Welcome to our dedicated page for OraSure Technologies news (Ticker: OSUR), a resource for investors and traders seeking the latest updates and insights on OraSure Technologies stock.
OraSure Technologies Inc., based in Bethlehem, Pennsylvania, is a pioneering medical devices company specializing in the development, manufacture, and distribution of oral fluid diagnostic and collection devices. As a leader in this field, OraSure offers a range of products designed to detect or diagnose critical medical conditions. The company operates through two primary segments: Diagnostics and Molecular Solutions.
In the Diagnostics segment, OraSure produces rapid oral diagnostic tests and specimen collection devices for infectious diseases, such as HIV and HCV. Notable products include the OraQuick® In-Home HIV Test, OraQuick Advance® Rapid HIV-1/2 Antibody Test, and the OraSure® HIV-1 Oral Specimen Collection Device. Additionally, the company offers the OraQuick® HCV Rapid Antibody Test, and various oral fluid testing solutions for drug abuse, such as the Intercept® Oral Fluid Drug Testing System and the Q.E.D.® Saliva Alcohol Test.
The Molecular Solutions segment focuses on kits used to collect, stabilize, and transport genetic material samples for molecular testing. These kits are essential for diagnosing hereditary diseases and infectious diseases, including COVID-19. The molecular solutions segment is a significant revenue driver for OraSure, with a substantial portion of sales originating from customers in the United States.
Beyond diagnostics, OraSure also manufactures and sells cryosurgical products like Histofreezer®, used for the cryosurgical removal of common and plantar warts, along with other benign skin lesions. These products are available both for professional physician office markets and over-the-counter use.
Recently, OraSure has announced its third-quarter 2023 financial results and certain business developments. Notably, the regular earnings conference call is scheduled for November 7, 2023. This announcement signifies the company's commitment to transparency and continuous communication with its stakeholders.
OraSure Technologies (NASDAQ: OSUR) has announced the acquisition of Sherlock Biosciences, expanding its diagnostic test portfolio with advanced molecular diagnostics technology. The key acquisition focuses on Sherlock's molecular self-test for Chlamydia Trachomatis (CT) and Neisseria Gonorrhoeae (NG), which provides results in under 30 minutes using self-collected swabs.
The CT/NG test is currently in clinical studies with FDA submission expected by end of 2025. Upon regulatory approval, revenue contribution is anticipated to begin in 2026. The total addressable market for CT/NG testing exceeds $1.5 billion. The acquisition also includes Sherlock's pipeline of molecular tests and next-generation platforms, featuring Ambient Temperature Amplification and CRISPR-based technologies.
OraSure Technologies (NASDAQ: OSUR) has received a federal contract through the Rapid Response Partnership Vehicle (RRPV) to develop a Marburg Virus Disease (MVD) rapid antigen test. The initial contract is valued at $7.5 million over multiple years, with potential value up to $11 million. The funding from BARDA aims to achieve FDA 510(k) clearance for a single-use lateral flow immunoassay test designed to detect Marburg virus antigens in individuals with risk factors and symptoms. OraSure has previously worked with BARDA on the InteliSwab® COVID-19 Rapid Test and maintains an ongoing partnership for their OraQuick® Ebola Rapid Antigen Test.
OraSure Technologies (NASDAQ: OSUR) has announced its participation in the upcoming Stephens Annual Investment Conference on Wednesday, November 20. The company will engage in a Q&A session scheduled for 1 p.m. ET. Investors can access a live webcast and replay of the session through OraSure's investor relations webpage. The webcast recording will remain available for approximately 90 days following the event.
OraSure Technologies (NASDAQ: OSUR) reported Q3 2024 financial results with total net revenues of $39.9 million, down 55% from $89.2 million in Q3 2023. Core revenues decreased 1% to $37.8 million, while COVID-19 revenues fell 96% to $2.2 million. The company reported a GAAP operating loss of $6.0 million and non-GAAP operating loss of $2.7 million. Key developments include receiving initial orders for OraQuick® HCV Self-test after WHO pre-qualification, expanding into blood proteomics, and exiting the Risk Assessment testing business. Cash and cash equivalents stood at $279 million, with Q4 2024 revenue guidance of $36-38 million.
