Syphilis

A study on point-of-care testing has shown how Syphilis Health Check™ could help significantly improve syphilis screening rates among pregnant patients with limited access to prenatal care, bridging vital gaps between maternal health and STI screening services. STONE HARBOR, N.J., Oct. 30, 2024 /PRNewswire/ -- Diagnostics Direct LLC, a leading provider of diagnostic testing solutions, is pleased to share newly published posters that provide vital insights into the role of rapid testing in improving maternal and neonatal health outcomes. Findings from Dr. Irene Stafford's Preg-OUT program in Southeastern Texas underscore the urgent need for enhanced syphilis detection and treatment in emergency and maternal healthcare settings. A healthcare provider holds a Syphilis Health Check™ test, a rapid diagnostic tool designed for point-of-care syphilis detection.

Updates Full-Year Guidance Results from Continuing Operations for third quarter 2024 versus last year: Revenue: $3.28 billion versus $3.06 billion Diluted EPS: $2.00 versus $2.11 Adjusted EPS: $3.50 versus $3.38 Free Cash Flow: $162 million versus $171 million Updated Full-Year 2024 Guidance: Revenue range of 6.6% to 7.3%; midpoint unchanged Adjusted EPS range of $14.30 to $14.70; midpoint down $0.10, due to the negative impact from weather of approximately $0.15 Free Cash Flow of $850 million to $980 million Announced three new acquisitions/lab management agreements, and closed two acquisitions during the quarter that support growth initiatives BURLINGTON, N.C., Oct. 24, 2024 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, today announced results for the third quarter ended September 30, 2024 and updated full-year guidance. "Labcorp achieved strong performance in Diagnostics and Biopharma Laboratories, including robust organic growth in the third quarter," said Adam Schechter, chairman and CEO of Labcorp. "Our results demonstrate momentum in our core businesses as we introduced new tests, and extended our leadership position in specialty testing. We announced or completed several transactions with health systems and regional/local laboratories, which aligns with our acquisition strategy. We are on track to finish 2024 with strong growth as we focus on science, technology, and innovation and bring new tests and services to our customers." Labcorp advanced key growth initiatives that supported its strategy: Announced an agreement to acquire select operating assets of Ballad Health's outreach lab services, expanding the company's laboratory and testing capabilities to rural communities in Tennessee, Virginia, North Carolina and Kentucky. Entered into a strategic collaboration with Naples Comprehensive Healthcare in Southwest Florida to manage the daily operations of its inpatient lab operations. Signed a new agreement to acquire select assets of Lab Works, an independent clinical laboratory located in Alabama. Closed the previously announced acquisition of select assets of BioReference Health's laboratory testing business. Completed the acquisition of select assets of Invitae ("Invitae"), extending Labcorp's leadership in specialty testing and ability to utilize genetic data to improve clinical trials and treatment regimens in oncology and select rare diseases. The company continues to make strides in science, technology, and innovation: Announced an expanded collaboration with Ultima Genomics to utilize its UG 100TM sequencing solution and ppmSeqTM technology to explore new whole genome sequencing clinical applications, including MRD in patients with early-stage solid tumor cancers. Received De Novo marketing authorization from the FDA for PGDx elio plasma focus Dx, the industry's only kitted, pan-solid tumor liquid biopsy test. Expanded Labcorp OnDemand offerings with additional consumer-initiated tests, including Syphilis and Luteinizing Hormone tests. Introduced a new Order Tracker Experience for Diagnostics customers, offering the majority of providers real-time visibility of test order status. Announced the expansion of its women's health solutions to include a personalized, comprehensive Postpartum Experience, through Ovia Health by Labcorp. Subsequent to the quarter, announced an exclusive agreement with NowDiagnostics (NOWDx) to distribute the first over-the-counter, point-of-care Syphilis blood test granted marketing authorization by the FDA. On October 10, 2024, Labcorp announced a quarterly cash dividend of $0.72 per share of common stock, payable on December 13, 2024, to stockholders of record at the close of business on November 26, 2024. Capital Allocation Summary At the end of the quarter, Labcorp's cash balance was $1.52 billion and total debt was $6.75 billion. The higher balances are due to Labcorp's financing activities to pre-fund maturing debt, over the next four months. During the quarter, the company invested $458.1 million on acquisitions, paid out $60.5 million in dividends, and used $75.0 million for share repurchases. Outlook for 2024 Labcorp is updating 2024 full year guidance to reflect its third quarter performance and full year outlook. The following guidance assumes foreign exchange rates effective as of September 30, 2024, for the remainder of the year. Enterprise level guidance includes the estimated impact from currently