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Sedana Medical
Interim / Quarterly Report • Oct 24, 2025
4549_10-q_2025-10-24_c8fc6980-e350-406d-bbcd-824227cb3993.pdf
Interim / Quarterly Report
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Interim Report
January-September 2025
sedana medical ab (publ)
" Improved EBITDA performance amid Q3 market headwinds"
Johannes Doll, President & CEO
Financial summary
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).
Sedana Medical AB (publ) is a pioneer medtech and pharmaceutical company focused on inhaled sedation to improve patients' life during and beyond sedation. Through the combined strengths of the medical device Sedaconda ACD and the pharmaceutical Sedaconda (isoflurane), Sedana Medical provides inhaled sedation for mechanically ventilated patients in intensive care. Sedana Medical was founded in 2005 and is listed on Nasdaq Stockholm. The company's head office is in Stockholm, Sweden.
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
Significant events during the period
First quarter
- In February, Sedaconda (isoflurane) received an additional year of market protection, extending the protection period to 2032.
- In February, the company announced that its second pivotal US study, INSPiRE-ICU 2, had met its primary efficacy endpoint.
Second quarter
- In April, the company announced that the US FDA has authorized the company to initiate an Early Access Program for its treatment, which provides patients who meet the program's criteria access to the treatment before market approval.
- In June, the company announced that both of the company's pivotal US studies, INSPiRE-ICU 1 and INSPiRE-ICU 2, have shown a greater reduction of opioid doses compared to the control group and have therefore met their first key secondary endpoint.
Third quarter
• In July, the results of the IsoCOMFORT study were published in the scientific journal Lancet Respiratory Medicine.
Market potential
With its innovative product portfolio for inhaled sedation, Sedana Medical is targeting mechanically ventilated patients in intensive care units. Geographically, Sedana Medical has a clear focus on today's direct markets in Europe (Germany, Spain, France, UK, and Benelux) and its largest potential market, the United States.
The company's main device Sedaconda ACD is approved and sold in more than 40 countries. In 15 of these countries, Sedana Medical has approval for both its main device Sedaconda ACD and its proprietary pharmaceutical Sedaconda (isoflurane).
In today's direct markets in Europe, a bit less than 1 million intensive care patients annually require mechanical ventilation and sedation. Based on this patient population, Sedana Medical sees a market potential for its current product portfolio of approximately 3-4 billion SEK.
In the United States, somewhat more than 2 million patients are mechanically ventilated and sedated each year. Assuming a comparable approved label as in Europe, the market potential in the United States is estimated to be 10-12 billion SEK. This number assumes a relatively modest price difference compared to Europe. If Sedana Medical manages to obtain a price differential that is in line with other sedation therapies, the potential could increase accordingly.
The global market potential is projected to grow at low-to-mid single digits per year in line with demographic trends.
In 2024, our sales level in Germany represented a penetration of approximately 13% of the market potential. The best performing sales territories in Germany had a penetration in excess of 20%. Meanwhile, the aggregate penetration in our other direct markets was still lower, leaving ample opportunities for growth.
In addition to the primary focus on Europe and the United States, Sedana Medical has distributors in more than 30 countries on all continents.
Strategic priorities
Sedana Medical has set 3 strategic priorities:
1. Achieve lasting and profitable sales growth in Europe
Our market authorizations in 15 European countries make Sedana Medical the only company offering an approved therapy for inhaled sedation in intensive care. With a strong focus on commercial execution and a prudent investment philosophy that prioritizes profitable growth, we aim at making inhaled sedation a standard therapy.
2. Maximize the opportunity in the United States
With more than 100,000 intensive care beds and a generally higher price level for sedation therapies, the United States represent our largest potential market. After completion of our Phase III clinical program, which has received FDA fast track designation, and contingent on FDA approval, we aspire to launch our products through our own commercial infrastructure.
3. Build a long-term profitable company
Sedana Medical's model with high gross margins and a concentrated customer base (hospitals with intensive care) favours attractive profitability as we continue to grow sales. It is a key priority to turn the Ex-US business profitable, so the US launch can be executed based on a stable financial platform. As we will gradually reach scale and grow the share of US sales, our long-term target is an EBITDA margin around 40%.
Financial guidance
For the full year 2025, we aim to achieve low-to-mid single digit positive EBITDA margin in our ex-US business by sustaining our growth trajectory and maintaining strict cost discipline.
Business update
Sales and commercial execution
Sedana Medical's vision is to make inhaled sedation the new standard of care in intensive care units (ICUs). Our therapy for inhaled sedation in the ICU consists of the unique medical device Sedaconda ACD, the pharmaceutical Sedaconda® (isoflurane) and accessories, and is being commercialized across Europe leveraging our own sales teams, and globally via distributors. We are focused on building a stronger commercial company by directing our investments towards profitable growth opportunities and enhancing the effectiveness of our sales organization. Our philosophy is to invest in countries that show good growth momentum and generate positive cash flow. For example, over the past year we have expanded our sales teams in our key markets Germany, Spain and UK. Reversely, we have reduced or delayed further investments in lower-potential geographies. With this approach, we ensure that all countries contribute positively to the company over time. We are also placing emphasis on enhancing our field force effectiveness. For example, we have implemented measures to maximize our customer-facing time, improve our customer targeting process, a more effective selling model and more rigorous performance management, including incentive schemes that reward high performance.
During Q3 2025 we report net sales growth of 7% excluding currency effects (4% in reported currency) compared with the same period in 2024. In our main market Germany, sales decreased 9% in Q3 excluding currency effects (12% in reported currency). After strong growth during the first half of the year, sales in Germany were negatively impacted during Q3 by markedly fewer patients in intensive care than in 2024.
In our other direct markets (Spain, France, UK and Benelux) sales grew by 22% in Q3 excluding currency effects (18% in reported currency). Among these markets, Spain continues to be the top performer in terms of growth.
In our distributor markets, sales increased 4% in Q3 excluding currency effects (0% in reported currency). Quarterly fluctuations are to be expected from this customer segment due to their less frequent buying patterns compared to our direct (hospital) customers. Following the acquisition of our Malaysian supplier Innovatif Cekal during Q4 2024, we report contract manufacturing revenue of 2,4 MSEK in Q3. Excluding contract manufacturing revenue, we report net sales growth of 1% in Q3 excluding currency effects (-2% in reported currency).
Regulatory and pricing/reimbursement approvals in Europe
Our pharmaceutical Sedaconda (isoflurane) has regulatory approval in 15 countries in Europe: Austria, Belgium, Croatia, Denmark, France, Germany, Italy, the Netherlands, Norway, Poland, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. So far, the pharmaceutical has been made available in Germany, France, Spain, Sweden, Norway, Belgium and the Netherlands. In addition, Sedaconda (isoflurane) has been launched in Slovenia via our distributor in the country.
Already in 2022, the UK National Institute for Health and Care Excellence (NICE) recommended the Sedaconda ACD as a cost-saving option for delivering inhaled sedation in intensive care. According to NICE, cost modelling had shown cost savings compared with intravenous (IV) sedation of approximately £3,800 per adult patient (30-day time horizon for adult patients needing mechanical ventilation for 24 hours or longer in intensive care).
Since 2025, Sedaconda (isoflurane) is also approved for mechanically ventilated children 3-17 years old in 13 European countries. The approval was based on the results of the IsoCOMFORT trial, a randomized active-controlled assessor-blinded study comparing the efficacy and safety of sedation with inhaled isoflurane, administered via the company's medical device Sedaconda ACD-S, with intravenous midazolam in mechanically ventilated patients 3-17 years old. In July 2025, the results of the IsoCOMFORT study were published in the scientific journal Lancet Respiratory Medicine.
