Financial Performance - As of June 30, 2023, the group’s current assets amounted to approximately RMB 1,942.4 million, including cash and cash equivalents of about RMB 1,674.7 million[7]. - The total remuneration costs incurred by the group for the six months ended June 30, 2023, were approximately RMB 72.8 million, an increase from approximately RMB 68.9 million for the same period in 2022[14]. - The financial cost increased from approximately RMB 1.3 million for the six months ended June 30, 2022, to approximately RMB 3.6 million for the same period in 2023, primarily due to bank loan interest related to cross-border funding arrangements[1]. - For the six months ending June 30, 2023, R&D expenses reached approximately RMB 205.3 million, an increase of approximately 103.5% from RMB 100.9 million for the same period in 2022[122]. - The company reported a loss before taxation of RMB 233,238,000, compared to a loss of RMB 161,026,000 in the previous year[172]. - Total comprehensive income for the period was a loss of RMB 135,031,000, compared to a loss of RMB 46,362,000 in the same period of 2022[172]. - As of June 30, 2023, the company reported revenue of RMB 11,304,000, with a gross profit of RMB 10,154,000[172]. - Other income for the period was RMB 39,523,000, compared to RMB 11,866,000 in the same period of 2022[172]. Research and Development - The company’s R&D team comprised approximately 100 professionals at the end of the reporting period, led by an international management team with extensive industry experience[20]. - The treatment for myopia progression control, NVK002, completed its one-year Phase III bridging trial in early August 2023, with patient recruitment for TAB014 expected to complete by the end of this year[19]. - The company is preparing for the Phase III clinical trial of another self-developed innovative asset, ZKY001[19]. - The company has filed multiple ANDA submissions for its generic assets, addressing unmet ophthalmic medical needs in China[33]. - The company has filed 2 additional ANDA submissions to the NMPA for Travoprost and Travoprost Timolol, indicating ongoing efforts in drug development[158]. - The continuing R&D activities for other key drug candidates utilized approximately HK$ 888.86 million, accounting for 46.00% of the total expected net proceeds[119]. - R&D activities for innovative and generic drug candidates utilized approximately HK$ 57.97 million, representing 3.00% of the total expected net proceeds[119]. - Zhaoke Ophthalmology is progressing its R&D efforts, with a new drug application for Cyclosporine A eye gel under review and multiple clinical projects in late-stage development[142]. Product Development and Commercialization - Zhaoke Ophthalmology's Bimatoprost Timolol eye drop (晶贝莹®) received marketing authorization from the NMPA in February 2023, with the first prescription issued on March 8, 2023[36][44]. - The company aims to enhance brand recognition through the commercialization of its first approved drug, which will support future innovative drug launches[36]. - The eye drop product is now available on JD Health, increasing accessibility for glaucoma patients[36]. - Zhaoke Ophthalmology launched its first commercialized drug, Bimatoprost Timolol eye drop, in May 2023 on JD Health, enhancing patient access to its products[137]. - The company has commercialized two products on Tmall: the heat compress eyepatch for mild dry eye disease in August 2022 and the Far Infrared Eye Heat Compress eyepatch in March 2023, expanding its product line[134]. Strategic Partnerships and Agreements - A strategic partnership was established with Aibono to explore opportunities in research, development, and commercialization of ophthalmic products[28]. - An exclusive licensing, supply, and distribution agreement was signed with Eyedetec Medical for the Eye Lipid Mobilizer™ in Greater China and several Southeast Asian countries[32]. - In March 2023, the company signed a distribution agreement with KDP for exclusive rights to market NVK002 in South Korea, including upfront and milestone payments[122]. - In June 2023, an exclusive license and distribution agreement was established with Eyedetec Medical for the Eye Lipid Mobilizer™ in Greater China and Southeast Asia[124]. - A strategic partnership was formed with Eyebright Medical in August 2023 to explore R&D and commercialization of ophthalmic products[125]. Share Options and Capital Structure - The Pre-IPO Share Option Scheme allows for the issuance of up to 45,732,000 shares, representing approximately 8.41% of the total issued share capital of 543,843,992 shares as of June 30, 2023[58]. - The company conditionally granted a total of 45,732,000 options to 109 grantees under the Pre-IPO Share Option Scheme, which represents approximately 8.41% of the total issued share capital as of June 30, 2023[77]. - The exercise price of the options granted under the Pre-IPO Share Option Scheme ranges from US$0.09 to US$1.14 per share[77]. - The Post-IPO Share Option Scheme was conditionally approved on April 1, 2021, allowing for a maximum of 53,515,550 shares to be issued, representing approximately 9.84% of the total issued share capital as of June 30, 2023[81]. - The total issued share capital of the company as of June 30, 2023, was 543,843,992 shares[71]. - The company has adopted two share option schemes that require disclosure under the Listing Rules[73]. - As of June 30, 2023, the number of options available for future grant under the Post-IPO Share Option Scheme was 45,695,550[110]. - The total number of outstanding options as of June 30, 2023, is 5,940,000 shares[100]. Financial Position and Assets - As of June 30, 2023, non-current assets amounted to RMB 594,951,000, a slight decrease from RMB 597,876,000 as of December 31, 2022[192]. - Current assets totaled RMB 1,942,415,000, compared to RMB 1,972,747,000 at the end of 2022, indicating a decrease in liquidity[192]. - Net current assets increased to RMB 1,778,207,000 from RMB 1,661,033,000, reflecting improved short-term financial health[192]. - Total assets less current liabilities were RMB 2,255,984,000, down from RMB 2,376,083,000, showing a decline in overall asset value[192]. - Non-current liabilities, including lease liabilities, were reported at RMB 26,390,000, a decrease from RMB 27,703,000[194]. - Total equity stood at RMB 2,229,594,000, down from RMB 2,348,373,000, indicating a reduction in shareholder equity[194]. - Cash and cash equivalents increased to RMB 1,716,351,000 from RMB 1,674,729,000, suggesting a positive cash flow situation[192]. - Trade and other payables rose to RMB 108,395,000 from RMB 83,418,000, indicating increased obligations[192]. - The company reported inventories of RMB 4,068,000, reflecting a new addition to current assets[192]. Corporate Governance and Compliance - The Audit Committee reviewed the interim financial report for the six months ended June 30, 2023, ensuring compliance with accounting standards[165]. - The interim financial report is unaudited, highlighting the need for caution in interpreting the figures presented[191]. - The company believes the current arrangement of having the same individual serve as both Chairman and CEO is beneficial and does not harm the balance of power[96]. - The company has not been involved in any material litigation or arbitration during the six months ended June 30, 2023[145]. - There were no significant events affecting the group after the reporting period up to the date of the report[91]. - The company does not recommend the distribution of an interim dividend for the six months ended June 30, 2023[92]. - The company did not declare an interim dividend for the six months ending June 30, 2023[126].
兆科眼科-B(06622) - 2023 - 中期财报