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What changed in Emergent BioSolutions Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Emergent BioSolutions Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+496 added−614 removedSource: 10-K (2026-02-27) vs 10-K (2025-03-04)

Top changes in Emergent BioSolutions Inc.'s 2025 10-K

496 paragraphs added · 614 removed · 370 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

133 edited+52 added−52 removed135 unchanged
Biggest changeSpecifically, on July 18, 2024, Bavarian Nordic announced that the European Medicines Agency had validated the marketing authorization application for CHIKV VLP, which triggered a development milestone payment receivable under the Purchase and Sale Agreement to the Company in the amount of $10.0 million (the "First Milestone Payment").
Biggest changeWe have achieved all four development milestones under the Purchase and Sale Agreement with Bavarian Nordic for aggregate payments of $80.0 million: $10.0 million upon Bavarian Nordic's announcement that the European Medicines Agency had validated the marketing authorization application for CHIKV VLP in July 2024; $20.0 million upon Bavarian Nordic's announcement that the FDA accepted and granted Priority Review for the Biologics License Application ("BLA") for CHIKV VLP in August 2024; $30.0 million, upon the FDA's approval of CHIKV VLP under the Priority Review for persons 12 years of age and older in February 2025; and $20.0 million upon the European Commission's approval of CHIKV VLP for persons 12 years of age and older in February 2025.
United States, Canada VIGIV CNJ-016 ® [Vaccinia Immune Globulin Intravenous (Human)] Treatment of complications due to vaccinia vaccination, including: • Eczema vaccinatum • Progressive vaccinia; • Severe generalized vaccinia; • Vaccinia infections in individuals who have skin conditions; and • Aberrant infections induced by vaccinia virus (except in cases of isolated keratitis).
United States, Canada CNJ-016 ® (VIGIV) [Vaccinia Immune Globulin Intravenous (Human)] Treatment of complications due to vaccinia vaccination, including: • Eczema vaccinatum • Progressive vaccinia; • Severe generalized vaccinia; • Vaccinia infections in individuals who have skin conditions; and • Aberrant infections induced by vaccinia virus (except in cases of isolated keratitis).
The Company has two patent families relating to the TEMBEXA ® product including but not limited to, those listed in the Orange Book: 8,962,829, 9,303,051, 9,371,344, 10,112,909, and 10,487,061. The latest expiring United States composition of matter patents expires in 2034. VIGIV CNJ-016 ® (Vaccinia Immune Globulin Intravenous (Human)).
The Company has two patent families relating to the TEMBEXA ® product including but not limited to, those listed in the Orange Book: 8,962,829, 9,303,051, 9,371,344, 10,112,909, and 10,487,061. The latest expiring United States composition of matter patents expires in 2034. CNJ-016 ® (VIGIV) (Vaccinia Immune Globulin Intravenous (Human)).
VIGIV CNJ-016 ® is the only polyclonal antibody therapeutic licensed by the FDA and Health Canada to address certain complications from replicating virus smallpox vaccination. The principal customer for VIGIV CNJ-016 ® is the USG, specifically HHS.
CNJ-016 ® (VIGIV) is the only polyclonal antibody therapeutic licensed by the FDA and Health Canada to address certain complications from replicating virus smallpox vaccination. The principal customer for CNJ-016 ® (VIGIV) is the USG, specifically HHS.
Government Contracting Our status as a USG contractor means that we are subject to various statutes and regulations, including: • the Federal Acquisition Regulation ("FAR") and agency-specific regulations supplemental to FAR, which comprehensively regulate the award, formation, administration and performance of government contracts; • the Defense Federal Acquisition Regulations Supplement ("DFARS") and agency-specific regulations supplemental to DFARS, which comprehensively regulate the award, formation, administration and performance of DoD government contracts; • the Department of State Acquisition Regulation which regulates the relationship between a Department of State organization and a contractor or potential contractor; • business ethics and public integrity obligations, which govern conflicts of interest and the hiring of former government employees, restrict the granting of gratuities and funding of lobbying activities and incorporate other requirements such as the Anti-Kickback Act, the Procurement Integrity Act, the False Claims Act and the Foreign Corrupt Practices Act; • export and import control laws and regulations, including but not limited to the Export Administration Regulations and International Traffic in Arms Regulations; and • laws, regulations and executive orders restricting the use and dissemination of information classified for national security purposes and the exportation of certain products and technical data.
Government Contracting Our status as a USG contractor means that we are subject to various statutes and regulations, including: • the Federal Acquisition Regulation ("FAR") and agency-specific regulations supplemental to FAR, which comprehensively regulate the award, formation, administration and performance of government contracts; • the Defense Federal Acquisition Regulations Supplement ("DFARS") and agency-specific regulations supplemental to DFARS, which comprehensively regulate the award, formation, administration and performance of DoW government contracts; • the Department of State Acquisition Regulation which regulates the relationship between a Department of State organization and a contractor or potential contractor; • business ethics and public integrity obligations, which govern conflicts of interest and the hiring of former government employees, restrict the granting of gratuities and funding of lobbying activities and incorporate other requirements such as the Anti-Kickback Act, the Procurement Integrity Act, the False Claims Act and the Foreign Corrupt Practices Act; • export and import control laws and regulations, including but not limited to the Export Administration Regulations and International Traffic in Arms Regulations; and • laws, regulations and executive orders restricting the use and dissemination of information classified for national security purposes and the exportation of certain products and technical data.
We make available, free of charge on our website, our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and all amendments to those reports filed or furnished pursuant to 24 Section 13(a) or 15(d) of the Securities Exchange Act of 1934 (the "Exchange Act") as soon as reasonably practicable after we electronically file those reports with, or furnish them to, the SEC.
We make available, free of charge on our website, our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and all amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934 (the "Exchange Act") as soon as reasonably practicable after we electronically file those reports with, or furnish them to, the SEC.
All phases of clinical studies must be conducted in conformance with the FDA’s bioresearch monitoring regulations and Good Clinical Practices ("GCP"), which include applicable ICH Guidelines and are collectively ethical and scientific quality standards for the conduct and reporting of clinical trials in human subjects. Marketing Approval – Biologics, Drugs and Vaccines Biologics License Application ("BLA")/New Drug Application ("NDA") .
All phases of clinical studies must be conducted in conformance with the FDA’s bioresearch monitoring regulations and Good Clinical Practices ("GCP"), which include applicable ICH Guidelines and are collectively ethical and scientific quality standards for the conduct and reporting of clinical trials in human subjects. 18 Marketing Approval – Biologics, Drugs and Vaccines Biologics License Application ("BLA")/New Drug Application ("NDA") .
In September 2016, we signed a combination development and procurement contract with Biomedical Advanced Research and Development Authority ("BARDA"), which included a five-year base period of performance to develop CYFENDUS ® for post-exposure prophylaxis of anthrax disease and to deliver to the SNS an initial two million doses, subsequently modified to three million doses in March 2017.
In 2016, we signed a combination development and procurement contract with Biomedical Advanced Research and Development Authority ("BARDA"), which included a five-year base period of performance to develop CYFENDUS ® for post-exposure prophylaxis of anthrax disease and to deliver to the SNS an initial two million doses, subsequently modified to three million doses in March 2017.
In addition, pursuant to various laws, our government contracts can be subject to unilateral termination or modification by the government for convenience, detailed auditing and accounting systems requirements, statutorily controlled pricing, sourcing and subcontracting restrictions and statutorily mandated processes for adjudicating contract disputes. The Project BioShield Act of 2004.
In addition, pursuant to various laws, our government contracts can be subject to unilateral termination or modification by the government for convenience, detailed auditing and accounting systems requirements, statutorily controlled pricing, sourcing and subcontracting restrictions and statutorily mandated processes for adjudicating contract disputes. 16 The Project BioShield Act of 2004.
We face potential future competition for the supply of anthrax vaccines if the USG chooses to procure alternative products or product candidates. GC Pharma, Blue Willow Biologics/Porton Biopharma, and Greffex are each currently developing anthrax vaccine product candidates, which are in various stages of clinical development.
We face potential future competition for the supply of anthrax vaccines if the USG chooses to procure alternative products or product candidates. GC Biopharma, Blue Willow Biologics/Porton Biopharma, and Greffex are each currently developing anthrax vaccine product candidates, which are in various stages of clinical development.
Following the acquisition, the 10-year contract with BARDA, valued at up to $680.0 million, to supply up to 1.7 million tablet and suspension formulations of TEMBEXA ® was novated to the Company, which contract was modified in September 2024 to execute additional procurement options valued at approximately $67.4 million.
Following the acquisition, the 10-year contract with BARDA, valued at up to $680.0 million, to supply up to 1.7 million tablet and suspension formulations of TEMBEXA ® was novated to the Company, which contract was modified in 2024 to execute additional procurement options valued at approximately $67.4 million.
In June 2019, we announced a contract award by HHS valued at approximately $535.0 million over 10 years for the continued supply of VIGIV CNJ-016 ® into the SNS for smallpox preparedness. VIGIV CNJ-016 ® has also been procured by a limited number of foreign governments.
In 2019, we announced a contract award by HHS valued at approximately $535.0 million over 10 years for the continued supply of CNJ-016 ® (VIGIV) into the SNS for smallpox preparedness. CNJ-016 ® (VIGIV) has also been procured by a limited number of foreign governments.
In the EU and Japan, TPOXX ® is indicated for the treatment of smallpox, mpox and cowpox, as well as the treatment of complications following vaccination against smallpox. Bioservices We also compete for bioservices with several biopharmaceutical product R&D organizations, contract manufacturers of biopharmaceutical products, other bioservices organizations, and university research laboratories.
In the EU and Japan, TPOXX ® is indicated for the treatment of smallpox, mpox and cowpox, as well as the treatment of complications following vaccination against smallpox. Bioservices We also compete for bioservices with several biopharmaceutical product R&D organizations, contract manufacturers of biopharmaceutical products (CDMOs), other bioservices organizations, and university research laboratories.
Adverse events that are reported after marketing approval can result in additional limitations being placed on the product’s distribution or use and, potentially, withdrawal or suspension of the product from the market. The FDA may also require post-approval clinical trials and/or safety labeling changes.
Adverse events that are reported after marketing approval can result in additional limitations being placed on the product’s distribution or use and, potentially, withdrawal or suspension of the product from the market. The FDA may also require post-approval clinical trials and/or labeling changes.
It has also procured and stockpiled many of our related products for potential use in the event of a PHT emergency, including BioThrax ® , ACAM2000 ® , Anthrasil ® , BAT ® , VIGIV CNJ-016 ® and raxibacumab products. 15 Funding for BARDA is provided by annual appropriations by Congress.
It has also procured and stockpiled many of our related products for potential use in the event of a PHT emergency, including BioThrax ® , ACAM2000 ® , ANTHRASIL ® , BAT ® , CNJ-016 ® (VIGIV) and raxibacumab products. Funding for BARDA is provided by annual appropriations by Congress.
Medical devices are classified into one of three classes—Class I, Class II or Class III—depending on the degree of risk and the level of control necessary to assure the safety and effectiveness of each medical device. Medical devices deemed to pose lower risks 19 are generally placed in either Class I or II.
Medical devices are classified into one of three classes—Class I, Class II or Class III—depending on the degree of risk and the level of control necessary to assure the safety and effectiveness of each medical device. Medical devices deemed to pose lower risks are generally placed in either Class I or II.
This can be (1) a determination by the Secretary of HHS that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad, and that involves CBRN agents, or a disease or condition that may be attributable to CBRN agents; (2) a determination by the Secretary of Homeland Security (“DHS”) that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a CBRN agent; (3) a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to United States military forces from an attack with a CBRN agent or an agent that may cause, or is otherwise associated with, an imminently life-threatening and specific risk to United States military forces; or (4) the identification of a material threat pursuant to section 319F–2 of the Public Health Service Act (“PHSA”) sufficient to affect national security or the health and security of United States citizens living abroad.
This can be (1) a determination by the Secretary of HHS that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad, and that involves CBRN agents, or a disease or condition that may be attributable to CBRN agents; (2) a determination by the Secretary of Homeland Security (“DHS”) that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a CBRN agent; (3) a determination by the Secretary of War that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to United States military forces from an attack with a CBRN agent or an agent that may cause, or is otherwise associated with, an imminently life-threatening and specific risk to United States military forces; or (4) the identification of a material threat pursuant to section 319F–2 of the Public Health Service Act (“PHSA”) sufficient to affect national security or the health and security of United States citizens living abroad.
In December 2023, TEMBEXA ® received approval by Health Canada. TEMBEXA ® faces competition from TPOXX ® (tecovirimat), an oral therapy for the treatment of smallpox disease that was approved by the FDA in July 2018 and is currently procured by the USG for the SNS. TPOXX ® is also approved in Canada and the EU.
In 2023, TEMBEXA ® received approval by Health Canada. TEMBEXA ® faces competition from TPOXX ® (tecovirimat), an oral therapy for the treatment of smallpox disease that was approved by the FDA in July 2018 and is currently procured by the USG for the SNS. TPOXX ® is also approved in Canada and the EU.
During the FDA's review of the application, the FDA will also typically inspect one or more clinical sites to ensure compliance with GCPs as well 17 as the facility or facilities at which the candidate is manufactured to ensure compliance with current good manufacturing practices ("CGMPs").
During the FDA's review of the application, the FDA will also typically inspect one or more clinical sites to ensure compliance with GCPs as well as the facility or facilities at which the candidate is manufactured to ensure compliance with current good manufacturing practices ("CGMPs").
Our failure to comply with these laws and regulations could subject us to criminal or civil penalties. Regulations Governing Reimbursement The marketing practices of U.S. pharmaceutical manufacturers are also subject to federal and state healthcare laws related to government funded healthcare programs.
Our failure to comply with these laws and regulations could subject us to criminal or civil penalties. 23 Regulations Governing Reimbursement The marketing practices of U.S. pharmaceutical manufacturers are also subject to federal and state healthcare laws related to government funded healthcare programs.
These sites allow us to meet our internal manufacturing needs as well as perform targeted services for our external customers. • Our Winnipeg and Gaithersburg sites house our development services expertise; • Our Canton, Lansing and Winnipeg sites house our commercial drug substance expertise; and 10 • Our Winnipeg site houses our drug product and packaging expertise.
These sites allow us to meet our internal manufacturing needs as well as perform targeted services for our external customers. • Our Winnipeg and Gaithersburg sites house our development services expertise; • Our Canton, Lansing and Winnipeg sites house our commercial drug substance expertise; and • Our Winnipeg site houses our drug product and packaging expertise.
Anthrasil ® Australia, Canada, Egypt, EU, Israel, Lebanon, Republic of Korea, Qatar, Saudi Arabia, Singapore, Turkey, United Kingdom, United Arab Emirates, U.S. U.S. EU, UK BAT ® Canada, China, EU, Japan, Mexico, Republic of Korea, United Kingdom, U.S. BioThrax ® Australia, Brazil, Canada, EU, India, Malaysia, Saudi Arabia, Singapore, United Kingdom, U.S. BaciThrax ® France CYFENDUS ® U.S.
ANTHRASIL ® Australia, Canada, Egypt, EU, Israel, Lebanon, Republic of Korea, Qatar, Saudi Arabia, Singapore, Turkey, United Kingdom, United Arab Emirates, U.S. U.S. EU, UK BAT ® Canada, EU, Japan, Mexico, United Kingdom, U.S. BioThrax ® Australia, Brazil, Canada, EU, India, Malaysia, Saudi Arabia, Singapore, United Kingdom, U.S. BaciThrax ® France CYFENDUS ® U.S.
We launched the Generation II NARCAN ® Nasal Spray device, which has a claim for enhanced temperature excursions and storage below 25°C. On January 18, 2024, the Company announced that the FDA has acknowledged the shelf-life extension of NARCAN ® Nasal Spray from 36 months to 48 months based on the Company’s four-year stability data.
We launched the Generation II NARCAN ® Nasal Spray device, which has a claim for enhanced temperature excursions and storage below 25°C. In January 2024, the Company announced that the FDA has acknowledged the shelf-life extension of NARCAN ® Nasal Spray from 36 months to 48 months based on the Company’s four-year stability data.
Of these product candidates, GC Pharma and Blue Willow Biologics have completed Phase 1 trials. • BAT ® . Our botulinum antitoxin immune globulin product is the only heptavalent antitoxin licensed by the FDA and Health Canada for the treatment of symptomatic botulism for all seven botulinum neurotoxin serotypes. Direct competition is currently limited. • CNJ-016 ® .
Of these product candidates, GC Biopharma and Blue Willow Biologics have completed Phase 1 trials. • BAT ® . Our botulinum antitoxin immune globulin product is the only heptavalent antitoxin licensed by the FDA and Health Canada for the treatment of symptomatic botulism for all seven botulinum neurotoxin serotypes. Direct competition is currently limited. • CNJ-016 ® .
On December 5, 2023, ACAM2000 ® vaccine received a Notice of Compliance from Health Canada for its Extraordinary Use New Drug Submission (EUNDS) for the indication of active immunization against smallpox disease for persons determined to be at high risk for smallpox infection. ACAM2000 ® is also licensed in Australia and Singapore for the smallpox indication.
In December 2023, ACAM2000 ® vaccine received a Notice of Compliance from Health Canada for its Extraordinary Use New Drug Submission (EUNDS) for the indication of active immunization against smallpox disease for persons determined to be at high risk for smallpox infection. ACAM2000 ® is also licensed in Australia and Singapore for the smallpox indication.
TEMBEXA ® is the first oral antiviral approved by the FDA for the treatment of smallpox disease caused by variola virus in adult and pediatric patients, including neonates. On September 26, 2022, we acquired exclusive worldwide rights to brincidofovir from Chimerix Inc. for the treatment of any human smallpox disease or any other disease caused by any orthopox virus.
TEMBEXA ® is the first oral antiviral approved by the FDA for the treatment of smallpox disease caused by variola virus in adult and pediatric patients, including neonates. In September 2022, we acquired exclusive worldwide rights to brincidofovir from Chimerix Inc. for the treatment of any human smallpox disease or any other disease caused by any orthopox virus.
ACAM2000 ® vaccine is a smallpox and mpox vaccine licensed by the FDA for active immunization for the prevention of smallpox and mpox disease in individuals determined to be at high risk for smallpox or mpox infection. The mpox indication was approved by the FDA following a supplemental Biological License Application ("sBLA") approval issued on August 29, 2024.
ACAM2000 ® vaccine is a smallpox and mpox vaccine licensed by the FDA for active immunization for the prevention of smallpox and mpox disease in individuals determined to be at high risk for smallpox or mpox infection. The mpox indication was approved by the FDA following a supplemental Biological License Application ("sBLA") approval issued in August 2024.
Like their constituent parts—e.g., drugs and devices—combination products are highly regulated and subject to a broad range of pre- and post-market requirements including premarket review, CGMPs and/or QSRs, adverse event reporting, periodic reports, labeling and advertising and promotion requirements and restrictions, market withdrawal and recall.
Like their constituent parts—e.g., drugs and devices—combination products are highly regulated and subject to a broad range of pre- and post-market requirements including premarket review, CGMPs and/or QMSRs, adverse event reporting, periodic reports, labeling and advertising and promotion requirements and restrictions, market withdrawal and recall.
Manufacturers and other entities involved in the manufacture and distribution of cleared, approved, or otherwise authorized products are required to register their establishments with the FDA, and in some instances state agencies, and they are subject to periodic unannounced or announced inspections by the FDA for compliance with CGMPs and/or QSRs and other requirements.
Manufacturers and other entities involved in the manufacture and distribution of cleared, approved, or otherwise authorized products are required to register their establishments with the FDA, and in some instances state agencies, and they are subject to periodic unannounced or announced inspections by the FDA for compliance with CGMPs and/or QMSRs and other requirements.
On February 15, 2023, the FDA Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee unanimously voted in favor (a total of 19 votes) that the benefit-risk profile of NARCAN ® Nasal Spray was supportive of its use as a nonprescription opioid overdose reversal agent.
In February 2023, the FDA Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee unanimously voted in favor (a total of 19 votes) that the benefit-risk profile of NARCAN ® Nasal Spray was supportive of its use as a nonprescription opioid overdose reversal agent.
FDA may request samples of any lot and, when deemed necessary for the safety, purity, and potency of the product, FDA may prohibit us from distributing a lot until FDA releases the lot. Several of our vaccines are subject to lot release protocols by the FDA and other regulatory agencies.
FDA may request samples of any lot and, when deemed necessary for the safety, purity, and potency of the product, FDA may prohibit us from distributing a lot until FDA releases the lot. Some of our vaccines are subject to lot release protocols by the FDA and other regulatory agencies.
These processes must be performed in compliance with the applicable portions of the QSR, which covers the methods and the facilities and controls for the manufacture, testing, production, quality assurance, labeling, packaging, distribution, installation and servicing of finished devices intended for human use.
These processes must be performed in compliance with the applicable portions of the QMSR, which covers the methods and the facilities and controls for the manufacture, testing, production, quality assurance, labeling, packaging, distribution, installation and servicing of finished devices intended for human use.
Both before and after a medical device is commercially distributed, manufacturers and marketers of the device have ongoing responsibilities under FDA regulations, including, for example, establishment registration and device listing; compliance with the requirements of the Quality System Regulation (“QSR”); compliance with requirements regarding the labeling and marketing of devices; medical device reporting regulations; correction and removal reporting regulations; compliance with requirements for Unique Device Identification (“UDI”); and post-market surveillance activities and requirements.
Both before and after a medical device is commercially distributed, manufacturers and marketers of the device have ongoing responsibilities under FDA regulations, including, for example, establishment registration and device listing; compliance with the requirements of the Quality Management System Regulation (“QMSR”); compliance with requirements regarding the labeling and marketing of devices; medical device reporting regulations; correction and removal reporting regulations; compliance with requirements for Unique Device Identification (“UDI”); and post-market surveillance activities and requirements.
We will be responsible for manufacturing, selling and distributing Ebanga TM (ansuvimab-zykl) in the U.S. and Canada and Ridgeback will serve as the global access partner. In July 2023, we announced we were awarded a 10-year contract by BARDA, valued at up to a maximum of $704 million, for advanced development, manufacturing scale-up, and procurement of Ebanga™.
