Valneva (NASDAQ:VALN) reported lower first-half revenue and wider losses for 2026, while maintaining its full-year sales outlook and emphasizing its cash position, restructuring measures and expectations for regulatory progress on its Lyme disease vaccine candidate with Pfizer.
CEO Thomas Lingelbach said the company ended the period with more than €120 million in cash following disciplined cash management, a recent offering and a restructuring program that included workforce reductions, project reprioritization and a focus on core operations. Cash at June 30 was €121.5 million, compared with €109.6 million at the end of 2025.
First-Half Sales Decline
CFO Peter Bühler said IXIARO sales declined to €44 million from €54.7 million. The decrease reflected a transition to a new German distributor in January, the timing of deliveries to the U.S. Department of Defense and a €1.5 million adverse foreign-exchange effect. The company expects to sign a new U.S. Department of Defense supply contract in the coming months and begin recognizing sales under that agreement in the second half.
DUKORAL sales declined to €14.7 million from €17.4 million. The prior-year period benefited from one-time doses supplied to Mayotte during a cholera outbreak, while 2026 sales were affected by the German distributor transition and some weakening in travel markets due to geopolitical factors.
IXCHIQ sales were €4.4 million, compared with €7.5 million in the first half of 2025. While the current period included the first shipment of drug substance to Brazilian partner Instituto Butantan, the prior-year period included 40,000 doses sold to La Réunion during a chikungunya outbreak and U.S. travel sales. Bühler said Valneva is evaluating IXCHIQ’s future commercial strategy, including a potential greater focus on endemic markets because of slow travel-market uptake.
Third-party product revenue fell to €1 million from €11.4 million after distribution agreements ended in December 2025 without renewal.
Losses Affected by IXCHIQ Charges
Valneva reported an operating loss of €49.9 million for the first half, compared with a €16.8 million loss a year earlier. Adjusted EBITDA loss widened to €40.1 million from €6 million.
Cost of goods and services rose to €59.5 million from €47.2 million. Bühler attributed the increase partly to exceptional IXCHIQ-related charges, including a €9.7 million provision for cancellation fees on external manufacturing commitments and a €4.5 million non-cash impairment on excess inventory following lower-than-expected sales.
Research and development spending declined to €30.2 million from €32.4 million due to reprioritization and rescheduling of activities. Marketing and distribution expense fell to €13.5 million from €20.3 million, while general and administrative expense declined to €15.4 million from €19 million. The first-half figures included €3.2 million in one-time restructuring costs.
The company expects its restructuring actions to produce favorable profit-and-loss and cash-flow effects in the second half and beyond. Bühler said Valneva expects gross margin to improve in the second half as first-half nonrecurring items do not repeat, though full-year gross margin may remain below the prior year’s level.
Lyme Vaccine Regulatory Progress Remains Central
Lingelbach said Pfizer continues to be positive about the outlook for the Lyme disease vaccine candidate, referred to during the call as LB6V. Pfizer has said it expects regulatory decisions within the next 12 months, according to Valneva.
Valneva said the vaccine showed point efficacy above 70% and a favorable safety profile, though the lower bound of the 95% confidence interval missed the targeted threshold in one analysis. Lingelbach noted that the lower confidence-interval bound exceeded 20% in a second prespecified analysis and said the company believes the totality of evidence, disease burden and potential health-economic benefit support the program.
During the question-and-answer session, Lingelbach confirmed Pfizer has filed with the European Medicines Agency and said European and U.S. regulatory activities are independent processes. He said he expects Europe could move first, while Pfizer continues to work with the FDA in support of a planned biologics license application submission.
Valneva shares development costs with Pfizer through licensure under the existing agreement. Lingelbach said any further investment in the program after licensure, including potential post-marketing work, would be addressed later and is not currently covered by the contract.
Pipeline and IXCHIQ Updates
For IXCHIQ, Valneva is supporting a Brazilian pilot vaccination campaign in adults ages 18 to 59, where more than 50,000 people have been vaccinated. Lingelbach said Brazil’s government aims to vaccinate at least 100,000 people as part of active pharmacovigilance before broader public-health deployment. Butantan’s locally manufactured version of the vaccine has been approved and is expected to be incorporated into Brazil’s public health system.
The company also expects results in coming months from two studies of its in-licensed tetravalent Shigella vaccine candidate: an adult controlled human infection study and an infant immunogenicity and safety study. Lingelbach said Valneva plans to determine next development steps based on the data, including whether potential optimization of dose, schedule or formulation is needed.
Valneva reaffirmed 2026 guidance for product sales of €135 million to €150 million and total revenue of €145 million to €160 million. Management said the commercial business is expected to continue generating positive cash flow.
Lingelbach corrected an earlier statement on timing for potential financial self-sustainability, saying the company sees potential to reach that position beginning in 2027, subject to Lyme vaccine approval and subsequent commercialization by Pfizer.
About Valneva (NASDAQ:VALN)
Valneva SE is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases. Headquartered in Saint-Herblain, France, the company applies inactivated whole-cell and recombinant technology platforms to address public health needs. Valneva’s research and development efforts span a range of viral and bacterial pathogens, with an emphasis on travel-related and emerging infectious diseases.
Among its marketed products, Valneva offers IXIARO®/JESPECT® for the prevention of Japanese encephalitis and DUKORAL® for the prevention of cholera and diarrhea caused by enterotoxigenic Escherichia coli.
