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Bavarian Nordic A/S

HERA has ordered 110,000 doses of the Company’s MVA-BN smallpox/monkeypox vaccine for donation to Member States

Deliveries will begin instantly and might be accomplished in the course of the subsequent months

Company upgrades monetary steerage for 2022

COPENHAGEN, Denmark, June 14, 2022 – Bavarian Nordic A/S (OMX: BAVA) introduced immediately that the European Health Emergency Preparedness and Response Authority (HERA) has ordered 110,000 doses of MVA-BN smallpox/monkeypox vaccine, which might be made obtainable to EU Member States, Norway and Iceland in response to the present monkeypox outbreak.

Established by the European Commission in September 2021, HERA’s objective is to strengthen Europe’s means to forestall, detect, and quickly reply to cross-border well being emergencies, by making certain the event, manufacturing, procurement, and equitable distribution of key medical countermeasures.

Deliveries of vaccines to HERA will begin instantly and might be accomplished in the course of the subsequent months.

Paul Chaplin, President and CEO of Bavarian Nordic stated: “We are happy to enter an settlement with HERA on supplying our vaccine, thus serving to to enhance the EU readiness and response in the course of the present outbreak of monkeypox all through Europe. By now, there are registered instances of monkeypox in additional than 20 European nations, and whereas we’ve already delivered important portions of our vaccine to some particular person EU member states, the availability to HERA now allows a extra built-in and coordinated strategy throughout your complete EU, according to HERA’s mission.”

As a consequence of the order from HERA, and different smaller orders, Bavarian Nordic raises its expectations for the monetary outcomes for 2022 with income now anticipated to be between DKK 1,900 and a pair of,100 million (beforehand between DKK 1,800 and a pair of,000 million), EBITDA expectations raised to a loss between DKK 600 and 800 million (beforehand a loss between DKK 700 and 900 million) and money and money equivalents at year-end now between DKK 1,500 and 1,700 million (beforehand between DKK 1,400 and 1,600 million). The steerage displays the numerous investments in analysis and improvement being made in 2022 to advance the Company’s two lead product candidates: a vaccine in opposition to respiratory syncytial virus (RSV) and a booster vaccine in opposition to COVID-19 into Phase 3 medical trials.

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About the smallpox/monkeypox vaccine
MVA-BN or Modified Vaccinia Ankara-Bavarian Nordic (marketed as IMVANEX® in Europe, JYNNEOS® within the U.S. and IMVAMUNE® in Canada) is a non-replicating smallpox vaccine developed in collaboration with the U.S. authorities to make sure provide of a smallpox vaccine for your complete inhabitants, together with immunocompromised people who aren’t advisable vaccination with conventional replicating smallpox vaccines. The vaccine was accepted by the European Commission in 2013 for immunization in opposition to smallpox in adults aged 18 years and older and has subsequently gained regulatory approvals in Canada and the U.S. the place the approval has been prolonged to incorporate the monkeypox indication as the one vaccine having obtained this to-date.

Bavarian Nordic has ongoing provide contracts with USA and Canada and has delivered the vaccine to a variety of undisclosed nations globally as a part of their nationwide organic preparedness. In current years, smaller portions of the vaccine have been equipped in response to sporadic instances of monkeypox. During the continued 2022 outbreak of monkeypox, Bavarian Nordic has labored with a number of governments to fulfil the rapid demand for the vaccine by way of a variety of provide agreements and is working to safe manufacturing of vaccines to fulfil the demand within the medium- to long run.

About Bavarian Nordic
Bavarian Nordic is a completely built-in vaccines firm centered on the event, manufacturing and commercialization of life-saving vaccines. We are a world chief in smallpox vaccines and have been a long-term provider to the U.S. Government of a non-replicating smallpox vaccine, which has been accepted by the FDA, additionally for the safety in opposition to monkeypox. The vaccine can also be accepted for defense in opposition to smallpox and monkeypox in Canada, and as a smallpox vaccine in Europe. Our business product portfolio moreover incorporates market-leading vaccines in opposition to rabies and tick-borne encephalitis. Using our stay virus vaccine platform know-how, MVA-BN®, we’ve created a various portfolio of proprietary and partnered product candidates designed to avoid wasting and enhance lives by unlocking the ability of the immune system, together with an Ebola vaccine, which is licensed to the Janssen Pharmaceutical Companies of Johnson & Johnson. We are additionally dedicated to the event of a subsequent era COVID-19 vaccine. For extra data go to www.bavarian-nordic.com.

Forward-looking statements
This announcement consists of forward-looking statements that contain dangers, uncertainties and different components, a lot of that are exterior of our management, that might trigger precise outcomes to vary materially from the outcomes mentioned within the forward-looking statements. Forward-looking statements embody statements regarding our plans, goals, targets, future occasions, efficiency and/or different data that’s not historic data. All such forward-looking statements are expressly certified by these cautionary statements and every other cautionary statements which can accompany the forward-looking statements. We undertake no obligation to publicly replace or revise forward-looking statements to mirror subsequent occasions or circumstances after the date made, besides as required by regulation.

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

Company Announcement no. 24 / 2022

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By Seth A. Dunbar

Seth Dunbar leads clinical research study operations and quality & compliance. He is experienced working with teams to help drug sponsors better leverage eSource data. With 10+ years of experience Seth brings expertise developing eClinical services that integrate data and technology to help companies optimise study execution.

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