-Continued, Steady Improvements in the Manufacturing Efficiency of IMVAMUNE(R) Smallpox Vaccines Further Increases Profitability in the Infectious Disease Division
- Group Reports a Nine-Month Positive Operating Profit - Raises Full Year Group Financial Expectations and Year-End Cash Preparedness
KVISTGAARD, Denmark, Nov. 13, 2012 (GLOBE NEWSWIRE) -- Bavarian Nordic A/S (OMX:BAVA) today publishes its interim financial results for the first nine months of 2012. Revenue for the period was DKK 750 million (2011: DKK 155 million) and the result before tax was a profit of DKK 17 million (2011: DKK 333 million loss). For the third quarter ending 30 September 2012, revenue was DKK 304 million (2011: DKK 97 million) and the result before tax was DKK 30 million (2011: DKK 58 million loss). As of 30 September 2012 the cash preparedness was DKK 666 million, including un-utilized credit lines of DKK 120 million.
The infectious disease division has further improved the efficiency in the manufacturing of IMVAMUNE(R) and Bavarian Nordic now expects to deliver more than 8 million doses to the U.S. Strategic National Stockpile in 2012, where it had previously expected to deliver 7.5 million doses. Also, as result of the improved efficiency, the group sees lower production costs. In addition, lower research and development costs will contribute to an improved financial result for the year as well as improved cash preparedness at year-end. Consequently, the company again raises its financial expectations for the year with revenues increasing from approximately DKK 900 million to approximately DKK 975 million and the result before tax improving by DKK 80 million from a loss of approximately DKK 150 million to a loss of approximately DKK 70 million. EBIT in the infectious disease division is raised to approximately DKK 300 million and EBIT in the cancer vaccine division is raised to a DKK 250 million loss. Also, the company raises its expectations for the year-end cash preparedness from approximately DKK 400 million to approximately DKK 525 million.
Significant achievements in the third quarter and up to the reporting date
- 2.6 million doses of IMVAMUNE(R) smallpox vaccine delivered to the U.S. Strategic National Stockpile during third quarter
- Continued, steady improvements in the IMVAMUNE(R) manufacturing efficiency throughout the period
- Smallpox vaccine contract (RFP-3) further expanded by USD 5 million in September by the U.S. Government
- U.S. Government has expanded the population eligible to receive IMVAMUNE(R) in an emergency, thus significantly increasing the future business potential
- New contract awarded by the U.S. Government to develop a veterinary vaccine against Foot-and-mouth disease further broadens the use of MVA-BN(R) as technology platform for the development of biological countermeasures
- Preliminary Phase 2 data for CV-301 presented at the ESMO 2012 Congress shows promise in metastatic breast cancer
Anders Hedegaard, President & CEO commented: "We are very pleased to report a continued strong performance in our infectious disease division with the manufacturing and deliveries of IMVAMUNE(R) smallpox vaccines for the U.S. Strategic National Stockpile again exceeding our targets. The division has further improved its profitability, contributing to an improved financial result for the group. The U.S. Government's recent expansions of our smallpox vaccine contract coupled with additional new contract awards that broaden the scope of our technology into new disease areas strengthen our confidence in a sustained partnership with the U.S. Government to address their requirements for biological countermeasures. In our cancer vaccine division we remain focused on the ongoing PROSPECT Phase 3 study in metastatic prostate cancer to strengthen enrollment in the study."
Selected, anticipated milestones
- Deliver more than 8 million doses IMVAMUNE(R) to the U.S. Strategic National Stockpile (2012)
- New IMVAMUNE(R) order from U.S. Government (2013)
- Report final Phase 2 data for CV-301 in breast cancer (2012)
- Expand CRADA with NCI for new cancer targets (2013)
- Initiate Phase 3 trial of IMVAMUNE(R) (2013)
- Initiate new Phase 2 study for the freeze-dried IMVAMUNE(R) (2013)
- Receive approval of MAA in Canada for IMVAMUNE(R) (2013)
- Receive approval of MAA in EU for IMVANEX(R) (2013)
The Company will host a conference call today at 2 pm CET (8 am EST). President and CEO, Anders Hedegaard will present the interim results. The accompanying presentation is available on the company's website: http://www.bavarian-nordic.com/q3. Additional participants from Bavarian Nordic are Paul Chaplin, Executive Vice President and Division President Infectious Diseases, Reiner Laus, Executive Vice President and Division President Cancer Vaccines, Ole Larsen, Executive Vice President and CFO and Rolf Sass Soerensen, Vice President Investor Relations. Dial-in numbers for the conference call are: UK: +44 (0)20 7162 0077. USA: +1 334 323 6201. The participant code is 924959. For additional countries and further details please visit http://www.bavarian-nordic.com/q3.
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 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 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
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