Bavarian Nordic - Interim Financial Report for the Period 1 January to 30 September 2013
(Thomson Reuters ONE) -
KVISTGAARD, Denmark, November 14, 2013 - Bavarian Nordic A/S (OMX: BAVA, OTC:
BVNRY) today publishes its interim financial results for the first nine months
of 2013. Revenue for the period was DKK 875 million (2012: DKK 750 million) and
the result before tax was a loss of DKK 18 million (2012: DKK 17 million
profit). The Infectious Diseases division remains profitable with an EBIT after
internal allocations of DKK 250 million in the period (2012: DKK 221 million).
As of September 30, 2013 the cash preparedness was DKK 546 million, including
unutilized credit lines of DKK 120 million. The company has research and
delivery contracts with the U.S. Government of which payments of up to USD 330
million (approximately DKK 1.8 billion) remain as of September 30, 2013. The
company maintains its 2013 full-year expectations with revenues in the level of
DKK 1,100 million and a break-even result before tax. The Infectious Diseases
division is expected to generate an EBIT of approximately DKK 360 million, which
will be offset by total costs of DKK 325 million in the Cancer Immunotherapy
division, primarily relating to the global Phase 3 study of PROSTVAC®. The
Group's cash preparedness at year-end is expected to be approximately DKK 600
million.
Group key figures are found at the end of this announcement. The full financial
statements for the period can be downloaded from the Company's website:
www.bavarian-nordic.com.
Highlights from the third quarter and up to the reporting date
* In August, IMVANEX® smallpox vaccine received marketing authorization in
Europe
* In August, enrollment of 4,000 subjects in the Phase 3 IMVAMUNE® lot
consistency trial was completed
* In July and August, patient enrollment in two Phase 2 studies, sponsored by
National Cancer Institute (NCI), combining PROSTVAC® and enzalutamide
(Xtandi®) began. One study investigates the combination in non-metastatic
castration sensitive prostate cancer and the other in metastatic castration-
resistant prostate cancer
Anders Hedegaard, President & CEO commented: "With a continued strong
performance, we remain on track to meet the financial expectations we set out
for the year. We are reaching completion of the final delivery for the initial
20 million dose order of IMVAMUNE smallpox vaccine to the U.S. Strategic
National Stockpile, and will soon begin delivering on the next contract we were
awarded in April this year. The European marketing authorization for IMVANEX in
August, our first regulatory product approval, represented a historic milestone
for the company and an important validation of our MVA BN vaccine technology
platform. Looking ahead, we remain highly focused on completing enrollment in
the PROSPECT Phase 3 study of PROSTVAC. Additionally, our intention now is to
prioritize colorectal cancer in the further clinical development of CV-301,
based on the promising clinical Phase 2 study results reported in May of this
year, and we are in the process of seeking regulatory input to determine next
steps in the clinical development strategy."
Selected upcoming milestones
* Deliver 7 million doses of IMVAMUNE to the U.S. Strategic National Stockpile
in 2013
* Initiate the final Phase 3 trial of IMVAMUNE in the fourth quarter of 2013
* Complete enrollment in the PROSPECT Phase 3 study of PROSTVAC in the first
half of 2014
* Report data from NCI-sponsored clinical trials of PROSTVAC
In order to further strengthen and expand its relations to the investor
community in USA, the company has appointed Seth Lewis as Vice President of
Investor Relations. He will be based in the U.S. and take up this new position
later in November. Seth Lewis joins the company from The Trout Group, LLC, where
he has held the position as Senior Vice President.
Contact
Anders Hedegaard, President & CEO. Phone +45 23 20 30 64
Webcast and conference call
The Company will host a conference call today at 2.00 pm CET (8.00 am EST).
President and CEO, Anders Hedegaard will present the interim 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 www.bavarian-nordic.com/webcast. On this page, the
accompanying presentation will be available prior to the conference call.
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.
IMVAMUNE® is approved 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 U.S. (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.
201320uk:
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originality of the information contained therein.
Source: Bavarian Nordic A/S via Thomson Reuters ONE
[HUG#1742861]
Unternehmensinformation / Kurzprofil:
Datum: 14.11.2013 - 07:38 Uhr
Sprache: Deutsch
News-ID 316358
Anzahl Zeichen: 7257
contact information:
Town:
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Kategorie:
Business News
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