Financial Data and Key Metrics Changes - Total revenue for Q1 2023 was $28.5 million, a decline of $1.1 million or 3.7% from Q1 2022, primarily due to a non-recurring licensing revenue of $1.2 million in the previous year [11][31] - GAAP gross margin was 59.5%, and non-GAAP gross margin was 53.1%, both representing sequential increases of over 1,000 basis points from Q4 2022 [8][37] - Operating expenses decreased from $32.7 million in Q1 2022 to $26.3 million in Q1 2023, contributing to a reduced net loss of $6.1 million compared to $18.2 million in the previous year [14][39] Business Line Data and Key Metrics Changes - Product revenue was $19.3 million, a decline of $1.4 million or 6.6% year-over-year, with instrument revenue being the largest contributor to this decrease [11][36] - Consumable revenues increased by 25% quarter-over-quarter, indicating a positive trend in this segment [31] - Services and other revenue were $8.6 million, down $0.2 million or 2.6% from Q1 2022 [12] Market Data and Key Metrics Changes - Softness in instrument demand was noted primarily in the Asia Pacific region, with significant volume activity declines from large distributors [21] - The company expects this softness to persist throughout the year, impacting overall instrument revenue [21] Company Strategy and Development Direction - The company is focused on a comprehensive transformation plan aimed at improving customer experience and operational efficiencies, with new product SKUs expected by the end of the year [7][30] - The strategy includes transitioning customer demand from existing assays to new assays through 2024, which is anticipated to enhance margins and scale revenue profitably [7][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the transformation plan and noted that Q1 performance exceeded expectations, leading to a modest increase in revenue guidance for 2023 [10][33] - The company anticipates gross margin headwinds in the second half of 2023 due to increased staffing and initial runs of new assays [15][32] Other Important Information - The company ended Q1 2023 with $329 million in unrestricted cash, a decrease of approximately $9.1 million from the previous quarter [9][39] - The FDA's recent approval of blood-based biomarkers is expected to play a significant role in neuro research and therapeutic development, positioning the company favorably in this market [41][43] Q&A Session Summary Question: Can you elaborate on the customer segments experiencing softness in instrument revenues? - Management indicated that softness is primarily observed in the Asia Pacific region, with large distributors showing reduced volume activity [21] Question: What is the go-to-market strategy for the Alzheimer's assay? - The company confirmed that their products are available for reference and specialty labs, focusing on P-tau assays and potential multiplex offerings [22][23] Question: Can you provide more details on the assay redevelopment program? - Management confirmed progress in the assay redevelopment program, with expectations to insert new materials into manufacturing lines in the coming quarters [50][51] Question: What is the expected mix shift between instruments, consumables, and Accelerator services? - Management noted a higher percentage mix of consumables and Accelerator services, with a lower percentage from instruments expected throughout the year [52]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number: 001-38319 QUANTERIX CORPORATION (Exact name of registrant as specified in its charter) Delaware 20-8957988 (Sta ...

OUR MISSION 3 Ultrasensitive biomarker detection to transform the future of healthcare (1) 808 GEOGRAPHY NA Europe Asia | --- | --- | --- | |-------|-------|-------| | | | | | | | | | | | | | | | | | | 60% | | CUSTOMER | --- | --- | |---------------|-------| | | | | Academia | 55% | | Pharma / CROs | 45% | | --- | --- | |-----------------|-----------------| | | | | INSTRUMENTS | ACCELERATOR | | Placements (2) | Projects (2) | | BIOMARKERS | PUBLICATIONS | | Cumulative (2) | Cumulative (2) | (2) (1) FY2022 a ...

Quanterix Corporation (NASDAQ:QTRX) Q4 2022 Earnings Conference Call March 3, 2023 8:30 AM ET Company Participants Masoud Toloue - CEO Mike Doyle - CFO Conference Call Participants Matt Sykes - Goldman Sachs Puneet Souda - SVB Securities Kyle Mikson - Canaccord Genuity Operator Good day, and thank you for standing by. Welcome to the Quanterix Corporation Q4 2022 Earnings Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer sess ...

