Sedana Medical Ab · OMXSTO:SEDANA
Sedana Medical Ab — Q3 2024 Earnings Presentation
21 slides from Sedana Medical Ab's earnings presentation, Oct 24, 2024
Slide 1: Q3 2024 Report
Q3 2024 Report Johannes Doll, CEO Johan Spetz, CFO Peter Sackey, CMO October 24, 2024 <
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: Q3 Summary: raising FY sales guidance and integrating European trial into US submission
Q3 Summary: raising FY sales guidance and integrating European trial into US submission Our 3 priorities Achieve growth in our Reach break-even ex- Make headway ex-US business US during 2024 towards US approval • YTD net sales of 130 MSEK • Q3 ex-US EBITDA improved • Enrolment of both US clinical (+
Slide 4: Sedana Medical has returned to a strong growth path
Sedana Medical has returned to a strong growth path – on track to deliver all-time high sales in 2024 Net sales Full Year SEK million YTD Successful restructuring Raised guidance (17-20% growth1) after post-Covid-19 period 159 154 142 • Streamlined corporate headquarters and 123 +19% improved overal
Slide 5: 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 • Restructuring measures have resulted in strong bottom line 45 49 38 37 41 40 improvement after 34 36 34 27 27 highest loss in the company’s history in 2022 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 • Q3 EBIT
Slide 6: The acquisition of our main supplier Innovatif Cekal will be another building block towards profitability
The acquisition of our main supplier Innovatif Cekal will be another building block towards profitability The deal Strategic rationale Financial impact • We will acquire Innovatif • The acquisition of IC is a • Over time (once stock Cekal, our main supplier good strategic fit and from pre-closing is
Slide 7: We are raising our FY sales guidance
We are raising our FY sales guidance Net Sales FY 2024 Communicated target: Status: 14-18% 19% YTD, raising FY sales guidance to Net Sales growth (excl. fx) 17-20%. EBITDA Communicated target: Status: Break-even Reached in Q1, negative ex-US EBITDA in Q2 in our ex-US EBITDA and Q3 due to seasonally
Slide 8: Germany has returned to growth in Q3
Germany has returned to growth in Q3 Net Sales Q3, MSEK Comments • Q3 sales were 9% above last year in local currency, YTD sales are up 7%. 25,6 24,2 • Sales level in Q3 at approximately the same level as in +6% Q2, while the average German ICU reported a seasonal decline of patients by 9%. • Contin
Slide 9: Other direct markets continued on their strong growth trajectory
Other direct markets continued on their strong growth trajectory Net Sales Q3, MSEK Comments • Spain continued to be the main growth engine, fuelled by strong commercial execution, favourable treatment 11,6 guidelines and pricing & reimbursement approval. We are continuing to invest in an expansion
Slide 10: Our distributor markets continued to deliver solid growth
Our distributor markets continued to deliver solid growth Net Sales Q3 2024, MSEK Comments • Distributor markets showed YoY growth for the fourth quarter in a row after a period of 2,5 declining sales. Main reason for the previous decline was high stock levels built up during 2,0 +24% Covid-19. • Th
Slide 11: The US represents our largest potential growth opportunity
The US represents our largest potential growth opportunity The US is by far our largest commercial opportunity Status • Both clinical trials in the US have completed enrolment in less than two Europe (direct markets) United States years respectively Ventilated adult • Long-term follow-up ICU patient
Slide 12: We will integrate our European trial into the US submission
We will integrate our European trial into the US submission Recent FDA input Our Decision Implications • FDA recommends to • Follow the FDA’s advice • Enhanced data include an additional to integrate the package, with clinical pooled efficacy analysis European trial data for 300 additional of all 3
Slide 13: The first step will be a feasibility phase, followed by execution of the proposed pooling strategy
The first step will be a feasibility phase, followed by execution of the proposed pooling strategy Approach to follow FDA’s Additional work compared to recommendation previous scope • Conduct a feasibility study to • Feasibility study determine the technical and clinical • Mapping and conversion of
Slide 14: 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 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: Most significant inhaled sedation presentations globally in Q3
Most significant inhaled sedation presentations globally in Q3 • Extracorporeal Life Support Organisation congress – Detroit, US • New England Critical Care Pharmacotherapy Symposium – Boston, US • Pan American and Iberian Federation of Critical Care Medicine and Intensive Therapy – webinar • Extrac
Slide 17: Financial result in Q3 2024
Financial result in Q3 2024 Net sales (MSEK, 12m rolling) Net sales Q3’24: 40 (34) MSEK, +16% y/y (+20% excl. fx) • Sales in Germany increased by 6% y/y (9% excl. fx) and reached 200 180 approx. the same sales level as in Q2 despite 9% less average ICU 160 patients (as per the typical seasonal patte
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 Sep 30 2024: 226 MSEK compared to 304 MSEK at 40 the beginning of the quarter. Change in cash of -78 MSEK driven 20 by capex (mainly US clinical study) of -36 (-42) MSEK, change in 0
Slide 19: Largest shareholders September 30, 2024
Largest shareholders September 30, 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 Q3 63 226M 2020 2021 2022 2023 2024 YTD • Robust gross • Majority of German • Clinical benefits vs. • Financed to execute margins of our
Slide 21: Q&A
6 sedanamedical Q&A