NEW YORK – OpGen said Wednesday after the close of the market that its second quarter revenues grew 28 percent year over year as the company continues to await US Food and Drug Administration clearance for its antimicrobial resistance test.
For the three months ended June 30, the Gaithersburg, Maryland-based firm reported revenues of $1.0 million compared to $788,901 a year ago, on par with the average analyst estimate of $1.0 million.
Product sales decreased 20 percent to $504,293 from $632,525; laboratory services revenue more than quadrupled to $5,250 from $1,100; and collaboration revenue more than tripled to $500,000 from $155,276 a year ago.
In Q2, OpGen submitted its Acuitas AMR Gene Panel and associated software for the detection of antibiotic resistance to the FDA for 510(k) clearance. The PCR-based test is designed to detect 47 antibiotic resistance genes in less than three hours from bacterial isolates.
"During the second quarter, we continued to execute against OpGen's highest priority of bringing our novel Acuitas AMR Gene Panel and Acuitas Lighthouse Software to market," OpGen Chairman and CEO Evan Jones said in a statement. "We engaged in ongoing dialogue with the FDA regarding our recent 510(k) submission for the Acuitas AMR Gene Panel for use with bacterial isolates. We are encouraged by our interactions with the agency and we are continuing to work towards receiving our first FDA clearance during 2019."
The company is also working to complete two additional FDA premarket submissions for its Acuitas AMR Gene Panel Urine and for its Acuitas Lighthouse Software, Jones noted. OpGen has begun testing to support these submissions and plans to complete trials and make initial submissions by the end of this year or the first quarter of 2020.
OpGen slashed its Q2 net loss to $2.6 million, or $.15 per share, from $3.3 million, or $.57 per share, a year ago, besting the average analyst net loss estimate of $.17 per share. The company used about 17.6 million shares to calculate per-share loss in the recently completed quarter compared to about 5.8 million shares a year ago.
The company's Q2 R&D expenses fell slightly to $1.2 million from $1.3 million, while its SG&A expenses dipped to around $2.0 million from $2.2 million.
OpGen finished the quarter with $3.1 million in cash and cash equivalents.
In morning trading on the Nasdaq, OpGen shares were down more than 2 percent to $0.32 per share.