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01/11 03:17
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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
The earnings call reveals mixed signals. While there are strong regulatory achievements and promising vaccine developments, the financial performance shows significant operating losses and reduced cash position. Guidance remains steady, but the lack of additional revenue recognition and vague responses in the Q&A highlight uncertainties. The operational cash burn reduction is positive, but overall, the sentiment is balanced by both positive and negative factors, leading to a neutral outlook.
Total Revenues EUR 97.6 million, a 37.8% increase year-over-year, driven by higher product sales and an increase in other revenues related to the licensing agreement with the Serum Institute of India for Valneva's single-shot chikungunya vaccine.
Product Sales EUR 91 million, a 33.3% increase year-over-year. Foreign currency fluctuation had an adverse impact of EUR 500,000.
IXIARO Sales EUR 54.7 million, a 30.6% increase year-over-year, driven equally by sales to travelers and the Department of Defense. Sales in the first quarter of 2024 were adversely impacted by supply constraints.
DUKORAL Sales EUR 17.4 million, a 16.4% increase year-over-year, supported by EUR 1.1 million sales to the French island of Mayotte to combat a local cholera outbreak.
IXCHIQ Sales EUR 7.5 million, compared to EUR 1 million in the first half of 2024. Sales benefited from a supply of 40,000 doses to the French island La Réunion during a major chikungunya outbreak.
Third-party Products EUR 11.4 million, an 8.8% increase year-over-year, primarily due to supply constraints in the first half of the prior year.
Gross Margin on Commercial Products (excluding IXCHIQ) 59.2% in the first half of 2025, compared to 47.7% in the prior year, driven by better manufacturing performance.
IXIARO Gross Margin 65.5%, compared to 57.5% in the first half of 2024.
DUKORAL Gross Margin 52.9%, compared to 34.8% last year.
IXCHIQ Gross Margin 66%.
Cost of Goods and Services EUR 47.2 million, compared to EUR 45.6 million during the same period last year. Includes EUR 5.9 million idle capacity cost.
Research and Development Expense EUR 32.4 million, compared to EUR 29.7 million in the first half of 2024, driven by costs related to the Shigella vaccine candidate following the R&D collaboration with LimmaTech Biologics.
Marketing and Distribution Expense EUR 20.3 million, compared to EUR 23.2 million in the prior year, due to a planned reduction in advertising and promotion spend related to IXCHIQ following its launch in early 2024.
G&A Expense EUR 19 million, compared to EUR 22.8 million in the first half of 2024, as a result of a program to increase operational efficiency.
Operating Loss EUR 16.8 million, compared to an operating profit of EUR 46.7 million last year. Last year's profit was due to the sale of a priority review voucher for EUR 90.8 million.
Adjusted EBITDA Minus EUR 6 million, compared to a positive EUR 56.2 million last year. Excluding the one-off PRV sale in the prior year, adjusted EBITDA improved by 80% year-over-year.
Cash Position EUR 161.3 million as of June 30, 2025, compared to EUR 168.3 million at the end of 2024. Cash used in operations was EUR 10.9 million, compared to EUR 66.3 million in the first half of 2024.
Lyme Disease Vaccine: Progressing Phase III study with over 9,000 participants. Regulatory applications in the US and Europe expected in 2026, with a potential launch in 2027.
Chikungunya Vaccine (IXCHIQ): Temporary restrictions lifted by FDA and EMA. Positive Phase III pediatric safety and immunogenicity results. Long-term antibody persistence being monitored for up to 10 years.
Shigella Vaccine: Phase II infant study launched, with data expected later this year. Phase IIb controlled human infection model study ongoing, with efficacy data expected early next year.
Zika Virus Vaccine: Phase I study ongoing to evaluate safety and immunogenicity. Future development depends on Phase I results and market potential.
Market Expansion for IXCHIQ: Secured additional marketing authorizations in the UK, Brazil, and Europe for adolescents 12 years and older. Exclusive vaccine marketing and distribution agreement in Germany with CSL Seqirus.
Response to Outbreaks: Supplied IXCHIQ to combat chikungunya outbreak in La Réunion and Mayotte. Supplied DUKORAL to address cholera outbreak in Mayotte.
Revenue Growth: Achieved total revenues of EUR 97.6 million, a 37.8% year-over-year increase. Product sales grew by 33.3%.
Operational Efficiency: Significant reduction in operating cash burn and improved gross margins for IXIARO and DUKORAL.
