Valneva’s 2025 Q4 Earnings Call: Lyme Vaccine Timelines, FDA Uncertainty, and Financial Milestone Discrepancies Clash

Date of Call: Mar 18, 2026

Financials Results

• Revenue: Total product sales of EUR 157.9M, decreasing -3.3% over 2024, with proprietary product sales (excluding currency) growing +9% YOY.
• Gross Margin: IXIARO gross margin stable versus prior year; Dukoral gross margin deteriorated in Q4 due to manufacturing batch failures.
• Operating Margin: Operating loss of EUR 82.1M in 2025 compared with operating profit of EUR 13.3M in 2024, which was driven by a non-recurring priority review voucher sale.

Guidance:

• Total product sales for 2026 expected to be EUR 145M-EUR 160M.
• Total revenues for 2026 expected to be EUR 155M-EUR 170M.
• Overall decrease versus 2025 due to further planned reduction in third-party sales, offset by proprietary product growth.
• Emphasis on enhancing R&D pipeline and reducing operating cash burn.

Business Commentary:

Financial Performance and Revenue Trends:

• Valneva reported total revenues exceeding EUR 170 million for 2025, slightly above 2024 levels, including almost EUR 160 million in product sales.
• The financial performance was influenced by foreign exchange headwinds, a reduction in third-party product sales, and growth in the proprietary travel vaccine portfolio.

Operational Efficiency and Cash Management:

• The company achieved more than a 20% reduction in operating cash burn.
• This was driven by disciplined cash management and continuous efforts to optimize operational efficiency.

Lyme Disease Vaccine Development:

• Valneva, in partnership with Pfizer, advanced its Lyme disease vaccine candidate, VLA15, with a pivotal phase 3 study, VALOR, involving approximately 10,000 individuals.
• The study's completion and data evaluation are anticipated to provide insights into the vaccine's efficacy and safety, with results expected in the first half of 2026.

Product Sales and Market Strategy:

• IXIARO sales reached EUR 98.4 million, growing by 4.6% compared to 2024, driven by the travel segment.
• Valneva focused on optimizing its commercial business and expanding market access, particularly for its IXCHIQ vaccine in endemic countries.

R&D Investment and Pipeline Expansion:

• Research and development expenses increased to EUR 85.3 million in 2025, driven by higher spending on the phase 2 Shigella vaccine candidate and continued investment in the chikungunya vaccine.
• The strategy emphasizes building a risk-balanced R&D pipeline, potentially through strategic in-licensing, to expand beyond vector-borne diseases.

Sentiment Analysis:

Overall Tone: Positive

• CEO stated 'Valneva once again demonstrated resilience, discipline, and an unwavering sense of purpose' and 'Our financial performance was solid.' He also expressed optimism about the Lyme disease vaccine candidate, calling it 'compelling' and 'could be transformational for Valneva.'

Q&A:

• Question from Maury Raycroft (Jefferies): Looking forward to seeing the Lyme data soon... Do you still see potential for a readout by end of first quarter, or is it likely could it get pushed to the second quarter? And also, can you talk about your involvement in the data analysis?
  Response: Pfizer is the sponsor and in total control; Valneva is fully blinded. Pfizer's official guidance is for a data readout in the first half of 2026, with hopes for mid-first half timing.

• Question from Brandon Folkes (H.C. Wainwright): How do you think about capital allocation going forward if Lyme is successful?
  Response: Positive phase 3 data would not trigger immediate milestones; first commercial sales milestones are about $143M, roughly 1.5 years away. Short-term capital profile unchanged; pipeline acceleration and augmentation would follow.

• Question from Damien Choplain (Stifel): When do you expect to receive an ACIP recommendation for VLA15 if approved? And do you believe a broad recommendation is achievable?
  Response: Timing is uncertain due to U.S. geopolitical environment. A broad recommendation is hoped for, contingent on positive phase 3 data showing favorable risk-benefit and health economic profile, especially against prevalent serotype 1.

• Question from Ami Fadia (Guggenheim): On the Lyme, appreciate everything you said around Pfizer running... what should we expect in terms of what, you know, endpoint or information is planning to be disclosed. And on the DoD contract... where that might stand.
  Response: Top-line data release from Pfizer will include the primary endpoint and safety; no other details are known. DoD contract renewal is expected this year, but timing is not guided.

