Under a deal with the US agency BARDA, Bavarian Nordic A/S (Copenhagen) will cash in US$96m in 2023 ffor the manufacturing of a n new buk product of smallpox/mpox vaccine, which was used in response to the mpox outbreak in 2022. Nearly 5.5 million doses have been manufactured for the U.S. government over the course of 2022 and 2023, and replenishment of the bulk inventory is necessary to fulfil the company’s long-term commitment to deliver a freeze-dried version of the vaccine for US smallpox preparedness. In addition, Bavarian Nordic will manufacture and supply additional liquid-frozen doses of the vaccine in 2023, valued at US$3m. The agreement includes additional services totalling US$21m, of which the majority will be received in 2024 and 2025.
As a consequence of the new order from BARDA combined with other minor mpox vaccine orders recently secured, expected savings from the discontinued RSV programme and including the impact from the acquisition of the travel vaccine portfolio from Emergent BioSolutions, Bavarian Nordic upgrades its financial guidance for 2023. Revenue is now expected to be approximately DKK6,9bn (previously approximately DKK6bn) and EBITDA is now expected to be approximately DKK2,3bn(previously approximately DKK2,2bnn).
Since 2003, Bavarian Nordic has worked with the U.S. government on the development, manufacturing and supply of a non-replicating smallpox vaccine to ensure all populations can be protected from smallpox, including people with weakened immune systems who are at high risk of adverse reactions to traditional smallpox vaccines, which are based on replicating vaccinia virus strains. The Company has supplied nearly 30 million doses of the liquid-frozen version to the US, with the vast majority being delivered for emergency use - and now expired - before approval of the vaccine by the FDA in 2019, which included an approval for the mpox indication as the only vaccine having obtained this to-date.
BARDA has supported the development of a freeze-dried version of the vaccine with longer shelf-life to replace the stockpile and in 2017 awarded the Company a ten-year contract for supply of freeze-dried vaccines. Under this contract Bavarian Nordic has manufactured bulk vaccine, corresponding to approximately 13 million doses, which are to be filled and finished from 2023 and onwards. However, the request from BARDA in 2022 to supply the liquid-frozen version of the vaccine to mitigate the mpox outbreak has reduced the inventory of bulk, thus calling for a replenishment to enable Bavarian Nordic to fulfill its contract for the freeze-dried version.