Quanterix(QTRX) - 2024 Q4 - Annual Report

Table of Contents Form 10-K Cover Page Information Registrant Information Quanterix Corporation filed its annual report on Form 10-K for the fiscal year ended December 31, 2024, with a commission file number of 001-38319, incorporated in Delaware and classified as an accelerated filer - Quanterix Corporation is an accelerated filer, not a well-known seasoned issuer or a large accelerated filer[3][4] Market Value and Shares Outstanding As of June 30, 2024, the aggregate market value of voting and non-voting common equity held by non-affiliates was approximately $477 million, with 38,776,208 shares of common stock outstanding as of March 11, 2025 Market Value and Shares Outstanding | Metric | Value | | :----- | :---- | | Aggregate Market Value (June 30, 2024) | ~$477 million | | Common Stock Outstanding (March 11, 2025) | 38,776,208 shares | Documents Incorporated by Reference Portions of the registrant's proxy statement for its 2025 Annual Stockholders' Meeting are incorporated by reference into Part III of this Annual Report on Form 10-K - Portions of the 2025 Annual Stockholders' Meeting proxy statement are incorporated by reference into Part III of the 10-K[8] Index to Form 10-K Note Regarding Forward-Looking Statements Forward-Looking Statements Disclaimer This section outlines the forward-looking nature of statements within the 10-K, emphasizing that actual results may differ materially due to various risks and uncertainties, particularly those detailed in the 'Risk Factors' section, cautioning readers not to rely on these statements as predictions of future events - The report contains forward-looking statements identifiable by words like 'anticipate,' 'believe,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'potential,' 'predict,' 'project,' 'seek,' 'should,' 'target,' 'will,' and 'would'[12] - Key forward-looking statements include those related to the planned acquisition of Akoya Biosciences, Inc., the acquisition of Emission, Inc., commercialization of products, future revenues, capital requirements, restatement risks, internal control effectiveness, Simoa technology's potential, and the launch of Simoa ONE[13][20] - Readers are advised not to rely on forward-looking statements as predictions and the company undertakes no obligation to update them, except as required by law[16] Service Marks, Trademarks, and Trade Names Company Trademarks The company lists its proprietary trademarks, including 'Quanterix,' 'Simoa,' 'Simoa HD-X,' 'Simoa HD-1,' 'Simoa ONE,' 'SR-X,' 'SP-X,' 'HD-X,' 'LucentAD,' 'Lucent Diagnostics,' and its logo - Key trademarks include Quanterix, Simoa, Simoa HD-X, Simoa HD-1, Simoa ONE, SR-X, SP-X, HD-X, LucentAD, Lucent Diagnostics, and the company logo[19] PART I Item 1. Business Quanterix Corporation is a life sciences company specializing in ultra-sensitive digital immunoassay platforms based on its proprietary Simoa detection technology, enabling the detection of protein biomarkers at ultra-low concentrations for early disease detection and research in neurology, oncology, and immunology, while also selling instruments, consumables, and providing assay development and sample testing services globally Overview Quanterix develops and commercializes ultra-sensitive digital immunoassay platforms using its proprietary Simoa detection technology, enabling reliable detection of protein biomarkers at ultra-low concentrations, supporting novel therapies and diagnostics, and aiming for earlier disease detection and prevention with an installed base of over 1,000 instruments and over 3,200 scientific citations - Quanterix's Simoa technology enables ultra-sensitive digital immunoassay platforms for detecting protein biomarkers at femtomolar range, significantly more sensitive than conventional ELISA[22][32] - The company has an installed base of over 1,000 Simoa instruments and over 3,200 scientific publications citing its technology, primarily in neurology, oncology, immunology, and inflammation[22] - Products and services include proprietary instruments, consumables, assay development, and sample testing through its CLIA-certified Accelerator Laboratory, including four Laboratory Developed Tests (LDTs)[23] Recent Developments Quanterix recently completed the acquisition of Emission, Inc. for $10.0 million upfront, with potential earnouts, to secure bead supply for its next-generation Simoa ONE instrument and expand into a new multi-plex segment, and also entered into an agreement to acquire Akoya Biosciences, Inc. in an all-stock merger, aiming to integrate spatial biology solutions with its biomarker detection capabilities - On January 8, 2025, Quanterix acquired Emission, Inc. for an upfront payment of $10.0 million, with an additional $10.0 million upon technical milestones and up to $50.0 million in earnout payments[24] - The Emission acquisition secures the supply of highly controlled beads for the next-generation Simoa ONE instrument and enables development of Nova Beads for third-party OEM customers[24] - On January 9, 2025, Quanterix agreed to acquire Akoya Biosciences, Inc. in an all-stock merger, where Akoya stockholders will receive 0.318 shares of Quanterix common stock per Akoya share[25][26] - The Akoya merger is expected to close in Q2 2025, subject to stockholder and regulatory approvals, and Quanterix may provide up to $30.0 million in bridge financing to Akoya[27][28] Industry Background Proteins are crucial physiological analytes, but conventional immunoassay technologies like ELISA have significant limitations in sensitivity and dynamic range, often failing to detect low-abundance proteins or early-stage disease markers in easily accessible samples like blood - Proteins are critical physiological analytes, extensively used as biomarkers in research and clinical diagnostics[29] - Conventional ELISA technology, despite being widely used for over 50 years, suffers from limited sensitivity and a narrow dynamic range, making it difficult to detect low-abundance proteins or early disease markers[29][30] Our Simoa Technology Quanterix's Simoa bead-based and planar array technologies significantly advance traditional ELISA by offering substantially greater protein detection sensitivity, enabling single molecule detection in the femtomolar range, which is billions of times more sensitive than conventional methods - Simoa bead-based digital immunoassays achieve single molecule detection by running enzyme-substrate reactions on individual molecules in tiny microwells, providing analytical sensitivity in the femtomolar range[32] - Simoa planar array immunoassays use spatially segregated micro-spots to concentrate signals, enabling multiplexing of up to 12 different assays within a single sample well with sensitivity similar to bead-based platforms[33] Our Strategy Quanterix's commercial