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Sedana Medical

Interim / Quarterly Report Jul 18, 2025

4549_ir_2025-07-18_6a739807-0b81-4088-a569-df990b38ea7a.pdf

Interim / Quarterly Report

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Interim Report

January-June 2025

sedana medical ab (publ)

"Promising US data and strong sales growth in Q2"

Johannes Doll, President & CEO

Q1 Q2 Q3 Q4

Financial summary

Second quarter 2025

  • Net sales for the quarter totalled MSEK 49.8 (41.1), equivalent to an increase of 21% compared to the corresponding quarter 2024. At constant exchange rates, sales increased by 27%.
  • Net sales excluding contract manufacturing totalled MSEK 47.1 (41.1), equivalent to an increase of 15% compared to the corresponding quarter in 2024. At constant exchange rates, sales increased by 21%.
  • Gross profit amounted to MSEK 34.9 (29.0), equivalent to a gross margin of 70,2% (70,5%).
  • Earnings before interest, taxes, depreciation and amortisation (EBITDA) totalled MSEK -4.1 (-12.9), equivalent to an EBITDA margin of -8,2% (-31,4%).
  • EBITDA ex-US was MSEK -0.2 (-9.7) for the quarter, corresponding to a margin of -0,4% (-23,7%).
  • Operating income (EBIT) totalled MSEK -9.5 (-18.0), equivalent to an EBIT margin of -19,0% (-43,9%).
  • Net income for the quarter was MSEK -13.3 (-17.2) and earnings per share before and after dilution was SEK -0.13 (-0.18). The improved result is due to increased sales and lower operating costs, partly offset by negative unrealised currency effects. The financial net includes unrealised currency effects on cash placed in USD of MSEK -3.3 (-2.3).
  • Cash and equivalents at the end of the quarter totalled MSEK 130.7 compared to MSEK 165.0 at the beginning of the quarter. Cash and equivalents were impacted by unrealised currency effects amounting to MSEK -3.3 (-2.3).
  • Cash flow from operating activities totalled MSEK -12.5 (1.9). The cash flow from operations outside the US has improved, but the total cash flow from operating activities has been affected by changes in short-term liabilities of MSEK -6.3 (5.4) and changes in short-term receivables of MSEK -3.2 (7.3).
  • Cash flow from investments in intangible assets amounted to MSEK -17.4 (-55.6) and mainly refers to registration preparation work in the USA.
  • Total cash flow for the quarter amounted to MSEK -31.1 (-54.4).

January-June 2025

  • Net sales for the period totalled MSEK 107.2 (89.9), equivalent to an increase of 19% compared to 2024. At constant exchange rates, sales increased by 22%.
  • Net sales excluding contract manufacturing totalled MSEK 102.8 (89.9), equivalent to an increase of 14% compared to the corresponding period 2024. At constant exchange rates, sales increased by 17%.
  • Gross profit amounted to MSEK 75.6 (63.7), equivalent to a gross margin of 70,5% (70,9%).
  • Earnings before interest, taxes, depreciation and amortisation (EBITDA) totalled MSEK -4.6 (-16.5), equivalent to an EBITDA margin of -4,3% (-18,5%).
  • EBITDA ex-US was MSEK 3.6 (-10.8) for the period, corresponding to a margin of 3,4% (-12,0%).
  • Operating income (EBIT) totalled MSEK -15.4 (-27.2), equivalent to an EBIT margin of -14,3% (-30,3%).
  • Net income for the period was MSEK -36.7 (3.4) and earnings per share before and after dilution was SEK -0.37 (0.03). Increased sales and lower operating costs have been offset by unrealised currency effects on cash and cash equivalents mainly placed in USD of MSEK -19.6 (17.1) and lower interest income of MSEK 2.3 (11.3).
  • Cash and cash equivalents and short-term investments at the end of the period totalled MSEK 130.7 compared to MSEK 194.0 at the beginning of the year.
  • Cash flow from operating activities totalled MSEK -6.4 (10.3). The cash flow from operations outside the US has improved, but total cash flow from operating activities has been affected by changes in short-term liabilities MSEK -3.0 (16.3) and changes in short-term receivables MSEK -3.1 (3.6).
  • Cash flow from investments in intangible assets amounted to MSEK -34.1 (-107.7) 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 -35.8 (-47.4).
  • Total cash flow for the period amounted to MSEK -43.6 (55.9). Total cash flow excluding short-term investments amounted to MSEK -43.6 (-99.4).

