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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): December 12, 2024
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:
| | | | | | | | |
| 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 December 16, 2024, Emergent BioSolutions Inc. (“Emergent”) announced that it received a contract option modification (“Modification No. 18”) of the BARDA AV7909 Contract (as defined below) from 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 $50 million. This modification relates to Emergent’s AV7909 development and procurement contract with the Biomedical Advanced Research and Development Authority, 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. 18 does not purport to be complete and is qualified in its entirety by reference to the full text of Modification No. 18, filed as Exhibit 10.1 to this Current Report. The BARDA AV7909 Contract was filed as Exhibit 10.2 to Emergent’s Quarterly Report on Form 10-Q for the period ended September 30, 2016, which was filed with the U.S. Securities and Exchange Commission on November 9, 2016.
On January 8, 2025, the Company announced the exercise of a contract option and modification (“Modification No. 3”) to the indefinite-delivery, indefinite-quantity (IDIQ) procurement contract (the “BioThrax IDIQ Contract”) with the U.S. Department of Defense and led by The Joint Program Executive Office for Chemical, Biological Radiological and Nuclear Defense (JPEO-CBRND), valued at approximately $20 million to supply Emergent’s product BioThrax® (Anthrax Vaccine Adsorbed) for use by all branches of the U.S. military as Pre-Exposure Prophylaxis (PrEP) for anthrax disease.
The preceding description of Modification No. 3 does not purport to be complete and is qualified in its entirety by reference to the full text of Modification No. 3, filed as Exhibit 10.2 to this Current Report. The BioThrax IDIQ Contract was filed as Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q for the period ended March 31, 2024, which was filed on May 2, 2024.
On December 16, 2024, and January 8, 2025, Emergent issued press releases announcing the respective contract modifications as discussed above. Copies of the press releases are furnished as Exhibit 99.1 and Exhibit 99.2, respectively, to this Current Report and incorporated herein by reference
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| | | | | | | | |
| Exhibit No. | | Description |
| 10.1 | | |
| 10.2 | | |
| 99.1 | | |
| 99.2 | | |
| 104 | | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
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. |
| | | |
| Dated: January 8, 2025 | By: | /s/ Richard S. Lindahl |
| | Name: Richard S. Lindahl Title: Executive Vice President, Chief Financial Officer and Treasurer |
| | |
Emergent BioSolutions Receives $50 Million Contract Option from BARDA to Procure Doses of CYFENDUS® (Anthrax Vaccine Adsorbed, Adjuvanted)
GAITHERSBURG, Md., Dec. 16, 2024 (GLOBE NEWSWIRE) – Emergent BioSolutions Inc. (NYSE: EBS) today announced that the Biomedical Advanced Research and Development Authority (BARDA) within the Administration for Strategic Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services has awarded a $50 million option to Emergent’s existing contract (HHSO100201600030C) for the acquisition of CYFENDUS® (Anthrax Vaccine Adsorbed, Adjuvanted).
Deliveries are expected to begin this calendar year and be complete by April 2025. This award follows a previously announced contract modification of $30.0 million to supply CYFENDUS® (Anthrax Vaccine Adsorbed, Adjuvanted) this year.
CYFENDUS® vaccine was approved by the U.S. Food & Drug Administration (FDA) in July 2023 as a two-dose anthrax vaccine for post-exposure prophylaxis use in individuals 18 through 65 years of age. Anthrax is a Tier 1 biological select agent due to its potential to be used for a bioterrorist incident and threat to public health and national security.
“An anthrax emergency continues to be a significant public health threat due to its ability to be easily disseminated, lethality, and potential for widespread impact,” said Paul Williams, senior vice president, products head at Emergent. “This procurement award further bolsters anthrax preparedness and demonstrates Emergent’s commitment to public health preparedness.”
In addition to the CYFENDUS® vaccine, Emergent’s anthrax franchise includes the BioThrax® vaccine, which continues to serve a critical purpose, as well as two treatments, Anthrasil® [Anthrax Immune Globulin Intravenous (Human)], a polyclonal antibody therapeutic, and raxibacumab, a monoclonal antibody therapeutic.
This project has been supported in whole or in part with federal funds from the 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 take CYFENDUS® vaccine if you are allergic to CYFENDUS® vaccine, BioThrax® (Anthrax Vaccine Adsorbed) or any ingredient of the vaccine.
