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News Article | February 8, 2017
Site: globenewswire.com

BETHLEHEM, Pa., Feb. 08, 2017 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (NASDAQ:OSUR), a leader in point-of-care diagnostic tests and specimen collection devices, today announced its consolidated financial results for the fourth quarter and full year ended December 31, 2016. “Our fourth quarter financial results exceeded expectations on the top and bottom lines,” said Douglas A. Michels, President and CEO of OraSure Technologies. “A major contributor to growth during both the quarter and full-year period was our international business. Expanding international sales of our HIV self-test and HCV product is a critical component of OraSure’s global growth strategy.” Consolidated net product revenues for the fourth quarter of 2016 approximated those of the same period in 2015, primarily as a result of higher international sales of OraQuick® HIV and HCV tests and higher sales of the Company’s molecular collection systems products, largely offset by lower domestic sales of the Company’s OraQuick® HIV and HCV products and lower OraQuick® Ebola sales. Consolidated net product revenues for the full year of 2016 increased 2% over 2015, primarily as a result of higher international sales of the Company’s OraQuick® HCV and HIV tests, and higher sales of the Company’s molecular collection systems and cryosurgical systems products. These increases were partially offset by lower domestic sales of the Company’s OraQuick® HIV and Ebola products. Consolidated other revenues for the fourth quarter and full year of 2016 were $6.9 million and $21.3 million, respectively. This compares to consolidated other revenues for the fourth quarter and full year of 2015 of $3.7 million and $15.3 million, respectively. Exclusivity revenues recognized under the Company’s HCV co-promotion agreement with AbbVie for the three months and year ended December 31, 2016 were $6.1 million and $18.9 million, respectively. AbbVie exclusivity revenues for the three months and year ended December 31, 2015 were $3.4 million and $13.5 million, respectively. Other revenues in the fourth quarter and full-year of 2016 also included $747,000 and $2.3 million, respectively, of funding received from the U.S. Biomedical Advanced Research Development Authority (“BARDA”). Other revenues for the fourth quarter and full year of 2015 included $319,000 and $1.8 million, respectively, in BARDA funding. Consolidated gross margin for the three months and year ended December 31, 2016 was 67% and 69%, respectively. Consolidated gross margin for the three months and year ended December 31, 2015 was 68% and 67%, respectively. Gross margin for the current quarter decreased due to a less favorable product mix and severance costs associated with a corporate restructuring plan implemented by the Company during the fourth quarter, partially offset by higher other revenues and improved overhead absorption. Gross margin for the full year improved primarily due to the increase in other revenues. Consolidated operating expenses decreased to $16.9 million during the fourth quarter of 2016 compared to $17.8 million in the fourth quarter of 2015. For the year ended December 31, 2016, consolidated operating expenses were $67.8 million, a reduction from the $72.2 million reported for the year ended December 31, 2015. The quarterly decrease was largely due to lower detailing costs associated with the AbbVie HCV co-promotion agreement, lower commission costs, a decrease in bad debt expense, and a reduction in research and development expenses recorded as a result of a payment received to settle a claim against one of the Company’s raw material suppliers. These decreases were partially offset by the corporate restructuring severance costs, increased legal fees, and higher staffing-related costs. The decrease in the full-year period was largely due to lower detailing costs associated with the AbbVie HCV co-promotion agreement and reduced research and development expenses due to the supplier settlement, partially offset by higher legal fees, severance costs, consulting fees and staffing-related expenses. The Company’s cash and short-term investment balance totaled $120.9 million at December 31, 2016, compared to $101.3 million at December 31, 2015. Working capital was $139.1 million at December 31, 2016, compared to $111.5 million at December 31, 2015. For the year ended December 31, 2016, the Company generated $22.8 million in cash from operations. The Company expects consolidated net revenues to range from $31.0 to $31.5 million and is projecting consolidated net income of $0.17 to $0.18 per share for the first quarter of 2017. This guidance reflects the absence of revenues and costs associated with the AbbVie HCV co-promotion agreement, which terminated at the end of 2016, and a lower gross margin contribution from the increasing amount of international sales expected in 2017. The quarterly guidance also includes the after-tax impact of a $12.5 million litigation settlement recently announced by the Company. Summary of Net Revenues by Market and Product (Unaudited) The Company will host a conference call and audio webcast to discuss the Company’s 2016 fourth quarter financial results, certain business developments and financial guidance for the first quarter of 2017, beginning today at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). On the call will be Douglas A. Michels, President and Chief Executive Officer, and Ronald H. Spair, Chief Financial Officer and Chief Operating Officer. The call will include prepared remarks by management and a question and answer session. In order to listen to the conference call, please either dial 844-831-3030 (Domestic) or 315-625-6887 (International) and reference Conference ID #49022171 or go to OraSure Technologies' web