Sedana Medical Ab · OMXSTO:SEDANA
Sedana Medical Ab — Q4 2025 Earnings Presentation
20 slides from Sedana Medical Ab's earnings presentation, Feb 12, 2026
Slide 1: Q4 and FY 2025 Report
Q4 and FY 2025 Report Johannes Doll, CEO Johan Spetz, CFO February 12, 2025 <
Slide 2: Disclaimer
Disclaimer Forward-looking statements This presentation may contain certain forward-looking statements and forecasts based on uncertainty, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on Sedana Medical’s busines
Slide 3: We have delivered on our ambition to reach full-year profitability ex-US
We have delivered on our ambition to reach full-year profitability ex-US Our 3 priorities Achieve growth in our Reach break-even ex- Make headway ex-US business US during 2025 towards US approval • All-time-high FY net sales • First-time positive EBITDA • Primary endpoint met and of 200 MSEK (+16%1
Slide 4: We have accomplished a successful turn-around after Covid-19
We have accomplished a successful turn-around after Covid-19 Net sales EBITDA Ex-US Successful restructuring SEK million SEK million Group after Covid-19 +16%1 200 • Streamlined corporate 6 headquarters and improved 179 159 -17 overall spend effectiveness 154 -40 -10 • Shifted resources to the 123 f
Slide 5: We have met our financial target for 2025 and set a new ambitious target for 2026
We have met our financial target for 2025 and set a new ambitious target for 2026 Financial Target 2025 Communicated target: Result: Positive ex-US EBITDA (low-to-mid single digit +3% range) (+4% excl. FX effects) Financial Target 2026 Mid-to-high single digit ex-US EBITDA and approaching group-leve
Slide 6: With >30% growth, our 'Other Direct Markets' continued on their strong growth path
With >30% growth, our ‘Other Direct Markets’ continued on their strong growth path Net Sales MSEK Comments • Spain continued to be the main growth engine, Q4 2025 FY 2025 with an expanded team and a focused strategy to establish inhaled sedation as mainstay therapy in +27% high-potential accounts. •
Slide 7: Germany grew 3% in 2025, with two very different halves of the year
Germany grew 3% in 2025, with two very different halves of the year Net Sales MSEK Comments Q4 2025 FY 2025 • Germany had a split year, with strong performance in H1 (+13%), but sales decline in H2, leading to fully year growth of 3% 0% • Sales performance reflects the unusual swings in ICU patient
Slide 8: Market headwinds from low patient numbers since May have affected H2 performance in Germany
Market headwinds from low patient numbers since May have affected H2 performance in Germany Weekly number of severe acute respiratory infections with ICU treatment Comments Source: Robert Koch Institut, based on 64 Sentinel hospitals • Up until April 2025, the flu season in Germany 180 was longer an
Slide 9: Distributor markets delivered a strong Q4
Distributor markets delivered a strong Q4 Net Sales MSEK Comments Q4 2025 FY 2025 • Distributor market sales are generally more volatile due to irregular ordering patterns and higher stock levels +1% • Focus of 2025 activities was on providing targeted support to prioritized partners, laying the 14,
Slide 10: US approval would meaningfully expand our addressable market
US approval would meaningfully expand our addressable market Europe (direct markets) United States Ventilated adult ICU patients p.a. ~1 million >2 million Market potential inhaled sedation (low- to mid-single digit 3-4 BSEK 10-12 BSEK growth p.a.) Status • Only approved ICU therapy • Two successful
Slide 11: Our preparations for NDA submission are on track
Our preparations for NDA submission are on track Progress towards US approval Upcoming milestones ✓ Two successful Phase III trials • Successful pre-NDA meeting with FDA in Q4 2025, with good alignment - Primary endpoint met in both studies on content, format and expectations for (incl. supplementar
Slide 12: Secondary endpoints showed several potential benefits
Secondary endpoints showed several potential benefits (subject to approval and label decision by the FDA) Clinical results Relevance in practice • Greater opioid • Opioids cause (dose-dependent) issues in the ICU, such as constipation, respiratory depresssion, withdrawal and delirium reduction vs. b
Slide 13: 31 prominent sites were involved in the trials
31 prominent sites were involved in the trials – building a strong platform for KOL engagement and launch success INSPiRE-ICU1 INSPiRE-ICU2 • Vanderbilt • Rush University • University of Colorado • Columbia University • Cleveland Clinic • Massachusetts General Hospital • UT Southwestern • University
Slide 14: We are receiving good interest in our Early Access Program
We are receiving good interest in our Early Access Program The EAP Benefits Status update • An FDA pathway to gain Besides helping difficult to • Approximately 10 access to an investigational sedate patients, the Early prominent US hospitals medical product before full Access Program brings value: h
Slide 15: We are preparing for launching ourselves in the US
We are preparing for launching ourselves in the US Market Strategy • The United States have • Therefore, we are preparing to build a commercial a market potential of US subsidiary and launch our therapy 10-12 BSEK (vs. 3-4 ourselves BSEK in today’s direct - Keep control of our assets and capture mor
Slide 16: Financial result in Q4 2025
Financial result in Q4 2025 Net sales (MSEK, 12m rolling) Net sales Q4’25: 51.8 (49.2) MSEK, +5% y/y (+11% excl. fx) 200 • Sales excluding contract manufacturing of 50.5 (48.4) MSEK, +4% y/y 180 (+10% excl. fx). 160 • Sales in Germany decreased 10% y/y (-6% excl. fx). Germany was 140 negatively impa
Slide 17: Cash flow and available funds
Cash flow and available funds Change in cash position (MSEK) excl short-term deposits • Cash per year-end 2025: 91 MSEK compared to 112 MSEK at 40 Sep 30, 2025. 20 0 • Change in cash of -21 MSEK mainly driven by investments in -20 intangible assets of -11 MSEK, which are mainly US-related. -40 • Cas
Slide 18: Largest shareholders Dec 31, 2025
Largest shareholders Dec 31, 2025 18 <
Slide 19: 3 reasons to believe in Sedana Medical
3 reasons to believe in Sedana Medical A therapy with A profitable and An opportunity to enter compelling benefits for growing core business the US, the highest patient and hospitals in Europe potential market • Clinically proven benefits • All-time-high sales in FY • Positive results in both for ve
Slide 20: A secanamedical
A secanamedical