Q3 2022 Report

Johannes Doll, CEO

Peter Sackey, CMO

Johan Spetz, CFO

October 25, 2022

Disclaimer

  • Forward-lookingstatements
  • 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 business, financial condition and results of operations. The terms "anticipates", "assumes", "believes", "can", "could", "estimates", "expects", "forecasts", "intends", "may", "might", "plans", "should", "projects", "will", "would" or, in each case, their negative, or other variations or comparable terminology are used to identify forward-looking statement. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied in a forward-looking statement or affect the extent to which a particular projection is realized. Factors that could cause these differences include, but are not limited to, implementation of Sedana Medical's strategy and its ability to further grow, risks associated with the development and/or approval of Sedana Medical's products candidates, ongoing clinical trials and expected trial results, the ability to further commercialize Sedaconda ACD and Sedconda (isoflurane), technology changes and new products in Sedana Medical's potential market and industry, the ability to develop new products and enhance existing products, the impact of competition, changes in general economy and industry conditions and legislative, regulatory and political factors.
  • No assurance can be given that such expectations will prove to have been correct. Sedana Medical disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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Why Sedana Medical?

Attractive fundamentals for significant value creation

  • High gross margins (70%) will yield attractive profits when we reach scale
  • Proof of concept: Germany already shows a high local EBITDA margin

Foundation laid for scale-up

  • Only approved therapy for inhaled sedation in ICUs in Europe, based on unique device
    • Proven clinical benefits vs. current standard of care (intravenous sedation)
    • Health-economicbenefits, confirmed by NICE
  • Clinical program underway in US, our largest-potential market

Positive momentum despite temporary market contraction

  • 69% higher YTDsales than 2019 (pre-pandemic)
  • Sales growth in direct markets in Q3
  • ~3new customers per week YTD and strong customer retention

Fully financed to deliver on strategic plan

  • Strong cash position of 676 MSEK, noneed to raise money
  • Started cost saving program in overhead and admin functions (while ring-fencing investments in sales growth)

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Q3 2022 Highlights

Financial performance

Launch in Europe underway

U.S. studies progressing

  • Net sales of SEK 27 million (-6%), explained by significantly lower sales in South America
  • Germany, our other direct markets and distributor markets outside South America showed positive growth
  • Gross margin of 70% (up from 68%) despite cost pressure in the supply chain, driven by price adjustment and management of freight cost
  • Cash balance of SEK 676 million
  • Sedaconda (isoflurane) now available in Germany, Sweden,
    Norway, the Netherlands, France and Slovenia
  • Local pricing and reimbursement process is progressing in Spain, with an ambition to launch around the turn of the year
  • Received approval in Switzerland, still awaiting approvals in Poland (expected Q4), Italy (expected end of year), and UK (delayed to 2023 due to high workload at MHRA)
  • Received MDR certification for Sedaconda ACD
  • INSPIRE-ICUtrials ongoing, majority of sites actively recruiting
  • Aiming at "last patient out" in Q4 next year and approval in 2024 (assuming patient recruiting according to plan)

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We still see less ventilated patients in the ICU (Germany example)

ICU patients1

Ventilated Covid-19 patients

Germany, average per day

Germany, average per day

6.147

5.560

-10%

436

349

-20%

Q3 '21

Q3 '22

Q3 '21

Q3 '22

1 Includes High-Care and ECMO setting

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Source: divi daily reports

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Sedana Medical AB published this content on 25 October 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 25 October 2022 10:43:38 UTC.