EBS 8-K
Emergent BioSolutions Inc. (EBS)
8-K
2026-09-01
For: 2026-08-18
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Added on
September 01, 2026
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 18, 2026
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction | (Commission File Number) | (IRS Employer | ||||||||||||
| of incorporation) | Identification No.) | |||||||||||||
(Address of principal executive offices, including zip code)
(240 ) 631-3200
(Registrant’s telephone number, including area code)
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01 Other Events
On August 18, 2026, Emergent BioSolutions Inc. (“Emergent”) received a contract modification (“Modification No. 21”) of the BARDA AV7909 Contract (as defined below) from the Office of the Assistant Secretary for Preparedness and Response to procure additional doses of CYFENDUS™ (Anthrax Vaccine Adsorbed, Adjuvanted) (previously known as “AV7909”) valued at $24 million.
This modification relates to Emergent’s AV7909 development and procurement contract with the Biomedical Advanced Research and Development Authority (“BARDA”), which became effective on September 30, 2016 (the “BARDA AV7909 Contract”) and has been modified from time to time. The preceding description of Modification No. 21 does not purport to be complete and is qualified in its entirety by reference to the full text of Modification No. 21. Modification No. 21, with relevant redactions to protect confidential and sensitive information, is filed herewith as Exhibit 10.1 and is incorporated herein by reference. The BARDA AV7909 Contract is filed as a material agreement of Emergent as Exhibit 10.51 with Emergent’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025.
On September 1, 2026, Emergent issued a press release announcing the contract modification. A copy of the press release is furnished as Exhibit 99.1 to this Current Report and incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description | |||||||
| 10.1 | ||||||||
| 99.1 | ||||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |||||||
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| EMERGENT BIOSOLUTIONS INC. | ||||||||
| Dated: September 1, 2026 | By: | /s/ RICHARD S. LINDAHL | ||||||
| Name: Richard S. Lindahl Title: Executive Vice President, Chief Financial Officer | ||||||||
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HHSO100201600030C P00021 Page 4 of 4 SECTION C DESCRIPTION/SPECIFICATIONS/WORK STATEMENT ARTICLE C.1. STATEMENT OF WORK is modified as follows: Independently and not as an agent of the Government, the Contractor shall furnish all necessary services, qualified personnel, material, equipment, and facilities not otherwise provided by the Government as needed to perform the Statement of Work dated August 2026, set forth in SECTION J List of Attachments, attached hereto and incorporated into this Prime Contract. SECTION J LIST OF ATTACHMENTS is modified as follows: 1. Statement of Work, dated August 2026, 10 pages End of Modification #21
August 2026 Page 1 ATTACHMENT 1: STATEMENT OF WORK NEXT GENERATION ANTHRAX VACCINE RFP 16-100- SOL-0015 AV7909 Anthrax Vaccine 1.0 Contractual Statement of Work Preamble to the Statement of Work Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work submitted in response to RFP 16-100-SOL- 00015. 1.1 Scope The scope of work for this contract includes AV7909 development activities through licensure that fall into the following areas: program management, nonclinical, clinical, regulatory, and chemistry, manufacturing, and controls (CMC). The scope of work also includes activities to support post-marketing requirements. 1.2 Objective The objective of this Statement of Work (SOW) is to conduct all necessary activities to advance the development of AV7909 through Biologics License Application (BLA) submission and approval and post- marketing requirements. Activities to meet the objective of this SOW fall in the following contract line item numbers (CLIN): CLIN 0001 – Approval of Emergency Use Authorization (EUA), licensure, approval, and clearance of product through the FDA (Base) CLIN 0001A – Conduct of a Phase 2 clinical study or other studies required by the FDA for the establishment of a specification (Option) CLIN 0012 – Include doxycycline arm in the conduct of the Phase 2 clinical drug-drug interaction study and qualify a redundant contract filler (Base) CLIN 0002 – Initial purchase, storage, and delivery of product (Base) CLIN 0003 – Phase 4 post marketing requirements (Option) CLIN 0004 - Surge Capacity – Additional procurement of product (EUA) (Option) – to CLIN 0006 – Surge Capacity – Additional procurement of product (EUA) (Option) – to doses CLIN 0010 – Surge Capacity - Additional procurement of product (EUA) (Option) – or more doses CLIN 0011A – Surge Capacity - Additional procurement of product (EUA and Licensed) (Option) – up to doses CLIN 0011B – Surge Capacity - Additional procurement of product (Licensed) (Option) – CLIN 0011C – Surge Capacity - Additional procurement of product (Licensed) (Option) – CLIN 0011D – Surge Capacity - Additional procurement of product (Licensed) (Option) – CLIN 0011E – Surge Capacity - Additional procurement of product (Licensed) (Option) – up to doses CLIN 0011F – Surge Capacity – Additional procurement of product (Licensed) (Option) – up to doses AV7909 Target Delivery Schedule (CLIN 0011A) Q2 2023 Q3 2023 Q4 2023 Apr – Jun Jul – Sep Oct [ ** ] [ ** ] [ ** ] [ ** ] [ ** ] [ ** ] [ ** ] [ ** ] [ ** ] [ ** ] [ ** ] [ ** ] [ ** ] [ ** ]
