Valneva Reports First Nine Months 2025 Financial Results and Provides Corporate Updates November 20, 2025 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 Stat ...

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].

Financial Performance - H1 2025 - Total revenues reached €97.6 million, representing a 38% year-over-year growth[10] - Product sales amounted to €91 million, driven by IXIARO®/JESPECT®, DUKORAL®, and IXCHIQ®[62] - IXCHIQ® sales showed significant growth, increasing by 688% to €7.5 million[62] - The company experienced a significant reduction in operating cash burn, targeting a 50% reduction compared to 2024[10] - Adjusted EBITDA was a loss of €6.0 million[64] Product Performance - H1 2025 - IXIARO®/JESPECT® sales increased by 30.6% to €54.7 million[62] - DUKORAL® sales increased by 16.4% to €17.4 million, including €1.1 million from doses supplied to Mayotte[62, 63] - Third-party product sales increased by 8.8% to €11.4 million[62] Financial Outlook - 2025 - The company projects product sales between €170 million and €180 million[70] - Total revenues are expected to be in the range of €180 million to €190 million[70] - R&D expenses are projected to be between €90 million and €100 million, partially offset by grant funding and R&D tax credits[70]

Core Viewpoint - Valneva SE reported strong financial results for the first half of 2025, with total revenues of €97.6 million, a 37.8% increase compared to the same period in 2024, while confirming its financial guidance for the year [5][6][28]. Financial Performance - Total revenues reached €97.6 million in H1 2025, up from €70.8 million in H1 2024, marking a 37.8% increase [6][28]. - Product sales amounted to €91.0 million, a 33.3% increase from €68.3 million in H1 2024 [6][10]. - The company reported a net loss of €20.8 million in H1 2025, compared to a net profit of €34.0 million in H1 2024, which included a one-time gain from the sale of a Priority Review Voucher [6][38]. - Cash and cash equivalents stood at €161.3 million as of June 30, 2025, slightly down from €168.3 million at the end of 2024 [43]. R&D and Regulatory Updates - Valneva is focused on the Phase 3 data readout for its Lyme disease vaccine candidate, VLA15, which is in collaboration with Pfizer [3][19]. - The company has made significant progress in clinical and regulatory areas, including the launch of IXCHIQ® in response to a chikungunya outbreak [7][15]. - IXCHIQ® sales increased to €7.5 million in H1 2025, compared to €1.0 million in H1 2024, benefiting from supply to La Réunion [16][17]. Commercial Developments - Valneva finalized a $32.8 million supply contract for IXIARO® with the U.S. Department of Defense [7][13]. - An exclusive agreement was signed with CSL Seqirus for the marketing and distribution of Valneva's vaccines in Germany [11]. - The company expects product sales to grow to €170-180 million in 2025, contributing to positive cash flow [6][40]. Cost Management - Operating cash burn was significantly reduced to €10.9 million in H1 2025 from €66.3 million in H1 2024, reflecting improved sales and cost management [6][40]. - Research and development expenses increased to €32.4 million in H1 2025, driven by costs related to the Shigella vaccine candidate [32].

Company Overview - Valneva SE is a specialty vaccine company focused on developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases, addressing unmet medical needs [6] - The company has advanced multiple vaccines from early R&D to approvals and currently markets three proprietary travel vaccines [7] - Revenues from its growing commercial business support the advancement of its vaccine pipeline, which includes candidates for Lyme disease, Shigella, Zika virus, and other public health threats [8] Vaccine Development and Regulatory Update - The European Medicines Agency (EMA) has lifted the temporary restriction on vaccinating individuals aged 65 and above with Valneva's chikungunya vaccine IXCHIQ® after a thorough safety review [1][2] - The review was initiated due to serious side effects observed mainly in elderly individuals with underlying medical conditions, but the EMA concluded that IXCHIQ® should be administered when there is a significant risk of chikungunya infection [2][3] - IXCHIQ® is effective in producing antibodies against the chikungunya virus, which is particularly beneficial for older individuals at increased risk of severe disease [3] Chikungunya Disease Context - Chikungunya virus (CHIKV) is a mosquito-borne disease causing debilitating symptoms, including fever and severe joint pain, with significant global outbreaks since 2004 [4][5] - The disease has been reported in over 110 countries, with more than 3.7 million cases in the Americas between 2013 and 2023, leading to a considerable medical and economic burden [5]

