Announcement • Jul 23
OraSure Technologies, Inc. to Report Q1, 2026 Results on Aug 05, 2026 OraSure Technologies, Inc. announced that they will report Q1, 2026 results at 4:00 PM, US Eastern Standard Time on Aug 05, 2026 Announcement • Jul 22
OraSure Technologies Receives Emergency Use Authorization For Second Generation OraQuick Ebola 2.0 Rapid Antigen Test OraSure Technologies, Inc. announced that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its second generation OraQuick Ebola 2.0 Rapid Antigen Test for use with whole blood in live patients, as well as cadaveric oral fluid from individuals suspected to have had Ebola disease at the time of death. The test can detect all four Ebola viruses currently known to cause disease in humans: Bundibugyo, Zaire, Sudan, and Taï Forest. The OraQuick Ebola Rapid Antigen Test originally received De Novo marketing authorization from the FDA in 2019, making it the first and only rapid antigen test to receive full authorization for the detection of Ebola virus. The second-generation test authorized by the FDA has increased sensitivity, new chemistry, and a more automated manufacturing process. It was developed in cooperation with the Biomedical Advanced Research and Development Authority (BARDA) under a contract granted in 2022. The current Ebola epidemic, centered in the Democratic Republic of the Congo with cases extending into neighboring Uganda, has already resulted in hundreds of deaths and prompted the World Health Organization to declare a global public health emergency. The Company is ramping up production of the OraQuick Ebola 2.0 Rapid Antigen Test to meet potential demand and expand access to a proven, reliable test. The OraQuick Ebola 2.0 Rapid Antigen Test is a single-use, qualitative immunoassay designed to detect antigens from viruses within the Orthoebolavirus genus as an aid in the diagnosis of Ebola disease, though it does not differentiate between viruses. The test is intended for individuals suspected of and with signs and symptoms of Ebola disease consistent with known risk factors for exposure, as well as for recently deceased individuals suspected of having Ebola disease at the time of death, allowing for proper treatment in living patients and safe burial practices for the deceased. Results are available directly on the test device in 30 minutes, and do not require instruments, batteries, smartphones, or laboratory analysis. This project has been funded in whole or in part with Federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50122C00079. Announcement • Jun 13
OraSure Technologies, Inc. Announces FDA Clearance for Colli-Pee Dx Urine Collection Kit for Use with Roche’s Cobas Molecular Lab Testing Equipment OraSure Technologies, Inc. announced U.S. Food and Drug Administration (FDA) clearance of its Colli-Pee™•Dx Urine Collection Kit from its subsidiary DNA Genotek Inc., for use with Roche’s tests for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG) and run on Roche’s cobas® 5800, 6800, and 8800 molecular diagnostic systems. The FDA-cleared collection kit supports at-home self-collection of first-void urine, enabling convenient sample collection at-home or in any private setting for both male and female patients. The clearance marks a significant advancement in patient-centric diagnostics, combining OraSure’s Colli-Pee™•Dx Urine Collection Kit, which includes NucleoPrecision™ Technology, a proprietary chemistry for DNA and RNA stabilization, with Roche’s cobas® high-throughput molecular testing capabilities. The Colli-Pee™•Dx Urine Collection Kit uses innovative stabilization technology to make STI laboratory testing easier by allowing reliable, private at-home urine collection and maintaining urine sample integrity at ambient temperatures. It expands access for individuals constrained by mobility, geography, or other barriers; improves patient convenience; and makes population-level screening programs feasible for broader, previously underserved populations. Healthcare providers can now prescribe, and laboratories can now receive, self-collected urine specimens directly from patients’ homes and process them seamlessly and at scale using Roche’s cobas® automated laboratory platforms. The Colli-Pee™•Dx Urine Collection Kit is designed to collect volumetric, first-void urine, ensuring optimal sample-to-preservative-ratio, a critical factor for STI detection, while offering a simple, non-invasive experience that prioritizes patient convenience and privacy. With FDA clearance, laboratories and health systems can now deploy a fully validated mail-in workflow that supports high-volume molecular STI testing without invasive sample collection methods. The collaboration enables the convenience of at-home urine collection, improves reach to populations in need, and supports public health initiatives focused on early detection and treatment of STIs. The Colli-Pee™•Dx Urine Collection Kit will be sold by OraSure subsidiary DNA Genotek. Recent Insider Transactions • May 21
Independent Director recently bought €193k worth of stock On the 14th of May, Steven Boyd bought around 75k shares on-market at roughly €2.57 per share. This transaction increased Steven's direct individual holding by 2x at the time of the trade. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought €197k more in shares than they have sold in the last 12 months. Announcement • Apr 21
OraSure Technologies, Inc., Annual General Meeting, Jun 03, 2026 OraSure Technologies, Inc., Annual General Meeting, Jun 03, 2026. Announcement • Apr 17
OraSure Technologies, Inc. Appoints John D. Bertrand as Independent Director to Its Board, Effective April 16, 2026 OraSure Technologies, Inc. announced the appointment of John D. Bertrand to its Board of Directors as an independent director, effective April 16, 2026. Mr. Bertrand is a healthcare technology executive with more than a decade of experience driving AI-enabled innovation in diagnostics. He co-founded Digital Diagnostics Inc. and most recently served as its Chief Executive Officer, helping to transform the company from a research-stage organization into a global commercial platform for disease diagnosis. Previously, Mr. Bertrand held senior leadership positions at Epic Systems Corporation, with responsibility spanning product development, customer success, and business development. He also served as a Senior Advisor to Bain Capital and as Executive in Residence at 8VC, with a focus on AI applications in healthcare information technology. Announcement • Mar 18
Altai Calls for Strategic Review at Orasure On March 18, 2026, Altai Capital Management announced that it has called for a strategic review, including a potential sale of Orasure Technologies Inc as part of its push for sweeping changes at the company. In addition, Altai Capital stated that it has sent a letter to the Company board detailing concerns over sustained underperformance and weak oversight. Further, Altai Capital urged the Company board to appoint its nominees, Rishi Bajaj and John Bertrand. Furthermore, Altai Capital criticized executive pay practices, arguing they are poorly aligned with shareholder interests, and it stressed that evaluating all strategic alternatives is essential to unlocking value. Announcement • Mar 17
