Saint-Herblain (France), June 3, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the results of two Phase 2 clinical trials of Lyme disease vaccine candidate, VLA15, were published in the peer-reviewed medical journal, The Lancet Infectious Diseases. These trials, as well as a third Phase 2 trial in pediatric participants, supported the design of the current pivotal Phase 3 trial, 'Vaccine Against Lyme for Outdoor Recreationists' (VALOR). Juan Carlos ...

Saint Herblain (France), May 31, 2024 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending authorization of Valneva's single-dose vaccine for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older. The European Commission (EC) will review the CHMP recommendation, and a decision on the marke ...

Valneva SE (NASDAQ:VALN) Q1 2024 Earnings Conference Call May 7, 2024 9:00 AM ET Company Participants Josh Drumm - VP, Global Investor Relations Thomas Lingelbach - President, CEO & Director Peter Buhler - CFO Conference Call Participants Max Herrmann - Stifel Rajan Sharma - Goldman Sachs Evan Wang - Guggenheim Samir Devani - RX Securities Limited Ed White - H.C. Wainwright & Co. Suzanne van Voorthuizen - Van Lanschot Kempen Maury Raycroft - Jefferies Josh Drumm Hello, and thank you for joining us to discu ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 13(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 19 ...

[Valneva's Participation at 24th World Vaccine Congress](index=1&type=section&id=Valneva%27s%20Participation%20at%2024th%20World%20Vaccine%20Congress) Valneva will actively participate in the 24th World Vaccine Congress, presenting on its chikungunya vaccine IXCHIQ®, moderating discussions, and receiving award nominations [Overview of Congress Participation](index=1&type=section&id=Overview%20of%20Congress%20Participation) Valneva SE announced its active participation in the 24th World Vaccine Congress in Washington D.C., from April 1-4, 2024, where it will present on its chikungunya vaccine IXCHIQ®, moderate a roundtable, and join a panel discussion - Valneva SE will participate in the **24th World Vaccine Congress** in Washington D.C. from **April 1-4, 2024**[1](index=1&type=chunk) - The company will present on its single-shot chikungunya vaccine, **IXCHIQ®**, moderate a roundtable, and participate in a panel discussion[1](index=1&type=chunk) - Valneva will have a display at booth 433 in the exhibit area[1](index=1&type=chunk) [Key Presentations and Discussions](index=1&type=section&id=Key%20Presentations%20and%20Discussions) Valneva executives and partners will lead and participate in several key sessions, including a roundtable on Zika and chikungunya, presentations on IXCHIQ® antibody persistence, and a panel discussion on chikungunya eradication efforts, alongside a presentation on the Lyme disease vaccine candidate VLA15 - Valneva's Head of Global Market Access & Value Evidence, Gerard Vondeling, and Market Access Manager, Adrianne de Roo, will moderate the 'Public Health Priorities: The Emerging Threats of Zika and Chikungunya' interactive roundtable on April 2[2](index=2&type=chunk) - Valneva's VP of Clinical Development, Susanne Eder-Lingelbach, will present on 'Antibody persistence of a single-dose live-attenuated chikungunya virus vaccine (VLA1553) in adults' on April 3[4](index=4&type=chunk) - Valneva's Chief Medical Officer, Dr. Juan Carlos Jaramillo, will participate in the 'Vaccine Development and Efforts towards Eradicating Chikungunya' panel discussion on April 3[4](index=4&type=chunk) - Eduardo Forleo-Neto from Pfizer will present '6-Valent, OspA-based Lyme Disease Vaccine (VLA15) - Clinical Development Overview' on April 3, discussing the Pfizer and Valneva partnered vaccine candidate[5](index=5&type=chunk) [Awards and Recognition](index=1&type=section&id=Awards%20and%20Recognition) Valneva's chikungunya vaccine, IXCHIQ®, has been nominated as a finalist for the 'Best Prophylactic Vaccine' award, and Valneva's CEO will present another industry award - Valneva is a finalist for the **'Best Prophylactic Vaccine' award** for IXCHIQ® at the Vaccine Industry Excellence Awards ceremony on **April 2**[3](index=3&type=chunk) - Valneva CEO Thomas Lingelbach will present the **'Best Production / Process Development award'** at the event[3](index=3&type=chunk) [Key Vaccine