Bavarian Nordic to Manufacture First Freeze-dried Doses of Smallpox Vaccine upon Exercise of Contract Option by the U.S. Government

• USD 119 million option exercised for the manufacturing of freeze-dried JYNNEOS in 2023 and 2024
• This represents the first set of options with a total value of USD 299 million to convert the existing bulk vaccine, previously purchased by BARDA, to approximately 13 million freeze-dried JYNNEOS doses

COPENHAGEN, Denmark, May 18, 2022 – Bavarian Nordic A/S (OMX: BAVA) announced today that the U.S. Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, has exercised the first options under the contract to supply a freeze-dried version of JYNNEOS smallpox vaccine, thus allowing for the first doses of this version to be manufactured and invoiced in 2023 and 2024.

The options have a value of USD 119 million and represent the first options exercised to convert bulk vaccine, which has already been manufactured and invoiced under previous contracts with BARDA, into freeze dried doses of JYNNEOS smallpox vaccine. Additional options on the contract valued at USD 180 million, if exercised support conversion of up to a total of approximately 13 million freeze dried doses of JYNNEOS smallpox vaccine that are expected to be manufactured in 2024 and 2025. The majority of the bulk vaccine for these doses has already been manufactured and invoiced.

The transfer of the freeze-drying process to our new fill and finish plant in Kvistgaard was initiated last year and following an FDA inspection in 2022 will lead to commercial manufacturing in 2023. A supplement to the existing liquid frozen JYNNEOS BLA will be made comprising the Phase 3 data, which has already been completed and reported, together with the manufacturing data to support the approval of the freeze-dried version of JYNNEOS in 2024. In parallel to these activities, we will, with the award of this first option, begin to manufacture and invoice freeze-dried JYNNEOS doses in 2023 and 2024.

Paul Chaplin, President and CEO of Bavarian Nordic said: “We are pleased to announce the exercise of the first options under our contract with the U.S. government to deliver a freeze-dried version of the smallpox vaccine with an improved shelf-life, which will be manufactured at our new fill and finish facility. This marks a significant milestone in our long-standing partnership with the U.S. government to ensure availability of life-saving vaccines for the entire population.”