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 the same period in 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 2024 [18][19] Business Line Data and Key Metrics Changes - IXIARO sales increased by 12.5% to EUR 74.3 million, driven by sales to the U.S. Department of Defense and increased sales in Europe [14] - DUKORAL sales decreased from EUR 22.3 million to EUR 21.5 million, impacted by foreign currency fluctuations and a transition to a new distributor in Germany [14][15] - IXCHIQ sales surged to EUR 7.6 million from EUR 1.8 million, aided by the supply of doses during a chikungunya outbreak [15] Market Data and Key Metrics Changes - The gross margin on commercial products, excluding IXCHIQ, improved to 57.2% from 48.6% in the prior year, driven by better manufacturing performance [16] - IXIARO's gross margin reached 63.2%, up from 58.8%, while DUKORAL's gross margin improved to 52.3% from 34.8% [16] Company Strategy and Development Direction - The company aims to focus on strategic investments in R&D and anticipates continuous growth in product sales, particularly from the Lyme disease vaccine, VLA15, expected to be a significant growth driver [21][22] - Valneva is working on expanding IXCHIQ into low- and middle-income countries (LMICs) and is exploring new partnerships to enhance market access [22][24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming Lyme vaccine data, which could lead to sustained profitability post-commercialization [21][22] - The company is focused on reducing cash burn and maintaining a strong cash position to support future growth initiatives [4][19] Other Important Information - The company successfully completed debt refinancing, enhancing financial flexibility [5] - Cash at the end of September 2025 was reported at EUR 143.5 million, down from EUR 168.4 million at the end of 2024 [19] Q&A Session Summary Question: Timeline for FDA response regarding IXCHIQ - Management indicated there is no predefined process for the FDA response and hopes for a collaborative interaction, although no specific timeline can be provided [29][30] Question: Impact of currency and distributor shift on DUKORAL - Management acknowledged currency impacts and noted a technical delay in sales due to the transition to a new distributor in Germany, expecting continued growth for DUKORAL [31][32] Question: Timing for Lyme phase III readout - Management stated that Pfizer controls the process and is taking steps to ensure timely results, with no major delays anticipated [36][38] Question: IXCHIQ BLA suspension and proposed remedies - The response to the FDA focused on medical evidence and a positive risk-benefit ratio, with ongoing pharmacovigilance reviews [40][41] Question: Launch timeline for VLA15 - Management confirmed that timelines communicated by Pfizer support a launch in the autumn of 2027, contingent on regulatory submission next year [46] Question: Future growth drivers for IXCHIQ - Management sees growth opportunities in travel and endemic countries, with ongoing discussions for market access in various territories [47][48] Question: Funding considerations for Zika vaccine candidate - Management highlighted uncertainties around funding and regulatory pathways, indicating that substantial funding would be necessary to proceed with development [54][55]

Core Insights - Valneva SE reported consolidated financial results for the first nine months of 2025, showing total revenues of €127.0 million, an increase of 8.9% compared to €116.6 million in the same period of 2024 [2][10][17] - The company experienced a net loss of €65.2 million in the first nine months of 2025, contrasting with a net profit of €24.7 million in the same period of 2024, primarily due to the absence of one-time proceeds from the sale of a Priority Review Voucher [2][28] - Valneva's financial position was strengthened through successful debt refinancing, which improved financial terms and reduced operating cash burn [2][10] Financial Performance - Total revenues for the first nine months of 2025 were €127.0 million, up from €116.6 million in 2024, driven by product sales of €119.4 million, which increased by 6.2% from €112.5 million [2][18] - Adjusted EBITDA loss was €37.7 million in the first nine months of 2025, compared to a profit of €48.6 million in the same period of 2024, influenced by the previous year's one-time sale of the Priority Review Voucher [27][28] - Cash and cash equivalents stood at €143.5 million as of September 30, 2025, down from €168.3 million at the end of 2024 [32] Product Sales and Portfolio - Valneva's commercial portfolio includes three travel vaccines: IXIARO/JESPECT, DUKORAL, and IXCHIQ, with IXIARO/JESPECT sales increasing by 12.5% to €74.3 million in the first nine months of 2025 [3][6] - DUKORAL sales decreased slightly to €21.5 million, impacted by currency fluctuations and a transition in distribution to CSL Seqirus [7][20] - IXCHIQ sales rose significantly to €7.6 million, aided by supply for a chikungunya outbreak, although U.S. license suspension affected traveler segment sales [8][9] Research and Development - Valneva is advancing its Lyme disease vaccine candidate, VLA15, with the Phase 3 VALOR study on track, and results expected in the first half of 2026 [11][12] - The company is also developing a tetravalent Shigella vaccine candidate, S4V2, which has received Fast Track designation from the FDA, indicating its potential to address unmet medical needs [13][14] - Positive Phase 1 results were reported for the Zika vaccine candidate, VLA1601, although further development will depend on securing funding [15][16] Cost Management - Operating expenses were managed effectively, with research and development expenses increasing to €59.7 million, primarily due to costs associated with the Shigella vaccine candidate [22] - Marketing and distribution expenses decreased to €28.6 million, reflecting reduced advertising and promotional spending [23] - General and administrative expenses were reduced to €29.5 million, attributed to lower recruitment and insurance costs [24]

Financial Performance - Valneva reported total revenues of €49.2 million for Q1 2025, a 50.3% increase from €32.8 million in Q1 2024 [8][28] - Product sales reached €48.6 million, up 51.2% from €32.1 million in the same period last year [8][28] - The company incurred a net loss of €9.2 million in Q1 2025, 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 [8][42] - Adjusted EBITDA loss was €0.6 million in Q1 2025, down from a profit of €73.0 million in Q1 2024 [8][41] - Operating cash burn was reduced by 71% to €8.1 million in Q1 2025 from €28.4 million in Q1 2024 [8][44] Product Sales and Growth - Sales of the Japanese Encephalitis vaccine IXIARO/JESPECT increased by 65.5% to €27.5 million in Q1 2025, driven by demand from travelers and the U.S. Department of Defense [6][29] - DUKORAL sales grew 9.4% to €12.3 million, supported by a supply agreement with the French government [9][30] - IXCHIQ sales rose significantly to €3.0 million from €0.2 million in Q1 2024, with most doses shipped in April 2025 [10][30] Cash Position and Financial Outlook - Cash and cash equivalents stood at €153.0 million as of March 31, 2025, down from €168.3 million at the end of 2024 [8][47] - The company confirmed its financial guidance for 2025, expecting product sales to grow to €170-180 million and total revenues to reach €180-190 million [2][8] - Total R&D investments are projected between €90-100 million for 2025, partially offset by grant funding and anticipated R&D tax credits [8] Clinical and Regulatory Developments - Valneva is anticipating the first data from its Lyme disease Phase 3 program by the end of 2025 [2] - The company received marketing authorization for IXCHIQ in the UK and Brazil, marking significant milestones for its chikungunya vaccine [11][12] - IXCHIQ has also received label extensions in the EU for adolescents and is under review in multiple countries [11][12] Strategic Partnerships and Future Plans - Valneva has entered into an exclusive license agreement with the Serum Institute of India to supply its chikungunya vaccine in Asia [12] - The company is focusing on ramping up sales and expanding its vaccine portfolio in additional countries [11] - Valneva aims to reduce third-party sales to less than 5% of overall product sales by 2026/2027 to improve gross margins [16]