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Bavarian Nordic A/S - Interim Report for the Period 1 January to 30 September 2009

Posted on: Wednesday, 11 November 2009, 07:45 CST

KVISTGARD, Denmark, November 11 /PRNewswire-FirstCall/ -- Today Bavarian Nordic published the company's third quarterly report 2009. The full report including the financial statements is available on the company's website: http://www.bavarian-nordic.com.

In the first nine months of 2009 Bavarian Nordic generated revenue of DKK 53 million and recorded a loss before tax of DKK 261 million. As of 30 September 2009 the Group's net free liquidity was DKK 304 million The company maintains its expectations for the financial result for the full year 2009 with revenues in the range of DKK 100-300 million and a pre-tax loss of between DKK 275-325 million. A prerequisite for maintaining the high end of the guidance is that the company will receive delivery allowance from the US authorities no later than beginning of December, leading to the possible initiation of deliveries of IMVAMUNE(R) to the US Government before the end of 2009. The net free liquidity at year-end is expected to be approximately DKK 175 million as a potential delivery to the US Government by late 2009 will not have a cash effect in 2009.

Following the FDA inspection of the IMVAMUNE(R) manufacturing facilities in May, Bavarian Nordic has made progress in the implementation of the corrective actions as required due to observations made by the FDA. The company expects to finalise its responses to the FDA no later than in the beginning of December and subsequently will await the FDA review and acceptance hereof. Consequently, the company maintains its expectations to initiate delivery of IMVAMUNE(R) to the US government before the end of second quarter of 2010.

During the first nine months of 2009, Bavarian Nordic reported further confirmatory data on PROSTVAC(TM), the company's late-stage prostate cancer vaccine candidate. Oral presentations were held at several cancer congresses, including ASCO and ECCO annual meetings. Bavarian Nordic expects that an end of phase II meeting with the FDA will take place during January 2010. While partnership negotiations are ongoing, the company is in preparations for Phase III and these are proceeding as planned.

Lately, the prostate cancer field has witnessed positive clinical results followed by attractive partnership deals. It has proven worthwhile for a number of companies to independently advance their projects into Phase III, thus maximising their value before they would eventually sign a licensing deal. Similarly, Bavarian Nordic is seeking to maximise and retain the value of its cancer portfolio. Consequently, Bavarian Nordic seeks the ability to advance PROSTVAC(TM) into Phase III of its own. In order for Bavarian Nordic to gain the independence to execute its short and long term activities within biodefence and cancer, the company is exploring available options for securing an optimum financial position.

Highlights from the period

Bavarian Nordic has signed contract with an EU country for the delivery of IMVAMUNE(R)

In September, Bavarian Nordic signed a contract with the military of an undisclosed EU country for the delivery of a small order for IMVAMUNE(R). The size and value of the contract is undisclosed. This marks the first time, Bavarian Nordic enters a contract with an EU country for the delivery of IMVAMUNE(R), and it demonstrates that there exists a real demand inside of EU for new and safer smallpox vaccines for preparedness stockpiles. The vaccines have been delivered.

Negotiations with the US authorities for the further development of IMVAMUNE(R)

Bavarian Nordic is currently in late-stage negotiations with the US authorities for a new contract to develop a freeze-dried version of the IMVAMUNE(R) smallpox vaccine. This potential new project will have no influence on the ongoing RFP-3 contract for the procurement of 20 million doses of IMVAMUNE(R) and the licensure of the current liquid-frozen formulation, but represents an additional business opportunity of major strategic importance. The company expects that the prospective contract will constitute the gateway towards securing additional contracts with the US Government and outside the US as well.

Further detailed PROSTVAC(TM) data presented at the ECCO 15 - 34th ESMO Congress

Further data from the Phase II study with PROSTVAC(TM) were presented at the European CanCer Organisation (ECCO), ECCO 15 - 34th ESMO Congress in Berlin in September. The data indicate the potential for a broader therapeutic use of PROSTVAC(TM) in metastatic prostate cancer

Important events after the period

Delivery of IMVAMUNE(R) to Canada completed

As planned, Bavarian Nordic has delivered 20,000 doses of IMVAMUNE(R) to the Canadian government. A pre-New Drug Submission (NDS) meeting with Health Canada (National Regulatory Authority) was held in October 2009 to discuss the potential to file an NDS in 2010 for IMVAMUNE(R) as a safer smallpox vaccine under a Notice of Compliance with Conditions (NOC/C). Conclusions from the meeting have not yet been finalised.

Encouraging data for MVA-BN(R) HIV multiantigen warrant further studies

Bavarian Nordic has completed the analysis of the Phase I/II studies with MVA-BN(R) HIV multiantigen. The final safety and immunogenicity data demonstrate that the vaccine induces a broad T cell response in HIV infected subjects. The high number of responders to the vaccine is encouraging and warrant further studies. Thus, in line with its strategy, Bavarian Nordic is now looking for a partner in order to secure the continued development of MVA-BN(R) HIV multiantigen in a full Phase II.

Bavarian Nordic acquires remaining shares in its subsidiary BN ImmunoTherapeutics Inc. and subsequently own 100% of the subsidiary

Bavarian Nordic has entered into a conditional agreement for the purchase of 400,521 shares in the US subsidiary, BN ImmunoTherapeutics Inc., from the CEO and President Reiner Laus and two former employees in the subsidiary with the purpose of obtaining full ownership of the subsidiary. Further, stock options issued to employees in the subsidiary are repurchased. This transaction forms part of Bavarian Nordic's strategy to strengthen the cancer business area and will give the company full control over the group's activities in this field.

The agreement will have no consequences for the future strategy, organisation and operation of BN ImmunoTherapeutics Inc.

The consideration to Reiner Laus and the two former employees will be paid in part with 136,177 new shares of DKK 10 each in Bavarian Nordic A/S and in part with a number of future milestone payments that are triggered upon the successful completion of a number of pre-defined development milestones.

Forward-looking statements

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.

About Bavarian Nordic

Bavarian Nordic A/S is a leading industrial 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 is focused in the three areas; biodefence, cancer and infectious diseases, and includes seven development programmes. Two programmes are ready for Phase III: IMVAMUNE(R), a third-generation smallpox vaccine is being developed under a contract with the US government, and PROSTVAC(TM), a therapeutic vaccine for advanced prostate cancer is being developed under a collaboration agreement with the National Cancer Institute.

Bavarian Nordic is listed on NASDAQ OMX Copenhagen under the symbol BAVA.

For more information please visit http://www.bavarian-nordic.com

SOURCE Bavarian Nordic A/S

Source: PR Newswire

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