Valneva reports revenue of 127 million euros over nine months, driven by IXIARO

Financial Results Driven by Revenue Growth and the Impact of R&D

Valneva reported consolidated revenue of 127 million euros for the first nine months of 2025, an 8.9% increase compared to the same period the previous year. This performance is mainly driven by product sales, which reached 119.4 million euros, supplemented by 7.5 million euros in other income from collaborations, licenses, and services. The company noted that this commercial momentum includes an unfavorable exchange rate effect of 1.3 million euros. The gross margin on product sales, excluding IXCHIQ, stands at 57.2%, a level the group considers strong given its current product mix.

The cost of sales was 71.1 million euros during this period. However, the operating loss amounted to 53.9 million euros, reflecting the intensity of research and development investments, particularly for the VLA15 program against Lyme disease and other clinical candidates. The net loss was 65.2 million euros, including a financial charge of 17.3 million euros related to debt servicing.

Adjusted EBITDA was negative at 37.7 million euros, a direct consequence of the company's ongoing investment cycle. Valneva emphasized that these expenses are partially offset by public grants and the French research tax credit. On the cash front, the group had 143.5 million euros in liquidity as of September 30, 2025. Cash flows from operating activities were negative at 28.4 million euros, while financing activities generated a positive cash flow of 8.7 million euros. Investment activities consumed 1.4 million euros. Additionally, the company benefited in February 2024 from a net proceeds of 90.8 million euros from the sale of a Priority Review Voucher (PRV), a non-recurring item that had strengthened its liquidity position.

IXIARO strengthens its position as a commercial driver despite challenges faced by IXCHIQ

Valneva's commercial portfolio is built on three main products. IXIARO (marketed as JESPECT in Europe), a vaccine against Japanese encephalitis, remains the primary contributor with sales of 74.3 million euros over nine months, confirming its status as a revenue cornerstone. This product benefits from strong demand among travelers to endemic areas as well as institutional orders.

DUKORAL, an oral cholera vaccine, generates 21.5 million euros in revenue over the period. It continues to benefit from steady demand, particularly in the travel medicine segment and institutional markets. IXCHIQ, a recently launched single-dose chikungunya vaccine, records sales of 7.6 million euros. This figure remains limited due to the temporary suspension of its license in the United States by the FDA, which significantly impacts the American traveler segment.

Third-party product sales, mainly arising from distribution agreements for vaccines developed by other labs, amount to 16.1 million euros. This segment is declining, as the company has ceased distribution of certain third-party products such as Rabipur/RabAvert and Encepur. This strategic realignment aims to focus commercial resources on its proprietary portfolio. Valneva has also strengthened its partnership agreements. In Germany, an exclusive commercialization agreement has been secured with CSL Seqirus to accelerate market penetration. In India, the company has signed an exclusive license with the Serum Institute of India for the chikungunya vaccine, paving the way for a strengthened presence in low- and middle-income countries (LMICs), where deliveries of active substance are planned.

An R&D Pipeline Focused on Lyme Disease, Shigellosis, and Zika

Valneva's main development project is VLA15, a Lyme disease vaccine candidate conducted in partnership with Pfizer. The phase 3 trial, named VALOR, is progressing as scheduled. Final results are expected in 2026, which, if successful, could lead to applications for marketing authorization with US and European authorities. This program represents a major strategic focus for the group, as Lyme disease is an unmet medical need, particularly in North America and Europe.

The group is also developing S4V2, a candidate targeting shigellosis, a bacterial infection that causes severe diarrhea, especially in developing countries. Valneva estimates that this market could exceed $500 million per year. Early-phase clinical trials are ongoing, with the company aiming to demonstrate the candidate's immunogenicity and tolerance before moving to more advanced phases. VLA1601, a Zika virus vaccine candidate, has shown positive results in phase 1, with good tolerance and an encouraging immune response. Additionally, long-term follow-up data for IXCHIQ indicate a high persistence of antibodies, with a seropositivity rate of 95% at four years, a differentiating factor Valneva plans to leverage against competitors.