Strategic Focus: Repositioning IXCHIQ for targeted use in specific populations and geographies. Exploring pipeline expansion post-successful Lyme vaccine Phase III.
Regulatory and Safety Challenges: Temporary restrictions were imposed by FDA and EMA on the use of the chikungunya vaccine (IXCHIQ) in elderly individuals due to serious adverse events observed during mass vaccination campaigns. Although these restrictions have been lifted, the updated safety sections in the labels highlight ongoing concerns about its use in frail elderly populations.
Operational Risks in Lyme Disease Vaccine Development: The Lyme disease vaccine program involves a complex Phase III study spanning three tick seasons with over 9,000 participants. Any delays or issues in data collection, case adjudication, or regulatory submissions could impact the planned 2027 launch.
Supply Chain and Manufacturing Constraints: IXIARO sales were previously impacted by supply constraints, and while improvements have been made, any future disruptions could affect revenue and operational performance.
Financial Risks: The company reported an operating loss of EUR 16.8 million in the first half of 2025, and while cash burn has been reduced, the reliance on future product approvals and sales growth to achieve profitability poses a financial risk.
Market and Competitive Risks: The chikungunya vaccine (IXCHIQ) faces challenges in market positioning, requiring careful targeting of the right populations and settings to ensure its success. Additionally, the Lyme disease vaccine will enter a market with no existing competitors, but its success depends on achieving high efficacy and safety standards.
R&D and Pipeline Risks: The company is heavily investing in R&D, including the Shigella and Zika vaccine programs, which are still in early to mid-stage development. Delays or failures in these programs could impact future growth and strategic objectives.
Lyme Disease Vaccine (VALOR Study): The VALOR Phase III study is progressing as planned, with over 9,000 participants enrolled. Regulatory applications in the U.S. and Europe are expected in 2026, with a potential launch in autumn 2027, targeting the 2028 tick season. Monitoring of Lyme cases will continue until October 2025, followed by data analysis and adjudication.
Chikungunya Vaccine (IXCHIQ): The company plans to expand access and label extensions for IXCHIQ, targeting all age groups. A robust clinical program is supported by a $40 million CEPI grant. Long-term antibody persistence is being monitored for up to 10 years, with 4-year results expected later in 2025. Phase IV studies aim to confirm effectiveness and safety in endemic regions.
Shigella Vaccine: Phase II infant study data is expected later in 2025, and Phase IIb controlled human infection model study efficacy data is anticipated in early 2026. The vaccine targets up to 85% of shigellosis infections and is a priority vaccine identified by WHO.
Zika Virus Vaccine: Phase I study is ongoing to evaluate safety and immunogenicity with an optimized formulation. Future development strategies will depend on Phase I results, external funding, and market potential.
Financial Guidance for 2025: Product sales are projected at EUR 170-180 million, with total revenues of EUR 180-190 million. R&D expenses are expected to be EUR 90-100 million, partially offset by grants and tax credits. Cash usage in operations is targeted to reduce by over 50% year-over-year.
The selected topic was not discussed during the call.
The earnings call revealed mixed financial performance, with a significant operating loss and negative EBITDA largely due to the absence of last year's PRV sale. While there were improvements in gross margins, the temporary U.S. license suspension for IXCHIQ and unclear FDA timelines add uncertainty. The Q&A highlighted management's lack of specific guidance on key issues like IXCHIQ's suspension and DUKORAL's growth in Germany, leading to a negative sentiment. The absence of clear guidance and the mixed financial results suggest a likely negative stock price reaction.
The earnings call reveals mixed signals. While there are strong regulatory achievements and promising vaccine developments, the financial performance shows significant operating losses and reduced cash position. Guidance remains steady, but the lack of additional revenue recognition and vague responses in the Q&A highlight uncertainties. The operational cash burn reduction is positive, but overall, the sentiment is balanced by both positive and negative factors, leading to a neutral outlook.
The earnings call presents a mixed picture. While there is strong sales growth and improved cash burn, the financial health is weakened by operating losses and a net loss. The shareholder return plan is neutral, with a share issuance and reduced cash burn. The Q&A section reveals uncertainties, particularly around regulatory risks and unclear guidance on key metrics. Despite strong financial performance, the market strategy faces competition and regulatory challenges. Overall, the sentiment is neutral, with no strong catalysts for significant short-term stock price movement.
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