Valneva Reports Full Year 2024 Results and Provides Business Updates and Outlook
Met 2024 growth targets for product sales (+13% vs 2023) and total revenues (+10% vs 2023)
Strong year-end cash position of €168.3 million including sale of Priority Review Voucher1, successful private placement and 67% reduction in operating cash burn
Substantial clinical and regulatory progress in 2024; further data readouts, product approvals and label extensions anticipated in 2025
2025 outlook reflects solid revenue growth and positive commercial cash flows to support strategic R&D investments with lower operating cash burn
Saint-Herblain (France), March 20, 2025, Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today reported its consolidated financial results for the year ended December 31, 2024 and provided key corporate updates and guidance for its future results. The consolidated financial results2 are available on the Company's website (Financial Reports, Valneva).
Valneva will provide a live webcast of its full-year 2024 results conference call beginning at 3 p.m. CET/10 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/4n8iegdt
2024 Financial Performance
Product sales reached €163.3 million for the year ended December 31, 2024 compared to €144.6 million in the same period of 2023, an increase of 13%
Total revenues were €169.6 million for the year ended December 31, 2024 compared to €153.7 million for the year ended December 31, 2023, an increase of 10%
Net loss of €12.2 million compared to a 2023 net loss of €101.4 million, including proceeds from the Priority Review Voucher (PRV) sale
67% reduction in operating cash burn (€67.2 million in 2024 compared to €202.7 million in 2023)
Cash and cash equivalents were €168.3 million as at December 31, 2024, compared to €126.1 million at December 31, 2023. Year-end cash was significantly augmented by the sale of the PRV and successful private placement3.
Financial OutlookThe Company provides the following guidance on its future results:
Product sales expected to grow to €170-180 million in 2025, driving positive cash-flows for the overall commercial business
Total revenues expected to reach €180-190 million in 2025
Total R&D investments expected between €90 - €100 million in 2025, which will be partially offset by grant fundings and anticipated R&D tax credits
Continued stringent focus on cash management supporting sufficient cash runway to reach key inflection points; targeting more than 50% lower operating cash burn in 2025
Peter Bühler, Valneva's Chief Financial Officer, commented, "Once again, we successfully delivered double digit sales growth, despite lower than anticipated launch-year IXCHIQ® sales in the U.S. We made significant clinical and regulatory progress last year, setting the stage for several important advancements to potentially drive value in 2025, most notably with the first Phase 3 study results for our lead Lyme disease vaccine candidate, VLA15. In 2025, we will continue to focus on commercial execution while investing strategically in advancing our science-driven pipeline to generate substantial future value. With over €168 million of cash at the end of 2024, we are entering 2025 in a good financial position to support these objectives."
R&D, Regulatory, and Strategic Highlights
Continued to progress Lyme disease program according to plan, including completion of primary vaccination series (three doses) in ongoing Phase 3 study VALOR, reporting of further positive Phase 2 booster results, and publication of Phase 2 data in the Lancet
Secured three additional regulatory approvals (Canada, Europe, UK) for world's first chikungunya vaccine, IXCHIQ®; filed adolescent label extension submissions and received positive opinion from the European Medicines Agency (EMA); awarded new $41.3 million grant from the Coalition for Epidemic Preparedness (CEPI)4 and signed exclusive license agreement with the Serum Institute of India (SII)5 for Asia
Augmented clinical pipeline with a leading tetravalent Shigella vaccine candidate6 and initiated Phase 2b trial; Granted Fast Track Designation by the United States Food and Drug Administration (FDA)
Advanced novel Zika vaccine candidate into Phase 1 clinical development
Finalized new $32.8 million IXIARO® supply contract with the U.S. Department of Defense (DoD) in January 20257
Key Upcoming Milestones:
First data readout for Lyme disease Phase 3 VALOR study expected at the end of 2025
Further chikungunya vaccine approvals, including the first endemic country (Brazil) and adolescent label extensions for IXCHIQ® in major travel markets
Initiation of Phase 3 pediatric trial of IXCHIQ® to support further potential label expansion
Launch of Phase 2 pediatric study of tetravalent Shigella vaccine candidate in the first half of 2025 and Phase 2b efficacy data from Human Challenge Study (CHIM)
Phase 1 results for Zika vaccine candidate
Financial Information
€ in million
12 months ending December 31,
2024
2023
Total Revenues
169.6
153.7
Product Sales
163.3
144.6
Net profit/(loss)
(12.2)
(101.4)
Adjusted EBITDA8
32.9
(65.2)
Cash
168.3
126.1
Commercial Portfolio
Valneva's commercial portfolio is composed of three 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.