August 2026 Page 4 o [ ** ] [ ** ] [ ** ] [ ** ]
August 2026 Page 7 Under the Base Period funding Emergent shall manufacture, fill, and deliver doses procured in fiscal year 2019 as an initial procurement to the Strategic National Stockpile (SNS). Emergent is approved to use management reserve funding for shipping costs associated with these deliveries. 1.7 CLIN 0003 - Phase 4 post marketing requirements (Option) Reclassified to CLIN 0001. See under CLIN 0001 for details. Program Management Emergent shall provide program management activities. The activities shall include but are not limited to: Identification of and management to, distinct stages of the product development pathway that are gates for Go/No Go decisions for advancing to the next stage of the Integrated Product Development Plan. Establishment of and tracking of milestones and timelines for the initiation conduct, and completion of product development activities for each stage with a budget (in direct costs) linked to each stage. Ongoing evaluation of qualitative and quantitative criteria and accompanying data used to assess the scientific merit and technical feasibility of proceeding to the next stage of product development. Maintaining and managing staff (in-house and contracted) to assure the necessary expertise and dedicated effort to perform the work. Directing and overseeing subcontractors and consultants to assure successful performance of planned activities within the cost and schedule constraints of the contract. Conducting performance measurement that shall include establishing an initial plan; defining measurable parameters; defining how these parameters relate to cost and schedule impacts; their approach in providing a detailed schedule that generates a critical path for the project; and a description of the cost-accounting system used or intended to be used based on budget estimates to monitor all costs related to the contract award for both Emergent and subcontractors on a real time basis. Manage contract activities in accordance with Earned Value Management. In this regard, Emergent shall: o Provide an Integrated Master Project Plan (including tabular and Gantt forms) to BARDA that clearly indicates the critical path to support product approval. The Integrated Master Project Plan shall outline key, critical path milestones, with “Go/No Go” decision criteria and a contract Work Breakdown Structure (due within 90 days of contract award with updates as requested by the Contracting Officer’s Representative (COR). o Submit an updated Integrated Master Schedule in an approved format. o Use principles of Earned Value Management System (EVMS) in the management of this contract. o Submit a plan for a Performance Measurement Baseline Review (PMBR) electronically via email to the Contracting Officer (CO) and COR for a PBMR to occur within 90 days of contract award. Develop and maintain a risk management plan. Participate in regular meetings to coordinate and oversee the contracting effort. [ ** ] [ ** ] [ ** ] [ ** ]
August 2026 Page 9 greater than months, but less than or equal months post-manufacture will be charged a unit dose price of per dose. BARDA will not accept any vaccine older than months post-manufacture. For delivery to the SNS, Emergent shall comply with the relevant associated activities and deliverables as outlined in the Quality Agreement (attached) as signed by Emergent, BARDA, and the SNS. Emergent shall provide appropriate documentation to BARDA for quality assurance of the final drug product delivered to the SNS and invoice appropriately. 1.9 Reporting Requirements and Deliverables Reports As part of the work to be performed under this contract, Emergent will prepare and deliver the following reports throughout the period of performance. Monthly Technical Progress Reports On the fifteenth (15) day of each month for the previous calendar month, Emergent will submit to the COR and the CO a Technical Progress Report covering the previous calendar month. The first reporting period consists of the first full month of performance plus any fractional part of the initial month. Thereafter, the reporting period will consist of each calendar month. The frequency of Technical Progress Reporting will be determined by the CO and COR during negotiations of the contract. The format and type of Technical Progress Report and Executive Summary will be provided by the COR. The Technical Progress Reports will summarize progress for the reporting period, such as: management and administrative updates, technical progress, issues, proposed work, manufacturing and supply chain management, and a summary of invoices. A Technical Progress