- Interim Summary
- Annual & Interim Reports
- Corporate Governance
President and CEO
THE THIRD QUARTER has been intense, both in terms of clinical development and preparation for our European launch. During the quarter, we also made progress in Asia through a distribution agreement in India. In terms of sales, the third quarter was a good quarter with growth of 29 percent.
The most important progress in the quarter have mainly been made in the area of clinical development and I particularly want to highlight the work on the European study. The patient recruitment proceeds as planned and the work of compiling and consolidating the results has begun. Thanks to the three Slovenian clinics that were included in August / September, we expect to be able to complete the study according to plan in December 2019 or in January 2020. With that in mind, we will be able to communicate the overall results about 3 months after the last patient in. We will be able to submit our application for a market approval in the summer of 2020 in 16 European countries in a first registration round and probably we can have a European market approval in the second half of 2021.
When it comes to the preparations for our pediatric study, they have progressed well during the quarter. The most important milestone is that we got AnaConDa approved for use in children, which is a prerequisite for starting the study in 2020. The approval also means that AnaConDa can be used in patients with severely impaired lung function and all together, this means that we have no restrictions on the use of AnaConDa, and we can address the entire market for mechanically ventilated intensive care patients. The pediatric study ensures a complete application for registration and thus ten years of market exclusivity in the EU. We are also pleased that the European Medicines Agency EMA wants the study protocol to be designed to show that inhalation sedation via AnaConDa is better than midazolam, which is today’s standard treatment for children. That means our therapy can be evaluated to be a first-hand treatment.
We also had the first meetings with the investigators in the pediatric study. At these meetings, the study protocol is reviewed and discussed in great detail in order to optimize investigators involvement. In its way, our clinical activities coincide with our commercial ones. Starting the pediatric study in several countries could be regarded as a pre-launch. We have close to 20 clinics in Germany, Sweden, France and Spain where we expect that the knowledge and interest in using our therapy will be huge at the time of launch.
In terms of our commercial work, we are now increasing the pace and we are developing our medical, sales and marketing departments in order to prepare for the launch of IsoConDa with our own sales organization in the largest European markets. This is the main reason why our expenses increased during the quarter. For example, a first major English seminar was held in Birmingham. It was very well attended by prospective customers. About 70 physicians and other healthcare professionals set aside a full day to hear about the benefits of inhalation sedation. Through the seminar we started our work in the UK seriously and we continue to participate in major international congresses. During the quarter we participated, amongst others, at ESICM in Berlin, which is one of the world’s largest intensive care congresses.
After the end of the quarter, we made a successful private placement of SEK 375 million before costs. The money will primarily be used to finance the way to market approval for AnaConDa and IsoConDa in the USA. The combination registration of AnaConDa and IsoConDa includes activities such as two clinical studies involving a total of approximately 500 patients, human factors validation programs, toxicity studies, safety database, adaptation of the European pediatric study to FDA requirements and application for market approval (NDA).
We started the human factors validation program together with Harvard during the quarter and expect it to be completed in the summer of 2020. As far as the toxicity studies are concerned, we have started preparatory investigations and expect these to be ready in the summer of 2020. This enable us to plan to submit our IND application to the FDA in the fourth quarter of 2020 in order to begin clinical studies in 2021 in USA. We have already begun to find clinics that want to collaborate with us and work closely with advisory boards at each clinic. Our ambition is to have a good geographical spread at our American clinics in order to secure the commercially important regions. The plan is to reach US approval in 2024 and around 2022 we will decide whether to launch ourselves or together with local partners.
After the end of the quarter, we also announced that we are part-financing the study SESAR, the world’s largest multi-center study, with AnaConDa. The purpose is to show that inhalation sedation with AnaConDa has lung protective properties. The study covers 700 patients and has the potential to dramatically change the perception of inhalation sedation in relation to intravenous sedation. The study is being conducted in France and is sponsored to a large extent by the French Ministry of Health and the EU, which we consider to be a huge success for our therapy. If the study supports the hypothesis that inhalation sedation via AnaConDa has therapeutic effects, leads to shorter ventilator treatment and a higher survival rate, it will be an important breakthrough for ICU patients worldwide with severe lung disease.
