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 June 30, 2021 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 (Stat ...

PART I — FINANCIAL INFORMATION [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) The unaudited condensed consolidated financial statements for Q1 2021 reflect significant asset growth to **$532.7 million** from a public offering, with revenue increasing **73%** to **$27.2 million** and net loss narrowing to **$10.1 million** [Unaudited Condensed Consolidated Balance Sheets](index=5&type=section&id=Unaudited%20Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2021, total assets significantly increased to **$532.7 million**, driven by a rise in cash to **$442.7 million** from a public offering, while stockholders' equity grew to **$471.5 million** Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | March 31, 2021 | December 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $442,672 | $181,584 | | Total current assets | $482,443 | $219,605 | | Total assets | $532,666 | $271,045 | | **Liabilities & Equity** | | | | Total current liabilities | $36,491 | $39,803 | | Total liabilities | $61,197 | $64,920 | | Total stockholders' equity | $471,469 | $206,125 | | Total liabilities and stockholders' equity | $532,666 | $271,045 | [Unaudited Condensed Consolidated Statements of Operations](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations) For Q1 2021, total revenue grew **73%** to **$27.2 million**, gross profit more than doubled to **$16.3 million**, and net loss narrowed to **$10.1 million**, despite a **41%** rise in operating expenses Condensed Consolidated Statements of Operations (in thousands, except per share data) | Metric | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Total revenue | $27,209 | $15,727 | | Gross profit | $16,349 | $6,813 | | Total operating expenses | $26,138 | $18,541 | | Loss from operations | $(9,789) | $(11,728) | | Net loss | $(10,104) | $(11,610) | | Net loss per share, basic and diluted | $(0.29) | $(0.41) | [Unaudited Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For Q1 2021, net cash used in operations was **$14.1 million**, while financing activities provided **$273.3 million** from a public offering, leading to a **$261.7 million** net increase in cash Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(14,089) | $(13,179) | | Net cash provided by (used in) investing activities | $2,435 | $(426) | | Net cash provided by financing activities | $273,313 | $861 | | Net increase (decrease) in cash and cash equivalents | $261,659 | $(12,744) | | Cash, restricted cash, and cash equivalents at end of period | $444,072 | $97,359 | - The company received net proceeds of **$269.7 million** from the sale of common stock in an underwritten public offering during the quarter[22](index=22&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the **$269.7 million** net proceeds from a February 2021 public offering, revenue recognition policies including **$2.3 million** in RADx grant revenue, and information on debt obligations - In February 2021, the company completed an underwritten public offering of approximately **4.1 million shares** of common stock, resulting in net proceeds of **$269.7 million**[31](index=31&type=chunk) Disaggregated Revenue by Type (in thousands) - Q1 2021 | Revenue Type | North America | EMEA | Asia Pacific | Total | | :--- | :--- | :--- | :--- | :--- | | Instruments | $3,756 | $2,833 | $372 | $6,961 | | Consumable and other products | $6,911 | $3,493 | $883 | $11,287 | | Service-type warranties | $971 | $438 | $62 | $1,471 | | Research services | $3,558 | $728 | $12 | $4,298 | - Under the RADx program workplan 2 (WP2) award, the company recognized **$2.3 million** in grant revenue and incurred **$1.8 million** in related R&D expense during the three months ended March 31, 2021[74](index=74&type=chunk) - As of March 31, 2021, the company had **$7.7 million** in outstanding long-term debt with Hercules Capital, with principal payments scheduled to begin on July 1, 2021 and conclude on October 1, 2021[110](index=110&type=chunk)[156](index=156&type=chunk)[157](index=157&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=43&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q1 2021 financial performance, highlighting a **73%** revenue increase to **$27.2 million**, improved gross margin to **60%**, and a narrowed net loss to **$10.1 million**, bolstered by a **$269.7 million** public offering [Results of Operations](index=48&type=section&id=Results%20of%20Operations) For Q1 2021, total revenue grew **73%** to **$27.2 million**, gross profit increased **140%** to **$16.3 million**, and loss from operations improved to **$9.8 million**, despite a **41%** rise in operating expenses Comparison of Results of Operations (in thousands) | Line Item | Q1 2021 | Q1 2020 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Total revenue | $27,209 | $15,727 | $11,482 | 73% | | Gross profit | $16,349 | $6,813 | $9,536 | 140% | | Research and development | $6,683 | $4,268 | $2,415 | 57% | | Selling, general, and administrative | $19,455 | $14,273 | $5,182 | 36% | | Loss from operations | $(9,789) | $(11,728) | $1,939 | 17% | | Net loss | $(10,104) | $(11,610) | $1,506 | 13% | - The increase in product revenue was primarily due to higher instrument demand and increased consumable sales as customers reopened from COVID-19 related shutdowns[146](index=146&type=chunk) - R&D expense increased by **57%** mainly due to compensation, development, and materials costs related to the NIH RADx program (WP2)[149](index=149&type=chunk) [Liquidity and Capital Resources](index=50&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity significantly improved in Q1 2021, with cash reaching **$442.7 million** due to **$269.7 million** net proceeds from a public offering, sufficient for at least the next 12 months of operations - In February 2021, the company received approximately **$269.7 million** in net proceeds from an underwritten public offering of **4,107,142 shares** of common stock[155](index=155&type=chunk) Cash Flow Summary (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(14,089) | $(13,179) | | Net cash provided by (used in) investing activities | $2,435 | $(426) | | Net cash provided by financing activities | $273,313 | $861 | - The company believes its current cash, cash equivalents, and expected revenue will be sufficient to meet anticipated operating cash requirements for **at least the next 12 months**[170](index=170&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=58&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) No material changes were reported to the company's market risk disclosures compared to its 2020 Annual Report on Form 10-K - There were no material changes to the company's market risk disclosures as of March 31, 2021, compared to those in the 2020 Annual Report on Form 10-K[181](index=181&type=chunk) [Controls and Procedures](index=58&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2021, with no material changes to internal control over financial reporting during the quarter - Management concluded that the company's disclosure controls and procedures were **effective** as of March 31, 2021[182](index=182&type=chunk) - **No material changes** to the company's internal control over financial reporting occurred during the first quarter of 2021[183](index=183&type=chunk) PART II — OTHER INFORMATION [Legal Proceedings](index=58&type=section&id=Item%201.%20Legal%20Proceedings) The company is **not currently a party to any material legal proceedings** - As of the filing date, the company was **not involved in any material legal proceedings**[185](index=185&type=chunk) [Risk Factors](index=58&type=section&id=Item%201A.%20Risk%20Factors) **No material changes** were reported to the risk factors previously disclosed in the 2020 Annual Report on Form 10-K - **No material changes** were reported to the risk factors described in the 2020 Annual Report on Form 10-K[186](index=186&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=58&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) On January 20, 2021, the company issued **7,347 shares** of common stock from the net, non-cash exercise of **10,000 warrants** by a consultant, exempt from registration - On January 20, 2021, **10,000 warrants** were exercised on a net, non-cash basis, resulting in the issuance of **7,347 shares** of common stock to a consultant[187](index=187&type=chunk) [Defaults Upon Senior Securities](index=60&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable [Mine Safety Disclosures](index=60&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable [Other Information](index=60&type=section&id=Item%205.%20Other%20Information) This item is not applicable [Exhibits](index=61&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Quarterly Report on Form 10-Q, including CEO and CFO certifications and XBRL interactive data files - Exhibits filed include CEO and CFO certifications (31.1, 31.2, 32.1) and XBRL data files (101, 104)[194](index=194&type=chunk)

Preliminary Information [Form 10-K Details](index=1&type=section&id=Form%2010-K%20Details) This section details the Form 10-K's basic filing information, including registrant, jurisdiction, address, trading symbol, and SEC status - Registrant: **QUANTERIX CORPORATION**, incorporated in Delaware, with principal executive offices at 900 Middlesex Turnpike, Billerica, MA 01821. Telephone: **(617) 301-9400**[2](index=2&type=chunk) - The registrant is an **Accelerated filer**, **Smaller reporting company**, and **Emerging growth company**[4](index=4&type=chunk) - As of June 30, 2020, common equity held by non-affiliates was approximately **$234 million**; as of March 1, 2021, **36,267,609 shares** of common stock were outstanding[4](index=4&type=chunk)[5](index=5&type=chunk) Securities Registered | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | :------------------ | :---------------- | :---------------------------------------- | | Common Stock, $0.001 par value per share | QTRX | The Nasdaq Global Market | [Documents Incorporated by Reference](index=1&type=section&id=Documents%20Incorporated%20by%20Reference) Portions of the 2021 Annual Meeting of Stockholders' definitive proxy statement are incorporated by reference into Part III - Portions of the definitive proxy statement for the **2021 Annual Meeting of Stockholders** are incorporated by reference into **Part III** of this Annual Report on Form 10-K[7](index=7&type=chunk) [Table of Contents](index=2&type=section&id=Table%20of%20Contents) The table of contents outlines the Form 10-K's structure, detailing items and page numbers across its four main parts - The report is structured into four main parts: **Part I** (Business, Risk Factors, Properties, Legal Proceedings), **Part II** (Market for Common Equity, Financial Data, MD&A, Market Risk, Financial Statements, Controls), **Part III** (Directors, Executive Compensation, Security Ownership, Related Transactions, Accountant Fees), and **Part IV** (Exhibits, Summary)[10](index=10&type=chunk) [Special Note Regarding Forward-Looking Statements](index=3&type=section&id=Special%20Note%20Regarding%20Forward-Looking%20Statements) This section cautions that the report contains forward-looking statements subject to risks, particularly those in 'Risk Factors' - The Annual Report contains forward-looking statements identifiable by words like 'anticipate,' 'believe,' 'expect,' 'intend,' 'may,' 'plan,' 'potential,' 'will,' and 'would'[12](index=12&type=chunk) - These statements are subject to risks, uncertainties, and assumptions, including those in 'Part I, Item 1A, Risk Factors,' and actual results could differ materially[13](index=13&type=chunk) - The company does not guarantee future results and undertakes no obligation to publicly update forward-looking statements, except as required by law[14](index=14&type=chunk) - Forward-looking statements include those about business model implementation, market size for Simoa technology, product commercialization, assay development, financial estimates, Simoa's impact on diagnostics and research, and financial performance[15](index=15&type=chunk) [Service Marks, Trademarks and Trade Names](index=5&type=section&id=Service%20Marks,%20Trademarks%20and%20Trade%20Names) This section clarifies the company's trademarks, including 'Quanterix' and 'Simoa,' and notes other marks do not imply endorsement - Key trademarks include '**Quanterix**,' '**Simoa**,' '**Simoa HD-X**,' '**Simoa HD-1**,' '**SR-X**,' '**SP-X**,' '**HD-X Analyzer**,' and '**HD-1 Analyzer**'[19](index=19&type=chunk) - The use of other companies' trade names, trademarks, or service marks does not imply a relationship with, or endorsement or sponsorship by, those companies[19](index=19&type=chunk) PART I [Item 1. Business](index=6&type=section&id=Item%201.