NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR TO
The Directed Issue
The board of directors of XVIVO has, based on the authorization to issue shares granted by the annual general meeting on
Investors in the Directed Issue include both existing and new shareholders such as
The interest from US clinics for XVIVO’s upcoming US heart preservation trial has been significant. On
Today, XVIVO is the European market leader within liver machine perfusion, supported by strong clinical data published in leading scientific journals. In 2022, 9,528 liver transplants were performed in the US (UNOS data). In order to become the the global market leader within abdominal machine perfusion, the Company has identified an opportunity to shorten the time to market in the US for the Liver Assist technology. This can be achieved by conducting a clinical trial to support the FDA PMA approval process for the Liver Assist in addition to the Company’s heart preservation trial, meaning that the Company aims to conduct regulatory processes for both heart and liver in the US.
The net proceeds from the Directed Issue are intended to be used for:
· Increased investment in US clinical trial infrastructure and support to create an efficient FDA PMA regulatory approval process for the heart preservation technology;
· Fast-track the preparation and start of the clinical trial and FDA PMA regulatory approval process for Liver Assist; and
· Scale-up of disposable production to ensure delivery capacity and decrease in cost of goods sold.
Prior to the Directed Issue, the Company's board of directors has made an overall assessment and carefully considered the possibility to raise capital through a rights issue with preferential right for the Company's existing shareholders. The board of directors considers that the reasons for deviating from the shareholders’ preferential right are (i) that a rights issue would take a significantly longer time to complete and entail a higher risk for a adverse effect on the share price, particularly in light of the current market volatility and the challenging market conditions, (ii) to diversify and strengthen the Company's shareholder base with international institutional investors, (iii) to carry out a directed share issue can be made at lower costs and with less complexity than a rights issue and in light of the current market conditions, the board of directors has assessed that a rights issue would also require external underwriting from a guarantor syndicate that would entail additional significant. Considering the above, the board of directors has made the assessment that a directed share issue with deviation from the shareholders’ preferential right is the most favourable alternative for XVIVO, creates value for the Company and is in the best interest of the Company’s shareholders. The board of directors thus considers that the reasons outweigh the main rule that new share issues are to be carried out with preferential rights for the shareholders.
The Directed Issue entails a dilution of approximately 5.1 percent of the number of shares and votes in the Company (calculated as the number of newly issued shares divided by the total number of shares in the Company after the Directed Issue). Through the Directed Issue, the number of shares and votes in the Company will increase by 1,600,000 from 29,899,470 to 31,499,470. The share capital will increase by approximately
Settlement of the Directed Issue is expected to take place on or about
Lock-up undertakings
In connection with the Directed Issue, the Company has agreed to a lock-up undertaking, with customary exceptions, on future share issuances for a period of 180 calendar days after the settlement date of the Directed Issue. In addition, XVIVO’s board members and shareholding members of the senior management have undertaken not to, subject to customary exceptions, divest any shares in XVIVO for a period of 180 days from the settlement date of the Directed Issue.
Advisors
Carnegie and
© Modular Finance, source