Bavarian Nordic Announces 2010 Full Year Results and Provides Update on Development Strategy for PROSTVAC®
10 March 2011
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Kvistgård, Denmark, March 10, 2011 - Bavarian
Nordic A/S (OMX: BAVA) today published its Annual Report 2010,
which 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.
In 2010, Bavarian Nordic generated revenues of DKK 314 million
and recorded a loss before tax of DKK 484 million. The financial
result for the year 2010 was roughly in line with the Company's
expectations and latest guidance. At year-end 2010, the cash
preparedness was DKK 460 million.
Anders Hedegaard, President & CEO of Bavarian Nordic said:
"With the initiation of IMVAMUNE® deliveries to the U.S.
and the regulatory progress of PROSTVAC®, 2010 was a great year
in Bavarian Nordic. We overcame the challenges in the scale up of
our production, and are now geared for production and delivery of
the remaining 18 million doses of IMVAMUNE® under the base
contract with the U.S. Government. Already by the end of 2011, the
deliveries will generate a positive cash flow in our Infectious
Disease division. Our Cancer Vaccine division has been working
diligently to finalize the preparations for the first programme in
Bavarian Nordic to enter pivotal Phase 3 studies;
PROSTVAC®."
Updated development strategy for
PROSTVAC®
Following recent agreement with the FDA on the Special Protocol
Assessment (SPA) received in December 2010 for the pivotal Phase 3
trial of PROSTVAC®, it is the Company's belief that the
development of PROSTVAC® carries a more favourable regulatory
approval threshold than previously anticipated.
PROSTVAC® represents a significant product opportunity for
Bavarian Nordic. PROSTVAC® is an "off-the-shelf" therapeutic
vaccine moving into late stage clinical development that in a fully
controlled Phase 2 study has demonstrated the potential to extend
the lives of people with advanced prostate cancer by 8.5 months
(approx. 50% increase) compared to placebo. PROSTVAC® has
created enthusiasm in the medical community and has received
positive feedback as a potential new and efficient vaccine for
prostate cancer.
It is the Company's opinion, that this potential is not fully
recognised in the current proposed deal terms, and that there could
be more benefits in terms of shareholder value from retaining
control in a full in house development program.
The Company believes that the overall development plan and the
timing of the PROSTVAC® Phase 3 trial shall be maintained in
order to secure speed to market.
Bavarian Nordic has ongoing partnership discussions for the
development and commercialization of PROSTVAC®. While securing
a partner for PROSTVAC® continues to be a key strategic goal
for Bavarian Nordic, the Company believes that maintaining the
momentum in the development of PROSTVAC® is critical for
maximizing value for shareholders.
Therefore, the Company is currently reviewing alternate options
to fund the continued development of PROSTVAC®, in particular
opportunities to pursue an independent development in parallel with
continuing the partnership discussions. As part of this review the
Company is considering a rights issue to generate sufficient funds
that in combination with positive cash flow from existing
operations in coming years can fund the pivotal PROSTVAC® Phase
3 trial. The Company intends to finalize its considerations and
present the conclusions at the Annual General Meeting on 26 April
2011.
Outlook for 2011
Bavarian Nordic's guidance for revenues and pre-tax results
include the financial effects of initiating the PROSTVAC® Phase
3 trial in 2011.
In 2011, Bavarian Nordic expects to deliver 4 million doses of
IMVAMUNE® to the U.S. Strategic National Stockpile, of which
approximately 3 million will be revenue recognized but only around
2 million contribute to the 2011 cash flow due to anticipated late
delivery and acceptance from BARDA in the fourth quarter of
2011.
In 2011, the Company expects revenue at the level of DKK 500
million and a pre-tax loss at the level of DKK 350 million.
Prospects for IMVAMUNE® 2012-13
The delivery of the expected remaining 14 million doses after
2011 under the RFP-3 contract is anticipated to be approximately
evenly split between 2012 and 2013. In summary, the projected
delivery schedule of IMVAMUNE® is expected to enable the
Bavarian Nordic Infectious Disease Division to be cash flow
positive as of fourth quarter of 2011 and onwards.
In 2012-2013, the accumulated free cash flow for the Infectious
Disease Division is expected to be positive by approximately DKK
350 million including costs for the Phase 3 trial for
IMVAMUNE®, but excluding the cash from the hold back of USD 50
million.
2010 highlights
- Regulatory progress for PROSTVAC® with the US health
authorities (FDA), including the successful completion of an end of
Phase 2 meeting, Fast Track status, and Special Protocol Assessment
agreement for the Phase 3 programme
- Fulfilment of FDA requirements to potentially support the use
of IMVAMUNE® in HIV infected subjects following a declared
emergency and subsequent initiation of deliveries to the U.S.