Financial Performance & Guidance - Quanterix expects modest growth in 2023 and anticipates a return to double-digit growth by 2024[24] - The company aims to be cash flow positive at revenue between $170 million and $190 million in 2023[24] - Q4 2022 GAAP gross margin was 48.8%, while the non-GAAP gross margin was 41.3%[8, 12, 35] - Q4 2022 GAAP revenue was $25.8 million[8, 12, 35] - Quanterix anticipates GAAP gross margin in the mid-40s and non-GAAP gross margin in the low-40s for the end of 2023[2] - The company expects cash burn to improve by approximately 10% in 2023[2] Product & Scientific Advancements - Simoa pTau181 and NfL were associated with Alzheimer's Disease (AD) incidence within 9 years of diagnosis[31] - A study showed that 10 mg/kg of Leqembi every two weeks reduced mean plasma pTau-181 by 24% from baseline in 79 weeks[25] - Simoa GFAP was associated with clinical AD incidence 9 to 17 years before diagnosis[33] Revenue Streams - Lilly MCA (Master Collaboration Agreement) projects contributed to revenue, with a 28% increase[1, 20, 21] - The company estimates Lilly MCA license fee revenue between approximately $103 million and $109 million[1]

PART I [Business](index=6&type=section&id=Item%201.%20Business) Quanterix specializes in ultra-sensitive digital immunoassay platforms, providing instruments and services for life science and pharmaceutical markets, undergoing a 2022 restructuring to enhance quality and market focus - The company's proprietary Simoa technology enables the detection of protein biomarkers at extremely low concentrations, a significant advancement over conventional ELISA technology[20](index=20&type=chunk)[21](index=21&type=chunk) - Simoa technology has been cited in over **2,000 scientific publications** and the company serves a customer base of over **1,300**[22](index=22&type=chunk)[32](index=32&type=chunk) - In Q3 2022, Quanterix initiated a Restructuring Plan, which included eliminating **119 positions** and starting an assay redevelopment program to improve manufacturing and delivery of high-quality assays at scale[23](index=23&type=chunk) - The company's installed instrument base grew to **876 instruments** as of December 31, 2022, providing a recurring revenue stream from consumables[32](index=32&type=chunk) [Our Products and Services](index=6&type=section&id=Our%20Products%20and%20Services) Quanterix offers Simoa instruments and biomarker assays, with its CLIA-certified Accelerator Laboratory providing contract research and LDTs Quanterix Instrument Portfolio | Instrument | Technology | Key Features | | :--- | :--- | :--- | | **HD-X** | Bead-based | Fully automated, high productivity, upgraded version of HD-1 | | **SR-X** | Bead-based | Compact benchtop, lower price, flexible assay prep | | **SP-X** | Planar array | High multiplexing capabilities, ideal for oncology/immunology | - The Accelerator Laboratory has completed over **1,900 projects** for more than **400 customers** and launched LDTs for pTau-181 (Alzheimer's evaluation) and NfL (neurodegeneration evaluation)[27](index=27&type=chunk) - Through its subsidiary UmanDiagnostics, the company supplies premier Neurofilament light chain (NfL) antibodies and ELISA kits, critical for its neurology assays[28](index=28&type=chunk) [Our Strategy](index=10&type=section&id=Our%20Strategy) The company's strategy drives Simoa technology adoption in life science and pharma, leveraging neurological biomarkers before expanding into diagnostics - Initial focus is on the life science research/pharma market due to reduced regulatory and reimbursement risk[35](index=35&type=chunk) - A core part of the strategy is to expand into the diagnostics market, leveraging Simoa's sensitivity to enable less-invasive blood-based tests[35](index=35&type=chunk) - The company is capitalizing on the increasing relevance of neurological biomarkers (NfL, pTau-181, pTau-217) in clinical trials for drugs like lecanemab and donanemab[35](index=35&type=chunk) [Our Market Opportunities](index=24&type=section&id=Our%20Market%20Opportunities) Quanterix targets a **$75 billion** market opportunity across life science research/pharma (**$20 billion**) and diagnostics (**$55 billion**) markets Total Addressable Market (TAM) | Market Segment | Estimated TAM | | :--- | :--- | | Life Science Research/Pharma | ~$20 billion | | Diagnostics | ~$55 billion | | **Total** | **~$75 billion** | [Intellectual Property](index=51&type=section&id=Intellectual%20Property) The company's core strength is its extensive intellectual property, built around proprietary Simoa technology, with numerous owned and licensed patents - The core Simoa bead-based technology originated at Tufts University and is exclusively licensed to Quanterix[166](index=166&type=chunk)[194](index=194&type=chunk) - As of March 1, 2023, the company owned **29 issued U.S. patents** and had **17 pending U.S. patent applications**, in addition to numerous international patents and applications[174](index=174&type=chunk) - The patent portfolio for the planar