Valneva Reports Half Year 2025 Financial Results and Provides Corporate Updates

Total revenues of €97.6 million compared to €70.8 million in the first half of 2024

Cash and cash equivalents of €161.3 million at end of June 2025

Further clinical and regulatory progress

2025 financial outlook confirmed

Saint-Herblain (France), August 12, 2025, Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today reported its condensed consolidated financial results for the first half of the year, ended June 30, 2025, and confirmed its 2025 financial guidance. The half year financial report, including the condensed consolidated interim financial report and the half year management report, is available on the Company's website (Financial Reports, Valneva).

Valneva will provide a live webcast of its first half 2025 results conference call beginning at 3 p.m. CEST/9 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/kkyrijxj

First Half 2025 Financial Update

Total revenues were €97.6 million compared to €70.8 million for the first half of 2024, an increase of 37.8%

Product sales reached €91.0 million compared to €68.3 million in the first half of 2024, an increase of 33.3%

Net loss of €20.8 million compared to a net profit of €34.0 million in the first half of 2024, which included one-time net proceeds of €90.8 million from the sale of a Priority Review Voucher (PRV)1

Significant reduction in operating cash burn (€10.9 million in the first half of 2025 compared to €66.3 million in the first half of 2024)

Cash and cash equivalents were €161.3 million as at June 30, 2025, compared to €168.3 million as at December 31, 2024

Cash at June 30, 2025 included €20.1 million of net proceeds from two At The Market (ATM) transactions with leading U.S. institutional healthcare investors Novo Holdings A/S and Frazier Life Sciences in Q2 20252

Financial OutlookThe Company confirms the following guidance for fiscal year 2025:

Product sales expected to grow to €170-180 million, driving positive cash flow for the commercial business

Total revenues expected to reach €180-190 million

Total R&D investments expected between €90-100 million, partially offset by grant funding 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 compared to the prior year

Peter Bühler, Valneva's Chief Financial Officer, commented, "As we approach the potentially transformative Phase 3 data readout for our Lyme disease vaccine candidate, we remain strategically focused on two key objectives - growing our commercial sales and effectively managing our cash. In the first half of the year, we again delivered double-digit sales growth while continuing to expand access to our vaccines. We also substantially reduced our spending and successfully leveraged our ATM program to welcome two new leading healthcare investors among our main shareholders, strengthening our financial position ahead of this important clinical catalyst."

Key R&D, Regulatory, and Commercial Updates

Finalized new $32.8 million IXIARO® supply contract with the U.S. Department of Defense (DoD) in January 20253

Signed exclusive agreement with CSL Seqirus to market and distribute Valneva's three proprietary vaccines in Germany 4

VALOR Lyme disease study on track; Pfizer confirmed all vaccinations have been completed5

Responded to French government's call for vaccine supply of IXCHIQ® to combat chikungunya outbreak in La Réunion6

Announced European Medicines Agency (EMA) and Food and Drug Administration (FDA)'s decisions to lift temporary restrictions on use of IXCHIQ® in elderly following their thorough review of the vaccine on reported serious adverse events (SAE's) in that age group

Secured additional marketing authorizations for IXCHIQ® in the United Kingdom (UK) and Brazil7, marking the world's first approval of a chikungunya vaccine in an endemic country8

Received label extension for IXCHIQ® in Europe for individuals 12 years of age and older9 and submitted additional adolescent label extension applications in other countries

Reported positive Phase 2 six-month antibody persistence and safety results in children10 vaccinated with IXCHIQ®, as well as high sustained immune response in adolescents one year after a single vaccination11

Announced first vaccination in Phase 2 infant study of tetravalent Shigella vaccine candidate S4V212

Financial Information(Unaudited results, consolidated per IFRS)

€ in million

6 months ended June 30,

 

2025

2024

Total revenues

97.6

70.8

Product sales

91.0

68.3

Net profit / (loss)

(20.8)

34.0

Adjusted EBITDA13

(6.0)

56.2

Cash

               161.3

               131.4

Commercial Portfolio

Valneva's commercial portfolio is composed of three travel vaccines, IXIARO®/JESPECT®, DUKORAL® and IXCHIQ®. The Company also distributes certain third-party products in countries where it operates its own marketing and sales infrastructure.

Valneva's sales in the first half of 2025 were €91.0 million compared to €68.3 million in the first half of 2024, which had been impacted by supply constraints. First half 2025 sales included €11.4 million of third-party sales. Valneva expects that third-party sales will gradually wind down to less than 5% of its total sales by 2026/2027, allowing the Company to improve gross margins.

In June 2025, Valneva announced an exclusive agreement with CSL Seqirus14, one of the world's largest influenza vaccine companies, for the marketing and distribution of Valneva's three proprietary vaccines in Germany. Under the agreed terms, CSL Seqirus recently launched Valneva's single-dose chikungunya vaccine IXCHIQ® and will begin commercializing Valneva's Japanese encephalitis vaccine IXIARO® and cholera/ETEC vaccine DUKORAL® from January 2026. This agreement has an initial three-year term and includes minimum annual purchasing quantities and standard termination clauses based on change of control and non-performance.

JAPANESE ENCEPHALITIS VACCINE IXIARO®/JESPECT®

In the first half of 2025, IXIARO®/JESPECT® sales increased by 30.6% to €54.7 million compared to €41.9 million in the first half of 2024. Sales to both travelers and the DoD showed double-digit growth compared to the first half of 2024, when sales were impacted by IXIARO® supply constraints.

In January 2025, Valneva secured a new $32.8 million contract with the DoD15. Similar to previous DoD contracts, it includes the possibility to purchase additional doses during the twelve months following the signing date.

CHOLERA / ETEC16-DIARRHEA VACCINE DUKORAL®

In the first half of 2025, DUKORAL® sales were €17.4 million compared to €14.9 million in the first half of 2024. This 16.4% growth was notably supported by the supply of doses to combat an outbreak on the French island of Mayotte for €1.1 million in the first quarter of 2025.

CHIKUNGUNYA VACCINE IXCHIQ®

In the first half of 2025, Valneva reported IXCHIQ® sales of €7.5 million compared to sales of €1.0 million in the first half of 2024, when the vaccine had just been launched in the U.S. First half IXCHIQ® sales benefited from the supply of vaccine doses to the French island La Réunion, primarily in the second quarter of the year, as the island experienced a major chikungunya outbreak.

In addition to ramping up sales and launching the vaccine in additional countries, Valneva is focused on expanding the vaccine's label and access. In April 2025, IXCHIQ® was granted marketing authorization in Brazil, marking ...