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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].
励晶太平洋(00575) - 2018 - 年度财报
2019-04-18 07:56
REGENT PACIFIC GROUP LIMITED (勵晶太平洋集團有限公司) (於開曼群島註冊成立之有限公司) 股票繃號: 575 2018 # 目 錄 頁次 業績概覽 2 4 主席報告 7 行政總裁報告 17 董事局報告 管理層對本集團業績之討論及分析 58 63 企業管治報告 環境、社會及管治報告 92 獨立核數師報告 98 經審核財務報表 103 綜合全面收益表 綜合財務狀況表 105 綜合權益變動表 106 綜合現金流量表 108 110 財務報表附註 業績概覽 業績概覽 二零一八年之財務業績概要及其他重要事件包括: ‧ 本公司股東應佔虧損31,090,000美元,主要是由於:(i)無 形 資 產(即FortacinTM)之 非 現 金 攤 銷 費 用 28,050,000美元;(ii)營運費用8,770,000美元;及(iii)有關本公司透過損益賬按公允價值處理之金融資產 之權益組合按照市值計算之虧損3,300,000美元;惟部分被從Recordati S.p.A.(「Recordati」)、江蘇萬邦醫 藥營銷有限責任公司(「江蘇萬邦醫藥」)及友華生技醫藥股份有限公司(「友華生技醫藥」)收取 ...