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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) will hold a conference call on February 24, 2022, at 5:00 PM ET to discuss its fourth-quarter 2021 financial results and business developments. The call will provide insights into the financial outlook for 2022, and revenue guidance for Q1 2022. Interested participants can join via telephone or webcast. Further details regarding the conference call are available on the company's website.
Fuad El-Hibri, founder and executive chairman of Emergent BioSolutions, announced his retirement effective April 1, 2022, after over 20 years of leadership. Under his guidance, the company grew significantly, launching products that address public health threats, including vaccines for anthrax and COVID-19. El-Hibri expressed gratitude to his team for their support and confidence in the company's ongoing strategic goals for 2024. Emergent generated approximately $1.6 billion in revenue in 2020 and will soon announce a new Chair of the Board to succeed El-Hibri.
Emergent BioSolutions reported preliminary 2021 revenues of $1.78 billion, a 14% increase year-over-year, but anticipates a decline in adjusted EBITDA to $512.5 million, down 19%. For 2022, the company projects revenues of $1.45 billion and an adjusted EBITDA margin of 21.5%. The guidance reflects a normalization in CDMO services and the impact of a generic market for NARCAN® Nasal Spray. Additionally, 2022 revenue estimates for key products include $280-$300 million from Anthrax vaccines and $240-$310 million from Nasal Naloxone products.
Emergent BioSolutions (NYSE: EBS) announced participation in three major investor conferences in Q1 2022. The 40th Annual J.P. Morgan Healthcare Conference is scheduled for January 10-13, with a presentation on January 10 at 8:15 am PST. Following this, the J.P. Morgan 2022 Global High Yield & Leveraged Finance Conference will occur from February 28 to March 2, with a presentation on February 28 at 2:00 pm EST. Lastly, the Cowen & Co. 42nd Annual Health Care Conference will take place March 7-9, with the presentation details to be updated. Webcasts will be accessible live and for replay on the company’s website.
Emergent BioSolutions Inc. (NYSE: EBS) has announced that the first participant has been dosed in its phase 1 study, EBS-UFV-001, which is assessing the safety, tolerability, and immunogenicity of its investigational universal influenza vaccine. The study aims to evaluate the vaccine's effectiveness against influenza A viruses and is taking place in Australia with 60 healthy adults involved. The company emphasizes its commitment to innovative R&D and public health solutions, focusing on a vaccine that could provide broad protection against varying influenza strains.
Emergent BioSolutions (NYSE: EBS) announced a stock repurchase program authorized by its Board of Directors, allowing for the buyback of up to $250 million of its common stock. This initiative, set to expire on November 11, 2022, showcases the company's confidence in its financial stability and growth prospects. As of September 30, 2021, the company held $403.8 million in cash and equivalents, with approximately 53.7 million shares outstanding. The buyback will be executed based on market conditions and is intended to enhance shareholder value.
Emergent BioSolutions reported Q3 2021 financial results with total revenues of $329 million, a 15% decrease from Q3 2020. The net loss was $32.7 million, resulting in a net loss per diluted share of $0.61. Adjusted EBITDA was ($3.3 million). The company secured a $399 million contract modification for AV7909 and initiated a pivotal Phase 3 study for its chikungunya vaccine. A multi-year agreement with Providence Therapeutics is valued at $90 million.
The forecast for 2021 is updated to $1.7 - $1.8 billion in total revenues.
Emergent BioSolutions (NYSE: EBS) will host a conference call on November 4, 2021, at 5:00 PM ET to discuss Q3 2021 financial results, recent developments, and the full-year outlook. Interested parties can join via telephone or webcast. The call will provide insights into the company's financial performance and strategic direction as it aims to enhance public health. For more details, visit the Emergent website.
Emergent BioSolutions (NYSE:EBS) announced the first participant dosed in its pivotal phase 3 study for the CHIKV VLP vaccine, targeting chikungunya disease. This single-dose vaccine candidate is the only VLP-based option in clinical testing. The study aims to enroll over 3,150 participants across 49 U.S. sites, focusing on its safety and immune response. Previous phase 2 results indicated strong immunogenicity and a favorable safety profile. Regulatory agencies have granted the vaccine several designations to expedite its development, addressing an unmet medical need.
Shuman, Glenn & Stecker is investigating potential claims against Emergent BioSolutions (EBS) related to a securities class action lawsuit. The lawsuit alleges that Emergent's executives misrepresented the company's ability to produce COVID-19 vaccines, specifically those of Johnson & Johnson and AstraZeneca, at its Baltimore facility. Following FDA inspections revealing significant operational issues and contamination incidents, Emergent's stock fell over 15% in early April 2021 and has since dropped to around $55 per share, failing to recover.
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