Allergic reactions: Appropriate medical treatment and supervision must be available after receiving CYFENDUS® vaccine to manage possible serious allergic reactions. Get medical help right away if you have any symptoms of a serious allergic reaction.
Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished immune response to CYFENDUS® vaccine.
Pregnancy: CYFENDUS® vaccine can cause fetal harm when administered to a pregnant individual. Before getting CYFENDUS® vaccine, tell your healthcare provider if you may be pregnant, plan to get pregnant soon, or are nursing a baby.
Adverse reactions: The most common adverse reactions reported were tenderness, pain, warmth, itching, swelling, redness, bruising, arm motion limitations, muscle aches, tiredness, headache, and fever.
U.S. Prescribing Information
The full Prescribing Information for CYFENDUS® vaccine can be found here.
About Emergent BioSolutions At Emergent, our mission is to protect and enhance life. For 25 years, we’ve been at work defending people from things we hope will never happen—so we are prepared just in case they ever do. We provide solutions for complex and urgent public health threats through a portfolio of vaccines and therapeutics that we develop and manufacture for governments and consumers. We also offer a range of integrated contract development and manufacturing services for pharmaceutical and biotechnology customers. To learn more about how we plan to protect or enhance 1 billion lives by 2030, 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 development, availability, and government procurement of CYFENDUS® vaccine and the continued development of Emergent’s anthrax franchise, 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
Emergent BioSolutions Announces Exercise of $20 Million Option to Supply U.S. Department of Defense with BioThrax® (Anthrax Vaccine Adsorbed)
GAITHERSBURG, Md., Jan. 8, 2024 (GLOBE NEWSWIRE) – Emergent BioSolutions Inc. (NYSE: EBS) today announced the exercise of contract option and modification valued at approximately $20 million to supply BioThrax® (Anthrax Vaccine Adsorbed) to the U.S. Department of Defense (DoD). The first delivery, which was valued at approximately $7 million began in December 2024, and remaining deliveries are expected in 2025.
“We’re pleased to continue our work with the U.S. Department of Defense to supply BioThrax® to protect our nation’s service members who have a high risk of exposure to anthrax,” said Paul Williams, senior vice president, products head at Emergent. “This procurement ensures a continued supply of this important medical countermeasure to the U.S. military and demonstrates our commitment to delivering solutions that address our customers’ needs to prepare for public health threats.”
This option is under Emergent’s existing indefinite-delivery, indefinite-quantity (IDIQ) procurement contract (W911SR24D0001) with the DoD and led by the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense to supply BioThrax® for use by all branches of the U.S. military as pre-exposure prophylaxis (PrEP) for anthrax disease.
On December 16, 2024, Emergent announced a $50 million contract option from the Biomedical Advanced Research and Development Authority (BARDA) to procure doses of CYFENDUS® (Anthrax Vaccine Adsorbed, Adjuvanted). In addition to BioThrax® and CYFENDUS®, Emergent’s anthrax franchise includes two treatments, Anthrasil® [Anthrax Immune Globulin Intravenous (Human)], a polyclonal antibody therapeutic, and raxibacumab, a monoclonal antibody therapeutic.
About BioThrax® (Anthrax Vaccine Adsorbed)
Indication
BioThrax® (Anthrax Vaccine Adsorbed) is a vaccine 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. (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.
Important Safety Information
Contraindications: Severe allergic reaction (e.g., anaphylaxis) after a previous dose of BioThrax® or a component of the vaccine.
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.
History of Anthrax Disease: History of anthrax disease may increase the potential for severe local adverse reactions.
Altered Immunocompetence: If BioThrax® is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the immune response may be diminished.
Limitations of Vaccine Effectiveness: Vaccination with BioThrax® may not protect all individuals.
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.
U.S. Prescribing Information
The full Prescribing Information for BioThrax® vaccine can be found here.
About Emergent BioSolutions At Emergent, our mission is to protect and enhance life. For 25 years, we’ve been at work defending people from things we hope will never happen—so we are prepared just in case they ever do. We provide solutions for complex and urgent public health threats through a portfolio of vaccines and therapeutics that we develop and manufacture for governments and consumers. We also offer a range of integrated contract development and manufacturing services for pharmaceutical and biotechnology customers. To learn more about how we plan to protect or enhance 1 billion lives by 2030, 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 development, availability, supply and government procurement of BioThrax® vaccine and the continued development of Emergent’s anthrax franchise, 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