- Interim Summary
- Annual & Interim Reports
- Corporate Governance
President and CEO
Sedana Medical operates according to a clear strategy to develop inhaled sedation into a global standard therapy in intensive care. The first quarter of the year was notable for preparations ahead of our European launch of Sedaconda (isoflurane) during the second half of the year and ahead of our forthcoming expansion in the United States. Day-to-day operations and our sales continued to be dominated by the COVID-19 pandemic.
ICU sedation is precisely the treatment that severely ill COVID-19 patients very often need, and demand for AnaConDa and accessories was strong during the third wave of the pandemic that hit many countries during the first quarter. Sales in the quarter were SEK 45 million, up 40 percent on the previous year, at constant exchange rates. The trend in sales continued to be highly positive as a result of COVID-19. We are, however, seeing a further increase in freight costs compared with previously, as a result of the pandemic, which has a negative impact on our gross profit. Adjusted for the increased freight costs our underlying gross margin is now slightly higher than in previous quarters. In terms of sales, we now recognise Germany, our distribution markets and other direct sales markets, which show that demand rose sharply in our distribution countries, focused on Latin America. Germany was hit by a third wave during the quarter, contributing to an increase mainly at the end of the quarter. Since the end of the quarter, we have also succeeded in having our quality system approved under MDR 2017/745, which is a decisive milestone for the future.
Our strategic plan to achieve our vision of making inhaled sedation a new global standard therapy in intensive care is based on four steps: 1) Establish AnaConDa in as many markets as possible. 2) Apply for marketing authorisation for Sedaconda, initially in the EU and later in other markets. 3) Secure strong medical evidence. 4) Establish the therapy in guidelines as a first-line alternative. We made progress in all these steps during the quarter.
With regard to establishing AnaConDa in as many markets as possible, during the quarter we strengthened our presence in the Middle East and South America, where we are working closely with our distributors. In South America, demand additionally increased sharply as a result of the pandemic, and we launched the therapy at many new clinics via our distributor. By establishing AnaConDa in as many markets as possible, we are building experience at the clinics ahead of market approval for Sedaconda. In that way, we are building on a solid foundation for continued expansion.
With regard to the second step in our strategy, having the pharmaceutical product Sedaconda and inhaled sedation therapy approved, it was very pleasing to submit applications for marketing authorisation for Sedaconda in the United Kingdom and Switzerland during the quarter. As a result, the treatment will move from being off-label to fully approved, and we will be able to sell the whole therapy, that is to say both the medical device AnaConDa with accessories and the pharmaceutical product Sedaconda. We submitted an EU application at the end of last year, and if everything goes well we anticipate approval in 15 EU countries during the second half of 2021. We anticipate being able to launch during the first half of 2022 in the United Kingdom and during 2022 in Switzerland.
Now that we are approaching commercialisation in Europe, our work has been concentrated on launch activities. A key factor in successful commercialisation is acceptance by payers in healthcare systems, and during the quarter we worked intensively to establish good contacts and have devoted a large amount of time to preparing price, procurement and reimbursement processes in various countries.
The preparations ahead of our American registration were intensive during the quarter. We are working on several parallel processes ahead of the IND (Investigational New Drug) application which is required to enable us to initiate two pivotal phase 3 studies. Among other things, we have initiated processes to recruit our own staff in the United States, to take part in the study work there, and during the quarter we continued to work in particular on completing the tox studies and the human factors validations to enable us to submit the IND application.
Some processes have, however, been delayed by the pandemic, in particular the interaction with the FDA, which has significantly prolonged response times. As a consequence, we no longer anticipate being able to obtain IND approval after the summer but rather during the autumn, and we therefore anticipate including the first patient in the study concerned at the end of Q1 or the beginning of Q2 2022. We are doing what we can to speed up the processes while maintaining quality and to prepare the clinics to be involved in the studies in the best possible way, for efficient patient recruitment when it gets underway.
With regard to the third step in our strategy, securing medical evidence with the help of more studies showing that inhaled sedation is a better and more cost-effective treatment than the current standard therapy, it is very pleasing that during the quarter we were able to announce that the first patient had been included in our paediatric study IsoCOMFORT (SED002). This study is conducted to investigate if inhaled sedation with Sedaconda delivered via AnaConDa is a safe and more effective method of sedation than intravenously administered midazolam for children below 18 years of age. The study is expected to be completed during the second half of 2022 and is intended to lead to an approved paediatric indication for inhaled sedation.
IsoCOMFORT (SED002) is our first own ‘superiority’ study. This means a study performed to show that inhaled sedation with AnaConDa has characteristics superior to intravenous standard sedation. The investigator-initiated studies we support – INASED, SESAR and ISCA – are all superiority studies performed to demonstrate significant benefits, for example with regard to wake-up times, shorter time to extubation, fewer side effects such as delirium, higher proportion of spontaneous breathing in patients, better oxygen uptake, shorter ICU treatment times etc. As a result, the treatment will gain ground and be included in national and international recommendations, as well as gradually taking the position of a new standard therapy throughout the world.
