Quanterix Corporation (NASDAQ:QTRX) Q1 2024 Earnings Conference Call May 8, 2024 8:30 AM ET Company Participants Francis Pruell - Investor Relations Masoud Toloue - President and Chief Executive Officer Vandana Sriram - Chief Financial Officer Conference Call Participants Puneet Souda - Leerink Partners Matt Sykes - Goldman Sachs Kyle Mikson - Canaccord Genuity Sung Ji Nam - Scotiabank Dan Brennan - TD Cowen Operator Good day and thank you for standing by. Welcome to the Quanterix Corporation Q1 2024 Earnin ...

Exhibit 99.1 Quanterix Releases Financial Results for the First Quarter of 2024 BILLERICA, Mass. – May 7, 2024 - Quanterix Corporation (NASDAQ: QTRX), a company fueling scientific discovery through ultrasensitive biomarker detection, today announced financial results for the first quarter ended March 31, 2024. For additional information on the non-GAAP financial measures included in this press release, please see "Use of Non-GAAP Financial Measures" and "Reconciliation of GAAP to Non-GAAP Financial Measures ...

Quanterix Corporation (NASDAQ:QTRX) Q4 2023 Results Conference Call February 29, 2024 4:30 PM ET Company Participants Vandana Sriram - CFO Masoud Toloue - President and CEO Conference Call Participants Matt Sykes - Goldman Sachs Puneet Souda - Leerink Partners Kyle Mikson - Canaccord Genuity Sung Ji Nam - Scotiabank Operator Good day, and thank you for standing by. Welcome to the Quanterix Corporation Q4 2023 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speak ...

Financial Performance - Total revenues for Quanterix Corporation were $122.4 million in 2023, up from $105.5 million in 2022, representing a growth of approximately 16.5%[275] - The company incurred a net loss of $32.3 million in 2023, compared to a net loss of $96.7 million in 2022, indicating a significant reduction in losses[275] - Total revenues increased by $16.8 million, or 16%, to $122.4 million for the year ended December 31, 2023, compared to $105.5 million for 2022[302] - Product revenue was $79.5 million, consisting of instrument sales of $15.7 million and consumables sales of $63.8 million, representing a 14% increase from $69.8 million in 2022[303] - Service revenue increased by $5.8 million, or 17%, to $40.3 million, primarily due to a $9.0 million increase in Accelerator Laboratory revenue[304] - Gross profit rose to $70.6 million, a 51% increase from $46.8 million in 2022, resulting in a gross margin of 58%[307] - Total costs of goods sold and services decreased by $7.0 million, or 12%, to $51.7 million, with cost of product revenue down by 20% to $32.6 million[307][308] - Interest income increased by $10.7 million, or 209%, to $15.8 million, driven by higher interest rates on cash and marketable securities[316] - Net cash used in operating activities was $18.9 million, an improvement from $48.3 million in 2022[326] - Net cash used in operating activities decreased by $29.4 million to $18.9 million in 2023 from $48.3 million in 2022, primarily due to reduced net loss and improved gross margin[328] - Net cash used in investing activities was $148.4 million in 2023, consisting of $175.6 million in marketable securities purchases and $3.8 million in property and equipment purchases[330] - Financing activities provided $2.7 million in cash during 2023, an increase from $2.3 million in 2022, from sales of common stock and exercise of options[332] - GAAP gross profit increased to $70.646 million in 2023 from $46.806 million in 2022, with GAAP gross margin rising to 57.7% from 44.4%[360] - Non-GAAP gross profit for 2023 was $62.5 million, up from $39.595 million in 2022, with non-GAAP gross margin improving to 51.1% from 37.5%[360] - Total operating expenses decreased to $120.347 million in 2023 from $148.510 million in 2022, reflecting cost management efforts[360] Product Development and Launches - Quanterix launched the LucentAD blood test for Alzheimer's disease in July 2023, with an improved version, LucentAD p-Tau 217, launched in October 2023; however, these tests are not expected to generate material revenues until late 2024 or later[278] - Quanterix completed a restructuring plan in 2022, eliminating 119 positions and launching five new Simoa Advantage PLUS assays, which began shipping in Q1 2024[279] - The company plans to expand