Bavarian Nordic A/S (OMX: BAVA) announced today the signing of a supply contract with an undisclosed country for the Company’s smallpox vaccine with the aim to ensure sufficient supply to meet the country’s requirements for vaccinating individuals at risk for monkeypox in the short to medium term. The vaccine is approved for use against monkeypox by the U.S. Food and Drug Administration and Health Canada as the only vaccine having obtained regulatory approval for this indication in any territory.
While the terms of the agreement remain undisclosed, the order will positively impact the Company’s financial guidance for 2022 as explained below.
Bavarian Nordic is currently in dialogue with several other governments concerning supply of the vaccine to mitigate the current monkeypox outbreak and to explore opportunities for longer term collaboration to build stockpiles for future preparedness. Officially, monkeypox cases have been reported in more than 15 countries as of to-date with numbers continuing to rise. In this unprecedented situation, the Company is making every possible effort to ensure sufficient availability of vaccines to meet the current demand.
Paul Chaplin, President and CEO of Bavarian Nordic said: “The current monkeypox outbreak, which is now affecting countries globally, calls for a swift and coordinated response from health authorities, and we are pleased to assist another country with supply of vaccines to fulfil a growing demand. Building on our vast experience and relations with governments in the procurement of vaccines for their national preparedness, we have rapidly adapted to this unprecedented situation and are working closely with other governments to make vaccines available as fast as possible to mitigate the situation.”
As a consequence of this order, and improved exchange USD/DKK rates among others, Bavarian Nordic raises its expectations for the financial result for 2022 with revenue now expected to be between DKK 1,300 and 1,500 million (previously between DKK 1,100 and 1,400 million), EBITDA expectations raised to a loss between DKK 1,000 and 1,200 million (previously a loss between DKK 1,000 and 1,300 million) and cash and cash equivalents at year-end now between DKK 1,100 and 1,200 million (previously between DKK 1,000 and 1,200 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.
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, the vaccine has been supplied in response to sporadic cases of monkeypox.
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 for protection against smallpox and monkeypox in Canada, and as a smallpox vaccine in Europe. 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. 20 / 2022