Financial Performance - Net loss for the period increased from RMB 383.1 million to RMB 668.0 million, reflecting a rise of 77.5%[7] - The company reported a loss of RMB 668.0 million for the six months ended June 30, 2022, compared to a loss of RMB 383.1 million for the same period in 2021[29] - Basic loss per share for the period was RMB (2.26), compared to RMB (1.31) in the previous year, indicating a worsening of loss per share[93] - The total comprehensive income for the six months ended June 30, 2022, was RMB (135,768) thousand, compared to RMB 931,614 thousand for the same period in 2021[198] Revenue and Expenses - Total revenue for the six months ended June 30, 2022, was RMB 1,044,000, compared to no revenue in the same period of 2021[93] - Gross profit for the same period was RMB 680,000, resulting in a gross margin of approximately 65%[93] - Total expenses for the six months ended June 30, 2022, amounted to RMB 5,511,000, a significant increase from RMB 2,876,000 in the same period of 2021, indicating an increase of 91.1%[135] - Research and development expenses increased from RMB 250.8 million in the six months ended June 30, 2021, to RMB 345.5 million in the six months ended June 30, 2022, a rise of 37.2%[7] Cash Flow and Liquidity - Cash and cash equivalents decreased from RMB 2,640.1 million as of December 31, 2021, to RMB 1,956.8 million as of June 30, 2022, mainly due to cash used in operating activities[46] - Net cash used in operating activities for the six months ended June 30, 2022, was RMB 515.4 million, compared to RMB 388.5 million for the six months ended June 30, 2021[47] - The current ratio as of June 30, 2022, was 2.37, compared to 30.22 as of June 30, 2021[51] Research and Development - The company has initiated over 10 discovery projects across various therapeutic areas, including oncology and mRNA vaccines[25] - The company plans to submit a new drug application for NEFECON in China for IgAN in the second half of 2022[12] - The company is preparing for multiple product launches in the next one to two years, supported by a newly established commercialization team with decades of experience in innovative drugs[9] Clinical Trials and Approvals - The company announced participation in a clinical trial collaboration with Gilead Sciences and Merck to evaluate sacituzumab govitecan in combination with Keytruda for NSCLC treatment[9] - Trodelvy® (sacituzumab govitecan) demonstrated a 34% reduction in the risk of disease progression or death in hormone receptor-positive, HER2-negative metastatic breast cancer patients, with a median progression-free survival (PFS) of 5.5 months compared to 4 months[10] - Trodelvy® received approval from the National Medical Products Administration in China for the treatment of adult patients with second-line metastatic triple-negative breast cancer (TNBC), marking the company's first innovative drug approved in China[10] Shareholder Structure and Equity - The company reported a significant shareholder structure, with Vistra Trust (Singapore) Pte. Limited holding approximately 44.69% of the shares[72] - C-Bridge Capital GP, Ltd. and its associated funds collectively own about 17.60% of the shares, indicating strong institutional support[72] - The total number of shares issued as of June 30, 2022, was 299,807,605, which is crucial for calculating ownership percentages[70] Stock Options and Incentives - The company has granted stock options to key executives, with exercise prices ranging from $0.18 to $72.49 HKD, reflecting a structured incentive plan[70] - The company has a total of 27,190,456 unexercised options as of June 30, 2022, with a weighted average exercise price of $2.57[190] - The total share-based compensation expense recognized for restricted shares for the six months ended June 30, 2022, was RMB 86,295 thousand, compared to RMB 47,777 thousand for the same period in 2021[187] Financial Position - Total assets decreased to RMB 5,922,869 from RMB 6,645,823, representing a decline of approximately 11%[94] - Total liabilities increased to RMB 963,542 from RMB 753,827, marking an increase of approximately 28%[95] - The company's total equity decreased to RMB 4,959,327 from RMB 5,891,996, reflecting a decline of about 16%[95] Strategic Partnerships and Collaborations - A partnership with China Resources Pharmaceutical Group was established to develop and commercialize mRNA vaccines, enhancing the company's position in the mRNA vaccine market[14] - The company entered into collaboration and licensing agreements with Arena Pharmaceuticals, involving milestone payments totaling RMB 41.1 million for development and commercialization efforts[142] Future Outlook - The company is positioned for future growth, with a focus on expanding its market presence and enhancing shareholder value through strategic initiatives[69] - The company plans to fully utilize the remaining unutilized proceeds by the second half of 2023[67]

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].

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].

