Valneva SE (VALN)

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Valneva Reports H1 2022 Results and Provides Corporate Updates

https://valneva.com/press-release/valneva-reports-h1-2022-results-and-provides-corporate-updates/

August 11, 2022

Excellent progress on late-stage clinical programs

Lyme Disease Vaccine Candidate VLA15

Phase 3 study initiated in August 2022[1]
Further positive Phase 2 results reported, including first pediatric data[2]

Single-Shot Chikungunya Vaccine Candidate VLA1553

Initiation of rolling submission for Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) imminent
Final positive pivotal Phase 3 results reported[3]
Final positive lot-to-lot consistency Phase 3 results reported[4]

Four marketing authorizations granted for inactivated COVID-19 vaccine

First Standard Marketing Authorization granted in Europe by the European Medicines Agency (EMA)[5]
Conditional Marketing Authorization granted in the United Kingdom (UK) by the Medicines and Healthcare products Regulatory Agency (MHRA)[6] and Emergency Use Authorizations granted in the Kingdom of Bahrain[7] and the United Arab Emirates (UAE)[8]

H1 revenue and cash

Total revenue of €93.2 million in the first half of 2022 compared to €47.5 million in the first half of 2021
Includes product sales of €33.3 million (vs €31.8 million in the first half of 2021) with first COVID-19 vaccine sales of €3.8 million
€59.9 million of other revenues (vs €15.7 million in the first half of 2021)
Cash position of €336.2 million as of June 30, 2022
Includes €90.5 ($95) million of proceeds from Pfizer’s investment in Valneva via an equity subscription agreement[9]

Updated FY 2022 Financial Guidance

Valneva expects total revenues to reach €340 million to €360 million in 2022 noting the continued recovery of travel vaccine sales, the revenue recognition linked to the EC and UK supply contracts and the recently revised Advance Purchase Agreement (APA) with the European Commission for the Company’s COVID-19 vaccine.
Product sales of the Company’s travel vaccine franchise are expected to reach €70 million to €80 million while COVID-19 product sales are expected to reach €30 million to €40 million.
Other Revenues are expected to reach approximately €240 million and will be mainly COVID-19 related. Other non-COVID-19 related revenues will be negative in 2022 due to the increased refund liability linked to the amendment of the VLA15 collaboration and license agreement with Pfizer. COVID-19 related Other Revenues will have no cash impact in 2022 and relate to revenues recognized in relation to the UK and EC Advance Purchase Agreements.
Valneva expects R&D expenses of €120 million to €135 million in 2022. The Company will continue investing in progressing its two leading, late-stage investigational vaccines against Lyme disease and chikungunya in the second half of 2022. Valneva will invest in further development of its current or any potential second-generation COVID-19 vaccine only if it receives the necessary funding or commitments to such funding during the third quarter of 2022. The Company also remains committed to further expanding its R&D pipeline, including through the advancement of some of the Company´s pre-clinical candidates towards clinical entry.