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) - 2022 - 中期财报