Sedana Medical (SEDANA) Q2 2025 earnings summary

Executive summary

• Achieved record Q2 2025 sales of just under SEK 50 million, up 27% year-over-year, with strong growth in Germany and Spain, and contract manufacturing revenue from the Malaysian plant.

• Positive US clinical trial results, FDA Fast Track designation, and Early Access Program approval position for future US market entry, with first patients expected in H2 2025.

• Published successful pediatric study in The Lancet, leading to approvals in 13 countries, label expansion, and extended data exclusivity until 2032.

• Ex-US business reached profitability, and integration of the Malaysian manufacturing plant (Innovatif Cekal) is progressing well, expected to improve gross margins.

• Cash position at quarter-end was SEK 131 million, with no external long-term debt and full financing for strategic plans.

Financial highlights

• Q2 net sales reached SEK 49.8–50 million, up 21% year-over-year (27% at constant FX), with 6% from contract manufacturing.

• Gross margin held steady at 70.2% in Q2, with gross profit of SEK 34.9–35 million.

• Q2 EBITDA improved to -SEK 4 million (from -SEK 13 million last year); ex-US EBITDA at or near breakeven.

• Cash and equivalents at quarter-end were SEK 130.7–131 million, with no external long-term debt.

• CapEx significantly reduced to SEK 17 million in Q2, mainly for US regulatory activities.

Outlook and guidance

• On track to achieve full-year positive ex-US EBITDA in the low- to mid-single digit range, with 4% achieved year-to-date.

• Q3 expected to be seasonally weaker, with a stronger Q4 anticipated; US NDA submission planned for early 2026.

• Early Access Program in the US to begin in Q4 2025, with commercial launch preparations underway.

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