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].

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]