Bavarian Nordic Publishes its Annual Results 2008
27 Marzo 2009 - 6:00AM
PR Newswire (US)
KVISTGAARD, Denmark, March 27 /PRNewswire-FirstCall/ -- Today
Bavarian Nordic published the company's Annual Report 2008. The
report is available on the company's website:
http://www.bavarian-nordid.com/. Bavarian Nordic's revenue for the
year 2008 was DKK 209 million with a loss before tax of DKK 183
million, which was in line with the Company's latest guidance. At
year-end 2008, net free cash and cash equivalents stood at DKK 796
million. For 2009, Bavarian Nordic expects revenue in the region of
DKK 375 million, and a pre-tax loss in the region of DKK 225
million. Revenue will primarily be generated from the delivery of
IMVAMUNE(R) to the United States under the RFP-3 contract and
billing of the continuation of the RFP-2 contract and contracts for
smallpox vaccines already entered with other countries. For 2009,
the Company will make extraordinarily large drawings on cash as a
result of increased costs for scaling up production, the continuing
build-up of stockpiles of vaccine, preparation of the Phase III
study of PROSTVAC(TM) and increased costs of Phase II and the
preparation of Phase III studies of IMVAMUNE(R). It is expected
that drawings on cash in the current year will be at the level of
DKK 400 million. Accordingly, the Company's net free liquidity is
expected to be at the level of DKK 400 million at the end of the
year. The expectations regarding the liquidity are based on a
dollar exchange rate of approx. 6 DKK/USD. Bavarian Nordic expects
to strengthen its net free liquidity in 2010 and in the years ahead
via the delivery of already entered IMVAMUNE(R) contracts. Thus, at
the end of 2012, Bavarian Nordic's net free liquidity is expected
to be in level with 2008. 2008 highlights - Strong progress in the
pipeline with two new programmes added and two other programmes
entered clinical trials: - PROSTVAC(TM), a late-stage vaccine
candidate for the treatment of advanced prostate cancer, was
acquired as part of the partnership that was entered with the
National Cancer Institute. Very promising data were reported,
showing prolonged survival combined with a favourable safety
profile. Phase III studies expected to be initiated in 2010. -
MVA-BN(R) Anthrax, a new preclinical programme for an anthrax
vaccine, is expected to enter clinical trials in 2010. - MVA-BN(R)
HIV multiantigen, in development as prophylactic and therapeutic
vaccine against HIV, initiated clinical Phase I/II trials. - The
company's MVA-BN(R) based prostate cancer vaccine also entered
clinical Phase I/II trials. - A milestone payment of USD 25 million
was received after submission of important IMVAMUNE(R) data. - The
data that were generated from a larger Phase II study with
IMVAMUNE(R) was submitted to the US health authorities for
evaluation whether they can potentially support the use of
IMVAMUNE(R) in a declared emergency. - More than 2,400 subjects
have now been vaccinated with IMVAMUNE(R) - The first IMVAMUNE(R)
contracts outside USA were signed with Canada and an Asian country.
Anders Hedegaard, President & CEO of Bavarian Nordic, said:
"2008 was a successful year for Bavarian Nordic where all our
primary goals were achieved. We implemented a new strategy, and
this has already borne fruit. Our increased focus on cancer
therapies which through to the partnership with the NCI led to the
acquisition of PROSTVAC(TM) has strengthened our pipeline and we
feel very optimistic about our cancer vaccines in the future. At
the end of the year, we submitted the important safety data for
IMVAMUNE(R) to the US health authorities and are now awaiting just
one approval in order to initiate the delivery of the 20 million
doses under the RFP-3 contract. In 2009 we will have a continued
strong focus on fulfilling this contract as well as a strong focus
on preparing for the Phase III studies that we expect to initiate
with both IMVAMUNE(R) and PROSTVAC(TM) in 2010." Strong foundation
for future growth and earnings Despite the financial crisis and an
economic slowdown, Bavarian Nordic recorded a positive development
in 2008, and has laid a strong foundation for further value
creation in 2009 and the years ahead. The expected positive
development is based on the following elements: - Two vaccines
moving into Phase III trials - Strong financial position -
Profitable ongoing development and procurement contracts with a
value of more than DKK 3.5 billion - Expectations to the US
government's exercise of the contract option for additional
development and procurement, worth more than DKK 6 billion -
Ongoing contracts with countries outside USA - Partnership with the
NCI, a world leading cancer research organisation - Strong patent
portfolio - Pipeline with promising results - Future licensing
agreement for PROSTVAC(TM) - The world's only manufacturing
facility dedicated to the commercial-scale production of MVA based
vaccines Important events after the balance sheet date IMVAMUNE(R)
- end-of-Phase II meeting held with the FDA After concluding the
Phase II development of IMVAMUNE(R), Bavarian Nordic held an
end-of-Phase-II meeting with the US health authorities (FDA) in the
beginning of 2009 in order to discuss the Phase III study design.
