Rising to the Challenges of Rare Disease Treatment NASDAQ: SNGX March 27, 2026 Forward-Looking Statements This presentation contains forward-looking statements. All statements other than statements of historical facts contained in this presentation, including statements regarding our future results of operations and financial position, business strategy, prospective products and product candidates and their development, regulatory approvals, ability to commercialize our products and product candidates and a ...

Core Insights - Pfizer is seeking regulatory approval for a Lyme disease vaccine candidate despite it failing a late-stage trial [1][2] - The vaccine demonstrated a more than 70% reduction in infection rates compared to placebo, which Pfizer believes is sufficient for regulatory submission [2][3] Company Overview - The Lyme disease vaccine is not expected to be a major revenue driver, with peak annual sales estimated at $1 billion by partner Valneva, while Pfizer's overall revenue forecast for the year is around $60 billion [4] - The Covid-19 vaccine is projected to contribute over $5 billion to Pfizer's revenue this year [4] Clinical Trial Details - The vaccine trial missed its statistical goal due to insufficient cases of Lyme disease among participants, leading to a reduction in the study size from approximately 18,000 to 9,400 participants [2][8] - No safety concerns were reported during the trial [9] Market Context - Lyme disease affects about half a million Americans annually, yet there is currently no human vaccine available, following the withdrawal of LYMErix in 1998 due to safety concerns [6][7] - The vaccine targets the outer surface protein A of the Lyme disease-causing bacteria, aiming to prevent transmission from ticks to humans [9]

AUSTIN, Texas, March 19, 2026 (GLOBE NEWSWIRE) -- via IBN – IBN, a multifaceted communications organization engaged in connecting public companies to the investment community, is pleased to announce the release of the latest episode of The BioMedWire Podcast as part of its sustained effort to provide specialized content distribution via widespread syndication channels. The BioMedWire Podcast delivers dynamic interviews with industry experts at the forefront of pharmaceutical and biotech advancement. The lat ...

Chief Financial Officer Peter Bühler reported total product sales of EUR 157.9 million , in line with guidance, down 3.3% year over year (down 1.3% at constant currency). He attributed the decline primarily to a planned reduction in third-party product sales and, to a lesser extent, adverse currency impacts. Bühler said proprietary product sales, excluding currency effects, grew 9% year over year.Chief Executive Officer Thomas Lingelbach said total revenues exceeded EUR 170 million in 2025, slightly above 2 ...

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]

Valneva Conference Call Summary Company Overview - **Company**: Valneva - **Industry**: Biotechnology, specializing in vaccines - **Business Model**: Fully integrated model for developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases [2][3] Core Products - **Travel Vaccines**: - **IXIARO**: Licensed vaccine against Japanese encephalitis, primarily used by the U.S. Department of Defense [5] - **DUKORAL**: Vaccine against cholera and ETEC, acquired two years ago [6] - **Chikungunya Vaccine**: Recently licensed, targeting endemic countries rather than travel markets [7][8] Financial Performance - **Sales Growth**: - Historical year-over-year growth in proprietary products, with double-digit growth rates expected to continue [10] - Total revenues projected to include approximately $15 million above product sales [28] - **Strategic Focus**: - Aim to reduce third-party product sales to below 5% of total revenue by 2026 [10] - Cash flow generation from proprietary products to support R&D investments [10][28] Lyme Disease Vaccine Development - **Partnership**: Collaborating with Pfizer on a Lyme disease vaccine, the only advanced program globally [11] - **Market Opportunity**: - Estimated 80 million people in the U.S. and 200 million in Europe live in high-risk areas [17] - Potential annual sales projected to exceed $1 billion, depending on uptake rates [18] - **Clinical Trials**: - Data readout expected in H1 2026 from a placebo-controlled study involving over 10,000 participants [19][20] - Focus on efficacy after a 3-dose priming and booster schedule [19] Other Vaccine Programs - **Chikungunya**: - Focus on outbreak preparedness in endemic countries, with ongoing pilot vaccination campaigns in Brazil [25][26] - **Shigella**: - Two phase 2 studies underway, one in children and one in adults, with early signs of efficacy being monitored [27] Strategic Vision - **Future Growth**: - Plans to leverage expertise in vaccine development to address unmet medical needs [29] - Open to strategic in-licensing or M&A to expand into new disease areas, including enteric diseases and herpes viruses [30] - **Long-term Goals**: - Aim for sustained financial self-sustainability while continuing to innovate in vaccine development [29][30] Conclusion - Valneva is positioned as a leading specialty vaccine company with a strong pipeline and strategic partnerships, particularly in the Lyme disease vaccine space, while also focusing on expanding its product offerings and maintaining financial health through proprietary sales and R&D investments [2][3][29]

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]