- Interim Summary
- Annual & Interim Reports
- Corporate Governance
President and CEO
Sedana Medical is working to develop inhaled sedation with AnaConDa and IsoConDa to become a new global standard therapy in intensive care. The third quarter began in the best way with positive top line-results from our pivotal phase 3 study SED-001 which is the basis for the registration of our upcoming drug for inhaled sedation – the most important milestone for the company in many years. In addition, the business continued to be characterized by the covid-19 pandemic but also by intensive work, partly with completing the application for a European marketing approval but also with preparations for our upcoming US expansion.
The Covid-19 pandemic puts a strong stamp on our entire business since ICU sedation is just the treatment that seriously ill covid-19 patients often need. As our treatment leads to potentially fewer side effects and better oxygen uptake in the lungs, demand for AnaConDa and accessories has been strong during the year. An additional contributing factor to the strong demand is that the treatment contributes to increased patient capacity in ICU units, which was important during the pandemic.
The sales increase during the quarter was 31 percent in SEK (39% adjusted for currency fluctuations), which we interpret as the initial sales pressure due to the pandemic has decreased in line with the reduced number of covid-19 patients in the intensive care units, although the clinics continue to demand our treatment for patients other than covid-19 patients.
Sales have been strong in most European countries. Even outside Europe, including Canada and Mexico, there has been great interest and sales are gradually increasing. The increased interest is probably, to some extent, an effect of the pandemic, but also due to the fact that we have a new distributor in Mexico. In Canada, we now have a wide range of clinics that use AnaConDa, among other things in a new investigator-initiated trial.
Our strategic planning for how to achieve our vision to make inhaled sedation a new global standard therapy in intensive care is based on 3 steps:
Our registration study, SED-001, is the single largest advance in inhaled sedation since AnaConDa was developed, and we are extremely proud to have conducted the world’s largest study of inhaled sedation in intensive care. Based on the good top-line results from the study that we published at the beginning of the quarter, we have worked hard to compile an application for marketing approval that we will submit as soon as possible during the last quarter of this year, which means that we are well on our way to reaching the second step to reach our vision.
In a first registration round, we submit the application for 15 EU countries plus the United Kingdom, which due to Brexit has its own national process. If all goes well, we expect an approval during the second half of 2021. After that, an application for another group of EU countries can be submitted, which normally takes 6 months to obtain approval for.
During the quarter, progress was also made in several of the investigator-initiated trials that we support. Among other things, it is very gratifying to see that both INASED and SESAR have started and that the studies have been able to continue despite the pandemic. SESAR is carried out with the aim of showing that inhaled sedation with AnaConDa has lung protective properties in comparison with propofol and, among other things, increased survival as a target. INASED is performed with the aim of showing a reduced incidence of delirium and improved cognitive recovery after sedation with AnaConDa. Through this type of investigator-initiated trials, as well as already published evidence and the own studies that we are planning in the US next year, we gather evidence that will form the basis for a paradigm shift in intensive care. We will contin-ue to support this type of trials as it is an important cornerstone in our continued regulatory and commercial expansion.
As we now approach commercialization in Europe, our work is focused on launch activities. A key factor for a successful commercialization is the acceptance from payers in the healthcare systems. Therefore, it was very gratifying to see that NICE in the UK (National Institute for Clinical Excellence) issued a MIB (Medtech Innovation Briefing) on the use of AnaConDa as an alternative to intravenous sedation in intensive care. NICE is responsible for providing national guidance on treatments for public healthcare in the UK. The MIB document refers to five analyzes of a total of 1 098 patients which show that inhaled sedation with AnaConDa is as effective as intravenous sedation and can reduce ventilator time. It was very encouraging to see the range of positive statements from the clinical experts in the MIB document. Obtaining such a positive MIB from NICE, without the treatment being yet fully approved, is a strong recognition and will impact positively for future recommendations from other advisory institutes and future dialogues with payers.
Preparations for next year’s American phase 3 studies have been intense during the quarter. To confirm and ensure efficacy and safety, two clinical, randomized and blinded studies of approximately 250 patients each will be performed. We have appointed a CRO that we will work with and we already have interest from over 30 centers to participate in the studies. There are reputable centers and investigators who have shown interest so far and the plan is to have about 40 American centers in the studies. We are working to be able to submit an IND (Investigational New Drug) application during the first part of 2021 to obtain permission to start the studies. An IND approval assumes that the toxicity studies have been completed and it is gratifying to be able to state that these are progressing at a good pace and according to plan. Depending on how the pandemic develops, we expect to be able to obtain an IND approval before the summer in order to be able to include the first patient in each study during the second half of 2021.
We look forward to starting our studies and feel well prepared. Our work with the European study has taught us a lot that we benefit from in the design and execution of the American studies. The goal is to reach a US registration in 2024 and in 2022 we will decide on our commercialization strategy for the US.
All in all, we are adding another extremely intensive but successful quarter behind us. The pandemic has undeniably accelerated interest in our treatment, despite the fact that the pandemic itself thankfully seems to be slowing down in many countries, which means a return to normal conditions in the intensive care units around the world. I look forward to coming back to you.
Christer Ahlberg, President and CEO
Read the report in its entirety here.
Dates for upcoming information
|17-19 November, 2020||Sedana attending 11th Annual Jefferies Global Healthcare Conference – Click here for more information.|
|24 November, 2020||Sedana attending Nordea Innovation seminar 2020.|
|25 November, 2020||Sedana attending Redeye Life Science day 2020 – Click here for more information.|
|25 February, 2021||Year End Report 2020|
|15 April, 2021||Annual report 2020|
|10 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 2020
Annual General Meeting 2019
Annual General Meeting 2018
Notice of Annual General Meeting in Sedana Medical AB (publ)
The shareholders in Sedana Medical AB (publ) are hereby summoned to attend the Annual General Meeting on Tuesday 22 May 2018 at 4 p.m. at. Erik Penser Bank, Apelbergsgatan 27, Stockholm. Registrations starts 15:30 CET.
Shareholders who wish to attend the Annual General Meeting must be listed as shareholders in the register kept by Euroclear Sweden AB on Wednesday, May 16, 2018, and must notify the company of their intention to participate in the meeting no later than Wednesday, May 16, 2018 at the following address: Sedana Medical AB (publ), Berga Backe 2, 182 53 Danderyd, Sweden. The registration can also be done by telephone +46 (0) 8- 124 05 200 or by e-mail to firstname.lastname@example.org. In the registration, name, address, telephone number (daytime), person / organization number, shareholding and information about possible representatives / assistants must be stated. There are a total of 17,280,538 shares and votes in Sedana Medical AB (publ). Shareholders represented by proxy shall issue a written, day-to-day power of attorney for the proxy or, should the right to vote for the shares be divided among different representatives, the representatives, together with information on the number of shares each representative is entitled to vote for. If the power of attorney is issued by a legal entity, a certified copy of the registration certificate or equivalent of the legal entity evidencing the authority to issue the proxy, shall be appended. The original power of attorney and any registration certificate should be sent to the company well before the meeting at the above address. Proxy form is available on the company’s website, www.sedanamedical.com. Shareholders who have registered in a nominee register by bank or securities depository must, in order to be entitled to participate in the meeting, register the shares in their own name. Such registration, which may be temporary, must be duly effected in the share register maintained by Euroclear Sweden AB on Wednesday, May 16, 2017, which means that the shareholders must notify the nominees well in advance of this date. Shareholders are reminded of their right to request information under Chapter 7. Section 32 of the Swedish Companies Act.
