Financial Data and Key Metrics Changes - The company reported revenue of RMB 446 million for 2025, representing a 48% year-over-year growth, although the first half was impacted by supply constraints [12][14] - Revenue from Nephicon alone reached RMB 520 million in August, indicating a strong recovery from earlier supply issues [13] - Full year revenue guidance for 2025 is set between RMB 1.6 billion to RMB 1.8 billion, with Nephicon expected to contribute RMB 1.2 billion to RMB 1.4 billion [13][14] - The gross margin on a cash basis was 76.4%, slightly lower than 2024 due to price reductions after NRDL inclusion, but expected to recover above 80% in the long run [14] - The non-IFRS net loss was approximately RMB 147 million, down 31% year-over-year, indicating improved operational efficiency [14] Business Line Data and Key Metrics Changes - Nephicon generated RMB 825 million in revenue from January to August, with strong market demand leading to a significant uptick in sales after regulatory approval [4][5] - The autoimmune disease franchise, particularly Velsipiti, is progressing well with NDA reviews and expected early 2026 approval [7][8] - XERAVA in the anti-infective segment showed steady growth, with revenue increasing by 37% year-over-year [23] Market Data and Key Metrics Changes - The company aims to expand Nephicon's market coverage to 1,000 hospitals, targeting approximately 30,000 new patients [18][20] - The estimated market for IgAN in China includes about 5 million patients, with significant growth potential as the company expands its reach [19][20] - The ulcerative colitis market is projected to grow, with peak sales for Velsipiti expected to reach RMB 5 billion [34] Company Strategy and Development Direction - The company is focused on a dual strategy of commercialization and in-house discovery, with significant investments in R&D to support long-term growth [35][72] - Plans include localizing production for various products and preparing for NRDL negotiations to enhance market access [72] - The company is also exploring partnerships and in-licensing opportunities to bolster its product pipeline and market presence [76] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving operational profitability earlier than previously guided, now targeting Q4 2025 [15] - The company is optimistic about the upcoming regulatory approvals and market launches, which are expected to drive revenue growth [71][72] - Management highlighted the strong clinical data supporting their products, which positions them favorably in the market [82] Other Important Information - The company completed a strategic investment of USD 30.9 million in I Mab, becoming the largest shareholder with a 16.1% stake [12][70] - The company is advancing its proprietary mRNA technology platform, which is expected to enhance its R&D capabilities and product offerings [48][49] Q&A Session Summary Question: Peak sales for Etrasimod - Management noted that the potential for Etrasimod is higher than previously stated due to strong clinical data and an underdeveloped market, with preparations underway for commercial launch [80][82][86] Question: Development plans for EVER-one - Management confirmed that they are in the design stage for pivotal trials and are planning to initiate these studies in 2026, with ongoing discussions for potential partnerships [89][90][92]

Financial Data and Key Metrics Changes - The company reported revenue of RMB 446 million for 2025, representing a 48% year-over-year growth, although the first half was impacted by supply constraints [14][15] - Revenue from Nephicon alone reached RMB 520 million in August 2025, indicating a strong recovery from earlier supply issues [15] - The full-year revenue guidance for 2025 is set between RMB 1.6 billion to RMB 1.8 billion, with Nephicon expected to contribute RMB 1.2 billion to RMB 1.4 billion [16] - The gross margin on a cash basis was 76.4%, slightly lower than 2024 due to price reductions after NRDL inclusion, but expected to recover above 80% in the long run [17] - The non-IFRS net loss was approximately RMB 147 million, down 31% year-over-year, indicating improved operational efficiency [18] Business Line Data and Key Metrics Changes - Nephicon generated RMB 825 million in revenue from January to August 2025, with NRDL coverage achieved in 29 provinces [6][7] - The autoimmune disease franchise, particularly Velsipiti, is in the final stages of NDA review, with expectations for early 2026 approval [9] - XERAVA in the anti-infective franchise showed steady growth, with revenue growth of 37% year-over-year [26] Market Data and Key Metrics Changes - The company plans to expand Nephicon's market coverage to 1,000 hospitals, targeting 30,000 new IGAM patients [22] - The estimated market for IGAM in China includes about 5 million patients, with 100,000 new confirmed cases each year [23] - The ulcerative colitis market is projected to reach RMB 14 billion, with significant unmet medical needs [29] Company Strategy and Development Direction - The company aims to achieve operational profitability in 2025, with a focus on expanding its commercial platform and advancing