- Interim Summary
- Annual & Interim Reports
- Corporate Governance
Vice President Commercial Operations
At the end of July, an important milestone was reached with the gratifying news that we received – earlier than expected – DCP approval for the pharmaceutical product Sedaconda (isoflurane), as well as the treatment inhaled sedation. As a result, we are now seeking national approvals to launch the inhaled sedation therapy in 15 European countries. These national processes are expected to take about 1-3 months. Further encouraging news was announced on 13 August when Sedaconda1 received its first national approval, from the French medicines agency ANSM.
Sales in the quarter totalled SEK 40 million, an increase of about 3 percent at fixed exchange rates compared to last year. The gross margin for the quarter was 66 percent, up 2 percentage points year-on-year as a result of lower transport costs in the quarter as a greater proportion of freight was carried by sea rather than by air.
In Germany, our largest market, we saw continued strong momentum with sales up year-on-year and almost in line with Q1, despite a sharp downturn in the number of Covid-19 intensive care patients in May-June. This is a positive sign that clinics are continuing to broaden use beyond Covid-19 patients.
Other direct sales in Europe decreased compared to last year as a result of the slowing third wave of the pandemic. The previous year was notable for a massive increase in sales during April-May, at the start of the pandemic. These countries, which have a substantially smaller customer base than Germany, are even more affected in terms of sales by the decreasing number of Covid-19 patients in the ICU. However, we are seeing continued momentum here too, with existing and new hospital customers beginning to broaden use to other patient groups. These relationships will be very valuable for future marketing authorisations.
Sedana Medical operates according to a clear strategy based on several steps to develop inhaled sedation into a global standard therapy in intensive care.
The first step in the strategy is to establish AnaConDa (to be renamed Sedaconda ACD) in selected markets. During the quarter, we continued to strengthen our presence in our distributor markets, particularly in Latin America. Sales increased sharply compared to the previous year, and Mexico is our second largest market in the second quarter. Latin America is one of the regions in the world where the pandemic has put the greatest strain on health systems, with acute shortages of propofol in many countries. Our success can also be largely attributed to our local distributor, one of Latin America’s leading distributors of healthcare products. There is strong interest in launching and selling AnaConDa/Sedaconda ACD in the markets we do not cover ourselves, which gives us the opportunity to work with the best distributors in each country.
With regard to the second step in our strategy, having the pharmaceutical product Sedaconda and inhaled sedation therapy approved, it was very pleasing to obtain DCP approval in July, as well as the first national marketing authorisation in France in August. Now that we are approaching commercialisation in Europe, our work has been concentrated on pre-launch activities. We are focusing on the pricing, procurement and reimbursement processes in each country, which is sometimes resource-intensive work, but acceptance by purchasers in healthcare systems is a key factor for successful commercialisation. In addition, despite continued shutdowns in many of our markets, we have managed to step up our level of activity at local congresses and meetings. We have also organised our own well-attended symposia in conjunction with these congresses. All in all, our level of activity has increased and will increase further as we come closer to the start of sales.
Part of the work ahead of the launch is the change of name for our medical device AnaConDa to Sedaconda ACD, which stands for Anaesthetic Conserving Device. The name strengthens the link to Sedana Medical and the unique area of use of sedation. The pharmaceutical product Sedaconda (isoflurane) is to be administered via AnaConDa/Sedaconda ACD, together making up the inhaled sedation therapy. The name change will be launched on 1 October.
Preparations ahead of our American registration were intense during the quarter. Shortly after the end of the quarter, we were able to announce that we had held an End of Phase II meeting with the US Food and Drug Administration (FDA). The purpose of this advisory meeting was to discuss the documentation ahead of phase 3 and to agree on the plan and design of the phase 3 studies. The meeting was successful – the FDA accepted our proposed phase 3 programme, including the study design and the primary endpoint for the studies – and means that we are able to enter phase 3 in line with the previously communicated timetable.
We are now working to submit an Investigational New Drug (IND) application in the autumn to allow us to start clinical studies and enrol the first patients in the studies at the turn of Q1/Q2 2022. There has been significant interest in participating in the studies from a large number of leading US centres. We aim to include around 30 centres and look forward to starting the inclusion of patients. We have established a subsidiary and recruited employees in the United States who will be involved in the studies. By successfully carrying out two randomised controlled trials, each including around 250 patients, we plan to obtain marketing authorisation before the end of 2024.
