Bavarian Nordic A/S

Bavarian Nordic Enters License and Manufacturing Agreement for its Mpox Vaccine with Serum Institute of India

• Tech transfer of MVA-BN^® will help increase global mpox vaccine manufacturing capacity and further expand the equitable access to vulnerable populations.
• Serum Institute of India obtains license to MVA-BN for the Indian market.

COPENHAGEN, Denmark, December 16, 2024 – Bavarian Nordic A/S (OMX: BAVA) announced today a license and manufacturing agreement for its MVA-BN^® mpox vaccine with Serum Institute of India Pvt. Ltd. (“SII”). Under the agreement, the companies will undertake a technology transfer of the current manufacturing process for MVA-BN^® to SII to enable supply for the Indian market, for which SII obtains the license to sell and distribute the vaccine. Furthermore, upon the relevant regulatory approvals, the agreement enables SII to perform contract manufacturing of MVA-BN for Bavarian Nordic which expands the manufacturing capacity, ensuring global access even during outbreaks of mpox.

The license agreement is based on a profit-sharing model with no associated upfront or milestone payments. SII will be responsible for seeking and maintaining regulatory approval of the vaccine in India. The parties will cover their own costs associated with the technology transfer.

Bavarian Nordic continues to explore additional opportunities to establish partnerships to ensure the equitable access to MVA-BN, including with local African manufacturers.

Adar Poonawalla, CEO, Serum Institute of India, said, “Our mission has always been to deliver high-quality, affordable vaccines worldwide. The recent mpox outbreak underscores the critical need for a swift and coordinated response. Partnering with Bavarian Nordic on the MVA-BN mpox vaccine reflects our shared commitment to protect millions at risk. Leveraging our manufacturing strength and rapid response capabilities, we aim to enhance epidemic preparedness and expand access to life-saving vaccines, safeguarding vulnerable populations and easing the global burden of mpox."

Paul Chaplin, President & CEO of Bavarian Nordic, said: “We are pleased to enter this license and manufacturing agreement for MVA-BN as an mpox vaccine, which represents significant progress in our endeavors to expand access to the vaccine for all populations. While there are currently no capacity constraints, scaling of global manufacturing is an important step to ensure the continued equitable access to the vaccine for all countries, and we are pleased to establish this collaboration with SII, the world’s largest vaccine manufacturer by volume. We continue to work with partners globally to explore additional opportunities for local manufacturing to further support vaccine supply.”

About Serum Institute of India
Serum Institute of India Pvt. Ltd, is a global leader in vaccine manufacturing, dedicated to providing affordable vaccines worldwide. Present across 170+ countries, including the US, UK, and Europe, SII holds the distinction of being the world's largest vaccine manufacturer. SII's multifunctional production and one-of-the-largest facility in Manjri, Pune, with an annual capacity of 4 billion doses, has saved over 30 million lives over the years. For more information, visit www.seruminstitute.com.

About Bavarian Nordic
Bavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. 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.

Contact investors:
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

Contact media:
Nicole Seroff, Vice President Corporate Communications, nise@bavarian-nordic.com, Tel: + 45 53 88 06 03

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• 2024-12-16-en