%20Business) Quanterix is a life sciences company specializing in ultra-sensitive digital immunoassay platforms based on proprietary Simoa technology [Overview](index=6&type=section&id=Overview) Quanterix develops ultra-sensitive digital immunoassay platforms using proprietary Simoa technology for research and diagnostics - Quanterix develops ultra-sensitive digital immunoassay platforms based on proprietary Simoa detection technology[21](index=21&type=chunk) - Simoa platforms enable reliable detection of protein biomarkers in extremely low concentrations, often undetectable by conventional methods[21](index=21&type=chunk) - The technology provides insights into protein biomarkers' role in human health, facilitating a shift towards earlier detection, monitoring, prognosis, and prevention[21](index=21&type=chunk) - Simoa technology has been cited in over **1,100 scientific publications** and adopted by over **950 customers**, including all **20 largest biopharmaceutical companies**[24](index=24&type=chunk) [Our Products and Services](index=6&type=section&id=Our%20Products%20and%20Services) Quanterix offers three Simoa instruments, numerous assay kits, contract research services, and COVID-19 tests with EUAs - Quanterix offers three Simoa instruments: **HD-X** (launched H2 2019, fully automated, bead-based), **SR-X** (launched Dec 2017, compact benchtop, bead-based), and **SP-X** (launched Apr 2019, planar array, high multiplexing)[31](index=31&type=chunk) - The company provides approximately **86 analyte-specific single-plex and multi-plex bead-based assay kits** and about **100 planar array reagent kits** for neurology, infectious disease, immunology, oncology, and cardiology[28](index=28&type=chunk) - Contract research services are offered through the **CLIA-certified Accelerator Laboratory**, completing over **1,300 projects** for ~**360 customers**[29](index=29&type=chunk) - Acquired UmanDiagnostics AB in August 2019, securing supply of neurofilament light (**Nf-L**) antibodies and Nf-L ELISA kits, recognized as best-in-class for highly sensitive Nf-L detection[30](index=30&type=chunk)[35](index=35&type=chunk) - Developed **SARS-CoV-2 semi-quantitative IgG** and **N Protein Antigen tests**, receiving FDA Emergency Use Authorizations (**EUAs**) in December 2020 and January 2021, respectively[36](index=36&type=chunk) [Our Market Opportunities](index=10&type=section&id=Our%20Market%20Opportunities) Simoa platforms target life science research, diagnostics, and precision health screening, with a potential $55 billion diagnostic market - Simoa platforms address life science research, diagnostics, and precision health screening markets[38](index=38&type=chunk) - Simoa's sensitivity can improve existing diagnostics, enable new non-invasive tests, and has significant potential in companion diagnostics for drug development and monitoring[42](index=42&type=chunk)[43](index=43&type=chunk) - Precision health screening applications could involve regular blood draws to monitor protein biomarker levels in asymptomatic individuals for early disease detection[44](index=44&type=chunk)[45](index=45&type=chunk) Estimated Addressable Market Opportunities (Annual) | Market Segment | Estimated Potential (Billions USD) | | :-------------------------------- | :--------------------------------- | | Pre-COVID Life Science Research (Neurology, Immunology, Oncology) | $1.0 | | COVID-19 Life Science Research | $0.2 | | Expanded Life Science Research (other areas, decentralized trials) | $7.0 | | Diagnostics & Precision Health Screening (Aggregate) | $55.0 | | - Neurology Diagnostics | $18.0 | | - Proteomic Liquid Biopsy | $20.0 | | - COVID Diagnostics | $12.0 | | - Precision Health Screening | $5.0 | [Our Competitive Strengths](index=14&type=section&id=Our%20Competitive%20Strengths) Quanterix's strengths include proprietary ultra-sensitive Simoa technology, deep scientific validation, flexible assay design, and an attractive business model - Proprietary ultra-sensitive **Simoa digital immunoassay technology platforms** enable less invasive procedures and smaller sample sizes, detecting proteins undetectable by conventional methods[48](index=48&type=chunk) - Technology platforms leverage and improve upon industry-standard **ELISA technology** by adding digital capability, making them easily integrated into existing customer workflows[48](index=48&type=chunk) - Deep and expanding scientific validation with over **1,100 scientific publications** and a customer base of over **950**, including all **20 largest biopharmaceutical companies**[48](index=48&type=chunk) - Leading market position solidified by robust customization capabilities, assay design flexibility, and the full automation of the **HD-X instrument**, providing high R&D productivity[48](index=48&type=chunk) - Highly experienced senior management team with over **20 years** of relevant industry experience[50](index=50&type=chunk) Consumables Revenue Growth | Year | Consumables Revenue (Millions USD) | % of Total Revenue | | :--- | :--------------------------------- | :----------------- | | 2020 | $27.4 | 32% | | 2019 | $25.6 | - | | 2018 | $13.8 | - | [Our Strategy](index=16&type=section&id=Our%20Strategy) Quanterix's strategy focuses on expanding protein detection, leveraging Nf-L, and growing through collaborations and acquisitions - Focus on the expanding market for protein detection and analysis, recognizing proteins as more relevant than nucleic acids for understanding health and disease in real-time[52](index=52&type=chunk) - Drive adoption of **Simoa technology** in life science research (near-term) and diagnostics/precision health screening (long-term), leveraging its sensitivity for new, less-invasive diagnostic tests and early disease detection[52](index=52&type=chunk) - Leverage the growing importance of **Nf-L** as a biomarker for neurodegenerative conditions, solidified by the acquisition of Uman and its best-in-class Nf-L antibodies[52](index=52&type=chunk) - Grow into new markets organically with customers and through strategic collaborations, such as licensing Nf-L antibodies to **Siemens Healthineers** and bead-based single molecule detection patents to **Abbott Laboratories** for IVD[54](index=54&type=chunk) - Grow through strategic acquisitions, exemplified by **Aushon BioSystems** (planar array technology, SP-X instrument) and **UmanDiagnostics** (Nf-L antibodies)[54](index=54&type=chunk) [Industry Background](index=18&type=section&id=Industry%20Background) The industry highlights proteins' critical role in health, with Simoa technology enabling detection of previously undetectable proteins - Proteins are critical for nearly all biological processes, providing a powerful window into an organism's health that genomic research alone cannot offer[56](index=56&type=chunk) - Of over **100,000 different proteins**, approximately **10,500** are secreted in blood, but fewer than **1,300** are consistently detectable by conventional immunoassay technologies in healthy individuals[57](index=57&type=chunk) - **Simoa technology**, by enabling the study of more of the proteome, is expected to have a profound impact on proteomic research, similar to the Human Genome Project's impact on genomic research[61](index=61&type=chunk) - This enhanced detection capability is central to earlier detection, monitoring, prognosis, and prevention of diseases and injuries[61](index=61&type=chunk) [Existing Technologies and Their Limitations](index=20&type=section&id=Existing%20Technologies%20and%20Their%20Limitations) Existing protein analysis technologies like ELISA and mass spectrometry have limitations in sensitivity and dynamic range - Conventional protein analysis technologies (**ELISA**, Western blotting, mass spectrometry, etc.) have limitations such as dilution of product molecules, narrow dynamic range, low detection limits, and procedural complexity, restricting sensitivity[63](index=63&type=chunk)[68](index=68&type=chunk) - These technologies can only detect a fraction of the estimated **10,500 secreted proteins** in human blood[63](index=63&type=chunk) - **PCR**, a widely used genomic analysis method, amplifies DNA sequences but can introduce distortion and bias into data, especially at low concentrations, due to repeated enzyme use and heating/cooling cycles[65](index=65&type=chunk) [Our Simoa Technology](index=22&type=section&id=Our%20Simoa%20Technology) Simoa technology advances ELISA with ultra-sensitive bead-based digital immunoassays and high-multiplex planar array technology - **Simoa bead-based digital immunoassays** trap single molecules in tiny microwells (**40 trillionths of a milliliter**), **2.5 billion times smaller** than traditional ELISA wells, allowing digital readout of individual molecules for unprecedented sensitivity[67](index=67&type=chunk) - Simoa bead-based technology enables multiplexing by using beads labeled with different fluorescent dyes, maintaining single-plex precision, and has launched **4-plex neurology** and **6-plex human cytokine assays**[76](index=76&type=chunk)[78](index=78&type=chunk) - **Simoa planar array immunoassays** use spatially segregated micro-spots within microtiter plate wells, concentrating the signal to a surface area **1,000 times smaller** than traditional ELISA, enabling multiplexing up to **12 different assays per well**[79](index=79&type=chunk) - Simoa bead-based technology can detect nucleic acids (e.g., **microRNA-122** for liver toxicity) with **PCR-like sensitivity** but without amplification distortion and bias, and with reduced cross-contamination[88](index=88&type=chunk)[90](index=90&type=chunk)[91](index=91&type=chunk) [Our Market Opportunities (Detailed)](index=31&type=section&id=Our%20Market%20Opportunities%20(Detailed)) Simoa expands life science research, improves diagnostics, and enables precision health screening for early disease detection - Simoa platforms are well-positioned to capture a significant share of the life science research market due to superior sensitivity, automated workflow, multiplexing, and broader sample compatibility[94](index=94&type=chunk) - Simoa technology is being integrated into drug development protocols by pharmaceutical and biotechnology companies to efficiently monitor drug impact on biomarkers and predict side effects, utilized in over **800 clinical trials**[96](index=96&type=chunk) - Simoa's sensitivity can enable earlier detection of diseases and injuries, develop new non-invasive diagnostic tests (e.g., blood tests for TBI, replacing CT scans), and advance companion diagnostics for patient stratification and treatment monitoring[99](index=99&type=chunk)[100](index=100&type=chunk)[101](index=101&type=chunk) - Precision health screening could involve regular blood draws to monitor low-abundance protein biomarkers in asymptomatic individuals for early disease onset detection, facilitating a shift towards prevention[103](index=103&type=chunk)[104](index=104&type=chunk) Estimated Addressable Market Potential (Annual) | Market Segment | Estimated Potential (Billions USD) | | :-------------------------------- | :--------------------------------- | | Pre-COVID Life Science Research (Neurology, Immunology, Oncology) | $1.0 | | COVID-19 Life Science Research | $0.2 | | Expanded Life Science Research | $7.0 | | Diagnostics & Precision Health Screening (Aggregate) | $55.0 | | - Neurology Diagnostics | $18.0 | | - Proteomic Liquid Biopsy | $20.0 | | - COVID Diagnostics | $12.0 | | - Precision Health Screening | $5.0 | [Our Key Focus Areas](index=35&type=section&id=Our%20Key%20Focus%20Areas) Quanterix focuses on neurology, oncology, COVID-19, inflammation, cardiology, and infectious disease with ultra-sensitive biomarker detection - **Neurology**: Simoa detects neurological