Core Insights - Valneva reported total product sales of EUR 157.9 million for the year, a decrease of 3.3% year over year, attributed mainly to a planned reduction in third-party product sales and adverse currency impacts [1][5] - The company achieved total revenues exceeding EUR 170 million in 2025, with a cash position of nearly EUR 110 million and a more than 20% reduction in operating cash burn [2][5] - The upcoming phase 3 data for the Lyme disease vaccine candidate VLA15, partnered with Pfizer, is highlighted as a significant near-term value driver [3][6] Financial Performance - Valneva's total revenues for 2025 were reported at over EUR 170 million, with product sales around EUR 158 million and an operating loss of EUR 82.1 million [5][21] - The company guided for 2026 product sales between EUR 145 million and EUR 160 million, and total revenues of EUR 155 million to EUR 170 million, indicating a forecasted decline mainly due to planned cuts in third-party sales [5][22] - Operating cash burn was reduced by over 20%, reflecting disciplined cash management [2][5] Product and Pipeline Highlights - IXIARO sales grew to EUR 98.4 million, a 4.6% increase year over year, while IXCHIQ reached EUR 8.4 million, driven by a pilot campaign in Brazil [4][9] - Third-party product sales fell to EUR 19.2 million, down from EUR 33.2 million, due to the termination of distribution contracts [4][9] - The Lyme disease vaccine VLA15 is undergoing a pivotal phase 3 trial with results expected in the first half of 2026 [6][10] Research and Development - R&D expenses increased to EUR 85.3 million, driven by higher spending on the phase 2 Shigella program and increased investment in IXCHIQ [20] - The company is also focusing on the chikungunya vaccine IXCHIQ, with a pilot vaccination campaign initiated in Brazil [15][16] - Progress is being made on the Shigella candidate S4V2, with ongoing phase 2 studies and data expected around mid-2026 [17] Strategic Outlook - Management emphasized a focus on self-sustainability, particularly if the Lyme vaccine is approved, aiming for potential profitability [22] - The company is refining its commercial strategy and expanding partnerships for its vaccine portfolio, particularly in low- and middle-income countries [15][16]

Financial Data and Key Metrics Changes - Total revenues exceeded EUR 170 million, slightly above 2024 levels, with almost EUR 160 million in product sales [4] - Operating cash burn reduced by over 20%, driven by disciplined cash management [5] - Loss for the period reached EUR 115.2 million, with an adjusted EBITDA reported 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 reduction in third-party sales [15] - IXIARO sales grew to EUR 98.4 million, representing a growth of 4.6% [15] - IXCHIQ sales increased to EUR 8.4 million from EUR 3.7 million in the prior year [16] Market Data and Key Metrics Changes - Proprietary product sales, excluding currency effects, grew by 9% year-over-year [15] - Third-party sales decreased significantly from EUR 33.2 million to EUR 19.2 million due to the termination of distribution contracts [16] Company Strategy and Development Direction - The company aims to become a leading vaccine biotech company by growing its commercial business and optimizing cash generation [6] - Plans to enhance the R&D pipeline with a focus on vector-borne diseases and expanding beyond this area [23] - Strategic in-licensing to augment the pipeline and create a risk-balanced portfolio of innovative vaccine assets [23] Management's Comments on Operating Environment and Future Outlook - Management highlighted resilience in a year marked by geopolitical uncertainty and rising vaccine hesitancy [4] - Positive phase 3 results for the Lyme disease vaccine candidate could be transformational, delivering substantial revenue [22] - The company expects total product sales in 2026 to be between EUR 145 million and EUR 160 million, with a focus on reducing operating cash burn [20] Other Important Information - The company closed the year with a cash position of nearly EUR 110 million and enhanced financial flexibility through successful debt refinancing [4] - The Lyme disease vaccine candidate, VLA15, is currently in a pivotal phase 3 study with results expected in the first half of 2026 [6][9] Q&A Session Summary Question: What is the expected timeline for the Lyme data readout? - Management indicated that Pfizer controls the study execution and expects data around mid of H1 2026 [27] Question: What gives confidence in VLA15's efficacy across different serotypes? - Management noted preclinical models showed promising results, but human data is still needed to confirm efficacy across serotypes [30] Question: How will capital allocation change if Lyme is successful? - Management stated that positive phase 3 data would not yield immediate milestones, with commercial sales milestones expected later [34] Question: What is the status of the DoD contract for IXIARO? - Management confirmed that a new contract is expected this year, and current shipments continue under the existing contract [46][58] Question: What are the next steps for the chikungunya vaccine VLA1553? - Management expects approval from Anvisa soon and is evaluating commercialization strategies in Asia [62][64]

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]

Full Year 2025 Financial Results and Business Update Disclaimer A Leading Specialty Vaccine Company This presentation does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, Valneva SE shares to any person in the USA or in any jurisdiction to whom or in which such offer or solicitation is unlawful. Valneva is a European company. Information distributed is subject to European disclosure requirements that are different from those of the United States. Financial sta ...

