Bavarian Nordic Announces 2012 Full Year Results

Bavarian Nordic Announces 2012 Full Year Results

KVISTGAARD, Denmark, March 12, 2013 (GLOBE NEWSWIRE) -- Bavarian Nordic A/S
(OMX: BAVA) today published its 2012 Annual Report. Revenue was DKK 1,017
million (DKK 524 million in 2011). The Group recorded a loss before tax of DKK
49 million (DKK 296 million loss in 2011). Revenue and results were
significantly improved, compared to original expectations for the year. This
was primarily due to the successful optimization of the production of smallpox
vaccine which allowed for more doses to be delivered than anticipated,
combined with lower production costs. A total of 8.3 million doses of
IMVAMUNE(r) were delivered to the U.S. in 2012. Following the optimization and
the increased deliveries, the infectious disease division became profitable
with an EBIT of DKK 282 million (DKK 52 million loss in 2011).

At year-end 2012, the cash preparedness was DKK 670 million (DKK 704 million
as of 31 December 2011), and this was also significantly improved compared to
the original guidance.

For 2013, Bavarian Nordic expects revenue at the level of DKK 1,100 million
and a break-even result before tax. The revenue will primarily be generated
from deliveries of IMVAMUNE(r) to the U.S. Strategic National Stockpile. The
cash preparedness at year-end is expected to be roughly DKK 600 million.

The full financial statements for 2012 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: "Our financial
results for 2012 were most satisfactory and reflect the progress we have
achieved in our production and deliveries of smallpox vaccine for the U.S.
Government. This part of our business is now profitable and will also
contribute to our expected strong financial results in 2013 as we expect a new
contract from the U.S. Government to be awarded soon for continued delivery of
IMVAMUNE(r). We also saw progress in our Phase 3 trial of PROSTVAC(r), which
is now active in 10 countries and will soon be initiated in all remaining
planned countries."

Significant achievements in 2012 and up to the reporting date

  *The PROSPECT Phase 3 trial of PROSTVAC(r) in prostate cancer began
    enrollment in Europe and is now active in 10 countries
  *Promising Phase 2 data for CV-301 in breast cancer were presented at the
    European Society of Medical Oncology 2012 congress
  *Productivity of IMVAMUNE(r) manufacturing significantly improved over the
    year, resulting in more deliveries to the U.S. Additionally, the
    Infectious Diseases division became profitable
  *We delivered 8.3 million doses of IMVAMUNE(r) to the U.S. Strategic
    National Stockpile
  *The U.S. Government expanded the population eligible to receive
    IMVAMUNE(r) in an emergency, which significantly increased the vaccine's
    future business potential
  *A marketing application for IMVANEX(r) (IMVAMUNE(r)) was submitted to the
    European Medicines Agency. A decision on European approval is anticipated
    in 2013, and also from the Canadian health authorities for the application
    that was submitted in 2011
  *Additional USD 55 million was awarded in funding by the U.S. Government to
    support the IMVAMUNE(r) Phase 3 trial, as well as new research and
    development to expand the use of the MVA-BN(r) vaccine platform technology
    into other diseases
  *A new order contract for IMVAMUNE(r) was received from Canada to replenish
    its existing stockpile
  *In January 2013, Bavarian Nordic announced that it will transform its
    manufacturing facility in Kvistgaard into a multipurpose facility to
    accommodate the production of clinical trial material as well as the
    future commercial production of PROSTVAC(r)
  *In February 2013, James B. Breitmeyer was appointed new President of the
    Cancer Vaccine division. He has also joined the Bavarian Nordic executive
    management

Selected upcoming milestones

  *Obtain new IMVAMUNE(r) delivery contract with the U.S. Government
  *Deliver 7 million doses of IMVAMUNE(r) to the U.S. Strategic National
    Stockpile in 2013
  *Complete enrolment in the IMVAMUNE(r) Phase 3 lot consistency trial
  *Initiate Phase 3 non-inferiority trial of IMVAMUNE(r)
  *Obtain marketing authorization for IMVAMUNE(r) in Canada
  *Obtain marketing authorization for IMVANEX(r) (IMVAMUNE(r)) in the EU
  *Initiate Phase 2 study with the freeze-dried version of IMVAMUNE(r) to
    support emergency use
  *Report data from NCI-sponsored clinical trials of PROSTVAC(r)
  *Report data from NCI-sponsored clinical trials of CV-301 and determine
    development strategy

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 the participation of the executive management team.
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 www.bavarian-nordic.com/webcast.

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(r), 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(r) has been tested in nearly 600 patients. In infectious diseases,
the company's lead program is IMVAMUNE(r), a non-replicating 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.

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