anticipated capital allocation, including acquisitions, share repurchases and dividends. Use of Adjusted Measures The company has provided in this press release and accompanying tables "adjusted" financial information that has not been prepared in accordance with GAAP, including adjusted net income, adjusted EPS (or adjusted net income per share), adjusted operating income, adjusted operating margin, free cash flow, and certain segment information. The company believes these adjusted measures are useful to investors as a supplement to, but not as a substitute for, GAAP measures, in evaluating the company's operational performance. The company further believes that the use of these non-GAAP financial measures provides an additional tool for investors in evaluating operating results and trends, and growth and shareholder returns, as well as in comparing the company's financial results with the financial results of other companies. However, the company notes that these adjusted measures may be different from and not directly comparable to the measures presented by other companies. Reconciliations of these non-GAAP measures to the most comparable GAAP measures and an identification of the components that comprise "special items" used for certain adjusted financial information are included in the tables accompanying this press release. The company today is providing an investor relations presentation with additional information on its business and operations, which is available in the investor relations section of the company's website at . Analysts and investors are directed to the website to review this supplemental information. A conference call discussing Labcorp's quarterly results will be held today at 9:00 a.m. ET and is available by registering at this link, which will provide a dial-in number and unique PIN to access the call. It is recommended that participants join 10 minutes prior to the start of the call, although participants may register and join at any time during the call. A live webcast of Labcorp's quarterly conference call on October 24, 2024, will be available at the Labcorp Investor Relations website beginning at 9:00 a.m. ET. This webcast will be archived and accessible through September 10, 2025. About Labcorp Labcorp (NYSE: LH) is a global leader of innovative and comprehensive laboratory services that helps doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions. We provide insights and advance science to improve health and improve lives through our unparalleled diagnostics and drug development laboratory capabilities. The company's more than 67,000 employees serve clients in approximately 100 countries, provided support for 84% of the new drugs and therapeutic products approved in 2023 by the FDA, and performed more than 600 million tests for patients around the world. Learn more about us at . Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements, including, but not limited to, statements with respect to (i) the estimated 2024 guidance and related assumptions, (ii) the spin-off of the company's Clinical Development and Commercialization Services business, now Fortrea Holdings Inc., (iii) the impact of various factors on operating and financial results, including the projected impact of the COVID-19 pandemic on the company's businesses, operating results, cash flows and/or financial condition, as well as global economic and market conditions, (iv) future business strategies, (v) expected savings, synergies and other benefits to the Company, customers or patients from acquisitions and other transactions and partnerships, and (vi) opportunities for future growth. Each of the forward-looking statements is subject to change based on various important factors, many of which are beyond the company's control, including without limitation: (i) the effect of recently completed holding company reorganization on the company's business generally; (ii) the failure to receive tax-free treatment with respect to the spin-off for U.S. federal income purposes; (iii) the impact of spin-off related items; (iv) potential difficulties with employee retention; (v) the trading price of the company's stock, competitive actions and other unforeseen changes and general uncertainties in the marketplace; (vi) changes in government regulations, including healthcare reform; (vii) customer purchasing decisions, including changes in payer regulations or policies; (viii) other adverse actions of governmental and third-party payers; (ix) changes in testing guidelines or recommendations; (x) federal, state, and local government responses to the COVID-19 pandemic, and the volume of COVID-19 Testing performed by the company; (xi) the impact of global geopolitical events; (xii) the effect of public opinion on the company's reputation; (xiii) adverse results in material litigation matters; (xiv) the impact of changes in laws and regulations applicable to the company; (xv) failure to maintain or develop customer relationships; (xvi) the company's ability to develop or acquire new products and adapt to technological changes; (xvii) failure in information technology, systems, or data security; (xviii) the impact of potential losses under repurchase agreements; (xix) adverse weather conditions; (xx) the number of revenue days in a financial period; (xxi) employee relations; (xxii) personnel costs; (xxiii) inflation; (xxiv) increased competition; and (xxv) the effect of exchange rate fluctuations. These factors, in some cases, have affected and in the future (together with other factors) could affect the company's ability to implement the company's business strategy, and actual results could differ materially from those suggested by these forward-looking statements. As a result, readers are cautioned not to place undue reliance on any of the forward- looking statements. The company has no obligation to provide any updates to these forward-looking statements even if its expectations change. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Further information on potential factors, risks and uncertainties that could affect operating and financial results is included in the company's most recent Annual Report on Form 10-K and subsequent Forms 10-Q, including in each case under the heading RISK FACTORS, and in the company's other filings with the SEC. The information in this press release should be read in conjunction with a review of the company's filings with the SEC including the information in the company's most recent Annual Report on Form 10-K, and subsequent Forms 10-Q, under the heading "MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS". The consolidated revenue and adjusted segment operating income are presented net of intersegment transaction eliminations and other amounts not used in determining segment performance. Adjusted operating income and adjusted operating margin are non-GAAP measures. See the subsequent reconciliation of non-GAAP financial measures. SOURCE Labcorp Holdings Inc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

The contract will provide an initial commitment of $19.6 million and up to $135.2 million over a six-year period, supporting drug manufacturing and phase 1 trials for the two programs GigaGen’s recombinant polyclonals are part of Grifols’ robust innovation strategy and commitment to delivering the next generation of antibody drugs for patients and healthcare professionals SAN CARLOS, Calif., Oct. 03, 2024 (GLOBE NEWSWIRE) -- GigaGen Inc., a biotechnology company advancing transformative antibody drugs for immunodeficiencies, infectious diseases and checkpoint-resistant cancers, and a subsidiary of Grifols, announced today that it has been awarded a contract 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 award, valued at up to $135.2 million, is to develop a recombinant polyclonal antibody therapy for botulinum neurotoxins (BoNT) and a second biothreat of interest to the agency that will be determined at a later time. “We are thrilled to have been awarded this BARDA contract and are proud to continue our collaboration with the U.S. government to advance innovative therapies against naturally emerging and intentional biological threats,” said Carter Keller, senior vice president of Grifols and head of GigaGen. “GigaGen aims to change the way infectious diseases are treated with the world’s only recombinant polyclonal antibody therapeutic platform. Building on our successful collaboration with the Department of Defense (DOD), this project demonstrates the versatility of our recombinant polyclonal antibody platform, which is ideally suited for rapid responses to imminent biological threats.” The BARDA project builds upon GigaGen’s contract awarded by the U.S. DOD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in 2022. The DOD project demonstrated the utility of GigaGen’s first-in-class recombinant human polyclonal antibody discovery platform against biological threats, focusing on two BoNT variants. Following success in this program that included in vivo neutralization of the two botulinum neurotoxins, the BARDA project will support the manufacturing and initial clinical development of a drug product that targets all seven BoNT variants. BoNT, one of the most toxic biological substances, is produced by the bacterium Clostridium botulinum and can cause progressive muscle paralysis from the head to the rest of the body, which can be fatal if left untreated. GigaGen recently received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to initiate a Phase 1 clinical trial to evaluate the company’s first recombinant polyclonal antibody therapeutic for the treatment of hepatitis B virus (HBV) infection, GIGA-2339. The company anticipates initiating the trial in Q4 2024. 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; Biomedical Advanced Research and Development Authority, under contract number 75A50124C00049. About GigaGen’s platformGigaGen’s next-generation recombinant polyclonal platform offers a novel way to develop synthetic polyclonal antibody therapeutics in the laboratory, which are potentially more powerful than what a natural immune response can provide. Using high-throughput, single-cell genomic and protein engineering technology, GigaGen creates cell lines that express recombinant human antibodies against a diversity of infectious disease antigens. The polyclonal cell bank can then be used to continuously manufacture recombinant polyclonal products against the pathogen of interest at existing manufacturing facilities. GigaGen has demonstrated that its products are hundreds of times more