Valneva's Q1 2024
Financial Results and Business Update
May 7, 2024
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 universel 2023)
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 22, 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).
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, the potential approval of 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 VLA1553, VLA15 and VLA1601, 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.
Valneva - Q1 2024 Analyst Presentation | 2 |
Agenda
Introduction
Business Update
Financial Report Q1 2024
Financial Outlook
Newsflow
Q&A
Valneva - Q1 2024 Analyst Presentation | 3 |
First Quarter 2024 Key Results and Corporate Updates
Q1 Pipeline Progress
- Chikungunya: ACIP recommendation and first commercial revenues
- Lyme disease: Participants expected to complete primary vaccinations in Q2
- Zika virus: Advanced second-generation candidate to Phase 1
Q1 Financial Highlights (as of March 31, 2024)
- Proceeds from PRV sale led to:
- Q1 net profit of €58.9m; €176.6m in cash
- Product sales of €32.1m in line with full-year guidance; total revenue €32.8m
- Significantly extended cash runway with recent update to debt financing agreement
Reiterated strong mid-term financial outlook
- Solidly funded with significantly lower expected cash burn going forward (final Lyme Phase 3 payment in Q2)
- Operational business considered sufficiently funded (excluding debt repayment) until Lyme commercial revenues enable sustained profitability*
*Subject to successful development, licensure and launch of the Company's Lyme disease vaccine candidate partnered with Pfizer.
Valneva - Q1 2024 Analyst Presentation | 4 |
Agenda
Introduction
Business Update
Financial Report Q1 2024
Financial Outlook
Newsflow
Q&A
Valneva - Q1 2024 Analyst Presentation | 5 |
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 | Capture | Maximize |
Commercial | R&D Upside | integrated |
Growth | 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
- Expect cash-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 - Q1 2024 Analyst Presentation | 6 |
The World's First and
Only Chikungunya
Vaccine
IXCHIQ® / VLA1553
*IXCHIQ® is approved by the U.S. Food & Drug Administration (FDA) and is indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV.
Continued approval of IXCHIQ® in the U.S. is contingent upon verification of clinical benefit in confirmatory studies.
IXCHIQ® Key Features and Differentiators
▪ We expect to benefit by being first to market with a potentially best-in-class vaccine
▪ We believe we have a differentiated and competitive product characterized by a strong and durable immunological response from a single injection
▪ No difference in immunogenicity between younger and older adults (65+ years old)
▪ Generally well tolerated among the >3,600 adults and 754 adolescents evaluated for safety1
1 Please refer to the full Prescribing Information for contraindications, warnings, and other important information: https://www.fda.gov/media/173758/download
Valneva - Q1 2024 Analyst Presentation | 8 |
IXCHIQ® Launch Success
Continued Progress on Plan Execution
Coming
Soon
Build HCP | Gain ACIP | Ensure Customer | Activate |
Awareness & | |||
Approval & | Stocking & Build | Consumers & | |
Stock Distributor | |||
CDC Acceptance | Payor Coverage | Engage Military | |
Channel | |||
Next Steps:
- Support customers who are already actively protecting travelers
- Activate consumers to seek travel health consults
- Ensure military officials understand risk, impact and threat levels
- Continuously monitor outbreaks and threat level, and adjust plans accordingly
Valneva - Q1 2024 Analyst Presentation | 9 |
Driving Value by Executing Global Launch Plan
Multiple ex-U.S. regulatory processes currently ongoing1
Additional
Additional Markets
United States
Initial approval for adults
Priority Review
Voucher - sold
ACIP recommendation
Label expansion: adolescent, pediatric
Canada
Filed NDS2
May 2023
Expect review completion mid-20243
Adolescent study expected to support label expansion
Europe / UK
Filed with EMA4 October 20235
Granted accelerated assessment by EMA's CHMP6
CHMP opinion expected mid-2024
Expect MHRA7 submission in 2024 via reliance route
Brazil
IXCHIQ® filing
Q4 2023
First potential licensure in CHIKV- endemic country in 2024
Complete tech transfer and VLA1555 filing; potential licensure 2025
LATAM/ Certain LMICs9
Prioritization and first submission in 2024
WHO pre-qualification
Target countries with established travelers' or endemic markets
- IXCHIQ® is not currently approved in any other country or jurisdiction outside of the U.S.; 2. New drug submission; 3. Based on Health Canada's performance standards of approx. 300 days from acceptance; 4.. European Medicines Agency;
- Valneva Submits Chikungunya Vaccine Marketing Application to EMA and Announces CHMP Accelerated Assessment; 6. Committee for Medicinal Products for Human Use; 7. Medicines and Healthcare Products Regulatory Agency; 8. Pre- filing processes are ongoing and can take approximately 12 months from filing acceptance to potential approval; 9. Low-and-middle-income countries
Valneva - Q1 2024 Analyst Presentation | 10 |
Attachments
- Original Link
- Original Document
- Permalink
Disclaimer
Valneva SE published this content on 07 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 07 May 2024 05:16:04 UTC.