The authorities assessed that the paediatric extension of the Sedaconda indication brings a significant clinical benefit over existing therapies. Therefore, they granted an additional year of market protection, extending the protection period until 2032. During the protection period, no generic product can be launched for sedation of mechanically ventilated patients in the ICU.
US clinical program and launch preparations
The US has the highest commercial potential of all markets for Sedana Medical. We estimate the market potential for our inhaled sedation products in the United States to 10-12 BSEK. This figure is approximately three times greater than the combined market potential of our current direct markets. Several factors contribute to this significant opportunity, including the larger population size, a medical practice favouring intubation more than in Europe, and an overall attractive pricing environment.
Sedana Medical's US clinical program INSPiRE-ICU completed patient recruitment for the two pivotal INSPiRE-ICU 1 and 2 clinical trials in Q2 2024. The two randomized double-blind clinical studies aim to confirm and ensure efficacy and safety, based on similar set-up and end-points as our European study (SED001). The total number of patients included in the two studies was 557 (of which 470 randomized and the remainder run-in patients), recruited across 30 clinics.
Both INSPiRE-ICU 1 and INSPiRE-ICU 2 met their primary endpoint: to prove that inhaled sedation with isoflurane is an effective sedation method by establishing non-inferiority compared with intravenous sedation using propofol. The safety results were in line with expectations (no unexpected safety concerns arose during the study). In addition, both studies showed a greater reduction of opioid doses compared to the control group and have therefore met their first key secondary endpoint. Wake-up times after end of treatment were short overall, with more than 75% of patients in the isoflurane group waking up within one hour from ending sedation. The safety data, in terms of adverse events and 30-day outcomes,
showed an overall similar proportion of patients with serious adverse events in the two study groups and did not reveal any new safety signals for isoflurane. A clinically relevant, but not statistically significant difference in mortality was found in favor of isoflurane. The main study results are publicly available on the clinical trials portal ClinicalTrials.gov, and will be followed by peer-reviewed publications.
In April 2025, the U.S. Food and Drug Administration (FDA) approved our application to initiate an Early Access Program (EAP) for our investigational inhaled sedation therapy. An EAP is designed to allow patients with serious or life-threatening conditions to receive an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available and where the potential patient benefits outweigh the potential risks. The EAP is approved for "difficult-to-sedate" patients, i.e. those who are unable to achieve and maintain target sedation levels with IV sedatives. We will provide our products free of charge to participating hospitals. The first patients are expected to be treated in the fourth quarter of 2025.
Ahead of our NDA submission, we are pursuing a strategy of derisking the submission by seeking frequent interactions with the FDA and creating alignment on important aspects of the file before we submit. During 2024, such interactions resulted in an opportunity for us to include our successful European study SED-001 in the US submission. In early 2023, the FDA granted our clinical program Fast Track Designation. Fast Track is a process designed to facilitate the development and expedite the review of therapies that treat serious conditions and fill an unmet medical need. The purpose is to get important new therapies to the patient faster. Sedana Medical will have the opportunity to discuss with FDA at a pre-NDA meeting if any of the potential benefits of the Fast Track Designation (i.e. priority review) will apply to Sedaconda, which might have a positive effect on overall communicated timelines.
Beyond clinical benefits for patients, the key determinant of a medical product's success in the US market lies in its reimbursement status and impact on customers' economics. Although a variety of inpatient hospital payment mechanisms exist, the DRG ("diagnoses-related groups") system is the dominant one for ventilated patients in the ICU. Under the DRGs, a hospital is paid a preset rate based on the patient's diagnoses and procedures. For mechanically ventilated patients, this will in most cases mean that hospitals will see a tangible positive financial effect if patients wake up fast, spend less time on the ventilator and leave the ICU faster. We have shown these benefits of inhaled sedation in our European trial, and are currently conducting further analysis, including pooling, of our US trial results based on encouraging trends in the data.
Moreover, heightened awareness of opioid risks in the US, exacerbated by the opioid crisis with over 100,000 overdose deaths annually, positions our inhaled sedation therapy as a compelling alternative. As US our studies have replicated the significant reduction of opioid use observed in our previous studies, we expect to benefit from the widespread preference for opioid-sparing therapies.
The benefits of inhaled sedation are also well aligned with existing treatment recommendations, such as the CDC's "Wake up and Breathe" Collaborative, which is intended to get patients off the ventilator sooner and improve recovery time, opening opportunities to get well positioned in treatment guidelines. Based on these insights, we are highly optimistic about the commercial success of inhaled sedation in the US.
As our US clinical trials have been completed, our focus has shifted to finalizing our dossier for NDA submission. In parallel, we are providing scientific exchange and disease awareness, and also engage with key opinion leaders and healthcare professionals to further enhance our understanding of the US market ahead of launch.
Sedana Medical expects to be sufficiently financed to achieve US approval, with MSEK 112 in cash at the end of Q3 2025.
Cost management and profitability
We report a gross margin of 71.6% in Q3 2025, compared with 71.2% in Q3 2024 and 70.2% in Q2 2025. In line with our expectation, we see a positive effect on the gross margin during the quarter from reduced cost of goods for our main product (Sedaconda ACD) following the acquisition of our supplier in Malaysia (Innovatif Cekal). At the same time, the contract manufacturing at Innovatif Cekal has a negative effect on our gross margin at the Group level, in particular during quarters with seasonally lower sales in our core business. Q3 includes a re-classification of general warehousing costs from cost of goods sold to selling expenses which has resulted in a non-recurring positive effect for the gross margin of 669 KSEK. We report operating expenses of MSEK 40 in Q3 2025, which is down from MSEK 43 in Q3 2024, as we continue to reduce cost and find efficiencies in our organization.
Group EBITDA for the quarter was MSEK -6 compared to MSEK -9 in the same quarter last year, and ex-US EBITDA for the quarter was MSEK -2, compared with MSEK -5 in the same quarter last year. The underlying improvement in profitability continues, and we remain focused on profitable growth opportunities and making sure we manage our resources in a prudent way, to launch in the US backed by a solid foundation in Europe.
ESG sustainability
Sedana Medical aims to be a responsible partner to all customers, suppliers, employees, and other stakeholders, as well as an attractive long-term investment for our shareholders. Sedana Medical's Code of Conduct constitutes a framework for what the company considers to be responsible and appropriate conduct to build a long-term sustainable business. In our Annual Report 2024 we present updated information on our ESG sustainability work, please find the full report on our website.
New accounting principle introduced in 2025
The accounting principles related to reporting of intercompany currency effects have changed as of 2025. This refers to the currency effects in the Group that arise when translating balance sheet items related to intragroup loans between the parent company and subsidiaries in the Group. In 2024, the effects were reported as part of other operating expenses and
income that affected total operating expenses and operating profit. From 2025, the effects are reported as part of net financial items and do not affect operating expenses and operating profit. In this interim report we have also adjusted the corresponding periods of 2024 to provide accurate comparison between periods. The reason for the change is that intra-Group loans are not considered part of the company's operations and should therefore not affect operating performance metrics.
The operating profit during Q3 2025 amounted to KSEK -10,727 compared to KSEK -13,875 in Q3 2024, which means an improvement by KSEK 3,148. The new accounting principle has led to a positive adjustment in the operating profit in Q3 2025 by KSEK 744 and a positive adjustment to the operating profit in Q3 2024 by KSEK 431. The result after financial items is unchanged.
