Bavarian Nordic A/S - Interim Report for the Period 1 January to 30 September 2009
By Bavarian Nordic As, PRNETuesday, November 10, 2009
KVISTGARD, Denmark, November 11 - Today Bavarian Nordic published the company's third quarterly report
2009. The full report including the financial statements is available on the
company's website: www.bavarian-nordic.com.
In the first nine months of 2009 Bavarian Nordic generated revenue of DKK
53 million and recorded a loss before tax of DKK 261 million. As of 30
September 2009 the Group's net free liquidity was DKK 304 million The company
maintains its expectations for the financial result for the full year 2009
with revenues in the range of DKK 100-300 million and a pre-tax loss of
between DKK 275-325 million. A prerequisite for maintaining the high end of
the guidance is that the company will receive delivery allowance from the US
authorities no later than beginning of December, leading to the possible
initiation of deliveries of IMVAMUNE(R) to the US Government before the end
of 2009. The net free liquidity at year-end is expected to be approximately
DKK 175 million as a potential delivery to the US Government by late 2009
will not have a cash effect in 2009.
Following the FDA inspection of the IMVAMUNE(R) manufacturing facilities
in May, Bavarian Nordic has made progress in the implementation of the
corrective actions as required due to observations made by the FDA. The
company expects to finalise its responses to the FDA no later than in the
beginning of December and subsequently will await the FDA review and
acceptance hereof. Consequently, the company maintains its expectations to
initiate delivery of IMVAMUNE(R) to the US government before the end of
second quarter of 2010.
During the first nine months of 2009, Bavarian Nordic reported further
confirmatory data on PROSTVAC(TM), the company's late-stage prostate cancer
vaccine candidate. Oral presentations were held at several cancer congresses,
including ASCO and ECCO annual meetings. Bavarian Nordic expects that an end
of phase II meeting with the FDA will take place during January 2010. While
partnership negotiations are ongoing, the company is in preparations for
Phase III and these are proceeding as planned.
Lately, the prostate cancer field has witnessed positive clinical results
followed by attractive partnership deals. It has proven worthwhile for a
number of companies to independently advance their projects into Phase III,
thus maximising their value before they would eventually sign a licensing
deal. Similarly, Bavarian Nordic is seeking to maximise and retain the value
of its cancer portfolio. Consequently, Bavarian Nordic seeks the ability to
advance PROSTVAC(TM) into Phase III of its own. In order for Bavarian Nordic
to gain the independence to execute its short and long term activities within
biodefence and cancer, the company is exploring available options for
securing an optimum financial position.
Highlights from the period
Bavarian Nordic has signed contract with an EU country for the delivery
of IMVAMUNE(R)
In September, Bavarian Nordic signed a contract with the military of an
undisclosed EU country for the delivery of a small order for IMVAMUNE(R). The
size and value of the contract is undisclosed. This marks the first time,
Bavarian Nordic enters a contract with an EU country for the delivery of
IMVAMUNE(R), and it demonstrates that there exists a real demand inside of EU
for new and safer smallpox vaccines for preparedness stockpiles. The vaccines
have been delivered.
Negotiations with the US authorities for the further development of
IMVAMUNE(R)
Bavarian Nordic is currently in late-stage negotiations with the US
authorities for a new contract to develop a freeze-dried version of the
IMVAMUNE(R) smallpox vaccine. This potential new project will have no
influence on the ongoing RFP-3 contract for the procurement of 20 million
doses of IMVAMUNE(R) and the licensure of the current liquid-frozen
formulation, but represents an additional business opportunity of major
strategic importance. The company expects that the prospective contract will
constitute the gateway towards securing additional contracts with the US
Government and outside the US as well.
Further detailed PROSTVAC(TM) data presented at the ECCO 15 - 34th ESMO
Congress
Further data from the Phase II study with PROSTVAC(TM) were presented at
the European CanCer Organisation (ECCO), ECCO 15 - 34th ESMO Congress in
Berlin in September. The data indicate the potential for a broader
therapeutic use of PROSTVAC(TM) in metastatic prostate cancer
Important events after the period
Delivery of IMVAMUNE(R) to Canada completed
As planned, Bavarian Nordic has delivered 20,000 doses of IMVAMUNE(R) to
the Canadian government. A pre-New Drug Submission (NDS) meeting with Health
Canada (National Regulatory Authority) was held in October 2009 to discuss
the potential to file an NDS in 2010 for IMVAMUNE(R) as a safer smallpox
vaccine under a Notice of Compliance with Conditions (NOC/C). Conclusions
from the meeting have not yet been finalised.
Encouraging data for MVA-BN(R) HIV multiantigen warrant further studies
Bavarian Nordic has completed the analysis of the Phase I/II studies with
MVA-BN(R) HIV multiantigen. The final safety and immunogenicity data
demonstrate that the vaccine induces a broad T cell response in HIV infected
subjects. The high number of responders to the vaccine is encouraging and
warrant further studies. Thus, in line with its strategy, Bavarian Nordic is
now looking for a partner in order to secure the continued development of
MVA-BN(R) HIV multiantigen in a full Phase II.
Bavarian Nordic acquires remaining shares in its subsidiary BN
ImmunoTherapeutics Inc. and subsequently own 100% of the subsidiary
Bavarian Nordic has entered into a conditional agreement for the purchase
of 400,521 shares in the US subsidiary, BN ImmunoTherapeutics Inc., from the
CEO and President Reiner Laus and two former employees in the subsidiary with
the purpose of obtaining full ownership of the subsidiary. Further, stock
options issued to employees in the subsidiary are repurchased. This
transaction forms part of Bavarian Nordic's strategy to strengthen the cancer
business area and will give the company full control over the group's
activities in this field.
The agreement will have no consequences for the future strategy,
organisation and operation of BN ImmunoTherapeutics Inc.
The consideration to Reiner Laus and the two former employees will be
paid in part with 136,177 new shares of DKK 10 each in Bavarian Nordic A/S
and in part with a number of future milestone payments that are triggered
upon the successful completion of a number of pre-defined development
milestones.
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
pipeline is focused in the three areas; biodefence, cancer and infectious
diseases, and includes seven development programmes. Two programmes are ready
for Phase III: IMVAMUNE(R), a third-generation smallpox vaccine is being
developed under a contract with the US government, and PROSTVAC(TM), a
therapeutic vaccine for advanced prostate cancer is being developed under a
collaboration agreement with the National Cancer Institute.
Bavarian Nordic is listed on NASDAQ OMX Copenhagen under the symbol BAVA.
For more information please visit www.bavarian-nordic.com
Contact: Anders Hedegaard, President & CEO, Bavarian Nordic, +45-23-20-30-64
Tags: Bavarian Nordic A/S, denmark, Europe, Kvistgard