REGENT PACIFIC(00575)
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励晶太平洋(00575) - 2023 - 年度财报
2024-04-25 08:30
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 - 年度业绩
2024-03-27 22:31
Financial Performance - The company reported a loss attributable to shareholders of approximately $25,050,000 for the year ended December 31, 2023, primarily due to amortization expenses of intangible assets totaling about $22,180,000 and operational and R&D expenses of approximately $6,070,000[9]. - The company recorded a capital loss of approximately $1,550,000 as of December 31, 2023, a decrease of about $4,150,000 from the previous year, primarily due to the loss attributable to shareholders[2]. - The company reported a net loss of $25,049,000 for the year ended December 31, 2023, an improvement from a net loss of $36,427,000 in 2022, reflecting a reduction of approximately 31%[18]. - The group reported a total comprehensive loss of $30,463,000 for 2023, compared to a loss of $36,008,000 in 2022, indicating a 15.5% improvement[46][51]. - The biopharmaceutical segment's loss before tax for 2023 was $25,290,000, compared to a loss of $26,607,000 in 2022, reflecting a 4.9% improvement[46][51]. - The company reported a deferred tax credit of $5,387,000 in 2023, compared to a tax expense of $433,000 in 2022, indicating a significant shift[60]. - The company recognized a tax credit of approximately $5.41 million for the year ended December 31, 2023, compared to a tax expense of approximately $420,000 for the year ended December 31, 2022[72]. - The company’s total assets decreased to $2,785,000 in 2023 from $2,312,000 in 2022, while total liabilities significantly decreased from $18,316,000 to $3,581,000, indicating improved financial health[20][21]. Revenue and Growth - In 2023, the company reported total revenue of $291,000, a substantial increase from $114,000 in 2022, representing a growth of approximately 155%[17]. - The group’s revenue for the year 2023 was $317,000, compared to $223,000 in 2022, representing a 42.2% increase[41]. - Patent licensing income increased significantly to $171,000 in 2023 from $35,000 in 2022, a growth of 388.6%[41]. - Revenue from the Deep Longevity segment totaled $291,000 in 2023, up from $114,000 in 2022, marking a 155.3% increase[41]. - The company expects royalty income from Fortacin™ to experience exponential growth starting in 2024 as production resumes in Europe and supply to commercial partners is restored[15]. Drug Development and Commercialization - The company aims to submit a new drug application for Senstend™ to the National Medical Products Administration by the end of Q1 2024, with expectations of approval within 12 months, potentially generating $5,000,000 and $2,000,000 in revenue from the Chinese market[3][5]. - The company has made significant progress in the commercialization of Fortacin™ in Europe, with strong demand observed in France, Germany, Italy, and Portugal, following its reintroduction in 2023[3]. - The company achieved a significant milestone in 2023 by successfully completing the Phase III clinical study in China for Fortacin™, with all four primary endpoints met[11]. - The company is actively discussing licensing Fortacin™ rights to pharmaceutical companies in Japan and South Korea, which could further increase royalty income[7]. - The company is addressing feedback from the FDA regarding the special protocol assessment for Fortacin™ in the U.S. and plans to engage further in the first half of 2024[7]. - The company has completed approximately 90% of the documentation for the new drug application for Senstend™ in China, awaiting the signing of a manufacturing and supply agreement with Jiangsu Wanbang Pharmaceutical[5]. Strategic Initiatives - The company has integrated Deep Longevity into its existing business, focusing on developing AI-driven aging clock technologies and commercializing various products[6]. - The