2013-03-12 08:08:55 -
KVISTGAARD, Denmark - March 12, 2013 - 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® 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® to the U.S. Strategic National Stockpile. The cash
preparedness at year-end is expected to be roughly DKK 600 million.
Group key figures are found at the end of this announcement. 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®.
We also saw progress in our Phase 3 trial of PROSTVAC®, 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® 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® 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® to the U.S. Strategic National
Stockpile
* The U.S. Government expanded the population eligible to receive IMVAMUNE® in
an emergency, which significantly increased the vaccine's future business
potential
* A marketing application for IMVANEX® (IMVAMUNE®) 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® Phase 3 trial, as well as new research and development
to expand the use of the MVA-BN® vaccine platform technology into other
diseases
* A new order contract for IMVAMUNE® 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®
* 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® delivery contract with the U.S. Government
* Deliver 7 million doses of IMVAMUNE® to the U.S. Strategic National
Stockpile in 2013
* Complete enrolment in the IMVAMUNE® Phase 3 lot consistency trial
* Initiate Phase 3 non-inferiority trial of IMVAMUNE®
* Obtain marketing authorization for IMVAMUNE® in Canada
* Obtain marketing authorization for IMVANEX® (IMVAMUNE®) in the EU
* Initiate Phase 2 study with the freeze-dried version of IMVAMUNE® to support
emergency use
* Report data from NCI-sponsored clinical trials of PROSTVAC®
* 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. Additional participants from Bavarian Nordic are James
Breitmeyer, Executive Vice President and Division President Cancer Vaccines,
Paul Chaplin, Executive Vice President and Division President Infectious
Diseases, Ole Larsen, Executive Vice President & CFO and Rolf Sass Sørensen,
Vice President Investor Relations. 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. 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 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 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.
Group Key Figures 2008-2012
DKK million 2012 2011 2010 2009 2008
--------------------------------------------------------------------------------
Income statement
Revenue 1,016.6 523.6 314.1 74.8 208.8
Production costs 513.6 403.4 444.5 140.1 196.7
Research and development costs 357.4 261.7 188.6 164.0 129.6
Distribution and administrative
costs 177.3 166.8 155.1 111.9 92.0
Income before interest and tax
(EBIT) (31.7) (308.3) (474.1) (341.2) (209.5)
Financial items, net (17.0) 11.9 (9.4) 10.1 26.2
Income before company tax (48.7) (296.4) (483.4) (331.1) (183.3)
Net profit for the year (240.0) (268.4) (389.9) (266.3) (150.4)
Balance sheet
Total non-current assets 644.3 865.2 850.6 715.1 594.2
Total current assets 894.9 1,111.4 616.5 556.0 1,100.0
Total assets 1,539.2 1,976.6 1,467.1 1,271.1 1,694.3
Equity 999.7 1,207.6 810.4 704.2 1,015.1
Non-current liabilities 54.2 105.4 106.5 113.0 52.7
Current liabilities 485.3 663.6 550.2 453.9 626.5
Cash Flow Statement
Securities, cash and cash
equivalents 549.9 584.0 355.7 185.0 795.9
Cash flow from operating activities 20.1 (375.2) (239.9) (484.0) (22.4)
Cash flow from investment
activities 71.0 (261.8) (45.8) 26.1 (81.5)
Investment in tangible assets 20.9 31.2 45.7 50.6 12.0
Cash flow from financing activities (9.6) 642.4 471.0 (30.8) (15.1)
Financial Ratios (in DKK)( 1))
Earnings (basic) per share of DKK
10 (2)) (9.2) (10.3) (14.9) (10.2) (5.8)
Net asset value per share
(historical) 38.3 46.3 62.5 88.6 129.9
Net asset value per share
(adjusted) (3)) 38.3 46.3 31.1 27.0 38.9
Share price at year-end
(historical) 50 38 245 144 132
Share price at year-end (adjusted)
(3)) 50 38 190 94 86
Share price/Net asset value per
share (historical) 1.3 0.8 3.9 1.6 1.0
Share price/Net asset value per
share (adjusted) (2) + 3)) 1.3 0.8 6.1 3.5 2.2
Number of outstanding shares at
year-end 26,094 26,094 12,962 7,952 7,816
Equity share 65% 61% 55% 55% 60%
Number of employees, converted to
full-time, at year-end 450 439 402 354 294
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. Due to rights issue in 2011 earnings per share and net asset value per share
for 2008-2011 have been recalculated based on the average number of shares
for 2012/outstanding shares at year-end 2012.
3. Year-end share prices for 2008-2010 have been adjusted for subsequent
capital increases.
201306uk:
hugin.info/100065/R/1684274/551590.pdf
Bavarian Nordic Annual Report 2012:
hugin.info/100065/R/1684274/551612.pdf
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Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Bavarian Nordic A/S via Thomson Reuters ONE
[HUG#1684274]
