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Valneva Reports Strong 2018 Results, Expects Further Growth and Major Pipeline Progression in 2019

Major R&D milestones achieved in 2018, double-digit product sales revenue growth delivered; Lyme and chikungunya programs expected to advance further in 2019

Strong financial results in 2018

• Product sales revenue of €103.5 million in 2018, representing 16% growth at constant exchange rate (CER)
• Exceeded guidance of >€100 million
• IXIARO® sales revenue growth 19% (CER) in 2018
• DUKORAL® sales 12% higher (CER) in 2018 despite H1 supply constraints
• Total revenues were €113.0 million in 2018
• EBITDA of €13.1 million in 2018
• Exceeded guidance of €5.0 million to €10.0 million
• Net profit of €3.3 million; first ever profitable annual result for Valneva
• R&D investment of €25.3 million in 2018, in line with guidance of €25 million to €30 million
• €50 million financing led by blue-chip U.S. healthcare investors combined with positive operating cash flow of €16.3 million resulted in strong cash position of €81.7 million at the end of 2018
• Biopharma (Pharmakon) loan fully repaid in January 2019 thereby reducing cost of capital in 2019
• Further €15 million European Investment Bank loan facility available
• Double-digit product sales growth expected to continue in 2019
• Valneva expects product sales revenues in 2019 of between €115 million and €125 million, representing 15% to 20% (CER) year on year growth
• New $59 million IXIARO® supply contract with the US Department of Defense (DoD) recently announced; DoD option to increase to $70 Million
• Doses to be supplied in 2019 and 2020
• IXIARO® product sales growth expected to be 15% (CER) or more, according to supply logistics with DoD
• Further DUKORAL® product sales growth of up to 5% (CER) is expected
• Other revenues (service revenue, license fees) are expected to approach 2018 levels
• Overall revenue expected to be between €125 million and €135 million in 2019
• Gross margin is expected to be above 60% and net operating margin, prior to R&D investments4, is expected to be between 25% to 35%
  • Valneva expects to invest €35 million to €40 million in R&D projects, notably Lyme and chikungunya, in 2019
  • Valneva expects to generate EBITDA of €5 million to €10 million in 2019
  • Key R&D Progress reported in 2018
  • Valneva reported nine key R&D milestones in 2018, the highest number in the Company’s history, including:
  • Positive Phase 1 data for its Lyme disease vaccine candidate. Valneva also aligned its development strategy with both the FDA and EMA, and advanced the program into Phase 2
  • Initiation of Phase 1 clinical trial for the Company’s promising vaccine candidates Positive initial data reported for both candidates
  • Further significant R&D progress expected in 2019
  • against chikungunya and Zika
  • Major confirmatory and supportive data points for the Lyme vaccine candidate (VLA15):
  • First booster data including final Phase 1 data5 (Q1)
  • Determination of final doses and initiation of second Phase 2 trial (Q2)
  • Further alignment with regulators on Phase 3 strategy
  • Development acceleration of chikungunya vaccine candidate (VLA1553)
  • Phase 1 data (ungrouped) including first intrinsic human challenge (Q2/3)
  • Alignment with regulators on potential route to licensure (Q2/3)
  • Initiation of next clinical trial (by end 2019)
  • David Lawrence, Valneva’s Chief Financial Officer, commented, “2018 has been a significant year for Valneva. We broke the €100 million threshold for product sales, made significant progress in R&D and successfully executed a strategic capital raise as part of our capital formation strategy. 2019 is already off to an excellent start with the new DoD IXIARO® supply contract and positive Phase 1 interim results for our chikungunya vaccine candidate. We are excited about continuing to execute our strategy and unlocking shareholder value.”

Saint Herblain (France), February 21, 2019 – Valneva SE (“Valneva” or “the Company”), a biotech company developing and commercializing vaccines for infectious diseases with major unmet needs, reported today its full year unaudited6 consolidated financial results for the year ending December 31, 2018. A brief unaudited report, including the profit and loss statement and the balance sheet, is available on the Company’s website, www.valneva.com.

A webcast for the financial community and media will be held today at 3:00 pm. (CET). A replay will be available on the Company’s website. Please refer to this link: https://edge.media-server.com/m6/p/dk7vyzzx

Valneva Investor and Media Contacts
Laetitia Bachelot-Fontaine
Global Head of Investor Relations & Corporate Communications
M +33 (0)6 4516 7099
investors@valneva.com

Teresa Pinzolits
Corporate Communications Specialist
T +43 (0)1 20620 1116
communications@valneva.com