November 2025, the Centers for Medicare & Medicaid Services approved a reimbursement rate of $897 for our LucentAD Complete test.
During the second quarter of 2026, we completed multiple clinical utility and implementation studies evaluating LucentAD Complete across the Alzheimer's disease diagnostic pathway, including primary care and specialty neurology settings. Results from these studies were presented at the Alzheimer's Association International Conference and are being prepared for peer-reviewed publication.
Beginning July 1, 2026, members covered under Anthem Blue Cross and Blue Shield medical policies can receive coverage for qualifying blood-based biomarker testing, including LucentAD Complete, when medical necessity criteria are met.
We believe these clinical and reimbursement milestones support broader adoption of LucentAD Complete and may facilitate additional commercial and government payer coverage over time.
In November 2025, the Centers for Medicare & Medicaid Services approved a reimbursement rate of $897 for our LucentAD Complete multiplex test. This milestone provides a nationally recognized reference price, an important step for coverage decision with private issuers, enables broader access, and supports efforts to bring this multiplex diagnostic solution to hospitals and laboratories across the country. We are also completing multiple clinical utility studies across the diagnostic continuum spanning from primary care through specialty neurology settings. These studies are expected to demonstrate how LucentAD Complete could improve clinician confidence, patient access, and outcomes at each decision point, which could support obtaining payor coverage including a Local Coverage Determination.
As part of the acquisition of Akoya, we assumed a diagnostics development agreement (the "Development Agreement") with a biopharmaceutical customer (the "Biopharma Customer"). On February 25, 2026, the Development Agreement was terminated by mutual agreement of the parties and, in connection with such termination, we will transfer certain know-how to the Biopharma Customer and grant a non-exclusive, sub-licensable, fully paid license of the related intellectual property. No further consideration is due to either party for the know-how transfer or license.
The in-process research and development ("IPR&D") intangible asset generated by the Akoya acquisition consisted solely of the intellectual property being transferred to the Biopharma Customer. As a result of the termination of the Development Agreement, we can no longer realize the benefit of the IPR&D asset. During the three months ended March 31, 2026, the IPR&D was fully impaired and we recorded an impairment charge of $19.3 million.
Additionally, as a result of the termination of the Development Agreement, we recognized $21.6 million of one-time income during the three months ended March 31, 2026, which includes $13.7 million of non-cash income from the contract's related off-market liability and $7.9 million of deferred revenue. These amounts were recorded in other income, net on our Consolidated Statements of Operations, as the termination of an acquired, off-market contract is unusual and infrequent in nature.
Goodwill Impairment
Due to declines in our revenue during the second quarter of 2026, we concluded that it was more likely than not that the fair value our single reporting unit was less than its carrying amount. As a result, we performed a quantitative impairment test as of June 30, 2026 and determined the carrying value of our reporting unit exceeded its fair value. As a result, we recorded a goodwill impairment charge of $26.9 million during the three months ended June 30, 2026.
As part of the acquisition of Akoya, we assumed a diagnostics development agreement (the "Development Agreement") with a biopharmaceutical customer. On February 25, 2026, the Development Agreement was terminated by mutual agreement of the parties. As a result of the termination, during the three months ended March 31, 2026, we recorded an impairment charge of $19.3 million for the related in-process research and development intangible asset. Additionally, we recognized one-time income which included $14.0 million of non-cash income from the contract's related off-market liability and $7.9 million of deferred revenue. These amounts were recorded in other income, net on our Consolidated Statements of Operations, as the termination of an acquired, off-market contract is unusual and infrequent in nature.
During the first quarter endedof March 31, 2026,2026 we changed our accounting policy for classifying shipping and handling costs for product sales, which are primarily comprised of costs paid to third-party shippers for transporting products to customers. Historically, shipping and handling costs have been recorded in selling, general and administrative expenses. Under the new accounting policy, shipping and handling costs are recorded in cost of product revenue. We believe this classification is preferable because including these costs in cost of product revenue will better align the costs with the related revenue in the calculation of gross profit and is consistent with the practices of other companies in the same industry. We applied the change in accounting principle retrospectively to all periods presented.
We applied the change in accounting principle retrospectively to all periods presented. The accompanying Consolidated Statements of Operations and this Management's Discussion and Analysis of Financial Condition and Results of Operations reflect the effect of the change in accounting principle for all periods presented,principle, which includes a reclassification of $1.6$1.3 million and $2.9 million from selling, general and administrative to cost of product revenue during the three and six months ended MarchJune 31,30, 2025.2025, respectively. The change in accounting principle had no impact on revenues, loss from operations, net loss, or net loss per share and did not affect the Consolidated Balance Sheets, Consolidated Statements of Comprehensive Loss, Consolidated Statements of Cash Flows, or Consolidated Statements of Stockholders’ Equity.