its R&D pipeline [19][37] - The strategy includes leveraging a combination of commercial execution and in-house discovery to drive growth [72] - The company is also pursuing strategic investments, such as a USD 30.9 million investment in I Mab, to enhance its oncology platform [70] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong market potential for Nephicon and Velsipiti, citing robust clinical data and regulatory approvals [81][82] - The company is optimistic about achieving peak sales of RMB 5 billion for Nephicon, supported by a growing patient base and favorable market conditions [80] - Future growth is expected to be driven by multiple near-term catalysts, including upcoming NDA approvals and market expansions [71][72] Other Important Information - The company has made significant progress in its R&D platform, including advancements in mRNA technology and CAR T therapies [48][49] - The company is preparing for pivotal trials in 2026 for its autoimmune renal disease treatments, indicating a strong pipeline for future growth [45][46] Q&A Session Summary Question: Peak sales for Etrasimod - The company raised peak sales estimates for Etrasimod to RMB 5 billion due to strong clinical data and an underdeveloped market with significant unmet needs [80][81] Question: Clinical development plan for EVER-one - The company is finalizing the design for a Phase II basket trial and plans to initiate pivotal studies in 2026, with ongoing regulatory interactions [88][89]

Financial Data and Key Metrics Changes - The company reported a full year 2024 revenue of RMB706.7 million, reflecting a significant 461% year-on-year growth, exceeding the guidance of RMB700 million [6][22] - Gross margin on a cash basis was 83% for the full year 2024, indicating strong operational efficiency [6][23] - Non-IFRS net loss narrowed to approximately RMB537.6 million, down by 25% year-on-year [7][24] - Cash balance stood at RMB1.6 billion, providing flexibility for future growth [8][25] Business Line Data and Key Metrics Changes - Total product revenue reached RMB706.7 million, with Nephicom generating RMB353.4 million, representing a year-on-year growth of 1581% [9][10] - Cerava contributed RMB252.8 million in revenue, marking a 256% increase year-on-year [10] - Distribution and selling expenses increased to RMB508.1 million, but the commercial expense to revenue ratio decreased significantly by 111.9 percentage points [24] Market Data and Key Metrics Changes - The company has successfully listed Natricon in the National Reimbursement Drug List (NRDL), which is expected to enhance patient access and drive growth [11][32] - Over 10,000 new IgAN patients have been prescribed Nephicom since its NRDL inclusion [68] - The company plans to expand its sales organization to 200 sales representatives to cover 80% of the addressable market potential [34] Company Strategy and Development Direction - The company aims to achieve cash level breakeven by the end of 2025, focusing on a dual engine growth strategy that includes strong commercial execution and internal developments [9][26] - The first engine focuses on a China-centric commercial platform with key products like Nephicom, XERAVA, and Valsivity, while the second engine emphasizes in-house R&D for innovative therapeutics [27][28] - The company is committed to expanding its pipeline in renal diseases and infectious diseases, with a focus on innovative therapeutics and diagnostics [29][35] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's transformation from a biotech to a biopharma company, highlighting the strong revenue generation from continuing operations [26][89] - The company is optimistic about the future growth potential, particularly with the expected approval of key products and the expansion of its commercial infrastructure [28][62] - Management noted the importance of generating real-world evidence to support product positioning and adoption in the market [71][83] Other Important Information - The company has made significant advancements in its pipeline, including the development of mRNA cancer vaccines and in vivo CAR T programs [47][56] - The company has received U.S. IND approval for its personalized cancer vaccine program, marking a significant milestone [54] Q&A Session Summary Question: Can you share more on the NRDL implementations and competition in IgAN? - Management reported that over 10,000 new IgAN patients have been prescribed Nephicom since NRDL inclusion, with ongoing efforts to expand the sales team to better cover target hospitals [68][70] - The company believes Nephicom's unique profile and clinical data will position it favorably against emerging competition in the IgAN market [70][72] Question: What feedback has been received regarding etrasimod and its usage? - Early feedback from doctors and patients in the Great Bay Area has been positive, with the product positioned as a first-line therapy for biologics-naive patients [81][83] Question: Will there be more detailed safety data for EVA-one? - Management confirmed that one-year follow-up data will be shared, with ongoing efforts to provide updates on safety and efficacy [80][82]