Valneva Reports Full Year 2021 Results and Provides Corporate Updates
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 Company’s 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 VLA2001
- €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
Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported its audited consolidated financial results for the year ending December 31, 2021 and provided corporate updates. The 2021 audited consolidated financial statements are available on the Company’s website (Financial Reports – Valneva).
Valneva will provide a live webcast of its full-year 2021 results conference call beginning at 3 p.m. CET today. This webcast will also be available on the Company’s website. Please refer to this link: https://edge.media-server.com/mmc/p/qieuu6at
Peter Bühler, Valneva’s Chief Financial Officer, commented, “2021 was an exceptional year for Valneva, marked by unprecedented R&D progress and our successful Nasdaq listing. We reported positive Phase 3 results for two vaccine candidates (COVID-19 and chikungunya) and we expect both vaccines, if approved, to make a positive change to people’s lives. With close to €350 million in cash, we entered 2022 in a strong position and will continue to focus on gaining regulatory approvals and preparing market entry for our key late-stage programs.”
About Valneva SE
Valneva is a specialty vaccine company focused on the development, production and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. The Company takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these diseases. Valneva 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
VP, Global Communications and European Investor Relations
M +33 (0)6 4516 7099
investors@valneva.com