Altai Capital Management Issues Letter to OraSure Board On March 17, 2026, Altai Capital Management, L.P. announced that it has delivered a letter to the OraSure Technologies, Inc. board of directors, outlining a 5-pillar case for change in response to significant and continued underperformance. In addition, Altai Capital calls on the Board to reach a fair settlement that results in the appointment of its director nominees, Rishi Bajaj and John Bertrand, to the Board. Further, Altai Capital’s letter includes chronic underperformance of Company’s share price, a Board without skin in the game, misaligned CEO compensation, the imperative for a strategic review, and the qualifications of the nominees. Furthermore, Altai Capital emphasizes the need for change to preserve and deliver value for its investors and has formally nominated the 2 candidates for election at the 2026 Annual Meeting of Shareholders. Announcement • Feb 26
OraSure Technologies, Inc. Provides Earnings Guidance for the First Quarter 2026 OraSure Technologies, Inc. provided earnings guidance for the first quarter 2026. For the quarter, the company expects total revenues of $26 million to $29 million, which includes a negligible amount of COVID-19 testing revenues. Announcement • Jan 05
OraSure Technologies, Inc. Submits CT/NG Molecular Self-Test and Colli-Pee™? Urine Collection Device for FDA Review OraSure Technologies, Inc. announced that it submitted two separate applications at the end of 2025 to the U.S. Food and Drug Administration (FDA) for clearance of its rapid molecular self-test for Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG) as well as its Colli-Pee at-home urine collection device for sexually transmitted infections (STIs). OTI's rapid self-test for CT/NG is built on the Sherlock molecular diagnostics platform and is designed to provide results in approximately 30 minutes in a disposable, over-the-counter format. The test uses a self-collected swab, and results can be read directly on the hand-held testing device without the need for an electrical connection, enhancing flexibility and convenience. OTI estimates that testing for CT/NG represents a total addressable market of more than $1.5 billion. Today, the vast majority of CT/NG tests in the U.S. are processed in centralized laboratories, creating an opportunity for meaningful market expansion through the introduction of an affordable rapid self-test. OTI also submitted the Colli-Pee device, which is designed for at-home urine collection and is aligned with patient preferences for private and convenient diagnostic testing. The submission covers multiple STI indications and is being pursued in collaboration with a leading diagnostics platform provider. receipt of clearance for the Colli-Pee™? device for these indications would be in addition to the existing Research-use Only (RUO) product and is expected to expand access to testing and further strengthen OTI's leadership position in novel collection devices and chemistries. Announcement • Dec 17
Altai Capital Announces Intention to Nominate Candidates for Election to OraSure Board On December 17, 2025, Altai Capital Management, L.P. announced that it has notified the Board of Directors of OraSure Technologies, Inc. of its intention to nominate 2 candidates, John Bertrand and Rishi Bajaj, for election to the Board at the upcoming 2026 Annual Meeting of Stockholders. Altai cited the company's significant share price underperformance, poor strategic and capital allocation decisions, and ineffective cash deployment as reasons for the nominations. Announcement • Nov 07
OraSure Technologies, Inc. (NasdaqGS:OSUR) signed a definitive merger agreement to acquire BioMedomics, Inc. for $4 million. OraSure Technologies, Inc. (NasdaqGS:OSUR) signed a definitive merger agreement to acquire BioMedomics, Inc. for $4 million on November 5, 2025. The upfront purchase price of $4 million in cash is subject to adjustments for transaction costs, indebtedness, holdback amounts, and working capital adjustments. Additionally, the agreement includes contingent consideration, which will be paid based on the achievement of defined revenue targets by December 31, 2031. The closing of the foregoing transaction is subject to various customary conditions, and is expected to occur within the fourth quarter of 2025. Announcement • Nov 06
OraSure Technologies, Inc. Provide Earnings Guidance for the Fourth Quarter 2025 OraSure Technologies, Inc. provided earnings guidance for the fourth quarter 2025. For the quarter, the Company is guiding Total revenues of $25 million to $28 million, which includes less than $100,000 of COVID-19 testing revenues. Announcement • Sep 10
Altai Capital Intends to Nominate Board Candidates to OraSure Technologies Board On September 9, 2025, Altai Capital Management announced that has its sights set on the seats of 2 directors up for re-election next year and Altai Capital stated that one of the proposed candidates may be Altai founder Rishi Bajaj. Announcement • Aug 06
OraSure Technologies, Inc. Provides Earnings Guidance for the Third Quarter of 2025 OraSure Technologies, Inc. provided earnings guidance for the third quarter of 2025. For the quarter, the company expects total revenues of $27 million to $30 million, which includes less than $100,000 of COVID-19 testing revenues. Announcement • Aug 04
Orasure Appoints Anne Messing as Chief Commercial Officer OraSure Technologies, Inc. announced that Anne Messing has joined OTI as Chief Commercial Officer. Ms. Messing brings more than 25 years of commercial leadership experience across the healthcare industry, including in life sciences, diagnostics, and clinical laboratory services, with a proven track record of driving growth, building high-performing sales teams, and transforming strategic vision into demonstrable results and sustainable success. In her role at OTI, she will be responsible for Sales, Marketing, Strategic Alliances, and Product Management, and will shape the vision and management of OTI’s product portfolio in its aim to achieve market leadership and drive long-term growth.Prior to joining OTI, Ms. Messing was Vice President and General Manager of the U.S. Region for Becton Dickinson (BD) Biosciences, spearheading initiatives that outperformed market benchmarks and generated meaningful sales growth from legacy products as well as new product launches. Complementing her 12 years of sales and marketing leadership at BD, she also has deep healthcare experience from prior roles at Danaher, Quest Diagnostics, Siemens Healthcare Diagnostics, and ARUP Laboratories. She spent the early part of her career in the lab as a certified medical technologist and advanced through various levels of management to ultimately lead all the clinical laboratories at Beaumont Hospital in Royal Oak, Michigan. She received her Bachelor of Science in Medical Technology from Northern Michigan University and her Master of Science in Administration from Central Michigan University. Announcement • Jul 22
OraSure Technologies, Inc. to Report Q2, 2025 Results on Aug 05, 2025 OraSure Technologies, Inc. announced that they will report Q2, 2025 results on Aug 05, 2025 Announcement • Jul 10
