GenMark diagnostics Q3 revenues up 28 percent

Third Quarter Revenue Increased 28% Versus Prior Year to $10.8 million ePlex Gaining Momentum in Europe; Preparation for U.S. Launch Underway ePlex Clinical Sample Testing Completed at Clinical Study Sites; Q4 FDA Submission on Track Completed $29 Million ATM Offering; Ended Q3 with Cash Balance of $54.2 million.GenMark Diagnostics,a leading provider of automated, multiplex molecular diagnostic testing systems, announced financial results for the third quarter ended September 30, 2016.

Revenue for the third quarter of 2016 was $10.8 million, an increase of 28% over the prior year period.Gross profit for the third quarter of 2016 was $6.5 million, or 60% of revenue, compared with $5.1 million, or 60% of revenue in the same period of 2015.

In addition to continued strong performance from XT-8 in the USA, during the third quarter we also realized our first ePlex revenues in Europe. Over the past few months, our ePlex commercialization efforts have been highly effective. Since our last update, we have more than doubled the number of ePlex customer agreements to more than thirty. Our global funnel of ePlex opportunities continues to strengthen, and customer feedback remains very positive,” said Hany Massarany, President and Chief Executive Officer of GenMark. “Furthermore, we recently completed the testing of clinical samples required for 510(k) clearance of the ePlex instrument and its Respiratory Pathogen (RP) panel. Our teams are now preparing clinical study reports for submission to the FDA this quarter, in line with our expectations. Additionally, we raised $29 million of cash during the quarter in an at-the-market (ATM) equity offering of common stock further strengthening our balance sheet,” added Massarany.

Operating expenses for the third quarter of 2016 were $18.1 million compared to $16.2 million in the same period for 2015. The increase was mainly driven by research and development expenses as efforts continued towards the launch of ePlex.

The Company ended the quarter with $54.2 million in cash and cash equivalents and intends to continue utilizing its cash balances to invest in the global commercialization of the ePlex system. The Company’s existing debt facility can provide up to an additional $20 million to support the launch of ePlex internationally as well as domestically.

Business Outlook

For full year 2016, the Company continues to expect revenue in the range of $47 to $51 million and gross margin in the range of 57% to 59%.


GenMark Diagnostics is a leading provider of automated, multiplex molecular diagnostic testing systems that detect and measure DNA and RNA targets to diagnose disease and optimize patient treatment. Utilizing GenMark’s proprietary eSensor detection technology, GenMark’s eSensor XT-8 system is designed to support a broad range of molecular diagnostic tests with a compact, easy-to-use workstation and self-contained, disposable test cartridges. The eSensor detection technology is also incorporated into GenMark’s sample-to-answer system, ePlex