NDA submission and improved EBITDA
Second quarter 2026
- Net sales for the quarter totaled MSEK 49.1 (49.8), equivalent to a decrease of 1% compared to the corresponding quarter in 2025. At constant exchange rates, sales were flat.
- Net sales excluding contract manufacturing amounted to MSEK 47.2 (47.1), remaining in line with the corresponding quarter of 2025. At constant exchange rates, sales increased by 1%.
- Gross profit amounted to MSEK 35.8 (34.9), corresponding to a gross margin of 73% (70%).
- Earnings before interest, taxes, depreciation and amortization (EBITDA) totaled MSEK -1.9 (-4.1), corresponding to an EBITDA margin of -4% (-8%).
- EBITDA ex‑US amounted to MSEK 0.8 (-0.2) for the quarter, equivalent to a margin of 2% (0%).
- Operating income (EBIT) totaled MSEK -9.4 (-9.5), corresponding to an EBIT margin of -19% (-19%).
- Net income for the period amounted to MSEK -9.6 (-13.3), and earnings per share before and after dilution were SEK -0.10 (-0.13). The improved result is mainly attributable to a higher gross profit of MSEK 35.8 (34.9) and improved net financial items of MSEK 0.9 (-2.5).
- Total cash flow for the quarter amounted to MSEK -29.5 (-31.1). Cash and cash equivalents amounted to MSEK 51.8 at the end of the quarter, compared with MSEK 80.7 at the beginning of the quarter.
- Cash flow from operating activities totaled MSEK -7.7 (-12.5) of which impact from net working capital was MSEK -4.8 (-9.5).
- Cash flow from investments in intangible assets amounted to MSEK -20.1 (-17.4) and mainly refers to registration preparatory work in the USA.
January-June 2026
- Net sales for the period totaled MSEK 102.5 (107.2), equivalent to a decrease of 4% compared to 2025. At constant exchange rates, sales decreased by 1%.
- Net sales excluding contract manufacturing amounted to MSEK 97.9 (102.8), equivalent to a decrease of 5% compared to the corresponding period in 2025. At constant exchange rates, sales decreased by 2%.
- Gross profit amounted to MSEK 73.6 (75.6), corresponding to a gross margin of 72% (70%).
- Earnings before interest, taxes, depreciation and amortization (EBITDA) totaled MSEK -0.1 (-4.6), corresponding to an EBITDA margin of 0% (-4%).
- EBITDA ex‑US amounted to MSEK 5.9 (3.6) for the period, equivalent to a margin of 6% (3%).
- Operating income (EBIT) totaled MSEK -15.1 (-15.4), corresponding to an EBIT margin of -15% (-14%).
- Net income for the period amounted to MSEK -13.3 (-36.7), and earnings per share before and after dilution were SEK -0.13 (-0.37). The improved result was driven by a higher gross margin, lower operating expenses and improved net financial items of MSEK 3.4 (-20.0).
- Total cash flow for the interim period amounted to MSEK -41.8 (-43.6). Cash and cash equivalents amounted to MSEK 51.8 at the end of the period, compared with MSEK 91.0 at the beginning of the year.
- Cash flow from operating activities totaled MSEK -5.0 (-6.4), of which impact from net working capital was MSEK -2.0 (-3.5).
- Cash flow from investments in intangible assets amounted to MSEK -33.6 (-34.1) and mainly refers to registration preparatory work in the USA.
CEO comments
NDA submission and improved EBITDA
We submitted our New Drug Application (NDA) to the FDA in June, a major milestone on the path to our US market entry. Sales momentum in all markets outside Germany accelerated broadly, which compensated for a weak quarter in Germany and led to flat Group sales against a strong quarter last year. We again improved EBITDA in both our ex-US business and at Group level – a testament to our successful financial turnaround – and are on track to deliver our full-year guidance. We remain financed to execute on our plan and have added a new 50 MSEK credit facility with a local bank as an extra safeguard against unforeseen costs associated with the FDA review.
NDA submission – a major step toward our highest-potential market
The biggest achievement during the quarter was the submission of our New Drug Application (NDA) to the FDA in June, slightly ahead of our public guidance. This marks a major milestone on our path to our highest-potential market.
With the dossier now in the FDA’s hands, the review process has formally started. Over the coming weeks, the agency will validate our submission and, assuming acceptance, we expect the FDA to communicate a PDUFA date – the target date by which the agency aims to complete its review and decide on approval – in August or September. At the same time, we also expect a decision on our application for priority review.
While review risks can never be fully eliminated, we have worked systematically to reduce regulatory risks. For example, on the clinical side, both pivotal trials met their primary endpoints, secondary endpoints were either in our favor or showed no difference versus the comparator, and we saw no new safety signals. On manufacturing, the acquisition of our main supplier, Innovatif Cekal, has given us significantly tighter control over inspection readiness. In human factors, we worked with a specialized partner to conduct thorough testing with physicians, pharmacists, respiratory therapists and registered nurses, in line with FDA guidelines. We have also conducted several mock audits with former FDA inspectors, covering our manufacturing site, quality systems, our clinical trial oversight, as well as select suppliers.
With the submission complete, our focus has shifted increasingly toward launch preparations. This includes for instance pricing studies and the development of a tailored value story for each key stakeholder group in the US healthcare system, covering both clinical and health-economic benefits. We remain confident in the value inhaled sedation with isoflurane can bring to US hospitals. It offers a compelling reduction in opioid use, supports early wake-up, mobilization and discharge from the ICU, and should therefore generate meaningful financial benefits for hospitals.
We estimate the addressable market in the US at around USD 1 billion, roughly three times the combined market potential of all our current direct markets. Achieving penetration levels similar to what we have built in Germany or Spain could take Sedana Medical to an entirely new scale.