• Question from Rajan Sharma (Goldman Sachs): Could you maybe just help us understand the gross margin progression in 2026?... Also on the in-licensing and M&A... what that could look like.
  Response: IXIARO gross margin stable; Dukoral impacted by Q4 batch write-offs. Idle capacity costs of ~EUR 10M likely to persist. In-licensing/M&A to expand beyond vector-borne diseases, focusing on areas like enteric diseases (AMR) and EBV, with dedicated team evaluating opportunities.

• Question from Simon Scholes (First Berlin): On the chikungunya vaccine and the status of VLA1553... Secondly, following the suspension of the SII licensing deal... outline your next steps in Asia with regard to IXCHIQ.
  Response: VLA1553 (chikungunya) regulatory approval by Anvisa is expected soon after updates. For Asia, evaluating change of custody, partners, and commercialization/manufacturing structures to address unmet need, with plans to announce progress in late 2026.

Contradiction Point 1

Lyme Disease (VLA15) Phase 3 Data Readout Timeline

Inconsistent guidance on when positive phase 3 data could be available.

What are your thoughts on the recent earnings report? - Maury Raycroft (Jefferies)

2025Q4: Pfizer has indicated the data will be released in the first half of 2026, with hopes it comes around 'mid-H1'. - Thomas Lingelbach(CEO)

Is the Lyme disease (VLA15) phase 3 data readout still expected in Q1 2026 or likely delayed to Q2? - Maurice Raycroft (Jefferies LLC)

2025Q3: No major delays are anticipated... All timelines support a launch in the latter part of 2027, which is necessary to protect against the 2028 tick season. - Thomas Lingelbach(CEO)

Contradiction Point 2

IXCHIQ License Suspension and FDA Engagement

Contradictory statements on the timeline and nature of the FDA's response to the license suspension.

Simon Scholes (First Berlin) - Simon Scholes (First Berlin)

2025Q4: Valneva is taking control of commercialization and manufacturing in Asia... An update is expected in the latter part of 2026. - Thomas Lingelbach(CEO)

What are IXCHIQ's next steps in Asia following the suspension of the Serum Institute of India licensing deal? - Vamil Divan (Guggenheim Securities, LLC)

2025Q3: No predefined timeline exists for the FDA’s response... Valneva hopes for a collaborative dialogue with the FDA, potentially in 2025. - Thomas Lingelbach(CEO)

Contradiction Point 3

Shigella (S4V2) Development Pathway and Decision Criteria

Different criteria for progressing the Shigella vaccine candidate.

Brandon Folkes (H.C. Wainwright) - Brandon Folkes (H.C. Wainwright)

2025Q4: If the data shows pilot efficacy and a correlation between immune response and protection, Valneva will progress the program. - Thomas Lingelbach(CEO)

What criteria will Valneva use to decide whether to proceed with full development of Shigella (S4V2) based on the phase 2 data expected mid-2026? - Theodora Robigl (Goldman Sachs)

2025Q3: The Zika program faces significant uncertainty... Return on investment is not obvious without clarifications on licensure. - Thomas Lingelbach(CEO)

Contradiction Point 4

Timeline for Financial Milestones from Lyme Vaccine

Contradiction on when the $143 million milestone payment from Pfizer is triggered.

What was Brandon Folkes' question to the company during the earnings call? - Brandon Folkes (H.C. Wainwright)

2025Q4: Upon positive phase 3 data, no milestone payments are due immediately; the next milestone is a combined $143 million payment upon first commercial sales in Europe and the U.S., likely in ~1.5 years. - Peter Bühler(CFO)

How should investors assess capital allocation and capital profile given the Lyme vaccine's success? - Rajan Sharma (Goldman Sachs)

2025Q1: The $143 million milestone is payable upon first commercial sales in the U.S., first commercial sales in Europe, and receipt of an ACIP opinion, all expected in 2027, not at Phase 3 completion. - Peter Bühler(CFO)

Contradiction Point 5

IXIARO Gross Margin Trajectory

Contradiction on whether the Q1 2025 gross margin for IXIARO is representative of the product's normal run rate.

Rajan Sharma (Goldman Sachs) - Rajan Sharma (Goldman Sachs)

2025Q4: IXIARO gross margin is stable vs. 2024 but was impacted in 2025 by a site transfer to a new manufacturing facility. - Peter Bühler(CFO)

How will the ~€10 million in 2025 idle capacity costs impact the gross margin progression in 2026? - Simon Scholes (First Berlin)

2025Q1: The Q1 IXIARO gross margin of 73% is not expected to be representative for the full year. - Peter Bühler(CFO)