Core Insights - Valneva SE has entered into an exclusive agreement with CSL Seqirus for the marketing and distribution of its three proprietary vaccines in Germany [1][2] - The agreement includes the commercialization of Valneva's chikungunya vaccine IXCHIQ® starting July 2025, and its Japanese Encephalitis vaccine IXIARO® and cholera/ETEC vaccine DUKORAL® from January 2026 [2] - This new agreement replaces a previous partnership with Bavarian Nordic, which is set to conclude at the end of December 2025 [2][3] Company Performance - Valneva's product sales reached €48.6 million in Q1 2025, with €42.8 million coming from proprietary vaccines [4] - The company anticipates product sales to grow to €170-180 million in 2025, contributing to positive cash flows for its commercial business [4] Strategic Focus - The partnership with CSL Seqirus is expected to enhance Valneva's commercial sales in Germany, leveraging CSL's strong presence in the travel vaccine market [4] - Valneva specializes in developing vaccines for infectious diseases, focusing on unmet medical needs and applying expertise across multiple vaccine modalities [5][6] Pipeline Development - Revenues from the commercial business support the advancement of Valneva's vaccine pipeline, which includes a Lyme disease vaccine candidate partnered with Pfizer and a Shigella vaccine candidate [7]

Core Viewpoint - Valneva SE reported strong financial results for Q1 2025, with significant revenue growth and reduced operational cash burn, while confirming its financial guidance for the year [3][5][6]. Financial Performance - Total revenues for Q1 2025 were €49.2 million, a 50.3% increase from €32.8 million in Q1 2024 [5][6]. - Product sales reached €48.6 million, up 51.2% from €32.1 million in the same period last year [6][31]. - The company reported a net loss of €9.2 million compared to a net profit of €58.9 million in Q1 2024, which included €90.8 million from the sale of a Priority Review Voucher [6][45]. - Operating cash burn was reduced by 71% to €8.1 million in Q1 2025 from €28.4 million in Q1 2024 [6][47]. - Cash and cash equivalents stood at €153.0 million as of March 31, 2025, down from €168.3 million at the end of 2024 [6][50]. Product Sales and Market Developments - IXIARO®/JESPECT® sales increased by 65.5% to €27.5 million, driven by demand from travelers and the U.S. Department of Defense [10][32]. - DUKORAL® sales grew 9.4% to €12.3 million, supported by a supply agreement with the French government [12][33]. - IXCHIQ® sales surged to €3.0 million from €0.2 million in Q1 2024, with initial sales related to a chikungunya outbreak response [13][34]. - Third-party product sales increased to €5.8 million from €4.1 million, reflecting recovery from previous supply constraints [18][35]. Research and Development Highlights - Valneva is advancing its Lyme disease vaccine candidate, VLA15, with primary vaccinations completed and data expected by the end of 2025 [20][21]. - The company is also developing a tetravalent Shigella vaccine candidate, S4V2, with ongoing Phase 2 studies [23][24]. - A Phase 1 trial for a Zika vaccine candidate, VLA1601, is currently underway, with results anticipated this year [28][29]. Strategic Partnerships and Regulatory Progress - Valneva secured a $32.8 million supply contract for IXIARO® with the U.S. Department of Defense [7][11]. - The company received marketing authorization for IXCHIQ® in the UK and Brazil, marking significant milestones for its chikungunya vaccine [7][14][15]. - Valneva has entered into a licensing agreement with the Serum Institute of India to expand access to its chikungunya vaccine in Asia [15][61]. Financial Outlook - The company expects product sales to grow to €170-180 million in 2025, with total revenues projected to reach €180-190 million [6][5]. - R&D investments are anticipated to be between €90-100 million in 2025, partially offset by grant funding and tax credits [6][5].

Core Insights - Valneva SE has received marketing authorization from Brazil's ANVISA for its single-dose chikungunya vaccine IXCHIQ®, marking the first approval of a chikungunya vaccine in an endemic country [1][2] - The vaccine is part of Valneva's strategy to enhance access in low- and middle-income countries (LMICs), supported by CEPI and the EU [1][6] - The approval allows for large-scale clinical trials in Brazil, including Phase 4 trials to gather additional data on vaccine effectiveness [3] Company Developments - IXCHIQ® is already approved in the EU for individuals aged 12 and older and in the U.S., Canada, and the U.K. for those aged 18 and older [2] - Valneva is collaborating with Instituto Butantan for local manufacturing and distribution of the vaccine in Brazil, with potential approval for another vaccine candidate, VLA1555, expected in mid-2025 [4] - The company aims to ensure rapid access to its vaccines in Brazil and other regional markets, addressing a significant public health need as Brazil reported over 1 million chikungunya cases since 2019 [5][6] Clinical Trials and Research - Valneva is conducting a Phase 2 trial in children aged 1 to 11 years in the Dominican Republic and Honduras, with positive results reported in January 2025 [7] - A pivotal Phase 3 study in children is expected to begin in Q4 2025, with plans to evaluate the vaccine in pregnant women in outbreak-affected countries [8] Public Health Context - Chikungunya virus, transmitted by Aedes mosquitoes, has caused significant outbreaks globally, with over 720,000 cases reported in the Americas from January to July 2023 [5][10] - The World Health Organization has identified chikungunya as a major public health issue, with the disease's economic impact expected to grow due to climate change [10]