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励晶太平洋(00575) - 2023 - 年度财报
00575REGENT PACIFIC(00575)2024-04-25 08:30

Financial Performance - The Company reported a loss attributable to shareholders of approximately US25.05million,primarilyduetoatotalamortisationchargeofapproximatelyUS25.05 million, primarily due to a total amortisation charge of approximately US22.18 million on intangible assets and operating and R&D expenses of approximately US6.07million[3].−TheGrouprecordedalossattributabletoshareholdersofapproximatelyUS6.07 million[3]. - The Group recorded a loss attributable to shareholders of approximately US25.05 million, primarily due to a total amortization charge of approximately US22.18milliononintangibleassets[18][22].−PlethorarecordedanoperatinglossofapproximatelyGBP0.67million(orapproximatelyUS22.18 million on intangible assets[18][22]. - Plethora recorded an operating loss of approximately GBP 0.67 million (or approximately US0.83 million) for the year ended 31 December 2023, consistent with the previous year[100]. - Loss before taxation for 2023 was (30,463,000),downfrom(30,463,000), down from (36,008,000) in 2022, reflecting better financial performance[127]. - Loss for the year attributable to shareholders for 2023 was (25,049,000),comparedto(25,049,000), compared to (36,427,000) in 2022, indicating a decrease in losses[127]. - Total revenue and fair value loss on financial instruments for 2023 was (539,000),comparedto(539,000), compared to (4,020,000) in 2022, indicating a significant improvement[127]. - Revenue less expenses before impairment losses for 2023 was (27,713,000),animprovementfrom(27,713,000), an improvement from (34,995,000) in 2022[127]. - Operating loss after impairment losses and provisions for 2023 was (30,383,000),comparedto(30,383,000), compared to (34,995,000) in 2022, showing a reduction in losses[127]. Capital and Shareholder Equity - As of December 31, 2023, the Group recorded a capital deficiency of approximately US1.55million,adecreaseofapproximatelyUS1.55 million, a decrease of approximately US4.15 million from the previous year, mainly due to the loss attributable to shareholders[3]. - The capital deficiency as of December 31, 2023, was approximately US1.55million,adecreaseofapproximatelyUS1.55 million, a decrease of approximately US4.15 million from the previous year[48]. - The Company has eliminated its debt by offsetting approximately US14.84millioninshareholderloansthroughtheissuanceof2,166,571,194newshares[41].−Totalassetsdecreasedto14.84 million in shareholder loans through the issuance of 2,166,571,194 new shares[41]. - Total assets decreased to 2,795,000 in 2023 from 26,318,000in2022,showingasignificantreductioninassetbase[130].−Currentliabilitiesdecreasedto26,318,000 in 2022, showing a significant reduction in asset base[130]. - Current liabilities decreased to (3,581,000) in 2023 from (18,316,000)in2022,indicatingimprovedliquidity[130].−Totalliabilitiesdecreasedto(18,316,000) in 2022, indicating improved liquidity[130]. - Total liabilities decreased to (4,346,000) in 2023 from (23,721,000)in2022,reflectingareductioninoveralldebt[130].−Netliabilitiesfor2023were(23,721,000) in 2022, reflecting a reduction in overall debt[130]. - Net liabilities for 2023 were (1,551,000), a decline from net assets of 2,597,000in2022,indicatingashifttowardsanegativenetassetposition[130].ProductDevelopmentandRegulatoryProgress−ThePhase3studiesforSenstend™inChinasuccessfullymetallfourco−primaryendpoints,withtheNDAsubmissiontoNMPAexpectedin2024andapprovalanticipated12monthsthereafter[3].−TheNDAforSenstend™isapproximately902,597,000 in 2022, indicating a shift towards a negative net asset position[130]. Product Development and Regulatory Progress - The Phase 3 studies for Senstend™ in China successfully met all four co-primary endpoints, with the NDA submission to NMPA expected in 2024 and approval anticipated 12 months thereafter[3]. - The NDA for Senstend™ is approximately 90% complete, with the finalisation of the manufacturing and supply agreement pending[10]. - The Group is working towards submitting the NDA for Senstend™ to NMPA in 2024 and engaging with the FDA to finalize the phase 3 study in the US[26][32]. - The successful completion of phase 3 randomized clinical studies in China met all four co-primary endpoints, marking a significant milestone for the Group[20][23]. - Senstend™ has completed Phase 3 double-blinded placebo-controlled studies