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Bavarian Nordic – Interim Financial Report for the Period 1 January to 30 September 2013

KVISTGAARD, Denmark, November 14, 2013 – 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.

Group key figures are found at the end of this announcement. The full financial statements for the period can be downloaded from the Company's website: www.bavarian-nordic.com.

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.” 

Selected upcoming milestones

  • Deliver 7 million doses of IMVAMUNE to the U.S. Strategic National Stockpile in 2013
  • Initiate the final Phase 3 trial of IMVAMUNE in the fourth quarter of 2013
  • Complete enrollment in the PROSPECT Phase 3 study of PROSTVAC in the first half of 2014
  • Report data from NCI-sponsored clinical trials of PROSTVAC

In order to further strengthen and expand its relations to the investor community in USA, the company has appointed Seth Lewis as Vice President of Investor Relations. He will be based in the U.S. and take up this new position later in November. Seth Lewis joins the company from The Trout Group, LLC, where he has held the position as Senior Vice President.

Contact

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

Webcast and conference call

The Company will host a conference call today at 2.00 pm CET (8.00 am EST). President and CEO, Anders Hedegaard will present the interim results followed by a Q&A session with participation of the Company’s executive management. Dial-in numbers for the conference call are: Denmark: +45 32 72 80 18, UK: +44 (0) 844 571 8957, USA: +1 866 682 8490. A webcast of the conference call will be broadcast simultaneously at www.bavarian-nordic.com/webcast. On this page, the accompanying presentation will be available prior to the conference call.

About Bavarian Nordic

Bavarian Nordic is an international biotechnology company developing and manufacturing novel cancer immunotherapies and vaccines for infectious diseases. Lead product candidates are PROSTVAC®, an immunotherapy product candidate for advanced prostate cancer that is the subject of an ongoing pivotal Phase 3 clinical trial and IMVAMUNE®, a non-replicating smallpox vaccine candidate in Phase 3 development, which is being developed and supplied for emergency use to the U.S. Strategic National Stockpile under a contract with the U.S. Government. IMVAMUNE® is approved in the European Union under the trade name IMVANEX®.

Bavarian Nordic's shares are listed on NASDAQ OMX Copenhagen under the symbol BAVA (Reuters: BAVA.CO, Bloomberg: BAVA.DC). The company has a sponsored Level 1 ADR program listed in the U.S. (OTC) under the symbol BVNRY.

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.

Company Announcement no. 20 / 2013