Valneva Presents its H1 2015 Results and Provides Business Update

The Company reports strong H1 revenues, expects significant improvement in revenues and profitability of its JE vaccine in 2016

  • Revenues and Grants increased to EUR 39.2m in H1 2015 (vs EUR 16.5m in H1 2014)

  • Revenue growth mainly driven by the inclusion of newly acquired activities in Sweden (EUR 14.9m) and strong in-market sales of IXIARO®/JESPECT® (+54% to EUR 15.1m)
  • Cash position of EUR 43.7m at June 30, 2015, strengthened by the successful completion of a EUR 45m capital increase at the beginning of the first half
  • Strong news flow announced in H1:
  • Acquisition of the DUKORAL® franchise and the Nordics trade business Decision to take direct control over marketing and distribution of IXIARO® to increase margin and profitability
  • Marketing & distribution agreement for DUKORAL® and Vivotif® with US firm PaxVax
  • Signing of seven new EB66® deals, including an exclusive license agreement with Jianshun Biosciences to commercialize the cell-line in China
  • Second approval in Japan for a human flu vaccine produced in EB66® cells
  • Signing of an exclusive worldwide IC31® license with ITS (now Vaxin)
  • Enrollment for phase II/III of Pseudomonas vaccine candidate now completed. Valneva and development partner GSK amend current study protocol for additional clinical endpoints - data expected in Q2 2016.
  • Enrollment for phase II study of C. Difficile vaccine candidate now completed - results expected at the end of 2015.

Outlook:

  • Following the Company’s decision to take direct control of IXIARO®’s marketing and distribution, Valneva expects 2015 overall IFRS revenues and grants to reach the lower end of its previous guidance range of EUR 75 to 85 million due to the short-term transition impact. The Company expects to fully make up for this short-term adverse financial impact already in 2016 with a significant improvement in the revenues and profitability of its Japanese encephalitis vaccine.
  • Valneva will continue to report a loss in 2015 in order to support its strategy of focused spending in research and development and to create long-term value through innovation. Financial results in the 2015 second half will be marked by the integration of the recently acquired DUKORAL® and Nordics trade business and the transition of the marketing and distribution of the Company’s key value generator IXIARO®, setting the base for moving towards break-even following the transitional period in 2015.

Thomas Lingelbach, President and Chief Executive Officer and Franck Grimaud, Deputy CEO of Valneva, commented, “In the first half, Valneva has delivered on its strategy to become a fully integrated vaccine biotech company by acquiring a second commercial vaccine and taking direct control of the marketing and distribution of its products. Following a transitional period in the second half of 2015, we foresee a significant increase in the revenues and profitability of our Japanese encephalitis vaccine and expect our DUKORAL® vaccine to become profitable. We also look forward to the phase II results of our Clostridium difficile vaccine candidate at the end of 2015, the phase II/III results of our Pseudomonas aeruginosa vaccine candidate in 2016 and the launch of the phase I clinical trial for our Lyme Borreliosis vaccine candidate next year.”

European biotechnology company Valneva SE (“Valneva” or “the Company”) reports today its consolidated financial results for the first half year ended June 30, 2015. The Half Year Financial Report including the condensed consolidated interim financial report and the half year management report is available on the Company’s website www.valneva.com

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