- Initial base award secures additional IMVAMUNE bulk contract of USD 100 million
- Contract includes initial options valued at USD 439 million
- Potential for contract value to increase if options to purchase additional IMVAMUNE bulk or freeze dried doses are exercised.
- Company to host conference call tomorrow at 3:00 pm CEST (09:00 am EDT)
COPENHAGEN, Denmark, September 27, 2017 - Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) today announced the award of a sole source contract from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), for the procurement of freeze-dried IMVAMUNE ® smallpox vaccine. The potential value of the initial base and optional awards is in excess of USD 539 million.
The initial award in the contract calls for the manufacturing and storage of USD 100 million of IMVAMUNE bulk. This is the third such award to manufacture vaccine bulk; with the two prior orders totaling USD 233 million. The initial options in the contract are divided between two distinct areas, the first of which is the filling and freeze-drying of IMVAMUNE from the three bulk awards, with total potential value of USD 299 million. The second part of the contract contains provisions for clinical development, regulatory commitments, and parts of the establishment and validation of fill/finish activities, with potential value of up to USD 140 million. The award also contains options to acquire additional vaccine bulk and/or freeze-dried doses of IMVAMUNE in the future.
To ensure the production capacity to secure the future IMVAMUNE stockpile at the U.S. Strategic National Stockpile, Bavarian Nordic will invest approximately USD 75 million over the coming years in the construction of a fill/finish manufacturing line at its facility in Denmark. As part of Bavarian Nordic's long-standing partnership with BARDA, a potential optional award of up to USD 33 million (part of the USD 140 million mentioned above) is dedicated to process transfer, and validation of the new manufacturing line. This strategic investment will allow Bavarian Nordic to recognize the full value chain of the manufacturing process, to maintain control of the product cycle throughout, and the potential to provide these services to third parties in the future.
"We are proud to be part of a long-standing and successful partnership with BARDA and this latest contract starts a new chapter, as we supply an improved formulation of our vaccine as part of the U.S. government commitment to protect the nation from a smallpox outbreak " said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic. "Our latest strategic investment that will expand our manufacturing capacities will add value, not only to our partnerships, but also to our proprietary pipeline."
The contents of this announcement do not affect the Company's expectations for the financial results for 2017.
Conference call and webcast The management of Bavarian Nordic will host a conference call tomorrow, Thursday, September 28, 2017 at 3:00 PM CEST (9:00 AM EDT) to discuss the award of this contract. Dial-in numbers for the conference call are: Denmark: +45 32 71 16 58, UK: +44 (0) 20 3427 1910, USA: +1 212 444 0896. Participant code is 8258368. A live and archived webcast of the call and relevant slides will be available at http://www.bavarian-nordic.com/investor/event...event=5321 .
Federal funding acknowledgements This project has been funded in whole or in part with federal funds from the HHS Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201700019C.
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. 28 / 2017
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