We are responsible for manufacturing, selling and distributing Ebanga TM (ansuvimab-zykl) in the U.S. and Canada and Ridgeback will serve as the global access partner. In 2023, we announced we were awarded a 10-year contract by BARDA, valued at up to a maximum of $704 million, for advanced development, manufacturing scale-up, and procurement of Ebanga™.
Department of Defense ("DoD") and led by the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, with a maximum value up to $235.8 million, to supply BioThrax ® vaccine for use by all branches of the U.S. military as Pre-Exposure Prophylaxis (PrEP) for anthrax disease.
Department of War ("DoW") and led by the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, with a maximum value up to $235.8 million, to supply BioThrax ® vaccine for use by all branches of the U.S. military as Pre-Exposure Prophylaxis (PrEP) for anthrax disease.
The information contained on, or that can be accessed through, our website is not a part of, or incorporated by reference into, this Annual Report on Form 10-K. 25
The information contained on, or that can be accessed through, our website is not a part of, or incorporated by reference into, this Annual Report on Form 10-K. 26
The FDA's regulations also require, among other things, the 20 investigation and correction of any deviations from CGMP or failures to follow the QSR and the maintenance of applicable documentation by the sponsor and any third-party manufacturers involved in producing the approved, cleared, or otherwise authorized product. Regulation Outside of the U.S.
The FDA's regulations also require, among other things, the investigation and correction of any deviations from CGMP or failures to follow the QMSR and the maintenance of applicable documentation by the sponsor and any third-party manufacturers involved in producing the approved, cleared, or otherwise authorized product. Regulation Outside of the U.S.
On December 22, 2023, Emergent Canada Inc. received the MDEL, enabling the direct distribution of naloxone convenience kits containing medical devices and NARCAN ® Nasal Spray in Canada, which distribution was launched in 2024. 11 The following table lists the registered trademarks for NARCAN ® (naloxone HCl) Nasal Spray: Trademark Country of Registration NARCAN ® Benelux, Canada, Denmark, Estonia, EU, Finland, Germany, Ireland, Italy, Norway, Spain, Sweden, United Kingdom, U.S.
In December 2023, Emergent Canada Inc. received the MDEL, enabling the direct distribution of naloxone convenience kits containing medical devices and NARCAN ® Nasal Spray in Canada, which distribution was launched in 2024. 12 The following table lists the registered trademarks for NARCAN ® (naloxone HCl) Nasal Spray: Trademark Country of Registration NARCAN ® Benelux, Canada, Denmark, Estonia, EU, Finland, Germany, Ireland, Italy, Norway, Spain, Sweden, United Kingdom, U.S.
On January 8, 2025, the Company announced the exercise of a third option and modification to the IDIQ contract valued at approximately $20 million to supply BioThrax ® vaccine for use by all branches of the U.S. military as Pre-Exposure Prophylaxis (PrEP) for anthrax disease.
In January 2025, the Company announced the exercise of a third option and modification to the IDIQ contract valued at approximately $20 million to supply BioThrax ® vaccine for use by all branches of the U.S. military as Pre-Exposure Prophylaxis (PrEP) for anthrax disease.
On November 24, 2023, we submitted a Medical Device Establishment License (MDEL) Application to Health Canada that would permit Emergent to distribute naloxone convenience kits containing medical devices (gloves and CPR mask) and Narcan ® Nasal Spray (4mg) to comply with provincial legislative requirements.
In November 2023, we submitted a Medical Device Establishment License (MDEL) Application to Health Canada that would permit Emergent to distribute naloxone convenience kits containing medical devices (gloves and CPR mask) and Narcan ® Nasal Spray (4mg) to comply with provincial legislative requirements.
As a result of the FDA’s announcement, the scope of orphan drug exclusivity and other issues relating to the FDA’s implementation of the Orphan Drug Act with respect to previously approved and future products may be the subject of litigation or legislation. Vaccine and Therapeutic Product Lot Protocol.
As a result of the FDA’s announcement, the scope of orphan drug exclusivity and other issues relating to the FDA’s implementation of the Orphan Drug Act with respect to previously approved and future products may be the subject of litigation or legislation. Vaccine and Therapeutic Product Lot Release Requirements.
NARCAN ® Nasal Spray was approved as an OTC medication on March 29, 2023. It was the first 4 mg naloxone nasal spray available OTC in the U.S.
NARCAN ® Nasal Spray was approved as an OTC medication in March 2023. It was the first 4 mg naloxone nasal spray available OTC in the U.S.
In September 2024, BARDA elected to exercise Option 1 (valued at approximately $41.9 million) under the contract for work related to drug substance engineering, scale-up, stability, process validation and commercial readiness. Raxibacumab injection.
In 2024, BARDA elected to exercise Option 1 (valued at approximately $41.9 million) under the contract for work related to drug substance engineering, scale-up, stability, process validation and commercial readiness.
Additionally, we have a centralized R&D organization and an enterprise-wide governance approach to managing our portfolio of R&D projects. Commercial Product Segment In the U.S. and Canadian markets, our Commercial business primarily focuses on sales of NARCAN ® (naloxone HCl) Nasal Spray.
Additionally, we have a centralized R&D organization and an enterprise-wide governance approach to managing our portfolio of R&D projects. Commercial Product Segment In the U.S. and Canadian markets, our Commercial business primarily focuses on sales of naloxone products, NARCAN ® (naloxone HCl) Nasal Spray and KLOXXADO ® (nalonxone HCI) Nasal Spray.
Because the manufacturing process for biological products is complex, the FDA requires for many biologics, including most vaccines and immune globulin products, that each product lot undergo thorough testing for purity, potency, identity and sterility.
The manufacturing process for biological products is complex, therefore the FDA requires for many biologics, including most vaccines and immune globulin products, that each product lot undergo FDA testing for purity, potency, identity and sterility.
In addition to domestic government sales, BAT ® antitoxin continues to be sold internationally, with deliveries to 25 foreign countries in 2024. 7 BioThrax ® (Anthrax Vaccine Adsorbed). BioThrax ® vaccine is the only vaccine licensed by the FDA for pre-exposure prophylaxis of anthrax disease in persons at high risk of exposure.
In addition to domestic government sales, BAT ® antitoxin continues to be sold internationally, with deliveries to 19 foreign countries in 2025. 7 BioThrax ® (Anthrax Vaccine Adsorbed). BioThrax ® vaccine is the only vaccine licensed by the FDA for pre-exposure prophylaxis of anthrax disease in persons at high risk of exposure.
On September 3, 2019, we announced the award by the USG of a contract valued at up to approximately $2.0 billion over 10 years for the continued supply of ACAM2000 ® vaccine into the SNS, assuming all contract options are exercised.
In 2019, we announced the award by the USG of a contract valued at up to approximately $2.0 billion over 10 years for the continued supply of ACAM2000 ® vaccine into the SNS, assuming all contract options are exercised (the "ACAM2000 ® Contract").
Any drug, biologic or medical device product for which we receive FDA marketing authorization will be subject to continuing regulation by the FDA, including, among other things, record keeping requirements, reporting of adverse events, providing FDA with updated safety and efficacy information, product sampling and distribution requirements (for drugs and biologics), restrictions on advertising and promotion, and FDA inspections.
Any drug, biologic or medical device product for which we receive FDA marketing authorization will be subject to continuing regulation by the FDA, including, among other things, record keeping requirements, reporting of adverse events, providing FDA with updated safety and efficacy information, filing changes to manufacturing process and analytical testing, product sampling and distribution requirements (for drugs and biologics), restrictions on advertising and promotion, and FDA inspections.
As such, the key components of the business structure include the following four product and service categories: NARCAN ® commercial product, Anthrax - Medical Countermeasures (“MCM”) Products, Smallpox - MCM products and Emergent Bioservices (CDMO) (“Bioservices” ).
As such, the key components of the business structure include the following four product and service categories: Commercial products, consisting of NARCAN ® Nasal Spray and KLOXXADO ® , Anthrax – Medical Countermeasures (“MCM”) Products, Smallpox - MCM products, and Emergent Bioservices (CDMO) (“Bioservices”).
OUR OPERATING SEGMENTS Our business is organized in three reportable segments: • our Commercial Product Segment consisting of NARCAN ® Nasal Spray; • our MCM Products Segment consisting of Anthrax—MCM products, Smallpox—MCM products and Other Products (as discussed below) ; and • our Services Segment consisting of our Bioservices portfolio.
OUR OPERATING SEGMENTS Our business is organized in three operating segments: • our Commercial Product Segment consisting of NARCAN ® Nasal Spray and KLOXXADO ® (naloxone HCl) Spray; • our MCM Products Segment consisting of Anthrax—MCM products, Smallpox—MCM products and Other Products (as discussed below) ; and • our Services Segment consisting of our Bioservices portfolio.
United States Ebanga™ (ansuvimab-zykl) , for injection Treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection.
United States Ebanga™ (ansuvimab-zykl) , for injection Treatment of infection caused by Orthoebolavirus zairense in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Orthoebolavirus zairense infection.
Our raxibacumab product is indicated for the treatment of adult and pediatric patients with inhalational anthrax in combination with appropriate antibacterial drugs and for prophylaxis of inhalational anthrax when alternative therapies are not available or appropriate. 8 TEMBEXA ® (brincidofovir) tablets and oral suspension.
Our raxibacumab product is indicated for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. TEMBEXA ® (brincidofovir) tablets and oral suspension.
On May 8, 2020, we announced the finalization of a previously announced contract with HHS, valued at up to $550.0 million, if all options under the contract are exercised. The contract has two deliverables.
In 2020, we announced the finalization of a previously announced contract with HHS, valued at up to $550.0 million, if all options under the contract are exercised. The contract has two deliverables.
TEMBEXA ® Argentina, Australia, Brazil, Canada, Chile, China, EU, Hong Kong, India, Israel, Japan, Mexico, New Zealand, Norway, Russia, Singapore, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, U.S. CNJ-016 ® U.S.
TEMBEXA ® Argentina, Australia, Brazil, Canada, Chile, China, EU, Hong Kong, India, Israel, Japan, Mexico, New Zealand, Norway, Russia, Singapore, South Africa, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, U.S.
On July 1, 2022, we entered into an asset purchase agreement and a license agreement with Ridgeback Biotherapeutics (“Ridgeback”) to expand the availability of Ebanga TM (ansuvimab-zykl). This included a license to the Ebanga™ trademark and to certain patent rights related to Ebanga TM (ansuvimab-zykl).
In 2022, we entered into an asset purchase agreement and a license agreement with Ridgeback Biotherapeutics (“Ridgeback”) to expand the availability of Ebanga TM (ansuvimab-zykl). This included a license to use the Ebanga™ trademark and to certain patent rights related to Ebanga TM (ansuvimab-zykl).
Ebanga faces competition from another monoclonal antibody, Inmazeb ® (atoltivimab, maftivimab and odesivimab-ebgn), which was approved by the FDA in October 2020 with the same indication. Inmazeb ® is currently procured by the USG for the SNS . • NARCAN ® .
Ebanga faces competition from another monoclonal antibody, Inmazeb ® (atoltivimab, maftivimab and odesivimab-ebgn), which was approved by the FDA in October 2020 with the same indication. Inmazeb ® is currently procured by the USG for the SNS . 14 • Naloxone Commercial Products.
This multiple-year contract is intended to support the replacement of the smallpox vaccine stockpile and included a one-year base period of performance in 2019 valued at approximately $170.0 million, and nine option years. The number of doses under the base period were delivered by year end 2019. On May 28, 2020, we announced the exercise by the U.S.
This multiple-year contract is intended to support the replacement of the smallpox vaccine stockpile and included a one-year base period of performance in 2019 valued at approximately $170.0 million, and nine option years. The number of doses under the base period were delivered by year-end 2019. The U.S.
Our Bioservices consist of development services, bulk drug substance manufacturing, fill, finish, and packaging of final drug product. Collectively, this portfolio of services provides the capability to support “molecule-to-market” solutions to clients engaged in drug development through commercialization. These services are provided to innovator biopharmaceutical companies and non-governmental organizations ("NGOs").
Our Bioservices consist of development and analytical services, bulk drug substance manufacturing, drug product formulation and filling, and packaging of final drug product. Collectively, this portfolio of services provides the capability to support “molecule-to-market” solutions to clients engaged in drug development through commercialization of specific product types. These services are provided to biopharmaceutical innovator companies and non-governmental organizations ("NGOs").
This type of exclusivity is known as reference product exclusivity. The approval of a supplemental BLA or certain subsequent BLAs does not give rise to a new date of first licensure, and, consequently, does not yield an additional period of reference product exclusivity.
The approval of a supplemental BLA or certain subsequent BLAs does not give rise to a new date of first licensure, and, consequently, does not yield an additional period of reference product exclusivity.
Ebanga TM (ansuvimab-zykl) is a monoclonal antibody with antiviral activity provided through a single IV infusion (over 60 minutes) for the treatment of Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus.
Ebanga TM (ansuvimab-zykl) is a monoclonal antibody with antiviral activity provided through a single IV infusion (over 60 minutes) for the treatment of infection caused by Orthoebolavirus zairense in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Orthoebolavirus zairense infection.
On November 6, 2024, Emergent announced that TEMBEXA ® will be included in a clinical trial conducted and sponsored by PANTHER, under the leadership of the Africa Centers for Disease Control and Prevention, as part of the MpOx Study in Africa.
In 2024, Emergent announced that TEMBEXA ® would be included in a clinical trial conducted and sponsored by PANTHER, under the leadership of the Africa Centers for Disease Control and Prevention, as part of the Mpox Study in Africa (MOSA).
We believe that our investments in employee engagement and leadership development are essential to building the capabilities needed to realize our business strategy. As of December 31, 2024, we had approximately 900 employees globally.
We believe that our investments in employee engagement and leadership development are essential to building the capabilities needed to realize our business strategy. As of December 31, 2025, we had approximately 900 employees globally. During 2025, our number of employees globally stayed consistent.
There have been recent legislative proposals to reduce the duration of the 12-year reference product exclusivity period, but none has been enacted to date. Moreover, many states have enacted laws that address pharmacy substitution practices involving biosimilar products. Post-Approval Requirements.
There have been legislative proposals to reduce the duration of the exclusivity periods, but none has been enacted to date. Moreover, many states have enacted laws that address pharmacy substitution practices involving biosimilar products. Post-Approval Requirements.
Potential Sanctions For all FDA-regulated products, if the FDA finds that a manufacturer has failed to comply with applicable laws and regulations, or that a product is ineffective or poses an unreasonable health risk, it can institute or seek a wide variety of enforcement actions and remedies, including but not limited to: • restrictions on products, manufacturers or manufacturing processes; • restrictions on the labeling or marketing of a product; • restrictions on distribution or use of a product; • requirements to conduct post-marketing studies or clinical trials; • warning letters or untitled letters; • withdrawal of the products from the market; • refusal to approve pending applications or supplements to approved applications that are submitted; • recall of products; • fines, restitution or disgorgement of profits or revenues; • suspension or withdrawal of marketing approvals; • refusal to permit the import or export of our products; • product seizure; and • injunctions or the imposition of civil or criminal penalties. 21 Health regulatory authorities in other countries have similar rules and regulations although the specifics vary from jurisdiction to jurisdiction.
However, reliance-based or recognition-based regulatory decisions are not eligible under this procedure. 22 Potential Sanctions For all FDA-regulated products, if the FDA finds that a manufacturer has failed to comply with applicable laws and regulations, or that a product is ineffective or poses an unreasonable health risk, it can institute or seek a wide variety of enforcement actions and remedies, including but not limited to: • restrictions on products, manufacturers or manufacturing processes; • restrictions on the labeling or marketing of a product; • restrictions on distribution or use of a product; • requirements to conduct post-marketing studies or clinical trials; • warning letters or untitled letters; • withdrawal of the products from the market; • refusal to approve pending applications or supplements to approved applications that are submitted; • recall of products; • fines, restitution or disgorgement of profits or revenues; • suspension or withdrawal of marketing approvals; • refusal to permit the import or export of our products; • product seizure; and • injunctions or the imposition of civil or criminal penalties.
These declarations could apply to ACAM2000 ® , Anthrasil ® , BAT ® , BioThrax ® , CYFENDUS ® , raxibacumab and VIGIV CNJ-016 ® products, as covered MCMs. The declarations for anthrax and botulism expire on December 31, 2027. The declaration for smallpox, mpox, and other orthopox expires on December 31, 2032.
These declarations could apply to ACAM2000 ® , ANTHRASIL ® , BAT ® , BioThrax ® , CYFENDUS ® , raxibacumab and CNJ-016 ® (VIGIV) products, as covered MCMs. The declarations for anthrax and botulism expire on December 31, 2027.
In 2024, we continued two contracts with HHS for Anthrasil Anthrax IGIV: 1) a development and procurement contract which was successfully completed as of September 2024, and 2) an active delivery order issued under a multiple award, indefinite delivery/indefinite quantity contract.
In 2024, we continued two contracts with HHS for ANTHRASIL ® : 1) a development and procurement contract which was successfully completed as of September 2024, and 2) an active delivery order issued under a multiple award, indefinite delivery/indefinite quantity contract. The delivery order was successfully completed in July 2025 with formal close out executed in September 2025.
Commercial Product Our current Commercial portfolio consists of the following product: COMMERCIAL PRODUCTS Product Indication(s) Regulatory Approvals NARCAN ® (naloxone HCI) Nasal Spray Emergency treatment of known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression. United States, Canada Description of Commercial Product NARCAN ® Nasal Spray.
Commercial Products Our current commercial portfolio consists of the following product: COMMERCIAL PRODUCTS Product Indication(s)* Regulatory Approvals NARCAN ® (naloxone HCI) Nasal Spray Emergency use to reverse known or suspected opioid overdose as manifested by respiratory and/or severe central nervous system depression.
They are as follows: • Top Priorities ◦ Talent Attraction, Engagement & Development ◦ Ethics & Compliance ◦ Product Quality & Patient Safety ◦ Sustainable Innovation ◦ Product Affordability & Accessibility ◦ Responsible Supply Chain • Relative Priorities ◦ Supplier Product Quality, Reliability and Compliance ◦ Clinical Trial Practices ◦ Employee Health and Safety ◦ Climate Impact ◦ Sustainability and Corporate Responsibility Oversight Corporate Responsibility for Environmental Management We recognize that our operations have an impact on both local and global communities from the energy we source, the waste we generate, and the water we discharge.
The SASB standards provide guidelines on key sustainability issues that directly impact the operational performance and financial condition of our company. 25 Priority Issues Our priority issues are as follows: • Top Priorities ◦ Talent Attraction, Engagement & Development ◦ Ethics & Compliance ◦ Product Quality & Patient Safety ◦ Sustainable Innovation ◦ Product Affordability & Accessibility ◦ Responsible Supply Chain • Relative Priorities ◦ Supplier Product Quality, Reliability and Compliance ◦ Clinical Trial Practices ◦ Employee Health and Safety ◦ Climate Impact ◦ Sustainability and Corporate Responsibility Oversight Corporate Responsibility for Environmental Management We recognize that our operations have an impact on both local and global communities from the energy we source, the waste we generate, and the water we discharge.
NARCAN ® Nasal Spray, EBANGA™, TEMBEXA ® , CYFENDUS ® and BioThrax ® are produced externally in whole or in part by contract manufacturers. However, we perform the majority of the work internally to produce CYFENDUS ® and BioThrax ® .
The following products are manufactured internally: ACAM2000 ® , ANTHRASIL ® , BAT ® and CNJ-016 ® (VIGIV). NARCAN ® Nasal Spray, EBANGA™, TEMBEXA ® , CYFENDUS ® and BioThrax ® are produced externally in whole or in part by contract manufacturers. However, we perform the majority of the work internally to produce CYFENDUS ® and BioThrax ® .
NARCAN ® Nasal Spray may face additional generic and branded competition in the future. • Raxibacumab and Anthrasil ® [Anthrax Immune Globulin Intravenous (Human)].
Our naloxone products may face additional generic and branded competition in the future. • Raxibacumab and ANTHRASIL ® [Anthrax Immune Globulin Intravenous (Human)].
On December 10, 2024, Emergent completed its FDA establishment registration (per Title 21 CFR Part 807) to authorize Emergent to distribute imported convenience kits containing medical devices (gloves and CPR mask) in the U.S. These convenience kits provide devices that support treatment of opioid overdose.
KLOXXADO ® , a prescription product, is also available to patients with prescriptions at pharmacies. In December 2024, Emergent completed its FDA establishment registration (per Title 21 CFR Part 807) to authorize Emergent to distribute imported convenience kits containing medical devices (gloves and CPR mask) in the U.S. These convenience kits provide devices that support treatment of opioid overdose.
For the FDA to approve an interchangeable biosimilar product, it must conclude that the product is biosimilar to the reference product, can be expected to produce the same clinical result as the reference product in any given patient, and—for a product that is administered more than once to an individual—alternating or switching between the proposed interchangeable product and the reference product would not create an increased risk in terms of safety or diminished efficacy compared to using the reference product only. 18 FDA will not accept a biosimilar application until four years after the date of first licensure of a biological product licensed under section 351(a) of the PHSA, and FDA will not approve a biosimilar application until 12 years after such date of first licensure.
For the FDA to approve an interchangeable biosimilar product, it must conclude that the product is biosimilar to the reference product, can be expected to produce the same clinical result as the reference product in any given patient, and—for a product that is administered more than once to an individual—alternating or switching between the proposed interchangeable product and the reference product would not create an increased risk in terms of safety or diminished efficacy compared to using the reference product only.
MCM Products Segment Our Government - MCM business focuses primarily on procurement of MCM products and procured product candidates by domestic and international government customers, with an emphasis on the U.S. Government (“USG”), which is our largest customer.
MCM Products Segment Our Government - MCM business focuses primarily on procurement of MCM products and procured product candidates by domestic and international government customers, with an emphasis on the USG, which is our largest customer. We also sell MCM products and procured product candidates to domestic and international non- and quasi-government organizations and to governments outside of the U.S.
BioThrax ® vaccine is also approved by the FDA for post-exposure prophylaxis administration in combination with antimicrobial therapy in the event of suspected or confirmed exposure to Bacillus anthracis . Anthrax is a potentially fatal disease caused by the spore-forming bacterium, Bacillus anthracis . Inhalational anthrax is the most lethal form of anthrax.
