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Sedana Medical (SEDANA) investor relations material
Sedana Medical Q2 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Executive summary
Achieved record Q2 sales of nearly SEK 50 million, up 27% year-over-year, with strong growth in Germany and Spain and ex-US business reaching profitability.
Positive US clinical trial results, FDA Fast Track designation, and Early Access Program approval support future US market entry.
Published successful pediatric study in The Lancet, leading to expanded approvals and extended data exclusivity in Europe.
Cash position at quarter-end was SEK 131 million, with no external long-term debt and full financing for strategic plans.
Integration of Malaysian manufacturing plant progressing, contributing to sales and expected margin improvement.
Financial highlights
Q2 net sales reached SEK 49.8 million, up 27% year-over-year (21% organic growth), with 6% from contract manufacturing.
Gross margin steady at 70.2% in Q2, with gross profit of SEK 35 million.
Q2 EBITDA improved to negative SEK 4 million from negative SEK 13 million last year; ex-US EBITDA at 0% for Q2 and 4% YTD.
Cash flow from operations in Q2 was negative SEK 12 million, mainly due to working capital changes.
Cash and equivalents at quarter-end were SEK 131 million, down from SEK 165 million at the start of the quarter.
Outlook and guidance
Confident in meeting full-year target of positive ex-US EBITDA in low to mid single digit range.
Q3 expected to be seasonally weaker, with stronger Q4 anticipated.
US NDA submission planned for early 2026, with commercial launch preparations underway.
Lower CapEx levels expected to continue, with further reduction after FDA submission.
Long-term EBITDA margin target around 40% as US sales scale.
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