Candidates](index=1&type=section&id=Key%20Vaccine%20Candidates) This section details Valneva's leading vaccine candidates, including the approved chikungunya vaccine IXCHIQ® and the Phase 3 Lyme disease vaccine VLA15 [IXCHIQ® (Chikungunya Vaccine)](index=1&type=section&id=IXCHIQ%C2%AE%20%28Chikungunya%20Vaccine%29) IXCHIQ® is Valneva's single-shot, live-attenuated chikungunya vaccine, approved in the U.S. and recommended by the CDC for individuals 18 years and older at increased risk of exposure, with continued approval contingent on confirmatory studies - **IXCHIQ® is the world's first and only chikungunya vaccine** to address this unmet medical need[3](index=3&type=chunk) - It is approved in the U.S. and recently recommended by the U.S. Advisory Committee on Immunization Practices (ACIP), with these recommendations adopted by the **Centers for Disease Control and Prevention (CDC)**[3](index=3&type=chunk) - IXCHIQ® is a live-attenuated vaccine 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[6](index=6&type=chunk) - Continued approval for this indication is contingent upon verification and description of clinical benefit in confirmatory studies, as it was approved under FDA's accelerated approval pathway[6](index=6&type=chunk) [VLA15 (Lyme Disease Vaccine)](index=1&type=section&id=VLA15%20%28Lyme%20Disease%20Vaccine%29) VLA15 is the most advanced Lyme disease vaccine candidate, currently in Phase 3 clinical development in partnership with Pfizer, targeting six common OspA serotypes and demonstrating a strong immune response and satisfactory safety profile - VLA15 is the **most advanced Lyme disease vaccine candidate** currently in clinical development, with **two Phase 3 trials** in progress (VALOR - NCT05477524 and NCT05634811)[7](index=7&type=chunk) - It is partnered with **Pfizer** for this study and global commercialization, with recruitment completion for the study announced in **December 2023**[5](index=5&type=chunk) - This investigational multivalent protein subunit vaccine targets the outer surface protein A (OspA) of Borrelia burgdorferi, covering the **six most common OspA serotypes** prevalent in North America and Europe[7](index=7&type=chunk) - VLA15 has demonstrated a **strong immune response and satisfactory safety profile** in pre-clinical and clinical trials so far[7](index=7&type=chunk) [About Valneva SE](index=1&type=section&id=About%20Valneva%20SE) Valneva SE is a specialty vaccine company focused on developing and commercializing prophylactic vaccines for unmet medical needs, supported by a robust pipeline and commercial business [Company Profile and Strategy](index=1&type=section&id=Company%20Profile%20and%20Strategy) Valneva SE is a specialty vaccine company focused on developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases, aiming to provide first-, best-, or only-in-class solutions for unmet medical needs - Valneva SE is a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing **unmet medical needs**[8](index=8&type=chunk) - The company takes a highly specialized and targeted approach, applying deep expertise across multiple vaccine modalities[8](index=8&type=chunk) - Valneva focuses on providing either **first-, best- or only-in-class vaccine solutions**[8](index=8&type=chunk) [Pipeline and Commercial Business](index=1&type=section&id=Pipeline%20and%20Commercial%20Business) Valneva has a strong track record of advancing vaccines from R&D to approval, currently marketing three proprietary travel vaccines and leveraging its commercial infrastructure for third-party vaccines, with revenues supporting its pipeline, including the Lyme disease and Zika virus vaccine candidates - Valneva has a strong track record, having advanced multiple vaccines from early R&D to approvals[9](index=9&type=chunk) - The company currently markets **three proprietary travel vaccines** as well as certain third-party vaccines leveraging its established commercial infrastructure[9](index=9&type=chunk) - Revenues from its growing commercial business help fuel the continued advancement of its vaccine pipeline[10](index=10&type=chunk) - The pipeline includes the **only Lyme disease vaccine candidate in advanced clinical development** (partnered with Pfizer), as well as vaccine candidates against the Zika virus and other global public health threats[10](index=10&type=chunk)

