• Total Product Sales: EUR163.3 million, a 13% increase over 2023.
• IXIARO Sales: EUR94.1 million, a 28% growth compared to 2023.
• DUKORAL Sales: EUR32.3 million, an 8% increase from the previous year.
• IXCHIQ Initial Sales: EUR3.7 million following its launch in 2024.
• Operating Profit: EUR20.7 million, driven by non-recurring income from the sale of a priority review voucher.
• Net Loss: EUR12.2 million for the period.
• Adjusted EBITDA: EUR32.9 million.
• Cash Position: EUR168 million in cash and cash equivalents at year-end 2024.
• R&D Expenses: EUR74.1 million, a 24% increase from 2023.
• Gross Margin of Commercial Products: 50.6%, up from 46% in 2023.
• 2025 Revenue Guidance: Total product sales expected to reach EUR170-180 million.
• 2025 R&D Investment Guidance: Expected to be between EUR90-100 million.

• Warning! GuruFocus has detected 8 Warning Signs with INRLF.

Release Date: March 20, 2025

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

Positive Points

• Valneva SE (INRLF) achieved double-digit year-on-year sales growth, with sales exceeding EUR160 million, aligning with their 2024 guidance.
• The company maintained a strong cash position at year-end, close to EUR170 million, with a significantly lower operating cash burn.
• Valneva SE (INRLF) successfully executed regulatory approvals, including three additional IXCHIQ approvals and significant label extensions.
• The company expanded access to IXCHIQ with launches in Canada, Europe, and the UK, and entered a new Asian partnership for key endemic markets.
• Valneva SE (INRLF) anticipates transformative potential for its Lyme vaccine candidate VLA 15, with phase 3 study data readout expected by the end of 2025.

Negative Points

• The company experienced delays in the approval process for IXCHIQ in Brazil, affecting the timeline for starting the pilot vaccination program.
• Valneva SE (INRLF) reported a decrease in third-party sales due to supply constraints and a strategic focus on proprietary products.
• Research and development expenses increased by 24% in 2024, driven by tech transfers and new vaccine candidates, impacting overall costs.
• The company faces uncertainties related to the timing of regulatory processes, such as the MMWR publication and ACIP meetings, affecting market access.
• Valneva SE (INRLF) acknowledged that the ramp-up of IXCHIQ sales was slower than anticipated, requiring a revision of midterm sales guidance.

Q & A Highlights

Q: Can you elaborate on the cash burn guidance, which is going down by over 50%, and provide context on the R&D expenses going up for the coming year? A: Peter Buhler, CFO: The reduction in cash burn is due to several factors, including sales growth, cost containment, and improved working capital management. We also expect to collect two years' worth of R&D tax credits in 2025. The increase in R&D expenses is primarily due to the chikungunya phase 4 trial and the new Shigella program, which are ramping up in 2025.

Q: What risks or opportunities do you see stemming from RFK's role now in the administration, especially regarding vaccine sentiment? A: Thomas Lingelbach, CEO: We are monitoring the situation carefully. Our vaccines target areas of high unmet medical need and are mostly paid out of pocket, so they are not currently subject to significant criticism. We believe that science will prevail, and efficacious vaccines like ours will be used to benefit those in need.

Q: Did you take any price increases on IXIARO and DUKORAL at the beginning of this year? A: Thomas Lingelbach, CEO: We did not implement any material price increases for our products in 2025, so the volume comparison is almost like-for-like.

Q: Can you provide an update on the approval process for IXCHIQ in Brazil? A: Thomas Lingelbach, CEO: We anticipated approval in the first quarter but have experienced some delays. The review process is nearing completion, and we hope to receive approval soon, which is necessary to start the pilot vaccination program.

Q: How do you plan to leverage your first-mover advantage with the chikungunya vaccine, especially with Bavarian Nordic's recent approval? A: Thomas Lingelbach, CEO: We believe that increasing disease awareness is key, and the presence of competitors can help drive this awareness. Our focus is on leveraging our first-mover advantage by emphasizing the severity of chikungunya and the benefits of vaccination.

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