Press Release: Valneva Reports Full Year 2025 Audited Consolidated Financial Results

Dow Jones03-18 14:00
   -- Total revenues of EUR174.7 million in line with guidance, including 
      EUR157.9 million in product sales 
 
   -- Strong year-end cash position of EUR109.7 million, with enhanced 
      financial flexibility following successful debt refinancing and a 21% 
      reduction in operating cash burn 
 
   -- 2026 to be a potentially transformational year with Phase 3 Lyme disease 
      data expected in the first half of the year 

Lyon (France), March 18, 2026 -- Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported its audited consolidated financial results for the year ended December 31, 2025, provided corporate updates and confirmed its financial guidance for 2026(1) . The Company also announced the filing of its annual report on Form 20-F and Universal registration document (URD) for the financial year ended December 31, 2025 with the U.S. Securities and Exchange Commission (SEC) and the French financial market authority (Autorité des marchés financiers or AMF), respectively. The full-year 2025 consolidated financial results are available on the Company's website (Financial Reports -- Valneva) (2) .

Valneva will provide a live webcast of its full-year 2025 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/qj2g7e52

2025 Financial Performance

   -- Total revenues of EUR174.7 million, up from EUR169.6 million in 2024, 
      including the recognition of variable consideration relating to the 
      Company's research collaboration and licensing agreement for the Lyme 
      disease program 
 
   -- Product sales of EUR157.9 million, compared to EUR163.3 million in 2024, 
      reflecting the planned wind-down of third-party sales (-42.3% versus 
      2024). Proprietary product sales increased by 9% at constant exchange 
      rate (CER)3 
 
   -- Net loss amounted to EUR115.2 million compared to a net loss of EUR12.2 
      million in 2024, while the prior year amount benefited from a EUR90.8 
      million net gain related to the sale of the Priority Review Voucher (PRV) 
      received for IXCHIQ$(R)$ 
 
   -- Operating cash burn continued to decline, improving to EUR52.9 million in 
      2025 compared to EUR67.2 million in 2024 and EUR202.7 million in 2023 

Reiterated 2026 Outlook and Financial Guidance

   -- First Phase 3 data readout for Lyme disease vaccine candidate (VLA15) 
      anticipated in the first half of 2026, with regulatory submissions 
      expected to follow as planned by Pfizer, subject to positive results 
 
          -- If approved, VLA15 will be the fourth vaccine successfully 
             developed by Valneva and subsequent commercialization by Pfizer 
             would enable Valneva to further expand and accelerate its pipeline 
             of innovative vaccines in line with the Company's strategic vision 
 
   -- First Phase 2 data for tetravalent Shigella vaccine candidate S4V2 are 
      expected mid-2026, with a decision on subsequent development steps in the 
      second half of 2026 
 
   -- Further enhancement of the Company's R&D pipeline with differentiated 
      vaccine candidates addressing areas of high unmet medical need 
 
   -- Total revenues for full-year 2026 are expected to range between EUR155 
      million and 170 million, including product sales between EUR145-160 
      million 
 
          -- The lower product sales guidance in 2026 versus the prior year 
             reflects continued growth of established commercial brands, offset 
             by the planned wind-down of third-party sales, as previously 
             guided. 
 
   -- Disciplined cash management will remain a priority, with operating cash 
      burn expected to decline further in 2026, while continuing to support 
      strategic R&D investments 

Peter Bühler, Valneva's Chief Financial Officer, commented, "We are approaching the potentially transformative Phase 3 data readout for our Lyme disease vaccine candidate, an inflection point that could significantly shape our Company's future and strengthen our long--term strategy. While 2025 tested our resilience, it also underscored the strength of our team's disciplined execution. In 2026, we remain firmly committed to prudent capital allocation to support sustainable growth and advance our strategic vision."

Financial Information

 
EUR in million       12 months ended December 31, 
-------------------  ------------------------------ 
                           2025            2024 
                     ----------------  ------------ 
Total revenues                  174.7         169.6 
-------------------  ----------------  ------------ 
Product sales                   157.9         163.3 
-------------------  ----------------  ------------ 
Net profit/(loss)             (115.2)        (12.2) 
-------------------  ----------------  ------------ 
Adjusted EBITDA(4)             (59.4)          32.9 
-------------------  ----------------  ------------ 
Cash                            109.7         168.3 
-------------------  ----------------  ------------ 
 

Commercial Portfolio

Valneva's commercial portfolio comprises three vaccines, IXIARO(R) /JESPECT(R) , DUKORAL(R) and IXCHIQ(R) . The Company's main third--party product distribution contract concluded in 2025 and this activity is now expected to naturally wind down, as previously communicated.

