- Interim Summary
- Annual & Interim Reports
- Corporate Governance
President and CEO
2020 was, to say the least, an exceptional year, as a result of the COVID-19 pandemic, which posed great challenges. As far as Sedana Medical is concerned, I am proud that we succeeded in helping medical care in many places around the world in 2020. In addition, our therapy really had an opportunity to show how much it can offer, both to individual patients and to medical care as a whole.
The fourth quarter was notable for intensive work, firstly with activities ahead of the launch of Sedaconda in Europe during the second half of 2021 and secondly with preparations ahead of our future phase III studies in the United States.
The COVID-19 pandemic has a great impact on our entire business operation, as ICU sedation is precisely the therapy that severely ill COVID-19 patients often need. As our therapy potentially leads to fewer side effects and better oxygen uptake in the lungs, demand for AnaConDa and its accessories was strong during the year. An additional factor contributing to strong demand is that the therapy contributes to increased patient capacity in ICU, which has been important during the pandemic.
Sales showed strong increase in the quarter by as much as 129 percent (137% excluding currency effects), to SEK 46 million, and sales for the full year doubled to SEK 142 million. We interpret this as indicating that the initial sales pressure due to the pandemic has increased again as a result of a second wave with a rise in the number of COVID-19 patients in intensive care units, but also that the ICUs, including new ones, are continuing to use our therapy for patients other than those being treated for COVID-19. We are also seeing an increase in demand in new regions such as Central and South America as a consequence of their severe COVID-19 situation.
The results for some of the secondary endpoints in the phase III study forming the basis for clinical registration Sedaconda (SED-001) were presented at the ESICM congress in December. The secondary endpoints show that Sedaconda (isoflurane) enables faster and controlled recovery, reduced need for opiates and a higher proportion of spontaneous breathing compared with propofol. A high proportion of spontaneous breathing is important as it improves the prospects of lung function being maintained during and other ventilator therapy.
The Sedaconda study was designed as a non-inferiority study, which means that its primary purpose is to show that our therapy is not inferior to propofol in maintaining an adequate sedation level. Based specifically on the study design, the good results for the study’s secondary endpoints were not something we had anticipated. We have seen in previous studies that inhaled sedation has a faster and predictable recovery time, but it is highly positive to have this confirmed in a large, randomised study. Being able to reduce the use of opiates for these patients and make spontaneous breathing possible using the therapy is of great clinical significance. The full results of the study will be presented in a scientific journal in 2021.
The top-line results reported in July 2020 show that Sedaconda, delivered via AnaConDa, is an effective and safe method of sedation for mechanically ventilated intensive care patients comparable to propofol. The results will form the basis for the application for market approval for the drug candidate Sedaconda for inhaled sedation in intensive care units that we submitted in November to the German regulatory authority BfArM and a number of other European regulatory authorities under what is known as a DCP procedure.
The application marks the starting point for the review process for Sedaconda in 15 EU Member States, including Norway. If all goes well, we anticipate authorisation during the second half of 2021. An application for a second group of EU Member States can then be submitted. It normally takes around six months to obtain authorisation for a second group of countries.
When we obtain marketing authorisation for Sedaconda, we will be able to exclusively launch the inhaled sedation therapy in Europe. The therapy consists of our pharmaceutical product Sedaconda , which will then be authorised to only be administrated via our medical device AnaConDa. We chose Sedaconda as the name to highlight the link to Sedana Medical and the pharmaceutical product’s unique use in sedation. At the same time, we communicate that the pharmaceutical product is to be delivered via AnaConDa by retaining CONDA in the name.
The European authorisation will provide very good support in future registration processes in other markets where we are working to make inhaled sedation a standard method within intensive care. After the end of the quarter, we submitted applications to Switzerland and the United Kingdom, which following Brexit works solely with national applications. Our work on the European study has taught us a lot that we benefit from in the design and execution of the American studies, for example.
