Valneva Announces H1 2024 Financial Results and Corporate Updates

Valneva SE, a specialty vaccine company, has announced its financial results for the first half of 2024, showing promising performance and strategic advancements. Total revenues for this period reached €70.8 million, with product sales accounting for €68.3 million, aligning with the company's expectations. The company reported a net profit of €34.0 million, significantly boosted by proceeds from the sale of a Priority Review Voucher (PRV). The operating profit was €46.7 million, a stark contrast to the operating loss of €35.0 million recorded in the first half of 2023.

Valneva's cash position stood strong at €131.4 million, with a projection for substantially lower cash burn in the second half of 2024. This optimistic outlook is due to the completion of its payments for the Lyme disease program's R&D budget in the second quarter. The updated debt financing agreement has significantly extended the company's cash runway.

For the full year 2024, Valneva has confirmed its financial guidance, expecting total revenues between €170 million and €190 million, with product sales anticipated to be between €160 million and €180 million. R&D investments are projected to range from €60 million to €75 million, and other income, including €95 million from the PRV sale, is expected to be between €100 million and €110 million.

In terms of strategic pipeline expansion, Valneva has obtained an exclusive worldwide license for the S4V Shigella vaccine candidate, adding this Phase 2 clinical asset to its R&D pipeline without impacting its financial guidance. The company has also received additional marketing authorizations for the single-shot IXCHIQ® vaccine in Europe and Canada, with ongoing regulatory reviews in the UK and Brazil. The U.S. Centers for Disease Control and Prevention (CDC) has adopted recommendations from the Advisory Committee on Immunization Practices (ACIP) for IXCHIQ®.

Significant progress was made in the development of Valneva's chikungunya vaccine, IXCHIQ®. A new grant of $41.3 million from the Coalition for Epidemic Preparedness Innovations (CEPI) will support Phase 4 costs and other studies to enhance access to the vaccine. Positive six-month data from a Phase 3 adolescent study of IXCHIQ® has been reported, with expectations to submit label extensions for use in 12 to 17-year-olds in the U.S., Europe, and Canada in the second half of 2024. Additionally, two-year antibody persistence data for IXCHIQ® was published in The Lancet Infectious Diseases, demonstrating sustained immune response.

In the Lyme disease vaccine program, Valneva and Pfizer have completed primary vaccinations of over 9,000 participants in the Phase 3 "VALOR" trial. This collaboration remains the only Lyme disease vaccine program in late-stage clinical development, with FDA Fast Track designation. The completion of primary vaccinations marks a significant milestone, with a Biologic License Application (BLA) submission expected by 2026, pending positive trial outcomes.

Valneva's first half of 2024 saw product sales of €68.3 million, compared to €69.7 million in the same period of 2023. The decline was primarily due to supply constraints for IXIARO® and third-party products. However, IXIARO®/JESPECT® sales increased by 38% to €41.9 million, driven mainly by sales to the U.S. military and increased traveler demand. Conversely, DUKORAL® sales decreased to €14.9 million due to reduced marketing investments amid regulatory evaluations of a new manufacturing site.

The newly launched IXCHIQ® vaccine saw its first sales in the U.S., totaling €1.0 million, following CDC’s endorsement. The company anticipates further approvals in the UK and Brazil in the second half of 2024 and expanded its partnership with CEPI to broaden access to the vaccine in low- and middle-income countries (LMICs).

The company's clinical pipeline includes significant advancements, such as the initiation of a Phase 1 trial for a second-generation Zika vaccine candidate, VLA1601. This trial aims to evaluate safety and immunogenicity across various dosages, with results expected in the first half of 2025.

Financially, Valneva's total product sales showed a minor year-over-year decline, with notable growth in IXIARO®/JESPECT® sales. Despite a decrease in DUKORAL® sales, the overall gross margin on commercial product sales improved. Research and development expenses increased to €29.7 million, driven by higher costs related to new facility operations and ongoing R&D activities.

In summary, Valneva's first half of 2024 demonstrated robust financial performance, strategic pipeline expansions, and significant advancements in its vaccine portfolio, setting a solid foundation for future growth and reduced cash burn in the latter half of the year.