Business Growth and Development - In 2021, Everest Medicines achieved significant milestones across its business sectors, expanding its workforce to over 400 employees, more than doubling from the end of 2020[10]. - The company successfully completed patient recruitment for its Phase 2b bridging study (EVER-132-001) within three months, achieving top-line results that meet global quality standards[10]. - Everest Medicines submitted multiple New Drug Applications (NDA) and a Biologics License Application (BLA) for Trodelvy in Greater China, Singapore, and South Korea for the treatment of adult patients with second-line and later metastatic triple-negative breast cancer (TNBC)[10]. - The company also submitted an NDA for Xerava in mainland China and Hong Kong for the treatment of adult patients with complicated intra-abdominal infections[10]. - Everest Medicines is advancing its late-stage assets into other indications, including developing Trodelvy for HR+/HER2- metastatic breast cancer and other cancers[12]. - The company anticipates stable progress on clinical data milestones for Trodelvy, Xerava, Nefecon, etrasimod, and other assets in its pipeline throughout 2022[12]. - Despite the challenging environment, Everest Medicines continued to accelerate high-quality clinical trials and expand its global footprint by establishing teams in South Korea, Singapore, and Taiwan[10]. - The company is positioned as a commercially capable biopharmaceutical company with expectations for NDA and BLA approvals in 2022[10]. - The company established a new drug discovery team of 26 professionals to enhance its internal R&D capabilities[13]. - The company expanded its new drug discovery and commercialization capabilities, moving into a new 1,700 square meter research center in Zhangjiang, focusing on oncology, nephrology, and mRNA vaccine projects[22]. - The commercial team has grown to 128 members by December 31, 2021, preparing for multiple product launches in 2022[22]. Financial Performance - The net loss for the year ended December 31, 2021, decreased to RMB 1,008.7 million from RMB 5,658.2 million, mainly due to a reduction in losses from the fair value changes of financial instruments issued to investors[19]. - The adjusted loss for the year was RMB 777.3 million, an increase of RMB 174.4 million compared to RMB 602.9 million in the previous year, primarily due to increased R&D and distribution expenses[20]. - As of December 31, 2021, the company's R&D expenses increased by RMB 236 million to RMB 613.4 million, primarily due to an increase in clinical trial numbers and the expansion of the internal drug discovery team[19]. - General and administrative expenses decreased by RMB 35.1 million to RMB 242.7 million, mainly due to reduced expenses related to the company's public listing in 2020[19]. - Distribution and selling expenses rose by RMB 165 million to RMB 198.2 million, attributed to the expansion of the commercial organization and pre-commercialization activities[19]. - The company's cash and cash equivalents decreased from RMB 4,481.1 million as of December 31, 2020, to RMB 2,640.1 million as of December 31, 2021, primarily due to upfront payments related to licensing agreements and investments in R&D projects and commercialization activities[73]. - Net cash used in operating activities for the year ended December 31, 2021, was RMB 729.9 million, compared to RMB 471.9 million for the year ended December 31, 2020, with the net loss for the respective years being RMB 1,008.7 million and RMB 5,658.2 million[74]. - Net cash used in investing activities for the year ended December 31, 2021, was RMB 975.8 million, primarily due to the purchase of intangible assets amounting to RMB 865.9 million[76]. - The adjusted loss for the year ended December 31, 2021, was RMB 777.3 million, compared to RMB 602.9 million for the year ended December 31, 2020, reflecting the impact of non-cash items and one-time events[72]. Clinical Trials and Drug Development - The FDA approved TrodelvyTM for treating adult patients with second-line metastatic TNBC, showing a 57% reduction in the risk of disease progression or death, with median progression-free survival (PFS) extended from 1.7 months to 4.8 months[23]. - The overall response rate (ORR) for TrodelvyTM in the TROPHY study was 27.7%, with a median response duration of 7.2 months, based on data from 112 patients[25]. - The company announced a 38.8% ORR in the EVER-132-001 bridging study for sacituzumab govitecan in adult patients with previously treated unresectable locally advanced or metastatic TNBC[25]. - The