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

Promising US data and strong sales growth in Q2

The first half of 2025 has been a successful period for Sedana Medical, with two record quarters in sales, a profitable ex-US business, and the release of positive clinical trial data in the United States.

Positive clinical trial data in the US

With the FDA granting our program Fast Track Designation and authorizing an Early Access program prior to full market approval, we find ourselves in a promising position as we advance towards entering our largest potential market.

The release of the US clinical trial data has further strengthened our confidence with regards to the US submission and possible commercial success after launch. Both our pivotal clinical trials met their primary end point and showed good safety data – crucial results for the FDA's assessment of our therapy.

In addition, both trials have shown a greater reduction of opioid doses compared to the control group and have therefore met their first key secondary endpoint. Reducing the use of opioids in a vulnerable patient population is generally considered an important clinical benefit in a country that is still plagued by a devastating opioid epidemic and more than 100,000 overdose deaths per year.

In clinical practice, intravenous (IV) sedatives – the current standard of care – are oftentimes associated with long and unpredictable wake-up times, causing difficulties in the daily ICU routines. Therefore, it was encouraging to see that 75% of isoflurane patients were awake within 60 minutes after stopping sedation.

Another important potential value proposition lies in the fact that our pharmaceutical isoflurane – unlike IV sedatives - is eliminated almost entirely independently from liver and kidneys, which allows for its use in patients with renal or hepatic impairments, a common phenomenon in intensive care.

Further analysis is ongoing to identify additional potential points of differentiation in the data, for example with regards to the promising trends towards lower mortality and more ICU-free days in the isoflurane group across both trials. In parallel, the work on compiling the FDA submission is progressing according to plan.

We have received strong interest in our Expanded Access Program and expect to have the first patients treated in the second half of this year.

Best Q2 sales to date

On the operational side, we delivered the highest second quarter sales to date, reaching 49.8 MSEK. This represents a strong 27% increase compared to last year excluding currency effects, of which 21% were organic and 6% stem from contract manufacturing revenue generated by our newly acquired manufacturing plant in Malaysia.

With 19% growth in local currency, our main market Germany stood out with excellent performance in the second quarter, albeit compared to a somewhat weaker comparator quarter last year. After some turnover in the sales team last year, all sales districts are now staffed, new colleagues have been successfully onboarded, and the team is fully focused on executing our sales acceleration plan – with very encouraging results.

Among our direct markets outside Germany, Spain showed the strongest performance and continued to show solid growth from both existing and new customers.

At the same time, we saw a temporary sales decline in the UK, due to special circumstances in a few important customers, such as a temporary delivery halt due to payment delays and personnel changes in an ICU, as well as a delayed start-up in two high-potential accounts. With several new customers starting up over the next months, we are anticipating a return to growth in a timely manner.

In France, our performance has been negatively affected by execution issues and - contrary to all other countries – by the publication of the SESAR study. While French customers using isoflurane have shown robust growth year-to-date, we have seen lower sales in accounts that still use sevoflurane. We are implementing a plan to reignite sales growth by switching remaining sevoflurane users to on-label isoflurane and enhancing our sales focus on accounts with the highest growth potential.

Meanwhile, the smallest part of our core business, the distributor business, grew by 32% excluding currency effects in Q2, following a sales decline in Q1. Quarterly fluctuations are normal and expected due to more irregular purchasing patterns and overall higher average stock levels.

A comparably small, but important contributor to our growth is our new paediatric indication, and we are proud to see the results of our IsoCOMFORT study (SED002) published in the Lancet Respiratory Medicine. Our successful IsoCOMFORT study has thus led to paediatric approval in 13 European countries, 3 additional years of data exclusivity and market protection until 2032, and now to a publication in a highly ranked journal. This is an excellent overall outcome for the company – besides the apparent benefits for a vulnerable patient population.

Profitability in the ex-US business

We have set a clear target to reach positive EBITDA in our ex-US business for the full year, through a combination of continued sales growth and discipline on the cost side. I see the company well on track towards this goal: our H1 EBITDA in our ex-US business was positive 4 MSEK, a 4% margin excluding exchange rate effects.

As an additional building block towards sustainable profitability, the integration of our newly acquired manufacturing plant in Malaysia is progressing well and we look forward to the positive gross margin effect during the 2nd half of the year.

2025 – an exciting year for Sedana Medical

With strong operational performance and encouraging progress in the US, we are well on track for an exciting and important year. I would like to thank you for your support and look forward to updating you on our continued progress.

