Aug 13, 2026 earnings call — Half-year results and Lyme vaccine update
Company reaffirmed 2026 product sales guidance of EUR 135 million to EUR 150 million.
Revenue $0.0B (est $0.0B) · EPS $-0.40 (est $-0.28)
Key quotes
"You know that the vaccine showed a very strong point efficacy, greater than 70%, a very good safety profile."
"The company implemented the restructuring program in June 2026, and operating expenses in the first half year included onetime cost of EUR 3.2 million related to that program."
"We have more than 50,000 people already vaccinated today."
Analyst Q&A 6
regulatory update and costs
Q (Tara Bancroft · TD Cowen): The analyst asked for any regulatory update on the Lyme vaccine and for details on who would pay for another Phase III or post-marketing study and how that would affect Valneva's capital plans.
A: Management said Pfizer is making good regulatory progress and they hope to announce next steps soon. Valneva's existing agreement with Pfizer covers sharing development costs to licensure; anything beyond licensure is not part of the contract and further investment would be discussed only after licensure.
"Pfizer are making very good progress with the regulatory agencies." — Thomas Lingelbach (CEO)
Shigella data timing and Lyme progress
Q (Maurice Raycroft · Jefferies): The analyst asked what is gating the Shigella update (operational, analysis, or regulatory), whether the data disclosure will clarify the path forward, and whether the U.S. and Europe Lyme regulatory paths are parallel.
A: Management said Shigella faced delays because LimmaTech was acquired and there are cleanup steps, but they are in the last steps of data validation and final analysis and expect to disclose soon. They will combine the human challenge data and the pediatric immunogenicity data to decide next steps and may need to optimize dose, schedule or formulation; they have regulatory advisers and do not expect to seek new formal advice. For Lyme, both U.S. and Europe processes are independent and progressing, and management thinks Europe may go first while Pfizer works with the FDA on its planned BLA.
"So there are a couple of key cleanup steps right now, but we are in the last and final steps on data validation and putting the conclusions together, final analysis, et cetera." — Thomas Lingelbach (CEO)
why Europe first and agency differences
Q (Guggenheim): The analyst asked why Pfizer filed in Europe before the FDA, whether there are differences in how EMA and FDA view vaccine data, and if the European filing derisks the FDA filing.
A: Management confirmed Pfizer filed with the European Medicines Agency and said they are pleased about that progress. They would not speculate on why one agency is earlier than the other, and they said regulators look at the same data (safety, efficacy, immunogenicity) and the totality of clinical evidence; there are only minor nuances on stats or post-marketing commitments and no material historical differences.
"I mean we have safety data, we have efficacy data, we have immunogenicity data and the data are the same." — Thomas Lingelbach (CEO)
strategy: R&D vs commercial
Q (Suzanne van Voorthuizen · Kempen): The analyst asked whether Valneva is shifting to an R&D/biotech identity over commercial, how much that depends on Lyme's success, and whether the sale of the French site reduces ongoing costs.
A: Management said the commercial business is subscale but valuable to remain integrated; their aim is to take cash from commercial operations and reinvest it into R&D. They said Lyme's success will heavily affect capacity to invest because of favorable deal economics, and the Nantes site sale and centralizing R&D in Vienna will bring efficiency and cost reduction over time, though there are immediate redundancy and restructuring costs.
"By the end of the day, we would like to take the cash out of our commercial business and reinvest it in R&D." — Thomas Lingelbach (CEO)
cost guidance and gross margin
Q (Shyam Kotadia · Goldman Sachs): The analyst asked how to model SG&A and R&D for the rest of the year given restructuring and whether the prior 25%–35% OpEx reduction target versus 2025 still holds; also asked about realistic gross margin expectations for H2 2026.
A: Management said SG&A efficiency trends seen in H1 will continue and R&D costs should decrease in H2; the prior rough guidance on cost reduction versus 2025 still holds because it was not confirmed or revised. On gross margin, they expect much better margin in H2 than in H1, likely not fully back to last year's level for the full year but much closer, with a positive trend into 2027.
"We have not confirmed it. We have also not revised it, which means it still holds true." — Peter Buhler (CFO)
Brazil launch and pilot program length
Q (Simon Scholes · First Berlin): The analyst asked when commercial sales of the locally approved IXCHIQ vaccine in Brazil might start and how long the Pilot Vaccination Program will continue given 50,000 already vaccinated.
A: Management said partner Butantan is doing launch planning, so it is too early to discuss commercial prospects; there is clear interest to include the vaccine in Brazil's healthcare system and they have seen initial drug substance sales to Butantan. On the pilot program, the Ministry of Health owns it and targets a minimum of 100,000 people vaccinated to collect active pharmacovigilance data, which could be reached by the latter part of the year.
"Therefore, I would consider it a bit too early to really talk about, I would say, commercial prospects." — Thomas Lingelbach (CEO)