励晶太平洋2023年年报

CONTENTS 目录 2 PerformanceOverview 业绩概览 5 Chairman’sStatement 主席报告行政总裁报告 9 CEO’sReport 董事会报告 20 Directors’Report 董事及高级管理层 55 BiographicalDetailsofDirectorsand SeniorManagement 之履历详情 管理层对本集团业绩 Management’sDiscussionandAnalysisoftheGroup’sPerformance 62 之讨论及分析企业管治报告 CorporateGovernanceReport 73 环境、社会及管治报告 106 Environmental,SocialandGovernanceReport 独立核数师报告 132 IndependentAuditor’sReport 综合损益及其他全面 138 ConsolidatedStatementofProfitorLossand OtherComprehensiveIncome 收益表 综合财务状况表 ConsolidatedStatementofFinancialPosition 140 综合权益变动表 142 ConsolidatedStatementofChangesinEquity 综合现金流量表 144 ConsolidatedStatementofCashFlows 综合财务报表附注 146 NotestotheConsolidatedFinancialStatements 释义 257 Definitions 公司资料 264 CorporateInformation P业E绩RF概OR览MANCEOVERVIEW Asummaryofthefinancialperformanceandothernotableeventsfortheyearended31December2023include: •AlossattributabletoshareholdersoftheCompanyofapproximatelyUS$25.05million,whichwasmainlyattributableto:(i)atotalamortisationchargeofapproximatelyUS$22.18millionontheintangibleassets,beinganon-cashitem;(ii)theGroup’soperatingandR&DexpensesofapproximatelyUS$6.07million,and (iii)impairmentlossonanintangibleassetandright-of-useassetsofapproximatelyUS$1.52millionandUS$1.15millionrespectively,beingnon-cashitems,whichwereoffsetsomewhatby(iv)thetaxcreditinrespectofthedeferredtaxliabilitiesofapproximatelyUS$5.41million.Goingforward,therewillnolongerbeanannualamortisationchargerelatingtothepatent(Fortacin™),whichamountedtoapproximatelyUS$21.80millionfor2023. •TheGrouprecordedacapitaldeficiencyofapproximatelyUS$1.55millionasat31December2023(At31December2022:shareholders’equityofapproximatelyUS$2.60million),withthedecreaseofapproximatelyUS$4.15millionbeingmainlyattributabletothelossattributabletoshareholdersoftheCompany,whichwereoffsetsomewhatbytheRightsIssue. •InrespectoftheprogressbeingmadewithSenstend™inthePRC,thePhase3doubleblindedplacebo-controlledstudiescompletedduringthefirsthalfof2023andsuccessfullymetallfourco-primaryendpointsofIntra-vaginalejaculationlatencytime(“IELT”).TheCompany,itsregulatoryconsultantandWanbangBiopharmaceuticalhavemadesignificantprogressincompilingtheNDAdossiertoNMPAwiththeaimofsubmittingtheNDAtoNMPAin2024,withapprovalexpected12monthsthereafter.IftheNMPAgrantsanimportlicenceforSenstend™,US$5million(beforedeductionofPRCwithholdingtax)shallbepayabletotheGroupfromWanbangBiopharmaceutical.Inaddition,uponfirstcommercialsaleofSenstend™inChina,US$2million(beforedeductionofPRCwithholdingtax)shallbepayabletotheGroupfromWanbangBiopharmaceutical. 截至二零二三年十二月三十一日止年度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25,050,000美元，主要是由于：(i)无形资产之摊销费用总额约22,180,000美元（属非现金项目）；(ii)本集团的营运及研发开支约6,070,000美元；及(iii)无形资产及使用权资产减值亏损分别约1,520,000美元及1,150,000美元（属非现金项目），部分被(iv)递延税项负债税项抵免约5,410,000美元所抵销。此后，将不再产生与专利(Fortacin™)有关的年度摊销支出，而二零二三年有关支出约为21,800,000美元。 •截至二零二三年十二月三十一日，本集团录得资本亏损约1,550,000美元（二零二二年十二月三十一日：股东权益约2,600,000美元），减少约4,150,000美元主要源自本公司股东应占亏损，部分被供股所抵销。 •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”）的所有四个共同主要终点。本公司、其监管顾问及江苏万邦医药于编制向国家药品监督管理局提交的新药申请文件取得重大进展，目标于二零二四年向国家药品监督管理局提交新药申请，预期将于12个月后获得批准。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,therewasfurthercommunicationandpositiveprogressmadebetweentheFDAandPlethoraregardingthePhase 3studiesprotocolandtheSpecialProtocolAssessment(“SPA”). •InrespectofEurope,RecordatirecommencedsalesinFrance,Germany,ItalyandPortugalin2023andPlethoraunderstandsthatthereturnofFortacin™tothemarketinthesecountrieshasbeenverypositivewiththefirstbatchofunitsinthesecountriesreceivingstrongdemandfrompatients.WeremainhopefulthatthenewmanufacturerwillbeabletooffercontinuoussupplyofFortacin™toRecordatiandourothercommercialstrategicpartners,whichshouldallowforthegenerationofroyaltyrevenuefortheGroup. •Inrespectoftheotherterritories,beingcertaincountriesinSouth-EastAsia,ourlicenseesareindiscussionswiththenewmanufacturerontermsfor(i)regulatorysupportforsubmittingavariationtotherelevanthealthauthorityfortheappointmentofthenewmanufacturer,and(ii)commercialtermsforthemanufactureandsupplyofFortacin™fortheirrespectiveterritories.TheGroupisindiscussionsforoutlicencingtherightstoFortacin™to(i)apharmaceuticalcompanyfortheJapanesemarket,and(ii)apharmaceuticalcompanyfortheSouthKoreanmarket. •Fromabusinessdevelopmentstandpoint,theGrouphascontinuedtoimplementandintegrateDeepLongevitywithourexistingbusiness.DeepLongevityiscontinuingitsgrowthjourneywithmultipleinitiativesaroundbuildingouttheteam,product,technologyandcommercialmodels.DeepLongevityiscommittedtobuildingandcommercialisingvariousagingclocksusingitsleadingAIleddeeplearningtechnology. •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。 •欧洲方面，Recordati于二零二三年在法国、德国、意大利及葡萄牙重新开始销售，据Plethora所知，Fortacin™积极重返该等国家市场，于该等国家的首批产品受到患者的强烈追捧。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作伙伴持续供应Fortacin™，该举措将为本集团带来