Form 8-K - Current report

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): November 21, 2023

EMERGENT BIOSOLUTIONS INC.

(Exact name of registrant as specified in its charter)

Delaware

001-33137

14-1902018

(State or other jurisdiction

(Commission File Number)

(IRS Employer

of incorporation)

Identification No.)

400 Professional Drive, Suite 400,

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, Par Value $0.001 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 November 21, 2023, Emergent Product Development Gaithersburg Inc., a wholly owned subsidiary of Emergent BioSolutions Inc. (together with all its wholly owned subsidiaries, “Emergent”), received a contract option (“Modification No. 16”) of the BARDA AV7909 Contract (as defined below) from the Office of the Assistant Secretary for Preparedness and Response, an agency of the U.S. Department of Health and Human Services, exercising an option valued at $75 million for Emergent to procure additional doses of newly licensed CYFENDUS™ (Anthrax Vaccine Adsorbed, Adjuvanted) (previously known as “AV7909”). 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. Deliveries of CYFENDUS™ are expected to begin this calendar year and be complete by the end of the first quarter of 2024.

The preceding description of Modification No. 16 does not purport to be complete and is qualified in its entirety by reference to the full text of Modification No. 16. Modification No. 16, with relevant redactions to protect confidential and sensitive information, is expected to be filed as an exhibit to Emergent’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023. The BARDA AV7909 Contract is filed as a material agreement of Emergent as exhibit 10.54 with Emergent’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022.

A copy of the Company’s press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.

Item 9.01.  Financial Statements and Exhibits

(d) Exhibits.


Exhibit No.						Description
99.1						Press release issued by Emergent BioSolutions Inc. on November 28, 2023
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.


	EMERGENT BIOSOLUTIONS INC.

Dated: November 28, 2023	By:	/s/ RICHARD S. LINDAHL
		Name: Richard S. Lindahl Title: Executive Vice President, Chief Financial Officer and Treasurer

Emergent BioSolutions Receives $75 Million Contract Option from BARDA to Procure Doses of CYFENDUS™ (Anthrax Vaccine Adsorbed, Adjuvanted)

GAITHERSBURG, Md., Nov. 28, 2023 (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 at the United States Department of Health and Human Services has awarded a $75 million option to Emergent’s existing contract (HHSO100201600030C) for the acquisition of newly licensed anthrax vaccine CYFENDUS™ (Anthrax Vaccine Adsorbed, Adjuvanted). Deliveries are expected to begin this calendar year and be complete by the end of the first quarter of 2024.

Previously known as AV7909, 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 years of age and older. Anthrax is considered a high-priority national security threat and has the potential for major public health impact.

“CYFENDUS™ vaccine is a critical component of Emergent’s anthrax medical countermeasures franchise, and supports the U.S. government's anthrax preparedness strategy, said Paul Williams, senior vice president, products head at Emergent. “This procurement helps ensure the nation has sufficient anthrax vaccine and aligns with Emergent’s longstanding commitment to strengthen public health preparedness.”

In 2016, BARDA and Emergent extended their partnership to support clinical development and manufacturing efforts for the AV7909 vaccine, including a Phase 3 trial to demonstrate safety and efficacy, working toward the goal of eventual FDA licensure. A pre-Emergency Use Authorization (EUA) package was submitted in December 2018, and the first pre-EUA doses of AV7909 were delivered to the U.S. government in 2019. In April 2022, Emergent submitted the Biologics License Application to the FDA for review, leading to approval and licensure in July 2023. This latest contract option supplements previous contract procurements and supports the U.S. biodefense preparedness efforts.

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, Twitter, and Instagram.

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

lindahlr@ebsi.com

Media Contact:

Assal Hellmer

Vice President, Communications

mediarelations@ebsi.com

Cover Page Cover Page	Nov. 21, 2023
Cover [Abstract]
Document Type	8-K
Document Period End Date	Nov. 21, 2023
Entity Registrant Name	EMERGENT BIOSOLUTIONS INC.
Entity Incorporation, State or Country Code	DE
Entity File Number	001-33137
Entity Tax Identification Number	14-1902018
Entity Address, Address Line One	400 Professional Drive
Entity Address, Address Line Two	Suite 400
Entity Address, City or Town	Gaithersburg
Entity Address, State or Province	MD
Entity Address, Postal Zip Code	20879
City Area Code	240
Local Phone Number	631-3200
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity Emerging Growth Company	false
Title of 12(b) Security	Common Stock, Par Value $0.001 per share
Trading Symbol	EBS
Security Exchange Name	NYSE
Entity Central Index Key	0001367644
Amendment Flag	false