Episurf Medical announces SEK 98m rights issue, Board proposes amendments to articles of association, publishes quarterly report early and terminates a financing arrangement

NOT FOR RELEASE, DISTRIBUTION OR PUBLICATION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES OF AMERICA, AUSTRALIA, CANADA, THE UNITED KINGDOM, JAPAN, NEW ZEALAND, SINGAPORE, SWITZERLAND, SOUTH AFRICA OR ANY OTHER JURISDICTION IN WHICH THE RELEASE, DISTRIBUTION OR PUBLICATION WOULD BE UNLAWFUL

Episurf Medical AB (publ) (”Episurf Medical” or the “Company”) today announces that the board has resolved on a share issue of SEK 98.3 million through a partially guaranteed preferential rights issue (the “Rights Issue”). 70.0 per cent of the Rights Issue has been guaranteed through subscription commitments and guarantee undertakings, corresponding to approximately SEK 68.8m. In addition, declarations of intention to subscribe for up to their pro rata share has been received from existing shareholders Rhenman Partners Asset Management AB and a small cap fund owned by a Swedish pension company. Subscription commitments, Guarantee commitments and declarations of intention to subscribe for shares amounts to, in total approximately SEK 76.0m

The board’s resolution is subject to approval by the extraordinary general meeting (“EGM”) to be held on May 7, 2019. In order to allow the Rights Issue, the board of directors also proposes amendments to the articles of association. Notice to shareholders of the EGM will be published through a separate press release. In connection with the Rights Issue, the board has decided to publish the financial report for the first quarter on 18 April 2019, ahead of the previously announced date.

The board has furthermore resolved not to call upon any additional tranches under the previously announced financing agreement with L1 Capital and has decided to terminate the agreement.

Background and motive

Episurf Medical addresses major medical needs not met by today’s orthopaedic industry, with a vision to help more people return to living their lives as they wish. To fulfil this vision, Episurf Medical’s business idea is to provide orthopaedic surgeons with clinically first-class patient-specific treatment alternatives through Episurf Medical's proprietary technology for imaging analysis, implant design and manufacturing. The Company recently announced that the 500th Episealer® surgery had been planned and the clinical results to date are compelling.

Episurf Medical's operational strategy is based on four cornerstones:

  • Develop clinical and health economic data to support the Episealer® technology. 
  • Establish the Episealer® technology with a large user base of orthopaedic surgeons and Key Opinion Leaders globally. 
  • Ensure production and reimbursement opportunities for highly profitable products. 
  • Ensure technological relevance and a high degree of innovation. 

At the end of 2017, the results from the first multicenter study were published in a peer-reviewed journal, which showed good to excellent results. Additional case studies and patient follow-ups three to five years after surgery strengthen the Company's view that the Episealer® technology will deliver excellent long-term results. Episealer® is now being evaluated in several clinical studies and the Company is at the very beginning of a large multicenter study in the US and Europe.

In December 2018, the Company received approval from the Food and Drug Administration (FDA) to initiate a major multicenter study in the US and Europe, which will form the basis of the Company's future application for market approval in the USA. This study has been named EPIC-knee study. In February 2018, the Company announced its long-term financial targets.

The Company foresees the following development during the years to come, divided into three main phases:

  • The first phase spans over the coming 12 months. During this period, the Company's costs will increase in connection with the recruitment of clinics, and surgeries being carried out in the EPIC-knee-study. During this period, the Company also expects clinical results from the on-going European multicenter study to be presented. The Company furthermore expects clinical results from the first comparative study carried out at the university hospital Charité in Berlin, as well as the first 5-year data from Episealer® patients.
  • After that, the Company will enter into a phase where the Company anticipates the financial result to develop positively, through higher sales and lower costs. This phase is expected to start when the patients in the FDA-study enter the follow-up period which runs over 24 months.
  • In the third phase, after approximately 12 months of recruitment and 24 months of follow-up, the Company will strive to as soon as possible submit an application for market approval in the USA. As previously announced, the Company will evaluate the possibility to carry out a launch in the USA together with a partner.

The clinical performance of the Episealer® implant is the single most important factor for the Company now preparing to expand its operations in existing, as well as into new, markets. In view of the fact that more money will be required to execute the set strategy, the board of Episurf Medical have resolved, subject to approval by the EGM, on a Rights Issue which is covered by subscription and guarantee commitments up to 70.0 per cent, corresponding to approximately SEK 68.8 million. In addition, declarations of intention to subscribe for up to an additional SEK 7.1m have been received by the Company.

The Company intends to use approximately 35 percent of the net proceeds from the Rights issue to finance the EPIC-Knee study, and approximately 65 percent to finance the continued expansion of the European business, which includes commercialisation efforts and investments in clinical studies.  