OraSure Launches Novel Blood Collection Device for Proteomic Research OraSure Technologies, Inc. announced the launch of its HEMAcollect™?PROTEIN product to meet the evolving needs of proteomic researchers. The product, developed by OTI subsidiary DNA Genotek, is an evacuated blood collection tube (BCT) designed to preserve and stabilize plasma proteins in whole blood for up to seven days. Currently available for research use only, the collection tube with its proprietary stabilizing liquid preserves plasma proteins, facilitating storage and transport of blood samples at ambient temperature, which are limitations of general blood collection tubes. It is anticipated that the use of the product for sample collection will deliver operational and financial efficiencies to proteomic researchers and support the generation of high-quality data. The HEMAcollect™? PROTEIN BCT, powered by ProteoPrecision™? technology, minimizes hemolysis and activation of platelets, ensuring the sample accurately reflects the body's state at collection. It is compatible with a broad range of proteomic technologies including mass spectrometry, immunoassays, and high-throughputinity-based platforms. Together with its wholly-owned subsidiaries, DNA Genotek Inc. and Sherlock Biosciences, Inc., OTI is a leader in the development, manufacture, and distribution of rapid diagnostic tests and sample collection and stabilization devices designed to discover and detect critical medical conditions. OTI'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, and direct to consumers. Announcement • May 09
Orasure Technologies, Inc. Announces Resignation of Chief Product Officer Kathleen G. Weber Effective June 30, 2025 OraSure Technologies, Inc. announced that on May 8, 2025, Kathleen G. Weber notified the company of her resignation as Chief Product Officer, effective June 30, 2025. Ms. Weber’s resignation will be treated as a resignation for “Good Reason,” as defined in Amendment No. 2 to the Employment Agreement dated January 1, 2019, by and among Ms. Weber, the Company, and DNA Genotek Inc., the Company’s wholly-owned subsidiary. Announcement • May 08
Orasure Technologies, Inc. Provides Earnings Guidance for the Second Quarter of Fiscal Year 2025 OraSure Technologies, Inc. provided earnings guidance for the second quarter of fiscal year 2025. For the period, the Company anticipates Core revenues in of $28 million to $32 million, and COVID-19 and Risk Assessment testing revenues of approximately $0.5 million. Announcement • Apr 24
OraSure Technologies, Inc. to Report Q1, 2025 Results on May 07, 2025 OraSure Technologies, Inc. announced that they will report Q1, 2025 results at 4:00 PM, US Eastern Standard Time on May 07, 2025 Announcement • Apr 07
OraSure Technologies, Inc., Annual General Meeting, May 14, 2025 OraSure Technologies, Inc., Annual General Meeting, May 14, 2025. Announcement • Mar 24
OraSure Technologies, Inc. (NasdaqGS:OSUR) announces an Equity Buyback for $40 million worth of its shares. OraSure Technologies, Inc. (NasdaqGS:OSUR) announces a share repurchase program. Under the program, the company will repurchase up to $40 million worth of its shares. The program will be funded from cash on hand. The program will be valid for 24 months. Announcement • Feb 26
OraSure Technologies, Inc. Provides Financial Guidance for the First Quarter of Fiscal 2025 OraSure Technologies, Inc. provided financial guidance for the first quarter of fiscal 2025. For the period, the company is guiding revenues of $27.5 million to $31.5 million. The company anticipates core revenues of $27 million to $31 million, which includes approximately $1 million of Risk Assessment testing revenues. The company anticipates COVID-19 revenues of approximately $0.5 million. Announcement • Feb 14
OraSure Technologies, Inc. to Report Q4, 2024 Results on Feb 25, 2025 OraSure Technologies, Inc. announced that they will report Q4, 2024 results on Feb 25, 2025 Announcement • Jan 15
Nowdiagnostics, Inc. Files Countersuit Against Frivolous Orasure Claims NOWDiagnostics, Inc. announced that it has filed a claim on January 13 against OraSure Technologies (OraSure), asserting breach of contract, theft of a non-public device, misappropriation of trade secrets, unfair competition, and other violations of state and federal law for damages in federal court in the Eastern District of Pennsylvania. NOWDx is seeking compensatory and punitive damages and payment of attorneys’ fees, among other legal remedies. Nowdx’S Countersuit Asserts A Pattern of Unlawful Actions by Orasure Beginning in 2023, After It Had Approached Nowdx to Discuss Nowdx’S Technology and Potential to Expand Orasure’S Product Portfolio. the Evidence of Orasure’S Wrongdoing Was Recently Uncovered by an Internal Investigation After Orasure Filed A Baseless Lawsuit Against Nowdx in November 2024. Nowdx Is Pursuing Claims Against Orasure For, Among Other Things: Orasure’S Illegal Retention of A Non-Public Nowdx Prototype and In-Market Devices; Orasure’S Efforts to Develop Product Technology Using Confidential Information It Learned During Discussions with Nowdx; Orasure’S Improper Retention of Nowdx’S Highly Confidential Information, Including Detailed Product Roadmaps and Specific Technical Documents; the Access and Use of Nowdx’S Proprietary Data and Information by Senior Members of Orasure’S Team; Orasure’S Attempts to Internally Develop the Same Products Nowdx Had Presented to It During Discussions Between the Parties; and Orasure’S Retention of Nowdx’S Confidential, Trade Secret Information That Was Shared in 2023. Announcement • Jan 08
OraSure Technologies, Inc.'s OraQuick HIV Self-Test Receives Approval for Use in Adolescents OraSure Technologies, Inc. announced that The Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA) has approved a labeling change to the OraQuick HIV Self-Test that will increase access to HIV testing for adolescents. The change expands the approved age range to include individuals 14 years of age and older for the OraQuick HIV Self-Test. Previously the test was approved for use in those 17 and older. According to the most recent data available from the Centers for Disease Control & Prevention, it is estimated that 19% of new HIV diagnoses in the United States were among young people aged 13 to 24, and only 6% of high school students have ever been tested for HIV. Almost half of young people with HIV do not know that they have it. The OraQuick HIV Self-Test has been available direct to consumers in the U.S. since 2012. Since its launch, OraSure has been committed to providing consumers with access to critical information and connection to care. The packaging contains robust educational material and linkage to care information, giving individuals information that they can use to make informed decisions, regardless of the test result. Announcement • Dec 20
OraSure Technologies, Inc. (NasdaqGS:OSUR) acquired Sherlock Biosciences, Inc. from a group of shareholders. OraSure Technologies, Inc. (NasdaqGS:OSUR) acquired Sherlock Biosciences, Inc. from a group of shareholders on December 19, 2024.