biomarkers (**Nf-L**, tau, GFAP, UCH-L1) in blood at ultra-low levels, traditionally only detectable in CSF, advancing research in MS, Alzheimer's, dementia, Parkinson's, and TBI. Simoa Nf-L assay is **840-fold more sensitive** than conventional ELISA[108](index=108&type=chunk)[109](index=109&type=chunk)[114](index=114&type=chunk) - **Oncology**: Simoa's ultra-sensitivity enables early detection of oncology biomarkers, potential liquid biopsy alternatives to mammograms and biopsies, and monitoring of immunotherapy responses (e.g., IFN-gamma, IL-6). An ultra-sensitive PSA assay is **>1,000-fold more sensitive** than conventional ELISA for prostate cancer recurrence prediction[119](index=119&type=chunk)[120](index=120&type=chunk)[121](index=121&type=chunk)[122](index=122&type=chunk) - **COVID-19**: Developed **Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test** (EUA Dec 2020) and **Simoa SARS-CoV-2 N Protein Antigen Test** (EUA Jan 2021) for HD-X instrument, targeting vaccine response and early infection detection[124](index=124&type=chunk)[125](index=125&type=chunk)[126](index=126&type=chunk) - **Inflammation**: Simoa assays measure inflammatory and anti-inflammatory molecules (cytokines, chemokines) in serum/plasma with unprecedented sensitivity, enabling new discoveries and drug monitoring for diseases like Crohn's disease, asthma, and rheumatoid arthritis[127](index=127&type=chunk)[128](index=128&type=chunk)[129](index=129&type=chunk) - **Cardiology**: Simoa's high sensitivity has the potential for early prediction of heart attacks and other cardiac events[130](index=130&type=chunk) - **Infectious Disease**: Simoa enables early-stage detection of infectious disease antigens (e.g., HIV p24, C. difficile toxins) with sensitivity comparable to nucleic acid testing but with higher specificity and without amplification biases[131](index=131&type=chunk)[132](index=132&type=chunk)[133](index=133&type=chunk)[134](index=134&type=chunk) [Our Products and Services (Detailed)](index=44&type=section&id=Our%20Products%20and%20Services%20(Detailed)) Quanterix's portfolio includes RUO instruments, assay kits, homebrew kits, Nf-L antibodies, and CLIA-certified Accelerator Lab services - Simoa assays and consumables include ~**87 bead-based kits** (neurology, infectious disease, immunology, oncology), **two EUA-approved SARS-CoV-2 assays**, ~**120 planar array reagent kits** (immunology, oncology), and homebrew kits for custom assay development[142](index=142&type=chunk)[150](index=150&type=chunk) - **Nf-L antibodies and ELISA kits** are sold through Uman (acquired 2019), recognized for unparalleled sensitivity and specificity, with a licensing and supply arrangement with Siemens Healthineers[142](index=142&type=chunk)[154](index=154&type=chunk) - Services include contract research through the **CLIA-certified Accelerator Laboratory** (over **1,300 projects** for ~**360 customers**), supporting sample testing, homebrew, and custom assay development, and extended warranty/service contracts[142](index=142&type=chunk)[155](index=155&type=chunk)[158](index=158&type=chunk) Quanterix Product Key Attributes | Product | Key Attributes | | :------ | :------------- | | **HD-X** | Next-generation (launched H2 2019), Simoa bead-based, ultra-sensitive multiplex immunoassay, fully automated, up to 400 samples/8-hour shift, homebrew capabilities. | | **SR-X** | Launched Dec 2017, Simoa bead-based, benchtop, lower price, same sensitivity/dynamic range/homebrew as HD-X, up to 6-plex, flexible assay prep. | | **SP-X** | Launched Apr 2019, Simoa planar array, benchtop, lower price, similar sensitivity/dynamic range/homebrew as HD-X, up to 10-plex, flexible assay prep. | [Research and Development](index=49&type=section&id=Research%20and%20Development) Quanterix continuously invests in R&D to enhance Simoa platform sensitivity, expand its assay menu, and develop new instruments - Continuous R&D efforts focus on improving platform sensitivity, examining new assay formats, and enhancing instrumentation performance[157](index=157&type=chunk) - Assay menu expansion is guided by key opinion leaders, customer feedback, homebrew projects, Accelerator Laboratory projects, and new publications on industry-relevant biomarkers[159](index=159&type=chunk) - The company intends to develop and market new instruments with different and/or improved capabilities to broaden its market reach[160](index=160&type=chunk) [Sales and Marketing](index=51&type=section&id=Sales%20and%20Marketing) Quanterix distributes products via direct sales and distributors, targeting key opinion leaders, with a lengthy sales cycle - Distribution channels include direct field sales in **North America** and **Europe**, and third-party distributors/agents in other markets (e.g., Australia, Brazil, China, Japan)[161](index=161&type=chunk) - Sales and marketing target key opinion leaders, laboratory directors, and principal investigators at leading biotechnology, pharmaceutical, and governmental research institutions[163](index=163&type=chunk) - Awareness is increased through trade shows, academic conferences, webinars, and sponsoring the annual **Powering Precision Health (PPH) Summit**[164](index=164&type=chunk)[165](index=165&type=chunk) - The sales cycle for Simoa systems is typically **6 to 12 months or longer**, involving numerous interactions, in-depth evaluations, and adherence to customer budget cycles[166](index=166&type=chunk) [Manufacturing and Supply](index=52&type=section&id=Manufacturing%20and%20Supply) Quanterix outsources bead-based instrument manufacturing, produces planar array instruments and kits internally, and manages supply risks - Manufacturing strategy: outsource bead-based instrument development/manufacturing (**HD-X by STRATEC**, **SR-X by Paramit**) and internally develop/manufacture planar array instruments (**SP-X**) and all assay kits[167](index=167&type=chunk)[168](index=168&type=chunk)[170](index=170&type=chunk) - Relies on a limited number of suppliers, including single-source suppliers, for instrument components and assay kit reagents[170](index=170&type=chunk)[171](index=171&type=chunk)[173](index=173&type=chunk) - Mitigates supply risk by carrying significant inventory of critical components and increasing assay shelf life (e.g., bead-based assays from **6 to 12+ months**)[170](index=170&type=chunk)[171](index=171&type=chunk) - Uman's Nf-L antibody production is outsourced to a contract manufacturer, with bulk material processed and kits assembled in-house at Umeå, Sweden[174](index=174&type=chunk)[175](index=175&type=chunk) [Key Agreements](index=54&type=section&id=Key%20Agreements) Quanterix has key agreements with STRATEC, Paramit, Abbott Laboratories (license), and NIH (RADx program funding) - Development Agreement and Supply Agreement with **STRATEC**: STRATEC developed the Simoa HD instrument (now HD-X) and is the exclusive supplier. The development fee and warrant obligations have been met, and the minimum purchase commitment under the supply agreement has been satisfied[176](index=176&type=chunk)[177](index=177&type=chunk) - **Paramit Manufacturing Services Agreement**: Paramit produces and tests the SR-X instrument on an as-ordered basis. The agreement has an initial **three-year term** with automatic **one-year extensions**[181](index=181&type=chunk)[182](index=182&type=chunk) - Non-Exclusive License Agreement with **Abbott Laboratories** (Sept 2020): Granted Abbott a non-exclusive, worldwide, royalty-bearing license for bead-based single molecule detection patents in IVD. Received an initial **$10.0 million license fee** and is eligible for milestone fees and low single-digit royalties[183](index=183&type=chunk)[184](index=184&type=chunk) - Contracts with the **NIH under RADx** (Sept 2020): Awarded **$18.2 million (WP2)** to accelerate development, scale-up, and deployment of SARS-CoV-2 antigen test, building on initial WP1 funding. Funding is milestone-based and subject to Federal Acquisition Regulations (FAR)[185](index=185&type=chunk) [Competition](index=56&type=section&id=Competition) Quanterix competes in life science instrumentation and lab services, facing rivals in protein detection and diagnostics - Competes with established and development-stage life science companies in protein and nucleic acid detection (e.g., **Bio-Techne**, **Luminex**, **MesoScale Discovery**, Gyros, Nanostring)[186](index=186&type=chunk)[188](index=188&type=chunk) - Accelerator Laboratory competes with other research laboratories (e.g., Covance, Q2 Solutions, Myriad RBM, Monogram Biosciences, PPD Laboratories)[188](index=188&type=chunk) - In diagnostics and precision health screening, expects to compete with large companies like **Siemens**, **Abbott**, **Roche**, Ortho Clinical Diagnostics, and Thermo Fisher Scientific[188](index=188&type=chunk) - Principal competitive factors include sensitivity, cost of instruments/consumables, assay menu, reputation, innovation, accuracy/reproducibility, and customer support infrastructure[189](index=189&type=chunk)[192](index=192&type=chunk) [Intellectual Property](index=58&type=section&id=Intellectual%20Property) Quanterix protects its Simoa technology through exclusive licenses, patents, trademarks, and trade secrets, aiming for broad coverage - Core **Simoa bead-based technology** is exclusively licensed from **Tufts University**, including **18 patents** and **2 patent applications**[190](index=190&type=chunk)[195](index=195&type=chunk) - Owns **24 issued U.S. patents** and **22 pending U.S. patent applications**, along with numerous international patents, covering methods for single molecule detection, analyte capture, concentration determination, instruments, and specific analyte measurements (e.g., PSA, Nf-L, tau)[201](index=201&type=chunk)[202](index=202&type=chunk)[203](index=203&type=chunk)[205](index=205&type=chunk)[206](index=206&type=chunk)[207](index=207&type=chunk)[208](index=208&type=chunk)[209](index=209&type=chunk)[210](index=210&type=chunk)[211](index=211&type=chunk) - Acquired **Aushon's patent portfolio** for planar array technology, including **9 issued U.S. patents** and international equivalents[212](index=212&type=chunk) - Patent strategy is multilayered, protecting fundamental detection methods, specific analyte detection, novel instrumentation/consumables, and specific uses (e.g., biomarkers, diagnostics)[191](index=191&type=chunk)[194](index=194&type=chunk) - Protects intellectual property through patents, trademarks, trade secrets, copyrights, and contractual restrictions (confidentiality, IP assignment agreements)[213](index=213&type=chunk)[385](index=385&type=chunk) [Government Regulation](index=64&type=section&id=Government%20Regulation) Quanterix's RUO products are generally not FDA-regulated, but diagnostic products require costly clearances and compliance - Most products are '**Research Use Only**' (RUO) and not subject to FDA clearance, but are monitored for clinical intent under RUO/IUO Guidance[218](index=218&type=chunk) - COVID assays received **Emergency Use Authorizations (EUAs)** from FDA, allowing marketing during the public health emergency under lower evidence standards than traditional pathways[226](index=226&type=chunk)[227](index=227&type=chunk)[347](index=347&type=chunk) - Future clinical diagnostic products will be regulated as medical devices by FDA, requiring **510(k) clearance**, **De Novo classification**, or **Premarket Approval (PMA)**, which are expensive and time-consuming processes[220](index=220&type=chunk)[221](index=221&type=chunk)[222](index=222&type=chunk)[223](index=223&type=chunk)[225](index=225&type=chunk)[338](index=338&type=chunk)[339](index=339&type=chunk) - Operates a **CLIA-certified laboratory**, subject to federal (CLIA) and state regulations, including biennial inspections and proficiency testing. Potential changes in FDA regulation of Laboratory Developed Tests (LDTs) could increase regulatory burden[235](index=235&type=chunk)[236](index=236&type=chunk)[237](index=237&type=chunk)[238](index=238&type=chunk)[239](index=239&type=chunk)[240](index=240&type=chunk) - International markets (e.g., EU) have stringent medical device regulations, such as the new **IVD Regulation** (effective May 2022), which increases requirements for conformity assessment and classification (Uman's Nf-L