{"id":8370,"date":"2020-05-14T06:00:00","date_gmt":"2020-05-14T06:00:00","guid":{"rendered":"https:\/\/www.acarix.com\/acarix-ab-publ-publicerar-delarsrapport-januari-mars-2020-2\/"},"modified":"2024-11-18T19:05:50","modified_gmt":"2024-11-18T19:05:50","slug":"acarix-ab-publ-publicerar-delarsrapport-januari-mars-2020-2","status":"publish","type":"post","link":"https:\/\/d.ptpl.dev\/acarix\/acarix-ab-publ-publicerar-delarsrapport-januari-mars-2020-2\/","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 class=\"mfn-wp-retain\">Press release (MAR)<\/p>\n<p class=\"mfn-wp-retain\">Malm&ouml;, 14 maj, 2020<\/p>\n<p class=\"mfn-wp-retain\"><strong>Acarix AB (publ) publicerar del&aring;rsrapport, januari &ndash; mars 2020<\/strong><\/p>\n<p class=\"mfn-wp-retain\">Fortsatt fokus p&aring; strategiska prioriteringar<\/p>\n<p class=\"mfn-wp-retain\">Under kvartalet fortsatte vi att fokusera p&aring; v&aring;ra prioriteringar samtidigt som vi hanterade effekterna av covid&shy;19&shy;pandemin. Vi har haft fortsatt dialog med b&aring;de amerikanska l&auml;kemedelsverket (FDA) r&ouml;rande v&aring;rt amerikanska marknads&shy; godk&auml;nnande och tyska G&shy;BA ang&aring;ende &aring;terbetalningsprocessen i Tyskland.<\/p>\n<p class=\"mfn-wp-retain\"><em>Utdrag ur VD Per Perssons kommentar till del&aring;rsrapporten.<\/em><\/p>\n<p class=\"mfn-wp-retain\"><strong>F&ouml;rsta kvartalet 2020 j&auml;mf&ouml;rt med samma period 2019<\/strong><\/p>\n<ul type=\"disc\">\n<li>Under f&ouml;rsta kvartalet uthyrdes ett (5 system s&aring;ldes) CADScor&reg;System och 370 (640) eng&aring;ngspl&aring;ster s&aring;ldes. Dessutom levererades 240 eng&aring;ngspl&aring;ster f&ouml;r v&aring;ra p&aring;g&aring;ende kliniska pr&ouml;vningar.<\/li>\n<li>Int&auml;kterna uppgick till 121 kSEK (299), med ett bruttoresultat om 109 kSEK (209) och en bruttomarginal om 90 procent (70).<\/li>\n<li>R&ouml;relsekostnaderna uppgick till 10&nbsp;904 kSEK (13&nbsp;038).<\/li>\n<li>Resultat f&ouml;re skatt uppgick till &ndash;10&nbsp;815 kSEK (&ndash;12&nbsp;822).<\/li>\n<li>Nettokassafl&ouml;det fr&aring;n den l&ouml;pande verksamheten uppgick till &ndash;8&nbsp;575 kSEK (&shy;13&nbsp;101).<\/li>\n<li>Beh&aring;llning av likvida medel uppgick till 45&nbsp;019 kSEK (51&nbsp;581).<\/li>\n<li>Resultat per aktie uppgick till &ndash;0,21 SEK (&ndash;0,56). Inga utsp&auml;dningseffekter uppkom.<\/li>\n<\/ul>\n<p class=\"mfn-wp-retain\"><strong>H&auml;ndelser under f&ouml;rsta kvartalet 2020<\/strong><\/p>\n<ul type=\"disc\">\n<li>Den 14 januari 2020 meddelade bolaget att CADScor&reg;System f&ouml;r f&ouml;rsta g&aring;ngen anv&auml;nds kommersiellt i Storbritannien och de f&ouml;rsta patienterna utv&auml;rderas. Dr Amrit Takhar och hans team p&aring; Wansford och Kingscliffe Practice n&auml;ra Peterborough &auml;r den f&ouml;rsta kliniken i Storbritannien som anv&auml;nder den unika CADScor&shy;tekniken f&ouml;r att utv&auml;rdera patienter som lider av stabila br&ouml;stsm&auml;rtor.<\/li>\n<li>Den 18 februari meddelade bolaget att den randomiserade, kliniska multicenterstudien FILTER&shy;SCAD har p&aring;b&ouml;rjats. FILTER&shy;SCAD studien syftar till att analysera kostnadseffektivitet och s&auml;kerhet som konsekvens vid ett anv&auml;ndande av CADScor&reg;System som uteslutande test f&ouml;r patienter med symtom p&aring; stabil kransk&auml;rlssjukdom. FILTER&shy;SCAD studien kommer att omfatta totalt 2&nbsp;000 patienter med misst&auml;nkt stabil kransk&auml;rlssjukdom vid fyra sjukhus i Danmark och Lunds universitetssjukhus i Sverige.