Core Insights - Valneva SE reported its audited consolidated financial results for the year ended December 31, 2025, confirming its financial guidance for 2026 and filing its annual report with regulatory authorities [1][3][43] Financial Performance - Total revenues for 2025 were €174.7 million, an increase from €169.6 million in 2024, driven by product sales and collaboration agreements [6][7][24] - Product sales amounted to €157.9 million, down from €163.3 million in 2024, reflecting a planned reduction in third-party sales by 42.3% [7][10] - The net loss for 2025 was €115.2 million, compared to a net loss of €12.2 million in 2024, primarily due to the absence of a significant gain from the sale of a Priority Review Voucher in the previous year [7][32] - Operating cash burn improved to €52.9 million in 2025 from €67.2 million in 2024, indicating better cost management [6][34] Product Sales Breakdown - IXIARO®/JESPECT® sales increased by 4.6% to €98.4 million, benefiting from growth in the travel market [11] - DUKORAL® sales were €31.9 million, slightly down from €32.3 million in 2024, affected by currency fluctuations and distribution changes [12] - IXCHIQ® sales rose to €8.4 million from €3.7 million in 2024, supported by its launch in several European countries [13] Clinical Developments - The Phase 3 data readout for the Lyme disease vaccine candidate VLA15 is expected in the first half of 2026, which could significantly impact the company's future [4][15] - Valneva is also advancing its Shigella vaccine candidate S4V2, with Phase 2 results anticipated mid-2026 [21][22] 2026 Financial Guidance - Total revenues for 2026 are projected to be between €155 million and €170 million, with product sales expected to range from €145 million to €160 million [6][7] - The guidance reflects continued growth in established brands but anticipates a decline in third-party sales [7][10] Cash Position and Management - The company ended 2025 with a strong cash position of €109.7 million, down from €168.3 million in 2024, but with improved financial flexibility following successful debt refinancing [6][37] - Disciplined cash management will remain a priority, with expectations for further reductions in operating cash burn in 2026 [7][34]

A Leading Specialty Vaccine Company March 2026 Disclaimer This presentation does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, Valneva SE shares to any person in the USA or in any jurisdiction to whom or in which such offer or solicitation is unlawful. Valneva is a European company. Information distributed is subject to European disclosure requirements that are different from those of the United States. Financial statements and information may be prepared ac ...

Core Insights - Valneva SE, a specialty vaccine company, is set to present and engage with investors at various upcoming conferences in the United States and Europe [1][2] Group 1: Upcoming Conferences - CEO Thomas Lingelbach and CFO Peter Buhler will discuss key value drivers and upcoming catalysts, including the Phase 3 data readout for VLA15, the Lyme disease vaccine candidate, expected from Pfizer in the first half of 2026 [2] - The TD Cowen 46th Annual Health Care Conference will take place on March 4, 2026, at 11:10 am ET in Boston, Massachusetts, featuring a presentation and investor meetings [3] - The 2026 Jefferies Biotech on the Beach Summit is scheduled for March 10, 2026, in Miami, Florida, focusing on investor meetings [3] - The Van Lanschot Kempen Life Sciences Conference will occur on April 15, 2026, in Amsterdam, Netherlands, with opportunities for institutional investors to meet Valneva management [4] Group 2: Company Overview - Valneva SE specializes in developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases, addressing unmet medical needs with a targeted approach [5] - The company has a strong track record of advancing multiple vaccines from early R&D to approvals and currently markets three proprietary travel vaccines [6] - Revenues from the growing commercial business support the advancement of Valneva's vaccine pipeline, which includes the only Lyme disease vaccine candidate in advanced clinical development partnered with Pfizer, as well as candidates for other global public health threats [7]

