Quanterix Corporation Releases Operating Results for Fourth Quarter and Full Year 2021

BILLERICA, Mass.--(BUSINESS WIRE)-- Quanterix (NASDAQ: QTRX), a company digitizing biomarker analysis with the goal of advancing the science of precision health, today announced financial results for the fourth quarter and twelve months ending December 31, 2021.

“We‘ve reached an important inflection point with the achievement of several key milestones, namely, our license and collaboration agreements with Eli Lilly, FDA Breakthrough Device Designation for plasma pTau-181 for Alzheimer’s disease (AD), and ending a strong 2021 with another record quarter. We have nearly $400 million on our balance sheet and the recruitment of several key executives that strengthen both RUO and diagnostics potential,” said Kevin Hrusovsky, Chairman and Chief Executive Officer, Quanterix. “With our new agreements in place, we now have access to Lilly’s marquis P-tau217 antibody technology for AD and a collaboration framework for future projects across all disease categories. As we build our franchise in 2022, we look forward to partnering with other bio-pharmaceuticals, payors, researchers, and investors to unlock the massive opportunity for asymptomatic medicine using precision health proteomics.”

For more information on the new agreements with Lilly to advance diagnosis and treatment of Alzheimer’s disease, please see the press release issued today.

Quanterix also announced the Company’s executive leadership succession plan. Effective April 25, 2022, President Masoud Toloue will succeed Chairman & Chief Executive Officer Kevin Hrusovsky as CEO and join Quanterix’ Board of Directors. Hrusovsky will move into an active Executive Chairman role, continuing to serve on the Board and support key strategic initiatives and important customer, partner and investor relationships. For more information on the succession plan, please see the full release issued today.

Fourth Quarter 2021 Financial Highlights

Key financial results for the fourth quarter of 2021 are shown below:

• Q4 GAAP total revenue, which includes grant revenue of $1.0M, was $30.3M versus prior year Q4 of $26.1M, which included grant revenue of $4.5M, an increase of 16%;
• Q4 non-GAAP total revenue was $29.3M versus prior year Q4 of $21.6M, an increase of 35%;
• Q4 GAAP product revenue was $23.5M versus prior year Q4 of $15.7M, an increase of 49%;
• Q4 GAAP service and other revenue was $5.7M versus prior year Q4 of $5.5M, an increase of 3%;
• Q4 GAAP gross margin was 53.7% versus prior year Q4 of 57.6%; and
• Q4 non-GAAP gross margin was 53.5% versus prior year Q4 of 50.8%.

Full Year 2021 Financial Highlights

Key financial results for FY 2021 are shown below:

• FY GAAP total revenue, which includes grant revenue of $5.2M, was $110.6M versus prior year FY of $86.4M; which included one-time license revenue of $11.2M and grant revenue of $6.4M, an increase of 28%;
• FY non-GAAP total revenue was $105.3M versus prior year FY of $68.8M, an increase of 53%;
• FY GAAP product revenue was $81.1M versus prior year FY of $44.0M, an increase of 84%;
• FY GAAP service and other revenue was $23.6M versus prior year FY of $24.1M, a decrease of 2%;
• FY GAAP gross margin was 55.8% versus prior year FY of 55.8%; and
• FY non-GAAP gross margin was 55.4% versus prior year FY of 49.2%.

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 Non-GAAP Financials” below.

