Core Points - Valneva SE has received marketing authorization from the UK for IXCHIQ®, the world's first chikungunya vaccine, which is a single-dose vaccine for individuals aged 18 and older [1][3] - The approval is based on Phase 3 data showing that IXCHIQ® induces a strong immune response that can last for at least three years [2] - Valneva has received regulatory approvals for IXCHIQ® in the US, Europe, and Canada, and expects approval in Brazil in Q1 2025 [3] Company Developments - The Chief Medical Officer of Valneva emphasized the importance of the vaccine for UK travelers, especially given the current chikungunya outbreak in India, which has seen 370,000 cases reported from January 2019 to July 2024 [4] - Valneva has partnered with CEPI to support late-stage development and expand access to IXCHIQ® in low- and middle-income countries, with a $41.3 million grant from the EU to facilitate this [5][11] - An exclusive license agreement with the Serum Institute of India has been signed to supply the vaccine in Asia at affordable prices [6] Industry Context - Chikungunya is a mosquito-borne viral disease that has been spreading globally since 2004, with over 3.7 million cases reported in the Americas between 2013 and 2023 [9] - The World Health Organization has identified chikungunya as a major public health problem, with the disease's economic impact expected to grow due to climate change [9][10]

Core Viewpoint - Valneva SE has signed a new contract worth $32.8 million with the U.S. Department of Defense for the supply of its Japanese encephalitis vaccine, IXIARO® [1][2]. Company Overview - Valneva is a specialty vaccine company focused on developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases [6]. - The company has a strong track record of advancing multiple vaccines from early R&D to approvals and currently markets three proprietary travel vaccines [7]. - Valneva's commercial revenues support the advancement of its vaccine pipeline, which includes candidates for Lyme disease, Shigella, Zika virus, and other public health threats [8]. Product Information - IXIARO® is the only Japanese encephalitis vaccine approved by the U.S. Food and Drug Administration (FDA) and is indicated for active immunization against the disease [3][4]. - The vaccine is approved for individuals aged two months and older in various regions, including the U.S., Europe, and Canada [4]. - Japanese encephalitis is a serious infectious disease primarily found in Asia, with an estimated 70,000 cases occurring annually [5]. Contract Details - The new one-year contract allows the DoD to purchase a minimum of $32.8 million worth of IXIARO® vaccines, with the option for additional doses [2]. - Deliveries under this contract will commence immediately, continuing from a previous supply contract signed in September 2023 [2].

Core Insights - Valneva SE reported positive Phase 3 trial data for its chikungunya vaccine IXCHIQ, which is the first licensed vaccine for this virus, addressing a significant unmet medical need [1][2][10] Group 1: Trial Data and Efficacy - The Phase 3 trial VLA1553-321 demonstrated a seroresponse rate of 98.3% one year after a single-dose vaccination in adolescents who were CHIKV negative at baseline, confirming a strong and long-lasting antibody response [4] - The vaccine was generally well tolerated among adolescents, with no safety issues reported by the Independent Data Safety Monitoring Board throughout the trial [5] - The trial involved 754 adolescents and was conducted in Brazil, representing the first clinical trial in an endemic area [6][7] Group 2: Market Impact and Financials - Following the announcement of the trial results, Valneva's share price increased by 1.4% to $4.37, indicating positive market sentiment due to rising chikungunya cases [3] - Valneva has a market capitalization of $346.6 million and is projected to achieve an 8.3% earnings growth in 2024 [3] Group 3: Global Expansion and Regulatory Efforts - Valneva is pursuing marketing authorization for IXCHIQ in Brazil and has submitted applications to the European Medicines Agency and Health Canada, aiming to enhance the vaccine's global reach [8][9] - The Phase 3 trial data may support regulatory approval in Brazil and other Latin American countries, reflecting Valneva's strategic efforts to improve vaccine access in low and middle-income nations [9] Group 4: Public Health Context - The geographical spread of chikungunya, worsened by climate change, highlights the urgent need for accessible vaccines, with over 3.7 million cases reported in the Americas over the past decade [10] - Valneva's advancements with IXCHIQ position the company as a leader in specialty vaccines, contributing to the fight against emerging infectious diseases [11]

Antibody levels remained high at 96% seroresponse in line with the two-year persistence data This long-lasting antibody persistence was comparable in older (65+) and younger adults Saint-Herblain (France), December 3, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported positive antibody persistence data three years after vaccination with a single dose of its chikungunya vaccine IXCHIQ®. The results are in line with Valneva’s expectations for this vaccine, confi ...

Valneva SE (VALN) recently applied for a label extension to the FDA to potentially extend the use of its chikungunya vaccine, IXCHIQ. Currently approved for adults, the vaccine may soon be accessible to adolescents aged 12 to 17 years, following the label extension. This submission is backed by positive adolescent Phase 3 data that demonstrated a 99.1% immune response rate and a favorable safety profile in adolescents. Expanding access to this age group addresses a critical gap, particularly as chikungunya ...

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 ...