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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 and Humanigen have entered into a contract development and manufacturing (CDMO) agreement to accelerate production of lenzilumab, an antibody aimed at treating COVID-19 related cytokine storms. The deal leverages manufacturing capacity reserved by the U.S. government through the Department of Defense and aims for an emergency use authorization (EUA) in Q1 2021. Emergent's advanced facilities in Baltimore will support increased production, forming a key part of Humanigen's growth strategy.
Emergent BioSolutions (NYSE: EBS) announced participation in key investor conferences for Q1 2021. These include:
- 39th Annual J.P. Morgan Healthcare Conference from January 11-14, 2021, with a presentation on January 11 at 8:20 am EST.
- J.P. Morgan 2021 Global High Yield & Leveraged Finance Conference on March 1-3, 2021, with details to be updated on their website.
- Cowen 41st Annual Health Care Conference from March 1-4, 2021, also pending updates.
Webcasts will cover recent developments and financial results.
Emergent BioSolutions (EBS) and Mount Sinai Health System have initiated a clinical program to evaluate COVID-HIG for post-exposure prophylaxis against SARS-CoV-2. Two Phase 1 studies will assess safety and pharmacokinetics in healthy adults and adults with mild COVID-19. The U.S. Department of Defense has provided $34.6 million in funding, alongside a prior $14.5 million grant from HHS. The partnership aims to protect high-risk individuals, such as healthcare workers, by leveraging Mount Sinai's plasma collection capabilities, although COVID-HIG is not yet FDA-approved.
Emergent BioSolutions (EBS) reported strong Q3 2020 results with total revenues of $385.2 million, up 24% from Q3 2019. Year-to-date revenues reached $972.4 million, a 30% increase. Adjusted net income rose to $119.0 million, or $2.19 per diluted share in Q3. The company refined its 2020 financial forecast, projecting total revenues between $1.52 - $1.58 billion and adjusted net income between $375 - $405 million.
Despite strong performance, product sales declined 21% due to lower sales of travel health vaccines.
Emergent BioSolutions (EBS) will host a conference call on November 5, 2020, at 5:00 PM ET, to discuss Q3 2020 financial results, recent business developments, and revenue guidance for Q4 2020 and full year 2020. The call can be accessed via telephone or live webcast. Details including dial-in numbers and conference ID are provided in the release. The company aims to enhance life through specialty products and services, aspiring to protect or enhance 1 billion lives by 2030.
Emergent BioSolutions (NYSE:EBS) has initiated a Phase 3 clinical trial for its COVID-19 Human Immune Globulin (COVID-HIG) under the sponsorship of NIAID. This trial, named INSIGHT-013, aims to evaluate the safety and efficacy of COVID-HIG in hospitalized COVID-19 patients, with approximately 500 participants expected. COVID-HIG is intended to augment the natural antibody response to SARS-CoV-2 when combined with remdesivir. Emergent has secured $14.5 million in funding for COVID-HIG and is also exploring its use in high-risk populations.
Emergent BioSolutions (NYSE: EBS) announced a partnership with the Boston Red Sox, Cincinnati Reds, Philadelphia Phillies, and MAPDA to promote awareness of overdose reversal medicines on International Overdose Awareness Day, August 31, 2020. The collaboration will include special announcements and presentations aimed at emphasizing the importance of accessing life-saving medications. Doug White, SVP of Emergent, stressed the need for public awareness and access to these medicines to combat opioid overdoses. The initiative aligns with Emergent's mission to enhance public health and community safety.
Emergent BioSolutions (NYSE: EBS) announced the appointment of Marvin L. White as a Class II director on its board, effective October 1, 2020. Mr. White, who previously served on the board from 2010 to 2016, brings significant experience from the pharmaceutical and healthcare sectors. He has held leadership positions at Aptevo Therapeutics, St. Vincent Health, and Eli Lilly. His role on the board aims to enhance the company's growth strategy and increase shareholder value, as emphasized by executive chairman Fuad El-Hibri.
Emergent BioSolutions (NYSE: EBS) has announced its participation in several upcoming virtual investor conferences through September 2020. Key events include the NYSE Healthcare & Technology Investor Access Day on August 18, the Midwest IDEAS Investor Conference on August 27, and the Wells Fargo Virtual Healthcare Conference on September 9, among others. These conferences will feature presentations discussing recent business developments, financial results, and future guidance. Webcasts will be available live and for replay on the Emergent website under the 'Investors' section.
Emergent BioSolutions (NYSE: EBS) announced the FDA's approval to extend the shelf life of NARCAN® Nasal Spray from 24 to 36 months. This marks a significant improvement for this emergency opioid overdose treatment, which is the first FDA-approved nasal naloxone. Doug White, Senior VP, emphasized the extension as part of their ongoing innovation to meet healthcare needs.
In July, Emergent launched a new Generation II NARCAN® device that enhances storage conditions, making the product more accessible in emergencies.