COPENHAGEN, Denmark, November 9, 2016 - Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) announced today its interim financial results for the first nine months of 2016. 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 .
Key highlights from the report
- In October, the first Phase 2 clinical trial of MVA-BN RSV was initiated. The study will help to identify the optimal dose and schedule for a subsequent Phase 2b field efficacy study planned for initiation in 2017
- In October, a Phase 2 trial investigating the combination of PROSTVAC and ipilimumab in patients with localized prostate cancer was initiated at the University of California, San Francisco
- In September, Phase 1 results for the MVA-BN RSV vaccine were presented at the 10th International Respiratory Syncytial Virus Symposium
- In September, Christopher Heery, M.D. was appointed Chief Medical Officer of Bavarian Nordic with immediate effect
- In September, Janssen completed a submission for Emergency Use Assessment and Listing for the Ad26.ZEBOV/MVA-BN Filo prime-boost Ebola vaccine regimen to the World Health Organization
- In August, Bavarian Nordic entered a drug supply agreement with Bristol-Myers Squibb, providing OPDIVO for the upcoming clinical trial of CV301 in NSCLC
- The second planned interim analysis of the Phase 3 study of PROSTVAC occurred in July, confirming that the study should continue without modification. Final study data are anticipated in 2017 with a third interim analysis occurring prior to that
"We are very excited by the progress in Bavarian Nordic in 2016 to date. We have recently seen the initiation of two clinical trials for both PROSTVAC and RSV, and are currently screening patients for our lung cancer study combining CV301 and nivolumab. This not only progresses our pipeline, but also differentiates our profile in immuno-oncology and infectious diseases. We also recently had the pleasure of welcoming Christopher Heery as our new CMO. He will help us to continue this trajectory and to identify new opportunities for the Company going forward," said Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic.
Financial performance Revenue for the nine month period ending September 30, 2016 was DKK 591 million, of which DKK 452 million was recognized in the third quarter. This is in line with the Company's expectations, as the majority of revenue relates to production of IMVAMUNE bulk drug substance produced for the U.S. Government, which primarily occurs in the second half of 2016. Thus approximately 40% of the year's revenue is expected to be recognized in the last quarter of 2016.
| DKK million | USD million | |||
| 9m 2016 | 9m 2015 | 9m 2016 | 9m 2015 | |
| Revenue | 591 | 703 | 88 | 105 |
| EBIT | (82) | 2 | (12) | 0 |
| Cash preparedness, period-end | 1,647 | 1,618 | 247 | 242 |
Outlook for 2016
The Company maintains its financial expectations for 2016. For detailed assumptions, refer to the 2015 Annual Report. The expectations to cash preparedness at year-end were previously upgraded from DKK 1,300 million to DKK 1,900 million as result of a capital increase in April 2016.
| 2016E | DKK million | USD million |
| Revenue | 1,000 | 150 |
| EBIT | 0 | 0 |
| Cash preparedness, year-end * | 1,900 | 284 |
* Cash preparedness includes cash, cash equivalents, investments in securities and the aggregate amount of undrawn credit lines.
Danish kroner (DKK) is the Company's functional currency. All USD figures provided above are based upon an assumed exchange rate of DKK 6.68 per 1.00 USD, which was the exchange rate as of September 30, 2016.
Conference call and webcast The management of Bavarian Nordic will host a conference call today at 2 pm CET (8 am ET) to present the interim 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 1919, USA: +1 646 254 3363. Participant code is 1909904. A live and archived webcast of the call and relevant slides will be available at http://www.bavarian-nordic.com/investor/event...event=4532 .
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 Ianvestor Relations (EU) Tel: +45 61 77 47 43
Seth Lewis Vice President Investor Relations (US) Tel: +1 978 341 5271
Company Announcement no. 28 / 2016
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