{"id":2901,"date":"2019-07-12T05:30:00","date_gmt":"2019-07-12T05:30:00","guid":{"rendered":"https:\/\/www.xvivogroup.com\/us\/mfn_news\/historiskt-pma-godkannande-och-framsteg-i-fou-portfoljen\/"},"modified":"2019-07-12T05:30:00","modified_gmt":"2019-07-12T05:30:00","slug":"historiskt-pma-godkannande-och-framsteg-i-fou-portfoljen","status":"publish","type":"mfn_news","link":"https:\/\/www.xvivogroup.com\/us\/pressreleases\/historiskt-pma-godkannande-och-framsteg-i-fou-portfoljen\/","title":{"rendered":"HISTORISKT PMA-GODK\u00c4NNANDE OCH FRAMSTEG I FoU-PORTF\u00d6LJEN"},"content":{"rendered":"<p><strong><span>ANDRA KVARTALET 2019 (APRIL &#8211; JUNI)<\/span><\/strong><strong><span><br \/> <\/span><\/strong><\/p>\n<ul>\n<li><span>Segment f\u00f6rs\u00e4ljning utan kapitalvaror \u00f6kade under kvartalet med 20 procent och uppgick till 50,5 MSEK (42,2). \u00d6kningen motsvarar 13 procent i lokala valutor. Total f\u00f6rs\u00e4ljning (inklusive kapitalvaror) under kvartalet \u00f6kade med 22 procent och\u00a0 uppgick till 56,4 MSEK (46,1). \u00d6kningen motsvarar 15 procent i lokala valutor.<\/span><\/li>\n<li>Varm perfusion stod f\u00f6r 45 procent (43) av f\u00f6rs\u00e4ljningen utan kapitalvaror.<\/li>\n<li><span>R\u00f6relseresultatet f\u00f6re avskrivningar (EBITDA), justerat f\u00f6r kostnader f\u00f6r aktiebaserat bonusprogram f\u00f6r anst\u00e4llda utanf\u00f6r Sverige, uppgick till 12,1 MSEK (10,9), motsvarande en EBITDA-marginal om 21 procent (24). Redovisad EBITDA uppgick till 8,1 MSEK (8,1) motsvarande en EBITDA-marginal om 14 procent (18).<\/span><\/li>\n<li>R\u00f6relseresultat justerat f\u00f6r kostnad f\u00f6r aktiebaserat bonusprogram f\u00f6r anst\u00e4llda utanf\u00f6r Sverige uppgick till 5,9 MSEK (6,8). Redovisat r\u00f6relseresultat uppgick till 1,9 MSEK (4,0), efter att avskrivningar om 6,1 MSEK (4,1) belastat kvartalet.<\/li>\n<li>Nettoresultatet uppgick till 2,2 MSEK (3,9), vilket gav ett resultat per aktie om 0,08 SEK (0,15).<\/li>\n<li><span>Kassafl\u00f6<\/span><span>det fr\u00e5<\/span><span>n den l<\/span><span>\u00f6pande verksamheten uppgick under kvartalet till 21,0 MSEK (13,1). Kassafl\u00f6det fr\u00e5n investeringsverksamheten uppgick till -27,8 MSEK (-19,2 MSEK).<\/span><\/li>\n<li>XVIVO erh\u00f6ll PMA-godk\u00e4nnande (Premarket Approval) fr\u00e5n FDA f\u00f6r produkterna XPS\u2122 och STEEN Solution\u2122 f\u00f6r f\u00f6rs\u00e4ljning p\u00e5 den amerikanska marknaden. PMA-godk\u00e4nnandet var det f\u00f6rsta av sitt slag.<\/li>\n<li><span>XVIVO:s patent f\u00f6r hj\u00e4rtpreservationsv\u00e4tska godk\u00e4nda i USA och Europa.<\/span><\/li>\n<li><span>L\u00e4kemedelsverket gav klartecken f\u00f6r kliniska studier i Sverige med bolagets nya produkter f\u00f6r hj\u00e4rtpreservation.<\/span><\/li>\n<li><span>Nyemission till f\u00f6ljd av utnyttjande av teckningsoptioner gav ett kapitaltillskott om cirka 27 MSEK.<\/span><\/li>\n<li><span>Kanada nytt land med XPS\u2122<\/span><\/li>\n<\/ul>\n<p><strong><span>PERIODEN 2019 (JANUARI &#8211; JUNI)<br \/> <\/span><\/strong><\/p>\n<ul>\n<li><span>Segment f\u00f6rs\u00e4ljning utan kapitalvaror \u00f6kade under f\u00f6rsta halv\u00e5ret med 21 procent och uppgick till 97,3 MSEK (80,1). \u00d6kningen motsvarar 13 procent i lokala valutor. Total f\u00f6rs\u00e4ljning (inklusive kapitalvaror) under perioden \u00f6kade med 18 procent och uppgick till 104,1 MSEK (88,6). \u00d6kningen motsvarar 9 procent i lokala valutor.<\/span>\u00a0<\/li>\n<li>Varm perfusion stod f\u00f6r 44 procent (39) av f\u00f6rs\u00e4ljningen utan kapitalvaror.