The operating profit during Jan-Sep 2025 amounted to KSEK -26,088 compared to KSEK -41,119 in Jan-Sep 2024, which means an improvement by KSEK 15,031. The new accounting principle has led to a positive adjustment in the operating profit in Jan-Sep 2025 by KSEK 2,443 and a negative adjustment to the operating profit in Jan-Sep 2024 by KSEK 1,188. The result after financial items is unchanged.
Financial overview
| Jul-Sep | Jan-Sep | Jan-Dec | |||
|---|---|---|---|---|---|
| (KSEK) | 2025 | 2024 | 2025 | 2024 | 2024 |
| Net sales | 41,205 | 39,720 | 148,452 | 129,597 | 178,754 |
| Gross profit | 29,493 | 28,266 | 105,091 | 91,986 | 126,142 |
| Gross margin % | 72% | 71% | 71% | 71% | 71% |
| EBITDA | -5,569 | -8,575 | -10,187 | -25,067 | -30,582 |
| EBITDA margin % | -14% | -22% | -7% | -19% | -17% |
| EBITDA ex-US | -1,741 | -4,845 | 1,897 | -15,635 | -16,862 |
| Operating income (EBIT) | -10,727 | -13,875 | -26,088 | -41,119 | -52,179 |
| Operating margin % | -26% | -35% | -18% | -32% | -29% |
| Income after net financial items | -11,924 | -22,479 | -47,301 | -18,640 | -9,948 |
| Net income | -12,417 | -22,616 | -49,145 | -19,172 | -10,674 |
| Net income margin % | -30% | -57% | -33% | -15% | -6% |
| Total assets | 965,786 | 998,238 | 965,786 | 998,238 | 1,019,395 |
| Equity | 908,406 | 949,994 | 908,406 | 949,994 | 958,227 |
| Equity ratio % | 94% | 95% | 94% | 95% | 94% |
| Quick ratio % | 328% | 602% | 328% | 602% | 450% |
| Debt to equity ratio % | 6% | 5% | 6% | 5% | 6% |
| Average number of full-time employees for the period | 111 | 72 | 108 | 75 | 77 |
| Number of employees at balance date | 117 | 78 | 117 | 78 | 109 |
| Number of employees and consultants at balance date | 129 | 86 | 129 | 86 | 125 |
| Average number of shares before dilution | 99,336,960 | 99,336,960 | 99,336,960 | 99,336,960 | 99,336,960 |
| Average number of shares after dilution | 99,336,960 | 99,336,960 | 99,336,960 | 99,336,960 | 99,336,960 |
| Number of shares at balance date before dilution | 99,336,960 | 99,336,960 | 99,336,960 | 99,336,960 | 99,336,960 |
| Number of shares at balance date after dilution | 99,336,960 | 99,336,960 | 99,336,960 | 99,336,960 | 99,336,960 |
| Earnings per share before dilution, SEK | -0.12 | -0.23 | -0.49 | -0.19 | -0.11 |
| Earnings per share after dilution, SEK | -0.12 | -0.23 | -0.49 | -0.19 | -0.11 |
Group performance
Net sales
Net sales for the quarter amounted to KSEK 41,205 (39,720), corresponding to an increase of 4% compared to the same quarter last year. Adjusted for currency effects, the quarter showed an increase of 7%.
In our main market, Germany, sales decreased by 12% (9 % at constant exchange rates) during the quarter due to significantly fewer intensive care patients than is normal for the season, and in our Other direct markets sales increased by 18% (22% at constant exchange rates), compared to the same quarter last year. Among our Other direct markets, Spain continues to be the main growth driver. Sales in our distributor markets was in line with the same quarter last year (increased by 4% at constant exchange rates).
For the interim period, net sales amounted to KSEK 148,452 (129,597), which corresponded to an increase of 15% compared to 2024. Adjusted for currency effects, the increase was 18%.
| Jul-Sep | Jan-Sep | Jan-Dec | |||||||
|---|---|---|---|---|---|---|---|---|---|
| (KSEK) | 2025 | 2024 | % | %* | 2025 | 2024 | % | %* | 2024 |
| Germany | 22,633 | 25,600 | -12% | -9% | 83,363 | 80,797 | 3% | 6% | 110,459 |
| Other direct sales | 13,438 | 11,417 | 18% | 22% | 47,824 | 37,234 | 28% | 32% | 54,077 |
| Distributor markets | 2,706 | 2,704 | 0% | 4% | 10,433 | 11,566 | -10% | -7% | 13,425 |
| Contract manufacturing | 2,428 | - | n/a | n/a | 6,833 | - | n/a | n/a | 793 |
| Total net sales | 41,205 | 39,720 | 4% | 7% | 148,452 | 129,597 | 15% | 18% | 178,754 |
*) at constant exchange rates
Gross profit and margin
The gross profit for the quarter amounted to KSEK 29,493 (28,266), corresponding to a gross margin of 71.6 (71.2)%. For the interim period, the gross profit amounted to KSEK 105,091 (91,986) corresponding to a gross margin of 70.8 (71.0)%. During the quarter we have re-classified general warehousing costs from cost of goods sold to selling expenses which has had a non-recurring positive effect on the gross profit of 669 KSEK in total.
Selling expenses
Selling expenses for the quarter amounted to KSEK -23,024 (-23,558). For the interim period selling expenses amounted to KSEK -75,355 (-76,633). The decrease during the quarter and interim period compared to the previous year is mainly driven by efficiency improvements in logistics and distribution.
Administrative expenses
Administrative expenses for the quarter amounted to KSEK -12,040 (-13,719). For the interim period, administrative expenses amounted to KSEK -39,948 (-40,047). The decrease during the quarter compared to the previous year is mainly driven by efficiency improvements and organizational changes and that the comparison period includes non-recurring costs related to the acquisition of Innovatif Cekal.
Research and development expenses
Research and development expenses for the quarter amounted to KSEK -4,898 (-5,476). For the interim period, research and development expenses amounted to KSEK -15,126 (-15,494).
Other operating income/expenses
Other operating income and expenses mainly consists of unrealized exchange rate differences on operating items. These totaled KSEK -257 (-613) for the quarter.
For the interim period, Other operating income and expenses were KSEK -751 (-931).
Net financial items and earnings per share
Financial net for the quarter totaled KSEK -1,198 (-8,604). For the interim period the financial net was KSEK -21,213 (22,480). The amounts mainly consist of unrealised currency effects on cash and cash equivalents primarily placed in USD, totalling KSEK -1,290 (-10,349) for the quarter and KSEK -21,202 (6,623) for the interim period and interest income KSEK 664 (2,519) for the quarter and KSEK 2,997 (13,804) for the interim period.
Group tax expense for the quarter was KSEK -492 (-137). For the period, the tax expense totaled KSEK -1,844 (-532), primarily attributable to taxes in Malaysia and Germany.
Consequently, earnings per share amounted to SEK -0.12 (-0.23) for the quarter and SEK -0.49 (-0.19) for the interim period.
Capitalized development expenditures
Capitalized development expenditures as of September 30, 2025 amounted to KSEK 736,098 compared to KSEK 700,339 at the beginning of the year. The amount mainly consists of expenses related to clinical studies and registration preparation work in connection with the European market approval of Sedaconda (isoflurane) and in preparation for future market approval in the USA. The increase compared to the end of the year amounts to KSEK 35,759 and mainly relates to registration preparation work in the USA, as well as certain investments related to the company's pediatric approval. The investments for the interim period amount to KSEK 48 970, depreciations and amortizations amount to KSEK 12 044, and currency revaluation effects amount to KSEK -1 167. The company sees no indication of impairment risk related to capitalized development expenditures.
Inventory
As of 30 September, inventory amounted to KSEK 40,690 compared to KSEK 45,560 at the beginning of the year. The inventory mainly consists of finished goods and trade goods. The decrease is attributable to increased sales.
Equity and debt
Equity on 30 September was KSEK 908,406, compared to KSEK 958,227 at the beginning of the year. This corresponds to SEK 9.14 (9.56) per share. Equity/assets ratio was 94%, compared to 94% at the beginning of the year. Debt/equity ratio on September 30 was 6 %, compared to 6 % at the beginning of the year.
Cash, cash position and short-term investments
Cash and cash equivalents decreased during the quarter by KSEK -18,743 to KSEK 111,962 at the end of the quarter compared to KSEK 130,705 at the beginning of the quarter.
Cash flow from operating activities before changes in working capital for the quarter was KSEK -4,727 (-8,986). Cash flow from changes in working capital totaled KSEK 3,626 (-20,347) which during the quarter was impacted by changes in shortterm liabilities of KSEK -412 (-16,828) and accounts receivables of KSEK 5,325 (-2,522). Consequently, the cash flow from operating activities amounted to KSEK -1,101 (29,333).
Cash flow from investments in intangible assets amounted to KSEK -14,850 (-36,331) and mainly consists of development costs for registration preparation work for Sedaconda ACD and Sedaconda (isoflurane) in the USA.
Cash flow from financing activities for the quarter totaled KSEK -833 (-964) and relates to amortization of lease liabilities.
Currency revaluation differences in cash and cash equivalents amounted to KSEK -1,572 (-10,515) during the quarter and are mainly related to cash and cash equivalents held in USD. Cash flow per share for the quarter amounted to SEK -0.17 (-0.68).
During the interim period cash and cash equivalents decreased by KSEK -81,998 and totaled KSEK 111,962 on September 30, compared to KSEK 193,960 at the beginning of the year.
Cash flow from operating activities before changes in working capital for the period was KSEK -7,623 (-23,104). Cash flow from changes in working capital amounted to KSEK 91 (4,053) which during the period was impacted by changes in shortterm liabilities of KSEK -3426 (-518) and accounts receivables of KSEK 2,182 (1,060). As a result, cash flow from operating activities totaled KSEK -7,533 (-19,051)
Cash flow from investments in intangible assets amounted to KSEK -48,970 (-144,038) for the interim period and mainly consists of development costs for registration preparation work for Sedaconda ACD and Sedaconda (isoflurane) in the USA, as well as minor investments related to the company's pediatric approval.
Investment in subsidiaries amounted to KSEK -650 (0). Repayment of short-term investment was KSEK 0 (155,307) and total cash flow from investment activities amounted to KSEK -50,295 (10,402).
Cash flow from financing activities for the period totaled KSEK -2,968 (-2,759) and relates to amortization of lease liabilities.
Currency revaluation differences in cash and cash equivalents amounted to KSEK -21,202 (6,623) and is mainly related to unrealised currency effects on cash and cash equivalents placed in USD.
Cash flow per share for the period was SEK -0.61 (-0.11).
Parent company
The Parent Company's net sales for the period totaled KSEK 141,520 (129,468), of which intra-group sales were KSEK 5,396 (5,572).
Operating income for the period totaled KSEK -25,087 (-39,248). Net financial items were KSEK -34,380 (15,151) and mainly refers to unrealised foreign exchange losses on cash and cash equivalents in USD, interest on cash and cash equivalents, as well as unrealised exchange rate changes on intra-group receivables and liabilities.
In the corresponding period last year, the financial net mainly consisted of unrealised gains in USD, interest received on the deposit that was repaid during the quarter, interest on other cash and cash equivalents, and unrealised exchange rate changes on intra-group receivables and liabilities
Shareholders' equity in the Parent Company totaled KSEK 961,182 at 30 September 2025, compared to KSEK 994,171 at the beginning of the year. This corresponds to a decrease of KSEK 32,989. Share capital totaled KSEK 2,483, compared to KSEK 2,483 at the beginning of the year.
Cash and cash equivalents stood at KSEK 89,742, compared to KSEK 176,424 at the beginning of the year.
The Sedana Medical share
Sedana Medical share was listed on Nasdaq First North Growth Market Stockholm in 2017 and is since January 25, 2023 listed on Nasdaq Stockholm. Market capitalisation at the end of the third quarter was MSEK 1,270.
The price paid for Sedana Medical shares was SEK 19.02 at the beginning of the year and SEK 12.78 at the end of the quarter. The lowest closing price during the interim period was recorded on April 7 and was SEK 6.65. The highest closing price was recorded on February 13 and was SEK 20.00
Share information
| Jul-Sep | Jan-Sep | Jan-Dec | |||
|---|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | 2024 | |
| Net income, KSEK | -12,417 | -22,616 | -49,145 | -19,172 | -10,674 |
| Cash flow, KSEK | -17,171 | -67,315 | -60,795 | -11,409 | -60,013 |
| Number of shares at balance date | 99,336,960 | 99,336,960 | 99,336,960 | 99,336,960 | 99,336,960 |
| Average number of shares | 99,336,960 | 99,336,960 | 99,336,960 | 99,336,960 | 99,336,960 |
| Outstanding warrants at balance date | 0 | 824,947 | 0 | 824,947 | 824,947 |
| Average number of warrants | 824,947 | 899,173 | 824,947 | 874,431 | 874,431 |
| Share capital at balance date, KSEK | 2,483 | 2,483 | 2,483 | 2,483 | 2,483 |
| Equity at balance date, KSEK | 908,406 | 949,994 | 908,406 | 949,994 | 958,227 |
| Earnings per share before dilution, SEK | -0.12 | -0.23 | -0.49 | -0.19 | -0.11 |
| Earnings per share after dilution, SEK | -0.12 | -0.23 | -0.49 | -0.19 | -0.11 |
| Equity per share, SEK | 9.14 | 9.56 | 9.14 | 9.56 | 9.65 |
| Cash flow per share, SEK | -0.17 | -0.68 | -0.61 | -0.11 | -0.60 |
Largest shareholders at the end of the period Facts about the share
| No of shares | Share | |
|---|---|---|
| Linc AB | 13,526,519 | 13.6% |
| Anders Walldov direkt och indirekt (Brohuvudet AB) | 10,000,000 | 10.1% |
| Lannebo Kapitalförvaltning | 7,958,254 | 8.0% |
| Premier Miton Investors | 5,035,098 | 5.1% |
| Ola Magnusson direkt och indirekt (Magiola AB) | 4,312,288 | 4.3% |
| Sten Gibeck | 4,201,597 | 4.2% |
| Avanza Pension | 3,673,725 | 3.7% |
| Lancelot Asset Management AB | 2,500,000 | 2.5% |
| Handelsbanken Funds | 2,130,291 | 2.1% |
| Nordnet Pension Funds | 2,104,528 | 2.1% |
| Livförsäkringsbolaget Skandia | 1,923,491 | 1.9% |
| Highclere International Investors LLP | 1,713,250 | 1.7% |
| Thomas Eklund | 1,666,464 | 1.7% |
| Skandia Funds | 1,606,367 | 1.6% |
| AXA | 1,235,603 | 1.2% |
| Fifteen largest shareholders | 63,587,475 | 64.0% |
| Others | 35,749,485 | 36.0% |
| Total | 99,336,960 | 100.0% |
Trading Nasdaq Stockholm
No of shares as per Sep 30, 2025 99 336 960
Market cap as per Sep 30, 2025 SEK 1,270 million
Ticker SEDANA
ISIN SE0015988373
LEI-code 549300FQ3NJRI56LCX32
Contacts and invitation to presentation
Johannes Doll, President and CEO, +46 76 303 66 66 Johan Spetz, CFO, +46 73 036 37 89 [email protected]
Presentation of the interim report
Sedana Medical presents the interim report to investors, asset managers, analysts and media on October 24 2025 at 13.30. The presentation will be held in English and takes place via telephone conference and audio webcast. More information is available at: https://www.finwire.tv/webcast/sedana-medical/q3-2025/
After the presentation, a recorded version of the webcast will be available at: https://sedanamedical.com/financial-reportspresentations/presentations/
Nomination committee for the 2026 Annual General Meeting
Medical's Nomination Committee for the 2026 Annual General Meeting has been appointed and consists of Karl Tobieson, appointed by Linc AB, Patrik Walldov, appointed by Anders Walldov (including indirect holding via Brohuvudet AB), Erik Durhan, appointed by Lannebo Fonder and Claus Bjerre, Chairman of the Board. The Nomination Committee together represents 31,69 percent of the voting rights for all voting shares in the company as of September 30, 2025. The Nomination Committee shall submit proposals for resolution by the 2026 General Meeting pertaining to the election of Chairman of the Meeting, fees and composition of the Board, auditors' fees and the election of auditors and, if necessary, proposal for changes in the instruction to the Nomination Committee. Shareholders wishing to submit proposals to Sedana Medical's Nomination Committee can do so by sending an e-mail to [email protected] (subject "Nomination Committee") or by letter posted to Sedana Medical AB (publ), Attn: Sedana Medical Nomination Committee, Svärdvägen 3A, SE-182 33, Danderyd, Sweden. A proposal must reach the Nomination Committee no later than by April 8, 2026, to be included in the notice to attend and the agenda for the annual general meeting.
