Bavarian Nordic Reports First Half 2012 Financial Results
(Thomson Reuters ONE) -
* Continued strong performance in the manufacturing of IMVAMUNE® smallpox
vaccines
* Infectious disease division increases profitability
* Raises full year group financial expectations and year-end cash preparedness
KVISTGAARD, Denmark, August 28, 2012 - Bavarian Nordic A/S (OMX: BAVA) today
publishes its first half 2012 results. Revenue for the period was DKK 445
million (2011: DKK 58 million) and the result before tax was a loss of DKK 13
million (2011: DKK 275 million loss). For the second quarter ending 30 June
2012, revenue was DKK 278 million (2011: DKK 29 million) and the result before
tax was DKK 22 million (2011: DKK 140 million loss). As of 30 June 2012 the cash
preparedness was DKK 631 million, including un-utilised credit lines of DKK 120
million.
The infectious disease division continues to improve efficiency in the
manufacturing of IMVAMUNE®. Thus Bavarian Nordic will deliver more doses to the
U.S. Strategic National Stockpile in 2012 than previously targeted. Combined
with income from new research and development contracts, this will generate
higher revenue for the year. Consequently, the company raises its financial
expectations for the year with revenues increasing from approximately DKK 850
million to approximately DKK 900 million and the result before tax improving by
DKK 50 million from a loss of approximately DKK 200 million to a loss of
approximately DKK 150 million. Also, the company raises its expectations for the
year-end cash preparedness from approximately DKK 350 million to approximately
DKK 400 million.
Significant achievements in the first half and up to the reporting date
* 5.2 million doses of IMVAMUNE® delivered to the U.S. Strategic National
Stockpile in 2012 to-date
* Continued improvements in the IMVAMUNE® manufacturing efficiency over the
first quarters of 2012
* RFP-3 contract modifications increases total contract value by USD 32
million to USD 545 million
* Broadened the scope of the MVA-BN® vaccine platform technology through new
U.S. Government contract. The contract valued at up to USD 17.9 million
supports the development of technologies to accelerate and/or enhance the
immune response to a recombinant MVA-BN® based vaccine
* U.S. Government has significantly expanded the population eligible to
receive IMVAMUNE® in an emergency to cover all individuals with HIV
infection or atopic dermatitis, including pregnant, nursing mothers and
children
* As a consequence of new Danish tax legislation, the company has partially
written down its deferred tax asset by DKK 182 million
* Marketing application for IMVANEX® (IMVAMUNE®) submitted to the European
Medicines Agency
* The PROSPECT Phase 3 study of PROSTVAC® has begun enrolment in the first
countries outside USA
* Interim analysis of a Phase 2 combination study of PROSTVAC® and Quadramet®
presented at the 2012 ASCO Annual Meeting
* Phase 1 data from study combining PROSTVAC® and ipilimumab indicate
potential synergy from combining treatments
Anders Hedegaard, President & CEO commented: "We are pleased to report a
continued strong performance in our infectious disease division with the
manufacturing and deliveries of IMVAMUNE® smallpox vaccines for the U.S.
Strategic National Stockpile proceeding well. The division has improved its
profitability, contributing to an improved financial result for the group. An
expansion of our current contract with the U.S. Government to support a larger
Phase 3 study coupled with the recent expansion of the population eligible to
receive IMVAMUNE® in an emergency sustain and strengthen our partnership with
the U.S. Government. We are also happy to announce that our PROSPECT Phase 3
trial of PROSTVAC® has now begun enrolment in Europe and we continue to add new
clinical trial sites in the U.S. and additional countries to support recruitment
for the trial."
Selected, anticipated milestones
* Deliver 7.5 million doses IMVAMUNE® to the U.S. Strategic National Stockpile
(2012)
* Report Phase 2 data for CV-301 in breast cancer (Q4, 2012)
* Expand CRADA with NCI for new cancer targets
* Initiate Phase 3 trial of IMVAMUNE® (Q4, 2012)
* Initiate new Phase 2 study for the freeze-dried IMVAMUNE® (H1, 2013)
* Receive approval of MAA in Canada for IMVAMUNE® (H1, 2013)
* Receive approval of MAA in EU for IMVANEX® (2013)
Contact
Anders Hedegaard, President & CEO. Phone +45 23 20 30 64
Conference call
The Company will host a conference call today at 2 pm CET (8 am EST). President
and CEO, Anders Hedegaard will present the half year results. The accompanying
presentation is available on the company's website: http://www.bavarian-
nordic.com/q2. Additional participants from Bavarian Nordic are Paul Chaplin,
Executive Vice President and Division President Infectious Diseases, Reiner
Laus, Executive Vice President and Division President Cancer Vaccines, Ole
Larsen, Executive Vice President and CFO and Rolf Sass Sørensen, Vice President
Investor Relations. Dial-in numbers for the conference call are: UK: +44 (0)207
1620 177. USA: +1 334 323 6201. The participant code is 921026. For additional
countries and further details please visit http://www.bavarian-nordic.com/q2.
About Bavarian Nordic
Bavarian Nordic is a vaccine-focused 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 targets cancer
and infectious diseases, and includes ten development programs. In oncology, the
company's lead program is PROSTVAC®, a therapeutic vaccine candidate for
advanced prostate cancer that is the subject of an ongoing pivotal Phase 3 trial
and is being developed under a collaboration agreement with the National Cancer
Institute. In clinical Phase 1 and Phase 2 trials, PROSTVAC® has been tested in
nearly 600 patients. In infectious diseases, the company's lead program is
IMVAMUNE®, a third-generation smallpox vaccine candidate that is being developed
and supplied for emergency use to the U.S. Strategic National Stockpile under a
contract with the U.S. Government. 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.
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Source: Bavarian Nordic A/S via Thomson Reuters ONE
[HUG#1636341]
Unternehmensinformation / Kurzprofil:
Datum: 28.08.2012 - 07:50 Uhr
Sprache: Deutsch
News-ID 178012
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