First Quarter 2026 Financial Results and Business Update
Agenda
Introduction
Business Update
Financial Report Q1 2026
Business and Financial Outlook
Q&A
Q1 2026 Financial and Business Highlights Reported >70% Efficacy for Lyme disease vaccinePfizer plans 2026 regulatory filings
Strong Financial Position €105.3m in CashExcludes €37m gross proceeds
from recent capital raise*
Q1 2026
€30.Gm Total Revenues€30.5m in Product Sales
Disciplined Cash ManagementLaunched comprehensive program to further reduce operating expenses
AgendaIntroduction
Business Update
Financial Report Q1 2026
Business and Financial Outlook
Q&A
LB6V / VLA15
World's leading Lyme Disease Vaccine CandidateLB6V (formerly VLA15) Demonstrates Strong Efficacy in Phase 31
Results strengthen confidence - Pfizer planning regulatory submissions in U.S. and Europe
Vaccine Efficacy
Pre-specified Analysis
(Season 2)
From Day 28 post-dose 4
From Day 1 post-dose 4
Efficacy (G5% CI)
73% (16, 94)
75% (22, 94)
Safety
Vaccine candidate was well tolerated
No safety concerns identified at time of analysis
Fewer than anticipated Lyme disease cases were accrued over the study period, and the pre-determined statistical criterion (95% confidence interval lower bound >20) was not met in the first pre-specified analysis (primary endpoint)
Given the clinically meaningful efficacy and the fact that the 95% confidence interval lower bound was >20 in the second pre-specified analysis, Pfizer is confident in the vaccine's potential and is planning submissions to regulatory authorities
No vaccine is currently available to prevent Lyme disease in humans
Commercial opportunity for Valneva
U.S: 87 million
Population Living in Endemic Regions1,2
Europe: 223 million
Population Living in Endemic Regions1,2
>$1 billion estimated global market6
Annual Burden of Disease
U.S. : ~476K cases
Europe : >132K cases
Severe Manifestations3
10-30% cases develop
Lyme carditis
Lyme neuroborreliosis
Lyme arthritis
Persistent Symptoms4,5
5-10% cases continue to have persistent symptoms following treatment
1 Kugeler et al. Emerging Infectious Disease, 2021 (doi.org/10.3201/eid2702.202731); 2 Davidson, A., Davis, J., Brestrich, G., Moisi, J., Jodar, L., C Stark, J. H. (in press) (2025). Lyme borreliosis incidence across Europe, 2015-2023: a surveillance-based review and analysis. Vector-borne and Zoonotic Diseases.; 3 Schwartz et al. Morbidity and Mortality Weekly Report Nov. 10, 2017; 4 Ursinus: https://www.thelancet.com/journals/lanepe/article/PIIS2666-7762(21)00119-8/fulltext; 5 Aucott, J.N., et al., Risk of post-treatment Lyme disease in patients with ideally-treated early Lyme disease: A prospective cohort study. Int J Infect Dis, 2022. 116: p. 230-237.; 6 Lyme Disease research and analysis conducted by an independent market research firm
VLA15 is a Compelling Opportunity in an Underserved MarketFirst-Mover Advantage in Highly Receptive Market
Only Lyme disease vaccine candidate in late-stage clinical development
First potential Lyme vaccine in nearly 30 years
Differentiated Product Profile
Proven MoA with broader coverage: multivalent
(six key serotypes)
Modern, state of the art recombinant protein vaccine
Compelling Target Population and Use Case
Broad addressable population (age 5+)
High and growing disease burden in high-risk areas
Exploding tick population in target markets
Strategic Fit
with Pfizer's Vaccine
Franchise
Leverages Pfizer's established commercial capabilities in adult and pediatric vaccines
Attractive Commercial Dynamics
Prophylactic vaccine model supports predictable demand and repeat dosing
Potential inclusion in routine immunization schedules for high-risk areas
IXCHIQ® / VLA1553
A Highly Differentiated single-shot Chikungunya VaccineIXCHIQ®: Focused on Confirming Efficacy/Safety and Expanding Access
Robust clinical program supported by CEPI grant
Pilot Vaccination Campaign Ongoing (Brazil)
To serve as the basis for post-marketing commitment studies
Launched in February 2026 with partner Instituto Butantan in select municipalities in Brazil
Adults aged 18 - 59 years
objective to achieve 20 - 40% coverage within the target population; >30,000 vaccinated to datePost-Marketing Effectiveness Studies
To confirm effectiveness and to optimize description of the safety profile
Observational effectiveness study in Brazil
Pragmatic randomized controlled effectiveness and safety study: adults (and adolescents - tbc) in endemic countries
Ensuring Greater Access
To address unmet medical needs in endemic countries
Expanding network of manufacturing and distribution partners in low-and-middle-interest countries (LMICs)
May 2026: Locally manufactured vaccine approved in Brazil (VLA1555 / "Butantan-chik"); expected to be incorporated into Brazil's public health system 11
S4V2
