Valneva lowers 2025 financial outlook due to loss of Ixchiq vaccine marketing

[Recession graph]
J Studios

* Valneva SE (NASDAQ:VALN [https://seekingalpha.com/symbol/VALN]) is cutting its 2025 full-year sales and revenue guidance as a result of the US FDA's August decision to revoke [https://seekingalpha.com/news/4488549-valneva-chikungunya-vaccine-suspended-in-us] the marketing authorization for its chikungunya vaccine Ixchiq over safety concerns.
* Product sales are now projected at €155M-€170M, down from €170-€180M prior. Revenue is now expected at €165M-€180M, from €180M-€190M before.
* The France-based vaccine company also said that it entered into a debt facility of up to $500M with funds managed by Pharmakon Advisors. The initial tranche of $215M will be used to pay off an existing debt facility with Deerfield Management Company and OrbiMed. The other up to $285M can be drawn in the future for business development.
* Valneva noted [https://valneva.com/wp-content/uploads/2025/10/2025_10_06_VLA_Refinancing_PR_EN_Final.pdf] that a phase 3 trial of its Lyme disease vaccine asset is on schedule. Partner Pfizer (PFE [https://seekingalpha.com/symbol/PFE]) is expected to submit a Biologics License Application to the FDA and a Marketing Authorization Application to European Medicines Agency in 2026, assuming positive phase 3 data.
* Shares are down ~3% in Monday afternoon trading.

MORE ON VALNEVA

* Valneva Outlook: Safety Blow To Ixchiq And Valuation Concerns [https://seekingalpha.com/article/4816693-valneva-outlook-safety-blow-to-ixchiq-and-valuation-concerns]
* Valneva SE 2025 Q2 - Results - Earnings Call Presentation [https://seekingalpha.com/article/4812783-valneva-se-2025-q2-results-earnings-call-presentation]
* Valneva SE (VALN) Q2 2025 Earnings Call Transcript [https://seekingalpha.com/article/4812782-valneva-se-valn-q2-2025-earnings-call-transcript]
* Valneva suspended from marketing chikungunya shot in U.S. over safety concerns [https://seekingalpha.com/news/4488549-valneva-chikungunya-vaccine-suspended-in-us]
* Valneva reports 1H results; reaffirms FY outlook [https://seekingalpha.com/news/4483640-valneva-reports-1h-results-reaffirms-fy-outlook]