its sales and marketing efforts and invest in its diagnostics business, including the launch of additional Laboratory Developed Tests (LDTs)[276] - Research and development expenses are expected to increase as the company focuses on improving existing products and launching new ones, particularly in diagnostics[289] Customer Base and Market Presence - The company has completed over 2,200 projects for more than 480 customers globally using Simoa platforms, showcasing its extensive customer base[273] - Approximately 82% of the HD Instrument installed base were HD-X instruments by the end of 2023, reflecting strong adoption of the upgraded technology[267] - Quanterix's Simoa technology has been cited in over 2,700 scientific publications, indicating significant scientific validation and interest in its applications[265] - Approximately 37% of total revenue in 2023 was generated from customers outside the United States, compared to 38% in 2022[363] Financial Position and Capital Management - As of December 31, 2023, the company had cash and cash equivalents of $174.4 million and $146.9 million in marketable securities[319] - The company is assessing potential acquisitions and may need to raise additional capital if existing resources are insufficient[322] - The company expects to continue incurring additional capital expenditures to support expanding infrastructure and workforce in future periods[329] - The STRATEC Supply Agreement includes a total purchase commitment of $3.7 million, with $1.0 million due within one year from December 31, 2023[337] - Remaining lease payments due within one year total $7.1 million, with additional payments of $14.7 million, $15.5 million, and $15.7 million due in subsequent years[335] Market Risks - The company is exposed to market risks including fluctuations in foreign currency exchange rates and interest rates affecting returns on cash and marketable securities[362] - A hypothetical 10% decrease in overall interest rates would have reduced interest income by approximately $1.3 million for the year ended December 31, 2023[368] - The company has not entered into any foreign currency hedging contracts to date, but may consider doing so in the future[364] - A 10% adverse change in foreign exchange rates would decrease potential cash inflows from foreign denominated receivables by $0.8 million[363] - The company’s expenses are primarily denominated in U.S. dollars, with some incurred in Canada, Europe, Japan, and China[363] - The company does not expect its operating results or cash flows to be materially affected by sudden changes in market interest rates[367] - The company has the ability to hold marketable securities until maturity, mitigating potential risks from interest rate fluctuations[367] - Fluctuations in foreign exchange rates could potentially harm the business in the future[363]

Financial Performance - The company reported net losses of $7.8 million and $19.9 million for the three and nine months ended September 30, 2023, respectively, compared to $35.1 million and $78.1 million for the same periods in 2022[129]. - Total revenues increased by $4.7 million, or 18%, to $31.3 million for the three months ended September 30, 2023, compared to $26.6 million for the same period in 2022[146]. - Total revenues for the nine months ended September 30, 2023, increased by $11.1 million, or 14%, to $90.8 million compared to $79.7 million for the same period in 2022[162]. - Product revenue was $19.7 million, an increase of $2.0 million, or 11%, compared to $17.7 million in the prior year, driven by a $6.1 million increase in sales of consumables[147]. - Service revenue rose to $10.9 million, up $2.6 million, or 31%, primarily due to a $3.3 million increase in Accelerator Laboratory revenue[148]. - Product revenue for the nine months ended September 30, 2023, was $58.6 million, an increase of $5.5 million, or 10%, compared to $53.1 million for the same period in 2022[163]. - Service revenue increased by $4.3 million, or 17%, to $30.1 million for the nine months ended September 30, 2023, driven by higher volumes in sample testing and assay development services[165]. - Collaboration and license revenue rose to $1.2 million, a 158% increase from $0.5 million in the prior year, primarily due to a