US/UK/Canada

Share

Contacts

  • Johannes Doll

    President & CEO


    +46 (0)76 303 66 66
    http://www.sedanamedical.com
    • Pick a time period -
    Tags ( Active)

    Sedana Medical AB’s Interim report January-June 2024

    Enrolment of both US clinical trials completed, on track for first results in 2H.Second quarter 2024 · Net sales for the quarter totaled MSEK 41.1 (37.3), equivalent to an increase of 10% compared to the same quarter 2023. At constant exchange rates, sales increased by 10%. · Gross profit was MSEK 29.0 (26.6) equivalent to a margin of 71% (71%). · Earnings before interest, taxes, depreciation and amortization (EBITDA) totaled MSEK -13.9 (-10.7), equivalent to an EBITDA margin of -34% (-29%). EBITDA ex-US for the quarter was MSEK -10.8 (-10.2) corresponding to a margin of -26% (-

    Sedana Medical to acquire its main supplier to take control of supply chain and reduce cost of goods

    Sedana Medical AB (publ) announces it has today entered into an agreement to acquire Innovatif Cekal, the supplier of the company’s main product (Sedaconda ACD). The acquisition will enable better control of the supply chain and improved profitability by reducing the cost of goods sold. The purchase price of 34 MSEK on a cash and debt free basis will be financed with existing cash.“I am excited about acquiring Innovatif Cekal as this transaction is a perfect fit with our strategy. After streamlining our non-customer-facing functions and implementing a vigorous shift of resources towards the

    Invitation to presentation of Sedana Medical’s interim report for the second quarter 2024

    Sedana Medical AB (publ) plans to present its interim report for the second quarter of 2024 on Tuesday July 23 at 13:30 CET.According to the financial calendar, Sedana Medical plans to publish the interim report for the second quarter 2024 on Tuesday July 23 at approximately 07.00 CET. Sedana Medical hereby invites to a presentation of the report on the same day, where the CEO Johannes Doll will present the report in English together with Johan Spetz, CFO, and Peter Sackey, CMO, as well as answer questions.   Date: Tuesday, July 23, 2024 Time (CET): 13:30   More info and link

    Sedana Medical completes patient recruitment for its clinical program in the US

    Sedana Medical AB (publ) announces that all 235 randomized patients have been recruited for its INSPiRE-ICU 2 phase III clinical trial in the United States. Earlier this spring, Sedana Medical reported the completion of enrolment to the parallel phase III clinical trial INSPiRE-ICU 1. The company anticipates topline results from both trials in the second half of 2024, with a planned New Drug Application (NDA) submission in the first quarter of 2025.“The completion of INSPiRE-ICU 2 concludes Sedana Medical´s clinical trials in the United States. Running this study together with esteemed

    Report from Sedana Medical’s annual general meeting on 22 May 2024

    Sedana Medical AB (publ)’s annual general meeting was held on Wednesday, 22 May 2024 and the main resolutions passed were the following.Regarding full details of the resolutions, referral is made to the notice convening the general meeting and the complete proposals. The notice convening the general meeting and the complete proposals are available at the company’s website, www.sedanamedical.com.   Adoption of the income statements and the balance sheets The general meeting resolved to adopt the income statement and balance sheet and the consolidated income statement and

    Sedana Medical AB's Interim report January-March 2024

    Off to a strong start with record sales in Q1First quarter 2024 · Net sales for the quarter totalled MSEK 48.8 (37.8), equivalent to an increase of 29% compared to the same quarter 2023. At constant exchange rates, sales increased by 28%. · Gross profit was MSEK 34.8 (27.5) equivalent to a margin of 71% (73%). The decrease is mainly due to product mix effects. · Earnings before interest, taxes, depreciation and amortisation (EBITDA) totalled MSEK -1.0 (-10.7), equivalent to an EBITDA margin of -2% (-28%). EBITDA ex-US for the quarter was MSEK 1.6 (-10.1) corresponding to a margin

    Sedana Medical completes patient recruitment for INSPiRE-ICU 1 clinical trial in the US

    Sedana Medical AB (publ) announces that all 235 randomized patients have been recruited for its INSPiRE-ICU 1 phase III clinical trial in the United States. Concurrently, the identical INSPiRE-ICU 2 trial is nearing completion, with 23 of 235 randomized patients remaining. The company anticipates topline results from both trials in the second half of 2024, with a planned New Drug Application (NDA) submission in the first quarter of 2025.“The completion of the INSPiRE-ICU 1 study marks a true milestone for Sedana Medical. Launching the randomized controlled multicenter studies across the

    Notice of Annual General Meeting in Sedana Medical

    The board of directors of Sedana Medical AB (publ) has resolved to convene an annual general meeting of shareholders to be held Wednesday, 22 May 2024. Further details on the proposals can be found in the notice convening the meeting, below. The notice is expected to be published in the Swedish Official Gazette (Post- och Inrikes Tidningar) and on the company’s website within the next few days.NOTICE OF ANNUAL GENERAL MEETING IN SEDANA MEDICAL AB (PUBL)   The annual general meeting of Sedana Medical AB (publ) will be held on Wednesday, 22 May 2024 at 2:00 pm at Vendevägen 89,

