Bavarian Nordic Announces its Interim Report for the Period 1 January to 31 March 2009
28 Abril 2009 - 7:00AM
PR Newswire (US)
KVISTGAARD, Denmark, April 28 /PRNewswire-FirstCall/ -- Yesterday
Bavarian Nordic Announced its Interim Results for the First Quarter
of 2009 - Positive Developments in the Biodefence and Cancer
Business Areas - End of Phase II Meeting Lays Down Pathway for the
Licensure of IMVAMUNE(R) - Preparations for the Delivery of
IMVAMUNE(R) to the USA are Progressing According to Plan -
PROSTVAC(TM) Data Have Been Accepted for an Oral Presentation at
the ASCO Annual Meeting In the first quarter of 2009 Bavarian
Nordic generated revenue of DKK 17 million and recorded a loss
before tax of DKK 83 million. The expectations for the financial
result for the full year 2009 are maintained at revenues in the
region of DKK 375 million, and a pre-tax loss in the region of DKK
225 million. As of 31 March 2009 the Group's net free liquidity was
DKK 627 million. Highlights from the period 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.
Based on the meeting, Phase III studies are expected to be
initiated in 2010. PROSTVAC(TM) data presented at international
cancer symposium In February 2009, 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 confirm 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 earlier disease settings and thus in a larger patient
group. Important events after the period PROSTVAC(TM) data accepted
for an oral presentation at the ASCO Annual Meeting Professor
Philip Kantoff, MD, Dana-Farber Cancer Institute, Harvard Medical
School who is the principal investigator in the PROSTVAC(TM) study
will present the Phase II results at the 2009 American Society of
Clinical Oncology (ASCO) Annual Meeting in Orlando May 29 to June
2, 2009. Anders Hedegaard, President & CEO of Bavarian Nordic
said: "Bavarian Nordic recorded strong progress in the first
quarter of 2009. We successfully held an end of Phase II meeting
with the FDA on IMVAMUNE(R) and have essentially agreed a pathway
for the licensure of the vaccine. Data from studies with our new
prostate cancer vaccine, PROSTVAC(TM) were presented at a major
international cancer symposium and we are pleased to see, that
these data indicate that the vaccine can be used in an earlier
disease setting. This broadens the market potential of the vaccine.
We also got the acceptance from ASCO to present PROSTVAC(TM) at
this year's annual meeting in May and we see this as a great
recognition of the excellent potential of the vaccine." Financial
statement for the period (1 January - 31 March 2009, un-audited)
The comparison figures for the same period 2008 are stated in
parenthesis. The revenue totalled DKK 17 million (DKK 14 million).
The revenue derives from sale under the RFP-2 contract with the US
health authorities. Production costs totalled DKK 41 million (DKK
32 million). The production costs are higher due to higher batch
production at the Kvistgaard facility. The Group's research and
development costs totalled DKK 36 million (DKK 28 million)
excluding development costs from the RFP-3 contract of DKK 10
million, of which DKK 8 million are capitalised as intangible
assets under construction. Sales costs totalled DKK 6 million (DKK
4 million). The increase primarily derived from increase in
commercial activities on IMVAMUNE(R). Administrative costs totalled
DKK 23 million (DKK 17 million). Income before tax was a deficit of
DKK 83 million (deficit of DKK 62 million). Net result was a
deficit of DKK 66 million (deficit of DKK 50 million). As of 31
March 2009 the Group's net free liquidity was DKK 627 million (DKK
971 million). Year to date cash flow from operations is negative
with DKK -132 million (DKK -67 million). Cash flow from investment
activities is DKK 33 million (DKK 127 million) and cash flow from
financing activities is DKK -4 million (DKK -4 million). The net
changes in cash and cash equivalents is negative with DKK -169
million (DKK +57 million) year to date. After the close of the
first quarter, the company decided to reduce the outstanding
foreign exchange contracts. The remaining foreign exchange
contracts of USD 46 million cover the expected USD income from the
RFP-3 contract in 2009. The reduction in the outstanding foreign
exchange contracts has been executed in order to eliminate the
adverse effect on the liquidity a rise in USD will have. The
Group's equity as of 31 March 2009 was DKK 893 million (DKK 1,226
million.). The decrease flows from retained earnings. Financial
expectations Bavarian Nordic maintains its expectations for the
financial result for 2009. Thus, the company 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.
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
Copyright