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Bavarian Nordic

Earnings Release Mar 8, 2012

3354_10-k_2012-03-08_aacf488d-93e4-49eb-be8e-6fa5075acca7.html

Earnings Release

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Bavarian Nordic Announces 2011 Full Year Results

Bavarian Nordic Announces 2011 Full Year Results

KVISTGAARD, Denmark, March 8, 2012 - Bavarian Nordic A/S (OMX: BAVA) today published its 2011 Annual Report. The 2011 financial statements show improved revenue, result before tax and year-end cash preparedness compared to the announced outlook for the year. Revenue was DKK 524 million, compared with a guidance of DKK 500 million. The revenue was primarily generated from the deliveries of four million doses of IMVAMUNE® to the US health authorities. The Group recorded a loss before tax of DKK 296 million, compared with a guided loss of DKK 350 million. The improved financial result was due to costs that were lower than anticipated, mainly related to a slight delay in the initiation of the PROSTVAC® Phase 3 trial, as well as ordinary cost-saving initiatives. At year-end 2011, the cash preparedness was DKK 704 million, compared with the latest upgraded guidance of DKK 650 million.

For 2012, Bavarian Nordic expects revenue at the level of DKK 850 million and a pre-tax loss at the level of DKK 200 million. The revenue will primarily be generated from deliveries of seven million doses IMVAMUNE® to the US Strategic National Stockpile. The cash preparedness at year-end is expected to be roughly DKK 350 million.

Group key figures are found at the end of this announcement. The full financial statements for 2011 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: "2011 was a year of substantial achievements, making it among the best operational years in our history. We met our two major objectives for the year: initiating Phase 3 trials with PROSTVAC® and delivering four million doses of IMVAMUNE® smallpox vaccines to the USA after a successful scale-up of production. The year, however also presented us with the challenge to fund the Phase 3 development of PROSTVAC®."

Significant achievements in 2011 and up to the reporting date

  • Initiated the pivotal Phase 3 trial of PROSTVAC® in metastatic prostate cancer 
  • Delivered four million doses IMVAMUNE® to the US Strategic National Stockpile
  • Received a USD 25 million milestone payment under the US government contract after a successful scale-up of production
  • Phase 3 protocol for IMVAMUNE® agreed with the FDA
  • Extended the contract for development of freeze-dried IMVAMUNE® to a total value of USD 94 million
  • IMVAMUNE® delivery contracts signed with Denmark and an another European NATO country
  • Raised nearly DKK 700 million in a rights issue through the placement of new shares with both existing shareholders as well as new, international healthcare specialist investors 
  • Expanded the cancer pipeline through expanded collaboration with the National Cancer Institute (NCI) which included rights to new cancer vaccine product candidates (CV-301) for multiple cancer indications 
  • Marketing authorization application for IMVAMUNE® submitted to the Canadian health authorities
  • Marketing authorization application for IMVANEX® (IMVAMUNE®) submitted to the European health authorities in February 2012

Selected, upcoming milestones

  • Deliver seven million doses IMVAMUNE® to the US Strategic National Stockpile (2012)
  • Phase 2 data for CV-301 in breast cancer (H2, 2012)
  • Initiate Phase 3 trial of IMVAMUNE® (H2, 2012)
  • Initiate Phase 2 study for the freeze-dried IMVAMUNE® (H1, 2013)
  • Approval of MAA in Canada for IMVAMUNE® (2012)

Changes to financial calendar for 2012

The company has moved its reporting date for the first quarterly results 2012 to 22 May 2012.

Conference call

The Company will a conference call today at 3.30 pm CET (9.30 am EST). President and CEO, Anders Hedegaard will present the annual results. The accompanying presentation is available on the company's website: www.bavarian-nordic.com/ar2011. Additional participants from Bavarian Nordic are Reiner Laus, Executive Vice President and Division President Cancer Vaccines, Paul Chaplin, Executive Vice President and Division President Infectious Diseases, Ole Larsen, CFO and Rolf Sass Sørensen, Vice President Investor Relations. Dial-in numbers for the conference calls are:  UK: +44 (0)20 7162 0077. USA: +1 334 323 6201. For additional countries and further details please visit www.bavarian-nordic.com/ar2011.

