Sedana Medical (SEDANA) Q4 2024 earnings summary

Executive summary

• Achieved record annual sales of SEK 179 million, up 17% year-over-year, in line with raised guidance.

• Both pivotal US phase 3 trials met primary endpoints for non-inferiority and safety, supporting US market entry plans.

• Pediatric indication approved in nine countries, extending market protection in Europe to 2032.

• Ex-US business nearly profitable, with positive EBITDA in Q1 and Q4, and a small full-year loss of SEK 15 million, improved from SEK 40 million prior year.

• Acquisition of main supplier Innovatif Cekal completed, expected to improve EBITDA margin by 2 percentage points from H2 2025.

Financial highlights

• Q4 net sales reached SEK 49 million, up 10% year-over-year, marking the best Q4 to date.

• Gross margin stable at 71% for the year and 70% in Q4, excluding contract manufacturing revenue.

• Group EBITDA for Q4 was negative SEK 5 million, improved from negative SEK 9 million last year.

• Cash at year-end was SEK 194 million, with cash burn slowing due to reduced CapEx and clinical trial completion.

• Q4 net income was SEK 8.5 million, with a full-year net loss of SEK 10.7 million, improved from SEK 59.6 million loss prior year.

Outlook and guidance

• Targeting positive full-year EBITDA ex-US in 2025, aiming for low to mid-single-digit margin.

• Continued growth expected in key direct markets (Spain, UK, France), with sales acceleration plan underway in Germany.

• Preparing for direct US market launch, building a commercial subsidiary, and maintaining option for partnerships.

• No specific sales growth guidance for 2025; focus remains on profitability and cost discipline.

• Long-term goal: 40% EBITDA margin as US sales scale.