ebs-20231005

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): October 5, 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 October 5, 2023, Emergent BioSolutions Inc. (the “Company”) issued a statement announcing recent communications it received from the U.S. Food and Drug Administration (the “FDA”) related to the Company’s Camden manufacturing facility in Baltimore, Maryland.

The FDA has determined that the inspection classification of this facility is “voluntary action indicated” (“VAI”). A VAI inspection classification indicates that, although investigators found and documented objectionable conditions during the inspection, the FDA will not take or recommend regulatory or enforcement action because the objectionable conditions do not meet the threshold for action at this time. Based on the FDA’s determination that the Camden facility is VAI, the facility is considered to be in a minimally acceptable state of compliance with regard to current good manufacturing practice (CGMP). Furthermore, the FDA has concluded that this inspection is “closed” under 21 CFR 20.64(d)(3).

The FDA also sent Emergent a “Warning Letter close-out letter” which states that “it appears that [Emergent has] adequately addressed the violations contained in [the] Warning Letter” that was originally issued to Emergent on August 10, 2022 regarding the Camden facility.

A copy of the Company statement 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						Company statement issued on October 5, 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: October 5, 2023	By:	/s/ RICHARD S. LINDAHL
		Name: Richard S. Lindahl Title: Executive Vice President, Chief Financial Officer and Treasurer