Sedana Medical AB’s Year-end report 2025

Fourth quarter 2025

• Net sales for the quarter totaled MSEK 51.8 (49.2), equivalent to an increase of 5% compared to the corresponding quarter in 2024. At constant exchange rates, sales increased by 11%.
• Gross profit amounted to MSEK 37.6 (34.2), corresponding to a gross margin of 73% (69%).
• Net sales excluding contract manufacturing totaled MSEK 50.5 (48.4), equivalent to an increase of 4% compared to the corresponding quarter in 2024. At constant exchange rates, sales increased by 10%.
• Earnings before interest, taxes, depreciation and amortisation (EBITDA) totaled MSEK 0.1 (-5.5), corresponding to an EBITDA margin of 0.1% (-11%). EBITDA ex-US amounted to MSEK 4.0 (-1.2), equivalent to a margin of 8% (-3%).
• Operating income (EBIT) totaled MSEK -6.1 (-11.1), corresponding to an EBIT margin of -12% (-22%).
• Net income for the period amounted to MSEK -10.1 (8.5), and earnings per share before and after dilution were SEK -0.10 (0.09). Operating income improved by MSEK 5.0 compared to the corresponding quarter last year, but net financial items decreased by MSEK 23.6, resulting in a reduction in net income of MSEK 18.7.
• Cash and cash equivalents amounted to MSEK 91.0 at the end of the quarter, compared with MSEK 112.0 at the beginning of the quarter. Cash and cash equivalents were affected by unrealised currency effects of MSEK -1.9 (16.2).
• Cash flow from operating activities before changes in working capital totaled MSEK 0.2 (6.3) for the quarter. Cash flow was positively impacted by received interest of MSEK 3.3 (11.8).
• Total cash flow for the quarter improved to MSEK -19.1 (-48.6), mainly resulting from improved EBITDA, reduced investments in intangible assets of MSEK -11.0 (-28.8) mainly referring to registration preparatory work in the USA, and that the comparator period includes net cash flow from the acquisition of Innovatif Cekal of MSEK -25.0.

January-December 2025

• Net sales for the period totaled MSEK 200.2 (178.8), equivalent to an increase of 12% compared to 2024. At constant exchange rates, sales increased by 16%.
• Net sales excluding contract manufacturing totaled MSEK 192.1 (178.0), equivalent to an increase of 8% compared to the corresponding period in 2024. At constant exchange rates, sales increased by 12%.
• Gross profit amounted to MSEK 142.7 (126.1), corresponding to a gross margin of 71% (71%).
• Earnings before interest, taxes, depreciation and amortisation (EBITDA) totaled MSEK -10.1 (-30.6), equivalent to an EBITDA margin of -5% (-17%). EBITDA ex-US amounted to MSEK 5.9 (-16.9), corresponding to a margin of 3% (-9%).
• Operating income (EBIT) totaled MSEK -32.2 (-52.2), corresponding to an EBIT margin of -16% (-29%).
• Net income for the year totaled MSEK -59.2 (-10.7), and earnings per share before and after dilution were SEK -0.60 (-0.11). Increased sales were offset by currency effects on cash, mainly held in USD, amounting to MSEK -23.1 (22.8), lower interest income of MSEK 3.4 (16.5), and unrealised exchange rate effects on intra-group receivables and liabilities MSEK 5.4 (3.0).
• Cash and cash equivalents and short-term investments totaled MSEK 91.0 at the end of the period, compared with MSEK 194.0 at the beginning of the year.
• Cash flow from operating activities totaled MSEK -12.8 (-11.8). Cash flow was affected by received interest of MSEK 3.4 (16.5) and a decrease in operating liabilities of MSEK -7.7 (0.2).
• Cash flow from investments in intangible assets amounted to MSEK -60.0 (-172.8) and mainly relates to registration preparatory work in the USA. Net cash flow from the acquisition of Innovatif Cekal amounted to MSEK -0.6 (-25.0).
• Total cash flow for the full year amounted to MSEK -79.8 (-60.0). Total cash flow excluding the repayment of short-term investments amounted to MSEK -79.8 (-215.3).

CEO comments

Positive EBITDA in our ex-US business

2025 marked a successful year for Sedana Medical. We achieved first-time profitability in our core business outside the United States, demonstrating the strength of our transformed operating model and providing a solid, cash-generating foundation for further growth. At the same time, we made significant progress in reducing the risks related to US approval, with successful pivotal trials, FDA authorization of an Early Access Program and positive regulatory interactions.

Profitability in our core business outside the US

Coming out of the COVID-19 pandemic, we set an ambitious goal: to reach profitability in our core business before launching our therapy in the United States. We believed it was essential to build our US expansion on a stable, cash-generating platform – one that demonstrates proof of concept and helps us finance the upcoming US launch investments. Today, I am proud to say that we have delivered on that ambition during the full year 2025.

