- Interim Summary
- Annual & Interim Reports
- Corporate Governance
President and CEO
During the third quarter, major steps were taken towards our vision of becoming world leader in inhalation sedation within intensive care.
In order to fully sell inhalation sedation, you must have a medical device that administers the volatile drugs to the patient and have the medicine approved for intensive care. In Europe, our medical device AnaConDa is approved for the administration of volatile drugs. However, our drug candidate IsoConDa has not yet been approved for intensive care. In the United States neither AnaConDa nor IsoConDa are approved.
The work to increase the use of AnaConDa technology and to establish ourselves in several European countries continues. During the quarter, we set up our own sales organization in the UK and we have now delivered AnaConDa to intensive care clinics in Liverpool and Hull. The plan is to be represented in several European markets with established networks and reference clinics when the approval of IsoConDa comes in order to quickly penetrate the market. With the establishment of our own direct sales channel in the UK, we are now well on our way towards our plan, which is very pleasing.
Sales growth for the quarter was 24% compared with the same period last year despite the fact that the drug has not yet been approved. This underlines the medical value of inhalation sedation. The rate of the increase is also in line with our stated ambition to have an average annual sales increase of more than 20% until the registration of IsoConDa takes place.
That the increase is lower than in the first half of the year is mainly explained by the seasonal pattern. During the winter, more patients are usually placed on intensive care units for sedation. Just this year, during the winter season and early spring, the trend was clearer than usual with an extreme influenza epidemic in most parts of Europe, while the summer was both longer and warmer than usual in many European countries.
EBITDA in Q3 was MSEK -964, which is in line with our plans as operational costs increase as we develop the organization and increase our market presence.
Our ongoing clinical registration study in Germany, to receive the IsoConDa drug approved for inhalation sedation in intensive care in Europe, continues. At the beginning of April, the study was limited after the Central Ethics Committee requested some clarifications, but after the summer the study could resume. It is a relief that the break was so limited, and we are now recruiting all types of mechanically ventilated patients. For each day, we will take another step closer to a registration of the drug IsoConDa, which also significantly increases the potential of our AnaConDa product.
We expect the interim analysis for the study to end before the turn of the year and that we can communicate the results of the analysis in the first quarter 2019. The purpose of the interim analysis is to determine how many patients are ultimately needed to show the result requested in order to apply for marketing approval of IsoConDa in Europe. The results of the interim analysis will also give us an indication of when we will be able to launch IsoConDa in Europe.
The registration work for both pharmaceutical and medical device has begun in the United States and we have now been notified that our first meeting with the US Food and Drug Administration (FDA) will take place in the end of March 2019. The meeting will clarify the requirements we must meet for to have both products approved in the United States. Only after the meeting, when final protocol has been obtained from the FDA, we will be able to communicate a schedule of when the therapy can be approved in the United States.
We thought we would meet the FDA around the turn of the year 2018/19. The fact that the meeting is expected to happen later does not affect the estimated time to market, but instead means that we will have more material for the FDA at the meeting. Our European interim analysis will be an important piece in the puzzle.
It is gratifying that after the end of the quarter we received approval of AnaConDa in Japan. The approval means that AnaConDa may be marketed, sold and used for the administration of volatile anesthetics for mechanically ventilated patients in Japan. We are now working to provide our Japanese distributor with the necessary tools, including price reimbursement, to launch AnaConDa. As in Europe, IsoConDa is still not approved and it is also necessary to initiate a registration process for the drug in order to reach the full potential of the market. We estimate that patients in Japan require over 1 million mechanically ventilated days per annum.
After the end of the quarter, we presented a health economics study at the European Congress ISPOR in Barcelona. The study showed significant clinical and economic benefits of long-term sedation with AnaConDa and isoflurane versus intravenous sedation with propofol or midazolam. The study involved surgical intensive care patients who require prolonged sedation (> 96 hours) and mechanical ventilation.
In summary, I am very pleased with our work during the quarter. We have good development in all our three focus areas; the registration work of the IsoConDa drug in Europe, the development of US registration with both AnaConDa and IsoConDa, and market build up and preparation for effective and successful launch in Europe at the time of the registration of the therapy.
Christer Ahlberg, President and CEO
Read the interim report in its entirety here.