Comparison of Results of Operations for the Three Months Ended MarchJune 31,30, 2026 and 2025:
Total revenues increased $6.1$8.4 million, or 20%,34%, to $36.4$32.9 million for the three months ended MarchJune 31,30, 2026, compared to $30.3$24.5 million for the three months ended MarchJune 31,30, 2025. For the three months ended June 30, 2026, product revenue consisted of instrument sales of $3.7 million and sales of consumables and other products of $19.8 million.
For the three months ended March 31, 2026, product revenue consisted of instrument sales of $4.1 million and sales of consumables and other products of $21.4 million. Product revenue increased $4.7$6.6 million, or 23%,39%, to $25.5$23.5 million for the three months ended MarchJune 31,30, 2026, compared to $20.7$16.8 million for the three months ended MarchJune 31,30, 2025. The increase was primarily due to the acquisition of Akoya, which added $8.7$9.3 million of product revenue. Product revenue forFor the legacy Quanterix businessbusiness, product revenue decreased $3.9$2.7 million, or 19%,million primarily due to a full quarter impact in 2026 from reductions in US federal research funding and macro-economic conditions. The impact of these conditions did not begin until the end of the first quarter in 2025 and resulted in lower consumablesweaker demand from both academic and pharmaceutical customers as research grant funding remains constrained and research and development spending declined.
Instrument revenues remained flat in the first quarter of 2026 and weWe expect softness in instrument sales to continue induring the remainder of 2026 as a result of what we believe is a constrained capital funding environment. As we implement the strategic changes to update our HD-X and continue investment inimprove our instruments,commercial execution, or as funding conditions improve, we anticipate a recovery in instrument demand. We also expect the continued uncertain macro-economic environment to cause fluctuations in consumables sales during the remainder of 2026.
We expect the continued uncertain macro-economic environment to cause fluctuations in consumable sales in 2026.
Service and other revenue increased $1.6$1.9 million, or 18%,27%, to $10.4$9.0 million, for the three months ended MarchJune 31,30, 2026, compared to $8.8$7.1 million for the three months ended MarchJune 31,30, 2025. The increase was primarily due to the acquisition of Akoya, which added $3.7$3.0 million of service and other revenue. For the legacy Quanterix business, service and other revenue decreased $2.1$1.0 million, or 24%,million primarily due to lower volumes of sample testing and assay development services in our Accelerator Laboratory. This decline is primarilyLaboratory driven by reduced pipeline development during 2025 and large pharmaceutical projects that have not repeated.development. While we continue to see strong opportunities in the market, the uncertain macro-economic environment is expected to continue to drive fluctuations in Accelerator Laboratory revenue induring the remainder of 2026.
Total cost of goods sold and services increased $5.4$5.8 million, or 35%,40%, to $20.8$20.2 million for the three months ended MarchJune 31,30, 2026, compared to $15.5$14.5 million for the three months ended MarchJune 31,30, 2025.
Cost of product revenue increased $3.8$4.0 million, or 33%,38%, to $15.1$14.6 million for the three months ended MarchJune 31,30, 2026, compared to $11.3$10.6 million for the three months ended MarchJune 31,30, 2025. This increase was primarily due to the acquisition of Akoya, which added $6.3$5.1 million to cost of product revenue.revenue, including $2.9 million of amortization of acquired intangible assets. This increase was partially offset by a $2.8$1.1 million decrease in the legacy Quanterix business primarily related to (1) a $1.8 million decreasereductions in headcount and related compensation and benefit costs, including stock-based compensation,costs from athe May 2025 restructuring plan implemented in 2025, (2) improvements in inventory management, and (3) lower product sales.plan.
Cost of service and other revenue increased $1.6$1.7 million, or 37%,45%, to $5.7$5.6 million for the three months ended MarchJune 31,30, 2026, compared to $4.2$3.9 million for the three months ended MarchJune 31,30, 2025. This increase was primarily due to the acquisition of Akoya, which added $1.0$1.2 million to cost of service and other revenue.
Research and development expense decreased $2.7$1.3 million, or 27%,14%, to $7.3$7.8 million for the three months ended MarchJune 31,30, 2026, compared to $10.0$9.1 million for the three months ended MarchJune 31,30, 2025. The decrease was primarily due to a $1.9 million decrease from a non-recurring contingent payment arrangement in 2025 associated with the acquisition of Emission and was partially offset by the research and development expenses added from the acquisition of Akoya.