1. Opening of the meeting
2. Election of Chairman of the Meeting
3. Preparation and approval of the voting list
4. Election of two persons to approve the minutes of the meeting
5. Determination of whether the meeting has been duly convened
6. Approval of the agenda
7. Presentation of the annual report and the auditor’s report, the consolidated accounts and the consolidated audit report
8. Statement by the CEO, Christer Ahlberg
9. Resolution on approval of the statement of income and balance sheet and consolidated income statement and
consolidated balance sheet.
10. Resolution on allocation of the company’s earnings according to the established balance sheet
11. Resolution on discharge from liability of the members of the Board of Directors and the Managing Director
12. Determination of fees to the Board of Directors and the Auditor
13. Determination of the number of Board members and, where applicable, deputy members, as well as the number of auditors and any deputy auditors
14. Election of Board of Directors and Auditor and any deputy members
15. Resolution on principles for appointment and instruction regarding nomination committee
16. Resolution regarding authorization for the Board of Directors to issue new shares
17. Closing of the Meeting
Proposition for resolutions
Resolution on allocation of the company’s result (item 10)
The board of directors proposes that the company’s results shall be carried forward.
Board etc. (item 2 and 12–14)
Nomination Committee, consisting of:
- Karl Tobieson, Chairman of the Nomination Committee and representing Linc AB
- Sten Gibeck, owner and board member of Sedana Medical AB (publ)
- Ola Magnusson, owner and board member of Sedana Medical AB (publ)
- Tony McCarthy, representing Michael Ryan
- Thomas Eklund to be elected chairman of the meeting (item 2).
- The Board of Directors shall consist of six (6) members and no deputies. The Company shall have one Auditor and no deputy auditors. (item 13).
- A total fee to the Board of Directors of SEK 525,000, of which SEK 225,000 to the Chairman of the Board, SEK 50,000 each to Sten Gibeck, Bengt Julander, Ola Magnusson and Michael Ryan, and SEK 100,000 to Eva Walde. (item 12).
- Fees to the auditor in accordance with the approved invoice. (item 12).
- Re-election of the board members Thomas Eklund, Sten Gibeck, Bengt Julander, Ola Magnusson och Michael Ryan and election of Eva Walde as new member of the board (item 14). Further information regarding the proposed board members to be found at www.sedanamedical.com.
- Re-election of Thomas Eklund as Chairman of the Board (item 14).
- Re-election of R3 as an audit company with mandate until the 2019 Annual General Meeting (item 14).
Principles for the appointment of the Nomination Committee and instructions for the Nomination Committee (item 15)
It is proposed that the AGM decides to establish principles for the appointment of the Nomination Committee in accordance with the following.
Principles of determination
The chairman of the board shall, by the end of the third quarter of Sedana Medical’s financial year each year, ensure that the company’s voting three largest shareholders or ownership groups are invited to each appoint each member to be included in the nomination committee. The reconciliation is based on Euroclear Sweden AB’s shareholder list (owner group) as of the last banking day in September or any other evidence that shareholders or group of owners at this time report as evidence of their shareholding. Where one or more shareholders refrain from appointing a member of the Nomination Committee, one or more of the following shareholders in ownership shall be offered to appoint a member of the Nomination Committee. However, no more than five additional shareholders need not to be contacted, unless the Chairman of the Board finds that there are special reasons for this. When shareholders are contacted with a request for the appearance of a member of the Nomination Committee, the Chairman of the Board shall make the necessary rules of procedure such as the latest response date, etc.
The Nomination Committee shall consist of a total of at least three members, including the Chairman of the Board, which is included in the Nomination Committee and convenes the first meeting of the Nomination Committee.
The composition of the Nomination Committee shall be published as soon as it has been appointed. The chairman of the nomination committee shall, unless the members agree otherwise, be the member appointed by the largest shareholder. However, the Chairman of the Board or other Board member shall not be the Chairman of the Nomination Committee. The Nomination Committee shall hold its mandate until a new Nomination Committee has been appointed. Fees shall not be paid to members of the Nomination Committee. The member shall leave the nomination committee if the shareholder who appointed this member no longer has substantially the same ownership interest as when the member was appointed. If the Nomination Committee subsequently ceases to have at least three members, the Chairman of the Board shall act for a new member to be appointed according to the principles stated above. However, if there are no special reasons, no changes shall be made to the composition of the Nomination Committee if only minor changes in the voting number have taken place or the change occurs later than two months before the AGM.
