ebs-202509020001367644false00013676442025-09-022025-09-02
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): September 2, 2025
EMERGENT BIOSOLUTIONS INC.
(Exact name of registrant as specified in its charter)
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| Delaware | | 001-33137 | | 14-1902018 |
| (State or other jurisdiction | | (Commission File Number) | | (IRS Employer |
| of incorporation) | | | | Identification No.) |
300 Professional Drive,
Gaithersburg, Maryland 20879
(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):
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
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| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
| Common Stock, $0.001 par value per share | EBS | New York Stock Exchange |
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 29, 2025, Emergent BioSolutions Inc. (“Emergent”) received a contract modification (“Modification No. 20”) 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 $30.0 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. 20 does not purport to be complete and is qualified in its entirety by reference to the full text of Modification No. 20. Modification No. 20, 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 10.57 with Emergent’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024.
On September 2, 2025, 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.
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| 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.
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| EMERGENT BIOSOLUTIONS INC. |
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| Dated: September 5, 2025 | By: | /s/ RICHARD S. LINDAHL |
| | Name: Richard S. Lindahl Title: Executive Vice President, Chief Financial Officer and Treasurer |
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Emergent BioSolutions Awarded $30 Million Contract Modification for CYFENDUS® (Anthrax Vaccine Adsorbed, Adjuvanted), a Two-Dose Anthrax Vaccine for Post-Exposure Prophylaxis Use
GAITHERSBURG, Md., September 2, 2025 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced it has received a $30 million contract modification 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). Deliveries are expected to begin this calendar year and are scheduled to be completed by March 2026.
"This new contract modification is the next step in our ongoing engagement with the U.S. government, with the shared goal to help ensure medical countermeasures, like CYFENDUS® vaccine, are readily available to safeguard civilian populations against the potential threat of anthrax,” said Paul Williams, senior vice president, head of products business, global government & public affairs at Emergent. “We're proud to leverage a U.S.-based supply chain for our anthrax vaccines, as we believe this is critical to Emergent’s leadership and continued support of the U.S. government’s national security priorities.”
Anthrax is a Tier 1 biological threat due to its potential to be used for a bioterrorist incident and threat to public health and national security. CYFENDUS® vaccine 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.
This follows a previously announced contract modification of $50 million to supply CYFENDUS® (Anthrax Vaccine Adsorbed, Adjuvanted) in December 2024. This project has been supported 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 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 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