Of the decrease, $4.1 million was related to the legacy Quanterix business and was primarily due to a (1) $1.9 million decrease from a non-recurring charge in 2025 associated with the contingent compensation payable under the acquisition of Emission, (2) a $1.1 million decrease in costs of outside services, research lab supplies, and equipment to enable product development, and (3) a $1.0 million decrease in headcount and related compensation and benefit costs, including stock based compensation, from a restructuring plan implemented in 2025. These decreases were partially offset by the acquisition of Akoya which added $1.4 million research and development expenses.
We believe that our continued investment in research and development is essential to our long-term competitive position.position Weand we expect that the realization of synergies from the acquisition of Akoya should enable us to maintain research and development expense at a more consistent level period to period in the future.
Selling, general and administrative expense decreased $1.4$3.0 million, or 4%,10%, to $29.8$27.4 million for the three months ended MarchJune 31,30, 2026, compared to $31.2$30.4 million for the three months ended MarchJune 31,30, 2025.
OfThe the decrease, $7.1 million was related to the legacy Quanterix business anddecrease was primarily due to (1) a $3.2$4.0 million decrease in due diligence and other acquisition costs related to the acquisitions of Akoya and Emission in 2025, (2) a $1.9 million decrease from a non-recurring charge in 2025 associated with the contingent compensation payable under the acquisition of Emission, (3) a $1.6$2.6 million decrease in headcount and related compensation and benefit costs,costs includingfrom stockthe basedMay compensation,2025 restructuring plan and changes in our executive team, and (3) a $1.9 million decrease from a restructuringnon-recurring plancontingent implementedpayment arrangement in 2025,2025 andassociated (4) a $1.2 million decrease in professional services and consulting fees related to our annual audit and completingwith the remediationacquisition of the material weaknesses in our internal control over financial reporting described in our 2025 Form 10-K.Emission. These decreases were partially offset by the(1) acquisitiona of Akoya, which added $5.7$1.1 million ofincrease in consulting fees related to strategic initiatives and corporate matters, (2) a $1.0 million increase in professional services and technology integration costs, and (3) the selling, general and administrative expenses.expenses added from the acquisition of Akoya.
Impairment and Restructuring Costs
We recorded an impairment charge of $26.9 million during the three months ended June 30, 2026 related to impairment of the remaining goodwill from the acquisition of Akoya. During the three months ended June 30, 2025, we recorded impairment and restructuring costs of $7.7 million relating to a goodwill impairment charge and severance and related benefit expenses from the May 2025 restructuring plan.
Impairment
We recorded impairment costs of $19.8 million for the three months ended March 31, 2026 primarily related to the impairment of an IPR&D intangible asset. As a result of the termination of the Development Agreement in the first quarter of 2026, we can no longer realize the benefits of the IPR&D asset acquired as part of the Akoya acquisition.
Interest income decreased $2.4$1.9 million, or 73%,72%, to $0.9$0.8 million during the three months ended June 30, 2026, compared to $2.7 million for the three months ended MarchJune 31, 2026, as compared to $3.3 million for the three months ended March 31,30, 2025. The decrease was primarily due to lower interest rates and a lower balance of cash, cash equivalents, and marketable securities.
ChangeThe change in fair value of contingent liabilities decreasedwas $1.9a million,loss orof 496%,$0.1 million for the three months ended MarchJune 31,30, 2026.2026 as compared to income of $4.3 million for the three months ended June 30, 2025. The change was driven by the achievement of certain performance targets and updates to the valuation inputs. The contingent arrangements relate to the acquisition of Emission and the assumption of Akoya's contingent liability from its acquisition of the Quantitative Pathology Solutions division of PerkinElmer, Inc. in 2018. The decrease was due to updates to the valuation inputs.
Comparison of Results of Operations for the Six Months Ended June 30, 2026 and 2025:
The following table sets forth select Consolidated Statements of Operations data, and such data as a percentage of total revenues (in thousands, except percentages):
Revenues
Total revenues increased $14.5 million, or 26%, to $69.3 million for the six months ended June 30, 2026, compared to $54.8 million for the six months ended June 30, 2025. For the six months ended June 30, 2026, product revenue consisted of instrument sales of $7.8 million and sales of consumables and other products of $41.2 million.