BioThrax ® vaccine is also approved by the FDA for post-exposure prophylaxis of disease following suspected or confirmed Bacillus anthracis exposure, when administered in conjunction with recommended antibacterial drugs. Anthrax is a potentially fatal disease caused by the spore-forming bacterium, Bacillus anthracis . Inhalational anthrax is the most lethal form of anthrax.
United States, Canada BAT ® [Botulism Antitoxin Heptavalent (A,B,C,D,E,F,G)-(Equine)] Treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin serotypes A, B, C, D, E, F, or G in adults and pediatric patients.
United States ANTHRASIL ® [Anthrax Immune Globulin Intravenous (Human)] Treatment of inhalational anthrax in adult and pediatric patients in combination with appropriate antibacterial drugs. United States, Canada BAT ® [Botulism Antitoxin Heptavalent (A,B,C,D,E,F,G)-(Equine)] Treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin serotypes A, B, C, D, E, F, or G in adults and pediatric patients.
Fraud, Abuse and Anti-Corruption Laws The U.S. and most other jurisdictions have detailed requirements that apply to government and private health care programs, and a broad range of fraud and abuse laws, transparency laws, and other laws.
Health regulatory authorities in other countries have similar rules and regulations although the specifics vary from jurisdiction to jurisdiction. Fraud, Abuse and Anti-Corruption Laws The U.S. and most other jurisdictions have detailed requirements that apply to government and private health care programs, and a broad range of fraud and abuse laws, transparency laws, and other laws.
We work closely with our suppliers for these specialty programs and operate under long-term agreements. 14 INTELLECTUAL PROPERTY We actively seek to protect intellectual property related to our assets, including patent rights, trademark rights, trade secrets and proprietary confidential information, through defense and enforcement of existing rights and pursuit of protection on new and arising innovations.
INTELLECTUAL PROPERTY We actively seek to protect intellectual property related to our assets, including patent rights, trademark rights, trade secrets and proprietary confidential information, through defense and enforcement of existing rights and pursuit of protection on new and arising innovations.
Support Anti-Terrorism by Fostering Effective Technology Act of 2002. The Support Anti-terrorism by Fostering Effective Technologies Act of 2002 (“SAFETY Act”) was enacted to create certain liability limitations for Qualified Anti-Terrorism Technologies (“QATTs”) for claims arising out of, related to, or resulting from an act of terrorism.
The Support Anti-terrorism by Fostering Effective Technologies Act of 2002 (“SAFETY Act”) was enacted to create certain liability limitations for Qualified Anti-Terrorism Technologies (“QATTs”) for claims arising out of, related to, or resulting from an act of terrorism. DHS administers the SAFETY Act program, which provides two potential categories of liability protections – designation and certification.
If the RLD’s NDA holder or patent owner initiates patent litigation to enforce an Orange Book-listed patent within 45 days after receiving notice of a paragraph IV certification, the FDA generally is prohibited from approving the application until 30 months from the date of receipt of the paragraph IV notice, although this stay may terminate earlier depending upon the resolution of the litigation, if the court issues an order terminating the stay, or if the patent owner or exclusive patent licensee consents to approval of the application before the expiration of the stay.
Alternatively, the ANDA or 505(b)(2) NDA applicant may submit a statement that there are no relevant patents or that a method-of-use patent does not claim a proposed indication or other condition of use for which the applicant is seeking approval. 19 If the RLD’s NDA holder or patent owner initiates patent litigation to enforce an Orange Book-listed patent within 45 days after receiving notice of a paragraph IV certification, the FDA generally is prohibited from approving the application until 30 months from the date of receipt of the paragraph IV notice, although this stay may terminate earlier depending upon the resolution of the litigation, if the court issues an order terminating the stay, or if the patent owner or exclusive patent licensee consents to approval of the application before the expiration of the stay.
CYFENDUS ® (Anthrax Vaccine Adsorbed, Adjuvanted) (referred to as investigational product AV7909 prior to FDA approval in July 2023). CYFENDUS ® vaccine was approved by the FDA for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial drugs.
CYFENDUS ® vaccine was approved by the FDA for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial drugs. In 2021, AV7909 was granted orphan drug designation by the FDA. In 2023, the FDA approved our BLA for CYFENDUS ® .

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeNARCAN ® Nasal Spray also faces branded competition from prescription products, such as Kloxxado™ (naloxone HCl nasal spray 8mg), a branded product developed by Hikma, Zimhi™ (naloxone), a branded injectable product developed by Adamis Pharmaceuticals Corporation, Rextovy TM, (naloxone HCL nasal spray 4 mg), a branded product developed by Amphastar Pharmaceuticals, Inc. and its naloxone injection product, Teleflex Medical Inc.'s Intranasal Mucosal Atomization Device, OPVEE ® (nalmefene nasal spray 2.7mg), a branded product developed by Opiant Pharmaceuticals Inc, (now a wholly owned subsidiary of Indivior PLC), and Rezenopy ® (naloxone HCL nasal spray 10mg), a branded product manufactured by Summit Biosciences Inc., as well as OTC products, such as RiVive TM (naloxene HCl nasal spray 3mg), a branded product developed by Harm Reduction Therapeutics.
Biggest changeNARCAN ® Nasal Spray also faces branded competition from prescription products, such as Zimhi™ (naloxone), a branded injectable product developed by Adamis Pharmaceuticals Corporation, Rextovy TM, (naloxone HCL nasal spray 4 mg), a branded product marketed by ZMI Pharma, Inc., Teleflex Medical Inc.'s Intranasal Mucosal Atomization Device, and Rezenopy ® (naloxone HCL nasal spray 10mg), a branded product manufactured by Summit Biosciences Inc., as well as OTC products, such as RiVive TM (naloxene HCl nasal spray 3mg), a branded product developed by Harm Reduction Therapeutics. 45 NARCAN ® (naloxone HCl) Nasal Spray may also face additional generic and branded competition in the future.
From time to time, we may experience deviations in the manufacturing process, including as a result of regulatory action, that may take significant time and resources to resolve and, if unresolved, may affect manufacturing output and could cause us to fail to satisfy customer orders or contractual commitments, lead to a termination of one or more of our contracts, lead to delays in our clinical trials, result in litigation, or other restrictions on the marketing or manufacturing of a product, any of which could be costly to us, damage our reputation and negatively impact our business.
From time to time, we may experience deviations in the manufacturing process, including as a result of regulatory action, that may take significant time and resources to resolve and, if unresolved, may affect manufacturing output and could cause us to fail to satisfy customer orders or contractual commitments, lead to a termination of one or more of our contracts, lead to delays in our clinical trials, result in litigation, or result in other restrictions on the marketing or manufacturing of a product, any of which could be costly to us, damage our reputation and negatively impact our business.
If we are audited or investigated and such audit or investigation were to uncover improper or illegal activities, we could be subject to civil and criminal fines and penalties, administrative sanctions, including suspension or debarment from government contracting, and suffer significant reputational harm.
If we are audited or investigated and such audit or investigation were to uncover improper or illegal activities, we could be subject to civil and criminal fines and penalties, and administrative sanctions, including suspension or debarment from government contracting, and we could suffer significant reputational harm.
These declarations apply to certain of our products, namely BioThrax ® , ACAM2000 ® , CYFENDUS ® , raxibacumab, Anthrasil ® , BAT ® and VIGIV CNJ-016 ® products, as covered countermeasures. Manufacturers are not entitled to protection under the PREP Act in cases of willful misconduct or for cases brought in non-U.S. tribunals or under non-U.S. law.
These declarations apply to certain of our products, namely BioThrax ® , ACAM2000 ® , CYFENDUS ® , raxibacumab, ANTHRASIL ® , BAT ® and CNJ-016 ® (VIGIV) products, as covered countermeasures. Manufacturers are not entitled to protection under the PREP Act in cases of willful misconduct or for cases brought in non-U.S. tribunals or under non-U.S. law.
We rely on PREP Act protection for BioThrax ® , raxibacumab, ACAM2000 ® , CYFENDUS ® , Anthrasil ® , BAT ® and VIGIV CNJ-016 ® products, and SAFETY Act protection for BioThrax ® in addition to our insurance coverage to help mitigate our product liability exposure for these products.
We rely on PREP Act protection for BioThrax ® , raxibacumab, ACAM2000 ® , CYFENDUS ® , ANTHRASIL ® , BAT ® and CNJ-016 ® (VIGIV) products, and SAFETY Act protection for BioThrax ® in addition to our insurance coverage to help mitigate our product liability exposure for these products.
A number of more established companies are also pursuing strategies to acquire or in-license products in the biopharmaceutical field. These companies may have a competitive advantage over us due to their size, cash resources, cost of capital, effective tax rate and greater clinical development and commercialization capabilities.
A number of more established companies are also pursuing strategies to acquire or in-license products in the biopharmaceutical field. These companies may have a competitive advantage over us due to their size, cash resources, cost of capital, effective tax rate or greater clinical development and commercialization capabilities.
Debt financing can have significant adverse consequences for our business, including: • requiring us to dedicate a substantial portion of cash flows from operations to payment on our debt, which would reduce available funds for other corporate initiatives; • increasing the amount of interest that we have to pay on debt with variable interest rates, if market rates of interest increase, to the extent we are unable to offset such risk through our hedging instruments; 48 • subjecting us, as under our Senior Secured Credit Facilities and the indenture governing the Senior Unsecured Notes, to restrictive covenants that reduce our ability to take certain corporate actions, acquire companies, products or technology, or obtain further debt financing; • requiring us to pledge our assets as collateral, which could reduce financial flexibility; and • increasing our exposure to adverse economic and industry conditions, furthering disadvantaging us against our competitors that have less debt, better debt servicing options or stronger debt servicing capacity.
Debt financing can have significant adverse consequences for our business, including: • requiring us to dedicate a substantial portion of cash flows from operations to payment on our debt, which would reduce available funds for other corporate initiatives; • increasing the amount of interest that we have to pay on debt with variable interest rates, if market rates of interest increase, to the extent we are unable to offset such risk through our hedging instruments; • subjecting us, as under our Senior Secured Credit Facilities and the indenture governing the Senior Unsecured Notes, to restrictive covenants that reduce our ability to take certain corporate actions, acquire companies, products or technology, or obtain further debt financing; • requiring us to pledge our assets as collateral, which could reduce financial flexibility; and • increasing our exposure to adverse economic and industry conditions, furthering disadvantaging us against our competitors that have less debt, better debt servicing options or stronger debt servicing capacity.
Issues that could delay or prevent successful integration or cost synergies of an acquired business or products include, among others: • retaining existing customers and attracting new customers; • retaining key employees; • diversion of management attention and resources; • conforming internal controls, policies and procedures, business cultures and compensation programs; • consolidating corporate and administrative infrastructures; • successfully executing technology transfers and obtaining required regulatory approvals; 51 • consolidating sales and marketing operations; • identifying and eliminating redundant and underperforming operations and assets; • assumption of known and unknown liabilities; • coordinating geographically dispersed organizations; • managing tax costs or inefficiencies associated with integrating operations; and • risks associated with intellectual property rights related to an acquisition or collaboration, including but not limited to, license rights, freedom-to-operate, litigation, and loss of proprietary confidential information, know-how, and trade secrets.
Issues that could delay or prevent successful integration or cost synergies of an acquired business or products include, among others: • retaining existing customers and attracting new customers; • retaining key employees; • diversion of management attention and resources; • conforming internal controls, policies and procedures, business cultures and compensation programs; • consolidating corporate and administrative infrastructures; • successfully executing technology transfers and obtaining required regulatory approvals; • consolidating sales and marketing operations; • identifying and eliminating redundant and underperforming operations and assets; • assumption of known and unknown liabilities; • coordinating geographically dispersed organizations; • managing tax costs or inefficiencies associated with integrating operations; and • risks associated with intellectual property rights related to an acquisition or collaboration, including but not limited to, license rights, freedom-to-operate, litigation, and loss of proprietary confidential information, know-how, and trade secrets.
Among other things, HITECH makes HIPAA's security standards directly applicable to “business associates,” or independent contractors or agents of covered entities that create, receive or obtain protected health information in connection with providing a service for or on behalf of a covered entity; • the Physician Payments Sunshine Act and its implementing regulations require certain manufacturers of drugs, biologics, medical devices and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program to report certain payments and transfers of value made to U.S. physicians, prescribers and teaching hospitals, as well as ownership or investment interests held by physicians, and their immediate family members; and 37 • state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payor, including commercial insurers; state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts; state, local and foreign laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, obtain pharmaceutical agent licensure, and/or otherwise restrict payments that may be made to health care providers and entities; and state, local and foreign laws that require drug manufacturers to report information related to payments and other transfers of value to health care providers or entities, or marketing expenditures .
Among other things, HITECH makes HIPAA's security standards directly applicable to “business associates,” or independent contractors or agents of covered entities that create, receive or obtain protected health information in connection with providing a service for or on behalf of a covered entity; • the Physician Payments Sunshine Act and its implementing regulations require certain manufacturers of drugs, biologics, medical devices and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program to report certain payments and transfers of value made to U.S. physicians, other prescribers and teaching hospitals, as well as ownership or investment interests held by physicians, and their immediate family members; and 39 • state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payor, including commercial insurers; state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts; state, local and foreign laws that require pharmaceutical companies to comply with the pharmaceutical industry’s otherwise voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, obtain pharmaceutical agent licensure, and/or otherwise restrict payments that may be made to health care providers and entities; and state, local and foreign laws that require drug manufacturers to report information related to payments and other transfers of value to health care providers or entities, or marketing expenditures .
If, in connection with any future inspection, regulatory authorities find that we are not in substantial compliance with all applicable requirements, or if they are not satisfied with the corrective actions we take, our regulators may undertake enforcement action against us, which may include: • warning letters, untitled letters, and other communications; • product seizure or withdrawal of the product from the market; • restrictions on the marketing or manufacturing of a product; 40 • suspension or withdrawal of regulatory approvals or refusal to approve pending applications or other marketing submissions, or supplements to approved applications; • fines or disgorgement of profits or revenue; and • injunctions or the imposition of civil or criminal penalties.
If, in connection with any future inspection, regulatory authorities find that we are not in substantial compliance with all applicable requirements, or if they are not satisfied with the corrective actions we take, our regulators may undertake enforcement action against us, which may include: • warning letters, untitled letters, and other communications; • product seizure or withdrawal of the product from the market; • restrictions on the marketing or manufacturing of a product; • suspension or withdrawal of regulatory approvals or refusal to approve pending applications or other marketing submissions, or supplements to approved applications; • fines or disgorgement of profits or revenue; and • injunctions or the imposition of civil or criminal penalties.
A summary of our risks includes, but is not limited to, the following: • Reduced demand for and/or funding for procurement of CYFENDUS ® , ACAM2000 ® , VIGIV CNJ-016 ® , BAT ® and/or BioThrax ® , discontinuation of funding of our USG procurement and development contracts. • Inability to secure follow-on product procurement contracts with the USG upon the expiration of any of our existing procurement contracts. • Our inability to maintain quality and compliance in all of our manufacturing operations. • Damage to, destruction of, or any unplanned disruption at our development and/or manufacturing facilities may impede our ability to manufacture our products, as well as deliver our bioservices. • Our operations, including our use of hazardous materials, chemicals, bacteria and viruses expose us to significant potential liabilities. • Clinical trials of product candidates are expensive and time-consuming, and their outcome is uncertain. • We may fail to capitalize on the most scientifically, clinically or commercially promising or profitable product candidates. • Failure to comply with complex laws and regulations pertaining to government contracts and resources required for responding to related government inquiries. • Conditions associated with approvals and ongoing regulation of products may limit how and the extent to which we manufacture and market them. • Failure to comply with various health care laws could result in substantial penalties. • Failure to comply with obligations under USG pricing programs may require reimbursement for underpayments and the payment of substantial penalties, sanctions and fines. • The extent to which we may be able to lawfully offer to sell and sell unapproved products in many jurisdictions may be unclear or ambiguous and such activities may subject us to regulatory enforcement actions. • Development and commercialization of pharmaceutical products and our biologic products are subject to evolving competition from private and public sector competition, or biosimiliar manufacturers. • NARCAN ® (naloxone HCl) Nasal Spray is currently subject to generic and branded competition and may be subject to additional branded and generic competition in the future. • Biologic products may be affected by the approval and entry of follow-on biologics, or biosimilars in the United States and other jurisdictions. • Challenges in obtaining or maintaining intellectual property rights and defense or enforcement of such rights. • Potential discrepancies or challenges with respect to licenses, including our failure to comply with obligations under such licenses. • Potential loss or misappropriation of proprietary information, know-how, and trade secrets which carries the risk of reducing the value of our technology and products. • Entry of competing generic drugs upon expiration of patents and/or regulatory exclusivity or with patents no longer in force. • The loss of sole-source suppliers or an increase in the price of inventory. • If other parties do not perform as contractually required or as expected, we may not be able to obtain regulatory approval for or commercialize our product candidates. 26 • Unfavorable results of legal proceedings and government investigations could adversely impact our business, financial condition and results of operations. • Our work on PHTs has exposed us to criticism and may expose us to further criticism, from the media, government personnel and others, which could further harm our reputation, negatively affect our share price, operations and our ability to attract and retain talent. • Cybersecurity incidents involving us, our business partners, collaborators or other third parties could harm our ability to operate our business effectively in light of our heightened risk profile. • We could face product liability exposure associated with the use of our medical products.
A summary of our risks includes, but is not limited to, the following: • Reduced demand for and/or funding for procurement of CYFENDUS ® , ACAM2000 ® , CNJ-016 ® (VIGIV), BAT ® and/or BioThrax ® , discontinuation of funding of our USG procurement and development contracts. • Inability to secure follow-on product procurement contracts with the USG upon the expiration of any of our existing procurement contracts. • Our inability to maintain quality and compliance in all of our manufacturing operations. • Damage to, destruction of, or any unplanned disruption at our development and/or manufacturing facilities may impede our ability to manufacture our products, as well as deliver our bioservices. • Our operations, including our use of hazardous materials, chemicals, bacteria and viruses expose us to significant potential liabilities. • Clinical trials of product candidates are expensive and time-consuming, and their outcome is uncertain. • We may fail to capitalize on the most scientifically, clinically or commercially promising or profitable product candidates. • Failure to comply with complex laws and regulations pertaining to government contracts and resources required for responding to related government inquiries. • Conditions associated with approvals and ongoing regulation of products may limit how and the extent to which we manufacture and market them. • Failure to comply with various health care laws could result in substantial penalties. • Failure to comply with obligations under USG pricing programs may require reimbursement for underpayments and the payment of substantial penalties, sanctions and fines. • The extent to which we may be able to lawfully offer to sell and sell unapproved products in many jurisdictions may be unclear or ambiguous and such activities may subject us to regulatory enforcement actions. • Development and commercialization of pharmaceutical products and our biologic products are subject to evolving competition from private and public sector competition, or biosimiliar manufacturers. • NARCAN ® (naloxone HCl) Nasal Spray and KLOXXADO ® (naloxone HCI) Nasal Spray are currently subject to generic and branded competition and may be subject to additional branded and generic competition in the future. • Biologic products may be affected by the approval and entry of follow-on biologics, or biosimilars in the United States and other jurisdictions. • Challenges in obtaining or maintaining intellectual property rights and defense or enforcement of such rights. • Potential discrepancies or challenges with respect to licenses, including our failure to comply with obligations under such licenses. • Potential loss or misappropriation of proprietary information, know-how, and trade secrets which carries the risk of reducing the value of our technology and products. • Entry of competing generic drugs upon expiration of patents and/or regulatory exclusivity or with patents no longer in force. • The loss of sole-source suppliers or an increase in the price of inventory. • If other parties do not perform as contractually required or as expected, we may not be able to obtain regulatory approval for or commercialize our product candidates. 27 • Unfavorable results of legal proceedings and government investigations could adversely impact our business, financial condition and results of operations. • Our work on PHTs has exposed us to criticism and may expose us to further criticism, from the media, government personnel and others, which could further harm our reputation, negatively affect our share price, operations and our ability to attract and retain talent. • Cybersecurity incidents involving us, our business partners, collaborators or other third parties could harm our ability to operate our business effectively in light of our heightened risk profile. • We could face product liability exposure associated with the use of our medical products.
If we 45 are unable to locate or establish alternative suppliers, our ability to manufacture our products and product candidates could be adversely affected and could harm our revenues, cause us to fail to satisfy contractual commitments, lead to a termination of one or more of our contracts or lead to delays in our clinical trials, any of which could be costly to us and otherwise materially harm our business, financial condition, operating results and cash flows.
If we are unable to locate or establish alternative suppliers, our ability to manufacture our products and product candidates could be adversely affected and could harm our revenues, cause us to fail to satisfy contractual commitments, lead to a termination of one or more of our contracts or lead to delays in our clinical trials, any of which could be costly to us and otherwise materially harm our business, financial condition, operating results and cash flows.
We also rely on single-source suppliers for the materials necessary to produce NARCAN ® (naloxone HCl) Nasal Spray, such as the naloxone active pharmaceutical ingredient and other excipients, along with the vial, stopper and device. Where a particular single-source supply relationship is terminated, we may not be able to establish additional or replacement suppliers for certain components or materials quickly.
We also rely on single-source suppliers for the materials necessary to produce NARCAN ® (naloxone HCl) Nasal Spray, such as the naloxone active pharmaceutical ingredient and other excipients, along with the vial, stopper and device. 47 Where a particular single-source supply relationship is terminated, we may not be able to establish additional or replacement suppliers for certain components or materials quickly.
Third-party claims of alleged patent infringement could delay, stop or affect the development and commercialization of our products and product candidates. Such challenges, while ongoing, could be costly, requiring and utilizing company resources. Such challenges, if successful, may impact marketing or launch of products, or require ongoing license and/or royalty fees associated with potential settlement agreements.
Third-party claims of alleged patent infringement could delay, stop or otherwise affect the development and commercialization of our products and product candidates. Such challenges, while ongoing, could be costly, requiring and utilizing company resources. Such challenges, if successful, may impact marketing or launch of products, or require ongoing license and/or royalty fees associated with potential settlement agreements.
