NEW YORK (GenomeWeb) – GenMark Diagnostics reported after the close of the market on Tuesday a 28 percent rise in first quarter revenues, an increase helped by the placement of 22 of its XT-8 molecular diagnostic systems during the period.
For the three-month period ended March 31, GenMark's revenues rose to $10.1 million from $7.9 million in the same period a year earlier, in line with the average Wall Street estimate.
The firm's net loss for the quarter increased to $9.9 million, or $.24 a share, from a year-ago loss of $8.8 million, or $.21 a share, again matching analysts' average estimate.
GenMark's R&D spending in the quarter was up nearly 21 percent to around $8.8 million. Meanwhile, SG&A expenses increased to around $7.1 million from roughly $5.9 million the year before reflecting the costs associated with the planned launch of the firm's ePlex sample-to-answer molecular diagnostics system later this year.
GenMark expects to submit the system to US regulators in the first quarter of next year.
At the end of the first quarter, GenMark had cash and cash equivalents totaling roughly $36.9 million.
The company reiterated its full-year 2015 revenue guidance in the range of $38 million to $40 million. GenMark also said it expects to place around 50 additional XT-8 analyzers in the first half of this year and between 25 and 35 in the second half of the year. The current total installed base of analyzers in the US is 562
GenMark also said it expects to place around 50 additional XT-8 analyzers in the first half of this year and between 25 to 35 in the second half of the year. The current total installed base of analyzers in the US is 562.
During a conference call, GenMark President and CEO Hany Massarany noted that the decrease in expected XT-8 analyzer placements between the first and second halves of the year reflects a planned shift in the company's commercial focus onto the ePlex system.
According to Massarany, GenMark will approximately double its commercial organizations globally by year-end. At the end of 2014, the company had around 30 salespeople.
"We are also building … funnels along the way," he said. "We are showing the system at … conferences and also meeting with key potential customers at those meetings, of course. We are also working on training the sales organizations over time as we expand the commercial force."
Meanwhile, GenMark continues to plan for clinical trials to support approvals for the various assays that will run on ePlex, including the company's lead ones for gram-positive and gram-negative bacterial identification panels, as well as a respiratory panel.
Massarany added during the call that GenMark is already in discussions with the US Food and Drug Administration and has come to an agreement with the agency on the design of the studies that will support the panels' submissions for approval.
The company continues to expect that the lead assays will launch alongside the ePlex system or shortly thereafter, with additional panels for HCV genotyping, central nervous system infection, and fungal infection rolling out later.