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08-11-2017 07:51:52

Bavarian Nordic Announces Interim Results for the First Nine Months of 2017

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COPENHAGEN, Denmark, November 8, 2017 - Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) announced today its interim financial results in line with guidance for the first nine months of 2017 and business progress for the third quarter of 2017.

Third quarter highlights and subsequent events

  • In October, the Canadian Department of National Defence exercised another option for the procurement of 20,000 doses of IMVAMUNE® smallpox vaccine, and has thereby exercised 80,000 doses to-date of the 180,000 doses in the on-going smallpox vaccine framework agreement.

  • In September, Bavarian Nordic was awarded a contract valued at up to USD 539 million for supply of freeze-dried IMVAMUNE to the U.S. Government

  • In September, preliminary follow up results from the Phase 2 study of MVA-BN® RSV were reported, showing that after six months, a persistent antibody response against RSV could still be observed. Concurrently, the Company announced its plans for initiating a human challenge trial in 2018

  • In September, the PROSPECT Phase 3 study of PROSTVAC® as a monotherapy in metastatic prostate cancer was discontinued after recommendation from the independent Data Monitoring Committee that the study was unlikely to reach its primary endpoint of overall survival.

  • 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 vaccines against hepatitis B virus (HBV) and the human immunodeficiency virus (HIV-1). As part of the license agreement, Johnson & Johnson Innovation - JJDC, Inc. subscribed for 512,102 new shares in Bavarian Nordic in a private placement, raising gross proceeds of DKK 207.5 million.

Financial results

  • Revenue generated for the nine months ending September 30, 2017 was DKK 1,329 million/USD 211 million (DKK 591 million/USD 94 million in the first nine months of 2016).

  • The income before interest and tax (EBIT) was a gain of DKK 531 million/USD 84 million (loss of DKK 82 million/USD 13 million in the first nine months of 2016).

  • As of September 30, 2017 the Group's cash preparedness was DKK 2,808 million/USD 445 million (DKK 1,647 million/USD 261 million as of September 30, 2016), including unutilized credit lines.

 "While the stoppage of the PROSPECT study was a setback in our ambition to develop improved treatment options for patients, our belief in our platform and its capabilities remains as strong as ever. Our company continues to execute on our growth strategy and we continue to see the fruits of our labour, not only with the clinical advancements in RSV and with CV301, but also with the expansion of our partnerships with Janssen and the US Government, ensuring the future growth of the company." said Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic.

Outlook for 2017 maintained

Bavarian Nordic maintains its financial expectations for 2017 as announced July 27, 2017. As only limited revenues are expected in the fourth quarter, the Company still expects revenues of approximately DKK 1,300 million/USD 206 million for the full year, earnings before interest and tax (EBIT) of approximately DKK 350 million/USD 56 million and a cash preparedness at year-end of approximately DKK 2,600 million/USD 412 million.

Danish kroner (DKK) is the Company's functional currency. All USD figures provided above are based upon an assumed exchange rate of DKK 6.30 per 1.00 USD, which was the exchange rate as of September 30, 2017.

Anticipated selected pipeline developments

H2 2017

  • Initiate Phase 2 booster-study of MVA-BN RSV in subjects previously vaccinated in the earlier Phase 2 study last year

  • Initiate Phase 2 of the combination of CV301 and KEYTRUDA in first line NSCLC

  • Initiate Phase 1 fowlpox booster study of BN-Brachyury

H1 2018

  • Report top-line results from Phase 3 non-inferiority study of IMVAMUNE

  • Report results from MVA-BN RSV booster-study

  • Initiate human challenge study of MVA-BN RSV

  • Report Phase 1 results of combination of CV301 and OPDIVO

  • Initiate Phase 2 study of the combination of CV301 and TECENTRIQ in bladder cancer

  • Emerging results from investigator-sponsored Phase 2 combination trials of PROSTVAC

  • Report results from Phase 1 booster study of BN-Brachyury

  • H2 2018

    • End of Phase 2 meeting with FDA to determine registration pathway for MVA-BN RSV in elderly

    • Report Phase 2 results (ORR) from combination of CV301 and KEYTRUDA in NSCLC

    • Initiate Phase 2 study of BN-Brachyury in Chordoma

    • Initiate Phase 2 study of BN-Brachyury in second indication

    Conference call and webcast

    The management of Bavarian Nordic will host a conference call today at 2 pm CET (8 am EST) to present the interim results followed by a Q&A session. A listen-only version of the call can be accessed via https://www.bavarian-nordic.com/investor/events.aspx?event=5051. To join the Q&A session, use one of the following dial-in numbers: Denmark: +45 32 71 16 60, UK: +44 (0) 20 3427 1911, USA: +1 646 254 3364. Participant code is 7659153.

    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. 29 / 2017

    About Bavarian Nordic

    Bavarian Nordic is a fully integrated biotechnology company focused on the development of innovative and safe therapies against cancer and infectious diseases. Using our live virus vaccine platform technology, MVA-BN®, we have created a diverse portfolio of proprietary and partnered product candidates intended to improve the health and quality of life for children and adults. We supply our IMVAMUNE® non-replicating smallpox vaccine to the U.S. Strategic National Stockpile and other government stockpiles. The vaccine is approved in the European Union (under the trade name IMVANEX®) and in Canada. Registration studies are currently underway in the U.S. In addition to our long-standing collaboration with the U.S. government on the development of IMVAMUNE® and other medical countermeasures, our infectious disease pipeline comprises a proprietary RSV program as well as vaccine candidates for Ebola, HPV, HBV and HIV, which are developed through a strategic partnership with Janssen. Additionally, in collaboration with the National Cancer Institute, we have developed a portfolio of active cancer immunotherapies, designed to alter the disease course by eliciting a robust and broad anti-cancer immune response while maintaining a favorable risk-benefit profile. Through multiple industry collaborations, we seek to explore the potential synergies of combining our immunotherapies with other immune-modulating agents, e.g. checkpoint inhibitors. 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.

    Interim Report Q3 2017


    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

    Vedhæftet fil: 823913.pdf

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