The market for current products can also depend on what resources can be devoted to marketing or selling products, or how companies are positioned to adapt more quickly to new 42 technologies, respond to scientific advances or patient preferences and needs, initiate or withstand substantial price competition and/or procure third-party licensing and collaborative arrangements.
The market for current products can also depend on what resources can be devoted to marketing or selling products, or how companies are positioned to adapt more quickly to new technologies, respond to scientific advances or patient preferences and needs, initiate or withstand substantial price competition and/or procure third-party licensing and collaborative arrangements.
A number of states have passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing 36 cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
A number of states have passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
Future statutory or regulatory changes or CMS binding guidance could affect the ASP calculations for our products and the resulting Medicare payment rate and could negatively impact our results of operations. Pricing and rebate calculations vary among products and programs, involve complex calculations and are often subject to interpretation by us, governmental or regulatory agencies and the courts.
Future statutory or regulatory changes or CMS binding guidance could affect the ASP calculations for our products and the resulting Medicare payment rate and could negatively impact our results of operations. 40 Pricing and rebate calculations vary among products and programs, involve complex calculations and are often subject to interpretation by us, governmental or regulatory agencies and the courts.
Our decisions to allocate our R&D, management and financial resources toward particular product candidates or therapeutic areas may not lead to the development of viable commercial products and may divert 33 resources from better business opportunities. Similarly, our decisions to delay or terminate product development programs could also cause us to miss valuable opportunities.
Our decisions to allocate our R&D, management and financial resources toward particular product candidates or therapeutic areas may not lead to the development of viable commercial products and may divert resources from better business opportunities. Similarly, our decisions to delay or terminate product development programs could also cause us to miss valuable opportunities.
Unexpected refunds to the government, and responding to a government investigation or enforcement action, can be expensive and time-consuming, and could have a material adverse effect on our business, financial condition, results of operations and growth prospects. From time to time, we sell unapproved MCMs to government entities under certain circumstances.
Unexpected refunds to the government, and responding to a government investigation or enforcement action, can be expensive and time-consuming, and could have a material adverse effect on our business, financial condition, results of operations and growth prospects. 41 From time to time, we sell unapproved MCMs to government entities under certain circumstances.
If we become aware that our reporting for a prior 38 quarter was incorrect, or has changed as a result of recalculation of the pricing data, we are obligated to resubmit the corrected data for a period not to exceed twelve quarters from the quarter in which the data originally were due.
If we become aware that our reporting for a prior quarter was incorrect, or has changed as a result of recalculation of the pricing data, we are obligated to resubmit the corrected data for a period not to exceed twelve quarters from the quarter in which the data originally were due.
Cybersecurity incidents could lead to the loss of trade secrets or other intellectual property or the public exposure of personal information, including sensitive personal information, of our employees, clinical trial patients, customers and others. Responding to any such threats may also be expensive and time-consuming.
Cybersecurity incidents could lead to the loss of trade secrets or other intellectual property or the public exposure of personal information, including sensitive personal information, of our employees, clinical trial patients, customers and others. Evaluating and responding to any such threats may also be expensive and time-consuming.
Compliance with current or future laws and regulations in this area can require significant costs and we could be subject to substantial 31 fines and penalties in the event of noncompliance. In addition, the risk of contamination or injury from these materials cannot be completely eliminated.
Compliance with current or future laws and regulations in this area can require significant costs and we could be subject to substantial fines and penalties in the event of noncompliance. In addition, the risk of contamination or injury from these materials cannot be completely eliminated.
If one or more legal matters were resolved against us or an indemnified third party in a reporting period for amounts above management’s 46 expectations, our financial condition and operating results for that reporting period could be materially adversely affected.
If one or more legal matters were resolved against us or an indemnified third party in a reporting period for amounts above management’s expectations, our financial condition and operating results for that reporting period could be materially adversely affected.
Any material weakness in our internal control over financial reporting could have an adverse effect on our business and financial results and our 50 ability to meet our reporting obligations could be negatively affected, each of which could negatively affect the trading price of our common stock.
Any material weakness in our internal control over financial reporting could have an adverse effect on our business and financial results and our ability to meet our reporting obligations could be negatively affected, each of which could negatively affect the trading price of our common stock.
We will continue to face future competition from other companies and governments, universities and other non-profit research organizations in respect to our products, any products that we acquire, our current product candidates and any products we may seek to develop or commercialize in the future.
We will continue to face future competition from other companies and governments, universities and other non-profit research organizations in respect of our products, any products that we acquire, our current product candidates and any products we may seek to develop or commercialize in the future.
Because we participate in the Medicaid rebate program, we are required to report average sales price ("ASP"), information to CMS for certain categories of drugs that are paid for under Part B of the Medicare program.
Because we participate in the Medicaid rebate program, we are also required to report average sales price ("ASP"), information to CMS for certain categories of drugs that are paid for under Part B of the Medicare program.
Although we continually evaluate and update security measures, there can be no assurance that any additional security measures would protect these facilities from terrorist efforts determined to disrupt our manufacturing activities. 30 Problems may arise during the production of our products and product candidates, as well as those we produce for our Bioservices customers, due to the complexity of the processes involved in product development, manufacturing and shipment or other factors.
Although we continually evaluate and update security measures, there can be no assurance that any additional security measures would protect these facilities from terrorist efforts determined to disrupt our manufacturing activities. 31 Problems may arise during the production of our products and product candidates, as well as those we produce for our Bioservices customers, due to the complexity of the processes involved in product development, manufacturing and shipment or other factors.
Under our contracts with the USG, we may not be able to limit third parties, including our competitors, from accessing certain of these technology or data rights, including intellectual property, in providing products and services to the USG. 29 MANUFACTURING RISKS An inability to maintain manufacturing compliance at our manufacturing facilities, which could damage our reputation and adversely affect our business, financial condition, operating results and cash flows.
Under our contracts with the USG, we may not be able to limit third parties, including our competitors, from accessing certain of these technology or data rights, including intellectual property, in providing products and services to the USG. 30 MANUFACTURING RISKS An inability to maintain manufacturing compliance at our manufacturing facilities, which could damage our reputation and adversely affect our business, financial condition, operating results and cash flows.
Once marketing authorization has been granted, we and our business partners will remain subject to ongoing regulatory oversight of our medical products, including with respect to labeling; safety surveillance and reporting; registration and listing requirements; CGMP and QSR requirements relating to manufacturing, quality control, quality assurance, and corresponding maintenance of records and documents; advertising and promotional activities; requirements regarding the distribution of samples to physicians and related recordkeeping; and medical device design, development and manufacturing.
Once marketing authorization has been granted, we and our business partners will remain subject to ongoing regulatory oversight of our medical products, including with respect to labeling; safety surveillance and reporting; registration and listing requirements; CGMP and QMSR requirements relating to manufacturing, quality control, quality assurance, and corresponding maintenance of records and documents; advertising and promotional activities; requirements regarding the distribution of samples to physicians and related recordkeeping; and medical device design, development and manufacturing.
GOVERNMENT CONTRACTING RISKS We currently derive, and historically derived a substantial portion of our revenue from USG procurement of CYFENDUS ® , ACAM2000 ® , VIGIV CNJ-016 ® , BAT ® and/or BioThrax ® .
GOVERNMENT CONTRACTING RISKS We currently derive, and historically derived a substantial portion of our revenue from USG procurement of CYFENDUS ® , ACAM2000 ® , CNJ-016 ® (VIGIV), TEMBEXA ® , BAT ® and/or BioThrax ® .
For all FDA-regulated products, if the FDA finds that a manufacturer has failed to comply with applicable laws and regulations, or that a product is ineffective or poses an unreasonable health risk, it can institute or seek a wide variety of enforcement actions and other remedies, including but not limited to: 35 • restrictions on such products, manufacturers or manufacturing processes; • restrictions on the labeling or marketing of a product; • restrictions on distribution or use of a product; • requirements to conduct post-marketing studies or clinical trials; • warning letters or untitled letters; • refusal to approve pending applications or supplements to approved applications that are submitted; • delay in or refusal to approve, clear or authorize pending PMA applications, 510(k) premarket submissions, or de novo authorization requests; • fines, restitution or disgorgement of profits or revenues; • suspension or withdrawal of marketing approvals; • refusal to permit the import or export of our products; • product seizure; and • injunctions or the imposition of civil or criminal penalties.
For all FDA-regulated products, if the FDA finds that a manufacturer has failed to comply with applicable laws and regulations, or that a product is ineffective or poses an unreasonable health risk, it can institute or seek a wide variety of enforcement actions and other remedies, including but not limited to: • restrictions on such products, manufacturers or manufacturing processes; • restrictions on the labeling or marketing of a product; • restrictions on distribution or use of a product; • requirements to conduct post-marketing studies or clinical trials; • warning letters or untitled letters; • refusal to approve pending applications or supplements to approved applications that are submitted; • delay in or refusal to approve, clear or authorize pending PMA applications, 510(k) premarket submissions, or de novo classification requests; • fines, restitution or disgorgement of profits or revenues; • suspension or withdrawal of marketing approvals; • refusal to permit the import or export of our products; 37 • product seizure; and • injunctions or the imposition of civil or criminal penalties.
Such deviations may require us to revise manufacturing processes or change manufacturers. Additionally, as our equipment ages, it will need to be replaced, which has the potential to result in similar consequences. Success rates can also vary dramatically at different stages of the manufacturing process, which can reduce yields and increase costs.
Such deviations may require us to alter manufacturing processes or change manufacturers. Additionally, as our equipment ages, it will need to be replaced, which has the potential to result in similar consequences. Success rates can also vary dramatically at different stages of the manufacturing process, which can reduce yields and increase costs.
Our long-term success depends, in part, upon our ability to develop, receive regulatory approval for and commercialize product candidates we develop or acquire and, if we are not successful, our business, financial condition, operating results and cash flows may suffer. Our product candidates and the activities associated with them are subject to extensive FDA regulation and oversight.
Our long-term success depends, in part, upon our ability to develop, receive regulatory approval for and commercialize product candidates we develop or acquire and, if we are not successful, our business, financial condition, operating results and cash flows may suffer. Our product candidates and the activities associated with them in the U.S. are subject to extensive FDA regulation and oversight.
If the FDA or any foreign regulatory authority determines that any of our communications constitute pre-approval promotion or promotion of an off-label use, the FDA could request that we modify our promotional materials, issue an untitled letter or warning letter, or subject us to regulatory or enforcement actions, including injunction, seizure, civil fine or criminal penalties.
Moreover, if the FDA or any foreign regulatory authority determines that any of our communications constitute pre-approval promotion or promotion of an off-label use, the FDA or foreign regulatory authority could request that we modify our promotional materials, issue an untitled letter or warning letter or the foreign equivalent, or subject us to regulatory or enforcement actions, including injunction, seizure, civil fine or criminal penalties.
Department of Agriculture and the DoD, as well as regulatory authorities in Canada. PRODUCT DEVELOPMENT AND COMMERCIALIZATION RISKS The product candidates that we work on internally or for third-party customers may not be safe or effective and even if they are, we may be unable to manufacture sufficient quantities to meet demand.
Department of Agriculture and the DoW, as well as regulatory authorities in Canada. PRODUCT DEVELOPMENT AND COMMERCIALIZATION RISKS The product candidates that we work on internally or for third-party customers may not be safe or effective and even if they are, we may be unable to manufacture sufficient quantities to meet demand.
Responding to challenges from stockholders, such as proxy contests, media campaigns or other public or private means, could be costly and time consuming and could have an adverse effect on our reputation and divert the attention and resources of management and our board of directors, which could have an adverse effect on our business and operational results.
Responding to challenges from stockholders, such as stockholder proposals, media campaigns, proxy contests or other public or private means, could be costly and time consuming and could have an adverse effect on our reputation and divert the attention and resources of management and our board of directors, which could have an adverse effect on our business and operational results.
NARCAN ® Nasal Spray was approved as an over-the-counter (“OTC”) medication in the U.S. on March 29, 2023 and became available to retailers and e-commerce providers nationwide in August 2023. If demand for NARCAN ® Nasal Spray increases beyond our current estimates, there could be supply interruptions.
NARCAN ® Nasal Spray was approved as an over-the-counter (“OTC”) medication in the U.S. in March 2023 and became available to retailers and e-commerce providers nationwide in August 2023. If demand for NARCAN ® Nasal Spray increases beyond our current estimates, there could be supply interruptions.
For example, ACAM2000 ® vaccine faces competition from JYNNEOS TM vaccine, which product has been procured by the USG in recent years. If we are unable to secure particular contracts, we may not be able to operate in the market for products that are provided under 28 those contracts.
For example, ACAM2000 ® vaccine faces competition from JYNNEOS TM vaccine, which has been procured by the USG in recent years. If we are unable to secure particular contracts, we may not be able to operate in the market for products that are provided under those contracts.
If we cannot offer a competitive compensation package to attract and retain the qualified personnel necessary for the continued development of our business, we may not be able to maintain our operations or grow our business. 54 ITEM 1B. UNRESOLVED STAFF COMMENTS Not applicable.
If we cannot offer a competitive compensation package to attract and retain the qualified personnel necessary for the continued development of our business, we may not be able to maintain our operations or grow our business. 57 ITEM 1B. UNRESOLVED STAFF COMMENTS Not applicable.
As with any approved product, there is a risk that we may encounter challenges causing delays or an inability to deliver CYFENDUS ® , ACAM2000 ® , VIGIV CNJ-016 ® , BAT ® and/or BioThrax ® , which may have a material effect on our ability to generate and recognize revenue. 27 Our USG procurement and development contracts require ongoing funding decisions by the USG.
As with any approved product, there is a risk that we may encounter challenges causing delays or an inability to deliver CYFENDUS ® , ACAM2000 ® , CNJ-016 ® (VIGIV), TEMBEXA ® , BAT ® and/or BioThrax ® , which may have a material effect on our ability to generate and recognize revenue. 28 Our USG procurement and development contracts require ongoing funding decisions by the USG.
If any such actions are instituted against us and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant fines or other sanctions. Efforts to ensure that our business arrangements with third parties comply with health care laws and regulations will involve substantial costs.
If any such actions are instituted against us and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant fines or other sanctions. Efforts to ensure that our business arrangements with third parties comply with healthcare laws and regulations will involve substantial costs.
In addition, for the “Big Four” federal agencies—the DVA, the DoD, the PHS (including the Indian Health Service), and the Coast Guard—we must make covered drugs available at pricing that is capped at the statutory federal ceiling price ("FCP").
In addition, for the “Big Four” federal agencies—the DVA, the DoW, the PHS (including the Indian Health Service), and the Coast Guard—we must make covered drugs available at pricing that is capped at the statutory federal ceiling price ("FCP").
We cannot ensure that our submissions will not be found by CMS to be incomplete or incorrect. In order for our products to be reimbursed by the primary federal governmental programs, we must report certain pricing data to the USG.
We cannot ensure that CMS will not find our submissions to be incomplete or incorrect. In order for our products to be reimbursed by the primary federal governmental programs, we must report certain pricing data to the USG.
The contract consists of a base period of performance with two option periods valued at approximately $121 million, which were exercised on September 5, 2024 and January 10, 2025, respectively, and option periods for procurement of Ebanga TM over five years valued at up to $583 million, one of which was awarded in September 2024 (valued at $41.9 million).
The contract consists of a base period of performance with two option periods valued at approximately $121 million, which were exercised in September 2024 and January 2025, respectively, and option periods for procurement of Ebanga TM over five years valued at up to $583 million, one of which was awarded in September 2024 (valued at $41.9 million).
An EUA terminates when the EUA is revoked or the emergency declaration underlying the 39 EUA terminates. An EUA is not a long-term alternative to obtaining FDA approval, licensure, clearance, or other marketing authorization for a product.
An EUA terminates when the EUA is revoked or the emergency declaration underlying the EUA terminates. However, an EUA is not a long-term alternative to obtaining FDA approval, licensure, clearance, or other marketing authorization for a product.
In patent litigation related to Teva’s ANDA filing, a trial court decided in favor of Teva, and this decision was subsequently affirmed by the Court of Appeals for the Federal Circuit. The FDA approved Teva's ANDA on April 19, 2019. On December 22, 2021, Teva commenced the launch of its generic naloxone nasal spray.
In patent litigation related to Teva’s ANDA filing, a trial court decided in favor of Teva, and this decision was subsequently affirmed by the Court of Appeals for the Federal Circuit. The FDA approved Teva's ANDA in April 2019 and in December 2021 Teva commenced the launch of its generic naloxone nasal spray.
We purchase certain supplies used in our manufacturing processes from non-exclusive, or single sources due to quality considerations, costs or constraints resulting from regulatory requirements. We depend on certain single-source suppliers for key materials, manufacturing and other services necessary to produce and release the majority of our products and certain product candidates.
We purchase certain supplies used in our manufacturing processes from non-exclusive, or single sources due to quality considerations, costs or constraints resulting from regulatory requirements. We depend on certain single-source suppliers for key materials, API, excipients, components, devices, manufacturing and other services necessary to produce and release the majority of our products and certain product candidates.
Debt financing can have significant adverse consequences for our business, including: • the level, timing and cost of product sales and Bioservices; • the extent to which we acquire or invest in and integrate companies, businesses, products or technologies; • the acquisition of new facilities and capital improvements to new or existing facilities; • the payment obligations under our indebtedness; • the scope, progress, results and costs of our development activities; • our ability to obtain funding from collaborative partners, government entities and non-governmental organizations for our development programs; • the extent to which we repurchase common stock under any future share repurchase program; and • the costs of commercialization activities, including product marketing, sales and distribution.
Debt financing can have significant adverse consequences for our business, including: • the level, timing and cost of product sales and Bioservices; • the extent to which we acquire or invest in and integrate companies, businesses, products or technologies; • the acquisition of new facilities and capital improvements to new or existing facilities; • the payment obligations under our indebtedness; • the scope, progress, results and costs of our development activities; • our ability to obtain funding from collaborative partners, government entities and non-governmental organizations for our development programs; • limiting the extent to which we may repurchase shares of our common stock; and • the costs of commercialization activities, including product marketing, sales and distribution.
The Senior Secured Credit Facilities include the Term Loan Facility, which had an outstanding principal balance of $250.0 million as of December 31, 2024, and the ability to borrow up to $100.0 million under the Revolving Credit Agreement (subject to certain adjustments described therein).
The Senior Secured Credit Facilities include the Term Loan Facility, which had an outstanding principal balance of $150.0 million as of December 31, 2025, and the ability to borrow up to $100.0 million under the Revolving Credit Agreement (subject to certain adjustments described therein).
A number of factors could cause interruptions, including: • equipment malfunctions or failures; • technology malfunctions; • cyber-attacks; • work stoppages or slowdowns; • civil unrest and protests, including by animal rights activists; • injunctions; • damage to or destruction of our manufacturing equipment, or of one or more of our facilities; • findings and recommendations of health authorities or qualified persons in connection with facility inspections; • ongoing supply chain interruptions; and • product contamination or tampering.
A number of factors could cause interruptions, including: • equipment malfunctions or failures; • technology malfunctions; • cyber-attacks; • work stoppages or slowdowns; • civil unrest and protests, including by animal rights activists; • litigation, investigations or government enforcement actions; • damage to or destruction of our manufacturing equipment, or of one or more of our facilities; • findings and recommendations of health authorities or qualified persons in connection with facility inspections; • ongoing supply chain interruptions; and • product contamination or tampering.
Department of Defense (“DoD”) are generally fixed price contracts. We expect that any future procurement contracts we successfully secure with the USG would likely also be fixed price contracts. Under a fixed price contract, we are required to deliver our products at a fixed price regardless of the actual costs we incur.
We expect that any future procurement contracts we successfully secure with the USG would likely also be fixed price contracts. Under a fixed price contract, we are required to deliver our products at a fixed price regardless of the actual costs we incur.
In addition, we have outstanding an aggregate principal amount of $450.0 million of our Senior Unsecured Notes. We may also seek additional debt financing to support our ongoing activities or to provide additional financial flexibility.
In addition, we have outstanding an aggregate principal amount of $439.7 million of our Senior Unsecured Notes. We may also seek additional debt financing to support our ongoing activities or to provide additional financial flexibility.
The failure to comply with laws governing international business practices may result in substantial civil and criminal penalties, suspension or debarment from government contracting, and other sanctions, and can cause reputational harm. The SEC also may bring enforcement actions against issuers for violations of the FCPA’s accounting provisions.
The failure to comply with laws governing international business practices may result in substantial civil and criminal penalties, suspension or debarment from government contracting, and other sanctions, and can cause reputational harm. The SEC also may bring enforcement actions against issuers for violations of the FCPA’s accounting provisions. Changes to tax legislation may adversely affect our business.
For drug products, we must promote the product in a manner consistent with the full prescribing information or, for 510(k) cleared devices, consistent with the cleared indication. The FDA, DOJ, and OIG impose stringent restrictions on manufacturers’ communications regarding unapproved/uncleared products and unapproved/uncleared uses of approved/cleared products.
For drug products, we must promote the product in a manner consistent with the full prescribing information or, for devices, consistent with the approved or cleared indications for use. The FDA, DOJ, and OIG impose stringent restrictions on manufacturers’ communications regarding unapproved/uncleared products and unapproved/uncleared uses of approved/cleared products.
On July 31, 2023, we were awarded a 10-year contract by BARDA for the advanced development, manufacturing scale-up, and procurement of Ebanga TM (ansuvimab-zykl) treatment for Ebola.
For example, in July 2023, we were awarded a 10-year contract by BARDA for the advanced development, manufacturing scale-up, and procurement of Ebanga TM (ansuvimab-zykl) treatment for Ebola.
We may not have sufficient cash flow from our operations to pay our substantial debt. As described in Note 10, “Debt” in the Notes to Consolidated Financial Statements in Part II, Item 8. of this Annual Report on Form 10-K, as of December 31, 2024, we have approximately $700.0 million of total indebtedness, which includes our outstanding Senior Unsecured Notes.
We may not have sufficient cash flow from our operations to pay our substantial debt. As described in Note 11, “Debt” in the Notes to Consolidated Financial Statements in Part II, Item 8. of this Annual Report on Form 10-K, as of December 31, 2025, we have approximately $589.7 million of total indebtedness, which includes our outstanding Senior Unsecured Notes.
