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Valneva Reports Q1 2021 Financial Results and Business Update

  • Excellent progress on clinical programs in the first quarter of 2021 for:
    • VLA15, currently the only clinical stage vaccine candidate against Lyme disease
      • Initiation of additional Phase 2 trial to accelerate pediatric development
    • VLA2001, currently the only inactivated, adjuvanted vaccine candidate for COVID-19 in clinical trials in Europe:
      • Initiation of pivotal Phase 3 clinical trial
      • Participation in the world’s first COVID-19 vaccine booster trial in the UK
      • Publication of Phase 1/2 results
    • VLA1553, currently the only Phase 3 chikungunya vaccine program worldwide
      • Recruitment completion for pivotal Phase 3 trial
  • Successful Nasdaq listing (Q2 event); $107.6 million of gross proceeds raised in a US initial public offering and a concurrent private placement in Europe
  • Cash and cash equivalents of €235.9 million at March 31, 2021
    • Q1 2021 cash and cash equivalents do not include proceeds of $107.6 million from the Company’s recent Global Offering
  • Total revenue of €23.2 million in the first quarter of 2021 compared to €35.2 million in the first quarter of 2020
    • Product sales of €1 million in the first quarter of 2021 (€32.7 million in the first quarter of 2020), affected by the COVID-19 pandemic impact on the travel industry
    • €7.1 million of Other Revenues (revenues from collaborations, licensing and services) in the first quarter of 2021 (€2.5 million in the first quarter of 2020)
  • EBITDA[1] loss of €28.3 million in the first quarter of 2021 reflecting increased R&D investment in clinical stage programs, and lower sales (compared to EBITDA profit of €2.4 million in Q1 2020)
    • R&D investment increased to €27.7 million in the first quarter of 2021 compared to €13.3 million in the first quarter of 2020

FY 2021 financial guidance updated
Updated guidance, excluding VLA2001 related activities (including revenue, costs of goods sold, R&D investments), for full-year 2021:

  • Total revenues, excluding VLA2001, of €80 million to €105 million
    • Range modified noting that, despite initial signs of recovery in travel vaccine sales being seen, the 2021 outlook remains soft
  • R&D expenses, excluding VLA2001, of €65 million to €75 million

Thomas Lingelbach, Valneva’s Chief Executive Officer, commented, “Valneva continues to achieve significant R&D milestones thanks to the huge efforts of our team and our partners. Our recent successful Nasdaq listing marks a significant strategic step for Valneva as we look forward. I would like to take this opportunity to thank our existing and new shareholders, partners and employees for their support and contribution to our journey. We are now in a strong position to continue to execute our key programs and continue to build shareholder value.”

About Valneva SE
Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. The Company has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

Valneva Investor and Media Contacts
Laetitia Bachelot-Fontaine
Director Investor Relations &
Corporate Communications
M +33 (0)6 4516 7099

Teresa Pinzolits
Corporate Communications Specialist
T +43 (0)1 20620 1116