Sweden · Delayed Price · Currency is SEK Sedana Medical AB Earnings Call Transcripts
Fiscal Year 2026
-
NDA submission to the FDA marks a pivotal step toward U.S. market entry, with profitability improving despite flat group sales. Strong growth in Spain, France, and the U.K. offsets a sharp decline in Germany, while cash burn is expected to decrease post-submission.
-
Q1 2026 saw a slight sales decline due to lower ICU occupancy and strikes, but profitability improved with positive group EBITDA and strong ex-U.S. margins. U.S. market entry remains on track, with NDA submission expected mid-year and early access programs underway.
Fiscal Year 2025
-
Delivered record sales and first-ever positive ex-US EBITDA, driven by strong growth in Spain and improved margins from cost discipline. US pivotal trials succeeded, with FDA Fast Track and early access program; US launch expected in 2027 pending approval.
-
Q3 sales were below expectations due to lower ICU admissions, but profitability improved and ex-U.S. EBITDA remained positive. U.S. market entry preparations are on track, with robust clinical data and an early access program supporting future growth.
-
Record sales and improved profitability driven by strong growth in Germany and other direct markets, with positive clinical trial results and regulatory progress in the U.S. supporting future expansion. Gross margin remains stable, CapEx is down, and the company is on track to meet its full-year EBITDA target.
-
Two large U.S. ICU trials confirmed isoflurane's non-inferiority to propofol for sedation, with significant opioid reduction and similar wake-up times. Trends favored isoflurane for ICU-free days and mortality, supporting a strong case for U.S. approval and commercial adoption.
-
Record Q1 sales grew 18% year-over-year, with strong direct market performance and stable 71% gross margin. EBITDA improved, CapEx dropped, and the FDA approved an expanded access program in the US. Cash position remains solid at SEK 165 million.
-
The SESAR study found higher mortality and fewer ventilator-free days with sevoflurane vs. propofol in ARDS patients, likely due to over-sedation and renal toxicity. Isoflurane has shown safety and efficacy in trials. The company is intensifying efforts to convert sevoflurane users to isoflurane and maintains its outlook.
Fiscal Year 2024
-
Annual sales hit a record SEK 179 million, up 17% year-over-year, with strong growth in Spain, UK, and France. Both US pivotal trials met primary endpoints, supporting US entry plans, while ex-US business nears profitability and cash burn declines.
-
Record Q3 sales and improved profitability led to raised full-year guidance. U.S. FDA submission will now include European trial data, extending the timeline by a year but strengthening the case. Supplier acquisition is set to boost margins and supply chain control.
-
Sales grew 20% year-over-year in H1 2024, exceeding guidance, with strong performance in Spain and the UK offsetting a weak quarter in Germany. U.S. clinical trial enrollment is complete, reducing cash burn, and the main supplier acquisition is set to boost margins.