Bavarian Nordic Announces First Half 2015 Results
(Thomson Reuters ONE) -
COPENHAGEN, Denmark, August 25, 2015 - Bavarian Nordic A/S (OMX: BAVA, OTC:
BVNRY) today publishes its interim financial results for the first half of
2015. Revenue for the period was DKK 624 million (2014: DKK 450 million), the
income before interest and tax (EBIT) was a profit of DKK 85 million (2014: DKK
70 million loss) and the net profit was DKK 107 million (2014: DKK 54 million
loss). Financial expectations for the full year are maintained.
Significant events in the second quarter of 2015 and up to the reporting date
* In May, preliminary Phase 1 results were announced for the Ebola prime-boost
vaccine regimen of MVA-BN® Filo and Janssen's AdVac® technology showing that
the vaccine regimen was immunogenic, regardless of the order of vaccine
administration. In July, a Phase 2 study of the vaccine regimen was
initiated in Europe in more than 600 healthy adults.
* Furthermore in May, positive results from two pivotal clinical studies of
IMVAMUNE smallpox vaccine were announced. Both studies, a pivotal Phase 2
study in 650 subjects comparing freeze-dried IMVAMUNE to liquid-frozen
IMVAMUNE, and a Phase 3 study in 4,000 subjects demonstrating lot
consistency with liquid-frozen IMVAMUNE, met their primary endpoints.
* In June, the U.S. Government exercised several contract options for the
development of a multivalent MVA-BN-based filovirus vaccine, bringing the
total value of the contract to approximately USD 33 million.
* In July, Bavarian Nordic received a new order from the U.S. Government
(BARDA) for bulk supply of IMVAMUNE valued at USD 133 million. This bulk
material could be converted into freeze-dried IMVAMUNE at a later date.
* In July, an NCI-sponsored Phase 2 study of PROSTVAC in up to 150 patients
with localized prostate cancer was initiated.
* In August, a Phase 1 study investigating a new MVA-BN based vaccine against
Respiratory Syncytial Virus (RSV) was initiated. The study will enroll 63
healthy adult subjects and assess safety, tolerability and immunogenicity of
MVA-BN RSV.
Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: "The
second quarter has seen a number of successes. As we continue to work toward
final data in the PROSPECT study, our partners at the NCI have continued to
investigate PROSTVAC in the potential treatment landscape for men with prostate
cancer, both with the initiation of a new, large phase 2 study for men with
earlier stage disease, as well as the full recruitment of a study of PROSTVAC in
combination with enzalutamide. We have secured U.S. government contracts of
almost USD 150 million for IMVAMUNE and filovirus vaccine, with the IMVAMUNE
order initiating the move towards a freeze dried formulation and the replacement
of the 20 million dose stockpile. We have also seen the initiation of clinical
trials with another commercial infectious disease candidate targeting RSV. This
is a large, unmet illness with a massive cost to the healthcare system in both
elderly and infant populations."
Selected short-term objectives and opportunities
* Manufacture and deliver MVA-BN Filo vaccine to Janssen (targeting 2 million
doses to contribute to the MVA-BN/AdVac Ebola prime-boost vaccine regimen)
(2015)
* Initiation of Phase 3 clinical trials of the Ebola prime-boost vaccine
regimen (2015)
* Complete transfer of validated freeze-dried manufacturing process for
IMVAMUNE to a commercial scale facility (2015)
Complete enrollment and report Phase 1 data of MVA-BN RSV (H1, 2016)
* Manufacture IMVAMUNE bulk vaccine under USD 133 million contract with BARDA
(2016)
* Finalize validation of the PROSTVAC commercial manufacturing process and
prepare launch material (2016)
* Potential expanded collaboration with Janssen on additional infectious
disease targets
* Secure IMVANEX/IMVAMUNE orders from rest of world
Advance clinical studies exploring the therapeutic potential of PROSTVAC in
combination with Yervoy® (ipilimumab) and potentially other checkpoint
inhibitors as part of the clinical collaboration with Bristol-Myers Squibb
* Interim analyses of the PROSTVAC Phase 3 clinical trial
The board of directors appoints Dr. Frank Verwiel
The board of directors has appointed Dr. Frank Verwiel as observer of the board
with the intention to nominate him for election to the board at the ordinary
general meeting in 2016. Dr. Verwiel previously served as President & CEO of
Aptalis Pharma, Inc. and director of the board of Aptalis Holdings Inc. prior to
its acquisition by Forest (now Allergan).
Financials
Danish kroner (DKK) is the Company's functional currency. All USD figures
provided below are based upon a USD/DKK exchange rate of 6.40.
+-----------------+-----------+-----------+-----------+-----------+
| | H1 2015| H1 2014| H1 2015| H1 2014|
| |DKK million|DKK million|USD million|USD million|
+-----------------+-----------+-----------+-----------+-----------+
|Revenue | 624| 450| 98| 70|
+-----------------+-----------+-----------+-----------+-----------+
|EBIT | 85| (70)| 13| (11)|
+-----------------+-----------+-----------+-----------+-----------+
|Cash preparedness| 1,669| 423| 261| 66|
+-----------------+-----------+-----------+-----------+-----------+
Bavarian Nordic maintains its 2015 full-year financial expectations with revenue
at the level of DKK 1,000 million and a break even result before interest and
tax (EBIT). Revenue will primarily be generated from deliveries of bulk material
totaling approximately 2 million doses of MVA-BN Filovirus vaccine under the
Janssen license agreement and 0.3 million doses of IMVAMUNE to the U.S.
