FDA review under way and sales growth returns
Third quarter 2026
January-September 2026
CEO comments
FDA review under way and sales growth returns
The FDA’s acceptance of our New Drug Application (NDA) for review, with a target decision date (PDUFA) of April 16, 2027, brings us a decisive step closer to the US market. Meanwhile, net sales grew 7% at constant exchange rates, with Germany improving considerably and our other markets continuing to grow. Coming out of our seasonally weakest quarter, ex-US EBITDA remains positive year to date, and we expect to meet our financial guidance for the full year.
NDA accepted for review
The FDA’s acceptance of our NDA for review was a key milestone in the quarter. It confirms that our application is sufficiently complete for a substantive review, and the FDA has set a PDUFA date of April 16, 2027. Every FDA review involves uncertainties, and approval is never a given. So far, however, we have had a constructive dialogue with the agency, and we are responding to their questions as the review progresses.
If approved, the opportunity in the US is substantial. The addressable market of at least USD 1 billion could take Sedana Medical onto a new growth trajectory, grounded in a strong product-market fit: In a country with one of the highest rates of opioid-related deaths in the world, reducing opioid exposure has become a priority throughout the healthcare system. Our randomized controlled trials have consistently shown reduced opioid use with inhaled sedation, and we believe this will resonate strongly with US clinicians. Furthermore, reducing length of stay in intensive care is a major factor in therapy adoption. All reasons to look forward to an exciting launch in our highest potential market.
Sales growth returned
Net sales for the quarter amounted to 44.2 MSEK (41.2), an increase of 7% at constant exchange rates. Our other direct markets grew 11% in the quarter, and the business with our distributors increased by 27%, while sales in Germany declined 2%.
Our performance in Germany has improved considerably, from a decline of 18% at constant FX rates in the first half of the year to a decline of 2% in the third quarter. External conditions have been unfavorable so far this year. Robert Koch Institute data show significantly fewer ICU admissions with severe acute respiratory infections (SARI) in the first half of the year compared with last year, and only in the third quarter did levels come close to last year's.
We are, however, not waiting for external factors to turn in our favor. Instead, we have further sharpened our commercial execution with a clear focus on increasing penetration in high-potential accounts. Every key account manager has clarity on the high-priority accounts in their territory, and activities have shifted markedly, with the vast majority now directed at prioritized top accounts. Sales to these high-potential accounts have shown solid growth in the quarter already - early evidence that the approach is working.
Spain remains a strong market, with year-to-date growth on track. Growth was softer in the third quarter, a seasonally slow period in which many ICUs operate at reduced capacity, with fewer patients and critical care beds in use and more staff who are less familiar with our therapy.
France continued to perform strongly, supported by the opening of the AP-HP network, where Sedaconda (isoflurane) was listed for the first time earlier this year. The listing gives us access to 38 university hospitals in and around Paris where we were previously prevented from selling Sedaconda (isoflurane), and we continue to convert these into active customers alongside the targeted pursuit of other high-priority accounts, such as in the Lyon area. We also achieved a successful outcome in the tender with UniHA, the largest French public hospital purchasing group, with the listing of our drug renewed.
In the UK, sales grew modestly in the quarter. We see significant growth potential in this market and are restructuring our commercial footprint to capture it, with a stronger presence in London and the South East, where many high-potential hospitals are concentrated.
Distributor markets again delivered good growth in the quarter, this time led by South America.
Improved profitability year to date and significantly reduced cash burn
The third quarter is usually the weakest quarter from a sales perspective, and EBITDA is therefore lower before we enter the typically stronger fourth quarter. Nevertheless, ex-US EBITDA remains positive year-to-date, and we reconfirm our expectation to meet our financial guidance for the full year. Group EBITDA improved to -7.1 MSEK year-to-date, compared to -10.2 MSEK last year, corresponding to a margin of -5% (-7%). The gross margin was slightly lower in the quarter, as a delayed shipment increased the share of lower-margin contract manufacturing sales.
At the end of the quarter, we had a cash balance of 40 MSEK and, in addition, access to the 50 MSEK credit facility put in place with a local bank. Cash burn has been significantly reduced compared to the previous quarter, to approximately 14 MSEK from 30 MSEK in the second quarter. The second quarter was the final intensive period of the NDA submission. We have now entered a new phase in which we are responding to questions from the FDA, which has so far required considerably less cash.
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Looking ahead
We are entering an intense final quarter of the year. Our focus is on commercial execution in our core markets, building on the regained growth and accelerating it going forward, while navigating the FDA review towards the PDUFA date in April. We enter this period with a more focused commercial organization, and a US opportunity within reach.
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) Thursday Oct 22, 2026.
More info and link to the audiocast: https://www.finwire.tv/webcast/sedana-medical/q3-2026/
If you wish to participate via teleconference: +46 8 446 824 88. Meeting ID: 883 3639 6866 followed by #.