Financial Performance - Everest Medicines reported revenue of RMB 125.9 million from its first product, Yiga®, within five months of launch, significantly exceeding the initial forecast of RMB 70 million to RMB 100 million[5]. - Revenue increased by RMB 113.1 million or 884% to RMB 125.9 million for the year ended December 31, 2023, primarily due to the commercialization of products in mainland China and Hong Kong[9]. - The company achieved revenue of RMB 125.9 million in 2023, significantly exceeding the previous guidance of RMB 70 million to RMB 100 million[34]. - The combined revenue from Iqmod and Iqia is projected to reach RMB 700 million in 2024[36]. - The company anticipates revenue exceeding the initial guidance of RMB 700 million to RMB 1 billion during its commercialization year in 2023[29]. Product Development and Commercialization - The company received NDA approval for its primary IgA nephropathy treatment, Nanfukang®, in Macau and mainland China, with plans for commercialization in mainland China in the first half of 2024[5]. - Everest Medicines plans to launch Nanfukang® in Singapore and Hong Kong in 2024, following its commercialization in Macau[5]. - The company plans to commercialize the nephrology product, Naimu, in mainland China in 2024, supported by a new sales team of approximately 120 employees[8]. - TARPEYO® received approval from the National Medical Products Administration in China for the treatment of primary IgA nephropathy in November 2023, with plans for market launch in 2024[13]. - The company plans to submit a new drug application for the combination of cefepime and tanibartin for treating complex urinary tract infections in 2024[22]. Clinical Trials and Research - The company is advancing the global Phase 2b PALIZADE clinical study for zetomipzomib in collaboration with Kezar Life Sciences, targeting autoimmune diseases[6]. - The mRNA platform is expected to advance therapeutic vaccine development into clinical trials in 2024, enhancing the company's R&D product portfolio[12]. - In a Phase 3 clinical trial (NeflgArd), TARPEYO® demonstrated a statistically significant improvement in estimated glomerular filtration rate (eGFR) compared to placebo, with an average increase of 5.05 mL/min/1.73 m² over two years (P<0.0001)[13]. - The company completed patient recruitment for the open-label extension study of TARPEYO® in August 2023, aimed at assessing long-term efficacy and safety in Chinese patients[15]. - The company plans to advance the global, placebo-controlled Phase 2b clinical trial PALIZADE for Zetomipzomib in patients with active lupus nephritis[26]. Financial Position and Expenses - Cash and cash equivalents as of December 31, 2023, amounted to RMB 2,349.7 million[10]. - R&D expenses decreased by RMB 269.6 million to RMB 540.1 million for the year ended December 31, 2023, due to several candidate drugs completing clinical trials and entering registration or commercialization stages[9]. - The company reported a loss of RMB 844.5 million for the year ended December 31, 2023, compared to a loss of RMB 247.3 million for the previous year, marking a significant increase in losses[39]. - The net cash used in operating activities for the year ended December 31, 2023, was RMB 769.2 million, compared to RMB 1,155.8 million for the year ended December 31, 2022[60]. - The current ratio improved from 3.92 in 2022 to 8.36 in 2023, indicating a stronger liquidity position[61]. Strategic Partnerships and Collaborations - Everest Medicines partnered with Pfizer for the approval of Iqmod (VELSIPITY®) for treating moderate to severe ulcerative colitis, with plans to submit a new drug application in China[6]. - The company entered into a collaboration and licensing agreement with Kezar Life Sciences for the development and commercialization of Zetomipzomib (澤托佐米) in Greater China, Korea, and parts of Southeast Asia, with Kezar entitled to receive an upfront payment of 125.5 million in future milestone payments[25]. - The company has terminated its collaboration with Providence in February 2023, retaining full rights to develop mRNA products independently[8]. - The company has entered into a collaboration agreement with Kezar Life Sciences to develop the drug Zetomipzomib for autoimmune diseases in Greater China and Southeast Asia[37]. - The company is collaborating with Venatorx Pharmaceuticals on the development of cefepime-tanibartin, with positive results from a global Phase 3 trial expected to be submitted in 2024[22]. Governance and Corporate Structure - The board of directors has undergone several changes, with new appointments and resignations noted for 2024[69]. - The company is committed to maintaining high ethical standards and transparency in its operations to maximize long-term shareholder returns[165]. - The board emphasizes the importance of managing overall business risks and providing high-quality products and services to customers[165]. - The company has adopted the corporate governance code as a benchmark for its governance practices, emphasizing the importance of high standards in protecting shareholder interests[166]. - The company has established appropriate insurance arrangements for directors and senior management against legal claims arising from corporate activities[181]. Employee and Shareholder Engagement - The company has a total employee count of 432 as of December 31, 2023, an increase from 365 in 2022, with 416 located in China[77]. - The total compensation for directors, including basic salary, housing allowance, and discretionary bonuses, amounted to approximately RMB 24.7 million, with discretionary bonuses totaling RMB 9.1 million for the year ending December 31, 2023[138]. - The company has made charitable donations of approximately RMB 15.8 million for the year ended December 31, 2023, compared to zero in 2022[84]. - The company emphasizes the importance of gender diversity at all levels and aims to increase female representation in senior management and the board[193]. - The company aims to align the interests of eligible participants with the group's interests through the post-IPO share incentive plan[129]. Market Expansion and Future Outlook - Everest Medicines aims to establish a sales team of 120 representatives by the end of 2024, targeting 600 core hospitals to cover at least 60% of market potential[5]. - The company aims to achieve cash breakeven by 2025, focusing on high-value therapeutic areas such as kidney diseases, anti-infection, and autoimmune diseases[8]. - The company aims to expand the market for Iqmod to approximately 5 million IgA nephropathy patients in mainland China in 2024[34]. - The company is focused on developing innovative therapies to meet unmet medical needs in Greater China and other emerging markets in the Asia-Pacific region[71]. - The company is dedicated to fostering a culture of compliance and ethical business practices across all levels of the organization[165].
云顶新耀-B(01952) - 2023 - 年度财报