Bavarian Nordic Announces Annual Report 2016
(Thomson Reuters ONE) -
COPENHAGEN, Denmark, March 15, 2017 - Bavarian Nordic A/S (OMX: BAVA, OTC:
BVNRY) announced today its Annual Report for 2016. Below is a summary of
business progress and financial performance for the year, and financial outlook
for 2017 from the report. The full report is attached as a PDF file and can be
found on the company's website, www.bavarian-nordic.com.
Key highlights
* Consistent with previous years we have generated revenues above DKK 1
billion and recorded a break-even result. Cash preparedness was
significantly strengthened and has more than tripled over the last three
years.
* We received a new USD 100 million bulk vaccine order from the U.S.
Government for IMVAMUNE smallpox vaccine, which remains our base revenue
driver. A tender process is expected to be initiated during 2017 potentially
allowing us to continue deliveries of IMVAMUNE in a freeze-dried
formulation. We also completed enrollment of the final Phase 3 study of the
liquid-frozen formulation required prior to submission for U.S. approval.
* The first and second interim analyses of the Phase 3 study of PROSTVAC have
been completed and the study continues as planned. We expect the third
analysis around mid-2017 and final data before year-end. Three new Phase 2
clinical studies of PROSTVAC were initiated during the year, notably a
combination study of PROSTVAC and YERVOY(®), a checkpoint inhibitor from
Bristol-Myers Squibb. A study combining PROSTVAC with YERVOY and OPDIVO(®)
(also from Bristol-Myers Squibb) will begin soon.
* We reported promising Phase 1 data for MVA-BN RSV, our vaccine candidate
against respiratory syncytial virus, which is designed to induce a broad
immune response through inclusion of five RSV-associated antigens - a highly
differentiated approach. We also completed enrollment of a Phase 2 study of
the vaccine in 400 subjects. Results from this study are expected in mid-
2017 and will provide important information for larger efficacy studies.
* In line with our strategy to expand our cancer immunotherapy pipeline, we
initiated the first clinical study of CV301 as combination therapy. The
study will serve as a proof-of-concept in patients with non-small cell lung
cancer in combination with OPDIVO, which was provided through a drug supply
agreement with Bristol-Myers Squibb. In 2017 and beyond, we expect the
initiation of additional combination trials of CV301 in other indications,
including a Phase 2 study in bladder cancer with Tecentriq(®) (atezolizumab)
which will be supplied by Roche. Additionally we expect for the NCI to begin
Phase 2 trials of MVA-BN Brachyury in the second half of the year.
* Our collaboration with Janssen on vaccines for infectious diseases continues
to evolve. Janssen completed a submission for Emergency Use Assessment and
Listing for the prime-boost Ebola vaccine to the World Health Organization,
and has also continued the late-stage development of the vaccine.
Furthermore, a clinical study of a multivalent prime-boost vaccine was
initiated, designed to protect not only against Ebola, but also Sudan and
Marburg viruses. In 2017, Janssen will initiate the first-in-human study of
the HPV vaccine they licensed in late 2015, and they retain the option to
license two additional disease targets.
Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: "2016
was an important year for Bavarian Nordic, both in the advancement and
diversification of our clinical pipeline, and from a financial perspective as
well. The year has seen the initiation of six clinical trials, positive data
from our first clinical study in RSV, and the expansion of our partnerships.
Financially we continue to see revenues from our core businesses, providing us
with yet another breakeven result, and additional capital inflows from both new
and existing investors which has allowed us to triple our cash preparedness over
the past three years. We are proud of these achievements and 2017 will be just
as significant as we prepare for pivotal events in our pipeline with data read
outs from our Phase 2 RSV and Phase 3 PROSTVAC studies."
Financial Performance
Bavarian Nordic's overall financial results for 2016 were in line with the
Company's latest guidance. While the revenue and earnings before interest and
taxes (EBIT) projections were maintained throughout the year, expectations to
the year-end cash preparedness were upgraded in April 2016 to DKK 1,900 million
after successfully raising DKK 665 million in a private placement, and again in
January 2017 to DKK 2,300 million, primarily as a result of payments for
IMVAMUNE deliveries, which were received earlier than expected.
Danish kroner (DKK) is the Company's functional currency. All USD figures
provided below are based upon an assumed exchange rate of DKK 7.05 per 1.00 USD,
which was the exchange rate as of December 31, 2016.
DKK million USD million
2016 guidance actual guidance actual
------------------------------------------------------------
Revenue 1,000 1,007 142 143
EBIT 0 33 0 5
Cash preparedness, year-end 2,300 2,292 326 325
------------------------------------------------------------
Revenue was comprised of DKK 758 million from sale of IMVAMUNE bulk drug
substance to the U.S. Government, DKK 74 million from the sale of IMVAMUNE final
drug product to other customers, DKK 94 million from ongoing development
contracts, and DKK 81 million from the remaining IMVAMUNE holdback in our
contract with the U.S. Government.
Outlook for 2017
2017E DKK million USD million
------------------------------------------------------
Revenue 1,300 184
EBIT 350 50
Cash preparedness, year-end * 2,400 340
------------------------------------------------------
* Cash preparedness includes cash, cash equivalents, investments in securities
and the aggregate amount of undrawn credit lines.
Bavarian Nordic expects revenue of DKK 399 million from recognition of the
upfront payment received from Bristol Myers Squibb (BMS) as part of the global
license option for PROSTVAC. This is based upon the assumption that we provide
BMS with top-line PROSPECT (Phase 3) data in the second half of 2017. Revenues
of approximately DKK 800 million are expected from the production of bulk
material of IMVAMUNE for the U.S. Government, as well as from delivery of doses
of IMVAMUNE to the Public Health Agency of Canada. Additional revenues of
approximately DKK 100 million are expected from ongoing research and development
contracts.
Research and development costs are expected to total approximately DKK 425
million.
Conference call and webcast
The management of Bavarian Nordic will host a conference call today at 2 pm CET
(9 am EDT) to present the annual 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 1911, USA: +1 646 254 3364. Participant code is 7659153. A live and
archived webcast of the call and relevant slides will be available at
http://www.bavarian-nordic.com/investor/events.aspx?event=5047.
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. 6 / 2017
2017-06-en:
http://hugin.info/100065/R/2087739/787965.pdf
Bavarian Nordic Annual Report 2016:
http://hugin.info/100065/R/2087739/788006.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq 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
Unternehmensinformation / Kurzprofil:
Datum: 15.03.2017 - 07:48 Uhr
Sprache: Deutsch
News-ID 530203
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contact information:
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