Financial Performance - Revenue for the six months ended June 30, 2024, was RMB 49,769,000, compared to RMB 11,304,000 for the same period in 2023, representing a significant increase [7]. - Gross profit for the period was RMB 42,840,000, up from RMB 10,154,000 in the previous year, indicating a strong improvement in profitability [7]. - The loss for the period was RMB 75,802,000, a decrease from RMB 233,778,000 in the same period last year, indicating a narrowing of losses [7]. - Non-HKFRS adjusted loss for the period was RMB 75,689,000, compared to RMB 218,178,000 in the prior year, highlighting a significant improvement [8]. - The company reported a total comprehensive income loss of RMB 15,351,000 for the period, compared to RMB 135,031,000 in the previous year, indicating a positive trend [7]. - Other income increased to RMB 44,514,000 from RMB 39,523,000, contributing positively to the financial performance [7]. - Total comprehensive income for the period was a loss of RMB 15.4 million for the six months ended June 30, 2024, compared to a loss of RMB 135.0 million in the same period of 2023 [90]. - Adjusted loss for the period was RMB 75.7 million for the six months ended June 30, 2024, compared to RMB 218.2 million in the same period of 2023 [90]. Research and Development - R&D expenses decreased to RMB 89,797,000 from RMB 205,346,000 year-over-year, reflecting a reduction in investment in research and development [7]. - Zhaoke Ophthalmology reported R&D expenses of approximately RMB 89.8 million for the first half of 2024, a decrease from RMB 205.3 million in the same period of 2023 [16]. - R&D expenses for the six months ended June 30, 2024, were RMB 89.8 million, a decrease of 56.3% from RMB 205.3 million in the same period of 2023 [70]. - Clinical trial professional service fees accounted for RMB 31.2 million of R&D expenses for the six months ended June 30, 2024, compared to RMB 141.5 million in the same period of 2023 [100]. Clinical Trials and Product Development - The Phase III clinical trial of NVK002, aimed at myopia progression control in children, completed the last patient visit in August 2024 [11]. - The company anticipates announcing topline results from the China CHAMP trial of NVK002 and completing the Phase III trial of TAB014 for wet age-related macular degeneration by the end of 2024 [18]. - The ANDA for NVK002, a low-dose atropine eye drop for myopia control, has been filed, with the Phase III clinical trial completing on August 5, 2024 [24][25]. - The company has started the Phase II study of BRIMOCHOL PF and CARBACHOL PF for presbyopia, following IND approval in January 2024 [13]. - TAB014, a bevacizumab-based antibody for wAMD, is in Phase III clinical trials, with patient recruitment completed ahead of schedule [48]. - The Phase III trial for TAB014 is expected to be completed by the end of 2024, followed by an NDA submission [48]. - Zhaoke Ophthalmology has conducted Phase II clinical trials for ZKY001, focusing on corneal epithelial defects (CED) after eye surgery, with potential for rapid adoption in other corneal repair applications [50][51]. Market Expansion and Licensing - Zhaoke Ophthalmology is exploring licensing opportunities outside China, with partnerships established in Southeast Asia, South Korea, and Australia [19]. - The company is strategically expanding its market presence beyond Greater China into other selected markets [23]. - The company is actively exploring licensing and collaboration opportunities across Asia, Australia, and the U.S., with discussions ongoing with the FDA regarding a potential clinical trial for CsA Ophthalmic Gel [85]. - The company has established partnerships with leading firms in overseas markets, including a distribution agreement with Kwangdong Pharmaceutical Co., Ltd. for BRIMOCHOL PF in South Korea [29]. Financial Management and Assets - The company has a cash balance of approximately RMB 1.3 billion as of June 30, 2024, providing ample resources for key programs and achieving positive cash flow [16]. - Total current assets as of June 30, 2024, were RMB 1,757.1 million, a slight decrease from RMB 1,794.6 million as of December 31, 2023 [117]. - The company primarily funded its working capital requirements through net proceeds from the Global Offering during the reporting period [119]. - The company aims to maintain healthy liquidity for its operations by closely monitoring cash uses and balances [119]. Shareholder Information - As of June 30, 2024, Lee's Pharm holds a long position of 140,379,600 shares, representing approximately 25.70% of the shareholding [142]. - Lee's Pharm International has a beneficial ownership of 138,192,000 shares, accounting for approximately 25.30% of the shareholding [142]. - The total issued share capital of the company as of June 30, 2024, is 546,139,172 shares [140]. - The company has recorded interests of various directors, with each holding 200,000 shares under the Post-IPO Share Option Scheme [140]. Employee and Corporate Governance - The company employed a total of 297 employees as of June 30, 2024, with 33.4% in R&D [129]. - Zhaoke launched a new tiered mentorship program and a rotational scheme to support employee development during the reporting period [78]. - Zhaoke is committed to enhancing its ESG performance and published its fourth ESG report in April 2024 to inform stakeholders about its socially responsible practices [80].
兆科眼科(06622) - 2024 - 中期财报