In addition to our ambition to grow 20% per year before the registration of IsoConDa in Europe, we have previously also stated that we will deliver an EBITDA result that is not significantly negative. As registration gets closer, the work of building up larger medical, sales and marketing organizations in and outside of Europe has intensified and we no longer provide an EBITDA forecast for the time before registration. We clarify that our sales turnover target of SEK 500 million and the EBITDA margin target of about 40 percent three years after the European registration of IsoConDa only apply to Europe. Sales outside Europe, for example sales in China and Japan are not included in this target and we do not communicate forecasts for these markets at this time.
In summary, we have experienced another strong quarter that takes us closer to our goals; to register IsoConDa in Europe in the second half of 2021, to obtain market approval in the US in 2024 and to establish ourselves in the major markets in Asia. The goals are a first step towards our vision of making inhalation sedation with AnaConDa and IsoConDa a standard treatment for mechanically ventilated patients in intensive care worldwide. Our estimate of the total market potential for inhalation sedation in intensive care is SEK 20- 30 billion annually. Through the private placement, we got a number of new investors and I want to take this opportunity to thank you for the trust given to us by both old and new owners. I look forward to the continued journey with you all.
Christer Ahlberg, President and CEO
Read the report in its entirety here.
Dates for upcoming information
|20-21 Nov 2019||Jefferies 2019 London Healthcare Conference|
|27 Nov 2019||VATOR SECURITIES UNICORN SUMMIT 2019|
|3 Mar 2020||CARNEGIE NORDIC HEALTHCARE SEMINAR, 3-4 MARCH 2020|
|5 Mar 2020||Year-end report 2019|
|22 Apr 2020||Annual report 2019|
|3-4 Jun 2020||Nordic Mid/Small Cap Seminar 2020|
Annual & Interim Reports
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Annual General Meeting 2019
Annual General Meeting 2018
Notice of Annual General Meeting in Sedana Medical AB (publ)
The shareholders in Sedana Medical AB (publ) are hereby summoned to attend the Annual General Meeting on Tuesday 22 May 2018 at 4 p.m. at. Erik Penser Bank, Apelbergsgatan 27, Stockholm. Registrations starts 15:30 CET.
Shareholders who wish to attend the Annual General Meeting must be listed as shareholders in the register kept by Euroclear Sweden AB on Wednesday, May 16, 2018, and must notify the company of their intention to participate in the meeting no later than Wednesday, May 16, 2018 at the following address: Sedana Medical AB (publ), Berga Backe 2, 182 53 Danderyd, Sweden. The registration can also be done by telephone +46 (0) 8- 124 05 200 or by e-mail to firstname.lastname@example.org. In the registration, name, address, telephone number (daytime), person / organization number, shareholding and information about possible representatives / assistants must be stated. There are a total of 17,280,538 shares and votes in Sedana Medical AB (publ). Shareholders represented by proxy shall issue a written, day-to-day power of attorney for the proxy or, should the right to vote for the shares be divided among different representatives, the representatives, together with information on the number of shares each representative is entitled to vote for. If the power of attorney is issued by a legal entity, a certified copy of the registration certificate or equivalent of the legal entity evidencing the authority to issue the proxy, shall be appended. The original power of attorney and any registration certificate should be sent to the company well before the meeting at the above address. Proxy form is available on the company’s website, www.sedanamedical.com. Shareholders who have registered in a nominee register by bank or securities depository must, in order to be entitled to participate in the meeting, register the shares in their own name. Such registration, which may be temporary, must be duly effected in the share register maintained by Euroclear Sweden AB on Wednesday, May 16, 2017, which means that the shareholders must notify the nominees well in advance of this date. Shareholders are reminded of their right to request information under Chapter 7. Section 32 of the Swedish Companies Act.
1. Opening of the meeting
2. Election of Chairman of the Meeting
3. Preparation and approval of the voting list
4. Election of two persons to approve the minutes of the meeting
5. Determination of whether the meeting has been duly convened
6. Approval of the agenda
7. Presentation of the annual report and the auditor’s report, the consolidated accounts and the consolidated audit report
8. Statement by the CEO, Christer Ahlberg
9. Resolution on approval of the statement of income and balance sheet and consolidated income statement and
consolidated balance sheet.