strategy, known as 'GET,' focuses on growing its assay menu, expanding into adjacent markets, and translating its technology into diagnostics, involving rapid internal menu expansion, leveraging neurological biomarkers, strategic acquisitions, and developing new instruments to penetrate oncology and immunology markets, while also building global infrastructure for Alzheimer's disease testing - The company's 'GET' strategy involves three core growth vectors: Grow menu, Expand into adjacencies, and Translate into diagnostics[34] - Key strategic initiatives include: rapid internal menu expansion (20 new assays launched in 2024), growing leadership in neuro-based biomarkers (e.g., Alzheimer's disease), strategic acquisitions (Emission, Akoya), expanding into oncology and immunology with Simoa ONE, and increasing presence in diagnostics, including building Alzheimer's testing infrastructure[34] - The Simoa ONE instrument, expected to launch by end of 2025, aims for a 10-fold increase in sensitivity and enhanced plexing/specificity, targeting oncology and immunology[34] Our Products and Services Quanterix offers three Simoa instruments (HD-X, SR-X, SP-X) for ultra-sensitive protein detection, along with approximately 65 bead-based and 45 planar array assay kits and consumables, with recent additions including Nova Beads from the Emission acquisition and NfL antibodies/ELISA kits from UmanDiagnostics, while its CLIA-certified Accelerator Laboratory provides sample testing, custom assay development, and four neurological LDTs, including the LucentAD Complete test for Alzheimer's disease, accessible via the Lucent Diagnostics portal - Quanterix offers three Simoa instruments: HD-X (fully automated, bead-based, 84% of HD installed base by end of 2024), SR-X (compact, benchtop, bead-based), and SP-X (planar array, multiplex chemiluminescent immunoassay)[35][36][37][38] - The company provides approximately 65 analyte-specific single-plex and multi-plex assay kits for bead-based instruments and 45 for planar array instruments, covering neurology, infectious disease, immunology, and oncology[39] - Through its Accelerator Laboratory, Quanterix offers sample testing, homebrew and custom assay development, and four neurological LDTs: LucentAD p-Tau 181, Simoa NfL LDT, LucentAD p-Tau 217, and LucentAD Complete (a multi-marker algorithmic test)[43] - The Lucent Diagnostics portal, launched in July 2023, provides healthcare providers with a streamlined workflow for ordering and tracking Alzheimer's disease tests[44] Research and Development Quanterix is continuously investing in R&D to enhance its Simoa platform's sensitivity and measurement capabilities, expand its assay menu, and develop new instruments, with a key focus on the Simoa ONE, expected to launch by late 2025, which will offer a 10-fold increase in sensitivity and improved plexing/specificity using optically encoded barcodes and proprietary beads - R&D efforts focus on improving platform sensitivity, expanding the assay menu, and developing new instruments[46] - The Simoa ONE instrument, expected to launch by the end of 2025, is designed to provide up to a 10-fold increase in sensitivity over current Simoa platforms, with enhanced plexing and specificity[47] Our Key Focus Areas Quanterix focuses its Simoa technology on high-growth areas with unmet needs: neurology (especially Alzheimer's disease, where Simoa enables blood-based biomarker detection like p-Tau 217 and multi-marker algorithmic tests, and other conditions like MS and TBI), oncology and immunology (for early detection, monitoring, and immunotherapy response), and inflammation (for understanding disease biology and drug efficacy) - Simoa technology significantly advances neurology research by enabling ultra-low level detection of neurological biomarkers in blood, overcoming limitations of the blood-brain barrier and traditional invasive methods[49] - The LucentAD p-Tau 217 LDT and LucentAD Complete multi-marker algorithmic test (combining p-Tau 217, Aβ42, Aβ40, NfL, GFAP) offer high accuracy for Alzheimer's disease diagnosis, with LucentAD Complete receiving FDA Breakthrough Device designation[52][53] - Simoa technology is also instrumental in research for multiple sclerosis (NfL as a prognostic aid, granted Breakthrough Device designation) and traumatic brain injury (identifying biomarkers like NfL, tau, GFAP, UCH-L1)[54][55][56] - In oncology and immunology, Simoa's ultra-sensitivity enables early detection of cancer biomarkers, monitoring of immunotherapy responses (e.g., IFN-gamma, IL-6), and has potential as a liquid biopsy alternative[58][59] - Simoa assays measure low levels of inflammatory proteins (cytokines, chemokines) in serum and plasma, offering insights into inflammatory diseases and monitoring anti-inflammatory drug efficacy[61][62] Sales and Marketing Quanterix distributes its Simoa instruments and consumables through direct sales and support teams in North America and Europe, and via third-party distributors in other international markets, with 136 employees in sales, support, and marketing as of December 31, 2024, and plans for further global expansion - Distribution channels include direct field sales in North America and Europe, and a combination of sales force and third-party distributors in countries like Australia, Brazil, China, India, Japan, and South Korea[64] - As of December 31, 2024, the sales, sales support, and marketing team comprised 136 employees[65] - Future plans include expanding direct presence in Europe and developing a comprehensive distribution network in China and other Asia-Pacific countries[65] Manufacturing and Supply Quanterix outsources manufacturing of its Simoa bead-based instruments (HD-X to STRATEC, SR-X to Paramit) but manufactures its planar array instrument and all assay kits in-house, relying on a limited number of suppliers, including single-source suppliers, for components and reagents, mitigating risks through inventory control and long-term agreements where possible, with the recent acquisition of Emission allowing in-house manufacturing of Nova Beads - Simoa HD-X instruments are manufactured by STRATEC (Germany), and SR-X instruments by Paramit (California), while SP-X instruments and all assay kits are manufactured in-house at Billerica, Massachusetts[66][67][69] - The company relies on a limited number of suppliers, including single-source suppliers, for instrument components and assay kit reagents, but believes alternatives are available if needed, though with potential delays and costs[69][70][71][72] - The acquisition of Emission in January 2025 enables in-house manufacturing of Nova Beads, proprietary dye-encapsulating magnetic beads, from readily available materials[73] - Uman's NfL antibodies are outsourced for cultivation and purification, while NfL ELISA kits are manufactured in-house at Uman from