Financial Performance - Net loss decreased from RMB 623.5 million to RMB 383.1 million, primarily due to a reduction in fair value losses on financial instruments issued to investors[5]. - Other comprehensive income increased from RMB 282.6 million to RMB 567.3 million, mainly due to increased income from fair value changes of financial assets[5]. - The company recorded a loss of RMB 383.1 million for the six months ended June 30, 2021, compared to a loss of RMB 623.5 million for the same period in 2020[26]. - The loss attributable to equity holders of the company decreased from RMB 623.5 million for the six months ended June 30, 2020, to RMB 383.1 million for the same period in 2021, mainly due to a reduction in the fair value loss on financial instruments issued to investors[37]. - The adjusted loss attributable to equity holders for the six months ended June 30, 2021, was RMB 303.1 million, compared to RMB 245.9 million for the same period in 2020[40]. - The company reported a net loss of RMB 383,108 thousand for the six months ended June 30, 2021, an improvement from a net loss of RMB 623,531 thousand in the same period of 2020, representing a reduction of approximately 38.6%[124]. - Basic and diluted loss per share for the six months ended June 30, 2021, was RMB 1.31, significantly improved from RMB 25.06 in the same period of 2020[124]. Research and Development - R&D expenses increased from RMB 161.0 million for the six months ended June 30, 2020, to RMB 250.8 million for the six months ended June 30, 2021, primarily due to additional clinical trials and team expansion[5]. - The company has six clinical-stage candidates, including sacituzumab govitecan-hziy and etrasimod, undergoing registration trials for eight different indications[10]. - The company is actively recruiting top talent for its drug discovery team and establishing a research facility in Zhangjiang, Shanghai[11]. - The company anticipates announcing multiple late-stage clinical trial data in 2021 and 2022, along with submitting additional new drug applications[10]. - The company completed patient recruitment for the NefIgArd Phase 3 global registration trial of Nefecon for treating IgA nephropathy in China[8]. - The company initiated a Phase 2 basket trial in China to evaluate sacituzumab govitecan-hziy in 180 patients with various TROP-2 high-expressing cancers[15]. - The company is conducting a multi-regional trial for Etrasimod in ulcerative colitis across China, Korea, and Taiwan[12]. Clinical Trials and Approvals - The company’s candidate drug, sacituzumab govitecan-hziy, received priority review from the National Medical Products Administration in China for treating advanced or metastatic triple-negative breast cancer[6]. - The company received approval from the National Medical Products Administration of China in March 2021 for a clinical trial of sacituzumab govitecan-hziy to treat 180 patients with recurrent or refractory esophageal squamous cell carcinoma, gastric cancer, and cervical cancer[7]. - The company’s partner, Gilead Sciences, received full approval from the FDA for TrodelvyTM for treating metastatic triple-negative breast cancer[6]. - A global Phase 3 registration clinical trial for sacituzumab govitecan-hziy in treating metastatic urothelial carcinoma has been initiated, with the first patient dosed in China in August 2021[6]. - An Asian Phase 3 study has been launched to evaluate the efficacy and safety of sacituzumab govitecan-hziy in hormone receptor-positive, HER2-negative metastatic breast cancer patients[6]. - The company plans to submit a new drug application for sacituzumab govitecan-hziy in South Korea and Taiwan in the second half of 2021[24]. Financial Position and Cash Flow - As of June 30, 2021, cash and cash equivalents amounted to RMB 3,971.0 million[5]. - Net cash used in operating activities for the six months ended June 30, 2021, was RMB 388.5 million, compared to RMB 219.9 million for the same period in 2020[43]. - Cash used in investing activities for the six months ended June 30, 2021, was RMB 83.1 million, primarily for the purchase of intangible assets[44]. - The company is in a net cash position as of June 30, 2021, making the debt-to-equity ratio not applicable[46]. - The company recorded a foreign exchange loss of RMB 31,328 thousand for the six months ended June 30, 2021, compared to a gain of RMB 385 thousand in the same period of 2020[120]. - The company has maintained 100% ownership in its subsidiaries, including Everest Medicines (US) Limited and Everest Medicines (Singapore) Pte. Limited, as of June 30, 2021[97]. Employee Compensation and Team Expansion - General and administrative expenses rose from RMB 101.3 million to RMB 107.4 million during the same period, mainly due to increased employee compensation from team expansion[5]. - Total employee compensation for the six months ended June 30, 2021, was RMB 212.6 million, compared to RMB 137.6 million for the same period in 2020, representing a 54.4% increase[51]. - The company employed a total of 227 full-time employees as of June 30, 2021, with 48% in clinical development[51]. - The company appointed a new Chief Commercial Officer in February 2021 to lead commercial planning and execution[9]. - The company appointed Dr. Yang Wei as Chief Scientific Officer on April 15, 2021, to strengthen its drug discovery organization[23]. Strategic Partnerships and Collaborations - The company established a commercial team focused on oncology, internal medicine, and infectious diseases, expanding its geographical coverage with new offices in South Korea, Taiwan, and Singapore[10]. - The company entered into a comprehensive agreement with Providence to promote mRNA vaccines and therapies in emerging Asian markets[10]. - The company established strategic partnerships with Tencent Holdings, Sipai Health Technology, and Meixin Health Technology to explore innovative solutions for drug accessibility and patient affordability[22]. - The company has established collaboration and licensing agreements with Arena Pharmaceuticals and Tetraphase Pharmaceuticals for the development and commercialization of specific products in various regions[134]. Shareholder Information and Equity Structure - The company has a significant shareholder, Vistra Trust (Singapore) Pte. Limited, holding 44.29% of the ordinary shares[64]. - C-Bridge Healthcare Fund GP IV, L.P. holds 18.02% of the company's ordinary shares, totaling 53,639,823 shares[65]. - C-Bridge Capital GP, Ltd. and its affiliates collectively own 16.79% of the company, with 50,000,000 shares each[66]. - The company has a total of 297,718,750 shares issued as of June 30, 2021[62]. - The company has granted unexercised options for a total of 20,267,908 shares under the pre-IPO share incentive plan[71]. Future Outlook and Plans - The company aims to expand its innovative drug portfolio through licensing and building its own drug discovery capabilities in unmet medical needs[24]. - The company plans to submit a new drug application for Nefecon to the National Medical Products Administration in China in the first half of 2022[18]. - The company expects to announce the top-line results of the Phase 2 registration clinical trial EVER-132-001 for metastatic TNBC in China in the second half of 2021[17]. - The company is focused on expanding its market presence and enhancing its product pipeline through strategic investments and partnerships in the biopharmaceutical sector[96].
云顶新耀(01952) - 2021 - 中期财报