Sedana Medical (SEDANA) Q2 2024 earnings summary

Executive summary

• H1 2024 net sales reached 89.9–90 MSEK, up 20% year-over-year, surpassing guidance of 14–18% growth.

• Q2 net sales were 41–41.1 MSEK, up 10% year-over-year, marking a record Q2.

• Completed enrollment in both US clinical trials, reducing execution risk and progressing toward NDA submission in Q1 2025.

• Announced acquisition of main supplier Innovatif Cekal for 34 MSEK, expected to improve EBITDA margin by 2pp and enhance supply chain control.

• Ex-US business returned to growth, achieving positive EBITDA in Q1 and targeting break-even for 2024.

Financial highlights

• Q2 2024 net sales: 41–41.1 MSEK (up 10%); H1 2024 net sales: 89.9–90 MSEK (up 20%).

• Q2 gross profit: 29 MSEK (margin 71%); H1 gross profit: 63.7 MSEK (margin 71%).

• Q2 EBITDA: -13.9 to -14 MSEK (group); ex-US EBITDA: -11 MSEK; negative FX effect of -2 MSEK.

• Cash at Q2 end: 304 MSEK, down from 361 MSEK at quarter start, mainly due to US clinical study investments.

• Cash flow from operations in Q2: 1.9–2 MSEK; capex expected to decrease as US trial costs wind down.

Outlook and guidance

• Tracking above full-year sales growth guidance of 14–18%, expecting all-time high sales in 2024.

• Expects positive ex-US EBITDA again in Q4, with break-even targeted for 2024.

• NDA submission for US market planned for Q1 2025; US launch targeted for 2026, pending FDA approval.

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

• Long-term EBITDA margin target around 40% as US sales scale.