OraSure Technologies, Inc. (NasdaqGS:OSUR) completed the acquisition of Sherlock Biosciences, Inc. from a group of shareholders on December 19, 2024. Announcement • Dec 03
OraSure Technologies, Inc. Receives Federal Funding for Development of Marburg Virus Rapid Antigen Test from Biomedical Advanced Research and Development Authority OraSure Technologies, Inc. announced that it received an award through the Rapid Response Partnership Vehicle (RRPV) for the development of a Marburg Virus Disease (MVD) rapid antigen test. The RRPV is a Consortium funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). The initial contract award, valued at approximately $7.5 million over multiple years in the base period with potential value up to $11 million, funds the development to achieve U.S. Food and Drug Administration (FDA) 510 (k) clearance of a single-use lateral flow immunoassay intended for the qualitative detection of antigens from viruses within the Marburg virus genus. OraSure has previously collaborated with BARDA in the development of the InteliSwab COVID-19 Rapid Test and maintains an ongoing partnership focused on enhancements to its 510(k) cleared point-of-care OraQuick Ebola Rapid Antigen Test. This project 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 (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction Number: 75A50123D00005. Announcement • Nov 08
OraSure Technologies, Inc. Provides Revenue Guidance for the Fourth Quarter of 2024 OraSure Technologies, Inc. provided revenue guidance for the fourth quarter of 2024. The company is guiding to fourth quarter 2024 revenues of $35 million to $37 million, which includes $1to $2 millionof Risk Assessment testing revenues. The Company anticipates COVID-19 revenuesin Fourth Quarter 2024 of approximately $1 million. Reported Earnings • Nov 08
Third quarter 2024 earnings released: US$0.06 loss per share (vs US$0.15 profit in 3Q 2023) Third quarter 2024 results: US$0.06 loss per share (down from US$0.15 profit in 3Q 2023). Revenue: US$39.9m (down 55% from 3Q 2023). Net loss: US$4.51m (down 140% from profit in 3Q 2023). Revenue is expected to decline by 16% p.a. on average during the next 3 years, while revenues in the Medical Equipment industry in Germany are expected to grow by 5.9%. Over the last 3 years on average, earnings per share has increased by 81% per year but the company’s share price has fallen by 21% per year, which means it is significantly lagging earnings. Announcement • Oct 23
OraSure Technologies, Inc. to Report Q3, 2024 Results on Nov 06, 2024 OraSure Technologies, Inc. announced that they will report Q3, 2024 results on Nov 06, 2024 Announcement • Sep 11
OraSure Technologies, Inc. Appoints John P. Kenny as New Member of the Board, Member of the Nominating and Corporate Governance Committee OraSure Technologies, Inc. announced On September 5, 2024, the Board of Directors (the “Board”) of OraSure Technologies, Inc. (the “Company”) increased the number of directors who may serve on the Board from six (6) to seven (7), effective as of September 6, 2024 (the “Effective Date”), pursuant to authority granted in the Company’s Certificate of Incorporation. In addition, on September 5, 2024, the Board appointed John P. Kenny as a new member of the Board, with such appointment to be effective as of the Effective Date. Mr. Kenny will serve as a Class I Director, with an initial term expiring at the Company’s 2025 Annual Meeting of Stockholders, and as a member of the Board’s Nominating and Corporate Governance Committee. New Risk • Aug 08
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of German stocks, typically moving 6.7% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 74% per year for the foreseeable future. Minor Risks Share price has been volatile over the past 3 months (6.7% average weekly change). Large one-off items impacting financial results. Reported Earnings • Aug 07
Second quarter 2024 earnings released: US$0.008 loss per share (vs US$0.065 loss in 2Q 2023) Second quarter 2024 results: US$0.008 loss per share (improved from US$0.065 loss in 2Q 2023). Revenue: US$54.3m (down 36% from 2Q 2023). Net loss: US$615.0k (loss narrowed 87% from 2Q 2023). Revenue is expected to decline by 22% p.a. on average during the next 3 years, while revenues in the Medical Equipment industry in Germany are expected to grow by 6.3%. Over the last 3 years on average, earnings per share has increased by 77% per year but the company’s share price has fallen by 24% per year, which means it is significantly lagging earnings. Announcement • Jul 23
OraSure Technologies, Inc. to Report Q2, 2024 Results on Aug 06, 2024 OraSure Technologies, Inc. announced that they will report Q2, 2024 results on Aug 06, 2024 New Risk • May 10
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 4.4% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 149% per year for the foreseeable future. Minor Risks Large one-off items impacting financial results. Shareholders have been diluted in the past year (4.4% increase in shares outstanding). Announcement • May 10
OraSure Technologies, Inc. Provides Revenue Guidance for the Second Quarter of 2024 OraSure Technologies, Inc. provided revenue guidance for the second quarter of 2024. The Company is guiding to second quarter of 2024 revenue of $50 million to $55 million, which includes core revenue of $33 million to $36 million and InteliSwab revenue of $17 million to $19 million. Second Quarter 2024 guidance includes approximately $650,000 of revenue from the Diversigen business that plan to exit. Reported Earnings • May 09
First quarter 2024 earnings released: US$0.048 loss per share (vs US$0.37 profit in 1Q 2023) First quarter 2024 results: US$0.048 loss per share (down from US$0.37 profit in 1Q 2023). Revenue: US$54.1m (down 65% from 1Q 2023). Net loss: US$3.58m (down 113% from profit in 1Q 2023). Revenue is expected to decline by 24% p.a. on average during the next 3 years, while revenues in the Medical Equipment industry in Germany are expected to grow by 7.0%. Over the last 3 years on average, earnings per share has increased by 72% per year but the company’s share price has fallen by 13% per year, which means it is significantly lagging earnings. New Risk • Apr 05
