Bavarian Nordic A/S – Interim Report for the period 1 January to 31 March 2011
31 May 2011
Download pdf
Not for release, publication
or distribution in the United States, Canada, Australia or
Japan
This announcement does not constitute
an offer to sell or the solicitation of an offer to buy the
securities of Bavarian Nordic A/S (the "Securities") in the United
States or in any other jurisdiction. The Securities may not be
offered or sold in the United States absent registration or an
exemption from registration under the U.S. Securities Act of 1933,
as amended. The issuer of the Securities has not registered, and
does not intend to register, any portion of the Offering in the
United States or in any jurisdiction outside Denmark and the United
Kingdom, and does not intend to conduct a public offering of the
Securities in the United States or in any other jurisdiction
outside Denmark and the United Kingdom. Copies of this announcement
are not being made and may not be distributed or sent into the
United States, Canada, Australia or Japan.
This announcement is only being
distributed to, and is only directed at, persons in the United
Kingdom that are qualified investors, as that term is defined in
the Prospectus Directive, that are also (i) "investment
professionals" falling within Article 19(5) of the Financial
Service and Markets Act 2000 (Financial Promotion) Order 2005 (the
"Order") or (ii) "high net worth entities" and other persons to
whom it may lawfully be communicated, falling within the meaning of
Article 49(2)(a) to (d) of the Order (all such persons being
"relevant persons"). The securities of Bavarian Nordic A/S (the
"Securities") are only available to relevant persons and any
invitation, offer or agreement to subscribe, purchase or otherwise
acquire such Securities will be engaged in only with relevant
persons. Any person who is not a relevant person should not act or
rely on this announcement or any of its content.
Click here for full report in PDF
Kvistgaard, Denmark, May 31, 2011 - Bavarian Nordic A/S
(OMX: BAVA) today publishes its first quarter 2011 results.
Bavarian Nordic generated revenue of DKK 29 million and recorded a
loss before tax of DKK 135 million. As of 31 March 2011 the cash
preparedness was DKK 326 million, including credit lines of DKK 112
million. After the successful completion of a rights issue in May
2011, the cash preparedness has been significantly strengthened and
amounts to approximately DKK 825 million by end of May. The company
maintains its full-year expectations with revenues in the level of
DKK 500 million, and a pre-tax loss in the level of DKK 350
million. The cash preparedness at year-end is expected to be in the
level of DKK 525 million.
Anders Hedegaard, President & CEO commented on the interim
report: "Since we announced our new development strategy for
PROSTVAC® there has been much focus on Bavarian Nordic and we
are therefore delighted that the successful rights issue
last week has enabled us to pursue the independent development of
PROSTVAC® and thus initiate the Phase 3 trial in the second
half of 2011 as planned. At the same time we have secured both the
progress of the project, as well as a strong position in the
further discussions with potential partners by maintaining the
value of the project in the company. We have also witnessed
important events in our Infectious Disease division, especially
with the expansion of the contract for freeze-dried IMVAMUNE®,
which further strengthens the ties with the U.S. Government,
leading to potential new, future contracts."
Highlights from the period
- Marketing authorization application for IMVAMUNE® submitted
in Canada
In March, Bavarian Nordic submitted a marketing authorization
application in Canada for IMVAMUNE®. If found acceptable by
Health Canada following a standard NDS review time of approximately
one year, IMVAMUNE® will be indicated for active immunization
against smallpox in the general population of 18 years and
older.
- New Phase 2 study comparing PROSTVAC® and chemotherapy
versus chemotherapy
A new multicenter, randomized Phase 2 study of 144 patients with
metastatic castration-resistant prostate cancer (mCRPC) was
initiated in February 2011. The study will compare PROSTVAC®
followed by docetaxel (chemotherapy) versus docetaxel alone.
Currently, PROSTVAC® is being investigated alone or as
combination therapy in six ongoing clinical Phase 1 and Phase 2
studies in a total of more than 370 patients in different disease
settings.
Important events after the period
- DKK 653 million net raised in successful rights issue
In May, Bavarian Nordic successfully completed an offering,
generating net proceeds of DKK 653 million. The rights issue
attracted positive attention from both domestic and international
blue chip and healthcare specialist investors. The proceeds from
the rights issue will be used to pursue the independent development
of PROSTVAC® which is expected to start the pivotal Phase 3
trial in the second half of 2011.
- Patent position on MVA-BN® yet again successfully
defended
In April, the ICC International Court of Arbitration rendered its
decision in favour 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.
- U.S. Government expands development contract for freeze-dried
IMVAMUNE®
In April, the U.S. Government through the Biomedical Advanced
Research and Development Authority (BARDA) 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, thus underscoring the continued commitment to support the
IMVAMUNE® development programme.
Conference call
The company will host a conference call today, Tuesday,
May 31 at 2 p. m. CET. President and CEO, Anders Hedegaard will
present the interim results followed by a Q&A session. 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.
Contact:
Anders Hedegaard, President & CEO.
Phone: +45 23 20 30 64