BILLERICA, Mass. / Feb 29, 2024 / Business Wire / Quanterix Corporation (NASDAQ: QTRX), a company fueling scientific discovery through ultrasensitive biomarker detection, today announced financial results for the fourth quarter and twelve months ended December 31, 2023.

“The fourth quarter marked the successful completion of our corporate transformation. We now have a strong, scalable foundation for growth and innovation,” said Masoud Toloue, President and Chief Executive Officer of Quanterix. “Our research business is in a solid position, and we see continued high demand among our research customers. Additionally, we are making progress on our diagnostics efforts, with a dedicated commercial team now in place for our LucentAD p-Tau 217 LDT. We believe we are well positioned to meet the demand for blood-based biomarker testing to support the rollout of new Alzheimer’s therapies and to aid providers in the diagnosis of the disease.”

Fourth Quarter Financial Highlights

• Revenue was $31.5 million, a 22% increase from $25.8 million for the corresponding prior year period.
• GAAP gross margin was 53.2% as compared to 48.8% for the corresponding prior year period. Non-GAAP gross margin was 46.5% as compared to 41.3% for the corresponding prior year period.
• Net loss was $12.4 million as compared to $18.6 million for the corresponding prior year period.
• Net cash usage in the quarter was $6.4 million as compared to $5.0 million for the corresponding prior year period.

Full Year Financial Highlights

• Revenue was $122.4 million, a 16% increase from $105.5 million for the prior year.
• GAAP gross margin was 57.7% as compared to 44.4% for the prior year. Non-GAAP gross margin was 51.1% as compared to 37.5% for the corresponding prior year.
• Net loss was $32.3 million as compared to $96.7 million for the prior year.
• Net cash usage for the year was $17.4 million as compared to $57.7 million for the corresponding prior year period. Cash, cash equivalents, marketable securities, and restricted cash were $323.9 million as of December 31, 2023, as compared to $341.3 million as of December 31, 2022.

Operational and Business Highlights

• Quanterix’s six quarter corporate transformation program is now complete. Newly developed assays are now in production and available to customers.
• Quanterix announced first collaborations with five health networks to aid the diagnosis and clinical management of individuals with Alzheimer’s Disease. AdventHealth, Mass General Brigham, Mayo Clinic, MUSC, and UPMC will leverage Quanterix technology and assays to streamline care for Alzheimer’s patients.
• Eli Lilly announced the launch of their p-Tau 217 blood-based diagnostics test, which runs on the Quanterix platform.
• Continued progress on two important studies for multi-marker test development and validation. Phase 1 is now complete for both the CANTATE and BioHermes trials, with readouts expected in 2024. Quanterix also advanced several US-based prospective clinical studies supporting leading academic research centers, the University of Pennsylvania Health System and UPMC, to evaluate Simoa® blood-based biomarkers as part of Alzheimer’s Disease clinical care workflows.

2024 Full Year Business Outlook

Management expects full-year 2024 revenue to be in the range of $139 to $144 million. This guide is for our research-only business and does not include revenues from Diagnostics testing, which to date have not been material. GAAP gross margin percentage is expected to be in the range of 57-61%, and non-GAAP gross margin percentage is expected to be in the range of 51-55%. Additionally, the Company anticipates 2024 cash usage in the range of $25 to $30 million.

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” below.

Conference Call

In conjunction with this announcement, the Company will host a conference call on February 29, 2024 at 4:30 p.m. E.T. Click here to pre-register for the conference call and obtain your dial-in number and passcode.

Interested investors can also listen to the live webcast from the Event Details page in the Investors section of the Quanterix website at http://www.quanterix.com. An archived webcast replay will be available on the Company’s website for one year.

Financial Highlights

Use of Non-GAAP Financial Measures

To supplement our financial statements presented on a U.S. GAAP basis, we present non-GAAP gross profit, non-GAAP gross margin, non-GAAP total operating expenses, and non-GAAP loss from operations, which are calculated by including shipping and handling costs for product sales within cost of goods sold instead of within selling, general, and administrative expenses. 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 our competitors. Management believes that presentation of these non-GAAP measures provides useful information to investors in assessing our operating performance within our industry and in order to allow comparability to the presentation of other companies in our industry where shipping and handling costs are included in cost of goods sold for products. The non-GAAP financial information presented here should be considered in conjunction with, and not as a substitute for, the financial information presented in accordance with U.S. GAAP. Set forth below is a reconciliation of non-GAAP gross profit, non-GAAP gross margin, non-GAAP total operating expenses, and non-GAAP loss from operations to their most directly comparable GAAP financial measures.

Reconciliation of GAAP to Non-GAAP Financial Measures

About Quanterix

From discovery to diagnostics, Quanterix’s ultrasensitive biomarker detection is driving breakthroughs only made possible through its unparalleled sensitivity and flexibility. The Company’s Simoa technology has delivered the gold standard for earlier biomarker detection in blood, serum or plasma, with the ability to quantify proteins that are far lower than the Level of Quantification of conventional analog methods. Its industry-leading precision instruments, digital immunoassay technology and CLIA-certified Accelerator laboratory have supported research that advances disease understanding and management in neurology, oncology, immunology, cardiology and infectious disease. Quanterix has been a trusted partner of the scientific community for nearly two decades, powering research published in more than 2,700 peer-reviewed journals. Find additional information about the Billerica, Massachusetts-based company at https://www.quanterix.com or follow us on Twitter and LinkedIn.

Forward-Looking Statements

Quanterix’s current financial results, as discussed in this press release, are preliminary and unaudited, and subject to adjustment. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements about Quanterix’s financial performance, including statements under the header “Full Year Business Outlook” set forth above, and are subject to a number of risks, uncertainties and assumptions. Forward-looking statements in this press release are based on Quanterix’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause Quanterix’s actual results to differ from those expressed or implied in the forward-looking statements in this press release include, but are not limited to, those described in our periodic reports filed with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein. Except as required by law, Quanterix assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.