励晶太平洋2023中期报告
CONTENTS 目录 2PerformanceOverview业绩概览 5ReviewandProspects回顾及展望 12Management’sDiscussionandAnalysisoftheGroup’sPerformance 18CondensedConsolidatedStatementofProfitorLossandOtherComprehensiveIncome 20CondensedConsolidatedStatementofFinancialPosition 22CondensedConsolidatedStatementofChangesinEquity 管讨理论层及对分本析集团业绩之简其明他综全合面损收益益及表 简明综合财务状况表 简明综合权益变动表 23CondensedConsolidatedStatementofCashFlows简明综合现金流量表 25NotestotheCondensedConsolidatedFinancialStatements 简明综合财务报表附注 64TradingRecordOverLastFiveYears过去五年营业纪录 65OtherInformation其他资料 81Definitions释义 88CorporateInformation公司资料 P业E绩RF概OR览MANCEOVERVIEW Asummaryofthefinancialperformanceandothernotableeventsforthesixmonthsended30June2023include: •AlossattributabletoshareholdersoftheCompanyofapproximatelyUS$12.20million,whichwasmainlyattributableto:(i)anamortisationchargeofapproximatelyUS$12.38millionontheintangibleassets,beinganon-cashitem;and(ii)theGroup’soperatingandR&DexpensesofapproximatelyUS$2.94million,whichwereoffsetsomewhatby(iii)arealisedandanunrealisedmarked-to-marketgaininrespectoftheCompany’sequityportfolioofFAFVPLofapproximatelyUS$91,000andUS$19,000respectively. •Shareholders’equityincreasedby339.01%toapproximatelyUS$11.40millionasat30June2023fromapproximatelyUS$2.60millionasat31December2022.TheincreasewasduetotheincreaseoftotalequitybyapproximatelyUS$21.67million(beforeexpenses)aftercompletionoftheRightsIssueon12January2023,whichwassomewhatnetoffbythelossattributabletoshareholdersoftheCompanyofapproximatelyUS$12.20millionforthesixmonthsended30June2023. •InrespectoftheprogressbeingmadewithSenstend™inthePRC,thePhase3doubleblindedplacebo-controlledstudiescompletedduringthefirsthalfof2023andsuccessfullymetallfourco-primaryendpointsofIntra-vaginalejaculationlatencytime(“IELT”).TheCompany,itsregulatoryconsultantandWanbangBiopharmaceuticalhavemadesignificantprogressincompilingtheNDAdossiertoNMPAwiththeaimofsubmittingtheNDAbytheendofQ32023,withapprovalexpected12monthsthereafter.IftheNMPAgrantsanimportlicenceforSenstend™,US$5million(beforedeductionofPRCwithholdingtax)willbepayabletotheGroupfromWanbangBiopharmaceutical.Inaddition,uponfirstcommercialsaleofSenstend™inChina,US$2million(beforedeductionofPRCwithholdingtax)shallbepayabletotheGroupfromWanbangBiopharmaceutical. 截至二零二三年六月三十日止六个月之财务业绩概要及其他重要事件包括： •本公司股东应占亏损约12,200,000美元，主要是由于：(i)无形资产之摊销费用约12,380,000美元（属非现金项目）；及(ii)本集团的营运及研发开支约2,940,000美元，有关金额部分被(iii)本公司股本投资组合内之透过损益账按公允价值处理之金融资产之已变现及未变现按市值计价收益分别约91,000美元及19,000美元所抵销。 •股东权益由二零二二年十二月三十一日的约2,600,000美元，增加339.01%至二零二三年六月三十日的约11,400,000美元。增长乃由于于二零二三年一月十二日供股完成后，权益总额增加约21,670,000美元（扣除开支前），有关增长被截至二零二三年六月三十日止六个月本公司股东应占亏损约12,200,000美元所部分抵销。 •Senstend™于中国的进展方面，第三期双盲安慰剂对照研究已于二零二三年上半年完成，并成功达到阴道内射精延迟时间 （“阴道内射精延迟时间”）的所有四个共同第一终点。本公司、其监管顾问及江苏万邦医药于新药申请文件筹备方面取得重大进展，旨在于二零二三年第三季度末前向国家药品监督管理局提交新药申请，并于此后预期12个月内获得批准。倘国家药品监督管理局授予Senstend™进口许可证，则江苏万邦医药将须向本集团支付5,000,000美元（扣除中国预扣税前）。此外，Senstend™于中国进行首次商业销售后，江苏万邦医药将须向本集团支付2,000,000美元（扣除中国预扣税前）。 2REGENTPACIFICGROUPLIMITED励晶太平洋集团有限公司 业绩概览 PERFORMANCEOVERVIEW •InrespectoftheprogressbeingmadewithFortacin™intheUS,therewasfurthercommunicationandpositiveprogressmadebetweentheFDAandPlethoraregardingthePhase3studiesprotocolandtheSpecialProtocolAssessment(“SPA”).WearehopefulthatPlethorawillreceiveSPAagreementfromtheFDAinthesecondhalfofthisyearandthereafterthattheCompanycanproceedwithitsPhase3studies. •InrespectofEurope,RecordatirecommencedsalesinGermanyandItalyinFebruary2023andPlethoraunderstandsthatthereturnofFortacin™tothemarketinthesecountrieshasbeenverypositivewiththefirstbatchofunitsinGermanyandItalyreceivingstrongdemandfrompatients.Themanufacturerreleased30,000unitsinFebruary2023andthenext30,000unitsareslatedfordeliveryattheendofAugust2023.WeremainhopefulthatthenewmanufacturerwillbeabletooffercontinuoussupplyofFortacin™toRecordatiandourothercommercialstrategicpartnersbringinginroyaltyrevenuefortheGroup. •Inrespectoftheotherterritories,beingcertaincountriesinSouth-EastAsiaandIsrael,ourlicenseesareindiscussionswiththenewmanufacturerontermsfor(i)regulatorysupportforsubmittingavariationtotherelevanthealthauthorityfortheappointmentofthenewmanufacturer,and(ii)commercialtermsforthemanufactureandsupplyofFortacin™fortheirrespectiveterritories.TheGroupisindiscussionsforoutlicencingtherightstoFortacin™to(i)apharmaceuticalcompanyfortheJapanesemarket,and(ii)apharmaceuticalcompanyfortheSouthKoreanmarket. •Fromabusinessdevelopmentstandpoint,theGrouphascontinuedtoimplementandintegrateDeepLongevitywithourexistingbusiness.DeepLongevityiscontinuingitsgrowthjourneywithmultipleinitiativesaroundbuildingouttheteam,product,technologyandcommercialmodels.DeepLongevityiscommittedtobuildingandcommercialisingvariousagingclocksusingitsAIleddeeplearning. •Fortacin™于美国的进展方面，美国食品及药品监督管理局与Plethora已就第三期研究方案及特殊方案评估（“特殊方案评估”）展开进一步沟通并取得积极进展。我们希望Plethora能于本年度下半年接获美国食品及药品监督管理局的特殊方案评估协议，此后，本公司方能进行第三期研究。 •欧洲方面，Recordati于二零二三年二月在德国及意大利重新开始销售，据Plethora所知，Fortacin™积极重返德国及意大利市场，于该等国家的首批产品受到患者的强烈追捧。制造商于二零二三年二月推出30,000个产品，下一批30,000个产品预计将于二零二三年八月底交付。我们保持信心，新的制造商有望向Recordati及我们的其他商业战略合
