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GenMark Diagnostics Q4 Revenues Rise 84 Percent on MDx Sales

NEW YORK – GenMark Diagnostics said after the close of the market on Thursday that its fourth quarter revenues rose 84 percent year over year, in line with preliminary Q4 revenues reported in January.

For the three months ended Dec. 31, 2020, the Carlsbad, California-based company reported revenues of $50.1 million compared to $27.2 million in Q4 2019 and beating analysts' consensus estimate of $47.1 million.

Product revenues grew 84 percent year over year to $49.4 million from $26.9 million, while other revenues rose 131 percent to $730,000 from $316,000.

GenMark said its ePlex molecular diagnostic product revenue for Q4 was $45.4 million, an increase of 138 percent over the fourth quarter of 2019. The company placed 70 net new ePlex analyzers in the quarter and finished the year with a global installed base of 792 ePlex analyzers. Its ePlex installed base grew 50 percent year over year.

In Q4, the annuity per analyzer was approximately $220,000 compared to approximately $148,000 in Q4 2019, GenMark said.

The company said it increased manufacturing capacity by more than 75 percent versus the prior year with the completion of the first of two new production lines during the quarter.

"2020 was truly a transformational year for GenMark both financially and operationally," Scott Mendel, the company's president and CEO, said in a statement. "Our priorities in 2021 include increased adoption of our [blood culture identification and respiratory] panels, as well as driving further market penetration for our differentiated ePlex platform."

On a conference call to discuss GenMark's financial results, Mendel noted that the company has not commented on rumors that it is exploring a sale after being approached by potential buyers. Further, GenMark did not provide any information for the Bloomberg article that reported the potential sale earlier this month, he said, adding that such "rumors can be very distracting for a company."

In a related development, shares of Luminex, a GenMark competitor, rose as much as 16 percent in Thursday trading on the Nasdaq following a report that DiaSorin is considering acquiring Luminex. 

Diagnostic companies, with more cash available driven by the demand for coronavirus diagnostic testing, are carefully considering acquisitions.

Based on what it is seeing with other COVID-19 trends, GenMark is "planning for a return to a more typical demand level" for its respiratory panel in the spring and summer and expects stronger demand in the fall and winter, Mendel said. Demand for its ePlex Respiratory Pathogen Panel 2, or RP2, continues to drive a large portion of GenMark's current revenue, he said.

Nonetheless, its blood culture identification (BCID) panels "create a significant opportunity for continued revenue growth," Mendel said. In 2020, about 50 percent of its product placements included BCID. "Pre-pandemic, our three BCID panels drove about 80 percent of our placements, and we expect a similar trend as COVID-19 gets under control through broader vaccination and herd immunity," Mendel said.

Mendel added that GenMark's BCID panels represent an important driver of company revenues in 2021 and beyond. "The bloodstream infection market for multiplex molecular diagnostics is very large and in the early stages of adoption," he said. "Our latest estimates are that this [addressable] market opportunity is approximately $900 million dollars and only about 15 to 20 percent penetrated."

The company's Q4 net loss narrowed to $3.7 million, or $.05 per share, from a net loss of $10.3 million, or $.17 per share, in Q4 2019, and missed analysts' average estimate for a net loss of $.01 per share.

GenMark reported that its Q4 R&D expenses rose 34 percent to $9.1 million from $6.8 million, while its SG&A expenses grew 12 percent to $12.4 million from $11.1 million.

For full-year 2019, GenMark said its total revenues rose 95 percent to $171.6 million from $88 million in 2019, beating the consensus Wall Street estimate for revenues of $168.7 million.

Product revenues increased 95 percent to $169.1 million from $86.8 million, and other revenues doubled to $2.4 million from $1.2 million.

ePlex product revenue for full-year 2020 was $152.6 million, an increase of 155 percent over 2019.

The firm's net loss for the year narrowed to $18.6 million, or $.28 per share, from a net loss of $47.4 million, or $.82 per share, in 2019, missing analysts' average estimate for a net loss $.24 per share.

The company's 2018 R&D expenses increased 12 percent to $30.3 million from $27.1 million in the year-ago period. Its SG&A expenses for the year rose 12 percent to $48.7 million from $43.3 million in 2019.

GenMark ended the year with cash and cash equivalents of $40.6 million and short-term marketable securities of $87.6 million.

For full-year 2021, GenMark expects revenues in the range of $188 million to $198 million, which would represent year-over-year growth of 10 percent to 15 percent.

In 2021, global ePlex placements are expected to range from 200 to 220 net new analyzers, with annuity per analyzer expected to be between $175,000 and $190,000.