Financial Data and Key Metrics Changes - Total revenues for Valneva exceeded EUR 170 million, slightly above 2024 levels, with nearly EUR 160 million in product sales [4] - Operating loss reached EUR 82.1 million compared to an operating profit of EUR 13.3 million in 2024, primarily due to non-recurring income from the sale of a priority review voucher in the previous year [20] - The company reported a loss for the period of EUR 115.2 million, with adjusted EBITDA at -EUR 51.4 million [20] Business Line Data and Key Metrics Changes - Total product sales reached EUR 157.9 million, decreasing by 3.3% over 2024, primarily due to planned reductions in third-party sales [15] - IXIARO sales grew to EUR 98.4 million, a 4.6% increase from EUR 94.1 million in 2024, driven by the travel segment [15] - IXCHIQ sales increased significantly to EUR 8.4 million from EUR 3.7 million in the prior year, including the supply of 40,000 doses to La Réunion [16] Market Data and Key Metrics Changes - The company noted a significant reduction in third-party sales from EUR 33.2 million to EUR 19.2 million due to the termination of distribution contracts [16] - Other revenues increased from EUR 6.3 million to EUR 16.8 million, driven by a EUR 10 million revenue recognition related to a license agreement with Pfizer [17] Company Strategy and Development Direction - Valneva aims to become a leading vaccine biotech company by focusing on growing its commercial business and optimizing cash generation [5] - The company is advancing its Lyme disease vaccine candidate, VLA15, which represents a significant opportunity in an underserved market [6] - Valneva plans to expand beyond vector-borne diseases and is exploring in-licensing opportunities to enhance its R&D pipeline [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of the Lyme disease vaccine, with positive phase 3 results expected to be transformational for the company [22] - The company anticipates total product sales in 2026 to be between EUR 145 million and EUR 160 million, reflecting further planned reductions in third-party product sales [20] - Management emphasized the importance of cash management and reducing operating cash burn as key focuses moving forward [20] Other Important Information - Valneva achieved a more than 20% reduction in operating cash burn through disciplined cash management [5] - The company is investing in the further development of IXCHIQ and has initiated a pilot vaccination campaign in Brazil [10] Q&A Session Summary Question: When will Lyme data be available? - Management indicated that Pfizer controls the phase 3 study and expects data in the first half of 2026, with hopes for mid-H1 results [28] Question: What is the confidence level regarding VLA15's efficacy across different serotypes? - Management stated that preclinical models have shown promising results, but human data is still needed to confirm efficacy across serotypes [32] Question: What is the status of the DoD contract for IXIARO? - Management confirmed that a new contract is expected this year, and it is included in the revenue guidance for 2026 [63] Question: What are the criteria for ACIP recommendations for VLA15? - Management noted that ACIP recommendations depend on safety and efficacy data, with a focus on high-risk populations [44] Question: What are the next steps for IXCHIQ in Asia? - Management is evaluating potential partners and commercialization strategies for IXCHIQ in Asia, with announcements expected later this year [68]

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]

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 [2] Financial Impact - IXCHIQ sales 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] Commitment to Safety and Access - Valneva is committed to maintaining high safety standards and will continue to engage with health authorities regarding IXCHIQ [3] - The CEO emphasized the company's commitment to providing access to IXCHIQ globally, especially in low-and-middle-income countries affected by chikungunya outbreaks [4] Industry Context - Chikungunya virus (CHIKV) is a mosquito-borne disease that has been identified in over 110 countries, with significant medical and economic burdens expected to grow due to climate change [5][6] - The World Health Organization (WHO) has highlighted chikungunya as a major public health problem, indicating the ongoing need for effective vaccines [6]

Core Viewpoint - Bavarian Nordic A/S has received marketing authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its chikungunya vaccine, VIMKUNYA, aimed at individuals aged 12 and older, with a planned launch in the UK during the summer of 2025 [1][2][3]. Group 1: Vaccine Approval and Launch - The approval of VIMKUNYA follows a review under the international recognition procedure, acknowledging prior approvals from other regulatory bodies, including the European Commission [2]. - This marks the third approval for Bavarian Nordic's chikungunya vaccine, following approvals from the U.S. FDA and the European Commission in February 2025 [3]. Group 2: Disease Background - Chikungunya is a mosquito-borne disease that has emerged in over 110 countries, with significant outbreaks reported in Asia, Africa, and the Americas [4]. - In 2024, there were 620,000 reported cases of chikungunya globally, resulting in over 200 deaths, indicating a potential underreporting of the disease [4]. Group 3: Vaccine Details and Efficacy - VIMKUNYA is a single-dose, adjuvanted VLP recombinant protein vaccine designed for active immunization against chikungunya virus [5]. - Phase 3 clinical trials involving over 3,500 participants demonstrated that 21 days post-vaccination, up to 97.8% of individuals developed neutralizing antibodies [6]. Group 4: Company Overview - Bavarian Nordic is a global vaccine company focused on improving health through innovative vaccines, with a strong portfolio in travel vaccines and public health preparedness [7].

Core Insights - Valneva SE has submitted a label extension application to the UK Medicines and Healthcare products Regulatory Agency (MHRA) to expand the use of its chikungunya vaccine, IXCHIQ®, to adolescents aged 12 to 17 years, following a positive opinion from the European Medicines Agency (EMA) for the same extension in the EU [1][2]. Company Developments - IXCHIQ® is the world's first licensed chikungunya vaccine, currently approved for individuals aged 18 and older in the U.S., Europe, Canada, and the UK [2][3]. - Valneva has committed to supplying 40,000 doses of IXCHIQ® to La Réunion, responding to a call from the French government amid ongoing chikungunya outbreaks [3][4]. - The company is focused on expanding the vaccine's accessibility, with positive Phase 3 data showing a 99.1% immune response in adolescents after a single dose, and a sustained 98.3% sero-response rate one year post-vaccination [4][5]. Partnerships and Funding - In Q3 2024, Valneva expanded its partnership with the Coalition for Epidemic Preparedness Innovations (CEPI) through a $41.3 million grant aimed at increasing vaccine access in low- and middle-income countries (LMICs) [5][6]. - An exclusive license agreement was signed with the Serum Institute of India to supply IXCHIQ® in Asia, ensuring affordable pricing for public health markets in LMICs [6][7]. - Valneva previously established a license agreement with Instituto Butantan in Brazil for a local chikungunya vaccine, further enhancing its distribution capabilities in Latin America [7]. Public Health Context - Chikungunya has emerged as a significant public health concern, with outbreaks reported in India, Brazil, and La Réunion, and the World Health Organization (WHO) has identified it as a major public health problem [3][9]. - The chikungunya virus has been reported in over 110 countries since its re-emergence in 2004, with over 3.7 million cases documented in the Americas between 2013 and 2023 [9].