Now that we are approaching commercialisation in Europe, our work has been focused on launching activities in Europe, while our work in the United States has also intensified, albeit on preparations ahead of the phase III studies. We are working towards being able to submit an IND (Investigational New Drug) application during the summer of 2021 to obtain authorisation to begin the studies. IND authorisation is conditional on the commenced toxicity studies being completed. It is therefore gratifying to be able to note that these studies have progressed at a good pace and according to plan. Depending on how the pandemic develops, we anticipate being able to obtain IND authorisation during the summer in order to be able to include the first patient in each study during the second half of 2021.
A further patent for AnaConDa was granted during the quarter. The technique protected by the patent enables what is known as dead space to be reduced, using inserts and is key to the continued development of inhaled sedation. A decrease in dead space for mechanically ventilated patients is always desirable for intensive care, as it makes lung-protective ventilation possible in comparison with higher dead space. As well as seeing great clinical benefits, we are greatly strengthening our patent protection with this patent. Any competitors or ordinary, passive HME filters will not be able to reduce their dead spacing using inserts without infringing our new patent. The patent has been granted in Europe, and we have also filed a patent application in the United States and other countries.
I would like to take the opportunity to thank all the employees for their great contribution during an intensive and challenging 2020. The fourth quarter has really laid the foundation for a very exciting 2021, with the launch in Europe and the first patients being included in our clinical trials in the United States.
I look forward to coming back to you during the year.
Christer Ahlberg, President and CEO
Read the report in its entirety here.
Dates for upcoming information
|15 April, 2021||Annual report 2020|
|6 May, 2021||Q1 interim report 2021|
|10 May, 2021||Annual General Meeting|
|12 August, 2021||Q2 interim report 2021|
|4 November, 2021||Q3 interim report 2021|
Annual & Interim Reports
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Annual General Meeting 2021
Annual General Meeting 2020
Annual General Meeting 2019
Annual General Meeting 2018
Corporate governance includes information about our Board of Directors, the management team, guidelines for remuneration to the senior management, our auditors, general meetings and our articles of association.
Board of Directors
The registered office of the company is situated in the municipality of Danderyd. The Board of Directors shall consist of not less than three (3) and not more than six (6) members.
|Thomas Eklund Chairman
of the Board
of the Board
|Bengt Julander Member
of the Board
of the Board
|Eva Walde Member
of the Board
|Christoffer Rosenblad Member
of the Board
President and CEO
|Sylvia Buddenbaum Eriksson
|Robert vom Dorp
Vice President Business Development
Chief Technology Officer
Supply Chain and Manufacturing Director
Vice President Commercial Operations
Vice President Regulatory Affairs and QA
Guidelines for remuneration to senior management
The main principle is that remuneration and other employment conditions for members of senior manage¬ment shall be based on market terms and be competitive in order to ensure that the group can attract and retain competent senior managers at a reasonable cost for the company.
The total remuneration for senior management shall consist of fixed salary, variable remuneration, pension and other benefits.
The Board fee is decided by the Annual General Meeting. In so far as board members elected by the Annual General Meeting are performing work that stretches beyond the tasks of the Board of Directors, it shall be possible to pay them for such work. Such remuneration shall be market-based and shall be approved by the Board of Directors.
The remuneration to the Board of Sedana Medical is determined at the Annual General Meeting following proposals from the Nomination Committee.
During 2020 an audit committee was established. On behalf of the Board, the Audit Committee monitors and reviews the following:
- The scope and correctness of the financial statements
- Compliance with legal and regulatory requirements
- Internal control over financial reporting
- Risk management
- The Annual Report and interim reports
- Audits and audit fees
Members of the Audit Committee
The Audit Committee consists of three Board members as appointed by the Board. The current members are:
Christoffer Rosenblad (Chairman of the Committee)
Öhrlings PricewaterhouseCoopers AB was elected as auditors at the Annual General Meeting in May 2020 for the period leading up to the Annual General Meeting 2020. The principal responsible is authorized public accountant Leonard Daun.