Comments from the CEO, Pål Ryfors: 

“I am very happy for the strong support among our shareholders in preparing for this financing. We are executing on a very clear strategy, and we have a great deal of visibility into the next milestones. The Episealer® technology is revolutionary and patients who previously been told to wait for decades for a knee replacement, suddenly have a new option. We have several patients who have had the implant for more than five and six years, and the clinical pipeline is very exciting. We are taking the right steps for future value creation” says Pål Ryfors, CEO Episurf Medical. 

The Rights Issue in summary 

  • The board of directors of Episurf Medical has resolved, subject to approval by the EGM, on a preferential right issue of SEK 98.3m. 
  • The terms of the Rights Issue stipulate that for each (1) existing share, two new shares will be issued at issue price of SEK 1.40 per new share. If fully subscribed, a total of 70 227 372 new shares will be issued, and the total proceeds will amount to SEK 98 318 320.80.  
  • Current shareholders have entered into subscription commitments in the Rights Issue of a total of SEK 15.8m, corresponding to approximately 16.1 percent of the Rights Issue. An additional SEK 53.0m, corresponding to 53,9 percent of the Rights Issue, is covered by guarantee commitments. 
  • The board of directors' resolution is subject to approval by the EGM to be held on May 7, 2019. Notice of the EGM will be published through a separate press release.  
  • In order to allow the Rights Issue, the board of directors proposes amendments to the articles of association pertaining to the limits of the share capital and number of shares. Complete proposal will be presented at the latest three weeks ahead of the EGM. 
  • The record date for participation in the Rights Issue is May 14, 2019. 
  • The subscription period in the Rights Issue takes place between May 15 and May 29 2019. 

The Rights Issue

On 5 April, 2019, the Board of Episurf Medical resolved, subject to approval by the Extraordinary General Meeting, on a share issue of up to 70 227 372 shares with preferential rights for the Company’s existing shareholders. The subscription price amounts to SEK 1.40 per share, meaning that the Company will receive up to approximately SEK 98.3m, before issue costs, through the Rights Issue if fully subscribed.

For each class A share and each class B share held on the record date of 14 May, 2019, shareholders will receive two (2) subscription rights of class A and class B respectively. One (1) class A subscription right entitles to subscription of one (1) class A share and one (1) class B subscription right entitles to subscription of one (1) class B share. If not all shares issued in the Rights Issue are subscribed for with subscription rights (primary preferential right), the Board of Directors shall decide on the allotment of new shares of class A and B subscribed for without subscription rights in accordance with the following:

1)      Firstly, shares not subscribed for with primary preferential right shall be offered to all shareholders for subscription (subsidiary preferential right). If shares thus offered for subscription are insufficient for the subscription that takes place through a subsidiary preferential right, the shares shall be divided among subscribing parties in relation to the previous shareholding. To the extent this cannot take place, the shares shall be divided by the drawing of lots.

2)      Secondly, the shares shall be allotted to others that have subscribed for new shares without subscription rights, pro rata to the number of shares that each has applied to subscribe for.

3)      Ultimately, the shares shall be allotted to those who guaranteed the Rights Issue pursuant to separate guarantee commitments with the Company, with allocation in relation to the size of their respective commitments.

Record date for participation in the Rights Issue is May 14, 2019, and the subscription period takes place during the period May 15 – May 29, 2019. The last day of trading in Episurf Medical’s share including the right to participation in the Rights Issue is May 10, 2019. Trading in subscription rights of series B shall take place on Nasdaq Stockholm during the period May 15 – May 27 2019.

Existing shareholders, together representing 19.1 per cent of the number of shares and 20.1 per cent of the number of votes, have undertaken to vote in favor of the Rights Issue at the AGM and subscribe for up to their pro rata shares in an amount of SEK 15.8m, corresponding to approximately 16.1 percent of the share issue. In addition, the Rights Issue is covered by guarantee commitments amounting to approximately SEK 53.0m, corresponding to approximately 53.9 percent of the share issue. Thus, the Rights Issue is covered up to 70.0 percent by subscription and guarantee commitments. The subscription and guarantee commitments have not been secured. In addition, declarations of intention to subscribe for up to an additional SEK 7.1m have been received by the Company.

The Board’s decision on implementing the Rights Issue is subject to approval from the EGM to be held on May 7, 2019. Notice to the EGM will be published through a separate press release.

Full terms and conditions for the Rights Issue as well as other information about the Company will be disclosed in the prospectus published no later than the day before the subscription period starts.

Change of reporting date for earnings report for the first quarter

In conjunction with the Rights Issue, the board has decided to publish the financial report for the first quarter 2019 on April 18, 2019, ahead of the previously announced date.

Financing agreement with L1 Capital

In February 2018, the Company entered into a financing agreement with L1 Capital. The Company today announces that the Company intends to terminate the financing agreement and therefore will not call upon any additional financing tranches. Only one tranche has been utilized, in conjunction with the entry into force of the agreement in the spring of 2018.