ELISA kit is Class B)[244](index=244&type=chunk)[245](index=245&type=chunk) - Subject to environmental, health, and safety laws (e.g., OSHA) for hazardous materials, waste disposal, and employee safety[246](index=246&type=chunk) [Employees and Human Capital](index=74&type=section&id=Employees%20and%20Human%20Capital) Quanterix had 314 employees in 2020, focusing on attracting diverse talent through competitive compensation and an inclusive culture - As of December 31, 2020, Quanterix had **314 full-time employees** (**273 in US**, **41 international**), with **118 in sales/support/marketing**, **74 in engineering/R&D**, **72 in manufacturing/operations**, and **50 in G&A**[247](index=247&type=chunk) - Success depends on attracting and retaining highly qualified management and technical employees, with a turnover rate lower than the industry average[247](index=247&type=chunk) - Committed to a diverse, inclusive, and safe work environment, sponsoring a **Diversity, Equity and Inclusion Committee**, providing respectful workplace training, and recruiting diverse talent (**45% women**, **30% non-white** as of Dec 31, 2020)[248](index=248&type=chunk)[249](index=249&type=chunk) - Provides competitive compensation (salaries, bonuses, 401(k) match, healthcare, PTO, family leave) and equity-based grants to facilitate retention[251](index=251&type=chunk) - Maintains an 'open door' policy and strictly prohibits retaliation, emphasizing foundational values: **Accountability, Trust, Teamwork, and Transparency (AT&T3)**[250](index=250&type=chunk)[252](index=252&type=chunk) - Prioritizes employee health, safety, and wellness, implementing remote work and significant safety measures in response to COVID-19[253](index=253&type=chunk) [Corporate Information](index=76&type=section&id=Corporate%20Information) Quanterix Corporation was incorporated in Delaware in 2007 and provides SEC filings free of charge on its website - Incorporated in Delaware in **April 2007** as 'Digital Genomics, Inc.', later changed to 'Quanterix Corporation' in August 2007[254](index=254&type=chunk) - Principal executive offices are at **900 Middlesex Turnpike, Billerica, Massachusetts 01821**[254](index=254&type=chunk) - Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments are available free of charge on the company's website (**www.quanterix.com**) under 'Investors—Financial Information—SEC Filings'[255](index=255&type=chunk) [Item 1A. Risk Factors](index=76&type=section&id=Item%201A.%20Risk%20Factors) This section outlines numerous risks that could materially and adversely affect Quanterix's business and future growth [Risk Factor Summary](index=78&type=section&id=Risk%20Factor%20Summary) Key risks include ongoing losses, market acceptance, regulatory compliance, operational challenges, and intellectual property issues - Key risks include: incurring annual losses, fluctuating operating results, limited commercial history, and dependence on market acceptance of products[259](index=259&type=chunk) - Significant decrease in sales of the neurological biomarker **Nf-L assay** could materially adversely affect the business[259](index=259&type=chunk) - Subject to extensive regulatory requirements for **COVID-19 EUAs**; failure to comply or termination of EUAs could harm the business[259](index=259&type=chunk) - Epidemic diseases like **COVID-19** could negatively affect business operations, customer obligations, and demand[259](index=259&type=chunk) - Release of **NIH RADx funding** is milestone-based, with no assurance of timely achievement[259](index=259&type=chunk) - Long-term results depend on improving existing products and successfully introducing new ones; undetected errors or defects could harm reputation[259](index=259&type=chunk)[300](index=300&type=chunk) - Challenges in establishing or maintaining strategic collaborations and licensing arrangements[263](index=263&type=chunk)[302](index=302&type=chunk) - International activities expose the company to various risks, including manufacturing problems, reliance on single contract manufacturers, and intellectual property infringement claims[263](index=263&type=chunk) [Risks Related to Our Financial Condition](index=80&type=section&id=Risks%20Related%20to%20Our%20Financial%20Condition) Quanterix has a history of net losses, expects continued losses, and faces capital needs and NOL limitations - Expects losses to continue for at least the next **24 months** due to investments in commercial expansion and technology development[262](index=262&type=chunk) - Quarterly and annual operating results and cash flows have fluctuated and may continue to do so, influenced by factors like customer adoption, order timing, consumable utilization, new product introductions, and collaboration revenues[265](index=265&type=chunk)[266](index=266&type=chunk) - Future growth requires significant capital expenditures and may divert financial resources; failure to manage growth effectively could harm business and reputation[268](index=268&type=chunk)[271](index=271&type=chunk) - Future capital needs are uncertain, and additional funds may be required for sales/marketing, acquisitions, R&D, regulatory clearances, hiring, and public company costs. Inability to obtain funds could lead to delays or cessation of operations[272](index=272&type=chunk)[274](index=274&type=chunk) - Federal net operating loss (**NOLs**) carryforwards of approximately **$199.3 million** as of December 31, 2020, may be subject to limitations under **Section 382** of the Internal Revenue Code due to past or future ownership changes[275](index=275&type=chunk) Net Losses and Accumulated Deficit | Metric | 2020 (Millions USD) | 2019 (Millions USD) | 2018 (Millions USD) | | :----- | :------------------ | :------------------ | :------------------ | | Net Loss | $(31.5) | $(40.8) | $(31.5) | | Accumulated Deficit (as of Dec 31, 2020) | $(247.8) | - | - | [Risks Related to Our Business](index=86&type=section&id=Risks%20Related%20to%20Our%20Business) Quanterix faces risks from market acceptance, NIH funding, epidemic disruptions, lengthy sales cycles, and manufacturing issues - Failure of products to achieve and sustain sufficient market acceptance, especially against competing technologies, could adversely affect revenue[277](index=277&type=chunk) - Future success depends on penetrating existing customer base and attracting new customers, which is time-consuming and expensive[278](index=278&type=chunk)[280](index=280&type=chunk) - Sales of the neurological biomarker **Nf-L assay** are increasingly important (**8% of total revenue in 2020**); a significant decrease could materially affect the business[281](index=281&type=chunk) - **NIH RADx program funding** (**$18.2 million** for SARS-CoV-2 antigen test) is milestone-based and subject to U.S. government budgetary constraints, policy changes, and FAR provisions, including unilateral termination[282](index=282&type=chunk)[284](index=284&type=chunk)[287](index=287&type=chunk) - Epidemic diseases like **COVID-19** can disrupt operations, supply chains, customer access, and demand, negatively impacting financial results[289](index=289&type=chunk) - Sales cycle for Simoa instruments is lengthy and variable (**6-12+ months**), making revenue forecasting difficult[291](index=291&type=chunk) - Long-term results depend on continuous improvement of existing products and successful introduction of new products/assays, requiring significant R&D investment and facing risks of market acceptance and obsolescence[292](index=292&type=chunk)[293](index=293&type=chunk)[298](index=298&type=chunk) - Manufacturing problems, delays, or reliance on single contract manufacturers (**STRATEC for HD-X**, **Paramit for SR-X**) and limited suppliers for consumables could limit revenue growth or increase losses[315](index=315&type=chunk)[317](index=317&type=chunk)[318](index=318&type=chunk)[321](index=321&type=chunk) - Inability to attract, recruit, train, retain, and integrate key personnel, especially highly-trained sales and technical support staff, could harm operating results and growth[313](index=313&type=chunk)[322](index=322&type=chunk) - International operations (**48% of 2020 product revenue from outside North America**) expose the company to foreign regulatory requirements, currency fluctuations, political instability, and anti-bribery laws (e.g., FCPA)[306](index=306&type=chunk)[309](index=309&type=chunk)[310](index=310&type=chunk) - Integrating acquired businesses (e.g., Aushon, Uman) can be expensive, time-consuming, and disruptive, potentially affecting product sales and management focus[328](index=328&type=chunk)[330](index=330&type=chunk)[333](index=333&type=chunk) [Risks Related to Government Regulation and Diagnostic Product Reimbursement](index=106&type=section&id=Risks%20Related%20to%20Government%20Regulation%20and%20Diagnostic%20Product%20Reimbursement) Quanterix faces significant regulatory risks for diagnostic products, including FDA clearances, EUA revocations, and reimbursement policies - Marketing products for clinical diagnostic or health screening use will require costly and time-consuming FDA clearances (**510(k)**, **De Novo**, **PMA**) or approvals, which may not be obtained timely or at all[336](index=336&type=chunk)[338](index=338&type=chunk)[339](index=339&type=chunk) - **COVID-19 EUAs** are temporary and based on lower evidence standards; they can be revised or revoked if emergency conditions cease or problems are identified, impacting the ability to market these products[347](index=347&type=chunk)[349](index=349&type=chunk)[351](index=351&type=chunk) - Failure to comply with governmental regulations applicable to its **CLIA-certified laboratory** could lead to suspension, limitation, or revocation of certification, severely impacting operations[360](index=360&type=chunk)[362](index=362&type=chunk) - Reliance on third parties for future diagnostic product studies (e.g., clinical trials) introduces risks if they do not perform satisfactorily[363](index=363&type=chunk) - Unfavorable pricing regulations or third-party coverage and reimbursement policies for diagnostic procedures could harm business, as payors often follow CMS decisions[364](index=364&type=chunk) - Current and future legislation (e.g., **ACA**) and global regulatory reforms (e.g., **EU MDR**) may increase the difficulty and cost of obtaining marketing approval and commercializing products, potentially reducing prices and profitability[353](index=353&type=chunk)[357](index=357&type=chunk)[365](index=365&type=chunk)[366](index=366&type=chunk) - Products may be subject to recalls by FDA or foreign authorities due to deficiencies, diverting resources and harming reputation and financial results[352](index=352&type=chunk) [Risks Related to Our Operations](index=116&type=section&id=Risks%20Related%20to%20Our%20Operations) Quanterix's operations are vulnerable to IT system failures, data breaches, and compliance with data privacy laws like GDPR - Dependence on information technology systems (HR, accounting, manufacturing, sales, etc.) makes the business vulnerable to failures, downtime, physical/electronic break-ins, and viruses[370](index=370&type=chunk)[371](index=371&type=chunk) - Security breaches, data loss, or inappropriate disclosure of sensitive information could compromise intellectual property, lead to enforcement actions (e.g., **GDPR fines up to €20 million or 4% of global revenue**), litigation, and reputational damage[372](index=372&type=chunk)[373](index=373&type=chunk)[375](index=375&type=chunk)[376](index=376&type=chunk)[377](index=377&type=chunk) - Operations are subject to complex environmental, health, and safety laws (e.g., EPA, OSHA) regarding hazardous materials and waste, with risks of accidental contamination or injury and potential liability[378](index=378&type=chunk) [Risks Related to Intellectual Property](index=118&type=section&id=Risks%20Related%20to%20Intellectual%20Property) Quanterix's competitive advantage relies on protecting IP, facing risks from patent validity challenges and costly litigation - Inability to protect intellectual property (patents, trademarks, trade secrets) could reduce competitive advantage, lead to infringement by third parties, and incur substantial litigation