Reaching this point required a fundamental transformation of the company and a change of how we deploy resources across the organization. We streamlined corporate headquarters and non-customer-facing functions, while sharpening our focus on commercial execution and becoming significantly more customer-centric. Our support functions are now more effective with only half the number of employees, and at the same time we have built a larger and more impactful field force. We introduced a rigorous, data-driven investment approach, increasing resources in profitable and growing countries, and adjusting where performance has not yet met expectations. In parallel, the acquisition of our main supplier in Malaysia, Innovatif Cekal, strengthened our control over the value chain and improved the cost of goods for our main device.

As a result, we achieved 3% positive EBITDA margin in our core business outside the US for the full year 2025 and 8% in Q4. Also at the Group level, EBITDA improved by 12 percentage points year-on-year, and we even reached slightly positive EBITDA in the fourth quarter.

The full-year ex-US profit is the first in Sedana Medical’s history as a listed company and marks a significant milestone. I would like to sincerely thank all colleagues across the organization for their dedication, resilience, and commitment in making this a reality.

Best Q4 sales to date despite lower ICU occupancy in Germany

Full-year sales reached 200 MSEK, corresponding to growth of 16% excluding exchange rate effects. Of this, 12% was organic growth, while 4% came from contract manufacturing activities at our plant in Malaysia.

I am pleased that all regions contributed positively to our growth on a full year basis, and that we reached new all-time high sales for each quarter during the year. Especially our direct markets outside Germany, including Spain, UK and France, stood out as the main growth driver. The Spanish success story over the last years demonstrates that a focused approach, targeted at establishing inhaled sedation as a standard therapy in high-potential hospitals, and engaging an increasing number of key opinion leaders believing in the benefits of the therapy, leads to rapidly increasing adoption rates – a model that we are replicating in other geographies.

While the overall result for the year is solid, it is worth noting that growth rates differed significantly between the first and second half of the year, with growth in H1 amounting to 22% excluding exchange rate effects, compared with only 9% in H2. In the fourth quarter, we delivered year-over-year growth of 11% excluding exchange rate effects, of which 10% was organic.

A key explanation for the differences during the year lies in lower ICU occupancy (fewer intensive care patients) during the second half of the year, which affected our performance most notably in Germany. According to data published by the Robert Koch Institute, the German flu season in Q1 and parts of Q2 2025 was longer and more pronounced than in 2024, providing tailwinds to our sales in the first half. Since May, the trend has reversed, and in Q4 specifically hospital admissions for severe acute respiratory infections requiring intensive care were approximately 20% lower year-on-year. As a result, German Q4 sales were 6% lower than in the previous year and the full year growth in Germany shrank to only 3%.

While seasonal swings in ICU activity are normal, our focus remains firmly on the factors we can influence. We continue to prioritize strong commercial execution, maximizing time in the field, concentrating resources on the highest-potential opportunities, and further improving the quality and impact of our customer interactions. I am convinced that these priorities will continue to drive sustainable growth going forward.

Important steps to reduce risks related to approval in the United States

The United States represents the single largest growth opportunity for Sedana Medical. Upon receiving US approval, we would expect our addressable market to quadruple versus today. This strong potential is driven by a higher number of ventilator beds, a clinical practice that favors intubation to a greater extent than in Europe, and a generally higher price level.

During 2025, we made several important advances to reduce the risk of our US approval. Both pivotal clinical trials met their primary endpoints and showed no new safety findings. In addition, the secondary endpoints offer several potential opportunities for meaningful differentiation versus current sedation practices, both in terms of patient benefits and health-economic advantages for hospitals. These may for instance include lower opioid requirements and a higher number of ICU-free days.

We were also encouraged by the FDA’s approval of an Early Access Program, which allows use of our therapy in difficult-to-sedate patients when targeted sedation cannot be maintained with intravenous sedatives. Furthermore, in a positive pre-NDA meeting held in the fourth quarter, the FDA confirmed that the safety and efficacy data generated in our clinical program appear adequate to permit submission and review of a New Drug Application (NDA).

With these important steps completed, we believe we have significantly strengthened our position and reduced the key risks on the path toward bringing our therapy to patients in the United States. Our focus now is on finalizing the NDA dossier for submission mid-year, while further intensifying our planning and preparations for a potential US launch.

A pivotal year ahead

Reflecting on the achievements in 2025, I look into 2026 with optimism. With a therapy that offers compelling benefits for both patients and hospitals, a profitable and growing core business in Europe, and the opportunity to enter the United States as early as 2027, Sedana Medical is set up for success in the next phase of value creation.

I would like to thank all of you for your continued support and trust, and I look forward to updating you on our progress.

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) February 12, 2026.

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

If you wish to participate via teleconference: +46 8505 39728. Meeting ID: 883 4763 0883 followed by #.