Bavarian Nordic is Planning a Rights Issue of DKK 250-300 Million. The Company Has Convened an Extraordinary General Meeting
Kvistgård, Denmark, December 1, 2009 - Bavarian Nordic A/S (OMX: BAVA) has today convened an Extraordinary General Meeting that will take place on December 18, 2009. In that respect, the board has proposed to extend the current authorisation to increase the company's share capital with the purpose of carrying out a rights issue with pre-emptive rights for existing shareholders. The rights issue is expected to be completed in the beginning of 2010 in consideration of market conditions among other things.
In order for Bavarian Nordic to gain the independence to execute its activities within biodefence and cancer, the company has explored available options for securing an optimum financial position. Subsequent to discussions with selected shareholders, the company has concluded a rights issue to be the most suitable approach. The company expects proceeds from the rights issue in the level of DKK 250-300 million.
The use of proceeds will ensure the continued momentum in the production of IMVAMUNE® smallpox vaccines to ensure speedy and sufficient delivery under the RFP-3 order for 20 million doses once delivery allowance is granted by the US authorities. Once delivery allowance is granted, Bavarian Nordic intends to scale up its production frequency. In that respect, the company's bank has notified Bavarian Nordic its willingness to discuss the establishment of facilities for financing of operations going forward.
Meanwhile, Bavarian Nordic will gradually continue its preparations for Phase III studies with PROSTVAC™, a therapeutic vaccine candidate for patients suffering from advanced prostate cancer. According to plan, an end of Phase II meeting will be held with the U.S. Food and Drug Administration (FDA) in January 2010 in order to discuss the design of the Phase III studies. Subsequently, the company expects to obtain a Special Protocol Assessment (SPA) which specifies the requirements for target fulfilment in Phase III.
The strategy for the Phase III development of PROSTVAC™ will be determined after the end of Phase II meeting with the FDA and the subsequent SPA agreement.
Provided that the rights issue is completed with the expected proceeds generated, and that the RFP-3 contract will be fulfilled according to plan, Bavarian Nordic expects to have sufficient funds for its operations until the end of 2012, whereupon the company expects its cash preparedness to cover the operational needs for an order-producing company.
Bavarian Nordic has engaged Nordea Markets (Division of Nordea Bank Danmark A/S) and SEB Enskilda, Skandinaviska Enskilda Banken AB (publ), Copenhagen Branch as financial advisors in the rights issue.
Status of the RFP-3 contract Bavarian Nordic is currently awaiting delivery allowance from the US authorities in order to initiate the delivery of 20 million doses of IMVAMUNE® under the RFP-3 contract.
Following the FDA inspection of the IMVAMUNE® manufacturing facilities in the spring 2009, Bavarian Nordic has made progress in the implementation of the actions as required due to observations made by the FDA. The company expects to finalise its responses to the FDA during this week and subsequently will await the final acceptance from the FDA. Consequently, the company maintains its expectations to initiate delivery of IMVAMUNE® before the end of first half 2010.
To date, Bavarian Nordic has fulfilled a number of important milestones in the contract, including the completion of the Phase II development of IMVAMUNE® and submission of data that support the potential use of IMVAMUNE® in a declared emergency. The fulfilment of these milestones has triggered USD 125 million in milestone payments. Once delivery of IMVAMUNE® is expectedly initiated, the remainder of the contract, with a total value of USD 500 million, will be invoiced proportionally to the deliveries. However, a small part of the total contract sum, corresponding to 10%, is payable only upon licensing of the vaccine with the FDA.
Provided that the delivery allowance will be granted no later than during first half of 2010, Bavarian Nordic expects to deliver 4-5 million doses of IMVAMUNE® before the end of 2010. The remaining doses are expected to be evenly delivered in 2011 and 2012.
The company's expectations for the financial result for 2009 are unchanged compared to the guidance in third quarterly report.