Preliminary time plan for the Rights Issue

May 7, 2019                          EGM

May 10, 2019                        Last day of trading including the right to receive subscription rights

May 13, 2019                        First day of trading excluding the right to receive subscription rights

May 14, 2019                        Record date for participation in the Rights Issue

May 15 - May 27, 2019         Trading in subscription rights

May 15 - May 29, 2019         Subscription period

June 4, 2019                         Publication of the outcome in the Rights Issue

Financial and legal advisors 

Redeye AB act as financial advisors and DLA Piper Sweden act as legal advisor to Episurf Medical in connection with the rights issue.

For more information, please contact: 

Pål Ryfors, CEO, Episurf Medical
Tel: +46 (0) 709 62 36 69
Email: 
pal.ryfors@episurf.com 

About Episurf Medical

Episurf Medical is endeavoring to bring people with painful joint injuries a more active, healthier life through the availability of minimally invasive and individualised treatment alternatives. Episurf Medical’s Episealer® individualised implants and Epiguide® surgical drill guides are developed for treating localised cartilage injury in joints. Episurf Medical’s μiFidelity® system enables implants to be cost-efficiently tailored to each individual’s unique injury for the optimal fit and minimal intervention. Episurf Medical’s head office is in Stockholm, Sweden. Its share (EPIS B) is listed on Nasdaq Stockholm. For more information, go to the company’s website: www.episurf.com.

This information is information that Episurf Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 07.45 CEST on 5 April 2019.


IMPORTANT INFORMATION

The information in this press release does not constitute an offer to acquire, subscribe for or otherwise trade with shares or other securities in Episurf Medical. No action has been taken, nor will any actions be taken, to permit an offer to the public in any other jurisdiction than Sweden. An invitation to eligible persons to subscribe for shares in Episurf Medical will only be made through the prospectus which Episurf Medical intends to publish on or about 9 May 2019.

The information in this press release may not be published or distributed, directly or indirectly, within or into the United States of America (including its territories and possessions, any state of the United States and the District of Columbia, the “USA”), Australia, Canada, Hong Kong, Japan, New Zealand, South Africa, Switzerland, the United Kingdom or any jurisdiction where doing so might be unlawful, subject to legal restrictions or require other actions than the ones prescribed under Swedish law. Actions in violation of these instructions may constitute a breach of applicable securities law. This press release does not constitute an offer of invitation to acquire or subscribe for shares in the USA. No subscription rights, paid subscribed shares (BTA) or shares or other securities issued by the Company (the “Securities”) have been, nor will they be, registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”) or the securities laws in any other state or jurisdiction in the USA and no Securities may be offered, subscribed, used, pledged, sold, retailed, delivered or transferred, directly or indirectly, in or into the United States other than pursuant to an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and in compliance with any applicable securities laws of any state or other jurisdiction of the United States. The Securities have not been and will not be approved or registered by the Securities and Exchange Commission (SEC), any state securities authority or other authority in the USA. No such authority has assessed or made any statements about the offer or the accuracy or reliability of the prospectus. To assert the contrary is a criminal act in the USA.

Within the European Economic Area ("EEA"), no offer of Securities is made in any other jurisdiction than Sweden. In other member states in the EEA which have implemented the Directive 2003/71/EC of the European Parliament and of the Council ("Prospectus Directive"), an offer of Securities may only be made in accordance with an exemption from the Prospectus Directive and any relevant implementation measures (including measures to implement the Directive 2010/73/EU of the European Parliament and of the Council).

This press release may contain certain forward-looking statements which reflect Episurf Medical's current view of future events and financial and operational developments. Words such as "intends", "estimates", "expects", "may", "plans", "deems", "believes", "assesses", "anticipates", "will", and other similar expressions which imply indications or predictions regarding future developments or trends, and which are not based on historical facts, constitute forward-looking information. Forward-looking information is by nature affiliated with known and unknown risks and uncertainties since it is dependent on future events and circumstances. Forward-looking information does not constitute any guarantee regarding future results or development and the actual outcome may materially differ from forward-looking statements. The information, assessments and forward-looking statements in this press release are only relevant as of the date of this press release and may change without notice.

Tags:

About Us

Episurf Medical is endeavoring to bring people with painful joint injuries a more active, healthier life through the availability of minimally invasive and personalized treatment alternatives. Episurf Medical’s Episealer® personalized implants and Epiguide® surgical drill guides are developed for treating localized cartilage injury in joints. Episurf Medical’s μiFidelity® system enables implants to be cost-efficiently tailored to each individual’s unique injury for the optimal fit and minimal intervention. Episurf Medical’s head office is in Stockholm, Sweden. Its share (EPIS B) is listed on Nasdaq Stockholm. For more information, go to the company’s website: www.episurf.com.