Annual general meeting 2026
The annual general meeting will be held on Wednesday May 27, 2026 in Danderyd. More details will be provided in the notice to attend the annual general meeting.
Financial calendar
Year-End Report 2025 February 12 2026 Annual Report 2025 April 15 2026 Interim Report Q1 2026 April 23 2026 Annual General Meeting 2026 May 27, 2026 Interim Report Q2 2026 July 17, 2026 Interim Report Q3 2026 October 22 2026
The interim report for Sedana Medical AB (publ) has been issued by the company's CEO after authorization by the board.
Danderyd 24 October 2025
Johannes Doll President and CEO
This interim report has been subject to review by the company's auditors.
This document has been prepared in Swedish and English versions. In the event of any discrepancies between the Swedish and English versions, the Swedish version will take precedence.
Auditor's report
To the Board of Sedana Medical AB (publ) reg. no. 556670-2519
Introduction
We have reviewed the condensed interim financial information (interim report) of Sedana Medical AB (publ) as of September 30 2024 and the nine-month period then ended. The board of directors and the CEO are responsible for the preparation and presentation of the interim financial information in accordance with IAS 34 and the Swedish Annual Accounts Act. Our responsibility is to express a conclusion on this interim report based on our review.
Scope of Review
We conducted our review in accordance with the International Standard on Review Engagements ISRE 2410, Review of Interim Report Performed by the Independent Auditor of the Entity. A review consists of making inquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review is substantially less in scope than an audit conducted in accordance with International Standards on Auditing, ISA, and other generally accepted auditing standards in Sweden. The procedures performed in a review do not enable us to obtain assurance that we would become aware of all significant matters that might be identified in an audit. Accordingly, we do not express an audit opinion.
Conclusion
Based on our review, nothing has come to our attention that causes us to believe that the interim report is not prepared, in all material respects, in accordance with IAS 34 and the Swedish Annual Accounts Act, regarding the Group, and with the Swedish Annual Accounts Act, regarding the Parent Company.
Stockholm 24 October 2025
Öhrlings PricewaterhouseCoopers AB
Lars Kylberg Authorized Public Accountant
Consolidated income statement, summary
| Jul-Sep | Jan-Sep | Jan-Dec | |||
|---|---|---|---|---|---|
| (KSEK) | 2025 | 2024 | 2025 | 2024 | 2024 |
| Net sales | 41,205 | 39,720 | 148,452 | 129,597 | 178,754 |
| Cost of goods sold | -11,712 | -11,455 | -43,361 | -37,612 | -52,612 |
| Gross profit | 29,493 | 28,266 | 105,091 | 91,986 | 126,142 |
| Selling expenses | -23,024 | -23,558 | -75,355 | -76,633 | -104,796 |
| Administrative expenses | -12,040 | -13,719 | -39,948 | -40,047 | -51,799 |
| Research and development expenses | -4,898 | -5,476 | -15,126 | -15,494 | -20,294 |
| Other operating income | 373 | -9,927 | 2,661 | 1,680 | 2,507 |
| Other operating expenses | -630 | 10,539 | -3,411 | -2,611 | -3,938 |
| Operating income | -10,727 | -13,875 | -26,088 | -41,119 | -52,179 |
| Net financial items | -1,198 | -8,604 | -21,213 | 22,480 | 42,231 |
| Income before taxes | -11,924 | -22,479 | -47,301 | -18,640 | -9,948 |
| Income tax | -492 | -137 | -1,844 | -532 | -726 |
| Net income | -12,417 | -22,616 | -49,145 | -19,172 | -10,674 |
| Earnings per share, based on earnings attributable to the parent company's ordinary shareholders: |
|||||
| Before dilution | -0.12 | -0.23 | -0.49 | -0.19 | -0.11 |
| After dilution | -0.12 | -0.23 | -0.49 | -0.19 | -0.11 |
| Operating income (EBIT) | -10,727 | -13,875 | -26,088 | -41,119 | -52,179 |
| Whereof amortisation of intangible assets | -4,015 | -3,963 | -12,044 | -11,887 | -16,075 |
| Whereof depreciation of tangible assets | -1,142 | -1,336 | -3,857 | -4,166 | -5,522 |
| EBITDA | -5,569 | -8,575 | -10,187 | -25,067 | -30,582 |
Consolidated statement of other comprehensive income, summary
| Jul-Sep | Jan-Sep | Jan-Dec | |||
|---|---|---|---|---|---|
| (KSEK) | 2025 | 2024 | 2025 | 2024 | 2024 |
| Net income | -12,417 | -22,616 | -49,145 | -19,172 | -10,674 |
| Other comprehensive income | |||||
| Items that can later be reclassified to the income statement: |
|||||
| Translation differences from foreign operations | 163 | 318 | -1,993 | -901 | -1,593 |
| Other comprehensive income, net after tax | 163 | 318 | -1,993 | -901 | -1,593 |
| Total comprehensive income | -12,253 | -22,298 | -51,139 | -20,073 | -12,267 |
| Total comprehensive income as a whole attributable to the parent company's shareholders |
-12,253 | -22,298 | -51,139 | -20,073 | -12,267 |
Consolidated balance sheet, summary
| (KSEK) | Sep 30, 2025 | Sep 30, 2024 | Dec 31, 2024 |
|---|---|---|---|
| ASSETS | |||
| Intangible assets | |||
| Capitalised development expenditure | 736,098 | 675,179 | 700,339 |
| Concessions, patents, licenses, etc. | 3,320 | 3,588 | 3,594 |
| Goodwill1 | 24,883 | - | 26,569 |
| Tangible assets | |||
| Machinery and other technical facilities | 407 | 652 | 588 |
| Equipment, tools and installations | 2,945 | 2,188 | 3,688 |
| Rights of use | 4,523 | 7,751 | 6,349 |
| Financial assets | |||
| Other long-term assets | 45 | 46 | 47 |
| Deferred tax assets | 22 | 22 | 22 |
| Total non-current assets | 772,243 | 689,427 | 741,195 |
| Inventory | 40,690 | 39,464 | 45,560 |
| Current tax receivables | 4,095 | 3,757 | 2,360 |
| Accounts receivable | 23,005 | 18,743 | 26,539 |
| Prepaid expenses and accrued income | 9,289 | 16,749 | 5,855 |
| Other receivables | 4,502 | 3,704 | 3,928 |
| Cash and cash equivalents | 111,962 | 226,394 | 193,960 |
| Total current assets | 193,543 | 308,811 | 278,200 |
| TOTAL ASSETS | 965,786 | 998,238 | 1,019,395 |
| (KSEK) | Sep 30, 2025 | Sep 30, 2024 | Dec 31, 2024 |
|---|---|---|---|
| EQUITY AND LIABILITIES Equity |
|||
| Share capital | 2,483 | 2,483 | 2,483 |
| Other contributed capital | 1,228,214 | 1,226,507 | 1,226,934 |
| Translation difference | -5,785 | -3,100 | -3,792 |
| Retained earnings including net profit | -316,507 | -275,896 | -267,399 |
