Valneva SE Q4 FY2025 earnings call

• Resilience and focus in 2025: Despite geopolitical uncertainty, vaccine hesitancy, and biotech consolidation, Volneva stayed focused, agile, and strengthened its position as an innovative vaccine company. - Financial performance: Total revenues exceeded €170 million, cash position nearly 110 billion euros, and operating cash burn reduced by over 20%. - Strategic evolution: Three pillars - grow commercial business and optimize cash generation, maximize R&D upside, leverage integrated business model. - Portfolio updates: Lyme disease vaccine candidate VLA-15 in VALOR study with ~10,000 individuals, data expected in first half of 2026; Ixchic in pilot vaccination campaign in Brazil, focusing on post-marketing effectiveness and global market access; Shigella vaccine candidate S4V2 with two phase two studies ongoing, data expected mid-2026.

Total revenues exceeded €170 million, with almost €160 million in product sales. Ixiara sales were 98.4 million euros (4.6% growth or 7.2% at constant currency). Tukeral sales were €31.9 million (essentially flat, -1.2% or +1.8% at constant currency). XTRIX sales were €8.4 million. Third-party sales reduced from 33.2 million euros to 19.2 million euros. Other revenues increased from €6.3 million to €16.8 million due to a €10 million revenue recognition from the line agreement with Pfizer. Cost of goods and services increased by 8.6 million euros, with an 8.5 million euro inventory write-off in the fourth quarter. Research and development expenses increased from 74.1 million euros in 2024 to 85.3 million euros in 2025. Marketing and distribution expense decreased from 62.4 million euros in 2024 to 37.4 million euros. G&A expenses decreased from 42.8 million euros to 37.3 million euros. Operating loss was €82.1 million compared to operating profit of 13.3 million euros in 2024. Loss for the period was 115.2 million euros, and adjusted EBITDA was -51.4 million euros.

• 2026 product sales expected 145 to 160 million euros, total revenues 155 to 170 million euros. - Expect to progress in enhancing R&D pipeline of differentiated vaccine candidates. - Cash focus on reducing operating cash burn. - Subject to successful Lyme disease vaccine approval and commercialization, expect to become financially self-sustainable and potentially profitable.

Q: Regarding LIME data readout timing, involvement in data analysis, communication with Pfizer, and confidence in VLA-15 efficacy across serotypes.

A: Pfizer is in control of data readout, expected mid-H1; weekly interaction with Pfizer; preclinical models tested against all serotypes but immunological protection in humans not confirmed across all serotypes.

Q: On capital allocation if LIME successful and threshold for Shigella S4V2 program.

A: Positive phase three data won't bring immediate milestones; for Shigella, if controlled human infection models show pilot efficacy and correlation between immunogenicity and protection, will progress program.

Q: On NCIP recommendation for VLA-15, expected info in press release, and DOD contract for Xero.

A: Uncertain on NCIP timing; Pfizer to release top-line data including primary endpoint; expect new DOD contract this year but no timeline.

Q: On Chikungunya vaccine 1555 status and XCHIC's Asia strategy.

A: Expect 1555 approval soon; evaluating commercialization and manufacturing strategies in Asia for XCHIC.

Q: On LIME booster data and Xero DOD contract in guidance.

A: No initial booster in phase three; DOD contract included in 2026 guidance.