Valneva SE

Valneva reported H1 2026 product sales of EUR 64 million versus EUR 91 million in H1 2025, and total revenues of EUR 65.8 million versus EUR 97.6 million. Sales excluding third-party products were down 18.3% year over year at constant currency. IXIARO sales were EUR 44 million versus EUR 54.7 million; DUKORAL sales were EUR 14.7 million versus EUR 17.4 million; IXCHIQ sales were EUR 4.4 million versus EUR 7.5 million; and third-party products fell to EUR 1 million from EUR 11.4 million. Operating loss was EUR 49.9 million versus EUR 16.8 million, adjusted EBITDA loss was EUR 40.1 million versus EUR 6 million, and cash at June 30 was EUR 121.5 million versus EUR 109.6 million at year-end 2025. The company confirmed 2026 guidance for product sales of EUR 135 million to EUR 150 million and total revenues of EUR 145 million to EUR 160 million, and said it expects a new U.S. Department of Defense IXIARO contract in the coming months plus better gross margin in the second half after first-half one-offs.

Thomas Lingelbach framed the first half as a period of financial strengthening after the Lyme Phase III uncertainty, emphasizing cash discipline, the recent offering, and a restructuring program intended to improve P&L and cash flow in the second half and beyond. He was notably constructive on Lyme, saying Pfizer is making good progress with regulators and that the company shares Pfizer’s positive view on licensure prospects in the next 12 months. He also described IXCHIQ and Shigella as strategic opportunities, with a pivot toward endemic markets for chikungunya and next steps on Shigella to be decided once the data are disclosed.

Peter Buhler said product sales declined to EUR 64 million from EUR 91 million, with weakness driven by IXIARO phasing and Germany distributor transition, lower DUKORAL after a prior-year Mayotte outbreak order, and lower IXCHIQ travel sales after a prior-year La Reunion outbreak order. He highlighted first-half gross margin pressure from non-recurring items, including a EUR 9.7 million provision for IXCHIQ manufacturing cancellation fees and a EUR 4.5 million non-cash impairment of excess IXCHIQ inventory, plus higher idle costs from manufacturing transfer. He noted R&D fell to EUR 30.2 million, marketing and distribution to EUR 13.5 million, and G&A to EUR 15.4 million, with EUR 3.2 million of restructuring costs in H1 and expected savings later in the year. Cash was EUR 121.5 million at June 30, and he reaffirmed 2026 revenue guidance while saying commercial business should continue generating positive cash flow and product gross margin should improve in H2.

Analysts focused heavily on the Lyme regulatory path, asking whether Europe and the U.S. are moving in parallel and whether Valneva could add detail on Pfizer’s filing strategy; management said the two processes are independent, Europe may go first, and Pfizer is working closely with the FDA, but Valneva would not speculate further. On potential post-licensure Lyme work, Thomas said Valneva’s current Pfizer agreement only covers development costs to licensure, and anything beyond that would be discussed later, not before approval. Questions on Shigella centered on delays and next steps; management said the program is in final data validation after some cleanup steps tied to LimmaTech’s acquisition by Lilly, and the goal is to disclose data and next development steps shortly thereafter, without needing direct new regulatory advice right now. Analysts also asked about the restructuring and margins, and Peter said SG&A efficiency should continue, R&D should decline in H2, the earlier 25% to 35% OpEx reduction comment still holds, and full-year gross margin should be much closer to last year’s level.