Financial Performance - Revenue for the six months ended June 30, 2024, was RMB 60.8 million, a decrease of 15.6% from RMB 72.0 million for the same period in 2023[3]. - Other income and gains fell to RMB 27.3 million, down RMB 93.8 million from RMB 121.1 million in the prior year, primarily due to a decrease in foreign exchange gains[4]. - Loss for the period narrowed to RMB 167.0 million, a decrease of RMB 51.7 million from RMB 218.7 million in the prior year[5]. - Adjusted loss for the period, excluding the impact of equity-settled share-based payments, was RMB 152.6 million, down RMB 36.8 million from RMB 189.4 million[6]. - Adjusted loss excluding foreign exchange gains was RMB 158.7 million, a significant decrease of 43.7% from RMB 281.7 million in the previous year, driven by effective cost reduction strategies[6]. - The gross profit for the six months ended June 30, 2024, was RMB 51.9 million, compared to RMB 59.4 million for the same period in 2023[33]. - The pre-tax loss for the six months ended June 30, 2024, was RMB 167.0 million, compared to RMB 218.7 million for the same period in 2023[33]. - Total comprehensive loss for the period was RMB 168,242,000, compared to RMB 276,243,000 in the same period last year, showing a 39.2% decrease[86]. - The company reported a net loss of RMB 167,033,000 for the six months ended June 30, 2024, compared to a net loss of RMB 218,694,000 for the same period in 2023, representing a 23.5% improvement[88]. Research and Development - R&D expenses decreased to RMB 130.8 million, down RMB 95.3 million from RMB 226.1 million in the previous year, attributed to improved R&D efficiency[5]. - The company maintains a strategic focus on advancing core R&D programs without engaging in new business development activities during the reporting period[16]. - The company has a pipeline that includes one commercialized product, eight clinical assets, and several preclinical projects, emphasizing a "combination and complementary" R&D strategy[18]. - The product pipeline includes 10 candidates focused on oncology, with various stages from preclinical to late-stage clinical trials[19]. - The company is conducting several late-stage clinical studies for Xivio® (Selinexor), including a Phase III trial in combination with bortezomib and low-dose dexamethasone for relapsed/refractory multiple myeloma[26]. - The latest results from the I/II phase TORCH-2 study of Onatasertib (ATG-008) showed an overall response rate (ORR) of 53.3% and a disease control rate (DCR) of 86.7% in cervical cancer patients who had not previously received checkpoint inhibitors[8]. - The I phase trials of ATG-101 for advanced/metastatic solid tumors and B-cell non-Hodgkin lymphoma (B-NHL) are ongoing in mainland China, Australia, and the United States[9]. - The I phase trial of ATG-022 (Claudin 18.2 antibody-drug conjugate) has shown preliminary efficacy data with one complete response (CR) and one partial response (PR) among gastric cancer patients[12]. Cost Management - Selling and distribution expenses were RMB 56.0 million, a reduction of RMB 32.2 million from RMB 88.2 million, mainly due to the absence of milestone payments related to commercialization in the Asia-Pacific region[5]. - Administrative expenses decreased to RMB 58.5 million, down RMB 25.3 million from RMB 83.8 million, primarily due to reduced employee costs[5]. - Employee costs dropped from RMB 86.9 million to RMB 51.3 million, reflecting a decrease of RMB 35.6 million[36]. - The company reported no milestone payments related to commercialization in the Asia-Pacific region for the six months ended June 30, 2024, compared to RMB 21.3 million for the same period in 2023[38]. - The adjusted R&D costs for the six months ended June 30, 2024, were approximately RMB 130.8 million, down from RMB 226.1 million for the same period in 2023[33]. Corporate Governance - The company is committed to maintaining high standards of corporate governance to protect shareholder interests and enhance corporate value[57]. - The board consists of three executive directors, one non-executive director, and three independent non-executive directors, ensuring sufficient checks and balances[57]. - The company plans to continue reviewing its corporate governance practices to ensure compliance with the Corporate Governance Code[57]. - The company appointed Dr. Mei Jianming as the Chairman and CEO, who has extensive experience in identifying strategic opportunities[55]. - Dr. Zhang Xiaojing, with over 20 years of experience in oncology and pharmaceuticals, was appointed as Chief Medical Officer in December 2022[55]. Market and Product Development - The company successfully integrated its product into the National Medical Insurance Directory in December 2023, leading to necessary price adjustments[4]. - The Korean National Health Insurance Service approved reimbursement for XPOVIO® (Selinexor) for adult patients with relapsed or refractory multiple myeloma (rrMM) effective July 1, 2024[7]. - The China National Medical Products Administration approved a new indication for XPOVIO® (Selinexor) as a monotherapy for adult patients with relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL) who have received at least two lines of systemic therapy[7]. - The company has submitted New Drug Applications (NDAs) for XPOVIO® (Selinexor) in multiple regions including Macau, Malaysia, Thailand, and Indonesia for the treatment of rrMM and rrDLBCL[18]. - The company is advancing its clinical trials globally with partners in various regions[19]. Shareholder Information - As of June 30, 2024, the board of directors and senior executives hold a total of 183,597,994 shares, representing approximately 27.20% of the company[63]. - The company has not purchased, sold, or redeemed any of its listed securities during the reporting period[59]. - The company has confirmed compliance with the standards set forth in the "Standard Code" for securities trading by directors throughout the reporting period[58]. - The company has not noted any incidents of employees failing to comply with the "Standard Code" during the reporting period[58]. - The company’s management has seen a significant number of options granted, with 1,020,000 options exercised by a senior executive[73]. Financial Position - Cash and bank balances as of June 30, 2024, were RMB 1,023.7 million, down from RMB 1,187.7 million as of December 31, 2023[43]. - Current assets totaled RMB 1,112.6 million, including cash and bank balances of RMB 1,023.7 million[43]. - The current ratio as of June 30, 2024, was 572.4%, down from 650.6% as of December 31, 2023[44]. - The company’s total liabilities for other payables and accrued items are unsecured and interest-free, with their book value approximating fair value due to their short-term nature[126]. - The company’s total reserves as of June 30, 2024, were RMB 993,608,000, down from RMB 1,713,322,000 as of June 30, 2023[88].
德琪医药-B(06996) - 2024 - 中期财报