Executive Summary / Key Takeaways

• Quanterix leverages its proprietary Simoa ultra-sensitive digital immunoassay technology, which offers significantly higher sensitivity (up to 1000x vs. conventional methods) and multiplexing capabilities compared to competitors, enabling the detection of protein biomarkers at previously undetectable levels.
• The company is executing a three-pronged strategy focused on expanding its assay menu, entering adjacent markets like immunology and oncology (organically and via acquisition), and building a global diagnostic testing infrastructure for Alzheimer's disease.
• Recent strategic moves, including the acquisition of Emission, Inc. and the pending merger with Akoya Biosciences, are designed to secure key manufacturing capabilities, expand market reach into tissue-based biomarkers, and accelerate the path to scale and profitability.
• Despite achieving Q1 2025 revenue of $30.3 million, the company revised its full-year 2025 guidance downwards to $120 million-$130 million, reflecting significant pressure from the macroeconomic funding environment, including estimated NIH funding reductions and biopharma spending conservatism impacting Accelerator lab revenue.
• To counter headwinds and accelerate profitability, Quanterix is implementing a substantial cost reduction plan targeting $30 million in savings in 2025, scaling to $55 million annualized by 2026, and expects to achieve cash flow breakeven as a combined entity with Akoya in 2026, projecting a cash balance north of $100 million by year-end 2026.

The Foundation of Ultra-Sensitivity: Simoa Technology

Quanterix Corporation operates at the forefront of precision health, specializing in the development and commercialization of ultra-sensitive digital immunoassay platforms. At the heart of the company's offering is its proprietary Simoa (Single Molecule Array) detection technology. This technology represents a significant leap beyond conventional analog immunoassay methods, enabling the reliable detection of protein biomarkers in blood, serum, and other bodily fluids at ultra-low concentrations, often in the femtomolar range. The tangible benefit of Simoa's sensitivity is its ability to quantify biomarkers at levels up to 1,000 times lower than traditional platforms, providing a single femtogram per milliliter limit of detection for key analytes like pTau-217. This superior performance allows researchers and clinicians to detect biomarkers at the very earliest stages of disease, potentially before symptoms manifest, and to precisely monitor subtle changes in biomarker levels over time.

The company's journey began with the introduction of its Simoa HD-1 instrument, followed by the compact SR-X and the planar array-based SP-X. The upgraded HD-X, now comprising approximately 84% of the installed HD base of over 1000 instruments, serves as a workhorse for high-throughput applications. Recognizing the capital intensity of instrument purchases, Quanterix strategically built out its CLIA-certified Accelerator Laboratory. This lab provides customers with access to Simoa technology through contract research services, sample testing, and assay development without requiring an upfront instrument investment. This service model has proven resilient, particularly in challenging capital environments, contributing significantly to the company's revenue and providing a valuable channel for customer engagement and assay validation.

In the competitive landscape, Quanterix's technological edge in sensitivity provides a distinct moat. While larger, diversified players like Thermo Fisher Scientific (TMO) and Abbott Laboratories (ABT) offer broad diagnostic and life science tool portfolios, and more specialized companies like Bio-Rad Laboratories (BIO) compete in protein analysis, Simoa's quantifiable sensitivity advantage sets it apart in applications requiring the detection of extremely low-abundance biomarkers. This technical superiority supports premium pricing for assays and services, contributing to gross margins that, while variable, have shown improvement and can exceed those of some larger competitors in specific product categories. However, Quanterix's smaller scale compared to TMO and ABT results in higher operating costs per unit, impacting overall profitability and cash flow generation relative to these giants.

Strategic Expansion and Recent Transformations

Quanterix's strategy is built on three core pillars: expanding its assay menu, moving into adjacent markets, and translating its technology into diagnostics. The company has demonstrated consistent execution on menu expansion, launching numerous new assays, including 20 in 2024 alone, with a strong focus on neurology, immunology, and oncology. This continuous flow of new, high-value assays is critical for driving recurring consumables revenue from the growing installed base and attracting new customers.

