Quanterix Corporation Releases Operating Results for Third Quarter 2019

On November 6, 2019 Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis to advance the science of precision health, reported financial results for the three and nine months ended September 30, 2019 (Press release, Quanterix, NOV 6, 2019, View Source [SID1234550488]).

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"We are pleased with our execution and yet another record quarter with strong revenue growth, successful early launch of our new HD-X Analyzer and material progress accelerating global adoption of our ultra-sensitive Simoa technology," said Kevin Hrusovsky, Chief Executive Officer, President and Chairman, Quanterix. "We are excited to have accelerated the HD-X Analyzer shipments a quarter early and also to have strengthened our balance sheet with a successful follow-on offering. We believe our growth trajectory and financial performance speak for themselves. We remain confident in our impressive opportunity for value creation as we pioneer disruption in healthcare. Our next major opportunity to advance our commercial momentum is by participating in the upcoming Powering Precision Health Summit in Barcelona, Spain on November 19, 2019 where over 40 top researchers are lined up to present on the disruptive potential of biomarker technology to transform drug development and enable a sea change advance in precision health."

Third Quarter 2019 Financial Highlights

Key financial results for the third quarter of 2019 are shown below:

·Q3 revenue was $14.9M versus prior year Q3 of $10.6M, an increase of 41%; Excluding $1.3M in revenue recognized in Q3 2018 in connection with the termination of a license agreement, non-GAAP year-over-year revenue growth was 62%;

·Q3 product revenue was $10.7M versus prior year Q3 of $6.0M, an increase of 80%;

·Q3 service and other revenue was $4.2M versus prior year Q3 of $3.0M, an increase of 39%; and

·Q3 GAAP gross margin was 47.1% versus prior year Q3 of 52.8%; Q3 non-GAAP gross margin was 51.8% versus prior year Q3 of 46.2%, an increase of 560 bps.

YTD 2019 Financial Highlights

Key financial results for 2019 YTD are shown below:

· YTD revenue was $40.8M versus prior year YTD of $26.8M, an increase of 53%. On a non-GAAP basis, year-over-year revenue growth was 61%;

· YTD product revenue was $29.1M versus prior year YTD of $15.9M, an increase of 83%;

·YTD service and other revenue was $11.8M versus prior year YTD of $8.7M, an increase of 35%; and

·YTD gross margin was 48.9% versus prior year YTD of 47.6%, YTD non-GAAP gross margin was 50.7% versus prior year YTD of 45.0%, an increase of 570 bps.

For additional information on the non-GAAP financial measures included in this press release, please see "Use Non-GAAP Financial Measures" and "Reconciliation of GAAP to Non-GAAP Financial Measures" below.

Third Quarter 2019 Business Highlights

·We began shipments of the HD-X Analyzer ahead of our Q4 expectation, following a successful Early Access Program. Trade-ins for the HD-1 instrument are outpacing expectations.

·Our Nf-L assay was highlighted in a record 50 publications at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Stockholm, Sweden, continuing to demonstrate the growing momentum for clinical validity of this marker. Serum based Nf-L measurements were reported in major trials such as Novartis’ Phase III ASCLEPIOS trial, Roche’s results for Phase III OPERA I, II and ORATORIO trials, and Biogen’s data generated in collaboration with Siemens Healthineers using Quanterix/UmanDiagnostics Nf-L antibodies to adapt the Simoa assay onto a routine analyzer platform. We also hosted an extremely well-attended networking reception convening many leading opinion leaders in the field.

· We successfully raised $69M in gross proceeds through our follow-on offering, further strengthening our balance sheet with growth capital. Nearly $120M before expenses have been added to our balance sheet this year.

·We continued to strengthen our leadership team with a number of key hires. Dr. Tatiana Plavina joined us as vice president of Clinical BioMarker Strategy where she will focus on further advancing our industry by leading efforts on Nf-L and other biomarkers as clinically-meaningful tools for drug development and clinical care. Tatiana joins Quanterix after a successful 18-year career at Biogen, where she has been a biomarker leader, advancing clinical trials, developing a companion diagnostic test for Tysabri, and furthering the clinical relevance of serum Nf-L assay for drug development as a measure of neuronal health.

·Earlier this week, we entered into a licensing and supply arrangement with Siemens Healthineers for access to Quanterix’ proprietary Nf-L antibodies. We are pleased to have the opportunity to work with as formidable a partner as Siemens Healthineers to accelerate the availability of an Nf-L test for patients around the world.

·Quanterix was invited to present its disruptive approach to using minimally invasive biomarkers at a number of high-profile venues, including the SVB Leerink Healthcare CEO Summit, the Laguna Biotech CEO Forum, and the Healthcare CEO Summit in partnership with the Cleveland Clinic. We were also featured on "Nasdaq Spotlight" where we discussed our biomarker potential to enable precision health and participated in an interview with the author of the new book, "The First Cell: And the Human Cost of Pursuing Cancer to the Last," where we highlighted the potential of our newly released Simoa SP-X oncology technology in the battle against cancer. View Source

·Quanterix will be an exclusive Platinum Sponsor of the 2019 Powering Precision Health (PPH) Summit scheduled for November 19 in Barcelona, Spain, which continues to receive solid interest from opinion leaders and researchers from around the world. More than 40 speakers will be presenting their research across two full concurrent tracks in neurology and oncology.

Conference Call

In conjunction with this announcement, Quanterix Corporation will host a conference call on November 6 at 4:30 p.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: 5798993. A live webcast will also be available at: View Source and through the Investors section of the Company’s website,