in China, meeting all four co-primary endpoints of IELT[53]. - The FDA has provided feedback on the NDA submission process, with major elements of the protocol agreed upon, although a "no agreement" statement was issued regarding the SPA request[67]. - The FDA issued a "not approvable" statement regarding the evaluation questionnaire for Fortacin™, requiring evidence from the completion of the Phase III clinical trial before analysis can proceed[71]. Market and Commercialization Strategy - The Group remains focused on the successful commercialisation of Fortacin™/Senstend™ in key markets including the US, China, and Southeast Asia[6]. - Upon NMPA granting an import licence for Senstend™, the Group expects to receive US5 million from Wanbang Biopharmaceutical, and an additional US2millionuponthefirstcommercialsaleinChina[3].−Senstend™hasthepotentialtohelpaninitialtargetmarketofapproximately9millionpatientsinChinainitsfirstyear,growingtoover170millionpatientsbyitstenthyear[11][14].−TheGroupanticipatesexponentialgrowthinroyaltyincomefromFortacin™startingin2024duetoresumedmanufacturinginEurope[31].−TheCompanyaimstocommercialiseitsdeeplearningagingclocktechnologyandMindAge©offering,partneringwithclinicsandinsurancecompanies[6].−TheGroupisindiscussionsforout−licensingFortacin™rightstopharmaceuticalcompaniesfortheJapaneseandSouthKoreanmarkets,whichcouldincreaseroyaltyrevenue[12][14].OperationalDevelopments−Fortacin™hasresumedsalesinFrance,Germany,Italy,andPortugal,withstrongdemandobservedforthefirstbatchofunits[5].−DeepLongevityhasmadesignificantprogressin2023,includingthelaunchofitsSenoClock®platformandacquiringitsfirstcustomerinthepublichospitalspace[17][21].−TheCompanylaunchedSenoClock®Goldin2023,signingitsfirstcustomers,includingpublichospitals,andplanstoexpanditsproductofferingin2024[35].−TheGroupisnegotiatingout−licensingrightsforFortacin™withpharmaceuticalcompaniesinJapanandSouthKorea[81].−TheCompanyismonitoringgeopoliticaluncertainties,particularlyinUkraine,butcurrentlydoesnotexperienceanymaterialimpactonitsbusiness[47].ShareOptionsandCapitalManagement−OnJanuary12,2023,theCompanyissued2,166,571,194newsharesatasubscriptionpriceofHK2 million upon the first commercial sale in China[3]. - Senstend™ has the potential to help an initial target market of approximately 9 million patients in China in its first year, growing to over 170 million patients by its tenth year[11][14]. - The Group anticipates exponential growth in royalty income from Fortacin™ starting in 2024 due to resumed manufacturing in Europe[31]. - The Company aims to commercialise its deep learning aging clock technology and MindAge© offering, partnering with clinics and insurance companies[6]. - The Group is in discussions for out-licensing Fortacin™ rights to pharmaceutical companies for the Japanese and South Korean markets, which could increase royalty revenue[12][14]. Operational Developments - Fortacin™ has resumed sales in France, Germany, Italy, and Portugal, with strong demand observed for the first batch of units[5]. - Deep Longevity has made significant progress in 2023, including the launch of its SenoClock® platform and acquiring its first customer in the public hospital space[17][21]. - The Company launched SenoClock® Gold in 2023, signing its first customers, including public hospitals, and plans to expand its product offering in 2024[35]. - The Group is negotiating out-licensing rights for Fortacin™ with pharmaceutical companies in Japan and South Korea[81]. - The Company is monitoring geopolitical uncertainties, particularly in Ukraine, but currently does not experience any material impact on its business[47]. Share Options and Capital Management - On January 12, 2023, the Company issued 2,166,571,194 new shares at a subscription price of HK0.0785 per share through a rights issue[156]. - The Company's authorized share capital remained unchanged during the year ended December 31, 2023, with no shares repurchased[161]. - The total number of options granted during the year is 76,400,000, while 6,072,388 options lapsed[195]. - The total number of options outstanding as of December 31, 2023, is 6,729,723 after adjustments from the Rights Issue and Share Consolidation[192]. - The adjustments to the Options were confirmed to comply with the relevant terms of the Scheme and Listing Rules by the independent financial adviser, Maxa Capital Limited[182]. - The options granted are exercisable from May 3, 2024, to May 2, 2033[167].