JAPANESE ENCEPHALITIS VACCINE IXIARO®/JESPECT®
In 2024, IXIARO®/JESPECT® sales increased by 28% to €94.1 million, showing double-digit sales growth to both travelers and the DoD compared to 2023.
In 2024, Valneva supplied additional doses of IXIARO® to the DoD under the contract signed in September 2023, which allowed the DoD to purchase additional doses during the following twelve months.
In January 2025, Valneva secured a new $32.8 million contract with the DoD9. Similar to previous contracts, it includes the possibility to purchase additional doses during the following twelve months.
CHOLERA / ETEC10-DIARRHEA VACCINE DUKORAL®
In 2024, DUKORAL® sales grew 8% reaching €32.3 million supported by increased sales in Canada, the biggest travel market for DUKORAL®, as well as improved product availability resulting in replenishment orders from indirect markets.
CHIKUNGUNYA VACCINE IXCHIQ®
IXCHIQ® is the world's first licensed chikungunya vaccine available to address this significant unmet medical need. It is approved in the U.S.11, Europe12, Canada13 and the United Kingdom14 for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older.
IXCHIQ® was launched in the U.S., Canada and France in March, October and November 2024, respectively. Considering IXCHIQ® is the first vaccine worldwide against this unmet need, Valneva's commercial teams focused in 2024 on raising awareness on the disease, shaping the market and booking first sales. The Company recognized initial sales of €3.7 million in 2024.
Since the start of 2025, Valneva has focused on ramping up sales and launching the vaccine in additional countries, including the Nordics and Austria. A marketing application is under review in Brazil, which would represent the first approval in an endemic country. Label extension applications are also under review in the U.S., Europe and Canada to potentially extend the use of IXCHIQ®, which is currently approved in adults, to adolescents 12 to 17 years of age. In February 2025, the Committee for Medicinal Products for Human Use (CHMP) of EMA adopted a positive opinion recommending authorization of a label extension for IXCHIQ® in adolescents 12 years of age and older15.
Additionally, Valneva recently expanded its partnership with CEPI16 to support broader access to the vaccine in Low-and-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 EU's Horizon Europe program.
Within the framework of its CEPI agreement, Valneva also announced an exclusive license agreement with the Serum Institute of India (SII)17 to enable supply of its chikungunya vaccine in Asia.
In parallel, Valneva is continuing to generate additional clinical data to support label extensions and further establish IXCHIQ® as a differentiated brand. The Company notably reported positive three-year Phase 3 persistence data demonstrating antibody persistence in 96% of study participants, positive twelve-month Phase 3 data in adolescents and the world's first positive Phase 2 pediatric data for a chikungunya vaccine.
These data supporting potential label extensions, combined with anticipated ex-U.S. and endemic product launches are expected to significantly expand access of IXCHIQ® and contribute to its future revenues.
THIRD-PARTY DISTRIBUTION
Valneva distributes certain third-party vaccines in countries where it operates its own marketing and sales infrastructure. In 2024, third-party sales decreased by €2.5 million to €33.2 million compared to €35.7 million in 2023, as a result of third parties' supply constraints in the first half of the year.
As previously communicated, Valneva expects to gradually wind down third-party sales to less than 5% of overall product sales by 2026 / 2027, resulting in overall gross margin improvement.
Clinical Vaccine Candidates
LYME DISEASE VACCINE CANDIDATE, VLA15
Phase 3 primary vaccination completed; booster vaccinations ongoing
