Bavarian Nordic Reports Financial Results for the First Half of 2013
KVISTGAARD, Denmark, August 22, 2013 - Bavarian Nordic A/S (OMX: BAVA) today publishes its results for the first half of 2013. Revenue for the period was DKK 556 million (2012: DKK 445 million) and the result before tax was a loss of DKK 43 million (2012: DKK 13 million loss). The Infectious Disease division remains profitable with an EBIT after internal allocations of DKK 131 million in the period (2012: DKK 116 million). As of June 30, 2013 the cash preparedness was DKK 695 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 384 million (approximately DKK 2.1 billion) remain as of June 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 cash preparedness at year-end is expected to be roughly DKK 600 million.
Highlights from the second 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, enrollment in two Phase 2 studies combining PROSTVAC® and enzalutamide began. One study investigates the combination in non-metastatic castration sensitive prostate cancer and the other in metastatic castration-resistant prostate cancer
- In June, consolidation and expansion activities began at the manufacturing facility in Denmark to accommodate the future commercial production of PROSTVAC
- In May the license for the CV-301 immunotherapy candidate was expanded to include colorectal cancer and promising data on the use of CV-301 in colorectal cancer was published in the peer-reviewed clinical journal, Annals of Surgery
- In May, a Phase 2 study to support emergency use of the freeze-dried version of IMVAMUNE® was initiated
- In May, a sponsored Level 1 ADR program was launched in the U.S., allowing U.S. investors to trade Bavarian Nordic shares in local currency
- In April, the Company received a new contract valued up to USD 228 million from the U.S. Government for the continued production and deliveries of IMVAMUNE smallpox vaccine
- In April, an interim analysis plan for the Phase 3 PROSPECT trial of PROSTVAC was agreed with the FDA
Anders Hedegaard, President & CEO commented: "The EU marketing authorization for IMVANEX announced earlier this month represented a historic milestone for Bavarian Nordic and an important validation of our MVA BN® vaccine technology platform. Additionally over the past quarter, we have had a number of significant developments. Most importantly, we secured a new IMVAMUNE supply contract in April from the U.S. government. While these developments illustrate the progress we are making in our corporate growth strategy, they also underscore the success of our collaborations with various U.S. institutions."
Selected upcoming milestones
- Deliver 7 million doses of IMVAMUNE to the U.S. Strategic National Stockpile in 2013
- Initiate IMVAMUNE Phase 3 non-inferiority trial
- Complete enrollment in the PROSPECT Phase 3 study of PROSTVAC
- Report data from NCI-sponsored clinical trials of PROSTVAC
- Report development strategy for CV-301
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 EDT). 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.
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. 17 / 2013