company launched the SenoClock® platform through Deep Longevity, achieving significant progress in the public hospital sector[8]. - The company launched SenoClock® Gold in 2023, successfully acquiring its first batch of registered customers, including public hospitals, and plans to expand the product range in 2024[15]. - The company is exploring potential mergers and acquisitions to bolster its growth strategy[111]. - The company emphasizes the importance of intellectual property in its business model[111]. Financial Management and Risks - The company is facing challenges from high inflation, high interest rates, and geopolitical uncertainties, which may continue to impact the business environment in 2024[11][14]. - The company aims to implement operational plans to control costs and generate sufficient operating cash flow to meet current and future obligations[29]. - The company is focused on cost control measures and timely collection of receivables to improve cash flow[30]. - There is significant uncertainty regarding the company's ability to continue as a going concern, depending on the successful implementation of its plans[28]. - The group faces significant risks related to its equity in Plethora and the performance of its investment portfolio due to global market volatility[87]. - The group operates in USD, exposing it to foreign exchange risks related to currency fluctuations[88]. Corporate Governance and Compliance - The board has prepared a cash flow forecast for the 15 months ending March 31, 2025, estimating the company's cash needs and believes it has sufficient working capital to meet current requirements[27]. - The company has entered into a loan agreement with Galloway for a total of $2,000,000 at an interest rate of 8%, with $400,000 already drawn down[29]. - The company has not early adopted any new standards or interpretations that have been issued but are not yet effective[38]. - The independent auditor, Roshan Mei, was appointed effective June 21, 2023, following the resignation of the previous auditor, Hong Kong Lee & Associates[98]. - The company is committed to adhering to Hong Kong Financial Reporting Standards in its financial disclosures[110]. Shareholder Matters - The board has resolved not to declare a final dividend for the year ended December 31, 2023, consistent with the previous year[96]. - The rights issue raised approximately HKD 170,080,000 (or about $21,670,000) before expenses, with a net amount of approximately HKD 163,800,000 (or about $20,870,000) after estimated expenses[76]. - Approximately 63.63% (up to HKD 104,230,000 or about $13,280,000) of the net proceeds from the rights issue will be used for debt repayment[76]. - The company has not repurchased, sold, or redeemed any of its listed securities during the year ended December 31, 2023[101].
励晶太平洋(00575) - 2023 - 中期财报
2023-09-20 08:30
CONTENTS 目 錄 | 2 | Performance Overview | 業績概覽 | | --- | --- | --- | | 5 | Review and Prospects | 回顧及展望 | | 12 | Management's Discussion and | 管理層對本集團業績之 | | | Analysis of the Group's Performance | 討論及分析 | | 18 | Condensed Consolidated Statement of Profit or | 簡明綜合損益及 | | | Loss and Other Comprehensive Income | 其他全面收益表 | | 20 | Condensed Consolidated Statement | 簡明綜合財務狀況表 | | | of Financial Position | | | 22 | Condensed Consolidated Statement | 簡明綜合權益變動表 | | | of Changes in Equity | | | 23 | Condensed Conso ...
励晶太平洋(00575) - 2023 - 中期业绩
2023-08-29 14:48
香港交易及結算所有限公司及香港聯合交易所有限公司對本公佈之內容概不負 責,對其準確性或完整性亦不發表任何聲明,並明確表示,概不對因本公佈全部或 任何部份內容而產生或因倚賴該等內容而引致之任何損失承擔任何責任。 (於開曼群島註冊成立之有限公司) (股份代號:���) 截至二零二三年六月三十日止六個月之 未經審核中期業績 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: • 12,200,000 (i) 本公司股東應佔虧損約 美元,主要是由於: 無形資產之攤銷 12,380,000 (ii) 費用約 美元(屬非現金項目);及 本集團的營運及研發開支約 2,940,000 (iii) 美元,有關金額部分被 本公司股本投資組合內之透過損益賬按公 91,000 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 美元 19,000 及 美元所抵銷。 • 2,600,000 339.01% 股東權益由二零二二年十二月三十一日的約 美元,增加 至 11,400,000 ...
