Bavarian Nordic Announces First Half 2016 Results
(Thomson Reuters ONE) -
COPENHAGEN, Denmark, August 17, 2016 - Bavarian Nordic A/S (OMX: BAVA, OTC:
BVNRY) announced today its interim financial results for the first half of
2016. Below is a summary of business progress and financial performance for the
period. The full interim report is attached as a PDF file and can be found on
the company's website, www.bavarian-nordic.com.
Key highlights from the report
* In August, Bavarian Nordic entered a drug supply agreement with Bristol-
Myers Squibb, providing OPDIVO(®) (nivolumab) for the upcoming clinical
trial of CV301 as combination therapy in non-small cell lung cancer.
* The second planned interim analysis of the Phase 3 study of PROSTVAC
occurred in July, confirming that the study should continue without
modification. Final study data are anticipated in 2017 with a third interim
analysis occurring prior to that.
* A new Phase 2 study of PROSTVAC in 44 patients who have undergone a radical
prostatectomy has been initiated at the Medical University of South
California.
* A Phase 1 study of an MVA-BN-based vaccine against yellow fever was
initiated in July by the U.S. National Institute of Allergy and Infectious
Diseases.
* In June, the Public Health Agency of Canada (PHAC) exercised an option for
the supply of 171,000 doses of IMVAMUNE to the national stockpile at a total
value of USD 7.7 million. This option builds upon an initial order of
189,000 doses, comprising a total of 360,000 doses ordered by PHAC, to date.
* In June, Bavarian Nordic received a USD 12.3 million milestone payment from
the U.S. Biomedical Advanced Research Development Authority (BARDA) as
expected. This payment was part of a contractual holdback related to the
development of IMVAMUNE.
* In May, positive top-line results from a Phase 1 study of MVA-BN RSV were
reported in 63 healthy adults, aged 18-65. The results suggest the potential
of MVA BN RSV to be the first broad spectrum vaccine for RSV, demonstrating
a clear dose effect and the ability of the vaccine to stimulate a broad
antibody and T cell response to multiple RSV proteins.
* In May, BARDA ordered another bulk supply of IMVAMUNE, valued at USD 100
million. This order will be produced and revenue recognized in 2017. To
date, a total of USD 233 million has been invested by BARDA for bulk
vaccine, which can be converted to freeze-dried vaccine at a later date.
"I am very pleased with the progress of the company this year. We have
successfully built on our relationships with the U.S. and the Canadian
governments, resulting in new supply orders for our IMVAMUNE smallpox vaccine
for delivery in 2016 and beyond. Additional discovery programs continue to be
investigated with various governmental and health agencies as well. Internally,
our pipeline has never been stronger, with phase 2 studies for both RSV and
NSCLC starting this fall, and additional studies to follow shortly thereafter.
PROSTVAC continues to proceed towards overall survival data in our phase 3
study, which we anticipate in 2017, and multiple studies continue to be
initiated by our collaborators both as monotherapy and in combination," said
Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic.
Financial performance
As previously announced, manufacturing and release of commercial products will
primarily occur later in 2016 and thus more than 85% of the year's revenue is
expected to be recognized in the second half of 2016. Hence, only DKK 139
million in revenue was recognized during first half.
DKK million USD million
6m 2016 6m 2015 6m 2016 6m 2015
--------------------------------------------------------------
Revenue 139 624 21 94
EBIT (207) 85 (31) 13
Cash preparedness, period-end 1,894 1,669 283 249
--------------------------------------------------------------
Outlook for 2016
The Company maintains its financial expectations for 2016. For detailed
assumptions, refer to the 2015 Annual Report. Upon completion of the capital
increase in April, the expectations to cash preparedness at year-end were
upgraded from DKK 1,300 million to DKK 1,900 million.
2016E DKK million USD million
------------------------------------------------------
Revenue 1,000 149
EBIT 0 0
Cash preparedness, year-end * 1,900 284
------------------------------------------------------
* Cash preparedness includes cash, cash equivalents, investments in securities
and the aggregate amount of undrawn credit lines.
Danish kroner (DKK) is the Company's functional currency. All USD figures
provided above are based upon an assumed exchange rate of DKK 6.70 per 1.00 USD,
which was the exchange rate as of June 30, 2016.
Conference call and webcast
The management of Bavarian Nordic will host a conference call today at 2 pm CET
(8 am EDT) to present the interim results followed by a Q&A session. Dial-in
numbers for the conference call are: Denmark: +45 32 71 16 58, UK: +44 (0)
20 3427 1905, USA: +1 646 254 3367. Participant code is 9392645. A live and
archived webcast of the call and relevant slides will be available at
http://www.bavarian-nordic.com/investor/events.aspx?event=4531.
About Bavarian Nordic
Bavarian Nordic is a fully integrated biotechnology company focused on the
development, manufacturing and commercialization of cancer immunotherapies and
vaccines for infectious diseases, based on the Company's live virus vaccine
platform. Through long-standing collaborations, including a collaboration with
the U.S. government, Bavarian Nordic has developed a portfolio of vaccines for
infectious diseases, including the non-replicating smallpox vaccine,
IMVAMUNE(®), which is stockpiled for emergency use by the United States and
other governments. The vaccine is approved in the European Union (under the
trade name IMVANEX(®)) and in Canada. Bavarian Nordic and its partner Janssen
are developing an Ebola vaccine regimen, which has been fast-tracked, with the
backing of worldwide health authorities, and a vaccine for the prevention and
treatment of HPV. Additionally, in collaboration with the National Cancer
Institute, Bavarian Nordic has developed a portfolio of active cancer
immunotherapies, 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. All such forward-looking
statements are expressly qualified by these cautionary statements and any other
cautionary statements which may accompany the forward-looking statements. 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.
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
Company Announcement no. 24 / 2016
2016-24-en:
http://hugin.info/100065/R/2035297/758086.pdf
Interim Report Q2 2016:
http://hugin.info/100065/R/2035297/758085.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#2035297]
Unternehmensinformation / Kurzprofil:
Datum: 17.08.2016 - 07:53 Uhr
Sprache: Deutsch
News-ID 489578
Anzahl Zeichen: 9409
contact information:
Town:
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Kategorie:
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