VALNEVA Reports Strong Business Performance In First Nine Months. Company Raises Financial Guidance For FY 2016

Lyon, France, Nov. 09, 2016 (GLOBE NEWSWIRE) -- Valneva Reports Strong Business Performance in First Nine Months

Company Increases Financial Guidance for Full Year 2016

Nine Months financial performance ahead of initial expectations:
  • Total revenues and grants grew to €70.7 million in the first nine months of 2016 (vs. €60.7 million in the same period of 2015) benefiting from a more than 60% increase of IXIARO ®/JESPECT ® revenues to €40.1 million.
  • Valneva reported a positive EBITDA of €3.5 million in the first nine months of 2016 (vs. an EBITDA loss of €4.3 million in the same period of 2015) despite a slightly negative EBITDA of minus €1.2 million in the third quarter of 2016 (vs. €1.0 million positive EBITDA in the same period of 2015).
  • Nine months 2016 net loss was impacted by a non-cash impairment charge on acquired intangible assets following the discontinuation of the Pseudomonas program in Q2.
  • Positive operating cash flow of €8.0 million in the first nine months of 2016 brought cash position to €40.3 million as of September 30, 2016 (vs. €37.3 million as of September 30, 2015).
  • Strong nine months performance was driven by revenue and EBITDA growth in the first two quarters of 2016, while third quarter 2016 revenues and grants slightly decreased to €19.4 million (vs. €21.5 million in the third quarter of 2015) due to usual quarterly fluctuations.

2016 Outlook

Based on the Company's strong year to date financial performance, Valneva raises its FY 2016 operating guidance:
  • The Company now expects EBITDA profit of €1-5 million in FY 2016 compared to its previous guidance of less than €5 million of EBITDA loss, while still investing around €25 million in R&D.
  • Valneva narrows its revenue guidance to the upper end of the previously communicated range and now expects FY 2016 IFRS revenues to reach between €95 and €100 million with product sales of between €75 and €80 million and a gross margin on product sales higher than 50%. 

Key upcoming clinical milestones
  • Following successful completion of Phase II and comparison of its data with the only more advanced vaccine program targeting primary prevention of Clostridium difficile Infections, Valneva continues to seek a partner and is in discussion with several potential partners. The Company has therefore revised its expected timelines for entering into a partnering deal to 2017.
  • Valneva confirms it will initiate a Phase I clinical trial of its Lyme borreliosis vaccine candidate before the end of 2016. The Company will hold a Key Opinion Leader conference and live webcast for investors on Lyme in New York on December 12, 2016.
  • Valneva expects to launch a second clinical program in 2017 from its promising pre-clinical portfolio which includes vaccine candidates against Chikungunya and Zika.

Thomas Lingelbach, President and CEO and Franck Grimaud, Deputy CEO of Valneva, commented, "We are excited that our financial performance clearly confirms the company's transition towards financial self-sustainability while maintaining significant investments in promising R&D programs including much-needed vaccines such as our Lyme disease vaccine candidate. Besides further anticipated growth of our product sales, the ongoing R&D partnership discussions, including those on our C. difficile vaccine candidate, may provide additional upside going forward."

Key Financial Information

(unaudited)
€ in thousand 3 months ended September 30, 9 months ended September 30,
    2016     2015     2016     2015  
Revenues & grants   19,354     21,468     70,741     60,682  
Net profit/(loss)   (7,007 )   (5,164 )   (46,467 )   (4,218 )
EBITDA [1]   (1,209 )   1,039     3,463     (4,307 )
Net operating cash flow   4,155     (6,054 )   7,990     (19,032 )
Cash, short-term deposits and marketable securities, end of period   40,293     37,258     40,293     37,258  

Lyon (France), November 9, 2016 - Valneva SE ("Valneva" or "the Company"), a leading independent pure play vaccine company, reported today its consolidated financial results for the first nine months and third quarter of the year ending September 30, 2016. The financial report, including the condensed consolidated interim financial report, is available on the Company's website www.valneva.com

A webcast for financial analysts, fund managers, investors and journalists will be held today at 2:00 pm (CET). A replay will be available on the Company's website. Please refer to this link: