Sedana Medical Year-end Report, January – December 2018. - Strong growth and positive registration work development

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“The fourth quarter and 2018 have been eventful, but in many ways, it is only the start of our journey. I look forward with excitement to the future.” - Christer Ahlberg, President and CEO Sedana Medical (publ)

Fourth quarter, October – December 2018

  •  Net sales during the fourth quarter amounted to 15 242 (10 796) KSEK corresponding to an increase of 41% compared with the same period in 2017.
  •  Earnings before interest, taxes, depreciation and amortisation (EBITDA) amounted to -1 474 (-838) KSEK. This corresponds to an EBITDA margin of -9,7% (-7,8%).
  •  Earnings before interest and taxes (EBIT) amounted to -2 450 (-1 912) KSEK, which corresponds to an EBIT margin of -16,1% (-17,7%)
  •  Cash flow from operations before changes in working capital amounted to -1 250 (-960) KSEK.
  •  Cash flow from investment activities amounted to -7 431 (-7 965) KSEK.
  •  Cash flow for the period amounted -15 787 (-4 906) KSEK.
  •  Liquid funds at the end of the period amounted to 159 351 (85 322) KSEK.

January – December 2018

  •  Net sales during full year 2018 increased to 57 896 (40 428) KSEK corresponding to an increase of 43% compared with full year 2017.
  •  EBITDA amounted to -4 232 (-736) KSEK and the EBITDA margin was -6,5% (0,3%).
  •  EBIT amounted to -8 238 (-3 488) KSEK and the EBIT margin was -14,2% (-8,6%).
  •  Cash flow from operations before change in working capital amounted -2 761 (-4 232) KSEK.
  •  Cash flow from investment activities amounted to -29 127 (-25 882) KSEK.
  •  Cash flow for the period amounted to 73 869 (76 953) KSEK.

Significant events during October – December

  • Sedana Medical received market approval for AnaConDa in Japan.
  • Sedana Medical presented a health economic analysis at the European Conference for Health Economics and Outcomes Research 2018 (ISPOR) in Barcelona, showing clinical and economic benefits of inhaled isoflurane sedation via AnaConDa versus conventional intravenous sedation with propofol or midazolam.

Significant events after the reporting period 

  • Sedana Medical has been approved for its planned pediatric study from the Pediatric Committee of EMA, European Medicines Agency, (PDCO).
  • Sedana Medical announced on the 8th of March 2019 the results of the interim analysis for the company's pivotal phase III study which shows smaller variations in efficacy than anticipated and the study will therefore only need to cover a total of 300 patients instead of initially estimated 550 patients.

Please find the full year-end report at: www.sedanamedical.com under Investors.

Sedana Medical will hold a telephone conference at 10:30 am (CET) today Tuesday.
To participate, please dial: +46 8 505 583 51
Or join us at: https://tv.streamfabriken.com/2019-03-12-sedana-medical-press-conference 

For additional information, please contact:

Christer Ahlberg, CEO, Sedana Medical AB
+46 70 675 33 30
christer.ahlberg@sedanamedical.com

Maria Engström, CFO, Sedana Medical AB
+46 70 674 33 30
maria.engstrom@sedanamedical.com

Thomas Eklund, Chairman of the Board, Sedana Medical AB
+46 70 824 20 25
thomas.eklund@investorab.com

Sedana Medical is listed on Nasdaq First North in Stockholm. 
The company's Certified Adviser is Erik Penser Bank, +46 8 463 83 00, certifiedadviser@penser.se.

This information is such that Sedana Medical AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact persons above, on March 12, 2019 at 7:00 a.m. (CET). 

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Sedana Medical AB (publ) has developed and sells the medical device AnaConDa, for the administration of volatile anaesthetics to mechanically ventilated patients. A major clinical registration study is currently ongoing to obtain market approval in Europe for inhalation sedation in intensive care units with the pharmaceutical IsoConDa® (isoflurane).

Sedana Medical has direct sales in the Nordic countries, Germany, France, Great Britain and Spain as well as external distributors in the rest of Europe, Canada, Australia, Japan and South Korea. The company headquarters are based in Stockholm, Sweden with R&D operations in Ireland.

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