Valneva (VLA) Investor Day 2024 summary

Strategic Overview and Business Model

• Focus on developing, manufacturing, and commercializing unique vaccines for high unmet medical needs, maintaining a fully integrated model with commercial and R&D pillars.

• Emphasis on financial self-sustainability, targeting profitability post-Lyme vaccine launch and subsequent royalties, with profitability targeted for 2027.

• Commercial business has rebounded post-COVID, surpassing pre-pandemic levels by 12% in 2023, with a goal to double growth by 2026-2027.

• Recent financial actions, including a €60 million private placement, aim to support key program execution and provide flexibility through the Lyme vaccine launch in 2027.

• Strategy emphasizes expanding global reach, R&D partnerships, and efficient execution to generate clinical catalysts and maximize value.

Pipeline and Product Development

• Lyme disease vaccine (VLA15) in phase 3, partnered with Pfizer, is the most clinically advanced globally, with pivotal efficacy data expected end of 2025, aiming for licensure in 2026 and market launch in 2027.

• Ixchiq, the first and only approved chikungunya vaccine, is expanding globally with label extensions, launches in Europe and Canada, and ongoing Phase 4 and pediatric studies.

• Shigella vaccine candidate, in partnership with LimmaTech, is advancing through phase 2 with a quadrivalent/tetravalent approach, targeting both travel and endemic markets, with phase 3 planned post-Lyme data.

• Zika vaccine program reactivated with a second-generation candidate in phase 1, with data expected in H1 2025, focusing on improved immunogenicity and durability.

• Early-stage R&D includes work on EBV and a next-generation ETEC vaccine, aiming to build a robust enteric disease portfolio.

Commercial and Market Outlook

• Ixiaro and Dukoral continue to drive growth, with Ixiaro expected to deliver double-digit growth for at least three years.

• Ixchiq's global opportunity estimated at €500 million, with expansion into new geographies, label updates, and increased insurance coverage supporting uptake.

• Shigella vaccine peak sales estimated at €500 million, with the majority of revenue expected from LMIC pediatric markets and significant travel segment potential.

• Financial guidance for 2024: product sales of €160-180 million, total revenues €170-190 million, and R&D spend of €60-75 million; targeting over €100 million in Ixchiq sales by year three post-launch.

• Product sales reached €68.3 million in H1 2024, up 7% year-over-year, with IXIAROⓇ and IXCHIQⓇ driving growth.