NEW YORK (GenomeWeb) – GenMark Diagnostics reported after the close of the market on Thursday that its fourth quarter revenues rose 21 percent year over year, in line with preliminary Q4 revenues reported in January.
For the three months ended Dec. 31, 2018, the company reported revenues of $19.4 million, up from $16.0 million in Q4 2017, and beating the analysts' consensus estimate of $19.1 million.
The firm said its ePlex analyzer Q4 revenues increased about 110 percent year over year to $12.1 million. It placed 42 net new ePlex analyzers in Q4 and finished the year with a global installed base of 354.
GenMark said that in Q4 it received US Food and Drug Administration clearance for the company’s ePlex Blood Culture Identification Gram-Positive Panel (BCID-GP) and Fungal Pathogen Panel (BCID-FP). The firm also said that it expanded and restructured a term loan agreement, adding $11 million to its balance sheet on Feb. 1, with the potential to increase that by an additional $15 million upon meeting certain revenue milestones.
GenMark President and CEO Hany Massarany said in a statement that the firm's accomplishments in 2018 included driving global commercial ePlex adoption, expanding its ePlex test menu, and improving manufacturing cost and yield efficiencies.
"With a highly experienced commercial team and expanded ePlex menu, this year we will remain focused on growing our market share and installed base of ePlex systems," he said.
On a conference call to discuss the firm's financial performance, Massarany said that "based on what we know" about how its application to the FDA for clearance of its gram-negative BCID panel has progressed, the firm anticipates receiving clearance for the panel this quarter.
Cowen analyst Doug Schenkel said in a research note on Friday that he anticipates sales of the BCID panels will generate about $5 million to $6 million in 2019 revenues for GenMark.
Massarany said that the firm achieved strong market adoption of its ePlex system in 2018 and that the system will continue to be a significant business priority for the firm in 2019 and beyond.
The company's Q4 net loss narrowed to $11.6 million, or $.21 per share, from a net loss of $14.5 million, or $.26 per share, in Q4 2017, missing the analysts' average estimate for a net loss of $.18 per share.
GenMark reported that its Q4 R&D expenses fell 31 percent to $5.9 million from $8.5 million. Its SG&A expenses fell 4 percent to $9.9 million from $10.3 million.
For full-year 2018, GenMark reported that total revenues rose 35 percent to $70.8 million from $52.5 million in 2017, beating the consensus Wall Street estimate of $70.4 million. The firm's full-year ePlex revenues rose 270 percent year over year to $37.9 million.
The firm's net loss for the year narrowed to $50.5 million, or $.91 per share, from a net loss of $61.9 million, or $1.21 per share, in 2017, but it missed the analysts' average estimate for a net loss of $.88 for the year.
The company's 2018 R&D expenses fell 35 percent to $27.9 million from $42.8 million in the year-ago period. Its SG&A expenses for the year rose 7 percent to $39.3 million from $36.8 million in 2017.
GenMark ended the year with cash and cash equivalents of $36.3 million and short-term marketable securities of $8.9 million.
GenMark also announced that Scott Mendel, currently the firm's CFO, is moving to a newly created role of COO. Simultaneously, the firm has promoted Johnny Ek, its vice president of finance and corporate controller since 2013, to CFO.
For full-year 2019, the company anticipates revenues of $85 million to $90 million. Wall Street analysts, on average, are expecting 2019 revenues of $86.7 million for the firm.
GenMark added that global ePlex placements are expected to be in the range of 170 to 190 net new analyzers with an annuity per analyzer of $135,000 to $145,000.
Massarany said that GenMark is investing in menu expansion and ongoing product innovation. The firm's top priority from a menu development perspective is a GI panel, he said, but declined to say when the firm expects to launch the panel.
Over the past five years or so, the global respiratory multiplex testing market grew from approximately $150 million to $500 million per year, Massarany said. "We expect syndromic testing for other infectious disease states to follow the same path, especially bloodstream and gastrointestinal infections. And with a growing number of other disease states that are transitioning to multiplex molecular testing, including central nervous system, lower respiratory tract, and bone and joint infections, to name a few, we believe this market opportunity has the potential to exceed $2.5 billion annually over the next five years."
The firm's commercial plans for international expansion are on track, he noted. In Central and Western European countries, GenMark has exclusive distributors working with its own dedicated teams. The firm has also expanded distributor channels and partnerships in other countries, including in Eastern Europe, Massarany said. Further, the firm has signed up multiple distribution agreements in Middle Eastern countries, but it hasn't yet begun commercial distribution activities in the Asia-Pacific and Latin America regions.
Genmark's shares were up more than 14 percent to $7.79 in morning trading on the Nasdaq.