Company Overview - Valneva SE is a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases, addressing unmet medical needs [10][11] - The company has advanced multiple vaccines from early R&D to approvals and currently markets three proprietary travel vaccines, including the world's first and only chikungunya vaccine, IXCHIQ® [11][12] Chikungunya Vaccine Response - Valneva is responding to a chikungunya outbreak in France's Island of La Réunion by providing 40,000 doses of its vaccine IXCHIQ® starting in early April 2025, with the option to supply more [1] - The vaccine supply is supported by the local public health agency and is prioritized for adults aged 65 and over with co-morbidities, as recommended by France's national public health agency [1][4] Outbreak Context - Chikungunya cases in La Réunion have surged, with 8,600 cases recorded and almost 3,000 new cases reported during the week of March 3 to 9, 2025 [2] - Local authorities have implemented a Level 4 emergency crisis management plan to contain the outbreak, and the CDC has issued a travel alert due to the risk of transmission to mainland France [2] Vaccine Approval and Expansion - IXCHIQ® is the first licensed chikungunya vaccine approved in the U.S., Europe, Canada, and the UK for individuals aged 18 and older, with a recent positive opinion from the EMA for a label extension to individuals aged 12 and older [3][5] - Valneva is focused on expanding the vaccine's label and access, including a partnership with CEPI supported by a $41.3 million grant to enhance access in Low- and Middle-Income Countries (LMICs) [5][6] International Partnerships - Valneva has signed an exclusive license agreement with the Serum Institute of India to supply the chikungunya vaccine in Asia at affordable prices for public health markets in LMICs [6][7] - This agreement complements a previous license signed with Instituto Butantan in Brazil for the development and marketing of a local chikungunya vaccine for distribution in Latin America and selected LMICs [7]

Saint Herblain (France), March 24, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it is responding to the chikungunya outbreak that is rapidly intensifying in France’s Island of La Réunion with its vaccine IXCHIQ®. In agreement and with support from the local public health agency, the Agence Régionale de Santé La Réunion, Valneva will provide 40,000 doses starting early April, with an option to provide more, through distribution agreements with the I ...

Joshua Drumm Thank you. Hello, and thank you for joining us to discuss Valneva’s Full Year 2024 Results and Corporate Update. It’s my pleasure to welcome you today. In addition to our press release and analyst presentation, you can find our consolidated financial results for the 12 months ended December 31, 2024, which were published earlier today available within the Financial Reports section on our Investor website. I’m joined today by Valneva’s CEO, Thomas Lingelbach; and CFO, Peter Bühler, who will prov ...

Core Insights - Valneva SE reported consolidated financial results for the year ended December 31, 2024, highlighting double-digit sales growth and significant clinical and regulatory progress, setting the stage for future advancements in 2025 [1][3][5]. Financial Performance - Product sales increased by 13% to €163.3 million in 2024 from €144.6 million in 2023, while total revenues rose by 10% to €169.6 million from €153.7 million [6][35]. - The net loss for 2024 was €12.2 million, a significant improvement from a net loss of €101.4 million in 2023, largely due to the sale of a Priority Review Voucher [6][46][47]. - Operating cash burn was reduced by 67% to €67.2 million in 2024 compared to €202.7 million in 2023, with cash and cash equivalents at €168.3 million at year-end [5][49][51]. R&D and Regulatory Highlights - Valneva made substantial clinical and regulatory progress, including the completion of primary vaccinations in the Phase 3 study for its Lyme disease vaccine candidate, VLA15, and securing additional regulatory approvals for its chikungunya vaccine, IXCHIQ® [7][24][30]. - The company anticipates further data readouts and product approvals in 2025, with a focus on advancing its science-driven pipeline [5][6]. Product Portfolio - Valneva's commercial portfolio includes three vaccines: IXIARO®/JESPECT®, DUKORAL®, and IXCHIQ®, with IXIARO® sales increasing by 28% to €94.1 million in 2024 [10][11][36]. - DUKORAL® sales grew by 8% to €32.3 million, driven by increased demand in Canada [13][37]. - Initial sales of IXCHIQ® amounted to €3.7 million in 2024 following its launch in multiple markets [38]. Future Outlook - The company expects product sales to grow to €170-180 million and total revenues to reach €180-190 million in 2025, with R&D investments projected between €90-100 million [6][5]. - Valneva aims to maintain a strong cash position to support strategic investments while targeting a more than 50% reduction in operating cash burn in 2025 [5][6].

