Core Viewpoint - Valneva SE is actively participating in the 26th World Vaccine Congress, showcasing its advancements in vaccine development, particularly for chikungunya, and engaging with partners in the industry [1][5]. Group 1: Company Participation and Events - Valneva will be represented by its CEO Thomas Lingelbach and senior executives at the World Vaccine Congress from March 31 to April 2, 2026 [1]. - On April 1, 2026, Susanne Eder-Lingelbach will present updates on chikungunya vaccine development, focusing on Phase IV and real-world evidence studies [2]. - Valneva's Chief Medical Officer, Dr. Juan Carlos Jaramillo, will participate in a panel discussion on chikungunya and mosquito-borne vaccines on the same day [4]. Group 2: Chikungunya Vaccine Campaign - Valneva and Instituto Butantan have launched a pilot vaccination campaign for the chikungunya vaccine IXCHIQ® in Brazil, with over 12,000 individuals vaccinated to assess the vaccine's effectiveness and safety in real-world conditions [3]. Group 3: Chikungunya Overview - Chikungunya virus (CHIKV) is a mosquito-borne disease causing significant health issues, with over 3.7 million cases reported in the Americas from 2013 to 2023 [6]. - The World Health Organization (WHO) has identified chikungunya as a major public health concern, with its impact expected to grow due to climate change [6]. Group 4: Company Background - Valneva is a specialty vaccine company focused on developing, manufacturing, and commercializing vaccines for infectious diseases, addressing unmet medical needs [7]. - The company has a strong track record in advancing vaccines from early R&D to approvals and currently markets three proprietary travel vaccines [8].

Core Viewpoint - Valneva SE is actively participating in the 26th World Vaccine Congress, showcasing its advancements in vaccine development, particularly for chikungunya, and engaging with partners in the industry [1][5]. Group 1: Company Participation and Events - Valneva will be represented by its CEO Thomas Lingelbach and senior executives at the World Vaccine Congress from March 31 to April 2, 2026 [1]. - On April 1, 2026, Susanne Eder-Lingelbach will present updates on chikungunya vaccine development, focusing on Phase IV and real-world evidence studies [2]. - Valneva's Chief Medical Officer, Dr. Juan Carlos Jaramillo, will participate in a panel discussion on chikungunya and mosquito-borne vaccines on the same day [4]. Group 2: Chikungunya Vaccine Campaign - Valneva and Instituto Butantan have launched a pilot vaccination campaign for the chikungunya vaccine IXCHIQ® in Brazil, with over 12,000 individuals vaccinated to assess the vaccine's effectiveness and safety in real-world conditions [3]. Group 3: Industry Context - Chikungunya virus (CHIKV) is a significant public health concern, with over 3.7 million cases reported in the Americas between 2013 and 2023, and its economic impact is expected to grow due to climate change [6]. - The World Health Organization (WHO) has identified chikungunya as a major public health problem, emphasizing the need for effective vaccines [6]. Group 4: Company Overview - Valneva is a specialty vaccine company focused on developing, manufacturing, and commercializing vaccines for infectious diseases, addressing unmet medical needs [7]. - The company has a strong track record in advancing vaccines from early R&D to approvals and currently markets three proprietary travel vaccines [8]. - Revenues from its commercial business support the advancement of its vaccine pipeline, which includes candidates for Lyme disease and Shigella, among others [9].

Core Insights - Valneva SE reported its audited consolidated financial results for the year ended December 31, 2025, confirming its financial guidance for 2026 and filing its annual report with regulatory authorities [1][3][43] Financial Performance - Total revenues for 2025 were €174.7 million, an increase from €169.6 million in 2024, driven by product sales and collaboration agreements [6][7][24] - Product sales amounted to €157.9 million, down from €163.3 million in 2024, reflecting a planned reduction in third-party sales by 42.3% [7][10] - The net loss for 2025 was €115.2 million, compared to a net loss of €12.2 million in 2024, primarily due to the absence of a significant gain from the sale of a Priority Review Voucher in the previous year [7][32] - Operating cash burn improved to €52.9 million in 2025 from €67.2 million in 2024, indicating better cost management [6][34] Product Sales Breakdown - IXIARO®/JESPECT® sales increased by 4.6% to €98.4 million, benefiting from growth in the travel market [11] - DUKORAL® sales were €31.9 million, slightly down from €32.3 million in 2024, affected by currency fluctuations and distribution changes [12] - IXCHIQ® sales rose to €8.4 million from €3.7 million in 2024, supported by its launch in several European countries [13] Clinical Developments - The Phase 3 data readout for the Lyme disease vaccine candidate VLA15 is expected in the first half of 2026, which could significantly impact the company's future [4][15] - Valneva is also advancing its Shigella vaccine candidate S4V2, with Phase 2 results anticipated mid-2026 [21][22] 2026 Financial Guidance - Total revenues for 2026 are projected to be between €155 million and €170 million, with product sales expected to range from €145 million to €160 million [6][7] - The guidance reflects continued growth in established brands but anticipates a decline in third-party sales [7][10] Cash Position and Management - The company ended 2025 with a strong cash position of €109.7 million, down from €168.3 million in 2024, but with improved financial flexibility following successful debt refinancing [6][37] - Disciplined cash management will remain a priority, with expectations for further reductions in operating cash burn in 2026 [7][34]

A Leading Specialty Vaccine Company March 2026 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 ac ...