array technology was acquired with Aushon Biosystems in 2018 and includes at least **ten issued U.S. patents**[186](index=186&type=chunk) [Government Regulation](index=57&type=section&id=Government%20Regulation) Most Quanterix products are Research Use Only, but its CLIA-certified lab offers LDTs subject to CLIA regulations, with potential for future FDA oversight - Most current products are labeled "For Research Use Only. Not for Diagnostic Procedures," which generally exempts them from FDA premarket review[197](index=197&type=chunk) - The company operates a CLIA-certified laboratory, which is subject to federal standards under the Clinical Laboratory Improvement Amendments of 1988 (CLIA)[218](index=218&type=chunk) - The FDA has granted Breakthrough Device designation for the Simoa pTau-181 blood test for Alzheimer's evaluation and the Simoa NfL plasma test for multiple sclerosis, potentially accelerating their review processes[86](index=86&type=chunk)[99](index=99&type=chunk)[214](index=214&type=chunk) [Risk Factors](index=73&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including net losses, operational challenges from restructuring, reliance on single-source manufacturers, and internal control weaknesses - The company has a history of annual net losses, incurring a **net loss of $96.7 million** in 2022, and expects losses to continue[254](index=254&type=chunk) - There is a risk that the company may fail to achieve the intended cost savings and quality benefits from its 2022 Restructuring Plan and assay improvement program[251](index=251&type=chunk)[272](index=272&type=chunk)[273](index=273&type=chunk) - Quanterix relies on single contract manufacturers for its Simoa HD-X (STRATEC) and SR-X (Paramit) instruments, posing a significant supply chain risk[251](index=251&type=chunk)[292](index=292&type=chunk) - Management identified material weaknesses in internal control over financial reporting as of December 31, 2022, which could result in material misstatements if not remediated[251](index=251&type=chunk)[261](index=261&type=chunk) - A significant portion of revenue comes from a few large customers, and the loss of any of these could harm operating results[251](index=251&type=chunk)[277](index=277&type=chunk) [Properties](index=124&type=section&id=Item%202.%20Properties) Quanterix's headquarters are in a leased **91,600 sq ft** facility in Billerica, MA; a newly leased **85,800 sq ft** Bedford facility will be subleased - The company's principal facility is a **91,600 sq. ft.** leased space in Billerica, MA, with a lease term extending from April 2019[398](index=398&type=chunk) - A newly leased **85,800 sq. ft.** facility in Bedford, MA, will not be occupied as part of the 2022 Restructuring Plan; the company intends to sublease this space[398](index=398&type=chunk)[401](index=401&type=chunk) [Legal Proceedings](index=126&type=section&id=Item%203.%20Legal%20Proceedings) As of December 31, 2022, Quanterix was not a party to any material legal proceedings, only non-material matters - As of December 31, 2022, the company was not party to any material legal proceedings[402](index=402&type=chunk) PART II [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=126&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) In FY2022, total revenue decreased **5%** to **$105.5 million**, net loss widened to **$96.7 million** due to lower gross margin and restructuring/impairment charges [Results of Operations](index=147&type=section&id=Results%20of%20Operations) For FY2022, total revenue decreased **5%** to **$105.5 million**, product revenue fell, service revenue grew, leading to a **68%** increase in net loss to **$96.7 million** Comparison of Operations for Years Ended Dec 31, 2022 and 2021 | Financial Metric | 2022 (in thousands) | 2021 (in thousands) | Change (%) | | :--- | :--- | :--- | :--- | | **Total Revenue** | **$105,522** | **$110,556** | **(5)%** | | Product Revenue | $69,808 | $81,062 | (14)% | | Service & Other Revenue | $34,495 | $23,629 | 46% | | **Gross Profit** | **$46,806** | **$61,728** | **(24)%** | | Gross Margin | 44% | 56% | (12) p.p. | | **Total Operating Expenses** | **$148,510** | **$120,314** | **23%** | | Research & Development | $25,890 | $27,978 | (7)% | | Selling, General & Admin | $91,995 | $92,336 | (0)% | | Restructuring & Impairment | $29,347 | $0 | N/A | | **Loss from Operations** | **($101,704)** | **($58,586)** | **(74)%** | | **Net Loss** | **($96,700)** | **($57,688)** | **(68)%** | - The decrease in product revenue was primarily due to reducing production levels of consumables to ensure quality[485](index=485&type=chunk) - The increase in service and other revenue was primarily due to revenue recognized from the Lilly Collaboration Agreement[486](index=486&type=chunk)[487](index=487&type=chunk) - The company incurred significant one-time expenses in 2022, including **$3.8 million** in restructuring costs, **$8.2 million** in goodwill impairment, and **$17.4 million** in other long-lived asset impairment[495](index=495&type=chunk) [Liquidity