励晶太平洋(00575) - 2022 - 年度财报
2023-04-26 08:49
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 - 年度业绩
2023-03-29 14:32
香港交易及結算所有限公司及香港聯合交易所有限公司對本公佈之內容概不負 責,對其準確性或完整性亦不發表任何聲明,並明確表示,概不對因本公佈全部或 任何部份內容而產生或因倚賴該等內容而引致之任何損失承擔任何責任。 Endurance RP Limited * 壽 康 集 團 有 限 公 司 (於開曼群島註冊成立之有限公司) 575 (股份代號: ) 截至二零二二年十二月三十一日止年度之 經審核末期業績 壽康集團有限公司董事會欣然公佈本集團截至二零二二年十二月三十一日止年度 之經審核綜合業績,連同上一年度的比較數據。 業績概覽 截至二零二二年十二月三十一日止年度之財務業績概要及其他重要事件包括: • 36,430,000 (i) 本公司股東應佔虧損約 美元,主要是由於: 無形資產之攤銷費 24,950,000 (ii) 用總額約 美元(屬非現金項目); 本集團的營運及研發開支約 6,020,000 (iii) ...
励晶太平洋(00575) - 2022 - 中期财报
2022-09-27 08:32
Financial Performance - The Company reported a loss attributable to shareholders of approximately US$20.06 million for the six months ended June 30, 2022, primarily due to an amortization charge of approximately US$12.34 million on intangible assets and operating and R&D expenses of approximately US$3.01 million[4]. - Shareholders' equity decreased to approximately US$19.26 million, a decline of approximately 50.32% compared to December 31, 2021, driven by the loss attributable to shareholders[4]. - The Group reported a loss attributable to shareholders of approximately US$20.06 million for the first half of 2022, primarily due to an amortization charge of approximately US$12.34 million on intangible assets and operating and R&D expenses of approximately US$3.01 million[27]. - Shareholders' equity decreased to US$19.26 million, representing a decline of approximately 50.32% compared to December 31, 2021, driven by the loss attributable to shareholders[28]. - The Group's loss for the period was US$20.06 million, compared to a profit of US$2.66 million in the same period of 2021[132]. - The total comprehensive income for the period was a loss of $19,636,000, compared to a profit of $2,852,000 in the previous period[140]. - The loss attributable to shareholders of the Company for the period was $20,062,000, compared to a profit of $2,661,000 in the previous period[140]. - For the six months ended June 30, 2022, the Group reported revenue of US$13,000, a significant decrease of 99.6% compared to US$3.27 million in the same period of 2021[132]. - Total income and fair value loss on financial instruments for the period was US$5.42 million, compared to a gain of US$19.04 million in the previous year[132]. Investment and Development - The Company is progressing with the development of Fortacin™ in the US, having completed the Phase 3 study protocol and scheduled a "Type C" meeting with the FDA for Q3 2022[7]. - In Europe, Recordati has engaged a new third-party manufacturer for Fortacin™, with approval from the EMA expected by Q3 2022, which will allow for the resumption of commercial supply[8]. - The Company aims to commercialize Fortacin™/Senstend™ in key markets including the US, China, Asia, Latin America, and the Middle East[15]. - The Phase 3 clinical trial for Fortacin™ has commenced with 210 patients enrolled and 128 subjects randomized as of July 22, 2022, indicating approximately 70% and 40% completion respectively[29]. - The estimated completion for enrollment and randomization of the Phase 3 study is expected by November 2022, only one month later than previously advised[29]. - The ongoing Phase 3 study aims to determine the effects of Senstend™ on the Index of Premature Ejaculation and the Intra-vaginal Ejaculation Latency Time[36]. - The clinical study for Senstend™ aims to evaluate its impact on premature ejaculation index and vaginal ejaculation delay time[38]. - NMPA submission for Senstend™ is scheduled for Q2 2023[40]. - All costs associated with the clinical trials are being covered by Wanbang Biopharmaceutical[42]. - If the clinical study meets its endpoints, Wanbang Biopharmaceutical will pay the Group US$5 million upon NMPA granting an import license for Senstend™[43]. - Upon the first commercial sale of Senstend™ in China, an additional US$2 million will be payable to the Group from Wanbang Biopharmaceutical[44]. - The Medicines and Health products Regulatory Agency approved a variation for Senstend™, widening the PGAK-1 impurity specification from 0.5% to 1% and total impurities from 1% to 2%[50]. - The shelf life of Senstend™ has been increased from 18 months to 24 months following regulatory approval[50]. - Orient EuroPharma is preparing to place new orders for Fortacin™ in Taiwan, Hong Kong, and Macau once commercial supply resumes[9]. - SK-Pharma submitted its marketing authorization in Israel, expecting approval by Q4 2023, while also preparing for marketing authorizations in several Balkan countries[9]. - The Group is in discussions for out-licensing the rights to Fortacin™ to a Japanese