OraSure Technologies, Inc. (NASDAQ: OSUR) has announced its upcoming earnings conference call for the third quarter 2024. The call is scheduled for November 6, 2024, at 5 p.m. ET. Investors and interested parties can access the webcast through OraSure's investor relations website. The webcast link will be available at https://orasure.gcs-web.com/events-and-presentations, with registration required at least 10 minutes before the call starts. The webcast will be archived on the website for approximately 90 days after the event. For those wishing to ask questions during the call, a pre-registration link is provided. After registering, participants will receive access details via email.
OraSure Technologies (NASDAQ: OSUR) has elected Jack Kenny to its Board of Directors, effective September 9, 2024. Kenny, with over 30 years of experience in leadership roles in the in vitro diagnostics, molecular, and lab services industries, will serve as a Class I Director with an initial term expiring at OraSure's 2025 Annual Meeting of Stockholders. His addition brings the board to seven members.
Kenny is the former CEO of Meridian Bioscience, where he led a successful turnaround. His extensive experience includes executive roles at Siemens Healthcare, Becton Dickinson, Danaher , and Quest Diagnostics. OraSure's Board Chair, Mara Aspinall, expressed confidence in Kenny's ability to contribute significant value and industry expertise to the company's ongoing efforts to strengthen its foundation, elevate core growth, and accelerate profitability.
OraSure Technologies reported Q2 2024 financial results with total revenue of $54.3 million, down 36% year-over-year. Core revenue decreased 7% to $35.4 million, while COVID-19 revenue fell 60% to $18.9 million. The company achieved a GAAP EPS of $(0.01) and non-GAAP EPS of $0.07. Key highlights include:
- OraQuick HCV Self-test became the first globally to earn WHO pre-qualification
- Strong momentum with Syphilis Health Check launch
- Expanding Sample Management applications into saliva-based liquid biopsy
- On track to achieve operating cash flow break-even for core business by end of 2024
OraSure expects Q3 2024 revenues of $37-$41 million, including Core revenues of $36-$39 million and InteliSwab revenues of $1-$2 million.
OraSure Technologies, Inc. (NASDAQ: OSUR) has announced its upcoming earnings conference call for the second quarter of 2024. The call is scheduled for August 6, 2024, at 5 p.m. ET. Investors and interested parties can access the webcast through OraSure's investor relations website. The company will discuss its Q2 2024 financial results and provide updates on certain business developments during the call.
To participate and ask questions during the conference, attendees must pre-register using the provided link. The webcast will be archived on OraSure's website for approximately 90 days after the call. This announcement allows investors to prepare for the upcoming financial disclosure and gain insights into the company's recent performance and future outlook.
OraSure Technologies (NASDAQ: OSUR) is supporting National HIV Testing Day on June 27, 2024. The company, known for its point-of-care and home diagnostic tests, emphasizes the importance of HIV testing to control the epidemic. The CDC estimates 1.2 million people in the U.S. are living with HIV, with 14% unaware of their status. OraSure's OraQuick® HIV Self-Test, a vital tool in these efforts, has been distributed via programs like the CDC’s Together Take Me Home, targeting high-risk communities. A new, more sustainable version of the test, with enhanced educational materials, has been launched. OraSure’s collaboration with organizations like KFF supports free HIV testing at Walgreens locations to raise awareness and encourage testing.
OraSure Technologies, Inc. reported Q1 '24 revenue of $54.1 million with a GAAP EPS of $(0.05) and Non-GAAP EPS of $0.04. Restructuring initiatives are expected to yield $15 million in annual expense reductions. Recent actions aim to streamline the business and achieve cash flow breakeven by end of 2024. The company is investing in innovation and partnerships to drive long-term growth.
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