Core Insights - Valneva SE reported preliminary unaudited full-year 2025 revenue of €174.7 million, including €157.9 million in product sales, which is in line with guidance [4][5] - The company anticipates a transformative year in 2026 with Phase 3 data for its Lyme disease vaccine candidate expected in the first half of the year [5][10] - Valneva's Chief Executive Officer, Thomas Lingelbach, has had his contract renewed for an additional three years, ensuring continuity in leadership [5][10] 2025 Financial Results - Total revenues for 2025 were €174.7 million, compared to €169.6 million in 2024, reflecting a year-over-year growth of approximately 0.6% [5][7] - Product sales decreased to €157.9 million from €163.3 million in 2024, a decline of 3.3%, with third-party sales dropping by 42.3% to €19.2 million [5][7] - Excluding third-party sales, product sales increased by 6.7% year-over-year, with a 9% increase at constant exchange rates [7] Cash Position and Financial Guidance - The company reported a strong year-end cash position of €109.7 million as of December 31, 2025, down from €168.3 million in 2024, following successful debt refinancing [5][7] - For 2026, total revenues are expected to range between €155-170 million, with product sales projected between €145-160 million, reflecting continued growth in established brands but a decline in third-party sales [5][10] - Operating cash burn is expected to decline further in 2026 while maintaining strategic R&D investments [5] R&D Pipeline and Future Prospects - The first Phase 3 data readout for the Lyme disease vaccine candidate is anticipated in the first half of 2026, with regulatory submissions planned by Pfizer, contingent on positive results [5][10] - Valneva is also progressing with its tetravalent shigella vaccine candidate, with a decision on further development expected in the second half of 2026 [5][10] - The company aims to enhance its R&D pipeline with differentiated vaccine candidates targeting areas of high unmet medical need [5][10]

Core Insights - Valneva SE and Instituto Butantan have initiated a Pilot Vaccination Strategy (PVS) in Brazil for Valneva's chikungunya vaccine, IXCHIQ®, aimed at generating real-world evidence on its effectiveness and safety [1][2] Group 1: Pilot Vaccination Strategy - The PVS will be implemented in ten Brazilian municipalities selected based on epidemiological and operational criteria, targeting adults aged 18 to 59 years with a goal of achieving 20% to 40% vaccine coverage [2] - Valneva will donate up to 500,000 doses of IXCHIQ® to the Brazilian Ministry of Health for the program [2] - IXCHIQ® received marketing approval in Brazil in April 2025, marking the first approval of a chikungunya vaccine in an endemic country [2] Group 2: Public Health Context - Brazil has reported over one million chikungunya cases from January 2019 to July 2024, including 263,502 cases in 2024, resulting in 246 deaths [3] - The World Health Organization has called for urgent action to prevent a potential major chikungunya epidemic globally [3] Group 3: Collaboration and Support - Valneva and Instituto Butantan signed an agreement in January 2021 for the technology transfer of the chikungunya vaccine, which will be developed and commercialized in Latin America [4] - This collaboration is supported by the Coalition for Epidemic Preparedness Innovations (CEPI) and the European Union [4]

Financial Performance - Total revenues for the first nine months of 2025 reached €127.0 million, an 8.9% increase compared to the same period in 2024, despite headwinds and reduced third-party sales [11] - Product sales amounted to €119.4 million, a 6.2% increase from €112.5 million in the first nine months of 2024 [51] - IXCHIQ® sales saw significant growth, reaching €7.6 million, a 330% increase compared to €1.8 million in the same period of 2024 [51] - The company experienced a significant reduction in operating cash burn, with €28.4 million compared to €76.7 million in the first nine months of 2024 [11] - Valneva anticipates product sales between €155 million and €170 million for 2025 [59] Product & Pipeline Updates - IXIARO®/JESPECT® sales increased by 12.5%, reaching €74.3 million compared to €66.0 million in the first nine months of 2024 [51] - DUKORAL® sales decreased slightly by 3.4%, with sales of €21.5 million compared to €22.3 million in the first nine months of 2024 [51] - Valneva completed all vaccinations in the VALOR Phase 3 study for VLA15 (Lyme disease vaccine) and expects efficacy read-out in H1 2026 [16, 27] - The global market for Shigella vaccine is expected to exceed $500 million annually [48] Strategic Initiatives - Valneva successfully refinanced its debt, enhancing financial flexibility to Q4 2030 [11] - The company secured a new $32.8 million IXIARO® contract with the U.S Department of Defense [16] - Valneva responded to the French government's call for IXCHIQ® to combat chikungunya outbreaks in La Réunion and Mayotte [16]

