KVISTGAARD, Denmark, May 16, 2013 (GLOBE NEWSWIRE) -- Bavarian Nordic A/S (OMX:BAVA) today publishes its first quarter 2013 results. Revenue for the period was DKK 206 million (2012: DKK 168 million) and the result before tax was a loss of DKK 41 million (2012: DKK 35 million loss). The Infectious Disease division remains profitable with an EBIT of DKK 38 million in the period (2012: DKK 47 million). After receiving payments related to the new delivery contract, awarded by the U.S. Government in April 2013, the cash preparedness was DKK 694 million at the beginning of May 2013, including unutilized credit lines of DKK 120 million. The company has research and delivery contracts with the U.S. Government of which payments of USD 393 million (approx. DKK 2.2 billion) remain by the reporting date. 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 period and up to the reporting date
- 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(r) smallpox vaccine
- 1.6 million doses of IMVAMUNE(r) delivered to the U.S. during first quarter
- The first of two Phase 3 studies of IMVAMUNE(r) was initiated in the U.S.
- A Phase 2 study to support emergency use of the freeze-dried version of IMVAMUNE(r) was initiated
- Consolidation of manufacturing activities has begun at the facility in Kvistgaard, Denmark
- An interim analysis plan for the Phase 3 PROSPECT trial of PROSTVAC(r) was agreed with the FDA
- James Breitmeyer was appointed new President of the Cancer Vaccines Division
Anders Hedegaard, President & CEO commented: "2013 has so far been a great year for Bavarian Nordic as we have accomplished a number of significant results. Our new, large contract with the U.S. Government ensures our production for the next years and provides a good foundation for the infectious disease division to remain profitable. Concurrently, the development of IMVAMUNE(r) has witnessed significant progress. We have both initiated the Phase 3 registration study with the current version of the vaccine as well as a pivotal Phase 2 study with the freeze-dried version. As part of the consolidation of our manufacturing activities we will soon be expanding our facility in Denmark to accommodate the future commercial production of PROSTVAC(r), The Phase 3 trial of PROSTVAC(r) progresses with a new man at the helm in the cancer vaccine division and we have reached an agreement with the FDA to conduct an interim analyses of the trial, which may shorten the development time."
Selected upcoming milestones
- Deliver 7 million doses of IMVAMUNE(r) to the U.S. Strategic National Stockpile in 2013
- Complete enrolment in the first IMVAMUNE(r) Phase 3 trial (lot consistency)
- Initiate Phase 3 non-inferiority trial of IMVAMUNE(r)
- Potential marketing authorization for IMVANEX(r) (IMVAMUNE(r)) in the EU
- Potential marketing authorization for IMVAMUNE(r) in Canada
- Initiate Phase 2 combination studies of PROSTVAC(r) and enzalutamide (hormone therapy)
- Report data from NCI-sponsored clinical trials of PROSTVAC(r)
- Determine development strategy for CV-301
- Expand CRADA with NCI for new cancer targets
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 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(r), a therapeutic vaccine candidate for advanced prostate cancer that is the subject of an ongoing pivotal Phase 3 clinical trial and is being developed under a collaboration agreement with the National Cancer Institute. In clinical Phase 1 and Phase 2 trials, PROSTVAC(r) has been tested in nearly 600 patients. In infectious diseases, the company's lead program is IMVAMUNE(r), a non-replicating 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. IMVAMUNE(r) is currently in clinical Phase 3 development and marketing authorization applications have been filed in EU and Canada. 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.
Contact: Anders Hedegaard, President & CEO. Phone +45 23 20 30 64
Source:Bavarian Nordic A/S