Q1 2025 Sedana Medical AB (publ) Earnings Call Transcript
Key Points
- Sedana Medical AB (FRA:7D2A) reported a record quarterly sales of 57.5 million SEK, marking an 18% year-over-year growth.
- The company achieved a stable gross margin of 71% and anticipates further improvement due to the acquisition of a Malaysian supplier.
- The FDA approved Sedana Medical's early access program, allowing eligible patients to access their therapy before official market authorization.
- Sedana Medical's US trials have shown positive high-level results, and the company has been granted fast track designation by the FDA.
- The company has received national approval in 11 European countries for its pediatric indication, extending market protection until 2032.
- The distributor business saw a significant decline in sales, with a 39% year-over-year decrease due to timing of orders.
- The company reported a small negative EBITDA on a group level, primarily due to US-related operating expenses and exchange rate headwinds.
- There is uncertainty regarding potential tariffs on products imported for the early access program in the US.
- The company faces challenges in France due to a higher share of off-label sevoflurane use, requiring more effort to switch customers to isoflurane.
- The early access program in the US will incur costs as products are provided for free, impacting operational expenses.
Hello and welcome to today's webcast withtona Medical. We see you Johannesto, see for Joann's Spitz, and Simour Petersakki will present the report for the first quarter of 2025. After the presentation, there will be a Q&A. So if you're calling in and want to ask a question, please press 9 to raise your hand, and then start 6 to unmute yourself on hand at the word. You can also send in questions via the form to the right, and with that said, hand over the word to you guys.
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Thank you. Welcome to our Q1 report 2025.
Thank you very much for joining us today. Let's jump straight into the highlights on page 3. This is a quarterly report that I'm very happy with as we have made strong progress across all of our three priorities. On the top line, we have come out of the gate strong with a new record in quarterly sales of 57.5 million SE, which is the first quarter ever above 50 million and a year over year growth of 18%.
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