approved sourced materials[74][75] Key Agreements Quanterix has a Strategic Development Services and Equity Participation Agreement and a Supply and Manufacturing Agreement with STRATEC for its Simoa HD instruments, requiring exclusive procurement, and a Manufacturing Services Agreement with Paramit for its SR-X instrument, with automatic annual extensions, both including termination clauses and obligations for supply and intellectual property - Quanterix has a Strategic Development Services and Equity Participation Agreement and a Supply and Manufacturing Agreement with STRATEC for Simoa HD instruments, requiring exclusive procurement[76] - The STRATEC Supply Agreement is terminable by either party with 12 months' notice, or under specific conditions like insolvency or material breach, with provisions for IP licensing upon termination[77] - A Manufacturing Services Agreement with Paramit covers the production and testing of SR-X instruments, with an initial three-year term and automatic one-year extensions, terminable with nine months' notice for convenience[78][80] Competition Quanterix operates in highly competitive life science research and diagnostic markets, facing established and development-stage companies like Bio-Techne, Thermo Fisher Scientific, and Roche, with key competitive factors including sensitivity, cost, reputation, innovation, accuracy, and customer support, and aims to enhance its position through global expansion, new product introductions, and collaborations - Quanterix competes with established and development-stage life science companies such as Bio-Techne, MesoScale Discovery, Thermo Fisher Scientific, and others in proteomics discovery and clinical research[81] - Competitive factors include sensitivity, cost of instruments and consumables, reputation, innovation, accuracy and reproducibility, and customer support infrastructure[82] - The company aims to enhance its competitive position through global expansion, innovative new product introductions, and collaborations[82] Intellectual Property Quanterix protects its technology through a multi-layered patent strategy covering fundamental detection methods, specific analyte detection, instrumentation, and applications, holding over 100 issued patents and applications expiring between 2025 and 2042, and also relies on trade secrets, know-how, and confidentiality agreements, acknowledging risks of independent development or unauthorized disclosure - Quanterix employs a multi-layered patent strategy covering fundamental single molecule detection methods, specific analyte detection, novel instrumentation, consumables, manufacturing processes, and specific uses (biomarkers and diagnostics)[84][85] - As of December 31, 2024, the company owned or exclusively licensed over 100 issued patents and patent applications, expected to expire between 2025 and 2042[86] - The company also relies on trade secrets, know-how, confidentiality agreements, and technological innovation to maintain its competitive position[88] License Agreement with Tufts University Quanterix holds an exclusive, worldwide license from Tufts University for its core Simoa bead-based technology, requiring low single-digit royalties on net sales and a portion of sublicensing revenues, along with annual maintenance fees and patent prosecution cost reimbursements, with the license subject to termination if Quanterix breaches its obligations, which would materially adversely affect its business - Quanterix exclusively licenses its core Simoa bead-based technology from Tufts University, which originated in Professor David Walt's laboratory[87][89] - Under the license, Quanterix pays low single-digit royalties on net sales, a portion of sublicensing revenues, annual maintenance fees, and reimburses patent prosecution costs[90] - The agreement is terminable by Tufts under various conditions, including failure to pay, material breach, or lack of diligent commercialization efforts, which would severely impact Quanterix's business[91] Government Regulation The majority of Quanterix's products are 'Research Use Only' (RUO), but its four Laboratory Developed Tests (LDTs) are subject to CLIA certification, with the FDA's recent Final Rule (April 2024) phasing in medical device regulation for most LDTs, potentially increasing regulatory burden and costs, though Quanterix's existing LDTs may qualify for continued enforcement discretion, while international regulations, such as the EU IVD Regulation, also impose stricter requirements, with Uman's NfL ELISA kit needing to comply by May 2027 - Most Quanterix products are labeled 'For Research Use Only' (RUO), but the company offers four CLIA-certified LDTs for neurological conditions[92][94] - The FDA's Final Rule (April 2024) will phase in medical device regulation for most LDTs over four years, increasing regulatory burden, costs, and potential delays for new LDTs[98][99][100] - Quanterix's LDTs, offered as of May 6, 2024, may qualify for continued enforcement discretion from premarket review and most quality system requirements under the FDA's Final Rule[99] - In the EU, new IVD Regulation introduces a risk-based classification system and increased conformity assessment requirements; Uman's NfL ELISA kit, classified as Class B, must comply by May 2027[103][104] Other Governmental Regulation Quanterix is subject to evolving privacy and data security laws globally, including HIPAA, HITECH, CCPA, CPRA, and GDPR, which impose strict requirements on handling personal and health information, with non-compliance potentially leading to significant fines and reputational damage, and the company also adheres to environmental, health, and safety laws, such as OSHA and EPA regulations, for workplace safety and waste management - Quanterix is subject to U.S. federal and state privacy laws (HIPAA, HITECH, CCPA, CPRA) and international regulations (GDPR) governing the collection, storage, and processing of sensitive personal and health information[106][107][108][109] - Compliance with these evolving data privacy laws is costly and complex, with potential for significant financial penalties and reputational harm for non-compliance[110] - The company also complies with federal, state, and local environmental, health, and safety laws, including OSHA requirements for workplace safety and EPA regulations for hazardous waste management[111][112] Employees and Human Capital As of December 31, 2024, Quanterix had 471 full-time employees globally, with a focus on talent management through competitive compensation, career growth, and an inclusive culture, reflected in a diverse workforce with approximately 47% women and 37% people of color, and an emphasis on business ethics and employee well-being - As of December 31, 2024, Quanterix had 471 full-time employees (411 in the U.S., 60 internationally), with 136 in sales/marketing, 