{"id":1607,"date":"2021-11-11T07:00:00","date_gmt":"2021-11-11T07:00:00","guid":{"rendered":"https:\/\/d.ptpl.dev\/acarix\/acarix-ab-publ-publicerar-delarsrapport-januari-september-2021\/"},"modified":"2024-08-06T12:25:13","modified_gmt":"2024-08-06T12:25:13","slug":"acarix-ab-publ-publicerar-delarsrapport-januari-september-2021","status":"publish","type":"post","link":"https:\/\/d.ptpl.dev\/acarix\/acarix-ab-publ-publicerar-delarsrapport-januari-september-2021\/","title":{"rendered":"Acarix AB (publ) publicerar del\u00e5rsrapport, januari \u2013 september 2021"},"content":{"rendered":"<div class=\"mfn-preamble\"><strong><\/strong><\/div>\n<div>\n<p>Press release<\/p>\n<p>Malm\u00f6, 11 november, 2021<\/p>\n<p><strong>Acarix AB (publ) publicerar d<\/strong><strong>el\u00e5rsrapport<\/strong><strong>, <\/strong><strong>januari<\/strong> <strong>\u2013<\/strong> <strong>september<\/strong><strong> 20<\/strong><strong>2<\/strong><strong>1<\/strong><\/p>\n<p><strong>Positiv trend och nyemission g\u00f6r det m\u00f6jligt att \u00f6ka expansionstakten<\/strong><\/p>\n<p>Det ser alltmer lovande ut f\u00f6r Acarix p\u00e5 den amerikanska marknaden. I slutet av oktober erh\u00f6ll vi en s\u00e5 kallad CPT-kod fr\u00e5n American Medical Association (AMA). CPTkoden inneb\u00e4r att det FDA-godk\u00e4nda CADScor\u00ae-systemet kan ers\u00e4ttas i det amerikanska f\u00f6rs\u00e4kringssystemet. Vi erh\u00f6ll koden efter noggrann utv\u00e4rdering av AMA och p\u00e5 rekommendation av American College of Cardiologists (ACC). Detta \u00e4r ett viktigt genombrott och ett erk\u00e4nnande av v\u00e5r teknologi som \u00f6ppnar ytterligare d\u00f6rrar f\u00f6r oss p\u00e5 USA-marknaden. I v\u00e5rt nyligen annonserade samarbetsavtal med Proximo Medical f\u00e5r vi omedelbar access till en s\u00e4ljkanal och de f\u00f6rsta utv\u00e4rderingarna hos slutkund p\u00e5b\u00f6rjas i skrivande stund.<\/p>\n<p><em>Utdrag ur VD Per Perssons kommentar till del\u00e5rsrapporten.<\/em><\/p>\n<p><strong>Tredje<\/strong><strong> kvartalet 202<\/strong><strong>1<\/strong><strong> j\u00e4mf\u00f6rt med samma period 20<\/strong><strong>20<\/strong><\/p>\n<ul type=\"disc\">\n<li>Under tredje kvartalet s\u00e5ldes 18 (17) CADScor\u00aeSystem och 2 310 (1 320) patcher.<\/li>\n<li>Int\u00e4kterna uppgick till 1 231 kSEK (791), med ett bruttoresultat om 936 kSEK (552) och en bruttomarginal om 76 procent (70).<\/li>\n<li>R\u00f6relsekostnaderna uppgick till 11 638 kSEK (9 440).<\/li>\n<li>Resultat f\u00f6re skatt uppgick till \u201310 693 kSEK (\u20138 880).<\/li>\n<li>Kassafl\u00f6det fr\u00e5n den l\u00f6pande verksamheten uppgick till \u201310 295 kSEK (\u20136 418). Periodens nettokassafl\u00f6de uppgick till \u201310 224 kSEK (40 951).<\/li>\n<li>Resultat per aktie uppgick till \u20130,08 SEK (\u20130,11). Inga utsp\u00e4dningseffekter uppkom<\/li>\n<\/ul>\n<p><strong>F\u00f6rsta <\/strong><strong>nio m\u00e5naderna<\/strong><strong> 202<\/strong><strong>1<\/strong><strong> j\u00e4mf\u00f6rt med 20<\/strong><strong>20<\/strong><\/p>\n<ul type=\"disc\">\n<li>Under de f\u00f6rsta nio m\u00e5naderna s\u00e5ldes totalt 46 (20) CADScor\u00aeSystem och 5 100 (2 120) eng\u00e5ngspl\u00e5ster, vilket generade int\u00e4kter p\u00e5 2 832 kSEK (1 204) med ett bruttoresultat om 2 098 kSEK (881), motsvarande en bruttomarginal p\u00e5 74 procent (73).<\/li>\n<li>R\u00f6relsekostnaderna uppgick till 37 576 kSEK (30 925).<\/li>\n<li>Resultat f\u00f6re skatt uppgick till \u201335 508 kSEK (\u201330 085).<\/li>\n<li>Kassafl\u00f6det fr\u00e5n den l\u00f6pande verksamheten uppgick till \u201334 878 kSEK (24 141).