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Valneva SE and its officers or directors following adverse events reported after vaccination with its chikungunya virus vaccine [1][2]. Group 1: Investigation Details - The investigation is initiated on behalf of investors of Valneva SE, focusing on possible securities fraud or other unlawful business practices [1]. - The U.S. Centers for Disease Control and Prevention (CDC) is investigating five hospitalizations for cardiac or neurologic events in individuals aged 65 and older after receiving Valneva's chikungunya virus vaccine [2]. Group 2: Market Impact - Following the CDC's announcement, Valneva's American Depositary Receipt (ADR) price dropped by $1.06, or 13.57%, closing at $6.75 per ADR on February 28, 2025 [2]. Group 3: Firm Background - Pomerantz LLP is recognized as a leading firm in corporate, securities, and antitrust class litigation, with a history of recovering multimillion-dollar damages for victims of securities fraud and corporate misconduct [2].

Saint-Herblain (France), March 3, 2025 – Valneva SE (NASDAQ:VALN, PARIS:VLA) a specialty vaccine company, today announced that its senior management will participate at upcoming investor conferences in the United States and Europe. CEO Thomas Lingelbach and CFO Peter Bühler will present at the TD Cowen 45th Annual Health Care Conference, taking place March 3 - 5, 2025, in Boston, MA. Mr. Lingelbach and Mr. Peter Bühler will also meet with institutional investors during the Van Lanschot Kempen Life Sciences ...

If granted, IXCHIQ® will become the first vaccine against the chikungunya virus (CHIKV) available in the EU for adolescents 12 years of age and older Saint Herblain (France), February 28, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending authorization of a label extension for IXCHIQ®, Valneva’s single-dose vaccine ...

Met 2024 growth targets for sales revenue (+13% vs 2023) and total revenues (+10% vs 2023)Strong year-end cash position of €168.3 millionSubstantial clinical and regulatory progress in 2024, leading to multiple anticipated data readouts, product approvals and label extensions in 20252025 outlook reflects solid revenue growth and positive commercial cash flows to support strategic R&D investments with lower operating cash burn Saint-Herblain (France), February 18, 2025 – Valneva SE (NASDAQ:VALN, PARIS:VLA) a ...

Saint Herblain (France), February 5, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization in the United Kingdom (UK) for the world’s first and only chikungunya vaccine, IXCHIQ®. The single-dose vaccine is indicated for active immunization for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older. The vaccine is ...

Core Points - Valneva SE has received marketing authorization from the UK for IXCHIQ®, the world's first chikungunya vaccine, which is a single-dose vaccine for individuals aged 18 and older [1][3] - The approval is based on Phase 3 data showing that IXCHIQ® induces a strong immune response that lasts for at least three years [2] - Valneva has received regulatory approvals for IXCHIQ® in the US, Europe, and Canada, and expects approval in Brazil in Q1 2025 [3] Regulatory Approvals - The UK approval is the fourth for IXCHIQ®, which is already approved in the US, Europe, and Canada for adults aged 18 and older [3] - Valneva is pursuing label extension applications to include adolescents aged 12 to 17 in the US, Europe, Canada, and the UK [3] Market Context - The approval comes amid a chikungunya outbreak in India, where 370,000 cases were reported from January 2019 to July 2024, highlighting the need for vaccination among travelers [4] - In 2023, 920,000 UK travelers visited India, making it crucial to provide access to IXCHIQ® for their protection [4] Partnerships and Funding - Valneva has partnered with CEPI to support late-stage development and expand access to IXCHIQ® in low- and middle-income countries (LMICs) [5][6] - CEPI has provided a $41.3 million grant to Valneva to enhance access to the vaccine in LMICs and support post-marketing studies [5][6] Production and Distribution - Valneva has signed an exclusive license agreement with the Serum Institute of India to supply IXCHIQ® in Asia at affordable prices for public health markets [6] - The company also has a license agreement with Instituto Butantan in Brazil for local chikungunya vaccine development and distribution [7] Disease Overview - Chikungunya is a mosquito-borne viral disease causing severe joint pain and other symptoms, with significant outbreaks reported globally since 2004 [8][9] - The World Health Organization has identified chikungunya as a major public health problem, with the economic impact expected to grow due to climate change [9]