In This Article:
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Total Revenue: EUR49.2 million for Q1 2025, up from EUR32.8 million in Q1 2024.
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Product Sales: EUR48.6 million, a 51.2% increase compared to Q1 2024.
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IXIARO Sales: EUR27.5 million, a 65.5% increase year-over-year.
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DUKORAL Sales: EUR12.3 million, a 9.4% increase year-over-year.
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IXCHIQ Sales: EUR3 million, up from EUR200,000 in Q1 2024.
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Gross Margin on Commercial Products (excluding IXCHIQ): 62.7%, up from 43.9% in Q1 2024.
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IXIARO Gross Margin: 72.6%, improved from 52% last year.
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DUKORAL Gross Margin: 52.2%, up from below 40% in Q1 2024.
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Operating Loss: EUR6 million, compared to an operating profit of EUR68.2 million in Q1 2024.
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Net Loss: EUR9.2 million, compared to a profit of EUR58.9 million in Q1 2024.
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Cash and Cash Equivalents: EUR153 million as of March 31, 2025.
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Cash Used in Operations: Reduced to EUR8.1 million from EUR28.4 million in the prior year.
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Guidance for Fiscal Year 2025: Product sales expected between EUR170 million and EUR180 million; total revenues between EUR180 million and EUR190 million.
Release Date: May 07, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
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Valneva SE (INRLF) reported strong financial performance in Q1 2025 with total revenues reaching almost EUR50 million.
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The company secured a new IXIARO contract with the US Department of Defense, highlighting strong demand for its products.
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Valneva SE (INRLF) achieved significant regulatory milestones, including marketing authorization for IXCHIQ in the UK and label extensions in Europe.
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The company reported positive clinical data, including high sustainable response in adolescents for IXCHIQ and positive phase 2 pediatric results.
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Valneva SE (INRLF) significantly reduced its operating cash burn, reflecting effective cash management strategies.
Negative Points
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The company experienced recent changes to IXCHIQ recommendations due to reports of serious adverse events in frail elderly individuals.
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Valneva SE (INRLF) reported an operating loss of EUR6 million for Q1 2025, compared to an operating profit in the prior year.
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The company faces uncertainties related to tariffs and potential impacts on its manufacturing footprint.
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There are ongoing investigations into serious adverse events associated with IXCHIQ, with no definitive causality established yet.
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Valneva SE (INRLF) did not provide specific guidance on gross margins for 2025, creating uncertainty about future profitability.
Q & A Highlights
Q: What are the next steps regarding the IXCHIQ label extension application for adolescents, and are there any updates on safety language? A: Thomas Lingelbach, CEO, stated that the review with the FDA is ongoing, and they are awaiting a response for the label extension to include individuals aged 12 and above. The company is committed to safety standards and is supporting regulatory authorities in evaluating cases, particularly concerning frail older individuals.