Report will not be required for the period when the same month Annual Progress Reports or a Final Report are due. Emergent will submit one copy of the Technical Progress Report electronically via e-mail to the CO and COR. Annual Progress Reports On the thirtieth (30th) calendar day following the last day of each reporting period, Emergent will submit to the COR and the CO an Annual Progress Report. The first reporting period consists of the first full year of performance plus any fractional part of the initial year. Thereafter, the reporting period shall consist of each calendar year. Annual Progress Reports will summarize progress for the reporting period, such as: management and administrative updates, technical progress, issues, proposed work, manufacturing and supply chain management, and a summary of invoices. An Annual Progress Report will not be required for the period when the Final Technical Progress Report is due. Draft Final Report and Final Report Emergent will submit the Draft Final Progress Report forty-five (45) calendar days prior to the expiration date of the contract and the Final Progress Report on or before the expiration date of the contract. These reports will include a summation of the work performed and results obtained for execution of various studies or technical work packages during the entire contract period of performance. This report will be in sufficient detail to describe comprehensively the results achieved. An electronic copy of the Draft Final Report and Final Report will be submitted to the COR and CO. FDA Regulatory Agency Correspondence, Meeting Summaries, and Submissions With regard to interactions with the FDA, Emergent shall: Forward the initial draft minutes to BARDA within five business days of any formal meeting with the FDA or other regulatory agency, and forward the final minutes when available. [ ** ] [ ** ] [ ** ][ ** ]
August 2026 Page 10 Forward the initial draft minutes to BARDA within five business days of any informal meeting with the FDA or other regulatory agency, and forward the final minutes when available and if applicable. Forward the dates and times of any meeting with the FDA and other regulatory agencies to BARDA as soon as the meeting times are known and make arrangements for appropriate
August 2026 Page 13 13 Earned Value Management System Requirements Subject to the requirements under FAR 52.234-4 Earned Value Management System, the Contract shall use principles of Earned Value Management System (EVMS) in the management of this contract (include this plan as part of the monthly, annual, and final reports). The Contractor shall also submit a Performance Measurement Baseline Review plan electronically via email to the CO and COR for a PMBR to occur within 90 days of contract award, and an Integrated Master Schedule electronically via email as outlined in a format agreed upon by BARDA to the COR and CO. The Offeror shall deliver an Earned Value Contract Performance Report on a monthly basis. As detailed in Section F.3.2 Subpart F.No Longer Required from the period starting 10/01/2023 onward.
Emergent BioSolutions Awarded Contract Modification Valued at Approximately $24 Million for CYFENDUS® (Anthrax Vaccine Adsorbed, Adjuvanted)
GAITHERSBURG, Md., September 1, 2026 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced a contract modification valued at approximately $24 million from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), to supply CYFENDUS® (Anthrax Vaccine Adsorbed, Adjuvanted) for anthrax preparedness efforts. Anthrax remains a significant global biological threat due to its potential use in a bioterrorism event and its implications for public health and national security.
“This newly executed CYFENDUS® contract modification with the U.S. government highlights the continued importance of maintaining readiness against anthrax threats,” said Paul Williams, senior vice president, head of products business, global government & public affairs at Emergent. “Emergent remains committed to ensuring access to CYFENDUS® and strengthening preparedness through reliable domestic manufacturing and supply.”
CYFENDUS® was approved by the U.S. Food and Drug Administration in July 2023 as a two-dose anthrax vaccine for post-exposure prophylaxis use in individuals 18 through 65 years of age when given with recommended antibacterial drugs. A recent NEJM Evidence study by Tillman et al. examines the use of the CYFENDUS® vaccine for post-exposure prophylaxis following anthrax exposures in Wyoming, further reinforcing the importance of maintaining preparedness capabilities and access to effective medical countermeasures against this high-consequence biological threat.1
This award builds on Emergent’s work with the U.S. government to support anthrax preparedness. Earlier this year, Emergent announced a delivery order valued at up to $21.5 million to supply BioThrax® (Anthrax Vaccine Adsorbed) to the U.S. Department of War.
This project has been funded in whole or in part with federal funds from the U.S. Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600030C.
