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Emergent BioSolutions, Inc. (NYSE: EBS) is a global life sciences company dedicated to protecting and enhancing life. With a mission to secure public health, Emergent develops, manufactures, and distributes a broad portfolio of medical countermeasures for biological and chemical threats as well as emerging infectious diseases. The company is committed to safeguarding lives and aims to protect and enhance 50 million lives with its products by 2025.
Headquartered in Gaithersburg, Maryland, Emergent operates through three primary segments: Commercial, Products, and Services. The Commercial segment, which generates the majority of the company's revenue, includes key products such as NARCAN® Nasal Spray—a life-saving medication for opioid overdoses. NARCAN® has become widely accessible in pharmacies, grocery stores, and online retailers, significantly increasing public availability since its over-the-counter approval by the FDA in March 2023.
Emergent is also known for its role in developing and manufacturing vaccines and therapeutics, particularly for governments and healthcare providers. The company's Baltimore Bayview manufacturing facility recently received a “No Action Indicated” status from the FDA, confirming its compliance with good manufacturing practices. This recognition underscores Emergent's dedication to quality and compliance in its manufacturing processes.
Financially, Emergent is focused on stabilizing its operations and strengthening its balance sheet. The recent restructuring plan aims to streamline operations, close certain manufacturing facilities, and reduce workforce by 300 employees, resulting in annualized savings of approximately $80 million. Despite these changes, Emergent remains dedicated to its core business areas and continues to offer integrated contract development and manufacturing services to pharmaceutical and biotechnology customers.
Key recent developments include the extension of NARCAN® Nasal Spray's shelf life from 36 to 48 months and its widespread distribution across the U.S. and Canada. Emergent is also actively working with partners like the National Safety Council to educate businesses and the public about opioid overdose prevention and response.
Emergent is committed to its long-term vision of protecting and enhancing 1 billion lives by 2030. The company continues to innovate and expand its product offerings while maintaining a strong focus on public health and safety.
Emergent BioSolutions (NYSE:EBS) announced positive Phase 2 results for its chikungunya virus vaccine candidate. The study included 60 healthy adults, showing that the vaccine was well-tolerated and immunogenic in both vaccine-naïve participants and those previously vaccinated against other alphavirus vaccines. Notably, the seroconversion rate was 100% in both groups. The findings were presented at the ASTMH annual meeting, highlighting the potential utility of the vaccine for U.S. military personnel facing heightened exposure risks. Currently, there are no approved vaccines for chikungunya disease.
Emergent BioSolutions (NYSE: EBS) has scheduled a conference call for November 8, 2022, at 5:00 PM ET to review its Q3 2022 financial results, recent business developments, and 2022 financial outlook. Investors can join via webcast or by phone after registering. A replay will be accessible on the company’s investor page. Emergent BioSolutions focuses on defending public health threats through vaccines and therapeutics and aims to enhance the lives of one billion people by 2030.
Emergent BioSolutions (NYSE: EBS) has successfully acquired exclusive worldwide rights to TEMBEXA® (brincidofovir) from Chimerix. The FDA-approved antiviral, indicated for smallpox treatment in all age groups, enhances Emergent's medical countermeasure portfolio. The acquisition follows regulatory approvals, including BARDA's consent for a $680 million contract covering up to 1.7 million treatment courses. Emergent's initial payment is $238 million, with additional milestone and royalty payments based on U.S. and international sales.
Emergent BioSolutions (NYSE: EBS) has commenced dosing the first participant in a Phase 1 clinical trial of EBS-LASV, a VSV-vectored vaccine aimed at combating Lassa virus infections. The study, co-funded by CEPI, will assess the vaccine's safety and immunogenicity in around 36 healthy adults in Ghana. Dr. Kelly Warfield emphasized the company's commitment to addressing public health threats, while CEPI highlighted the urgency of developing solutions against Lassa fever, which currently lacks approved vaccines or treatments.
Emergent BioSolutions (NYSE: EBS) announced participation in several investor conferences in August and September 2022. Key events include the 12th Annual Midwest IDEAS Investor Conference on August 24, a fireside chat at the Wells Fargo 2022 Healthcare Conference and Leveraged Finance Conference on September 8, and the Morgan Stanley 20th Annual Global Healthcare Conference from September 12-14. Webcast presentations will cover recent business developments and financial results, available live and on replay from the Emergent website.
Emergent BioSolutions (NYSE: EBS) reported Q2 2022 results with total revenues of $242.7 million, down 39% year-over-year. Net loss reached $56.4 million, marking a significant decline from the prior year's profit of $4.6 million. Adjusted EBITDA stood at $(28.8) million, down from $49.5 million. The company executed an agreement to acquire TEMBEXA and announced an FDA review of its anthrax vaccine. For 2022, total revenue guidance has been set at $1.15 to $1.25 billion, with CDMO revenues projected at $105 to $125 million.
Emergent BioSolutions Inc. (NYSE: EBS) will host a conference call on August 1, 2022, at 5:00 PM ET to discuss its Q2 2022 financial results and provide revenue guidance for Q3 2022 and the full year. The call will cover recent business developments and financial outlook. Participants can join via webcast or telephone after registration. A replay will be available on Emergent's Investors page.
Emergent focuses on public health threats, developing vaccines and therapeutics, and offering contract development services.
Emergent BioSolutions (NYSE: EBS) has formed a collaboration with Ridgeback Biotherapeutics to enhance availability of Ebanga™ (Ansuvimab-zykl) for Ebola treatment. Emergent will manage manufacturing, sales, and distribution in the U.S. and Canada, while Ridgeback will ensure free access to patients in endemic regions through its compassionate use program. Ebanga™, FDA-approved since December 2020, is crucial for combating Ebola. The partnership emphasizes both companies' commitment to addressing public health threats and ensuring equitable access to life-saving treatments.
Emergent BioSolutions (NYSE:EBS) appointed Sujata Dayal as a Class II director, effective July 15, 2022, with her term expiring at the 2023 annual meeting. Dayal brings extensive experience in healthcare compliance, having previously served at Medline, Johnson & Johnson, Biomet, and Abbott Laboratories. As a new board member, she joins the Nominating and Corporate Governance Committee and the Special Committee on Manufacturing and Quality Oversight, positioning her to significantly contribute to the company's growth and compliance efforts.
Emergent BioSolutions Inc. (NYSE:EBS) announced that the FDA has accepted for review its Biologics License Application (BLA) for AV7909, a new anthrax vaccine candidate for post-exposure prophylaxis in individuals aged 18-65. The Prescription Drug User Fee Act goal date for the FDA's decision is April 2023. This application is based on pivotal phase 3 clinical study data evaluating the vaccine's efficacy and safety. Emergent has collaborated with the U.S. government for over 20 years on this project, aiming to enhance public health preparedness against anthrax threats.
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