Positive Group EBITDA despite market headwinds
First quarter 2026
- Net sales for the quarter totaled MSEK 53.4 (57.5), equivalent to a decrease of 7% compared to the corresponding quarter in 2025. At constant exchange rates, sales decreased by 2%.
- Gross profit amounted to MSEK 37.8 (40.7), corresponding to a gross margin of 71% (71%).
- Earnings before interest, taxes, depreciation and amortization (EBITDA) totaled MSEK 1.8 (-0.6), corresponding to an EBITDA margin of 3% (-1%).
- EBITDA ex-US amounted to MSEK 5.1 (3.8) for the quarter, equivalent to a margin of 10% (7%).
- Operating income (EBIT) totaled MSEK -5.7 (-5.9), corresponding to an EBIT margin of -11% (-10%).
- Net income for the period amounted to MSEK -3.7 (-23.4), and earnings per share before and after dilution were SEK -0.04 (-0.24). The improved result is mainly attributable to the negative net financial items in the preceding year, which were driven by unrealized currency effects on cash and cash equivalents held in USD.
- Cash and cash equivalents amounted to MSEK 80.7 at the end of the quarter, compared with MSEK 91.0 at the beginning of the quarter.
- Cash flow from operating activities totaled MSEK 2.7 (6.0). The main driver of the difference relative to last year is increasing inventory.
- Cash flow from investments in intangible assets amounted to MSEK -13.5 (-16.7) and mainly refers to registration preparatory work in the USA. Investments in property, plant and equipment as well as subsidiaries totaled MSEK -0.4 (-0.8).
- Total cash flow for the quarter amounted to MSEK -12.2 (-12.5).
CEO comments
Positive Group EBITDA despite market headwinds
In the first quarter of 2026, we delivered positive EBITDA at Group level, despite markedly fewer patients in intensive care units across our main markets compared to last year. This demonstrates the ongoing transformation of Sedana Medical into a profitable and scalable business that delivers results even in a more challenging market environment. In the US, we remain on track to submit our New Drug Application (NDA) to the FDA in mid-2026.
Continued progress in profitability despite sales headwinds
Sales in the first quarter were 2% lower than last year at constant exchange rates. The main driver was a lower number of sedated ICU patients compared to the unusually strong first quarter of 2025, which was supported by a severe and prolonged flu season. This effect was visible across several of our key markets. Despite the sales decline, we reached a positive EBITDA margin of 3% at Group level, corresponding to 5% at constant exchange rates - a clear improvement compared to the negative ETBIDA margin of -1% in Q1 last year. In our ex-US business, the EBITDA margin was strong at 10%, or 11% at constant exchange rates, up from 7% last year.
This development builds on the progress of recent years and reflects the structural improvements we have implemented - fundamentally reshaping how we operate and how we allocate resources across the organization. We have streamlined corporate headquarters and non-customer-facing functions, while sharpening our focus on commercial execution and becoming significantly more customer-centric. Our support functions are now more effective with only half the number of employees, and at the same time we have built a larger and more impactful field force. We introduced a rigorous, data-driven investment approach, increasing resources in profitable and growing countries, and adjusting where performance has not yet met expectations. These measures have led to a continuous improvement of our bottom line.
Gross margin remained solid above 70% during the quarter. The share of our contract manufacturing business in Malaysia in total sales was higher this quarter, which temporarily masks the positive margin effect stemming from better cost of goods of our main device after the acquisition of Innovatif Cekal.
Sales impacted by lower ICU occupancy
In Germany, the market environment during the quarter was particularly challenging. According to data from the Robert Koch Institute, ICU admissions for severe acute respiratory infections were approximately 15% lower year-on-year, with patient numbers never reaching the peak levels of last year and the seasonal decline starting earlier than in 2025. As a consequence, sales in Germany declined by 15%. Our response is clear: we remain focused on what we can control and are rolling out field force productivity initiatives, such as sales territory realignment, additional sales training and further steering of our activities towards accounts with the highest growth potential.