<\/li>\n<li>Den 12 mars 2020 erh&ouml;ll bolaget bekr&auml;ftande feedback fr&aring;n de tyska myndigheterna, Federal Joint Committee, G&shy;BA, p&aring; ans&ouml;kan om kostnadsers&auml;ttning f&ouml;r CADScor&reg;System i Tyskland.<\/li>\n<li>Under det f&ouml;rsta kvartalet 2020 br&ouml;t covid&shy;19 pandemin ut och f&ouml;ljderna av utbrottet har sedan mars m&aring;nad haft en negativ p&aring;verkan p&aring; Acarix, och det finns en risk att detta kan leda till en negativ finansiell p&aring;verkan p&aring; koncernen. Inom Acarix arbetar vi f&ouml;r att s&auml;kerst&auml;lla att verksamheten forts&auml;tter att fungera efter v&aring;r b&auml;sta f&ouml;rm&aring;ga samtidigt som vi st&auml;ller v&aring;ra medarbetares h&auml;lsa i fokus. Detta g&ouml;r vi fr&auml;mst genom en uppmaning till f&ouml;retagets personal att arbeta hemifr&aring;n och ett resef&ouml;rbud. I v&aring;r bed&ouml;mning av de omedelbara effekterna kan vi konstatera att patientrekryteringen i v&aring;ra p&aring;g&aring;ende kliniska studier Filter Scad Studien och Dan&shy;NICAD II studien har avstannat vilket kan komma att f&ouml;rsena slutf&ouml;randet av studierna. Vidare har bolaget l&auml;mnat in en DeNovo&shy;ans&ouml;kan till FDA (American Food and Drug Administration) f&ouml;r produktgodk&auml;nnande inf&ouml;r lansering av CADScor&reg;System p&aring; den amerikanska marknaden. Det finns en risk att godk&auml;nnandeprocessen f&ouml;rsenas. <br \/> G&auml;llande ers&auml;ttningsprocessorn i Tyskland s&aring; p&aring;g&aring;r den tillsammans med G&shy;BA (Federal Joint Committee). I b&ouml;rjan av 2020 fick vi positiv &aring;terkoppling fr&aring;n G&shy;BA som r&auml;knade med att &aring;terkomma med ytterligare information under mitten av 2020. Det finns en risk att G&shy;BA:s &aring;terkoppling kan komma att f&ouml;rsenas. <br \/> D&aring; de flesta sjukhus, v&aring;rdcentraler och &auml;ven privatkliniker har begr&auml;nsat tillg&aring;ngen f&ouml;r kommersiell verksamhet ber&ouml;rs &auml;ven s&auml;lj och marknad i h&ouml;g grad s&aring; l&auml;nge covid&shy;19 situationen kvarst&aring;r. S&aring;v&auml;l internationella som nationella kongresser och utbildningsm&ouml;ten har under v&aring;ren st&auml;llts in eller skjutits fram till senare delen av &aring;ret. Detta sammantaget inneb&auml;r att en stor del av v&aring;ra kommersiella aktiviteter drabbas med motsvarande f&ouml;rskjutning s&aring; l&auml;nge covid&shy;19 krisen varar. Det &auml;r dock, givet den os&auml;kra situationen i nul&auml;get inte m&ouml;jligt att uppskatta hela den potentiella p&aring;verkan f&ouml;r Acarix.<\/li>\n<\/ul>\n<p class=\"mfn-wp-retain\"><strong>H&auml;ndelser efter den 31 mars 2020<\/strong><br \/>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&middot;Den 11 maj 2020 meddelade bolaget att den sista patienten inkluderats i den unders&ouml;kande SEISMO&shy;studien, vilken utv&auml;rdera m&ouml;jligheten att utveckla en algoritm f&ouml;r tidig uppt&auml;ckt av hj&auml;rtsvikt.<\/p>\n<p class=\"mfn-wp-retain\">Den fullst&auml;ndiga del&aring;rsrapporten finns tillg&auml;nglig via l&auml;nk nedan samt p&aring; www.acarix.com<\/p>\n<p class=\"mfn-wp-retain\"><strong>Kontaktpersoner f&ouml;r mer information <\/strong><\/p>\n<p class=\"mfn-wp-retain\">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&nbsp;990<\/p>\n<p class=\"mfn-wp-retain\">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&nbsp;333<\/p>\n<p class=\"mfn-wp-retain\"><strong>Om Acarix<\/strong><br \/>Acarix grundades 2009 och &auml;r noterat p&aring; Nasdaq First North Premier. Acarix