Valneva Reports Strong Q1 Revenue Growth and Positive EBITDA; Reaffirms Financial Guidance and Pipeline Outlook for 2016

Solid Q1 financial performance – EBITDA turns positive, confirming trend towards operational break-even

  • Total revenues and grants were €24.7 million in Q1 2016 (vs. €19.5 million in Q1 2015) benefitting from strong IXIARO®/JESPECT® growth and full inclusion of acquired DUKORAL® sales;
  • Q1 2016 sales performance driven by IXIARO® sales to the US military; travel market sales still negatively affected by transition towards new sales & marketing structure which has now been successfully completed;
  • DUKORAL® Q1 2016 sales down on a pro-forma basis as a result of the narrower updated product indication in Canada but in-line to meet full year Company expectations with good potential for further growth;
  • Q1 2016 EBITDA slightly above break-even at €0.0 million (vs. minus €1.0 million in Q1 2015);
  • Operating loss improved to €2.7 million (vs. €3.7 million in Q1 2015), net loss was €5.0 million (compared to adjusted net profit of €9.8 million in Q1 2015 which included a positive €13.2 million one-time acquisition effect);
  • Cash position at €33.4 million at end of March 2016.

Important R&D news-flow ahead

  • Valneva expects to release Phase II/III results for its Pseudomonas aeruginosa vaccine candidate in the second quarter of 2016;
  • The close-out of Valneva´s Phase II study for the Clostridium difficile vaccine candidate, for which successful Phase II topline data were reported at the end of 2015, is anticipated around mid-year 2016. GlaxoSmithKline (GSK) has informed Valneva that, for strategic reasons, it has waived its option rights ahead of the final data analysis and the start of the option exercise period. The company reaffirms its expectation to enter into a partnering agreement for this program by the end of this year;
  • Outcome of the proof of concept for the development of a Zika vaccine using the IXIARO® platform is expected within the coming months.

2016 Outlook
Valneva confirms its FY 2016 financial outlook:

  • 2016 IFRS revenues expected to reach €90 to €100 million, with product sales between €70 and €80 million - reflecting up to 30% growth over 2015 product sales;
  • Improved revenues due to Valneva´s new global marketing & distribution network are expected to lead to a gross margin on product sales of approximately 50% in 2016.
  • Valneva will continue to strive towards financial self-sustainability and expects to reduce its EBITDA loss to less than €5 million in 2016 while continuing to invest around €25 million in R&D.

Thomas Lingelbach, President and CEO and Franck Grimaud, Deputy CEO of Valneva, commented, “Our strong first quarter financial performance is consistent with our goal to establish Valneva as a fully integrated company that specializes in vaccines from discovery to commercialization in segments where innovative vaccines are needed. Importantly, our new global marketing & distribution network is now fully operational, allowing us to maximize the value of our own commercial products and potential customer products. We are looking forward to the important R&D news-flow ahead which has the potential to transform the Company.”

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