Bavarian Nordic A/S announced 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 ordered an additional 500,000 doses of liquid-frozen JYNNEOS®, a non-replicating smallpox vaccine and the only FDA-approved vaccine against monkeypox, for delivery in 2022. With the previous order from BARDA for 1.4 million doses of liquid-frozen JYNNEOS, awarded in 2020, this order will bring the total U.S. inventory of the vaccine to nearly 2 million doses. The doses will be manufactured from bulk vaccine already manufactured and invoiced under previous contracts with BARDA and currently stored at Bavarian Nordic.

The majority of this bulk, however, will be converted to approximately 13 million freeze-dried doses of JYNNEOS during 2023-2025. As a consequence of the new order from BARDA and other government orders recently secured, Bavarian Nordic raises its expectations for the financial results for 2022 with revenue now expected to be between DKK 1,800 and 2,000 million (previously between DKK 1,400 and 1,600 million), EBITDA expectations raised to a loss between DKK 700 and 900 million (previously a loss between DKK 900 and 1,100 million) and cash and cash equivalents at year-end now between DKK 1,400 and 1,600 million (previously between DKK 1,200 and 1,300 million). The guidance reflects the significant investments in research and development being made in 2022 to advance the Company's two lead product candidates: a vaccine against respiratory syncytial virus (RSV) and a booster vaccine against COVID-19 into Phase 3 clinical trials.