Financial Performance - Revenue increased from RMB 54 million in 2021 to RMB 12.8 million in 2022, primarily due to sales of Xerava and Trodelvy® in Singapore[13]. - The net loss for the year ended December 31, 2022, was RMB 247.3 million, a significant reduction from RMB 1,008.7 million in 2021, largely due to other income from the Trodelvy® transaction[13]. - Adjusted loss for the year ended December 31, 2022, was RMB 17.4 million, a decrease from RMB 777.3 million in 2021, reflecting improved financial performance[14]. - The company reported a loss of RMB 247.3 million for the year ended December 31, 2022, compared to a loss of RMB 1,008.7 million for the year ended December 31, 2021, primarily due to gains from the sale of Trodelvy®[43][56]. - Revenue for the year ended December 31, 2022, was RMB 12.8 million, generated from the sales of Ilaris and Trodelvy® in Singapore[44]. - Research and development expenses increased from RMB 613.4 million in 2021 to RMB 809.7 million in 2022, attributed to an increase in clinical trial numbers and expansion of the internal drug discovery team[43][44]. - Distribution and selling expenses rose from RMB 198.2 million in 2021 to RMB 326.7 million in 2022, mainly due to increased employee benefits and pre-commercialization activities[46]. - General and administrative expenses increased from RMB 242.7 million in 2021 to RMB 276.5 million in 2022, primarily due to higher professional service fees[47]. - Other net income surged to RMB 1,143.4 million in 2022 from RMB 22.9 million in 2021, primarily due to proceeds from the sale of Trodelvy®[50]. - Operating loss decreased from RMB 1,026.3 million in 2021 to RMB 256.8 million in 2022, mainly due to gains from the Trodelvy® transaction[51]. Strategic Direction and Growth - Everest Medicines' stock increased over 300% from a low of HKD 6.18 on October 31, 2022, to January 31, 2023, following the announcement of a new strategic direction[7]. - The company returned the rights to Trodelvy to Gilead Sciences to improve its balance sheet, focusing on key therapeutic areas with strong market potential[7]. - The new CEO, Mr. Luo Yongqing, appointed in September 2022, is expected to lead the company into a new phase of growth in commercial and clinical operations[7]. - The company aims to leverage its clinically validated mRNA technology platform to advance projects in its key therapeutic areas[7]. - Everest Medicines is seeking promising business development opportunities to acquire global rights to assets while enhancing its internal drug discovery team[7]. - The company has streamlined operations to improve organizational efficiency and adapt to external macroeconomic conditions[7]. - The company is committed to becoming a comprehensive biopharmaceutical company in the commercialization stage by 2023[7]. - Everest Medicines' strategic transformation in 2022 is aimed at better adapting to the evolving market landscape[7]. - The company is committed to developing new vaccines for major infectious diseases and cancer using its clinically validated mRNA technology platform[12]. - The company aims to commercialize Xerava and Nefecon in 2023, actively building a commercialization team to ensure successful product launches[32]. - The company is preparing for the commercialization of Xerava and Nefecon, with a dedicated commercial team being established[40]. - The company plans to advance existing clinical trials and initiate new ones, aiming for rapid market entry of therapies and vaccines[41]. Clinical Development and Product Pipeline - Significant progress was made in clinical development, production capacity, and internal drug discovery throughout 2022, particularly in kidney and infectious diseases[8]. - The company submitted a New Drug Application (NDA) for Nefecon in China for the treatment of primary IgA nephropathy, based on positive Phase 3 clinical trial data from 62 patients[9]. - The mRNA vaccine production facility, operational since December 2022, has an annual capacity of 700 million doses, supporting the company's growth strategy[10]. - The clinical team achieved significant progress in advancing potential best-in-class therapies for kidney disease and infectious diseases, with the mRNA vaccine production capacity reaching 700 million doses annually at the new facility in Zhejiang, China[8]. - Nefecon (TarpeyoTM) showed a statistically significant improvement in eGFR, with an average increase of 5.05 mL/min/1.73 m² compared to placebo over two years, and the treatment demonstrated a decline of only -2.47 mL/min/1.73 m² versus -7.52 mL/min/1.73 m² for placebo[19]. - The National Medical Products Administration of China accepted the new drug application for Nefecon for primary IgA nephropathy, which is expected to receive priority review[18]. - Xerava received approval from the National Medical Products Administration of China for commercialization, marking it as the first