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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) and Providence Therapeutics have established a five-year agreement valued at approximately $90 million for contract development and manufacturing services to support the development of Providence’s COVID-19 mRNA vaccine, PTX-COVID19-B.
This collaboration will enable Emergent to manufacture tens of millions of doses in 2022, with potential for hundreds of millions more. The manufacturing will utilize Emergent’s cGMP facility in Winnipeg, Canada, underscoring their commitment to addressing global public health needs.
Emergent BioSolutions has announced the start of a Phase 3 clinical trial for its COVID-19 Human Immune Globulin (COVID-HIG) to assess its efficacy and safety as a treatment for high-risk adult patients. Sponsored by NIAID, the study aims to enroll about 800 patients and examines the effects of hyperimmune globulin products on combating COVID-19 progression. The trial, named OTAC, will compare COVID-HIG infusions against a placebo, focusing on improving patient outcomes and reducing severe illness risks, particularly for immunocompromised individuals and older adults.
Emergent BioSolutions (NYSE: EBS) will attend several key investor conferences, including the IDEAS Midwest Conference (Aug 25-26) and the Wells Fargo Virtual Healthcare Conference (Sept 9-10). Key activities include pre-recorded presentations and 1-on-1 meetings. The company aims to discuss recent developments and financial guidance during these events. Emergent BioSolutions focuses on protecting public health and plans to enhance the lives of 1 billion people by 2030. For further details, visit their website.
Emergent BioSolutions Inc. (NYSE: EBS) reported Q2 2021 financial results, reaffirming its 2021 revenue forecast of $1.7 - $1.9 billion. Total revenues for Q2 were $397.5 million, a slight increase of 1% YoY, while net income plummeted 95% to $4.6 million. The company resumed production of Johnson & Johnson’s COVID-19 vaccine after FDA approval and secured contracts with U.S. and Canadian governments valued at over $238 million. Adjusted EBITDA declined 68% to $49.5 million, reflecting higher costs and inventory write-offs. The company anticipates Q3 revenues between $400 million and $500 million.
Emergent BioSolutions (NYSE:EBS) announced the resumption of production at its Bayview facility for Johnson & Johnson's Covid-19 vaccine bulk drug substance, following FDA reviews and a quality enhancement plan. CEO Robert Kramer highlighted this as a critical milestone in addressing public health threats. The company committed extensive resources to meet FDA standards and aims to ensure a strong supply chain for the vaccine. Emergent positions itself as a vital partner in epidemic preparedness and expresses gratitude towards government and industry collaborators.
Emergent BioSolutions partners with national nonprofit organizations to launch the Reverse the Silence campaign, raising awareness about opioid overdoses. The initiative features stories from Darren Waller and Dani Schaffer, who share personal experiences with addiction. According to CDC data, over 93,000 Americans died from drug overdoses in 2020, with opioids involved in 80% of those deaths. The campaign aims to encourage open communication about opioid risks and promote emergency preparedness.
Emergent BioSolutions Inc. (NYSE: EBS) will hold a conference call on July 29, 2021, at 5:00 PM ET to discuss its Q2 2021 financial results and provide revenue guidance for Q3 2021 and the full year. Investors can join via phone or webcast, with access details provided. Emergent aims to enhance life through its specialty products and services dedicated to public health, aspiring to protect or enhance one billion lives by 2030. For more details, visit their official website.
Emergent BioSolutions (NYSE:EBS) announced that two batches of its COVID-19 vaccine have received FDA authorization for emergency use, produced at the Bayview facility. The company is actively working with the FDA to address previous observations and aims to resume production soon. Emergent's Bayview facility, designated as a Center for Innovation in Advanced Development and Manufacturing, has been crucial for COVID-19 vaccine readiness since mid-2020. However, the company acknowledges the challenges of timely and sufficient vaccine production.
Emergent BioSolutions reported promising two-year data from its Phase 2 clinical trial for the chikungunya virus VLP vaccine, demonstrating a significant immune response. The study involved 415 healthy adults, showing that the SNA mean titers were 19 times higher than pre-vaccination levels after a single 40 µg dose. The vaccine was well-tolerated, with mostly mild side effects. All participants remained seropositive at one and two years post-vaccination. This data supports moving to a Phase 3 trial aimed at addressing the unmet need for chikungunya vaccination.
Emergent BioSolutions (NYSE: EBS) will host its 2021 Annual Meeting of Stockholders as a virtual-only event on May 20, 2021, at 9:00 AM EDT. Eligible stockholders can participate by accessing the meeting online at www.virtualshareholdermeeting.com/EBS2021 using their unique Control Number. Guests can attend in listen-only mode without voting rights. The company encourages participants to log in 15 minutes early. A replay of the event will be available on Emergent's website.