Sedana Medical (SEDANA) Q3 2026 earnings summary

Executive summary

• Q3 net sales were SEK 44.2M, up 7% YoY at constant FX, returning to growth after flat H1; Germany improved while other direct and distributor markets grew.

• FDA review of the US NDA is underway, with an April 16, 2027 PDUFA date; an FDA-authorized Early Access Program is progressing.

• 9M ex-US EBITDA remained positive, full-year 2026 guidance was reconfirmed, and Q3 cash burn eased from Q2.

Financial highlights

• Q3 net sales were SEK 44.2M versus SEK 41.2M, up 7% reported and at constant FX; excluding contract manufacturing, sales rose 5% to SEK 40.6M.

• Gross profit was SEK 30.8M versus SEK 29.5M; gross margin was 70% versus 72%, affected by higher contract-manufacturing mix and a positive one-time Q3 2025 reclassification.

• Q3 EBITDA was SEK -7.0M versus SEK -5.6M; opex was SEK 45M versus SEK 40M, including SEK 1M FX and SEK 2M higher depreciation.

• 9M EBITDA improved to SEK -7.1M from SEK -10.2M; ex-US EBITDA was SEK 2.6M versus SEK 1.9M.

• 9M sales were SEK 146.7M versus SEK 148.5M, down 1% reported but up 1% at constant FX; net loss narrowed to SEK 24.4M from SEK 49.1M.

Outlook and guidance

• FY 2026 guidance targets a mid-to-high single-digit ex-US EBITDA margin and near-positive Group EBITDA; guidance was reconfirmed.

• Q4 priorities include commercial execution in core markets and responding to FDA review questions; the PDUFA target date is April 16, 2027.

• US launch preparation includes pricing research and go-to-market planning, with a wholly owned commercial subsidiary preferred and complementary partnerships retained as an option.