{"id":1767,"date":"2020-05-14T06:00:00","date_gmt":"2020-05-14T06:00:00","guid":{"rendered":"https:\/\/d.ptpl.dev\/acarix\/acarix-ab-publ-publicerar-delarsrapport-januari-mars-2020\/"},"modified":"2024-08-06T12:25:25","modified_gmt":"2024-08-06T12:25:25","slug":"acarix-ab-publ-publicerar-delarsrapport-januari-mars-2020","status":"publish","type":"post","link":"https:\/\/d.ptpl.dev\/acarix\/acarix-ab-publ-publicerar-delarsrapport-januari-mars-2020\/","title":{"rendered":"Acarix AB (publ) publicerar del\u00e5rsrapport, januari \u2013 mars 2020"},"content":{"rendered":"<div class=\"mfn-preamble\"><strong><\/strong><\/div>\n<div>\n<p>Press release (MAR)<\/p>\n<p>Malm\u00f6, 14 maj, 2020<\/p>\n<p><strong>Acarix AB (publ) publicerar del\u00e5rsrapport, januari \u2013 mars 2020<\/strong><\/p>\n<p>Fortsatt fokus p\u00e5 strategiska prioriteringar<\/p>\n<p>Under kvartalet fortsatte vi att fokusera p\u00e5 v\u00e5ra prioriteringar samtidigt som vi hanterade effekterna av covid\u00ad19\u00adpandemin. Vi har haft fortsatt dialog med b\u00e5de amerikanska l\u00e4kemedelsverket (FDA) r\u00f6rande v\u00e5rt amerikanska marknads\u00ad godk\u00e4nnande och tyska G\u00adBA ang\u00e5ende \u00e5terbetalningsprocessen i Tyskland.<\/p>\n<p><em>Utdrag ur VD Per Perssons kommentar till del\u00e5rsrapporten.<\/em><\/p>\n<p><strong>F\u00f6rsta kvartalet 2020 j\u00e4mf\u00f6rt med samma period 2019<\/strong><\/p>\n<ul type=\"disc\">\n<li>Under f\u00f6rsta kvartalet uthyrdes ett (5 system s\u00e5ldes) CADScor\u00aeSystem och 370 (640) eng\u00e5ngspl\u00e5ster s\u00e5ldes. Dessutom levererades 240 eng\u00e5ngspl\u00e5ster f\u00f6r v\u00e5ra p\u00e5g\u00e5ende kliniska pr\u00f6vningar.<\/li>\n<li>Int\u00e4kterna uppgick till 121 kSEK (299), med ett bruttoresultat om 109 kSEK (209) och en bruttomarginal om 90 procent (70).<\/li>\n<li>R\u00f6relsekostnaderna uppgick till 10\u00a0904 kSEK (13\u00a0038).<\/li>\n<li>Resultat f\u00f6re skatt uppgick till \u201310\u00a0815 kSEK (\u201312\u00a0822).<\/li>\n<li>Nettokassafl\u00f6det fr\u00e5n den l\u00f6pande verksamheten uppgick till \u20138\u00a0575 kSEK (\u00ad13\u00a0101).<\/li>\n<li>Beh\u00e5llning av likvida medel uppgick till 45\u00a0019 kSEK (51\u00a0581).<\/li>\n<li>Resultat per aktie uppgick till \u20130,21 SEK (\u20130,56). Inga utsp\u00e4dningseffekter uppkom.<\/li>\n<\/ul>\n<p><strong>H\u00e4ndelser under f\u00f6rsta kvartalet 2020<\/strong><\/p>\n<ul type=\"disc\">\n<li>Den 14 januari 2020 meddelade bolaget att CADScor\u00aeSystem f\u00f6r f\u00f6rsta g\u00e5ngen anv\u00e4nds kommersiellt i Storbritannien och de f\u00f6rsta patienterna utv\u00e4rderas. Dr Amrit Takhar och hans team p\u00e5 Wansford och Kingscliffe Practice n\u00e4ra Peterborough \u00e4r den f\u00f6rsta kliniken i Storbritannien som anv\u00e4nder den unika CADScor\u00adtekniken f\u00f6r att utv\u00e4rdera patienter som lider av stabila br\u00f6stsm\u00e4rtor.<\/li>\n<li>Den 18 februari meddelade bolaget att den randomiserade, kliniska multicenterstudien FILTER\u00adSCAD har p\u00e5b\u00f6rjats. FILTER\u00adSCAD studien syftar till att analysera kostnadseffektivitet och s\u00e4kerhet som konsekvens vid ett anv\u00e4ndande av CADScor\u00aeSystem som uteslutande test f\u00f6r patienter med symtom p\u00e5 stabil kransk\u00e4rlssjukdom. FILTER\u00adSCAD studien kommer att omfatta totalt 2\u00a0000 patienter med misst\u00e4nkt stabil kransk\u00e4rlssjukdom vid fyra sjukhus i Danmark och Lunds universitetssjukhus i Sverige.