COPENHAGEN, Denmark, March 15, 2017 - Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) announced today its Annual Report for 2016. Below is a summary of business progress and financial performance for the year, and financial outlook for 2017 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
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Consistent with previous years we have generated revenues above DKK 1 billion and recorded a break-even result. Cash preparedness was significantly strengthened and has more than tripled over the last three years.
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We received a new USD 100 million bulk vaccine order from the U.S. Government for IMVAMUNE smallpox vaccine, which remains our base revenue driver. A tender process is expected to be initiated during 2017 potentially allowing us to continue deliveries of IMVAMUNE in a freeze-dried formulation. We also completed enrollment of the final Phase 3 study of the liquid-frozen formulation required prior to submission for U.S. approval.
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The first and second interim analyses of the Phase 3 study of PROSTVAC have been completed and the study continues as planned. We expect the third analysis around mid-2017 and final data before year-end. Three new Phase 2 clinical studies of PROSTVAC were initiated during the year, notably a combination study of PROSTVAC and YERVOY®, a checkpoint inhibitor from Bristol-Myers Squibb. A study combining PROSTVAC with YERVOY and OPDIVO® (also from Bristol-Myers Squibb) will begin soon.
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We reported promising Phase 1 data for MVA-BN RSV, our vaccine candidate against respiratory syncytial virus, which is designed to induce a broad immune response through inclusion of five RSV-associated antigens - a highly differentiated approach. We also completed enrollment of a Phase 2 study of the vaccine in 400 subjects. Results from this study are expected in mid-2017 and will provide important information for larger efficacy studies.
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In line with our strategy to expand our cancer immunotherapy pipeline, we initiated the first clinical study of CV301 as combination therapy. The study will serve as a proof-of-concept in patients with non-small cell lung cancer in combination with OPDIVO, which was provided through a drug supply agreement with Bristol-Myers Squibb. In 2017 and beyond, we expect the initiation of additional combination trials of CV301 in other indications, including a Phase 2 study in bladder cancer with Tecentriq® (atezolizumab) which will be supplied by Roche. Additionally we expect for the NCI to begin Phase 2 trials of MVA-BN Brachyury in the second half of the year.
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Our collaboration with Janssen on vaccines for infectious diseases continues to evolve. Janssen completed a submission for Emergency Use Assessment and Listing for the prime-boost Ebola vaccine to the World Health Organization, and has also continued the late-stage development of the vaccine. Furthermore, a clinical study of a multivalent prime-boost vaccine was initiated, designed to protect not only against Ebola, but also Sudan and Marburg viruses. In 2017, Janssen will initiate the first-in-human study of the HPV vaccine they licensed in late 2015, and they retain the option to license two additional disease targets.