Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number: 001-38319 QUANTERIX CORPORATION (Exact name of registrant as specified in its charter) Delaware 20-8957988 (Sta ...

Financial Data and Key Metrics Changes - The company reported GAAP revenue of $30.3 million for Q4 2021, with non-GAAP revenue of $29.3 million, representing a 36% increase year-over-year [53][54] - Full year 2021 revenues reached $110.6 million, with non-GAAP total revenues of $105.3 million, a 53% increase from 2020 [57] - Gross margins improved, with Q4 GAAP gross margin at 53.7%, down from 57.6% in Q4 2020, while non-GAAP gross margin was 53.5%, up approximately 270 basis points from 50.8% [58][59] Business Line Data and Key Metrics Changes - Product revenue in Q4 2021 was $23.5 million, a 49% increase year-over-year, with consumables revenue growing 66% to a record $16.8 million [54][55] - The company achieved record consumable growth of 100% in Q4 2021, with 211 instruments placed in the field during the year [22][56] Market Data and Key Metrics Changes - North America showed the strongest growth, driven by breakthrough designations and COVID-related work, leading to increased interest from pharma customers in Alzheimer's drugs [25][26] - The customer base remains balanced between pharma and academic sectors, with a strong position in neuro-related disease categories [26] Company Strategy and Development Direction - The company is transitioning leadership, with Masoud Toloue set to take over as CEO, allowing Kevin Hrusovsky to focus on strategic initiatives [8][11] - The collaboration with Eli Lilly is seen as a significant opportunity, with plans to expand into diagnostics and leverage partnerships with pharma companies [9][29] - The company aims to enhance its product offerings in precision health and proteomics, focusing on low-cost, scalable blood-based technologies [17][33] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about future growth, citing a strong pipeline and the potential for increased revenue from collaborations and diagnostics [47][48] - Concerns about geopolitical factors, inflation, and potential COVID variants were acknowledged, but the company remains committed to conservative guidance for 2022 [57][48] Other Important Information - The company raised $287 million in 2021, ending the year with nearly $400 million in cash [18] - The company plans to validate LDT for P-tau and NFL for MS in 2022 and initiate an Alzheimer's clinical trial for P-tau181 [49] Q&A Session Summary Question: Guidance and Revenue Mix - The company provided guidance for 2022, indicating that the Lilly revenue of $11 million is included, and expects accelerator growth to be the fastest [72][78] Question: Strategic Investments - The company plans to be judicious with its cash reserves, focusing on building laboratory capabilities and exploring partnerships rather than immediate acquisitions [81][84] Question: Neurology Landscape Changes - Management noted that the reimbursement landscape for Alzheimer's drugs has raised awareness about the need for less invasive diagnostic methods, which could benefit the company's blood-based approaches [94][96] Question: Future Revenue from Lilly - The relationship with Lilly is viewed as a model for future collaborations, with potential for recurring revenue as the partnership expands [100][103] Question: Balancing Core Business and Diagnostics - The company aims to balance growth in RUO with strategic investments in diagnostics, particularly in neuro, while maintaining a conservative approach to expectations [108][112]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 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) 20-8957988 (I.R.S. Employer Ide ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 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 ...

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)

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 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 (State or other jurisd ...

| --- | --- | --- | --- | --- | |----------------------------------------------------------|-------|-------|-------|-------| | | | | | | | | | | | | | 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 ...

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]。