The meeting was a success and there was an open and highly
constructive discussion with the FDA. Based on the meeting, Phase
III studies are expected to be initiated in 2010. The outcome of
the meeting has no impact on the delivery of vaccines to the
Strategic National Stockpile (SNS) under the RFP-3 contract with
the US government, which is still expected to be initiated in 2009.
PROSTVAC(TM) - further data presented In February 2009, the first
detailed data on PROSTVAC(TM) were presented at the international
cancer congress, 2009 Genitourinary Cancers Symposium in Orlando,
Florida. The data from three different studies once again confirms
the excellent safety and efficacy results previously reported, and
they support the further investigation of the vaccine in patients
suffering from advanced prostate cancer. The data also indicates
that PROSTVAC(TM) may be used in a larger patient group.
MVA-BN(R)-HER2 - data from ongoing studies reported. New studies to
be initiated. In February 2009, Bavarian Nordic reported data from
its Phase I/II studies with the therapeutic breast cancer vaccine
candidate, MVA-BN(R)-HER2. The data showed that the study met its
primary endpoint with regards to safety and by showing an immune
response. Oxford BioMedica - patent infringement suit continues The
patent infringement suit that was filed against Oxford BioMedica in
2008 continues. In January 2009, Bavarian Nordic filed a new
complaint after that the Judge, for procedural reasons, dismissed
the first complaint. If the court eventually should decide to
dismiss the suit this decision will bear no influence on the
substance of the patent case. It only influences the timing of the
start of the infringement case. Changes in management Executive
Vice President, Commercial Affairs, Nicolai Buhl Andersen has
chosen to resign from his position in Bavarian Nordic as of 1 May
2009 to work at Coloplast where he also worked previously. Steen
Vangsgaard has been appointed as his successor as from 27 March
2009. Steen Vangsgaard holds an MBA from London Business School. He
previously held the position as Vice President Commercial
Operations in Actavis A/S. Bavarian Nordic awards warrants The
Board of Directors in Bavarian Nordic A/S has today decided to
award warrants to a member of executive management and employees in
the Company and its subsidiaries. The Board decision is made in
accordance with the shareholder authorisation for the Board of
Directors adopted as Article 5f of the Articles of Association and
the Company's guidelines regarding incentive programs. The award is
made by the Board of Directors and exercise is limited by and
governed by the Danish Act on Options for Employees (the Stock
Option Act/aktieoptionsloven) regarding termination of employment
prior to exercise of warrants. A total of 25,000 warrants are
awarded for subscription of up to 25,000 shares of a nominal value
of DKK 10 at an exercise price of DKK 124 per share. The exercise
price has been established on the basis of the average share price
("closing price") for the Company's share in a period of 15
business days prior to this day added a 15 % premium. However, the
exercise price must at least be equal to the Company's average
exchange-listed price today. In the event that the average
exchange-listed price on the Company's shares today exceeds DKK 124
the exercise price shall be increased accordingly. If this becomes
relevant the Company will make a separate announcement to NASDAQ
OMX. The warrants can be exercised wholly or partly in a period of
14 days commencing from the day of publication of the Company's
Annual Report for 2011, from the day of publication of the
Company's Half Yearly Interim Results for 2012, from the day of
publication of the Company's Annual Report for 2012 and in a period
of 14 days commencing from the day of publication of the Company's
Half Yearly Interim Results for 2013. Referring to the Danish
Securities Act, Section 28a it is announced that Steen Vangsgaard,
who is a member of executive management and obliged to notify the
Company of transactions involving Bavarian Nordic securities is
awarded 5,000 warrants under the abovementioned award of warrants.
The value of each warrant equals DKK 39 and is calculated on the
Black-Scholes model with a risk-free interest rate of 2.5 per cent
and on the historical volatility of the shares. The calculation is
based on a market value of the share of DKK 103 per share. The
award of warrants will incur consequential amendments to the
Articles of Association. 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. About Bavarian Nordic Bavarian Nordic
A/S is a leading industrial 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 business strategy is focused in three areas: biodefence,
cancer and infectious diseases. Bavarian Nordic's proprietary and
patented technology MVA-BN(R) is one of the world's safest,
multivalent vaccine vectors. Bavarian Nordic has ongoing contracts
with the US government for the late-stage development and
procurement of the company's third-generation smallpox vaccine,
IMVAMUNE(R). Bavarian Nordic is listed on NASDAQ OMX Copenhagen
under the symbol BAVA. For more information please visit
http://www.bavarian-nordic.com/ DATASOURCE: Bavarian Nordic A/S
CONTACT: Contact (media only): Anders Hedegaard, President &
CEO, Bavarian Nordic, +45-23-20-30-64
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