10. Resolution on allocation of the company’s earnings according to the established balance sheet
11. Resolution on discharge from liability of the members of the Board of Directors and the Managing Director
12. Determination of fees to the Board of Directors and the Auditor
13. Determination of the number of Board members and, where applicable, deputy members, as well as the number of auditors and any deputy auditors
14. Election of Board of Directors and Auditor and any deputy members
15. Resolution on principles for appointment and instruction regarding nomination committee
16. Resolution regarding authorization for the Board of Directors to issue new shares
17. Closing of the Meeting
Proposition for resolutions
Resolution on allocation of the company’s result (item 10)
The board of directors proposes that the company’s results shall be carried forward.
Board etc. (item 2 and 12–14)
Nomination Committee, consisting of:
- Karl Tobieson, Chairman of the Nomination Committee and representing Linc AB
- Sten Gibeck, owner and board member of Sedana Medical AB (publ)
- Ola Magnusson, owner and board member of Sedana Medical AB (publ)
- Tony McCarthy, representing Michael Ryan
- Thomas Eklund to be elected chairman of the meeting (item 2).
- The Board of Directors shall consist of six (6) members and no deputies. The Company shall have one Auditor and no deputy auditors. (item 13).
- A total fee to the Board of Directors of SEK 525,000, of which SEK 225,000 to the Chairman of the Board, SEK 50,000 each to Sten Gibeck, Bengt Julander, Ola Magnusson and Michael Ryan, and SEK 100,000 to Eva Walde. (item 12).
- Fees to the auditor in accordance with the approved invoice. (item 12).
- Re-election of the board members Thomas Eklund, Sten Gibeck, Bengt Julander, Ola Magnusson och Michael Ryan and election of Eva Walde as new member of the board (item 14). Further information regarding the proposed board members to be found at www.sedanamedical.com.
- Re-election of Thomas Eklund as Chairman of the Board (item 14).
- Re-election of R3 as an audit company with mandate until the 2019 Annual General Meeting (item 14).
Principles for the appointment of the Nomination Committee and instructions for the Nomination Committee (item 15)
It is proposed that the AGM decides to establish principles for the appointment of the Nomination Committee in accordance with the following.
Principles of determination
The chairman of the board shall, by the end of the third quarter of Sedana Medical’s financial year each year, ensure that the company’s voting three largest shareholders or ownership groups are invited to each appoint each member to be included in the nomination committee. The reconciliation is based on Euroclear Sweden AB’s shareholder list (owner group) as of the last banking day in September or any other evidence that shareholders or group of owners at this time report as evidence of their shareholding. Where one or more shareholders refrain from appointing a member of the Nomination Committee, one or more of the following shareholders in ownership shall be offered to appoint a member of the Nomination Committee. However, no more than five additional shareholders need not to be contacted, unless the Chairman of the Board finds that there are special reasons for this. When shareholders are contacted with a request for the appearance of a member of the Nomination Committee, the Chairman of the Board shall make the necessary rules of procedure such as the latest response date, etc.
The Nomination Committee shall consist of a total of at least three members, including the Chairman of the Board, which is included in the Nomination Committee and convenes the first meeting of the Nomination Committee.
The composition of the Nomination Committee shall be published as soon as it has been appointed. The chairman of the nomination committee shall, unless the members agree otherwise, be the member appointed by the largest shareholder. However, the Chairman of the Board or other Board member shall not be the Chairman of the Nomination Committee. The Nomination Committee shall hold its mandate until a new Nomination Committee has been appointed. Fees shall not be paid to members of the Nomination Committee. The member shall leave the nomination committee if the shareholder who appointed this member no longer has substantially the same ownership interest as when the member was appointed. If the Nomination Committee subsequently ceases to have at least three members, the Chairman of the Board shall act for a new member to be appointed according to the principles stated above. However, if there are no special reasons, no changes shall be made to the composition of the Nomination Committee if only minor changes in the voting number have taken place or the change occurs later than two months before the AGM.
Shareholders who appoint a member of the Nomination Committee are entitled to vacate such a member and appoint a new member of the Nomination Committee.
