Valneva SE Q3 FY2024 earnings call

Financials - Product sales guidance narrowed to €160 million to €170 million for the current fiscal year, total revenue guidance to €170 million to €180 million. Cash position exceeded €150 million. ### R&D - Strong execution with Lyme Phase III on track, Chik adolescents data on time, and partnerships like CEPI for Chik development and LimmaTech for Shigella. ### Lyme Disease - Phase II fully recruited, on track for Phase III conclusions in 2025, regulatory filings in 2026, targeting sustained profitability from 2027 with Lyme vaccine success. ### Chikungunya (IXCHIQ) - World's first chikungunya vaccine with strong immune response, Phase III adolescent trial results, launches in Canada, preparing for France launch, expected approvals in Brazil and UK, and upcoming antibody persistence data. ### Shigella - Partnership with LimmaTech, Phase II studies imminent, potential approvals in 2030-2031. ### Zika Virus - Phase I of VLA1601 ongoing, expected Phase I results in first half 2025.

Product sales reached €112.5 million in the first nine months of 2024, growing 12% on a comparable basis. IXIARO sales totaled €66 million, up 31% year-over-year, driven by double-digit growth in the travel segment and US military. DUKORAL sales increased 6% to €22.3 million, with 85% growth in Q3. IXCHIQ sales were €1.8 million in the US by September 30. Third-party products declined 23% year-over-year to €29.1 million due to supply constraints. Total revenues for the period were €116.6 million, up from €111.8 million in the prior year. IXIARO gross margin was 58.8% of product sales, DUKORAL had a 34.8% gross margin, and third-party products had 32%.

Current Fiscal Year - Product sales guidance: €160 million to €170 million. Total revenue guidance: €170 million to €180 million. Other income expected: €100 million to €110 million. R&D expense expected: €65 million to €75 million. ### Midterm - Review IXCHIQ midterm guidance in coming months based on US sales trend, Canada/EU launches, and LMIC demand signals.

Uncertainty - Uncertainty in IXCHIQ uptake in the US market. ### Regulatory - Dependence on regulatory approvals and timelines for Lyme, Chik, Shigella, and Zika programs. ### Supply Chain - Supply chain constraints affecting third-party products.

Q: More on IXIARO orders and DOD uptake?

A: Stable demand expected for IXIARO with DOD, RFP for next contract imminent.

Q: MMWR publication timeline for IXCHIQ?

A: Timing uncertain, expected to drive US retail growth.

Q: IXCHIQ sales Q3 vs Q2?

A: Partly due to channel and uptake timing, monitoring into mid next year.

Q: VLA2112 EBV update?

A: Preclinical, evaluating antigen composition, clinical entry expected 2026-2027.

Q: R&D transfer costs?

A: Continue into 2025, end early 2026.

Q: IXCHIQ midterm guidance change?

A: Monitoring LMIC, Canada, EU launches to inform midterm guidance.

Q: IXIARO gross margin and idle costs?

A: IXIARO margin improving, idle costs decreasing as transfer to new site.