Financial Performance - No revenue was generated for the six months ended June 30, 2022, and June 30, 2021 [11]. - Adjusted loss increased by RMB168.7 million or approximately 56.3% from RMB299.9 million for the six months ended June 30, 2021, to RMB468.6 million for the six months ended June 30, 2022 [11]. - The company reported a total comprehensive loss of RMB518.4 million for the six months ended June 30, 2022, compared to RMB325.8 million for the same period in 2021, representing a 58.9% increase in losses [88]. - The loss attributable to equity holders for the period was RMB518.4 million, compared to RMB325.8 million in the previous year, indicating a worsening financial performance [151]. - Other income decreased by RMB2.9 million or 27.6%, from RMB10.5 million for the six months ended June 30, 2021, to RMB7.6 million for the same period in 2022 [88]. - The company has incurred operating losses in each year since its inception, with no drugs approved for commercial sale as of June 30, 2022 [88]. Research and Development - R&D costs increased by RMB178.9 million or approximately 63.4% from RMB282.2 million for the six months ended June 30, 2021, to RMB461.1 million for the six months ended June 30, 2022 [11]. - Clinical research expenses accounted for RMB306.1 million or 66.4% of total R&D costs for the six months ended June 30, 2022, compared to RMB158.2 million or 56.1% for the same period in 2021 [105]. - Employee benefit expenses, including share-based compensation, rose to RMB82.9 million or 17.9% of total R&D costs for the six months ended June 30, 2022, from RMB44.3 million or 15.7% in the prior year [105]. - The company has developed a pipeline of seven clinical-stage drug candidates, with approvals for clinical trials in the PRC, the U.S., and other regions [24]. - The company aims to cover indications including COVID-19, mCRPC, AGA, acne vulgaris, HCC, blood cancer, and BCC with its product pipeline [20]. Clinical Trials and Drug Development - On February 10, 2022, the first patient in China was enrolled in the phase III clinical trial of Pruxelutamide for COVID-19 treatment [11]. - The phase III clinical trial of Pruxelutamide in combination with Abiraterone completed enrollment of 718 patients on February 24, 2022 [16]. - Pyrilutamide's phase II clinical trial for male AGA patients in the U.S. completed patient enrollment in less than six months amid the COVID-19 pandemic [16]. - The phase II clinical trial of Pyrilutamide for male AGA patients showed a significant improvement in target area hair counts, with an increase of 22.73 hairs per cm² compared to baseline, P<0.001 [16]. - The first patient in the U.S. was dosed in the multi-regional phase II clinical trial of ALK-1 antibody and Nivolumab combination therapy for advanced HCC on May 2, 2022 [18]. Financial Position and Cash Flow - Cash and cash equivalents decreased from RMB930.1 million as of December 31, 2021, to RMB337.3 million as of June 30, 2022, a decline of RMB592.9 million [124]. - The current ratio fell from 694.4% as of December 31, 2021, to 343.7% as of June 30, 2022, primarily due to decreased cash and increased borrowings [125]. - Net cash used in operating activities for the six months ended June 30, 2022, was RMB708.1 million, an increase from RMB431.8 million for the same period in 2021, reflecting a significant rise in operational expenses [133][136]. - Net cash generated from financing activities was RMB66.6 million for the six months ended June 30, 2022, down from RMB842.2 million in the previous year [131]. - Total current assets decreased from RMB1,525.9 million as of December 31, 2021, to RMB1,176.8 million as of June 30, 2022, primarily due to a reduction in cash and cash equivalents [138][141]. Operational and Administrative Expenses - Administrative expenses rose by RMB15.9 million or 32.1%, from RMB49.6 million for the six months ended June 30, 2021, to RMB65.5 million for the six months ended June 30, 2022 [99]. - Employee benefit expenses, including share-based compensation, accounted for 65.9% of total administrative expenses in the first half of 2022, compared to 63.9% in the same period of 2021 [96]. - Marketing costs increased from RMB6.2 million for the six months ended June 30, 2021, to RMB10.6 million for the same period in 2022, a rise of 71% [90]. - Utilities and office expenses increased to RMB10.6 million, representing 16.3% of total administrative expenses for the six months ended June 30, 2022 [96]. - Depreciation and amortization expenses increased to RMB4.1 million, accounting for 6.3% of total administrative expenses for the six months ended June 30, 2022 [96]. Market and Strategic Initiatives - The company is actively seeking collaboration opportunities in the market from all business perspectives [20]. - The company is focusing on multiple indications for its AR-PROTAC compounds, targeting both male and female androgenetic alopecia and acne vulgaris [24]. - The company is exploring combination therapies for metastatic solid tumors, including those involving PD-1 inhibitors [24]. - The company is committed to advancing its clinical-stage products through ongoing research and development efforts [24]. - The company aims to leverage its clinical trial approvals to enhance its market presence and drive future growth [24].
开拓药业(09939) - 2022 - 中期财报