Bavarian Nordic Reports First Half 2012 Financial Results

  • Continued strong performance in the manufacturing of IMVAMUNE® smallpox vaccines
  • Infectious disease division increases profitability
  • Raises full year group financial expectations and year-end cash preparedness

KVISTGAARD, Denmark, August 28, 2012 - Bavarian Nordic A/S (OMX: BAVA) today publishes its first half 2012 results. Revenue for the period was DKK 445 million (2011: DKK 58 million) and the result before tax was a loss of DKK 13 million (2011: DKK 275 million loss). For the second quarter ending 30 June 2012, revenue was DKK 278 million (2011: DKK 29 million) and the result before tax was DKK 22 million (2011: DKK 140 million loss). As of 30 June 2012 the cash preparedness was DKK 631 million, including un-utilised credit lines of DKK 120 million.

The infectious disease division continues to improve efficiency in the manufacturing of IMVAMUNE® . Thus Bavarian Nordic will deliver more doses to the U.S. Strategic National Stockpile in 2012 than previously targeted. Combined with income from new research and development contracts, this will generate higher revenue for the year. Consequently, the company raises its financial expectations for the year with revenues increasing from approximately DKK 850 million to approximately DKK 900 million and the result before tax improving by DKK 50 million from a loss of approximately DKK 200 million to a loss of approximately DKK 150 million. Also, the company raises its expectations for the year-end cash preparedness from approximately DKK 350 million to approximately DKK 400 million.

Significant achievements in the first half and up to the reporting date

  • 5.2 million doses of IMVAMUNE® delivered to the U.S. Strategic National Stockpile in 2012 to-date
  • Continued improvements in the IMVAMUNE® manufacturing efficiency over the first quarters of 2012
  • RFP-3 contract modifications increases total contract value by USD 32 million to USD 545 million
  • Broadened the scope of the MVA-BN® vaccine platform technology through new U.S. Government contract. The contract valued at up to USD 17.9 million supports the development of technologies to accelerate and/or enhance the immune response to a recombinant MVA-BN® based vaccine
  • U.S. Government has significantly expanded the population eligible to receive IMVAMUNE® in an emergency to cover all individuals with HIV infection or atopic dermatitis, including pregnant, nursing mothers and children
  • As a consequence of new Danish tax legislation, the company has partially written down its deferred tax asset by DKK 182 million
  • Marketing application for IMVANEX® (IMVAMUNE® )submitted to the European Medicines Agency
  • The PROSPECT Phase 3 study of PROSTVAC® has begun enrolment in the first countries outside USA
  • Interim analysis of a Phase 2 combination study of PROSTVAC® and Quadramet® presented at the 2012 ASCO Annual Meeting
  • Phase 1 data from study combining PROSTVAC® and ipilimumab indicate potential synergy from combining treatments

Anders Hedegaard, President & CEO commented: "We are pleased to report a continued strong performance in our infectious disease division with the manufacturing and deliveries of IMVAMUNE® smallpox vaccines for the U.S. Strategic National Stockpile proceeding well. The division has improved its profitability, contributing to an improved financial result for the group.  An expansion of our current contract with the U.S. Government to support a larger Phase 3 study coupled with the recent expansion of the population eligible to receive IMVAMUNE® in an emergency sustain and strengthen our partnership with the U.S. Government. We are also happy to announce that our PROSPECT Phase 3 trial of PROSTVAC® has now begun enrolment in Europe and we continue to add new clinical trial sites in the U.S. and additional countries to support recruitment for the trial."

Selected, anticipated milestones

  • Deliver 7.5 million doses IMVAMUNE® to the U.S. Strategic National Stockpile (2012)
  • Report Phase 2 data for CV-301 in breast cancer (Q4, 2012)
  • Expand CRADA with NCI for new cancer targets
  • Initiate Phase 3 trial of IMVAMUNE® (Q4, 2012)
  • Initiate new Phase 2 study for the freeze-dried IMVAMUNE®(H1, 2013)
  • Receive approval of MAA in Canada for IMVAMUNE® (H1, 2013)
  • Receive approval of MAA in EU for IMVANEX® (2013)