Sedana Medical Ab · OMXSTO:SEDANA
Sedana Medical Ab — Q2 2021 Earnings Presentation
36 slides from Sedana Medical Ab's earnings presentation, Aug 19, 2021
Slide 1: Q2 Report 2021
Q2 Report 2021 Interim CEO & Commercial Director Jens Lindberg CMO Peter Sackey CFO Susanne Andersson August 19th, 2021 <
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 bus
Slide 3: Q2 2021 Highlights
Q2 2021 Highlights • Sedaconda launch well on track - European approval of Sedaconda (isoflurane) received & first national approval achieved in France – Appr. 1-3 months to receive approval in the 15 individual countries. – Appr. 3 months to products on shelf following national marketing authorisat
Slide 4: Our Purpose and Vision
Our Purpose To improve life during and beyond sedation Our Vision To make Inhaled Sedation a global standard therapy for critical care patients <
Slide 5: A new tagline & symbol to signal the significance of our journey
A new tagline & symbol to signal the significance of our journey <
Slide 6: Sedana Medical Vision & Strategic Evolution
Sedana Medical Vision & Strategic Evolution To make inhaled sedation a global standard therapy for critical care patients Extend; Level 4 Expand; Level 3 Inhaled Sedation a new standard treatment for ICUs Show superiority vs IV sedation around the world. Establish; Level 2 with new IIT & sponsored p
Slide 7: Sales Development Q2 2021
Sales Development Q2 2021 3% Sales growth YoY in local currencies 37% Sales growth 12 months rolling in local • Sales 40 (41) MSEK, 3% sales growth YoY in local currencies, (-2% in reported numbers) currencies • Substantial growth in Latin America, Mexico second largest market in Q2, increase in COV
Slide 8: Rapidly increasing adoption and usage despite off-label status
Rapidly increasing adoption and usage despite off-label status Case study: AnaConDa/Sedaconda ACD in Germany Increasing use globally • In 2010, new guidelines for sedation were published in Germany. • The guidelines put forward inhalation sedation and the use of isoflurane as an alternative to IV se
Slide 9: Continued influx of new customers during Q2
Continued influx of new customers during Q2 despite signs of ”COVID- fatigue” & more ICU beds being equipped with Gas Monitors # of new ICU customers during Q2 in Direct Sales Markets Share of ICU Beds in Direct Sales Markets with Gas Monitor 1 New ICU customer/day ~11% (+1%) ICU Beds w/o Gas Monito
Slide 10: 1H 21 sales in Germany much less dependent on COVID-19
1H 21 sales in Germany much less dependent on COVID-19 than in 1H 20 with stable sales doubled vs 1H 19 # of ICU Patients in Germany with COVID-19 from outbreak Monthly sales in Germany 2,0 Peak April 26 1,5 MEUR 1,0 0,5 0,0 Jan Feb Mar Apr May Jun 2019 2020 2021 <
Slide 11: 1H sales in other direct sales markets
1H 21 sales below 1H 20 sales in other Direct sales markets but importantly, more than 3 times higher than same periods 2019 # of ventilated patients in UK from outbreak 1H Sales in Other Direct sales Markets (excl Germany) 2,0 Peak January 21 >50% in 1,5 month of April MEUR 1,0 0,5 0,0 2018 2019 20
Slide 12: Sedaconda achieving regulatory approvals faster than expected
Sedaconda achieving regulatory approvals faster than expected with strong product label support Label approved for Sedaconda/ DCP approval First market Sedaconda ACD only achieved in 200 days, authorisation without time significantly faster achieved in France limitation & strong than normal review j
Slide 13: Inhaled Sedation with Sedaconda is here
Inhaled Sedation with Sedaconda® is here Sedaconda, delivered via the Sedaconda ACD, is the only approved inhaled sedation therapy for use during intensive care. Fast and Hepatic and renal Rapid and effective independent predictable sedation elimination wake-up <
Slide 14: First Sedaconda on shelf anticipated Nov/Dec
First Sedaconda on shelf anticipated Nov/Dec with price & reimbursement processes adding some launch delay in select markets National Sedaconda on shelf Price & reimbursement Approvals first markets processes finalised Aug/Sep ~Nov/Dec ~Q1 Aug Sep Oct Nov Dec Jan Feb Mar <
Slide 15: Sales organisation buildup in preparation for regulatory approvals
Sales organisation buildup in preparation for regulatory approvals Sedana Medical applies a direct sales model to key markets with plans to cover 15 EU countries in time for approval SEDANA MEDICAL CURRENT DIRECT SALES ORGANISATION SEDACONDA LAUNCH EUROPE o Submission in 15 EU countries November 202
Slide 16: Medical Highlights
% sedanamedical MEDICAL HIGHLIGHTS
Slide 17: The Sedaconda Study (SED001)
THE SEDACONDA STUDY First results from SEDACONDA® - A phase III multicenter randomized controlled trial evaluating efficacy and safety of isoflurane via the Anaesthetic Conserving Device for sedation in invasively ventilated patients (SED001) A Meiser1; T Volk1; U Günther2; R Knafeli4; M Bellgardt3;
Slide 18: Primary Endpoint: Sedation Efficacy
Primary Endpoint: Sedation Efficacy center randomized controlled trial e Anaesthetic Conserving Device key5; and SEDACONDA study group6 arlandes, Homburg, 2Klinikum Oldenburg, Carl-von-Ossietzky AND; 4MICU, University MedicalComparable Center, time spent in the target RASS range Ljubljana, SCHWEDEN;
