Bavarian Nordic Reports First Half 2011 Financial Results
(Thomson Reuters ONE) -
-- Conference Call Scheduled August 31, 2011 at 2 p.m. CET -
Kvistgaard, Denmark, August 31, 2011 - Bavarian Nordic A/S (OMX: BAVA) today
announced its half year 2011 results. Revenue generated for the six months ended
June 30, 2011 were DKK 58 million, compared to DKK 175 million for the six
months ended June 30, 2010.
For the six months ended June 30, 2011, the Company reported a loss before tax
of DKK 275 million compared to a net loss before tax of DKK 179 million, for the
six months ended June 30, 2010. The half year 2011 results were in line with
expectations.
As of 30 June 2011 the cash preparedness was DKK 800 million, including credit
lines of DKK 120 million.
The company maintains its full-year expectations with revenues of approximately
DKK 500 million, and a pre-tax loss estimate of DKK 350 million. The cash
preparedness at year-end is expected to be in the level of DKK 525 million.
Below is an extract of the most significant matters in the report as well as
important events after the balance sheet date. The full interim report is
available on the company's website: www.bavarian-nordic.com.
Highlights from the first half
* Successfully raised DKK 654 million in rights issue
In May, Bavarian Nordic successfully completed an offering, generating net
proceeds of DKK 654 million, allowing the company to pursue the development
of PROSTVAC® which is scheduled to start the pivotal Phase 3 trial in the
second half of 2011.
* U.S. Government expands development contract for freeze-dried IMVAMUNE®
In April, the U.S. Government increased the value of the existing contract
to develop a freeze-dried version of IMVAMUNE® smallpox vaccine from USD 40
million to USD 94 million. The increased funding will support additional
studies and manufacturing activities to further advance the development of
the freeze-dried version of IMVAMUNE® by the end of the contract period.
* Submitted a marketing authorization application for IMVAMUNE® in Canada
In March, Bavarian Nordic submitted a marketing authorization application
(MAA) in Canada for IMVAMUNE® for active immunization against smallpox in
the general population of 18 years and older.
* Signed two new delivery contracts for IMVAMUNE®
In June, Bavarian Nordic signed a contract with the Danish Defence and
second contract with European NATO country for the delivery of IMVAMUNE®.
* Initiated an NCI sponsored Phase 2 combination study with PROSTVAC® and
chemotherapy
In February, a new multicenter, randomized Phase 2 study of 144 patients
with metastatic castration-resistant prostate cancer (mCRPC) was initiated.
The study will compare PROSTVAC® followed by docetaxel (chemotherapy) versus
docetaxel alone.
* Presented PROSTVAC® data in early stage prostate cancer at the 2011 ASCO
Annual Meeting
In June at the 2011 ASCO Annual Meeting in Chicago, investigators from the
National Cancer Institute (NCI) presented data from a study with PROSTVAC®
in patients with locally recurrent prostate cancer. The data indicates that
PROSTVAC® is active in stages of prostate cancer as early as locally
recurrent disease.
* Successfully defended patent position on MVA-BN®
In April, the ICC International Court of Arbitration rendered its decision
in favor of Bavarian Nordic in the arbitration that had been pending against
Helmholtz Zentrum München since 2009. Helmholtz Zentrum München's claims of
rights to royalties on Bavarian Nordic's MVA-BN® based vaccines, including
IMVAMUNE®, were found to be baseless on all grounds.
Important events after the first half
* IMVAMUNE® Phase 3 expanded; still awaiting final regulatory guidelines from
the FDA
The FDA has recently announced a public workshop in September to discuss the
regulatory pathway for next generation smallpox vaccines, e.g. IMVAMUNE®,
for which licensure under the animal rule will be sought. Although this
novel regulatory path has delayed the initiation of the pivotal non-clinical
studies, the Phase 3 clinical study design has essentially been agreed with
the FDA, and planning of the trial will be initiated already this year,
although recruitment will only commence in the second half of 2012. The
deliveries of IMVAMUNE® under the RFP-3 base contract will not be affected
by the planning and subsequent initiation of the Phase 3 trial. As the Phase
3 design agreed with the FDA is larger and requires additional subjects than
initially proposed by Bavarian Nordic, the company has requested the U.S.
government to cover the added costs under a stipulation in the RFP-3
contract prior to the initiation of the study.
Anders Hedegaard, President & CEO commented on the interim report: "During first
half of 2011, we accomplished a number of significant events, supporting the
continued progress of our business. With the successful completion of a rights
issue in May, we have secured a timely launch of the pivotal Phase 3 trial of
PROSTVAC® later this year. We also successfully scaled up the production of
IMVAMUNE® and are on track to deliver the 4 million doses by the end of 2011.
Additionally, the expansion of the contract for freeze-dried IMVAMUNE® further
strengthens our ties with the U.S. Government, leading to potential future
contracts. Our strong cash position and secured contracts protect us well
against the current turmoil in the global markets."
Selected, upcoming milestones
* Initiation of Phase 3 study of PROSTVAC® in patients with asymptomatic or
minimally symptomatic metastatic castration-resistant prostate cancer (H2,
2011)
* Complete enrolment of patients and report initial immune data for MVA-BN®
HER2 in breast cancer (H2, 2011)
* Report final Phase 1/2 data for MVA-BN® PRO in prostate cancer (H1, 2012)
* Initiate Phase 3 study of IMVAMUNE® (H2, 2012)
* Approval of MAA in Canada for IMVAMUNE® (2012)
* Initiate Phase 1 study of MVA-BN® Anthrax (H1, 2012)
* Initiate Phase 1 study of MVA-BN® RSV (H1, 2012)
Conference call
The company will host a conference call today, Wednesday, August 31 at 2 p. m.
CET. President and CEO, Anders Hedegaard will present the interim results
followed by a Q&A session with additional attendance of Ole Larsen, CFO and Rolf
Sass Sørensen, Vice President Investor Relations and Communications. Dial-in
numbers for the conference call are: Denmark: +45 3271 4607, UK: +44 (0)20
7162 0077, US: +1 334 323 6201. The accompanying presentation is available on
the company's website:www.bavarian-nordic.com/q2.
Contact
Anders Hedegaard, President & CEO. Phone +45 23 20 30 64
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 clinical pipeline
targets cancer and infectious diseases, and includes seven development
programmes. Two programmes are under preparation for Phase III: PROSTVAC®, a
therapeutic vaccine for advanced prostate cancer is being developed under a
collaboration agreement with the National Cancer Institute, and IMVAMUNE®, a
third-generation smallpox vaccine is being developed under a contract with the
US government.
Bavarian Nordic is listed on NASDAQ OMX Copenhagen under the symbol BAVA.
For more information please visit www.bavarian-nordic.com
PROSTVAC® is a registered trademark in the U.S.
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.
Half-year-report-2011:
http://hugin.info/100065/R/1542402/472155.pdf
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Bavarian Nordic A/S via Thomson Reuters ONE
[HUG#1542402]
Unternehmensinformation / Kurzprofil:
Datum: 31.08.2011 - 08:12 Uhr
Sprache: Deutsch
News-ID 60881
Anzahl Zeichen: 9803
contact information:
Town:
Kvistgård
Kategorie:
Business News
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