Sedana Medical Ab · OMXSTO:SEDANA
Sedana Medical Ab — Q1 2023 Earnings Presentation
21 slides from Sedana Medical Ab's earnings presentation, Apr 27, 2023
Slide 1: Q1 2023 Report
Q1 2023 Report Johannes Doll, CEO Peter Sackey, CMO Johan Spetz, CFO April 27, 2023 <
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 busin
Slide 3: Q1 Highlights: we have made progress against all 3 priorities for the year
Q1 Highlights: we have made progress against all 3 priorities for the year 2023 priorities Bring Sedana Medical Get closer to break- Make headway back on a growth path even ex-US towards US approval Progress in Q1 • First growth quarter post- • Gross margin of 73% (up • INSPiRE-ICU clinical trials C
Slide 4: Q1 2023 was the first growth quarter after Covid-19
Q1 2023 was the first growth quarter after Covid-19 Net sales SEK million Comments 159 Full Year • Covid-19 resulted in a Q1 trend-break in the long- 142 term sales development 123 • Lower sales in 2022 due 72 to a significant decline in 58 ventilated ICU patients (both Covid and non- +12% Covid) 45
Slide 5: In Q1, we show growth in all our direct markets
In Q1, we show growth in all our direct markets Sales bridge Q1 2023 vs. Q1 2022 SEK million Comments Germany: Return to organic growth despite -2,2 less ICU patients +3,4 37,8 Other direct markets: Positive organic growth in all +12% direct markets, strongest growth +2,9 33,7 in Spain Distributor m
Slide 6: Market dynamics: patient numbers gradually normalize, but some headwinds remain
Market dynamics: patient numbers gradually normalize, but some headwinds remain Market dynamics in 2022 Update • Significantly less intubated • Still less ventilated ICU Less ICU patients throughout patients in Q1 compared to patients 2022 (both Covid and non- last year, but gap is Covid) narrowing
Slide 7: In Q1, we continued to see less ICU patients and ventilated Covid-19 patients, but gaps are narrowing
In Q1, we continued to see less ICU patients and ventilated Covid-19 patients, but gaps are narrowing ICU patients1 Ventilated Covid-19 patients Germany, average per day 2022 Germany, average per day 2022 2023 2023 8.000 2 500 7.500 2 000 -74% 7.000 1 500 6.500 1 000 6.000 500 -5% 0 0 January Februa
Slide 8: Despite some recent improvement, ICUs are still operating under constrained conditions
Despite some recent improvement, ICUs are still operating under constrained conditions (Germany example) Status in German ICUs Regular operations Number of ICUs Partly restricted operations Restricted operations 1 100 1 000 900 800 700 600 500 400 300 200 100 0 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 20
Slide 9: Regulatory approvals for Sedaconda (isoflurane) have been secured in 17 out of 18 countries
Regulatory approvals for Sedaconda (isoflurane) have been secured in 17 out of 18 countries Key Regulatory Pricing/reimb. Drug markets approval approval launch Germany Spain Q2/3 France UK Nordics Benelux Italy (distr.) H2 9 <
Slide 10: Good progress in Spain with Pricing/Reimbursement approval and updated treatment recommendations
Good progress in Spain with Pricing/Reimbursement approval and updated treatment recommendations Pricing and reimbursement Treatment algorithm • In April, the Spanish Ministry of • The Spanish intensive care society Health has granted Sedaconda SEMICYUC has issued new (isoflurane) pricing and treatm
Slide 11: We are making progress towards break-even
We are making progress towards break-even Gross margin Operating expenses1 EBITDA Percent of net sales MSEK MSEK 70 70 72 73 44,3 44,0 68 39,6 41,2 38,9 -10,7 -16,4 -17,6 -23,9 -25,1 Q1 Q2 Q3 Q4 Q1 Q1 Q2 Q3 Q4 Q1 Q1 Q2 Q3 Q4 Q1 22 22 22 22 23 22 22 22 22 23 22 22 22 22 23 Our goal is to reach break-
Slide 12: United States: FDA has granted Sedana Medical Fast Track Designation (FTD)
United States: FDA has granted Sedana Medical Fast Track Designation (FTD) FTD for Sedaconda Possible benefits • US development program • Clinical programs with Fast has received Fast Track Track Designation may Designation by FDA in benefit from January - Frequent communication • The purpose of an
Slide 13: Our INSPIRE-ICU trials are progressing according to plan, and we still aim at a launch in early 2025
Our INSPIRE-ICU trials are progressing according to plan, and we still aim at a launch in early 2025 2022 2023 2024 2025 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 INSPiRE-ICU 1 First patient in: April 2022 INSPiRE-ICU 2 First patient in: June 2022 NDA Submission NDA Approval US launch 13 <
Slide 14: Investigator-initiated trials – SESAR expected to complete enrollment this year
Investigator-initiated trials – SESAR expected to complete enrollment this year • Isoflurane and delirium (INASED) study – 145 patients recruited to date (250 planned) • Sevoflurane in ARDS (SESAR) study – 639 patients recruited to date (700 planned) – Enrollment completion expected in 2023 • Inhale
Slide 15: Recruitment has been completed for our paediatric study (IsoCOMFORT)
Recruitment has been completed for our paediatric study (IsoCOMFORT) IsoCOMFORT study Updates • The IsoCOMFORT study compares the • The last IsoCOMFORT patient was efficacy and safety of inhaled sedation enrolled in January with IV midazolam for sedation of mechanically ventilated ICU patients • Hig
Slide 16: Medical presence at meetings Q1 2023
Medical presence at meetings Q1 2023 • Stuttgart, Germany - Stuttgarter Invensivkongress F2F • Brussels, Belgium – ISICEM – F2F, Inhaled sedation workshop, Frontiers in sedation meeting • Berlin, Germany Forum Interdisziplinäre Intensivmedizin F2F • Bremen, Germany Symposium Intensivmedizin 2023 – F
Slide 17: Financial result in Q1 2023
Financial result in Q1 2023 Net sales (MSEK, 12m rolling) Net sales Q1’23: 38 (34) MSEK, +12% y/y (+5% excl. FX). 180 160 • Sales in Germany increased by 13% y/y (6% excl. FX), despite fewer 140 ventilated ICU patients. 120 • Other direct markets showed growth of 61% y/y (52% excl. FX), and all 100
Slide 18: Cash flow, cash balance and short-term deposits
Cash flow, cash balance and short-term deposits Cash flow (MSEK) excl 2021 cap. raise and allocation to short-term deposits • Cash flow from operations Q1’23: -7 (-28) MSEK, of which cash 40 flow from working capital of +3 MSEK mainly related to payments 20 from customers. 0 -20 • Cash flow from inv
Slide 19: Largest shareholders March 31, 2023
Largest shareholders March 31, 2023 19 <
Slide 20: Investment case - why Sedana Medical?
Investment case - why Sedana Medical? High gross Proof of Growth Strong balance margins concept opportunities sheet FY GM, in percent Cash and short-term 70 73 deposits 63 67 In SEK 560M 2020 2021 2022 Q1 2023 • Gross margins have • Majority of German • Clinical benefits vs. • Financed to execute in
Slide 21: Q&A
6 sedanamedical Q&A