company is conducting a Phase 3 study to evaluate sacituzumab govitecan's efficacy and safety in Asian patients with hormone receptor-positive, HER2-negative metastatic breast cancer, recruiting approximately 330 patients[26]. - The company is transforming into an integrated Asian biopharmaceutical company, focusing on global quality and local speed in asset advancement[22]. - Nefecon (TarpeyoTM) is a key candidate for treating primary IgA nephropathy, with the NefIgArd Phase 3 global registration trial completed for Chinese patient recruitment[29]. - Calliditas Therapeutics received accelerated review for Nefecon's MAA in April 2021, with a potential conditional approval in Q2 2022[29]. - TARPEYO was approved by the FDA as the first and only treatment for reducing proteinuria in adults with primary IgA nephropathy, showing a 34% reduction in proteinuria at 9 months compared to 5% with RASi[31]. - The company is actively pursuing partnerships to enhance its product pipeline and secure global rights for innovative therapies[47]. Market Position and Strategic Initiatives - The biotechnology sector faced challenges in 2021, with the Hang Seng Hong Kong-listed biotech index dropping over 27%, reflecting market uncertainties[10]. - The company was recognized as one of the "Top 10 Leading Companies in ADC Drugs" at the BioChina summit in June 2021[17]. - The company was included in major global stock indices, enhancing its visibility and liquidity in the capital markets[17]. - The company aims to continue its commitment to high-quality standards and innovation in drug development to meet unmet medical needs[17]. - The company is focused on expanding its market presence, particularly in China, Japan, and other Asian markets, under the leadership of Chief Commercial Officer Mr. Guo Yong[185]. - The company is exploring new markets, particularly in Asia, to leverage growth opportunities and diversify its revenue streams[178]. - The company aims to expand its market share by X% in the upcoming year through targeted marketing strategies and partnerships[173]. Corporate Governance and Leadership - The board of directors includes a mix of executive, non-executive, and independent non-executive members[85]. - The company has established a robust governance structure with independent directors on its board, ensuring accountability and strategic oversight[179]. - The board of directors consists of four executive directors, two non-executive directors, and three independent non-executive directors[192]. - The company has adopted the principles and code provisions of the Corporate Governance Code as its corporate governance standard[190]. - The company has complied with all applicable code provisions of the Corporate Governance Code during the reporting period[190]. - The company has a strong leadership team with significant experience in the pharmaceutical industry, including roles at major companies like Bayer and AstraZeneca[182]. - The company appointed Mr. Tan Bo as an independent non-executive director and chairman of the remuneration committee in September 2020, bringing extensive experience in finance and pharmaceuticals[179]. - The company has appointed a Chief Scientific Officer with over 20 years of experience in drug discovery and development[187]. Research and Development Focus - The company is funding ongoing and planned clinical trials for its core candidate drug, Etrasimod, with a budget allocation of 15%, amounting to HKD 569 million, of which HKD 556 million has been utilized[160]. - For the drug Sacituzumab Govitecan-hziy, the company allocated 20% of its funding, totaling HKD 759 million, with HKD 746 million already utilized[160]. - The company has allocated 10% of its funding, amounting to HKD 380 million, for the ongoing and planned clinical trials of Nefecon, with HKD 337 million utilized[160]. - The company is committed to enhancing its research and development efforts to bring new therapies to market[184]. - The company is actively developing new products and technologies, with a dedicated team of medical and scientific experts[184]. Future Outlook - Future outlook remains positive, with management expressing confidence in achieving long-term growth targets despite market challenges[175]. - The company plans to fully utilize the remaining unutilized funds by the second half of 2023[164]. - The company aims to expand the development of sacituzumab govitecan for new indications in collaboration with Gilead, targeting mUC, HR+/HER2- mBC, NSCLC, and other TROP-2 high-expressing cancers[50].
云顶新耀(01952) - 2021 - 年度财报