2023 Combined General Meeting
June 26, 2024
Lyon
Disclaimer
This presentation does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, Valneva SE shares to any person in the USA or in any jurisdiction to whom or in which such offer or solicitation is unlawful.
Valneva is a European company. Information distributed is subject to European disclosure requirements that are different from those of the United States. Financial statements and information may be prepared according to accounting standards which may not be comparable to those used generally by companies in the United States.
This presentation includes only summary information provided as of the date of this presentation only and does not purport to be comprehensive. Any information in this presentation is purely indicative and subject to modification at any time without notice. Valneva does not warrant the completeness, accuracy or correctness of the information or opinions contained in this presentation. None of Valneva, or any of its affiliates, directors, officers, advisors and employees is under any obligation to update such information or shall bear any liability for any loss arising from any use of this presentation. The information has not been subject to independent verification and is qualified in its entirety by the business, financial and other information that Valneva is required to publish in accordance with the rules, regulations and practices applicable to companies listed on Euronext Paris and the NASDAQ Global Select Market, including in particular the risk factors described in Valneva's universal registration document filed with the French Financial Markets Authority (Autorité des Marchés Financiers, or AMF) on March 22, 2024 (document d'enregistrement universel2023) under number D.24-0157 (the "2023 URD"), and in the Form 20-F filed with the U.S. Securities and Exchange Commission (SEC) on March 25, 2024, as well as the information in any other periodic report and in any other press release, which are available free of charge on the websites of Valneva (www.valneva.com) and/or the AMF (www.amf-france.org) and SEC (www.sec.gov).
Valneva Combined General Meeting - June 26, 2024
Certain information and statements included in this presentation are not historical facts but are forward-looking statements, including statements with respect to revenue guidance, the progress, timing, completion, and results of research, development and clinical trials for product candidates and estimates for future performance of both Valneva and certain markets in which it operates. The forward-looking statements (a) are based on current beliefs, expectations and assumptions, including, without limitation, assumptions regarding present and future business strategies and the environment in which Valneva operates, and involve known and unknown risk, uncertainties and other factors, which may cause actual results, performance or achievements to be materially different from those expressed or implied by these forward-looking statements, (b) speak only as of the date this presentation is released, and (c) are for illustrative purposes only. Investors are cautioned that forward-looking information and statements are not guarantees of future performances and are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Valneva
This presentation presents information about VLA15, VLA1601 and other investigational vaccine candidates that have not been approved for use and have not been determined by any regulatory authority to be safe or effective.
Management uses and presents IFRS results, as well as the non-IFRS measure of Adjusted EBITDA to evaluate and communicate its performance. While non-IFRS measures should not be construed as alternatives to IFRS measures, management believes non-IFRS measures are useful to further understand Valneva's current performance, performance trends, and financial condition. Adjusted EBITDA is a supplemental measure of performance used by investors and financial analysts. Management believes this measure provides additional analytical tools.
Proceedings of the Meeting
- Welcome
- AGM Preliminary Formalities
- Introduction
- Company Overview
- 2023 Financials
- Answers to Written Questions
- Auditor's Reports
- Presentation of the Resolutions
- Discussion
- Voting
- Conclusion
Proceedings of the Meeting
- Welcome
- AGM Preliminary Formalities
- Introduction
- Company Overview
- 2023 Financials
- Answers to Written Questions
- Auditor's Reports
- Presentation of the Resolutions
- Discussion
- Voting
- Conclusion
Preliminary Formalities
Sign attendance sheet (All)
Appoint AGM committee (Chair, Observers, Secretary)
Validation of the Quorum (Secretary)
Documents filed with the AGM committee (Secretary)
Agenda (Chairperson)
Valneva Combined General Meeting - June 26, 2024
Proceedings of the Meeting
- Welcome
- AGM Preliminary Formalities
- Introduction
- Company Overview
- 2023 Financials
- Answers to Written Questions
- Auditor's Reports
- Presentation of the Resolutions
- Discussion
- Voting
- Conclusion
Proceedings of the Meeting
- Welcome
- AGM Preliminary Formalities
- Introduction
- Company Overview
- 2023 Financials
- Answers to Written Questions
- Auditor's Reports
- Presentation of the Resolutions
- Discussion
- Voting
- Conclusion
A Leading Specialty Vaccine Company
Focused on vaccines that make a difference
Wedevelop, manufacture, & commercialize
prophylactic vaccines for infectious diseases
addressing unmet medical needs
- 2023 has been a major year for Valneva, with notably:
- The U.S. approval of IXCHIQ®, the world's first chikungunya vaccine
- The completion of participant recruitment for our Lyme Phase 3 trial, partnered with Pfizer
- A reduction of the Company's loss by more than €40 million
- The successful transition from atwo-tier system to a Board of Directors
- Additional milestones were reached in the first half of 2024, with:
- The €95 million sale of the Priority Review Voucher (PRV) Valneva received with IXCHIQ®FDA approval
- Health Canada approval of IXCHIQ®and EMA's positive opinion in Europe
- The extension of theinterest-only period of its existing loan agreement which significantly extended cash runway
Valneva Combined General Meeting - June 26, 2024
Valneva's Commercial and R&D Portfolio
Further extending a unique, best-in class portfolio
Program | Vaccine Design | Pre-Clinical | Phase 1 | Phase 2 | Phase 3 | Commercial | |||
IXIARO® | Only U.S./ EU approved vaccine against Japanese encephalitis | ||||||||
Commercial | |||||||||
DUKORAL® | Established Cholera (ETEC*) vaccine approved in >30 countries | ||||||||
Products | |||||||||
IXCHIQ® | World's first and only approved chikungunya vaccine (U.S.); Review ongoing in Europe, Canada & Brazil | ||||||||
VLA15: | Most clinically advanced Lyme vaccine program worldwide | ||||||||
Lyme disease | |||||||||
Clinical | |||||||||
VLA1553: | Phase 3 adolescent study (Brazil) and Phase 2 pediatric study support potential label expansion | ||||||||
Programs | Chikungunya | ||||||||
VLA1601: | Potential for first/best-in-class | ||||||||
Zika | |||||||||
VLA1554: | For partnering (e.g., RSV combo) | ||||||||
hMPV | |||||||||
Pre-Clinical | |||||||||
VLA2112: | |||||||||
Programs | EBV | ||||||||
Enteric | |||||||||
diseases | |||||||||
* ETEC indication in some markets only
Valneva Combined General Meeting - June 26, 2024
Our Strategy to become a Globally Recognized Vaccine Company
Contribute to a world where no one dies or suffers from a vaccine preventable disease
Drive | Maximize | |
Commercial | Capture | integrated |
Growth | R&D Upside | biotech model |
- Unlock IXCHIQ®value by building awareness and market
- Capitalize on the bundle effect within travel business
- Expand global reach; reach more LMICs via partnerships
- Expectcash-flow positivity from 2025
- Invest in new vaccines that address high unmet needs
- Leverage proven R&D engine and strategic partnerships
- Focus on vaccines that can make a difference (first, only,best-in-class)
- Generate meaningful catalysts - Next Phase 3 entry post Lyme
- Build continual value from R&D and commercial execution
- Support timely Lyme approval(s)
- Achieve sustained profitability with potential VLA15 commercial revenues from partner Pfizer*
*Subject to successful development, licensure and launch of the Company's Lyme disease vaccine candidate partnered with Pfizer
Valneva Combined General Meeting - June 26, 2024
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Valneva SE published this content on 26 June 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 26 June 2024 07:34:06 UTC.