site, www.orasure.com, and click on the Investor Relations page. Please click on the webcast link and follow the prompts for registration and access 10 minutes prior to the call. A replay of the call will be archived on OraSure Technologies' web site shortly after the call has ended and will be available for seven days. A replay of the call can also be accessed until February 15, 2017, by dialing 855-859-2056 (Domestic) or 404-537-3406 (International) and entering the Conference ID #49022171. OraSure Technologies is a leader in the development, manufacture and distribution of point-of-care diagnostic and collection devices and other technologies designed to detect or diagnose critical medical conditions. Its first-to-market, innovative products include rapid tests for the detection of antibodies to HIV and HCV on the OraQuick® platform, oral fluid sample collection, stabilization and preparation products for molecular diagnostic applications, and oral fluid laboratory tests for detecting various drugs of abuse. OraSure's portfolio of products is sold globally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, research and academic institutions, distributors, government agencies, physicians' offices, commercial and industrial entities and consumers. The Company's products enable healthcare providers to deliver critical information to patients, empowering them to make decisions to improve and protect their health. This press release contains certain forward-looking statements, including with respect to expected revenues and earnings/loss per share. Forward-looking statements are not guarantees of future performance or results. Known and unknown factors that could cause actual performance or results to be materially different from those expressed or implied in these statements include, but are not limited to: ability to market and sell products, whether through our internal, direct sales force or third parties; ability to manufacture products in accordance with applicable specifications, performance standards and quality requirements; ability to obtain, and timing and cost of obtaining, necessary regulatory approvals for new products or new indications or applications for existing products; ability to comply with applicable regulatory requirements; ability to effectively resolve warning letters, audit observations and other findings or comments from the FDA or other regulators; changes in relationships, including disputes or disagreements, with strategic partners or other parties and reliance on strategic partners for the performance of critical activities under collaborative arrangements; failure of distributors or other customers to meet purchase forecasts, historic purchase levels or minimum purchase requirements for our products; impact of replacing distributors; inventory levels at distributors and other customers; ability of the Company to achieve its financial and strategic objectives and continue to increase its revenues; ability to identify, complete, integrate and realize the full benefits of future acquisitions; impact of competitors, competing products and technology changes; impact of negative economic conditions, high unemployment levels and poor credit conditions; reduction or deferral of public funding available to customers; competition from new or better technology or lower cost products; ability to develop, commercialize and market new products; market acceptance of oral fluid testing or other products; changes in market acceptance of products based on product performance or other factors, including changes in testing guidelines, algorithms or other recommendations by the Centers for Disease Control and Prevention (“CDC”) and other agencies; ability to fund research and development and other products and operations; ability to obtain and maintain new or existing product distribution channels; reliance on sole supply sources for critical products and components; availability of related products produced by third parties or products required for use of our products; history of losses and ability to achieve sustained profitability; ability to utilize net operating loss carry forwards or other deferred tax assets; volatility of the Company’s stock price; uncertainty relating to patent protection and potential patent infringement claims; uncertainty and costs of litigation relating to patents and other intellectual property; availability of licenses to patents or other technology; ability to enter into international manufacturing agreements; obstacles to international marketing and manufacturing of products; ability to sell products internationally, including the impact of changes in international funding sources and testing algorithms; adverse movements in foreign currency exchange rates; loss or impairment of sources of capital; ability to meet financial covenants in credit agreements; ability to attract and retain qualified personnel; exposure to product liability and other types of litigation; changes in international, federal or state laws and regulations; customer consolidations and inventory practices; equipment failures and ability to obtain needed raw materials and components; the impact of terrorist attacks and civil unrest; and general political, business and economic conditions. These and other factors are discussed more fully in the Company’s Securities and Exchange Commission filings, including its registration statements, Annual Report on Form 10-K for the year ended December 31, 2015, Quarterly Reports on Form 10-Q, and other filings with the SEC. Although forward-looking statements help to provide information about future prospects, readers should keep in mind that forward-looking statements may not be reliable. The forward-looking statements are made as of the date of this press release and OraSure Technologies undertakes no duty to update these statements.


