Valneva SE Q3 FY2025 earnings call

• Key financial highlights: Total revenues reached EUR 127 million, a 9% growth despite headwinds; operating cash burn reduced; cash position over EUR 140 million; successful debt refinancing.
• Business highlights: IXCHIQ responded to outbreaks in La Réunion and Mayotte, secured regulatory wins in the U.K. and Brazil, and had label extensions; IXIARO finalized a U.S. Department of Defense contract; VALOR Phase III Lyme study completed; positive safety and immunogenicity data for Lyme; IXCHIQ antibody persistence data and pediatric data; positive Phase I results for Zika vaccine candidate VLA1601.
• Program details: Lyme remains a major unmet need; VALOR study completed with positive results; IXCHIQ has 95% 0 response rate after 4 years; Shigella program has ongoing clinical trials with expected results this year and next.

Product sales reached EUR 119.4 million in the first 9 months of 2025, an increase of 6.2% compared to EUR 112 million in the same period of 2024. IXIARO sales were EUR 74.3 million, up 12.5% year-over-year. DUKORAL sales decreased from EUR 22.3 million in the first 9 months of 2024 to EUR 21.5 million in 2025. IXCHIQ sales were EUR 7.6 million, a significant increase from EUR 1.8 million in 2024. Third-party products decreased by 28.5% year-over-year to EUR 16.1 million. Total revenues for the 9 months ended September 30, 2025, were EUR 127 million, a 9% increase from EUR 112.5 million in the prior year.

Valneva confirms financial guidance for the fiscal year 2025 with product sales expected to be between EUR 155 million and EUR 170 million, and total revenues between EUR 165 million and EUR 180 million. R&D expense is projected to be between EUR 80 million and EUR 90 million, partially offset by grant funding and anticipated R&D tax credits.

• Uncertainty around the FDA's timeline and process for resolving the suspension of IXCHIQ in the U.S. due to no prior precedent.
• Impact of distributor shifts in Germany on DUKORAL sales, described as a technical delay related to stock usage by the previous distributor.
• Uncertainty around private and public funding opportunities for advancing the Zika vaccine candidate, given regulatory and epidemiological challenges.

Q: On IXCHIQ, is there any timeline for hearing from the FDA?

A: There is no predefined process or timeline as there's no prior precedent for a similar suspension, but hope for a collaborative interaction this year.

Q: How to quantify the impact of the distributor shift in Germany on DUKORAL?

A: It's a technical delay as the existing distributor uses up stock before shipping to the new one; no specific numbers disclosed for individual countries, but expect continued growth of the DUKORAL brand.

Q: Regarding Lyme Phase III readout, would a later readout imply delays?

A: Pfizer is acting professionally and will not take regulatory risks; no major delays seen at this point, expecting topline data as early as possible.

Q: What was proposed in response to FDA regarding IXCHIQ suspension?

A: Response focused on real medical evidence, individual case analysis, positive health-economic benefit, and ongoing Phase IV program and pharmacovigilance review.

Q: On Zika vaccine, what factors weigh into taking the candidate forward?

A: Uncertainty around regulatory pathway, deprioritization by NGOs/public health agencies, and need for substantial funding to justify investment given capital allocation considerations