OpGen(US:OPGN)2023-05-15 18:41Revenue Sources - OpGen's revenue is generated from three sources: product sales, laboratory services, and collaboration revenue, with a focus on molecular diagnostics and informatics for infectious diseases [137]. - Total revenue for the three months ended March 31, 2023, increased approximately 94% to $913,444 compared to $469,745 in the same period in 2022 [139]. - Product sales rose by approximately 12% to $410,897, driven by additional cartridge and master mix sales [141]. - Collaboration revenue surged approximately 691% to $480,874, primarily due to a collaboration agreement with FIND [141]. Product Development and Testing - The Unyvero LRT test detects over 90% of common pneumonia-causing pathogens in hospitalized patients, addressing a medical need that incurs over $10 billion annually in U.S. healthcare costs [129]. - The Unyvero UTI test has completed enrollment of over 1,800 patient samples and is seeking FDA marketing authorization, which would make it the first rapid sample-to-answer UTI test cleared in the U.S. [130]. - The Acuitas AMR Gene Panel detects 28 genetic AMR markers in under 3 hours and has been installed in two commercial customer sites, with expectations for more contracts in 2023 [130]. - Ares Genetics' ARESdb database now covers over 130,000 bacterial isolates sequenced using NGS technology, providing valuable data for AMR research and diagnostics [131]. - The Unyvero A30 RQ system is designed for low-to-mid-plex testing and has completed verification and validation testing, with ongoing partnering discussions [133]. Financial Performance - Total operating expenses decreased approximately 5% to $5,983,555 compared to $6,315,485 in the same period in 2022 [140]. - Research and development expenses decreased approximately 22% to $1,812,831, attributed to reduced payroll costs and the conclusion of a clinical trial [142]. - Net cash used in operating activities for the three months ended March 31, 2023, was $4,962,618, a slight improvement from $5,041,400 in the same period in 2022 [147]. - As of March 31, 2023, cash and cash equivalents were $7.0 million, down from $7.4 million at December 31, 2022 [144]. - Outstanding borrowings under all tranches of the EIB loan facility were €10.7 million (approximately $11.6 million) as of March 31, 2023 [152]. - The company raised approximately $7.5 million in gross proceeds from a public offering closed in January 2023 [145]. - The company is considering multiple alternatives to meet capital needs, including additional equity and debt financings [144]. Regulatory and Compliance - OpGen is focused on regulatory clearances for its Unyvero UTI and IJI products, as well as compliance with the new IVDR in the EU, allowing continued commercialization of existing CE-IVD-marked products until at least 2026 [135]. - The company has ceased commercial operations for its SARS-CoV-2 test kit in 2023, following its previous CE-IVD-marking in 2022 [130]. - The company is classified as a smaller reporting company and is not required to disclose market risk information [159]. - Recent accounting pronouncements are detailed in Note 3 of the Form 10-Q, including expected adoption dates and effects on financial statements [156]. Partnerships and Collaborations - The company has received €0.7 million in funding from FIND for the development of the Unyvero A30 RQ platform, with total project revenue potential increased to €830,000 [130]. - OpGen's subsidiary Curetis has established distribution partnerships in 12 European countries and China to accelerate the commercialization of its products [134].