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OpGen Q1 Revenues Rise 34 Percent on Combination With Curetis

NEW YORK OpGen reported on Thursday morning that its first quarter revenues rose 34 percent year over year, driven by its recent merger with Curetis.

For the three months ended March 31, the Gaithersburg, Maryland-based company reported $829,716 in revenues compared to $616,933 in Q1 2020.

The revenue increase resulted from OpGen's business combination with Curetis, which closed at the beginning of the second quarter of 2020, the firm said.

OpGen posted product revenues of $613,918, up 67 percent year over year from $366,933, and collaboration revenues of $118,072, down 53 percent from $250,000 a year ago. The firm also reported Q1 laboratory services revenues of $97,726 compared to no such revenues in Q1 2020.

OpGen CEO Oliver Schacht noted in a statement that the firm recently announced the extension and expansion of its strategic collaboration with the New York State Department of Health and secured Chinese NMPA approval for the Curetis Unyvero instrument system.

The company is awaiting a clearance decision for its Unyvero pneumonia cartridge in China, where it is currently under review and pending approval, he said.

"As the pandemic's effect on the global economy subsides, we believe our balanced product portfolio and long-term pipeline growth initiatives give us the ability to maintain momentum throughout 2021," Schacht said.

The firm completed a $25 million registered direct offering with a healthcare-focused US institutional investor in the first quarter, as well as a warrant exercise and exchange deal that raised $9.7 million.

OpGen also said that the US Food and Drug Administration has resumed reviewing its 510(k) submission for the Acuitas AMR Gene Panel, which had been delayed due to the agency's prioritization of COVID-19 related Emergency Use Authorizations. The agency recently informed OpGen that it intends to provide written feedback by the end of May and to potentially complete the review by the end of August.

OpGen subsidiary Curetis also sent a pre-submission request to the FDA to discuss a regulatory pathway and clinical trial design for its Unyvero UTI test.

The company recently announced the publication of study results for its Unyvero HPN Panel to diagnose bacterial co-infections in patients with COVID-19 pneumonia in intensive care. The study showed a negative predictive value of 99.8 percent, which may help reduce unnecessary antibiotic use and support antibiotic stewardship efforts, the firm said.

OpGen's Ares Genetics subsidiary inked several agreements with early-access customers for its AreSupa pathogen assay this year.

The firm reported a Q1 net loss of $14.9 million, or $.50 per share, compared to a net loss of $3.9 million, or $.53 per share, in Q1 2020. OpGen calculated its Q1 2021 loss per share using approximately 29.5 million weighted average shares and its Q1 2020 loss per share using approximately 7.4 million weighted average shares.

The firm's first quarter R&D expenses more than doubled to $2.8 million from $1.2 million, while its SG&A costs climbed 80 percent to $3.6 million from $2.0 million.

As of March 31, OpGen had $39.4 million in cash and cash equivalents.

In morning trading on the Nasdaq, OpGen's shares were down 3 percent at $3.18.