Broad-based sales acceleration outside Germany
Group net sales for the quarter were 49.1 MSEK (49.8) and were flat at constant exchange rates. In our core business, excluding contract manufacturing, sales of 47.2 MSEK were in line with last year, up 1% at constant exchange rates versus the exceptional second quarter of 2025, when we delivered 27% year-over-year growth, of which 21% was organic. Consequently, year-to-date group sales totaled 102.5 MSEK (107.2), down 1% at constant exchange rates.
Contract manufacturing revenue from Innovatif Cekal was affected by a shipment originally planned for June that was delayed into July, due to currently constrained vessel availability. Without this timing effect, we would have seen solid growth in contract manufacturing for the quarter and avoided the slight sales decline at group level.
To calibrate our performance, it is worth noting that last year’s growth was unusually front-loaded. Full-year sales split 107 MSEK in H1 2025 and 93 MSEK in H2. In the first half of this year, we were thus up against a strong corresponding period last year.
Germany faced another difficult quarter. Sales declined 22% at constant exchange rates (-18% year-to-date). This is against a strong comparator as Germany had grown 19% in the second quarter of last year. The majority of decline is explained by fewer patients in intensive care: According to the Robert Koch Institute, Germany has seen fewer patients hospitalized with severe acute respiratory infections in 2026 than in 2025, with year-to-date hospitalizations down 11%. This is supported by several indicators from Germany's national intensive care registry (DIVI): the number of free ICU beds has increased by 12% while the total number of beds has not changed materially, available capacity for invasive ventilation has risen similarly, and the number of ICUs reporting that they are insufficiently staffed to treat their patients has dropped by 20% - all pointing to lower patient volumes in intensive care units. With the market conditions providing some headwinds, we are even more focused on improving execution to return to growth quickly. As more than half of German ICU hospitals are regular customers already, representing over two-thirds of the addressable market, our main growth opportunity is increasing penetration within existing accounts rather than expanding access. To unlock this potential, we are sharpening our focus on high-potential hospitals through territory optimization, increased visit frequency and enhanced sales training. New leadership has been put in place during the quarter to drive the re-acceleration program.
At the same time, I am very pleased to report that our Other Direct Markets accelerated broadly during the quarter, growing 41% at constant exchange rates. Every one of these markets improved versus Q1.
In Spain, the nationwide doctors’ strikes that began in January are continuing, for one week each month. Despite this, growth reaccelerated sharply during the quarter as our team has become more effective at reaching available stakeholders even during strike weeks. In parallel, we are making targeted progress in new patient populations, such as neurocritical care, where early clinical evidence from the investigator-led pilot study Neuro-Conda is helping us open conversations with neuro-critical ICUs.
France delivered solid growth in the quarter. The opening of the AP-HP network – where our Sedaconda (isoflurane) was referenced for the first time this year – is already showing effect, with 8 new hospital accounts opened so far. We are still in the process of restructuring our French organization and expect a new Country Manager to be in place by autumn.
In the UK, performance improved during the quarter. Historically, our field team focused on accounts that were easier to penetrate but offered lower long-term potential. We have now shifted the team’s focus to increase coverage of high-potential accounts, and are seeing promising early signs, though it will take time to fully play out.
Our distributor markets continued their solid trajectory, growing 26% in the quarter, driven by strong orders from the Kingdom of Saudi Arabia and South America.
Improved margins despite flat sales and an additional liquidity buffer
Despite broadly flat Group sales, we once again improved profitability, both in our ex-US business and at Group level, compared to the same period last year. Ex-US EBITDA reached 2% in the quarter (up from 0%) and 6% year-to-date (up from 3%). At Group level, EBITDA improved to -4% for the quarter (from -8%) and reached break-even year-to-date (0%, up from -4%). Gross margin improved to 73% in the quarter, compared with 70% in the prior year, mainly reflecting significantly lower cost of goods for our main device following the acquisition of Innovatif Cekal, as well as a more favorable sales mix with a lower share of contract manufacturing sales.
This continued improvement of our profitability demonstrates that the financial turnaround of recent years is delivering tangible results. We therefore remain on track to achieve our full-year guidance of approaching EBITDA break-even at Group level and a mid- to high-single-digit EBITDA margin in our ex-US business. We continue to believe that we are financed to execute on our plans. Every FDA review carries some cost uncertainty however, and we have therefore put in place a loan facility with a local bank, giving us access to up to 50 MSEK in additional funds should it be needed.
Looking ahead
Stepping back, I see Sedana Medical in a good place. We have completed a successful financial turnaround and reached profitability in our core business outside the US. Our full focus is now on re-accelerating sales growth across our markets. And with the FDA now reviewing our submission, our biggest opportunity – the United States – is no longer a distant ambition. It is becoming real.
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I would like to thank our employees for their continued dedication and our shareholders for their trust and support, and I look forward to updating you on our progress.
Johannes Doll, President and CEO
Please find the full report at: Interim Reports | Sedana Medical
This document has been prepared in both a Swedish and English version. In the event of any deviations, the Swedish version shall prevail.
Sedana Medical will hold a telephone conference at 13:30 pm (CET) Friday July 17, 2026.
More info and link to the audiocast: https://www.finwire.tv/webcast/sedana-medical/q2-2026/
If you wish to participate via teleconference: +46 8 5052 0017. Meeting ID: 966 6000 2846 followed by #.
For additional information, please contact:
Johannes Doll, CEO, +46 (0)76 303 66 66
Mikael Haag, CFO, +46 (0)79 583 42 59
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 2026-07-17 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, 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.