costs[379](index=379&type=chunk)[380](index=380&type=chunk)[382](index=382&type=chunk)[383](index=383&type=chunk)[385](index=385&type=chunk)[386](index=386&type=chunk) - Some owned and in-licensed IP is from government-funded programs, subject to federal regulations like '**march-in**' rights, reporting requirements, and a preference for U.S. industry, which could limit exclusive rights[387](index=387&type=chunk)[388](index=388&type=chunk)[389](index=389&type=chunk) - Exclusive license for **Simoa bead-based technology** from **Tufts University** is critical; breach of obligations (royalty payments, diligence) could lead to termination or loss of rights[390](index=390&type=chunk)[391](index=391&type=chunk) - May need or choose to obtain licenses from third parties for future products; failure to do so on reasonable terms could prevent commercialization or lead to injunctions/royalties[393](index=393&type=chunk) - Risk of being sued for infringing third-party IP rights, leading to costly and time-consuming litigation, potential injunctive relief, damages, or cross-licensing requirements[398](index=398&type=chunk)[399](index=399&type=chunk)[406](index=406&type=chunk) - Patent litigation to protect or enforce patents can be expensive, time-consuming, and unsuccessful, risking invalidation or narrow interpretation of patents[402](index=402&type=chunk)[403](index=403&type=chunk)[404](index=404&type=chunk)[405](index=405&type=chunk) - Inability to protect IP rights globally due to prohibitive costs or weaker foreign laws, allowing competitors to use technologies or export infringing products[411](index=411&type=chunk)[412](index=412&type=chunk)[413](index=413&type=chunk) - Changes in patent laws (e.g., **America Invents Act**, Supreme Court rulings) or patent jurisprudence could diminish the value of patents, weakening the ability to obtain or enforce them[415](index=415&type=chunk)[416](index=416&type=chunk)[417](index=417&type=chunk) - Non-compliance with procedural requirements for patent agencies can lead to abandonment or lapse of patent rights[418](index=418&type=chunk)[419](index=419&type=chunk) - Inadequate protection of trademarks and trade names could hinder brand recognition and competitive positioning[421](index=421&type=chunk) - Potential use of third-party open source software in future products carries risks of license non-compliance, requiring source code release or product re-engineering[422](index=422&type=chunk)[423](index=423&type=chunk) - Reliance on third-party software that may be difficult to replace or cause errors/failures, leading to lost customers or reputational harm[424](index=424&type=chunk)[425](index=425&type=chunk) [Risks Related to Our Common Stock and Being a Public Company](index=135&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock%20and%20Being%20a%20Public%20Company) Quanterix's stock price is volatile, principal stockholders have influence, no dividends are anticipated, and anti-takeover provisions exist - Stock price may fluctuate significantly due to factors like financial results, new product announcements, competition, regulatory news, litigation, market conditions, and financing efforts[429](index=429&type=chunk)[430](index=430&type=chunk)[433](index=433&type=chunk) - Principal stockholders and management own approximately **17.4%** of outstanding common stock (as of Dec 31, 2020), allowing significant influence over stockholder approval matters and potentially delaying or preventing takeovers[435](index=435&type=chunk) - No dividends have been paid, and none are anticipated in the foreseeable future; investment gains depend solely on stock price increases[436](index=436&type=chunk) - Anti-takeover provisions in corporate documents (e.g., authorized preferred stock, special meeting rules, staggered board) and Delaware law (**Section 203**) could impair takeover attempts[437](index=437&type=chunk)[439](index=439&type=chunk)[441](index=441&type=chunk)[442](index=442&type=chunk) - As an '**emerging growth company**' (**JOBS Act**), benefits from reduced disclosure requirements (e.g., auditor attestation exemption for Section 404(b)) and an extended transition period for new accounting standards, which may affect comparability for investors[443](index=443&type=chunk) - Incurs increased costs and devotes substantial management time to operating as a public company, including compliance with SEC rules, **Sarbanes-Oxley Act**, and **Dodd-Frank Act**, which increases net loss[444](index=444&type=chunk)[445](index=445&type=chunk)[446](index=446&type=chunk) [Item 1B. Unresolved Staff Comments](index=142&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) This item indicates that there are no unresolved staff comments from the SEC - Not applicable, indicating no unresolved staff comments[447](index=447&type=chunk) [Item 2. Properties](index=142&type=section&id=Item%202.%20Properties) Quanterix leases 91,600 sq ft for its Billerica headquarters and 6,500 sq ft for its Uman subsidiary in Sweden - Leases approximately **91,600 square feet** for headquarters in Billerica, Massachusetts, for office, laboratory, and manufacturing space[448](index=448&type=chunk) - The Billerica lease term is **11 years and five months**, starting April 1, 2019, with two five-year extension options[448](index=448&type=chunk) - Subsidiary Uman leases approximately **6,500 square feet** in Umeå, Sweden, for office, laboratory, manufacturing, and storage, with leases expiring between May 2020 and February 2023[449](index=449&type=chunk) [Item 3. Legal Proceedings](index=142&type=section&id=Item%203.%20Legal%20Proceedings) Quanterix is not currently a party to any material legal proceedings - The company is not currently a party to any material legal proceedings[450](index=450&type=chunk) [Item 4. Mine Safety Disclosures](index=142&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to Quanterix Corporation - Not applicable[451](index=451&type=chunk) PART II [Item 5. Market For Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=142&type=section&id=Item%205.%20Market%20For%20Registrant's%20Common%20Equity,%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Quanterix common stock trades on Nasdaq (QTRX); as of March 2021, 36.3 million shares were outstanding - Common stock is traded on **The Nasdaq Global Market** under the symbol "**QTRX**"[453](index=453&type=chunk) - As of March 1, 2021, there were approximately **39 stockholders of record** and **36,267,609 shares** of common stock outstanding[453](index=453&type=chunk) - No unregistered sales of equity securities or issuer purchases of equity securities occurred during the fourth quarter ended December 31, 2020[454](index=454&type=chunk)[455](index=455&type=chunk) [Item 6. Selected Financial Data](index=144&type=section&id=Item%206.%20Selected%20Financial%20Data) This section presents selected consolidated financial data for Quanterix, including statements of operations and balance sheet data Consolidated Statement of Operations Data (in thousands, except per share data) | Metric | 2020 | 2019 | 2018 | | :------------------------------------------ | :----- | :----- | :----- | | Total revenue | $86,377 | $56,734 | $37,632 | | Cost of revenue | 38,195 | 29,898 | 19,684 | | Gross profit | 48,182 | 26,836 | 17,948 | | Research and development | 20,174 | 16,190 | 15,805 | | Selling, general and administrative | 59,592 | 52,246 | 33,693 | | Total operating expenses | 79,766 | 68,436 | 49,498 | | Loss from operations | (31,584) | (41,600) | (31,550) | | Interest income (expense), net | (273) | 627 | 46 | | Other expense, net | (49) | (10) | (7) | | Loss before income taxes | (31,906) | (40,983) | (31,511) | | Income tax benefit (provision) | 376 | 187 | (25) | | Net loss | (31,530) | (40,796) | (31,536) | | Net loss per share, basic and diluted | $(1.07) | $(1.63) | $(1.43) | | Weighted-average common shares outstanding | 29,589 | 25,091 | 21,994 | Consolidated Balance Sheet Data (in thousands) | Metric | As of Dec 31, 2020 | As of Dec 31, 2019 | As of Dec 31, 2018 | | :-------------------------- | :----------------- | :----------------- | :----------------- | | Cash and cash equivalents | $181,584 | $109,155 | $44,429 | | Total assets | $271,045 | $169,951 | $67,611 | | Total long term debt | $7,673 | $7,587 | $7,623 | | Total stockholders' deficit | $206,125 | $128,658 | $41,065 | [Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=146&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on Quanterix's financial condition and results of operations, highlighting its platforms and strategic focus [Overview](index=146&type=section&id=Overview) Quanterix develops ultra-sensitive digital immunoassay platforms, generates recurring revenue, and expanded through acquisitions - Quanterix develops next-generation, ultra-sensitive digital immunoassay platforms (**Simoa HD-X**, **SR-X**, **SP-X**) for life sciences research and diagnostics, based on proprietary Simoa detection technology[462](index=462&type=chunk)[465](index=465&type=chunk) - Revenue streams include instruments, assay kits, consumables, and contract research services through the Accelerator Laboratory, with consumables expected to be an increasingly important recurring revenue contributor[464](index=464&type=chunk)[465](index=465&type=chunk) - Acquired **Aushon BioSystems** in January 2018 for **$4.0 million** (cash), gaining a CLIA-certified laboratory and planar array detection technology (leading to SP-X instrument)[467](index=467&type=chunk)[844](index=844&type=chunk)[845](index=845&type=chunk) - Acquired **UmanDiagnostics AB** in August 2019 for **$21.2 million** (cash and stock), securing neurofilament light (**Nf-L**) antibodies and ELISA kits[468](index=468&type=chunk)[850](index=850&type=chunk) - Entered Non-Exclusive License Agreement with **Abbott Laboratories** in September 2020, granting a royalty-bearing license for bead-based single molecule detection patents in IVD, receiving an initial **$10.0 million license fee**[469](index=469&type=chunk) - **COVID-19 pandemic** impacted instrument revenue (installation limitations) and consumables, but led to development of SARS-CoV-2 IgG antibody and N Protein Antigen tests (EUAs Dec 2020/Jan 2021) and **$18.2 million NIH RADx funding** for antigen test development[470](index=470&type=chunk)[471](index=471&type=chunk)[472](index=472&type=chunk) - Expects significant expenses and operating losses to continue for at least the next **24 months** due to expansion of sales/marketing, R&D, potential acquisitions, regulatory clearances, and public company costs[475](index=475&type=chunk)[476](index=476&type=chunk) Net Losses and Accumulated Deficit | Metric | 2020 (Millions USD) | 2019 (Millions USD) | 2018 (Millions USD) | | :----- | :------------------ | :------------------ | :------------------ | | Net Loss | $(31.5) | $(40.8) | $(31.5) | | Accumulated Deficit (as of Dec 31, 2020) | $(247.8) | - | - | [Financial Operations Overview](index=151&type=section&id=Financial%20Operations%20Overview) Quanterix recognizes revenue under ASC 606, accounts for grants by IAS 20, and manages various cost and expense categories - Revenue is recognized under **ASC 606** when customers obtain control of promised goods or services, reflecting expected consideration[477](index=477&type=chunk) - Product revenue from instruments is recognized upon installation for direct customers or shipping for distributors; consumables revenue is based on shipping terms[480](index=480&type=chunk) - Service and other revenue includes contract research services (recognized upon report delivery or over time) and service-type warranties (recognized ratably)[481](index=481&type=chunk) - Collaboration and license revenue includes license fees (recognized at point in time for functional IP) and sales- or usage-based royalties (recognized when underlying transaction occurs)[481](index=481&type=chunk) - Cost of product revenue includes instrument costs, raw materials, freight, personnel, and royalties. Cost of service revenue includes personnel and facility costs for Accelerator Laboratory and instrument servicing. Cost of collaboration revenue includes royalties to third parties[484](index=484&type=chunk)[485](index=485&type=chunk)[486](index=486&type=chunk) - Research and Development (**R&D**) expenses include personnel, supplies, third-party development, and allocated overhead, expected