To potentially include adolescents and antibody persistence up to two years Saint Herblain (France), November 26, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it has submitted a label extension application to the U.S. Food and Drug Administration (FDA) to potentially extend the use of its chikungunya vaccine IXCHIQ®, which is currently approved in adults, to adolescents aged 12 to 17 years. The application also includes adding the two-year antibody ...

Saint Herblain (France) and Schlieren (Zurich), November 13, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and LimmaTech Biologics AG, a clinical-stage biotech company developing vaccines for the prevention of life-threatening diseases, announced today that the first participant has been vaccinated in a Phase 2b controlled human infection model (CHIM) study of Shigella4V2 (S4V2), the world’s most clinically advanced tetravalent bioconjugate shigellosis vaccine candidate ...

Financial Data and Key Metrics Changes - Product sales reached €112.5 million, a 12% increase year-over-year, while total revenues were €116.6 million compared to €111.8 million in the first nine months of 2023 [36][40] - IXIARO sales increased by 31% to €66 million, driven by growth in both the travel segment and US military [36] - Adjusted EBITDA improved from a loss of €46 million to a positive EBITDA of €48.6 million [44] Business Line Data and Key Metrics Changes - DUKORAL sales grew by 6% to €22.3 million, with a significant 85% growth in Q3 [37][38] - IXCHIQ, the chikungunya vaccine, reported sales of €1.8 million in the US by September 30th [39] - Gross margin for IXIARO improved to 58.8% from 47.2% year-over-year, while total gross margin excluding IXCHIQ reached 48.6% [40][41] Market Data and Key Metrics Changes - The number of travelers to chikungunya endemic countries is expected to exceed pre-COVID levels, with a projected growth of 22% by 2030 [46] - The global market for a potential Shigella vaccine is expected to exceed $500 million annually, with significant demand in endemic countries [27] Company Strategy and Development Direction - The company is targeting sustained profitability from 2027 onwards, primarily driven by the success of the Lyme disease vaccine program [9] - Focus on growing commercial sales and advancing an attractive R&D pipeline, including programs for Shigella and Zika [11][12] - The company aims to expand access to IXCHIQ globally, with upcoming approvals in Brazil and the UK [22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term prospects of IXCHIQ despite slow uptake in the US market [10] - The company is monitoring performance indicators for IXCHIQ and expects to provide updated midterm guidance in the coming months [78] - Management highlighted the importance of the MMWR publication for accessing the retail channel in the US [57] Other Important Information - The cash position at September 30th was reported at €156.3 million, with a significant decrease in cash used in operating activities [45] - Research and development expenses increased due to tech transfer costs related to the IXIARO and IXCHIQ manufacturing operations [42] Q&A Session Summary Question: Update on IXIARO orders and DOD - Management expects stable demand for IXIARO from the DOD, estimating around 200,000 doses annually [54][55] Question: IXCHIQ sales growth in Q3 - Management noted that sales were impacted by channel inventory and anticipated improved growth moving forward [61] Question: Update on VLA2112 for Epstein-Barr Virus - The company is evaluating different antigen compositions and expects to conclude on the lead vaccine design next year [68][70] Question: R&D expenses and transfer costs - Transfer costs will continue into 2025, ending early 2026 as manufacturing operations transition to the new site [72] Question: IXCHIQ midterm guidance - Management is monitoring uptake trends and will provide updated guidance based on visibility from launches in Canada and Europe [78] Question: Gross margins and idle costs - Management expects IXIARO gross margins to continue improving, with idle costs decreasing as operations transition to the new facility [79][80]

 Nine-Month Key Financial Highlights Total revenues of €116.6 million, including product sales of €112.5 millionNet Profit of €24.7 million, including proceeds from the Priority Review Voucher (PRV)1 sale Operating profit of €34.2 million compared to an operating loss of €57.2 million in the first nine-months of 2023 Cash position of €156.3 million Includes €61.2 million in gross proceeds from recent private placement2Lower cash burn expected in the second half of 2024 as cost contributions to the agreed R& ...

Saint-Herblain (France), October 21, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announces today that members of its senior leadership team will present datasets on the world’s first and only approved chikungunya vaccine, IXCHIQ®, at several leading scientific conferences during the fourth quarter of 2024. At the International Society of Vaccines Annual Congress taking place in Seoul, South Korea, Valneva will present on the two-year antibody persistence and safety da ...

Saint-Herblain (France), September 13, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) ("Valneva" or the "Company"), a specialty vaccine company, today announces the successful pricing of its Private Placement (as defined below) for a final amount of €61,180,000. Peter Bühler, Valneva's Chief Financial Officer, commented, "We would like to thank our existing shareholders for their continued support, as well as the new healthcare specialist investors joining us through this raise. In addition to suppor ...

Saint-Herblain (France), September 12, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) ("Valneva" or the "Company"), a specialty vaccine company, today announces its intention to issue, subject to market conditions, approximately 22.6 million new ordinary shares (the "Offer Shares") at a price of €2.66 per Offer Share to certain categories of investors via a private placement through an accelerated bookbuilding process starting immediately. Context of the Offering The Issuer intends to use the net pro ...

Valneva SE (VALN) and Pfizer Inc. recently reported positive immunogenicity and safety data from their VLA15-221 Phase 2 study. Data from the study showed a strong immune response one month after a second booster dose in pediatric and adult populations. The safety and tolerability profile of VLA15 after a second booster dose was compared with that observed after the first booster. No safety concern was observed by an independent Data Monitoring Committee ("DMC") in any treatment or age group. The new favora ...

Shares of Valneva SE Sponsored ADR (VALN) have gained 3.5% over the past four weeks to close the last trading session at $7.32, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $18.33 indicates a potential upside of 150.4%. The average comprises four short-term price targets ranging from a low of $8.30 to a high of $26, with a standard deviation of $7.63. While the lowest estimat ...

First-Half Sales Performance in Line with Full-Year 2024 Guidance Total revenues of €70.8 million, including product sales of €68.3 million, in line with anticipated supply and sales phasing Net Profit of €34.0 million, including proceeds from PRV sale Operating profit of €46.7 million compared to an operating loss of €35.0 million in the first half of 2023 Cash position of €131.4 million Substantially lower cash burn expected in the second half of 2024 as Valneva completed its cost contributions to the agr ...