Sedana Medical Ab · OMXSTO:SEDANA
Sedana Medical Ab — Q4 2024 Earnings Presentation
21 slides from Sedana Medical Ab's earnings presentation, Feb 13, 2025
Slide 1: Q4 and FY 2024 Report
Q4 and FY 2024 Report Johannes Doll, CEO Johan Spetz, CFO Peter Sackey, CMO February 13, 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: Q4 Summary: primary endpoint met in both US trials and positive ex-US EBITDA
Q4 Summary: primary endpoint met in both US trials and positive ex-US EBITDA excl. one-offs in Q4 Our 3 priorities Achieve growth in our Reach break-even ex- Make headway ex-US business US during 2024 towards US approval • All-time-high FY net sales of • Q4 ex-US EBITDA improved • Positive high-leve
Slide 4: 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 • In both studies, all analyses of the primary the efficacy and safety of inhaled isoflurane endpoint demonstrated non-inferiority delivered via
Slide 5: 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 6: Sedana Medical delivered all-time high sales in 2024
Sedana Medical delivered all-time high sales in 2024 Net sales SEK million 179 Successful restructuring after post-Covid-19 period 159 154 +17%1 142 • Streamlined corporate 123 headquarters and improved overall spend effectiveness 72 • Shifted resources to the 58 frontline • Steered investments towa
Slide 7: At the same time, we have significantly improved our bottom line
At the same time, we have significantly improved our bottom line Sales 2022 2023 2024 Comments MSEK • Commercial focus and restructuring measures have resulted in strong 45 49 49 38 37 41 40 bottom line improvement 34 36 34 27 27 after highest loss in the company’s history in 2022 Q1 Q2 Q3 Q4 Q1 Q2
Slide 8: The acquisition of our main supplier Innovatif Cekal
The acquisition of our main supplier Innovatif Cekal is another building block towards profitability The deal Strategic rationale Financial impact • In Q4, we acquired • The acquisition of IC is a • Over time (once stock Innovatif Cekal, our good strategic fit and from pre-closing is main supplier b
Slide 9: We have met our financial targets 2024
We have met our financial targets 2024 Net Sales FY 2024 Communicated target: Result: 17-20% 17%. Net Sales growth excl. fx (increased from 14-18%) EBITDA Communicated target: Result: Break-even Reached in Q1 and Q4 (excl. one-off cost1) in our ex-US EBITDA during 2024 1 One-off cost: legal cost ass
Slide 10: We have set a new financial target for 2025
We have set a new financial target for 2025 Our prioritized geographies 2025 target Positive Europe (direct markets) United States FY EBITDA ex-US (low-to-mid single digits) Ventilated adult ICU patients p.a. ~1 million >2 million by sustaining our growth trajectory and Market potential inhaled seda
Slide 11: Our 'other direct markets' continued on their strong growth path
Our ‘other direct markets’ continued on their strong growth path Net Sales MSEK Comments Q4 2024 FY 2024 • Spain continued to be the main growth engine, with an expanded team and a focused strategy to establish inhaled sedation as mainstay therapy in +48% high-potential accounts. • UK has seen a sur
Slide 12: Germany grew 5% in 2024, with a flat Q4
Germany grew 5% in 2024, with a flat Q4 Net Sales MSEK Comments Q4 2024 FY 2024 • Germany grew sales by 5% in 2024, but flat development in Q4 • Soft FY growth driven by unusually low number +5% of ventilated patients in June and temporary vacancies and staff transition in the second half 106 110 •
Slide 13: Distributor markets delivered first full-year growth since 2021
Distributor markets delivered first full-year growth since 2021 Net Sales MSEK Comments Q4 2024 FY 2024 • Distributor market sales are generally more volatile due to irregular ordering patterns and higher stock levels +15% • Soft Q4, mostly due to timing of orders 13,4 • But first full-year growth f
Slide 14: Approval for 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 15: We are preparing for launching inhaled sedation ourselves in the US
We are preparing for launching inhaled sedation 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 asset
Slide 16: Inhaled sedation is well positioned for the US market access landscape
Besides the clinical benefits, inhaled sedation is well positioned for the US market access landscape 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’s
Slide 17: Financial result in Q4 2024
Financial result in Q4 2024 Net sales (MSEK, 12m rolling) Net sales Q4’24: 49 (45) MSEK, +10% y/y (+10% excl. fx) • Sales in Germany were unchanged 0% y/y (-1% excl. fx) in Q4 driven 200 180 by temporary vacancies and staff transition in the second half of 2024. 160 • Other direct markets report gro
Slide 18: 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 Dec 31 2024: 194 MSEK compared to 226 MSEK at 40 end-Q3. Change in cash of -32 MSEK driven by capex of -30 20 MSEK (mainly US) and acquisition of Innovatif Cekal -25. Offset 0 -20 -25
Slide 19: Largest shareholders December 31, 2024
Largest shareholders December 31, 2024 19 <
Slide 20: 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 In SEK, end of Q4 2024 63 194M 2020 2021 2022 2023 2024 • Robust gross • Majority of German • The only approved • Financed to execute margins of our ICU
Slide 21: Q&A
6 sedanamedical Q&A