With regard to the third step in our strategy; With the aid of more studies, securing medical evidence showing that inhaled sedation is a better and more cost-effective treatment than today’s intravenous standard therapy, it was very pleasing to be able to report during the quarter that the Sedaconda study (SED001) was named one of the three best posters at the 52nd DGIIN & ÖGIAIN intensive care conference from 16 to 18 June 2021. DGIIN & ÖGIAIN is the joint annual congress of the German and Austrian acute and intensive care associations. It is highly positive that the study is receiving attention in Germany, which is our largest market.
All in all, we look back on yet another intensive quarter with success in all the steps in our strategy. On 1 October, I will be handing over the baton to our incoming President and CEO Johannes Doll and will continue in my role as Commercial Director. We look forward to coming back to you.
Jens Lindberg, Vice President Commercial Operations
Read the report in its entirety here.
Dates for upcoming information
|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
|Claus BjerreMember &
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 & Manufacturing Director
Vice President Commercial Operations
Vice President Regulatory Affairs & 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 2021 for the period leading up to the Annual General Meeting 2022. 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 10 May 2021
§ 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 32,000,000 and not more than 128,000,000.
§ 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||8,314,933||9.02%||9.02%||2021-09-30|
|Linc AB (Bengt Julander)||7,598,804||8.24%||8.24%||2021-09-30|
|Third Swedish National Pension Fund||2,000,000||2.17%||2.17%||2021-09-30|
|Total number of owners||7,633||2021-09-30|
|Total number of shares||92,186,960||2021-09-30|
Source: Modular Finance
Sedana Medical has outstanding warrant programmes with a total maximum dilution of 547 272 shares.
Warrant program 2019/2022, total maximum dilution of 356 340 shares,
exercisable 1 July to 30 November 2022 at a strike price of 35,60 SEK per share.
Warrant program 2020/2023, total maximum dilution of 42 480 shares,
exercisable 1 July to 30 November 2023 at a subscription price of SEK 83,70 per share.
Warrant program 2020/2024, total maximum dilution of 148 452 shares,
exercisable 1 February to 31 May 2024 at a subscription price of SEK 123,90 per share.
|Aug 19, 2021||Sedana Medical – webcast Q2 2021 report.
To participate, please dial: +46 8 505 583 52
For additional log in information:
|May 6, 2021||Sedana Medical – webcast Q1 2021 report.||More info|
|Feb 25, 2021||Sedana Medical – webcast Q4 2020 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 2020 report.||More info|
|Sep 9, 2020||Sedana attending Carnegie Virtual Nordic Small Mid Cap Seminar.||View Program|
|Sep 2-3, 2020||Sedana attending Pareto Securities’ 11th Annual Healthcare Conference.||More info|
|Sep 1, 2020||Sedana attending Danske Bank Small & Mid Cap Seminar.||Play Video|
|Jul 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|
|Apr 8, 2020||Sedana Medical’s CEO on prioritizing in the Corona crisis.||Play Video|
|Nov 27, 2019||VATOR SECURITIES UNICORN SUMMIT 2019.||Play Video|
|Sep, 2019||Sedana Medical – Management Presentation September 2019.||View Presentation|
|Jun 10, 2019||Redeye Growth Day 2019.||Play Video|
|May 8, 2019||Presentation of the interim report for the first quarter 2019.||Play Video|
|Mar 14, 2019||Stockholm Corporate Finance Life Science Seminar.||Play Video|
|Mar 8, 2019||IsoConDa phase III pivotal study, interim analysis report, 8 March 10:30.||Play Video|
|Sep 6, 2018||Pareto Securities’ 9th Health Care seminar in Stockholm.||Play Video|
|Apr 27, 2018||Event at ProHearings (English).||Play Video|
|Mar 7, 2018||Sitdown at Erik Penser 2018 (Swedish).||Play Video|
|Mar 6, 2018||Stockholm Corporate Finance Life Science Seminar (Swedish).||Play Video|
|Nov 24, 2017||Redeye seminar (Swedish).||Play Video|
|Jun 29, 2017||Trading Direkt Interview with CEO Christer Ahlberg (Swedish).||Play Video|
|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 and Carl Mellerby, SEB|
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