pharmaceutical company and a pharmaceutical company based in the UAE for the GCC region[57]. Strategic Focus and Future Outlook - Deep Longevity, acquired in December 2020, is integrating with the existing business and has appointed a new CEO to redefine its strategy and focus on AI-led aging clocks[13]. - The Group is actively pursuing the commercialization of its deep learning aging clock technology and MindAge© products, collaborating with clinics, laboratories, and insurance companies[17]. - Deep Longevity is targeting the virtual mental health sector, which has an estimated total addressable market of US$89 billion, focusing on medium to large size employers in developed markets like the US, UK, and Europe in 2023[67]. - The company is committed to building and commercializing various aging clocks using AI-led deep learning models, with a special focus on the MindAge© offering[61]. - A new enterprise-grade MindAge© offering is being considered, aimed at large and mid-sized employers to help employees manage their virtual mental well-being[62]. - The newly appointed CEO, Deepankar Nayak, brings over 17 years of experience in technology consulting, which will be valuable for redefining the company's strategy[60]. - Deep Longevity aims to transform underwriting in the life and health insurance sector with its leading Aging Clocks, providing scalable and inexpensive solutions[68]. - The company is looking forward to announcing proof of concepts with various insurance and corporate partners in the health and wellbeing sector in the coming months[68]. - The Group is committed to seeking strategic and value-driven investments in the healthcare and life sciences sectors[17]. - The Group continues to monitor the impact of external factors such as the war in Ukraine and COVID-19 restrictions in China, which have affected economic growth and business operations[20]. Operational and Financial Management - The Group's operating and R&D expenses for the period were approximately US$3.01 million, contributing to the overall loss[27]. - R&D expenditure decreased by 62.50% to approximately US$0.60 million for the six months ended June 30, 2022, down from approximately US$1.60 million in 2021, attributed to the completion of the Phase II study and delays in the Phase III study[110]. - G&A expenditure decreased by 35.81% to approximately US$2.42 million for the six months ended June 30, 2022, down from approximately US$3.77 million in 2021, mainly due to salary reductions[110]. - Employee benefit expenses for the period were US$1.72 million, down from US$2.88 million in 2021[132]. - The Group did not have any material acquisitions or disposals of subsidiaries during the six months ended June 30, 2022[125]. - The Group employed 18 employees and 10 consultants as of June 30, 2022, maintaining the same number of employees as in 2021[130]. - The Group has sufficient operating funds to meet financial obligations for at least the next twelve months, despite significant uncertainties regarding its ability to continue as a going concern[169]. - The Group's cash flow projection indicates sufficient working capital to finance operations for at least the next twelve months[167]. - The Group plans to raise new capital through fundraising activities[165]. - The Group's financial performance remains stable despite the uncertainties surrounding its operations[169]. Market and Economic Conditions - The global GDP in Q1 2022 was around 4.8% above pre-COVID-19 levels, but growth is expected to slow significantly due to high inflation and geopolitical tensions[92]. - The outlook for major economies, including the US, UK, Europe, and Japan, suggests a likely recession within the next 12 to 18 months due to elevated inflation impacting real incomes[93]. - Risks for the remainder of 2022 are skewed towards the downside, with potential for a sharper economic slowdown rather than a soft landing[94]. Regulatory and Compliance - The Group's financial statements reflect the application of new accounting standards effective from January 1, 2022[172]. - The adoption of new or revised HKFRSs did not have any significant impact on the Group's financial performance and financial position[176]. - The Group continues to monitor the impact of new accounting standards on its financial reporting[176]. - The amendments to HKAS 1 require companies to disclose their material accounting policy information rather than just significant accounting policies[179]. - The amendments to HKAS 12 narrow the scope of the initial recognition exemption, making it inapplicable to transactions that give rise to equal and offsetting temporary differences[185].
