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Tuesday 22 May, 2012

bn@bavarian-nordic.com

Bavarian Nordic A/S - Interim Report for the pe...

Bavarian Nordic A/S - Interim Report for the period 1 January to 31 March 2012

KVISTGAARD, Denmark, May 22, 2012 - Bavarian Nordic A/S (OMX: BAVA) today publishes its first quarter 2012 results, showing a DKK 100 million improvement in income before tax compared to 2011. Bavarian Nordic generated revenue of DKK 168 million (2011: DKK 29 million) and recorded a loss before tax of DKK 35 million (2011: DKK 135 million loss). As of 31 March 2012 the cash preparedness was DKK 649 million, including credit lines of DKK 120 million. The company maintains its full-year expectations with revenues in the level of DKK 850 million, and a pre-tax loss in the level of DKK 200 million. The cash preparedness at year-end is expected to be in the level of DKK 350 million.

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

  • First quarter income before tax improved by DKK 100 million compared to first quarter 2011. The infectious disease division is profitable
  • IMVAMUNE® deliveries to the U.S. Strategic National Stockpile on track with 2.6 million doses delivered in 2012 to-date
  • Significant improvements in the IMVAMUNE® manufacturing productivity 
  • Marketing application for IMVANEX® (IMVAMUNE®) submitted to the European Medicines Agency  
  • Phase 1 study combining PROSTVAC® and ipilimumab immunotherapies reported, indicating potential synergy from combining treatments 
  • RFP-3 contract modifications increases total contract value with USD 32 million. The contract period has been extended to 2017
  • Warrants awarded to certain employees

Anders Hedegaard, President & CEO commented on the interim report: "We are pleased to report very strong performance in our infectious disease division with the manufacturing of IMVAMUNE® smallpox vaccines going very well. In our aim to improve the divisions' profitability, we have succeeded in increasing the productivity significantly due to a continued focus on optimization of resources and processes. In our cancer vaccine division, we continue to open new clinical trial sites for the PROSTVAC® Phase 3 trial and the recruitment of patients is proceeding according to plan."

Selected, upcoming milestones

  • Deliver seven million doses IMVAMUNE® to the U.S. Strategic National Stockpile (2012) 
  • Phase 2 data for CV-301 in breast cancer (H2, 2012) 
  • Initiate Phase 3 trial of IMVAMUNE® (H2, 2012) 
  • Initiate Phase 2 study for the freeze-dried IMVAMUNE® (H1, 2013) 
  • Approval of MAA in Canada for IMVAMUNE® (H1, 2013)
  • Approval of MAA in EU for IMVANEX® (2013)

Contact
Anders Hedegaard, President & CEO. Phone +45 23 20 30 64

Conference call
The Company will host a conference call today at 2 pm CET (8 am EST). President and CEO, Anders Hedegaard will present the first quarter results. The accompanying presentation is available on the company's website: www.bavarian-nordic.com/q1. Additional participants from Bavarian Nordic are Paul Chaplin, Executive Vice President and Division President Infectious Diseases, Ole Larsen, CFO and Rolf Sass Sørensen, Vice President Investor Relations. Dial-in numbers for the conference calls are:  UK: +44 (0)207 1620 177. USA: +1 334 323 6203. The participant code is 916860. For additional countries and further details please visit www.bavarian-nordic.com/q1.

About Bavarian Nordic
Bavarian Nordic is a vaccine-focused biotechnology company developing and producing novel vaccines for the treatment and prevention of life-threatening diseases with a large unmet medical need. The company's pipeline targets cancer and infectious diseases, and includes ten development programs. In oncology, the company's lead program is PROSTVAC®, a therapeutic vaccine candidate for advanced prostate cancer that is the subject of an ongoing pivotal Phase 3 trial and is being developed under a collaboration agreement with the National Cancer Institute. In clinical Phase 1 and Phase 2 trials, PROSTVAC® has been tested in nearly 600 patients. In infectious diseases, the company's lead program is IMVAMUNE®, a third-generation smallpox vaccine candidate that is being developed and supplied for emergency use to the U.S. Strategic National Stockpile under a contract with the U.S. Government. For more information, visit www.bavarian-nordic.com

Forward-looking statements
This announcement includes "forward-looking statements" that involve risks, uncertainties and other factors, many of which are outside of our control that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law.




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Source: Bavarian Nordic A/S via Thomson Reuters ONE

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