one-time increase from the Abbott License Agreement[166]. - Grant revenue increased by $0.5 million, or 146%, to $0.9 million for the nine months ended September 30, 2023, attributed to the receipt of a portion of the NIH Grant[167]. Expenses and Cost Management - The company expects to incur significant expenses and operating losses for at least the next 24 months due to expansion in sales, marketing, and research and development efforts[130]. - Total costs of goods sold and services decreased by $2.2 million, or 14%, to $13.6 million for the three months ended September 30, 2023[150]. - Cost of goods sold and services decreased by $8.5 million, or 19%, to $37.0 million for the nine months ended September 30, 2023, compared to $45.5 million in the prior year[168]. - Research and development expenses rose by $0.6 million, or 9%, to $7.2 million, mainly due to professional services fees for product development[153]. - Research and development expenses decreased by $2.4 million, or 12%, to $17.9 million for the nine months ended September 30, 2023, due to reduced headcount from the Restructuring Plan[171]. - Selling, general, and administrative expenses increased by $3.6 million, or 18%, to $23.6 million, attributed to higher professional services and consulting fees[154]. - GAAP total operating expenses decreased to $31,553 million in Q3 2023 from $47,547 million in Q3 2022, a reduction of 33.6%[200]. - Non-GAAP total operating expenses for Q3 2023 were $29,000 million, down from $45,908 million in Q3 2022, a decrease of 36.8%[200]. Profitability and Margins - Gross profit increased by $6.8 million, or 62%, to $17.8 million, representing 57% of total revenues[150]. - GAAP gross profit for Q3 2023 was $17,783 million, up from $10,944 million in Q3 2022, representing a 62.5% increase[200]. - Non-GAAP gross profit for Q3 2023 was $15,230 million, compared to $9,305 million in Q3 2022, reflecting a 63.8% increase[200]. - GAAP gross margin improved to 56.8% in Q3 2023 from 41.1% in Q3 2022[200]. - Non-GAAP gross margin increased to 48.6% in Q3 2023, up from 34.9% in Q3 2022[200]. - GAAP loss from operations for Q3 2023 was $13,770 million, compared to a loss of $36,603 million in Q3 2022, showing an improvement of 62.4%[200]. - Non-GAAP loss from operations remained at $13,770 million for Q3 2023, consistent with the loss reported in Q3 2022[200]. Cash and Investments - As of September 30, 2023, the company had cash, cash equivalents, and marketable securities totaling $327.7 million[129]. - As of September 30, 2023, the company had cash and cash equivalents of $201.3 million and marketable securities of $126.4 million[180]. - Net cash used in operating activities was $12.9 million for the nine months ended September 30, 2023, a reduction of $31.3 million from $44.2 million in the prior year[184]. - Net cash used in investing activities was $126.8 million for the nine months ended September 30, 2023, primarily for the purchase of marketable securities[186]. - Interest income, net increased by $2.5 million, or 144%, to $4.2 million, primarily due to higher interest rates on cash and cash equivalents[157]. - Interest income, net increased by $9.2 million, or 397%, to $11.5 million for the nine months ended September 30, 2023, primarily due to higher interest rates on cash and marketable securities[177]. Strategic Initiatives - In October 2023, the company entered into a license agreement with Janssen Sciences Ireland UC, granting worldwide rights to J&J's p-Tau 217 antibodies for clinical research and diagnostic products[130]. - The company launched Lucent Diagnostics in July 2023, introducing initial blood-based biomarker LDTs for evaluating cognitive symptoms related to Alzheimer's disease[131]. - The NIH Grant awarded the company a total value of $1.7 million for developing point-of-care diagnostic technologies, with $0.5 million received as of September 30, 2023[133]. - The company continues to utilize non-GAAP measures to assess operational performance and progress against the Restructuring Plan[197]. - Approximately 81% of the HD instrument installed base was comprised of HD-X instruments as of September 30, 2023[122]. - The company has completed over 2,200 projects for more than 470 customers globally using its Simoa platforms[127].

