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."
Significant achievements in 2013 and up to the reporting
date
* 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
Selected
upcoming milestones
* 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
http://www.bavarian-
nordic.com/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
DKK million 2013 2012
2011 2010
2009
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Income statement
Revenue 1,212.5 1,016.6 523.6
314.1 74.8
Production costs 484.7 513.6 403.4
444.5 140.1
Research and
development
costs 496.6
340.1 261.7 188.6 164.0
Distribution and
administrative
costs 197.8 194.6 166.8
155.1 111.9
Income before
interest and tax
(EBIT)
33.4 (31.7) (308.3) (474.1) (341.2)
Financial items,
net
(27.2) (17.0) 11.9 (9.4) 10.1
Income before
company tax 6.2 (48.7) (296.4)
(483.4) (331.1)
Net profit for
the year (46.7)
(240.0) (268.4) (389.9) (266.3)
Balance sheet
Total non-
current assets 551.8 644.3 865.2 850.6
715.1
Total current
assets 900.4 894.9 1,111.4
616.5 556.0
Total assets 1,452.2 1,539.2 1,976.6
1,467.1 1,271.1
Equity 976.3 999.7
1,207.6 810.4 704.2
Non-current
liabilities 86.7
54.2 105.4 106.5 113.0
Current
liabilities
389.3 485.3 663.6 550.2 453.9
Cash Flow
Statement
Securities, cash
and cash
equivalents 532.1
549.9 584.0 355.7 185.0
Cash flow from
operating
activities 147.1 20.1 (375.2) (239.9)
(484.0)
Cash flow from
investment
activities (146.5)
71.0 (261.8) (45.8) 26.1
- Investment in
intangible
assets
(111.0) (24.3) (16.5) (16.2) (45.5)
-
Investment in
property, plant
and equipment (44.4) (20.9)
(31.2) (45.7) (50.6)
Cash flow from
financing
activities
(7.1) (9.6) 642.4 471.0 (30.8)
Financial
Ratios
(in DKK)( 1))
Earnings (basic)
per share of DKK
10 (2))
(1.8) (9.2) (10.3) (14.9) (10.2)
Net asset value
per share
(historical) 37.4 38.3 46.3 62.5
88.6
Net asset value
per share
(adjusted) (3)) 37.4
38.3 46.3 31.1 27.0
Share price at
year-end
(historical) 89 50 38 245
144
Share price at
year-end
(adjusted) (3)) 89 50
38 190 94
Share price/Net
asset value per
share
(historical) 2.4 1.3 0.8 3.9
1.6
Share price/Net
asset value per
share (adjusted)
(2) + 3))
2.4 1.3 0.8 6.1 3.5
Number of
outstanding
shares at year-
end 26,094 26,094
26,094 12,962 7,952
Equity share 67% 65%
61% 55% 55%
Number of
employees,
converted to
full-time, at
year-end 426 450 439
402 354
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
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