Valneva's total product sales in 2025 were EUR157.9 million compared to EUR163.3 million in 2024, reflecting a 42.3% planned reduction in third party product sales (EUR19.2 million in 2025 versus EUR33.2 million in 2024). Excluding third-party sales, total product sales increased by 9% at CER.

JAPANESE ENCEPHALITIS VACCINE IXIARO(R) /JESPECT(R)

In 2025, IXIARO(R) /JESPECT(R) sales increased by 4.6% to EUR98.4 million, resulting from growth in the traveler's market. This compares with 2024, when IXIARO(R) sales were impacted by supply constraints. Sales at CER grew by 7.2% compared to 2025.

In January 2025, Valneva secured a new $32.8 million contract with the United States Department of Defense (DoD)(5) .

CHOLERA / ETEC(6) -DIARRHEA VACCINE DUKORAL(R)

In 2025, DUKORAL(R) sales were EUR31.9 million as compared to EUR32.3 million in 2024. Sales in 2025 were notably affected by EUR1.0 million of adverse currency effects, as well as lower sales in Germany due to the gradual transition of distribution to CSL Seqirus. Sales at CER grew by 1.8%.

CHIKUNGUNYA VACCINE IXCHIQ(R)

In 2025, Valneva reported IXCHIQ(R) sales of EUR8.4 million, compared to EUR3.7 million in 2024. Sales in 2025 benefited from the vaccine's launch in several European countries, including the supply of doses to help contain a major chikungunya outbreak on the French island of La Réunion. This growth was partly offset by the previously communicated label and user--restriction constraints(7) .

In January 2026, Valneva voluntarily withdrew the Biologics License Application (BLA) and Investigational New Drug $(IND)$ application for IXCHIQ(R) in the United States. The Company remains focused on expanding IXCHIQ(R) access and sales in other territories, including Low- and Middle-Income Countries (LMICs), where medical need remains high.

Clinical Vaccine Programs

LYME DISEASE VACCINE CANDIDATE -- VLA15

VALOR Phase 3 Results expected in the first half of 2026

Valneva and Pfizer are developing VLA15, a vaccine candidate targeting Borrelia, the bacterium that causes Lyme disease. VLA15 is the most advanced Lyme disease vaccine candidate currently in clinical development, with two Phase 3 trials underway. It leverages an established mechanism of action, inducing antibodies to Borrelia outer surface protein A (OspA) to prevent the transmission of Lyme borreliosis from infected ticks. The vaccine antigens are designed to target the six most prevalent Borrelia serotypes.

Pfizer is conducting a randomized, placebo-controlled Phase 3 field efficacy trial, VALOR (Vaccine Against Lyme for Outdoor Recreationists). Phase 3 vaccinations were completed in 2025 and VALOR trial results are expected to be reported in the first half of 2026.

Subject to positive Phase 3 results, Pfizer intends to submit a Biologics License Application (BLA) to the U.S. FDA and Marketing Authorization Application $(MAA)$ to the European Medicines Agency in 2026. Upon approval and successful commercialization of VLA15, Valneva would be eligible to receive $143 million in initial milestone payments from Pfizer, plus sales royalties ranging from 14% to 22% and up to $100 million in cumulative sales milestones.

CHIKUNGUNYA VACCINE - IXCHIQ(R) / VLA1553

Pilot vaccination campaign ongoing in Brazil

In February 2026, Valneva and Instituto Butantan announced the initiation of a Pilot Vaccination Strategy (PVS) in Brazil using Valneva's single-shot chikungunya vaccine, IXCHIQ(R) . The vaccination campaign will serve as the basis for post-marketing commitment studies evaluating the effectiveness and safety of IXCHIQ(R) in a real-world setting and generating real-world evidence in a large population.

The PVS, agreed to between the Brazilian Ministry of Health (MoH) and Instituto Butantan, will be implemented in ten Brazilian municipalities strategically selected based on epidemiological and operational criteria in support of the PVS. In line with the current IXCHIQ(R) label in Brazil, adults aged 18 to 59 years will be invited to participate, with the objective of achieving 20% to 40% vaccine coverage within the target population. Additionally, Valneva, through its partner Instituto Butantan, will donate up to 500,000 doses of IXCHIQ(R) to the Brazilian MoH, for use in the program.

SHIGELLA VACCINE CANDIDATE -- S4V2

First Phase 2 results expected mid-2026

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