Bavarian Nordic publishes its annual report 2009
(Thomson Reuters ONE) -
Today Bavarian Nordic published the company's Annual Report 2009. The report is
available on the company's website. Below is an extract of the most significant
matters in the report as well as important events after the balance sheet date.
The financial result for the year 2009 was in line with the company's
expectations and latest guidance. Revenue was DKK 75 million and the company
recorded a loss before tax of DKK 331 million. At year-end 2009, net free cash
and cash equivalents stood at DKK 185 million.
The net proceeds of almost DKK 300 million from the successful completion of a
rights issue in the beginning of 2010 enables Bavarian Nordic to maintain
momentum in the production of IMVAMUNE© and continue preparations for Phase III
for PROSTVAC(TM).
For 2010, Bavarian Nordic maintains its financial expectations with revenues in
the level of DKK 475 million, a pre-tax loss in the level of DKK 250 million and
net free cash and cash equivalents in the range of DKK 225 to DKK 275 million at
year-end. Bavarian Nordic expects to deliver and invoice 4-5 million doses of
IMVAMUNE® to the US authorities, which is the primary source of revenue, which
furthermore derives from the ongoing RFP-2 contract and the RFP contract for
freeze-dried IMVAMUNE®
2009 highlights
· PROSTVAC(TM) was presented at several international cancer conferences and
gained scientific recognition due to the previously reported and promising Phase
II results that demonstrated the potential to significantly extend the lives of
patients with advanced prostate cancer.
o A scientific paper on the mentioned Phase II study was submitted to the
prestigious Journal of Clinical Oncology in 2009. The paper was published in the
beginning of 2010.
o A more detailed analysis of the data indicates a broader usage of the vaccine,
including the potential for use of the vaccine in earlier disease settings,
which was supported by a review, published by key investigators from the
National Cancer Institute in the publication "Expert Opinion on Investigational
Drugs", Volume 18, Issue 7 2009.
· The delivery of IMVAMUNE® under the RFP-3 contract was delayed due to a GMP
inspection of the production facilities, performed by the U.S. Food and Drug
Administration (FDA). This led to a number of observations, requiring subsequent
adjustments. By the end of 2009, Bavarian Nordic had submitted its responses to
these observations as well as the required documentation of the changes to the
FDA for review and acceptance. On this background the company expects delivery
of IMVAMUNE® to the US authorities to be initiated before the end of first half
of 2010.
· A new contract for the development and process validation of a freeze-dried
version of IMVAMUNE® was awarded by the US authorities. The contract has a
total prospective value of USD 40 million and will address potential procurement
of IMVAMUNE® in excess of the RFP-3 contract.
· Bavarian Nordic continues to enter minor IMVAMUNE® contracts with countries
outside the US. In 2009 the first contract with an EU country was entered.
Furthermore the delivery of 20,000 doses to the Canadian authorities was
completed under the contract, awarded in 2008. Subsequently, the Canadian health
authorities recommended that Bavarian Nordic submit an NDS application for
consideration to license IMVAMUNE®. The NDS is expected to be filed in 2010,
possibly leading to the first license of IMVAMUNE® during 2011.
Important milestones in 2010
· In 2010, Bavarian Nordic expects to initiate the delivery of IMVAMUNE® to the
US under the RFP-3 contract. Thus, the company will start invoicing the
remainder of the contract, including payments of USD 375 million.
· Based upon discussions with the European Medicines Agency and the U.S. Food
and Drug Administration, Bavarian Nordic expects to clarify the regulatory
strategy and outline the Phase III programme for PROSTVAC(TM) during first half
of 2010. In the meantime, preparations are ongoing for the Phase III studies,
expected to commence in late 2010.
Anders Hedegaard, President & CEO of Bavarian Nordic, said: "2009 was successful
for our cancer business where our therapeutic prostate cancer vaccine,
PROSTVAC(TM) attracted a lot of positive attention. Through our participation at
several international cancer congresses we gained great recognition of the
positive Phase II results that have been demonstrated, which have led to our
decision to advance the programme into Phase III. Investors also saw great
promise in the vaccine, which was the centre of attention during the many
meetings we held throughout Europe and in the US, in connection with the rights
issue in the beginning of this year. The net proceeds of almost DKK 300 million
enables us to continue our Phase III preparations for PROSTVAC(TM) as well as
maintain our focus on the first deliveries of IMVAMUNE® under the RFP-3
contract. Despite the delay that was caused by the FDA inspection, we have had a
very constructive dialogue and collaboration with the FDA on the implementation
of changes in our production, and we still believe that the first doses will be
shipped during first half of 2010. Our good relations with the US were further
strengthened with the award of a contract for the development of a freeze-dried
version of IMVAMUNE® in the spring. Our contracts with the US combined with the
proceeds from the rights issue makes up a solid base for the further development
of Bavarian Nordic and are key to our success in 2010."
