- Interim Summary
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President and CEO
Positive top line results
The goal when we initiated the work with the study several years ago was to be able to register inhaled sedation with IsoConDa (isoflurane), administered with AnaConDa, in Europe in order to approach our vision to make inhaled sedation a new global standard method in intensive care. Through the positive top line results, we have come a long way towards our vision. The study reached its primary end point; to show that IsoConDa administered with AnaConDa is an effective sedation method for ventilator-intensive care patients that is not inferior to today’s intravenous standard sedation with propofol.
The strong top line results confirm the clinical experience of physicians worldwide and the strong study results will form the basis for the application for European market approval that we will submit as soon as possible during the fourth quarter of this year. In a first registration round, the application will cover 16 European countries and if all goes well, we expect approval in the second half of 2021. A market approval in Europe can also open the door to several other markets and we are currently investigating exactly which markets that quickly can open up based on a European registration.
The secondary objectives in the SED-001 study are currently being analyzed and will be presented together with the primary objectives in a scientific journal at the beginning of next year. Of course, we have high hopes also regarding the secondary results, but the strong top line results are sufficient as a basis for our application for market approval.
The SED-001 study is designed as a non-inferiority study, which means that its primary purpose is to show that our therapy is not worse than propofol in maintaining an adequate sedation level. The secondary goals of the study include time to wake up, proportion of time with spontaneous breathing, need for painkillers, ICU- and ventilator-free days and organ function over time. If these goals succeed in showing good results, it is of course a bonus, but nothing that we count on due to the study design. In that respect, we have higher hopes for the large investigator-initiated studies that we support; SESAR, INASED and ISCA.
These studies are done partly to show that inhaled sedation with AnaConDa has lung protective properties (SESAR) with increased survival as a result and partly to show a reduced incidence of delirium (INASED) and improved cognitive recovery after sedation which is a major problem in intensive care. Positive results would significantly strengthen our clinical base and each of the studies have the potential to dramatically change the view of inhaled sedation in relation to intravenous sedation. Through this type of study, we gather evidence which, if it is positive, together with already published evidence, can form the basis for a paradigm shift in intensive care. The studies are an important support in our continued regulatory and commercial expansion and provide an indication of the great potential of our therapy.
The same applies to the ISCA study, Inhaled Sedation in Covid-19-related Acute Respiratory Distress Syndrome, which was initiated in the quarter and is performed on at least 400 patients in about 30 intensive care units in France, Germany, Spain and Switzerland. The outcome for covid-19-ARDS patients receiving inhaled sedation is compared with the outcome for the same type of patients receiving intravenous sedation. Inhaled sedation is promising for this patient group as the treatment has anti-inflammatory effects and beneficial pharmacokinetics in patients with ARDS and multiple organ failure.
The covid-19 pandemic has not only affected the type of studies we choose to support but has also continued to strongly influence our entire business since ICU sedation is exactly the treatment that severe covid-19 ill patients need. In addition, our treatment can increase patient flow at ICU, which is important when access to ICU beds is limited.
Sales in the quarter were SEK 41 million, an increase of 133 percent compared with the same period last year. It is both completely new clinics that have been added as customers and current customers that have increased their use. The increase for the first half of the year consists of approximately 40% concerning new customers and 60% concerning existing customers. The EBITDA result was SEK -0,8 million and the gross margin was 67 percent, compared with 77 percent in the same period last year. The slightly lower gross margin is largely an effect of the fact that we sold a lot of gas monitors in the second quarter and that we have had higher costs for transportation due to the covid-19 situation. The gas monitors have lower gross margin. However, it is very promising for the future that more and more clinics will invest in more gas monitors used in connection with inhaled sedation.
Our commercial expansion has undeniably received an extra boost from the pandemic. In these times of crisis, it is obvious that a not yet achieved market approval has not played as big a role as usual and once we get a market approval, we will get it from a higher base than would have been the case without covid-19.
The pandemic has led to us receiving of a large number of inquiries about clinical studies, retrospective data collection and other studies to further clarify the benefits of inhaled sedation. It is, of course, extremely gratifying at the same time as it takes up some administrative resources. The ISCA study is one of the studies we, during the quarter, have decided to support, and we try to prioritize wisely between all the proposals that come to us.
There is great interest in our treatment even in the markets that we ourselves do not cover. During the quarter, we signed sales agreements with distributors in the Middle East and Eastern Europe. Through the expansion of our distributor network, we are strengthening our position ahead of the upcoming market launch of our therapy. On July 1, we also received market approval for AnaConDa in Saudi Arabia.
For Europe, our focus now is on submitting the registration documentation to the authorities during the fourth quarter, preparations for the commercialization and launch of our therapy and continued product development. Our clinical development focus will move from Europe to the USA in the coming years. Preparations for next year’s American phase 3 studies have been intensive during the quarter and we are rapidly approaching the start of our studies. To confirm and ensure efficacy and safety, two clinical, randomized and blinded studies of a total of 300 – 550 patients will be performed. The number of patients needed for both studies together is the same as we initially had as a requirement in the European study. Because the FDA imposed different requirements on the phase 3 studies than the SED-001 study, the SED-001 study could not constitute one of the two clinical studies required by the FDA. The SED-001 study, on the other hand, is of course supportive of our application and is also used in the safety database of in total 500 isoflurane patients, which is one of the FDA’s requirements.
Part of the preparations for the clinical studies are the toxicity studies that are currently underway and where we are breaking new ground week by week. The studies are progressing at a good pace and according to plan, but it has been a challenge to be the first company ever to carry out this type of long-term sedation. A large part of the work has been put on pure methodological issues in this full-scale tox program.
During the winter and spring of 2021, the plan is to start hiring staff in the United States. We are working to be able to submit an IND application during the first quarter of 2021 and to include the first patient in the clinical studies during next year. Right now, we are in the final stages of choosing CRO companies and the development of protocols and the plan is to have about 40 American centers in the studies. In the US, we are working for a combination registration, which means enhanced competition protection. We are pleased that the financing for our US work was secured through the directed new issue that was carried out in the autumn of 2019. 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
|5 Nov 2020||Interim report Q3|
|Nov 17-19, 2020||Sedana attending 11th Annual Jefferies Global Healthcare Conference – Click here for more information.|
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 email@example.com. 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 as of July 31, 2020.
|Name||Number of shares||Shareholding (%)|
|Handelsbanken funds||1 933 303||8,39%|
|Swedbank Robur funds||1 916 101||8,32%|
|Linc AB||1 826 600||7,93%|
|Anders Walldov direct and indirect (Brohuvudet AB)||1 630 000||7,07%|
|Sten Gibeck||1 325 246||5,75%|
|Ola Magnusson direct and indirect (Magiola AB)||1 230 744||5,34%|
|Berenberg funds||965 149||4,19%|
|Öhman Funds||767 680||3,33%|
|Tredje AP-Funds||563 979||2,45%|
|Anades Ltd.||481 478||2,09%|
|Nordnet Pension Insurance||475 506||2,06%|
|Avanza Pension||470 031||2,04%|
|Tedsalus AB (Thomas Eklund)||408 516||1,77%|
|Highclere International Investors LLP||396 502||1,72%|
|Christer Ahlberg||334 000||1,45%|
|Fifteen largest shareholders||14 725 635||63,89%|
|Others||8 321 105||36,11%|
|TOTAL:||23 046 740||100%|
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 17-19, 2020||Sedana attending 11th Annual Jefferies Global Healthcare Conference.||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|
|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: firstname.lastname@example.org