Product revenue increased $11.4 million, or 30%, to $49.0 million for the six months ended June 30, 2026, compared to $37.6 million for the six months ended June 30, 2025. The increase was due to the acquisition of Akoya, which added $18.0 million of product revenue. For the legacy Quanterix business, product revenue decreased $6.7 million primarily due to weaker demand from both academic and pharmaceutical customers as research grant funding remains constrained and research and development spending declined.
Service and other revenue increased $3.5 million, or 22%, to $19.4 million, for the six months ended June 30, 2026, compared to $15.9 million for the six months ended June 30, 2025. The increase was due to the acquisition of Akoya, which added $6.7 million of service and other revenue. For the legacy Quanterix business, service and other revenue decreased $3.2 million primarily due to lower volumes of sample testing and assay development services in our Accelerator Laboratory driven by reduced pipeline development.
Cost of Goods Sold and Services
Total cost of goods sold and services increased $11.1 million, or 37%, to $41.1 million for the six months ended June 30, 2026, compared to $30.0 million for the six months ended June 30, 2025.
Cost of product revenue increased $7.8 million, or 36%, to $29.8 million for the six months ended June 30, 2026, compared to $21.9 million for the six months ended June 30, 2025. This increase was due to the acquisition of Akoya, which added $10.3 million to cost of product revenue, including $5.6 million of amortization of acquired intangible assets. This increase was partially offset by a $1.2 million decrease in the legacy Quanterix business primarily related to reductions in headcount and related compensation and benefit costs from the May 2025 restructuring plan and lower product sales.
Cost of service and other revenue increased $3.3 million, or 41%, to $11.3 million for the six months ended June 30, 2026, compared to $8.0 million for the six months ended June 30, 2025. This increase was primarily due to the acquisition of Akoya, which added $2.3 million to cost of service and other revenue.
QTRX insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 2 Form 4 filings (2 insiders, 3 trade dates, 102,900 shares, about $296.0K) and open-market sales in 0 filings. Net open-market shares: 102,900 (purchases minus sales); net value about $296.0K.Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
| Trade date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2026-10-02 | Magovcevic-Liebisch Ivana |
Option exercise | 4,224 | — | — |
| 2026-10-01 | Mendel Scott |
Grant/award | 4,398 | $3.41 | $15.0K |
| 2026-10-01 | Donnelly William P |
Grant/award | 6,964 | $3.41 | $23.7K |
| 2026-09-15 | Miller Michael Francis |
Shares withheld for tax | 111 | $2.72 | $302 |
| 2026-09-15 | Miller Michael Francis |
Option exercise | 834 | — | — |
| 2026-09-15 | Miller Michael Francis |
Option exercise | 372 | — | — |
| 2026-09-15 | Miller Michael Francis |
Shares withheld for tax | 41 | $2.72 | $112 |
| 2026-09-15 | Miller Michael Francis |
Option exercise | 135 | — | — |
| 2026-09-15 | Miller Michael Francis |
Shares withheld for tax | 41 | $2.72 | $112 |
| 2026-09-15 | Miller Michael Francis |
Option exercise | 136 | — | — |
| 2026-09-15 | Miller Michael Francis |
Shares withheld for tax | 249 | $2.72 | $677 |
| 2026-09-15 | Miller Michael Francis |
Option exercise | 81 | — | — |
| 2026-09-15 | Miller Michael Francis |
Shares withheld for tax | 25 | $2.72 | $68 |
| 2026-08-31 | Miller Michael Francis |
Shares withheld for tax | 48 | $2.67 | $128 |
| 2026-08-31 | Miller Michael Francis |
Option exercise | 159 | — | — |
| 2026-08-19 | Elliott Jeffrey Thomas |
Option exercise | 3,955 | — | — |
| 2026-08-17 | Donnelly William P |
Option exercise | 2,802 | — | — |
| 2026-08-15 | Miller Michael Francis |
Option exercise | 81 | — | — |
| 2026-08-15 | Miller Michael Francis |
