Valneva reports €127 million in revenue over nine months despite suspension of IXCHIQ in the US

An Increase in Revenue Driven by Traveler Vaccines

Valneva reported a revenue of 127 million euros for the first nine months of 2025, marking an increase of 8.9% compared to the same period of the previous year. This overall performance includes product sales of 119.4 million euros and other revenues from collaborations, licenses, and services amounting to 7.5 million euros.

Profitability remains under pressure. The group posted an operating loss of 53.9 million euros during the period, impacted by selling costs of 71.1 million euros and financial charges of 17.3 million euros. The net loss reached 65.2 million euros, while the adjusted EBITDA stood at (37.7) million euros. The gross margin on product sales, excluding IXCHIQ, was 57.2%, reflecting a heavy cost structure for a company in the commercialization phase.

Regarding cash flow, Valneva had 143.5 million euros in liquidity as of September 30, 2025. Negative operating cash flow amounted to 28.4 million euros, partially offset by positive financing cash flow of 8.7 million euros. Investment activities consumed 1.4 million euros. In October 2025, the company refinanced its debt with Pharmakon Advisors to improve its financial conditions and enhance its flexibility.

IXIARO and DUKORAL lead sales, IXCHIQ hindered by US suspension

The IXIARO/JESPECT Japanese encephalitis vaccine is the main contributor to revenue, with sales of 74.3 million euros over nine months, accounting for nearly 62% of product sales. This performance solidifies Valneva's position in the travel vaccine segment, despite a competitive environment. Meanwhile, DUKORAL, the oral vaccine for cholera and traveler's diarrhea, generated 21.5 million euros in sales, representing about 18% of the total.

The launch of IXCHIQ, the chikungunya vaccine, recorded sales of 7.6 million euros during the period. This figure remains modest due to the temporary suspension of the US license by the FDA, affecting the outlook for the travel segment in the United States. In parallel, the company reported deliveries of the chikungunya vaccine's active substance to low- and middle-income countries, included in the forecasts.

Third-party product sales reached 16.1 million euros, about 13.5% of the total. This distribution activity, which notably included Rabipur/RabAvert and Encepur, is experiencing a decline with the gradual discontinuation of certain contracts. Currency effects negatively impacted product sales by 1.3 million euros, reflecting significant exposure to currency fluctuations, particularly against the US dollar.

Strategic partnerships to accelerate commercialization in Europe

Valneva has entered into several agreements aimed at expanding its commercial presence. In September 2025, the company signed an exclusive marketing agreement with CSL Seqirus for the distribution of its travel vaccines in Germany, the leading European market in the sector. This agreement is expected to enhance the penetration of IXIARO/JESPECT and DUKORAL in this key territory by leveraging CSL Seqirus's sales force.

Another major agreement was reached with the Serum Institute of India, involving an exclusive license for the production and marketing of the chikungunya vaccine in 155 low- and middle-income countries. This allows Valneva to cover a vast territory where public health needs are significant, while delegating local production to an experienced player in emerging markets.

In terms of R&D, the investments over nine months have supported the advancement of the pipeline. The company anticipates research spending of between 80 and 90 million euros for the 2025 fiscal year, partially funded by grants and the research tax credit. These investments notably cover advanced clinical trials and preclinical developments of new candidates.

Phase 3 VALOR trial for Lyme vaccine progresses on schedule

The primary catalyst for the group remains the Lyme disease vaccine candidate, VLA15, developed in partnership with Pfizer. The phase 3 VALOR clinical trial is progressing according to the established timeline. According to the press release, positive results from this study could pave the way for market authorization applications as early as 2026, offering a medium-term commercialization potential in a market that currently lacks an approved vaccine solution.

Meanwhile, Valneva continues to develop VLA1601, a vaccine candidate for the Zika virus, which has shown positive data in phase 1 trials with good tolerance and an encouraging immune response. The company has also published long-term follow-up data for IXCHIQ, demonstrating persistent antibodies in 95% of subjects at four years, a differentiating factor against potential competitors.

The S4V2 candidate for shigellosis represents another opportunity. Valneva estimates the potential market for this vaccine to exceed $500 million per year, given the absence of a licensed vaccine and the high incidence of the disease in developing countries. However, the program is still at an early stage, with regulatory and clinical uncertainties to overcome.

A Tight Regulatory Environment and Financing Risks to Watch

The suspension of IXCHIQ's license in the United States by the FDA is a major setback for the vaccine's growth in the American travelers segment, a key market for this type of product. This decision impacts short-term prospects and raises questions about the timeline for a possible resumption of commercial activities across the Atlantic. The company has not specified when this suspension might be resolved.

Ongoing clinical trials, particularly the VALOR trial for VLA15, carry risks of failure or delay, which could undermine commercialization plans. Similarly, the development of S4V2 and VLA1601 is subject to regulatory uncertainties and the need to demonstrate robust clinical efficacy in larger-scale trials.

Financially, despite the October 2025 refinancing with Pharmakon Advisors, cash consumption remains high amid ongoing operational losses. Dependence on distribution partners, highlighted by the gradual discontinuation of third-party products like Rabipur/RabAvert, also reduces revenue diversification. Exposure to exchange rate fluctuations, with a negative impact of 1.3 million euros recorded over nine months, adds an additional risk in a volatile monetary environment.

Confirmed Outlook Despite a Challenging Environment

Valneva is maintaining its targets for the 2025 fiscal year. The company anticipates total revenue between 165 and 180 million euros, with product sales expected between 155 and 170 million euros. These forecasts account for the delivery schedule of the chikungunya vaccine active ingredient to low- and middle-income countries, as well as the continued commercialization of travel vaccines in markets outside the United States.

According to the management, as cited in the statement, the third quarter focused on strengthening cash reserves, enabling the refinancing of debt under more favorable financial terms. The management emphasizes that commercial activity is expected to generate positive cash flows in the long term, although the exact timeline is not specified. Investments in R&D remain robust, with an allocation of 80 to 90 million euros slated for the year, partially covered by public financing.

The company positions itself as a niche player in vaccines for infectious diseases, with a portfolio of marketed products and a pipeline at various stages. The ability to quickly monetize the Lyme vaccine, should the VALOR trial succeed, is seen as a crucial lever for improving profitability. In the meantime, Valneva will need to manage its financial resources prudently while navigating a demanding regulatory environment and a competitive travel vaccine market. The company's performance in the upcoming quarters will largely depend on the regulatory developments of IXCHIQ in the United States and the clinical progress of VLA15.