• Product Sales: EUR112.5 million, a 12% increase over the prior year.

• Total Revenue: EUR116.6 million, up from EUR111.8 million in the first nine months of 2023.

• IXIARO Gross Margin: 58.8% compared to 47.2% one year ago.

• DUKORAL Sales: EUR22.3 million, a 6% increase year over year.

• Chikungunya Vaccine Sales: EUR1.8 million in the United States by September 30th.

• Operating Profit: EUR34.2 million versus an operating loss of minus EUR57.2 million in the prior year.

• Adjusted EBITDA: Improved from minus EUR46 million to positive EUR48.6 million.

• Cash Position: EUR156.3 million as of September 30th.

• R&D Expense: Increased to EUR48.6 million from EUR42.2 million in the prior year.

• Marketing and Distribution Expense: Increased by 5% to EUR35.7 million.

• General and Administrative Expense: Decreased by 7% to EUR32.6 million.

• Sale of PRV Income: EUR90.8 million.

• Cash Use in Operating Activities: Decreased from EUR136 million to EUR76.7 million.

• Guidance for Product Sales: Narrowed to EUR160 to EUR170 million for the current fiscal year.

• Guidance for Total Revenue: EUR170 to EUR180 million for the current fiscal year.

• Warning! GuruFocus has detected 9 Warning Signs with INRLF.

Release Date: November 07, 2024

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Valneva SE (INRLF) reported product sales of over EUR110 million for the first nine months of 2024, aligning with company guidance.

• The company has a strong cash position of more than EUR150 million, indicating solid financial health.

• Valneva SE (INRLF) is on track with its Lyme Disease vaccine program, with regulatory filings expected in 2026 and potential approval in 2027.

• The company has achieved FDA fast track designation for its Shigella vaccine program, highlighting its potential in addressing a significant health need.

• Valneva SE (INRLF) anticipates sustained profitability from 2027 onwards, driven by successful vaccine programs and improved commercial sales margins.

Negative Points

• The uptake of IXCHIQ in the US market has been slower than anticipated, leading to a narrowed sales guidance.

• Research and development expenses increased due to tech transfer costs, impacting overall financial performance.

• The company faces supply constraints affecting third-party product sales, which declined by 23% year over year.

• Valneva SE (INRLF) is still awaiting the MMWR publication, which is crucial for driving retail growth in the US.

• The transition of manufacturing operations to the new site in Scotland will continue to incur costs into 2025.