In Spain, we continued to grow at robust rates, albeit at slightly lower levels than what we have seen previously. Since January, Spain has seen the largest nation-wide doctor strikes in years, with physicians across specialties protesting for better working conditions and remuneration for one week each month. During strike periods, intensive care units operate with minimum staffing levels, which limits our access to healthcare professionals and reduces opportunities for engagement, training, and follow-up. Our continued growth despite these challenges underlines the strength of the platform we have built in Spain and the solid underlying demand for our therapy.
In France, performance was flat year-on-year while we temporarily had fewer people in the field during the quarter. This is part of our planned restructuring which is progressing well. Importantly, in Q1 we received formulary listing for our pharmaceutical Sedaconda/Cedaconda® (isoflurane) within the AP-HP hospital network, providing access to 38 university hospitals in and around Paris where we were previously prevented from selling isoflurane. This represents our most important growth opportunity in France at this point, and we are now fully focused on establishing inhaled sedation in these important hospitals.
In the UK, performance was relatively weak during the quarter. While lower patient numbers played a role, we are also actively refining our commercial approach, including a re-segmentation of NHS trusts with a stronger focus on high-potential accounts.
Our distributor markets delivered a robust quarter with 23% growth. While these markets tend to be more volatile due to longer ordering cycles, we expect continued growth during this year, supported by the strategic changes implemented last year. Those include a stronger focus on our key partners and an awarded tender in Saudi Arabia.
During the quarter, we have strengthened our sales leadership with a new VP International Markets and are now rolling out enhanced sales training and field force effectiveness tools for even better account prioritization, funnel management, and sales expansion. These initiatives are intended to revitalize growth over time and to make us less dependent on underlying market fluctuations.
Moving closer to US submission and first EAP patient treated
The United States remains our most important growth opportunity. With a significantly larger addressable market and more favorable pricing dynamics than in Europe, a future US launch has the potential to transform the scale of our business. Following the strong progress in 2025 with two successful pivotal trials, the authorization of an Early Access Program (EAP) and positive regulatory interactions with the FDA, we remain on track to submit our New Drug Application (NDA) to the FDA in mid-2026. While the final elements of the dossier are coming together, our focus is increasingly shifting toward launch preparations, including for instance our organizational build-up, the commercial roll-out plan, and our pricing strategy.
During the quarter, the first patient was treated under our EAP at Vanderbilt University Medical Center in Nashville, Tennessee. This program provides access to our therapy ahead of market authorization for "difficult-to-sedate" patients - those who are unable to achieve and maintain adequate sedation levels with intravenous sedatives. FDA's authorization of our EAP underlines the medical need for alternative sedation options in intensive care. From an operational standpoint, it will provide us with the opportunity to train important hospitals ahead of launch, test core processes and gather key insights for the future commercial launch.
On track to deliver on our goals
Our business will always be influenced to some extent by seasonal variations in ICU occupancy. The first quarter of 2026 clearly illustrates this dynamic, with lower patient volumes creating headwinds for sales. At the same time, the progress we have made in building a more efficient organization and a healthier cost structure is now paying off. Even in a softer market environment, we delivered solid profitability at both ex-US and Group level. With this, I see the company well on track to deliver on our ambitious goals for the year.
There are also exciting times ahead in the United States. With the NDA submission just a few months away, 2026 is set to bring significant progress as we advance toward conquering our highest-potential market.
I would like to thank our employees for their continued dedication and our shareholders for their trust and support. We remain focused on executing our strategy and look forward to updating you on our progress throughout the year.
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) Thursday April 23, 2026.
More info and link to the audiocast: https://www.finwire.tv/webcast/sedana-medical/q1-2026/
If you wish to participate via teleconference: +46 8 4468 2488. Meeting ID: 873 8016 7764 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. The information was submitted for publication, through the agency of the contact persons set out above, at 2026-04-23 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.