Core Insights - Valneva SE reported preliminary unaudited full-year 2025 revenue of €174.7 million, including €157.9 million in product sales, which is in line with guidance [4][5] - The company anticipates a transformative year in 2026 with Phase 3 data for its Lyme disease vaccine candidate expected in the first half of the year [5][10] - Valneva's Chief Executive Officer, Thomas Lingelbach, has had his contract renewed for an additional three years, ensuring continuity in leadership [5][10] 2025 Financial Results - Total revenues for 2025 were €174.7 million, compared to €169.6 million in 2024, reflecting a year-over-year growth of approximately 0.6% [5][7] - Product sales decreased to €157.9 million from €163.3 million in 2024, a decline of 3.3%, with third-party sales dropping by 42.3% to €19.2 million [5][7] - Excluding third-party sales, product sales increased by 6.7% year-over-year, with a 9% increase at constant exchange rates [7] Cash Position and Financial Guidance - The company reported a strong year-end cash position of €109.7 million as of December 31, 2025, down from €168.3 million in 2024, following successful debt refinancing [5][7] - For 2026, total revenues are expected to range between €155-170 million, with product sales projected between €145-160 million, reflecting continued growth in established brands but a decline in third-party sales [5][10] - Operating cash burn is expected to decline further in 2026 while maintaining strategic R&D investments [5] R&D Pipeline and Future Prospects - The first Phase 3 data readout for the Lyme disease vaccine candidate is anticipated in the first half of 2026, with regulatory submissions planned by Pfizer, contingent on positive results [5][10] - Valneva is also progressing with its tetravalent shigella vaccine candidate, with a decision on further development expected in the second half of 2026 [5][10] - The company aims to enhance its R&D pipeline with differentiated vaccine candidates targeting areas of high unmet medical need [5][10]

Core Insights - Valneva SE has released final immunogenicity and safety data from the Phase 2 study of its Lyme disease vaccine candidate, VLA15, indicating a strong immune response and favorable safety profile six months after a third booster dose [1][2][4] Vaccine Efficacy and Safety - The study demonstrated a robust anamnestic immune response across all age groups, confirming the vaccine's compatibility with the expected benefits of annual vaccination before Lyme season [2][4] - Antibody levels remained significantly higher with a three-dose primary vaccination schedule compared to a two-dose schedule, with geometric mean fold rises (GMFRs) ranging from 9.5-fold for Serotype 1 (ST1) to 15.6-fold for Serotype 2 (ST2) [5][6] - The highest GMFRs were observed in the 5 to 11-year-old age group, with levels ranging from 15.5-fold (ST1) to 28.5-fold (ST2), further validating the three-dose schedule and yearly booster [6] Regulatory Pathway - Pfizer aims to submit a Biologics License Application to the U.S. FDA and a Marketing Authorization Application to the European Medicines Agency in 2026, contingent on positive Phase 3 data [4] Operational Strategy - Valneva announced a strategic initiative to optimize its organizational footprint in France, planning to consolidate operations at its Lyon location and close the Nantes site [7] Market Reaction - Following the announcement, Valneva shares increased by 7.65%, reaching $9.19 [8]

Core Insights - Valneva SE announced positive final immunogenicity and safety data from the Phase 2 study of its Lyme disease vaccine candidate, VLA15, indicating strong immune response and favorable safety six months after a third booster dose, supporting the concept of yearly vaccinations before Lyme season [1][4][6] Company Overview - Valneva SE is a specialty vaccine company focused on developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases, addressing unmet medical needs [9] - The company has advanced multiple vaccines from early R&D to approvals and currently markets three proprietary travel vaccines [10] - Valneva's commercial revenues support the advancement of its vaccine pipeline, including the only Lyme disease vaccine candidate in advanced clinical development, partnered with Pfizer [11] Vaccine Development - VLA15 is the most advanced Lyme disease vaccine candidate, with all vaccinations completed in the pivotal VALOR Phase 3 trial [2] - The vaccine targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria causing Lyme disease, and covers the six most prevalent OspA serotypes in North America and Europe [5] - The Phase 2 study, VLA15-221, included a pediatric population and demonstrated that antibody levels remained well above baseline across all serotypes and age groups six months after the third booster dose [6][7] Market Need - There are currently no approved human vaccines for Lyme disease, with approximately 476,000 cases diagnosed annually in the U.S. and 132,000 cases reported in Europe [2][8] - The geographic expansion of Lyme disease highlights the pressing medical need for vaccination, as early symptoms are often overlooked, leading to serious chronic complications if untreated [8]