    Sedana Medical publishes its Annual Report for 2023

    Sedana Medical AB (publ) publishes its Annual Report for 2023. The Annual Report describes important events and financial information for 2023, as well as the progress the company has made on its strategic priorities during the year.“During the year 2023, Sedana Medical took several important steps towards becoming a stronger and healthier company. We have returned to consistent sales growth after the challenging post-Covid period, we have taken decisive steps towards reaching profitability in our ex-US business, and we are making progress towards our launch on the US market – our single

    Invitation to presentation of Sedana Medical’s interim report for the first quarter 2024

    Sedana Medical AB (publ) plans to present its interim report for the first quarter of 2024 on Thursday April 25 at 13:30 CET.According to the financial calendar, Sedana Medical plans to publish the interim report for the first quarter 2024 on Thursday April 25 at approximately 07.00 CET. Sedana Medical hereby invites to a presentation of the report on the same day, where the CEO Johannes Doll will present the report in English together with Johan Spetz, CFO, and Peter Sackey, CMO, as well as answer questions. Date: Thursday, April 25, 2024 Time (CET): 13:30 More info and link to

    Sedana Medical AB’s Year-end report 2023

    Full year sales at upper end of financial guidance and an exciting year aheadFourth quarter 2023 · Net sales for the quarter totalled MSEK 44.5 (35.8), equivalent to an increase of 24% compared to the same quarter 2022. At constant exchange rates, sales increased by 18%. · Gross profit was MSEK 31.0 (25.7) equivalent to a margin of 70% (72%). · Earnings before interest, taxes, depreciation and amortisation (EBITDA) totalled MSEK -9.1 (-17.6), equivalent to an EBITDA margin of -20% (-49%). EBITDA ex-US for the quarter was MSEK -8.1 (-17.4) corresponding to a margin of -19% (-49%).

    Invitation to presentation of Sedana Medical’s fourth quarter and year-end report for 2023

    Sedana Medical AB (publ) plans to present its fourth quarter and year-end report for 2023 on Thursday February 15 at 13:30 CET.According to the financial calendar, Sedana Medical plans to publish the fourth quarter and year-end report for 2023 on Thursday February 15 at approximately 07.00 CET. Sedana Medical hereby invites to a presentation of the report on the same day, where the CEO Johannes Doll will present the report in English together with Johan Spetz, CFO, and Peter Sackey, CMO, as well as answer questions. Date: Thursday, February 15 2024 Time (CET): 13:30 More info and

    Sedana Medical files submission for paediatric indication

    Sedana Medical AB (publ) announces that the company has submitted a Type II variation with the aim of including the paediatric population (3-17 years) into the existing Sedaconda[®] indication for inhaled sedation of mechanically ventilated patients in Europe.The submission is based on the results of the IsoCOMFORT trial, a randomised active-controlled assessor-blinded study comparing the efficacy and safety of sedation with inhaled isoflurane, administered via the company’s medical device Sedaconda ACD-S, with intravenous midazolam in mechanically ventilated patients 3 to 17 years old.

    Sedana Medical secures data exclusivity and market protection for Sedaconda[®] (isoflurane) until 2031

    Sedana Medical AB (publ) announces that the European Medicines Agency’s Paediatric Committee has issued a positive opinion regarding the compliance with the company’s Paediatric Investigation Plan. This confirms data exclusivity and market protection for Sedana Medical’s Sedaconda[®] (isoflurane) until 2031.In 2021, Sedana Medical’s proprietary pharmaceutical Sedaconda (isoflurane) received its first market authorization in Europe for administration via the medical device Sedaconda ACD for inhaled sedation of mechanically ventilated patients in intensive care. As part of the approval,

    Key results of Sedana Medical’s paediatric study IsoCOMFORT published

    Sedana Medical AB (publ) today announces that the main results from the paediatric IsoCOMFORT study have been published in the Clinical Trials Registry EudraCT.IsoCOMFORT was a randomised active-controlled assessor-blinded study comparing the efficacy and safety of sedation with inhaled isoflurane, administered via the company’s medical device Sedaconda ACD-S, with intravenous midazolam in mechanically ventilated paediatric patients 3 to 17 years old. The primary endpoint was to compare the time that the targeted sedation depth was maintained. Key secondary endpoints included opioid