Additionally, potential product liability claims related to our commercial products, including NARCAN ® (naloxone HCl) Nasal Spray, may be made by patients, health care providers or others who sell or consume these products. Such claims may be made even with respect to those products that possess regulatory approval for commercial sale.
Additionally, potential product liability claims related to our commercial products may be made by patients, health care providers or others who sell or consume these products. Such claims may be made even with respect to those products that possess regulatory approval for commercial sale.
This could cause substantial dilution to a person or group that attempts to acquire us on terms that our board of directors does not believe are in our best interests or those of our stockholders and may discourage, delay or prevent a merger or acquisition that stockholders may consider favorable, including transactions in which stockholders might otherwise receive a premium for their shares.
This could cause substantial dilution to a person or group that attempts to acquire us on terms that our board of directors does not believe are in our best interests or those of our stockholders and may discourage, delay or prevent a merger or acquisition that stockholders may consider favorable, including transactions in which stockholders might otherwise receive a premium for their shares. 55 Our stock price is volatile, and purchasers of our common stock could incur substantial losses.
The market price of our common stock may be influenced by many factors, including, among others: • contracts, decisions and procurement policies by the USG affecting our anthrax vaccines and our other products and product candidates; • the success of competitive products or technologies; • results of clinical and non-clinical trials of our product candidates; 53 • announcements of acquisitions, financings or other transactions by us; • litigation or legal proceedings; • public concern as to the safety of our products; • termination or delay of a development program; • the recruitment or departure of key personnel; • variations in our product revenue and profitability; and • the other factors described in this “Risk Factors” section.
The market price of our common stock may be influenced by many factors, including, among others: • contracts, decisions and procurement policies by the USG, and the addition or loss of any other customer affecting our anthrax vaccines and our other products and product candidates; • CDMO contracts with collaboration partners; • the success of competitive products or technologies; • results of clinical and non-clinical trials of our product candidates; • announcements of acquisitions, financings or other transactions by us; • current or future litigation, legal proceedings, or governmental investigations; • regulatory or public concern as to the safety of our products; • termination or delay of a development program; • the recruitment or departure of key personnel; • variations in our product revenue and profitability; and • the other factors described in this “Risk Factors” section.
Some states have similar requirements for devices. Because of the breadth of these laws, it is possible that some of our business activities could be subject to challenge under one or more of such laws. Government regulators enforce CGMP, QSR, and other requirements through periodic unannounced inspections of manufacturing facilities.
Because of the breadth of these laws, it is possible that some of our business activities could be subject to challenge under one or more of such laws. 42 Government regulators enforce CGMP, QMSR, and other requirements through periodic unannounced inspections of manufacturing facilities.
For a detailed description of the most significant regulations that affect our government contracting business, see the prior discussion under “Regulation - Government Contracting.” We may be subject to government investigations of compliance with government acquisition regulations. USG agencies routinely audit and investigate government contractors for compliance with applicable laws and standards.
For a detailed description of the most significant regulations that affect our government contracting business, see the discussion under “Regulation - Government Contracting” elsewhere in this Annual Report. We may be subject to government investigations into compliance with government acquisition regulations. USG agencies routinely audit and investigate government contractors for compliance with applicable laws and standards.
Similarly, promising results from earlier clinical trials of a product candidate may not be replicated in later clinical trials. Failure to successfully develop future product candidates may materially adversely affect our business, financial condition, operating results and cash flows.
Moreover, positive results from pre-clinical studies may not be predictive of similar results in human clinical trials and promising results from earlier clinical trials of a product candidate may not be replicated in later clinical trials. Failure to successfully develop future product candidates may materially adversely affect our business, financial condition, operating results and cash flows.
The Medicaid rebate amount is computed each quarter based on our submission to CMS of our current AMP and “best price” for the quarter.
The Medicaid rebate amount is computed each quarter based on our submission to CMS of our current average manufacturer price (“AMP”) and “best price” for the quarter.
Although BioThrax ® is designated and certified under the SAFETY Act, the law may not provide adequate protection from claims made against us. 47 If we cannot successfully defend ourselves against future claims that our products or product candidates caused injuries and if we are not entitled to indemnity by the USG, or the USG does not honor its obligations to us under the PREP Act or SAFETY Act, or if the liability protections under the PREP Act and SAFETY Act are not adequate to cover all claims, we may incur substantial liabilities.
If we cannot successfully defend ourselves against future claims that our products or product candidates caused injuries and if we are not entitled to indemnity by the USG, or the USG does not honor its obligations to us under the PREP Act or SAFETY Act, or if the liability protections under the PREP Act and SAFETY Act are not adequate to cover all claims, we may incur substantial liabilities.
Our level of indebtedness could have important consequences for us, including: • limiting our ability to obtain additional financing, if needed, for working capital, capital expenditures, acquisitions, debt service requirements or other purposes; • increasing our vulnerability to adverse economic, industry or competitive developments; • limiting our flexibility in planning for, or reacting to, changes in our business and industry; and • placing us at a competitive disadvantage compared to our competitors with less debt.
Our level of indebtedness could have important consequences for us, including: • limiting our ability to obtain additional financing, if needed, for working capital, capital expenditures, acquisitions, debt service requirements or other purposes; • increasing our vulnerability to adverse economic, industry or competitive developments; • limiting our flexibility in planning for, or reacting to, changes in our business and industry; and • placing us at a competitive disadvantage compared to our competitors with less debt. 50 Our indebtedness may increase from time to time for various reasons, including fluctuations in operating results, working capital needs, capital expenditures, acquisitions and/or joint ventures.
The IRA also requires manufacturers of certain Part B and Part D drugs to issue to HHS rebates based on certain calculations and triggers (i.e., when drug prices increase and outpace the rate of inflation).
Further, the Inflation Reduction Act of 2022 (the “IRA”) requires manufacturers of certain Part B and Part D drugs to issue to HHS rebates based on certain calculations and triggers (i.e., when drug prices increase and outpace the rate of inflation).
The occurrence of a default under any of these arrangements would permit the holders of the notes or the lenders under our Senior Secured Credit Facilities to declare all amounts outstanding under those borrowing arrangements to be immediately due and payable, and there is no assurance that we would have sufficient funds to satisfy any such accelerated obligations.
The occurrence of a default under any of these arrangements would permit the holders of the notes or the lenders under our Senior Secured Credit Facilities to declare all amounts outstanding under those borrowing arrangements to be immediately due and payable, and there is no assurance that we would have sufficient funds to satisfy any such accelerated obligations. 51 Our hedging programs have been, and any hedging program we initiate in the future will be, subject to counterparty default risk .
Competitive bidding for government contracts presents many risks and requirements, including: • the possibility that we may be ineligible to respond to a request for proposal; • the commitment of substantial time and attention of management and key employees to the preparation of bids and proposals; • the need to accurately estimate the resources and cost structure that will be required to perform any contract that we might be awarded; • the submission by third parties of protests to our responses to requests for proposal that could result in delays or withdrawals of those requests for proposal; and • in the event our competitors protest or challenge contract or grant awards made to us through competitive bidding, the potential that we may incur expenses or delays, and that any such protest or challenge could result in the resubmission of bids based on modified specifications, or in the termination, reduction or modification of the awarded contract.
Competitive bidding for government contracts presents many risks and requirements, including: • the possibility that we may be ineligible to respond to a request for proposal; • the commitment of substantial time and attention of management and key employees to the preparation of bids and proposals; • the need to accurately estimate the resources and cost structure that will be required to perform any contract that we might be awarded; • the submission by third parties of protests to contracts that we are awarded that could result in delays or withdrawals of the respective requests for proposal; and • in the event our competitors protest or challenge contract or grant awards made to us through competitive bidding, the potential that we may incur expenses or delays, and that any such protest or challenge could result in the resubmission of bids based on modified specifications, or in the termination, reduction or modification of the awarded contract. 29 The USG may choose not to award us future contracts for either the development of our new product candidates or for the procurement of our existing MCM and other commercialized products and may instead award such contracts to our competitors.
If we are unsuccessful in our efforts to identify and acquire other companies, products, or in-license and develop additional products, or if we acquire or in-license unproductive assets, it could have a material adverse effect on the growth of our business, and we could be compelled to record significant impairment charges to write-down the carrying value of our acquired intangible assets, which could materially harm our business, financial condition, operating results and cash flows.
If we are unsuccessful in our efforts to identify and acquire other companies, products, or in-license and develop additional products, or if we acquire or in-license unproductive assets, it could have a material adverse effect on the growth of our business, and we could be compelled to record significant impairment charges to write-down the carrying value of our acquired intangible assets, which could materially harm our business, financial condition, operating results and cash flows. 53 Our failure to successfully integrate acquired businesses and/or assets into our operations could adversely affect our ability to realize the benefits of such acquisitions and, therefore, to grow our business.
We may not maintain profitability in future periods or on a consistent basis. Our profitability has been substantially dependent on product sales, which historically have fluctuated significantly from quarter to quarter, and we expect that they will continue to fluctuate significantly based primarily on the timing of our fulfillment of orders from the USG.
Our profitability has been substantially dependent on product sales, which historically have fluctuated significantly from quarter to quarter, and we expect that they will continue to fluctuate significantly based primarily on the timing of our fulfillment of orders from the USG.
For example, such costs include inter partes review proceedings in the United States and oppositions in Europe, as well as costs associated with litigating and enforcing patent and trademark rights.
Other risks include associated costs, such as costs of patent prosecution and maintenance and costs associated with post-grant challenges. For example, such costs include inter partes review proceedings in the United States and oppositions in Europe, as well as costs associated with litigating and enforcing patent and trademark rights.
Laws and regulations governing international operations may preclude us from developing, manufacturing and selling certain products outside of the United States, require us to develop and implement costly compliance programs, and if violated, can lead to financial and other impacts.
Our reliance on third parties can introduce additional uncertainty into the process. 43 Laws and regulations governing international operations may preclude us from developing, manufacturing and selling certain products outside of the United States, require us to develop and implement costly compliance programs, and if violated, can lead to financial and other impacts.
The FDA and other agencies, including the U.S. Department of Justice (“DOJ”) and the HHS Office of Inspector General (“OIG”), closely regulate and monitor the marketing and promotion of medical products to ensure that they are marketed in a manner consistent with the FDA-approved label.
Department of Justice (“DOJ”) and the HHS Office of Inspector General (“OIG”), closely regulate and monitor the marketing and promotion of medical products to ensure that they are marketed in a manner consistent with the FDA-approved label and regulatory authorities in other countries may have similar policies.
As of December 31, 2024, we had unrestricted cash and cash equivalents of $99.5 million and remaining capacity under the Revolving Credit Agreement of $100.0 million. Also as of December 31, 2024, we had borrowings of $250.0 million on our Term Loan Facility and $450.0 million of Senior Unsecured Notes outstanding.
As of December 31, 2025, we had unrestricted cash and cash equivalents of $205.4 million and remaining capacity under the Revolving Credit Agreement of $100.0 million. Also as of December 31, 2025, we had borrowings of $150.0 million on our Term Loan Facility and $439.7 million of Senior Unsecured Notes outstanding.
For example, in 2021, multiple purported class action lawsuits were filed against us and certain of our current and former senior officers in the United States District Court for the District of Maryland seeking unspecified damages on behalf of a putative class of persons who purchased or otherwise acquired shares of our common stock during various date ranges.
Certain of these actions include, and future actual or threatened legal actions may include, claims for substantial and indeterminate amounts of damages, or may result in other actions adverse to us. 48 For example, in 2021, multiple purported class action lawsuits were filed against us and certain of our current and former senior officers in the United States District Court for the District of Maryland seeking unspecified damages on behalf of a putative class of persons who purchased or otherwise acquired shares of our common stock during various date ranges.
If we are unable to satisfy regulatory authority and/or USG requirements for the release of our products or product candidates, our ability to supply such products and product candidates to authorized buyers would be impaired until such time as we become able to meet such requirements, which could materially harm our future business, financial condition, operating results and cash flows.
If we are unable to satisfy regulatory authority and/or USG requirements for the release of our products or product candidates, our ability to supply such products and product candidates to authorized buyers would be impaired until such time as we become able to meet such requirements, which could materially harm our future business, financial condition, operating results and cash flows. 32 Our operations, including our use of hazardous materials, chemicals, bacteria and viruses, require us to comply with regulatory requirements and expose us to significant potential liabilities.
If our actual costs exceed our estimates, we may not be able to earn an adequate return or may incur a loss under these contracts, which could harm our operating results and materially reduce our net income. Our current procurement contracts with the U.S. Department of Health & Human Services (“HHS”) and the U.S.
If our actual costs exceed our estimates, we may not be able to earn an adequate return or may incur a loss under these contracts, which could harm our operating results and materially reduce our net income. Our current procurement contracts with the HHS and the DoW are generally fixed price contracts.
The commercial success of our product candidates can depend on many factors, including accomplishing the following in an economical manner: • successful development, formulation and CGMP or Quality System Regulation ("QSR") scale-up of manufacturing that meets FDA and/or foreign regulatory requirements; • successful program partnering; • successful completion of clinical or non-clinical development; • receipt of marketing approvals, clearances, or other authorizations from the FDA and equivalent foreign regulatory authorities; • establishment of commercial manufacturing processes and product supply arrangements; • training of a commercial sales force for the product; • successful registration and maintenance of relevant patent and/or other proprietary protection; • competitive pricing and market access; and • acceptance of the product by potential government and other customers. 32 In particular, the success of NARCAN ® (naloxone HCl) Nasal Spray, including in over-the-counter form, is subject to commercial availability of the product and our ability to gain sufficient market acceptance by physicians, patients, third-party payors and others in the medical community.
The commercial success of our product candidates can depend on many factors, including accomplishing the following in an economical manner: • successful development, formulation and CGMP or Quality Management System Regulation ("QMSR") scale-up of manufacturing that meets FDA and/or foreign regulatory requirements; • successful program partnering; • successful completion of clinical or non-clinical development; • receipt of marketing approvals, clearances, or other authorizations from the FDA and equivalent foreign regulatory authorities; • establishment of commercial manufacturing processes and product supply arrangements; • training of a commercial sales force for the product; 33 • successful registration and maintenance of relevant patent and/or other proprietary protection; • competitive pricing and market access; and • acceptance of the product by potential government and other customers.
We have a significant amount of intangible assets and property, plant and equipment on our balance sheet. The impairment tests require us to make an estimate of the fair value of our reporting units. An impairment could be recorded as a result of changes in assumptions, estimates or circumstances, some of which are beyond our control.
The impairment tests require us to make an estimate of the fair value of our reporting units. An impairment could be recorded as a result of changes in assumptions, estimates or circumstances, some of which are beyond our control.
This includes Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products. Further, the Inflation Reduction Act of 2022 (the “IRA”), was signed into law on August 16, 2022.
This includes Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeThe Company is not aware that any risks from cybersecurity threats, including because of any previous cybersecurity incidents, have materially affected or are reasonably likely to materially affect the company. The Company proactively reviews threats landscape, impacts to the company, and address any gaps where necessary. Also, we maintain security operations metrics, incident response plan and conduct tabletop exercises.
Biggest changeThe Company proactively reviews threats landscape, impacts to the company, and address any gaps where necessary. Also, we maintain security operations metrics, incident response plan, conduct tabletop exercises and perform an internal phishing campaign and awareness program.
ITEM 1C. CYBERSECURITY CYBERSECURITY The Company’s cybersecurity program is aligned and integrated into the overall company risk management process through its Enterprise Risk Management Program ("ERM"). At Emergent, ERM is a centralized process that prioritizes, and groups the top risks to our organization into 12 categories, one of which is Cybersecurity.
ITEM 1C. CYBERSECURITY CYBERSECURITY The Company’s cybersecurity program is aligned and integrated into the overall company risk management process through its Enterprise Risk Management ("ERM") Program . At Emergent, ERM is a centralized process that prioritizes, and groups the top risks to our organization into 12 categories, one of which is Cybersecurity.
The Committee is the primary oversight body to monitor the Company’s cybersecurity and related information technology risks and receives periodic updates from Company management (including, the Chief Information Officer and the CISO) on the Company’s policies, processes, procedures, and any significant developments related to the identification, mitigation, and remediation of cybersecurity risks.
The Committee is the primary oversight body to monitor the Company’s cybersecurity and related information technology risks and receives periodic updates from Company management (including the Chief Information Officer and the interim CISO) on the Company’s policies, processes, procedures, and any significant developments related to the identification, mitigation, and remediation of cybersecurity risks.
The purpose of the Committee is to assist the Board in fulfilling its oversight responsibilities relating to the Company’s compliance with laws, regulations, and industry standards that, if breached, may cause significant business, regulatory, or reputational damage to the Company, including oversight of the Company's: • Compliance with good (“x” = manufacturing, clinical, laboratory, pharmacovigilance, storage, distribution etc.) (GxP) and medical device Quality Systems Regulations (QSR); • Healthcare compliance, anti-corruption, privacy and data security landscape, medical product safety, supply chain, employee health and safety, political expenditures and lobbying activities, and government contracting; • Enterprise Risk Management program; and • Cyber and information security risks.
The purpose of the Committee is to assist the Board in fulfilling its oversight responsibilities relating to the Company’s compliance with laws, regulations, and industry standards that, if breached, may cause significant business, regulatory, or reputational damage to the Company, including oversight of the Company's: • Compliance with good (“x” = manufacturing, clinical, laboratory, pharmacovigilance, storage, distribution etc.) (GxP) and medical device Quality Management Systems Regulations (QMSR); • Healthcare compliance, anti-corruption, privacy and data security landscape, medical product safety, supply chain, employee health and safety, political expenditures and lobbying activities, and government contracting; • ERM program; and • Cyber and information security risks.
The Chair or Vice-Chair of the Committee meet as necessary with the Chief Information Officer and the CISO to engage in a more detailed review of the Company’s cybersecurity and information security activities. The Committee charter also requires that the Committee ensure that Company management provides an annual cyber and information security update to the Board of Directors.
The Chair or Vice-Chair of the Committee meets as necessary with the Chief Information Officer and the interim CISO to engage in a more detailed review of the Company’s cybersecurity and information security activities. The Committee charter also requires that the Committee ensure that Company management provides an annual cyber and information security update to the Board of Directors.
The Company proactively reviews threats landscape, impacts to the company, and address any gaps where necessary. Also, we maintain security operations metrics and incident response plan and conduct tabletop exercises. The Company engages outside consultants to review both its Cybersecurity posture, and maturity, and perform for a cyber assessments of the Company’s manufacturing/operational technology environments.
The Company proactively reviews the threat landscape, impacts to the company, and addresses any gaps where necessary. Also, we maintain security operations metrics and incident response plan and conduct tabletop exercises. The Company engages outside consultants to review both its Cybersecurity posture and maturity, and to perform cyber assessments for the Company’s manufacturing/operational technology environments.
As part of our ongoing Enterprise Risk Management ("ERM") enhancements, our ERM intranet page was launched in 2024 to centralize risk-related resources and policies. During the third quarter of 2024, a comprehensive reassessment of the Company's enterprise risks was conducted, with results thoroughly reviewed and communicated to executive leadership (VP and above) to align on key risks and strategic priorities.
As part of our ongoing ERM enhancements, our ERM intranet page was launched in 2024 to centralize risk-related resources and policies. The Company periodically performs a comprehensive reassessment of the Company's enterprise risks, with results thoroughly reviewed and communicated to executive leadership (VP and above) to align on key risks and strategic priorities.
The Company has a process in place to oversee and identify material risks from cybersecurity threats associated with its use of any third-party service provider, namely its Third-Party Risk Management Assessment Process. We utilize the NIST framework when assessing third parties. The framework covers 23 categories. When applicable, we may request if the third party vendor is SOC1/2, GDPR, certified.
The Company utilizes its Third-Party Risk Management Assessment Process to oversee and identify material risks from cybersecurity threats associated with its use of any third-party service provider. We utilize the NIST framework, which covers 23 categories. When applicable, we may inquire if the third-party vendor is SOC1/2, GDPR, certified.
Mitigations against risks are developed, as necessary, and all risks are monitored, reviewed quarterly, and reported to executive leadership and the Board of Directors. The ERM program and ERA process is described in the Company’s Enterprise Risk Management Policy which was released this year. The program includes enterprise level risks grouped in 12 risk categories.
Mitigations against risks are developed, as necessary, and all risks are monitored, reviewed quarterly, and reported to executive leadership and the Board of Directors. The ERM program and ERA process is described in the Company’s Enterprise Risk Management Policy. The program includes enterprise level risks grouped in 12 risk categories. Cybersecurity is included as a standing risk category.
Cybersecurity is included as a standing risk category. The ERM program does not itself independently review cybersecurity policies and practices. In first quarter 2024, ERM, in collaboration with Emergent’s Policy and Training Center of Excellence, provided training on Emergent’s Enterprise Risk Management Policy to all employees who are at the vice president level and above.
The ERM program does not itself independently review cybersecurity policies and practices. ERM, in collaboration with Emergent’s Policy and Training Center of Excellence, provides training on Emergent’s Enterprise Risk Management Policy to all employees who are at the vice president level and above.
In addition, the Company has: • Managed Security Service Provider (MSSP) that maintains 24 hours per day, 7 days per week, monitoring of the Company's environment; and • Performed an internal phishing campaign and awareness program. 56
In addition, the Company has managed Security Service Provider (MSSP) that maintains 24 hours per day, 7 days per week, monitoring of the Company's environment. 59
Moreover, the Company’s CISO provides cybersecurity updates to the entire board of directors and the board's Quality Compliance Management Risk Committee (the "Committee").
The Company is actively in the process of identifying a permanent CISO. Moreover, the Company’s CISO provides cybersecurity updates to the entire board of directors and the board's Quality, Compliance, Manufacturing and Risk Management Committee (the "Committee").
Additionally, the Company maintains a cybersecurity insurance policy to help mitigate the impacts of potential cybersecurity incidents. The Company’s Chief Information Security Officer (“CISO”) is responsible for assessing and managing the Cybersecurity risks with comprehensive oversight of information security functions with an emphasis on strategic leadership, governance, risk management and technical proficiency.