World's Most Clinically Advanced Tetravalent Shigella Vaccine CandidateS4V2: Opportunity to Develop First-in-Class Vaccine for a Life-Threatening Disease
Tetravalent bioconjugate vaccine with potential to cover up to ~85% of shigellosis infections1
Vaccine Highlights
World's most clinically advanced tetravalent Shigella vaccine candidate
Exclusive global license from (LMTB)2
Includes four most common pathogenic Shigella bacteria serotypes: S. flexneri 2a, 3a, 6, and S. sonnei
Positive initial Phase 1/2 clinical data reported3
Awarded FDA Fast Track designation
Market Opportunity
Global market expected to exceed
$500 million annually4
Second-leading cause of fatal diarrheal disease; Up to estimated 165 million cases and 600,000 deaths annually5
Identified as a priority vaccine by World Health Organization (WHO)6
Valneva has worldwide commercialization rights upon potential approval
Key Milestones
Phase 2 infant study launched in 2025; data expected in mid-2026
Ongoing Phase 2b CHIM7 study aiming to provide early look at potential efficacy; data expected in mid-2026
Valneva to progress into next development steps - subject to data
1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8878964/pdf/vaccines-10-00212.pdf; 2. Valneva and LimmaTech Enter into a Strategic Partnership to Accelerate the Development of the World's Most Clinically
Advanced Tetravalent Shigella Vaccine Candidate; 3 20240221_LimmaTech_Shigella-Interim-Data-PR_Final.pdf (lmtbio.com); 4 LEK 2024; Appox. 7 years after launch; 5. Shigellosis | CDC Yellow Book 2024;
AgendaIntroduction
Business Update
Financial Report Q1 2026
Business and Financial Outlook
Q&A
First Quarter 2026 Financials: Product Sales of €30.5 millionPrimarily reflects discontinuation of third-party sales, 2025 outbreak events, and distributor transition
€m (audited)
Q1 2026
Q1 2025
IXIARO®/JESPECT® 20.2 27.5
DUKORAL® | 8.6 | 12.3 | |
IXCHIQ® | 1.6 | 3.0 | |
Third-party products | 0.1 | 5.8 | |
Total product sales | 30.5 | 48.6 | |
Product sales (excluding third-party) | 30.4 | 42.8 |
Product sales (excluding third-party) at CER*
31.7
-26.0%
€m (audited)
Q1 2026
Q1 2025
First Quarter 2026 Financials: Income StatementProduct sales | 30.5 | 48.6 |
Other Revenues | 0.4 | 0.6 |
Revenues | 30.G | 49.2 |
Cost of goods and services | (26.2) | (23.0) |
Research and development expenses | (15.2) | (15.0) |
Marketing and distribution expenses | (7.0) | (10.4) |
General and administrative expenses | (8.2) | (9.0) |
Other income / (expense), net | 1.9 | 2.2 |
Operating profit / (loss) | (23.7) | (6.0) |
Finance and income taxes | (8.4) | (3.3) |
Profit / (Loss) for the period | (32.1) | (9.2) |
Adjusted EBITDA1 | (18.2) | (0.6) |
1 Q1 2026 Adjusted EBITDA was calculated by excluding €13.8 million (Q1 2025: €8.6 million) of income tax expense, finance income/expense, foreign exchange gain/(loss), depreciation, amortization and impairment from the €32.1 million loss (Q1 2025: €9.2 million loss) for the period as recorded in the consolidated income statement under IFRS.
Financial Guidance & OutlookFinancial Outlook
Updated 2026 Sales Guidance
Product Sales: €135 - €150 million; Commercial
business expected to remain cash-flow positive
Total Revenues: €145 - €160 million
Reflects, in part, an emerging adverse trend in
travel vaccine uptake across key markets, driven by geopolitical factors
Financial Outlook
Continued growth and cash flows from proprietary
commercialized vaccines
Strategic restructuring plan designed to streamline
global business operations; expected ~25-35% reduction in operating expenses vs 2025
Product gross margins expected to normalize
following one-off effects in Q1 2026
Potential for financial self-sustainability starting in 2027 subject to successful Lyme disease vaccine regulatory approval and commercialization
Our Next Phase as a Leading Vaccine Biotech CompanyPotential LB6V Success Would Offer Strategic Growth Opportunities
Leverage core strengths in vaccine development to deliver greater long-term value
Key initiatives:
Build scale in R&D pipeline post-VLA15 exit
Strategic in-licensing/MCA to augment clinical-stage pipeline
Curate a risk-balanced portfolio of innovative specialty, life-cycle and high-value vaccine assets
Expand vaccine focus beyond vector-borne diseases
Target new assets based on defined criteria (ongoing)
Advance EBV, ETEC/enteric disease candidates; strategic focus on reducing antimicrobial resistance (AMR)
Optimize integrated operations
Control value chain by investing into enhanced end-to-end capabilities
Structure commercial model to generate cash
Introduction
Business Update
Financial Report Q1 2026
Business and Financial Outlook
Q&A
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Valneva SE published this content on May 13, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on May 13, 2026 at 11:15 UTC.
