New contract will double the supply of monkeypox vaccines to HERA before year-end
Company upgrades financial guidance for 2022
COPENHAGEN, Denmark, September 7, 2022 – Bavarian Nordic A/S (OMX: BAVA) announced today that the European Health Emergency Preparedness and Response Authority (HERA) has ordered an additional 170,000 doses of MVA-BN smallpox/monkeypox vaccine, which will be made available to EU Member States, Norway and Iceland.
With deliveries scheduled before year-end, the new order will double the supply of monkeypox vaccines to HERA in 2022.
Paul Chaplin, President and CEO of Bavarian Nordic said: “European countries remain significantly affected by monkeypox and many EU Member States depend on the availability of vaccines through HERA to be able to respond to the outbreak. We are pleased to supply additional vaccines for deployment already this year, enabling HERA to step up their efforts in the short term.”
As a consequence of the recent order inflow, and considering the uncertainty associated with exact timing of supply of products close to year end, Bavarian Nordic raises its expectations for the financial results for 2022 with revenue now expected to be between DKK 2,800 and 3,000 million (previously between DKK 2,700 and 2,900 million) and EBITDA raised to a result between DKK 0 and a loss of DKK 200 million (previously a loss between DKK 100 and 300 million). The year-end cash position is expected to exceed DKK 1,700 million.
The European Health Emergency Preparedness and Response Authority (HERA) was established by the European Commission in September 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.
About the smallpox/monkeypox vaccine
MVA-BN or Modified Vaccinia Ankara-Bavarian Nordic (marketed as IMVANEX® in Europe, JYNNEOS® in the U.S. and IMVAMUNE® in Canada) is a non-replicating smallpox vaccine developed in collaboration with the U.S. government to ensure supply of a smallpox vaccine for the entire population, including immunocompromised individuals who are not recommended vaccination with traditional replicating smallpox vaccines. The vaccine was approved by the European Commission in 2013 for immunization against smallpox in adults aged 18 years and older and has subsequently gained regulatory approvals in Canada and the U.S. where the approval has been extended to include the monkeypox indication as the only vaccine having obtained this to-date.
Bavarian Nordic has ongoing supply contracts with USA and Canada and has delivered the vaccine to a number of undisclosed countries globally as part of their national biological preparedness. In recent years, smaller quantities of the vaccine have been supplied in response to sporadic cases of monkeypox. During the ongoing 2022 outbreak of monkeypox, Bavarian Nordic has worked with several governments and organizations to fulfil the immediate demand for the vaccine through a number of supply agreements and is working to secure manufacturing of vaccines to fulfil the demand in the medium- to long term.
About Bavarian Nordic
Bavarian Nordic is a fully integrated vaccines company focused on the development, manufacturing and commercialization of life-saving vaccines. We are a global leader in smallpox vaccines and have been a long-term supplier to the U.S. Government of a non-replicating smallpox vaccine, which has been approved by the FDA, also for the protection against monkeypox. The vaccine is also approved in Europe and Canada. Our commercial product portfolio furthermore contains market-leading vaccines against rabies and tick-borne encephalitis. Using our live virus vaccine platform technology, MVA-BN®, we have created a diverse portfolio of proprietary and partnered product candidates designed to save and improve lives by unlocking the power of the immune system, including an Ebola vaccine, which is licensed to the Janssen Pharmaceutical Companies of Johnson & Johnson. We are also committed to the development of a next generation COVID-19 vaccine. For more information visit www.bavarian-nordic.com.
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.
Europe: Rolf Sass Sørensen, Vice President Investor Relations, Tel: +45 61 77 47 43
US: Graham Morrell, Paddock Circle Advisors, firstname.lastname@example.org, Tel: +1 781 686 9600
Company Announcement no. 34 / 2022