Bavarian Nordic A/S – Interim Report for the period 1 January to 31 March 2011
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Kvistgaard, Denmark, May 31, 2011 - Bavarian Nordic A/S (OMX: BAVA) today publishes its first quarter 2011 results. Bavarian Nordic generated revenue of DKK 29 million and recorded a loss before tax of DKK 135 million. As of 31 March 2011 the cash preparedness was DKK 326 million, including credit lines of DKK 112 million. After the successful completion of a rights issue in May 2011, the cash preparedness has been significantly strengthened and amounts to approximately DKK 825 million by end of May. The company maintains its full-year expectations with revenues in the level of DKK 500 million, and a pre-tax loss in the level of DKK 350 million. The cash preparedness at year-end is expected to be in the level of DKK 525 million.
Anders Hedegaard, President & CEO commented on the interim report: "Since we announced our new development strategy for PROSTVAC® there has been much focus on Bavarian Nordic and we are therefore delighted that the successful rights issue last week has enabled us to pursue the independent development of PROSTVAC® and thus initiate the Phase 3 trial in the second half of 2011 as planned. At the same time we have secured both the progress of the project, as well as a strong position in the further discussions with potential partners by maintaining the value of the project in the company. We have also witnessed important events in our Infectious Disease division, especially with the expansion of the contract for freeze-dried IMVAMUNE®,which further strengthens the ties with the U.S. Government, leading to potential new, future contracts."
Highlights from the period
- Marketing authorization application for IMVAMUNE® submitted in Canada In March, Bavarian Nordic submitted a marketing authorization application in Canada for IMVAMUNE®. If found acceptable by Health Canada following a standard NDS review time of approximately one year, IMVAMUNE® will be indicated for active immunization against smallpox in the general population of 18 years and older.
- New Phase 2 study comparing PROSTVAC® and chemotherapy versus chemotherapy A new multicenter, randomized Phase 2 study of 144 patients with metastatic castration-resistant prostate cancer (mCRPC) was initiated in February 2011. The study will compare PROSTVAC®followed by docetaxel (chemotherapy) versus docetaxel alone. Currently, PROSTVAC® is being investigated alone or as combination therapy in six ongoing clinical Phase 1 and Phase 2 studies in a total of more than 370 patients in different disease settings.
Important events after the period
- DKK 653 million net raised in successful rights issue In May, Bavarian Nordic successfully completed an offering, generating net proceeds of DKK 653 million. The rights issue attracted positive attention from both domestic and international blue chip and healthcare specialist investors. The proceeds from the rights issue will be used to pursue the independent development of PROSTVAC® which is expected to start the pivotal Phase 3 trial in the second half of 2011.
- Patent position on MVA-BN® yet again successfully defended In April, the ICC International Court of Arbitration rendered its decision in favour of Bavarian Nordic in the arbitration that had been pending against Helmholtz Zentrum München since 2009. Helmholtz Zentrum München's claims of rights to royalties on Bavarian Nordic's MVA-BN® based vaccines, including IMVAMUNE®, were found to be baseless on all grounds.
- U.S. Government expands development contract for freeze-dried IMVAMUNE® In April, the U.S. Government through the Biomedical Advanced Research and Development Authority (BARDA) increased the value of the existing contract to develop a freeze-dried version of IMVAMUNE® smallpox vaccine from USD 40 million to USD 94 million, thus underscoring the continued commitment to support the IMVAMUNE® development programme.
Conference call The company will host a conference call today, Tuesday, May 31 at 2 p. m. CET. President and CEO, Anders Hedegaard will present the interim results followed by a Q&A session. Dial-in numbers for the conference call are: Denmark: +45 3271 4607, UK: +44 (0)20 7162 0077, US: +1 334 323 6201. The accompanying presentation is available on the company's website: www.bavarian-nordic.com.