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 - 年度财报