    Sedana Medical AB’s Interim report January-September 2023

    All-time-high Q3 sales and further steps towards ex-US profitabilityThird quarter 2023 · Net sales for the quarter totalled MSEK 34.3 (26.5), equivalent to an increase of 29% compared to the same quarter 2022. At constant exchange rates, sales increased by 16%. · Gross profit was MSEK 23.9 (18.4) equivalent to a margin of 70% (70%). · Earnings before interest, taxes, depreciation and amortisation (EBITDA) totalled MSEK -12.6 (-25.1), equivalent to an EBITDA margin of -37% (-95%). EBITDA ex-US for the quarter was MSEK -11.5 (-22.8). · Operating income (EBIT) totalled MSEK -18.1

    Sedana Medical’s Nomination Committee established

    According to the principles for the appointment of the Nomination Committee in Sedana Medical AB (publ), the Nomination Committee for the Annual General Meeting 2024 shall be composed of members appointed by the three largest shareholders as of September 30, along with the Chairman of the Board of Directors.The composition of the Nomination Committee has now been established, and Sedana Medical today announces that the Nomination Committee for the 2024 Annual General Meeting consists of: · Claus Bjerre, Chairman of the Board · Karl Tobieson, appointed by Linc AB · Patrik Walldov,

    The SESAR investigator-initiated trial completes patient enrollment

    Sedana Medical AB (publ) today announces that the enrollment of the planned 700 patients in the SESAR trial has been completed. The trial Sevoflurane for Sedation in Acute Respiratory Distress Syndrome: A Multicenter Prospective Randomized Trial (SESAR) is an investigator-initiated trial (IIT) that is supported in part by Sedana Medical and by the French Ministry of Health.The SESAR trial, comparing sevoflurane via the Sedaconda ACD with intravenous propofol for up to 7 days is led by professor Matthieu Jabaudon and his team from Clermont Ferrand, France. The patient population consists of

    Sedana Medical receives market approval in the UK

    The Medicines and Healthcare products Regulatory Agency (MHRA) has granted Sedana Medical AB (publ) marketing authorization for the company’s pharmaceutical product Sedaconda[®] (isoflurane) in the United Kingdom.This market approval will enable Sedana Medical to sell Sedaconda® (isoflurane) in the UK and to promote the clinical and health economic benefits of its therapy for inhaled sedation in intensive care. The medical device Sedaconda ACD has been sold in the UK for several years, and the company submitted the application for marketing authorization for Sedaconda® (isoflurane) in early

    Invitation to presentation of Sedana Medical’s interim report for the third quarter 2023

    Sedana Medical AB (publ) plans to present its interim report for the third quarter of 2023 on Thursday October 26 at 13:30 CET.According to the financial calendar, Sedana Medical plans to publish the interim report for the third quarter 2023 on Thursday October 26 at approximately 07.00 CET. Sedana Medical hereby invites to a presentation of the report on the same day, where the CEO Johannes Doll will present the report in English together with Johan Spetz, CFO, and Peter Sackey, CMO, as well as answer questions.   Date: Thursday, October 26, 2023 Time (CET): 13:30   More

    Sedana Medical receives US patent for Sedaconda ACD-S

    Sedana Medical AB (publ) announces that the US Patent and Trademark Office (USPTO) has granted Sedana Medical a patent for the medical device Sedaconda ACD-S (US Patent No. 11,707,593 B2). The patent will run until 2037.Sedaconda ACD-S is the main device in Sedana Medical’s therapy for inhaled sedation of mechanically ventilated patients in intensive care units. With an estimated market potential of 10-12 billion SEK, the United States constitutes the largest potential commercial opportunity for Sedana Medical. The company is currently conducting the INSPiRE-ICU Phase III clinical program

    Sedana Medical’s CEO and CFO acquire shares in the company

    Sedana Medical AB’s (publ) CEO Johannes Doll and CFO Johan Spetz have each acquired 100,000 shares in the company from the founders Ola Magnusson and Sten Gibeck. The transactions were done on 25 September 2023 at a price of SEK 18 per share, corresponding to a value of 1.8 MSEK per transaction. After the transactions, Ola Magnusson owns 4.4% and Sten Gibeck owns 4.2% of the shares in Sedana Medical.For additional information, please contact:Johannes Doll, CEO, +46 (0)76 303 66 66Johan Spetz, CFO, +46 (0)730 36 37 89ir@sedanamedical.com       About Sedana Medical Sedana

    Sedana Medical AB’s Interim report January-June 2023

    Strong sales momentum and a clear target to achieve EBITDA break-even in our Ex-US business during 2024Second quarter 2023 · Net sales for the quarter totalled MSEK 37.3 (26.9), equivalent to an increase of 39% compared to the same quarter 2022. At constant exchange rates, sales increased by 27%. · Gross profit was MSEK 26.6 (18.9) equivalent to a margin of 71% (70%). · Earnings before interest, taxes, depreciation and amortisation (EBITDA) totalled MSEK -10.7 (-23.9), equivalent to an EBITDA margin of -29% (-89%). · Operating income (EBIT) totalled MSEK -16.3 (-29.8),

    There are no items matching the current filter
    There are no more items matching the current filter
    Back to top

    Subscribe