Sedana Medical Ab · OMXSTO:SEDANA
Sedana Medical Ab — Q3 2025 Earnings Presentation
20 slides from Sedana Medical Ab's earnings presentation, Oct 24, 2025
Slide 1: Q3 2025 Report
Q3 2025 Report Johannes Doll, CEO Johan Spetz, CFO Peter Sackey, CMO October 24, 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: Sedana Medical – on track to deliver on our goals
Sedana Medical – on track to deliver on our goals Achieve growth in our Reach break-even Make headway Our 3 priorities ex-US business ex-US towards US approval • Q3 sales of 41.2 MSEK • Q3 gross margin at 72% • Primary endpoint met and (+7%1 YoY / 1%1 organic) positive secondary • Integration of Inn
Slide 4: We delivered the best quarterly sales to date in all quarters YTD
We delivered the best quarterly sales to date in all quarters YTD Net sales SEK million Full Year Successful restructuring 179 Q1-Q3 after post-Covid-19 period 159 154 142 • Streamlined corporate +18%1 headquarters and 123 improved overall spend effectiveness 72 • Shifted resources to the 148 58 130
Slide 5: Over time, we have significantly improved our bottom line
Over time, we have significantly improved our bottom line EBITDA Ex-US Comments MSEK Group • Commercial focus and 2022 2023 2024 2025 restructuring measures have resulted in strong 4 bottom line improvement since 2022 0 -2 -1 -1 -5 -1 • Progressing well towards -8 -10 -10 -10 -12 -4 -4 financial tar
Slide 6: The company is on track to deliver on our financial target
The company is on track to deliver on our financial target Our prioritized geographies 2025 target Positive FY EBITDA ex-US (low-to-mid single digits) by sustaining Europe (direct markets) United States our growth trajectory and Ventilated adult maintaining strict cost ICU patients p.a. ~1 million >
Slide 7: Q3 Sales decline in Germany
Q3 Sales decline in Germany Net Sales MSEK Comments Q3 YTD • Germany sales were down 9% in the quarter, YTD growth is now at 6% 80,8 83,4 +6% • Good impact from sales acceleration plan in excl. Fx H1 (+13% growth), but market headwinds (lower patient numbers) leading to less use and thus later and s
Slide 8: Market headwinds from low patient numbers in Q3
Market headwinds from low patient numbers in Q3 Hospitalization rate for severe acute respiratory infections Comments Per 100,000 inhabitants in Germany Source: Robert Koch Institut • In Q1 and Q2, the flu season in Germany was 35 longer and more severe than 2024 30 • Since May, hospital Q3 admissio
Slide 9: Continued growth in Other Direct Markets
Continued growth in Other Direct Markets Net Sales MSEK Comments Q3 YTD • Other Direct Markets grew sales by 22% in Q2, and 32% YTD 47,8 • Continued strong growth in Spain, with a +32% focused strategy to establish inhaled isoflurane excl. Fx sedation as mainstay therapy in high-potential 37,2 accou
Slide 10: Flat development in Distributor Markets
Flat development in Distributor Markets Net Sales MSEK Comments Q3 YTD • Distributor sales are generally more volatile due to irregular ordering patterns and higher stock levels. 11,6 -7% 10,4 • Flat development in Q3 after solid year-over- excl. Fx year growth in Q2 and sales decline in Q1 (which w
Slide 11: 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 12: Prominent clinical trial sites were involved – building a strong platform for KOL engagement
31 prominent clinical trial sites were involved – 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 • Universit
Slide 13: Progress towards NDA submission on track
Progress towards NDA submission on track Progress towards US approval Upcoming milestones ✓ Two successful Phase III trials • Pre-NDA meeting with FDA scheduled in Q4 to ensure alignment on content, - Primary endpoint met in both studies format and expectations for the (incl. supplementary and sensi
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: Medical activities Jan-Oct 2025
Medical activities Jan-Oct 2025 • ABBSAT, Leipzig • DGAI kongress, Kassel • Intensivsymposium Bremen • Sedate and ventilate course, Reading • UK Webinar on inhaled sedation • SEMICYUC & SEEIUC, Valencia • GFO Intensivpflegetag, Hennef • SedUCI sedation course, Lleida • SCLMICYUC congreso, Valladolid
Slide 16: Financial result in Q3 2025
Financial result in Q3 2025 Net sales (MSEK, 12m rolling) Net sales Q3’25: 41.2 (39.7) MSEK, +4% y/y (+7% excl. fx) 200 • Sales excluding contract manufacturing of MSEK 38.8 (39.7), -2% y/y 180 (+1% excl. fx). 160 • Sales in Germany decreased 12% y/y (-9% excl. fx). Germany was 140 negatively impact
Slide 17: Cash flow and available funds
Cash flow and available funds Change in cash position (MSEK) excl short-term deposits • Cash per Sep 30 2025: 112 MSEK compared to 131 MSEK at 40 June 30, 2025. Change in cash of -19 MSEK driven by capex of 20 -15 MSEK (mainly US-related). 0 -20 • Cash flow from operations Q3’25: -1.1 (-29.3) MSEK.
Slide 18: Largest shareholders Sep 30, 2025
Largest shareholders Sep 30, 2025 18 <
Slide 19: 3 reasons to believe in Sedana Medical
3 reasons to believe in Sedana Medical A therapy with A growing core An opportunity to enter compelling benefits for business at the brink of the US, the highest patient and hospitals profitability potential market • Clinically proven benefits • All-time-high sales in FY • Positive results in both f
Slide 20: Q&A
6 sedanamedical Q&A