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 4.5% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 140% per year for the foreseeable future. Minor Risks Large one-off items impacting financial results. Shareholders have been diluted in the past year (4.5% increase in shares outstanding). Announcement • Apr 04
OraSure Technologies, Inc., Annual General Meeting, May 14, 2024 OraSure Technologies, Inc., Annual General Meeting, May 14, 2024, at 10:00 US Eastern Standard Time. Agenda: To elect two Class III Directors to serve for a term expiring at the company’s Annual Meeting of Stockholders in 2027; to ratify the appointment of Grant Thornton LLP as the company’s independent registered public accounting firm for the year ending December 31, 2024; to approve, by an advisory (non-binding) vote, the compensation of the company’s named executive officers as disclosed in the Proxy Statement accompanying this Notice; to approve an amendment to company Certificate of Incorporation to limit the liability of certain officers of the company as permitted by recent amendments to Delaware law; and to consider such other business as may properly come before the meeting, and any adjournment(s) or postponement(s) thereof. New Risk • Feb 29
New minor risk - Earnings quality The company has large one-off items impacting its financial results. One-off items were 25% of the size of the rest of the company's trailing 12-month earnings before tax. This is considered a minor risk. One-off items are incomes or expenses that the company does not expect to repeat in future periods. Examples include profits from the sale of a business or expenses from a restructuring or legal settlements. If the company's reported statutory earnings include a large proportion of one-off items it means they may be an unreliable indicator of its true business performance as the earnings were skewed by these incomes or expenses. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 123% per year for the foreseeable future. Minor Risk Large one-off items impacting financial results. Reported Earnings • Feb 28
Full year 2023 earnings released: EPS: US$0.73 (vs US$0.25 loss in FY 2022) Full year 2023 results: EPS: US$0.73 (up from US$0.25 loss in FY 2022). Revenue: US$405.5m (up 4.6% from FY 2022). Net income: US$53.7m (up US$71.6m from FY 2022). Profit margin: 13% (up from net loss in FY 2022). The move to profitability was primarily driven by lower expenses. Revenue is expected to decline by 34% p.a. on average during the next 3 years, while revenues in the Medical Equipment industry in Germany are expected to grow by 6.7%. Over the last 3 years on average, earnings per share has increased by 68% per year but the company’s share price has fallen by 11% per year, which means it is significantly lagging earnings. Announcement • Feb 14
OraSure Technologies, Inc. to Report Fiscal Year 2023 Results on Feb 27, 2024 OraSure Technologies, Inc. announced that they will report fiscal year 2023 results After-Market on Feb 27, 2024 Valuation Update With 7 Day Price Move • Nov 15
Investor sentiment improves as stock rises 22% After last week's 22% share price gain to €6.05, the stock trades at a trailing P/E ratio of 10.3x. Average forward P/E is 25x in the Medical Equipment industry in Germany. Total loss to shareholders of 42% over the past three years. Announcement • Nov 08
OraSure Technologies, Inc. Provides Financial Guidance for the Fourth Quarter 2023 OraSure Technologies, Inc. provided financial guidance for the fourth quarter 2023. For the period, the Company is guiding revenue of $71 to $76 million, which includes core revenue of $33 to $35 million and InteliSwab® revenue of $38 to $41 million. Reported Earnings • Nov 08
Third quarter 2023 earnings released: EPS: US$0.15 (vs US$0.073 in 3Q 2022) Third quarter 2023 results: EPS: US$0.15 (up from US$0.073 in 3Q 2022). Revenue: US$89.2m (down 23% from 3Q 2022). Net income: US$11.2m (up 112% from 3Q 2022). Profit margin: 13% (up from 4.5% in 3Q 2022). The increase in margin was driven by lower expenses. Revenue is expected to decline by 43% p.a. on average during the next 3 years, while revenues in the Medical Equipment industry in Germany are expected to grow by 6.1%. Over the last 3 years on average, earnings per share has increased by 49% per year but the company’s share price has fallen by 22% per year, which means it is significantly lagging earnings. Announcement • Oct 24
OraSure Technologies, Inc. to Report Q3, 2023 Results on Nov 07, 2023 OraSure Technologies, Inc. announced that they will report Q3, 2023 results on Nov 07, 2023 New Risk • Oct 13
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 8.3% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (8.3% average weekly change). Earnings are forecast to decline by an average of 111% per year for the foreseeable future. Valuation Update With 7 Day Price Move • Aug 11
Investor sentiment improves as stock rises 27% After last week's 27% share price gain to €5.65, the stock trades at a trailing P/E ratio of 10.8x. Average forward P/E is 25x in the Medical Equipment industry in Germany. Total loss to shareholders of 50% over the past three years. New Risk • Aug 08
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 9.9% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (9.9% average weekly change). Earnings are forecast to decline by an average of 109% per year for the foreseeable future. Announcement • Aug 04
OraSure Technologies, Inc. Provides Revenue Guidance for the Third Quarter of 2023 OraSure Technologies, Inc. provided revenue guidance for the third quarter of 2023. The company is guiding to third quarter 2023 revenue of $72 million to $77 million, which includes core revenue of $37 million to $39 million and InteliSwab® revenue of $35 million to $38 million. Reported Earnings • Aug 04
Second quarter 2023 earnings released: US$0.065 loss per share (vs US$0.26 loss in 2Q 2022) Second quarter 2023 results: US$0.065 loss per share (improved from US$0.26 loss in 2Q 2022). Revenue: US$85.4m (up 6.5% from 2Q 2022). Net loss: US$4.80m (loss narrowed 75% from 2Q 2022). Revenue is expected to decline by 42% p.a. on average during the next 3 years, while revenues in the Medical Equipment industry in Germany are expected to grow by 6.0%. Over the last 3 years on average, earnings per share has increased by 17% per year but the company’s share price has fallen by 29% per year, which means it is significantly lagging earnings. Announcement • Jul 23
