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Sedana Medical (SEDANA) investor relations material
Sedana Medical Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2025 earnings summary24 Oct, 2025
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.
How do pre-NDA and EAP de-risk US approval?
Key drivers for ex-US EBITDA target achievement?
What is the commercial impact of pediatric approval?
U.S. submission: key de-risking factors?
Spain's growth model: replicable elsewhere?
Ex-U.S. business: funding U.S. launch?
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Next Sedana Medical earnings date
Q4 202513 Feb, 2026
Next Sedana Medical earnings date
Q4 202513 Feb, 2026
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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.
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