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.