Shareholders who appoint a member of the Nomination Committee are entitled to vacate such a member and appoint a new member of the Nomination Committee.
Nomination Committee assignment
The Nomination Committee shall prepare and propose to the Annual General Meeting:
- election of chairman of the meeting
- election of the chairman or members of the board of directors in the company’s board of directors
- election of auditor and, if applicable, auditor’s deputy
- proposals for remuneration to the chairman, board members, auditor and, where appropriate, committee work
- principles for the election of the nomination committee
The Chairman of the Board shall appropriately inform the Nomination Committee of information about the Board’s competence profile and working methods.
The Nomination Committee shall meet when required to fulfill its duties, at least twice a year. Notice of attendance is issued by the Chairman of the Nomination Committee (except for the first meeting convened by the Chairman of the Board). The member may request that the Nomination Committee be convened.
The nomination committee is to decide if at least half of the members participate. However, decisions in cases may not be taken, as far as possible, all members could participate in the matter. The decision of the Nomination Committee applies to the opinion for which more than half of the members present vote, or, in the same number of votes, the meaning of the nomination committee’s chairman.
An account of the Nomination Committee’s work in the form of proposals and opinions from the Nomination Committee shall be published on the Company’s website in good time before the Annual General Meeting.
Changes to these instructions
The Nomination Committee shall regularly evaluate these instructions and the nomination committee’s work and submit to the Annual General Meeting proposals for such changes to this instruction deemed appropriate by the Nomination Committee.
Authorization for the board to resolve on new issue of shares (item 16)
The Board of Directors proposes that the Annual General Meeting authorizes the Board to resolve on a number of occasions prior to the next Annual General Meeting, with or without prejudice to shareholders’ preferential rights, a new issue of shares which, in aggregate, does not exceed 15 percent of the total number of outstanding shares after use of the authorization. A new issue may be issued with or without notice regarding the amount, offsetting or other conditions referred to in Chapter 13, Section 5, first paragraph, 6 of the Swedish Companies Act. The purpose of the authorization is to give the board flexibility in the work to ensure that the company can be appropriately allocated capital for the financing of the business, business or product acquisition, and to enable the company’s ownership base to be broadened.
The annual report and other supporting documentation for resolutions will be available at the company’s offices, Sedana Medical AB (publ), Berga Backe 2, 182 53 Danderyd, and on www.sedanamedical.com, no later than three weeks prior to the meeting and will be sent to shareholders who so request and provide their postal address. All of the above documents will also be presented at the meeting. This notice is a translation of a Swedish notice and in case of any deviations between the both language versions, the Swedish version shall prevail.
The Board of Directors
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
|Robert vom Dorp
Vice President Business Development
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.
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%||2020-12-31|
|Nordnet Pension Insurance||501,422||2.18%||2.18%||2020-12-31|
|Third Swedish National Pension Fund||475,000||2.06%||2.06%||2020-12-31|
|Total number of owners||5,391||2020-12-31|
|Total number of shares||23,046,740||2020-12-31|
Source: Modular Finance
Sedana Medical has one outstanding warrant programme with a total maximum dilution of 89 085 shares.
Warrant program 2019/2022, total maximum dilution of 89 085 shares, exercisable until 30 November 2022
at a strike price of 142,23 SEK per share.
|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|
|Stock|| Sedana Medical
|Latest Price|| 346.0 SEK
|Return today|| -2.9%
|MCAP|| 7 974 MSEK
|Return this year|| +0.9%
|Total return this year|| +0.9%
|Year Low|| 329.0 SEK
|Year High|| 360.0 SEK
|ATH|| 372.5 SEK
|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