-- Total product sales of EUR64.0 million
-- In-line with expectations; full-year guidance of EUR135 -150
million reaffirmed
-- Solid cash position of EUR121.5 million as of end June 2026
-- Reflects disciplined cash management and proceeds from the recent
reserved offering1
-- Restructuring program implemented with positive P&L and cash flow
impacts expected in the second half of the year and beyond
-- Regulatory decisions for Lyme disease vaccine candidate expected in the
next twelve months2
-- Pfizer remains optimistic about obtaining registration for the
vaccine candidate3
Lyon (France), August 13, 2026 -- Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported its condensed consolidated financial results for the first half of the year ended June 30, 2026, provided key corporate updates, and reaffirmed its financial guidance for 2026. 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 half year 2026 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/zd7jniit/lan/en
First-half 2026 Financial Update
-- Total revenues were EUR65.8 million, including EUR64.0 million in product
sales, compared with EUR97.6 million and EUR91.0 million, respectively,
in the first half of 2025. The year-over-year decrease primarily reflects
the planned wind-down of third-party sales (down EUR10.5 million versus
the first half of 2025) and the expected phasing of product sales,
including the distribution transition in Germany and timing of IXIARO$(R)$
shipments to the U.S. Department of Defense (DoD).
-- Cash position was EUR121.5 million as of June 30, 2026, compared with
EUR109.7 million as of December 31, 2025. This strong cash position
reflects the positive impact of restructuring initiatives, disciplined
cash management and EUR37 million in gross proceeds from the successful
reserved offering completed in the second quarter of 2026.
-- Net loss of EUR63.3 million compared with a net loss of EUR20.8 million
in the first half of 2025, reflecting lower gross margin due to lower
sales and manufacturing volumes as well as one-off impacts on cost of
goods sold, including IXCHIQ(R)-related contract termination costs and
inventory write-offs.
Financial Outlook
-- Despite the continued adverse impact of the geopolitical environment on
travel, Valneva reaffirmed its 2026 guidance with expected product sales
of EUR135 million to EUR150 million and total revenues of EUR145 million
to EUR160 million.
-- Product gross margins are expected to improve in the second half of the
year following one-off effects in the first half of 2026
-- Valneva successfully implemented a global restructuring initiative4 to
reduce its cash burn through a significant workforce reduction, the
reprioritization and rescheduling of R&D activities and the streamlining
of its global operations. As part of this initiative, the Company also
agreed to sell its Nantes site in France for EUR6.2 million. A
preliminary sale agreement has been signed with Nantes Métropole,
and the transaction is expected to close in September 2026.
Peter Bühler, Valneva's Chief Financial Officer, commented, "Our focus over the past few months, following the Lyme VALOR results has been to restructure and refocus our operations. The successful financing completed in April has enabled us to build and maintain a strong cash position, allowing us to prioritize resources on our core business and key strategic priorities while preserving the flexibility to accelerate growth should the Lyme program progress successfully toward licensure and commercialization."
Financial Information
(Unaudited results, consolidated per IFRS)
EUR in million Six months ended June 30,
------------------------------- ---------------------------
2026 2025
------------------------------- ------------- ------------
Total Revenues 65.8 97.6
------------------------------- ------------- ------------
Product Sales 64.0 91.0
------------------------------- ------------- ------------
Profit / (loss) for the period (63.3) (20.8)
------------------------------- ------------- ------------
Adjusted EBITDA(5) (40.1) (6.0)
------------------------------- ------------- ------------
Cash and cash equivalents 121.5 161.3
------------------------------- ------------- ------------
Clinical Stage Programs
LYME DISEASE VACCINE CANDIDATE -- LB6V (formerly VLA15)
Regulatory decisions expected in the next twelve months
In March 2026, Valneva and Pfizer announced topline results from the Phase 3 VALOR "Vaccine Against Lyme for Outdoor Recreationists" clinical trial (NCT05477524) evaluating their investigational six valent OspA-based Lyme disease vaccine candidate LB6V(6) .
