Welcome to our dedicated page for Emergent Biosolutions news (Ticker: EBS), a resource for investors and traders seeking the latest updates and insights on Emergent Biosolutions stock.
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) has received FDA approval for NARCAN® Naloxone HCl Nasal Spray 4 mg, making it the first over-the-counter (OTC) naloxone spray in the U.S. This pivotal approval aims to combat the escalating opioid crisis, where someone dies from an overdose every eight minutes. NARCAN will be available without a prescription by late summer 2023. Since its launch in 2016, over 44 million doses have been distributed. The product retains its original formulation and strength, essential for reversing opioid effects. Emergent is committed to enhancing public health and facilitating access to life-saving treatments.
Emergent BioSolutions reported Q4 2022 revenues of $331 million, totaling $1.121 billion for FY 2022, in line with guidance. The company faced a net loss of $88 million for Q4 and $224 million for the full year. Adjusted EBITDA for Q4 was $34 million, with an adjusted gross margin of 48%. Looking ahead, Emergent projects FY 2023 revenues between $1.1 billion and $1.2 billion, with adjusted EBITDA expected to reach $100 million. The company anticipates improved operations and cost structures as it focuses on patient and customer priorities.
Emergent BioSolutions (NYSE:EBS) received a unanimous recommendation from the FDA’s advisory committees for the over-the-counter sale of NARCAN Nasal Spray, a 4 mg naloxone product for opioid overdose reversal. This vote supports expanding access to NARCAN, crucial amid rising overdose deaths, particularly those linked to synthetic opioids like fentanyl. In 2021, over 70,000 American lives were lost to such overdoses. The FDA's decision, expected by March 29, 2023, marks a significant step in addressing this public health crisis. Emergent aims to collaborate with stakeholders to enhance access and awareness of NARCAN as a lifesaving treatment.
Emergent BioSolutions (NYSE: EBS) has signed an agreement to sell its travel health business to Bavarian Nordic for up to $380 million, including future milestones. This includes the rights to VIVOTIF® and VAXCHORA® vaccines and a chikungunya vaccine candidate. Emergent will receive $270 million upfront, with potential additional payments of $110 million based on sales and development milestones. The transaction aims to enhance Emergent's focus on its core medical countermeasure products, improving profitability and fostering sustainable growth. The deal is expected to close in Q2 2023, pending regulatory approvals.
Emergent BioSolutions (NYSE: EBS) will conduct a conference call on February 27, 2023 at 5:00 PM ET to discuss its Q4 2022 financial results, recent business developments, and the 2023 financial outlook. Participants can join via webcast or telephone after registering in advance. The replay will be available on the company’s Investors page.
Emergent BioSolutions (NYSE: EBS) announced preliminary financial results for 2022, projecting total revenues between $1,100 million and $1,120 million, reflecting a 38% decrease from 2021. The company anticipates a net loss of $210 million to $190 million and an Adjusted EBITDA of $20 million to $40 million, down 94% year-over-year. Key strategic changes include the appointment of new leadership and a workforce reduction of 132 roles to achieve over $60 million in annual savings. Emergent plans to refocus on its core medical countermeasures and commercial products, with financial outlook for 2023 forthcoming.
Emergent BioSolutions (NYSE:EBS) has secured an indefinite-delivery, indefinite-quantity contract valued at up to $379.6 million to supply the Reactive Skin Decontamination Lotion Kit (RSDL®) to the U.S. military. The contract includes a base year starting December 2022 and four optional annual renewals. RSDL® has been utilized by the U.S. for 13 years and is designed to neutralize chemical warfare agents. Emergent emphasizes its commitment to public health and military preparedness through this contract.
Emergent BioSolutions Inc. (NYSE:EBS) has received FDA acceptance for its supplemental New Drug Application (sNDA) for NARCAN® (naloxone HCl) Nasal Spray as an over-the-counter (OTC) emergency treatment for opioid overdose, marking a historic first. The FDA has granted Priority Review, with a decision expected by March 29, 2023. The move aims to enhance access to NARCAN amid a rising opioid crisis, which saw over 71,000 fatalities from opioids in 2021 alone. Emergent plans to leverage five years of post-marketing data and Human Factors studies to support the application.
Emergent BioSolutions has announced a research award from the U.S. Department of Defense to evaluate the efficacy of its single-dose chikungunya virus vaccine candidate. The collaboration involves the Armed Forces Research Institute of Medical Sciences to conduct a Phase 3b clinical study assessing the vaccine's effectiveness in areas with active chikungunya transmission. The initiative is backed by a $10 million budget for planning and clinical phases, supporting the aim to combat chikungunya, a significant public health threat.
Emergent BioSolutions (NYSE: EBS) reported Q3 2022 financial results, revealing total revenues of $240 million, a decline of 27% compared to Q3 2021. The company faced a net loss of $75.7 million and adjusted EBITDA of $(15.2 million. Product sales fell 31% year-over-year, driven by decreased sales of nasal naloxone and ACAM2000. Despite challenges, the acquisition of TEMBEXA and ongoing clinical trials for vaccine candidates show potential for future growth. The revised 2022 financial outlook projects total revenues between $1.05 billion and $1.1 billion.
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