Financial Performance - The Company reported a loss attributable to shareholders of approximately US$25.05 million, primarily due to a total amortisation charge of approximately US$22.18 million on intangible assets and operating and R&D expenses of approximately US$6.07 million[3]. - The Group recorded a loss attributable to shareholders of approximately US$25.05 million, primarily due to a total amortization charge of approximately US$22.18 million on intangible assets[18][22]. - Plethora recorded an operating loss of approximately GBP 0.67 million (or approximately US$0.83 million) for the year ended 31 December 2023, consistent with the previous year[100]. - Loss before taxation for 2023 was $(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), 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), compared to $(4,020,000) in 2022, indicating a significant improvement[127]. - Revenue less expenses before impairment losses for 2023 was $(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), 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 US$1.55 million, a decrease of approximately US$4.15 million from the previous year, mainly due to the loss attributable to shareholders[3]. - The capital deficiency as of December 31, 2023, was approximately US$1.55 million, a decrease of approximately US$4.15 million from the previous year[48]. - The Company has eliminated its debt by offsetting approximately US$14.84 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 $26,318,000 in 2022, showing a significant reduction in asset base[130]. - Current liabilities decreased to $(3,581,000) in 2023 from $(18,316,000) in 2022, indicating improved liquidity[130]. - Total liabilities decreased to $(4,346,000) in 2023 from $(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 $2,597,000 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 US$5 million from Wanbang Biopharmaceutical, and an additional US$2 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 HK$0.0785 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].
励晶太平洋(00575) - 2023 - 年度财报