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In the first nine months of 2009 Bavarian Nordic generated revenue of DKK53 million and recorded a loss before tax of DKK 261 million. As of 30September 2009 the Group's net free liquidity was DKK 304 million The companymaintains its expectations for the financial result for the full year 2009with revenues in the range of DKK 100-300 million and a pre-tax loss ofbetween DKK 275-325 million. A prerequisite for maintaining the high end ofthe guidance is that the company will receive delivery allowance from the USauthorities no later than beginning of December, leading to the possibleinitiation of deliveries of IMVAMUNE(R) to the US Government before the endof 2009. The net free liquidity at year-end is expected to be approximatelyDKK 175 million as a potential delivery to the US Government by late 2009will not have a cash effect in 2009.
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Following the FDA inspection of the IMVAMUNE(R) manufacturing facilitiesin May, Bavarian Nordic has made progress in the implementation of thecorrective actions as required due to observations made by the FDA. Thecompany expects to finalise its responses to the FDA no later than in thebeginning of December and subsequently will await the FDA review andacceptance hereof. Consequently, the company maintains its expectations toinitiate delivery of IMVAMUNE(R) to the US government before the end ofsecond quarter of 2010.
During the first nine months of 2009, Bavarian Nordic reported furtherconfirmatory data on PROSTVAC(TM), the company's late-stage prostate cancervaccine candidate. Oral presentations were held at several cancer congresses,including ASCO and ECCO annual meetings. Bavarian Nordic expects that an endof phase II meeting with the FDA will take place during January 2010. Whilepartnership negotiations are ongoing, the company is in preparations forPhase III and these are proceeding as planned.
Lately, the prostate cancer field has witnessed positive clinical resultsfollowed by attractive partnership deals. It has proven worthwhile for anumber of companies to independently advance their projects into Phase III,thus maximising their value before they would eventually sign a licensingdeal. Similarly, Bavarian Nordic is seeking to maximise and retain the valueof its cancer portfolio. Consequently, Bavarian Nordic seeks the ability toadvance PROSTVAC(TM) into Phase III of its own. In order for Bavarian Nordicto gain the independence to execute its short and long term activities withinbiodefence and cancer, the company is exploring available options forsecuring an optimum financial position.
Highlights from the period
Bavarian Nordic has signed contract with an EU country for the deliveryof IMVAMUNE(R)
In September, Bavarian Nordic signed a contract with the military of anundisclosed EU country for the delivery of a small order for IMVAMUNE(R). Thesize and value of the contract is undisclosed. This marks the first time,Bavarian Nordic enters a contract with an EU country for the delivery ofIMVAMUNE(R), and it demonstrates that there exists a real demand inside of EUfor new and safer smallpox vaccines for preparedness stockpiles. The vaccineshave been delivered.
Negotiations with the US authorities for the further development ofIMVAMUNE(R)
Bavarian Nordic is currently in late-stage negotiations with the USauthorities for a new contract to develop a freeze-dried version of theIMVAMUNE(R) smallpox vaccine. This potential new project will have noinfluence on the ongoing RFP-3 contract for the procurement of 20 milliondoses of IMVAMUNE(R) and the licensure of the current liquid-frozenformulation, but represents an additional business opportunity of majorstrategic importance. The company expects that the prospective contract willconstitute the gateway towards securing additional contracts with the USGovernment and outside the US as well.
Further detailed PROSTVAC(TM) data presented at the ECCO 15 - 34th ESMOCongress
Further data from the Phase II study with PROSTVAC(TM) were presented atthe European CanCer Organisation (ECCO), ECCO 15 - 34th ESMO Congress inBerlin in September. The data indicate the potential for a broadertherapeutic 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) tothe Canadian government. A pre-New Drug Submission (NDS) meeting with HealthCanada (National Regulatory Authority) was held in October 2009 to discussthe potential to file an NDS in 2010 for IMVAMUNE(R) as a safer smallpoxvaccine under a Notice of Compliance with Conditions (NOC/C). Conclusionsfrom 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 withMVA-BN(R) HIV multiantigen. The final safety and immunogenicity datademonstrate that the vaccine induces a broad T cell response in HIV infectedsubjects. The high number of responders to the vaccine is encouraging andwarrant further studies. Thus, in line with its strategy, Bavarian Nordic isnow looking for a partner in order to secure the continued development ofMVA-BN(R) HIV multiantigen in a full Phase II.
Bavarian Nordic acquires remaining shares in its subsidiary BNImmunoTherapeutics Inc. and subsequently own 100% of the subsidiary
Bavarian Nordic has entered into a conditional agreement for the purchaseof 400,521 shares in the US subsidiary, BN ImmunoTherapeutics Inc., from theCEO and President Reiner Laus and two former employees in the subsidiary withthe purpose of obtaining full ownership of the subsidiary. Further, stockoptions issued to employees in the subsidiary are repurchased. Thistransaction forms part of Bavarian Nordic's strategy to strengthen the cancerbusiness area and will give the company full control over the group'sactivities 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 bepaid in part with 136,177 new shares of DKK 10 each in Bavarian Nordic A/Sand in part with a number of future milestone payments that are triggeredupon the successful completion of a number of pre-defined developmentmilestones.
Forward-looking statements
This announcement includes "forward-looking statements" that involverisks, uncertainties and other factors, many of which are outside of ourcontrol that could cause actual results to differ materially from the resultsdiscussed in the forward-looking statements. Forward-looking statementsinclude statements concerning our plans, objectives, goals, future events,performance and/or other information that is not historical information. Weundertake no obligation to publicly update or revise forward-lookingstatements 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 companydeveloping and producing novel vaccines for the treatment and prevention oflife-threatening diseases with a large unmet medical need. The company'spipeline is focused in the three areas; biodefence, cancer and infectiousdiseases, and includes seven development programmes. Two programmes are readyfor Phase III: IMVAMUNE(R), a third-generation smallpox vaccine is beingdeveloped under a contract with the US government, and PROSTVAC(TM), atherapeutic vaccine for advanced prostate cancer is being developed under acollaboration 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