| Equity attributable to the parent company's shareholders | 908,406 | 949,994 | 958,227 |
| Non-current liabilities | |||
| Deferred tax liabilities | 510 | 7 | 6 |
| Other provisions | 559 | 22 | 157 |
| Non-current lease liabilities | 1,811 | 3,507 | 2,583 |
| Other non-current liabilites | 7,956 | - | 6,776 |
| Total non-current liabilities | 10,836 | 3,536 | 9,521 |
| Current liabilities | |||
| Current lease liabilities | 2,245 | 3,735 | 3,334 |
| Accounts payable | 5,192 | 4,020 | 5,953 |
| Tax liabilities | 3,650 | 3,900 | 3,145 |
| Other liabilities | 7,031 | 6,392 | 10,601 |
| Accrued expenses and prepaid income | 28,426 | 26,661 | 28,615 |
| Total current liabilities | 46,544 | 44,708 | 51,647 |
| Total liabilities | 57,380 | 48,244 | 61,168 |
| TOTAL EQUITY AND LIABILITIES | 965,786 | 998,238 | 1,019,395 |
1 See page 21 Acquision of Innovatif Cekal
Consolidated statement of changes in equity, summary
| Closing equity at Sep 30, 2024 | 2,483 | 1,226,507 | -3,100 | -275,896 | 949,994 |
|---|---|---|---|---|---|
| Total transactions with the Group's owners |
- | 71 | - | - | 71 |
| Share-based remuneration | - | 71 | - | - | 71 |
| Transactions with the Group's owners | |||||
| Total comprehensive income | - | - | -901 | -19,172 | -20,073 |
| Other comprehensive income | - | - | -901 | - | -901 |
| Net income | - | - | - | -19,172 | -19,172 |
| Opening equity at Jan 1, 2024 | 2,483 | 1,226,435 | -2,199 | -256,724 | 969,995 |
| (KSEK) | Share capital | Other contributed capital |
Translation difference |
Retained earnings incl net income |
Total |
| Equity attributable to parent company shareholders |
| (KSEK) | Share capital | Other contributed capital |
Translation difference |
Retained earnings incl net income |
Total |
|---|---|---|---|---|---|
| Opening equity at Jan 1, 2025 | 2,483 | 1,226,934 | -3,792 | -267,399 | 958,227 |
| Net income | - | - | - | -49,145 | -49,145 |
| Other comprehensive income | - | - | -1,993 | 36 | -1,957 |
| Total comprehensive income | - | - | -1,993 | -49,109 | -51,102 |
| Transactions with the Group's owners | - | - | - | - | - |
| Share-based remuneration | - | 1,281 | - | - | 1,281 |
| Total transactions with the Group's owners |
- | 1,281 | - | - | 1,281 |
| Closing equity at Sep 30, 2025 | 2,483 | 1,228,215 | -5,785 | -316,507 | 908,406 |
Consolidated cash flow statement, summary
| Jul-Sep | Jan-Sep | Jan-Dec | |||
|---|---|---|---|---|---|
| (KSEK) | 2025 | 2024 | 2025 | 2024 | 2024 |
| Operating activities | |||||
| Operating income | -10,727 | -13,875 | -26,088 | -41,119 | -52,179 |
| Adjustments for non-cash items | |||||
| Depreciations and amortisations | 5,157 | 5,299 | 15,901 | 16,053 | 21,597 |
| Exchange rate differences | 353 | -383 | -305 | -3,844 | -4,224 |
| Other non-cash items | 974 | 133 | 4,615 | 1,792 | 2,457 |
| Interest received | 11 | 2 | 75 | 4,659 | 16,487 |
| Interest paid | -18 | -45 | -92 | -137 | -178 |
| Taxes paid | -478 | -118 | -1,729 | -507 | -718 |
| Cash flow from operating activities before changes in | -4,727 | -8,986 | -7,623 | -23,104 | -16,759 |
| working capital | |||||
| Cash flow from changes in working capital | |||||
| Increase (-)/ Decrease (+) in inventories | -1,287 | -997 | 1,335 | 3,510 | 2,622 |
| Increase (-)/ Decrease (+) in operating receivables | 5,325 | -2,522 | 2,182 | 1,060 | 2,201 |
| Increase (-)/ Decrease (+) in operating liabilities | -412 | -16,828 | -3,426 | -518 | 166 |
| Cash flow from operating activities | -1,101 | -29,333 | -7,533 | -19,051 | -11,769 |
| Investing activities | |||||
| Investments in intangible assets | -14,850 | -36,331 | -48,970 | -144,038 | -172,788 |
| Investments in tangible assets | -386 | -686 | -674 | -868 | -2,216 |
| Investment is subsidiaries | - | - | -650 | - | -24,976 |
| Sale of current investments | - | - | - | 155,307 | 155,307 |
| Cash flow from investing activities | -15,236 | -37,017 | -50,295 | 10,402 | -44,673 |
| Financing activities | |||||
| Amortisation of leasing liabilities | -833 | -964 | -2,968 | -2,759 | -3,571 |
| Cash flow from financing activites | -833 | -964 | -2,968 | -2,759 | -3,571 |
| Cash flow for the period | -17,171 | -67,315 | -60,795 | -11,409 | -60,013 |
| Cash and cash equivalents at the beginning of the period Currency revaluation difference |
130,705 -1,572 |
304,223 -10,515 |
193,960 -21,202 |
231,180 6,623 |
231,180 22,793 |
| Cash and cash equivalents at the end of the period | 111,962 | 226,394 | 111,962 | 226,394 | 193,960 |
Parent company income statement, summary
| Jul-Sep | Jan-Sep | Jan-Dec | |||
|---|---|---|---|---|---|
| (KSEK) | 2025 | 2024 | 2025 | 2024 | 2024 |
| Net sales | 38,733 | 39,686 | 141,520 | 129,468 | 177,736 |
| Cost of goods sold | -10,474 | -11,049 | -39,029 | -36,358 | -50,271 |
| Gross profit | 28,260 | 28,636 | 102,491 | 93,110 | 127,465 |
| Selling expenses | -11,477 | -13,105 | -36,412 | -41,457 | -57,625 |
| Administration costs | -25,840 | -23,607 | -86,598 | -83,729 | -112,560 |
| Research and development costs | -4,645 | -4,987 | -13,742 | -13,820 | -18,224 |
| Other operating income | 3,998 | -7,379 | 12,197 | 9,152 | 12,137 |
| Other operating expenses | -474 | 10,630 | -3,023 | -2,504 | -3,861 |
| Operating income | -10,179 | -9,812 | -25,087 | -39,248 | -52,668 |
| Net financial items | 78 | -7,549 | -9,294 | 24,098 | 43,828 |
| Income after net financial items | -10,101 | -17,361 | -34,380 | -15,151 | -8,839 |
| Group contribution | - | - | - | - | 11 |
| Income before tax | -10,101 | -17,361 | -34,380 | -15,151 | -8,828 |
| Income tax | - | - | - | - | - |
| Net income | -10,101 | -17,361 | -34,380 | -15,151 | -8,828 |
Parent company statement of other comprehensive income, summary
| Jul-Sep | Jan-Sep | Jan-Dec | |||
|---|---|---|---|---|---|
| (KSEK) | 2025 | 2024 | 2025 | 2024 | 2024 |
| Net income | -10,101 | -17,361 | -34,380 | -15,151 | -8,828 |
| Other comprehensive income | |||||
| Items that can later be reclassified to the income statement: |
|||||
| Translation differences from foreign operations | 15 | 16 | 110 | -83 | -139 |
| 15 | 16 | 110 | -83 | -139 | |
| Other comprehensive income, net after tax | |||||
| Total comprehensive income | -10,086 | -17,345 | -34,270 | -15,234 | -8,968 |
