Financial Data and Key Metrics Changes - Total revenues reached EUR 127 million for the nine months ended September 30, 2025, representing a growth of almost 9% compared to EUR 112.5 million in the same period of 2024 [4][16] - Product sales increased to EUR 119.4 million, up 6.2% from EUR 112 million in the first nine months of 2024 [14] - Operating loss reported at EUR 53.9 million compared to an operating profit of EUR 34.2 million in the prior year, primarily due to the sale of a priority review voucher in the previous year [18] Business Line Data and Key Metrics Changes - IXIARO sales reached EUR 74.3 million, increasing 12.5% year-over-year, driven by sales to the U.S. Department of Defense and increased sales in some European countries [14] - Ducoral sales decreased from EUR 22.3 million to EUR 21.5 million, impacted by foreign currency fluctuations and lower sales during the transition to a new distributor in Germany [14][15] - Exchange sales significantly increased to EUR 7.6 million from EUR 1.8 million, including the supply of doses to combat a chikungunya outbreak [15] Market Data and Key Metrics Changes - The company is focusing on expanding into low- and middle-income countries (LMICs) and new territories for IXIARO, leveraging its differentiated product profile [20][21] - The Lyme disease vaccine, VLA15, is expected to be a major growth driver, with regulatory submissions anticipated in 2026 and a potential launch in autumn 2027 [20][31] Company Strategy and Development Direction - The company aims to achieve sustainable profitability post-approval and commercialization of the Lyme disease vaccine, which is seen as a significant growth catalyst [20][21] - Valneva is actively identifying new opportunities for its R&D pipeline, aiming to build a coherent strategy for future vaccine candidates [22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming Lyme disease vaccine data, which is expected to be a pivotal moment for the company [20][37] - The company is focused on reducing cash burn and ensuring sufficient runway to reach key inflection points, with cash at September 30 reported at EUR 143.5 million [18][19] Other Important Information - The company successfully completed debt refinancing, enhancing financial flexibility [5] - Research and development expenses increased to EUR 59.7 million, partly due to costs related to the Shigella vaccine candidate [17] Q&A Session Summary Question: Timeline for FDA response regarding exchange - Management indicated there is no predefined process for the FDA response and hopes for a collaborative interaction [24][25] Question: Impact of currency and distributor shift on Ducoral sales - Management noted that the transition to a new distributor in Germany caused a technical delay in purchases, but growth for Ducoral is expected to continue [25][26] Question: Timing for Lyme phase 3 readout - Management stated that Pfizer controls the process and is taking steps to ensure an early readout, with no major delays anticipated [27][28] Question: Remedies proposed to FDA for exchange BLA suspension - The response to the FDA focused on medical evidence and positive risk-benefit ratios, with ongoing pharmacovigilance reviews [29] Question: Launch timeline for VLA15 - Management confirmed that timelines communicated by Pfizer support a launch in the autumn of 2027, contingent on regulatory submissions next year [30][31] Question: Funding considerations for Zika vaccine candidate - Management highlighted uncertainty around funding and regulatory pathways, indicating that substantial funding would be necessary to proceed with development [33][36]