Since then, Pfizer has been engaging with regulatory authorities to align on potential pathways to licensure and has expressed optimism regarding the vaccine candidate's regulatory approval prospects(7) . Regulatory decisions are expected in the next twelve months(8) .
LB6V is currently the only Lyme disease vaccine candidate in late-stage clinical development. The program has received PRIME designation from the European Medicines Agency $(EMA)$ and Fast Track designation from the U.S. Food and Drug Administration (FDA).
If approved, LB6V has the potential to address a significant unmet medical need, with more than 80 million people in the United States and over 200 million people in Europe estimated to live in areas at elevated risk of Lyme disease.
CHIKUNGUNYA VACCINE - IXCHIQ(R) / VLA1553
Ongoing post-marketing commitments activities, including Pilot Vaccination Campaign in Brazil
Several post-marketing commitments activities for IXCHIQ(R) are ongoing. These include the ongoing Pilot Vaccination Strategy (PVS) in Brazil. This is the first large-scale public vaccination campaign using IXCHIQ(R) in a real-world setting, conducted by the Brazilian Ministry of Health with support from Valneva and its local partner, Instituto Butantan. To date, approximately 50,000 adults aged 18 to 59 years have already been vaccinated as part of this campaign.
The PVS, together with several studies that are ongoing or in preparation(9) (,) (10) (,) (11) (,) (12) , will serve as the basis for current and planned post-marketing Phase 4 studies evaluating the effectiveness and safety of IXCHIQ(R) to generate real-world evidence in larger and more specialized populations.
SHIGELLA VACCINE CANDIDATE -- S4V2
First Phase 2 results expected shortly
S4V2 is the world's most clinically advanced tetravalent vaccine candidate against shigellosis, the second leading cause of fatal diarrhea worldwide.
Two clinical trials of S4V2, a Phase 2 infant safety and immunogenicity trial(13) , and a Phase 2b Human Challenge trial $(CHIM)$(14) , sponsored by LimmaTech Biologics AG, are ongoing. Results from both studies are expected in the third quarter of 2026. Based on the outcome of these studies and the future R&D strategy, Valneva will determine the appropriate next steps, including whether to assume responsibility for the vaccine candidate's late-stage clinical development(15) .
No approved multivalent Shigella vaccine is currently available outside of Russia or China, and the development of Shigella vaccines has been identified as a priority by the World Health Organization (WHO)(16) . In October 2024, the U.S. FDA granted Fast Track designation to S4V2, recognizing its potential to address a serious condition and fill an unmet medical need(17) . The global market opportunity for a vaccine against Shigella is estimated to exceed $500 million annually(18) .
First-Half 2026 Financial Review
(Unaudited, consolidated under IFRS)
Revenues
Valneva's total revenues were EUR65.8 million in the six months ended June 30, 2026, compared to EUR97.6 million for the same period in 2025. The decrease was primarily attributable to the planned discontinuation of the majority of third-party sales, the expected phasing of product sales, including the timing of IXIARO(R) shipments to the U.S. DoD, the distributor transition in Germany as well as non-recurring outbreak-related sales of DUKORAL(R) and IXCHIQ(R) recorded during the first half of 2025 that did not repeat in 2026.
Other revenues, including revenues from collaborations, licensing and services, amounted to EUR1.8 million in the first half of 2026 compared to EUR6.5 million for the same period in 2025, which included revenues recognized under the exclusive license agreement with the Serum Institute of India for IXCHIQ(R) , which was terminated in 2025.
Product Sales
Total product sales amounted to EUR64.0 million in the first half of 2026, compared to EUR91.0 million in the first half of 2025. In line with Valneva's strategy and prior communications, third-party distribution activities have significantly decreased following the expiration of the Company's main distribution agreement in 2025. Consequently, third-party product sales decreased by EUR10.5 million, or 91.6%, to EUR1.0 million in the first half of 2026 and are expected to represent less than 5% of product sales by the end of the year.
Comments