Valneva SE Q2 FY2025 earnings call

• Achieved total revenues close to EUR 100 million with significant year-over-year growth and a cash position over EUR 160 million. • Progress in Lyme disease vaccine program with VALOR Phase III study vaccination completed. • IXCHIQ secured additional marketing authorizations, saw high sustained 1-year immune response in adolescents, and positive Phase III pediatric safety/immunogenicity results. • Shigella program advanced with first controlled human infection model study and initiation of Phase II infant study. • Addressed unmet medical needs through supply agreements for IXIARO, IXCHIQ, and DUKORAL.

Product sales: IXIARO generated EUR 54.7 million, DUKORAL EUR 17.4 million, IXCHIQ EUR 7.5 million, and third-party products EUR 11.4 million. Total revenues were EUR 97.6 million. IXIARO contributed ~56.0% of total revenues, DUKORAL ~17.8%, IXCHIQ ~7.7%, and third-party products ~11.7%.

• Confirmed financial guidance for 2025: product sales expected to be EUR 170 million to EUR 180 million, total revenues EUR 180 million to EUR 190 million. • Projected R&D expenses of EUR 90 million to EUR 100 million, partially offset by grant funding and R&D tax credits. • Aim to reduce cash used in operations by over 50% year-over-year. • Expect continuous growth in product sales, strategic R&D investments, and improvement in gross margin post Lyme vaccine approval.

• Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from projections. • Risks detailed in periodic filings with SEC and French Market Authority.

Q: Regarding the 40,000 doses sold to the French government, should we expect any additional revenue recognition in Q3?

A: The 40,000 doses were all shipped in the first half, and revenue was fully recognized in the first half.

Q: Could you provide insight on the timing of Lyme vaccine Phase III data readout?

A: Data readout expected by end of first quarter 2026, with regulatory submissions around mid-2026, and all data to be out in time to support submissions.

Q: What might trigger an acceleration in IXCHIQ sales within the traveler market?

A: Lifting of restrictions and updated prescribing information, along with responding to emerging chikungunya outbreaks, could drive sales uptake.

Q: On the Lyme vaccine trial, what's the bar for success?

A: No aligned bar with regulators, but animal models and previous trials suggest non-inferiority or superiority expected after final dosing.