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].

Core Insights - Valneva SE, a specialty vaccine company, is set to present and hold investor meetings at various conferences in the US and Europe in June 2025 [1][2] Group 1: Upcoming Conferences - Valneva will participate in the Jefferies Global Healthcare Conference on June 5, 2025, in New York, featuring a fireside chat and investor meetings [4] - The company will also attend the Goldman Sachs 46th Annual Global Healthcare Conference on June 9, 2025, in Miami, FL, with a similar format [4] - Additionally, Valneva will engage in investor meetings at the Oddo BHF Nextcap Forum on June 12, 2025, and the BNP Paribas SMID Cap Conference on June 18, 2025, in Paris, France [5][6] Group 2: Key Discussion Topics - The discussions will focus on Valneva's commercial stage vaccines and its differentiated portfolio, particularly VLA15, which is the leading Lyme disease vaccine candidate partnered with Pfizer [2][8] - VLA15 is currently undergoing a pivotal Phase 3 trial, with the company expecting to release the first data by the end of 2025 [2] Group 3: Company Overview - Valneva specializes in developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases, addressing unmet medical needs [7] - The company has a strong track record of advancing multiple vaccines from early R&D to approvals and currently markets three proprietary travel vaccines [8] - Valneva's pipeline includes the only Lyme disease vaccine candidate in advanced clinical development, the world's most clinically advanced Shigella vaccine candidate, and candidates against the Zika virus and other public health threats [8]

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].