Fees for auditing in Sedana Medical are determined at the AGM following proposals from the Nomination Committee.
The General Meeting of shareholders is the highest decision-making entity in Sedana Medical AB. At the General Meeting, all shareholders are invited to exercise their rights according to their respective shareholdings.
Shareholders wishing to participate in General Meetings must be listed as a shareholder in a printout or other presentation of the entire share register reflecting the circumstances five weekdays before the General Meeting and notify the company no later than the date specified in the notice of the General Meeting. A shareholder may be accompanied by advisers at a General Meeting only if he or she notifies the company of the number of advisers in accordance with the procedure prescribed for in respect of notice of attendance to be made by a shareholder.
ARTICLES OF ASSOCIATION OF SEDANA MEDICAL AB (PUBL)
Reg. no. 556670-2519
Adopted at the annual general meeting held on 19 May 2020
§ 1 Name of the company
The name of the company is Sedana Medical AB (publ).
§ 2 Registered office of the board of directors
The registered office of the company shall be situated in the municipality of Danderyd.
§ 3 Object of the company’s activities
The object of the company’s activities is to develop, manufacture and market pharmaceuticals and medical- technical products, and other activities compatible therewith.
§ 4 Share capital
The share capital shall be not less than SEK 800,000 and not more than SEK 3,200,000.
§ 5 Number of shares
The number of shares shall be not less than 8,000,000 and not more than 32,000,000.
§ 6 Board of Directors
The board of directors shall consist of not less than three (3) and not more than six (6) members. The members are to be elected annually at the annual general meeting until the end of the next annual general meeting.
§ 7 Auditors
The company shall have a minimum of one (1) and a maximum of two (2) auditors, with a maximum of two (2) deputy auditors. A registered accounting firm may also be appointed as auditor.
§ 8 Place of General Meetings
Any general meeting in the Company shall be held in Danderyd or Stockholm.
§ 9 Notice of General Meeting
Notices of general meetings shall be made by announcement in the Swedish Official Gazette (Sw. Post- och Inrikes Tidningar) and by making the notice available on the company’s website. At the same time as notice is given it shall be announced in Dagens industri that a notice has been made.
Shareholders wishing to participate at a general meeting shall notify the company no later than the date specified in the notice of the general meeting. Such date may not be a Sunday, other public holiday, Saturday, Midsummer’s Eve, Christmas Eve or New Year’s Eve and may not occur earlier than the fifth weekday before the general meeting. A shareholder may be accompanied by advisors at a general meeting only if he or she notifies the company of the number of advisors in accordance with the procedure prescribed for in respect of notice of attendance to be made by a shareholder.
§ 10 Annual General Meeting
The following matters shall be addressed at the annual general meeting:
1. Election of chairman of the meeting
2. Preparation and approval of the voting register
3. Election of one or two persons to attest the minutes
4. Determination of whether the meeting has been duly convened
5. Approval of the agenda
6. Presentation of the annual report and auditor’s report and, where applicable, the consolidated financial statements and the auditor’s report on the group
7. Resolutions regarding:
(a) adoption of the balance sheet and income statement and, where applicable, the consolidated balance sheet and the consolidated income statement
(b) allocation of the company’s profit or loss according to the adopted balance sheet
(c) discharge from liability for board members and the managing director
8. Determination of fees to be paid to the board of directors and the auditors
9. Determination of the number of board members and, where applicable, deputy members, and the number of auditors and, where applicable, deputy auditors
10. Election of the board of directors and auditors
11. Any other business incumbent on the meeting according to the Swedish Companies Act or the articles of association
§ 11 Financial year
The company’s financial year shall be 1 January – 31 December.
§ 12 CSD clause
The shares of the company shall be registered in a CSD register in accordance with the Central Securities Depositaries and Financial Instruments Accounts Act (Sw. lagen (1998:1479) om värdepapperscentraler och kontoföring av finansiella instrument).
Click here to download the Articles of Association.