The Company’s Senior Vice President and Chief Information Officer, who is currently acting as the Company's interim Chief Information Security Officer (“CISO”), is responsible for assessing and managing the Cybersecurity risks with comprehensive oversight of information security functions with an emphasis on strategic leadership, governance, risk management and technical proficiency.
The CISO reports to the Quality Compliance Management Risk Committee twice per year and also reports to the Board twice per year. The Company has not incurred material cybersecurity incidents over the past three years.
Current Committee members are: Zsolt Harsanyi, Ph.D., Sujata Dayal, Don DeGolyer and Kathryn C. Zoon, Ph.D., all of whom are independent directors. The interim CISO reports to the Committee twice per year and also reports to the Board twice per year. 58 The Company has not incurred a material cybersecurity incident over the past three years.
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Current Committee members are: Zsolt Harsanyi, Ph.D., Sujata Dayal and Kathryn C. Zoon, Ph.D., all of whom are independent directors. 55 The Company's CISO is certified in Risk and Information Systems Control ® (CRISC) and Certified Information Privacy Professional/United States (CIPP/US).
Added
Additionally, the Company maintains cybersecurity insurance to help mitigate the impacts of potential cybersecurity incidents.
Added
The Company is not aware that any risks from cybersecurity threats, including because of any previous cybersecurity incidents, have materially affected or are reasonably likely to materially affect the company. For additional information related to cybersecurity related risks, refer to Part 1 Item 1A. Risk Factors.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changePrincipal locations include: Location Use Approximate square feet Owned/leased Operating Segment Lansing, Michigan Manufacturing operations, office and laboratory space. 336,000 Owned Products & Services Winnipeg, Manitoba, Canada Manufacturing operations, office and laboratory space. 160,000 (Owned); 15,800 (Leased) Owned/Leased Products & Services Gaithersburg, Maryland Laboratory space, office space and rental real estate. 173,000 (Owned); 11,547 (Leased) Owned/Leased Products & Services Canton, Massachusetts Manufacturing operations and warehouse space. 47,000 (Owned); 27,000 (Leased) Owned/Leased Products & Services Baltimore, Maryland (Bayview) Manufacturing facilities, office and laboratory space. 112,000 Owned Products & Services Elkridge, Maryland Warehouse space. 103,182 Leased Products & Services Rockville, Maryland Manufacturing facilities, office and warehouse space. 84,295 Owned Products & Services Each property is considered to be in good condition, adequate for its purpose, and suitably utilized according to the individual nature and requirements of the relevant operations.
Biggest changePrincipal locations include: Location Use Approximate square feet Owned/leased Operating Segment Lansing, Michigan Manufacturing operations, office and laboratory space. 336,000 Owned Products & Services Winnipeg, Manitoba, Canada Manufacturing operations, office and laboratory space. 160,000 (Owned); 15,800 (Leased) Owned/Leased Products & Services Gaithersburg, Maryland Laboratory space, office space and rental real estate. 173,000 (Owned); 11,547 (Leased) Owned/Leased Products & Services Canton, Massachusetts Manufacturing operations and warehouse space. 47,000 (Owned); 27,000 (Leased) Owned/Leased Products & Services Elkridge, Maryland Warehouse space. 103,182 Leased Products & Services Rockville, Maryland Manufacturing facilities, office and warehouse space. 84,295 Owned Products & Services Each property is considered to be in good condition, adequate for its purpose, and suitably utilized according to the individual nature and requirements of the relevant operations.
Our policy is to improve and replace property as considered appropriate to meet the needs of the individual operations. ITEM 3. LEGAL PROCEEDINGS See Item 8 of Part II, “Financial Statements and Supplemental Data — Notes to Consolidated Financial Statements" — Note 19, "Litigation." ITEM 4. MINE SAFETY DISCLOSURES Not applicable 57 PART II
Our policy is to improve and replace property as considered appropriate to meet the needs of the individual operations. ITEM 3. LEGAL PROCEEDINGS See Item 8 of Part II, “Financial Statements and Supplemental Data — Notes to Consolidated Financial Statements" — Note 20, "Litigation." ITEM 4. MINE SAFETY DISCLOSURES Not applicable 60 PART II
ITEM 2. PROPERTIES We own and lease approximately 1.2 million square feet of building space for development and manufacturing, laboratories, fill/finish facility services, offices and warehouse space for the conduct of our businesses at 12 locations in North America and Europe. Properties that have been leased expire on various dates between 2025 and 2034.
ITEM 2. PROPERTIES We own and lease approximately 1.0 million square feet of building space for development and manufacturing, laboratories, fill/finish facility services, offices and warehouse space for the conduct of our businesses at 11 locations in North America and Europe. Properties that have been leased expire on various dates between 2026 and 2034.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeStock Performance Graph The following graph provides a comparison of five year cumulative total stockholder returns of Emergent BioSolutions Inc.'s common stock, the Standard & Poor’s ("S&P") 500 Stock Index, the Russell 2000 Index, the S&P SmallCap 600 Index, the S&P Pharmaceuticals Index and the S&P Biotechnology Index.
Biggest changeThe remaining information required by Item 5 is hereby incorporated by reference from our Definitive Proxy Statement relating to our 2026 Annual Meeting of the Stockholders, to be filed with the SEC within 120 days following the end of our fiscal year. 61 Stock Performance Graph The following graph provides a comparison of five year cumulative total stockholder returns of Emergent BioSolutions Inc.'s common stock, the Standard & Poor’s ("S&P") 500 Stock Index, the Russell 2000 Index, the S&P SmallCap 600 Index, the S&P Pharmaceuticals Index and the S&P Biotechnology Index.
The annual changes for the five-year period shown on the graph are based on the assumptions that $100 had been invested in Emergent BioSolutions Inc.'s common stock and each index on December 31, 2019, all fiscal years end December 31 st and all dividends were reinvested.
The annual changes for the five-year period shown on the graph are based on the assumptions that $100 had been invested in Emergent BioSolutions Inc.'s common stock and each index on December 31, 2020, all fiscal years end December 31 st and all dividends were reinvested.
As of February 25, 2025, the closing price per share of our common stock on the New York Stock Exchange was $7.21 and we had 41 holders of record of our common stock. This number does not include beneficial owners whose shares are held by nominees in street name.
As of February 19, 2026, the closing price per share of our common stock on the New York Stock Exchange was $10.99 and we had 46 holders of record of our common stock. This number does not include beneficial owners whose shares are held by nominees in street name.
Dividend Policy We have not declared or paid any cash dividends on our common stock since becoming a publicly traded company in November 2006. We currently have no plans to pay dividends.
(2) Dollar amounts presented are inclusive of commissions and nondeductible 1% excise tax. Dividend Policy We have not declared or paid any cash dividends on our common stock since becoming a publicly traded company in November 2006. We currently have no plans to pay dividends.
Removed
The remaining information required by Item 5 is hereby incorporated by reference from our Definitive Proxy Statement relating to our 2025 Annual Meeting of the Stockholders, to be filed with the SEC within 120 days following the end of our fiscal year.
Added
Purchases of Equity In March 2025, the Company announced that its Board of Directors authorized the repurchase of up to $50.0 million of the Company’s common stock (the “2025 Share Repurchase Program”) on or before March 27, 2026.
Removed
Market Performance Company / Index 2019 2020 2021 2022 2023 2024 Emergent BioSolutions Inc. $ 100.00 $ 166.08 $ 80.57 $ 21.89 $ 4.45 $ 17.72 S&P 500 $ 100.00 $ 118.40 $ 152.39 $ 124.79 $ 157.59 $ 197.02 Russell 2000 $ 100.00 $ 119.96 $ 137.74 $ 109.59 $ 128.14 $ 142.93 S&P SmallCap 600 $ 100.00 $ 111.29 $ 141.13 $ 118.41 $ 137.42 $ 149.37 S&P 500 Pharmaceuticals $ 100.00 $ 107.53 $ 135.21 $ 146.65 $ 147.13 $ 159.21 S&P 500 Biotechnology $ 100.00 $ 108.63 $ 121.80 $ 140.85 $ 146.27 $ 147.24 58 ITEM 6. [RESERVED] 59
Added
In February 2026, the Company reauthorized the 2025 Share Repurchase Program for the repurchase of up to $50.0 million of the Company's common stock through March 31, 2027. Repurchases under the 2025 Share Repurchase Program may be made from time to time on the open market or in privately negotiated transactions.
Added
The timing and amount of any shares repurchased will be determined by the Company’s management based on its evaluation of market conditions and other factors, including the market price of the Company’s common stock, macroeconomic environment and other investment opportunities, consistent with applicable law. The 2025 Share Repurchase Program may be suspended or discontinued at any time.
Added
The table below presents information regarding shares of our common stock that we repurchased during the three months ended December 31, 2025 under the 2025 Share Repurchase Program: Issuer Purchases of Equity Securities Periods Total Number of Shares Purchased Average Price Paid Per Share (1) Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs Approximate Dollar Value of Shares That May Yet Be Purchased Under the Plans or Programs (2) October 1, 2025 - October 31, 2025 336,872 $ 9.45 336,872 $ 30,804,402 November 1, 2025 - November 30, 2025 272,921 $ 10.35 272,921 $ 27,945,048 December 1, 2025 - December 31, 2025 253,261 $ 11.93 253,261 $ 24,887,579 Total 863,054 863,054 (1) Exclusive of commissions and nondeductible 1% excise tax, which excise was imposed pursuant to the Inflation Reduction Act of 2022.
Added
Market Performance Company / Index 2020 2021 2022 2023 2024 2025 Emergent BioSolutions Inc. $ 100.00 $ 48.52 $ 13.18 $ 2.68 $ 10.67 $ 13.79 S&P 500 $ 100.00 $ 128.71 $ 105.40 $ 133.10 $ 166.40 $ 196.16 Russell 2000 $ 100.00 $ 114.82 $ 91.35 $ 106.82 $ 119.14 $ 134.40 S&P SmallCap 600 $ 100.00 $ 126.82 $ 106.40 $ 123.48 $ 134.22 $ 142.30 S&P 500 Pharmaceuticals $ 100.00 $ 125.75 $ 136.38 $ 136.84 $ 148.06 $ 188.27 S&P 500 Biotechnology $ 100.00 $ 112.13 $ 129.67 $ 134.65 $ 135.54 $ 171.44 ITEM 6. [RESERVED] 62

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

89 edited+41 added−144 removed30 unchanged
Biggest changeManagement believes that the assumptions and estimates related to the provision for income taxes are critical to the Company’s results of operations. 66 RESULTS OF OPERATIONS Consolidated and Segment Operating Results: Year Ended December 31, (in millions, except %) 2024 2023 $ Change % Change Revenues: Commercial Product sales, net: NARCAN ® $ 398.9 $ 487.5 $ (88.6) (18) % Other Commercial Products — 9.8 (9.8) (100) % Total Commercial Product sales, net 398.9 497.3 (98.4) (20) % MCM Product sales, net: Anthrax MCM 138.5 187.6 (49.1) (26) % Smallpox MCM 277.3 167.4 109.9 66 % Other Products 94.0 92.2 1.8 2 % Total MCM Product sales, net 509.8 447.2 62.6 14 % Services: Bioservices - Services 103.5 72.8 30.7 42 % Bioservices - Leases 1.4 5.7 (4.3) (75) % Total Services revenues 104.9 78.5 26.4 34 % Contracts and grants 30.0 26.3 3.7 14 % Total revenues $ 1,043.6 $ 1,049.3 $ (5.7) (1) % Operating expenses: Cost of Commercial Product sales (1) 185.9 210.3 (24.4) (12) % Cost of MCM Product sales (1) 219.4 305.6 (86.2) (28) % Cost of Bioservices (1) 276.0 189.5 86.5 46 % Research and development 70.7 111.4 (40.7) (37) % Selling, general and administrative 308.0 368.4 (60.4) (16) % Amortization of intangible assets 65.1 65.6 (0.5) (1) % Goodwill impairment — 218.2 (218.2) (100) % Impairment of long-lived assets 27.2 306.7 (279.5) (91) % Total operating expenses 1,152.3 1,775.7 (623.4) (35) % Loss from operations (108.7) (726.4) 617.7 85 % Other income (expense): Interest expense (71.0) (87.9) 16.9 19 % Gain on sale of business 24.3 74.2 (49.9) (67) % Other, net 12.5 8.9 3.6 40 % Total other income (expense), net (34.2) (4.8) (29.4) NM Loss before income taxes (142.9) (731.2) 588.3 80 % Income tax provision 47.7 29.3 18.4 63 % Net loss $ (190.6) $ (760.5) $ 569.9 75 % (1) Exclusive of intangible assets amortization NM - Not meaningful 67 Year Ended December 31, 2024 Compared with Year Ended December 31, 2023 Revenues and gross margin Year Ended December 31, (dollars in millions) 2024 2023 % Change Total revenues $ 1,043.6 $ 1,049.3 (1) % Contracts and grants 30.0 26.3 14 % Total segment revenues (1) $ 1,013.6 $ 1,023.0 (1) % Cost of sales or services Cost of Commercial Product sales $ 185.9 $ 210.3 (12) % Cost of MCM Product sales 219.4 305.6 (28) % Cost of Bioservices 276.0 189.5 46 % Total cost of sales or services $ 681.3 $ 705.4 (3) % Intangible asset amortization: Commercial Products $ 37.8 $ 38.6 (2) % MCM Products 27.3 27.0 1 % Total intangible asset amortization $ 65.1 $ 65.6 (1) % Total segment gross margin (1) $ 267.2 $ 252.0 6 % Total segment gross margin % (1) 26 % 25 % (1) We define total segment revenues, which is a non-GAAP financial measure, as our total revenues, less contracts and grants revenue.
Biggest changeManagement believes that the assumptions and estimates related to the provision for income taxes are material to the Company’s results of operations. 68 RESULTS OF OPERATIONS Consolidated and Segment Operating Results: Year Ended December 31, (in millions, except %) 2025 2024 $ Change % Change Revenues: Commercial Product sales, net: Naloxone $ 226.1 $ 398.9 $ (172.8) (43) % Total Commercial Product sales, net 226.1 398.9 (172.8) (43) % MCM Product sales, net: Anthrax MCM 114.3 138.5 (24.2) (17) % Smallpox MCM 266.1 277.3 (11.2) (4) % Other Products 76.3 94.0 (17.7) (19) % Total MCM Product sales, net 456.7 509.8 (53.1) (10) % All other revenues (1) 60.1 134.9 (74.8) (55) % Total revenues $ 742.9 $ 1,043.6 $ (300.7) (29) % Operating expenses: Cost of product and services sales, net (2) 326.2 681.3 (355.1) (52) % Research and development 53.2 70.7 (17.5) (25) % Selling, general and administrative 186.1 308.0 (121.9) (40) % Amortization of intangible assets 65.1 65.1 — — % Impairment of long-lived assets 12.2 27.2 (15.0) (55) % Total operating expenses 642.8 1,152.3 (509.5) (44) % Income (loss) from operations 100.1 (108.7) 208.8 192 % Other income (expense): Interest expense (59.3) (71.0) (11.7) (16) % Gain on sale of business — 24.3 (24.3) (100) % Gain (loss) on debt extinguishment (12.2) 0.6 (12.8) NM Other, net 54.2 11.9 42.3 NM Total other expense, net (17.3) (34.2) (16.9) (49) % Income (loss) before income taxes 82.8 (142.9) 225.7 158 % Income tax provision 30.2 47.7 (17.5) (37) % Net income (loss) $ 52.6 $ (190.6) $ 243.2 128 % (1) "All other revenues" includes Services and Contracts and grants revenue (2) Exclusive of intangible assets amortization NM - Not meaningful 69 Year Ended December 31, 2025 Compared with Year Ended December 31, 2024 Revenues and gross margin Year Ended December 31, (dollars in millions) 2025 2024 % Change Total revenues $ 742.9 $ 1,043.6 (29) % Contracts and grants 37.7 30.0 26 % Product and services sales, net $ 705.2 $ 1,013.6 (30) % Cost of product and services sales, net $ 326.2 $ 681.3 (52) % Intangible asset amortization 65.1 65.1 — % Gross margin (1) $ 313.9 $ 267.2 17 % Gross margin % (1) 45 % 26 % (1) Gross margin is calculated as product and services sales, net less cost of product and services sales, net and intangible asset amortization.
Segment adjusted gross margin percentage, which is a non-GAAP financial measure, is calculated as segment adjusted gross margin divided by revenues. The Company’s management utilizes segment adjusted gross margin and segment adjusted gross margin percentage for purposes of evaluating our ongoing operations and for internal planning and forecasting purposes.
Segment adjusted gross margin percentage, which is a non-GAAP financial measure, is calculated as segment adjusted gross margin divided by segment revenues. The Company’s management utilizes segment adjusted gross margin and segment adjusted gross margin percentage for purposes of evaluating our ongoing operations and for internal planning and forecasting purposes.
Segment adjusted gross margin percentage, which is a non-GAAP financial measure, is calculated as segment adjusted gross margin divided by revenues. The Company’s management utilizes segment adjusted gross margin and segment adjusted gross margin percentage for purposes of evaluating our ongoing operations and for internal planning and forecasting purposes.
Segment adjusted gross margin percentage, which is a non-GAAP financial measure, is calculated as segment adjusted gross margin divided by segment revenues. The Company’s management utilizes segment adjusted gross margin and segment adjusted gross margin percentage for purposes of evaluating our ongoing operations and for internal planning and forecasting purposes.
Significant judgments used for long-lived asset impairment assessments include identifying the appropriate asset groupings and primary assets within those groupings, determining whether events or circumstances indicate that the carrying amount of the asset may not be recoverable, determining the future cash 87 flows for the assets involved and assumptions applied in determining fair value, which include, reasonable discount rates, growth rates, market risk premiums and other assumptions about the economic environment.
Significant judgments used for long-lived asset impairment assessments include identifying the appropriate asset groupings and primary assets within those groupings, determining whether events or circumstances indicate that the carrying amount of the asset may not be recoverable, determining the future cash flows for the assets involved and assumptions applied in determining fair value, which include, reasonable discount rates, growth rates, market risk premiums and other assumptions about the economic environment.
Gross margin percentage is calculated as gross margin divided by revenues. (2) Segment adjusted gross margin, which is a non-GAAP financial measure, for our MCM Products segment is calculated as gross margin plus intangible asset amortization, restructuring costs and non-cash items related to changes in fair value of financial instruments and inventory step-up provision.
Gross margin percentage is calculated as gross margin divided by revenues. (2) Segment adjusted gross margin, which is a non-GAAP financial measure, for our MCM Products segment is calculated as gross margin plus intangible asset amortization, restructuring costs (benefits) and non-cash items related to changes in fair value of financial instruments and inventory step-up provision.
Our future capital requirements will depend on many factors, including (but not limited to): • the level, timing and cost of product sales and Bioservices; • the extent to which we acquire or invest in and integrate companies, businesses, products or technologies; • the acquisition of new facilities and capital improvements to new or existing facilities; • the payment obligations under our indebtedness; • the scope, progress, results and costs of our development activities; • our ability to obtain funding from collaborative partners, government entities and non-governmental organizations for our development programs; and • the costs of commercialization activities, including product marketing, sales and distribution.
Our future capital requirements will depend on many factors, including (but not limited to): • the level, timing and cost of product sales and services sales; • the extent to which we acquire or invest in and integrate companies, businesses, products or technologies; • the acquisition of new facilities and capital improvements to new or existing facilities; • the payment obligations under our indebtedness; • the scope, progress, results and costs of our development activities; • our ability to obtain funding from collaborative partners, government entities and non-governmental organizations for our development programs; and • the costs of commercialization activities, including product marketing, sales and distribution.
For drug product customers, we receive work in process inventory to be prepared for distribution. 65 Research and Development (“R&D”) Expenses We expense R&D costs as incurred.
For drug product customers, we receive work in process inventory to be prepared for distribution. Research and Development (“R&D”) Expenses We expense R&D costs as incurred.
Restructuring costs are recognized as an operating expense within the Consolidated Statement of Operations and are classified based on the Company's classification policy for each category of operating expense.
Restructuring costs (benefits) are recognized as an operating expense within the Consolidated Statement of Operations and are classified based on the Company's classification policy for each category of operating expense.
Development milestone payments for CHIKV VLP On July 18, 2024, Bavarian Nordic announced that the European Medicines Agency had validated the marketing authorization application for CHIKV VLP, which was submitted in June 2024. This approval triggered a milestone payment receivable under the Purchase and Sale Agreement to the Company in the amount of $10.0 million.
Development milestone payments for CHIKV VLP In July 2024, Bavarian Nordic announced that the European Medicines Agency had validated the marketing authorization application for CHIKV VLP, which was submitted in June 2024. This approval triggered a milestone payment receivable under the Purchase and Sale Agreement to the Company in the amount of $10.0 million.
Cost of Product Sales and Services Commercial and MCM Products - The primary expenses that we incur to deliver our NARCAN ® and MCM products consist of fixed and variable costs. We determine the cost of product sales for products sold during a reporting period based on the average manufacturing cost per unit in the period those units were manufactured.
Cost of Product Sales and Services Commercial and MCM Products - The primary expenses that we incur to deliver our Naloxone and MCM products consist of fixed and variable costs. We determine the cost of product sales for products sold during a reporting period based on the average manufacturing cost per unit in the period those units were manufactured.
In 2021, the Organization for Economic Cooperation and Development released model rules for a 15% global minimum tax applied to cross-border profits of certain large multinational corporations, known as Pillar Two. Pillar Two has now been enacted by approximately 36 countries, including Ireland.
In 2021, the Organization for Economic Cooperation and Development released model rules for a 15% global minimum tax applied to cross-border profits of certain large multinational corporations, known as Pillar Two. Pillar Two has now been enacted by approximately 60 countries, including Ireland.
Securities and shareholder litigation On September 12, 2024, the Company and the lead plaintiffs in stockholder litigation against the Company entered into an agreement in principle to settle the claims against the Company and each of the Company’s current and former officers and directors.
Securities and shareholder litigation In September 2024, the Company and the lead plaintiffs in stockholder litigation against the Company entered into an agreement in principle to settle the claims against the Company and each of the Company’s current and former officers and directors.
