励晶太平洋2023中期报告

CONTENTS目 錄 2Performance Overview業績概覽5Review and Prospects回顧及展望12Management’s Discussion andAnalysis of the Group’s Performance管理層對本集團業績之討論及分析18Condensed Consolidated Statement of Profit orLoss and Other Comprehensive Income簡明綜合損益及其他全面收益表20Condensed Consolidated Statementof Financial Position簡明綜合財務狀況表22Condensed Consolidated Statementof Changes in Equity簡明綜合權益變動表23Condensed Consolidated Statement of Cash Flows簡明綜合現金流量表25Notes to the Condensed Consolidated FinancialStatements簡明綜合財務報表附註64Trading Record Over Last Five Years過去五年營業紀錄65Other Information其他資料81Definitions釋義88Corporate Information公司資料 PERFORMANCE OVERVIEW業績概覽 截至二零二三年六月三十日止六個月之財務業績概要及其他重要事件包括： A summary of the financial performance and other notable eventsfor the six months ended 30 June 2023 include: •本公司股東應佔虧損約12,200,000美元，主 要 是 由 於：(i)無 形 資 產 之 攤 銷 費 用 約12,380,000美元（屬非現金項目）；及(ii)本集團的營運及研發開支約2,940,000美元，有關金額部分被(iii)本公司股本投資組合內之透過損益賬按公允價值處理之金融資產之已變現及未變現按市值計價收益分別約91,000美元及19,000美元所抵銷。 •A loss attributable to shareholders of the Companyof approximately US$12.20 million, which was mainlyattributable to: (i) an amortisation charge of approximatelyUS$12.38 million on the intangible assets, being a non-cashitem; and (ii) the Group’s operating and R&D expenses ofapproximately US$2.94 million, which were offset somewhatby (iii) a realised and an unrealised marked-to-market gainin respect of the Company’s equity portfolio of FAFVPL ofapproximately US$91,000 and US$19,000 respectively. •股東權益由二零二二年十二月三十一日的約2,600,000美元，增加339.01%至二零二三年六月三十日的約11,400,000美元。增長乃由於於二零二三年一月十二日供股完成後，權益總額增加約21,670,000美元（扣 除 開 支 前），有 關 增 長 被 截 至 二 零二三年六月三十日止六個月本公司股東應佔虧損約12,200,000美元所部分抵銷。 •Shareholders’ equity increased by 339.01% to approximatelyUS$11.40 million as at 30 June 2023 from approximatelyUS$2.60 million as at 31 December 2022. The increase wasdue to the increase of total equity by approximately US$21.67million (before expenses) after completion of the RightsIssue on 12 January 2023, which was somewhat net off bythe loss attributable to shareholders of the Company ofapproximately US$12.20 million for the six months ended 30June 2023. •Senstend™於中國的進展方面，第三期雙盲安慰劑對照研究已於二零二三年上半年完成，並成功達到陰道內射精延遲時間（「陰道內射精延遲時間」）的所有四個共同第一終點。本公司、其監管顧問及江蘇萬邦醫藥於新藥申請檔案籌備方面取得重 大 進 展，旨 在 於 二 零 二 三 年 第 三 季 度末前向國家藥品監督管理局提交新藥申請，並於此後預期12個月內獲得批准。倘國家藥品監督管理局授予Senstend™進口 許 可 證，則 江 蘇 萬 邦 醫 藥 將 須 向 本 集團 支 付5,000,000美 元（扣 除 中 國 預 扣 稅前）。此外，Senstend™於中國進行首次商業銷售後，江蘇萬邦醫藥將須向本集團支付2,000,000美元（扣除中國預扣稅前）。 •In respect of the progress being made with Senstend™ inthe PRC, the Phase 3 double blinded placebo-controlledstudies completed during the first half of 2023 andsuccessfully met all four co-primary endpoints of Intra-vaginal ejaculation latency time (“IELT”). The Company, itsregulatory consultant and Wanbang Biopharmaceutical havemade significant progress in compiling the NDA dossier toNMPA with the aim of submitting the NDA by the end of Q32023, with approval expected 12 months thereafter. If theNMPA grants an import licence for Senstend™, US$5 million(before deduction of PRC withholding tax) will be payableto the Group from Wanbang Biopharmaceutical. In addition,upon first commercial sale of Senstend™ in China, US$2million (before deduction of PRC withholding tax) shall bepayable to the Group from Wanbang Biopharmaceutical. PERFORMANCE OVERVIEW業績概覽 •Fortacin™於美國的進展方面，美國食品及藥品監督管理局與Plethora已就第三期研究方案及特殊方案評估（「特殊方案評估」）展開進一步溝通並取得積極進展。我們希望Plethora能於本年度下半年接獲美國食品及藥品監督管理局的特殊方案評估協議，此後，本公司方能進行第三期研究。 •In respect of the progress being made with Fortacin™ in theUS, there was further communication and positive progressmade between the FDA and Plethora regarding the Phase3 studies protocol and the Special Protocol Assessment(“SPA”). We are hopeful that Plethora will receive SPAagreement from the FDA in the second half of this year andthereafter that the Company can proceed with its Phase 3studies. •歐 洲 方 面，Re c o r d a t i於 二 零 二 三 年 二月 在 德 國 及 意 大 利 重 新 開 始 銷 售，據Plethora所知，Fortacin™積極重返德國及意大利市場，於該等國家的首批產品受到患者的強烈追捧。製造商於二零二三年二月推出30,000個產品，下一批30,000個產品預計將於二零二三年八月底交付。我們保持信心，新的製造商有望向Recordati及我們的其他商業戰略合作夥伴持續供應Fortacin™，從而為本集團帶來專利使用費收入。 •In respect of Europe, Recordati recommenced salesin Germany and Italy in February 2023 and Plethoraunderstands that the return of Fortacin™ to the market inthese countries has been very positive with the first batchof units in Germany and Italy receiving strong demandfrom patients. The manufacturer released 30,000 unitsin February 2023 and the next 30,000 units are slated fordelivery at the end of August 2023. We remain hopeful thatthe new manufacturer will be able to offer continuous supplyof Fortacin™ to Recordati and our other commercial strategicpartners bringing in royalty revenue for the Group. •其 他 地 區（即 東 南 亞 若 干 國 家 及 以 色 列）方面，我們的被許可方正與新製造商商討條 款，包 括(i)向 有 關 衞 生 當 局 提 交 變 更以委任新製造商的監管支援；及(ii)在其各自地區製造及供應Fortacin™的商業條款。本集團正討論將Fortacin™權利對外授權予(i)日本市場的一間製藥公司；及(ii)南韓市場的一間製藥公司。 •In respect of the other territories, being certain countries inSouth-East Asia and Israel, our licensees are in discuss