Quanterix Corporation (NASDAQ:QTRX) Q3 2023 Earnings Conference Call November 7, 2023 8:30 AM ET Company Participants Ed Joyce - VP, IR Masoud Toloue - President and CEO Vandana Sriram - CFO Conference Call Participants Kyle Mikson - Canaccord Genuity Jake Allen - Goldman Sachs Dan Brennan - Cowen Puneet Souda - Leerink Partners Operator Good day and thank you for standing by. Welcome to the Quanterix Corporation Q3 2023 Earnings Call. At this time, all participants are in a listen-only mode. After the spea ...

Financial Data and Key Metrics Changes - Second quarter revenue increased by 32% to $31 million compared to the same quarter in 2022 [10][21] - Non-GAAP gross margin improved to 56.4% from 29.1% in the prior year [31] - Net loss decreased from $24.9 million in Q2 2022 to $6.1 million in Q2 2023 [32] - Cash burn improved significantly, with the company achieving breakeven cash flow for the quarter [11][33] Business Line Data and Key Metrics Changes - Consumables revenue rose by 65% year-over-year, totaling $6 million [25] - Accelerator Services revenue increased by 23% to $10.6 million, driven by strong demand [26] - Instrument revenue declined by 38% to $3.5 million, reflecting global macroeconomic pressures [30] Market Data and Key Metrics Changes - The company launched LucentAD, a test for Alzheimer's diagnostics, which is expected to enhance screening capabilities [14][15] - The BioHermes clinical trial achieved positive results, supporting the correlation between p-tau181 and amyloid PET scans [19][20] Company Strategy and Development Direction - The company is in the final stages of a corporate transformation aimed at maximizing the potential of its Simoa technology [12] - Plans include launching new assay kit SKUs and implementing modern processes in operations [13] - The focus is on building global infrastructure for Alzheimer's testing and enhancing patient and provider education [15] Management's Comments on Operating Environment and Future Outlook - Management acknowledged ongoing macroeconomic pressures affecting capital purchases but expressed confidence in offsetting these challenges [49] - The company raised its full-year revenue guidance to a range of $110 million to $116 million [11][34] - Anticipated cash burn for the year is now estimated to be between $30 million and $35 million, a significant improvement from previous guidance [44] Other Important Information - The company is preparing for a leadership transition as the CFO plans to retire in early 2024 [35] - The recent approval of Leqembi for Alzheimer's therapy is expected to drive demand for the LucentAD test [15] Q&A Session Summary Question: What are the expectations for revenue guidance and potential impacts on the second half of the year? - Management indicated that the guidance reflects a conservative approach due to macroeconomic conditions affecting biotech funding [45][48] Question: When will the platform include p-Tau 217 and other markers? - Plans are in place to introduce p-Tau 217 as an LDT this year, with further developments expected [51][52] Question: What is the current level of validation for the assays and their scalability? - The company has robust clinical trial data supporting the assays, and scalability is a key focus for future growth [54][56] Question: Can you provide more details on the Abbott collaboration? - The revenue from Abbott is related to an expired license deal, contributing to one-time revenue this quarter [81] Question: What are the key milestones to watch for Quanterix in the next 12 months? - Key milestones include advancements in multi-marker tests and the adoption of blood biomarkers for diagnosis [102][103]

Q2 2023 Cash *Includes Lilly MCA revenue in FY2022 and YTD2023 Q2 2023 Earnings To supplement Quanterix's financial statements presented on a GAAP basis, Quanterix has provided certain non-GAAP financial measures. Management uses these non-GAAP measures to evaluate our operating performance in a manner that allows for meaningful period-to-period comparison and analysis of trends in our business and as a factor in assessing progress against the Restructuring Plan. Management believes that presentation of the ...

