Sedana Medical (SEDANA) Q1 2026 earnings summary

Executive summary

• Achieved positive Group EBITDA of SEK 1.8 million in Q1 2026 despite a 7% year-over-year sales decline, reflecting improved profitability and operational efficiency amid lower ICU occupancy and healthcare strikes, especially in Germany and Spain.

• Ex-U.S. EBITDA margin reached 10%, with gross margin stable at 71%.

• Transformation and restructuring efforts, including cost reductions and resource reallocation, enhanced operational efficiency and sales focus.

• U.S. market entry preparations are progressing, with NDA submission on track for mid-2026, supported by successful pivotal trials and Fast Track designation.

• Early Access Program launched in the U.S., with first patients treated and strong interest from major hospitals.

Financial highlights

• Net sales for Q1 2026 were SEK 53.4 million, down 7% year-over-year (2% at constant exchange rates).

• Group EBITDA margin was 3%; ex-U.S. EBITDA margin reached 10%.

• Gross margin held steady at 71%, despite a higher share of lower-margin contract manufacturing and distributor sales.

• Operating expenses reduced to SEK 43 million from SEK 46 million year-over-year.

• Cash at quarter-end was SEK 80.7 million, with positive cash flow from operations (+SEK 2.7 million).

Outlook and guidance

• Confident in meeting full-year guidance of mid- to high single-digit ex-U.S. EBITDA margin and approaching group-level EBITDA breakeven.

• US NDA submission planned for mid-2026; launch preparations underway.

• Sufficiently financed to achieve U.S. approval, with CapEx expected to remain at lower levels post-NDA submission.

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

• Expect seasonality and external factors to impact quarterly results, with improved growth anticipated in the second half of the year.