to increase[487](index=487&type=chunk) - Selling, General and Administrative (**SG&A**) expenses include sales/marketing, finance, legal, HR personnel, professional services, and public company costs, also expected to increase[488](index=488&type=chunk) - Grant revenue, not under ASC 606, is accounted for by analogy to **IAS 20**, recognized as services are performed, with asset-related grants reducing asset carrying value and income-related grants recognized separately as revenue[482](index=482&type=chunk)[509](index=509&type=chunk)[510](index=510&type=chunk)[511](index=511&type=chunk)[512](index=512&type=chunk)[514](index=514&type=chunk)[515](index=515&type=chunk) [Critical Accounting Policies, Significant Judgments and Estimates](index=153&type=section&id=Critical%20Accounting%20Policies,%20Significant%20Judgments%20and%20Estimates) Quanterix's critical accounting policies involve significant judgments for revenue, grant revenue, and stock-based compensation - Critical accounting policies involve significant judgment and complexity, including revenue recognition, fair value of acquired assets/liabilities, valuation allowances for deferred tax assets, and inventory valuation[489](index=489&type=chunk)[490](index=490&type=chunk) - Revenue recognition (**ASC 606**, adopted Jan 1, 2019): Requires judgment in identifying performance obligations, determining transaction price, and allocating to standalone selling prices (SSPs)[477](index=477&type=chunk)[478](index=478&type=chunk)[479](index=479&type=chunk)[493](index=493&type=chunk)[494](index=494&type=chunk)[501](index=501&type=chunk) - Grant revenue (e.g., **NIH RADx program**) is recognized by analogy to **IAS 20**; **$6.4 million** recognized in 2020, with **$4.4 million from WP2** and **$2.0 million from WP1**[509](index=509&type=chunk)[516](index=516&type=chunk)[517](index=517&type=chunk) - Stock-based compensation (**ASC 718**): Fair value estimated using Black-Scholes model; expense recognized over vesting period. Adopted **ASU 2018-07** in 2020, aligning non-employee awards with employee awards[519](index=519&type=chunk)[520](index=520&type=chunk)[521](index=521&type=chunk)[744](index=744&type=chunk)[745](index=745&type=chunk)[746](index=746&type=chunk) - Adopted **ASC 842 (Leases)** on January 1, 2020, recognizing operating lease ROU assets (**$12.2 million**) and liabilities (**$22.8 million**) on the balance sheet[591](index=591&type=chunk)[596](index=596&type=chunk)[749](index=749&type=chunk)[753](index=753&type=chunk) Disaggregated Revenue by Geography and Type (2020, in thousands) | Revenue Type | NA | EMEA | Asia Pacific | Total | | :------------------------ | :----- | :----- | :----------- | :------ | | **Product revenues** | | | | | | Instruments | $8,680 | $4,332 | $3,594 | $16,606 | | Consumable and other products | $14,305 | $10,854 | $2,252 | $27,411 | | **Service and other revenues** | | | | | | Service-type warranties | $3,171 | $1,543 | $207 | $4,921 | | Research services | $15,011 | $2,225 | $737 | $17,973 | | Other services | $700 | $435 | $100 | $1,235 | | **Collaboration and license revenue** | | | | | | Collaboration and license revenue | $11,685 | $124 | $— | $11,809 | Disaggregated Revenue by Geography and Type (2019, in thousands) | Revenue Type | NA | EMEA | Asia Pacific | Total | | :------------------------ | :----- | :----- | :----------- | :------ | | **Product revenues** | | | | | | Instruments | $6,250 | $5,243 | $3,393 | $14,886 | | Consumable and other products | $14,148 | $9,674 | $1,783 | $25,605 | | **Service and other revenues** | | | | | | Service-type warranties | $3,139 | $1,323 | $171 | $4,633 | | Research services | $8,845 | $704 | $456 | $10,005 | | Other services | $825 | $565 | $31 | $1,421 | | **Collaboration and license revenue** | | | | | | Collaboration and license revenue | $167 | $17 | $— | $184 | WP2 Grant Activity as of Dec 31, 2020 (in thousands) | Metric | Amount | | :------------------------------------------ | :----- | | Total grant revenue from R&D activities | $4,362 | | Total proceeds used for assets | $826 | | Total deferred proceeds for assets | $2,478 | | Total deferred grant revenue | $304 | | Total recognized | $7,970 | | Total amount accrued | $(2,968) | | Total cash received | $5,002 | | Total proceeds reasonably assured | $13,198 | | Total WP2 grant amount | $18,200 | Stock-Based Compensation Expense by Classification (in thousands) | Classification | 2020 | 2019 | 2018 | | :-------------------------------- | :----- | :----- | :----- | | Cost of product revenue | $189 | $86 | $55 | | Cost of service and other revenue | $311 | $238 | $173 | | Research and development | $1,129 | $718 | $513 | | General and administrative | $8,470 | $5,346 | $4,143 | | **Total** | **$10,099** | **$6,388** | **$4,884** | [Results of Operations](index=165&type=section&id=Results%20of%20Operations) Quanterix's total revenue increased by 52% in 2020 to $86.4 million, driven by collaboration and service revenue - Revenue increased by **$29.6 million (52%)** in 2020, primarily due to **$11.8 million** in collaboration and license revenue (Abbott agreement) and **$6.4 million** in grant revenue (NIH RADx), alongside increased service revenue[529](index=529&type=chunk)[531](index=531&type=chunk) - Cost of product revenue increased by **24%** in 2020 due to higher sales and a full year of Uman acquisition-related inventory/intangible amortization[532](index=532&type=chunk) - R&D expense increased by **25%** in 2020, mainly due to COVID-19 related work under NIH RADx grants[533](index=533&type=chunk) - SG&A expense increased by **14%** in 2020 due to headcount additions to support growth[534](index=534&type=chunk) - Revenue increased by **$19.1 million (51%)** in 2019, primarily from increased instrument and consumables sales, and higher Accelerator Laboratory services. Collaboration and license revenue decreased due to the termination of a bioMérieux arrangement in 2018[539](index=539&type=chunk) - Cost of product revenue increased by **64%** in 2019 due to higher sales and Uman acquisition-related amortization[540](index=540&type=chunk) - SG&A expense increased by **55%** in 2019 due to headcount, public company costs, new headquarters lease, and Uman acquisition costs (**$1.9 million**)[544](index=544&type=chunk) Comparison of Years Ended December 31, 2020 and 2019 (dollars in thousands) | Metric | 2020 | % of revenue | 2019 | % of revenue | $ change | % change | | :-------------------------------- | :----- | :----------- | :----- | :----------- | :------- | :------- | | Total revenue | $86,377 | 100% | $56,734 | 100% | $29,643 | 52% | | Product revenue | $44,017 | 52% | $40,491 | 72% | $3,526 | 9% | | Service and other revenue | $24,129 | 28% | $16,059 | 28% | $8,070 | 50% | | Collaboration and license revenue | $11,809 | 14% | $184 | 0% | $11,625 | 6,318% | | Grant revenue | $6,422 | 6% | $— | 0% | $6,422 | 100% | | Gross profit | $48,182 | 56% | $26,836 | 47% | $21,346 | 80% | | Research and development | $20,174 | 23% | $16,190 | 29% | $3,984 | 25% | | Selling, general, and administrative | $59,592 | 69% | $52,246 | 92% | $7,346 | 14% | | Loss from operations | $(31,584) | (37)% | $(41,600) | (73)% | $10,016 | 24% | | Net loss | $(31,530) | (37)% | $(40,796) | (72)% | $9,266 | 23% | Comparison of Years Ended December 31, 2019 and 2018 (dollars in thousands) | Metric | 2019 | % of revenue | 2018 | % of revenue | $ change | % change | | :-------------------------------- | :----- | :----------- | :----- | :----------- | :------- | :------- | | Total revenue | $56,734 | 100% | $37,632 | 100% | $19,102 | 51% | | Product revenue | $40,491 | 72% | $23,365 | 62% | $17,126 | 73% | | Service and other revenue | $16,059 | 28% | $12,117 | 32% | $3,942 | 33% | | Collaboration and license revenue | $184 | 0% | $2,150 | 6% | $(1,966) | (91)% | | Gross profit | $26,836 | 47% | $17,948 | 48% | $8,888 | 50% | | Research and development | $16,190 | 29% | $15,805 | 42% | $385 | 2% | | Selling, general, and administrative | $52,246 | 92% | $33,693 | 90% | $18,553 | 55% | | Loss from operations | $(41,600) | (73)% | $(31,550) | (84)% | $(10,050) | (32)% | | Net loss | $(40,796) | (72)% | $(31,536) | (84)% | $(9,260) | (29)% | [Liquidity and Capital Resources](index=170&type=section&id=Liquidity%20and%20Capital%20Resources) Quanterix has incurred net losses, financed operations through equity offerings, and expects existing cash to fund operations - Historically incurred annual net losses and negative cash flows from operations; net loss of **$31.5 million in 2020**, **$40.8 million in 2019**, and **$31.5 million in 2018**[547](index=547&type=chunk) - As of December 31, 2020, cash and cash equivalents were **$181.6 million**, with an accumulated deficit of **$247.8 million**[548](index=548&type=chunk)[475](index=475&type=chunk) - Expects existing cash and cash generated from commercial sales to fund operating expenses and capital expenditure requirements for at least the next **24 months**[272](index=272&type=chunk) - Sources of liquidity include equity offerings (IPO in 2017, at-the-market offering in 2019, underwritten public offerings in 2019 and 2020, and **$269.6 million net proceeds** from a Feb 2021 offering) and borrowings from credit facilities[549](index=549&type=chunk)[550](index=550&type=chunk)[553](index=553&type=chunk)[554](index=554&type=chunk)[555](index=555&type=chunk)[556](index=556&type=chunk) - Maintains a **$10.0 million loan facility with Hercules**, most recently amended in April 2019, extending interest-only payments through July 2021 and maturity to October 2021. Principal repayments of **$7.7 million** are due in 2021[557](index=557&type=chunk)[560](index=560&type=chunk)[562](index=562&type=chunk)[565](index=565&type=chunk) - Net cash used in operating activities was **$23.4 million** in 2020, primarily from net loss offset by non-cash charges and changes in operating assets/liabilities[569](index=569&type=chunk) - Net cash used in investing activities was **$0.6 million** in 2020, consisting of property/equipment additions offset by grant proceeds[574](index=574&type=chunk) - Net cash provided by financing activities was **$96.2 million** in 2020, mainly from public offerings[578](index=578&type=chunk) Net Cash Flows (in thousands) | Activity | 2020 | 2019 | 2018 | | :-------------------------------------- | :------- | :------- | :------- | | Net cash used in operating activities | $(23,365) | $(26,187) | $(28,721) | | Net cash used in investing activities | $(626) | $(25,376) | $(5,454) | | Net cash provided by (used in) financing activities | $96,236 | $116,197 | $(78) | | Net increase (decrease) in cash and cash equivalents | $72,245 | $64,634 | $(34,253) | [Off-Balance Sheet Arrangements](index=178&type=section&id=Off-Balance%20Sheet%20Arrangements) Quanterix did not have any significant off-balance sheet arrangements during the reported periods - The company did not have any off-balance sheet arrangements during the periods presented and does not currently have any[586](index=586&type=chunk) [Contractual Obligations, Commitments and Contingencies](index=179&type=section&id=Contractual%20Obligations,%20Commitments%20and%20Contingencies) Quanterix's contractual obligations include operating lease liabilities and term loan principal payments due by 2021 - Ongoing obligations related to license agreements with immaterial minimum annual payments[588](index=588&type=chunk) - Loan Agreement with **Hercules**: **$10.0 million debt facility**, with

| --- | --- | --- | --- | --- | |----------------------------------------------------------|-------|-------|-------|-------| | | | | | | | | | | | | | Q4 & FY 2020 Earnings Call | | | | | | Kevin Hrusovsky, Chairman, CEO & President March 2, 2021 | | | | | Forward-Looking Statements & Non-GAAP 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," "estima ...

Quanterix Corporation (NASDAQ:QTRX) Q4 2020 Earnings Conference Call March 2, 2021 4:30 PM ET Company Participants Amol Chaubal - Chief Financial Officer Kevin Hrusovsky - Chief Executive Officer Conference Call Participants Puneet Souda - SVB Leerink Sung Ji Nam - BTIG Operator Ladies and gentlemen, thank you for standing by and welcome to the Quanterix Corporation Q4 2020 Earnings Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instr ...