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.

Significant events after the period

• In July 2025, 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.

  1. 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.

Our growth trajectory accelerated during Q2 2025 as we report net sales growth of 27% excluding currency effects (21% in reported currency). In our main market Germany, we report net sales growth of 19% in Q2 excluding currency effects (13% in reported currency). In response to the lack of growth in Q4 2024, we implemented a sales acceleration plan in Germany, which is bearing fruit. In our other direct markets (Spain, France, UK and Benelux) sales grew by 22% in Q2 excluding currency effects (15% in reported currency). Among these markets, Spain continues to be the top performer in terms of growth. In our distributor markets, sales increased 32% in Q2 excluding currency effects (26% in reported currency). This follows a comparatively slower Q1 2025 for our distributor markets, and quarterly fluctuations are to be expected from this customer segment due to their less frequent buying patterns compared to our direct (hospital) customers. In addition, following the acquisition of our Malaysian supplier Innovatif Cekal during Q4 2024, we report contract manufacturing revenue of 2,7 MSEK in Q2 (sales to external contract manufacturing customers). Excluding contract manufacturing revenue, we report net sales growth of 21% in Q2 excluding currency effects (15% 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).

In December 2024 we received a positive decision from the authorities in all involved countries that sedation of mechanically ventilated children in intensive care is approvable in Europe. This marked the final step before 13 countries can grant national marketing authorizations, which were all subsequently received during the first half of 2025. The submission 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.

Based on the regulatory assessment that the paediatric extension of the Sedaconda indication brings a significant clinical benefit over existing therapies, Sedaconda (isoflurane) received, in February 2025, 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, as it has over 100,000 ICU beds and higher sedation therapy price levels than Europe. 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 in favor of intubation compared to Europe, and an overall attractive pricing environment.

Sedana Medical's US clinical program INSPiRE-ICU, aiming at obtaining market approval for inhaled sedation in the 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 the same set-up and end-points as our European study (SED001). The total number of patients included in the two studies is 557 (of which 470 randomized and the remainder run-in patients), recruited across 30 clinics. In December 2024, the company announced that INSPiRE-ICU 1 had met its 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 February 2025, equally positive results were announced for the second trial, INSPiRE-ICU 2.

In April 2025, we announced that the U.S. Food and Drug Administration (FDA) has 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 second half of 2025.

In June 2025, we announced that both our 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. Wakeup 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, with an absolute mortality difference of 5 percentage points at 30 days in both studies. The main study results are publicly available on the clinical trials portal ClinicalTrials.gov, and will be followed by more granular data reporting in peer-reviewed publications, expected later this year.

We plan to submit our New Drug Application (NDA) dossier to the FDA in early 2026. Ahead of 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 program now has completed the patient recruitment phase and focus has shifted to preparing our dossier for NDA submission, our US activities are simultaneously becoming more commercial. During the summer of 2024 we strengthened our Medical Affairs and Marketing presence in the US, to engage with key opinion leaders and healthcare professionals, and further enhance our understanding of the US market ahead of launch.

Importantly, Sedana Medical is financed to achieve US approval, with MSEK 131 in cash at the end of Q2 2025.

Cost management and profitability

We report a gross margin of 70.2% in Q2 2025, compared with 70.5% in Q2 2024. We are experiencing cost increases for materials and key components and maintain a close dialogue with our suppliers. As communicated previously, our target gross margin remains at least 70%, even though we may see some volatility due to market and product mix effects. As previously communicated we expect to see a positive gross margin effect from the integration of Innovatif Cekal during the second half of the year. We report operating expenses of MSEK 45 in Q2 2025, which is down from MSEK 46 in Q2 2024, as we continue to reduce cost and find efficiencies in our organization.

Group EBITDA for the quarter was MSEK -4 compared to MSEK -13 in the same quarter last year, and ex-US EBITDA for the quarter of MSEK 0, compared with MSEK -10 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 Q2 2025 amounted to KSEK -9,469 compared to KSEK -18,022 in Q2 2024, which means an improvement by KSEK 8,553. The new accounting principle has led to a negative adjustment in the operating profit in Q2 2025 by KSEK 2,496 and a positive adjustment to the operating profit in Q2 2024 by KSEK 1,037. The result after financial items is unchanged.