Asger Aamund

Chairman of the Board

Contact

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

About Bavarian Nordic

Bavarian Nordic is a vaccine-focused 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 targets cancer and infectious diseases, and includes ten development programs. In oncology, the company's lead program is PROSTVAC®, a therapeutic vaccine candidate for advanced prostate cancer that is the subject of an ongoing pivotal Phase 3 trial and is being developed under a collaboration agreement with the National Cancer Institute. In clinical Phase 1 and Phase 2 trials, PROSTVAC® has been tested in nearly 600 patients. In infectious diseases, the company's lead program is IMVAMUNE®, a third-generation smallpox vaccine candidate that is being developed and supplied for emergency use to the U.S. Strategic National Stockpile under a contract with the U.S. Government. 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.

Key Figures 2007-2011
DKK million 2011 2010 2009 2008 2007
Income statement
Revenue 523.6 314.1 74.8 208.8 332.1
Production costs 403.4 444.5 140.1 196.7 64.5
Research and development costs 261.7 188.6 164.0 129.6 243.6
Distribution and administrative costs 166.8 155.1 111.9 92.0 89.1
Income before interest and tax (EBIT) (308.3) (474.1) (341.2) (209.5) (65.0)
Financial items, net 11.9 (9.4) 10.1 26.2 14.5
Income before company tax (296.4) (483.4) (331.1) (183.3) (50.5)
Net profit for the year (268.4) (389.9) (266.3) (150.4) (63.5)
Balance sheet
Total non-current assets 865.2 850.6 715.1 594.2 538.8
Total current assets 1,111.4 616.5 556.0 1,100.0 1,193.2
Total assets 1,976.6 1,467.1 1,271.1 1,694.3 1,732.1
Equity 1,207.6 810.4 704.2 1,015.1 1,217.7
Non-current liabilities 105.4 106.5 113.0 52.7 134.7
Current liabilities 663.6 550.2 453.9 626.5 379.7
Cash Flow Statement
Securities, cash and cash equivalents 584.0 355.7 185.0 795.9 913.6
Cash flow from operating activities (375.2) (239.9) (484.0) (22.4) 163.2
Cash flow from investment activities (261.8) (45.8) 26.1 (81.5) (16.1)
Investment in tangible assets 31.2 45.7 50.6 12.0 5.8
Cash flow from financing activities 642.4 471.0 (30.8) (15.1) 440.4
Financial Ratios (in DKK) 1)
Earnings (basis) per share of DKK 10 2) (12.9) (18.8) (12.8) (7.3) (3.1)
Net asset value per share (historical) 46.3 62.5 88.6 129.9 155.8
Net asset value per share (adjusted) 3) 46.3 31.1 27.0 38.8 46.6
Share price at year-end (historical) 38 245 144 132 293
Share price at year-end (adjusted) 3) 38 190 94 86 191
Share price/Net asset value per share (historical) 0.8 3.9 1.6 1.0 1.9
Share price/Net asset value per share (adjusted) 2) + 3) 0.8 6.1 3.5 2.2 4.1
Number of outstanding shares at year-end 26,094 12,962 7,952 7,816 7,816
Equity share 61% 55% 55% 60% 70%
Number of employees, converted to full-time, at year-end 439 402 354 294 264
1) Earnings per share (EPS) is calculated in accordance with IAS 33 "Earning per share". The financial ratios have been calculated in accordance with "Anbefalinger og  Nøgletal 2010" (Recommendations and Financial ratios 2010).
2) Earnings per share and net asset value per share for 2007-2010 have been recalculated based on the average number of shares for 2011.
3) Share price at the end of the 2007-2010 have been adjusted for subsequent capital increases.

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