Bavarian Nordic Announces First Half 2017 Results
(Thomson Reuters ONE) -
COPENHAGEN, Denmark, August 25, 2017 - Bavarian Nordic A/S (OMX: BAVA, OTC:
BVNRY) announced today its interim financial results for the first half of 2017
and releases its financial calendar for 2018. Below is a summary of the
financial performance for the period and business progress for the last quarter.
The full interim report is attached as a PDF file and can be found on the
company's website, www.bavarian-nordic.com.
Recent highlights
* In July, Bavarian Nordic and Janssen expanded their partnership with an
additional worldwide license and collaboration agreement valued up to USD
879 million, granting Janssen the exclusive rights to Bavarian Nordic's MVA-
BN® technology for two additional programs, targeting vaccines against
hepatitis B virus (HBV) and the human immunodeficiency virus (HIV-1). The
companies are now collaborating on four product development programs
combining Bavarian Nordic's MVA-BN technology with Janssen's AdVac®
technology platform.
* As part of the license agreement, Johnson & Johnson Innovation - JJDC, Inc.
(JJDC) subscribed for 512,102 new shares in Bavarian Nordic in a private
placement, raising gross proceeds of DKK 207.5 million. Subsequently,
Bavarian Nordic received a major shareholder notification from JJDC, now
holding 5.77 % of the share capital and voting rights in Bavarian Nordic.
* In June, positive top-line results from a Phase 2 dose-ranging study of the
Company's universal RSV vaccine in 421 subjects were announced showing that
the vaccine was well tolerated and immunogenic at both dose levels
investigated, and confirmed the hypothesis that MVA-BN RSV is the first
vaccine candidate designed to induce a broad and robust immune response
against five distinct RSV proteins following a single vaccination. Subjects
that received a single vaccination will be given a booster vaccination later
this year and followed for another RSV season, to help establish the immune
responses 12 months post vaccination and the effect of a booster
vaccination.
* In June, the U.S. Department of Health and Human Services issued a notice of
intent to use other than full and open competition to award a sole source
contract to Bavarian Nordic for procurement of freeze-dried IMVAMUNE®
smallpox vaccine, and subsequently, a request for proposal was issued to
Bavarian Nordic. Pending final negotiations, a contract is anticipated
before year-end.
* In June the Public Health Agency of Sweden entered into an agreement with
Bavarian Nordic for the procurement of 35.000 doses of IMVANEX®. The
agreement includes an option to procure additional 100,000 doses.
* In June, the Company announced updated timing of the PROSPECT Phase 3 study
of PROSTVAC with the third interim analysis expected to occur in September
2017 and final results expected in the fourth quarter of 2017.
* Based upon current regulatory approvals and emerging standards of care, the
Company has decided to transition the ongoing CV301 trial in non-small cell
lung cancer into the first line maintenance setting, where checkpoint
inhibitors are now approved and broadly available. After discussions with
regulators, a randomized Phase 2 study will enroll 176 patients who will
receive either KEYTRUDA® (pembrolizumab) monotherapy, as standard of care,
or a combination of CV301 and standard of care.
* In May, the Company announced the appointment of Tommi Kainu, MD, PhD as
Executive Vice President and Chief Business Officer effective as of July
1, 2017.
"We are very proud of our recent accomplishments, and the progress seen in both
our internal pipeline as well as with our partners. With the recent positive
data in RSV, additional clarity on future IMVAMUNE orders, and expansions of our
partnerships, it is clear that the true potential our platform is only starting
to be realized. As we await final data for PROSTVAC later this year, we have
all the pieces in place to ensure the future success of this company, regardless
of any one single asset. The unique profile of our company, and our platform,
will allow us to benefit patients in numerous disease settings well into the
future." said Paul Chaplin, President & Chief Executive Officer of Bavarian
Nordic.
Financial performance
Revenues in the first half of 2017 were largely derived from the sale of
IMVAMUNE bulk drug substance to U.S. Government and were in line with the
Company's expectations. There were no revenues from sale of IMVAMUNE bulk drug
substance during the same period in 2016.
DKK million USD million
6m 2017 6m 2016 6m 2017 6m 2016
--------------------------------------------------------------
Revenue 595 139 91 21
EBIT 99 (207) 15 (32)
Cash preparedness, period-end 2,704 1,894 415 290
--------------------------------------------------------------
Outlook for 2017
The Company maintains its financial expectations for 2017 as announced July
27, 2017, where the expected cash preparedness at year-end was raised from
approximately DKK 2,400 million to approximately DKK 2,600 million after
entering the new license and collaboration agreement with Janssen. While the
majority of revenues will be derived from the sale of IMVAMUNE bulk drug
substance to U.S. Government, part of the revenues is composed by recognition of
the PROSTVAC upfront payment as revenue which is based upon the assumption that
top-line PROSPECT (Phase 3) data are reported in the second half of 2017. For
detailed assumptions, refer to the 2016 Annual Report.
2017E DKK million USD million
------------------------------------------------------
Revenue 1,300 199
EBIT 350 54
Cash preparedness, year-end * 2,600 399
------------------------------------------------------
* Cash preparedness includes cash, cash equivalents, investments in securities
and the aggregate amount of undrawn credit lines. This includes a EUR 50 million
unsecured loan from the European Investment Bank, which the Company anticipates
drawing on in second half of 2017.
Danish kroner (DKK) is the Company's functional currency. All USD figures
provided above are based upon an assumed exchange rate of DKK 6.52 per 1.00 USD,
which was the exchange rate as of June 30, 2017.
Conference call and webcast
The management of Bavarian Nordic will host a conference call today at 2 pm CEST
(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 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=5050.
Capital Markets Day
Bavarian Nordic will host a capital markets day for investors and analysts on
Thursday, September 21, 2017 in New York City, where the management of Bavarian
Nordic, collaborators from the National Cancer Institute and key opinion leaders
within the field of oncology and infectious diseases will give presentations on
the Company's business and future plans and opportunities.
For registration and more information, see www.bavarian-nordic.com/cmd.
Financial calendar 2018
The 2018 dates for announcement of the Company's financial reports and the
annual general meeting have been determined as follows:
March 12, 2018 2017 Annual Report
April 17, 2018 Annual General Meeting
May 24, 2018 First quarterly report (Q1) for the three-month period ended
31 March 2018
August 16, 2018 Half-year report (Q2) for the six-month period ended 30 June
2018
November 9, 2018 Third quarterly report (Q3) for the nine-month period ended 30
September 2018
Pursuant to Article 12 of the Articles of Association, shareholders who wish to
submit a request for proposals for consideration at the annual general meeting
must lodge this with the Company no later than Wednesday, March 7, 2018.
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 strategic partner
Janssen are developing an Ebola vaccine regimen, and therapeutic vaccines for
HPV, HBV and HIV. 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. 25 / 2017
2017-25-en:
http://hugin.info/100065/R/2129000/813272.pdf
Interim Report H1 2017:
http://hugin.info/100065/R/2129000/813273.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: 25.08.2017 - 07:54 Uhr
Sprache: Deutsch
News-ID 557812
Anzahl Zeichen: 12364
contact information:
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Kategorie:
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