27 in engineering/R&D, 240 in manufacturing/operations, and 68 in G&A[113] - The company focuses on attracting and retaining talent through competitive compensation, benefits (annual bonus/commission, 401(k), healthcare, equity grants), career growth, and on-the-job learning[114][115] - Quanterix promotes an inclusive culture with a focus on diversity, equity, and inclusion, reflected in its workforce composition (47% women, 37% people of color as of Dec 31, 2024) and adherence to a Corporate Code of Conduct and Ethics[116][117] Corporate Information Quanterix Corporation was incorporated in Delaware in April 2007 and is headquartered in Billerica, Massachusetts, making its SEC filings, including Annual Reports on Form 10-K, available free of charge on its investor relations website - Quanterix Corporation was incorporated in Delaware in April 2007 and is headquartered at 900 Middlesex Turnpike, Billerica, Massachusetts[119] - The company provides free access to its SEC filings (10-K, 10-Q, 8-K) on its investor relations website[120] Item 1A. Risk Factors This section details significant risks that could materially and adversely affect Quanterix's business, financial condition, results of operations, and future growth, categorized into those related to the proposed Akoya merger, the combined company post-merger, financial condition and reporting, general business operations, government regulation and diagnostic reimbursement, operational aspects, intellectual property, and common stock/public company status Risk Factor Summary The risk factor summary highlights key areas of concern, including uncertainties surrounding the Akoya merger, potential negative impacts on the combined company, risks related to financial reporting (e.g., material weaknesses, restatement), and various business-specific challenges such as market acceptance, competition, supply chain reliance, and regulatory compliance - Key risks include the potential failure to complete the Akoya merger, negative impacts on the combined company's stock price and operations, and substantial integration costs[125] - Financial reporting risks involve material weaknesses in internal control over financial reporting and the consequences of financial statement restatements[125] - Business risks encompass fluctuating operating results, inability to achieve profitability, failure of products to gain market acceptance, dependence on neurology sales, challenges in penetrating the diagnostics market, and reliance on single/limited suppliers[127] Risks Relating to the Merger The proposed merger with Akoya faces risks such as non-completion due to unmet conditions (e.g., stockholder/regulatory approvals), potential negative impact on Quanterix's stock price from dilution and sales of new shares, and disruptions from activist stockholders, with the pendency of the merger potentially diverting management attention, causing business disruptions, and incurring substantial costs, with no guarantee that bridge financing to Akoya will be repaid if the merger fails - The Akoya merger is subject to multiple conditions, including stockholder and regulatory approvals, and may be delayed or not completed, potentially incurring termination fees ($9 million payable by Quanterix, $7 million by Akoya)[127][128] - The issuance of approximately 15.8 million shares to Akoya stockholders will dilute current Quanterix stockholders (expected to own ~71% post-merger) and could cause the stock price to decline[132][133] - Activist stockholder opposition could delay merger approval, negatively affect business operations, and divert management resources[129] - Quanterix expects to incur substantial non-recurring costs related to the merger and integration, regardless of completion[144] Risks Relating to the Combined Company Combining Quanterix and Akoya's businesses may be more challenging, costly, or time-consuming than anticipated, potentially hindering the realization of expected benefits, synergies, and efficiencies, with integration difficulties possibly leading to loss of key employees, disruption of business relationships, and inconsistencies in operations, and the merger might also trigger change-in-control clauses in existing agreements, leading to contract modifications or terminations - Successful integration of Quanterix and Akoya is crucial for realizing anticipated benefits, but faces challenges such as retaining key employees, maintaining customer relationships, integrating technologies, and harmonizing operations and cultures[149][151] - Integration efforts may divert management attention from day-to-day operations, potentially disrupting business and impacting the combined company's revenues and operating results[151] - The merger could trigger change-in-control or assignment provisions in Akoya's agreements, potentially leading to contract terminations, renegotiations, or monetary damages, adversely affecting the combined company[153] Risks Related to our Financial Condition and Financial Reporting Matters Quanterix continues to face material weaknesses in internal control over financial reporting, specifically regarding inventory valuation and Accelerator Laboratory revenue, which could lead to future material misstatements and regulatory scrutiny, with the recent restatement of financial statements already incurring substantial costs and potentially harming investor confidence, and the company has a history of annual losses and expects them to continue, with limitations on using net operating losses (NOLs) to offset future income - As of December 31, 2024, Quanterix has unremediated material weaknesses in internal control over financial reporting related to inventory valuation (including capitalization of labor/overhead costs) and Accelerator Laboratory revenue[154][155] - The restatement of financial statements for prior periods has resulted in substantial costs and increased risk of legal proceedings and regulatory inquiries, potentially harming reputation and investor confidence[158] Net Losses (2022-2024) | Year Ended December 31, | Net Loss (in millions) | | :---------------------- | :--------------------- | | 2024 | $(38.5) | | 2023 | $(28.4) | | 2022 | $(99.6) | - The company expects to incur losses for at least the next 24 months and has an accumulated deficit of $470.1 million as of December 31, 2024[160] - Utilization of federal net operating loss (NOLs) carryforwards (approximately $320.0 million as of Dec 31, 2024) may be limited by Section 382 of the Internal Revenue Code due to potential ownership changes[161] Risks Related to our Business Quanterix's business faces risks from the failure of its products to achieve sufficient market acceptance, particularly its dependence on neurology sales, with penetrating the diagnostics market being challenging due to significant investments, complex regulations, and