OraSure Technologies, Inc. to Report Q2, 2023 Results on Aug 03, 2023 OraSure Technologies, Inc. announced that they will report Q2, 2023 results on Aug 03, 2023 Announcement • Jul 22
OraSure Technologies, Inc. Announces Election of Robert W. McMahon to its Board of Directors, Effective July 31, 2023 OraSure Technologies, Inc. announced the election of Robert W. McMahon, CMA, MBA, to the Company’s Board of Directors, effective July 31, 2023. Including McMahon, the company’s Board of Directors has seven members. Mr. McMahon is Senior Vice President and Chief Financial Officer for Agilent Technologies where he is responsible for Finance, Audit, Treasury, Tax, and Investor Relations. He has extensive leadership experience in business growth, mergers and acquisitions, and consistently delivering results while increasing profitability and improving cash flow. He will serve as a Class II Director with an initial term expiring at the Company’s 2026 Annual Meeting of Stockholders. Mr. McMahon has more than 30 years of experience as a senior finance professional. In his role at Agilent, he managed the company’s financials through the COVID-19 pandemic, ensuring stability for their workforce while focusing on key investments, maintaining cash flow, and providing frequent and transparent communication to investors. He has also led new opportunities for business growth with strategies to increase deal profitability and implemented new digital business models. Prior to his work for Agilent, Mr. McMahon spent four years serving as Chief Financial Officer for Hologic, where he led a team that reshaped the product portfolio and significantly improved company performance and profitability. He also spent more than 20 years at Johnson & Johnson where he held numerous leadership positions and his key responsibilities spanned corporate finance, financial planning and analysis, financial roadmaps, portfolio optimization, enterprise valuation, divestiture management, and business leadership. Mr. McMahon holds an MBA in Finance from the University of Central Florida and a bachelor’s degree in Finance from the University of Florida. Announcement • Jun 14
OraSure Technologies, Inc. Announces Study Concludes Self-Sampling Using Colli-Pee® Device for HPV Screening Is Both Cost Effective and Could Improve Patient Access OraSure Technologies, Inc. announced that a major health economics study featuring its Colli-Pee® device has been published in the biomedical journal “BMJ Open.” This study, conducted by experts from Aquarius Population Health Limited in London and the University of Manchester, presents valuable insights into the cost-effectiveness of self-sampling for routine human papillomavirus (HPV) primary cervical cancer screening using the Colli-Pee® UCM® self-collection device. The study's noteworthy findings suggest that self-sampling with the Colli-Pee® device could offer a more affordable alternative to clinician-collected sampling and other self-sampling methods. This has the potential to significantly expand access to cervical cancer screening for underserved and rural populations on a larger scale. The health-economic research employed an innovative cost-benefit analysis model, utilizing real-world evidence from England’s primary HPV NHS Cervical Screening Programme (NHSCSP). The study compared three sampling approaches using a deterministic decision-tree model. The biocomputational analysis simulated a cohort of 10,000 individuals representative of the 400,000 people with a cervix aged 25 to 64 in England’s NHSCSP during 2020 and 2021. The three sampling strategies evaluated were routine clinician-collected cervical sample (identified as the most expensive option), self-collected first-void urine via the Colli-Pee® device (the least expensive option), and self-collected vaginal swab (the second-most expensive). The Colli-Pee® first-void urine collection device evaluated in the study is manufactured by OraSure'sBelgium-based subsidiary, Novosanis. Valuation Update With 7 Day Price Move • Jun 05
Investor sentiment improves as stock rises 18% After last week's 18% share price gain to €5.30, the stock trades at a forward P/E ratio of 848x. Average forward P/E is 25x in the Medical Equipment industry in Europe. Total loss to shareholders of 42% over the past three years. Recent Insider Transactions • Jun 02
Chief Financial Officer recently bought €460k worth of stock On the 30th of May, Kenneth McGrath bought around 100k shares on-market at roughly €4.60 per share. This transaction amounted to 54% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was Kenneth's only on-market trade for the last 12 months. Valuation Update With 7 Day Price Move • May 17
Investor sentiment deteriorates as stock falls 20% After last week's 20% share price decline to €4.86, the stock trades at a forward P/E ratio of 840x. Average forward P/E is 26x in the Medical Equipment industry in Europe. Total loss to shareholders of 64% over the past three years. Announcement • May 12
Orasure Technologies, Inc. Provides Earnings Guidance for the Second Quarter 2023 OraSure Technologies, Inc. provided earnings guidance for the second quarter 2023. For the period, the company is guiding toward revenue of $62 to $67 million. Reported Earnings • May 11
First quarter 2023 earnings released: EPS: US$0.37 (vs US$0.28 loss in 1Q 2022) First quarter 2023 results: EPS: US$0.37 (up from US$0.28 loss in 1Q 2022). Revenue: US$155.0m (up 129% from 1Q 2022). Net income: US$27.2m (up US$47.2m from 1Q 2022). Profit margin: 18% (up from net loss in 1Q 2022). Revenue is expected to decline by 22% p.a. on average during the next 3 years, while revenues in the Medical Equipment industry in Germany are expected to grow by 6.5%. Over the last 3 years on average, earnings per share has fallen by 35% per year but the company’s share price has only fallen by 26% per year, which means it has not declined as severely as earnings. Announcement • May 04
OraSure Technologies, Inc. to Report Q1, 2023 Results on May 10, 2023 OraSure Technologies, Inc. announced that they will report Q1, 2023 results at 4:05 PM, US Eastern Standard Time on May 10, 2023 Reported Earnings • Feb 16
