Third quarter 2025

• Net sales for the quarter totaled MSEK 41.2 (39.7), equivalent to an increase of 4% compared to the corresponding quarter 2024. At constant exchange rates, sales increased by 7%.
• Net sales excluding contract manufacturing totaled MSEK 38.8 (39.7), equivalent to a decrease of 2% compared to the corresponding quarter in 2024. At constant exchange rates, sales increased by 1%.
• Gross profit amounted to MSEK 29.5 (28.3), equivalent to a gross margin of 71.6% (71.2%).
• Earnings before interest, taxes, depreciation and amortisation (EBITDA) totaled MSEK -5.6 (-8.6), equivalent to an EBITDA margin of -13.5% (-21.6%).
• EBITDA ex-US was MSEK -1.7 (-4.8) for the quarter, corresponding to a margin of -4.2% (-12.2%).
• Operating income (EBIT) totaled MSEK -10.7 (-13.9), equivalent to an EBIT margin of -26.0% (-34.9%).
• Net income for the quarter was MSEK -12.4 (-22.6) and earnings per share before and after dilution was SEK -0.12 (-0.23). The improved result is due to Increased sales and lower operating costs as well as improved contribution from financial items. The net financial items includes unrealised currency effects on cash placed in USD of MSEK -1.6 (-10.5) and lower interest income of MSEK 0.7 (2.5).
• Cash and equivalents at the end of the quarter totaled MSEK 112.0 compared to MSEK 130.7 at the beginning of the quarter. Cash and equivalents were impacted by unrealised currency effects amounting to MSEK -1.6 (-10.5).
• Cash flow from operating activities totaled MSEK -1.1 (-29.3). The cash flow from operations has improved to MSEK -4.7 (-9.0), changes in cash flow from operating activities has been affected by increase in inventory of MSEK -1.3 (1.0), changes in short-term receivables of MSEK 5.3 (-2.5), and changes in short-term liabilities of MSEK -0.4 (-16.8).
• Cash flow from investments in intangible assets amounted to MSEK -14.9 (-36.3) and mainly refers to registration preparation work in the USA.
• Total cash flow for the quarter amounted to MSEK -17.2 (-67.3).

January-September 2025

• Net sales for the period totaled MSEK 148.5 (129.6), equivalent to an increase of 15% compared to 2024. At constant exchange rates, sales increased by 18%.
• Net sales excluding contract manufacturing totaled MSEK 141.6 (129.6), equivalent to an increase of 9% compared to the corresponding period 2024. At constant exchange rates, sales increased by 12%.
• Gross profit amounted to MSEK 105.1 (92.0), equivalent to a gross margin of 70.8% (71.0%).
• Earnings before interest, taxes, depreciation and amortisation (EBITDA) totaled MSEK -10.2 (-25.1), equivalent to an EBITDA margin of -6.9% (-19.3%).
• EBITDA ex-US was MSEK 1.9 (-15.6) for the period, corresponding to a margin of 1.3% (-12,1%).
• Operating income (EBIT) totaled MSEK -26.1 (-41.1), equivalent to an EBIT margin of -17.6% (-31.7%).
• Net income for the period was MSEK -49.1 (-19.2) and earnings per share before and after dilution was SEK -0.49 (-0.19). Increased sales and lower operating costs have been offset by unrealised currency effects on cash and cash equivalents mainly placed in USD of MSEK -21.2 (6.6) and lower interest income of MSEK 3.0 (13.8).
• Cash and cash equivalents and short-term investments at the end of the period totaled MSEK 112.0 compared to MSEK 194.0 at the beginning of the year.
• Cash flow from operating activities totaled MSEK -7.5 (19.1). The cash flow from operations has improved to MSEK -7.6 (-23.1), the cash flow from operating activities has been affected by decrease in inventory of MSEK 1.3 (3.5), a decrease in short-term receivables MSEK 2.2 (1.1), and decrease in short-term liabilities MSEK -3.4 (0.5).
• Cash flow from investments in intangible assets amounted to MSEK -49.0 (-144.0) and mainly refers to our registration preparation work in the USA. Including last year's repaid deposits, cash flow from investing activities amounted to MSEK -50.3 (10.4).
• Total cash flow for the period amounted to MSEK -60.8 (-11.4). Total cash flow excluding short-term investments amounted to MSEK -60.8 (-166.7).

CEO comments

Improved EBITDA performance amid Q3 market headwinds

In Q3, sales growth was modest at 7%, primarily reflecting very low ICU occupancy in several of our key markets. Nevertheless, our ex-US EBITDA remains positive YTD, thanks to an improved gross margin and continued cost discipline. Meanwhile, we are preparing for an important milestone: our pre-NDA meeting with the FDA in Q4.

