Bavarian Nordic Announces Annual Report 2018

COPENHAGEN, Denmark, March 21, 2019 - Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) announced today its Annual Report for 2018. Below is a summary of business progress, financial performance for the year and financial outlook for 2019 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. 

Delivering on our strategy
Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: "We made excellent progress on our pipeline assets and delivered on all our plans in 2018. The Company initiated a number of new studies and reported important clinical data that confirmed Bavarian Nordic as the global leader in smallpox and in RSV vaccine development. This year will be another exciting year, as we continue to invest in our future with the initiation of new clinical studies evaluating new treatment options for cancer patients and the completion of our filling line investment that will secure improved revenues in the years ahead. We look forward to our first vaccine approval in the U.S. that will create new options beyond stockpiling to help the U.S. Government in their preparedness plans for smallpox and also have the real possibility to significantly improve our 2019 guidance if we sell the associated priority review voucher. Everyone in the company is excited about the opportunities ahead, as we continue to develop innovative products to improve public health and return to profitability within the coming years."

Key highlights

• Positive results from a Phase 3 study of MVA-BN smallpox vaccine were reported, demonstrating the same efficacy as the current FDA approved replicating smallpox vaccine. We filed a BLA for the vaccine, which was accepted with priority review by the FDA in December, with an anticipated approval in September 2019. 
• We initiated the construction of a new fill and finish facility to expand our manufacturing capabilities. To support this investment, the U.S. Government awarded USD 44 million for qualification of the facility, as well as transfer and validation of the freeze-drying production.
• Additional positive data for our RSV vaccine were reported and confirmed the durability of broad vaccine responses after 1 year that could be rapidly increased following an annual booster vaccination. As Phase 2 clinical development has been completed, discussions with the FDA are ongoing regarding the design of the Phase 3 study to support licensure of the vaccine.
• Significant progress was made with our immunotherapy assets with the initiation of 4 Phase 2 studies, with the first data already expected later this year.
  • Three Phase 2 clinical studies were initiated, evaluating our CV301 immunotherapy candidate in combination treatment with immune checkpoint inhibitors in three different indications (bladder, colorectal and pancreatic cancer) as part of a broad collaboration with industry and academic partners.
  • Our novel cancer immunotherapy candidate, BN-Brachyury, was granted orphan drug designation for the treatment of chordoma cancer by the FDA and we initiated a Phase 2 study in this indication, completing enrolment in the first stage ahead of schedule earlier this year.
• To ensure we continue to bring new innovative ideas to expand the pipeline we also announced new immunotherapy strategies to treat cancer patients with the first clinical trials expected in 2019.
• We continued to expand our partnership with the U.S. Government who once again recognized the value of our vaccine platform with the award of a contract from the U.S. Department of Defense to develop a vaccine against equine encephalitis virus, which is considered a potential biological threat. The contract has a potential value of USD 36 million and is in addition to the USD 1.8 billion that has already been awarded for MVA-BN as a smallpox vaccine.
• We made significant progress in our collaboration with Janssen with the initiation of a Phase 1/2a clinical trial of the therapeutic HPV vaccine regimen, which is expected to trigger a clinical milestone payment of USD 12.5 million later this year.
• Our executive management was strengthened with the appointment of Henrik Juuel as Chief Financial Officer.

Financial performance