The operating profit during Jan-Jun 2025 amounted to KSEK -15,361 compared to KSEK -27,245 in Jan-Jun 2024, which means an improvement by KSEK 11,884. The new accounting principle has led to a positive adjustment in the operating profit in Jan-Jun 2025 by KSEK 398 and a negative adjustment to the operating profit in Jan-Jun 2024 by KSEK 1,619. The result after financial items is unchanged.

Financial overview

Apr-Jun Jan-Jun
(KSEK) 2025 2024 2025 2024 2024
Net sales 49,752 41,056 107,247 89,877 178,754
Gross profit 34,945 28,951 75,598 63,720 126,142
Gross margin % 70% 71% 70% 71% 71%
EBITDA -4,063 -12,871 -4,618 -16,491 -30,582
EBITDA margin % -8% -31% -4% -18% -17%
EBITDA ex-US -211 -9,721 3,638 -10,789 -16,862
Operating income (EBIT) -9,469 -18,022 -15,361 -27,245 -52,179
Operating margin % -19% -44% -14% -30% -29%
Income after net financial items -11,924 -16,979 -35,376 3,839 -9,948
Net income -13,294 -17,213 -36,729 3,444 -10,674
Net income margin % -27% -42% -34% 4% -6%
Total assets 978,888 1,036,640 978,888 1,036,640 1,019,395
Equity 920,232 972,220 920,232 972,220 958,227
Equity ratio % 94% 94% 94% 94% 94%
Quick ratio % 371% 566% 371% 566% 450%
Debt to equity ratio % 6% 6% 6% 6% 6%
Average number of full-time employees for the period 108 75 106 76 77
Number of employees at balance date 118 81 118 81 109
Number of employees and consultants at balance date 131 89 131 89 125
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 -0.13 -0.18 -0.37 0.03 -0.11
Earnings per share after dilution, SEK -0.13 -0.18 -0.37 0.03 -0.11

Group performance

Net sales

Net sales for the quarter amounted to KSEK 49,752 (41,056), corresponding to an increase of 21 % compared to the same quarter last year. Adjusted for currency effects, the quarter showed an increase of 27 %.

In our main market, Germany, sales increased by 13 percent (19 percent at constant exchange rates) during the quarter, and in our Other direct markets sales increased by 15% (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 grew by 26 percent (32 percent at constant exchange rates).

For the interim period, net sales amounted to KSEK 107,247 (89,877), which corresponded to an increase of 19 % compared to 2024. Adjusted for currency effects, the increase was 22 %.

Apr-Jun Jan-Jun Jan-Dec
(KSEK) 2025 2024 % %* 2025 2024 % %* 2024
Germany 28,719 25,437 13% 19% 60,730 55,197 10% 13% 110,459
Other direct sales 13,887 12,094 15% 22% 34,386 25,817 33% 37% 54,077
Distributor markets 4,449 3,525 26% 32% 7,727 8,863 -13% -10% 13,425
Contract manufacturing 2,696 - n/a n/a 4,405 - n/a n/a 793
Total net sales 49,752 41,056 21% 27% 107,247 89,877 19% 22% 178,754

*) at constant exchange rates

Gross profit and margin

The gross profit for the quarter amounted to KSEK 34,945 (28,951), corresponding to a gross margin of 70,2 (70,5) %. For the interim period, the gross profit amounted to KSEK 75,598 (63,720) corresponding to a gross margin of 70,5 (70,9) %.

Selling expenses

Selling expenses for the quarter amounted to KSEK -25,590 (-26,726). For the interim period selling expenses amounted to KSEK -52,330 (-53,075). The decrease during the quarter and interim period compared to the previous year is mainly driven by marketing expenses, as well as freight and distribution.

Administrative expenses

Administrative expenses for the quarter amounted to KSEK -14,140 (-14,351). For the interim period, administrative expenses amounted to KSEK 27,907 (-26,329).

The increase compared to the previous year is due to temporarily higher costs for consultants in administrative functions resulting from organizational changes.

Research and development expenses

Research and development expenses for the quarter amounted to KSEK -5,153 (-4,747). For the interim period, research and development expenses amounted to KSEK -10,228 (-10,017).

Other operating income/expenses

Other operating income and expenses mainly consists of unrealized exchange rate differences on operating items. These totaled KSEK 469 (-1,149) for the quarter.

For the interim period, Other operating income and expenses were KSEK -493 (-1,543).

Net financial items and earnings per share

Financial net for the quarter totaled KSEK-2,455 (1,044). For the interim period the financial net was KSEK -20,015 (31,084). The amounts mainly consist of unrealised currency effects on cash and cash equivalents primarily placed in USD, totalling KSEK -3,291 (-2,280) for the quarter and KSEK -19,630 (17,138) for the period.

