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Valneva SE Reports FY 21 Results, Provides Corporate Update

Published 03/24/2022, 06:09 AM
Updated 03/24/2022, 06:41 AM

Excellent progress on clinical programs

Lyme Disease Vaccine Candidate VLA15

  • Further positive Phase 2 results, including booster response
  • Phase 3 expected to commence in the third quarter of 2022

Inactivated COVID-19 Vaccine Candidate VLA2001

  • Positive pivotal Phase 3 results
  • Purchase Agreements approved by European Commission (EC) and Kingdom of Bahrain for up to 60 million doses and one million doses, respectively, in 2022 and 2023
  • Positive homologous booster results between seven to eight months after primary vaccination
  • Confirmed neutralization of ancestral virus, Delta and Omicron variants in laboratory studies
  • Emergency Use Authorization granted in Bahrain; reviews ongoing with the European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA)

Single-Shot Chikungunya Vaccine Candidate VLA1553

  • Final positive pivotal Phase 3 results
  • Pre-submission process expected to commence in the second quarter of 2022

Strong full-year 2021 revenues and cash position

Total revenues of €348.1 million in 2021 compared to € 110.3 million in 2020, an increase of 216%

  • Includes € 94.8 million of product and other revenues (excluding COVID), at the higher end of the Companys previously communicated guidance of  € 85 to €100 million, and
  • € 253.3 million of COVID-related revenues under the terminated UK agreement

Cash position of € 346.7 million at December 31, 2021

  • Reflects $209.6 million of combined gross proceeds from Nasdaq initial public offering (IPO) and European placement in May 2021, plus November 2021 follow-on offering, and
  • Pre-payments under the EC COVID-19 vaccine supply agreement

2022 financial guidance

  • Total revenues between € 430 to € 590 million expected, including:
    • € 350 to € 500 million of COVID-19 vaccine sales subject to regulatory approvals and deliveries of VLA20011
    • € 60 to € 70 million of other vaccine sales
    • Approximately € 20 million of Other Revenues (revenues from collaborations, licensing and services)
  • R&D expenses expected between € 160 million to €200 million

Catch up on all of Valneva's earnings results here.

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