Financial Data and Key Metrics Changes - The company's GAAP revenue for Q3 2020 was $31.4 million, which included $11.2 million from a nonexclusive license agreement with Abbott and $1.9 million from the RADx Phase I award. Excluding these nonrecurring items, non-GAAP revenue was $18.3 million, representing a 22% increase compared to Q3 of the previous year [60][61] - Instrument revenues increased by 8%, and consumables revenue increased by 9%, despite challenges due to COVID-19 [61] - Year-to-date total revenues reached $60.2 million, with non-GAAP year-to-date revenues of $47.1 million, marking a 50% increase [64] Business Line Data and Key Metrics Changes - Service revenue saw a significant increase of 56%, finishing at $6.6 million, driven by the expansion of Accelerator services to support customers [63] - The revenue mix for the full year is approximately 40% consumables, 40% services, and 25% instruments [25] Market Data and Key Metrics Changes - Growth was strongest in Europe, with North America following closely in Q3. Approximately 60% of revenue is derived from pharma/biotech, particularly in the neuro sector and increasingly in oncology [26] - The company has run 128 Phase I/II/III drug trials within its Accelerator, with a focus on neurology and oncology [16][18] Company Strategy and Development Direction - The company is focused on advancing noninvasive early detection technologies, particularly in the fields of neurology and COVID-19, with a vision to revolutionize proteomics [27][28] - There is a strategic pivot towards digital opportunities in life sciences, aiming to enhance sensitivity and reduce invasiveness in testing [29][52] - The total addressable market (TAM) is estimated at $1 billion, with aspirations for a compound annual growth rate (CAGR) of 30% to 40% in the long term [57] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the recovery in demand in the U.S. and Europe, although concerns about a potential second wave of COVID-19 could impact operations [65] - The company is focused on gross margin expansion by evolving its mix towards high-margin consumables and services [66] Other Important Information - The company raised $91.4 million in net proceeds through a public offering during Q3 2020, with a strong balance sheet showing approximately $173 million in unrestricted cash [68][69] - The company has established significant relationships with the NIH and FDA, which are expected to enhance its capabilities in COVID-19 testing [96][97] Q&A Session Summary Question: Impact of FDA's positive stance on aducanumab on neurology trials - Management noted that the FDA's guidance on biomarkers could encourage the use of assays like Nf-L and pTau in trials, potentially leading to a resurgence in the pharmaceutical base for neurology [82][86] Question: Next steps in the RADx program - Management highlighted the ongoing collaboration with the NIH to scale up antigen assay kits, with a focus on improving detection in asymptomatic individuals [90][92] Question: Update on HD-X instrument upgrade cycle - Management indicated that there is expected to be a reacceleration of placements as academic customers return to labs, with a goal of converting about 50% of HD-1 customers to HD-X by year-end [97][100]

PART I — FINANCIAL INFORMATION [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for Quanterix Corporation for the period ended September 30, 2020 [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of September 30, 2020, shows a significant increase in total assets to $264.1 million from $170.0 million at year-end 2019, driven by a rise in cash and cash equivalents Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | Sep 30, 2020 | Dec 31, 2019 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $173,162 | $109,155 | | Accounts receivable, net | $26,262 | $10,906 | | Total current assets | $214,928 | $132,661 | | Total assets | $264,105 | $169,951 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $28,092 | $19,833 | | Total liabilities | $55,064 | $41,293 | | Total stockholders' equity | $209,041 | $128,658 | | Total liabilities and stockholders' equity | $264,105 | $169,951 | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For Q3 2020, Quanterix reported a net income of $2.2 million, a significant turnaround from a $9.9 million net loss in Q3 2019, driven by a 110% increase in total revenue Statement of Operations Summary (in thousands, except per share data) | Metric | Q3 2020 | Q3 2019 | Nine Months 2020 | Nine Months 2019 | | :--- | :--- | :--- | :--- | :--- | | Total revenue | $31,389 | $14,944 | $60,246 | $40,816 | | Gross profit | $21,106 | $7,033 | $33,132 | $19,969 | | Income (loss) from operations | $2,278 | $(10,243) | $(21,651) | $(30,116) | | Net income (loss) | $2,203 | $(9,870) | $(21,709) | $(29,838) | | Net income (loss) per share, diluted | $0.07 | $(0.37) | $(0.75) | $(1.24) | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the nine months ended September 30, 2020, net cash provided by financing activities was a substantial $94.2 million, mainly from a public offering, resulting in a $64.0 million net increase in cash Cash Flow Summary for the Nine Months Ended Sep 30 (in thousands) | Cash Flow Activity | 2020 | 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | $(28,019) | $(21,652) | | Net cash used in investing activities | $(2,149) | $(24,832) | | Net cash provided by financing activities | $94,160 | $115,473 | | **Net increase in cash and cash equivalents** | **$63,992** | **$68,989** | [Notes to Condensed Consolidated Financial Statements](index=13&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes provide critical context, detailing a $91.4 million net proceed from a public offering, a $10.0 million initial license fee from Abbott, and $1.9 million in NIH grant revenue - In August 2020, the company completed an underwritten public offering of approximately 3.0 million shares, resulting in net proceeds of **$91.4 million**[36](index=36&type=chunk)[150](index=150&type=chunk) - On September 29, 2020, Quanterix entered into a non-exclusive license agreement with Abbott Laboratories, granting Abbott a license to its bead-based single molecule detection patents. This agreement resulted in an initial license fee of **$10.0 million** recognized in Q3 2020[136](index=136&type=chunk)[138](index=138&type=chunk) - The company entered into a contract with the National Institutes of Health (NIH) under the RADx program to develop a SARS-CoV-2 antigen test. In Q3 2020, **$1.9 million** of grant revenue was recognized from this program[84](index=84&type=chunk)[85](index=85&type=chunk) Disaggregated Revenue by Type - Nine Months Ended Sep 30, 2020 (in thousands) | Revenue Type | Amount | | :--- | :--- | | Product revenues | $28,285 | | Service and other revenues | $18,631 | | Collaboration and license revenue | $11,401 | | **Total Revenue (excluding Grant)** | **$58,317** | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=55&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses significant revenue growth in Q3 2020, the impact of COVID-19, and a strong liquidity position with $173.2 million in cash, bolstered by a recent public offering [Overview](index=55&type=section&id=Overview) The overview describes Quanterix's Simoa technology, the impact of COVID-19 on operations and new opportunities, and the strategic license agreement with Abbott Laboratories - The company is developing a novel SARS-CoV-2 antigen test, supported by an NIH RADx program contract with a total award value of **$18.2 million**. The company recognized **$1.9 million** of grant revenue from this program in Q3 2020[169](index=169&type=chunk) - A non-exclusive license agreement was signed with Abbott Laboratories on September 29, 2020, which included an initial license fee of **$10.0 million**[167](index=167&type=chunk) - The COVID-19 pandemic has caused interruptions in customer laboratories and limited access for instrument installations, impacting revenues. However, the company has expanded its Accelerator Laboratory capacity to support affected customers[168](index=168&type=chunk)[169](index=169&type=chunk) [Results of Operations](index=60&type=section&id=Results%20of%20Operations) This section details a 110% surge in Q3 2020 total revenue to $31.4 million, driven by collaboration and grant revenues, and an improved gross margin of 67% Comparison of Three Months Ended September 30 (in thousands) | Metric | 2020 | 2019 | % Change | | :--- | :--- | :--- | :--- | | Total revenue | $31,389 | $14,944 | 110% | | Gross profit | $21,106 | $7,033 | 200% | | Gross Margin | 67% | 47% | N/A | | Income (loss) from operations | $2,278 | $(10,243) | 122% | Comparison of Nine Months Ended September 30 (in thousands) | Metric | 2020 | 2019 | % Change | | :--- | :--- | :--- | :--- | | Total revenue | $60,246 | $40,816 | 48% | | Gross profit | $33,132 | $19,969 | 66% | | Gross Margin | 55% | 49% | N/A | | Income (loss) from operations | $(21,651) | $(30,116) | 28% | - The increase in Q3 2020 revenue was primarily driven by **$11.2 million** in collaboration and license revenue from the Abbott agreement and **$1.9 million** in grant revenue from the RADx award[176](index=176&type=chunk)[177](index=177&type=chunk) [Liquidity and Capital Resources](index=66&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity is strong with $173.2 million in cash, significantly bolstered by a $91.4 million public offering, deemed sufficient for at least the next 12 months - As of September 30, 2020, the company had cash and cash equivalents of **$173.2 million**[173](index=173&type=chunk) - In August 2020, an underwritten public offering generated net proceeds of **$91.4 million**[200](index=200&type=chunk)[221](index=221&type=chunk) - Net cash used in operating activities for the nine months ended September 30, 2020 was **$28.0 million**, an increase from **$21.7 million** in the prior year period, primarily due to increases in accounts receivable and inventory[214](index=214&type=chunk)[216](index=216&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[225](index=225&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=75&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company states that there have been no material changes to its market risk disclosures since its Annual Report on Form 10-K for the year ended December 31, 2019 - There have been no material changes to the market risk information previously disclosed in the Annual Report on Form 10-K for the year ended December 31, 2019[234](index=234&type=chunk) [Item 4. Controls and Procedures](index=75&type=section&id=Item%204.%20Controls%20and%20Procedures) The company's disclosure controls and procedures were effective as of September 30, 2020, with no material changes in internal control over financial reporting during the quarter - Management concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report[235](index=235&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[236](index=236&type=chunk) PART II — OTHER INFORMATION [Item 1. Legal Proceedings](index=77&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently a party to any material legal proceedings - The company is not currently a party to any material legal proceedings[238](index=238&type=chunk) [Item 1A. Risk Factors](index=77&type=section&id=Item%201A.%20Risk%20Factors) A new risk factor highlights that the $18.2 million NIH RADx funding is milestone-based and subject to government's right to unilaterally terminate or modify the contract - A new risk factor was added concerning the WP2 contract with NIH under the RADx program for the development of a SARS-CoV-2 antigen test[239](index=239&type=chunk) - The contract's total award value of **$18.2 million** is contingent on achieving certain milestones, and there is no assurance the company can meet them to access the full funding[239](index=239&type=chunk) - The government contract contains provisions that are not typical in commercial agreements, such as the U.S. government's right to unilaterally terminate or modify the contract at its convenience, which could adversely affect revenue[241](index=241&type=chunk) [Item 6. Exhibits](index=80&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including the Non-Exclusive License Agreement with Abbott Laboratories and officer certifications - Key exhibits filed include the Non-Exclusive License Agreement with Abbott Laboratories, dated September 29, 2020, and certifications by the CEO and CFO[249](index=249&type=chunk)

Financial Performance - Q3 2020 GAAP总收入为3140万美元，同比增长110%[15]，调整后收入为1830万美元，同比增长22%[15]。 - 2020年至今，GAAP总收入为6020万美元，同比增长48%[15]，调整后收入为4710万美元，同比增长15%[15]。 - Q3 2020仪器收入为450万美元，同比增长8%[142]；耗材收入为720万美元，同比增长9%[142]；服务收入为660万美元，同比增长56%[142]。 - 2020年至今，仪器收入为1100万美元，同比增长7%[142]；耗材收入为1730万美元，同比下降8%[142]；服务收入为1860万美元，同比增长58%[142]。 - Q3 2020 GAAP毛利率为67.2%[142]，调整后毛利率为51.5%[142]；2020年至今，GAAP毛利率为55.0%[142]，调整后毛利率为48.4%[142]。 Strategic Focus and Market Opportunity - 公司战略重点转向COVID-19和神经系统疾病领域，以推动突破性业绩[6, 11]。 - 公司正在扩大诊断窗口，以覆盖无症状和症状前患者[82]。 - 公司正在抓住主要市场机会，目标是长期实现30%-40%的复合年增长率[121, 124, 127]。 Neurology and Biomarkers - Simoa®技术正在推动神经系统生物标志物测量领域的革命，尤其是在脑脊液和血液中[56, 59]。 - 血清Nf-L正在为主要的药物试验提供动力，市场规模达220亿美元，涉及16种药物[51]。 - 阿尔茨海默病血液检测即将实现，可以非常早期地检测到疾病[68, 72]。 COVID-19 Initiatives - 公司正在扩大对COVID-19的关注，包括高灵敏度抗原检测和血清学检测[79]。 - 公司获得了美国国立卫生研究院（NIH）RADx计划的2000万美元奖励[79]。