Parent company balance sheet, summary
| (KSEK) | Sep 30, 2025 | Sep 30, 2024 | Dec 31, 2024 |
|---|---|---|---|
| ASSETS | |||
| Intangible assets | |||
| Capitalised development expenditure | 699,379 | 642,121 | 665,834 |
| Tangible assets | |||
| Machinery and other technical facilities | 407 | 640 | 581 |
| Equipment, tools and installations | 2,408 | 2,086 | 2,977 |
| Financial assets | |||
| Participations in Group companies | 40,730 | 404 | 40,080 |
| Non-current receivables, group companies | 118,525 | 38,830 | 103,042 |
| Total non-current assets | 861,449 | 684,080 | 812,514 |
| Current assets | |||
| Inventory | 39,210 | 39,464 | 39,599 |
| Tax receivables | 4,095 | 3,719 | 2,259 |
| Accounts receivable | 17,833 | 16,752 | 22,606 |
| Receivables, group companies | 0 | 64,523 | 0 |
| Prepaid expenses and accrued income | 8,786 | 16,344 | 5,298 |
| Other receivables | 3,011 | 2,614 | 2,627 |
| Cash and cash equivalents | 89,742 | 215,000 | 176,424 |
| Total current assets | 162,676 | 358,415 | 248,813 |
| TOTAL ASSETS | 1,024,125 | 1,042,495 | 1,061,327 |
| (KSEK) | Sep 30, 2025 | Sep 30, 2024 | Dec 31, 2024 |
| EQUITY AND LIABILITIES | |||
| Equity | |||
| Restricted equity | |||
| Share capital | 2,483 | 2,483 | 2,483 |
| Fund for capitalised development expenses | 696,307 | 636,317 | 661,075 |
| Non-restricted equity | |||
| Share premium fund | 1,228,214 | 1,226,507 | 1,226,934 |
| Retained earnings | -931,442 | -862,678 | -887,493 |
| Net income | -34,380 | -15,151 | -8,828 |
| Equity attributable to the parent company's shareholders | 961,182 | 987,478 | 994,171 |
| Provisions | |||
| Other provisions | 559 | 22 | 157 |
| Total provisions | 559 | 22 | 157 |
| Non-current liabilities | |||
| Liabilities to group companies | 16,080 | - | 20,483 |
| Other non-current liabiliteis Total non-current liabilities |
7,956 24,036 |
- - |
6,776 27,260 |
| Current liabilities | |||
| Accounts payable | 4,630 | 4,124 | 5,904 |
| Liabilities to group companies | 412 | 19,505 | 584 |
| Tax debt | 3,119 | 3,368 | 1,848 |
| Other liabilities | 5,543 | 5,133 | 9,209 |
| Accrued expenses and deferred income | 24,644 | 22,866 | 22,195 |
| Total current liabilities | 38,348 | 54,995 | 39,740 |
| Total liabilities | 62,943 | 55,018 | 67,156 |
Other information
General information
Sedana Medical (publ), with corporate identity number 556670-2519, is a limited company registered in Sweden with registered office in Danderyd. The address of the head office is Svärdvägen 3A, SE-182 33 Danderyd, Sweden. The object of the company's operations is to develop, manufacture and sell medical devices and pharmaceuticals. Sedana Medical AB is the Parent Company of the Sedana Medical Group. Unless otherwise indicated, all amounts are stated in thousands of Swedish kronor (KSEK). All amounts, unless otherwise indicated, are rounded to the nearest thousand. Figures in brackets relate to the comparative year.
For the Group's financial assets and liabilities, their carrying amount is considered to be a reasonable estimate of fair value as they essentially refer to current receivables and liabilities, so that the discounting effect is insignificant.
Accounting principles
This interim report has been prepared in accordance with IAS 34 Interim Financial Reporting. The parent company Interim report has been prepared in accordance with the Annual Accounts Act and Swedish Financial Reporting Board recommendation RFR 2. Applied accounting policies agree with those described in the 2024 Annual Report of Sedana Medical. None of the other published standards and interpretations that are mandatory for the Group for the financial year 2025 are deemed to have any significant impact on the Group's financial reports.
Important estimates
Estimates and judgements are evaluated regularly and based on historical experience and other factors, including expectations of future events considered reasonable under prevailing circumstances. For further information, see the Group's 2024 Annual Report.
Alternative performance measures
Alternative performance measures relate to financial performance indicators used by the senior management and investors to assess the Group's earnings and financial position which cannot be read or derived directly from the financial statements. These financial performance indicators are intended to facilitate analysis of the Group's development. The alternative performance measures should accordingly be regarded as complementing the financial reporting prepared in accordance with IFRS. The financial performance indicators presented in this report may differ from similar indicators used by other companies. These key ratios that are not defined according to IFRS are also presented in the report because they are considered to constitute important supplementary key ratios for the company's results. For information on these key ratios and how they have been calculated, please see definitions on page 22 and https://sedanamedical.com/investors/financial-reports-presentations/
Risk
Sedana Medical's operations, earnings and financial position are affected by a number of risk factors. These are principally related to demand for medical devices, fluctuating exchange rates and access to funding. More information about Sedana Medical's risks and management of these risks can be found in the 2024 Annual Report on pages 32-34.
Personnel
During the period, the Group had an average of 111 (72) full time employees and 10 (5) full time consultants, representing an increase of 39 compared to the same period in 2024. In terms of total headcount (i.e. regardless of fulltime or part-time positions), the total number of employees was 117 and the total number of consultants was 12 at the end of the period, compared with 78 and 8, respectively, at same time in 2024. The change in the number of people is primarily a result of the acquisition of the subsidiary Innovatif Cekal and efficiency measures regarding central administrative and support functions. The number of employees at Innovatif Cekal is 38, and the number of consultants is 8, at the end of the period. The number of employees in the Group excluding Innovatif Cekal was 79, and the number of consultants was 4, at the end of the period.
