On November 4, 2021 Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis with the goal of advancing the science of precision health, reported financial results for the three months ending September 30, 2021 (Press release, Quanterix, NOV 4, 2021, View Source [SID1234594435]).
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"We are making critical advances across neurology and infectious disease with recent breakthrough device designation for an Alzheimer’s blood test and expanded EUA label for a COVID-19 test by the U.S. FDA," said Kevin Hrusovsky, Chairman and Chief Executive Officer, Quanterix. "Our Simoa phospho-Tau 181 (pTau-181) blood test is a critical potential aid in the diagnostic evaluation of Alzheimer’s disease, in particular by unlocking the possibility for earlier, more accessible, higher-throughput, non-invasive diagnosis to enable advances in neuro-diagnostic therapies. Furthermore, our label expansion for our Simoa SARS-CoV-2 N Protein Antigen Test demonstrates yet another example of Simoa’s potential for achieving asymptomatic and low-invasive clinical testing."
Third Quarter 2021 Financial Highlights
Key financial results for the third quarter of 2021 are shown below:
Q3 GAAP total revenue, which includes grant revenue of $1.0M, was $27.7M versus prior year Q3 of $31.4M; prior year Q3 included one-time license revenue of $11.2M and grant revenue of $1.9M;
Q3 non-GAAP total revenue was $26.7M versus prior year Q3 non-GAAP total revenue of $18.3M, an increase of 46%;
Q3 GAAP product revenue was $20.7M versus prior year Q3 of $11.7M, an increase of 77%;
Q3 GAAP service and other revenue was $5.9M versus prior year Q3 of $6.6M, a decrease of 10% over a strong 2020 driven by one time COVID-related services; our two year CAGR (Q319 – Q321) for services is 18%; and
Q3 GAAP gross margin was 55.1% versus prior year Q3 GAAP gross margin of 67.2%; Q3 non-GAAP gross margin was 54.8% versus prior year Q3 non-GAAP gross margin of 51.5%.
YTD 2021 Financial Highlights
Key financial results for YTD 2021 are shown below:
YTD GAAP total revenue, which includes grant revenue of $4.2M, was $80.3M versus prior year YTD of $60.2M; prior year YTD included one-time license revenue of $11.2M and grant revenue of $1.9M;
YTD non-GAAP total revenue was $76.0M versus prior year YTD non-GAAP total revenue of $47.1M, an increase of 61%;
YTD GAAP product revenue was $57.6M versus prior year YTD of $28.3M, an increase of 104%;
YTD GAAP service and other revenue was $18.0M, versus prior year YTD of $18.6M, a decrease of 4% over a strong 2020 driven by one time COVID-related services; our two year CAGR (YTD19 – YTD21) for services is 24%; and
YTD GAAP gross margin was 56.6% versus prior year YTD GAAP gross margin of 55.0%; YTD non-GAAP gross margin was 56.1% versus prior year YTD non-GAAP gross margin of 48.4%.
For additional information on the non-GAAP financial measures included in this press release, please see "Use of Non-GAAP Financial Measures" below.
Third Quarter 2021 Business Highlights
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 pTau-217 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;
Hosted the webinar: COVID-19 Testing in a Residential University Setting with leading pathologist Dr. John Roback, M.D., Ph.D., Professor of Pathology and Laboratory Medicine, Executive Vice-Chair for Clinical Operations, and Medical Director for Emory Medical Laboratories, that discussed implementation of a broad SARS-CoV-2 screening program for Emory students, faculty and staff, enabling a safe return to campus-based learning. To date, Emory has run over 120,000 tests using the Simoa SARS-CoV-2 N Protein Antigen Test;
Co-hosted the webinar, Cytokine Profiles and Personalized Therapeutics in COVID-19 Patients with Guy Gorochov, M.D., Ph.D., Professor of Medicine, Head of the Dept. of Immunology and Co-Director CIMI Research Centre, Sorbonne University/INSERM and Laurel Provencher, Ph.D., Sr. Director of Strategic Collaborations, Quanterix, who discussed recently published observations that describe distinct cytokine profiles and COVID-19 severity and mortality;
Kevin Hrusovsky delivered a presentation at the Second Annual Biomarkers for Alzheimer’s Disease Conference on Aug. 26 with Nicholas Ashton, Ph.D., Assistant Professor, Department of Psychiatry & Neurochemistry, University of Gothenburg. The presentation discussed key features of assay development of plasma pTau-181 and pTau-231 on the Simoa platform, provided an overview of plasma pTau across the AD continuum and featured head-to-head comparisons of pTau plasma biomarkers;
Delivered a presentation at the Precision Medicine Leaders’ Summit on transforming cancer detection with biomarker technology; and
Quanterix Simoa technology was highlighted in 125 new publications, bringing total Simoa-specific inclusions to more than 1,480 publications.
Conference Call
In conjunction with this announcement, Quanterix Corporation will host a conference call on November 4, 2021 at 4:30 p.m. EDT. 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: 3488875.
A live webcast will also be available at: View Source The webcast will be available on the Company’s website, View Source, for one year following completion of the call.
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.