Overall, we can look back on another intensive quarter. This is my twentieth quarter as CEO of Sedana Medical, and these are probably my last CEO Comments as the company’s CEO. It has been highly enjoyable and exciting years, and it has been an honour to build up Sedana Medical along with all the incredibly professional employees. In view of how well Sedana Medical has developed, the time feels right to hand over the baton to a new CEO.
The company has developed superbly well over those years, with a multiple increase in sales, while we have marketing authorisation within reach later this year and establishment of a presence in the United States in years to come. Sedana Medical today has a very solid foundation on which to successfully develop inhaled sedation into a global standard.
Christer Ahlberg, President and CEO
Read the report in its entirety here.
Dates for upcoming information
|19 August, 2021||Q2 interim report 2021|
|4 November, 2021||Q3 interim report 2021|
Annual & Interim Reports
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Annual General Meeting 2021
Annual General Meeting 2020
Annual General Meeting 2019
Annual General Meeting 2018
Corporate governance includes information about our Board of Directors, the management team, guidelines for remuneration to the senior management, our auditors, general meetings and our articles of association.
Board of Directors
The registered office of the company is situated in the municipality of Danderyd. The Board of Directors shall consist of not less than three (3) and not more than six (6) members.
|Thomas Eklund Chairman
of the Board
|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
Interim CEO & Vice President Commercial Operations
|Sylvia Buddenbaum Eriksson
|Robert vom Dorp
Vice President Business Development
Chief Technology Officer
Supply Chain & Manufacturing Director
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%||2021-06-30|
|Linc AB (Bengt Julander)||7,598,804||8.24%||8.24%||2021-06-30|
|Third Swedish National Pension Fund||1,900,000||2.06%||2.06%||2021-06-30|
|Total number of owners||6,333||2021-06-30|
|Total number of shares||92,186,960||2021-06-30|
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.
|May 6, 2021||Sedana Medical – webcast Q1 2021 report.
To participate, please dial: +46 8 505 566 426 93
For additional log in information:
|Feb 25, 2021||Sedana Medical – webcast Q4 report.||More info|
|Nov 26, 2020||Sedana attending Redeye Life Science Day 2020.||Play Video|
|Nov 17-19, 2020||Sedana attending 11th Annual Jefferies Global Healthcare Conference.||More info|
|Nov 5, 2020 – 14:00||Sedana Medical – webcast Q3 report.||More info|
|Sept 9, 2020||Sedana attending Carnegie Virtual Nordic Small Mid Cap Seminar.||View Program|
|Sept 2-3, 2020||Sedana attending Pareto Securities’ 11th Annual Healthcare Conference.||More info|
|Sept 1, 2020||Sedana attending Danske Bank Small & Mid Cap Seminar.||Play Video|
|July 10, 2020||Presentation of the positive top line result in the pivotal IsoConDa study.||Play Live Stream|
|May 19, 2020||CEO presentation in connection with AGM 2020-05-19.||Play Video|
|May 7, 2020||Presentation of the interim report for the first quarter 2020.||Play Video|
|April 8, 2020||Sedana Medical’s CEO on prioritizing in the Corona crisis.||Play Video|
|November 27, 2019||VATOR SECURITIES UNICORN SUMMIT 2019.||Play Video|
|September, 2019||Sedana Medical – Management Presentation September 2019.||View Presentation|
|June 10, 2019||Redeye Growth Day 2019.||Play Video|
|May 8, 2019||Presentation of the interim report for the first quarter 2019.||Play Video|
|March 14, 2019||Stockholm Corporate Finance Life Science Seminar.||Play Video|
|March 8, 2019||IsoConDa phase III pivotal study, interim analysis report, 8 March 10:30.||Play Video|
|September 6, 2018||Pareto Securities’ 9th Health Care seminar in Stockholm.||Play Video|
|April 27, 2018||Event at ProHearings (English).||Play Video|
|March 7, 2018||Sitdown at Erik Penser 2018 (Swedish).||Play Video|
|March 6, 2018||Stockholm Corporate Finance Life Science Seminar (Swedish).||Play Video|
|November 24, 2017||Redeye seminar (Swedish).||Play Video|
|June 29, 2017||Trading Direkt Interview with CEO Christer Ahlberg (Swedish).||Play Video|
|The LEI code is:||549300FQ3NJRI56LCX32|
|Certified Adviser:||Erik Penser Bank – Tel: +46 (0)8-463 80 00 – Apelbergsgatan 27, Box 7405, 103 91 Stockholm, Sweden|
|Analyst(s) covering Sedana Medical:||Peter Östling, Pareto Securities|
Sedana Medical Investor Relation
Sedana Medical AB (publ)
SE-182 32 Danderyd
Phone: +46 (0)8-124 05 200
Investor relation: firstname.lastname@example.org