Du är här

2016-05-13

Bavarian Nordic A/S: Bavarian Nordic Announces Interim Results for the First Three Months of 2016

COPENHAGEN, Denmark, May 13, 2016
- Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) announced today its interim
financial results for the first three months 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

* Successfully completed a private placement of 2.77 million new shares in
April, raising gross proceeds of DKK 665 million. The significantly
strengthened cash preparedness will enable the accelerated development of
key pipeline projects such as MVA-BN RSV and CV-301 cancer immunotherapy,
as well as allow for potential expansion of manufacturing capabilities.
* Results from the first Phase 1 study of the Ebola prime-boost vaccine
regimen were published in JAMA in April, showing that the vaccine regimen
produced an antibody response in 100 percent of healthy volunteers that was
sustained 8 months following immunization, indicating potential for a
durable response.
* The first, planned interim analysis of Phase 3 study of PROSTVAC occurred
in February, confirming that the study should continue without
modification. The final analysis is still anticipated in 2017 with two more
interim analyses occurring prior to that.
* Two new Phase 2 clinical studies of PROSTVAC were initiated by the National
Cancer Institute in the first quarter; a study investigating the
combination of PROSTVAC and docetaxel in 38 patients with non-metastatic
castration sensitive prostate cancer receiving androgen deprivation
therapy, and a study investigating PROSTVAC in 80 patients with
biochemically recurrent prostate cancer. Currently, eight Phase 2&3
clinical studies in more than 1,800 patients are ongoing, investigating
PROSTVAC as single or combination therapy in various stages of prostate
cancer.
* In January, an End of Phase 2 meeting was held with the FDA to discuss the
previously announced positive results of a Phase 2 study with IMVAMUNE. At
this meeting, the agency accepted that immunogenicity could be bridged
between the two formulations and that the proposed single Phase 3 lot
consistency study is sufficient for approval of freeze-dried IMVAMUNE.
Furthermore, based on the current safety database which includes data from
a large Phase 3 lot-consistency and safety study, FDA agreed that all
future trials involving MVA-BN would no longer require active cardiac
monitoring.
* At the request of certain health authorities, including BARDA and WHO,
Bavarian Nordic has submitted proposals outlining a concept for utilization
of MVA-BN in the development and manufacturing of vaccines in the fight
against emerging infectious diseases, including Zika virus. Any future
development in these areas would depend on funding availability.

"On the back of a successful capital raise in April, supported by both new and
existing international institutional investors, we continue to work towards
the initiation of multiple new clinical studies later in 2016. These studies
will advance key pipeline projects such as CV-301 for multiple cancers and
our RSV vaccine for which we expect to report Phase 1 results shortly. We
continue to see good support from our partners, including the U.S. Government
that has asked our advice on potential ways to deploy our MVA-BN platform in
the fight against emerging and tropical diseases, and from the NCI who
continues to advance PROSTVAC in combination studies. We also reported the
first interim analysis of the PROSTVAC Phase 3 study and look forward to
additional updates towards final data next year, as we continue to follow
patients in the study," 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 90% of the year's revenue is
expected to be recognized in the second half of 2016. Hence, only DKK 23
million in revenue was recognized during first quarter.

---------------------------------------------------------------------
| DKK million USD million |
| 3m 2016 3m 2015 3m 2016 3m 2015 |
| Revenue 23 235 4 36 |
| EBIT (153) (40) (22) (6) |
| Cash preparedness, period-end 1,365 1,619 209 248 |
---------------------------------------------------------------------
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 1,000 153 |
| EBIT 0 0 |
| Cash preparedness, year-end * 1,900 291 |
-----------------------------------------------------------
*
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 6.54 per 1.00
USD, which was the exchange rate as of March 31, 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 60, UK:
+44 (0) 20 3427 1912, USA: +1 646 254 3360. Participant code is 6964190. A
live and archived webcast of the call and relevant slides will be available
athttp://www.bavarian-nordic.com/investor/events.aspx?event=4530.

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
visitwww.bavarian-nordic.comor follow us on Twitter@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. 15 / 2016

201615en
http://hugin.info/100065/R/2011742/745298.pdf
Interim Report Q1 2016
http://hugin.info/100065/R/2011742/745288.pdf

---------------------------------------

This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Bavarian Nordic A/S via Globenewswire

HUG#2011742

Författare Hugin

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.