Valneva Se Stock Earnings Reports

Key points for investors:

- Lyme vaccine (VLA15 / Pfizer VLA15/LB6V): Phase III readout showed clinically meaningful efficacy — overall efficacy above 70% and the second prespecified statistical criterion met, while the first was not met due to fewer-than-anticipated accrual of cases. Pfizer is planning submissions to regulatory authorities; Valneva expects uncertainty in timing and has limited visibility into Pfizer-FDA interactions but anticipates file acceptance will be disclosed.

- Financials (Q1 2026): Total revenues €30.9m (down vs. prior year). Product sales €30.5m; IXIARO €20.2m (decline driven mainly by U.S. DoD phasing and some travel market softness), DUKORAL €8.6m, IXCHIQ €1.6m. Operating loss €23.7m; net loss €32.1m. Cash on hand at March 31 ~€105m (does not include April reserved offering proceeds).

- Guidance and cost actions: FY26 product sales guidance lowered to €135–150m and total revenues to €145–160m reflecting weaker travel vaccine uptake and geopolitical uncertainty. Company initiated a restructuring in April targeting a 10–15% global workforce reduction and a 25–35% reduction in operating expenses vs. 2025 to conserve cash.

- Margin and one-offs: Gross margins pressured in Q1 by higher manufacturing costs after transfer to the Almeida facility, failed batch write-offs, idle capacity and onerous IXCHIQ manufacturing commitments; management expects margins to normalize after one-off effects.

- Pipeline & other programs: IXCHIQ (Chikungunya) progressing — pilot campaign in Brazil (30k+ vaccinated to date), local licensure by Butantan achieved. Shigella tetravalent candidate: two readouts expected over the summer (children immunogenicity and controlled human infection model) which will inform next development steps. Preclinical EBV and enteric disease work continues.

- Manufacturing/regulatory note: FDA previously issued observations related to using the Almeida site for IXIARO U.S. supply; other regulators have approved Almeida. Valneva continues to release IXIARO from the existing facility and does not expect an immediate supply impact to the U.S. at this time.

- Key near-term catalysts: Pfizer’s regulatory filings/interaction timeline for Lyme, Shigella readouts this summer, continued progress on IXCHIQ rollout/access in endemic countries, and the financial impact of the restructuring and margin normalization.