August 2024 Organizational Restructuring Plan In August 2024, the Company initiated the August 2024 Plan at the Company’s Lansing facility, which reduced the Company’s workforce by approximately 70 employees, as well as eliminated several open positions. The Company also implemented non-labor optimization efforts, such as reducing the Company’s external and vendor spend.
August 2024 Organizational Restructuring Plan In August 2024, the Company initiated an organizational restructuring plan (the “August 2024 Plan”) at the Company’s Lansing facility, which reduced the Company’s workforce by approximately 70 employees, as well as eliminated several open positions. The Company also implemented non-labor optimization efforts, such as reducing the Company’s external and vendor spend.
Commercial Product Segment: The majority of our Commercial product revenue comes from the following product: NARCAN ® • NARCAN ® (naloxone HCl) Nasal Spray, an intranasal formulation of naloxone approved by the United States Food and Drug Administration (“FDA”) (including in over-the-counter ("OTC") form) and Health Canada for the emergency treatment of known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression.
Commercial Product Segment: The majority of our Commercial product revenue comes from the following product: Naloxone Products • NARCAN ® (naloxone HCl) Nasal Spray, an intranasal formulation of naloxone approved by the United States Food and Drug Administration (“FDA”) (including in over-the-counter (“OTC”) form) and Health Canada for the emergency treatment of known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression. • KLOXXADO ® (naloxone HCl) Nasal Spray.
Significant New Accounting Pronouncements See Note 2, “Summary of significant accounting policies” in the Notes to Consolidated Financial Statements in Part II, Item 8. of this Form 10-K. 88
Significant New Accounting Pronouncements See Note 2, “Summary of significant accounting policies” in the Notes to Consolidated Financial Statements in Part II, Item 8. of this Form 10-K. 79
Decisions regarding the elimination of positions and the closure of manufacturing facilities were subject to local law and consultation requirements in certain countries, as well as the Company’s business needs. The cumulative amount of restructuring charge related to the May 2024 Plan since inception is $19.8 million.
Decisions regarding the elimination of positions and the closure of manufacturing facilities were subject to local law and consultation requirements in certain countries, as well as the Company’s business needs. The cumulative amount of restructuring charge related to the May 2024 Plan since inception is $18.5 million.
On August 13, 2024, Bavarian Nordic announced that the FDA had accepted and granted priority review for the Biologics License Application for CHIKV VLP, which triggered a milestone payment receivable under the Purchase and Sale Agreement to the Company in the amount of $20.0 million.
In August 2024, Bavarian Nordic announced that the FDA has accepted and granted priority review for the Biologics License Application for CHIKV VLP, which triggered a milestone payment receivable under the Purchase and Sale Agreement to the Company in the amount of $20.0 million.
Gross margin percentage is calculated as gross margin divided by revenues. (2) Segment adjusted gross margin, which is a non-GAAP financial measure, for our Services segment, is calculated as gross margin plus intangible asset amortization and restructuring costs. Segment adjusted gross margin percentage, which is a non-GAAP financial measure, is calculated as segment adjusted gross margin divided by revenues.
Gross margin percentage is calculated as gross margin divided by revenues. (2) Segment adjusted gross margin, which is a non-GAAP financial measure, for our Commercial Products segment is calculated as gross margin plus intangible asset amortization and restructuring costs.
Under the proposed settlement, the claims against the Company and its officers and directors will be dismissed with prejudice and released in exchange for a payment from the Company of $40.0 million, $30.0 million of which was paid from insurance proceeds, and was funded in the fourth quarter of 2024.
Under the settlement, the claims against the Company and its officers and directors were dismissed with prejudice and released in exchange for a payment from the Company of $40.0 million, $30.0 million of which was paid from insurance proceeds, and was funded in the fourth quarter of 2024.
Public or bank debt financing, if available, may involve agreements that include covenants, like those contained in our Senior Unsecured Notes and our Senior Secured Credit Facilities, which could limit or restrict our ability to take specific actions, such as incurring additional debt, making capital expenditures, pursuing acquisition opportunities, buying back shares or declaring dividends.
Public or bank debt financing, if available, may involve agreements that include covenants, like those contained in our Senior Unsecured Notes, our Term Loan Agreement and our Revolving Credit Agreement, which could limit or restrict our ability to take specific actions, such as incurring additional debt, making capital expenditures, pursuing acquisition opportunities, buying back shares or declaring dividends.
The cumulative amount of restructuring charges related to the August 2024 Plan since inception is $3.3 million. All activities related to the August 2024 Plan were substantially completed during the fourth quarter of 2024.
The cumulative amount of restructuring charges related to the August 2024 Plan since inception is $2.5 million. All activities related to the August 2024 Plan were substantially completed during the fourth quarter of 2024.
Economic conditions, including market volatility and adverse impacts on financial markets, may make it more difficult to obtain financing on attractive terms, or at all. Any new debt funding, if available, may be on terms less favorable to us than our Senior Unsecured Notes or our Senior Secured Credit Facilities.
Economic conditions, including market volatility and adverse impacts on financial markets, may make it more difficult to obtain financing on attractive terms, or at all. Any new debt funding, if available, may be on terms less favorable to us than our Senior Unsecured Notes, our Term Loan Agreement or our Revolving Credit Agreement.
We also occasionally obtain financing from the sale of our common stock upon exercise of stock options. As of December 31, 2024, we had unrestricted cash and cash equivalents of $99.5 million and available borrowing capacity of up to $100.0 million under the Revolving Credit Agreement.
We also occasionally obtain financing from the sale of our common stock upon exercise of stock options. As of December 31, 2025, we had unrestricted cash and cash equivalents of $205.4 million and available borrowing capacity of up to $100.0 million under the Revolving Credit Agreement.
For contracts with direct retailers, the Company considers several factors in the estimation process for the allowance for returns of OTC NARCAN ® , including inventory levels within the distribution channel and historical return activity, including activity for product sold for which the return period has passed, as well as other relevant factors.
The Company considers several factors in the estimation process for the allowance for returns of OTC NARCAN ® , including inventory levels within the distribution channel, product shelf life and historical return activity, including activity for product sold for which the return period has passed, as well as other relevant factors.
This minimum tax is treated as a period cost beginning in 2024 and its impact is included on the Company's financial results of operations for the current period. The Company is monitoring legislative developments, as well as additional guidance from countries that have enacted legislation. We anticipate further legislative activity and administrative guidance in 2025.
This minimum tax is treated as a period cost beginning in 2024 and its impact is included in the Company's financial results of operations for the current period. The Company is monitoring legislative developments, as well as additional guidance from countries that have enacted legislation.
Actual results may differ from these estimates under different assumptions or conditions. Management believes the Company’s critical accounting policies and estimates are those related to revenue recognition, contingent consideration, and income taxes. Revenue Recognition The Company's product sales are recognized at a point-in-time generally upon delivery to the customer, depending on the performance obligation which the Company is delivering.
Actual results may differ from these estimates under different assumptions or conditions. Management believes the Company’s critical accounting policies and estimates are those related to revenue recognition, long-lived assets and inventories, net. Revenue Recognition The Company's product sales are recognized at a point-in-time generally upon delivery to the customer, depending on the performance obligation which the Company is delivering.
Our R&D expenses consist primarily of: ▪ personnel-related expenses; ▪ fees to professional service providers for, among other things, analytical testing, independent monitoring or other administration of our clinical trials and obtaining and evaluating data from our clinical trials and non-clinical studies; ▪ costs associated with technology transfer and scale up activities throughout the development stage, including internally and through third-party contract manufacturers; ▪ costs of Bioservices for our clinical trial material; and ▪ costs of materials intended for use and used in clinical trials and R&D.
Our R&D expenses consist primarily of: ▪ personnel-related expenses; ▪ fees to professional service providers for, among other things, analytical testing, independent monitoring or other administration of our clinical trials and obtaining and evaluating data from our clinical trials and non-clinical studies; ▪ costs associated with technology transfer and scale up activities throughout the development stage, including internally and through third-party contract manufacturers; ▪ costs of Bioservices for our clinical trial material; and ▪ costs of materials intended for use and used in clinical trials and R&D. 67 In many cases, we seek funding for development activities from external sources and third parties, such as governments and non-governmental organizations, or through collaborative partnerships.
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our consolidated financial statements and accompanying notes and other financial information included elsewhere in this Annual Report on Form 10-K (the “Annual Report”).
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The following discussion and analysis of our financial condition and results of operations for each of the two years in the period ended December 31,2025 should be read in conjunction with our consolidated financial statements and accompanying notes and other financial information included elsewhere in this Annual Report on Form 10-K (this “Annual Report”).
Uncertainties and Trends Affecting Funding Requirements We expect to continue to fund our short-term and long-term anticipated operating expenses, capital expenditures and debt service requirements from the following sources: • existing cash and cash equivalents; • net proceeds from the sale of our products and Bioservices; • development contracts and grant funding; • proceeds from potential asset sales; and • our Term Loan Agreement and Revolving Loans.
Uncertainties and Trends Affecting Funding Requirements We expect to continue to fund our short-term and long-term anticipated operating expenses, capital expenditures and debt service requirements, any future debt repurchases and any future repurchases of our common stock from the following sources: • existing cash and cash equivalents; • net proceeds from the sale of our products and Bioservices; • development contracts and grant funding; • proceeds from potential asset sales; and • our Term Loan Agreement and Revolving Loans. 76 There are numerous risks and uncertainties associated with product sales and with the development and commercialization of our product candidates.
We believe that these non-GAAP operating measures, when reviewed collectively with our GAAP financial information, provide useful supplemental information to investors in assessing our operating performance. Year Ended December 31, 2024 Compared with Year Ended December 31, 2023 Anthrax MCM Anthrax MCM sales decreased $49.1 million, or 26%, to $138.5 million in 2024.
We believe that these non-GAAP operating measures, when reviewed collectively with our GAAP financial information, provide useful supplemental information to investors in assessing our operating performance. Year Ended December 31, 2025 Compared with Year Ended December 31, 2024 Anthrax MCM Anthrax MCM sales decreased $24.2 million, or 17%, to $114.3 million in 2025.
Additionally, we have a development pipeline consisting of a diversified mix of both pre-clinical and clinical stage product candidates. Finally, we have a fully integrated portfolio of CDMO services which cover development services, drug substance manufacturing and drug product manufacturing and packaging. The Company structures the business with a focus on markets and customers.
Finally, we have a fully integrated portfolio of CDMO services which cover development services, drug substance manufacturing and drug product manufacturing and packaging. The Company structures the business with a focus on markets and customers.
Fluctuations in revenues result from the timing of the exercise of annual purchase options, the timing and amount of USG purchases, the availability of governmental funding and timing of Company delivery of orders that follow. 79 Smallpox MCM Smallpox MCM sales decreased $67.0 million, or 29%, to $167.4 million in 2023.
Fluctuations in revenues result from the timing of the exercise of annual purchase options, the timing of USG purchases, the availability of governmental funding and Company delivery of orders that follow. Smallpox MCM Smallpox MCM sales decreased $11.2 million, or 4%, to $266.1 million in 2025.
GAAP, which requires management to make estimates, judgments and assumptions that affect the amounts reported. Note 2, “Summary of significant accounting policies” of the Notes to Consolidated Financial Statements in Part II, Item 8. of this Form 10-K describes the accounting policies and methods used in the preparation of the Company’s consolidated financial statements.
Note 2, “Summary of significant accounting policies” of the Notes to Consolidated Financial Statements in Part II, Item 8. of this Form 10-K describes the accounting policies and methods used in the preparation of the Company’s consolidated financial statements.
The decrease was primarily due to a decrease in interest expense related to our syndicated borrowings and a decrease in amortization of debt service costs, partially offset by higher interest expense related to our Term Loan Agreement and the termination of our interest rate swap hedging agreements in 2023.
The decrease was primarily due to lower interest costs related to our prior syndicated borrowings, partially offset by higher interest expense related to our Term Loan Agreement, and an increase in amortization of debt service costs.
Total segment gross margin and gross margin percentage excludes contracts and grants revenues because the related costs are R&D expenses. See “Segment Results” for an expanded discussion of revenues and gross profit. Unallocated corporate operating expenses R&D Expenses R&D expenses decreased $40.7 million, or 37%, to $70.7 million in 2024.
Gross margin and gross margin percentage excludes Contracts and grants revenues because the related costs are R&D expenses. See “Reportable Segment Results” for an expanded discussion of revenues and gross profit. Unallocated corporate operating expenses R&D Expenses R&D expenses decreased $17.5 million, or 25%, to $53.2 million in 2025.
Year Ended December 31, (dollars in millions) 2024 2023 Net cash provided by (used in): Operating activities $ 58.7 $ (206.3) Investing activities 125.2 212.3 Financing activities (190.0) (535.7) Effect of exchange rate changes on cash, cash equivalents and restricted cash — (1.2) Net change in cash, cash equivalents and restricted cash $ (6.1) $ (530.9) Operating Activities: Net cash provided by operating activities increased $265.0 million in 2024.
Year Ended December 31, (dollars in millions) 2025 2024 Net cash provided by (used in): Operating activities $ 170.6 $ 58.7 Investing activities 69.4 125.2 Financing activities (136.6) (190.0) Effect of exchange rate changes on cash, cash equivalents and restricted cash 0.1 — Net change in cash, cash equivalents and restricted cash $ 103.5 $ (6.1) Operating Activities: Net cash provided by operating activities increased $111.9 million in 2025 compared with 2024.
Revenues for these OTC NARCAN ® arrangements are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established. Estimates of variable consideration includes allowance for returns under direct retailer contracts, specialty distributor fees, wholesaler fees, prompt payment discounts and government rebates.
Revenues for Naloxone products are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established. Estimates of variable consideration include allowance for returns, specialty distributor fees, wholesaler fees and prompt payment discounts.
For additional information, refer to Note 3, “Divestitures” in the Notes to Consolidated Financial Statements in Part II, Item 8. of this Form 10-K. 60 MCM Products Segment: The majority of our MCM product revenue comes from the following products and procured product candidates: Anthrax - MCM Products • Anthrasil ® (Anthrax Immune Globulin Intravenous (human)), the only polyclonal antibody therapeutic licensed by the FDA and Health Canada for the treatment of inhalational anthrax in combination with appropriate antibacterial drugs; • BioThrax ® (Anthrax Vaccine Adsorbed), the only vaccine licensed by the United States Food and Drug Administration (“FDA”) for the general use prophylaxis and post-exposure prophylaxis of anthrax disease; • CYFENDUS ® (Anthrax vaccine adsorbed (AVA), adjuvanted), previously known as AV7909, which was recently approved by the FDA for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial drugs.
MCM Products Segment: The majority of our MCM product revenue comes from the following products and procured product candidates: Anthrax - MCM Products • ANTHRASIL ® (Anthrax Immune Globulin Intravenous (human)), the only polyclonal antibody therapeutic licensed by the FDA and Health Canada for the treatment of inhalational anthrax in combination with appropriate antibacterial drugs; 63 • BioThrax ® (Anthrax Vaccine Adsorbed), the only vaccine licensed by the FDA for the general use prophylaxis and post-exposure prophylaxis of anthrax disease; • CYFENDUS ® (Anthrax vaccine adsorbed (AVA), adjuvanted), which was approved by the FDA in July 2023 for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial drugs.
See Note 3, “Divestitures” and Note 4, “Impairment and restructuring charges” in the Notes to Consolidated Financial Statements in Part II, Item 8. of this Form 10-K for more information related to these announcements.
See Note 4, “Divestitures” in the Notes to Consolidated Financial Statements in Part II, Item 8, of this Form 10-K for more information on the sale of RSDL ® .
We believe that these non-GAAP operating measures, when reviewed collectively with our GAAP financial information, provide useful supplemental information to investors in assessing our operating performance. NM - Not meaningful Year Ended December 31, 2023 Compared with Year Ended December 31, 2022 Anthrax MCM Anthrax MCM sales decreased $102.5 million, or 35%, to $187.6 million in 2023.
We believe that these non-GAAP operating measures, when reviewed collectively with our GAAP financial information, provide useful supplemental information to investors in assessing our operating performance. NM - Not meaningful Year Ended December 31, 2025 Compared with Year Ended December 31, 2024 Naloxone Naloxone sales decreased $172.8 million, or 43%, to $226.1 million in 2025.
Under the terms of a collaboration with Ridgeback Biotherapeutics (“Ridgeback”), Emergent will be responsible for the manufacturing, sale, and distribution of Ebanga™ in the U.S. and Canada, and Ridgeback will serve as the global access partner for Ebanga™; and • Trobigard ® atropine sulfate, obidoxime chloride auto-injector, a combination drug-device auto-injector procured product candidate that contains atropine sulfate and obidoxime chloride.
Under the terms of a collaboration with Ridgeback Biotherapeutics (“Ridgeback”), Emergent will be responsible for the manufacturing, sale, and distribution of Ebanga™ in the U.S. and Canada, and Ridgeback will serve as the global access partner for Ebanga™.
We now manage our business with a focus on three reportable segments: (1) a Commercial Product segment consisting of our NARCAN ® ; (2) a MCM Products segment consisting of the Anthrax - MCM, Smallpox - MCM and Other Products and (3) a Services segment consisting of our Bioservices portfolio.
The Company manages the business with a focus on three operating segments: (1) a Commercial Products segment consisting of NARCAN ® Nasal Spray and KLOXXADO ® Nasal Spray, (2) a MCM Products segment consisting of Anthrax - MCM, Smallpox - MCM and Other Products and (3) a Services segment consisting of our Bioservices offerings.
Fluctuations in revenues result from the timing of the exercise of annual purchase options in existing procurement contracts, the timing of USG purchases, the availability of governmental funding and Company delivery of orders that follow. Other Product Sales Other Product sales increased $1.8 million, or 2%, to $94.0 million in 2024.
Fluctuations in revenues from Smallpox MCM products result from the timing of the exercise of annual purchase options in existing procurement contracts, the timing of USG purchases, the availability of governmental funding and Company delivery of orders that follow. Other Product Sales Other Product sales decreased $17.7 million, or 19%, to $76.3 million in 2025.
The effective annual tax rate decreased largely due to jurisdictional mix of income and losses, GILTI, and other permanent items. 69 SEGMENT RESULTS COMMERCIAL PRODUCT SEGMENT Year Ended December 31, (dollars in millions) 2024 2023 % Change Revenues $ 398.9 $ 497.3 (20) % Cost of sales 185.9 210.3 (12) % Intangible asset amortization 37.8 $ 38.6 (2) % Gross margin (1) $ 175.2 $ 248.4 (29) % Gross margin % (1) 44 % 50 % Add back: Intangible asset amortization 37.8 38.6 (2) % Segment adjusted gross margin (2) $ 213.0 $ 287.0 (26) % Segment adjusted gross margin % (2) 53 % 58 % (1) Gross margin is calculated as revenues less cost of sales and intangible asset amortization.
The effective annual tax rate differs from the prior year largely due to jurisdictional mix of income and losses, GILTI, and other permanent items. 71 SEGMENT RESULTS COMMERCIAL PRODUCTS SEGMENT Year Ended December 31, (dollars in millions) 2025 2024 % Change Revenues $ 226.1 $ 398.9 (43) % Cost of sales 130.1 185.9 (30) % Intangible asset amortization 37.8 37.8 — % Gross margin (1) $ 58.2 $ 175.2 (67) % Gross margin % (1) 26 % 44 % Add back: Intangible asset amortization 37.8 37.8 — % Restructuring costs 0.2 — NM Segment adjusted gross margin (2) $ 96.2 $ 213.0 (55) % Segment adjusted gross margin % (2) 43 % 53 % (1) Gross margin is calculated as revenues less cost of sales and intangible asset amortization.
MCM PRODUCTS SEGMENT Year Ended December 31, (dollars in millions) 2024 2023 % Change Revenues $ 509.8 $ 447.2 14 % Cost of sales 219.4 305.6 (28) % Intangible asset amortization 27.3 27.0 1 % Gross margin (1) $ 263.1 $ 114.6 130 % Gross margin % (1) 52 % 26 % Add back: Intangible asset amortization 27.3 27.0 1 % Changes in fair value of financial instruments 0.6 0.2 200 % Restructuring costs 7.2 5.6 29 % Inventory step-up provision 6.2 3.9 59 % Segment adjusted gross margin (2) $ 304.4 $ 151.3 101 % Segment adjusted gross margin % (2) 60 % 34 % (1) Gross margin is calculated as revenues less cost of sales and intangible asset amortization.
Commercial Products segment adjusted gross margin in the current year excludes the impact of intangible asset amortization of $37.8 million and restructuring costs of $0.2 million. 72 MCM PRODUCTS SEGMENT Year Ended December 31, (dollars in millions) 2025 2024 % Change Revenues $ 456.7 $ 509.8 (10) % Cost of sales 163.1 219.4 (26) % Intangible asset amortization 27.3 27.3 — % Gross margin (1) $ 266.3 $ 263.1 1 % Gross margin % (1) 58 % 52 % Add back: Intangible asset amortization 27.3 27.3 — % Changes in fair value of financial instruments — 0.6 (100) % Restructuring costs (benefits) (1.0) 7.2 (114) % Inventory step-up provision 5.4 6.2 (13) % Segment adjusted gross margin (2) $ 298.0 $ 304.4 (2) % Segment adjusted gross margin % (2) 65 % 60 % (1) Gross margin is calculated as revenues less cost of sales and intangible asset amortization.
Restructuring costs are recognized as an operating expense within the Consolidated Statement of Operations and are classified based on the Company’s classification policy for each category of operating expense.
All activities related to the May 2024 Plan were substantially completed during the third quarter of 2024. Restructuring costs (benefits) are recognized as an operating expense within the Consolidated Statement of Operations and are classified based on the Company's classification policy for each category of operating expense.
On October 4, 2024, the Court granted preliminary approval of the proposed settlement, ordered notice to the settlement class and scheduled a fairness hearing for February 27, 2025.
In October 2024, the Court granted preliminary approval of the proposed settlement, ordered notice to the settlement class and the court granted final approval of the settlement in February 2025.
Long-lived assets Long-lived assets such as finite lived intangible assets and property, plant and equipment are not required to be tested for impairment annually, instead they are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable.
