Valneva SE

Overview

1. "How the company got here" Valneva SE was formed in 2013 through the merger of two European biotechnology companies: Intercell from Austria and Vivalis SA from France. The company has since expanded its reach, listing on Euronext Paris in 2013 and on the Nasdaq in the United States in 2021. Valneva's journey has involved developing and bringing to market vaccines for infectious diseases, including navigating the complexities of clinical trials and regulatory approvals. The company has also experienced setbacks, such as the cancellation of a COVID-19 vaccine order by the UK government in 2021, which was related to manufacturing and supply chain issues rather than vaccine quality. 2. "What it actually does" Valneva SE is a specialty vaccine company. This means it focuses on creating vaccines, which are biological preparations that provide immunity to a particular infectious disease. The company develops, manufactures, and sells these vaccines, primarily targeting infectious diseases that currently have unmet medical needs, meaning there are limited or no existing vaccines available. Valneva's approach is to create vaccines that are either the first, best, or only available option for a specific disease. 3. "IXIARO®/JESPECT® (Japanese Encephalitis Vaccine)" Valneva's commercial portfolio includes IXIARO, also known as JESPECT in some regions, which is a vaccine designed to prevent Japanese encephalitis. Japanese encephalitis is a serious mosquito-borne viral infection that can cause inflammation of the brain. This vaccine is indicated for active immunization, meaning it's given to people to protect them before they are exposed to the disease. It is approved for use in Europe, North America, and Australia, and is often used by travelers visiting areas where the disease is common. 4. "DUKORAL® (Cholera Vaccine)" DUKORAL is an oral vaccine developed by Valneva that protects against cholera, a bacterial infection that causes severe diarrhea and dehydration. In some countries, it also offers protection against diarrhea caused by a specific type of E. coli bacteria. This vaccine is administered orally, meaning it's taken by mouth, and is approved for use in Europe and Canada, as well as Australia. It is primarily used by travelers to prevent gastrointestinal illnesses. 5. "IXCHIQ® (Chikungunya Vaccine)" IXCHIQ is Valneva's single-dose vaccine for the prevention of chikungunya virus disease. Chikungunya is a mosquito-borne illness that causes fever and severe joint pain. This vaccine has received marketing approval in Canada, the United Kingdom, Brazil, and Europe. It is a live-attenuated vaccine, meaning it uses a weakened form of the virus to stimulate an immune response without causing illness. 6. "VLA15 (Lyme Disease Vaccine Candidate)" Valneva is developing VLA15, a vaccine candidate aimed at preventing Lyme disease, which is caused by bacteria transmitted through tick bites and is the most common vector-borne illness in the Northern Hemisphere. This vaccine candidate has advanced significantly in clinical development, with pivotal Phase 3 trials completed. Valneva has partnered with Pfizer for the development and potential commercialization of this vaccine. The Marketing Authorization Application for VLA15 was accepted for review by the European Medicines Agency (EMA) in August 2026, with regulatory decisions anticipated in 2027. 7. "What management is betting on now" Valneva's current strategy focuses on driving commercial growth from its existing travel vaccines to generate cash, which can then be reinvested into research and development (R&D) for innovative new vaccines. A key priority is maximizing the potential of its R&D pipeline, particularly advancing its Lyme disease vaccine candidate, VLA15, which is seen as a potential "first, best, or only" in its class. The company also aims to fully leverage its integrated biotechnology model by expanding its clinical pipeline and enhancing its manufacturing and commercial operations. Valneva is committed to addressing diseases with significant unmet medical needs and aims to make its vaccines accessible, especially in low- and middle-income countries.