Sedana Medical Ab · OMXSTO:SEDANA
Sedana Medical Ab — Q2 2025 Earnings Presentation
20 slides from Sedana Medical Ab's earnings presentation, Jul 18, 2025
Slide 1: Q2 2025 Report
Q2 2025 Report Johannes Doll, CEO Johan Spetz, CFO Peter Sackey, CMO July 18th, 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 – a successful first half of 2025
Sedana Medical – a successful first half of 2025 Achieve growth in our Reach break-even Make headway Our 3 priorities ex-US business ex-US towards US approval • Best Q2 sales to date of • Q2 gross margin stable at • Primary endpoint met in 49,8 MSEK (+27%1 YoY / 70% both trials 21%1 organic) • EBITD
Slide 4: We delivered the best quarterly sales to date in both Q1 and Q2
We delivered the best quarterly sales to date in both Q1 and Q2 Net sales SEK million Full Year Successful restructuring 179 H1 after post-Covid-19 period 159 154 142 • Streamlined corporate headquarters and 123 improved overall spend effectiveness +22%1 72 • Shifted resources to the 58 frontline 10
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 -1 -1 -5 -1 • Progressing well towards -8 -10 -10 -10 -12 -4 -4 financial target
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: Strong sales growth in Germany
Strong sales growth in Germany Q2 Net Sales MSEK Comments Q2 • Germany grew sales by 19% in Q2, and 13% YTD • Strong improvement vs. 5% FY growth in 2024, when the business was affected by temporary vacancies and staff transition in the second half of 28,7 the year 25,4 19% excl. Fx • Team fully sta
Slide 8: Growth in Other Direct Markets driven by Spain
Growth in Other Direct Markets driven by Spain Q2 Net Sales MSEK Comments Q2 • Other Direct Markets grew sales by 22% in Q2, and 37% YTD • Continued strong growth in Spain, with a focused strategy to establish inhaled isoflurane sedation as mainstay therapy in high-potential accounts. 13,9 22% 12,1
Slide 9: Solid Q2 growth in Distributor Markets, following sales decline in Q1
Solid Q2 growth in Distributor Markets, following sales decline in Q1 Q2 Net Sales MSEK Comments Q2 • Distributor sales are generally more volatile due to irregular ordering patterns and higher stock levels. • Solid year-over-year growth in Q2, following sales decline in Q1 (which was driven by a So
Slide 10: Our paediatric study was published in the Lancet
Our paediatric study was published in the Lancet “Results of the current study showed that inhaled isoflurane sedation was non- inferior to intravenous midazolam for Summary – paediatric indication • In 13 European countries, the label of Sedaconda (isoflurane) now includes maintaining an adequate d
Slide 11: 31 prominent clinical trial sites were involved
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 12: The primary endpoint was met in both pivotal US studies
The primary endpoint was met in both pivotal US studies INSPiRE-ICU trial design High-level results INSPiRE-ICU 1 & 2 • Two identical phase III studies to confirm the efficacy and safety of inhaled isoflurane • In both studies, all analyses of the primary delivered via Sedaconda ACD, compared to IV
Slide 13: Secondary endpoint results were promising as well
Secondary endpoint results were promising as well (not yet peer-reviewed, more analyses to come) Results Relevance in practice • Greater opioid reduction • Opioids cause (dose-dependent) issues in the ICU, such as Clinical vs. baseline compared to constipation, respiratory depresssion, withdrawal an
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 • Currently, approximately access to an investigational sedate patients, the Early 10 prominent US medical product before full Access Program brings value:
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 Q2 2025
Financial result in Q2 2025 Net sales (MSEK, 12m rolling) Net sales Q2’25: 50 (41) MSEK, +21% y/y (+27% excl. fx) 200 • Sales excluding contract manufacturing of MSEK 47.1 (41.1), +15% y/y 180 (+21% excl. fx). 160 • Sales in Germany grew 13% y/y (19% excl. fx) as our acceleration plan 140 is showing
Slide 17: Cash flow and available funds
Cash flow and available funds Change in cash position (MSEK) excl effect of short-term deposits • Cash per June 30 2025: 131 MSEK compared to 165 MSEK at 40 Mar 31, 2024. Change in cash of -34 MSEK driven mainly by 20 capex of -17 MSEK (mainly US) and negative effects from 0 Of which change in chang
Slide 18: Largest shareholders June 30, 2025
Largest shareholders June 30, 2025 18 <
Slide 19: Investment case - why Sedana Medical?
Investment case - why Sedana Medical? High gross Proof of Growth Funded to margins concept opportunities execute our plan GM, in percent Cash 67 70 71 71 70 In SEK, end of Q2 2025 63 • The only approved 131M 2020 21 22 23 24 H1 25 inhaled sedation • Robust gross • Majority of German therapy for ICU
Slide 20: Q&A
6 sedanamedical Q&A