Company Overview - Valneva SE is a specialty vaccine company focused on developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases, addressing unmet medical needs [6] - The company has advanced multiple vaccines from early R&D to approvals and currently markets three proprietary travel vaccines [7] - Revenues from its growing commercial business support the advancement of its vaccine pipeline, which includes candidates for Lyme disease, Shigella, Zika virus, and other public health threats [8] Vaccine Development and Regulatory Update - The European Medicines Agency (EMA) has lifted the temporary restriction on vaccinating individuals aged 65 and above with Valneva's chikungunya vaccine IXCHIQ® after a thorough safety review [1][2] - The review was initiated due to serious side effects observed mainly in elderly individuals with underlying medical conditions, but the EMA concluded that IXCHIQ® should be administered when there is a significant risk of chikungunya infection [2][3] - IXCHIQ® is effective in producing antibodies against the chikungunya virus, which is particularly beneficial for older individuals at increased risk of severe disease [3] Chikungunya Disease Context - Chikungunya virus (CHIKV) is a mosquito-borne disease causing debilitating symptoms, including fever and severe joint pain, with significant global outbreaks since 2004 [4][5] - The disease has been reported in over 110 countries, with more than 3.7 million cases in the Americas between 2013 and 2023, leading to a considerable medical and economic burden [5]

Core Insights - Valneva SE has entered into an exclusive agreement with CSL Seqirus for the marketing and distribution of its three proprietary vaccines in Germany [1][2] - The agreement includes the commercialization of Valneva's chikungunya vaccine IXCHIQ® starting July 2025, and its Japanese Encephalitis vaccine IXIARO® and cholera/ETEC vaccine DUKORAL® from January 2026 [2] - This new agreement replaces a previous partnership with Bavarian Nordic, which is set to conclude at the end of December 2025 [2][3] Company Performance - Valneva's product sales reached €48.6 million in Q1 2025, with €42.8 million coming from proprietary vaccines [4] - The company anticipates product sales to grow to €170-180 million in 2025, contributing to positive cash flows for its commercial business [4] Strategic Focus - The partnership with CSL Seqirus is expected to enhance Valneva's commercial sales in Germany, leveraging CSL's strong presence in the travel vaccine market [4] - Valneva specializes in developing vaccines for infectious diseases, focusing on unmet medical needs and applying expertise across multiple vaccine modalities [5][6] Pipeline Development - Revenues from the commercial business support the advancement of Valneva's vaccine pipeline, which includes a Lyme disease vaccine candidate partnered with Pfizer and a Shigella vaccine candidate [7]

Total revenues of €49.2 million compared to €32.8 million in the first quarter of 2024Cash and cash equivalents of €153.0 million at end of March 2025Further clinical and regulatory progress2025 financial outlook confirmed Saint-Herblain (France), May 7, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported its financial results for the first quarter ending March 31, 2025, provided key corporate updates and confirmed its 2025 financial guidance. The condensed co ...

Core Insights - Valneva SE has received marketing authorization from Brazil's ANVISA for its single-dose chikungunya vaccine IXCHIQ®, marking the first approval of a chikungunya vaccine in an endemic country [1][2] - The vaccine is part of Valneva's strategy to enhance access in low- and middle-income countries (LMICs), supported by CEPI and the EU [1][6] - The approval allows for large-scale clinical trials in Brazil, including Phase 4 trials to gather additional data on vaccine effectiveness [3] Company Developments - IXCHIQ® is already approved in the EU for individuals aged 12 and older and in the U.S., Canada, and the U.K. for those aged 18 and older [2] - Valneva is collaborating with Instituto Butantan for local manufacturing and distribution of the vaccine in Brazil, with potential approval for another vaccine candidate, VLA1555, expected in mid-2025 [4] - The company aims to ensure rapid access to its vaccines in Brazil and other regional markets, addressing a significant public health need as Brazil reported over 1 million chikungunya cases since 2019 [5][6] Clinical Trials and Research - Valneva is conducting a Phase 2 trial in children aged 1 to 11 years in the Dominican Republic and Honduras, with positive results reported in January 2025 [7] - A pivotal Phase 3 study in children is expected to begin in Q4 2025, with plans to evaluate the vaccine in pregnant women in outbreak-affected countries [8] Public Health Context - Chikungunya virus, transmitted by Aedes mosquitoes, has caused significant outbreaks globally, with over 720,000 cases reported in the Americas from January to July 2023 [5][10] - The World Health Organization has identified chikungunya as a major public health issue, with the disease's economic impact expected to grow due to climate change [10]