On track to deliver on financial goal despite soft sales growth in Q3

The third quarter marked our highest Q3 sales to-date, albeit at a modest growth rate of 7%, of which only 1% was organic – a stark contrast to the excellent second quarter with 27% year-over-year growth. Year-to-date, we have grown the business by 18%, of which 12% was organic.

Differences in the seasonal pattern between years lead to volatility in our growth rates from time to time, but it is encouraging that our ex-US EBITDA margin was only slightly negative at -4%, and would have been -2% excluding currency effects. At the group level, including US-related operating costs, the EBITDA margin improved by eight percentage points, despite a three-point headwind from exchange rates.

This underscores the positive impact of our decisive cost saving measures as profitability in our core business is now in reach even in seasonally lower sales quarters. We report a gross margin for the quarter of 72%, which includes a positive effect from reduced cost of goods for our main device (Sedaconda ACD) from the acquisition of our main supplier Innovatif Cekal. In addition, we see a year-over-year reduction of operating expenses across the board (Sales, Administration, R&D). Besides a restructuring and staff reduction in our headquarter functions and continued streamlining of non-customer facing expenses, we are also seeing solid savings in distribution cost after establishing a local logistics hub in Spain.

Year-to-date, our ex-US EBITDA remains positive at 1%, or 3% excluding exchange rate effects - keeping us well on track to achieve our full-year target of low- to mid-single-digit positive ex-US EBITDA.

Low ICU occupancy in our main markets

The primary driver of the Q3 sales performance was a 9% sales decline in our main market Germany, which followed the strong 19% growth in Q2. Our year-to-date performance shows a 6% increase compared to the same period last year. Our performance is closely linked to ICU admissions for respiratory indications, which account for the majority of intubated patients. According to data published by Robert Koch Institut, the seasonal swings in 2025 have been quite different from last year. The flu season in Q1 and parts of Q2 was longer and more extensive than 2024, providing some tailwinds to our sales performance in the first half of the year. Since May, the trend has reversed and in Q3 specifically, hospital admissions for severe acute respiratory infections have fallen 34% year-over-year, translating into 20–25% fewer ICU cases. Also our own data indicate an overall lower ICU occupancy rate in the third quarter compared to the second quarter.

The effect on Sedana Medical was that less of our products were used during the end of Q2 and Q3, resulting in later and smaller re-orders. Meanwhile, we continue to execute our sales acceleration program, which had shown good effects in the first half of the year.

Our second largest market, Spain, continued to show robust growth in the quarter in line with the strong growth in previous quarters. As we reach meaningful sales levels, we are focused on maintaining the growth by establishing inhaled isoflurane sedation as a standard therapy across different patient types in more hospitals, and our strong KOL network is active in sharing their expertise with less experienced ICU teams.

In the UK, we saw a sales decline in the quarter. Besides similar seasonal effects as in Germany, the performance was negatively impacted by a temporary reduction in the sales force staffing, which has reduced presence in the field during the full quarter. Apart from fully staffing the team again, we are re-focusing on reigniting growth in our existing customer base.

In France, we continue to see very different performance depending on the customer type. While isoflurane customers continue to show robust growth, customers that have stayed with sevoflurane tend to use less inhaled sedation. By now, more than 60% of the SESAR clinical trial sites have switched to isoflurane.

Pre-NDA meeting with the FDA coming up

On the US side, intense work is ongoing to finalize our dossier for submission. An important upcoming milestone is the pre-NDA meeting that has been scheduled in Q4. A pre-NDA meeting is a formal discussion with the FDA to ensure alignment on content, format and expectations for the submission. In line with our established strategy, we see this meeting as an important opportunity to ensure we address as many FDA requests ahead of submission as possible and thus reduce the risk of review delays or additional work later on.

The pooling analyses – combining both US trials as well as several endpoints for all three clinical trials including the European study – have been completed, and the pre-NDA meeting will be used to confirm with the FDA that it meets their expectations.

We continue to see good interest from hospitals in our Expanded Access Program, which will give patients in need access to our therapy ahead of formal market approval. Preparations are in the final stretches, and we expect to see the first US patient treated with our products outside the clinical trials this year.

***

I would like to thank all of you for your continued trust and commitment. Together, we are approaching significant milestones - achieving full-year ex-US profitability and advancing toward US market approval, which would quadruple the number of addressable patients in our direct markets and could lift Sedana Medical to the next growth trajectory.

Johannes Doll, President and CEO

Please find the full report at: Interim Reports | Sedana Medical

This document has been prepared in both a Swedish and English version. In the event of any deviations, the Swedish version shall prevail.

Sedana Medical will hold a telephone conference at 13:30 pm (CET) October 24, 2025.

More info and link to the audiocast: https://www.finwire.tv/webcast/sedana-medical/q3-2025/

If you wish to participate via teleconference: +46 8 5053 9728. Meeting ID: 823 2902 8273 followed by #.