Item 1.01 Entry Into a Material Definitive Agreement.
On May 28, 2020, Emergent BioSolutions Inc. (including its wholly owned subsidiaries, “Emergent”), through its wholly owned subsidiary, Emergent Product Development Gaithersburg Inc., received a contract modification from the Office of the Assistant Secretary for Preparedness and Response (“ASPR”), an agency of the U.S. Department of Health and Human Services (“HHS”), exercising the first of nine annual contract options (the “First Option Exercise”) for Emergent to supply ACAM2000® (Smallpox (Vaccinia) Vaccine, Live) into the U.S. Strategic National Stockpile (“SNS”). The First Option Exercise is valued at approximately $176.2 million.
The First Option Exercise was made under Emergent’s existing 10-year contract (the “Contract” ) awarded by ASPR on August 30, 2019. The period of performance under the First Option Exercise requires Emergent to deliver doses of ACAM2000 into the SNS by December 31, 2020, therefore the entire amount is expected to be delivered in fiscal year 2020.
The preceding description of the First Option Exercise does not purport to be complete and is qualified in its entirety by reference to the First Option Exercise. The First Option Exercise, with relevant redactions to protect confidential and sensitive information, is expected to be filed as an exhibit to Emergent’s Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2020. The Contract is filed as a material agreement of Emergent as exhibit 10.48 with Emergent’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019.
Safe Harbor Statement
This 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, the timing of ACAM2000 deliveries and their impact on Emergent’s full year financial forecast, 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 Form 8-K, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances.
There are a number of important factors that could cause Emergent’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 ASPR/HHS to exercise any further 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.