COPENHAGEN, Denmark, August 15, 2019 – Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) announced today its interim financial results and business progress for the first half of 2019 and releases its financial calendar for 2020.
Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: “We have made important progress in our strategic objectives during the first half of this year with the initiation of a Phase 3 study for the freeze-dried formulation of MVA-BN and the expansion of our proof of concept Phase 2 study for BN-Brachyury. Our financial results are fully in line with our guidance and expectations and we are looking forward to the rest of the year with a rich news flow ahead of us. We expect to report additional clinical oncology data for CV301; finalize our registration plans for RSV; obtain our first ever US approval together with a priority review voucher for MVA-BN and lastly complete the construction of our fill and finish plant that will unlock higher future revenues and return the company to profitability. It is a very exciting time to be at Bavarian Nordic”.
OPERATIONAL HIGHLIGHTS
Delivering our strategy
Our strategy is four-fold, and aims to secure and reinforce a sustainable foundation, while also expanding the commercial opportunities:
Smallpox
Infectious diseases
Cancer immunotherapy
Commercial
OTHER DEVELOPMENTS
FINANCIALS AND OUTLOOK
Financial results for the first half in line with expectations
Danish kroner (DKK) is the Company’s reporting currency. The USD figures provided above are based upon an assumed exchange rate of DKK 6.56 per 1.00 USD, which was the exchange rate as of June 30, 2019.
Outlook for 2019 maintained
The majority of our 2019 revenues are related to the production and release of bulk smallpox vaccine for the U.S. Government, which will occur in the second half of 2019. Hence, we maintain our financial expectations for 2019 as announced on March 21, 2019 with revenues of approximately DKK 600 million/USD 92 million for the full year, a loss before interest and tax (EBIT) of approximately DKK 360 million/USD 55 million and a cash preparedness at year-end of approximately DKK 1,600 million/USD 246 million.
While the Company anticipates the award of a Priority Review Voucher upon the expected approval of MVA-BN smallpox vaccine by the FDA in 2019, income from the sale of this voucher has not been included in the guidance.
The financial expectations are based on an exchange rate of DKK 6.50 per 1.00 USD. For further details regarding assumptions behind the guidance see the Annual Report 2018.
Financial calendar 2019 and 2020
The 2020 dates for announcement of the Company’s financial reports and the annual general meeting have now been determined, and planned future reporting dates are as follows:
November 7, 2019 | Third quarterly report (Q3) for the nine-month period ended September 30, 2019 |
March 13, 2020 | 2019 Annual Report |
April 21, 2020 | Annual General Meeting * |
May 14, 2020 | First quarterly report (Q1) for the three-month period ended March 31, 2020 |
August 26, 2020 | Half-year report (Q2) for the six-month period ended 30 June 2020 |
November 11, 2020 | Third quarterly report (Q3) for the nine-month period ended 30 September 2020 |
* 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 11, 2020.
Conference call and webcast
The management of Bavarian Nordic will host a conference call today at 2 pm CEST (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 http://www.bavarian-nordic.com/investor/events.aspx?event=5504. To join the Q&A session, use one of the following dial-in numbers: Denmark: +45 32 72 80 42, UK: +44 (0) 844 571 8892, USA: +1 631-510-7495. Participant code is 5278296.
Contacts
Rolf Sass Sørensen
Vice President Investor Relations (EU)
Tel: +45 61 77 47 43
Graham Morrell
Paddock Circle Advisors (US)
graham@paddockcircle.com
Tel: +1 781 686 9600
Company Announcement no. 14 / 2019
About Bavarian Nordic
Bavarian Nordic is a fully integrated biotechnology company focused on the development of innovative 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.
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