<\/li>\n<li><span>R\u00f6relseresultatet f\u00f6re avskrivningar (EBITDA), justerat f\u00f6r kostnader f\u00f6r aktiebaserat bonusprogram f\u00f6r anst\u00e4llda utanf\u00f6r Sverige, uppgick till 20,8 MSEK (18,0), motsvarande en EBITDA-marginal om 20 procent (20). Redovisad EBITDA uppgick till 11,3 MSEK (15,2) motsvarande en EBITDA-marginal om 11 procent (17).<\/span><\/li>\n<li>R\u00f6relseresultat justerat f\u00f6r kostnad f\u00f6r aktiebaserat bonusprogram f\u00f6r anst\u00e4llda utanf\u00f6r Sverige uppgick till 9,6 MSEK (9,9). Redovisat r\u00f6relseresultat uppgick till 0,1 MSEK (7,1), efter att avskrivningar om 11,2 MSEK (8,1) belastat perioden.<\/li>\n<li><span>Nettoresultatet uppgick till 1,9 MSEK (7,7), vilket gav ett resultat per aktie om 0,07 SEK (0,29).<\/span><\/li>\n<li><span>Kassafl\u00f6<\/span><span>det fr\u00e5<\/span><span>n den l<\/span><span>\u00f6pande verksamheten uppgick under perioden till 21,2 MSEK (22,3). Kassafl\u00f6det fr\u00e5n investeringsverksamheten uppgick till -39,5 MSEK (-30,0 MSEK). <\/span><\/li>\n<li><span>Reimbursement f\u00f6r hela EVLP-processen erh\u00e5llet i Frankrike<\/span><span>.<\/span><\/li>\n<li><span>2 XPS\u2122 levererades under perioden januari-juni 2019. Vid kvartalets utg\u00e5ng hade 48 kliniker tillg\u00e5ng till XPS\u2122 eller LS\u2122.<\/span><\/li>\n<\/ul>\n<p><strong>TELEFONKONFERENS<\/strong><\/p>\n<p>VD Magnus Nilsson presenterar rapporten vid en telefonkonferens klockan 14:00 fredag den 12 juli 2019. <span>Telefon: +46 (0)8 5664 2651, ange kod 15013516#.<\/span><\/p>\n<p>G\u00f6teborg den 12 juli 2019<br \/> XVIVO Perfusion AB (publ)<br \/> Magnus Nilsson, VD<\/p>\n<div class=\"mfn-footer\">\n<p><span>F\u00f6r ytterligare information, v\u00e4nligen kontakta: <\/span><\/p>\n<p><span>Christoffer Rosenblad, CFO, +46 735 192 159, christoffer.rosenblad@xvivoperfusion.com<br \/>Magnus Nilsson, VD, +46 31 788 21 50, magnus.nilsson@xvivoperfusion.com<\/span><\/p>\n<p><span>F\u00f6r ytterligare information om XVIVO Perfusions verksamhet h\u00e4nvisas till bolagets hemsida, www.xvivoperfusion.com<\/span><\/p>\n<p><span>Denna information \u00e4r s\u00e5dan information som Xvivo Perfusion AB (publ) \u00e4r skyldigt att offentligg\u00f6ra enligt EU:s marknadsmissbruksf\u00f6rordning och lagen om v\u00e4rdepappersmarknaden. Informationen l\u00e4mnades, genom ovanst\u00e5ende kontaktpersons f\u00f6rsorg, f\u00f6r offentligg\u00f6rande klockan 07:30 den 12 juli 2019.<\/span><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>ANDRA KVARTALET 2019 (APRIL &#8211; JUNI) Segment f\u00f6rs\u00e4ljning utan kapitalvaror \u00f6kade under kvartalet med 20 procent och uppgick till 50,5&#8230;<\/p>\n","protected":false},"template":"","class_list":["post-2901","mfn_news","type-mfn_news","status-publish","hentry","mfn-news-tag-mfn","mfn-news-tag-mfn-type-ir","mfn-news-tag-mfn-lang-sv","mfn-news-tag-mfn-regulatory","mfn-news-tag-mfn-regulatory-mar","mfn-news-tag-mfn-regulatory-vpml","mfn-news-tag-mfn-report","mfn-news-tag-mfn-report-interim","mfn-news-tag-mfn-report-interim-q2"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>HISTORISKT PMA-GODK\u00c4NNANDE OCH FRAMSTEG I FoU-PORTF\u00d6LJEN - XVIVO<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.xvivogroup.com\/us\/pressreleases\/historiskt-pma-godkannande-och-framsteg-i-fou-portfoljen\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"HISTORISKT PMA-GODK\u00c4NNANDE OCH FRAMSTEG I FoU-PORTF\u00d6LJEN - XVIVO\" \/>\n<meta property=\"og:description\" content=\"ANDRA KVARTALET 2019 (APRIL &#8211; 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