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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) reaffirms its commitment to combating the opioid epidemic by expanding access to NARCAN® Nasal Spray and educating the public on opioid overdose response. The company is supporting the 'White House Challenge to Save Lives from Overdose' by implementing workplace safety measures and continuing its Ready to Rescue public awareness campaign.
Emergent has installed opioid emergency wall units in its facilities and provided NARCAN® Nasal Spray to employees. The company is also working with partners like the National Safety Council to educate businesses. Since NARCAN® Nasal Spray became available over the counter in August 2023, Emergent has distributed over 2,700 opioid emergency kits on college campuses and in public venues.
In response to recent CDC data showing a decline in opioid overdose deaths, Emergent is pledging to donate an additional 20,000 doses of NARCAN® Nasal Spray to communities in need. The company remains committed to expanding access and awareness through OTC availability, partnerships, and education initiatives.
Emergent BioSolutions Inc. (NYSE: EBS) has announced the closing of a new $100 million asset-backed loan facility (ABL) on September 30, 2024. The credit agreement, with Wells Fargo Bank as the administrative agent, provides revolving loan commitments with a maturity date of September 30, 2029, subject to early maturity triggers. This new facility adds to Emergent's liquidity, supporting its multi-year transformation plan. As of September 30, 2024, Emergent had a cash balance of approximately $150 million and undrawn access to the full $100 million ABL.
Joe Papa, president and CEO of Emergent, stated that the new ABL credit facility with favorable terms and extended maturity demonstrates the company's strengthened balance sheet and financial position. This agreement follows Emergent's recent refinancing of its debt, including a new credit facility agreement with Oak Hill Advisors for a term loan of up to $250 million announced on September 3, 2024.
Emergent BioSolutions Inc. (NYSE: EBS) has announced the execution of two contract options valued at $67.4 million for the procurement of additional TEMBEXA® (brincidofovir) treatment courses. This order supports the U.S. government's national preparedness efforts against human smallpox. The contract options, CLIN0004A and CLIN0005A, are part of Emergent's existing 10-year contract with a maximum potential value of $568 million.
TEMBEXA® is indicated for treating human smallpox disease in adult and pediatric patients, including neonates. The funding, secured through 2027, will ensure a continued supply of TEMBEXA® to address the threat of smallpox. This project is funded by the Department of Health and Human Services, Administration for Strategic Preparedness and Response, and Biomedical Advanced Research and Development Authority (BARDA) under contract number 75A50122C00047.
Emergent BioSolutions Inc. (NYSE: EBS) has secured approximately $400 million in orders for 2024 and 2025 related to its vaccinia, smallpox, and mpox product portfolio. This includes a U.S. government contract modification for ACAM2000® and CNJ-016® (VIGIV) contract options. In 2024, nearly $210 million in orders have been delivered, with an additional $185+ million confirmed for delivery through 2025.
The company recently received FDA approval for ACAM2000® to include mpox prevention in high-risk individuals. Emergent has also submitted an Expression of Interest to the WHO for Emergency Use Listing (EUL) of ACAM2000® for mpox. Additionally, Emergent has donated 50,000 doses of ACAM2000® for potential deployment in affected African countries.
Emergent BioSolutions Inc. (NYSE: EBS) has been awarded a $41.9 million contract modification by BARDA for the continued development of Ebanga™ (ansuvimab-zykl), a licensed treatment for Ebola virus disease. This option is part of a larger 10-year contract valued at approximately $121 million for advanced development and up to $583 million for procurement of Ebanga™ treatment.
The funding will support drug substance engineering, scale-up process validation, long-term stability studies, and commercial readiness. Emergent will also complete post-licensure commitments, including technology transfer for manufacturing scale-up and submission of a supplemental Biologics License Application to the FDA.
Emergent BioSolutions Inc. (NYSE: EBS) has successfully refinanced its debt, closing a new credit facility agreement with Oak Hill Advisors for a term loan of up to $250 million. The New Term Loan, maturing in August 2029, replaces the previous credit agreement scheduled to mature in May 2025. This refinancing is part of Emergent's multi-year plan to stabilize, turnaround, and transform the company.
Key points include:
- Excess proceeds will add cash to the balance sheet
- Emergent issued warrants to purchase 2.5 million shares of common stock
- The company agreed to issue $10 million worth of common stock to lenders
- Emergent is on track to reduce net debt by over $200 million this year
This refinancing provides Emergent with additional liquidity and flexibility to execute its business plan and continue providing critical, life-saving products.
Emergent BioSolutions (NYSE: EBS) has launched the second year of its Ready to Rescue initiative, expanding efforts to increase awareness and availability of NARCAN® Nasal Spray for opioid emergency preparedness. The campaign, featuring pro football legend Emmitt Smith, will include new college football tailgate stops, in-stadium activities, Greek Life events, and student wellness clinics.
The initiative aims to educate communities on opioid risks and how to be prepared with NARCAN® Nasal Spray, which is now available over-the-counter. Targeting college communities, where opioid misuse and dependency rates are highest among 18-25 year-olds, the campaign will visit several universities this fall to provide education and Ready to Rescue kits.
Emergent emphasizes the importance of widespread access to NARCAN® Nasal Spray, as opioid poisonings remain the leading cause of accidental death in the United States, despite a recent reduction in drug overdose deaths.
Emergent BioSolutions Inc. (NYSE: EBS) announced that the FDA has approved ACAM2000® for prevention of mpox disease in high-risk individuals. This single-dose vaccine, originally approved for smallpox in 2007, now has an expanded indication. The approval is based on human safety data and animal studies showing effectiveness against mpox virus exposure.
Emergent is actively engaging with global health leaders to support the response to the recent mpox outbreak, which the WHO declared a public health emergency. The company plans to donate 50,000 doses of ACAM2000® for potential deployment in Central Africa. This approval comes as mpox continues to spread, with over 95,000 cases reported across 115 non-endemic countries in 2022.
Emergent BioSolutions Inc. (NYSE: EBS) has finalized the sale of its Baltimore-Camden drug product facility to Bora Pharmaceuticals Co., (TWSE: 6472) for approximately $30 million, subject to post-closing adjustments. The transaction includes the transfer of assets, equipment, and workforce associated with the 87,000 square foot manufacturing site. This sale is part of Emergent's multi-year plan to stabilize, turnaround, and transform the company, with a focus on improving profitability and reducing debt. Joe Papa, President and CEO of Emergent, emphasized the significance of this milestone in creating a more customer-focused, leaner, and flexible organization.
Emergent BioSolutions (NYSE: EBS) is responding to the mpox public health emergency in Africa by donating 50,000 doses of its ACAM2000® vaccine through Direct Relief. This action follows the WHO's declaration of a public health emergency of international concern (PHEIC) due to the mpox outbreak in Central Africa. Emergent has filed a supplemental Biologics License Application (sBLA) with the FDA to expand ACAM2000®'s indication to include immunization against mpox virus, with a review target in Q3 2024.
The company is actively engaging with global health leaders and has the capacity to increase supply by approximately 40 million doses if needed. Emergent emphasizes the importance of ongoing efforts to produce and stockpile vaccines for orthopox viruses, including mpox and smallpox, in light of increasing outbreaks worldwide.