<\/li>\n<li>Beh\u00e5llning av likvida medel uppgick till 28 972 kSEK (76 413).<\/li>\n<li>Resultat per aktie uppgick till \u20130,25 SEK (\u20130,49). Inga utsp\u00e4dningseffekter uppkom.<\/li>\n<\/ul>\n<p><strong>H\u00e4ndelser <\/strong><strong>tredje<\/strong><strong> kvartalet 202<\/strong><strong>1<\/strong><\/p>\n<ul type=\"disc\">\n<li>Den 27 augusti meddelade bolaget att f\u00f6rsta resultaten fr\u00e5n Dan-NICAD II presenterats p\u00e5 ESC. Studien bekr\u00e4ftar en mycket god uteslutningsf\u00f6rm\u00e5ga hos CADScor\u00ae, n\u00e4ra 50 procent av patienter med medelh\u00f6g risk f\u00f6r CAD kan uteslutas fr\u00e5n ytterligare diagnostisering. Den ursprungliga Dan-NICAD I-studien visade att CADScor\u00ae hade ett h\u00f6gt negativt prediktivt v\u00e4rde i en kohort om 1 675 patienter med misst\u00e4nkt stabil kransk\u00e4rlssjukdom. Syftet med Dan-NICAD II-studien var att f\u00e5 en \u00e4nnu st\u00f6rre diagnostisk s\u00e4kerhet i ytterligare 1 732 patienter i en expanderad \u00e5ldersgrupp \u00f6ver 30 \u00e5r, med s\u00e4rskilt fokus p\u00e5 patienter med medelh\u00f6g risk.\n<\/li>\n<li>Den 7 september meddelade bolaget att en ny sjukv\u00e5rdsekonomisk studie l\u00e4gger fram bevis f\u00f6r v\u00e4rdet av CADScor\u00ae vid diagnostik av kransk\u00e4rlssjukdom. En expertgranskad publicering i septemberutg\u00e5van 2021 av PharmacoEconomics visar besparingar p\u00e5 uppskattningsvis 12,3 miljoner pund f\u00f6r det engelska sjukv\u00e5rdssystemet per 100 000 relevanta patienter n\u00e4r Acarix CADScor\u00ae-system anv\u00e4nds f\u00f6r att utesluta kransk\u00e4rlssjukdom (CAD). Artikelf\u00f6rfattarna utv\u00e4rderade nyttov\u00e4rdet f\u00f6r CADScor\u00ae-system f\u00f6r att utesluta CAD i ett tidigt skede av diagnostiseringen i England. Resultaten indikerar besparingar om 131 pund per patient p\u00e5 1 \u00e5rs tid. Slutsatsen \u00e4r att om CADScor\u00ae -testet sattes in f\u00f6re aktuella standardtester s\u00e5som datortomografi av hj\u00e4rtat minskade kostnaderna f\u00f6r sjukv\u00e5rden under flera olika tidshorisonter.\n<\/li>\n<li>Den 14 september meddelade bolaget att man inleder sin USA expansion och utser Helen Ljungdahl Round som chef f\u00f6r bolagets nyetablerade amerikanska dotterbolag Acarix Inc. Helen tilltr\u00e4dde sin tj\u00e4nst under september 2021 f\u00f6r att utveckla USA organisationen. Hon ing\u00e5r i Acarix AB:s ledningsgrupp. Helen Ljungdahl Round har mer \u00e4n tjugofem \u00e5rs erfarenhet av ledande och globala befattningar inom bland annat l\u00e4kemedelskoncernen Merck &amp; Co, Inc (MSD) och som Senior Vice President Global Marketing &amp; Business Development for GN Hearing. Helen var senast VD f\u00f6r Amnicell, ett biotech startup bolag baserat i New York City. Hon \u00e4r bosatt med familj i Pennsylvania, USA och har tillbringat st\u00f6rsta delen av sitt professionella liv i USA och inom amerikanska f\u00f6retag, inklusive styrelse uppdrag och r\u00e5dgivande verksamhet.\n<\/li>\n<\/ul>\n<p><strong>H\u00e4ndelser efter den <\/strong><strong>3<\/strong><strong>0<\/strong> <strong>september<\/strong><strong> 20<\/strong><strong>2<\/strong><strong>1<\/strong><\/p>\n<ul type=\"disc\">\n<li>Den 27 oktober meddelade bolaget att American Medical Associations (AMA) redaktionella panel godk\u00e4nde ans\u00f6kan om CPT-kod i kategori III CPT\u00ae (CPT III) f\u00f6r Acarix CADScor\u00ae-system. Ans\u00f6kan hade ett aktivt st\u00f6d fr\u00e5n American College of Cardiology (ACC) och godk\u00e4ndes av AMA utan anm\u00e4rkningar. CPT III-ers\u00e4ttningskoder