Valneva Reports a Strong Quarter Marked by Key Successes in its Strategic Execution and a Solid Financial Performance

Major progress in further building Valneva as a fully integrated company

  • New sales & marketing infrastructures for IXIARO® and DUKORAL® being established for key countries. Transfer of commercial activities for IXIARO® to Valneva´s own teams or new country partners to take place early next year
  • On track to deliver substantial IXIARO® product sales growth to approximately EUR 50m with a gross margin above 50% in 2016

Solid financial performance

  • Revenues and grants in the first 9 months of 2015 more than doubled to EUR 60.7m (vs 9-month revenues of EUR 29.3m in 2014). Revenues and grants increased to EUR 21.5m in Q3 2015 (vs EUR 12.8m in Q3 2014)
  • Revenue growth mainly driven by the inclusion of newly acquired activities in Sweden (EUR 24.2m in the first 9 months, EUR 8.8m in Q3) and continued strong sales revenues of IXIARO/JESPECT®
  • The Company delivered an EBITDA1 positive quarter (+ EUR 0.5m in Q3 2015) but expects negative EBITDA and increased net loss for the full year due to IXIARO® transition impacts and negative acquisition accounting effects linked to the DUKORAL® acquisition
  • Cash position of EUR 37.3m at quarter-end, slightly above cash position at end of previous quarter

1 Calculated by adding Q3 2015 amortization, depreciation and impairment of EUR 3.2m to Q3 2015 operating loss of EUR -2.7m

Signing of new agreements

  • Valneva announces the signing of two new agreements on its EB66® vaccine production platform

Significant near term clinical data points on the two most advanced R&D programs

  • Enrolment for Phase II study of C. difficile vaccine candidate completed and data analysis ongoing – First results to be announced in Q4 2015
  • Enrolment for Phase II/III study of Pseudomonas aeruginosa vaccine candidate completed and data analysis ongoing – Results to be announced in Q2 2016


  • Valneva expects 2015 overall IFRS revenues and grants to be above EUR 75 million, including product sales of approximately EUR 50 million. The Company anticipates a significant growth in product sales in 2016 mainly driven by increased IXIARO® uptake in the market and the positive effects on revenue recognition and profitability resulting from the new commercial organization in 2016
  • Valneva will continue to report a loss in 2015 due to its significant R&D investments supporting its strategy to create shareholder value through focused R&D investments in promising product candidates and growing financial contributions from commercial products. This growth strategy will set the base for moving towards break-even following the transition period in 2015

Thomas Lingelbach, President and CEO and Franck Grimaud, Deputy CEO of Valneva, commented, “We are progressing confidently in setting up our own marketing and distribution network which will allow us to further strengthen our position as a leading, fully integrated revenue stage vaccine company. We are looking forward to continuing building long-term value through our investments in innovative R&D programs with significant potential value inflection points including the results of the phase II study of our Clostridium difficile vaccine candidate at the end of 2015 and the phase II/III results of our Pseudomonas aeruginosa vaccine candidate in the second quarter of 2016.”

Valneva SE (“Valneva” or “the Company”), a leading pure play vaccine company, reported today its consolidated financial results for the third quarter ended September 30, 2015. The condensed consolidated interim financial report is available on the Company’s website

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