First-Half Sales Performance in Line with Full-Year 2024 Guidance Total revenues of €70.8 million, including product sales of €68.3 million, in line with anticipated supply and sales phasing Net Profit of €34.0 million, including proceeds from PRV sale Operating profit of €46.7 million compared to an operating loss of €35.0 million in the first half of 2023 Cash position of €131.4 million  Substantially lower cash burn expected in the second half of 2024 as Valneva completed its cost contributions to the agreed R&D budget for its partnered Lyme disease program in the second quarter Significantly extended cash runway with update of debt financing agreement1 Full-year 2024 Financial Guidance Confirmed Expected total revenues between €170 million and €190 million, including €160 million to €180 million of product sales Expected R&D investments between €60 million and €75 million Expected Other income between €100 million and €110 million, including €95 million from the PRV sale Strategic Pipeline Expansion, Strong Clinical and Regulatory Execution         Exclusive worldwide license for S4V Shigella vaccine candidate, adding an attractive Phase 2 clinical asset to Valneva's R&D pipeline without impacting full-year or mid-term financial guidance2 Additional marketing authorizations for single-shot IXCHIQ® granted in Europe and Canada ahead of initial guidance; Ongoing regulatory reviews in the UK and Brazil; Recommended by ACIP and adopted by U.S. CDC3 New CEPI grant4 of $41.3 million contributes significantly to Phase 4 costs and other studies supporting broader access to the world's first chikungunya vaccine Reported positive six-month data for Phase 3 adolescent study of IXCHIQ®5; expects to submit label extensions for 12 to 17 years old in the U.S., Europe and Canada in the second half of 2024 IXCHIQ® two-year antibody persistence data published in the Lancet Infectious Diseases IXCHIQ® pediatric Phase 2 study fully enrolled Completed primary vaccinations (three doses) of VALOR Lyme disease Phase 3 trial participants6 Initiated Phase 1 clinical trial for second-generation Zika vaccine candidate7 Financial Information(Unaudited results, consolidated per IFRS) € in million 6 months ended June 30,   2024 2023 Total revenues 70.8 73.7 Product sales 68.3 69.7 Net profit / loss 34.0 (35.0) Adjusted EBITDA8 56.2 (28.3) Cash                 131.4                204.4 Saint-Herblain (France), August 13, 2024 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today reported its consolidated financial results for the first half of the year, ended June 30, 2024. The half year financial report, including the condensed consolidated interim financial report and the half year management report, is available on the Company's website (Financial Reports – Valneva). Valneva will provide a live webcast beginning at 3 p.m. CEST / 9 a.m. EDT today. This webcast will also be available on the Company's website. Please refer to this link: https://edge.media-server.com/mmc/p/mmuf83o5  Peter Bühler, Valneva's Chief Financial Officer, commented, "Our first half sales performance is in line with our expectations. We aim to further capitalize on the travel industry recovery as we focus on ramping up sales for IXCHIQ® to support our commercial growth, while continuing to execute on our key R&D and regulatory milestones. The successful sale of our PRV and deferral of our loan reimbursement allow us to maintain a solid cash position and, with completion of our payments for the Lyme disease program in the second quarter, we anticipate a significantly lower cash burn in 2024."Commercial Portfolio Valneva's commercial portfolio is composed of three travel vaccines, IXIARO®/JESPECT®, DUKORAL® and recently launched IXCHIQ®. The Company also distributes certain third-party products in countries where it operates its own marketing and sales infrastructure. Valneva's sales in the first half of 2024 were €68.3 million compared to €69.7 million (€64.0 million excluding final COVID-19 vaccine sales) in the first half of 2023. While product sales grew meaningfully in the second quarter and included first sales for IXCHIQ®, first half 2024 sales were affected by previously reported supply constraints for IXIARO® and third-party products. JAPANESE ENCEPHALITIS VACCINE IXIARO®/JESPECT® In the first half of 2024, IXIARO®/JESPECT® sales increased by 38% to €41.9 million compared to €30.3 million in the first half of 2023. The increase primarily reflects sales to the U.S. military, which were minimal in the first half of 2023, as well as increased sales to travelers. CHOLERA / ETEC9-DIARRHEA VACCINE DUKORAL® In the first half of 2024, DUKORAL® sales were €14.9 million compared to €17.1 million in the first half of 2023. The decrease was due to reduced marketing investments while Valneva's new manufacturing site in Sweden underwent regulatory evaluation and approval. CHIKUNGUNYA VACCINE IXCHIQ® IXCHIQ® is the world's first and only licensed chikungunya vaccine available to address this significant unmet medical need. The vaccine is now approved in the U.S. 10, Europe11, and Canada12 for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older. The U.S. launch is underway while first sales in Canada and Europe are anticipated in the fourth quarter of 2024. Following adoption of the U.S. Advisory Committee on Immunization Practices (ACIP)'s recommendations by the U.S. Centers for Disease Control and Prevention (CDC)13 at the beginning of March 2024, Valneva recognized initial sales of €1.0 million in the first half of 2024. Key launch metrics, including stocking and re-stocking across all sales channels, active customer accounts, as well as reimbursement for IXCHIQ® by commercial and MediCare insurance plans continue to track in line with expectations. In addition to ramping up sales, Valneva is focusing on expanding the vaccine's label and access. The Company expects marketing authorizations in the UK and Brazil in the second half of 2024 and recently expanded its partnership with CEPI14 to support broader access to the vaccine in Low Middle-Income Countries (LMICs), post-marketing trials and potential label extensions in children, adolescents and pregnant women. CEPI will provide Valneva up to $41.3 million of additional funding over the next five years, with support from the European Union's (EU) Horizon Europe program. Based on positive pivotal six-month Phase 3 data reported in May 202415, Valneva expects to file for potential label extensions for use in adolescents aged 12 to 17 years in the second half of 2024. These data show that a single-dose vaccination with IXCHIQ® induces a high and sustained immune response in 99.1% of adolescents, and that the vaccine was generally well tolerated. Conducted in Brazil in collaboration with Instituto Butantan, the trial is also expected to support licensure of the vaccine in Brazil, which would be the first potential approval for use in endemic populations. Additionally, Valneva recently completed enrollment of a Phase 2 pediatric trial, VLA1553-221, in children aged 1 to 11 years16, designed to support a Phase 3 pivotal pediatric study and potential future label extension to this age group. The peer-reviewed medical journal, The Lancet Infectious Diseases, also just published the vaccine's Phase 3 antibody persistence results two years after vaccination with a single dose. The data show that IXCHIQ®'s robust immune response was sustained for two years by 97% of participants and was equally durable in younger and older adults17. These data, which further support the anticipated long-term durability of the immune response, will also be used to potentially expand the vaccine's current label. Valneva will continue to measure antibody persistence for a period of at least five years and expects to report three-year durability results later this year. THIRD-PARTY DISTRIBUTION Valneva distributes certain third-party vaccines in countries where it operates its own marketing and sales infrastructure. During the first half of 2024, third-party sales decreased by 37% to €10.5 million compared to €16.5 million in the first half of 2023 as a result of anticipated supply constraints. Valneva expects third-party sales to gradually wind down to less than 5% of overall product sales by 2026/2027, allowing the Company to improve gross margins. Clinical Vaccine Candidates LYME DISEASE VACCINE CANDIDATE – VLA15 Phase 3 primary vaccination completed Valneva and Pfizer ...