Financial Performance - The net loss decreased by RMB140.6 million or 66.3% from RMB212.1 million for the six months ended June 30, 2023, to RMB71.5 million for the six months ended June 30, 2024, mainly due to reduced research and development costs and administrative expenses [11]. - The total comprehensive loss for the six months ended June 30, 2024, was RMB 71.5 million, compared to RMB 212.1 million for the same period in 2023 [85]. - The loss and total comprehensive loss for the period ended June 30, 2024, was RMB 71.5 million, a significant improvement from RMB 212.1 million for the same period in 2023, representing a reduction of approximately 66.3% [108]. - Adjusted loss and total comprehensive loss for the period was RMB 66.9 million, compared to RMB 170.3 million in the prior year, indicating a decrease of about 60.7% [108]. - The operating loss improved to RMB 66,260,000 from RMB 206,437,000, showing a 67.9% decrease in losses [142]. - The loss before income tax was RMB 71,475,000, down from RMB 212,618,000, a 66.4% improvement [142]. - The company reported a loss of RMB 71,493,000 for the period ending June 30, 2024 [145]. Research and Development - Research and development costs decreased by RMB125.3 million or 76.1% from RMB164.6 million for the six months ended June 30, 2023, to RMB39.3 million for the six months ended June 30, 2024, as the company focused on core dermatology pipelines KX-826 and GT20029 [11]. - The company has six innovative potential first-in-class/best-in-class drug candidates at phase I-III clinical stage [12]. - KX-826's phase Ib/III clinical trial for male AGA treatment in combination with minoxidil was cleared by NMPA on February 1, 2024 [12]. - The phase II clinical trial of AR-PROTAC compound GT20029 for AGA treatment reached its primary endpoint with statistically significant results [13]. - The company completed the phase III clinical trial for male AGA in China and initiated a long-term safety phase III trial for KX-826 [14]. - The company is committed to becoming a leader in the research, development, and commercialization of innovative therapies in dermatology [14]. - The company has developed six clinical-stage drugs, including KX-826, AR-PROTAC compound (GT20029), and others, with approvals for clinical trials in China, the U.S., and other regions [23]. Clinical Trials and Approvals - KX-826 tincture 1.0% clinical trial for male adult AGA in China received NMPA clearance on June 4, 2024, showing significantly increased retention concentration compared to the 0.5% formulation [12]. - The clinical trial of KX-826 tincture 1.0% is expected to maintain excellent safety and present superior efficacy compared to the 0.5% formulation [14]. - The phase II clinical trial for idiopathic pulmonary fibrosis (IPF) has been approved in October 2023 [21]. - The phase II clinical trial for KX-826 in treating acne vulgaris included 160 patients, showing significant improvement in both non-inflammatory and inflammatory lesions by week 12 compared to the placebo group [40]. - The phase II clinical trial for GT20029 in China for AGA has reached its primary endpoint with statistically significant results [16]. - The first subject has been enrolled in the phase II clinical trial in China for acne treatment using GT20029 [16]. Financial Position and Cash Flow - The Group had cash and cash equivalents and time deposits of RMB333.7 million as of June 30, 2024, with unutilized bank facilities of RMB80.0 million, indicating sufficient cash to support clinical trials and research and development [11]. - Cash and cash equivalents decreased from RMB 456.3 million as of December 31, 2023, to RMB 333.7 million as of June 30, 2024, a decline of RMB 122.6 million [115]. - The current ratio decreased from 210.3% as of December 31, 2023, to 155.9% as of June 30, 2024, primarily due to the decrease in cash and cash equivalents [115]. - Net cash used in operating activities for the six months ended June 30, 2024, was RMB 110.7 million, consisting mainly of RMB 106.6 million used in operations [117]. - The Group's cash and cash equivalents at the end of the period were RMB 319.2 million, down from RMB 690.7 million at the end of the previous year [116]. - The company has no drugs approved for commercial sale and has not generated any revenue from drug sales for the six months ended June 30, 2024 [85]. Cost Management - Administrative expenses decreased by RMB17.3 million or 33.8% from RMB51.2 million for the six months ended June 30, 2023, to RMB33.9 million for the six months ended June 30, 2024, primarily due to reductions in employee benefits and share-based compensation expenses [11]. - Employee benefit expenses (including share-based compensation) decreased by RMB16.3 million, primarily due to a reduction in staff numbers [91]. - The company is focused on optimizing its cost structure while continuing to invest in R&D and clinical trials for future product development [91]. - Marketing costs decreased by RMB6.9 million from RMB8.6 million for the six months ended June 30, 2023, to RMB1.7 million for the same period in 2024 [87]. Product Development and Commercialization - The company launched its topical anti-hair loss solution for AGA under the new high-end cosmetics brand KOSHINÉ on July 10, 2024 [13]. - The company aims to expand its product portfolio with new cosmetic products including acne cream and whitening essence [14]. - The new high-end cosmetics brand KOSHINÉ, featuring KX-826, was officially launched, expected to provide stable revenue and cash flow for the company [33]. - The company plans to launch seven cosmetic product types by 2024, including products for anti-hair loss, acne treatment, and skin whitening [83]. - The company has introduced KX-826 as the main ingredient in a new topical anti-hair loss solution under its high-end cosmetics brand KOSHINÉ, marking its first commercialization attempt in dermatology [81]. Employee and Workforce - As of June 30, 2024, the Group had a total of 175 full-time employees, with clinical and R&D roles accounting for nearly 50% of the workforce [112]. - The total staff with clinical roles was 35, representing 20% of the total workforce, while R&D roles accounted for 52 employees, or 29.7% [112]. - Employee benefit expenses for the six months ended June 30, 2024, were RMB 49,465,000, significantly lower than RMB 125,850,000 for the same period in 2023 [179].
开拓药业-B(09939) - 2024 - 中期财报