励晶太平洋(00575) - 2020 - 中期财报
2020-09-23 01:58
Financial Performance - The company reported a loss attributable to shareholders of approximately $27.16 million, primarily due to an impairment loss of $13.3 million on intangible assets FortacinTM and amortization expenses of about $10.66 million[3]. - Shareholders' equity decreased to approximately $35.37 million, a reduction of about 43.42% compared to December 31, 2019, mainly due to the loss attributable to shareholders[3]. - Total revenue for the six months ended June 30, 2020, was $85,000, a decrease of 20.56% compared to $107,000 for the same period in 2019[11]. - Operating loss for the period was $15,480,000, with a significant increase in R&D expenses to $1,155,000 from $671,000 in the previous year[11]. - The net loss for the period was $27,156,000, compared to a net loss of $23,305,000 in the same period last year, reflecting a 16% increase in losses[14]. - The company's total assets decreased to $59,171,000 from $83,435,000 as of December 31, 2019, indicating a decline of 29.06%[15]. - The company's equity attributable to shareholders dropped to $35,365,000 from $62,503,000, a decrease of 43.25%[17]. - Basic and diluted loss per share for the period was $1.478, compared to $1.268 for the same period in 2019, representing a 16.54% increase in loss per share[14]. - The total comprehensive income for the period was $(27,139,000), compared to $(23,424,000) in the prior year, reflecting a worsening overall financial position[14]. - The company reported a total comprehensive income of $(23.423) million for the period, reflecting a significant decline compared to the previous year[20]. Impairment and Asset Valuation - The company incurred an impairment loss of $13.3 million on intangible assets during the reporting period[22]. - The fair value of FortacinTM decreased by $23,960,000, with significant reductions in the European market ($22,030,000) and the U.S. market ($3,210,000) during the first half of 2020[69]. - As of June 30, 2020, the carrying amount of intangible assets was $59,080,000, down from $83,037,000 as of December 31, 2019, reflecting a decrease of approximately 29%[65]. - The impairment loss for the FortacinTM patent was $13,300,000 for the six months ended June 30, 2020, compared to no impairment in the previous year[66]. Strategic Investments and Collaborations - The company is actively monitoring its strategic investments in Venturex Resources Limited and West China Coking & Gas Company Limited, holding approximately 7.51% and 25% of their respective total issued capital as of June 30, 2020[7]. - The company continues to collaborate with Youhua Biotech Co., Ltd. for the commercialization of FortacinTM in Hong Kong and Macau, with potential payments of up to $1.45 million based on market launch milestones[6]. - The company is focused on exploring acquisition and investment opportunities in the healthcare and life sciences sectors, particularly in patented technologies related to aging biomarkers[7]. - The company is in discussions with strategic partners in the Middle East, India, North America, and Latin America for potential licensing opportunities, although no agreements have been finalized[159]. COVID-19 Impact - The COVID-19 pandemic significantly impacted the company's operations, including delays in clinical trials and recruitment processes in certain regions[143]. - The ongoing COVID-19 pandemic is expected to adversely impact the company's operations, including the commercialization efforts of FortacinTM in China and other regions[170]. - The company continues to monitor the impact of COVID-19 on the distribution and marketing of FortacinTM, with Recordati resuming sales activities after initial lockdowns[159]. Financing and Cash Flow - The company has received a commitment for a loan financing of $6.8 million from Galloway Limited to cover all maturing current liabilities within twelve months after the reporting period[26]. - Cash flow from operating activities showed a net cash outflow of $3.916 million for the six months ended June 30, 2020, compared to an outflow of $4.488 million in the same period in 2019[22]. - The company’s financing activities generated a net cash inflow of $3.855 million, down from $4.403 million in the previous year[22]. - The company raised a total of $950,000 through the issuance of convertible bonds and $5,500,000 from shareholder loans and accrued salaries[84]. Research and Development - The company aims to complete the second