and Capital Resources](index=151&type=section&id=Liquidity%20and%20Capital%20Resources) Quanterix ended 2022 with **$338.7 million** in cash, primarily from equity offerings, believing current reserves are sufficient for the next 12 months Key Liquidity Metrics (as of Dec 31, 2022) | Metric | Amount (in millions) | | :--- | :--- | | Cash and Cash Equivalents | $338.7 | | Accumulated Deficit | ($402.2) | | Net Cash Used in Operating Activities (FY 2022) | ($48.3) | - The company financed operations primarily through equity offerings, including raising approximately **$270 million** in net proceeds in February 2021[503](index=503&type=chunk)[504](index=504&type=chunk) - Management believes that current cash and cash equivalents will be sufficient to meet anticipated operating cash requirements for at least the next 12 months[517](index=517&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=157&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company is exposed to credit, foreign currency, and interest rate risks, with foreign revenue at **38%** and interest rate risk considered minimal - One customer accounted for **13% of total revenue** for the year ended December 31, 2022[530](index=530&type=chunk) - Approximately **38% of total revenue in 2022** was generated from customers outside of North America, exposing the company to foreign currency exchange risk[531](index=531&type=chunk) - Interest rate risk is considered immaterial due to the short-term nature of the company's **$338.7 million** in cash and cash equivalents[533](index=533&type=chunk) [Financial Statements and Supplementary Data](index=157&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the company's audited consolidated financial statements for 2022, 2021, and 2020, including balance sheets and statements of operations Consolidated Balance Sheet Highlights (as of Dec 31) | Account (in thousands) | 2022 | 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $338,740 | $396,465 | | Total current assets | $381,403 | $448,955 | | Total assets | $434,199 | $501,527 | | **Liabilities & Equity** | | | | Total current liabilities | $30,958 | $36,977 | | Total liabilities | $75,259 | $60,575 | | Total stockholders' equity | $358,940 | $440,952 | Consolidated Statement of Operations Highlights (Year ended Dec 31) | Account (in thousands) | 2022 | 2021 | 2020 | | :--- | :--- | :--- | :--- | | Total revenue | $105,522 | $110,556 | $86,377 | | Gross profit | $46,806 | $61,728 | $48,182 | | Total operating expenses | $148,510 | $120,314 | $79,766 | | Loss from operations | ($101,704) | ($58,586) | ($31,584) | | Net loss | ($96,700) | ($57,688) | ($31,530) | | Net loss per share | ($2.61) | ($1.60) | ($1.07) | [Controls and Procedures](index=159&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded disclosure controls were ineffective as of Dec 31, 2022, due to material weaknesses in internal control, primarily from insufficient personnel - Management concluded that disclosure controls and procedures were **not effective** as of December 31, 2022[537](index=537&type=chunk) - Material weaknesses were identified in internal controls related to: (i) inventory accounting, (ii) salary and commissions expense, (iii) the financial statement close process, and (iv) property and equipment accounting[541](index=541&type=chunk)[549](index=549&type=chunk) - The primary cause of the control deficiencies was an insufficient number of qualified personnel in key accounting and finance functions[541](index=541&type=chunk) - A remediation plan is underway, which includes hiring more personnel, engaging consultants for technical accounting and system assessment, and providing additional training[544](index=544&type=chunk) PART III [Directors, Executive Compensation, Security Ownership, and Principal Accountant Fees](index=165&type=section&id=Item%2010%2C%2011%2C%2012%2C%2013%2C%2014) Information for Items 10-14, covering directors, executive compensation, security ownership, and accountant fees, is incorporated by reference from the 2023 proxy statement - The detailed information for Part III of the 10-K is not included directly in this report but is incorporated by reference from the forthcoming 2023 proxy statement[561](index=561&type=chunk)[562](index=562&type=chunk)[563](index=563&type=chunk) PART IV [Exhibits and Financial Statement Schedules](index=167&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists all exhibits filed with the 10-K, including corporate governance documents, material contracts, and certifications - This section provides a comprehensive list of all exhibits filed with the 10-K, including key agreements like the Exclusive License Agreement with Tufts University and manufacturing agreements with STRATEC and Paramit[570](index=570&type=chunk)[572](index=572&type=chunk)[574](index=574&type=chunk)

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number: 001-38319 QUANTERIX CORPORATION (Exact name of registrant as specified in its charter) (State or other juri ...