Contact
Anders Hedegaard, President & CEO. Phone +45 23 20 30 64
Webcast and conference call
A conference call will be held today at 9 a.m. (CET). President and CEO, Anders
Hedegaard will present the annual results. The accompanying presentation is
available on the company's website: www.bavarian-nordic.com/ar2009
Nordic are Reiner Laus, Executive Vice President og CEO of BN
ImmunoTherapeutics, Ole Larsen, CFO and Rolf Sass Sørensen, Vice President
Investor Relations.
Dial-in numbers for the conference call are: UK: +44 (0)20 7162 0077. USA: +1
334 323 6201
For additional countries and further details please visit
www.bavarian-nordic.com/ar2009.
Financial Review 2009
A pre-tax loss of DKK 331 million (2008: loss of DKK 209 million) was recorded
for the year, which was in line with our guidance in our announcement dated 18
December 2008.
Bavarian Nordic generated revenue of DKK 75 million in 2009 (DKK 209 million).
The revenue was primarily composed of revenue from the ongoing contracts with
the US health authorities (development contracts RFP-1 and RFP-2) and from
delivery of IMVAMUNE® primarily to Canada.
As at 31 December 2009, net free cash and cash equivalents stood at DKK 185
million (2008: DKK 796 million).
Equity was DKK 704 million at 31 December 2009 (2008: DKK 1,015 million).
Outlook for 2010
For 2010, Bavarian Nordic expects revenue in the level of DKK 475 million and a
pre-tax loss in the level of DKK 250 million.
Revenue will primarily be generated from the supply of IMVAMUNE® to the United
States under the RFP-3 contract. Furthermore revenue derives from the ongoing
RFP-2 contract and the RFP contract for freeze-dried IMVAMUNE®. Potential
IMVAMUNE® contracts with other countries are not included in the forecast.
In 2010, Bavarian Nordic expects to deliver and invoice 4-5 million doses of
IMVAMUNE® to the US authorities, including approximately 2 million doses which
have already been produced and are awaiting delivery allowance from the US
authorities. The remaining doses of the 20 million are expected to be evenly
delivered in 2011 and 2012. It is assumed that already produced doses of
IMVAMUNE© will be accepted for delivery.
Increased costs, including costs for the continued Phase III preparations for
PROSTVAC(TM) and the continued increase in the production activities for
IMVAMUNE®, will affect the 2010 result. Furthermore, a number of investments are
required in 2010. These are primarily related to scale-up of the production of
IMVAMUNE® at the Kvistgård facility, preparations for the production of
PROSTVAC(TM) at the Berlin facility, continued development of IMVAMUNE® and
general maintenance. These investments are expected to amount to approximately
DKK 90 million, of which one third relates to clinical development of IMVAMUNE®.
Based upon the assumptions for the expectations for 2010, including among others
that the delivery allowance for IMVAMUNE® to US authorities is obtained no later
than first half of 2010 and that a credit facility in the amount of DKK 150 to
200 million to finance working capital is obtained, the Company expects cash
preparedness in the range of DKK 225 to 275 million by the end of 2010.
Provided that the RFP-3 contract and marketing of IMVAMUNE® will be fulfilled
according to plan, Bavarian Nordic expects to have sufficient funds for its
operations until the end of 2012, where upon the Company expects its cash
preparedness to cover the operational needs for an order-producing company.
Important events after the balance sheet date
Successful rights issue generates net proceeds of approximately DKK 300 million
In February 2010, Bavarian Nordic completed an offering in which 3,960,307 new
shares with a nominal value of DKK 10 each were subscribed, corresponding to a
subscription rate of 99.6%.
The new shares were subscribed at DKK 80 per share with a nominal value of DKK
10, resulting in gross proceeds to Bavarian Nordic of approximately DKK 317
million, equivalent to net proceeds of approximately DKK 298 million after
deduction of expenses related to the offering.
