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OpGen Fourth Quarter Revenues Increase 8 Percent

NEW YORK -- OpGen announced after the close of the market on Tuesday an 8 percent revenue increase for the fourth quarter of 2019.

For the three months ended Dec. 31, 2019, OpGen's revenues grew to $821,674 from $758,959 million in Q4 2018. The company logged $570,674 in product revenue in Q4, and $250,000 in collaboration revenue.

Fourth quarter R&D expenses fell 42 percent to $1.1 million from $1.9 million, while SG&A costs dropped 19 percent to $1.7 million from $2.1 million.

Net loss for the fourth quarter was $2.5 million, or $0.61 per share, compared to $3.7 million, or $9.37 per share, in the same quarter a year ago. OpGen's Q4 2019 loss per share was calculated using approximately 4.2 million weighted average shares, while Q4 2018 loss per share was calculated using 398,525 shares.

Full-year revenue for 2019 was $3.5 million, up 19 percent from $2.9 million a year ago, driven largely by the company's Acuitas AMR Gene Panel and Acuitas Lighthouse informatics platforms. Revenue from the Acuitas AMR Gene Panel and Acuitas Lighthouse increased 147 percent to approximately $1.4 million, offsetting the company's FISH products, which decreased 12 percent to $2.1 million year over year.

OpGen's 2019 R&D spending fell 11 percent to $5.1 million from $5.7 million in 2018, while its SG&A expenses fell 9 percent to $7.8 million from $8.6 million.

Net loss for 2019 was $12.4 million, or $7.70 per share, compared to $13.4 million, or $44.49 per share in 2018. OpGen's 2019 loss per share was calculated using approximately 1.6 million weighted average shares, while 2018 loss per share was calculated using 300,453 shares.

OpGen finished the year with $2.7 million in cash and cash equivalents.

On a conference call to discuss the earnings result, OpGen CFO Tim Dec said the company wouldn't be providing financial guidance for 2020 due to uncertainty resulting from the COVID-19 epidemic. He did note that revenues were expected to grow this year after the merger, partially due to Curetis' strong US sales and marketing team and dedicated international commercial distribution partnership network.

Dec said OpGen's average daily trading volume has reached over 3 million shares per day, and the company has raised $13.2 million since mid-February due to its at-the-market offering agreement with HC Wainwright and exercises of $2 per share warrants issued in its October stock and warrant offering.

The company said that its merger with Curetis is nearing completion, with 99 percent of shareholder votes cast approving the deal. OpGen said it expects formal approval of the combination at a special meeting on March 30. Dec added that 2.66 million OpGen shares would be issued to Curetis as sole consideration for the purchase at the closing of the merger.

Last May, OpGen submitted its Acuitas AMR Gene Panel for the detection of antimicrobial resistance (AMR) genes in bacterial isolates to the US Food and Drug Administration for clearance, but said on Tuesday that exact timing of the regulatory approval is up in the air due to the ongoing SARS-CoV-2 pandemic. Jones said the agency had questions about the company's submission, but didn't specify what they were, only saying they related to product labeling.

The company also patented its Acuitas Lighthouse Profiling technology, which is used in the software for tracking AMR pathogens.

Last year, Curetis launched its Unyvero LRT Panel for BAL specimens after receiving 510(k) clearance from the FDA, and OpGen said it expects the panel to increase the market in the US for the company's Unyvero System.

"With the expected surge of hospitalized patients in ICUs globally (many ventilated) with COVID-19 viral infections, the anticipated rise in bacterial pneumonia as a likely complication, and expected to lead to significant comorbidity in many cases, the Unyvero lower respiratory tract infection test could become an important tool for hospitals combating the anticipated surge of severe COVID-19 cases," OpGen CEO Evan Jones said in a statement.

Jones also noted on the conference call that the company was evaluating "medical need for a potentially new product with SARS-CoV-2 added to the current Unyvero LRT Panel."

Curetis has also started offering the CE-IVD marked real-time PCR test kit for SARS-CoV-2 that was developed by BGI. Curetis CEO Oliver Schacht said on the call the company has shipped several thousand tests in the past 48 hours.

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