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2019-02-08 Bokslutskommuniké 2018
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2018-04-30 Ordinarie utdelning XVIVO 0.00 SEK
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2017-04-27 Ordinarie utdelning XVIVO 0.00 SEK
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2016-05-04 Ordinarie utdelning XVIVO 0.00 SEK
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2016-02-04 Bokslutskommuniké 2015
2015-10-23 Kvartalsrapport 2015-Q3
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2015-04-24 Ordinarie utdelning XVIVO 0.00 SEK
2015-04-23 Årsstämma 2015
2015-04-22 Kvartalsrapport 2015-Q1
2015-02-05 Bokslutskommuniké 2014
2014-10-24 Kvartalsrapport 2014-Q3
2014-10-24 Analytiker möte 2014
2014-08-13 Kvartalsrapport 2014-Q2
2014-04-30 Ordinarie utdelning XVIVO 0.00 SEK
2014-04-29 Årsstämma 2014
2014-04-23 Kvartalsrapport 2014-Q1
2014-02-07 Bokslutskommuniké 2013
2013-11-07 Analytiker möte 2013
2013-11-07 Kvartalsrapport 2013-Q3
2013-07-11 Kvartalsrapport 2013-Q2
2013-05-08 Ordinarie utdelning XVIVO 0.00 SEK
2013-05-07 Årsstämma 2013
2013-04-19 Kvartalsrapport 2013-Q1
2013-02-19 Bokslutskommuniké 2012
2012-11-01 Kvartalsrapport 2012-Q3

Beskrivning

LandSverige
ListaMid Cap Stockholm
SektorHälsovård
IndustriMedicinteknik
Xvivo Perfusion är verksamt inom medicinteknik. Bolaget tillhandahåller lösningar för transplantation av lungor. Exempel på produkter som bolaget levererar innefattar kanyler, organförvaring samt kyllösningar. Produkterna vidaresäljs till kliniker och forskningsinstitut runtom den globala marknaden, med störst närvaro inom Norden och Europa. Bolaget kom till via en avknoppning från Vitrolife under 2012 och har sitt huvudkontor i Göteborg.
2023-09-13 21:59:00

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR TO THE UNITED STATES, AUSTRALIA, CANADA, HONG KONG, JAPAN, NEW ZEALAND, SINGAPORE, SOUTH AFRICA, SOUTH KOREA OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL. ADDITIONAL RESTRICTIONS APPLY, PLEASE REFER TO IMPORTANT INFORMATION AT THE END OF THE PRESS RELEASE.

XVIVO Perfusion AB (publ) (“XVIVO” or the “Company”) has completed a directed share issue of 1,600,000 shares at a subscription price of SEK 275 per share (the “Directed Issue”), through which the Company receives SEK 440 million before deduction of transaction costs. The subscription price was determined through an accelerated book-building procedure conducted by Carnegie Investment Bank AB (publ) (“Carnegie”) and DNB Markets, a part of DNB Bank ASA, Sweden branch (“DNB Markets”) to act as Joint Bookrunners (together the “Joint Bookrunners”).

The Directed Issue
The board of directors of XVIVO has, based on the authorization to issue shares granted by the annual general meeting on 25 April 2023 and as announced by the Company through a press release earlier today, resolved on a directed issue of 1,600,000 shares at a subscription price of SEK 275 per share, corresponding to the closing price on the day of this announcement of the XVIVO share, as traded on Nasdaq Stockholm, consequently raising gross proceeds of SEK 440 million. The subscription price in the Directed Issue was determined through an accelerated book-building procedure led by the Joint Bookrunners and was, accordingly, in the assessment of the board of directors reflects market conditions and the demand for the Company's shares.

Investors in the Directed Issue include both existing and new shareholders such as Bure Equity AB, the Fourth AP Fund, Swedbank Robur Fonder, Eccenovo, Handelsbanken Fonder AB through the investment fund Hälsovård Tema, the Third AP Fund and a tier-one global international investor.

The interest from US clinics for XVIVO’s upcoming US heart preservation trial has been significant. On July 25, 2023, the FDA granted XVIVO approval to include Donation after Circulatory Death (“DCD”) hearts in its Investigational Device Exemption (“IDE”) clinical trial. Expanding the clinical trial to include DCD hearts means that the Company’s technology is additionally made available to approximately one third of the US donor pool.

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 SEK 40,894.01 from approximately SEK 764,193.202576 to approximately SEK 805,087. 212576.
Settlement of the Directed Issue is expected to take place on or about 18 September 2023.

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 DNB Markets acted as Joint Bookrunners in connection with the Directed Issue. Advokatfirman Vinge acted as legal counsel to the Company and Baker McKenzie acted as legal counsel to the Joint Bookrunners.

13 September 2023
Gothenburg
XVIVO Perfusion AB (publ)