OSUR: 2Q2023 Results

BETHLEHEM, PA, August 3, 2023 (GLOBE NEWSWIRE) – OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in point-of-care and home diagnostic tests, specimen collection devices, and microbiome laboratory and analytical services, today announced its financial results for the three months ended June 30, 2023.

“This quarter we continued to deliver clear progress on our transformation journey. Our disciplined execution on our priorities, including InteliSwab® contracts and enterprise-wide operating efficiencies, allowed us to generate positive operating cash flow and build our cash balance to $186 million as of June 30, 2023. We expect to drive additional productivity enhancements across our organization as part of our multi-year commitment to strengthen our foundation, such as facility consolidation, further leveraging automation, and controlling our non-production costs. As a result, we continue to believe we will achieve our target of breakeven in cash flow from operations for the core business by the end of 2024,” said OraSure President and CEO Carrie Eglinton Manner.

•Received purchase orders in July 2023 under existing contracts for delivery of InteliSwab® devices. These orders are expected to generate at least $70 million of revenue in the second half of 2023.

•Signed a collaboration to work on a multi-year project with the Regeneron Genetics Center® (RGC), a wholly-owned subsidiary of Regeneron Pharmaceuticals, Inc. that focuses on early gene discovery and functional genomics. RGC has chosen the OraGeneDx® device for all saliva collection requirements, along with leveraging OraSure's in-house kitting and single-order fulfillment services to remodel its DNA collection workflow.

•Continued progress on consolidating our manufacturing footprint to drive operating efficiencies, including re-shoring some of our capacity to the United States. We continue to make progress on the installation and testing of new equipment and automation capabilities at our new Opus Way facility in Bethlehem, Pa., in addition to our existing OraQuick® device automated production. As discussed in prior quarters, we expect this phase of the expansion to be completed in 2023, with additional facility consolidation to follow.

•Signed an agreement with the International Vaccine Institute (IVI) to utilize our Colli-Pee® first-void urine collection kits as part of a research study to understand the burden of human papillomavirus (HPV) among girls and women in low and lower middle-income countries.

•On track to achieve operating cash flow breakeven for the core business by the end of 2024.

The Company is guiding to Q3 2023 revenue of $72 to $77 million, which includes core revenue of $37 to $39 million and InteliSwab® revenue of $35 to $38 million. As part of our ongoing focus on enterprise-wide operating efficiency, the Company is on track to exceed the $15 million of annualized cost savings announced in Q1 2023.

OraSure has received Emergency Use Authorizations (EUA) from the FDA for its InteliSwab® COVID-19 rapid tests. The U.S. Food and Drug Administration (“FDA”) has authorized the InteliSwab® COVID-19 Rapid Test for Over-the-Counter (OTC) use without a prescription. The FDA has also authorized the InteliSwab® COVID-19 Rapid Test Pro for professional use in point of care (POC) CLIA-waived settings, and the InteliSwab® COVID-19 Rapid Test Rx for Prescription Home Use. These remarkably simple COVID-19 lateral flow tests use samples self-collected from the lower nostrils. The InteliSwab® test’s unique design incorporates a built-in swab fully integrated into the test stick. After users swab their lower nostrils, the test stick is swirled in a pre-measured buffer solution, and the result appears right on the test stick within 30 minutes, with no instruments, batteries, smartphone or laboratory analysis needed to see the result. With less than one minute of “hands-on time,” it is as simple as “Swab, Swirl, and See.”
This product has not been FDA cleared or approved, but it has been authorized by the FDA under an EUA. The emergency use of this product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. This product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
Development of the InteliSwab® COVID-19 Rapid Test has been funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract numbers 75A50120C00061 and 75A50121C00078, utilizing Health Care Enhancement Act (HCEA) funding. The DoD's Defense Assisted Acquisition (DA2) Cell led the manufacturing expansion effort for the InteliSwab® COVID-19 rapid test in coordination with the Department of the Air Force’s Acquisition COVID-19 Task Force (DAF ACT). The manufacturing effort was funded through the American Rescue Plan Act (ARPA) to enable and support domestic industrial base expansion for critical medical resources.

OraSure Technologies empowers the global community to improve health and wellness by providing access to accurate, essential information through effortless tests, collection kits and services. OraSure, together with its wholly-owned subsidiaries, DNA Genotek, Diversigen, and Novosanis, provides its customers with end-to-end solutions that encompass tools, services and diagnostics. The OraSure family of companies is a leader in the development, manufacture, and distribution of rapid diagnostic tests, sample collection and stabilization devices, and molecular services solutions designed to discover and detect critical medical conditions. OraSure’s portfolio of products is sold globally to clinical laboratories, hospitals, physician’s offices, clinics, public health and community-based organizations, research institutions, government agencies, pharmaceutical companies, commercial entities and direct to consumers. For more information on OraSure Technologies, please visit www.orasure.com.
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