EMERGENT BIOSOLUTIONS INC. Form 8-K (May 8, 2020)

Summary

A Form 8-K current report of Emergent BioSolutions Inc., dated May 8, 2020 and signed by Richard S. Lindahl, Executive Vice President, Chief Financial Officer and Treasurer. Under Item 8.01 the company reports that it finalized its contract with the U.S. Department of Health and Human Services to deliver final drug product of botulism antitoxin BAT into the U.S. Strategic National Stockpile, valued at up to approximately $550 million if all options are exercised. The first deliverable, negotiated in September 2019, is valued at up to approximately $90 million, plus options valued at up to approximately $94 million; the second, up to approximately $366 million, is bulk drug substance production over 10 years.

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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): May 8, 2020

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.

Emergent BioSolutions Inc. (the “Company”) has finalized a previously announced contract entered into with the U.S. Department of Health and Human Services (“HHS”) to deliver final drug product of botulism antitoxin, BAT® [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine)] into the U.S. Strategic National Stockpile (“SNS”) and maintain this critical infrastructure for botulism preparedness and response.

The contract is valued at up to approximately $550 million if all options are exercised and has two deliverables. The first deliverable, negotiated in September 2019 and valued at up to approximately $90 million, is to supply annual doses of BAT into the SNS for 10 years by converting existing bulk drug substance produced under a prior U.S. government contract into final drug product. This deliverable also includes options for additional doses valued at up to approximately $94 million over 10 years.

The second deliverable, valued at up to approximately $366 million, is for the production of additional doses of bulk drug substance over the next 10 years to maintain the plasma collection and production capability for this critical component of botulism response planning.

BAT, the only heptavalent botulism antitoxin licensed by the FDA, is indicated for the treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin serotypes A, B, C, D, E, F, or G in adults and pediatric patients. BAT is a plasma-derived therapy manufactured on the Company’s proprietary equine hyperimmune platform.

Safe Harbor Statement

This Current Report on Form 8-K includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding the total potential realizable value of the contract, maintaining production capability and the supply chain for botulism antitoxin for the next 10 years, and any other statements containing the words “believes,” “expects,” “anticipates,” “intends,” “plans,” “estimates” and similar expressions, are forward-looking statements. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Investors 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 Current Report on Form 8-K, and, except as required by law, we do not undertake to update any forward-looking statement.

There are a number of important factors that could cause the Company's actual results to differ materially from those indicated by such forward-looking statements, including the availability of funding for our U.S. government grants and contracts, decisions by HHS to exercise options under the contract and our manufacturing capabilities and strategy. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the SEC, when evaluating our forward-looking statements.

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: May 8, 2020 | By: | /s/ RICHARD S. LINDAHL
Name:Richard S. Lindahl Title: Executive Vice President, Chief Financial Officer and Treasurer

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