About CYFENDUS® (Anthrax Vaccine Adsorbed, Adjuvanted)
Indication
CYFENDUS® (Anthrax Vaccine Absorbed, Adjuvanted) is a vaccine indicated for post-exposure prophylaxis of anthrax disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when given with recommended antibacterial drugs. The efficacy of CYFENDUS® vaccine for post-exposure prophylaxis (PEP) is based solely on studies in animal models of inhalational anthrax.
Important Safety Information
Contraindication: Do not administer CYFENDUS® to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) following a previous dose of CYFENDUS®, BioThrax® (a licensed anthrax vaccine with the same active ingredient as CYFENDUS®) or any component of the vaccine.
Warnings and Precautions: Management of Acute Allergic Reactions: Appropriate medical treatment must be available to manage possible anaphylactic reactions following administration of CYFENDUS®. Pregnancy: CYFENDUS® can cause fetal harm when administered to a pregnant
individual. In an observational study, there were more birth defects in infants born to individuals vaccinated with BioThrax® (a licensed anthrax vaccine with the same active ingredient as CYFENDUS®) in the first trimester compared to infants born to individuals vaccinated post pregnancy or individuals never vaccinated with BioThrax®.
Adverse Reactions: The most common (≥10%) injection-site adverse reactions reported were tenderness, pain, arm motion limitation, warmth, induration, itching, swelling, and erythema/redness. The most common systemic adverse reactions were muscle aches, tiredness, and headache.
To report Suspected Adverse Reactions, contact Emergent BioSolutions at 1-800-768-2304 or [email protected]; or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.
Please see the Prescribing Information for CYFENDUS® for full safety information.
About BioThrax® (Anthrax Vaccine Adsorbed) BioThrax® vaccine is indicated for the active immunization for the prevention of disease caused by Bacillus anthracis in persons 18 through 65 years of age. BioThrax® is approved for (1) pre-exposure prophylaxis of disease in persons at high risk of exposure; and (2) post-exposure prophylaxis of disease following suspected or confirmed Bacillus anthracis exposure, when administered in conjunction with recommended antibacterial drugs. The efficacy of BioThrax® for post-exposure prophylaxis is based solely on studies in animal models of inhalational anthrax.
Select Important Safety Information
Contraindication: Severe allergic reaction (e.g., anaphylaxis) after a previous dose of BioThrax® or a component of the vaccine. Warnings and Precautions: Latex: The stopper of the vial contains natural rubber latex and may cause allergic reactions in latex sensitive individuals. Pregnancy: Avoid use in pregnancy unless the potential benefit outweighs the potential risk to the fetus. Adverse Reactions: The most common (>10%) local (injection-site) adverse reactions observed in clinical studies were tenderness, pain, erythema, edema, and arm motion limitation. The most common (≥5%) systemic adverse reactions were muscle aches, fatigue, and headache.
Please see the full Prescribing Information for BioThrax® for additional safety information.
About Emergent BioSolutions At Emergent, our mission is to protect and save lives. For over 25 years, we’ve been at work preparing those entrusted with protecting public health. We deliver protective and life-saving solutions for health threats like smallpox, mpox, botulism, Ebola, anthrax and opioid overdose emergencies. To learn more about how we help prepare communities around the world for today’s health challenges and tomorrow’s threats, visit our website and follow us on LinkedIn, X, Instagram, Apple Podcasts and Spotify.
Safe Harbor Statement This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including statements regarding the expected timing for delivery of the CYFENDUS® vaccine and Emergent’s ability to increase inventories of CYFENDUS® vaccine to meet requested levels within specified time frames, are forward-looking statements. We generally identify forward-looking statements by using words like “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “should,” “will,” “would,” and similar expressions or variations thereof, or the negative thereof, but these terms are not the exclusive means of identifying such statements. Forward-looking statements are based on our current intentions, beliefs, and expectations regarding future events based on information that is currently available. We cannot
guarantee that any forward-looking statement will be accurate. Readers should realize that if underlying assumptions prove inaccurate or if known or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Readers are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events, or circumstances. Readers should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the U.S. Securities and Exchange Commission, when evaluating our forward-looking statements.
Investor Contact:
Richard S. Lindahl
Executive Vice President, CFO
Media Contact:
Assal Hellmer
Vice President, Communications
1Tillman, C., Waranius, B. N., Van Houten, C., & Harrist, A. (2026). Cyfendus for Postexposure Prophylaxis after Inhalation Anthrax Exposures in Wyoming. NEJM Evidence, 5(7), EVIDpha2600122. doi.org.