For additional information on our revenues, refer to Note 14, "Revenue recognition" in the Notes to Consolidated Financial Statements in Part II, Item 8. of this Form 10-K. 78 Long-lived assets Long-lived assets such as finite lived intangible assets and property, plant and equipment are not required to be tested for impairment annually, instead they are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable.
The decrease was due to the impact of timing of sales related to CYFENDUS ® and lower sales of Anthrasil ® , coupled with a decrease in BioThrax ® sales, due to timing. Anthrax vaccine product sales are primarily made under annual purchase options exercised by the USG.
The decrease was due to lower volumes of CYFENDUS ® sales to the USG and international customers, primarily due to the impact of timing, partially offset by increases in ANTHRASIL ® sales to the Canadian government and BioThrax ® sales to foreign governments. Anthrax MCM product sales are primarily made under annual purchase options exercised by the USG.
Income tax provision (benefit) Income tax provision of $29.3 million for the year ended December 31, 2023 increased $18.4 million to a provision of $47.7 million for the year ended December 31, 2024. The effective tax rate was (33)% for the year ended December 31, 2024 as compared to (4)% in 2023.
Income tax provision Income tax provision of $47.7 million for the year ended December 31, 2024 decreased $17.5 million to a provision of $30.2 million for the year ended December 31, 2025. The effective tax rate was 36% for the year ended December 31, 2025 as compared to (33)% in 2024.
These decreases were partially offset by increases in revenue on the BARDA contract for the procurement of Ebanga TM , which was awarded in the current period, and TEMBEXA ® . 82 Financial Condition, Liquidity and Capital Resources Our financial condition is summarized as follows: December 31, (dollars in millions) 2024 2023 Change % Financial assets: Cash and cash equivalents $ 99.5 $ 111.7 (11) % Restricted cash 6.1 — NM Total cash, cash equivalents and restricted cash $ 105.6 $ 111.7 (5) % Borrowings: Debt, current portion $ — $ 413.7 (100) % Debt, net of current portion 663.7 446.5 49 % Total borrowings $ 663.7 $ 860.2 (23) % Working capital: Current assets $ 598.7 $ 679.5 (12) % Current liabilities 162.4 651.3 (75) % Total working capital $ 436.3 $ 28.2 NM NM - Not Meaningful Principal Sources of Capital Resources We have historically financed our operating and capital expenditures through existing cash and cash equivalents, cash from operations, development contracts and grant funding and borrowings under various credit agreements, including our Term Loan Agreement and other lines of credit we have established from time to time.
The increase was primarily related to work under the Ebanga TM program, partially offset by the wind-down of our other funded development initiatives. 74 Financial Condition, Liquidity and Capital Resources Our financial condition is summarized as follows: December 31, (dollars in millions) 2025 2024 Change % Financial assets: Cash and cash equivalents $ 205.4 $ 99.5 106 % Restricted cash 3.7 6.1 (39) % Total cash, cash equivalents and restricted cash $ 209.1 $ 105.6 98 % Borrowings: Debt 572.1 663.7 (14) % Total borrowings $ 572.1 $ 663.7 (14) % Working capital: Current assets $ 662.5 $ 598.7 11 % Current liabilities 132.2 162.4 (19) % Total working capital $ 530.3 $ 436.3 22 % NM - Not Meaningful Principal Sources of Capital Resources We have historically financed our operating and capital expenditures through existing cash and cash equivalents, cash from operations, development contracts and grant funding and borrowings under various credit agreements, including our Term Loan Agreement and other lines of credit we have established from time to time.
Gain on sale of business Gain on sale of business decreased $49.9 million, or 67%, to $24.3 million in 2024. The gain on sale of business in the current year is related to the sale of RSDL ® to SERB, partially offset by a loss the sale of the Company’s drug product facility in Baltimore-Camden to Bora.
The gain on sale of business in the prior year was related to the sale of RSDL ® to SERB, partially offset by a loss on the sale of the Company’s drug product facility in Baltimore-Camden to Bora. Gain (loss) on debt extinguishment Gain (loss) on debt extinguishment decreased $12.8 million to a $12.2 million loss in 2025.
We are currently focused on the following four PHT categories: chemical, biological, radiological, nuclear and explosives (“CBRNE”); emerging infectious diseases (“EID”); emerging health crises; and acute, emergency and community care. We have a product portfolio of 10 products that contribute a substantial portion of our revenue and are sold to government and commercial customers.
We are currently focused on the following four PHT categories: chemical, biological, radiological, nuclear and explosives (“CBRNE”); emerging infectious diseases (“EID”); emerging health crises; and acute, emergency and community care.
Sale of RSDL ® On July 31, 2024, the Company, through its wholly owned subsidiary Emergent BioSolutions Canada Inc., entered into the RSDL ® Agreement with SERB pursuant to which, among other things, the Company sold its worldwide rights to RSDL ® to SERB.
Sale of RSDL ® In July 2024, the Company entered into the Stock and Asset Purchase Agreement (the “RSDL ® Agreement”) with SERB Pharmaceuticals, through its wholly owned subsidiary BTG International Inc. (collectively, “SERB”), pursuant to which, among other things, the Company sold its worldwide rights to RSDL ® , to SERB (the “RSDL ® Transaction”).
For more information about the new Senior Secured Credit Facilities, see Note 10, “Debt” in the Notes to Consolidated Financial Statements in Part II, Item 8. of this Form 10-K.
See Note 4, “Divestitures” in the Notes to Consolidated Financial Statements in Part II, Item 8, of this Form 10-K for further discussion.
The U.S. government (“USG”) is the largest purchaser of our Government - MCM products and primarily purchases our products for the Strategic National Stockpile, a national repository of medical countermeasures including critical antibiotics, vaccines, chemical antidotes, antitoxins, and other critical medical supplies. The USG primarily purchases our products under long-term, firm fixed-price procurement contracts, generally with annual options.
We generate MCM Product revenues from the sale of our marketed products and procured product candidates. The U.S. government (“USG”) is the largest purchaser of our Government - MCM products and primarily purchases our products for the Strategic National Stockpile, a national repository of medical countermeasures including critical antibiotics, vaccines, chemical antidotes, antitoxins, and other critical medical supplies.
The Company's Bioservices arrangements are generally recognized on a percentage of completion basis utilizing a cost-to-cost method. Revenues are recognized as a percentage of the work completed during the period in an amount that reflects the percentage of the consideration which the Company expects to receive in exchange for the product or services.
Revenues are recognized as a percentage of the work completed during the period in an amount that reflects the percentage of the consideration which the Company expects to receive in exchange for the product or services. Estimating costs is subjective and requires assumptions about future activity and cost drivers.
From time to time, clients require suite reservations at our various manufacturing sites, which may be considered leases depending on the facts and circumstances. We have received contracts and grant funding from the USG and other non-governmental organizations to perform R&D activities, particularly related to programs addressing certain CBRNE threats and EIDs.
We have received contracts and grant funding from the USG and other non-governmental organizations to perform R&D activities, particularly related to programs addressing certain CBRNE threats and EIDs.
The decrease was primarily due to lower employee related expenses and compensation as a result of restructuring initiatives during 2023 and 2024, lower professional services fees related to corporate initiatives, including organizational transformation consulting fees, lower legal fees due to the wind-down of various legal matters and lower marketing costs.
The decrease was primarily due to a reduction in compensation and other employee related costs as a result of the restructuring initiatives during 2023 and 2024, as well as a decrease in professional services and legal fees related to general corporate initiatives in the prior year.
As such, the key components of the business structure include the following four product and service categories: Anthrax - Medical Countermeasures (“MCM”) Products, NARCAN ® , Smallpox - MCM products and Emergent Bioservices (CDMO) services (“Bioservices”). In the fourth quarter of 2023, we realigned our reportable operating segments to reflect recent changes in our internal operating and reporting process.
As such, the key components of the business structure include the following four product and service categories: Anthrax - Medical Countermeasures (“MCM”) products, Naloxone Commercial products, Smallpox - MCM products and Emergent Bioservices (CDMO) services (“Bioservices”).
FINANCIAL OPERATIONS OVERVIEW Revenues We generate Commercial Product revenues through sale of NARCAN ® Nasal Spray, which is sold commercially over-the-counter at retail pharmacies and digital commerce websites as well as through physician-directed or standing order prescriptions at retail pharmacies, health departments, local law enforcement agencies, community-based organizations, substance abuse centers and other federal agencies.
See Note 11, “Debt” in the Notes to Consolidated Financial Statements in Part II, Item 8, of this Form 10-K for more information on the Company's Term Loan Agreement. 66 FINANCIAL OPERATIONS OVERVIEW Revenues We generate Commercial Product revenues through the sale of Naloxone products, primarily NARCAN ® Nasal Spray, which is sold commercially over-the-counter at retail pharmacies and digital commerce websites as well as through physician-directed or standing order prescriptions at retail pharmacies, health departments, local law enforcement agencies, community-based organizations, substance abuse centers and other federal agencies, as well as KLOXXADO ® Nasal Spray, which is currently being integrated into our distribution network, NARCANDirect ® .
On February 14, 2025, Bavarian Nordic announced that the FDA approved CHIKV VLP under the Priority Review, which triggered a development milestone payment receivable under the Purchase and Sale Agreement to the Company in the amount of $30.0 million, which is expected to be received in the first half of 2025.
In February 2025, Bavarian Nordic announced that the FDA approved CHIKV VLP under the Priority Review, which triggered a $30.0 million development milestone payment to the Company. In addition, in February 2025 Bavarian Nordic also announced that the European Commission approved CHIKV VLP, which triggered a $20.0 million development milestone payment to the Company.
At the scheduled fairness hearing on February 27, 2025, the Court granted final approval of the settlement. The Company recorded the settlement and insurance recoverable amounts as pre-tax operating expense and income, respectively, within “Selling, general and administrative” expenses on the Consolidated Statement of Operations for the year ended December 31, 2024.
The Company recorded the settlement and insurance recoverable amounts as pre-tax operating expense and income, respectively, within “Selling, general and administrative” expenses on the Consolidated Statement of Operations for the year ended December 31, 2024. 65 Sale of Baltimore-Bayview Facility In March 2025, the Company completed the sale of its Baltimore-Bayview drug substance manufacturing facility to Syngene International (“Syngene”).
The increase was primarily attributable to the $50.0 million arbitration settlement with Janssen related to the Settlement Agreement, coupled with an increase in production at the Camden facility prior to the sale of the facility to Bora. The increase was partially offset by reduced production activities at the Company’s Canton and Winnipeg facilities.
The decrease was primarily attributable to the one time $50.0 million arbitration settlement with Janssen related to the 2022 termination of the Janssen Agreement (the “Settlement Agreement”), which was paid in 2024, coupled with lower revenue from the Company’s Camden facility in the current year, which was sold to Bora in the third quarter of 2024, partially offset by an increase in production at the Company's Winnipeg facility.
The Company believes that its sources of liquidity, including debt and cash flows from operating activities, are adequate to fund its operations for at least the next twelve months from the issuance of these consolidated financial statements.
As of December 31, 2025, the Company believes that its sources of liquidity, including debt and cash flows from operating activities, are adequate to fund its operations for at least the next twelve months from the issuance of these consolidated financial statements. 2025 Share Repurchase Program In March 2025, the Company announced that its Board of Directors had authorized the repurchase of up to $50.0 million of the Company’s common stock (the “2025 Share Repurchase Program”) on or before March 27, 2026.
The increase was due to higher ACAM2000 ® sales to non-U.S. customers and higher VIGIV CNJ-016 ® sales, primarily related to USG, partially offset by lower USG purchases of ACAM2000 ® , due to timing.
The decrease was primarily due to lower ACAM2000 ® sales volumes to both U.S. and non-U.S. customers, partially offset by increases in sales of TEMBEXA ® that did not occur in the prior year, and CNJ-016 ® (VIGIV).
We also generate revenue from our Services segment through our Bioservices portfolio, which is based on our established development and manufacturing infrastructure, technology platforms and expertise. Our services include a fully integrated molecule-to-market Bioservices business offering across development services, drug substance and drug product for small to large pharmaceutical and biotechnology industry and government agencies/non-governmental organizations.
Our services include a fully integrated molecule-to-market Bioservices business offering across development services, drug substance and drug product for small to large pharmaceutical and biotechnology industry and government agencies/non-governmental organizations. From time to time, clients require suite reservations at our various manufacturing sites, which may be considered leases depending on the facts and circumstances.
The decrease was due to a $27.2 million non-cash impairment charge in the second quarter of 2024 related to our Bayview and Rockville asset groups within the Bioservices reporting unit, compared with a $306.7 million non-cash impairment charge recorded in the second quarter of 2023 related to our Camden, Bayview and Rockville asset groups within the Bioservices reporting unit.
The decrease was due to the one time $27.2 million non-cash impairment charge in the second quarter of 2024 related to our Bayview and Rockville asset groups within the Bioservices reporting unit, partially offset by a $12.2 million impairment charge associated with the Maryland warehouse disposal group write-down during 2025. 70 Interest expense Interest expense decreased $11.7 million, or 16%, to $59.3 million in 2025.
As of December 31, 2024, the Company had fixed lease payment obligations of $15.3 million, with $3.6 million due within 12 months. The Company has non-cancelable purchase commitments of $632.4 million, with an estimated $195.6 million being due within 12 months. Critical Accounting Policies and Estimates Our consolidated financial statements and related disclosures are prepared in accordance with U.S.
The Company has non-cancelable purchase commitments of $474.8 million, with an estimated $142.9 million being due within 12 months. 77 Critical Accounting Policies and Estimates Our consolidated financial statements and related disclosures are prepared in accordance with U.S. GAAP, which requires management to make estimates, judgments and assumptions that affect the amounts reported.
The increase was primarily due to higher BAT ® product sales to USG and non-U.S. customers, partially offset by lower sales of RSDL ® , which was sold to SERB during the third quarter of 2024. Cost of Sales, Intangible Asset Amortization and Gross Margin Cost of MCM Product sales decreased $86.2 million, or 28%, to $219.4 million in 2024.
The decrease was primarily due to the sale of RSDL ® to SERB during the third quarter of 2024 and a decrease in BAT ® foreign sales, partially offset by higher USG BAT ® sales due to timing. 73 Cost of Sales and Gross Margin Cost of MCM Product sales decreased $56.3 million, or 26%, to $163.1 million in 2025.
Cash Flows The following table provides information regarding our cash flows for the years ended December 31, 2024 and 2023.
As of December 31, 2025, we had $19.7 million available to repurchase additional Senior Unsecured Notes. 75 Cash Flows The following table provides information regarding our cash flows for the years ended December 31, 2025 and 2024.
The decrease was largely due to lower sales volumes and higher shutdown related costs and inventory write-offs, coupled with an unfavorable product revenue mix which was weighted more heavily to lower margin products compared with the prior year.
The increase in gross margin percentage was primarily due to a favorable product sales mix which was weighted more heavily towards higher margin products and a decrease in shut-down and severance costs and inventory reserves compared with the prior year period.
For additional information on the Company's contingent consideration, refer to Note 8, "Fair value measurements" in the Notes to Consolidated Financial Statements in Part II, Item 8. of this Form 10-K.
Commercial Products and MCM Products are our two reportable segments (see Note 19, “Segment information” in the Notes to Consolidated Financial Statements in Part II, Item 8, of this Form 10-K for more information on our reportable segments).
Total segment gross margin percentage decreased 5 percentage points to 25%. The decrease was primarily due to a decrease in the MCM Products segment gross margin of $183.8 million, partially offset by increases in the Commercial Products segment gross margin and Bioservices segment gross margin of $65.0 million and $47.7 million, respectively.
Gross margin increased $46.7 million, or 17%, to $313.9 million in 2025. Gross margin percentage increased 19 percentage points to 45%. The increase was primarily due to improvements in Services gross margin of $160.5 million and in MCM Products gross margin of $3.2 million, partially offset by a decrease in Commercial Products gross margin of $117.0 million.
The decrease in cash used in financing activities was primarily due to proceeds from the Company's new Term Loan Agreement and a reduction in principal payments and proceeds on the revolving credit facility under the Prior Credit Agreement, partially offset by an increase in payments related to the prior Term Loan Facility and an increase in debt issuance costs associated with entry into the Term Loan Agreement and Revolving Credit Agreement. 84 Debt As of December 31, 2024, the Company has $700.0 million of fixed and variable rate debt with varying maturities, with no payable amounts within 12 months (see Note 10, “Debt” in the Notes to Consolidated Financial Statements in Part II, Item 8. of this Form 10-K).
Debt As of December 31, 2025, the Company has $589.7 million of fixed and variable rate debt with varying maturities, with no payable amounts within 12 months (see Note 11, “Debt” in the Notes to Consolidated Financial Statements in Part II, Item 8. of this Form 10-K).
The decrease was primarily driven by the discontinuation of prescription NARCAN ® due to the launch of OTC NARCAN ® in the third quarter of 2023 and lower Canadian retail sales, partially offset by higher sales of OTC NARCAN ® . Other Commercial Products Other Commercial Products sales decreased $9.8 million, or 100%, to no sales in 2024.
Cost of Sales and Gross Margin Cost of Commercial Products sales decreased $55.8 million, or 30%, to $130.1 million in 2025. The decrease was primarily due to lower sales of OTC NARCAN ® and lower Canadian sales of branded NARCAN ® , partially offset by an increase in KLOXXADO ® sales.
NM - Not meaningful Year Ended December 31, 2024 Compared with Year Ended December 31, 2023 Services Revenues Bioservices revenue increased $30.7 million, or 42%, to $103.5 million in 2024.
ALL OTHER REVENUES Year Ended December 31, 2025 Compared with Year Ended December 31, 2024 Services Revenues Services revenues decreased $82.5 million, or 79%, to $22.4 million in 2025.
If financing is unavailable or lost, our business, operating results, financial condition and cash flows would be adversely affected, and we could be forced to delay, reduce the scope of or eliminate many of our planned activities. 85 Unused Credit Capacity Available room under the Revolving Loans as of December 31, 2024 and the revolver under the Prior Credit Agreement as of December 31, 2023 was: December 31, (in millions) 2024 2023 Total Capacity $ 100.0 $ 300.0 Less: Outstanding Letters of Credit (1) — 0.5 Outstanding Indebtedness — 219.2 Unused Capacity $ 100.0 $ 80.3 (1) As a result of entering into the Revolving Credit Agreement during the third quarter of 2024, our outstanding letters of credit were moved to cash collateral.
If financing is unavailable or lost, our business, operating results, financial condition and cash flows would be adversely affected, and we could be forced to delay, reduce the scope of or eliminate many of our planned activities.
The decrease was primarily due to lower sales of TEMBEXA ® , partially offset by an increase related the exercise and full delivery in the current period of a $120 million option by the USG to purchase ACAM2000 ® .
The decrease was primarily due to an unfavorable price and volume mix of OTC NARCAN ® and lower Canadian sales of branded NARCAN ® , partially offset by an increase in KLOXXADO ® sales.
Commercial Product segment gross margin decreased $73.2 million, or 29%, to $175.2 million in 2024. Commercial Product segment gross margin percentage decreased 6 percentage points to 44% in 2024.
Commercial Products gross margin decreased $117.0 million, or 67%, to $58.2 million in 2025. Commercial Products gross margin percentage decreased 18 percentage points to 26% in 2025.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Biggest changeWe have assessed our exposure to changes in interest rates by analyzing the sensitivity to our operating results assuming various changes in market interest rates. A hypothetical increase of one percentage point in the SOFR rate as of December 31, 2024 would increase our interest expense by approximately $2.5 million annually.
Biggest changeFrom time to time, we may use derivative instruments to manage our interest rate risk and market risk exposure. We have assessed our exposure to changes in interest rates by analyzing the sensitivity to our operating results assuming various changes in market interest rates.
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK For a discussion of additional risks arising from our operations, see “Item 1A—Business—Risk Factors” in this 2024 Annual Report. Market Risks We have interest rate and foreign currency market risk.
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK For a discussion of additional risks arising from our operations, see “Item 1A—Business—Risk Factors” in this 2025 Annual Report. Market Risks We have interest rate and foreign currency market risk.
We currently do not hedge all of our foreign currency exchange exposure and the movement of foreign currency exchange rates could have an adverse or positive impact on our results of operations. 89
We currently do not hedge all of our foreign currency exchange exposure and the movement of foreign currency exchange rates could have an adverse or positive impact on our results of operations. 80
Because of the short-term maturities of our cash and cash equivalents, we believe that an increase in market rates would likely not have a significant impact on the realized value of our investments. Interest Rate Risk We have debt with a mix of fixed and variable rates of interest.
Because of the short-term maturities of our cash and cash equivalents, we believe that an increase in market rates would likely not have a significant impact on the realized value of our investments.
We terminated our interest rate swaps in June 2023, and we are satisfied with the current fix-float mix of the Company's debt portfolio. Floating rate debt carries interest based generally on the secured overnight financing rate ("SOFR"), as defined in our Term Loan Agreement, plus an applicable margin.
Interest Rate Risk We have debt with a mix of fixed and variable rates of interest and we are satisfied with the current fix-float mix of the Company's debt portfolio. Floating rate debt carries interest based generally on the secured overnight financing (“SOFR”), as defined in our Term Loan Agreement, plus an applicable margin.
Increases in interest rates could result in an increase in interest payments for our floating rate debt. See Note 10, "Debt" in the Notes to Consolidated Financial Statements in Part II, Item 8. of this Form 10-K. From time to time, we may use derivative instruments to manage our interest rate risk and market risk exposure.
Increases in interest rates could result in an increase in interest payments for our floating rate debt. We maintain an undrawn Revolver Loan that, if utilized, would bear interest and therefore could expose us to interest rate risk. See Note 11, "Debt" in the Notes to Consolidated Financial Statements in Part II, Item 8. of this Form 10-K.
Foreign Currency Exchange Rate Risk We have exposure to foreign currency exchange rate fluctuations worldwide and primarily with respect to the Euro, Canadian dollar, Singapore dollar and British pound.
A hypothetical increase of one percentage point in the SOFR rate as of December 31, 2025 would increase our interest expense by approximately $1.5 million annually. Foreign Currency Exchange Rate Risk We have exposure to foreign currency exchange rate fluctuations worldwide and primarily with respect to the Euro, Canadian dollar, Singapore dollar, Swiss franc, and British pound.

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