Nomination Committee assignment
The Nomination Committee shall prepare and propose to the Annual General Meeting:
- election of chairman of the meeting
- election of the chairman or members of the board of directors in the company’s board of directors
- election of auditor and, if applicable, auditor’s deputy
- proposals for remuneration to the chairman, board members, auditor and, where appropriate, committee work
- principles for the election of the nomination committee
The Chairman of the Board shall appropriately inform the Nomination Committee of information about the Board’s competence profile and working methods.
The Nomination Committee shall meet when required to fulfill its duties, at least twice a year. Notice of attendance is issued by the Chairman of the Nomination Committee (except for the first meeting convened by the Chairman of the Board). The member may request that the Nomination Committee be convened.
The nomination committee is to decide if at least half of the members participate. However, decisions in cases may not be taken, as far as possible, all members could participate in the matter. The decision of the Nomination Committee applies to the opinion for which more than half of the members present vote, or, in the same number of votes, the meaning of the nomination committee’s chairman.
An account of the Nomination Committee’s work in the form of proposals and opinions from the Nomination Committee shall be published on the Company’s website in good time before the Annual General Meeting.
Changes to these instructions
The Nomination Committee shall regularly evaluate these instructions and the nomination committee’s work and submit to the Annual General Meeting proposals for such changes to this instruction deemed appropriate by the Nomination Committee.
Authorization for the board to resolve on new issue of shares (item 16)
The Board of Directors proposes that the Annual General Meeting authorizes the Board to resolve on a number of occasions prior to the next Annual General Meeting, with or without prejudice to shareholders’ preferential rights, a new issue of shares which, in aggregate, does not exceed 15 percent of the total number of outstanding shares after use of the authorization. A new issue may be issued with or without notice regarding the amount, offsetting or other conditions referred to in Chapter 13, Section 5, first paragraph, 6 of the Swedish Companies Act. The purpose of the authorization is to give the board flexibility in the work to ensure that the company can be appropriately allocated capital for the financing of the business, business or product acquisition, and to enable the company’s ownership base to be broadened.
The annual report and other supporting documentation for resolutions will be available at the company’s offices, Sedana Medical AB (publ), Berga Backe 2, 182 53 Danderyd, and on www.sedanamedical.com, no later than three weeks prior to the meeting and will be sent to shareholders who so request and provide their postal address. All of the above documents will also be presented at the meeting. This notice is a translation of a Swedish notice and in case of any deviations between the both language versions, the Swedish version shall prevail.
The Board of Directors
Corporate governance includes information about our Board of Directors, the management team, guidelines for remuneration to the senior management, our auditors, general meetings and our articles of association.
Board of Directors
The registered office of the company is situated in the municipality of Danderyd. The Board of Directors shall consist of not less than three (3) and not more than six (6) members, 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
|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
General Manager Manufacturing, Supply and Logistics
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 October 31, 2019.
|Name||Number of shares||Shareholding (%)|
|Linc AB||2 116 901||9,31%|
|Handelsbanken funds||1 655 713||7,28%|
|Anders Walldov direct and indirect (Brohuvudet AB)||1 600 000||7,04%|
|Sten Gibeck||1 530 744||6,73%|
|Swedbank Robur funds||1 376 600||6,05%|
|Ola Magnusson direct and indirect (Magiola AB)||1 340 867||5,90%|
|Anades Ltd.||1 143 083||5,03%|
|Ron Farrell||631 062||2,78%|
|Berenberg funds||712 731||3,13%|
|Nordnet Pension Insurance||490 904||2,16%|
|Avanza Pension||488 284||2,15%|
|Öhman Funds||452 671||1,99%|
|Eklund Konsulting AB||416 616||1,83%|
|Tredje AP fonden||357 069||1,57%|
|Tony McCarthy||339 823||1,49%|
|Fifteen largest shareholders||14 653 068||64,45%|
|Others *||8 083 523||35,55%|
|TOTAL:||22 736 591||100%|
* Of which CEO’s ownership is 230 000 shares.
Source: Modular Finance
Sedana Medical has three outstanding warrant programmes with a total maximum dilution of 1 720 149 shares.
Warrant program 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 program 2017/2021, total maximum dilution of 310 149 shares, exercisable until 31 January 2021
at a strike price equaling 130% of the IPO price.
Warrant program 2019/2022, total maximum dilution of 370 000 shares, exercisable until 30 November 2022
at a strike price of 142,23 SEK per share.
|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:||Christian Lee, 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