competition, and the company's lengthy sales cycle for instruments and reliance on a few large customers, along with single or limited contract manufacturers and suppliers, posing significant operational and financial risks, while international operations are also subject to various geopolitical and regulatory challenges - Failure to achieve and sustain sufficient market acceptance for Simoa technology and new products like Simoa ONE could adversely affect revenue[162] - Sales of neurological assays are increasingly important, making the business vulnerable to decreases in this segment[163] - Penetrating the diagnostics market involves significant investments, complex regulatory frameworks, intense competition, and challenges in obtaining adequate reimbursement[164] - The company relies on single contract manufacturers for its HD-X (STRATEC) and SR-X (Paramit) instruments, and expects to for Simoa ONE, posing supply chain risks if manufacturers fail to perform[179] - International revenue, accounting for approximately 36% of total revenue in 2024, exposes the company to risks including foreign regulatory requirements, currency fluctuations, and compliance with anti-bribery laws like the FCPA[176] Risks Related to Government Regulation and Diagnostic Product Reimbursement Quanterix faces risks from changes in U.S. government policies, including tariffs and reduced federal research funding, with its products, especially LDTs, increasingly subject to medical device regulation by the FDA and foreign authorities, requiring costly and time-consuming clearances or approvals, and non-compliance with CLIA or other regulations could halt laboratory operations, while unfavorable pricing or reimbursement policies for diagnostic procedures could harm commercialization efforts - Changes in U.S. government policies, such as increased tariffs and potential reductions in federal research funding (e.g., NIH), could adversely affect business by raising costs and impacting demand[193][194] - If FDA regulates Quanterix's RUO products as medical devices or modifies LDT regulations, the company will face expensive, time-consuming, and uncertain regulatory clearance/approval processes[196][197][198][199][200] - Failure to comply with CLIA regulations could lead to suspension or revocation of laboratory operations and inability to offer LDTs[206] - Commercialization of diagnostic tests depends on favorable pricing regulations and third-party coverage/reimbursement policies, which are uncertain and subject to cost containment pressures[208] Risks Related to our Operations Quanterix relies heavily on its information technology systems, making it vulnerable to failures, cybersecurity breaches, and data loss, which could disrupt operations, compromise sensitive information, and lead to significant liabilities and reputational damage, and the company is also subject to rapidly evolving global data privacy and security laws, requiring continuous compliance efforts that may increase costs and impact business expansion - Dependence on information technology systems means failures or significant downtime could prevent business operations and management, with security measures not guaranteeing protection against all threats[209][210] - Cybersecurity breaches, including attacks by hackers, viruses, or employee error, could compromise sensitive data, lead to legal claims, regulatory penalties, and damage reputation[211][212][213] - The company is subject to evolving U.S. federal and state (e.g., CCPA, CPRA) and international (e.g., GDPR) data privacy and security laws, with non-compliance potentially resulting in enforcement actions, fines, and business disruption[216][217][218][221] Risks Related to Intellectual Property Quanterix's success depends on its ability to protect intellectual property (IP) through patents, trademarks, and trade secrets, but patents may be challenged, circumvented, or found invalid, and trade secrets may be disclosed, with government-funded IP subject to 'march-in' rights and U.S. manufacturing preferences, and loss of licensed technology rights, particularly from Tufts University, would severely harm the business, while the company also faces risks of costly infringement lawsuits and challenges in protecting IP globally - Inability to obtain and maintain intellectual property protection (patents, trademarks, trade secrets) could reduce competitive advantage and lead to substantial litigation costs[222][223][224] - Some owned and licensed IP, particularly from Tufts University, is government-funded and subject to federal regulations like 'march-in' rights and U.S. manufacturing preferences, which could limit exclusive rights[225] - Loss of exclusive license rights from Tufts University for Simoa bead-based technology would have a material adverse effect on the business[226][227] - The company faces risks of costly and time-consuming lawsuits for infringing third-party IP rights, or for enforcing its own patents, with uncertain outcomes and potential for substantial damages or injunctions[230][231][232] - Protecting IP globally is expensive and challenging, as foreign laws may offer less protection, and enforcement proceedings can be costly and divert resources[233][234][235] Risks Related to our Common Stock and Being a Public Company The market price of Quanterix's common stock has been and is expected to remain volatile due to various factors, including financial performance, new product announcements, competition, and regulatory changes, and the company has never paid dividends and does not anticipate doing so, meaning stockholder gains will depend solely on stock price appreciation, while anti-takeover provisions in its corporate documents and Delaware law could also deter acquisition attempts - The market price of Quanterix's common stock has fluctuated significantly and is expected to continue to do so, influenced by financial results, product announcements, competition, and regulatory developments[238][239] - The company has never paid dividends and does not anticipate paying any in the foreseeable future, making capital appreciation the sole source of gain for stockholders[241] - Anti-takeover provisions in the company's restated certificate of incorporation, by-laws, and Delaware law (Section 203 of the DGCL) could delay or prevent acquisition attempts, potentially limiting stockholder premiums[242][243][244] Item 1B. Unresolved Staff Comments This item states that there are no unresolved staff comments from the SEC - Item 1B is not applicable, indicating no unresolved staff comments[245] Item 1C. Cybersecurity Quanterix maintains a comprehensive cybersecurity risk management program, overseen by its Chief Information Officer (CIO) and the Audit Committee, designed to identify, assess, manage, and mitigate threats, with the program based on frameworks like NIST and