phase of the FortacinTM validation study by the end of 2020, with a target of randomizing approximately 101 subjects[3]. - Research and development expenses related to FortacinTM's U.S. clinical trial activities amounted to £920,000 (approximately $1,150,000), down from £1,310,000 (approximately $1,690,000) in 2019[162]. - R&D expenses decreased by 31.36% to approximately $1.16 million, down from $1.69 million in 2019, primarily due to delays in patient recruitment for FortacinTM's Phase II study[183]. Corporate Governance and Management - The company maintains its commitment to corporate governance and social responsibility standards in accordance with the policies set by the Hong Kong Stock Exchange[187]. - The board has resolved not to declare an interim dividend for the six months ended June 30, 2020[198]. - Total remuneration for key management personnel was $774,000 for the six months ended June 30, 2020, down from $911,000 for the same period in 2019[125]. Future Outlook - The company expects to submit a New Drug Application (NDA) to the FDA in the first quarter of 2023, contingent on the successful completion of the second phase study and subsequent third phase study[148]. - The company remains confident in launching FortacinTM in Hong Kong and Macau in 2020, depending on the COVID-19 situation and production capabilities[158]. - The company is optimistic about the future prospects as it continues to make progress with the U.S. FDA regarding FortacinTM and ongoing discussions with potential commercial partners[172].
励晶太平洋(00575) - 2019 - 年度财报
2020-04-29 02:32
Financial Performance - The company reported a shareholder loss of approximately $66,050,000 for 2019, primarily due to impairment losses of $26,000,000 and amortization expenses of $28,050,000 related to the intangible asset FortacinTM [3]. - Shareholder equity decreased by approximately 50.64% to about $62,500,000 compared to December 31, 2018, mainly due to the combined impairment and amortization expenses totaling approximately $54,050,000 [3]. - The company reported a loss attributable to shareholders of approximately $66,050,000, primarily due to impairment losses of $26,000,000 and amortization expenses of $28,050,000 related to the intangible asset FortacinTM [13]. - The company recorded a loss attributable to shareholders of approximately $66,050,000 for 2019, compared to a loss of approximately $31,090,000 in 2018 [68]. - The company’s segment recorded a loss of approximately $310,000 in 2019, a significant decline from a profit of approximately $2,840,000 in 2018 [69]. - The company reported a significant decrease in milestone and patent licensing revenue from approximately $6.24 million in 2018 to about $0.16 million in 2019, a decline of 97.44% [70]. - The company recorded a total revenue loss of $313,000 in 2019, compared to a revenue of $2,843,000 in 2018, marking a significant decline [88]. - The operating loss for 2019 was $64,114,000, an increase from $33,971,000 in 2018 [88]. - The net loss attributable to shareholders for 2019 was $66,048,000, compared to $31,087,000 in 2018 [89]. - The company's total assets decreased to $86,281,000 in 2019 from $144,762,000 in 2018 [89]. Product Development and Commercialization - FortacinTM was launched in the UK in February 2019, with plans for a rollout in Romania in 2020, subject to the COVID-19 pandemic and the transition from prescription to over-the-counter status [4]. - The company aims to complete the second phase of FDA validation for FortacinTM by the end of 2020, with a new drug application submission targeted for the first quarter of 2023 [4]. - The company continues to seek commercialization of FortacinTM in major markets including the U.S., China, Asia, Latin America, and the Middle East following its launch in Europe and the UK [40]. - FortacinTM has been relaunched in key European markets, but user numbers are significantly below expectations due to patients' reluctance to seek medical advice for premature ejaculation [17]. - Recordati is considering reclassifying FortacinTM from a prescription drug to an over-the-counter drug to address low sales, with a decision expected by the end of July 2020 [19]. - The company is committed to ongoing discussions with potential commercial partners to advance FortacinTM's market presence [26]. - The company has received commercialization rights for FortacinTM in Hong Kong and Macau, with potential approvals in other Asian regions expected in the coming months or