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Edge16 Oct 2026
Winner, Winner: The Chicken McNugget Story
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Sedana Medical
Sedana Medical (SEDANA) investor relations material
Sedana Medical Q3 2026 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2026 earnings summary22 Oct, 2026
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.
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Latest events from Sedana Medical
- NDA submitted to FDA; EBITDA improves, ex-Germany sales accelerate, Germany declines 22%.SEDANA
Q2 2026 - Positive EBITDA and stable margins achieved in Q1 2026 as U.S. launch preparations advanced.SEDANAQ1 2026
- Record sales, first ex-US EBITDA profit, and US NDA submission planned for mid-2026.SEDANAQ4 2025
- Record sales, stable margins, and positive US clinical data support strong future outlook.SEDANAQ2 2025
- Record Q3 sales, raised guidance, and US approval delayed by European trial integration.SEDANAQ3 2024
- H1 sales up 20%, Q2 at record 41 MSEK, US trial done, supplier acquired to boost margins.SEDANAQ2 2024
- SESAR showed sevoflurane increased mortality in ARDS, while isoflurane remains safe and effective.SEDANAStudy result
- Record sales, positive ex-US EBITDA, and FDA Early Access approval mark a pivotal quarter.SEDANAQ1 2025
- Record sales, US trial milestones, and margin-enhancing acquisition drive strong outlook.SEDANAQ4 2024
Next Sedana Medical earnings date
Q4 202611 Feb, 2027
Sedana Medical
Next Sedana Medical earnings date
Q4 202611 Feb, 2027
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Frequently asked questions
Sedana Medical AB develops, markets, and sells medical devices for anesthesia applications. It offers Anesthetic Gas Machines that deliver the anesthetic gasses oxygen, nitrous oxide, and ventilation of carbon dioxide; and Gas Monitors to measure the concentration of anesthetic gasses delivered by the machine. The company also provides monitoring solutions for intravenous anesthesia. Sedana Medical AB was founded in 2005 and is headquartered in Danderyd, Sweden.