Financial Data and Key Metrics Changes - Total product sales surpassed pre-pandemic levels by 12%, reaching €144.6 million, which represents a 26% increase compared to the previous year [81][96] - Operating losses were reduced to €82.1 million in 2023 from €113.4 million in 2022, while adjusted EBITDA loss remained nearly unchanged at €65.2 million [39][81] - Cash at year-end was €126.1 million, augmented by €95 million from the sale of the PRV, positioning the company strongly for future operations [54][72] Business Line Data and Key Metrics Changes - IXIARO sales reached €73.5 million, a 78% increase year-over-year, driven by market recovery and price increases [106] - DUKORAL sales increased by 72% to €29.8 million, benefiting from the recovery in the private and travel market [82] - Third-party product sales increased by 34% to €35.7 million, primarily due to a distribution agreement with Bavarian Nordic [37] Market Data and Key Metrics Changes - The chikungunya vaccine market is expected to exceed €0.5 billion, with €300 million to €400 million represented by the travel and military segments [75][99] - The company anticipates IXCHIQ sales to exceed €100 million in the third year post-launch, assuming competitive product entry [42][62] Company Strategy and Development Direction - The company aims to drive commercial growth through the recent approval of IXCHIQ and expected approvals in other territories, focusing on proprietary products [73][98] - The strategy includes leveraging partnerships to address low and middle-income countries and enhancing the R&D pipeline to meet unmet medical needs [28][99] - The company plans to achieve cash flow positivity from the commercial business by 2025, driven by continued growth in travel vaccine sales [87][96] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in returning to pre-COVID volume levels for travel vaccines, with expectations of continued growth in 2024 [59][96] - The company is not planning to raise further equity and is focused on maintaining a strong cash runway through operational financing [14][20] - Management highlighted the importance of the Lyme vaccine as a significant catalyst for future profitability [98][102] Other Important Information - The company has received FDA approval for the chikungunya vaccine, which is the first of its kind, and anticipates further regulatory approvals [71][74] - The company expects to initiate a Phase III trial for chikungunya in immunocompromised individuals in the first half of the year [57][90] Q&A Session Summary Question: What is the outlook for IXIARO margins? - Management indicated that IXIARO margins are expected to return to pre-COVID levels of nearly 70% from the current 52% [16][17] Question: What are the assumptions behind the €100 million sales target for IXCHIQ? - The target includes contributions from both travel and military segments, with expectations of a steep growth trajectory in year three post-launch [62][63] Question: How is the company addressing cash runway and financing needs? - Management confirmed that the company is sufficiently financed for operations and does not anticipate the need for additional equity raises [14][20]

Valneva SE (NASDAQ:VALN) Q3 2023 Earnings Conference Call November 9, 2023 9:00 AM ET Conference Call Participants Good day and thank you for standing by. Welcome to the Valneva 9 Months 2023 Financial Results Call. [Operator Instructions]. Thank you for joining us to discuss Valneva's 9 months 2023 results and corporate update. It's my pleasure to welcome you today. In addition to our press release and analyst presentation, you can find our consolidated financial results for the 9 months ended September 30 ...

Valneva SE (NASDAQ:VALN) Q2 2023 Earnings Conference Call September 21, 2023 9:00 AM ET Company Participants Maury Raycroft - Jefferies Samir Devani - Rx Securities Simon Scholes - First Berlin Damien Choplain - Oddo BHF Evan Wang - Guggenheim Securities Suzanne Van Voorthuizen - VLK Max Herrmann - Stifel I would now like to turn the conference over to your speaker, Joshua Drumm, VP, Global Investor Relations. Please go ahead, sir. As always, I'm joined today by Valneva's CEO, Thomas Lingelbach; and CFO, Pe ...

