KVISTGAARD, Denmark, March 11, 2015 - Bavarian Nordic A/S (OMX: BAVA,
OTC:
BVNRY) today published its 2014 annual report. Revenue was DKK 1,217
million /
USD 175 million (DKK 1,213 million / USD 175 million in 2013). The
Group
recorded an EBIT of DKK 17 million / USD 2 million (DKK 33 million / USD
5
million in 2013) and a net profit of DKK 26 million / USD 4 million (DKK
47
million loss / USD 7 million loss). Revenue and results were in line with
the
expectations for the year. At year-end 2014, the cash preparedness was
DKK
1,000 million / USD 144 million (DKK 652 million / USD 94 million as of
31
December 2013).
For 2015, Bavarian Nordic expects revenue at the level of
DKK 1,000 million /
USD 144 million and a break even result before interest and
tax (EBIT). The cash
preparedness at year-end is expected to be in the level of
DKK 1,100 million /
USD 159 million.
Danish kroner (DKK) is the Company's
functional currency. For convenience, the
Company presents selected figures in
USD above. These are based on a USD/DKK
exchange rate of 6.9395, which is the
official exchange rate of Danmarks
Nationalbank, the central bank of Denmark,
on March 10, 2015.
Consolidated key financial figures are found at the end of
this announcement.
The full financial statements for 2014 are available in the
annual report which
can be downloaded from the Company's website:
www.bavarian-nordic.com.
Paul Chaplin, President & CEO of Bavarian Nordic,
said: "2014 was a strong year
for Bavarian Nordic where we met our financial
and operational targets and even
exceeded our own expectations, as new
opportunities surfaced during the year.
Our technology has received strong
recognition by the closing of important
deals, with Johnson & Johnson and
Bristol-Myers Squibb, two industry leaders, in
each of our business areas. We
are in a transitional phase, preparing for
expanding the pipeline in areas of
unmet medical needs, while also continuing
our efforts to expand our
manufacturing capabilities that allows us to deliver
according to current and
future supply agreements."
Significant achievements in 2014 and up to the
reporting date
* The U.S. Government exercised an option valued at USD 118
million for
additional 4 million doses of IMVAMUNE smallpox vaccine,
bringing the total
number of doses delivered to-date to 28 million.
* The
U.S. Government also exercised an option valued at almost USD 22 million
under the existing development contract for freeze-dried IMVAMUNE to fund
the transfer of the validated manufacturing process to a commercial
manufacturing line with a larger capacity.
* Contracts were signed with the
Canadian Government for the delivery of more
than 60,000 doses of IMVAMUNE
with options for up to an additional 450,000
doses.
* A licensing and
supply agreement was entered with Janssen on MVA-BN® Filo
vaccine, which is
being investigated in a prime-boost regimen with Janssen
AdVac® vaccine
against Ebola. The agreement has a potential value of up to
USD 187 million
and includes an equity investment in Bavarian Nordic.
Janssen furthermore
obtained an exclusive option to collaborate on MVA-BN in
three additional
infectious disease targets.
* A first-in-human trial investigating MVA-BN
Filo as an Ebola vaccine was
initiated.
* Enrollment was completed in the
phase 3 study of PROSTVAC prostate cancer
immunotherapy. 1,298 patients
were enrolled in more than 200 centers across
15 countries.
* Two new
programs were added to the pipeline, both sponsored by our partner,
the
National Cancer Institute: A phase 2 combination study of CV-301
immunotherapy and BCG (Bacillus Calmette-Guerin) treatment was initiated in
patients with bladder cancer and a phase 1 study of MVA-BN Brachyury (a
tumor-associated antigen which is overexpressed in major solid tumor
indications) was initiated in patients with advanced cancer
* In February
2015, updated long-term survival data from an NCI sponsored
combination
study of PROSTVAC and Yervoy were presented. For patients
receiving
PROSTVAC and high doses of Yervoy, a median overall survival of
37.2 months
was shown, compared to a predicted survival of 18.5 months.
Furthermore,
approximately 20% of these remain alive at 80 months.
* In March 2015,
Bavarian Nordic entered into an exclusive agreement with
Bristol-Myers
Squibb for PROSTVAC, under which the Company could receive up
to USD 975
million, inclusive of USD 60 million upfront and potential
exercise
payment; potential development, regulatory and commercialization
milestone
payments; additional tiered double-digit royalties on future
sales. In
addition, the companies will collaborate to explore the
combination of
PROSTVAC with agents from Bristol-Myers Squibb's immune-
oncology
portfolio.
* Asger Aamund, founder and chairman of the board since the
inception of
Bavarian Nordic in 1994 stepped down. Gerard van Odijk, was
elected the new
chairman of the board. He has served as member of the board
since 2008.