Financing and IPO - Everest Medicines completed a $310 million Series C financing and successfully conducted an IPO on the Hong Kong Stock Exchange[23]. - The company was included in the Hang Seng Index within six months of becoming a public company[23]. - The company’s stock was included in the Hang Seng Composite Index and the Hang Seng Healthcare Index starting March 15, 2021, meeting the standards for inclusion in the Hong Kong Stock Connect[33]. - Cash and cash equivalents increased from RMB 1,061.0 million as of December 31, 2019, to RMB 4,481.1 million as of December 31, 2020, primarily due to C round financing and IPO proceeds[59]. - Net cash generated from financing activities for the year ended December 31, 2020, was RMB 5,637.9 million, primarily from the global IPO and C round financing[63]. Clinical Development and Regulatory Milestones - The first new drug application was approved in Singapore, and the company completed a Phase 3 registration clinical trial in China[23]. - The company aims to transform into a commercial growth stage with significant late-stage clinical and regulatory milestones planned for 2021[24]. - The company submitted a new drug application for Sacituzumab govitecan-hziy for mTNBC in Singapore in January 2021, which was accepted by the Health Sciences Authority[30]. - A Phase 2 registration clinical trial for Sacituzumab govitecan-hziy in mTNBC commenced in China in November 2020 and is ongoing[30]. - Nefecon was granted breakthrough therapy designation for the treatment of IgAN by the National Medical Products Administration in December 2020[31]. - The company plans to initiate patient recruitment for the global Phase 3 TROPiCS-04 trial in China, evaluating sacituzumab govitecan-hziy in mUC patients[40]. - The company anticipates key data analysis results for the Phase 2b trial of sacituzumab govitecan-hziy in mTNBC in China by the second half of 2021[40]. - The company is conducting a Phase 2/3 clinical trial for Crohn's disease and plans to initiate a Phase 3 trial for atopic dermatitis[38]. - Nefecon demonstrated significant efficacy in a global Phase 3 trial, showing a statistically significant reduction in urinary protein-creatinine ratio after 9 months of treatment in 199 primary IgAN patients[41]. Financial Performance - The net loss for the year increased significantly from RMB 214.5 million in 2019 to RMB 5,658.2 million in 2020, primarily due to a loss of RMB 4,938.0 million from the fair value changes of financial instruments issued to investors[27]. - Adjusted net loss for the year was RMB 602.9 million, up from RMB 163.1 million in 2019, an increase of RMB 439.8 million, mainly due to higher R&D and general administrative expenses[28]. - General and administrative expenses rose from RMB 53.9 million in 2019 to RMB 277.8 million in 2020, an increase of RMB 223.9 million, mainly due to IPO costs and increased employee compensation[27]. - Research and development expenses rose from RMB 150.9 million in 2019 to RMB 377.4 million in 2020, attributed to additional clinical trials for candidate drugs and expansion of the R&D team[48]. - The company reported a loss of RMB 5,658.2 million for the year ended December 31, 2020, compared to a loss of RMB 214.5 million for the year ended December 31, 2019[46]. Employee and Organizational Development - The company emphasizes the importance of its employees in achieving long-term growth and fostering a culture of personal development[25]. - Everest Medicines is dedicated to establishing productive partnerships and investing in young talent to support its team[25]. - The total employee compensation expense for the year ended December 31, 2020, was RMB 309.3 million, compared to RMB 152.6 million in 2019, reflecting a 102% increase[71]. - The company employed a total of 149 full-time employees as of December 31, 2020, with 56% in clinical development and business development roles[70]. - The company has adopted share plans to incentivize employees[82]. Governance and Risk Management - The board of directors includes four executive directors, two non-executive directors, and three independent non-executive directors, ensuring a diverse governance structure[143]. - The company has established three committees: the Audit Committee, the Remuneration Committee, and the Nomination Committee to oversee various aspects of the company's affairs[169]. - The board is responsible for leading and controlling the company, ensuring good internal control and risk management systems are in place[167]. - The company acknowledges that risk management is crucial for operational success, facing major operational risks including regulatory changes in the pharmaceutical market and competition with other pharmaceutical companies[187]. - The company has implemented a risk management framework to ensure appropriate application across departments[189]. Corporate Social Responsibility and Sustainability - The company is committed to fulfilling social responsibilities and promoting employee welfare and development[81]. - The environmental, social, and governance report covers the company's management policies and performance for the fiscal year 2020[198]. - The report outlines the company's initiatives regarding significant environmental, social, and governance matters, providing transparency and accountability to stakeholders[200]. - The company aims to provide clear insights into its environmental initiatives[200]. - Stakeholder engagement is a key focus in the company's sustainability efforts[200].