Strategic National Stockpile, the Public Health Agency of Canada, Canadian
Department of National Defence and an Asian country. Additional revenue is
expected from ongoing research and development contracts. The upfront payment
from the PROSTVAC option- and license agreement with Bristol-Myers Squibb will
be revenue recognized when the option matures.
The cash preparedness at year end is expected to be in the level of DKK 1,450
million and includes the loan facility of EUR 50 million from the European
Investment Bank.
As of the reporting date, all known external USD exposure is hedged.
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 along with a spreadsheet containing selected accounting
figures.
Conference call and webcast
The management of Bavarian Nordic will host a conference call today at 2 pm CET
(8 am EST) to present the interim results followed by a Q&A session. Dial-in
numbers for the conference call are: Denmark: +45 32 71 16 59, UK: +44 (0)
20 3427 1908, USA: +1 646 254 3360. A live and archived webcast of the call and
relevant slides will be available at http://www.bavarian-
nordic.com/investor/events.aspx?event=4209.
Contacts
Rolf Sass Sørensen
Vice President Investor Relations (EU)
Tel: +45 61 77 47 43
Seth Lewis
Vice President Investor Relations (US)
Tel: +1 978 341 5271
About Bavarian Nordic
Bavarian Nordic is a biopharmaceutical company focused on the development and
manufacturing of cancer immunotherapies and vaccines for infectious diseases.
Through a long-standing collaboration with the U.S. Government, Bavarian Nordic
has developed a portfolio of biological countermeasures, including the non-
replicating smallpox vaccine, IMVAMUNE(®), which is stockpiled for emergency use
by the U.S. and other governments. The vaccine is approved in the EU (under the
trade name IMVANEX(®)) and in Canada. Bavarian Nordic and its partner Janssen
are pioneering the development of an Ebola vaccine, which has been fast-tracked
by authorities in response to the current situation in West Africa.
Additionally, in collaboration with the National Cancer Institute, Bavarian
Nordic has developed a portfolio of active cancer immunotherapies based on its
versatile pox-virus based technologies, including PROSTVAC(®), which is
currently in Phase 3 clinical development for the treatment of advanced prostate
cancer. The company has partnered with Bristol-Myers Squibb for the potential
commercialization of PROSTVAC. For more information visit www.bavarian-
nordic.com or follow us on Twitter (at)bavariannordic.
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.
Consolidated Key Figures
DKK million 6m 2015 6m 2014 FY 2014
-------------------------------------------------------------------------------
un-audited un-audited audited
Income statements
Revenue 623.9 450.4 1,216.8
Production costs 202.1 229.0 495.1
Research and development costs 219.2 191.6 478.9
Distribution costs 27.4 22.7 45.1
Administrative costs 90.4 76.8 181.0
Income before interest and taxes (EBIT) 84.8 (69.7) 16.7
Financial items, net 62.7 5.9 47.7
Income before company tax 147.5 (63.8) 64.4
Net profit for the period 106.7 (53.7) 25.9
Balance sheet
Total non-current assets 518.0 582.1 568.1
Total current assets 1,702.6 673.1 1,319.2
Total assets 2,220.6 1,255.2 1,887.3
Equity 1,348.8 925.0 1,252.1
Non-current liabilities 50.9 82.7 51.9
Current liabilities 820.9 247.5 583.3
Cash flow statements
Securities, cash and cash equivalents 1,285.0 302.5 979.7
Cash flow from operating activities 306.3 (169.5) 338.8
Cash flow from investment activities (231.0) (60.6) (503.7)
- Investment in intangible assets (14.2) (31.0) (53.6)
- Investment in property, plant and equipment (6.7) (27.8) (52.4)
Cash flow from financing activities 15.1 (2.1) 216.3
Financial Ratios (DKK) (1))
Earnings (basic) per share of DKK 10 3.8 (2.1) 1.0
Net asset value per share (2)) 48.5 33.3 45.0
Share price at period-end 312 124 198
Share price/Net asset value per share (2)) 6.4 3.7 4.4
Number of outstanding shares at period-end 27,812 26,113 27,671
Equity share 61% 74% 66%
Number of employees, converted to full-time, at
period-end 419 421 422
-------------------------------------------------------------------------------
1) 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 2015" (Recommendations and Financial ratios
2015).
2) Due to issue of new shares in 2015, net asset value per share for 2014 has
been recalculated based on outstanding shares end Q2 2015.
201523en:
http://hugin.info/100065/R/1947304/707041.pdf
Interim Report Q2 2015 :
http://hugin.info/100065/R/1947304/707042.pdf
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire 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 GlobeNewswire
[HUG#1947304]
Unternehmensinformation / Kurzprofil:
Datum: 25.08.2015 - 07:02 Uhr
Sprache: Deutsch
News-ID 415603
Anzahl Zeichen: 14485
contact information:
Town:
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Kategorie:
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