years [6]. - The company expects to receive up to €33,000,000 (approximately $37,060,000) in further payments under a licensing agreement with Recordati upon reaching certain milestones related to European sales [14]. - FortacinTM's second phase validation study in the U.S. is ongoing and expected to complete by the end of 2020, with a potential third phase starting in H2 2021 and a new drug application submission in H1 2022 [22][30]. - The company is facing potential regulatory challenges and costs due to the UK's exit from the EU, which may impact its operations and financial performance [51]. Strategic Investments and Financial Management - The company continues to seek strategic and value-driven investments in the healthcare and life sciences sectors, particularly in the cannabis industry [7]. - The company successfully completed a financing round of $6,450,000 through convertible notes, despite initial expectations for a larger capital raise [8]. - The company is actively monitoring its strategic investment in Venturex Resources Limited, which accounted for approximately 8.44% of the company's equity as of December 31, 2019 [9]. - A settlement of $9,500,000 AUD (approximately $6,670,000) was reached with the Australian Taxation Office, significantly lower than the potential total liability [9]. - The company plans to sell non-core assets and investments to seek growth opportunities in the life sciences sector [76]. - The company is focused on acquiring revenue-generating assets in the healthcare and life sciences sectors to diversify its business [117]. - The company plans to divest its non-core assets in the healthcare and life sciences sectors to focus on its new strategies in these areas [129]. Regulatory and Market Risks - The global economic growth forecast for 2020 is 2.5%, with significant risks due to the COVID-19 pandemic, potentially leading to a recession [25]. - The company anticipates that the stock market will continue to experience significant volatility, impacting its share price regardless of business performance [24]. - The company is exposed to price volatility in gold, copper, zinc, and coal, which may significantly impact the value of its non-core assets [130]. - The company faces significant risks related to regulatory approvals, which may lead to delays or inability to launch products in various regions [152]. - The company's operations are heavily reliant on market perception, and negative reports regarding product safety could have a substantial negative impact on performance [154]. - The company must manage potential product liability risks, including adverse reactions during clinical trials, which could affect its ability to market products [155]. - The company faces various international risks, including unpredictable regulatory changes and trade barriers, which could affect its financial stability [157]. - The outbreak of the 2019 coronavirus is expected to negatively impact the commercialization efforts of FortacinTM in China, affecting cash flow, net sales, and profitability [161]. - The company faces risks related to Brexit, as the UK will become a third-party country to the EU, potentially complicating the release of pharmaceutical products in the EU [162]. Governance and Shareholder Matters - The company has established a corporate governance framework ensuring that all directors act in the best interests of the company and disclose any potential conflicts of interest [188]. - The board consists of three independent non-executive directors, David Comba, Julie Oates, and Mark Searle, representing over one-third of the board [191]. - The company has established various committees, including the Audit Committee, Remuneration Committee, and Technical Committee, to oversee governance and compliance [197]. - The board has the authority to appoint new directors as needed, with any appointed directors required to retire at the next annual general meeting [189]. - The company has not recommended any final dividend for the year ended December 31, 2019, consistent with the previous year [85]. - The company plans to adopt a semi-annual dividend policy, with total annual dividends not exceeding 35% of projected consolidated annual profits [86]. - The company believes that only profits and share premiums are available for distribution to shareholders [176]. - The company’s ability to pay dividends is subject to its financial condition and future economic outlook, as well as legal and contractual restrictions [87].