The push into adjacent markets and the goal of achieving "Simoa in all labs" is being pursued through both organic development and strategic acquisitions. The Simoa ONE platform, expected by the end of 2025, is a key organic initiative. It aims to push sensitivity even further (up to 10x existing systems) and increase multiplexing capabilities (up to 10-plex) with an intuitive workflow. A significant development related to Simoa ONE is the plan, starting in 2026, to offer unlocked assay kits compatible with the vast installed base of over 20,000 flow cytometers worldwide. This democratization strategy, enabled by embedding digital Simoa detection in kinetic dye-encoded beads, aims to dramatically expand access to Quanterix's ultra-sensitive technology without requiring customers to purchase a new high-capital instrument, potentially accelerating adoption in immunology and oncology labs.

Strategic acquisitions are central to accelerating market expansion. The January 2025 acquisition of Emission, Inc. secured access to specialized magnetic beads crucial for next-generation platforms and provided entry into a new multi-plex OEM segment. More significantly, the pending merger with Akoya Biosciences (AKYA) is designed to create the first integrated technology ecosystem for measuring biomarkers across both tissue (Akoya's strength) and blood (Quanterix's strength). This combination is strategically aimed at accelerating market development for novel tissue and liquid biopsies, particularly in oncology and immunology, expanding Quanterix's research addressable market from $1 billion to $5 billion and its diagnostics TAM from $10 billion to $15 billion. The rationale emphasizes the significant customer overlap and the potential for cross-selling Akoya's spatial biology solutions to Quanterix's base and vice versa.

Translating Simoa's sensitivity into diagnostics, particularly for Alzheimer's disease, is a major focus. The company has made significant strides with its LucentAD Complete test, a multi-marker algorithmic test combining p-Tau 217, NfL, GFAP, and Amyloid beta 40/42. Data from clinical cohorts indicate this test achieves over 90% accuracy while substantially reducing the intermediate diagnostic zone (by three-fold compared to single-marker tests), offering a more definitive result for patients. The pTau-217 single marker test has received FDA breakthrough designation, and the multi-marker test is progressing through clinical trials with enrollment expected to complete by Q4 2025. Quanterix is building a global testing infrastructure through partnerships with hospitals and reference labs and expects to introduce pricing for LucentAD Complete later in summer 2025, targeting high triple-digit reimbursement with potential for reimbursement to begin in early 2026. The company believes its technology's sensitivity is uniquely suited for AD diagnostics, ensuring results for all patients and enabling early detection and monitoring, differentiating it from competitors whose platforms may have higher unreadable sample rates.

Recent Financial Performance and Outlook

Quanterix's recent financial performance reflects the interplay of its strategic initiatives, operational execution, and the challenging external environment. In the first quarter of 2025, total revenue was $30.3 million, a 5% decrease compared to $32.1 million in Q1 2024. This decline was primarily driven by a 27% decrease in service and other revenue ($8.8 million vs. $12.0 million), largely due to lower Accelerator lab volumes and the completion of a collaboration agreement with Eli Lilly (LLY). Product revenue showed resilience, increasing 5% to $20.7 million, primarily from higher consumables pricing, although instrument revenue remained flat, reflecting the ongoing pressure on capital equipment sales. Collaboration and license revenue saw a significant increase, rising 397% to $0.8 million, mainly from LDT and diagnostic-related licenses.

Gross profit decreased 11% to $16.4 million in Q1 2025, with GAAP gross margin falling to 54.1% from 57.8% in Q1 2024. Non-GAAP gross margin also declined by 150 basis points to 49.7%, primarily due to a non-cash charge for inventory reserves. Operating expenses saw a substantial 27% increase to $42.8 million, driven by a 49% surge in R&D ($10.0 million vs. $6.7 million) and a 25% rise in SG&A ($32.5 million vs. $26.0 million). These increases were notably influenced by costs related to the Emission acquisition (contingent consideration charge) and the proposed Akoya acquisition (due diligence and professional fees), as well as investments in product development and SOX remediation efforts. The net loss for the quarter widened to $20.5 million from $11.2 million in Q1 2024.

