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OpGen Q2 Revenues Climb 20 Percent

NEW YORK – OpGen said after the close of the market on Wednesday that its second quarter revenues grew 20 percent year over year, driven primarily by growth in product revenues.

For the three months ended June 30, the Gaithersburg, Maryland-based firm reported revenues of $1.2 million compared to $1.0 million in Q2 2019, on par with previously announced preliminary results.

Year-over-year product sales increased 19 percent to $601,304 from $504,293; laboratory services revenues increased nearly five-fold to $25,992 from $5,250; and collaboration revenues climbed 12 percent to $561,089 from $500,000.

The financial results for the three months ended June 30 reflected the consummation of OpGen's merger with Curetis on April 1.

Oliver Schacht, president and CEO of OpGen, said in a statement that the firm had a successful second quarter "in context of the unprecedented uncertainty caused by the COVID-19 pandemic and resulting pipeline delays."

On a conference call to discuss OpGen's financial results, Schacht said that Q2 marked its first quarter operating as a combined company with Curetis and that the combined entities have successfully integrated their R&D projects, operations, and teams.

Regarding the impact of the COVID-19 pandemic on its business, he said that although "the hospital environment continues to be very challenging … some elective surgeries are now being scheduled once again, and various non-COVID-related clinical studies are beginning to re-enroll patient samples in specific regions and hospitals on a case-by-case basis."

OpGen has taken decisive action, he said, to reprioritize its R&D efforts "to ensure the long-term durability of our business. We continued to adjust our operations and business practices to capitalize on opportunities and help assist in the fight against the virus."

Schacht said in a statement that the firm's recent agreement with the European Investment Bank provided it with access to an additional €5 million ($5.9 million) tranche in non-dilutive debt financing that bolsters its ability to expand initiatives related to COVID-19.

The firm recently announced a copromotion partnership with Menarini Silicon Biosystems to market and promote Menarini’s portfolio of COVID-19-related products.

In Q2, OpGen's subsidiary Ares Genetics continued to execute strategic partnering programs with in vitro diagnostic and pharma companies and collaborations with medical and public health institutions, the firm said.

Ares Genetics also advanced its own R&D programs for artificial intelligence-based antibiotic susceptibility testing based on next-generation sequencing and published results from its collaborations with Sandoz, Johns Hopkins, and Mayo Clinic. It also initiated commercial projects with new customers including Siemens Technology Accelerator and Austrian Agency for Health and Food Safety.

OpGen said that Curetis has successfully completed the verification and clinical validation testing of its proprietary, rapid SARS CoV-2 PCR test kit for which it expects to soon receive the CE-IVD mark. The test allows detection of SARS CoV-2 directly from patient swabs in less than one hour and does not require prior RNA isolation, OpGen said.

Schacht noted on the conference call that in the second quarter OpGen continued to supply a rapid PCR test kit throughout Europe, which had been developed and CE marked by BGI, its strategic partner. "As end-customer prices have eroded significantly and transfer prices from third-party manufacturers have become less attractive, we have now developed our own proprietary PCR-based coronavirus test kit," Schacht said. "We are looking to [receive the] CE-IVD mark and then offer it to our network of distribution partners in Europe."

The firm said its submission to the US Food and Drug Administration is nearing completion for clearance of the Acuitas AMR Gene Panel for the detection of antimicrobial resistance genes in bacterial isolates.

The company noted that the German Federal Ministry for Economic Affairs and Energy has initiated an investigation of the OpGen business combination with Curetis with regard to its impact on the public order and security of the Federal Republic of Germany as well as national healthcare interests in light of the current COVID-19 pandemic.

OpGen's second-quarter net loss was $7.5 million, or $.49 per share, compared to $2.6 million, or $2.94 per share, a year ago. The company used about 15.4 million shares to calculate the per-share loss in the recently completed quarter compared to 882,286 million shares a year ago.

The company's Q2 R&D expenses rose 150 percent year over year to $3.0 million from $1.2 million, while its SG&A expenses rose 75 percent year over year to $3.5 million from $2.0 million.

OpGen finished the quarter with $12.9 million in cash and cash equivalents.

Shares of OpGen dropped more than 12 percent to $2.29 in Thursday morning trading on the Nasdaq.