Strategic National Stockpile. 2 million doses were delivered in
2010
- Performance-based milestone payment of USD 25 million received
under the RFP-3 contract
- Phase 2 data from study in atopic dermatitis patients submitted
to the FDA, potentially able to expand current planned use of
IMVAMUNE® in the US
- Phase 3 protocols submitted to the FDA to support the licensure
of IMVAMUNE® under the animal rule
- Milestones in development of freeze-dried IMVAMUNE®
completed, triggering the continued funding from the U.S.
Government (BARDA)
- Funding received from the U.S. National Institutes of Health
(NIH) to advance Bavarian Nordic's early research in the prevention
of filoviruses (Ebola and Marburg virus), using the MVA-BN®
platform
Important events after the balance sheet
date
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) treated
with PROSTVAC®. The study will compare PROSTVAC® followed
by docetaxel (chemotherapy) versus docetaxel alone.
Patients in the PROSTVAC® arm will receive an accelerated
treatment with PROSTVAC® (5 immunizations over 2 months)
followed by docetaxel and prednisone. The control arm will receive
upfront docetaxel and prednisone. After completion of study
therapy, patients are followed up every 3-6 months for 5
years.
The primary endpoint of the study is to evaluate the overall
survival. Secondary endpoints include the evaluation of
prostate-specific antigen (PSA) response rates and evaluation of
the association between development of PSA-specific immune
responses, time to progression, and overall survival in patients
treated with these regimens.
The study is being conducted by The Eastern Cooperative Oncology
Group (ECOG) - one of the largest clinical cancer research
organizations in the United States. Dr. Doug McNeel
(University of Wisconsin) is the Principle Investigator of the
study. The DCTD/NCI-sponsored1) study is being conducted under the
cooperative research and development agreement (CRADA) that
Bavarian Nordic has with the NCI for further development of
PROSTVAC®.
Bavarian Nordic in new research project aimed at
developing new cancer vaccines
In March 2011, Bavarian Nordic entered into a new Danish
research project, established with the purpose of identifying
pathogens (viruses and bacteria) that may cause cancer. The
identification of such viruses is an important step towards the
development of cancer vaccines. Bavarian Nordic has been elected as
partner in this project and will obtain the exclusive rights to
commercialize any cancer vaccines that may emerge from the project.
Until any viruses, leading to the development of new vaccines is
identified; the project carries minimal costs for Bavarian
Nordic.
The research project is part of a larger project, which today
received a large grant of almost DKK 90 million from the Danish
National Advanced Technology Foundation.
First quarterly results release date
changed
The company has moved its reporting date for the first quarterly
results 2011 from 18 May 2011 to 31 May 2011.
Annual General Meeting
The 2011 Annual General Meeting will be held at 4 p.m. on
Tuesday, 26 April 2011, at Comwell Borupgaard, Nørrevej 80,
DK-3070 Snekkersten, Denmark. In accordance with Article 12 in the
Company's Articles of Association, any shareholders who wish to
have specific issues on the agenda must submit a written request to
the Board of Directors no later than Monday 14 March 2011. Requests
must be sent by e-mail to investor@bavarian-nordic.com
or by ordinary post to the Company's headquarters.
Asger Aamund
Chairman of the Board
Webcast and conference call
The Company will host two conference calls today; one at 9 am
CET (3 am EST) and again at 4 pm CET (10 am EST). President and
CEO, Anders Hedegaard will present the annual results. The
accompanying presentation is available on the company's website: www.bavarian-nordic.com/ar2010.
Additional participants from Bavarian Nordic are Reiner Laus,
Executive Vice President and Division President Cancer Vaccines,
Ole Larsen, CFO and Rolf Sass Sørensen, Vice President
Investor Relations.
Dial-in numbers for the conference calls are: UK: +44
(0)20 7162 0077. USA: +1 334 323 6201
For additional countries and further details please visit www.bavarian-nordic.com/ar2010.
Financial Review 2010
A pre-tax loss of DKK 484 million (2009: loss of DKK 331
million) was recorded for the year. The Company's latest guidance
was an expected loss for 2010 of DKK 450 million. The negative
deviation is mainly because the Company had slightly lower revenue
than expected and has progressed further than expected with
preparations for PROSTVAC® Phase 3 studies, leading to
increased costs.
Bavarian Nordic generated revenue of DKK 314 million in 2010
(2009: DKK 75 million). The revenue is primarily composed of
revenue from deliveries of 2 million doses of IMVAMUNE® to the
US health authorities. The remaining revenue mainly comes from
ongoing contracts with the US health authorities (development
contracts RFP-2 and freeze-dried IMVAMUNE®).
The Group's cash preparedness was DKK 460 million at the end of
the year (2009: DKK 205 million).
Equity stood at DKK 810 million at 31 December 2010 (2009: DKK
704 million).
