 BETHLEHEM, Pa., Aug. 05, 2020 GLOBE NEWSWIRE -- OraSure Technologies, Inc. NASDAQ: OSUR, a leader in point-of-care diagnostic tests, specimen collection devices, and microbiome laboratory and analytical services, today announced its financial results for the three and six months ended June 30, 2020. In the second quarter, our work to leverage our scientific and technological expertise against the COVID-19 pandemic has already generated meaningful revenue. Our sample collection devices are being used for the collection, both in at-home and professional settings, and transport of samples for COVID-19 molecular testing. We are also developing a COVID-19 rapid antigen in-home self-test and an ELISA-based oral fluid COVID-19 antibody test, both of which we now expect to launch in the fourth quarter, said Stephen S. Tang, Ph.D., President and Chief Executive Officer. We are confident, given our ongoing initiative to scale up our production capacity, that OraSure will be able to deliver substantially increased volumes of collection and testing products, while ensuring that they meet the highest quality standards as we contribute to the fight against this global crisis. At the same time, we have continued to serve our existing customers across our business lines and to identify opportunities for business development that will contribute to longer-term sustainable growth.We further strengthened our balance sheet in June with the completion of an equity offering that included investments from top institutional healthcare investors, bringing us to 265.8 million in cash and investments as of June 30, 2020, with no debt, said Roberto Cuca, Chief Financial Officer. Although we are not providing formal guidance for the remainder of 2020 due to the uncertainty of the effect of the pandemic on our operations, we continue to anticipate that sales of our existing and new products for COVID-19 testing will offset the negative impact of the pandemic on our non-COVID-19 business.Second Quarter Financial Highlights Net revenues for the second quarter of 2020 were 29.3 million, a 25 decrease from the second quarter of 2019. Net product and services revenues were 28.3 million, a 24 decrease from the second quarter of 2019. Excluding cryosurgical revenues, the line of business the Company divested in August 2019, and revenues from the Diversigen subsidiary, which the Company acquired in November 2019, net revenues and product and services revenues declined 21 and 20, respectively, from the second quarter of 2019. Other revenue highlights: - Total product and service revenues for the Companys molecular business unit were 18.1 million during the second quarter of 2020, an increase of 4 from the second quarter of 2019. This increase included 8.5 million in sales of oral fluid collection devices for COVID-19 molecular testing. - International sales of the Companys OraQuick HIV products decreased 28 compared to the second quarter of 2019. This decrease was due to delays of shipments which moved from the end of the second quarter into the early third quarter. - Total laboratory service revenues in the second quarter of 2020 were 2.2 million compared to 1.2 million in the second quarter of 2019. Laboratory services in 2020 include the revenues generated by both of the Companys laboratory service subsidiaries, which are now operating under the Diversigen brand. Net loss for the second quarter of 2020 was 10.5 million, or 0.16 per share on a fully-diluted basis, compared to net income of 4.4 million, or 0.07 per share on a fully-diluted basis, for the second quarter of 2019. Net loss for the second quarter of 2020 included a 660,000 non-cash pre-tax benefit associated with the change in fair value of acquisition-related contingent consideration and 195,000 of acquisition-related transaction costs. Net income in the second quarter of 2019 included a 249,000 non-cash pre-tax charge associated with the change in the fair value of acquisition-related contingent consideration. The impact of these items were negligible to earnings per share in both periods. Cash and investments totaled 265.8 million at June 30, 2020, including 95 million in proceeds from an equity offering completed in June.COVID-19 Program UpdateOraSure is well positioned to support multiple modes for COVID-19 testing, including PCRMolecular, Antigen, and Antibody testing. To support capacity building for the Companys existing products and anticipated new product launches, the Company is executing on a series of capital investments intended to ensure scaled-up capacity to meet both current and anticipated substantial COVID-19-related demand. Use of existing oral fluid collection devices in molecular COVID-19 testing generated 8.5M in revenue in the second quarter. In the second quarter, devices from OraSures DNA Genotek subsidiary, including the ORAcollect RNA collection kit, OMNIgene ORAL saliva collection device, and OrageneDx device, were included in U.S. Food and Drug Administration FDA Emergency Use Authorizations EUAs granted to four customers. The EUAs granted to Clinical Reference Laboratory CRL, Biocerna, P23 Labs and Phosphorous enable the Companys devices to be used for supervised and unsupervised COVID-19 sample collection with their EUA assays for the detection of SARS-CoV-2. OraSures devices are also currently being used as part of several back-to-school and back-to-work programs across the country. The Company expects one or more of its products to be included in several additional EUAs to be granted in the near future. OraQuick Coronavirus Rapid Antigen Self-Test on track for EUA submission and subsequent launch in the fourth quarter. OraSure is developing a rapid antigen self-test, designed to produce a result for active COVID-19 infection within minutes, with no instrumentation needed to interpret the results and no need to transport samples to a lab for processing, enabling the detection of COVID-19 infection anytime, anywhere. The development of the test is supported by 710,310 of funding from the Biomedical Advanced Research and Development Authority BARDA, part of the U.S. Department of Health and Human Services HHS. The test is currently in human clinical testing. Although originally intended for use with oral fluid, this test has been modified to employ an easily and comfortably self-collected lower nostril sample in order to achieve the best possible accuracy. The Company fully expects to meet or exceed applicable FDA performance requirements, with EUA filing and subsequent commercial launch in the fourth quarter, pending regulatory approvals. To date, there are no COVID-19 tests for active infection which provide a result at the point of collection with no need for a diagnostic instrument to interpret the result. OraSure SARS-CoV-2 Antibody test anticipated to launch in the fourth quarter. The Company is also developing an Enzyme-Linked Immunosorbent Assay ELISA using oral fluid to detect human anti-SARS-CoV-2 antibodies that would enable specimen collection in any location, promoting social distancing. The test would utilize the Companys existing OraSure oral fluid specimen collection device. To date, there are no commercially available anti-SARS-CoV-2 antibody tests using oral fluid samples with automated assays. In June, OraSure received 629,217 in funding from BARDA to support the development of this test. OraSure has completed the final product design and this test is currently in human clinical testing. The Company fully expects to meet or exceed applicable FDA performance requirements for this product, file for EUA, and launch in the fourth quarter, pending regulatory approvals. The pan-SARS-coronavirus antigen rapid in-home self-test project has been funded in whole or in part with Federal funds from the Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50120C00061. The SARS-CoV-2 antibody test has been funded in whole or in part with federal funds from the Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50120C00122.Additional Second Quarter Business Highlights Continued progress in executing on innovation-driven growth strategy with purchase of UrSure, Inc., strengthening OraSures global leadership in the HIV testing field. In May, the Company announced that it had entered into a definitive agreement to acquire privately-owned UrSure, Inc., a company developing and commercializing products that measure adherence to HIV medications that prevent Pre-Exposure Prophylaxis or PrEP and treat HIV. This cash transaction, which approximated 3.1 million, closed in July and supports OraSures strategy of expanding its core offerings to include additional diagnostic products, particularly point-of-care tests that complement its current infectious disease portfolio and pipeline. OraSure will be able to offer a full HIV portfolio that covers the spectrum from screening to treatment adherence, two pillars of the federal governments Ending the HIV Epidemic: A Plan for America initiative. Continued expansion of sample collection products to meet the needs of research and academic institutions. In June, the Company, through its DNA Genotek subsidiary, introduced the OMNImetTMGUT ME-200 device for metabolomics, the first and only commercially available research use only device for in-home, self-collection of fecal samples for metabolomics. This product augments the Companys portfolio of multiomic sample collection products. 