Company Announcements

COPENHAGEN, Denmark, September 12, 2024 – Bavarian Nordic A/S (OMX: BAVA), the vaccine manufacturer of MVA-BN^®, the only approved non-replicating smallpox and mpox vaccine (marketed as JYNNEOS^®, IMVAMUNE^® and IMVANEX^®) today provided an update of its supply and manufacturing activities in support of the ongoing mpox outbreak.

Since the declaration of mpox as a Public Health Emergency of Continental Security (PHECS) by the Africa Centers for Disease Control (CDC) and the subsequent declaration of a Public Health Emergency of International Concern (PHEIC) by the World Health Organization (WHO), Bavarian Nordic has intensified the collaboration with global stakeholders to support the joint efforts to combat the mpox outbreak.

Importantly, thanks to donations from the European Commission, the U.S. government and Bavarian Nordic, the first doses of MVA-BN arrived last week in the Democratic Republic of Congo (DRC), the epicenter of the mpox outbreak. More than 250,000 doses have already been shipped, and further donations of more than 500,000 doses of MVA-BN have so far been pledged by other countries.

UNICEF and Africa CDC have indicated that there is an urgent need for sufficient vaccine to protect up to 1 million people in the high-risk areas of the DRC, while potentially up to 10-12 million doses could be required through 2025. Bavarian Nordic is committed to ensuring equitable access to its mpox vaccine, and in response to the current outbreak and the strong demand from governments and organizations, including HERA, Gavi, UNICEF and Africa CDC, the Company has prioritized the production of MVA-BN for the rest of the year to provide up to 2 million doses by year-end.

This decision has meant that certain existing orders for 2024 will be pushed out to 2025 to provide greater flexibility to fulfill additional urgent and imminent needs in other markets. While this will defer part of the planned revenue for 2024 into next year, new orders entered in the recent weeks will offset the deferred revenue, and thus the Company’s financial guidance for 2024 remains unchanged.

These new supply contracts include multi-year agreements with countries across different continents, including countries who have pledged vaccines for Africa. In addition, Bavarian Nordic has responded to the UNICEF emergency tender, calling for the immediate supply of up to 2 million doses in 2024, and has ongoing discussions with other organizations and individual governments around the globe.

Bavarian Nordic has informed Gavi and UNICEF that by focusing the full capacity to address the current public health emergency, the Company could supply up to 13 million MVA-BN doses by the end of 2025, including 2 million in 2024. While this appears to be sufficient to meet the anticipated short- to medium-term demand as expressed by customers and partners, the Company continues to explore additional levers that could further expand the capacity. This includes looking to transfer manufacturing to other companies either in Africa or other parts of the world. Based on these early, but highly constructive discussions, together with further planned improvements in the manufacturing process, Bavarian Nordic has identified another 50 million doses that pending regulatory approvals and demand could be supplied during the next 12-18 months.

Paul Chaplin, President & CEO of Bavarian Nordic, said: “As the supplier of the only non-replicating mpox vaccine that has shown to be highly effective during an mpox outbreak, we have been working closely with all governments and organizations to support the international efforts to combat the latest public health emergency. Just as during the outbreak in 2022/23, we will support all requests for vaccine and have already secured agreements and submitted responses to the UNICEF tender that will hopefully secure more access to MVA-BN globally. We remain committed to the equitable access either through prioritizing our own capacity, accelerating planned improvements in the manufacturing process and by exploring ways to further expand capacity through partnerships around the globe. Once again Bavarian Nordic, through innovation and our commitment to improving and saving lives has stepped forward as an important part of the international community’s response to the current public health emergency.”

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

Vedhæftet fil

• 2024-09-12-en