Sedana Medical (SEDANA) Q3 2024 earnings summary

Executive summary

• Achieved record Q3 net sales of SEK 40 million (MSEK 39.7), up 16% year-over-year and 20% in local currencies, with YTD net sales of SEK 130 million, exceeding previous guidance.

• Raised full-year net sales growth guidance to 17%-20% (from 14%-18%) due to strong year-to-date performance and momentum in key markets.

• Completed patient enrollment in both U.S. phase III trials; integrating the European SED001 trial into the U.S. FDA submission, extending the timeline by about a year and adding SEK 20-30 million in costs.

• Acquisition of main supplier Innovatif Cekal for SEK 34 million, expected to close in Q4 2024, will improve margins and supply chain control.

Financial highlights

• Q3 2024 net sales reached SEK 40 million (MSEK 39.7), up 16% year-over-year and 20% in local currencies.

• Gross profit increased to SEK 28 million (margin 71%), up from 70% in Q3 last year.

• Group EBITDA improved to SEK -9 million (margin -23%) from SEK -13 million year-over-year; ex-US EBITDA at SEK -5 million (margin -13%) versus SEK -12 million last year.

• Cash and cash equivalents at quarter-end were SEK 226 million, down from SEK 304 million, mainly due to CapEx and working capital changes.

• Cash flow from operations in Q3 was SEK -29 million, mainly due to US clinical study payments.

Outlook and guidance

• Full-year net sales growth guidance raised to 17%-20% (excluding currency effects) based on 19% year-to-date growth.

• Ex-US business achieved EBITDA breakeven in Q1; targeting break-even ex-US EBITDA for 2024.

• CapEx expected to decrease significantly in 2025 as U.S. trial recruitment is complete.

• Confident in sufficient cash reserves to execute strategic plans, including U.S. submission and supplier acquisition.