These R&D investments are supported by public grants, notably from Europe and the US, as well as the French research tax credit. The group forecasts R&D expenditures of between 80 and 90 million euros for the entire year of 2025, partially covered by these funding mechanisms. The strategy is to balance scientific ambition with financial discipline, in a context where regulatory visibility remains uncertain.

A Strategic Refinancing to Secure Financial Trajectory

In October 2025, Valneva completed a refinancing of its debt with Pharmakon Advisors under terms considered more favorable than the previous structure. This move aims to reduce financial burden and provide increased flexibility to support critical phases of clinical development.

The management highlights that this refinancing is a key step in strengthening the cash position. The company has also established an « At-The-Market » (ATM) stock sales program, allowing it to raise funds opportunistically based on needs and market conditions. This mechanism provides additional flexibility to finance ongoing operations and strategic investments without resorting to potentially dilutive massive capital increases.

The group notes that commercial activity is expected to generate positive cash flow over time as proprietary products gain traction and R&D costs stabilize. However, the trajectory remains exposed to regulatory uncertainties, particularly the lifting of the IXCHIQ license suspension in the United States and the outcomes of ongoing clinical trials. Valneva reminds that its reliance on currency fluctuations, particularly between the euro and the dollar, can affect its revenue. The company recorded a negative impact of 1.3 million euros on sales during the first nine months due to voluntary exchange rate effects. This exposure remains a risk factor in a volatile monetary environment.

2025 Guidance Confirmed Despite Uncertain Regulatory Environment

Valneva is maintaining its targets for the year 2025. The group expects revenue to range between 165 and 180 million euros, with product sales anticipated to be between 155 and 170 million euros. This forecast accounts for uncertainties related to the delivery schedule of the chikungunya vaccine active substance intended for low- and middle-income countries, as well as the impact of the suspension of the IXCHIQ license in the United States. According to management, the growing presence of IXCHIQ in markets outside the US, particularly in Europe and through licensing agreements in India, should partly offset the loss of US revenue.

The group is also relying on the resilience of IXIARO and DUKORAL sales, which continue to benefit from stable demand. However, the commercial momentum remains dependent on the resumption of international travel and the evolution of vaccination policies across different regions. R&D investments are expected to remain robust, between 80 and 90 million euros for the year, to support ongoing clinical trials and the preparation of authorization applications. Management indicates that these expenses will be partially offset by grants and tax credits, thereby limiting the net impact on cash flow.

The group identifies several medium-term growth drivers, notably the results of the phase 3 Lyme disease vaccine (VALOR) expected in 2026, which could pave the way for regulatory approvals and significant market potential. Additionally, the commercial agreement with CSL Seqirus in Germany and the license with the Serum Institute of India further strengthen geographical reach and the ability to penetrate high-potential segments.

A Delicate Balance Between Scientific Ambition and Economic Reality

Valneva is navigating a pivotal phase characterized by moderate revenue growth and significant R&D investments. As of September 30, the company holds 143.5 million euros in cash, bolstered by strategic refinancing, but remains exposed to regulatory uncertainties and clinical outcomes. The suspension of the IXCHIQ license in the United States impacts short-term commercial potential, while the R&D pipeline, particularly the Lyme disease vaccine, is a major focus for the future. Management maintains a stance of caution and budgetary discipline, keeping annual guidance unchanged. Strategic partnerships with CSL Seqirus and the Serum Institute of India reflect a commitment to expanding geographical presence and securing growth avenues.

However, the financial trajectory remains contingent on regulatory and clinical successes in the coming quarters. The company faces challenges with a high cost structure, still modest revenues, and reliance on medium-term scientific catalysts. The upcoming months will be crucial in assessing Valneva's ability to translate its ambitions into commercial results and convince investors of the robustness of its model in a demanding and competitive biotech sector.