Despite the Q1 performance exceeding internal expectations, management revised its full-year 2025 revenue guidance downwards to a range of $120 million to $130 million, representing a decline of 5% to 13% year-over-year. This conservative revision explicitly accounts for the broader macro funding environment, including an estimated additional 20% reduction in NIH funding levels impacting approximately 22% of revenue from US academic customers (implying ~500 basis points of pressure) and increased conservatism from biopharma/biotech customers leading to project pushouts and smaller ticket sizes in the Accelerator lab (factoring in a total of 900 basis points of pressure from pharma). Tariff impacts are also expected to contribute approximately 100 basis points of revenue pressure and 50-100 basis points on gross margin. The full-year non-GAAP gross margin is now guided to be between 50% and 54%.

To address these headwinds and accelerate the path to profitability, Quanterix announced a significant cost reduction plan targeting $15 million in operating expense reductions in 2025, scaling to $30 million annualized, and ultimately $55 million annualized savings by 2026. These savings are expected to be realized through operational efficiencies and synergies from the Akoya acquisition. Management projects standalone cash usage from operations in 2025 to be $35 million to $45 million, including $30 million invested in diagnostics and Simoa ONE. Following the expected Q2 2025 closing of the Akoya merger, which includes a cash component of up to $20 million and settlement of Akoya's debt, the company anticipates a cash balance of approximately $160 million at the end of Q2 2025. Factoring in combined company cash burn and cost reductions, the projected cash balance at the end of 2025 is approximately $120 million. The strategic plan, bolstered by cost controls and acquisition synergies, targets achieving cash flow breakeven as a combined company in 2026, with a projected cash balance exceeding $100 million by year-end 2026.

Risks and Challenges

While Quanterix possesses a differentiated technology and a clear strategic vision, several risks and challenges could impact its trajectory. The revised 2025 guidance highlights the significant sensitivity to the macroeconomic funding environment, particularly changes in NIH funding and biopharma spending. Prolonged or deeper cuts could further pressure revenue and delay the path to profitability. The successful execution of the announced cost reduction plan is crucial for achieving financial targets, but it carries risks, including potential loss of key personnel or disruption to operations.

The pending merger with Akoya Biosciences, while strategically compelling, introduces integration risks and potential disruptions. Achieving the projected $55 million in annualized synergies by 2026 is critical to the financial model but is subject to successful integration and realization of operational efficiencies. Furthermore, the merger has faced opposition from some stockholders, which could create uncertainty and divert management attention. The company also faces risks related to the adoption of its new products and diagnostic tests, including the LucentAD Complete test. Market acceptance, the pace of therapy adoption in Alzheimer's disease, and favorable reimbursement decisions are key factors influencing the revenue ramp from diagnostics. Competition in the diagnostics space, including from companies developing alternative technologies or single-marker tests, remains a factor. Finally, as the company continues to invest in R&D and expand its operations, maintaining effective internal controls over financial reporting, particularly following recent material weaknesses, is essential for reliable financial reporting and investor confidence.

Conclusion

Quanterix stands as a company with a foundational technological advantage in ultra-sensitive protein detection, strategically positioned to capitalize on the growing demand for advanced biomarker analysis in research and diagnostics. Its Simoa technology's unparalleled sensitivity provides a distinct competitive edge, enabling applications in areas like neurology, oncology, and immunology that are beyond the reach of conventional platforms. The company's strategic evolution, marked by continuous menu expansion, organic development of next-generation platforms like Simoa ONE, and transformative acquisitions such as Akoya Biosciences, aims to broaden its market reach and accelerate its growth trajectory.

While the near-term outlook is tempered by macroeconomic headwinds impacting academic funding and biopharma spending, leading to a downward revision in 2025 revenue guidance, Quanterix is taking decisive actions. The substantial cost reduction plan, coupled with expected synergies from the Akoya merger, forms a clear pathway towards achieving cash flow breakeven in 2026. The success of this strategy hinges on effective integration of acquired businesses, continued innovation in new assays and platforms, successful execution of the diagnostics commercialization plan (particularly for LucentAD Complete), and navigating the volatile funding environment. For investors, the story centers on the potential for a technology leader in a high-growth market to translate its sensitivity advantage into scaled profitability, provided it can successfully execute its strategic initiatives and manage the inherent risks in its expansion and integration efforts.