励晶太平洋(00575) - 2019 - 中期财报
2019-09-17 06:11
Financial Performance - The company reported a loss attributable to shareholders of $23.3 million, primarily due to amortization expenses of approximately $13.91 million related to intangible assets and a settlement amount of AUD 9.5 million (approximately $6.67 million) with the Australian Taxation Office[2]. - Shareholders' equity decreased to $103.19 million, a reduction of approximately 18.50% compared to December 31, 2018, mainly due to the loss attributable to shareholders[2]. - Total revenue for the six months ended June 30, 2019, was $955,000, compared to $2,063,000 for the same period in 2018, representing a decrease of approximately 53.7%[9]. - The company reported a net loss of $23,305,000 for the six months ended June 30, 2019, compared to a net loss of $14,296,000 for the same period in 2018, indicating an increase in losses of approximately 63.5%[9]. - The company's total comprehensive income for the period was $(23,424,000), compared to $(14,077,000) for the same period in 2018, representing an increase in comprehensive losses of approximately 66.5%[13]. - The company reported a pre-tax loss of $18,027,000, compared to a loss of $15,687,000 for the same period in 2018, representing an increase in loss of approximately 8.6%[24]. - The company reported a significant increase in professional and consulting fees, which rose to $671,000 in the first half of 2019 from $488,000 in the same period of 2018, an increase of approximately 37.5%[9]. Assets and Liabilities - The company's total assets decreased to $115,510,000 as of June 30, 2019, down from $140,275,000 as of December 31, 2018, a decline of approximately 17.6%[17]. - The net asset value per share decreased to $5.62 as of June 30, 2019, compared to $6.89 as of December 31, 2018, reflecting a decrease of approximately 18.4%[17]. - The company’s total liabilities increased to $(16,493,000) as of June 30, 2019, compared to $(4,487,000) as of December 31, 2018, indicating a significant increase in liabilities[17]. - The company's financial statements have been prepared on a going concern basis, indicating confidence in its ability to continue operations despite current losses[26]. Cash Flow and Liquidity - The net cash used in operating activities was $(4,488,000), a significant decline from a net cash inflow of $757,000 in the prior year, indicating a negative shift in operational cash flow[24]. - The company generated net cash from investing activities of $710,000, a recovery from a net cash outflow of $(67,000) in the previous year, reflecting improved investment performance[24]. - The company has assessed its future liquidity and cash flow, considering a potential issuance of convertible notes amounting to $6,450,000 by August 31, 2019, to support ongoing operations[26]. - The company’s cash and cash equivalents at the end of the period stood at $1,529,000, down from $3,091,000 at the end of June 30, 2018, indicating a year-over-year decline of approximately 50.6%[24]. Research and Development - Research and development expenses increased significantly to $1,689,000 in the first half of 2019, up from $642,000 in the same period of 2018, reflecting a rise of approximately 163.5%[9]. - Progress is being made in the approval process for FortacinTM with the U.S. FDA, with the second phase of validation studies ongoing and expected to be completed by the end of 2019[2]. - The company is expected to submit a new drug application for FortacinTM in the second half of 2020, pending the completion of the third phase of the U.S. FDA approval process[155]. Strategic Initiatives - The company has successfully launched FortacinTM in the UK and plans to introduce it in Romania and Greece later in 2019, with further expansion into other countries in the coming years[2]. - Discussions regarding the potential acquisition of Yooya have been terminated, leading to a focus on opportunities in the cannabis industry in China[5]. - The company is exploring potential investments and acquisition opportunities in the Chinese cannabis industry, particularly focusing on CBD-infused products[139]. Share Capital and Financing - The company issued convertible bonds with a principal amount of $17,500,000, bearing a 4% interest rate, maturing in 2022[3]. - The company plans to issue up to 719,435,294 new shares upon full conversion of the convertible bonds, subject to independent shareholder approval[4]. - The company has successfully completed the issuance of convertible notes amounting to $6.45 million (approximately HKD 50.31 million) under two conditional subscription agreements[135]. Compliance and Reporting Standards - The company adopted new Hong Kong Financial Reporting Standards (HKFRS) effective January 1, 2019, including HKFRS 16 on leases, which may impact future financial reporting[28]. - The group recognized lease liabilities totaling $903,000 as of January 1, 2019, after adjustments for previous operating lease commitments[36]. Market Performance - Recordati has relaunched FortacinTM in key countries including France, Germany, Italy, Portugal, Spain, and the UK, with positive initial feedback from doctors regarding its effectiveness compared to existing products[150]. - Approximately 40% of patients using FortacinTM in Italy are likely to repurchase the product, indicating strong market potential[152]. - Initial feedback from doctors in Italy, Germany, Spain, Portugal, and France regarding FortacinTM has been very positive, suggesting it meets prescription needs effectively[150].