<\/li>\n<li>Den 12 mars 2020 erh\u00f6ll bolaget bekr\u00e4ftande feedback fr\u00e5n de tyska myndigheterna, Federal Joint Committee, G\u00adBA, p\u00e5 ans\u00f6kan om kostnadsers\u00e4ttning f\u00f6r CADScor\u00aeSystem i Tyskland.<\/li>\n<li>Under det f\u00f6rsta kvartalet 2020 br\u00f6t covid\u00ad19 pandemin ut och f\u00f6ljderna av utbrottet har sedan mars m\u00e5nad haft en negativ p\u00e5verkan p\u00e5 Acarix, och det finns en risk att detta kan leda till en negativ finansiell p\u00e5verkan p\u00e5 koncernen. Inom Acarix arbetar vi f\u00f6r att s\u00e4kerst\u00e4lla att verksamheten forts\u00e4tter att fungera efter v\u00e5r b\u00e4sta f\u00f6rm\u00e5ga samtidigt som vi st\u00e4ller v\u00e5ra medarbetares h\u00e4lsa i fokus. Detta g\u00f6r vi fr\u00e4mst genom en uppmaning till f\u00f6retagets personal att arbeta hemifr\u00e5n och ett resef\u00f6rbud. I v\u00e5r bed\u00f6mning av de omedelbara effekterna kan vi konstatera att patientrekryteringen i v\u00e5ra p\u00e5g\u00e5ende kliniska studier Filter Scad Studien och Dan\u00adNICAD II studien har avstannat vilket kan komma att f\u00f6rsena slutf\u00f6randet av studierna. Vidare har bolaget l\u00e4mnat in en DeNovo\u00adans\u00f6kan till FDA (American Food and Drug Administration) f\u00f6r produktgodk\u00e4nnande inf\u00f6r lansering av CADScor\u00aeSystem p\u00e5 den amerikanska marknaden. Det finns en risk att godk\u00e4nnandeprocessen f\u00f6rsenas. <br \/> G\u00e4llande ers\u00e4ttningsprocessorn i Tyskland s\u00e5 p\u00e5g\u00e5r den tillsammans med G\u00adBA (Federal Joint Committee). I b\u00f6rjan av 2020 fick vi positiv \u00e5terkoppling fr\u00e5n G\u00adBA som r\u00e4knade med att \u00e5terkomma med ytterligare information under mitten av 2020. Det finns en risk att G\u00adBA:s \u00e5terkoppling kan komma att f\u00f6rsenas. <br \/> D\u00e5 de flesta sjukhus, v\u00e5rdcentraler och \u00e4ven privatkliniker har begr\u00e4nsat tillg\u00e5ngen f\u00f6r kommersiell verksamhet ber\u00f6rs \u00e4ven s\u00e4lj och marknad i h\u00f6g grad s\u00e5 l\u00e4nge covid\u00ad19 situationen kvarst\u00e5r. S\u00e5v\u00e4l internationella som nationella kongresser och utbildningsm\u00f6ten har under v\u00e5ren st\u00e4llts in eller skjutits fram till senare delen av \u00e5ret. Detta sammantaget inneb\u00e4r att en stor del av v\u00e5ra kommersiella aktiviteter drabbas med motsvarande f\u00f6rskjutning s\u00e5 l\u00e4nge covid\u00ad19 krisen varar. Det \u00e4r dock, givet den os\u00e4kra situationen i nul\u00e4get inte m\u00f6jligt att uppskatta hela den potentiella p\u00e5verkan f\u00f6r Acarix.<\/li>\n<\/ul>\n<p><strong>H\u00e4ndelser efter den 31 mars 2020<\/strong><br \/>\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00b7Den 11 maj 2020 meddelade bolaget att den sista patienten inkluderats i den unders\u00f6kande SEISMO\u00adstudien, vilken utv\u00e4rdera m\u00f6jligheten att utveckla en algoritm f\u00f6r tidig uppt\u00e4ckt av hj\u00e4rtsvikt.