Full year 2022 earnings released: US$0.25 loss per share (vs US$0.32 loss in FY 2021) Full year 2022 results: US$0.25 loss per share (improved from US$0.32 loss in FY 2021). Revenue: US$387.5m (up 66% from FY 2021). Net loss: US$17.9m (loss narrowed 22% from FY 2021). Revenue is expected to decline by 20% p.a. on average during the next 3 years, while revenues in the Medical Equipment industry in Germany are expected to grow by 6.2%. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 87 percentage points per year, which is a significant difference in performance. Announcement • Feb 15
OraSure Technologies, Inc. Provides Revenue Guidance for the First Quarter of 2023 OraSure Technologies, Inc. provided revenue guidance for the first quarter of 2023. The company is guiding toward first quarter of 2023 revenue of $125 to $130 million representing 85% to 92% growth relative to the first quarter of last year. Given the continued volatility with the COVID-19 market, the company is only providing quarterly financial guidance for fiscal year 2023; however, it is anticipating higher revenue in the first half of the year followed by lower sales in the second half as the Company works down its COVID-19 government contracts. Announcement • Feb 08
OraSure Technologies, Inc. to Report Q4, 2022 Results on Feb 14, 2023 OraSure Technologies, Inc. announced that they will report Q4, 2022 results at 4:05 PM, US Eastern Standard Time on Feb 14, 2023 Board Change • Nov 16
High number of new directors There are 5 new directors who have joined the board in the last 3 years. President, CEO & Director Carrie Eglinton Manner was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Announcement • Nov 16
OraSure Technologies, Inc. Announces Executive Changes On November 7, 2022, the board of directors of OraSure Technologies, Inc. appointed Kathleen G. Weber, the company's current President of Molecular Solutions, as the company's Chief Product Officer, effective November 14, 2022. In connection with the appointment of Ms. Weber as the company's Chief Product Officer, on November 7, 2022, the Company and Ms. Weber entered into Amendment No. 2 to that certain Employment Agreement, dated as of January 1, 2019, by and between the Company, DNA Genotek Inc., the Company's wholly-owned subsidiary, and Ms. Weber. The amendment reflects the change in Ms. Webers title and duties and makes certain changes to the Employment Agreements definition of Good Reason. Upon a resignation from employment by Ms. Weber for Good Reason, Ms. Weber would be entitled to severance benefits as set forth in the Employment Agreement, which severance benefits were not changed by the amendment. Lisa Nibauer has chosen to resign as the company's President of Diagnostics, effective November 11, 2022. Reported Earnings • Nov 10
Third quarter 2022 earnings released: EPS: US$0.073 (vs US$0.21 loss in 3Q 2021) Third quarter 2022 results: EPS: US$0.073 (up from US$0.21 loss in 3Q 2021). Revenue: US$116.5m (up 116% from 3Q 2021). Net income: US$5.27m (up US$20.3m from 3Q 2021). Profit margin: 4.5% (up from net loss in 3Q 2021). Revenue is expected to decline by 22% p.a. on average during the next 3 years, while revenues in the Medical Equipment industry in Germany are expected to grow by 5.7%. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 94 percentage points per year, which is a significant difference in performance. Announcement • Nov 04
Orasure Technologies Receives General Clearance for Its ORAcollect--Dx Device for over the Counter Use from the U.S. Food and Drug Administration OraSure Technologies, Inc. announced that the Company received U.S. FDA clearance for its ORAcollect(R)--Dx saliva collection device for OTC (i.e. direct-to-consumer) use. The device had been previously cleared for prescription use by the FDA. ORAcollect(R)--Dx joins the Oragene(R)--Dx product line which previously received FDA general clearance for prescription and OTC use. This new designation now allows ORAcollect(R)-- Dx devices to be used by OraSure's commercial partners and legally marketed with their therapeutics or devices in conjunction with their product's intended use. Both the ORAcollect(R)--Dx, and Oragene(R)--Dx devices are designed to be used by an adult at home, without direction from a healthcare professional. OraSure received this designation through its partnership with Grifols to support screening for alpha1-antitrypsin deficiency (alpha-1) in individuals who may be at risk for alpha-1. Alpha-1 raises patients' risks for lung disorders and it is estimated that about 3% of COPD patients have alpha-1. Beginning in Second Quarter 2023, Grifols will offer free AlphaID(TM) At Home Genetic Health Risk Service, supporting alpha-1 screening, that utilize the ORAcollect(R)--Dx device to help identify individuals at risk. Announcement • Nov 03
OraSure Technologies, Inc. Announces InteliSwab Covid-19 Rapid Test Now Available in Amazon’s Online Store OraSure Technologies, Inc. announced that its InteliSwab COVID-19 Rapid Test is now available in Amazon’s online store to customers in the United States. The product will be sold and fulfilled by Amazon and eligible for free Amazon Prime shipping. Testing with InteliSwab is simple: users swab their lower nostrils with the preassembled test device, swirl it in a pre-measured solution, and see their result on the device – with no drops to measure, and 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 test was recently selected by the federal government for nationwide school testing in part because it is easy to use. Announcement • Nov 02
OraSure Technologies, Inc. to Report Q3, 2022 Results on Nov 08, 2022 OraSure Technologies, Inc. announced that they will report Q3, 2022 results at 4:05 PM, US Eastern Standard Time on Nov 08, 2022 Recent Insider Transactions • Aug 30
Independent Director recently bought €200k worth of stock On the 26th of August, Ronny Lancaster bought around 50k shares on-market at roughly €4.00 per share. This transaction amounted to 91% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought €262k more in shares than they have sold in the last 12 months. Recent Insider Transactions • Aug 17