PART I — FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) The unaudited consolidated financial statements for Quanterix Corporation as of June 30, 2023, show a slight decrease in total assets to $429.2 million from $434.2 million at year-end 2022, with total revenues of $59.5 million and a reduced net loss of $12.2 million for the six months ended June 30, 2023 [Consolidated Balance Sheets](index=5&type=section&id=Consolidated%20Balance%20Sheets) As of June 30, 2023, the company's total assets were $429.2 million, a slight decrease from $434.2 million at December 31, 2022, with cash and cash equivalents at $329.5 million, total liabilities at $73.9 million, and total stockholders' equity at $355.4 million Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $329,525 | $338,740 | | Total current assets | $379,058 | $381,403 | | Total assets | $429,210 | $434,199 | | **Liabilities & Equity** | | | | Total current liabilities | $31,947 | $30,958 | | Total liabilities | $73,854 | $75,259 | | Total stockholders' equity | $355,356 | $358,940 | [Consolidated Statements of Operations](index=6&type=section&id=Consolidated%20Statements%20of%20Operations) For Q2 2023, total revenues increased 32% to $31.0 million, and net loss significantly reduced to $6.1 million from $24.9 million in Q2 2022, while for the six-month period, revenues grew 12% to $59.5 million, and net loss narrowed to $12.2 million from $43.1 million Q2 2023 vs Q2 2022 Performance (in thousands, except per share data) | Metric | Q2 2023 | Q2 2022 | | :--- | :--- | :--- | | Total Revenues | $31,029 | $23,500 | | Gross Profit | $19,138 | $8,711 | | Loss from Operations | $(9,561) | $(24,959) | | Net Loss | $(6,064) | $(24,902) | | Net Loss per Share | $(0.16) | $(0.67) | H1 2023 vs H1 2022 Performance (in thousands, except per share data) | Metric | H1 2023 | H1 2022 | | :--- | :--- | :--- | | Total Revenues | $59,485 | $53,052 | | Gross Profit | $36,064 | $23,270 | | Loss from Operations | $(18,981) | $(43,146) | | Net Loss | $(12,167) | $(43,055) | | Net Loss per Share | $(0.33) | $(1.17) | [Consolidated Statements of Cash Flows](index=9&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2023, net cash used in operating activities significantly reduced to $8.9 million from $29.6 million in the prior-year period, primarily due to a lower net loss, with cash, cash equivalents, and restricted cash at $332.2 million Cash Flow Summary for Six Months Ended June 30 (in thousands) | Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(8,869) | $(29,635) | | Net cash used in investing activities | $(784) | $(5,934) | | Net cash provided by financing activities | $690 | $1,190 | | **Net decrease in cash** | **$(8,963)** | **$(34,379)** | [Notes to Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) The notes provide detailed information on the company's accounting policies and financial activities, highlighting strong growth in consumables and research services, $1.4 million in revenue from its UltraDx agreement in H1 2023, and the impact of the 2022 restructuring plan - The company's business is centered on its proprietary **"Simoa" digital immunoassay platforms** for ultra-sensitive protein biomarker detection, serving life sciences research and diagnostics, and also provides contract research services through its CLIA-certified Accelerator Laboratory[29](index=29&type=chunk)[30](index=30&type=chunk) Disaggregated Revenue for Six Months Ended June 30, 2023 (in thousands) | Revenue Type | North America | EMEA | Asia Pacific | Total | | :--- | :--- | :--- | :--- | :--- | | Product Revenue | $20,454 | $12,439 | $6,086 | $38,979 | | Service Revenue | $15,380 | $2,880 | $871 | $19,131 | | Collaboration/License | $997 | $0 | $0 | $997 | | Grant Revenue | $378 | $0 | $0 | $378 | | **Total Revenues** | **$37,209** | **$15,319** | **$6,957** | **$59,485** | - In Q2 2023, the company received **one million ordinary shares of UltraDx valued at $1.0 million** as part of the UltraDx Agreement, which was recognized as revenue[48](index=48&type=chunk)[49](index=49&type=chunk) - The company recognized **$3.0 million in revenue** from the Lilly Collaboration Agreement in H1 2023, compared to $5.4 million in