Promising US data and strong sales growth in Q2

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).

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

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

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

Sedana Medical will hold a telephone conference at 13:30 pm (CET) July 18, 2025.

More info and link to the audiocast: https://www.finwire.tv/webcast/sedana-medical/q2-2025/

If you wish to participate via teleconference: +46 8 5050 0829. Meeting ID: 815 9659 8597 followed by #.

For additional information, please contact:

Johannes Doll, CEO, +46 (0)76 303 66 66
Johan Spetz, CFO, +46 (0)730 36 37 89
ir@sedanamedical.com

This information is information that Sedana Medical AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 2025-07-18 07:00 CEST.

About Sedana Medical

Sedana Medical AB (publ) is a pioneer medtech and pharmaceutical company focused on inhaled sedation to improve the patient’s 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 has direct sales in Benelux, France, Germany, Great Britain, the Nordics, and Spain. In other parts of Europe as well as in Asia, Australia, Canada, and South- and Central America, the company works with external distributors.

Sedana Medical was founded in 2005, is listed on Nasdaq Stockholm (SEDANA) and headquartered in Stockholm, Sweden.

Attachments

Sedana Medical Interim Report Q2'25

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