Group tax expense for the quarter was KSEK -1,370 (-234). For the period, the tax expense totalled KSEK -1,352 (-395), primarily attributable to taxes in Malaysia and Germany.

Consequently, earnings per share amounted to SEK -0.13 (-0.18) for the quarter and SEK -0.37 (0.03) for the interim period.

Capitalized development expenditures

Capitalized development expenditures as of June 30 amounted to KSEK 725,520 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 25,181 and mainly relates to registration preparation work in the USA, as well as certain investments related to the company's pediatric approval.

Inventory

As of 30 June, inventory amounted to KSEK 40,084 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 June was KSEK 920,232, compared to KSEK 958,264 at the beginning of the year. This corresponds to SEK 9.26 (9.79) per share. Equity/assets ratio was 94%, compared to 94% at the beginning of the year. Debt/equity ratio on June 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 -34,422 to KSEK 130,705 at the end of the quarter compared to KSEK 165,128 at the beginning of the quarter.

Cash flow from operating activities before changes in working capital for the quarter was KSEK -2,965 (-11,991). Cash flow from changes in working capital totaled KSEK -9,509 (13,902) which during the quarter was impacted by changes in shortterm liabilities of KSEK -6,342 (5,453) and accounts receivables of KSEK -3,243 (7,323). Consequently, the cash flow from operating activities amounted to KSEK -12,474 (1,911).

Cash flow from investments in intangible assets amounted to KSEK -17,431 (-55,617) and mainly consists of development costs for registration preparation work for Sedaconda ACD and Sedaconda (isoflurane) in the USA, as well as investments related to the company's pediatric approval.

Cash flow from financing activities for the quarter totaled KSEK -1,097 (-519) and relates to amortization of lease liabilities.

Currency revaluation differences in cash and cash equivalents amounted to KSEK -3,291 (-2,280) 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 -0.31 (-0.55).

During the interim period cash and cash equivalents decreased by KSEK -63,255 and totaled KSEK 130,705 on June 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 -2,896 (-14,118). Cash flow from changes in working capital amounted to KSEK -3,535 (24,400) which during the period was impacted by changes in short-term liabilities of KSEK -3,014 (16,311) and accounts receivables of KSEK -3,143 (3,582). As a result, cash flow from operating activities totalled KSEK -6,431 (10,282)

Cash flow from investments in intangible assets amounted to KSEK -34,120 (-107,706) 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 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 -35,058 (47,419).

Cash flow from financing activities for the period totaled KSEK -2,134 (-1,795) and relates to amortization of lease liabilities.

Currency revaluation differences in cash and cash equivalents amounted to KSEK -19,630 (17,138) 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 -0.44 (0.56).

Parent company

The Parent Company's net sales for the period totaled KSEK 102,786 (89,782), of which intra-group sales were KSEK 3,952 (3,989).

Operating income for the period totaled KSEK -14,908 (-29,436). Net financial items were KSEK -9,372 (31,647) 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 970,841 at 30 June 2025, compared to KSEK 994,171 at the beginning of the year. This corresponds to a decrease of KSEK 23,330. Share capital totaled KSEK 2,483, compared to KSEK 2,483 at the beginning of the year.

Cash and cash equivalents stood at KSEK 111,384, 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 second quarter was MSEK 1,099.

The price paid for Sedana Medical shares was SEK 19.02 at the beginning of the year and SEK 11.06 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

Apr-Jun Jan-Jun Jan-Dec
2025 2024 2025 2024 2024
Net income, KSEK -13,294 -17,213 -36,729 3,444 -10,674
Cash flow, KSEK -31,131 -54,407 -43,624 55,906 -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 824,947 824,947 824,947 824,947 824,947
Average number of warrants 824,947 899,173 824,947 899,173 874,431
Share capital at balance date, KSEK 2,483 2,483 2,483 2,483 2,483
Equity at balance date, KSEK 920,232 972,220 920,232 972,220 958,227
Earnings per share before dilution, SEK -0.13 -0.18 -0.37 0.03 -0.11
Earnings per share after dilution, SEK -0.13 -0.18 -0.37 0.03 -0.11
Equity per share, SEK 9.26 9.79 9.26 9.79 9.65
Cash flow per share, SEK -0.31 -0.55 -0.44 0.56 -0.60

Largest shareholders at the end of the period Facts about the

Trading
Nasdaq Stockholm
No of shares as per Jun 30,
2025
99 336 960
Market cap as per Jun 30, 2025
SEK 1,099 million
Ticker
SEDANA
ISIN
SE0015988373
LEI-code
549300FQ3NJRI56LCX32

share

Certification from the Board of Directors and the CEO

The Board of Directors and the Chief Executive Officer certify that this interim report presents a true and fair view of the operations, financial position and earnings of the parent company and the Group and describes material risks and uncertainties faced by the parent company and the companies forming part of the Group.