Slide 19: Lower opioid requirements with isoflurane, shorter wake-up time
Propofol group: bla Methods Lower opioid requirements with isoflurane, with similar pain scores in both groups & shorter • Study design:and more predictable wake-up time ky Conclusi na, • open-label de • Sh ort er an d more p red ict ab le wake-u p t ime wit h isoflu ran e • non-inferiority SEDACO M
Slide 20: Spontaneous breathing more common with isoflurane
Spontaneous breathing more common with isoflurane Estimated rate of spontaneous breathing Day 1: • Isoflurane 50.3% • Propofol 37.0% (p=0.013) Day 2: • Difference not statistically significant (p=0.131) <
Slide 21: Adverse Events
Adverse Events • Almost all events of hypertension, delirium, and agitation Most common AEs Isoflurane Propofol occurred shortly after stopping study sedation, deemed to be related to the rapid washout of the drug. Hypertension 6.7% 1.3% Delirium 5.3% 4.6% Oliguria 4.7% 4% • 17 Serious Adverse Event
Slide 22: Summary of findings
Summary of findings • Time spent in the target RASS range without rescue sedation was similar in isoflurane and propofol groups • Opioid requirements were lower with isoflurane (with no indication of increased pain as shown by BPS scores) • Spontaneous breathing was more frequent in isoflurane group
Slide 23: A strong SmPC, the foundation for all promotional communication
A strong SmPC, the foundation for all promotional communication No 48 hour limitation Sedaconda ACD the only approved device in combination with Sedaconda “No effect on the exposure of isoflurane in patients with impaired hepatic and/or renal function anticipated” “Rapid and predictable onset of and
Slide 24: Clinical Development
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Slide 25: Combination registration of Sedaconda in USA
Combination registration of Sedaconda in USA 505 (b) (2) approval pathway The FDA has accepted that Sedana Medical is taking the 505 (b) (2) path to registration, which somewhat simplifies the use of previously collected data. FDA positive about combined registration Randomized, assessor-blinded stu
Slide 26: Non-clinical program for US IND and NDA
Non-clinical program for US IND and NDA 1. Long-term (rodent and non-rodent) exposure studies prior to IND • No findings of concern to date • Studies on track for IND Q4 2021 2. Studies for NDA • Pre- and Post-natal Development study – ongoing • 28-day (rodent, non-rodent) repeated exposure studies
Slide 27: US Human factors program for IND and NDA
US Human factors program for IND and NDA 1. Formative phase (requirement for to IND) • First formative study completed spring 2021 • Second formative study September 2021 2. Validation phase (after IND), planned for spring 2022 • Based on findings from the formative phase • Not mandatory for IND and
Slide 28: Development programme to support regulatory approvals
Development programme to support regulatory approvals 2019 2020 2021 2022 2023 2024 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 SED001 Sedaconda (Europe adult) SED002 Iso-COMFORT (Europe pediatric) FPI July 2017 FPI Q1 2021 LPO Feb 2020 LPO Q2 2022 Report Q2 2020 Report H
Slide 29: Timeline – registration activities in Europe and US
Timeline – registration activities in Europe and US NDA/ MAA Combi- Approval nation product Approval 2021 2022 2023 2024 • Marketing approval of Sedaconda in • Completion of IsoCOMFORT • Pediatric European marketing 15 countries approval of Sedaconda • IsoCOMFORT (paediatric study) • Second round of
Slide 30: Preliminary study site map US Clinical Trials
Preliminary study site map US Clinical Trials <
Slide 31: Financial Highlights
% sedanamedical FINANCIAL IG LIG TS
Slide 32: Financial results
Financial results 1) Investing for future Gross profit development Net sales Q2’21: 40 (41) MSEK, -2% YoY, +3% in local currencies Net sales 1H’21: 85 (74) MSEK, +14% YoY, +20% in local currencies Gross Profit Q2’21: 26 (26) MSEK Gross Margin Q2’21: 66 (64) % • Improved margin due to larger proporti
Slide 33: Financial balances and Cash
Financial balances and Cash 1) • Cash flow from operations Q2’21: -12 (2) MSEK Cash flow from operations 1H’21: -25 (-6) MSEK • Cash flow from investment Q2’21: -23 (-18) MSEK Cash flow from investment 1H’21: -44 (-32) MSEK of which the vast majority is related to product development. • Cash flow fo
Slide 34: Largest shareholders June 30, 2021
Largest shareholders June 30, 2021 No of share Share Handelsbanken Funds 8 495 052 9,2% Swedbank Robur Funds 8 314 933 9,0% A split (4:1) was made at the end of May 2021 Linc AB 7 598 804 8,2% Anders Walldov direct and 7 100 000 7,7% indirect (Brohuvudet AB) Ola Magnusson direct and 4 613 728 5,0% i
Slide 35: Q2 2021 Highlights
Q2 2021 Highlights • Sedaconda launch well on track - European approval of Sedaconda (isoflurane) received & first national approval achieved in France – Appr. 1-3 months to receive approval in the 15 individual countries. – Appr. 3 months to products on shelf following national marketing authorisat
Slide 36: Questions
% sedanamedical QUESTIONS