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Bavarian Nordic Reports Third Quarter 2013 Financial Results

KVISTGAARD, Denmark, Nov. 14, 2013 (GLOBE NEWSWIRE) -- Bavarian Nordic A/S (OMX:BAVA) (OTC:BVNRY) today publishes its interim financial results for the first nine months of 2013. Revenue for the period was DKK 875 million (2012: DKK 750 million) and the result before tax was a loss of DKK 18 million (2012: DKK 17 million profit). The Infectious Diseases division remains profitable with an EBIT after internal allocations of DKK 250 million in the period (2012: DKK 221 million). As of September 30, 2013 the cash preparedness was DKK 546 million, including unutilized credit lines of DKK 120 million. The company has research and delivery contracts with the U.S. Government of which payments of up to USD 330 million (approximately DKK 1.8 billion) remain as of September 30, 2013. The company maintains its 2013 full-year expectations with revenues in the level of DKK 1,100 million and a break-even result before tax. The Infectious Diseases division is expected to generate an EBIT of approximately DKK 360 million, which will be offset by total costs of DKK 325 million in the Cancer Immunotherapy division, primarily relating to the global Phase 3 study of PROSTVAC®. The Group's cash preparedness at year-end is expected to be approximately DKK 600 million.

The full financial statements for the period can be downloaded from the Company's website: .

Highlights from the third quarter and up to the reporting date

  • In August, IMVANEX® smallpox vaccine received marketing authorization in Europe
  • In August, enrollment of 4,000 subjects in the Phase 3 IMVAMUNE® lot consistency trial was completed
  • In July and August, patient enrollment in two Phase 2 studies, sponsored by National Cancer Institute (NCI), combining PROSTVAC® and enzalutamide (Xtandi®) began. One study investigates the combination in non-metastatic castration sensitive prostate cancer and the other in metastatic castration-resistant prostate cancer

Anders Hedegaard, President & CEO commented: "With a continued strong performance, we remain on track to meet the financial expectations we set out for the year. We are reaching completion of the final delivery for the initial 20 million dose order of IMVAMUNE smallpox vaccine to the U.S. Strategic National Stockpile, and will soon begin delivering on the next contract we were awarded in April this year. The European marketing authorization for IMVANEX in August, our first regulatory product approval, represented a historic milestone for the company and an important validation of our MVA BN vaccine technology platform. Looking ahead, we remain highly focused on completing enrollment in the PROSPECT Phase 3 study of PROSTVAC. Additionally, our intention now is to prioritize colorectal cancer in the further clinical development of CV-301, based on the promising clinical Phase 2 study results reported in May of this year, and we are in the process of seeking regulatory input to determine next steps in the clinical development strategy."

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