Sedana Medical Ab · OMXSTO:SEDANA
Sedana Medical Ab — Q1 2025 Earnings Presentation
20 slides from Sedana Medical Ab's earnings presentation, May 6, 2025
Slide 1: Q1 2025 Report
Q1 2025 Report Johannes Doll, CEO Johan Spetz, CFO Peter Sackey, CMO May 6th, 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 – strong progress across our 3 priorities
Sedana Medical – strong progress across our 3 priorities Achieve growth in our Reach break-even Make headway Our 3 priorities ex-US business ex-US towards US approval • Best quarterly sales to date • Q1 Gross margin stable at • FDA approval for Early in Q1 2025 of 57,5 MSEK 71% Access Program (+18%1
Slide 4: In Q1, we delivered the best quarterly sales to date
In Q1, we delivered the best quarterly sales to date Net sales SEK million Full Year Successful restructuring 179 Q1 after post-Covid-19 period 159 154 142 • Streamlined corporate headquarters and 123 improved overall spend 130 effectiveness 72 • Shifted resources to the 58 57 frontline +18% • Steer
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 -1 -1 -5 -1 • In Q1 2025, ex-US EBITDA -8 -10 -10 -12 -4 -11 margin was 7% (8% exc
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: Germany is back to growth
Germany is back to growth Net Sales MSEK Comments Q1 2025 • Germany grew sales by 8% in Q1 2025, after 5% FY growth in 2024 and flat Q4, 2024 • Business was affected by temporary vacancies +8% and staff transition in the second half of 2024 32,0 • Team fully staffed again and sales acceleration 29,8
Slide 8: 'Other Direct Markets' continued on their strong growth path
‘Other Direct Markets’ continued on their strong growth path Net Sales MSEK Comments Q1 2025 • Spain continued to be the main growth engine, with an expanded team and a focused strategy to establish inhaled sedation with isoflurane as mainstay therapy in high-potential accounts. +49% • UK has seen a
Slide 9: Distributor markets showed a significant decline due to large S. American order last year
Distributor markets showed a significant decline due to large S. American order last year Net Sales MSEK Comments Q1 2025 • Distributor market sales are generally more volatile due to irregular ordering patterns and higher stock levels -39% • Significant sales decline in Q1, partly driven by a South
Slide 10: FDA has approved our Early Access Program
FDA has approved our Early Access Program Expanded Access Program Eligible patients Benefits An FDA pathway to gain “Difficult-to-sedate" patients, The Early Access Program will access to an investigational when targeted sedation be beneficial in several ways medical product... cannot be maintained
Slide 11: Primary endpoint met in both pivotal US studies
Primary endpoint 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 endpoint
Slide 12: 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 13: 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 14: Besides the clinical benefits, inhaled sedation with isoflurane is well positioned for US market access
Besides the clinical benefits, inhaled sedation with isoflurane is well positioned for US market access Fit with hospital Wide-spread Fit with existing reimbursement preference for opioid treatment mechanism sparing therapies recommendations • DRG (“diagnoses-related • Much higher awareness of • CDC
Slide 15: We have received approval for our paediatric indication and a further year of market protection
We have received approval for our paediatric indication and a further year of market protection Approvals Market protection • In December, we received a positive • Sedaconda® (isoflurane) has received decision from the authorities that the an additional year of market paediatric indication of Sedaco
Slide 16: Financial result in Q1 2025
Financial result in Q1 2025 Net sales (MSEK, 12m rolling) Net sales Q1’25: 57 (49) MSEK, +18% y/y (+18% excl. fx) • Sales in Germany grew 8% y/y (8% excl. fx) in Q1’25 against a strong 200 180 comparator in Q1’24, as our acceleration plan is showing effect. 160 • Other direct markets report growth o
Slide 17: Cash flow and available funds
Cash flow and available funds Change in cash position (MSEK) excl 2021 cap. raise and short-term deposits • Cash per Mar 31 2025: 165 MSEK compared to 194 MSEK at 40 Dec 31, 2024. Change in cash of -29 MSEK driven by capex of - 20 0 17 MSEK (mainly US) and negative currency effects of 16 MSEK Total
Slide 18: Largest shareholders March 31, 2025
Largest shareholders March 31, 2025 18 <
Slide 19: Investment case - why Sedana Medical?
Investment case - why Sedana Medical? High gross Proof of Growth Strong balance margins concept opportunities sheet GM, in percent Cash 67 70 71 71 71 In SEK, end of Q1 2025 63 • The only approved 165M 2020 21 22 23 24 2025 inhaled sedation • Robust gross • Majority of German therapy for ICU • Finan
Slide 20: Q&A
6 sedanamedical Q&A