Following registration of the 3,960,307 new shares with a nominal value of DKK
10 each, Bavarian Nordic's nominal share capital will be DKK 119,120,520
corresponding to 11,912,052 shares with a nominal value of DKK 10 each.
PROSTVAC(TM) paper published by the peer-reviewed Journal of Clinical Oncology
In January 2010, a paper on the previously reported Phase II study with
PROSTVAC(TM) was published in Journal of Clinical Oncology, the official journal
of ASCO.
Bavarian Nordic and Oxford BioMedica settle all legal disputes on MVA-BN®
In January 2010 Bavarian Nordic and Oxford BioMedica reached a global settlement
ending the legal disputes between the parties on matters relating to MVA-BN®.
Under the agreement, Bavarian Nordic granted a license to its MVA-BN® patents in
return for Oxford BioMedica making milestone payments and royalties.
Under the settlement, the terms of which are confidential, all pending
litigation will cease and all oppositions filed at the European Patent Office by
Oxford BioMedica will be withdrawn. In addition both companies have agreed to
initiate business discussions concerning a possible future collaboration based
on each company's expertise in poxvirus vaccines and Bavarian Nordic's
commercial manufacturing capability.
Group Key Figures 2005-2009
Amounts in DKK millions
2009 2008 2007 2006 2005
Income
statements
Revenue 74.8
208.8 332.1 175.3 247.6
Production costs 140.1
196.7 64.5 136.3 132.2
Research and development costs 164.0 129.6
243.6 118.4 114.4
Distribution and Administrative costs
111.9 92.0 89.1 124.4 75.4
Other operating expenses -
- - - 45.4
Income before interest and tax (EBIT) (341.2)
(209.5) (65.0) (203.8) (119.8)
Financial items, net 10.1
26.2 14.5 (1.0) 3.4
Income before company tax (331.1)
(183.3) (50.5) (204.8) (116.4)
Net profit for the year (266.3)
(150.4) (63.5) (160.9) (94.7)
Balance sheet
data
Total non-current assets 715.1 594.2
538.8 568.2 472.4
Total current assets 556.0
1,100.0 1,193.2 386.2 456.2
Total assets 1,271.1
1,694.3 1,732.1 954.4 928.6
Shareholders equity 704.2 1,015.1
1,217.7 691.4 630.1
Long-term current liabilities 113.0 52.7
134.7 150.6 212.2
Short-term current liabilities 453.9 626.5
379.7 112.4 86.3
Cash Flow Statements
Net cash including securities 185.0 795.9
913.6 332.7 269.0
Cash flow from operating activities (484.1)
(22.4) 163.2 (194.5) (54.9)
Cash flow from investment activities 26.1
(81.5) (16.1) (192.2) (196.9)
Investment in tangible assets 50.6 12.0
5.8 73.9 151.2
Cash flow from financing activities (30.8)
(15.1) 440.4 219.0 464.2
Financial Ratios (in
DKK)
Earnings per
share
- Basic earnings, per share of DKK 10 (34.0)
(18.7) (8.0) (25.8) (17.6)
- Diluted earnings, per share of DKK 10 (34.0)
(18.7) (8.0) (25.8) (17.6)
PE, price/earnings ratio 88.6 129.9
155.8 108.4 108.7
Share price at the year-end 144 132
293 582 476
Share price/Net assets value per share 1.6 1.0
1.9 5.4 4.4
Numbers of outstanding shares, year-end 7,952 7,816
7,816 6,376 5,797
Shareholders´ equity share
55% 60% 70% 72% 67%
Number of employees (full time), year-end 354 294
264 233 224
Earnings per share (EPS) is calculated in accordance with IAS 33 "Earning per
share". The financial ratios have been calculated in accordance with
"Anbefalinger og Nøgletal 2005" (Recommendations and Financial ratios
2005).
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; cancer, biodefence and infectious diseases, and includes seven
development programmes. Two programmes are under preparation for Phase III:
PROSTVAC(TM), 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
[HUG#1391908]
Annual Report 2009: http://hugin.info/100065/R/1391908/349648.pdf
2010-15-uk: http://hugin.info/100065/R/1391908/349644.pdf
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Datum: 09.03.2010 - 02:01 Uhr
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