Valneva (NASDAQ:VALN) reported lower first-quarter revenue and a wider loss for 2026, while management said the company is focused on conserving cash as it awaits the next regulatory steps for its Lyme disease vaccine candidate being developed with Pfizer.
Chief Executive Officer Thomas Lingelbach said the quarter was “certainly dominated” by the Phase 3 readout for the Lyme disease vaccine candidate VLA15, also referred to by Pfizer as LB6V. He said the study showed “strong efficacy,” but that the first pre-specified statistical criterion was not met, while a second pre-specified analysis met its criterion.
Lingelbach said the statistical issue was tied to fewer Lyme disease cases than anticipated over the study period, which led to a wider confidence interval. Still, he said Pfizer is planning regulatory submissions because of the clinically meaningful efficacy and the second pre-specified analysis.
First-quarter sales decline on delivery timing, travel trends
Chief Financial Officer Peter Bühler said product sales totaled 30.5 million euros in the first quarter of 2026, down from 48.6 million euros a year earlier. Total revenue was 30.9 million euros, compared with 49.2 million euros in the first quarter of 2025.
IXIARO sales were 20.2 million euros, compared with 27.5 million euros a year earlier. Bühler said the decline was primarily due to the phasing of scheduled deliveries to the U.S. Department of Defense under the contract signed in January 2025.
DUKORAL sales fell to 8.6 million euros from 12.3 million euros. Bühler said the prior-year period included one-time sales tied to supplying doses to Mayotte after a local cholera outbreak. He also cited the impact of a change in distribution partner for certain European Union countries, mainly Germany, where residual inventories were sufficient to satisfy first-quarter demand. He said new product deliveries are expected to resume in the second quarter.
IXCHIQ sales were 1.6 million euros, down from 3 million euros in the prior-year quarter, which had benefited from initial doses supplied to the French island of La Réunion in response to a major outbreak as well as travel sales in the U.S. Third-party product sales declined to 100,000 euros from 5.8 million euros as Valneva intentionally winds down distribution of third-party products to focus on its proprietary portfolio.
Loss widens as margins contract
Valneva reported an operating loss of 23.7 million euros in the first quarter, compared with a smaller loss a year earlier, driven by lower sales and gross margin. The company’s net loss was 32.1 million euros, compared with 9.2 million euros in the first quarter of 2025.
Cost of goods and services rose to 26.2 million euros from 21.3 million euros despite lower sales. Bühler cited several factors, including higher idle costs following the manufacturing transfer to the new Almeida facility, failed batches, inventory provisions and onerous contracts related to IXCHIQ. He also said the first quarter of 2025 benefited from a positive standard cost adjustment.
The gross margin on commercial product sales, excluding IXCHIQ, was 45.2%, compared with 62.7% a year earlier. IXIARO’s gross margin was 50.8%, down from 72.6%, due to higher manufacturing costs, increased batch write-offs and lower overhead absorption. Bühler said IXCHIQ’s gross margin was negative, impacted by cancellation fees related to external manufacturing commitments after lower-than-anticipated sales.
Research and development expense was stable at 15.2 million euros, mainly reflecting investments in IXCHIQ, Shigella and a preclinical Epstein-Barr virus project. Marketing and distribution expense fell to 7 million euros from 10.4 million euros, mainly due to lower IXCHIQ spending, particularly in the U.S. General and administrative costs declined to 8.2 million euros from 9 million euros.
Guidance cut and restructuring announced
Valneva ended March with 105 million euros in cash and cash equivalents, compared with 110 million euros at the end of the prior fiscal year. Bühler said the figure does not include initial proceeds from the company’s reserved offering completed in April 2026.
The company lowered its 2026 outlook, citing “emerging adverse trends in travel vaccine uptakes” in key markets driven by geopolitical factors. Valneva now expects product sales of 135 million euros to 150 million euros and total revenue of 145 million euros to 160 million euros for fiscal 2026.
Management also said Valneva initiated a restructuring plan in April to streamline operations and focus resources on key projects. The plan includes a global workforce reduction of about 10% to 15% and is expected to reduce operating expenses by 25% to 35% compared with 2025 levels.
In response to an analyst question, Bühler said the full payback from people-cost reductions would occur next year because of legal processes and notice periods, particularly in Austria. He said external spending reductions have already started and are expected to generate meaningful savings during the remainder of 2026 and into 2027. Most of the savings, he said, are expected in research and development.
Lyme vaccine remains central focus
Lingelbach said Lyme disease remains a major medical need and market opportunity, noting that no human vaccine is currently available to prevent the disease. He said nearly 90 million people in North America and more than 200 million in Europe live in high-risk areas, with reported annual disease burdens of about 500,000 cases in the U.S. and more than 100,000 in Europe. He added that reported figures are likely underreported.
During the question-and-answer session, analysts repeatedly asked about Pfizer’s regulatory plans. Lingelbach said Pfizer is preparing for meetings with regulatory authorities but declined to provide more detail. Asked whether Valneva has insight into Pfizer’s FDA discussions, he said Valneva is not actively involved in preparations or discussions between Pfizer and regulators, but is informed through existing steering structures at different time points than the broader market.
Lingelbach said Pfizer has stated it will present the full Lyme dataset at a forthcoming conference, though he said the specific conference had not been confirmed to his knowledge. He also said Valneva’s current assumption is that acceptance of a filing would be disclosed.
IXCHIQ and Shigella programs advance
Valneva also highlighted ongoing work for IXCHIQ, its chikungunya vaccine. Lingelbach said a pilot vaccination campaign is underway in Brazil for adults ages 18 to 59, targeting 20% to 40% coverage across various municipalities. More than 30,000 people have been vaccinated to date, with the company aiming for more than 100,000 overall.
He also said Butantan’s locally produced chikungunya vaccine, Butantan-CHIK, achieved licensure in Brazil. Lingelbach described the milestone as a major achievement in an effort supported by CEPI to advance vaccine access in countries that can benefit from it.
On Shigella, Lingelbach said Valneva’s candidate is among the most advanced tetravalent vaccine candidates against shigellosis, targeting the four most common pathogenic Shigella bacteria. Two studies are ongoing: one in children in Africa and another controlled human infection model assessing immunogenicity and pilot efficacy. Readouts are expected over the summer.
Lingelbach said the company will review the Shigella data before deciding next development steps. He said there has been no strategic change to the program because of restructuring, though the pace or phasing may differ from earlier assumptions.
Looking ahead, Lingelbach said Valneva will focus on its base business, key strategic projects and cash preservation while planning for a successful Lyme outcome. If the Lyme vaccine is approved and commercialized, he said it could create “very significant strategic growth opportunities” for the company.
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.