Transactions with related parties
Transactions with related parties are conducted on market terms. In 2024, a consultancy agreement was signed between Sedana Medical and The Eriah Group Inc. Board member Donna Haire is the CEO of The Eriah Group Inc., and the company has invoiced services amounting to KSEK 580 (62) for the period 2025.
Sedana Medical reports compensation and benefits to senior executives in accordance with IAS 19 Employee benefits. Additional information can be found in Sedana Medical's annual report for 2024, page 50-51 and page 58.
Acquisition of Innovatif Cekal
On November 29, 2024, Sedana Medical acquired all shares in Innovatif Cekal, the supplier of the company's main product (Sedaconda ACD). Innovatif Cekal is consolidated into Sedana Medical's financial reports starting from December 1, 2024.
The purpose of the acquisition is to increase our control over the supply chain and improve profitability by reducing the cost of goods. The acquisition will give Sedana Medical direct control over a larger share of our cost of goods sold, which reduces the risks related to future cost fluctuations and supply disruptions. The acquisition enables improved control of the
future scale-up of production capacity to meet our growth plans. Over time, when the existing stock at the time of closing has been sold, the deal is expected to add two percentage points to Sedana Medical's EBITDA margin.
The balance sheet of Innovatif Cekal as of November 29, 2024 has been established. The final purchase price for the shares amounts to 34 million SEK on a cash and debt-free basis, adjusted for changes in net working capital, and has been financed through the company's own liquid assets. 75% of the preliminary purchase price was paid on November 29, 2024. The short-term liability related to the final purchase price was settled in May 2025 and the remaining 25% will be paid in two years. Translation differences regarding reported goodwill between November 29 and September 30 amount to MSEK -0.7.
| (KSEK) | |
|---|---|
| Purchase consideration | |
| Cash | 32,228 |
| Deferred purchase price | 6,776 |
| Total purchase consideration | 39,004 |
| (KSEK) | |
| Fair value of acquired assets and assumed liabilities | |
| Intangible assets | 242 |
| Property, plant and equipment | 632 |
| Inventory | 4,993 |
| Current receivables excluding cash and cash equivalents | 4,582 |
| Cash and cash equivalents | 4,238 |
| Deferred tax liabilities | -55 |
| Current liabilities | -2,909 |
| Total acquired net assets excluding goodwill | 11,722 |
| Goodwill Total acquired net assets |
27,283 39,004 |
| Minus | |
| Deferred purchase price | -6,776 |
| Cash | -4,238 |
| Net cash flow from acquisition of operation | 27,990 |
Performance based incentive program (LTI 2024)
The Annual General Meeting 2024 decided on a performance-based incentive program LTI 2024 for employees of Sedana Medical, comprising 1,133,810 performance rights in the form of warrants. To ensure the delivery of the warrants and future estimated social security contributions in connection with the exercise of the options, Sedana Medical's subsidiary Sedana Medical Incentive AB has subscribed for 1,490,053 warrants, of which 1,062,803 were allocated to employees as of September 30, 2025. The performance rights have been issued to participants in the program free of charge. Each warrant entitles the holder to acquire one new share in the company at an exercise price of SEK 26.33. The outcome of LTI 2024 is conditional on the company achieving a performance target regarding the average annual growth rate of net sales for the financial years 2024, 2025, and 2026 ("Performance Target"), excluding currency effects. The Performance Target has been determined by the company's board of directors, taking into account the company's business plan and is deemed to be in line with market practice and appropriate. Detailed information on the Performance Target and the outcome of LTI 2024 will be provided during the first half of 2027. If the Performance Target is not fully met, a participant's right to exercise Performance Rights will gradually be reduced to zero, depending on the extent the Performance Target is reached.
At the end of the period, the full utilization of the performance-based incentive program would increase the share capital by KSEK 37 through the issuance of 1,449,053 shares, corresponding to a dilution of 1.5 percent.
Performance based incentive program (LTI 2025)
The Annual General Meeting 2025 decided on a performance-based incentive program LTI 2025 for employees of Sedana Medical, comprising 1,133,810 performance rights in the form of warrants. To ensure the delivery of the warrants and future estimated social security contributions in connection with the exercise of the options, Sedana Medical's subsidiary Sedana Medical Incentive AB has subscribed for 1,490,053 warrants, of which none were allocated to employees as of September 30, 2025.
Warrant programme
At the end of the period Sedana Medical had no outstanding warrants.
| Programme | Position | Number of acquired warrants at the beginning of the period |
Number of acquired warrants during the period |
Number of expired warrants during the period |
Number of repurchased warrants during the period |
Number of warrants at the end of the period |
Terms* | Strike price (SEK) |
|---|---|---|---|---|---|---|---|---|
| 2022/2025:1 | CEO | 495,000 | - | -495,000 | - | - | 1:1 | 46.24 |
| 2022/2025:1 | Senior management | - | - | - | - | - | 1:1 | 46.24 |
| 2022/2025:1 | Other employees | - | - | - | - | - | 1:1 | 46.24 |
| 2022/2025:1 | Total | 495,000 | - | -495,000 | - | - | 1:1 | 46.24 |
| Exercise period 30 May 2025 - 30 September 2025 | ||||||||
| 2022/2025:2 | CEO | - | - | - | - | - | 1:1 | 46.24 |
| 2022/2025:2 | Senior management | 231,606 | - | -231,606 | - | - | 1:1 | 46.24 |
| 2022/2025:2 | Other employees | 98,341 | - | -98,341 | - | - | 1:1 | 46.24 |
| 2022/2025:2 | Total | 329,947 | - | -329,947 | - | - | 1:1 | 46.24 |
| Exercise period 30 May 2025 - 30 September 2025 | ||||||||
| Totalt | CEO | 495,000 | - | -495,000 | - | - | ||
| Totalt | Senior management | 231,606 | - | -231,606 | - | - | ||
| Totalt | Other employees | 98,341 | - | -98,341 | - | - | ||
| Total | 824,947 | - | -824,947 | - | - |
* 1:1 = 1 warrant = 1 share at conversion
Definitions
Average number of full-time employees during the period
Number of full-time employees at the end of each period divided by number of periods
Balance sheet total
Total assets
Cash flow per share
Cash flow for the period divided by average number of shares before dilution
Debt to equity ratio
Total liabilities divided by total equity
EBIT
Operating income/Earnings before interest and taxes
EBITDA
Earnings before interest, taxes, depreciation and amortisation
EBITDA margin
EBITDA divided by net sales
EBITDA ex-US
Operating income (EBIT) less depreciation and write-downs as well as operating expenses attributable to the company's US business
Equity to assets ratio
Total equity divided by total assets
Equity per share
Equity divided by number of shares at the end of the period, before dilution
Gross margin
Gross profit divided by net sales
Net income margin
Net income divided by net sales
Number of employees at the end of the period
Number of employees excluding consultants regardless of employment rate per balance sheet date. Sick leave and parental leave are included. Holidays are not excluded
Number of employees and consultants at the end of the period
Number of employees including consultants regardless of employment rate per balance sheet date. Sick leave and parental leave are included. Holidays are not excluded
Operating margin
Operating income divided by net sales
Quick ratio
Current assets excluding inventories divided by current liabilities