Fourth Quarter and Full Year Business Highlights

• The Company strengthened its balance sheet by successfully raising $287.5 million in gross proceeds through a follow-on offering completed in Q1. Quanterix had $399.0 million in cash, cash equivalents and restricted cash on the balance sheet as of December 31, 2021.
• Quanterix’ Simoa phospho-Tau 181 (pTau-181) blood test was granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA) as an aid in diagnostic evaluation of Alzheimer’s disease.
• The FDA expanded the Emergency Use Authorization (EUA) label for Quanterix’ Simoa SARS-CoV-2 N Protein Antigen Test to include testing with nasal swab and saliva samples, and for asymptomatic serial testing with nasal swab samples. The expanded label established this test as the first antigen test authorized for use with saliva samples.
• Quanterix’ Simoa HD-X technology and assays were used to measure pTau217 using antibodies developed by Eli Lilly and Company for its Phase 2 TRAILBLAZER-ALZ study, which was presented by Lilly at the Alzheimer’s Association International Conference (AAIC) 2021.
• Following the FDA approval of ADUHELM™, Biogen conducted biomarker studies on Phase 3 EMERGE and ENGAGE trial samples, utilizing Quanterix’ Simoa HD-X to measure plasma pTau-181. Dr. Oskar Hansson from University of Lund reported preliminary data showing a dose-dependent reduction in plasma pTau-181 levels following treatment with ADUHELM, which correlated with decreases in brain amyloid as measured by PET scan and a slowing of cognitive decline across four independent assessment tools.
• Instrument installations increased by 32% in 2021 to 708 at year-end, with many HD-X instruments being used for neuro-related applications.
• Quanterix’ Simoa technology powered the largest and most diverse global investigation in the role of plasma neurofilament light (NfL) for dementia diagnosis, published in Nature Communications. The research marks the most robust effort to date to assess the use of NfL in blood to screen for neurodegeneration as a cause of cognitive symptoms, to differentiate among neurodegenerative disorders and distinguish psychiatric disorders, and to derive age-related concentration cutoffs that may help to maximize plasma NfL’s usefulness in a clinical setting.
• Data presented at the 2021 Clinical Trials on Alzheimer’s Disease (CTAD) conference described a prototype Simoa plasma pTau-231 assay and its potential role in detecting Alzheimer’s disease pathology. This emerging biomarker allows for detection even earlier in the disease continuum, when patients are asymptomatic and not yet exhibiting brain pathology in PET imaging studies.
• The Company welcomed Masoud Toloue, with a high growth track record from PerkinElmer, to the position of President of Quanterix and Diagnostics. The Company subsequently accounced its executive transition plan as noted above. The Company also appointed Michael Doyle, a strong financial executive with deep public company experience, to the position of Chief Financial Officer and Treasurer. Laurie Olson, a seasoned industry executive who brings more than three decades of experience in commercial and corporate strategy from Pfizer, Inc., joined Quanterix’ Board of Directors.
• Quanterix was named a finalist for the Deloitte Fast 500 list, which ranks the fastest-growing technology, media, telecommunications and life sciences companies based in North America. The annual ranking is based on percentage revenue growth over the Company’s last three fiscal years.
• Academic publication pull-through performance continued to be strong. Quanterix’ Simoa technology was highlighted in a record 465 new publications in 2021, bringing total Simoa-specific inclusions to over 1,585.

Conference Call

In conjunction with this announcement, Quanterix Corporation will host a conference call on March 1, 2022 at 8:30 a.m. EST. Individuals interested in listening to the conference call may do so by dialing (833) 686-9351 for domestic callers, or (612) 979-9890 for international callers. Please reference the following Conference ID: 5230769.

A live webcast will also be available at: https://edge.media-server.com/mmc/p/udpgv5ou. You may also access the live webcast by visiting the News & Events page within the Investors section of the Quanterix website at www.quanterix.com. The webcast will be available on the Company’s website for one year following completion of the call.

Financial Highlights (in thousands)

Weighted average shares outstanding was 36.7 million for Q4 2021 and 36.0 million for YTD 2021.

Use of Non-GAAP Financial Measures

To supplement the Company’s financial statements presented on a GAAP basis, the Company has provided certain non-GAAP financial measures, including non-GAAP revenue and non-GAAP gross margin. Management uses these non-GAAP measures to evaluate the Company’s operating performance in a manner that allows for meaningful period-to-period comparison and analysis of trends in its business. Management believes that such measures are important in comparing current results with prior period results and are useful to investors and financial analysts in assessing the Company’s operating performance. 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 GAAP. Investors are encouraged to review the reconciliation of these non-GAAP measures to their most directly comparable GAAP financial measures set forth below.

About Quanterix

Quanterix is a company that’s digitizing biomarker analysis with the goal of advancing the science of precision health. The company’s digital health solution, Simoa, has the potential to change the way in which healthcare is provided today by giving researchers the ability to closely examine the continuum from health to disease. Quanterix’ technology is designed to enable much earlier disease detection, better prognoses and enhanced treatment methods to improve the quality of life and longevity of the population for generations to come. The technology is currently being used for research applications in several therapeutic areas, including oncology, neurology, cardiology, inflammation and infectious disease. The company was established in 2007 and is located in Billerica, Massachusetts. For additional information, please visit https://www.quanterix.com.

Forward-Looking Statements

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. Forward-looking statements in this news release are based on Quanterix’ 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’ actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Quanterix’ filings 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.

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