Financial Data and Key Metrics Changes - Revenue in Q2 2020 was $13.1 million, a decrease of 3% compared to the previous year, primarily impacted by the COVID-19 pandemic [64] - Year-to-date total revenues reached $28.9 million, reflecting a 12% increase [65] - Non-GAAP gross margin for Q2 was 44.1%, down from 51.2% in the prior year, influenced by the HD-1 trade-in program and lower cost absorption due to reduced consumables revenue [66][67] Business Line Data and Key Metrics Changes - Instrument revenue was $2.8 million, consistent with the prior year despite access challenges [64] - Consumables revenue finished at $4 million, a decline of 34% compared to the previous year [65] - Services revenue increased by 33% to $6.3 million, driven by expanded Accelerator services capacity [65] Market Data and Key Metrics Changes - North America saw a growth of 27%, while Europe and Asia experienced faster growth [53] - The academic sector has been slower to recover compared to pharma, with a strong focus on COVID-related research [99] Company Strategy and Development Direction - The company aims to leverage its Simoa technology for earlier and less invasive disease detection, particularly in neurology and infectious diseases [12][19] - There is a focus on expanding into the diagnostics market, with aspirations to partner with IVD companies [24][48] - The company anticipates a long-term revenue growth target of 30% to 40%, primarily driven by research, with potential for diagnostics to enhance this growth [78][81] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about recovering to a strong growth trajectory in the second half of the year despite ongoing challenges from the pandemic [69] - The company is seeing positive momentum in its Accelerator services and anticipates further growth in consumables as pharma trials ramp up [94] Other Important Information - The company has secured significant contracts, including a $1 million contract with a large payer group and a feasibility study with the NIH [75][80] - The number of third-party peer-reviewed publications has approached 900, with a significant focus on neurology [49] Q&A Session Summary Question: What is the source of incremental demand for the Accelerator? - Management noted that demand is coming from both new customers and existing customers utilizing newer technologies for immune system studies and COVID-related research [72][74] Question: How does the recent progress impact long-term revenue growth targets? - The growth target remains strong, with advancements in diagnostics expected to enhance the research business, although significant revenue from diagnostics may take a year or two to materialize [77][81] Question: What is the expected recovery trajectory for the services business? - The services business is expected to continue growing, supported by large population studies and the ability to conduct testing with small sample sizes [92][93] Question: How is the academic sector expected to recover? - The academic sector is beginning to reopen, with interest in COVID-related research, and the company anticipates good instrument and consumable pull-through as labs return to normal operations [98][99]

PART I — FINANCIAL INFORMATION This section provides the unaudited condensed consolidated financial statements and management's discussion and analysis for Quanterix Corporation [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) This section presents Quanterix Corporation's unaudited condensed consolidated financial statements, including balance sheets, statements of operations, cash flows, and comprehensive notes [Unaudited Condensed Consolidated Balance Sheets](index=5&type=section&id=Unaudited%20Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$162.9 million**, while total liabilities rose to **$51.9 million**, leading to a decline in stockholders' equity Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2020 | December 31, 2019 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $88,806 | $109,155 | | Total current assets | $114,238 | $132,661 | | Total assets | $162,940 | $169,951 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $18,897 | $19,833 | | Long term lease liabilities | $22,458 | $— | | Total liabilities | $51,906 | $41,293 | | Total stockholders' equity | $111,034 | $128,658 | | Total liabilities and stockholders' equity | $162,940 | $169,951 | [Unaudited Condensed Consolidated Statements of Operations](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations) Q2 2020 revenue decreased **3%** to **$13.1 million** with a wider net loss, while year-to-date revenue grew **11.5%** to **$28.9 million**, also with an increased net loss Statements of Operations Summary (in thousands, except per share data) | Metric | Q2 2020 | Q2 2019 | YTD 2020 | YTD 2019 | | :--- | :--- | :--- | :--- | :--- | | Product revenue | $6,790 | $8,776 | $16,623 | $18,322 | | Service and other revenue | $6,317 | $4,760 | $12,079 | $7,550 | | **Total revenue** | **$13,130** | **$13,536** | **$28,857** | **$25,872** | | Gross profit | $5,213 | $6,931 | $12,026 | $12,936 | | Loss from operations | $(12,201) | $(10,514) | $(23,929) | $(19,873) | | **Net loss** | **$(12,302)** | **$(10,563)** | **$(23,912)** | **$(19,968)** | | Net loss per share | $(0.43) | $(0.46) | $(0.85) | $(0.88) | [Unaudited Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to **$20.6 million**, while investing cash outflow decreased and financing cash inflow significantly dropped Cash Flow Summary (in thousands) | Activity | Six Months Ended June 30, 2020 | Six Months Ended June 30, 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | $(20,600) | $(12,820) | | Net cash used in investing activities | $(1,361) | $(9,830) | | Net cash provided by financing activities | $1,476 | $50,272 | | **Net (decrease) increase in cash** | **$(20,485)** | **$27,622** | | Cash at end of period | $89,806 | $73,051 | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Detailed notes explain business operations, accounting policies, revenue recognition, the UmanDiagnostics acquisition, and the adoption of ASC 842 - The company develops and sells ultra-sensitive digital immunoassay platforms based on its proprietary "**Simoa**" technology for life sciences research and diagnostics, with key products including the **Simoa HD-X**, **SR-X**, and **SP-X** instruments[23](index=23&type=chunk)[24](index=24&type=chunk) - On January 1, 2020, the company adopted the new lease accounting standard, **ASC 842**, resulting in the recognition of operating lease Right-of-Use (ROU) assets of **$12.2 million** and operating lease liabilities of **$22.8 million** on the balance sheet[46](index=46&type=chunk)[50](index=50&type=chunk) - The acquisition of **UmanDiagnostics AB** was completed on August 1, 2019, for an aggregate purchase price of **$21.2 million**, securing a long-term supply of critical Nf-L antibodies[26](index=26&type=chunk)[122](index=122&type=chunk) Disaggregated Revenue by Geography - Six Months Ended June 30, 2020 (in thousands) | Revenue Type | North America (NA) | EMEA | Asia Pacific | Total | | :--- | :--- | :--- | :--- | :--- | | Product revenues | $7,631 | $6,336 | $2,656 | $16,623 | | Service and other revenues | $9,846 | $1,486 | $747 | $12,079 | | Collaboration and license revenue | $144 | $11 | $— | $155 | | **Total** | **$17,621** | **$7,833** | **$3,403** | **$28,857** | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=47&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial performance, attributing Q2 revenue decrease and year-to-date increase to COVID-19 impacts on product and service revenues, and details liquidity and capital resources - The **COVID-19 pandemic** has had a mixed impact on the business, negatively affecting instrument and consumables revenue but partially offset by increased demand for services from the company's Accelerator Laboratory[147](index=147&type=chunk)[148](index=148&type=chunk)[155](index=155&type=chunk) - As of June 30, 2020, the company had cash and cash equivalents of **$88.8 million**, which management believes will be sufficient to meet operating cash requirements for at least the **next 12 months**[150](index=150&type=chunk)[202](index=202&type=chunk) [Results of Operations](index=52&type=section&id=Results%20of%20Operations) Q2 2020 total revenue decreased **3%** to **$13.1 million**, while year-to-date total revenue increased **12%** to **$28.9 million**, both periods showing gross margin contraction Revenue Comparison - Q2 2020 vs Q2 2019 (in thousands) | Revenue Stream | Q2 2020 | Q2 2019 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Product revenue | $6,790 | $8,776 | $(1,986) | (23)% | | Service and other revenue | $6,317 | $4,760 | $1,557 | 33% | | **Total revenue** | **$13,130** | **$13,536** | **$(406)** | **(3)%** | Revenue Comparison - YTD 2020 vs YTD 2019 (in thousands) | Revenue Stream | YTD 2020 | YTD 2019 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Product revenue | $16,623 | $18,322 | $(1,699) | (9)% | | Service and other revenue | $12,079 | $7,550 | $4,529 | 60% | | **Total revenue** | **$28,857** | **$25,872** | **$2,985** | **12%** | - **Gross margin declined** in both the three and six-month periods of 2020 compared to 2019, primarily due to a higher proportion of instrument sales versus consumables, and amortization costs from the Uman acquisition-related inventory and intangible assets[156](index=156&type=chunk)[165](index=165&type=chunk) - **SG&A expenses decreased by $0.3 million** for Q2 2020 year-over-year, mainly because the prior-year period included **$0.9 million** in acquisition costs for Uman[159](index=159&type=chunk) [Liquidity and Capital Resources](index=56&type=section&id=Liquidity%20and%20Capital%20Resources) Liquidity is primarily from equity offerings and debt, with **$112.5 million** raised in 2019 and **$20.6 million** net cash used in operations for H1 2020 - In 2019, the company raised a total of **$112.5 million** in net proceeds from two equity offerings: an "at-the-market" offering (**$48.0 million**) and an underwritten public offering (**$64.5 million**)[174](index=174&type=chunk)[175](index=175&type=chunk) Cash Flow Summary - Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2020 | 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | $(20,600) | $(12,820) | | Net cash used in investing activities | $(1,361) | $(9,830) | | Net cash provided by financing activities | $1,476 | $50,272 | - The company has a loan agreement with **Hercules Capital**, with an amendment in April 2019 extending the interest-only payment period through July 1, 2021, and the maturity date to October 1, 2021[185](index=185&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=66&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) No material changes to market risk disclosures have occurred since the 2019 Annual Report on Form 10-K - There were **no material changes** to the company's market risk disclosures as of June 30, 2020[212](index=212&type=chunk) [Item 4. Controls and Procedures](index=66&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective, with no material changes in internal control over financial reporting during the quarter - The Principal Executive Officer and Principal Financial Officer concluded that the company's disclosure controls and procedures were **effective** as of June 30, 2020[213](index=213&type=chunk) - **No changes in internal control** over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[214](index=214&type=chunk) PART II — OTHER INFORMATION This section covers legal proceedings, risk factors, and a list of exhibits filed with the quarterly report [Item 1. Legal Proceedings](index=68&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings - As of the filing date, Quanterix is **not involved in any material legal proceedings**[217](index=217&type=chunk) [Item 1A. Risk Factors](index=68&type=section&id=Item%201A.%20Risk%20Factors) No material changes to the company's risk factors have occurred since the prior 2019 Annual Report and Q1 2020 Quarterly Report - **No material changes** to the company's risk factors have occurred since the filing of the Q1 2020 10-Q[218](index=218&type=chunk) [Item 6. Exhibits](index=69&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Quarterly Report on Form 10-Q, including officer certifications and XBRL data - The exhibits filed with this report include **certifications** from the Principal Executive Officer and Principal Financial Officer as required by the Sarbanes-Oxley Act of 2002, as well as **XBRL data files**[225](index=225&type=chunk)