HIPAA, involving external experts for evaluation, and including mandatory employee training, and the CIO regularly reports to the CEO and Board of Directors on cybersecurity posture and risks - Quanterix has a cybersecurity risk management program overseen by its CIO (with over 20 years of IT experience) and the Audit Committee of the Board of Directors[246][249][250] - The program incorporates policies and activities across domains like access control, data protection, threat intelligence, incident response, and third-party risk management, based on NIST, HIPAA, and GDPR frameworks[246][247] - External cybersecurity consultants and auditors are engaged for evaluating and testing risk management systems, and all employees undergo rigorous cybersecurity training[248][250] Item 2. Properties Quanterix's corporate headquarters are in Billerica, Massachusetts, occupying an approximately 91,600 square foot leased facility for office, laboratory, and manufacturing, and the company also leases additional office and laboratory space in Bedford, Massachusetts, and internationally in the Netherlands, Sweden, and China, believing its current facilities are adequate - Corporate headquarters are in Billerica, Massachusetts, in a 91,600 sq ft leased facility for office, lab, and manufacturing[251] - Additional leased office and laboratory spaces are located in Bedford, Massachusetts, the Netherlands, Sweden, and China[251] Item 3. Legal Proceedings Quanterix is involved in routine lawsuits, claims, and investigations but is not currently party to any legal proceedings expected to have a material adverse effect on its financial condition or results of operations - The company is involved in ordinary course legal matters but is not currently party to any proceedings expected to have a material adverse effect on its financial condition or results of operations[253] Item 4. Mine Safety Disclosures This item states that there are no mine safety disclosures applicable to the company - Item 4 is not applicable[254] PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities Quanterix's common stock trades on The Nasdaq Global Market under the symbol 'QTRX,' with approximately 18 holders of record as of March 3, 2025, and the company has not paid dividends and does not anticipate doing so in the foreseeable future, with information on equity compensation plans incorporated by reference, and no unregistered sales or issuer purchases of equity securities in 2024 - Quanterix common stock is traded on The Nasdaq Global Market under the symbol 'QTRX'[256] - As of March 3, 2025, there were approximately 18 holders of record for the common stock[256] - The company has never declared or paid dividends and intends to retain future earnings for business development and growth[241][257] - No unregistered sales of equity securities or issuer purchases of equity securities occurred during the year ended December 31, 2024[259][260] Item 6. Reserved This item is reserved and not applicable - Item 6 is reserved and not applicable[263] Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on Quanterix's financial condition and operational results for 2024 and 2023, covering the company's business overview, recent developments including acquisitions and product launches, detailed analysis of revenue and expenses, liquidity, cash flows, and critical accounting policies, with total revenues of $137.4 million in 2024, a 12% increase from 2023, but a net loss of $38.5 million Overview Quanterix, a life sciences company, develops ultra-sensitive digital immunoassay platforms using Simoa technology for research and diagnostics, enabling early disease detection, selling instruments (HD-X, SR-X, SP-X) and consumables globally, and offering contract research and LDT services through its CLIA-certified Accelerator Laboratory, with total revenues for 2024 at $137.4 million, up 12% from 2023, but continuing net losses and expected significant expenses for growth and R&D - Quanterix develops and commercializes ultra-sensitive digital immunoassay platforms based on proprietary Simoa detection technology for life sciences research and diagnostics[267] - The company's installed base of Simoa instruments (HD-X, SR-X, SP-X) generates recurring revenue from consumables[268][269][270][272] - The CLIA-certified Accelerator Laboratory provides contract research services and Laboratory Developed Test (LDT) services, completing over 2,400 projects for more than 500 customers[274] Total Revenues and Net Loss (2023-2024) | Metric | 2024 (in millions) | 2023 (in millions) | | :----- | :----------------- | :----------------- | | Total Revenues | $137.4 | $122.4 | | Net Loss | $(38.5) | $(28.4) | - The company expects to incur significant expenses and operating losses for at least the next 24 months due to expansion, R&D, diagnostics initiatives, and potential regulatory burdens[276] Recent Business Developments Quanterix received ISO 13485 certification in January 2025, indicating compliance with medical device manufacturing quality standards, announced an agreement to acquire Akoya Biosciences, Inc. in an all-stock merger to integrate spatial biology solutions and expand into oncology and immunology, completed the acquisition of Emission Inc. in January 2025 for $10.0 million upfront, securing bead supply for next-generation platforms, launched LucentAD Complete, a multi-marker blood test for Alzheimer's, and its LucentAD Complete and p-Tau 217 tests received FDA Breakthrough Device designation, with the assay redevelopment program substantially completed in Q4 2023, improving assay quality and manufacturing efficiency - On January 31, 2025, Quanterix received ISO 13485 certification for its Billerica, Massachusetts operations, signifying compliance with international medical device manufacturing quality management systems[276] - On January 9, 2025, Quanterix entered an agreement to acquire Akoya Biosciences, Inc. in an all-stock merger, aiming to create an integrated technology ecosystem for biomarker identification across tissue and blood[277][278] - On January 8, 2025, Quanterix acquired Emission Inc. for an upfront payment of $10.0 million, with potential additional payments, to secure highly-uniform dye-encapsulating magnetic beads for its next-generation Simoa ONE instrument[280] - In October 2024, Quanterix launched LucentAD Complete, a multi-marker blood test for Alzheimer's disease, and its LucentAD Complete and LucentAD p-Tau 217 blood tests received FDA Breakthrough Device designation in January 2025 and March 2024, respectively[282][283] - The six-quarter assay redevelopment program was substantially completed in Q4 2023, leading to improved protocols, manufacturing efficiencies, and reagent improvements for higher quality and longer shelf-life assays[286] Components of Results of Operations Quanterix's revenues are categorized