Bavarian Nordic Receives Order from HERA and Announces Significant Donation of Vaccines in Response to the Mpox Outbreak in Africa

• HERA will procure 175,420 doses for immediate response to the concerning mpox outbreak in Africa, and furthermore, Bavarian Nordic will donate 40,000 doses to HERA, also to be distributed to the Africa CDC.

COPENHAGEN, Denmark, August 13, 2024 – Bavarian Nordic A/S (OMX: BAVA) announced today a new order from HERA (the European Health Emergency Preparedness and Response Authority) for the Company’s MVA-BN^® vaccine, the only FDA and EMA-approved mpox vaccine. HERA will procure 175,420 doses of the vaccine for donation to the Africa CDC (Centres for Disease Control and Prevention) in support of their strengthened response to the mpox outbreak which is spreading across the African continent. Additionally, Bavarian Nordic will donate 40,000 doses to HERA, also to be donated to the Africa CDC.

This larger donation follows a recent pledge from the Company for 15,000 doses as part of coordinated response in the African region by Gavi, WHO and UNICEF.

Currently, only two African countries have granted Emergency Use Authorization for the MVA-BN vaccine, but the WHO last week requested Bavarian Nordic to submit an Expression of Interest for Emergency Use Listing (EUL) of the vaccine, which could accelerate its accessibility to African countries where national regulatory approvals are not yet in place. Furthermore, the Africa CDC has today declared a Public Health Emergency of Continental Security, a new framework aimed to further strengthen and accelerate the public health response against mpox across the entire region.

“Strong global partnerships are at the very core of our European Health Union. Health security threats know no borders and today, thanks to the collaboration between the European Commission, Africa Centre for Disease Control and Bavarian Nordic, we make 215,000 vaccines available to protect the most vulnerable in countries affected by the outbreak of mpox in Africa. Preparedness and response to health threats is a global endeavour which we are determined to pursue collectively and with solidarity across borders,” said Stella Kyriakides, European Commissioner for Health and Food Safety

“Mpox is spreading at an alarming rate in Africa, calling for further action from the international community. We are proud to support HERA’s contribution of vaccines to the region and are pleased to announce an additional donation from Bavarian Nordic. We also applaud the initiatives from the Africa CDC and WHO to strengthen and coordinate the public health response, helping to ensure our vaccine can reach more people on the African continent,” said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic.

The order from HERA will have no impact on the Company’s overall financial guidance for 2024 but brings the total value of secured contracts close to the lower level of the revenue guidance for the Public Preparedness business in 2024, from which DKK 2,700-3,000 million is expected of a total expected revenue of DKK 5,000-5,300 million for the full year.

About HERA
The European Health Emergency Preparedness and Response Authority (HERA) was established by the European Commission in 2021 with the purpose to strengthen Europe’s ability to prevent, detect, and rapidly respond to cross-border health emergencies, by ensuring the development, manufacturing, procurement, and equitable distribution of key medical countermeasures. HERA has also made commitments to support health crises beyond Europe.

Bavarian Nordic has worked with HERA since the 2022 mpox outbreak, initially through direct procurement agreements, followed by the signing of a joint procurement agreement which has enabled EU Member States and additional countries in the European Economic Area (EEA) as well as Western Balkan countries to procure the mpox vaccine for national use.

About the mpox vaccine
MVA-BN or Modified Vaccinia Ankara-Bavarian Nordic is a non-replicating smallpox vaccine and the only mpox vaccine approved in the U.S. and Switzerland (marketed as JYNNEOS^®), Canada (marketed as IMVAMUNE^®), and the EU/EEA and United Kingdom (marketed as IMVANEX^®). Originally developed in collaboration with the U.S. government to ensure the supply of a smallpox vaccine for the entire population, including immunocompromised individuals who are not recommended vaccination with traditional replicating smallpox vaccines, MVA-BN has been indicated for use in the general adult population (18 years and older) in individuals considered at risk for smallpox or mpox. During the 2022-2023 mpox outbreak, the vaccine was granted an Emergency Use Authorization by the U.S. FDA for both pre- and post-exposure use in adolescents.

Bavarian Nordic has been a long-term supplier of the vaccine to the U.S. and Canada as well as several other countries as part of their national biological preparedness. During the 2022-2023 mpox outbreak, Bavarian Nordic has furthermore supported governments and supranational organizations by expanding access to the vaccine to more than 70 countries worldwide.

About Bavarian Nordic
Bavarian Nordic is a fully integrated vaccine company with a mission to protect and save lives through innovative vaccines. We are a global leader in smallpox and mpox vaccines, supplied to governments to enhance public health preparedness and have a strong portfolio of vaccines for travelers and endemic diseases. For more information visit www.bavarian-nordic.com.

Forward-looking statements
This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of our control, that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law.

Contacts
Europe: Rolf Sass Sørensen, Vice President Investor Relations, rss@bavarian-nordic.com, Tel: +45 61 77 47 43
US: Graham Morrell, Paddock Circle Advisors, graham@paddockcircle.com, Tel: +1 781 686 9600

Company Announcement no. 23 / 2024

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• 2024-23-en