Group 1 - Valneva SE is a specialty vaccine company focused on developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases, addressing unmet medical needs [4][6] - The company is advancing multiple vaccine candidates, including VLA15, the leading Lyme Disease vaccine in Phase 3 development partnered with Pfizer, and VLA1601, a second-generation Zika virus vaccine in Phase 1 clinical development [2][6] - Valneva's commercial business includes the ongoing launch of IXCHIQ®, the first and only approved chikungunya vaccine, contributing to the funding of its vaccine pipeline [2][6] Group 2 - Valneva will participate in several investor conferences in June 2024, including the Jefferies Global Healthcare Conference and the Goldman Sachs 45th Annual Global Healthcare Conference, to discuss its vaccine candidates and commercial strategies [3] - Institutional investors are invited to request one-on-one meetings with management during these conferences [3]

Core Insights - Valneva SE is actively participating in several investor conferences in June 2024 to discuss its vaccine candidates and commercial business [1][2] Group 1: Vaccine Development - Valneva is developing VLA15, the leading Lyme Disease vaccine candidate, which is currently in Phase 3 development and partnered with Pfizer [2][6] - The company is also advancing VLA1601, a second-generation Zika virus vaccine candidate, which is in Phase 1 clinical development [2][6] Group 2: Commercial Business - Valneva is launching IXCHIQ®, the first and only approved chikungunya vaccine, as part of its growing commercial business [2][6] - The revenues from the commercial business are supporting the advancement of the vaccine pipeline, including the Lyme disease and Zika virus vaccine candidates [6] Group 3: Investor Engagement - Institutional investors can request one-on-one meetings with management at various conferences, including the Jefferies Global Healthcare Conference and Goldman Sachs 45th Annual Global Healthcare Conference [3] - The conferences will feature formats such as fireside chats and investor meetings, providing opportunities for direct engagement with the company's management [3] Group 4: Company Overview - Valneva is a specialty vaccine company focused on developing, manufacturing, and commercializing vaccines for infectious diseases [4] - The company has a strong track record of advancing multiple vaccines from early R&D to approvals and currently markets three proprietary travel vaccines [5]

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), 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 ...