Molecular diagnostic testing systems provider GenMark Diagnostics, Inc. (GNMK:NASDAQ), yesterday announced financial results for the fourth quarter and year ended December 31, 2019.
The company reported that for FY/19, total revenue increased 24% to $88.02 million, compared to $70.76 million in FY/18. During the same period, the firm highlighted that ePlex system revenue increased by more than 59% to $60.3 million. For FY/19, the firm posted a net loss of $0.82 per share, compared to a net loss of $0.91 per share FY/18.
The firm stated that for Q4/19, total revenue increased 40% to $27.2 million, compared with $19.4 million in Q4/18. The company indicated that ePlex revenue in Q4/19 increased 58% to $19.2 million, over the corresponding Q4/18 period. The company stated that for Q4/19 it recorded a net loss of $0.17 per share, versus a $0.21 loss per share in Q4/18.
GenMark noted that it placed 38 net new ePlex analyzers in Q4/19, which expanded its global installed base to 527 at year-end 2019 and that the average annuity per ePlex analyzer rose to $148,000 in 2019, up from $139,000 in 2018.
Scott Mendel, interim president and CEO commented, "2019 was a turning point for our company. From the FDA clearance and launch of our suite of blood culture identification panels to our significant improvement in gross margin, our team delivered meaningful results through teamwork and clearly defined goals...As revenue crosses over the $100 million mark in 2020, we are increasingly focused on driving towards cash flow positivity. We expect continued strong U.S. ePlex revenue growth, which is the vast majority of our business."
The company provided some forward guidance and advised that it expects FY/20 revenue to be in the range of $100-110 million. FY/20 ePlex revenues are expected to increase by greater than 30% and are estimated to comprise 70-80% of FY/20 total revenue. Additionally, global ePlex placements are expected to range from 130-160 net new analyzers with an annuity per analyzer between $130,000 and $135,000.
In a separate news release, the company reported "initial shipments of ePlex Research Use Only (RUO) test kits designed to detect the SARS-CoV-2 virus. Initial RUO test kits were recently shipped to the company's Hong Kong distributor, as well as several U.S. customers that have access to clinical samples. GenMark plans to use this information to support submission of an Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for the ePlex SARS-CoV-2 test to address this developing global public health emergency."
Interim CEO Mendel remarked, "In just one month, our team completed the design, manufacture and shipment of initial tests to customers for validation of our assay design using clinical samples. This is a strong demonstration of the GenMark teams' scientific and operational expertise, the capability of our novel ePlex technology, and our ability to quickly adapt ePlex to meet a specific market need...COVID-19 is a global health emergency and we believe it is important to use our technology and resources to contribute in the fight against this disease."
GenMark Diagnostics is headquartered in Carlsbad, Calif., and is a provider of multiplex molecular diagnostic solutions. The company states that "its proprietary eSensor® detection technology, GenMark's eSensor XT-8® and ePlex® systems are designed to support a broad range of molecular diagnostic tests with compact, easy-to-use workstations and self-contained, disposable test cartridges." The firm's ePlex product is designed to address infectious disease testing needs in the areas of respiratory, bloodstream and gastrointestinal infections.
GenMark Diagnostics started the day with a market capitalization of around $203.9 million with approximately 58.08 million shares outstanding and a short interest of about 3.40%. GNMK shares opened higher today at $4.50 (+$0.99, +28.21%) over yesterday's $3.51 closing price. The stock has traded today between $4.15 and $5.13 per share and is currently trading at $4.54 (+$1.03, +29.34%).
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