H1 2022[52](index=52&type=chunk) - As of June 30, 2023, there was **$39.8 million of total unrecognized stock-based compensation expense**, expected to be recognized over a weighted-average period of 2.9 years[82](index=82&type=chunk) - The 2022 Restructuring Plan led to a **$25.6 million impairment charge in 2022**, including $8.2 million for goodwill, with no further impairment charges recorded in H1 2023 and a restructuring reserve of $0.3 million remaining at June 30, 2023[109](index=109&type=chunk)[110](index=110&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=32&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes the **12% revenue growth** in the first six months of 2023 to increased sales of consumables and higher average selling prices, with significant improvement in operating and net loss due to the 2022 Restructuring Plan, and believes current liquidity is sufficient for at least the next 12 months - The company launched **LucentAD in July 2023**, a blood-based biomarker test to aid in evaluating patients with cognitive symptoms consistent with early Alzheimer's disease[128](index=128&type=chunk) - The Restructuring Plan initiated in August 2022 is expected to yield **annualized operating expense savings of approximately $25 million**[141](index=141&type=chunk) - Management believes that current cash and cash equivalents of **$329.5 million**, along with cash from sales, will be sufficient to meet operating cash requirements for at least the next 12 months[171](index=171&type=chunk)[182](index=182&type=chunk) [Comparison of Results of Operations for the Three Months Ended June 30, 2023 and 2022](index=38&type=section&id=Comparison%20of%20Results%20of%20Operations%20for%20the%20Three%20Months%20Ended%20June%2030,%202023%20and%202022) In Q2 2023, total revenues increased **32% to $31.0 million**, with gross profit surging **120% to $19.1 million** and operating expenses decreasing **15% to $28.7 million**, leading to a **62% reduction in loss from operations** to $9.6 million Q2 2023 vs Q2 2022 Results (in thousands) | Item | Q2 2023 | Q2 2022 | Change (%) | | :--- | :--- | :--- | :--- | | Total Revenues | $31,029 | $23,500 | 32% | | Gross Profit | $19,138 | $8,711 | 120% | | Total Operating Expenses | $28,699 | $33,670 | (15)% | | Loss from Operations | $(9,561) | $(24,959) | 62% | - The increase in product revenue was primarily due to higher consumables sales, increased average selling prices, and a **$1.0 million one-time revenue from UltraDx shares**, which offset lower instrument sales[144](index=144&type=chunk) - The decrease in operating expenses was primarily due to **reductions in headcount from the Restructuring Plan**, with R&D down **10%** and SG&A down **20%**[150](index=150&type=chunk)[151](index=151&type=chunk) [Comparison of Results of Operations for the Six Months Ended June 30, 2023 and 2022](index=41&type=section&id=Comparison%20of%20Results%20of%20Operations%20for%20the%20Six%20Months%20Ended%20June%2030,%202023%20and%202022) For H1 2023, total revenues grew **12% to $59.5 million**, gross profit increased **55% to $36.1 million**, and total operating expenses fell **17% to $55.0 million**, resulting in a **56% reduction in operating loss** to $19.0 million H1 2023 vs H1 2022 Results (in thousands) | Item | H1 2023 | H1 2022 | Change (%) | | :--- | :--- | :--- | :--- | | Total Revenues | $59,485 | $53,052 | 12% | | Gross Profit | $36,064 | $23,270 | 55% | | Total Operating Expenses | $55,045 | $66,416 | (17)% | | Loss from Operations | $(18,981) | $(43,146) | 56% | - Cost of product revenue decreased **31% to $14.3 million** due to improved inventory management and lower instrument sales[163](index=163&type=chunk) - R&D and SG&A expenses decreased by **22% and 19% respectively**, primarily due to headcount reductions from the Restructuring Plan[164](index=164&type=chunk)[165](index=165&type=chunk) [Liquidity and Capital Resources](index=45&type=section&id=Liquidity%20and%20Capital%20Resources) The company's principal source of liquidity is its **$329.5 million in cash and cash equivalents** as of June 30, 2023, with net cash used in operating activities for H1 2023 significantly improving by **70% to $8.9 