Dates for upcoming information
|29 Nov 2018, 10:00 New York time||Nordic – American Life Science Conference New York|
|21 Mar 2019||Year-end report 2018|
|25 Apr 2019||Annual Report 2018|
|8 May 2019||Interim Report Q1 2019|
|28 May 2019||Annual General Meeting 2019|
|22 Aug 2019||Interim Report Q2 2019|
|13 Nov 2019||Interim Report Q3 2019|
Annual & Interim Reports
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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, with not more than three (3) deputy members. Currently the Board of Directors consists of six (6) members elected at the Annual General Meeting on 22 May 2018 for the period until the end of the next Annual General Meeting.
|Thomas Eklund Chairman
of the Board
of the Board
|Bengt Julander Member
of the Board
of the Board
|Michael Ryan Member
of the Board
|Eva Walde Member
of the Board
President and CEO
Vice President Head of R&D and Quality
|Robert vom Dorp
Vice President Head of Sales
Vice President Head of Marketing
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.
At the Annual General Meeting on 19 May 2017 it was resolved that the fees payable to the Board of Directors for the period until the end of the Annual General Meeting 2018 shall amount to a total of SEK 350,000, of which SEK 150,000 shall be paid to the Chairman of the Board of Directors and SEK 50,000 to each of the other ordinary board members.
Christina Kallin Sharpe, authorised public accountant at R3 Revisionsbyrå was re-elected as auditor for the company until the end of the next Annual General Meeting.
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
§ 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 with not more than three (3) deputy 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.
§ 8 Place of General Meetings
Any General Meeting of 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 in General Meetings must be listed as 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. The last mentioned 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 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.
§ 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) disposition av bolagets vinst eller förlust enligt den fastställda balansräkningen
(c) discharge from liability for the Board of Directors 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).
Below is Sedana Medical’s ownership structure as of September 30, 2018.
|Name||Number of shares||Shareholding (%)|
|Linc AB||1 901 901||9,93%|
|Sten Gibeck||1 605 744||8,38%|
|Magiola Consulting AB||1 296 000||6,77%|
|Anders Walldov direct and indirectly (Brohuvudet AB)||1 150 634||6,01%|
|Anades Ltd.||1 068 083||5,58%|
|State Street Bank & Trust||774 177||4,04%|
|Ron Farrell||731 062||3,82%|
|JP Morgan Bank Luxemburg||582 147||3,04%|
|Alto Invest SA||490 572||2,56%|
|Avanza pension||483 815||2,53%|
|Eklund Konsulting AB||474 156||2,48%|
|BNP Paribas||457 085||2,39%|
|Swedbank Robur Microcap||450 000||2,35%|
|Nordnet Pensionsförsäkring AB||379 348||1,98%|
|Fifteen largest shareholders||12 539 087||65,46%|
|Others *||6 617 504||34,54%|
|TOTAL:||19 156 591||100%|
* Of which CEO’s ownership is 230 000 shares.
Sedana Medical has two outstanding warrant programmes with a total maximum dilution of 1 350 149 shares.
Warrant 2014/2019, total maximum dilution of 1 040 000 shares, exercisable until 31 December 2019
at a strike price of 2,50 SEK/share.
Warrant 2017/2021, total maximum dilution of 310 149 shares, exercisable until 31 January 2021
at a strike price equaling 130% of the IPO price.
|November 22, 2018||Presentation of the interim report for the third quarter 2018.||Click here to view.|
|September 06, 2018||Pareto Securities’ 9th Health Care seminar in Stockholm.||Click here to view.|
|August 30, 2018||Presentation of the interim report for the second quarter 2018.||Click here to view.|
|May 22, 2018||Presentation of the interim report for the first quarter 2018.||Click here to view.|
|April 27, 2018||Event at ProHearings (English).||Click here to view.|
|March 7, 2018||Sitdown at Erik Penser 2018 (Swedish).||Click here to view.|
|March 6, 2018||Stockholm Corporate Finance Life Science Seminar (Swedish).||Click here to view.|
|November 24, 2017||Redeye seminar (Swedish).||Click here to view.|
|June 29, 2017||Trading Direkt Interview with CEO Christer Ahlberg (Swedish).||Click here to view.|
|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