Financial Data and Key Metrics Changes - Total revenues for Q1 2023 reached EUR 33.5 million, an increase of 53.4% compared to Q1 2022, while product sales increased by 98.6% to EUR 32.1 million, driven by the recovery of the international travel market [11][12] - Gross margin for commercial products, excluding COVID-19, deteriorated to 48.4% compared to 68% in the first quarter of last year, affected by one-off effects in the prior year [28] - Operating loss for the first quarter was negative EUR 16.6 million, an improvement from negative EUR 18.4 million one year ago, while adjusted EBITDA reached negative EUR 12.3 million compared to negative EUR 13.3 million in the previous year [38] Business Line Data and Key Metrics Changes - Sales of IXIARO and DUKORAL both quadrupled year-over-year, reflecting strong recovery in the travel market [27] - Third-party product sales decreased by almost 20% due to supply constraints under a distribution agreement with Bavarian Nordic [27] - Sales and marketing expenses increased significantly from EUR 2 million in Q1 2022 to EUR 9 million in Q1 2023, driven by prelaunch activities for the chikungunya vaccine [37] Market Data and Key Metrics Changes - The company reported solid year-over-year growth across all markets, with price increases for IXIARO and DUKORAL in most markets [27] - Direct sales accounted for 71.6% of total sales in Q1 2023, down from 91% in 2022, due to high sales to Bavarian Nordic for distribution in Germany [73] Company Strategy and Development Direction - The company aims to submit regulatory applications for its chikungunya vaccine in the U.S. and Europe by 2026, a delay from the previous target of 2025 [8] - Valneva is focusing on expanding its clinical pipeline through acquisitions or partnerships to enhance its early clinical stage assets [15] - The company maintains a strong cash position of over $250 million and expects product sales to reach or exceed pre-pandemic levels in 2023 [16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about reaching the upper end of the sales guidance for 2023, citing a strong start in Q1 and ongoing recovery in travel [72] - The company acknowledged supply constraints in Q1 but anticipates no further issues going forward [80] - Management remains confident in the strength of its vaccine candidates despite a one-year delay in the Lyme program [43] Other Important Information - The chikungunya vaccine is positioned as the world's first if approved, with a PDUFA date confirmed for the end of August 2023 [20] - The company is preparing for a potential DoD contract for IXIARO and is in discussions regarding stockpiling opportunities for the chikungunya vaccine [62][72] Q&A Session Summary Question: Clarification on Lyme cohorts and strategy - Management could not disclose exact cohort sizes but indicated an end of 9,000 participants, with a strategy to maintain the current protocol despite a one-year delay [42][44] Question: Chikungunya mid-cycle review details - No significant safety concerns were reported during the mid-cycle review, and no further points were discussed that would impact the review process [45] Question: Enrollment focus for Lyme disease - Additional cohorts will be U.S. and Canada focused, with no enrollment in Europe [51] Question: Stockpiling opportunities for chikungunya - Discussions are ongoing, but no additional studies are expected beyond those already planned [52] Question: Revenue recognition from Pfizer collaboration - No revenue was recognized in the current quarter, but potential revenue could be recognized in the future as the Phase 3 trial progresses [84]

EXHIBIT 99.1 Valneva to Present on its Chikungunya Vaccine Candidate and Host a Roundtable at the 23rd World Vaccine Congress in Washington D.C. Saint Herblain (France), March 30, 2023 –Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announced today it will present on its single-shot chikungunya vaccine candidate, VLA1553, and host a roundtable on Zika vaccines next week at the 23 World Vaccine Congress in Washington, D.C. On April 4, 2023, at 11.40am EDT, Valneva's Chief Medica ...