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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) reported Q4 2024 financial results showing total net revenues decreased 51% to $37.4 million from $75.9 million in Q4 2023, primarily due to declining COVID-19 revenues. Core revenues increased 10% year-over-year to $36.5 million, with Diagnostics revenues up 9% to $18.8 million and Sample Management Solutions up 14% to $14.8 million.
The company reported a GAAP operating loss of $12.4 million compared to operating income of $3.9 million in Q4 2023. Cash and cash equivalents stood at $267.8 million. Notable developments include the acquisition of Sherlock Biosciences to expand molecular diagnostics capabilities, FDA approval for expanded age range of OraQuick HIV Self-Test, and a $7.5 million BARDA contract for Marburg Virus Disease test development. The company guides Q1 2025 revenues between $27.5-31.5 million.
OraSure Technologies (NASDAQ: OSUR) has scheduled its Q4 2024 earnings conference call for February 25, 2025, at 5 p.m. ET. The company will discuss fourth quarter financial results and business developments during the call.
A webcast will be available on OraSure's investor relations website, with registration required at least 10 minutes before the call. The webcast recording will be accessible for approximately 90 days after the event. Participants who wish to ask questions during the call must pre-register through a provided link to receive access details.
OraSure Technologies (NASDAQ: OSUR), a leading provider of point-of-need and home diagnostic tests and sample management solutions, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. The company's management team will deliver their presentation on Thursday, January 16, 2025, at 9:00 a.m. PT.
Interested parties can access both a live webcast and replay of the presentation through the 'Events and Presentations' section of OraSure's investor relations website. This significant healthcare industry event provides OraSure an opportunity to showcase its developments and strategies to investors and healthcare professionals.
OraSure Technologies (NASDAQ: OSUR) announced FDA approval for expanding the age range of its OraQuick® HIV Self-Test to include individuals 14 years and older, down from the previous minimum age of 17. This expansion addresses a critical need, as CDC data shows that 19% of new HIV diagnoses in the US occur among those aged 13-24, with only 6% of high school students ever being tested for HIV. Almost half of young people with HIV are unaware of their status.
The OraQuick® HIV Self-Test has been available to US consumers since 2012. The test includes educational materials and care information to help users make informed decisions regardless of results. This approval aims to increase HIV testing accessibility among adolescents and support early connection to care for those testing positive.
OraSure Technologies announced the expansion of its OraQuick® HIV Self-Test approved age range to include individuals 14 years and older, down from the previous minimum age of 17. This development is particularly significant as CDC data shows that 19% of new HIV diagnoses in the United States occur among young people aged 13-24, with only 6% of high school students ever being tested for HIV. Almost half of young people with HIV are unaware of their status.
The OraQuick® HIV Self-Test has been available to U.S. consumers since 2012. The test includes comprehensive educational materials and care information to help users make informed decisions regardless of results. This expansion aims to increase HIV testing accessibility among adolescents and support early connection to care for those who test positive.
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.
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