million**, and management believing current capital is sufficient for at least the next 12 months Cash Flow Summary for Six Months Ended June 30 (in thousands) | Activity | 2023 | 2022 | Change (%) | | :--- | :--- | :--- | :--- | | Net cash used in operating activities | $(8,869) | $(29,635) | 70% | | Net cash used in investing activities | $(784) | $(5,934) | 87% | | Net cash provided by financing activities | $690 | $1,190 | (42)% | - The company's future funding requirements depend on market acceptance of products, costs of sales and R&D, and the success of its restructuring and assay improvement programs[183](index=183&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=51&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company states that as of June 30, 2023, there have been no material changes to the market risk information from what was described in its Annual Report on Form 10-K for the year ended December 31, 2022 - There were no material changes to the company's market risk disclosures as of June 30, 2023, compared to the end of 2022[197](index=197&type=chunk) [Controls and Procedures](index=51&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that due to previously disclosed material weaknesses in internal control over financial reporting, the company's disclosure controls and procedures were not effective as of June 30, 2023, with a remediation plan underway, though financial statements are believed to be fairly presented - Management concluded that disclosure controls and procedures were **not effective** at a reasonable assurance level as of June 30, 2023, due to ongoing remediation of material weaknesses identified as of December 31, 2022[198](index=198&type=chunk)[202](index=202&type=chunk) - The company is actively implementing a remediation plan, which includes hiring a Corporate Controller, engaging accounting and third-party consultants, enhancing the ERP system, and providing regular training to finance personnel[205](index=205&type=chunk) - Management will not consider the material weaknesses remediated until the new controls have operated effectively for a sufficient period of time[207](index=207&type=chunk) PART II — OTHER INFORMATION [Legal Proceedings](index=56&type=section&id=Item%201.%20Legal%20Proceedings) As of June 30, 2023, Quanterix was not a party to any legal proceedings that would be expected to have a material adverse effect on its financial condition or results of operations - The company is not currently party to any pending or threatened litigation expected to have a material adverse effect on its financials[211](index=211&type=chunk) [Risk Factors](index=56&type=section&id=Item%201A.%20Risk%20Factors) The company reports no material changes to the risk factors described in its Annual Report on Form 10-K for the year ended December 31, 2022 - As of the filing date, there were no material changes to the risk factors previously disclosed in the Annual Report on Form 10-K[213](index=213&type=chunk) [Other Information](index=56&type=section&id=Item%205.%20Other%20Information) On August 4, 2023, the Board of Directors adopted amended and restated bylaws addressing SEC Rule 14a-19 (universal proxy rule) and modifying stockholder meeting adjournment procedures, with no directors or officers adopting or terminating Rule 10b5-1 trading plans during Q2 2023 - On August 4, 2023, the company's Board of Directors approved and adopted amended and restated bylaws[217](index=217&type=chunk) - The bylaw amendments address new SEC universal proxy rules (Rule 14a-19) and update stockholder meeting adjournment procedures per Delaware law[217](index=217&type=chunk) - No directors or officers adopted or terminated any Rule 10b5-1 trading plans during the three months ended June 30, 2023[219](index=219&type=chunk) [Exhibits](index=59&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including the Restated Bylaws, certifications by the CEO and CFO as required by the Sarbanes-Oxley Act, and XBRL data files - Filed exhibits include the Restated Bylaws (Exhibit 3.2), Sarbanes-Oxley Act Section 302 and 906 certifications, and XBRL interactive data files[221](index=221&type=chunk)

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