Financial Performance - The Company reported a loss attributable to shareholders of approximately US$36.43 million for the year ended December 31, 2022, primarily due to a total amortization charge of approximately US$24.95 million, operating and R&D expenses of approximately US$6.02 million, and marked-to-market losses of approximately US$3.78 million and US$0.35 million on its equity portfolio [2]. - The Group recorded a loss attributable to shareholders of approximately US$36.43 million for the year, primarily due to a total amortisation charge of approximately US$24.95 million on intangible assets, operating and R&D expenses of approximately US$6.02 million, and marked-to-market losses of approximately US$3.78 million and US$0.35 million on the equity portfolio [15]. - Total revenue for the year ended December 31, 2022, was a loss of US$4,020,000, compared to a profit of US$18,235,000 in 2021 [139]. - The operating loss after impairment losses for 2022 was US$34,995,000, an increase from US$13,873,000 in 2021 [139]. - Loss attributable to shareholders for the year was US$36,427,000, compared to US$12,598,000 in 2021 [139]. Shareholders' Equity - Shareholders' equity decreased by approximately 93.30% to approximately US$2.60 million as of December 31, 2022, mainly due to the loss attributable to shareholders; however, post year-end, equity increased by approximately US$21.67 million following the completion of a Rights Issue [2]. - Following the completion of the Rights Issue in January 2023, shareholders' equity increased to approximately US$24.27 million, an increase of approximately 833.46% [41]. - The completion of the rights issue in January 2023 increased shareholders' equity to approximately US$21.67 million and left the Company debt-free [16]. Drug Development and Regulatory Approvals - The Company aims to submit a New Drug Application (NDA) for Senstend™ to the NMPA in Q3 2023, contingent on the successful completion of a Phase 3 randomized controlled trial, which could yield US$5 million upon NDA submission and US$2 million upon the first commercial sale in China [2]. - The Phase 3 study protocol for Fortacin™ in the US was completed, and a roadmap for NDA submission was established following positive feedback from a "Type C" meeting with the FDA, with plans to sign a special protocol assessment in Q2 2023 [4]. - Wanbang Biopharmaceutical completed the randomisation of 295 subjects in the Phase 3 study, with initial data expected in early Q2 2023 and NDA submission targeted for Q3 2023 [20]. - The Group is working with its commercial partner in China to submit the NDA for Senstend™ to NMPA in Q3 2023, which is expected to be a game changer if approved [31]. - The NDA submission in China is targeted for Q3 2023, with approval anticipated 12 months later, depending on the NMPA's response to any deficiencies [59]. Manufacturing and Supply Chain - An alternative European manufacturer for Fortacin™ was approved by the EMA in Q3 2022, with production starting in December 2022, and the first two batches released in February 2023 for Germany and Italy [4]. - The Group resumed manufacturing and supply of Fortacin™ in Europe, leading to anticipated royalty income from its European commercial partner [20]. - The European commercial partner received EMA approval on September 15, 2022, for adding an alternative manufacturer, with the first two commercial batches of Fortacin™ delivered in February 2023 for sale in Germany and Italy [63]. Strategic Investments and Business Development - The Company has integrated Deep Longevity into its existing business, hiring a new CEO to redefine its strategy and focus on commercializing AI-led aging clocks [4]. - The Group is actively pursuing strategic investments in the healthcare and life sciences sectors, focusing on commercialisation opportunities related to Deep Longevity's patented technology [21]. - The Group's business development efforts are aimed at driving revenue growth by connecting with various industries, including providers, insurers, and software developers [24]. - Deep Longevity continues to grow, with new leadership and a commitment to building and commercialising various aging clocks using AI-led deep learning models [22]. - DLI is actively pursuing partnerships with health-oriented apps and platforms to enhance customer journeys through white-label technology solutions [90]. Market Outlook and Economic Conditions - The Group remains focused on the successful commercialisation of Fortacin™/Senstend™ in key markets including the US, China, Asia, Latin America, and the Middle East [11]. - The Group is optimistic about the economic outlook for the region post-COVID-19, despite ongoing challenges from the war in Ukraine and inflationary pressures [30]. - The company is optimistic about the economic outlook in the region following the lifting of COVID-19 restrictions, expecting significant growth in royalty income from Fortacin™ starting in 2023 [114]. Technology and Product Development - The launch of SenoClock©, the first SaaS platform for aging clocks, has been initiated with the first customers signed up [20]. - DLI launched SenoClock© in late 2022 and has signed its first customers, with plans to expand its product offerings in 2023, including the introduction of MindAge© [32]. - DLI's SenoClock© platform is a cloud-first, SaaS© solution designed to serve hundreds of enterprises globally, utilizing a highly scalable architecture [101]. - Deep Longevity's technology can be embedded in existing applications with minimal upfront costs, facilitating easier market entry [78]. Financial Position and Risk Management - The Group recapitalized its financial position post year-end, raising approximately US$21.67 million from a Rights Issue, resulting in a debt-free status and sufficient working capital for the next 12 months [5]. - The cash resources of Plethora were approximately GBP 37,000 (or approximately US$44,000) for the year ended December 31, 2022, down from approximately GBP 122,000 (or approximately US$166,000) in 2021 [110]. - The Group's financial risk management objectives and policies are detailed in note 30 to the Financial Statements [143]. Share Option Scheme - The Share Option Scheme (2016) allows for a maximum of 173,725,118 shares to be issued upon exercise of options, representing 10% of the total issued ordinary shares at the date of adoption [179]. - The total number of shares that may be issued under the scheme, when aggregated with other schemes, shall not exceed 10% of the total issued ordinary share capital [185]. - The vesting period for Options is a minimum of 12 months, with one-third of the Options exercisable at each of the first, second, and third anniversary dates after the grant [197].
励晶太平洋(00575) - 2022 - 年度财报