News Article | March 1, 2017
Site: globenewswire.com

BETHLEHEM, Pa., March 01, 2017 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (NASDAQ:OSUR), a leader in point of care diagnostic tests and specimen collection devices, today announced that its OraQuick® HIV Self-Test has been designated as eligible for procurement by purchasing entities entitled to access Global Fund and/or UNITAID resources. The OraQuick® HIV Self-Test has been classified by the Global Fund’s Expert Review Panel for Diagnostics as CATEGORY-2. The classification facilitates product procurement for 12 months with Global Fund and/or UNITAID resources. During this period, OraSure is expected to pursue and obtain WHO (World Health Organization) pre-qualification of the product or approval from another stringent regulatory agency. “We are pleased to have received the endorsement of the Global Fund’s Expert Panel,” said Douglas A. Michels, President and CEO of OraSure Technologies. “The classification enables government organizations implementing HIV self-test pilots and programs to access funding for the OraQuick® HIV Self-Test.  We expect the OraQuick® HIV Self-Test to be a valuable tool in reducing HIV infection rates globally.  The Global Fund’s action allows for the procurement of our test while we pursue WHO prequalification.” About the Global Fund and UNITAID The Global Fund is a partnership between governments, civil society, the private sector and people affected by diseases. The partnership organization is designed to finance programs aimed at accelerating the end of HIV/AIDS, tuberculosis and malaria as epidemics. For more information, please visit http://www.theglobalfund.org. UNITAID is engaged in finding new ways to prevent, treat and diagnose HIV/AIDS, tuberculosis and malaria. UNITAID identifies promising health solutions and invests in them to establish their viability in support of widespread adoption and impact. For more information, please visit http://www.unitaid.com. OraSure Technologies is a leader in the development, manufacture and distribution of point of care diagnostic and collection devices and other technologies designed to detect or diagnose critical medical conditions. Its first-to-market, innovative products include rapid tests for the detection of antibodies to HIV and HCV on the OraQuick® platform, oral fluid sample collection, stabilization and preparation products for molecular diagnostic applications, and oral fluid laboratory tests for detecting various drugs of abuse. OraSure's portfolio of products is sold globally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, research and academic institutions, distributors, government agencies, physicians' offices, commercial and industrial entities and consumers. The Company's products enable healthcare providers to deliver critical information to patients, empowering them to make decisions to improve and protect their health. For more information on OraSure Technologies, please visit www.orasure.com.