into product (instruments, consumables), service and other (contract research, warranties, repairs), collaboration and license, and grant revenue, with cost of goods sold and services including manufacturing, personnel, and royalties for products and direct costs for services, and operating expenses comprising research and development, selling, general and administrative, other lease costs, and impairment/restructuring, while other income/expense includes interest income, foreign currency gains/losses, and income tax expense - Product revenue includes sales of instruments (HD-X, SR-X, SP-X) and consumables (assays, kits, parts, reagents, antibodies)[287][288][290] - Service and other revenue consists of fixed-fee contract research services through the Accelerator Laboratory, initial service-type warranties, extended service contracts, and training[291] - Collaboration and license revenue is derived from licensing technology, IP, and know-how to third parties, often with sales or usage-based fees and future royalties[292] - Cost of product revenue includes manufacturing, assembly, contract manufacturer costs, personnel, royalties, and overhead, while cost of service and other revenue covers direct costs for Accelerator Laboratory operations and warranty services[294][295] - Operating expenses include R&D (personnel, supplies, third-party development), selling, general and administrative (sales/marketing, finance, legal, professional services, shipping/handling), other lease costs, and impairment/restructuring charges[296][297][299][300] Comparison of Results of Operations for Years Ended December 31, 2024 and 2023 In 2024, Quanterix's total revenues increased by 12% to $137.4 million, driven primarily by a 28% increase in service revenue and a 223% surge in collaboration and license revenue, while product revenue remained flat due to decreased instrument sales, with gross profit rising by 12% to $83.1 million, and operating expenses increasing by 13% to $135.7 million, mainly due to higher selling, general and administrative expenses and increased R&D investment, resulting in a net loss of $38.5 million, a 36% increase from 2023 Consolidated Statements of Operations Data (2023 vs. 2024) | Metric (in thousands) | 2024 | % of Revenue (2024) | 2023 | % of Revenue (2023) | Change (Amount) | Change (%) | | :-------------------- | :--- | :------------------ | :--- | :------------------ | :-------------- | :--------- | | Revenues: | | | | | | | | Product revenue | $79,740 | 58% | $79,670 | 65% | $70 | —% | | Service and other revenue | $51,244 | 37% | $40,089 | 33% | $11,155 | 28% | | Collaboration and license revenue | $4,452 | 3% | $1,380 | 1% | $3,072 | 223% | | Grant revenue | $1,985 | 1% | $1,229 | 1% | $756 | 62% | | Total revenues | $137,421 | 100% | $122,368 | 100% | $15,053 | 12% | | Costs of goods sold and services: | | | | | | | | Cost of product revenue | $33,304 | 24% | $29,103 | 24% | $4,201 | 14% | | Cost of service and other revenue | $21,013 | 15% | $19,041 | 16% | $1,972 | 10% | | Total costs of goods sold and services | $54,317 | 39% | $48,144 | 39% | $6,173 | 13% | | Gross profit | $83,104 | 60% | $74,224 | 61% | $8,880 | 12% | | Operating expenses: | | | | | | | | Research and development | $31,082 | 23% | $26,064 | 21% | $5,018 | 19% | | Selling, general and administrative | $101,618 | 74% | $89,111 | 73% | $12,507 | 14% | | Other lease costs | $3,020 | 2% | $3,712 | 3% | $(692) | (19)% | | Impairment and restructuring | $0 | 0% | $1,328 | 1% | $(1,328) | (100)% | | Total operating expenses | $135,720 | 99% | $120,215 | 98% | $15,505 | 13% | | Loss from operations | $(52,616) | (39)% | $(45,991) | (37)% | $(6,625) | 14% | | Interest income | $14,655 | 11% | $15,839 | 13% | $(1,184) | (7)% | | Other income (expense) | $(136) | 0% | $2,517 | 2% | $(2,653) | (105)% | | Loss before income taxes | $(38,097) | (28)% | $(27,635) | (22)% | $(10,462) | 38% | | Income tax expense | $(434) | 0% | $(719) | (1)% | $285 | (40)% | | Net loss | $(38,531) | (28)% | $(28,354) | (23)% | $(10,177) | 36% | - Product revenue remained flat at $79.7 million, with a $5.3 million increase in consumables sales offset by a $5.3 million decrease in instrument sales due to reduced demand[307] - Service revenue increased by $11.2 million (28%) to $51.2 million, primarily from higher volumes of Accelerator Laboratory sample testing and assay development services[308] - Collaboration and license revenue surged by $3.1 million (223%) to $4.5 million, mainly due to LDT and other diagnostic-related license revenues[309] - Research and development expense increased by $5.0 million (19%) to $31.1 million, driven by higher headcount and costs for outside services and lab supplies for product development[314] - Selling, general and administrative expense increased by $12.5 million (14%) to $101.6 million, primarily due to higher headcount, professional services for material weakness remediation and acquisitions, and increased marketing[315] Liquidity and Capital Resources As of December 31, 2024, Quanterix had $56.7 million in cash and cash equivalents and $232.4 million in marketable securities, which management believes will be sufficient for at least 12 months of operations, with future liquidity requirements including sales and marketing, R&D, working capital, and general corporate expenses, with additional needs for merger and acquisition activities, including the Emission acquisition and potential bridge financing for Akoya, and the company may seek additional capital through equity, debt, or collaboration arrangements if needed Liquidity Position (December 31, 2024) | Metric | Amount (in millions) | | :----- | :------------------- | | Cash and Cash Equivalents | $56.7 | | Marketable Securities | $232.4 | - Management believes current liquidity is sufficient for at least 12 months of anticipated operating cash requirements[322] - Future capital requirements depend on growth pace, new product/service introductions (e.g., Lucent Diagnostics, Simoa ONE), regulatory needs, and M&A activities[323] - The Emission acquisition involved an upfront payment of $10.0 million, and Quanterix may provide up to $30.0 million in bridge financing to Akoya prior to the merger closing[324] - Additional funds, if needed, may be raised through public/private equity, debt offerings, or collaboration/licensing arrangements, which could lead to dilution or restrictive covenants[325][326] Cash Flows Quanterix experienced a net decrease in cash, cash equivalents, and restricted cash of $117.0 million in 2024, with net cash used in operating activities increasing to $35.2 million, primarily due to a higher net loss and increased working capital needs, and net cash used in investing activities at $82.3 million, mainly from marketable securities purchases, partially offset by maturities, while net cash provided