CADScor&reg;System anv&auml;nder en avancerad sensor som placeras p&aring; huden ovanf&ouml;r hj&auml;rtat f&ouml;r att lyssna p&aring; ljudet av hj&auml;rtkontraktion och turbulent fl&ouml;de. Det har utformats f&ouml;r att vara ett allt-i-ett-system i den meningen att signalen fr&aring;n hj&auml;rtat spelas in, bearbetas och visas som en patientspecifik s.k. CAD-score p&aring; sk&auml;rmen. Presentation av m&auml;tresultaten erh&aring;lls p&aring; mindre &auml;n 8 minuter. Som en s&auml;ker metod och l&auml;mplig f&ouml;r anv&auml;ndning i b&aring;de prim&auml;rv&aring;rden och p&aring; inneliggande patienter kan CADScor&reg;System potentiellt komma att spela en viktig roll f&ouml;r patient-triage, n&aring;got som g&ouml;r att m&aring;nga patienter inte beh&ouml;ver unders&ouml;kas ytterligare med invasiva, diagnostiska metoder.<\/p>\n<p class=\"mfn-wp-retain\"><em>Denna <\/em><em>information <\/em><em>&auml;r regulatorisk information som Acarix AB (publ)<\/em> <em>ska offentligg&ouml;ra enligt EU:s marknadsmissbruksf&ouml;rordning.<\/em> <em>Informationen l&auml;mnades f&ouml;r publicering genom ovanst&aring;ende kontaktpersons f&ouml;rsorg den 14 maj 2020 kl 08.00.<\/em><\/p>\n<p class=\"mfn-wp-retain\">\n<\/div>\n<div class=\"mfn-footer mfn-attachment\">\n<p class=\"mfn-wp-retain\"><strong>Bifogade filer<\/strong><\/p>\n<hr>\n<p class=\"mfn-wp-retain\"><a href=\"https:\/\/ml-eu.globenewswire.com\/Resource\/Download\/41b34c03-de5b-4448-a26c-23b504469eda\" target=\"_blank\" rel=\"nofollow noopener\">PM_Acarix_Q1_2020 sv<\/a><br \/><a href=\"https:\/\/ml-eu.globenewswire.com\/Resource\/Download\/07f19d1f-f270-4b54-8ce9-9a2d2ffbf6cf\" target=\"_blank\" rel=\"nofollow noopener\">Acarix Dela&#778;rsrapport 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 class=\"mfn-attachment\"><a class=\"mfn-attachment-link\" href=\"https:\/\/storage.mfn.se\/proxy\/pm_acarix_q1_2020-sv.pdf?url=https%3A%2F%2Fml-eu.globenewswire.com%2FResource%2FDownload%2F41b34c03-de5b-4448-a26c-23b504469eda\"><span class=\"mfn-attachment-icon\"><img decoding=\"async\" src=\"https:\/\/storage.mfn.se\/proxy\/pm_acarix_q1_2020-sv.pdf?url=https%3A%2F%2Fml-eu.globenewswire.com%2FResource%2FDownload%2F41b34c03-de5b-4448-a26c-23b504469eda&type=jpg\"><\/span>PM_Acarix_Q1_2020 sv<\/a><\/div><div class=\"mfn-attachment mfn-primary\"><a class=\"mfn-attachment-link\" href=\"https:\/\/storage.mfn.se\/proxy\/acarix-delarsrapport-q1-2020_final.pdf?url=https%3A%2F%2Fml-eu.globenewswire.com%2FResource%2FDownload%2F07f19d1f-f270-4b54-8ce9-9a2d2ffbf6cf\"><span class=\"mfn-attachment-icon\"><img decoding=\"async\" src=\"https:\/\/storage.mfn.se\/proxy\/acarix-delarsrapport-q1-2020_final.pdf?url=https%3A%2F%2Fml-eu.globenewswire.com%2FResource%2FDownload%2F07f19d1f-f270-4b54-8ce9-9a2d2ffbf6cf&type=jpg\"><\/span>Acarix Dela\u030arsrapport Q1 2020_Final<\/a><\/div><\/div>","protected":false},"excerpt":{"rendered":"<p>Press release (MAR) Malm&ouml;, 14 maj, 2020 Acarix AB (publ) publicerar del&aring;rsrapport, januari &ndash; mars 2020 Fortsatt fokus p&aring; strategiska<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[157,140,149,139,158,148,155,142],"tags":[],"class_list":["post-8370","post","type-post","status-publish","format-standard","hentry","category-mfn-report-interim","category-mfn-type-ir","category-mfn-regulatory-mar","category-mfn","category-mfn-report-interim-q1","category-mfn-regulatory","category-mfn-report","category-mfn-lang-sv"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - 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