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].

Core Viewpoint - Valneva SE, a specialty vaccine company, is actively engaging with investors through upcoming conferences in the U.S. and Europe, highlighting its vaccine pipeline and revenue expectations for 2025 [1][2]. Company Overview - Valneva SE develops, manufactures, and commercializes prophylactic vaccines for infectious diseases, focusing on unmet medical needs and employing a specialized approach across various vaccine modalities [3]. - The company has a strong track record of advancing multiple vaccines from early R&D to approvals, currently marketing three proprietary travel vaccines, including the world's first chikungunya vaccine [4]. Financial Expectations - Valneva's marketed vaccines are projected to generate revenue between €170 million and €180 million in 2025 [2][5]. - The revenue from the commercial business supports the advancement of the vaccine pipeline, which includes the only Lyme disease vaccine candidate in advanced clinical development, partnered with Pfizer, and other candidates targeting global public health threats [5]. Upcoming Events - Valneva's CEO and CFO will present at the TD Cowen 45th Annual Health Care Conference in Boston from March 3-5, 2025, and will also meet with institutional investors at the Van Lanschot Kempen Life Sciences Conference in Amsterdam on April 2-3, 2025 [1][2]. - The TD Cowen presentation will be available via live webcast [2].

Core Viewpoint - Valneva SE's IXCHIQ® vaccine is recommended for authorization to extend its use to adolescents aged 12 and older in the EU, marking a significant step in combating chikungunya virus (CHIKV) [1][2][4] Company Developments - Valneva received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for IXCHIQ®, which is already authorized for individuals 18 years and older since July 2024 [1][2] - The company plans to submit additional label extension applications to the U.S. FDA and Health Canada for the use of IXCHIQ® in adolescents [4] - Valneva has expanded its partnership with the Coalition for Epidemic Preparedness Innovations (CEPI) through a $41.3 million grant to enhance vaccine access in low- and middle-income countries [5][6] Clinical Data - Phase 3 data indicated that IXCHIQ® induces a high immune response in 99.1% of adolescents, with a sustained immune response in 98.3% one year post-vaccination [3] - The vaccine was reported to be generally safe and well tolerated in adolescents aged 12 to 17 years [3][4] Market Context - Chikungunya virus has been identified in over 110 countries, with significant economic and medical burdens expected to grow due to climate change [10] - The World Health Organization (WHO) has recognized chikungunya as a major public health issue, highlighting the need for effective vaccines [10] Strategic Partnerships - Valneva signed an exclusive license agreement with the Serum Institute of India to supply IXCHIQ® in Asia, focusing on affordable pricing for public health markets in low- and middle-income countries [6][7] - The company also has a prior agreement with Instituto Butantan in Brazil for local vaccine development and distribution [7]

Core Viewpoint - Valneva SE reported strong preliminary financial results for 2024, achieving double-digit sales growth and a solid cash position, while outlining a positive outlook for 2025 with significant clinical and regulatory advancements expected [4][7][8]. 2024 Performance - Total revenues for 2024 were €169.6 million, a 10% increase from €153.7 million in 2023 [8]. - Product sales revenue reached €163.3 million, reflecting a 13% growth compared to €144.6 million in 2023 [8]. - Year-end cash and cash equivalents stood at €168.3 million, up from €126.1 million in 2023, bolstered by the sale of a Priority Review Voucher and a successful private placement [8]. 2025 Financial Outlook - Sales revenues are projected to grow to between €170 million and €180 million, with total revenues expected to reach €180 million to €190 million [8]. - Total R&D investments are anticipated to be between €90 million and €100 million, partially offset by grant funding and R&D tax credits [8]. - The company expects to maintain a lower operating cash burn of less than €30 million in 2025, compared to over €60 million in 2024 [8]. Regulatory, R&D and Strategic Highlights - Significant clinical and regulatory progress was made in 2024, with multiple anticipated data readouts and product approvals expected in 2025 [7][9]. - The company is advancing its Lyme disease vaccine candidate, VLA15, with the first Phase 3 study results expected by the end of 2025 [6][9]. - Valneva secured three additional regulatory approvals for its chikungunya vaccine, IXCHIQ®, and initiated a Phase 2b trial for a tetravalent Shigella vaccine candidate [9][15]. Key Upcoming Catalysts - The first data readout from the Lyme disease Phase 3 study is anticipated by the end of 2025 [6]. - Phase 2b efficacy data for the Shigella vaccine candidate is expected in mid-2025, along with the launch of a pediatric study [15].

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]

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 can last 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] Company Developments - The Chief Medical Officer of Valneva emphasized the importance of the vaccine for UK travelers, especially given the current chikungunya outbreak in India, which has seen 370,000 cases reported from January 2019 to July 2024 [4] - Valneva has partnered with CEPI to support late-stage development and expand access to IXCHIQ® in low- and middle-income countries, with a $41.3 million grant from the EU to facilitate this [5][11] - An exclusive license agreement with the Serum Institute of India has been signed to supply the vaccine in Asia at affordable prices [6] Industry Context - Chikungunya is a mosquito-borne viral disease that has been spreading globally since 2004, with over 3.7 million cases reported in the Americas between 2013 and 2023 [9] - The World Health Organization has identified chikungunya as a major public health problem, with the disease's economic impact expected to grow due to climate change [9][10]

Core Viewpoint - Valneva SE has signed a new contract worth $32.8 million with the U.S. Department of Defense for the supply of its Japanese encephalitis vaccine, IXIARO® [1][2]. Company Overview - Valneva is a specialty vaccine company focused on developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases [6]. - The company has a strong track record of advancing multiple vaccines from early R&D to approvals and currently markets three proprietary travel vaccines [7]. - Valneva's commercial revenues support the advancement of its vaccine pipeline, which includes candidates for Lyme disease, Shigella, Zika virus, and other public health threats [8]. Product Information - IXIARO® is the only Japanese encephalitis vaccine approved by the U.S. Food and Drug Administration (FDA) and is indicated for active immunization against the disease [3][4]. - The vaccine is approved for individuals aged two months and older in various regions, including the U.S., Europe, and Canada [4]. - Japanese encephalitis is a serious infectious disease primarily found in Asia, with an estimated 70,000 cases occurring annually [5]. Contract Details - The new one-year contract allows the DoD to purchase a minimum of $32.8 million worth of IXIARO® vaccines, with the option for additional doses [2]. - Deliveries under this contract will commence immediately, continuing from a previous supply contract signed in September 2023 [2].