Valneva Announces Q3 2024 Financial Results and Corporate Updates

Valneva SE, a specialty vaccine company, has released its financial results for the first nine months of 2024. The company reported total revenues of €116.6 million, with product sales contributing €112.5 million to this figure. Net profit during this period was €24.7 million, bolstered by proceeds from the sale of a Priority Review Voucher (PRV). Operating profit amounted to €34.2 million, in stark contrast to an operating loss of €57.2 million reported in the same period of the previous year. Valneva maintained a cash position of €156.3 million, which includes proceeds from a recent private placement. The company anticipates reduced cash burn in the latter half of 2024, as cost contributions for its partnered Lyme disease program have been completed.

For the entire year of 2024, Valneva has narrowed its financial guidance, expecting total product sales between €160 million and €170 million and total revenues between €170 million and €180 million. Research and development (R&D) investments are projected to be between €65 million and €75 million. Other income is expected to range from €100 million to €110 million, which includes €95 million from the PRV sale.

Valneva is in the process of launching the world’s first chikungunya vaccine in Canada and Europe, with potential approvals expected in Brazil by the fourth quarter of 2024 and in the UK by the first quarter of 2025. The company has also expanded its strategic pipeline, securing an exclusive worldwide license for the S4V2 Shigella vaccine candidate, which has recently been granted FDA Fast Track designation. Furthermore, key label extensions for the chikungunya vaccine IXCHIQ® have been submitted in Europe and Canada.

Valneva has strengthened its pipeline with a new $41.3 million grant from CEPI to support IXCHIQ® Phase 4 costs and other studies. Additionally, the Phase 3 trial for the Lyme disease vaccine candidate VLA15, partnered with Pfizer, has completed primary vaccinations. Valneva is also advancing a Phase 1 clinical trial for a second-generation Zika vaccine candidate.

Financially, Valneva's results for the nine months ending September 30, 2024, showed significant growth. Total revenues rose to €116.6 million from €111.8 million in the same period the previous year. Product sales increased to €112.5 million from €106.1 million, reflecting a 12% growth excluding COVID-19 vaccine sales. Notably, IXIARO®/JESPECT® sales grew by 31% to €66 million, driven by strong demand from travelers and the US military. DUKORAL® sales increased to €22.3 million, aided by resumed marketing investments after regulatory inspection at Valneva’s new Swedish manufacturing site.

Initial sales for IXCHIQ® were recorded at €1.8 million following the US Advisory Committee on Immunization Practices (ACIP)'s recommendations. Third-party product sales, however, decreased by 23% to €22.5 million due to supply constraints. Other revenues, including from collaborations and licenses, totaled €4.2 million, down from €5.7 million the previous year.

Operating results improved significantly, with a recorded operating income of €34.2 million versus a loss of €57.2 million in 2023, largely due to the PRV sale. Adjusted EBITDA profit was €48.6 million, compared to a loss of €46 million in the same period the previous year. The net profit of €24.7 million marked a turnaround from a net loss of €69.3 million in 2023.

Valneva's research and development expenses increased to €48.6 million, driven by higher costs related to the new Almeida manufacturing facility. Marketing and distribution expenses also rose to €35.7 million due to the IXCHIQ® launch. General and administrative expenses decreased slightly to €32.6 million.

Cash flow from operations showed improvement, with net cash used in operating activities reduced to €76.7 million from €136.8 million in 2023. Investing activities generated €72.2 million, largely benefiting from the PRV sale. Financing activities contributed €35.3 million, aided by proceeds from a private placement. As of September 30, 2024, Valneva's cash and cash equivalents stood at €156.3 million.

Valneva remains focused on advancing its vaccine pipeline and commercializing its products, leveraging its R&D capabilities and strategic partnerships to drive growth and profitability.