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Press Release

Bavarian Nordic Announces First Half 2017 Results


Posted on: 25 Aug 17

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 @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

Attachments:

http://www.globenewswire.com/NewsRoom/AttachmentNg/1b6eb20b-737a-4f98-b310-b02e1081d83f

Attachments:

http://www.globenewswire.com/NewsRoom/AttachmentNg/f0d0c418-c90f-4a9b-89a4-a35100b958eb

GlobeNewswire
globenewswire.com

Last updated on: 28/08/2017

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