Outlook for 2011
In 2011, Bavarian Nordic expects to deliver 4 million doses of
IMVAMUNE® to the U.S. Strategic National Stockpile, of which
approximately 3 million will be revenue recognized but only around
2 million contribute to the 2011 cash flow due to anticipated late
delivery and acceptance from BARDA in the fourth quarter of
2011.
Bavarian Nordic's guidance for revenues and pre-tax results
include the financial effects of initiating the PROSTVAC® Phase
3 trial in 2011.
The Company is currently reviewing alternate options to fund the
continued development of PROSTVAC®, in particular opportunities
to pursue an independent development in parallel with continuing
the partnership discussions. As part of this review of options the
Company is considering a rights issue to generate sufficient funds
that in combination with positive cash flow from existing
operations in coming years can fund the pivotal PROSTVAC® Phase
3 trial. The Company intends to finalize its considerations and
present the conclusions at the Annual General Meeting on 26 April
2011, where the Company expects to provide guidance for its 2011
year-end cash preparedness as well.
In 2011, the Company expects revenue at the level of DKK 500
million and a pre-tax loss at the level of DKK 350 million. The
revenue of DKK 500 million is expected to be generated from
deliveries of IMVAMUNE® under the RFP-3 contract and revenue
from ongoing research contracts, including the contract for
freeze-dried IMVAMUNE® and the RFP-2 IMVAMUNE®
contract.
The free cash flow from operations and investments for 2011 are
projected to be negative by approximately DKK 600 million and are
expected to be almost equally split between the two divisions. In
the Infectious Disease Division, these financial effects are
primarily due to the scale up in production from two to four
batches per week, as well as the time gap between deliveries in
late 2011 and payment. In January, the Company successfully scaled
up production from two to three batches per week and a scale-up to
four batches per week is projected for the third quarter of 2011.
In the Cancer Vaccines Division, the negative cash flow is mostly
related to the initiation of the Phase 3 trial for PROSTVAC®.
The trial cost is estimated to be USD 150m over the period 2011 to
2015.
In case no alternate options to fund the continued development
of PROSTVAC® in 2011 materialises, Bavarian Nordic will be in a
situation where the Group would have to postpone the initiation of
the pivotal Phase 3 trial for PROSTVAC® and reduce existing
research and development programmes except for IMVAMUNE® and
reduce costs in the supporting functions and investments in order
to continue operations.
Group Key Figures
2006-2010
DKK
million
2010
2009
2008
2007
2006
Income
statement
Revenue
314.1
74.8
208.8
332.1
175.3
Production
costs
444.5 140.1
196.7
64.5
136.3
Research and development
costs
210.8 164.0
129.6
243.6
118.4
Distribution and administrative
costs
132.9 111.9
92.0
89.1
124.4
Income before interest and tax
(EBIT)
(474.1)
(341.2)
(209.5)
(65.0) (203.8)
Financial items,
net
(9.4)
10.1
26.2
14.5
(1.0)
Income before company
tax
(483.4)
(331.1)
(183.3)
(50.5) (204.8)
Net profit for the
year
(389.9)
(266.3)
(150.4)
(63.5) (160.9)
Balance
sheet
Total non-current
assets
829.2 715.1
594.2
538.8
568.2
Total current
assets
637.9 556.0
1,100.0
1,193.2
386.2
Total
assets
1,467.1 1,271.1
1,694.3
1,732.1
954.4
Equity at
year-end
810.4 704.2
1,015.1
1,217.7
691.4
Long-term current
liabilities
106.5 113.0
52.7
134.7
150.6
Short-term current
liabilities
550.2 453.9
626.5
379.7
112.4
Cash Flow
Statement
Securities, cash and cash
equivalents
355.7 185.0
795.9
913.6
332.7
Cash flow from operating
activities
(239.9)
(484.0)
(22.4)
163.2 (194.5)
Cash flow from investment
activities
(45.8)
26.1
(81.5)
(16.1) (192.2)
Investment in tangible
assets
45.7
50.6
12.0
5.8
73.9
Cash flow from financing
activities
471.0
(30.8)
(15.1)
440.4
219.0
Financial Ratios (in
DKK)
Earnings per share
- basic earnings per share of DKK
10
(33.5)
(34.0)
(18.7)
(8.0)
(25.8)
- diluted earnings per share of DKK
10
(33.5)
(34.0)
(18.7)
(8.0)
(25.8)
Net asset value per
share
62.5
88.6
129.9
155.8
108.4
Share price at the
year-end
245
144
132
293
582
Share price/Net asset value per
share
3.9
1.6
1.0
1.9
5.4
Numbers of outstanding shares at the year-end 12,962
7,952
7,816
7,816
6,376
Equity
share
55%
55%
60%
70%
72%
Number of employees (full-time) at
year-end
402
354
294
264
233
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 2010"
(Recommendations and Financial ratios 2010).
Contact:
Anders Hedegaard, President & CEO.
Phone: +45 23 20 30 64