BETHLEHEM, Pa., Feb. 27, 2017 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (NASDAQ:OSUR), a leader in point of care diagnostic tests and specimen collection devices, today announced that Douglas A. Michels, President and CEO, will speak to the investment community at the Raymond James 38th Annual Institutional Investors Conference in Orlando, Florida.  The conference will be simultaneously webcast over the Internet. Mr. Michels is scheduled to speak on March 6, 2017, at approximately 8:40 AM Eastern Time (5:40 AM Pacific Time).  Interested investors can access the live webcast of the presentation by going to OraSure Technologies’ web site, www.orasure.com, and clicking on the Investor Info link.  A replay of the webcast will be available on OraSure Technologies’ web site for seven days.  Alternatively, you can access the live webcast of the presentation via the following link: http://wsw.com/webcast/rj104/osur. About OraSure Technologies OraSure Technologies is a leader in the development, manufacture and distribution of point of care diagnostic and collection devices and other technologies designed to detect or diagnose critical medical conditions. Its first-to-market, innovative products include rapid tests for the detection of antibodies to HIV and HCV on the OraQuick® platform, oral fluid sample collection, stabilization and preparation products for molecular diagnostic applications, and oral fluid laboratory tests for detecting various drugs of abuse. OraSure's portfolio of products is sold globally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, research and academic institutions, distributors, government agencies, physicians' offices, commercial and industrial entities and consumers. The Company's products enable healthcare providers to deliver critical information to patients, empowering them to make decisions to improve and protect their health. For more information on OraSure Technologies, please visit www.orasure.com.


BETHLEHEM, Pa., Feb. 27, 2017 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (NASDAQ:OSUR), a leader in point of care diagnostic tests and specimen collection devices, today announced that Douglas A. Michels, President and CEO, will speak to the investment community at the Raymond James 38th Annual Institutional Investors Conference in Orlando, Florida.  The conference will be simultaneously webcast over the Internet. Mr. Michels is scheduled to speak on March 6, 2017, at approximately 8:40 AM Eastern Time (5:40 AM Pacific Time).  Interested investors can access the live webcast of the presentation by going to OraSure Technologies’ web site, www.orasure.com, and clicking on the Investor Info link.  A replay of the webcast will be available on OraSure Technologies’ web site for seven days.  Alternatively, you can access the live webcast of the presentation via the following link: http://wsw.com/webcast/rj104/osur. About OraSure Technologies OraSure Technologies is a leader in the development, manufacture and distribution of point of care diagnostic and collection devices and other technologies designed to detect or diagnose critical medical conditions. Its first-to-market, innovative products include rapid tests for the detection of antibodies to HIV and HCV on the OraQuick® platform, oral fluid sample collection, stabilization and preparation products for molecular diagnostic applications, and oral fluid laboratory tests for detecting various drugs of abuse. OraSure's portfolio of products is sold globally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, research and academic institutions, distributors, government agencies, physicians' offices, commercial and industrial entities and consumers. The Company's products enable healthcare providers to deliver critical information to patients, empowering them to make decisions to improve and protect their health. For more information on OraSure Technologies, please visit www.orasure.com.


Patent
Orasure Technologies, Inc. | Date: 2012-07-16

A sample collection kit includes a sample collector, a polycarbonate container, and a preservative solution. The sample collector includes an absorbent pad with a collecting element that receives a sample of oral fluid. The absorbent pad also includes an interior portion that extends into a handle. The handle includes an upper casing and a lower casing. The collecting element can be treated with a surfactant to optimize recovery of analytes from the oral sample and/or their absorbance onto the absorbent pad. A polycarbonate container receives the absorbent pad or the sample collector and stores it for testing of analytes. A dextran sulfate preservative solution is included in the polycarbonate container that inhibits enzymatic activity on a collected sample.


Patent
Orasure Technologies, Inc. | Date: 2011-11-21

A method and a device for collection and assay of oral fluids are disclosed. The method places an assay device into an oral cavity, removes the device, and determines the presence or absence of an analyte. The assay device comprises an assay portion housing a lateral flow assay strip, a neck portion extending from the assay portion and forming a channel for fluid delivery to the assay strip; a collection strip in fluid communication with the lateral flow assay strip; and a blocking strip coupled between and in flow communication with the lateral flow assay strip and the collection strip. The channel is defined by a narrow part proximal to the assay portion and a part which receives oral fluid and has a substantially wider channel width. The collection strip has a first portion disposed within the channel and a second portion protruding outwardly from the neck opening.