Below is Sedana Medical’s ownership structure.
|Name||Num. of shares||Capital||Votes||Verified|
|Swedbank Robur Funds||2,110,895||9.16%||9.16%||2021-03-31|
|Linc AB (Bengt Julander)||1,899,701||8.24%||8.24%||2021-03-31|
|Third Swedish National Pension Fund||475,000||2.06%||2.06%||2021-03-31|
|Total number of owners||6,536||2021-03-31|
|Total number of shares||23,046,740||2021-03-31|
Source: Modular Finance
Sedana Medical has outstanding warrant programmes with a total maximum dilution of 136 818 shares.
Warrant program 2019/2022, total maximum dilution of 89 085 shares,
exercisable 1 July to 30 November 2022 at a strike price of 142.23 SEK per share.
Warrant program 2020/2023, total maximum dilution of 10 620 shares,
exercisable 1 July to 30 November 2023 at a subscription price of SEK 334.60 per share.
Warrant program 2020/2024, total maximum dilution of 37 113 shares,
exercisable 1 February to 31 May 2024 at a subscription price of SEK 495.52 per share.
|Feb 25, 2021||Sedana Medical – webcast Q4 report.||More info|
|Nov 26, 2020||Sedana attending Redeye Life Science Day 2020.||Play Video|
|Nov 17-19, 2020||Sedana attending 11th Annual Jefferies Global Healthcare Conference.||More info|
|Nov 5, 2020 – 14:00||Sedana Medical – webcast Q3 report.||More info|
|Sept 9, 2020||Sedana attending Carnegie Virtual Nordic Small Mid Cap Seminar.||View Program|
|Sept 2-3, 2020||Sedana attending Pareto Securities’ 11th Annual Healthcare Conference.||More info|
|Sept 1, 2020||Sedana attending Danske Bank Small & Mid Cap Seminar.||Play Video|
|July 10, 2020||Presentation of the positive top line result in the pivotal IsoConDa study.||Play Live Stream|
|May 19, 2020||CEO presentation in connection with AGM 2020-05-19.||Play Video|
|May 7, 2020||Presentation of the interim report for the first quarter 2020.||Play Video|
|April 8, 2020||Sedana Medical’s CEO on prioritizing in the Corona crisis.||Play Video|
|November 27, 2019||VATOR SECURITIES UNICORN SUMMIT 2019.||Play Video|
|September, 2019||Sedana Medical – Management Presentation September 2019.||View Presentation|
|June 10, 2019||Redeye Growth Day 2019.||Play Video|
|May 8, 2019||Presentation of the interim report for the first quarter 2019.||Play Video|
|March 14, 2019||Stockholm Corporate Finance Life Science Seminar.||Play Video|
|March 8, 2019||IsoConDa phase III pivotal study, interim analysis report, 8 March 10:30.||Play Video|
|September 6, 2018||Pareto Securities’ 9th Health Care seminar in Stockholm.||Play Video|
|April 27, 2018||Event at ProHearings (English).||Play Video|
|March 7, 2018||Sitdown at Erik Penser 2018 (Swedish).||Play Video|
|March 6, 2018||Stockholm Corporate Finance Life Science Seminar (Swedish).||Play Video|
|November 24, 2017||Redeye seminar (Swedish).||Play Video|
|June 29, 2017||Trading Direkt Interview with CEO Christer Ahlberg (Swedish).||Play Video|
7 490 MSEK
|Return this year||
|Total return this year||
|The LEI code is:||549300FQ3NJRI56LCX32|
|Certified Adviser:||Erik Penser Bank – Tel: +46 (0)8-463 80 00 – Apelbergsgatan 27, Box 7405, 103 91 Stockholm, Sweden|
|Analyst(s) covering Sedana Medical:||Peter Östling, Pareto Securities|
Sedana Medical Investor Relation
Sedana Medical AB (publ)
SE-182 32 Danderyd
Phone: +46 (0)8-124 05 200
Investor relation: email@example.com