Start Time: 16:30 January 1, 0000 5:03 PM ET Quanterix Corporation (NASDAQ:QTRX) Q3 2022 Earnings Conference Call November 08, 2022, 16:30 PM ET Company Participants Masoud Toloue - CEO Michael Doyle - CFO Conference Call Participants Alex Vukasin - Canaccord Genuity Matt Sykes - Goldman Sachs Stephanie Yan - Cowen Operator Good day and thank you for standing by. Welcome to the Quanterix Corporation's Third Quarter 2022 Earnings Call. At this time, all participants are in a listen-only mode. After the speak ...

November 8, 2022 Q3 2022 Earnings Call Forward-Looking Statements & Pro-Forma Financial Measures This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forwardlooking statements in th ...

Financial Data and Key Metrics Changes - Total revenues for Q2 2022 were $23.5 million, representing a 7% decline year-over-year [11][15] - Consumable revenue declined by 29% year-over-year, significantly impacting overall revenue [11][16] - Pro-forma gross margin for Q2 2022 was 28.3%, down from 47.5% in Q2 2021, reflecting quality-related challenges and increased costs [11][20] - Operating expenses increased to $31.6 million in Q2 2022, up $5.9 million from the previous year, driven by headcount increases and other costs [22] Business Line Data and Key Metrics Changes - Product revenue in Q2 2022 was $14.8 million, a decrease of 21% compared to Q2 2021, with consumables being the largest contributor to this decline [15][16] - Service revenue increased by 51% year-over-year to $8.5 million, bolstered by collaborations, particularly with Eli Lilly [18] Market Data and Key Metrics Changes - The market opportunity in neurodegenerative research is growing, with increased demand for ultrasensitive tools for early biomarker detection [27] - The company has over 1800 publications demonstrating the effectiveness of Simoa technology in advancing drug approvals and biomarker discovery [29] Company Strategy and Development Direction - The company is undergoing a comprehensive operational plan to address quality challenges and improve the manufacturability of assays [10][30] - Focus has been realigned around three principles: Quality, Innovation, and Positioning to unlock translational market value [10] - The company aims to return to double-digit revenue growth by 2024, following the completion of its restructuring efforts [12] Management's Comments on Operating Environment and Future Outlook - Management acknowledges significant challenges but emphasizes a comprehensive operational plan to improve quality and scalability [30] - The company remains committed to transforming diagnostics for neurodegenerative diseases and advancing biomarker research [30] Other Important Information - A reduction in workforce affecting approximately 130 employees has been announced as part of the restructuring plan [10][13] - Kevin Hrusovsky has stepped down as Executive Chairman, with Martin Madaus appointed as the new Independent non-Executive Chairman [14] Q&A Session Summary Question: Can you discuss the quality challenges and their impact? - Management highlighted high costs of quality related to manufacturing processes and product stability, leading to a redevelopment program for assays [33] Question: What gives confidence in the flat revenue guidance despite layoffs? - Management noted that demand for Simoa products remains strong, and the focus on quality and innovation will support future growth [36] Question: Are collaborations with Eli Lilly and other partners impacted? - Management confirmed that there are no anticipated impacts on existing collaborations, including those with Eli Lilly [38] Question: What triggered the strategic review of the business? - The strategic review was initiated to assess operational efficiency and resource allocation, particularly in light of significant costs associated with product delivery [42] Question: How does the company differentiate its tests from competitors? - Management emphasized the extensive publication record and the sensitivity of their tests, which leverage Simoa technology for superior results [61][62] Question: What are the updates on the pTau-181 test and its market potential? - The company launched the first pTau-181 laboratory developed tests, which are expected to pave the way for future diagnostic applications [66]