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Sedana Medical
Sedana Medical (SEDANA) investor relations material
Sedana Medical Q4 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q4 2025 earnings summary12 Feb, 2026
Executive summary
Achieved first-time positive EBITDA in ex-US business (3% FY, 8% Q4), marking a turnaround from prior losses and meeting 2025 financial targets.
Full-year net sales reached SEK 200.2 million, up 16% year-over-year at constant exchange rates, with Q4 sales at an all-time high of SEK 52 million.
US pivotal trials met all primary endpoints, with FDA Fast Track Designation, Early Access Program approval, and positive pre-NDA meeting confirming data adequacy.
Strategic focus on commercial execution, cost discipline, and targeted investments in high-growth markets, including restructuring headquarters post-COVID-19.
Set new 2026 target for mid-to-high single-digit ex-US EBITDA and approaching group-level profitability.
Financial highlights
Q4 net sales: SEK 51.8 million, up 5% year-over-year (11% FX-adjusted); full-year net sales: SEK 200.2 million, up 16% at constant FX.
Q4 gross margin: 73% (up from 69%); full-year gross margin: 71%.
Q4 EBITDA at group level: SEK 0.1 million (0.1% margin); ex-US Q4 EBITDA: SEK 4.0 million (8% margin).
Year-end cash balance: SEK 91 million; Q4 cash flow from operations: SEK -5.2 million; total Q4 cash flow: SEK -19.1 million.
Full-year EBITDA: SEK -10.1 million (vs. -30.6 million prior year); ex-US EBITDA: SEK 5.9 million (3% margin).
Outlook and guidance
Expects ex-US EBITDA to grow to mid- to high-single-digit positive range in 2026 and approach group-level break-even.
NDA submission for US approval planned mid-2026; potential US launch in 2027, depending on FDA review timeline.
Sufficient financing projected for US approval; long-term target: EBITDA margin around 40% as US sales scale.
What are the key US market differentiation points?
How will US launch investments be funded?
Specific German market growth initiatives?
How will EAP participation impact US launch?
What actions address Germany's H2 sales decline?
Is current cash sufficient for US approval process?
U.S. market adoption strategy
Germany sales strategy for seasonal swings
Future gross margin impact from Malaysia acquisition
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Next Sedana Medical earnings date
Q1 202623 Apr, 2026
Sedana Medical
Next Sedana Medical earnings date
Q1 202623 Apr, 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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