Danderyd July 18, 2025

Claus Bjerre Hilde Furberg Jens Viebke
Chairman of the Board Board member Board member
Donna Haire Christoffer Rosenblad Johannes Doll
Board member Board member President and CEO

This interim report has not been subject to review by the company's auditors.

The report has been prepared in both Swedish and English versions. In the event of any discrepancies between the Swedish and English versions, the Swedish version will take precedence.

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 July 18 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/q2-2025/

After the presentation, a recorded version of the webcast will be available at: https://sedanamedical.com/investors

Financial calendar

Interim Report Q3 2025 October 24 2025

Consolidated income statement, summary

Apr-Jun Jan-Jun
(KSEK) 2025 2024 2025 2024 2024
Net sales 49,752 41,056 107,247 89,877 178,754
Cost of goods sold -14,807 -12,105 -31,650 -26,157 -52,612
Gross profit 34,945 28,951 75,598 63,720 126,142
Selling expenses -25,590 -26,726 -52,330 -53,075 -104,796
Administrative expenses -14,140 -14,351 -27,907 -26,329 -51,799
Research and development expenses -5,153 -4,747 -10,228 -10,017 -20,294
Other operating income 1,102 11,315 2,288 11,607 2,507
Other operating expenses -633 -12,464 -2,781 -13,150 -3,938
Operating income -9,469 -18,022 -15,361 -27,245 -52,179
Net financial items -2,455 1,044 -20,015 31,084 42,231
Income before taxes -11,924 -16,979 -35,376 3,839 -9,948
Income tax -1,370 -234 -1,352 -395 -726
Net income -13,294 -17,213 -36,729 3,444 -10,674
Earnings per share, based on earnings attributable to
the parent company's ordinary shareholders:
Before dilution -0.13 -0.18 -0.37 0.03 -0.11
After dilution -0.13 -0.18 -0.37 0.03 -0.11
Operating income (EBIT) -9,469 -18,022 -15,361 -27,245 -52,179
Whereof amortisation of intangible assets -4,012 -3,964 -8,029 -7,924 -16,075
Whereof depreciation of tangible assets -1,394 -1,187 -2,714 -2,830 -5,522
EBITDA -4,063 -12,871 -4,618 -16,491 -30,582

Consolidated statement of other comprehensive income,

summary

Apr-Jun Jan-Jun Jan-Dec
(KSEK) 2025 2024 2025 2024 2024
Net income -13,294 -17,213 -36,729 3,444 -10,674
Other comprehensive income
Items that can later be reclassified to the income
statement:
Translation differences from foreign operations -1,804 891 -2,157 -1,219 -1,593
Other comprehensive income, net after tax -1,804 891 -2,157 -1,219 -1,593
Total comprehensive income -15,098 -16,322 -38,885 2,225 -12,267
Total comprehensive income as a whole
attributable to the parent company's shareholders
-15,098 -16,322 -38,885 2,225 -12,267