by financing activities was $0.5 million from stock plan proceeds Cash Flow Summary (in thousands) | Cash Flow Activity | 2024 | 2023 | | :----------------- | :--- | :--- | | Net cash used in operating activities | $(35,164) | $(18,849) | | Net cash used in investing activities | $(82,265) | $(148,454) | | Net cash provided by financing activities | $456 | $2,691 | | Net decrease in cash, cash equivalents, and restricted cash | $(116,973) | $(164,612) | - Net cash used in operating activities increased by $16.3 million in 2024, driven by a higher net loss, increased headcount, and lower labor/overhead capitalization, partially offset by working capital changes[329][330] - Net cash used in investing activities decreased to $82.3 million in 2024, primarily due to $295.6 million in marketable securities purchases and $216.7 million from maturities[332] - Net cash provided by financing activities was $0.5 million in 2024, mainly from common stock issued under employee stock purchase plans and option exercises[334] Future Cash Obligations Quanterix's future cash obligations include payments for the Emission acquisition (upfront, technical milestones, and earnouts up to $50.0 million by 2029) and potential bridge financing for Akoya (up to $30.0 million), with operating lease liabilities for office, laboratory, and manufacturing spaces amounting to $46.1 million in undiscounted future payments, with $7.3 million due in 2025 - Future cash obligations include payments for the Emission acquisition: $10.0 million upfront, $10.0 million upon technical milestones, and up to $50.0 million in earnout payments through December 31, 2029[324][336] - Quanterix may provide up to $30.0 million in bridge financing to Akoya prior to the merger closing[324][336] Operating Lease Liabilities (as of December 31, 2024) | Period | Undiscounted Lease Payments (in millions) | | :----- | :---------------------------------------- | | 2025 | $7.3 | | 2026-2027 | $15.1 | | 2028-2029 | $16.1 | | >5 years | $7.6 | | Total | $46.1 | Critical Accounting Policies and Estimates Quanterix's critical accounting policies involve significant judgment and estimation, particularly for revenue recognition under ASC Topic 606, which requires a five-step framework to identify performance obligations, determine transaction prices (including variable consideration), and allocate revenue, with other critical areas including inventory reserves (assessing slow-moving, excess, and obsolete inventory) and impairment of long-lived assets (estimating future cash flows for ROU assets, property, and equipment) - Revenue from Contracts with Customers (ASC 606) requires judgment in identifying performance obligations, determining transaction prices (including variable consideration like sales/usage-based royalties), allocating prices, and recognizing revenue[342][343][344][349] - Instrument sales directly to customers include installation and a service-type warranty (separate performance obligation), while sales to distributors include a license to resell and an assurance-type warranty (not a separate performance obligation)[345][346] - Inventory reserves require judgment based on historical activity, forecasted demand, estimated material life, and market conditions to reduce carrying value for slow-moving, excess, or obsolete inventory[353] - Impairment of other long-lived assets (operating lease ROU assets, property and equipment) involves significant judgment in estimating undiscounted and discounted future cash flows to assess recoverability[354] Non-GAAP Financial Measures Quanterix uses non-GAAP financial measures, including adjusted gross profit, adjusted gross margin, adjusted total operating expenses, and adjusted loss from operations, to provide a more comparable view of its operating performance, with these adjustments primarily involving reclassifying shipping and handling costs for product sales from selling, general and administrative expenses to cost of product revenue - Quanterix presents non-GAAP financial measures (adjusted gross profit, adjusted gross margin, adjusted total operating expenses, adjusted loss from operations) to provide meaningful period-to-period comparison and industry comparability[355] - These non-GAAP measures are calculated by reclassifying shipping and handling costs for product sales from selling, general and administrative expenses into cost of product revenue[355] Non-GAAP Reconciliation (Twelve Months Ended December 31) | Metric (in thousands) | 2024 | 2023 | | :-------------------- | :--- | :--- | | Gross profit (GAAP) | $83,104 | $74,224 | | Shipping and handling costs | $(8,113) | $(8,146) | | Adjusted gross profit (non-GAAP) | $74,991 | $66,078 | | Gross margin (GAAP) | 60.5% | 60.7% | | Adjusted gross margin (non-GAAP) | 54.6% | 54.0% | | Total operating expenses (GAAP) | $135,720 | $120,215 | | Shipping and handling costs | $(8,113) | $(8,146) | | Adjusted total operating expenses (non-GAAP) | $127,607 | $112,069 | | Loss from operations (GAAP) | $(52,616) | $(45,991) | | Adjusted loss from operations (non-GAAP) | $(52,616) | $(45,991) | Recent Accounting Pronouncements This section refers to Note 2 for a full description of recent accounting pronouncements, including their expected adoption dates and potential effects on the Consolidated Financial Statements - Refer to Note 2 for details on recently adopted and to-be-adopted accounting standards[357] Item 7A. Quantitative and Qualitative Disclosures about Market Risk Quanterix is exposed to market risks from foreign currency exchange rate fluctuations and interest rate changes, with international operations, accounting for approximately 37% of revenue in 2024, exposing the company to currency risks, though a hypothetical 10% adverse change would not be material, and the company's cash, cash equivalents, and marketable securities are primarily short-term, highly-rated debt securities, limiting material exposure to interest rate changes, though declines would reduce investment income - Approximately 37% of total revenue in 2024 was generated from customers outside the United States, exposing the company to foreign currency exchange rate fluctuations (Canadian dollars, Euros, British pounds, Swedish krona, Japanese yen, Chinese yuan)[359] - A hypothetical 10% adverse change in exchange rates on foreign denominated receivables would decrease potential cash inflows by $1.1 million as of December 31, 2024[359] - As of December 31, 2024, cash, cash equivalents ($56.7 million), and marketable securities ($232.4 million) are held in highly rated, short-term debt securities, limiting material exposure to interest rate changes[361] - A hypothetical 10% decrease in overall interest rates during 2024 would have reduced interest income by approximately $1.4 million[362] Item 8. Financial Statements and Supplementary Data This item indica