NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR TO
The Directed Issue
The subscription price and the number of new shares in the Directed Issue will be determined through an accelerated bookbuilding procedure, which will commence immediately following the publication of this press release and will be led by the Joint Bookrunners. Closing of the accelerated bookbuilding procedure, pricing and allocation of the new shares are expected to take place before the commencement of trading on Nasdaq Stockholm at
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 costs. 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.
Since the subscription price in the Directed Issue will been determined through an accelerated bookbuilding procedure, the board of directors assesses that the subscription price will reflect market terms and conditions.
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