Consolidated balance sheet, summary

(KSEK) Jun 30, 2025 Jun 30, 2024 Dec 31, 2024
ASSETS
Intangible assets
Capitalised development expenditure 725,520 643,057 700,339
Concessions, patents, licenses, etc. 3,385 3,542 3,594
Goodwill1 25,110 - 26,569
Tangible assets
Machinery and other technical facilities 466 719 588
Equipment, tools and installations 2,978 1,949 3,688
Rights of use 5,351 8,302 6,349
Financial assets
Other long-term assets 46 47 47
Deferred tax assets
20 23 22
Total non-current assets
Inventory 762,877 657,639 741,195
Tax receivables 40,084 38,467 45,560
Accounts receivable 3,488 3,140 2,360
Prepaid expenses and accrued income 28,457 16,362 26,539
Other receivables 8,359 13,036 5,855
Capitalised development expenditure 4,918 3,773 3,928
Cash and cash equivalents 130,705 304,224 193,960
Total current assets 216,011 379,001 278,200
TOTAL ASSETS 978,888 1,036,640 1,019,395
(KSEK) Jun 30, 2025 Jun 30, 2024 Dec 31, 2024
EQUITY AND LIABILITIES
Equity
Share capital 2,483 2,483 2,483
Other contributed capital 1,227,787 1,226,435 1,226,934
Translation difference -5,716 -3,419 -3,792
Retained earnings including net profit -304,323 -253,280 -267,399
Equity attributable to the parent company's shareholders 920,232 972,220 958,227
Non-current liabilities
Deferred tax liabilities 779 6 6
Other provisions 425 - 157
Non-current lease liabilities 2,223 4,220 2,583
Other non-current liabilites 7,844 - 6,776
Total non-current liabilities 11,271 4,226 9,521
Current liabilities
Current lease liabilities 2,648 3,679 3,334
Accounts payable 5,230 15,105 5,953
Tax liabilities 3,258 3,399 3,145
Other liabilities 7,284 5,541 10,601
Accrued expenses and prepaid income 28,964 32,470 28,615
Total current liabilities 47,385 60,194 51,647
Total liabilities 58,656 64,420 61,168
TOTAL EQUITY AND LIABILITIES 978,888 1,036,640 1,019,395

1 See page 21 Acquision of Innovatif Cekal

Consolidated statement of changes in equity, summary

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, 2024 2,483 1,226,435 -2,199 -256,724 969,995
Net income - - - 3,444 3,444
Other comprehensive income - - -1,219 - -1,219
Total comprehensive income - - -1,219 3,444 2,225
Transactions with the Group's owners
Total transactions with the Group's
owners
- - - - -
Closing equity at Jun 30, 2024 2,483 1,226,435 -3,418 -253,280 972,220
(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 -267,398 958,227
Net income - - - -36,729 -36,729
Other comprehensive income - - -2,157 36 -2,120
Total comprehensive income - - -2,157 -36,692 -38,849
Transactions with the Group's owners - - - - -
Share-based remuneration - 854 - - 854
Total transactions with the Group's
owners
- 854 - - 854
Closing equity at Jun 30, 2025 2,483 1,227,788 -5,948 -304,090 920,232

Consolidated cash flow statement, summary

Apr-Jun Jan-Jun
(KSEK) 2025 2024 2025 2024 2024
Operating activities
Operating income -9,469 -18,022 -15,361 -27,245 -52,179
Adjustments for non-cash items
Depreciations and amortisations 5,406 5,151 10,744 10,753 21,597
Exchange rate differences -1,893 155 -659 -3,461 -4,224
Other non-cash items 4,358 1,000 3,641 1,659 2,457
Interest received 11 16 63 4,656 16,487
Interest paid -40 -59 -74 -92 -178
Taxes paid -1,337 -232 -1,250 -389 -718
Cash flow from operating activities before changes in -2,965 -11,991 -2,896 -14,118 -16,759
working capital
Cash flow from changes in working capital
Increase (-)/ Decrease (+) in inventories 76 1,126 2,622 4,508 2,622
Increase (-)/ Decrease (+) in operating receivables -3,243 7,323 -3,143 3,582 2,201
Increase (-)/ Decrease (+) in operating liabilities -6,342 5,453 -3,014 16,311 166
Cash flow from operating activities -12,474 1,911 -6,431 10,282 -11,769
Investing activities
Investments in intangible assets -17,431 -55,617 -34,120 -107,706 -172,788
Investments in tangible assets -892 -182 -1,050 -182 -2,216
Investment is subsidiaries - - -650 - -24,976
Sale of current investments - - - 155,307 155,307
Cash flow from investing activities -18,323 -55,799 -35,820 47,419 -44,673
Financing activities
Amortisation of leasing liabilities -1,097 -519 -2,134 -1,795 -3,571
Cash flow from financing activites -1,097 -519 -2,134 -1,795 -3,571
Cash flow for the period -31,131 -54,407 -43,624 55,906 -60,013
Cash and cash equivalents at the beginning of the period 165,128 360,911 193,960 231,180 231,180
Currency revaluation difference -3,291 -2,280 -19,630 17,138 22,793
Cash and cash equivalents at the end of the period 130,705 304,223 130,705 304,223 193,960