product for the company in China[8]. - The company announced the successful preclinical proof of concept for the mRNA rabies vaccine, showcasing its internal drug discovery capabilities[23]. - The company is advancing a bivalent COVID-19 booster candidate vaccine targeting the Omicron variant, with ongoing rolling submissions for IND applications[22]. - EVER001, a next-generation BTK inhibitor for kidney disease, received IND approval for a Phase 1b clinical trial[19]. - The company expects to submit new drug applications for Nefecon in South Korea, Hong Kong, and Taiwan in 2023[19]. - The company plans to submit a new drug application for Taniborbactam for treating cUTI in China in 2023[26]. - EVER206 showed good tolerability in a Phase 1 clinical study with no acute kidney injury observed, supporting its progression to Phase 3 trials[26]. - Etrasimod achieved a clinical remission rate of 27.0% at week 12 in the ELEVATE UC study, compared to 7.4% for the placebo group, with a significant difference of 19.8%[28]. - The FDA is expected to make a decision on the new drug application for Etrasimod in the second half of 2023, marking its first potential approval globally[28]. Collaborations and Licensing Agreements - The company established an exclusive collaboration with Taiwan Dongyang Pharmaceutical for the commercialization of Xerava in Taiwan[9]. - The company signed a licensing agreement with Calliditas for Nefecon in South Korea, expanding its international commercial footprint[30]. - The agreement with Immunomedics allows the company to receive up to 280 million, for the development and commercialization of Trodelvy in several regions[30]. - The company has established an exclusive collaboration with Taiwan Dongyang for the commercialization of Xerava in Taiwan, leveraging their experience in launching new antibiotics[24]. Governance and Management - The company is committed to maintaining a strong governance structure with a diverse board composition[186]. - The management team includes experienced professionals from various sectors, enhancing the company's strategic capabilities[191]. - The company has established a remuneration committee to determine and recommend compensation policies for directors and senior management[168]. - The company emphasizes the importance of strong governance with the appointment of independent directors to enhance oversight and strategic direction[193][194][196]. - The company has not entered into any management or administrative contracts for the majority of its business as of December 31, 2022[101]. - The board consists of four executive directors, two non-executive directors, and three independent non-executive directors as of the last practicable date[186]. - Mr. Luo Yongqing was appointed as the CEO and executive director on September 19, 2022, bringing over 25 years of experience in the healthcare industry[186]. - The company has not disclosed any significant events affecting its operations since the end of the reporting period[184]. Employee and Compensation - The group reported a total employee compensation cost of RMB 853.1 million for the year ended December 31, 2022, an increase from RMB 574.8 million in the previous year[88]. - As of December 31, 2022, the group had 365 employees, a decrease from 405 employees in 2021[85]. - The group’s clinical development team comprised 36.16% of total employees, indicating a strong focus on this area[86]. - The total compensation for directors for the year ended December 31, 2022, was approximately RMB 68.7 million[168]. - The company has granted stock options to directors, with Mr. Luo Yongqing eligible for up to 4,700,000 shares under the post-IPO stock option plan[105]. Market and Investment - The Hong Kong-listed biotechnology sector showed signs of recovery in late 2022, positively impacting investor sentiment towards Everest Medicines[7]. - The company has established a strong product pipeline, including potential first-in-class or best-in-class therapeutic assets and mRNA vaccines, covering short, medium, and long-term opportunities[33]. - The company has entered into a licensing agreement with Calliditas to expand rights in Greater China and Singapore to Korea[37]. - The company plans to fully utilize the remaining unutilized net proceeds by the second half of 2024[181]. - The company has not been involved in any significant litigation or arbitration as of December 31, 2022[176]. Risk Factors - The group faced significant risks including financial condition, clinical development uncertainties, and reliance on business partners and third parties[81]. - The group has no significant contingent liabilities as of December 31, 2022, indicating a stable financial position[70]. - The company has not entered into any hedging transactions to manage foreign currency risks, which may affect operational performance due to currency fluctuations[71].
云顶新耀-B(01952) - 2022 - 年度财报