Bavarian Nordic Announces 2013 Full Year Results

KVISTGAARD, Denmark, March 19, 2014 – Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) today published its 2013 annual report. Revenue was DKK 1,213 million / USD 224 million (DKK 1,017 million / USD 188 million in 2012). The Group recorded a profit before tax of DKK 6 million / USD 1 million (DKK 49 million loss / USD 9 million loss in 2012). Revenue and results were in line with the expectations for the year. As planned, the Company delivered 7 million doses of IMVAMUNE^® to the U.S. in 2013, of which 1.4 million doses relate to the new contract that was entered in April 2013. 

At year-end 2013, the cash preparedness was DKK 652 million / USD 120 million (DKK 670 million / USD 124 million as of 31 December 2012), which was DKK 50 million / USD 9 million above the original guidance.

Starting in 2014, the Company will provide its guidance on the result line as earnings before interest and tax (previously earnings before tax). For 2014, Bavarian Nordic expects revenue at the level of DKK 1,200 million / USD 222 million and a break-even result before interest and tax. The revenue will primarily be generated from deliveries of IMVAMUNE to the U.S. Strategic National Stockpile, based on BARDA’s expected exercise of the second part of the contract that was awarded in 2013. The cash preparedness at year-end is expected to be in the level of DKK 600 million / USD 111 million. 

Danish kroner (DKK) is the Company’s functional currency. All USD figures provided above are based upon a USD/DKK exchange rate of 5.4. 

Group key figures are found at the end of this announcement. The full financial statements for 2013 are available in the annual report which can be downloaded from the Company’s website: www.bavarian-nordic.com. 

Anders Hedegaard, President & CEO of Bavarian Nordic said: “2013 was an impactful year for Bavarian Nordic, with the first product approval of IMVANEX based on 10 years of platform and product development work, a new contract from the U.S. government for the continued production and supply of IMVAMUNE smallpox vaccine to the national stockpile valued up to USD 228 million, and sound financial performance. 2013 was also the year where PROSPECT, the Phase 3 study of our PROSTVAC immunotherapy candidate for prostate cancer, went global and by year-end the trial had opened in nearly all of the planned countries and sites. The lengthiness of regulatory processes has prolonged the initiation of key clinical trial sites in important geographic territories. As a consequence, we now anticipate the study to be fully enrolled by year-end 2014. Future interim analyses of the PROSPECT study will offer the opportunity to evaluate whether the results provide opportunity for filing for approval sooner than anticipated.” 

• Approval of IMVANEX^® by the European Commission. The vaccine was approved for active immunization against smallpox disease in the general adult population, including people with weakened immune systems (e.g. those diagnosed with HIV or atopic dermatitis). The vaccine was also approved, under the trade name IMVAMUNE, by Health Canada for active immunization against smallpox in a public health emergency
• A new contract valued up to USD 228 million was awarded by the U.S. Government for the continued supply of IMVAMUNE smallpox vaccine to the U.S. Strategic National Stockpile for use in the event of a smallpox emergency. Deliveries under this contract began in November, following completion of the delivery of 20 million doses under the initial contract awarded in 2007
• Initiation and completion of enrollment of 4,000 subjects in the first of two Phase 3 trials of IMVAMUNE in the U.S. The second Phase 3 study is planned to begin in 2014. A Phase 2 study of freeze-dried IMVAMUNE was also fully recruited, designed to meet the emergency use requirements in the U.S.
• In February 2014, we were awarded a contract by the Defense Threat Reduction Agency (DTRA), a part of the United States Department of Defense, for the development of an MVA-BN based vaccine against the bacteria Burkholderia pseudomallei and Burkholderia mallei, both of which are considered potential biological threats to national security
• An interim analysis plan for the PROSPECT trial was agreed with the FDA.
• As part of the pre-launch planning for PROSTVAC, we began expansion of our manufacturing facility in Kvistgaard, Denmark to accommodate the future commercial production of PROSTVAC
• Two Phase 2 studies of PROSTVAC in combination with enzalutamide were initiated by the National Cancer Institute, exploring the potential combination in both early and later-stage prostate cancer
• For our second immunotherapy candidate, CV-301, metastatic colorectal cancer was prioritized as the lead indication based on promising Phase 2 data announced in May 2013. Discussions with regulatory authorities on a potential larger randomized, placebo-controlled trial are ongoing

• Complete enrollment in the PROSPECT trial (H2, 2014)
• Secure final portion of IMVAMUNE delivery contract with the U.S. government (USD 118 million)
• Complete Phase 2 study of freeze-dried IMVAMUNE to support a pre-EUA submission (requirement for stockpiling)
• Initiate final Phase 3 trial of IMVAMUNE (H1, 2014)
• Continue to research the potential of PROSTVAC in combination with checkpoint inhibitors, androgen deprivation therapies and radiotherapy
• Initiation of NCI-sponsored Phase 1 study of MVA-BN Brachyury (H1, 2014)
• Initiation of NCI-sponsored Phase 2 study of CV-301 in bladder cancer (H1, 2014)
• Finalize development plan for CV-301 in colorectal cancer based upon feedback from the FDA (H2, 2014) followed by initiation of randomized, controlled trial depending on availability of funds
• Potential IMVANEX/IMVAMUNE orders from rest of world 

Webcast and conference call

The Company will host a conference call today at 2.00 pm CET (9.00 am EDT). President and CEO, Anders Hedegaard will present the annual results followed by a Q&A session with participation of the Company’s executive management. Dial-in numbers for the conference call are: Denmark: +45 32 72 80 18, UK: +44 (0) 844 571 8957, USA: +1 866 682 8490. A webcast of the conference call will be broadcast simultaneously at /investor/events.aspx?event=2871. On this page, the accompanying presentation will be available prior to the conference call.

Asger Aamund

Chairman of the Board

Contact

Anders Hedegaard, President & CEO. Phone +45 23 20 30 64

About Bavarian Nordic

Bavarian Nordic is an international biotechnology company developing and manufacturing novel cancer immunotherapies and vaccines for infectious diseases. Lead product candidates are PROSTVAC^®, an immunotherapy product candidate for advanced prostate cancer that is the subject of an ongoing pivotal Phase 3 clinical trial and IMVAMUNE^®, a non-replicating smallpox vaccine candidate in Phase 3 development, which is being developed and supplied for emergency use to the U.S. Strategic National Stockpile under a contract with the U.S. Government. The vaccine is approved in Canada under the trade name IMVAMUNE and in the European Union under the trade name IMVANEX^®. 

Bavarian Nordic's shares are listed on NASDAQ OMX Copenhagen under the symbol BAVA (Reuters: BAVA.CO, Bloomberg: BAVA.DC). The company has a sponsored Level 1 ADR program listed in the US (OTC) under the symbol BVNRY. 

For more information, visit www.bavarian-nordic.com. 

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.  

Group Key Figures 2009-2013

1)    Earnings per share (EPS) is calculated in accordance with IAS 33 "Earning per share". Other financial ratios have been calculated in accordance with "Anbefalinger og Nøgletal 2010" (Recommendations and Financial ratios 2010)

2)    Due to the rights issue in 2011, earnings per share and net asset value per share for 2009-2011 have been recalculated based on the average number of shares for 2013/outstanding shares at year-end 2013

3)   Year-end share prices for 2009-2010 have been adjusted for subsequent capital increases

Company Announcement no. 2 / 2014