Parent company income statement, summary

Apr-Jun Jan-Jun Jan-Dec
(KSEK) 2025 2024 2025 2024 2024
Net sales 47,031 41,021 102,786 89,782 177,736
Cost of goods sold -12,999 -11,675 -28,555 -25,309 -50,271
Gross profit 34,032 29,346 74,231 64,473 127,465
Selling expenses -12,157 -13,756 -24,934 -28,351 -57,625
Administration costs -30,290 -33,722 -60,758 -60,121 -112,560
Research and development costs -4,610 -4,128 -9,097 -8,833 -18,224
Other operating income 3,323 9,959 8,199 16,531 12,137
Other operating expenses -470 -12,421 -2,549 -13,135 -3,861
Operating income -10,171 -24,722 -14,908 -29,436 -52,668
Net financial items 4,812 1,978 -9,372 31,647 43,828
Income after net financial items -5,359 -22,744 -24,279 2,211 -8,839
Group contribution - - - - 11
Income before tax -5,359 -22,744 -24,279 2,211 -8,828
Income tax - - - - -
Net income -5,359 -22,744 -24,279 2,211 -8,828

Parent company statement of other comprehensive income, summary

Apr-Jun Jan-Jun
(KSEK) 2025 2024 2025 2024 2024
Net income -5,359 -22,744 -24,279 2,211 -8,828
Other comprehensive income
Items that can later be reclassified to the income
statement:
Translation differences from foreign operations -53 55 96 -99 -139
-53 55 96 -99 -139
Other comprehensive income, net after tax
Total comprehensive income -5,411 -22,689 -24,183 2,112 -8,968

Parent company balance sheet, summary

(KSEK) Jun 30, 2025 Jun 30, 2024 Dec 31, 2024
ASSETS
Intangible assets
Capitalised development expenditure 689,942 610,585 665,834
Tangible assets
Machinery and other technical facilities 464 699 581
Equipment, tools and installations 2,358 1,816 2,977
Financial assets
Participations in Group companies 40,730 404 40,080
Non-current receivables, group companies 111,582 38,798 103,042
Total non-current assets 845,076 652,301 812,514
Current assets
Inventory 37,876 38,467 39,599
Tax receivables 3,483 3,102 2,259
Accounts receivable 23,398 14,616 22,606
Receivables, group companies 1,156 59,496 0
Prepaid expenses and accrued income 7,806 12,604 5,298
Other receivables 3,485 2,568 2,627
Cash and cash equivalents 111,384 295,692 176,424
Total current assets 188,588 426,545 248,813
TOTAL ASSETS 1,033,664 1,078,846 1,061,327
(KSEK) Jun 30, 2025 Jun 30, 2024 Dec 31, 2024
EQUITY AND LIABILITIES
Equity
Restricted equity
Share capital 2,483 2,483 2,483
Fund for capitalised development expenses 686,308 604,196 661,075
Non-restricted equity
Share premium fund 1,227,787 1,226,435 1,226,934
Retained earnings -921,458 -830,573 -887,493
Net income -24,279 2,211 -8,828
Equity attributable to the parent company's shareholders 970,841 1,004,752 994,171
Provisions
Other provisions 425 - 157
Total provisions 425 - 157
Non-current liabilities
Liabilities to group companies 11,292 - 20,483
Other non-current liabiliteis
Total non-current liabilities
7,844
19,136
-
-
6,776
27,260
Current liabilities
Accounts payable 4,144 15,065 5,904
Liabilities to group companies 7,375 23,078 584
Tax debt 2,677 2,875 1,848
Other liabilities 5,894 3,964 9,209
Accrued expenses and deferred income 23,173 29,113 22,195
Total current liabilities 43,262 74,094 39,740
Total liabilities 62,823 74,094 67,156
TOTAL EQUITY AND LIABILITIES 1,033,664 1,078,846 1,061,327

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 108 (76) full time employees and 11 (5) full time consultants, representing an increase of 38 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 118 and the total number of consultants was 13 at the end of the period, compared with 81 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 37, and the number of consultants is 8, at the end of the period. The number of employees in the Group excluding Innovatif Cekal was 81, and the number of consultants was 5, 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 409 (0) 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 June 30 amount to MSEK-2.1.

(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 June 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 June 30, 2025.

Warrant programme

At the end of the period Sedana Medical had 824,947 outstanding warrants where 1 warrant equals 1 share at conversion.

Number of
acquired
warrants at
the
beginning of
Number of
acquired
warrants
during the
Number of
expired
warrants
during the
Number of
repurchased
warrants
during the
Number of
warrants at
the end of
Strike
price
Programme Position the period period period period the period Terms* (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

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