Shares withheld for tax | 25 | $2.59 | $65 |
| 2026-08-15 | Miller Michael Francis |
Option exercise | 136 | — | — |
| 2026-08-15 | Miller Michael Francis |
Shares withheld for tax | 41 | $2.59 | $106 |
| 2026-08-15 | Miller Michael Francis |
Option exercise | 135 | — | — |
| 2026-08-15 | Miller Michael Francis |
Shares withheld for tax | 41 | $2.59 | $106 |
| 2026-08-15 | Miller Michael Francis |
Option exercise | 372 | — | — |
| 2026-08-15 | Miller Michael Francis |
Shares withheld for tax | 111 | $2.59 | $287 |
| 2026-08-15 | Miller Michael Francis |
Option exercise | 834 | — | — |
| 2026-08-15 | Miller Michael Francis |
Shares withheld for tax | 249 | $2.59 | $645 |
| 2026-08-13 | Donnelly William P |
Open-market purchase | 72,245 | $2.93 | $211.7K |
| 2026-08-12 | Donnelly William P |
Open-market purchase | 27,155 | $2.75 | $74.7K |
| 2026-07-31 | Miller Michael Francis |
Shares withheld for tax | 39 | $3.48 | $136 |
| 2026-07-31 | Miller Michael Francis |
Option exercise | 130 | — | — |
| 2026-07-15 | Miller Michael Francis |
Option exercise | 136 | — | — |
| 2026-07-15 | Miller Michael Francis |
Option exercise | 834 | — | — |
| 2026-07-15 | Miller Michael Francis |
Shares withheld for tax | 111 | $4.24 | $471 |
| 2026-07-15 | Miller Michael Francis |
Option exercise | 372 | — | — |
| 2026-07-15 | Miller Michael Francis |
Shares withheld for tax | 41 | $4.24 | $174 |
| 2026-07-15 | Miller Michael Francis |
Option exercise | 81 | — | — |
| 2026-07-15 | Miller Michael Francis |
Shares withheld for tax | 25 | $4.24 | $106 |
| 2026-07-15 | Miller Michael Francis |
Shares withheld for tax | 249 | $4.24 | $1.1K |
| 2026-07-15 | Miller Michael Francis |
Shares withheld for tax | 41 | $4.24 | $174 |
| 2026-07-15 | Miller Michael Francis |
Option exercise | 135 | — | — |
| 2026-07-08 | Mendel Scott |
Option exercise | 8,073 | — | — |
| 2026-07-08 | Lai Goldman Myla |
Option exercise | 8,073 | — | — |
| 2026-07-01 | Mendel Scott |
Grant/award | 3,456 | $4.34 | $15.0K |
| 2026-07-01 | Donnelly William P |
Grant/award | 5,472 | $4.34 | $23.7K |
| 2026-06-30 | Miller Michael Francis |
Option exercise | 130 | — | — |
| 2026-06-30 | Miller Michael Francis |
Shares withheld for tax | 39 | $4.32 | $168 |
| 2026-06-15 | Sriram Vandana |
Shares withheld for tax | 315 | $3.10 | $976 |
| 2026-06-15 | Sriram Vandana |
Option exercise | 263 | — | — |
| 2026-06-15 | Sriram Vandana |
Shares withheld for tax | 79 | $3.10 | $245 |
| 2026-06-15 | Sriram Vandana |
Option exercise | 514 | — | — |
| 2026-06-15 | Sriram Vandana |
Shares withheld for tax | 154 | $3.10 | $477 |
| 2026-06-15 | Sriram Vandana |
Option exercise | 1,056 | — | — |
| 2026-06-15 | Miller Michael Francis |
Option exercise | 834 | — | — |
| 2026-06-15 | Miller Michael Francis |
Shares withheld for tax | 249 | $3.10 | $772 |
| 2026-06-15 | Miller Michael Francis |
Option exercise | 135 | — | — |
| 2026-06-15 | Miller Michael Francis |
Shares withheld for tax | 41 | $3.10 | $127 |
| 2026-06-15 | Miller Michael Francis |
Option exercise | 136 | — | — |
| 2026-06-15 | Miller Michael Francis |
Shares withheld for tax | 111 | $3.10 | $344 |
| 2026-06-15 | Miller Michael Francis |
Option exercise | 372 | — | — |
Well-known investors holding QTRX (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| First Eagle Investment Management | 2026-06-30 | 2,753,165 | $11.9M | 0.02% | Added 112% |
| AQR Capital Management (Cliff Asness) | 2026-06-30 | 1,343,005 | $5.8M | 0.0% | Added 1496% |
| Citadel Advisors (Ken Griffin) | 2026-06-30 | 229,736 | $992.5K | 0.0% | Added 277% |
| Point72 Asset Management (Steve Cohen) | 2026-06-30 | 225,653 | $974.8K | 0.0% | Added 142% |
| Renaissance Technologies | 2026-06-30 | 136,207 | $479.4K | — | Sold out |
| Millennium Management (Israel Englander) | 2026-06-30 | 40,662 | $175.7K | 0.0% | Reduced 94% |
| Two Sigma Investments | 2026-06-30 | 35,185 | $123.9K | — | Sold out |
| D. E. Shaw & Co. | 2026-06-30 | 17,672 | $76.3K | 0.0% | New position |