Sedana Medical (SEDANA) Q3 2025 earnings summary

Executive summary

• Q3 2025 net sales grew 4% year-over-year (7% at constant exchange rates), with year-to-date sales up 18% and 12% organic growth.

• Gross margin improved to 71.6% in Q3, aided by cost reductions and the acquisition of a key supplier.

• EBITDA loss narrowed to SEK -5.6 million in Q3, with ex-U.S. EBITDA nearly break-even and operational efficiency improved.

• U.S. market entry preparations are progressing, with a pre-NDA FDA meeting scheduled and an Early Access Program underway.

• Cash and equivalents at quarter-end were SEK 112 million, down from SEK 131 million in Q2, mainly due to U.S. CapEx.

Financial highlights

• Q3 net sales reached SEK 41.2 million, up 4% year-over-year (7% excluding FX); nine-month net sales were SEK 148.5 million, up 15%.

• Gross profit for Q3 was SEK 29.5 million, with a gross margin of 71.6%.

• Group EBITDA for Q3 was negative SEK 5.6 million, an improvement year-over-year; ex-U.S. EBITDA was negative SEK 1.7 million.

• Cash flow from operations improved to negative SEK 1.1 million in Q3.

• Operating income (EBIT) for Q3 was SEK -10.7 million, with a net income loss of SEK -12.4 million.

Outlook and guidance

• Targeting low- to mid-single-digit positive ex-U.S. EBITDA margin for full year 2025, with Q4 traditionally stronger.

• U.S. NDA submission is on track, with a pre-NDA meeting scheduled for Q4 and potential launch in 2027.

• Sufficient financing is expected to reach U.S. approval.