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OpGen Posts 70 Percent Increase in Q3 Revenues Amid Shuffling of Portfolio

NEW YORK — OpGen reported after the close of the market Wednesday a 70 percent year-over-year increase in its third quarter revenues, beating its preliminary revenue announcement of a 54 percent increase.

For the three-month period ended Sept. 30, OpGen posted revenues of $1.1 million versus year-ago revenues of $648,220, beating Wall Street estimates of $1 million in revenues.

Third quarter product sales rose nearly 6 percent to $601,562 from $570,035, while the Gaithersburg, Maryland-based firm posted $342,311 in revenues from collaborations versus $75,000 in the same period last year. Laboratory services revenue was up to $112,892 compared to $185 in the year-ago period.

In its preliminary revenue announcement, OpGen said it would be reprioritizing its product portfolio, platform pipeline, and priorities to consolidate the product portfolio on the Unyvero platform, which it adopted during its acquisition of Curetis earlier this year. The platform will be expanded beyond lower respiratory tract infections to include complicated urinary tract infections and invasive joint infections, with clinical trials expected to begin in 2021, the company said in a statement.

On a conference call to discuss the financial results, OpGen CEO Oliver Schacht said the firm aims to hold pre-submission meetings with the US Food and Drug Administration about the Unyvero tests in the first half of 2021. Additionally, there has been progress with China's National Medical Products Association for Unyvero, with the potential for regulatory approval and commercial launch in China in 2021, he said.

Legacy fluorescent in situ hybridization, or FISH, products will be discontinued by mid-2021 and clinical trials for the Acuitas AMR Gene Panel for urine have been discontinued as the firm shifts its focus to the Unyvero system, which is cleared by the FDA.

The firm still anticipates clearance from the FDA on its Acuitas AMR Gene Panel for isolates, which it submitted last year. Last month it responded to additional information requests from the agency. Schacht said that once the panel is cleared, the company should be ready for a commercial launch about a month later. Despite the shift to Unyvero, Schacht said there are no plans to discontinue the Acuitas.

Curetis, meanwhile, obtained CE marking during the quarter for its SARS-CoV-2 test kit. Schacht said the company hasn't decided if it will submit the Curetis test to FDA for Emergency Use Authorization, since there are a lot of PCR-based tests with EUA in the US already. In the US, OpGen has a copromotion agreement with Menarini Silicon Diagnostics for Menarini's SARS-CoV-2 test.

Subsidiary Ares Genetics also received news from an undisclosed in vitro diagnostic partner that it will be exclusively negotiating a licensing agreement for Ares' clinical diagnostics technology in the coming months.

OpGen's net loss in the quarter climbed to $7.7 million, or $.40 per share, from $3.5 million, or $3.95 per share, the year before. The company used 19.1 million shares to calculate its loss-per-share figure for Q3 2020 compared to 882,280 shares used in Q3 2019

It fell short of the consensus Wall Street estimate of a loss of $.36 per share.

Its R&D spending in the third quarter rose 118 percent to $2.4 million from $1.1 million while its SG&A costs dropped 74 percent to $3.3 million from $1.9 million.

At the end of September, OpGen had cash and cash equivalents totaling $10.5 million.

OpGen CFO Timothy Dec said the firm would not be providing financial guidance for the rest of the year due to uncertainties from the COVID-19 pandemic.