Core Insights - Valneva SE reported positive antibody persistence data for its chikungunya vaccine IXCHIQ® four years post-vaccination, confirming strong and long-lasting antibody levels across all age groups [1][2][9] Vaccine Efficacy - Among 254 healthy adults in the trial, 95% maintained neutralizing antibody titers significantly above the seroresponse threshold four years after a single-dose vaccination [2][4] - Antibody persistence in older adults (65+) was comparable to younger adults (18-64 years) in terms of geometric mean titers and seroresponse rates [2][9] Safety Profile - The trial VLA1553-303, supported by CEPI and the EU's Horizon Europe program, reported no safety concerns or ongoing adverse events at the time of participant enrollment [3][4] - Long-term safety data was collected for up to two years, with no serious adverse events reported [3] Strategic Partnerships - Valneva expanded its partnership with CEPI in 2024 to enhance vaccine access in low- and middle-income countries (LMICs) [4][12] - An exclusive license agreement was established with the Serum Institute of India to facilitate vaccine supply in Asia [4][12] Public Health Context - Chikungunya virus has been identified in over 110 countries, with significant economic and medical burdens expected to increase due to climate change [5][10] - The World Health Organization has recognized chikungunya as a major public health issue, emphasizing the need for effective vaccination strategies [5][10] Company Overview - Valneva is a specialty vaccine company focused on developing and commercializing vaccines for infectious diseases, addressing unmet medical needs [6][8] - The company has a strong track record in advancing multiple vaccines from early research to approvals, including proprietary travel vaccines [7][8]

Company Overview - Valneva SE is a specialty vaccine company focused on developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases, addressing unmet medical needs [7] - The company has advanced multiple vaccines from early R&D to approvals and currently markets three proprietary travel vaccines [8] Recent Developments - The FDA has suspended the license for Valneva's chikungunya vaccine IXCHIQ® due to four new reports of serious adverse events (SAEs) consistent with chikungunya-like illness, effective immediately [1][2] - This suspension follows the FDA's earlier decision to lift a recommended pause for individuals aged 60 and older, based on an investigation of reported SAEs primarily among elderly individuals with multiple underlying health conditions [2] Financial Impact - Sales of IXCHIQ® contributed €7.5 million to Valneva's total product sales of €91 million in the first half of 2025, with a significant portion attributed to a one-time delivery of vaccine doses for a chikungunya outbreak in La Reunion [4] - Valneva is evaluating the potential financial impact of a permanent withdrawal of the IXCHIQ® license in the United States but has not modified its revenue guidance at this time [4] Commitment to Safety and Access - Valneva is committed to upholding high safety standards and will continue to engage proactively with health authorities in all territories where IXCHIQ® is licensed [3] - The CEO emphasized the company's commitment to maintaining access to IXCHIQ® as a global health tool for addressing chikungunya outbreaks, particularly in low-and-middle-income countries [4] Chikungunya Overview - Chikungunya virus (CHIKV) is a mosquito-borne viral disease that has caused significant outbreaks globally since 2004, with over 3.7 million cases reported in the Americas between 2013 and 2023 [5][6] - The World Health Organization (WHO) has highlighted chikungunya as a major public health problem, with the medical and economic burden expected to grow due to climate change [6]

Core Viewpoint - Valneva SE has received marketing authorization from Health Canada for its single-dose chikungunya vaccine, IXCHIQ®, for individuals aged 12 years and older, marking a significant milestone in addressing the chikungunya virus [1][3]. Company Developments - IXCHIQ® is now authorized for adults in Canada and has received an adolescent label extension in Europe [1]. - The vaccine demonstrates a sustained immune response for 24 months in 97% of participants, with similar durability across age groups [2]. - Valneva's Chief Medical Officer emphasized the importance of making the vaccine accessible to all age groups, especially in endemic regions [3]. - IXCHIQ® was the first chikungunya vaccine approved in an endemic country, receiving authorization from Brazil earlier this year [3][4]. Industry Context - Chikungunya is increasingly recognized as a public health issue, with recent outbreaks reported in Brazil, India, and China [3][5]. - The World Health Organization has identified chikungunya as a major public health problem, with over 3.7 million cases reported in the Americas between 2013 and 2023 [5]. - Valneva's partnership with the Coalition for Epidemic Preparedness Innovations (CEPI) aims to enhance access to IXCHIQ® in low- and middle-income countries [3][4][6].