Valneva SE Q1 FY2025 earnings call

Financial Performance

• Total revenues near €50M; reduced operating cash burn; cash position over €150M.

Regulatory Progress

• IXIARO contract awarded by US DoD; responded to chikungunya and cholera outbreaks with IXCHIQ and DUKORAL; IXCHIQ marketing authorizations in UK, EU, Brazil; label extensions for IXCHIQ.

Clinical and Pipeline

• High immune response in adolescents for IXCHIQ; Phase 2 pediatric results for IXCHIQ; Phase 2 infant study for Shigella vaccine; Zika Phase 1 expected later this year.

Lyme Disease

• Ongoing Phase 3 study; no Lyme vaccine available; growing global burden of Lyme disease.

IXCHIQ Updates

• Label changes due to adverse events in frail elderly; ongoing investigations; preparing post-marketing Phase 4 program.

Total revenues for Q1 2025 reached almost €50 million. Product sales were €48.6 million. IXIARO sales were €27.5 million (56.6% of product sales), DUKORAL sales were €12.3 million (25.3% of product sales), IXCHIQ sales were €3 million (6.2% of product sales), and third-party products were €5.8 million (11.9% of product sales).

Product Sales

• Guidance: €170M-€180M product sales; €180M-€190M total revenues.

R&D Expenses

• Expected to be between €90M and €100M, partially offset by grants.

Cash Burn

• Goal to reduce operational cash burn by 50% year-over-year; potential sustained profitability from 2027 with Lyme vaccine approval.

• IXCHIQ: Label changes and safety concerns leading to precautionary decisions; ongoing investigations for adverse events.
• General: Forward-looking statements subject to risks in SEC and French Market Authority filings; potential impact of tariffs and regulatory dynamics.

Q: On IXCHIQ label extension, status of FDA review?

A: The review with the FDA is still ongoing; waiting for reply on adolescent label extension application.

Q: Lyme Phase 3 p-value?

A: Can't disclose p-value, but the study is sufficiently powered according to epidemiological studies.

Q: Sales growth and guidance?

A: First quarter revenues above consensus, no change to full-year guidance as first quarter phasing is in line with expectations.

Q: Mayotte order and IXCHIQ phasing?

A: Mayotte order for DUKORAL was fulfilled in Q1; La Réunion order for 40,000 IXCHIQ doses had some supplied in Q2.

Q: IXCHIQ dose reconsiderations?

A: No immediate reconsideration for pediatric studies as no unexpected safety profile seen in younger populations.

Q: Lyme infection rate and cohorts?

A: Monitoring ongoing, no comment on specific infection rates; first cohort not receiving second booster yet.

Q: IXIARO seasonality and gross margin?

A: No material seasonality impact; IXIARO gross margin expected to improve but not at Q1's 72.6% level; DUKORAL gross margin roughly representative of Q1 results.

Q: Idle capacity and gross margin sustainability?

A: Idle costs ~€2M related to large capacity and new manufacturing site transfer; IXIARO gross margin not expected to stay at 73% full-year; DUKORAL gross margin not guided but Q1 results are representative.