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]

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]

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]

Core Insights - Valneva SE announced positive results from its Phase 1 clinical trial for VLA1601, a second-generation vaccine candidate against the Zika virus, demonstrating improved immune response and safety [1][5][7] Group 1: Clinical Trial Details - The Phase 1 trial, VLA1601-102, involved approximately 150 participants aged 18 to 49 in the U.S., who received two doses of the vaccine at varying dosages [2] - The trial evaluated the safety and immunogenicity of VLA1601, which is an aluminum-adjuvanted inactivated vaccine, with additional adjuvants tested in the low-dose group [2][4] - Data up to Day 57 indicated that VLA1601 was generally safe and well tolerated across all treatment arms, with no safety concerns identified [3] Group 2: Immunogenicity Results - VLA1601 induced an immune response across all treatment arms, with the strongest response observed in the double-adjuvanted groups, showing significantly higher neutralizing antibody titers compared to the single-adjuvant group [4] - The second-generation vaccine candidate showed higher peak seroconversion rates (>93% vs 86%) and a greater peak Geometric Mean Fold Increase of titers (>56 fold vs >7 fold) compared to the first-generation vaccine [5] Group 3: Development Context - VLA1601 is developed using the manufacturing platform of Valneva's licensed Japanese encephalitis vaccine IXIARO®, which has been optimized for other vaccine candidates [6][9] - The Chief Medical Officer of Valneva highlighted the growing public health challenge posed by Zika virus due to climate change, but noted that further development of VLA1601 will depend on securing significant funding opportunities [7]

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].

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]

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].