2023 Annual Business Report

Letter from the CEO

2023 was a significant year for Valneva, celebrating a decade of dedication and delivering against major milestones.

Letter from the CEO

Financials & Outlook

At Valneva we focus on where we can make a positive impact on global health by providing prophylactic vaccines that make a difference, limiting the threat of infectious diseases.

In 2023, we proudly celebrated our 10th anniversary and looked back on a decade of dedication to advancing vaccines for better lives. Today, we are as committed as ever to our vision of contributing to a world in which no one dies or suffers from a vaccine-preventable disease.

In this remarkable year, we brought our third vaccine from early R&D to approval. Together, we achieved the US licensure for our chikungunya vaccine, IXCHIQ® – the world’s first licensed vaccine available to address this debilitating disease. In line with our aim to make this product available to as many people we can, we have prioritized regulatory submissions in Canada, Europe, as well as in Brazil with our partner Instituto Butantan. We’ve also turned our attention to the marketing and distribution of IXCHIQ® in the U.S, where we have doubled our commercial investment in anticipation of future market development. With this addition to our commercial portfolio, we currently market three proprietary travel vaccines, as well as certain third-party vaccines.

Product sales for our travel vaccines have surpassed pre-COVID levels and as such, future revenues from our growing commercial business will help support investments in the continued advancement of our vaccine R&D pipeline. In addition to our ongoing development activities for chikungunya, our focused R&D pipeline includes the only Lyme disease vaccine candidate in advanced clinical development, partnered with Pfizer, as well as early-stage vaccine candidates against the Zika virus and other public health threats.

For our Lyme disease vaccine program, VLA15, we are now making excellent progress with the Phase 3 VALOR trial in the U.S. and Europe together with Pfizer. We completed the recruitment of 9,437 participants for this trial in December, which builds on previous positive Phase 1 and 2 trial results and includes both adult and pediatric participants. The aim of the VALOR trial is to confirm the efficacy, safety, lot consistency, and immunogenicity of VLA15. We look forward to executing this trial successfully, and Pfizer aims to submit a Biologics License Application to the U.S. Food and Drug Administration and a Marketing Authorization Application to the European Medicines Agency in 2026, subject to positive data which are expected at the end of 2025.

As we continued to evolve in 2023, Valneva also made several decisions to improve our organization. In terms of operations, we divested our CTM unit in Sweden, while retaining our key manufacturing sites in Sweden and Scotland, where Valneva has made major investments into Valneva’s long-term future. Valneva also made changes with regards to governance to enhance operational management efficiency, transitioning from a two-tier governance model to a more standard one-tier model led by a Board of Directors, complemented by a new Executive Committee.

We are aware that as our business continues to grow, so does our role in society. We are committed to improving our sustainability and governance, and we are focused on making Valneva an even better place to work for our global staff. To do this, Valneva has created a new structure to analyze and set objectives related to our environmental, social and governance (ESG) responsibilities, setting ourselves up to make important progress in 2024 and beyond.

As a company, we will continue to play a pioneering role by providing first-in-class, best-in-class or entirely unique vaccine solutions while maintaining the highest standards in quality and compliance. We are focusing on our people to achieve these goals, dedicating a renewed effort to talent management and organizational development.

In 2024, we look forward to launching IXCHIQ® in the U.S., and potential approvals of our chikungunya vaccine in Europe, Canada, and Brazil, while advancing our Lyme disease vaccine candidate with Pfizer, further enhancing our R&D pipeline, and investing in maximizing the value of our commercial business.

We thank our employees, partners, investors, and shareholders for their support as we develop, manufacture, and distribute vaccines that make a difference.

 Thomas Lingelbach Chief Executive Officer