COPENHAGEN, Denmark, March 7, 2016 – Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) announced today its Annual Report for 2015. Below is a summary of business progress and financial performance for the year, and financial outlook for 2016 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 FROM THE REPORT
PROSTVAC
- Signed commercial agreement with Bristol-Myers Squibb
- Several new Phase 2 studies initiated; further studies planned
- First Phase 3 interim analysis has occurred and the study continues as planned
IMVAMUNE
- Completed deliveries to the U.S. Strategic National Stockpile
- New USD 133 million bulk vaccine order from U.S. Government
- Additional deliveries to Canada and new supply order
- Reported first Phase 3 study for liquid-frozen formulation
- Reported Phase 2 data for freeze-dried formulation to support requirements for U.S. stockpiling
Janssen Collaboration
- The AdVac/MVA-BN Filo Ebola prime-boost vaccine regimen was rapidly advanced from preclinical to Phase 3 clinical development in nine months
- 2 million doses of MVA-BN Filo produced and delivered
- Received additional funding of up to USD 33 million from U.S. Biomedical Advanced Research and Development Authority as subcontractor to Janssen
- Expanded collaboration through new therapeutic HPV vaccine agreement valued at up to USD 171 million
Other pipeline and business areas
- Initiated Phase 1 study of MVA-BN RSV
- Reported Phase 1 results for MVA-BN Brachyury
- Received additional USD 15 million funding for MVA-BN Filo under contract with the U.S. National Institutes of Allergy and Infectious Diseases
- Prospective registered public offering of ADSs in the United States
Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: “2015 was another great year for Bavarian Nordic, which is highlighted by the strong progress made in all our key business areas, but also by our ability to generate a significant revenue stream from both research and delivery contracts, which enable us to rapidly advance our commercial pipeline in pursuit of our growth strategy. We have prepared for multiple new clinical studies later this year in order to advance our own RSV program into Phase 2 as well as to broaden our immunotherapy portfolio with CV-301 in multiple cancers. In addition, our recent partnerships with Bristol-Myers Squibb and Janssen, with whom we have recently expanded our collaboration, will also continue to build scientific validation of our technology through ongoing and planned clinical trials.”
FINANCIAL PERFORMANCE & OUTLOOK
Bavarian Nordic’s overall financial results for 2015 were in line with the Company’s latest guidance. While the guided revenue and earnings before interest and taxes (EBIT) were maintained throughout the year, expectations to the year-end cash preparedness were upgraded in May 2015 after entering into a loan facility agreement of EUR 50 million with the European Investment Bank.
| DKK million | USD million | |||
| 2015 | guidance | actual | guidance | actual |
| Revenue | 1,000 | 1,021 | 146 | 149 |
| EBIT | – | 2 | – | – |
| Cash preparedness, year-end | 1,450 | 1,451 | 212 | 212 |
Revenue was composed of DKK 762 million from the sale of MVA BN Filo Bulk Drug Substance to Janssen, DKK 78 million from the sale of IMVAMUNE/IMVANEX and DKK 181 million primarily from ongoing development contracts with the U.S. Government.
Outlook for 2016
| 2016E | DKK million | USD million |
| Revenue | 1,000 | 146 |
| EBIT | – | – |
| Cash preparedness, year-end * | 1,300 | 190 |
* Cash preparedness includes cash, cash equivalents, investments in securities and the aggregate amount of undrawn credit lines.
Bavarian Nordic expects revenue in the level of DKK 750 million from production and supply of IMVAMUNE/IMVANEX smallpox vaccine, including production of bulk vaccine under the contract with the U.S. Government. Revenue in the level of DKK 250 million is expected from ongoing research and development contracts with the U.S. Government as well as part of the upfront payment on the HPV license agreement with Janssen. Manufacturing and release of commercial products will primarily occur later in 2016 and thus more than 90% of the year’s revenue is expected to be recognized in the second half of 2016.
Research and development costs are expected to total approximately DKK 580 million, of which DKK 475 million will be recognized in the P&L.
The Company continues to evaluate financing options based on market conditions, including, as previously announced, a prospective registered public offering in the United States of our American Depositary Shares, the timing and terms of which have not yet been determined. The expected year-end cash preparedness does not include proceeds from any prospective issuance of shares.
Danish kroner (DKK) is the Company’s functional currency. All USD figures provided above are based upon an assumed exchange rate of DKK 6.83 per 1.00 USD, which was the exchange rate as of December 31, 2015.
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 annual results followed by a Q&A session. Dial-in numbers for the conference call are: Denmark: +45 32 71 16 58, UK: +44 (0) 20 3427 1912, USA: +1 212 444 0895. Participant code is 5267141. A live and archived webcast of the call and relevant slides will be available at http://www.bavarian-nordic.com/investor/events.aspx?event=4529.
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 @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. 4 / 2016
HUG#1992222