Independent Chairman of the Board recently bought €53k worth of stock On the 12th of August, Michael Celano bought around 12k shares on-market at roughly €4.38 per share. This was the largest purchase by an insider in the last 3 months. This was Michael's only on-market trade for the last 12 months. Reported Earnings • Aug 11
Second quarter 2022 earnings released: US$0.26 loss per share (vs US$0.019 loss in 2Q 2021) Second quarter 2022 results: US$0.26 loss per share (down from US$0.019 loss in 2Q 2021). Revenue: US$80.2m (up 39% from 2Q 2021). Net loss: US$18.8m (loss widened US$17.4m from 2Q 2021). Over the next year, revenue is forecast to grow 2.5%, compared to a 7.4% growth forecast for the industry in Germany. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 96 percentage points per year, which is a significant difference in performance. Announcement • Aug 03
OraSure Technologies, Inc. to Report Q2, 2022 Results on Aug 09, 2022 OraSure Technologies, Inc. announced that they will report Q2, 2022 results at 4:05 PM, US Eastern Standard Time on Aug 09, 2022 Announcement • Jul 16
OraSure Technologies, Inc. Announces Executive Changes As previously disclosed, on May 23, 2022, Kathleen G. Weber, who currently serves as the OraSure Technologies, Inc.'s President of Molecular Solutions, notified the Company of her intention to resign from the Company, effective August 21, 2022. Ms. Weber has notified the Company of her decision to rescind her resignation as President of Molecular Solutions. On July 15, 2022, the board of directors of the Company accepted the rescission of Ms. Weber’s resignation. As a result, Ms. Weber will continue to serve as the Company’s President of Molecular Solutions under the previously existing employment agreement by and between Ms. Weber and the Company, that was described in the Company’s Definitive Proxy Statement for its Annual Meeting of Stockholders filed with the Securities and Exchange Commission on April 7, 2022 (the “Proxy Statement”). Announcement • Jul 15
OraSure Technologies LaunchesNewProduct for Microbiome Researchers to Study DNA and RNA OraSure Technologies, Inc. announced that its OMNIgene®•GUT DNA and RNA product (OMR-205) is now available to gut microbiome researchers. The product allows for self-collection, stabilization, storage and transportation of both microbial DNA and RNA at ambient temperature for gut microbiome profiling. It is made by OraSure’s subsidiaryDNA Genotek. DNA Genotek has a proven track record of supporting companiesoffering diagnostic testing in the human genomics space. Their microbiome collection device portfolio is used in more than 90 countries and has been featured in more than 200 scientific publications. Announcement • Jun 11
OraSure Technologies, Inc. Announces Resignation of Agnieszka M. Gallagher as Executive Vice President, General Counsel and Chief Compliance Officer, Effective June 25, 2022 On June 3, 2022, Agnieszka M. Gallagher, who currently serves as OraSure Technologies, Inc.’s Executive Vice President, General Counsel and Chief Compliance Officer, notified the company of her termination of her employment with the company with Good Reason related to company organizational changes. Ms. Gallagher will be leaving the Company on June 25, 2022. Announcement • May 18
OraSure Technologies, Inc. Announces That Its InteliSwab® Covid-19 Rapid Tests Detect the Omicron BA.2, BA.2.12.1, BA.3 and BA.5 Subvariants OraSure Technologies, Inc. announced that its InteliSwab® COVID-19 rapid tests detect the Omicron BA.2, BA.2.12.1, BA.3 and BA.5 subvariants with similar levels of detection to the original SARS-CoV-2 strain and other previous variants of concern, including Delta, Alpha, Beta, Gamma and Omicron BA.1. The Omicron sublineage studies were conducted using live SARS-CoV-2 virus at an independent, third-party laboratory and showed InteliSwab® detected the Omicron variants at similar viral load levels, or limit of detection, as previous variants that were tested. esting with InteliSwab® is simple: users swab their lower nostrils with the test stick, swirl it in a pre-measured solution, and see their result on the test stick in 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.” About InteliSwab®: OraSure has received Emergency Use Authorizations (EUA) from the FDA for its InteliSwab® COVID-19 rapid tests. The 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. InteliSwab®’s unique design incorporates a built-in swab fully integrated into the end of the test stick. 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. Multiple government agencies, including the U.S. Department of Defense (DoD) and Department of Health and Human Services (HHS) are working to address COVID-19 testing needs. Development of the InteliSwab® COVID-19 Rapid Test has been funded in whole or in part with federal funds from the HHS; the Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, Division of Research, Innovation and Ventures under contract number 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’s Response to COVID-19: OraSure is leveraging its expertise in infectious disease testing and molecular sample collection with EUAs for rapid COVID-19 antigen self testing and molecular sample collection for PCR-based tests. The Company’s portfolio of COVID-19 tests and collection kits all feature easy, convenient, pain-free self-collection, and help increase access to testing, while alleviating the burden on the healthcare system and minimizing exposure risks. Reported Earnings • May 11
First quarter 2022 earnings released: US$0.28 loss per share (vs US$0.053 profit in 1Q 2021) First quarter 2022 results: US$0.28 loss per share (down from US$0.053 profit in 1Q 2021). Revenue: US$67.7m (up 16% from 1Q 2021). Net loss: US$20.0m (down US$23.7m from profit in 1Q 2021). Over the next year, revenue is forecast to grow 26%, compared to a 7.1% growth forecast for the industry in Germany. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 98 percentage points per year, which is a significant difference in performance. Board Change • Apr 27
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Interim CEO & Director Nancy Gagliano was the last director to join the board, commencing their role in 2021. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model.