Sedana Medical (SEDANA) Q1 2025 earnings summary

Executive summary

• Achieved record Q1 sales of SEK 57.5 million, up 18% year-over-year, with 15% organic growth and strong performance in Germany and other direct markets.

• Gross margin stable at 71%; ex-US EBITDA margin positive at 7% (8% excluding FX), group EBITDA improved to minus SEK 1 million (margin -1%).

• FDA approved an expanded access program (EAP) in the US, allowing pre-approval use for difficult-to-sedate patients; NDA submission planned for early 2026.

• Cash position at quarter-end was SEK 165 million, with no long-term debt and positive operating cash flow.

• Integration of Malaysian manufacturing plant progressing, expected to improve gross margin in H2 2025.

Financial highlights

• Net sales grew 18% year-over-year to SEK 57.5 million, with strong growth in Germany (8%) and other direct markets (49-50%).

• Gross profit reached SEK 41 million, gross margin stable at 71%.

• Group EBITDA improved to minus SEK 1 million from minus SEK 4 million last year; ex-US EBITDA positive at SEK 4 million.

• CapEx reduced to SEK 17 million from SEK 52 million year-over-year.

• Cash flow from operations was SEK 6 million in Q1 2025.

Outlook and guidance

• Confident in delivering positive full-year ex-US EBITDA in the low to mid-single digits.

• Anticipates further gross margin improvement in H2 from the Malaysian acquisition.

• CapEx expected to remain at a significantly lower level than previous years.

• US NDA submission planned for early 2026; first US patients expected under EAP in H2 2025.

• Long-term target: Group EBITDA margin around 40% as US sales scale.