* Paul Chaplin, Ph.D. was appointed President & CEO of Bavarian
Nordic. He
succeeded Anders Hedegaard who decided to seek new challenges
outside the
company after 7 years serving as CEO. Paul Chaplin has been
with Bavarian
Nordic for more than 15 years, the last 10 years as part of
the executive
management team.
Selected upcoming milestones
*
Manufacture and deliver MVA-BN Filo vaccine to Janssen (targeting 2 million
doses to contribute to the prime-boost regimen) (2015)
* Initiation of Phase
2 and Phase 3 clinical trials of the Ebola prime-boost
vaccine regimen
*
Potential new orders for MVA-BN Filo
* Potential expanded collaboration with
Janssen on additional infectious
disease targets
* Complete Phase 2 study
of freeze-dried IMVAMUNE to support a pre-EUA
submission (requirement for
stockpiling) (2015)
* Complete transfer of validated freeze-dried
manufacturing process to a
commercial scale facility (2015)
* Secure
IMVANEX/IMVAMUNE orders from rest of world
* Investigational New Drug
submission for MVA-BN RSV followed by initiation of
Phase 1 study (H1,
2015)
* Advance clinical studies exploring the therapeutic potential of
PROSTVAC in
combination with Yervoy and other potential checkpoint
inhibitors as part of
the clinical collaboration with Bristol-Myers Squibb
* Finalize validation of the PROSTVAC commercial manufacturing process and
prepare launch material
* Interim analyses of the PROSTVAC Phase 3 clinical
trial
Webcast and conference call
The Company will host a conference call
today at 2.00 pm CET (9.00 am EDT).
President and CEO, Paul Chaplin 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=4207. On this page,
the accompanying
presentation will be available prior to the conference
call.
Contacts
Rolf Sass Sørensen, Vice President Investor Relations (EU).
Phone
+45 61 77 47 43
Seth Lewis, Vice President Investor Relations (US). Phone
+ 1 978 341 5271
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.
Consolidated Key Figures
DKK million 2014
2013 2012 2011
2010
---------------------------------------------------------------------------
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Income
statement
Revenue 1,216.8 1,212.5 1,016.6
523.6 314.1
Production costs 495.1 484.7 513.6
403.4 444.5
Research and development costs 478.9 496.6
340.1 261.7 188.6
Distribution and administrative
costs
226.1 197.8 194.6 166.8 155.1
Income before
interest and tax
(EBIT) 16.7 33.4 (31.7)
(308.3) (474.1)
Financial items, net 47.7 (27.2)
(17.0) 11.9 (9.4)
Income before company tax 64.4
6.2 (48.7) (296.4) (483.4)
Net profit for the year 25.9
(46.7) (240.0) (268.4) (389.9)
Balance sheet
Total non-current assets
568.1 551.8 644.3 865.2 850.6
Total current assets
1,319.1 900.4 894.9 1,111.4 616.5
Total assets
1,887.3 1,452.2 1,539.2 1,976.6 1,467.1
Equity
1,252.1 976.3 999.7 1,207.6 810.4
Non-current
liabilities 51.9 86.7 54.2 105.4 106.5
Current
liabilities 583.3 389.3 485.3 663.6
550.2
Cash Flow Statement
Securities, cash and cash
equivalents
979.7 532.1 549.9 584.0 355.7
Cash flow from
operating activities 338.7 147.1 20.1 (375.2) (239.9)
Cash flow
from investment activities (503.7) (146.5) 71.0 (261.8) (45.8)
-
Investment in intangible assets (53.6) (111.0) (24.3) (16.5)
(16.2)
- Investment in property, plant and
equipment
(52.4) (44.4) (20.9) (31.2) (45.7)
Cash flow from financing
activities 216.2 (7.1) (9.6) 642.4 471.0
Financial Ratios (in
DKK) (1))
Earnings (basic) per share of DKK 10 1.0 (1.8) (9.2)
(12.1) (25.7)
Net asset value per share
(historical)
45.2 37.4 38.3 46.3 62.5
Net asset value per share
(adjusted)
(2)) 45.2 35.3 36.1
43.6 29.3
Share price at year-end (historical) 198 89 50
38 245
Share price at year-end (adjusted)
(3))
198 89 50 38 190
Share price/Net asset
value per
share (historical) 4.4 2.4 1.3
0.8 3.9
Share price/Net asset value per
share (adjusted) (2) +) (3))
4.4 2.5 1.4 0.9 6.5
Number of outstanding shares
at
year-end 27,671 26,094 26,094 26,094
12,962
Equity share 66% 67% 65% 61%
55%
Number of employees, converted to
full-time, at year-end
422 426 450 439 402
1) Earnings per share (EPS) are
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 issue of new shares in
2014, net asset value per share for 2010-2013
have been recalculated based on
outstanding shares at year-end 2014
3) Year-end share price for 2010 has been
adjusted for rights issue in May
2011
[HUG#1901301]
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