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Total Revenue: EUR127 million, a growth of 9% year-over-year.

Product Sales: EUR119.4 million, up 6.2% from the previous year.

Cash Position: EUR143.5 million as of September 30, 2025.

Operating Loss: EUR53.9 million compared to an operating profit of EUR34.2 million in the prior year.

Adjusted EBITDA: Negative EUR37.7 million.

Research and Development Expense: EUR59.7 million, increased from EUR48.6 million in the previous year.

Gross Margin on Commercial Products (excluding exchick): 57.2%, improved from 48.6% in the prior year.

Cash Used in Operating Activities: EUR28.4 million, reduced from EUR76.7 million in the previous year.

Financial Guidance for 2025: Product sales of EUR155 to EUR170 million and total revenues of EUR165 to EUR180 million.

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Release Date: November 20, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Valneva SE (INRLF) reported a 9% increase in total revenues, reaching EUR127 million for the first nine months of 2025.

The company successfully reduced its operating cash burn, resulting in a cash position of over EUR140 million.

Valneva SE (INRLF) completed its debt refinancing, enhancing financial flexibility with a new partner, Pharmaon.

The company secured additional marketing authorizations for its products in the UK and Brazil, and label extensions in Europe and Canada.

Positive phase 1 results were reported for the second-generation Zika vaccine candidate VLA 1,601, indicating promising development.

Valneva SE (INRLF) faced a temporary restriction and US license suspension for its chikungunya vaccine, adversely impacting sales in the traveler segment.

The company reported an operating loss of EUR53.9 million for the first nine months of 2025, compared to an operating profit in the prior year.

Research and development expenses increased significantly, driven by costs related to the Shigella vaccine candidate and Ichick phase 4 commitments.

Third-party product sales decreased by 28.5% year-over-year, reflecting the anticipated discontinuation of certain distribution agreements.

Uncertainty around private and public funding opportunities poses a challenge for advancing the Zika vaccine candidate.

Q: Is there any timeline for when Valneva might hear back from the FDA regarding the suspension of the chikungunya vaccine in the U.S.? A: Unfortunately, there is no predefined process or precedent for this type of suspension, so there is no specific timeline. Valneva hopes to engage in a dialogue with the FDA soon, especially after delays caused by the government lockdown.

Q: Regarding the Lyme disease vaccine Phase 3 readout, could the timing of the data release be delayed into the second quarter of 2026? A: Pfizer controls the process and is working professionally and quickly. While they aim for an early readout, they will not take regulatory risks. The timeline remains as planned, with hopes for an early readout of the top-line data.

Q: What has Valneva proposed to the FDA as a remedy for the chikungunya vaccine BLA suspension? A: Valneva's response focuses on real medical evidence, individual case analysis, and reiterating the positive health economic benefit. They have ongoing Phase 4 programs and more stringent pharmacovigilance reviews to address safety concerns.

Q: Can you provide more details on the factors influencing the decision to advance the Zika vaccine candidate, particularly regarding funding? A: While Valneva has promising data, regulatory pathways are uncertain, and major health agencies have deprioritized Zika. Without substantial public or private funding, it would not be prudent for Valneva to invest further in this program alone.

Q: Will Valneva be able to launch the Lyme disease vaccine in time for the 2027 peak season? A: Pfizer has reconfirmed the regulatory submission timeline for next year, which supports a launch in late 2027. The accelerated approval pathway is crucial to meet this timeline, ensuring vaccination before the 2028 Lyme season.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.