Aug 28 2009
Today Bavarian Nordic published the company's half-year interim report 2009. The full financial statements are available on the company's website: http://www.bavarian-nordic.com. Below is an extract of the most significant matters in the report as well as events after the balance sheet date.
In the first half of 2009 Bavarian Nordic generated revenue of DKK 33 million and recorded a loss before tax of DKK 188 million. As of 30 June 2009 the Group's net free liquidity was DKK 489 million.
Bavarian Nordic's new prostate cancer vaccine - PROSTVAC(TM) has been further validated and shows blockbuster potential. Bavarian Nordic is progressing the development and Phase III preparations of PROSTVAC(TM):
- End of phase II meeting with the FDA in Q4, 2009 and expected initiation of Phase III in 2010 - Five ongoing clinical Phase I and II studies in different patient populations - Preparing the production for Phase III studies - Scientific publication of data - Ongoing discussions with prospective licensing partners
The U.S. Food and Drug Administration (FDA) has performed a GMP inspection of the IMVAMUNE(R) manufacturing facilities. These GMP inspections occurred at both Bavarian Nordic's Kvistgaard facility and at IDT in May 2009. The management of Bavarian Nordic consider these inspections to be successfully completed, and the corrective actions triggered by the inspections will be implemented within short time, causing no further investments. Bavarian Nordic has an ongoing and positive dialogue with FDA which confirms the expectations to start deliveries of IMVAMUNE(R) under the RFP-3 contract following the satisfactory implementation of the corrective actions. On this background the company expects delivery 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.