<\/p>\n<p>Den fullst\u00e4ndiga del\u00e5rsrapporten finns tillg\u00e4nglig via l\u00e4nk nedan samt p\u00e5 www.acarix.com<\/p>\n<p><strong>Kontaktpersoner f\u00f6r mer information <\/strong><\/p>\n<p>Per Persson, VD <br \/>e-post: <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=yyM3yrKRBqCnoTPwln5lBvEGZ6PkCTaLO923KyKQQK3zmg-DirptI4qVuZ9JtPPt66cvGM3geCbE7eXTjknaSqrxTa7mRXjf1akU1NCKhVM=\" target=\"_blank\" title=\"\" rel=\"nofollow noopener\"><u>per.persson@acarix.com<\/u><\/a> <br \/>tel: +46 736 005\u00a0990<\/p>\n<p>Christian Lindholm, CFO <br \/>e-post: <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=MSNFOppjL5oAQqQehjHTuXu4s6vhQ4t9tzklYFFh4ns5fg857OSfZpJZw-5IHHuS4gWmehyyl18RkVwbSatxRyrRtm0PM0LlQ93B3GjtDkHzTowR1HYe_GRf8a_bzbeJ\" target=\"_blank\" title=\"\" rel=\"nofollow noopener\"><u>christian.lindholm@acarix.com<\/u><\/a><br \/>tel: +46 705 118\u00a0333<\/p>\n<p><strong>Om Acarix<\/strong><br \/>Acarix grundades 2009 och \u00e4r noterat p\u00e5 Nasdaq First North Premier. Acarix CADScor\u00aeSystem anv\u00e4nder en avancerad sensor som placeras p\u00e5 huden ovanf\u00f6r hj\u00e4rtat f\u00f6r att lyssna p\u00e5 ljudet av hj\u00e4rtkontraktion och turbulent fl\u00f6de. Det har utformats f\u00f6r att vara ett allt-i-ett-system i den meningen att signalen fr\u00e5n hj\u00e4rtat spelas in, bearbetas och visas som en patientspecifik s.k. CAD-score p\u00e5 sk\u00e4rmen. Presentation av m\u00e4tresultaten erh\u00e5lls p\u00e5 mindre \u00e4n 8 minuter. Som en s\u00e4ker metod och l\u00e4mplig f\u00f6r anv\u00e4ndning i b\u00e5de prim\u00e4rv\u00e5rden och p\u00e5 inneliggande patienter kan CADScor\u00aeSystem potentiellt komma att spela en viktig roll f\u00f6r patient-triage, n\u00e5got som g\u00f6r att m\u00e5nga patienter inte beh\u00f6ver unders\u00f6kas ytterligare med invasiva, diagnostiska metoder.<\/p>\n<p><em>Denna <\/em><em>information <\/em><em>\u00e4r regulatorisk information som Acarix AB (publ)<\/em> <em>ska offentligg\u00f6ra enligt EU:s marknadsmissbruksf\u00f6rordning.<\/em> <em>Informationen l\u00e4mnades f\u00f6r publicering genom ovanst\u00e5ende kontaktpersons f\u00f6rsorg den 14 maj 2020 kl 08.00.<\/em><\/p>\n<\/p>\n<\/div>\n<div class=\"mfn-footer mfn-attachment\">\n<p><strong>Bifogade filer<\/strong><\/p>\n<hr\/>\n<p><a href=\"https:\/\/d.ptpl.dev\/acarix\/wp-content\/uploads\/2024\/08\/41b34c03-de5b-4448-a26c-23b504469eda.pdf\" target=\"_blank\" rel=\"nofollow noopener\">PM_Acarix_Q1_2020 sv<\/a><br \/><a href=\"https:\/\/d.ptpl.dev\/acarix\/wp-content\/uploads\/2024\/08\/07f19d1f-f270-4b54-8ce9-9a2d2ffbf6cf.pdf\" target=\"_blank\" rel=\"nofollow noopener\">Acarix Dela\u030arsrapport Q1 2020_Final<\/a><\/p>\n<\/div>\n<div class=\"mfn-footer\"><\/div>\n<script>\n                Array.prototype.slice.call(document.querySelectorAll(\".mfn-footer.mfn-attachment\")).forEach(function (el) { el.remove() });\n            <\/script>\n        <div class=\"mfn-attachments-container\"><\/div>","protected":false},"excerpt":{"rendered":"<p>Press release (MAR) Malm\u00f6, 14 maj, 2020 Acarix AB (publ) publicerar del\u00e5rsrapport, januari \u2013 mars 2020 Fortsatt fokus p\u00e5 strategiska<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[59],"tags":[62,63,70,71,72],"class_list":["post-1767","post","type-post","status-publish","format-standard","hentry","category-press","tag-regulatory","tag-regulatorymar","tag-subreport","tag-subreportinterim","tag-subreportinterimq1"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - 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