beviljas f\u00f6r ny teknik samt nya tj\u00e4nster och f\u00f6rfaranden. I enlighet med CPT III-processen ska den nya koden f\u00f6r CADScor\u00ae-system offentligg\u00f6ras av Center for Medicare and Medicaid services (CMS) den 1 januari 2022 och bli tillg\u00e4nglig f\u00f6r amerikanska betalande parter och v\u00e5rdgivare den 1 juli 2022. Enligt processen specificeras inget visst belopp i koden och Acarix kommer nu att samarbeta med utvalda betalande parter f\u00f6r att fastst\u00e4lla ers\u00e4ttnings- och betalningsniv\u00e5n. N\u00e4r en kod har tr\u00e4tt i kraft kan v\u00e5rdgivarna l\u00e4mna in ans\u00f6kningar om ers\u00e4ttning via standardiserade faktureringsprocesser.\n<\/li>\n<li>Den 5 november meddelande bolaget avsikten att genomf\u00f6ra en 100 procent garanterad f\u00f6retr\u00e4desemission om cirka 79,3 MSEK f\u00f6r att m\u00f6jligg\u00f6ra expansion p\u00e5 USA-marknaden. Samma dag kallade \u00e4ven styrelsen till en extra bolagsst\u00e4mma f\u00f6r att godk\u00e4nna F\u00f6retr\u00e4desemissionen den 23 november 2021.\n<\/li>\n<li>Den 8 november meddelade bolaget finansiella och operationella m\u00e5ls\u00e4ttningar f\u00f6r \u00e5r 2024 \u2013 att n\u00e5 en oms\u00e4ttning \u00f6verstigande 200 MSEK och en bruttomarginal om minst 80 procent. Det motsvarar en etablerad bas om 3 000 CADScor system i slutet av 2024, med tonvikt p\u00e5 USA-marknaden.\n<\/li>\n<li>Den 9 november meddelade bolaget att man tecknat ett Commercial Access avtal med Proximo Medical LLC. Avtalet m\u00f6jligg\u00f6r snabb kommersiell expansion i USA med s\u00e4ljk\u00e5r som t\u00e4cker strategiska stater i USA. Avtalet \u00e4r en del av s\u00e4ljstrategin f\u00f6r USA-marknaden.\n<\/li>\n<\/ul>\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=Bt-l78tV0sq6dPIFGekw5Y9wW9xoYxqTmwOsKkZdMN7HVtGvwAuMaMkbF0MIqsPjIFrKxIln3_0JEAn4DvNgSYL8YrXt7vic5VFbeJn3Nbs=\" target=\"_blank\" rel=\"nofollow noopener\">per.persson@acarix.com<\/a> <br \/>tel: +46 736 005\u00a0990<\/p>\n<p>Christian Lindholm, CFO <br \/>e-post: <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=jmmvRRgwynE8vbXrCK-HW-Sw07rRxS2C1y-oU47mI39l6h0Gwofj55ktZVbYHVrN7CS64ySVpheI28KYYBAhs0kqzLdzzFI7SfdbInjP3ue-iYC2yS9UKXOsjHWRHECq\" target=\"_blank\" rel=\"nofollow noopener\">christian.lindholm@acarix.com<\/a><br \/>tel: +46 705 118\u00a0333<\/p>\n<p><strong>Om Acarix<\/strong><br \/>Acarix \u00e4r ett svenskt medicintekniskt bolag som utvecklar innovativa l\u00f6sningar f\u00f6r snabb AI-baserad uteslutning av kransk\u00e4rlssjukdom (CAD). Det CE-m\u00e4rkta CADScor<sup>\u00ae<\/sup> System, som \u00e4ven har f\u00e5tt DeNovo-godk\u00e4nnande fr\u00e5n FDA, \u00e4r avsett f\u00f6r patienter som upplever br\u00f6stsm\u00e4rta med misst\u00e4nkt kransk\u00e4rlssjukdom, och har utformats f\u00f6r att bidra till att minska miljontals fall av on\u00f6dig, invasiv och kostsam diagnostisk. Med hj\u00e4lp av en icke-invasiv metod ber\u00e4knar CADScor-systemet p\u00e5 mindre \u00e4n 10 minuter en patientspecifik s.k.CAD-score som med 97\u00a0procents s\u00e4kerhet kan utesluta kransk\u00e4rlssjukdom. Acarix \u00e4r noterat p\u00e5 Nasdaq First North Premier Growth Market (ticker: ACARIX). Redeye AB (+46 (0)8 121\u00a0576 90, <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=E4sR4t7Ms_hXMp23C2BCnysmhEDAAMI_S220S6_q-mt2U4IZepuGEnZxhR411OSzy54NutgdgyFsf3hEIXLJnmd4MCnTaRcMmCGdWWG9fQBixhmg-prX3wpBCydtvmDj\" target=\"_blank\" rel=\"nofollow noopener\">certifiedadviser@redeye.se<\/a>) \u00e4r bolagets Certified Adviser. 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