Patent
Orasure Technologies, Inc. | Date: 2011-01-31

A sample collector and test device is disclosed. The sample collector and test device may be used together as a diagnostic tool for collecting and assay of analytes contained in a sample. A sample collector is also disclosed which may be used with existing sample containers and or test devices. The sample collector may indicate sample adequacy when a sufficient volume of sample has been collected for assay and may also include a sample retaining feature which retains a portion of expressed sample for confirmatory testing, if desirable. The sample collector may also include a mechanism for expressing sample in a sample collector and/or test device. A test device is also disclosed for retaining and assay of an expressed sample. The disclosed test device may be used with existing sample collectors. In a preferred embodiment, test device is used with a preferred sample collector. Test device may include a locking feature for locking a sample retained on a sample collector or test device may be used to receive expressed sample collected from a syringe or another suitable sample delivery device.


Patent
Orasure Technologies, Inc. | Date: 2015-02-18

A cryo-surgical system may comprise a container containing a refrigerant, a delivery tube having a first end configured to be in flow communication with the container and a second end opposite the first end. The system may further include a plurality of flexible finger portions disposed proximate a second end of the delivery tube opposite the first end, an applicator bud having a body portion disposed within the plurality of flexible finger portions and a contact surface extending from the plurality of flexible finger portions. An adjustment ring may be disposed along the delivery tube adjacent to the plurality of flexible finger portions. The contact surface of the bud may be changeable by adjustment of the adjustment ring.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 145.91K | Year: 2012

DESCRIPTION (provided by applicant): The objective of this research application is the development of a simple, highly portable test system for rapid screening for human immunodeficiency virus (HIV) and hepatitis at the point of care (POC). This test system will be capable of identifying patients infected by HIV, hepatitis C virus (HCV) and hepatitis B virus (HBV) in a small drop of blood obtained by finger stick. This will allow the use of this test syste in settings such as physician offices, public health testing clinics, community outreach centers and mobile testing facilities. It is the intention to obtain regulatory approvals in the US, such tat this system can be used outside of traditional laboratory settings by individuals with minimal training. This will enable maximum access to populations at greatest risk for HIV and hepatitis. It is expected that by enabling increased testing of high risk populations, a higher proportion of infected individuals will be diagnosed and gain earlier access to appropriate medical treatment. The test system will consist of test cartridges specific for each disease state and a simple-to-use instrument providing objective results to the user. Use of manual, rapid tests has previously been shown to be effective in increasing diagnosis of HIV. Currently, approximately 25% of HIV infection and more than half of the cases of HCV and HBV infection are undiagnosed. This reservoir of undiagnosed infection represents a growing burden of mortality and morbidity and also contributes to greater transmission rates within the population. Improved therapeutic outcomes in infected individuals who are treated earlier in the course of disease are now well documented. Improved the rapid tests for treatment of HCV were recently approved inthe US and reduction of future morbidity and mortality will be highly dependent on expanded testing and diagnoses. Additionally, early treatment of HIV infected individuals has been shown to greatly reduce the risk of disease transmission. Increased testing and treatment of individuals infected with these blood borne viruses will significantly improve health outcomes in infected individuals and reduce transmission through reduction of community viral burden. PUBLIC HEALTH RELEVANCE: The purpose ofthis project is to develop a new and proprietary system that can detect the presence of infection by HIV, hepatitis B or hepatitis C from a small drop of finger-stick blood. This will expand testing opportunities, increase disease diagnoses and enable moreindividuals to become more aware of their status and thus receive earlier intervention in the course of disease. This will result in improved health care outcomes; reduced disease transmission, as well as reducing overall medical costs.


Patent
Orasure Technologies, Inc. | Date: 2014-12-05

A method of preparing a cryo-surgical system for treatment includes accessing a container containing a refrigerant, a delivery tube having a first end configured to be in flow communication with the container and a second end opposite the first end. The system further includes a plurality of flexible finger portions disposed proximate the second end of the delivery tube opposite the first end. A porous applicator bud is disposed proximate the second end of the delivery tube. The porous applicator bud includes a body portion disposed between the plurality of flexible finger portions and a contact surface extending from the plurality of flexible finger portions. An adjustment ring disposed along the delivery tube adjacent to the plurality of flexible finger portions can be used to adjust the size of the contact surface of the porous applicator bud.

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