potent than plasma-derived antibody therapies. They replicate and enhance the natural antibody diversity, encompassing thousands of antibodies. This offers a significant advantage over monoclonal antibody therapies, as they can address the vast diversity of circulating pathogen variants and help prevent immune escape upon pathogen mutation. About GrifolsGrifols is a global healthcare company founded in Barcelona in 1909 committed to improving the health and well-being of people around the world. A leader in essential plasma-derived medicines and transfusion medicine, the company develops, produces, and provides innovative healthcare services and solutions in more than 110 countries. Patient needs and Grifols’ ever-growing knowledge of many chronic, rare and prevalent conditions, at times life-threatening, drive the company’s innovation in both plasma and other biopharmaceuticals. The company is focused on treating conditions across a broad range of therapeutic areas: immunology, hepatology and intensive care, pulmonology, hematology, neurology, and infectious diseases. A pioneer in the plasma industry, Grifols continues to grow its network of donation centers, the world’s largest with over 390 across North America, Europe, Africa and the Middle East, and China. As a recognized leader in transfusion medicine, Grifols offers a comprehensive portfolio of solutions designed to enhance safety from donation to transfusion, in addition to clinical diagnostic technologies. It provides high quality biological supplies for life-science research, clinical trials, and for manufacturing pharmaceutical and diagnostic products. The company also supplies tools, information and services that enable hospitals, pharmacies and healthcare professionals to efficiently deliver expert medical care. Grifols, with more than 24,000 employees in more than 30 countries and regions, is committed to a sustainable business model that sets the standard for continuous innovation, quality, safety, and ethical leadership. The company’s class A shares are listed on the Spanish Stock Exchange, where they are part of the Ibex-35 (MCE:GRF). Grifols non-voting class B shares are listed on the Mercado Continuo (MCE:GRF.P) and on the U.S. NASDAQ through ADRs (NASDAQ:GRFS). GigaGen is advancing transformative antibody drugs for immunodeficiencies, infectious diseases and checkpoint resistant cancers by leveraging industry-leading, single-cell technologies. Its novel technology platforms uniquely capture and recreate complete immune repertoires as functional antibody libraries. This approach has enabled the creation of first-in-class recombinant polyclonal antibody therapies for the treatment of infectious diseases. In addition, GigaGen’s lead oncology asset, GIGA-564, is an anti-CTLA-4 monoclonal antibody that has demonstrated improved anti-tumor efficacy and reduced toxicities in preclinical models through a unique mechanism of action. For more information, please visit www.grifols.com or www.gigagen.com. Media Contacts:Michael RubensteinLifeSci Communicationsmrubenstein@lifescicomms.comTel: +1- 561-289-7981 Grifols Press Officemedia@grifols.comTel. +34 93 571 00 02 LEGAL DISCLAIMERThe facts and figures contained in this report that do not refer to historical data are “future projections and assumptions”. Words and expressions such as “believe”, “hope”, “anticipate”, “predict”, “expect”, “intend”, “should”, “will seek to achieve”, “it is estimated”, “future” and similar expressions, in so far as they relate to the Grifols group, are used to identify future projections and assumptions. These expressions reflect the assumptions, hypotheses, expectations and predictions of the management team at the time of writing this report, and these are subject to a number of factors that mean that the actual results may be materially different. The future results of the Grifols group could be affected by events relating to its own activities, such as a shortage of supplies of raw materials for the manufacture of its products, the appearance of competitor products on the market, or changes to the regulatory framework of the markets in which it operates, among others. At the date of compiling this report, the Grifols group has adopted the necessary measures to mitigate the potential impact of these events. Grifols, S.A. does not accept any obligation to publicly report, revise or update future projections or assumptions to adapt them to events or circumstances subsequent to the date of writing this report, except where expressly required by the applicable legislation. This document does not constitute an offer or invitation to buy or subscribe shares in accordance with the provisions of the following Spanish legislation: Royal Legislative Decree 4/2015, of 23 October, approving recast text of Securities Market Law; Royal Decree Law 5/2005, of 11 March and/or Royal Decree 1310/2005, of 4 November, and any regulations developing this legislation. In addition, this document does not constitute an offer of purchase, sale or exchange, or a request for an offer of purchase, sale or exchange of securities, or a request for any vote or approval in any other jurisdiction. The information included in this document has not been verified nor reviewed by the external auditors of the Grifols group.