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Bavarian Nordic A/S - Half Year Interim Report 2009
Date:8/28/2009

ry of IMVAMUNE(R) to the US government to be initiated during the period between fourth quarter of 2009 and the end of second quarter 2010.

As the company is awaiting the exact timing of the FDA review and final acceptance the timing of the actual initiation of delivery is at present uncertain. In order to reflect this, the expectations for the financial result for the full year 2009 are at present indicated as a range. The expected revenue of DKK 375 million was based on the delivery of 2 million doses of IMVAMUNE(R) in 2009. Depending on the timing for initiation of delivery, the revenue is now expected to be in the range of DKK 100-300 million, based on a maximum delivery of 1.5 million doses. The result before tax is expected to be a loss between DKK 275-325 million (previously DKK 225 million). The net free liquidity at year-end is expected to be in the range between DKK 175-350 million (previously DKK 400 million). Bavarian Nordic maintains its long-term expectations to the net free liquidity to be around DKK 800 million by year-end 2012.

In order for the company to maintain a solid cash position, the company has implemented a number of operational activities, thus postponing certain costs and investments until deliveries under RFP-3 can begin.

IMVAMUNE(R) - third generation smallpox vaccine candidate

Deliveries under the RFP-3 contract

In order to initiate the delivery of the 20 million doses of IMVAMUNE(R) to the US under the RFP-3 contract, Bavarian Nordic has to fulfil certain requirements set by the U.S. Food and Drug Administration (FDA) to potentially support the use of IMVAMUNE(R) following a declared emergency. These requirements include animal efficacy data, clinical safety data and the demonstration that the manufacturing of IMVAMUNE(R) is in accordance with industry standards associated with a marketed product.

Bavarian Nordic has successfully
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SOURCE Bavarian Nordic A/S
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Related biology technology :

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3. Bavarian Nordic A/S - Interim Report for the Period 1 January to 30 June 2008
4. Bavarian Nordic Receives USD 25 Million Milestone Payment After Submission of Important IMVAMUNE(R) Data to The U.S. Health Authorities
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