四川科倫博泰生物醫藥股份有限公司 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ( 於中華人民共和國註冊成立的股份有限公司 ） (A joint stock company incorporated in the People's Republic of China with limited liability) Stock Code 股份代號：6990 | 2 | 公司資料 | | --- | --- | | 4 | 董事長聲明 | | 6 | 管理層討論與分析 | | 41 | 董 事、監 事 及 高 級 管 理 層 | | 52 | 董事報告 | | 85 | 監事報告 | | 88 | 企業管治報告 | | 108 | 環 境、社 會 和 管 治 報 告 | | 173 | 獨立核數師報告 | | 178 | 綜合損益表 | | 179 | 綜合損益及其他綜合收益表 | | 180 | 綜合財務狀況表 | | 182 | 綜 合權益變動表 | | 184 | 綜合現金流量表 | | 185 | 財務報表附註 | | 241 | 財務摘要 | | 2 ...

Investment Rating - The investment rating for the company is "Buy" (maintained) [5] Core Views - The company is expected to achieve high growth driven by commercialization and milestone achievements, with smooth progress in overseas markets [5] - The company reported a narrowing net loss of 267 million RMB in 2024, a 53.5% year-on-year reduction, with total revenue of 1.933 billion RMB, reflecting a 25.5% increase [7] - The company is entering a commercialization phase with promising data and backing from Merck, indicating potential for increased global value [7] Financial Performance Summary - Revenue projections for 2025-2027 are 1.963 billion RMB, 3.007 billion RMB, and 5.363 billion RMB respectively, with growth rates of 1.55%, 53.18%, and 78.35% [6][8] - The company is expected to achieve a positive net profit of 877 million RMB by 2027, with a significant increase in earnings per share from -2.40 RMB in 2025 to 3.86 RMB in 2027 [6][8] - The company's reasonable equity value is estimated at 81 billion HKD, based on a DCF method with a perpetual growth rate of 2% and WACC of 8.58% [7]

Investment Rating - The report maintains an "Outperform" rating for Sichuan Kelun-Biotech Biopharmaceutical with a target price of HKD 297.20, reflecting an upward revision of 48.5% from the previous target price of HKD 200.1 [2][22]. Core Insights - The company has entered a phase where R&D collaboration revenue and commercial sales serve as dual growth drivers, with a sales team expanding to 360 members by the end of 2024 [4][15]. - The company reported a revenue of RMB 1.93 billion for 2024, a 25.5% year-over-year increase, with a gross profit of RMB 1.27 billion and a gross margin of 65.9%, up 16.6 percentage points [3][14]. - Regulatory and R&D catalysts are expected to be abundant in 2025, with three NDAs submitted that are likely to be approved within the year, contributing to incremental revenue growth [5][19]. Financial Performance - Revenue forecasts for 2025-2027 have been adjusted to RMB 1.96 billion, RMB 2.98 billion, and RMB 4.47 billion, reflecting year-over-year growth of +1.4%, +52.2%, and +49.9% respectively [21]. - The net profit forecast for 2025-2027 has been revised to -RMB 280 million, RMB 240 million, and RMB 1.02 billion, showing a significant improvement from previous estimates [21]. - As of December 31, 2024, the company had cash and financial assets of RMB 3.08 billion, reflecting a 21.6% year-over-year increase [3][14]. Product Pipeline and Market Potential - The company has three approved products covering five indications, with ongoing clinical trials for SKB264 and other promising molecules in its pipeline [4][16]. - SKB264 has seen steady sales growth since its market launch in November 2024, with peak sales estimated to reach USD 6-7 billion [16]. - A167, the first PD-L1 inhibitor approved for nasopharyngeal carcinoma, holds significant commercial potential due to the high prevalence of the disease in China [17]. Valuation Methodology - The valuation is based on a DCF model with a weighted average cost of capital of 9.4% and a terminal growth rate of 3.5%, leading to a target price of HKD 297.20 per share [22].

Investment Rating - The report maintains a "Buy" rating for the company, indicating an expected relative increase of over 15% compared to the CSI 300 index in the next six months [1][11]. Core Insights - The company's performance aligns with expectations, with the core product, Lukan Satuzumab, anticipated to become a blockbuster drug due to its rapid sales growth potential and multiple approved indications [1][4][5]. - The company reported a revenue of 1.933 billion yuan for 2024, reflecting a year-on-year growth of 25.5%, with a significant reduction in annual losses [3][7]. Financial Summary - Revenue projections for 2025-2027 are estimated at 2.093 billion yuan, 4.046 billion yuan, and 6.451 billion yuan, respectively, with growth rates of 8%, 93%, and 59% [7]. - The company expects to reduce its net losses significantly, with projections of -582 million yuan in 2025, -485 million yuan in 2026, and a profit of 836 million yuan in 2027 [7]. - The diluted earnings per share (EPS) is projected to improve from -1.20 yuan in 2024 to 3.68 yuan in 2027 [7]. Product Development and Market Potential - Lukan Satuzumab has received approval for two indications and is expected to gain a third indication by late 2025, which will enhance its market potential [4][5]. - The company has established a sales team of over 400 personnel, targeting major hospitals and expanding into lower-tier markets, which is expected to drive rapid sales growth [4][5].

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Insights - The company has successfully transitioned to commercialization, with significant revenue growth expected from the drug Lukanosatuzumab, which was approved in China on November 22, 2024. The total revenue for 2024 is projected to be 1.933 billion yuan, representing a year-on-year growth of 25.5% [6] - The company reported a net loss of 267 million yuan for 2024, a reduction of 53.5% compared to the previous year, indicating improved financial performance [6] - The approval of Lukanosatuzumab for two indications in China and ongoing global clinical trials in collaboration with MSD highlight the company's strong pipeline and potential for future growth [6][7] - Financial forecasts have been adjusted, with expected net losses of 707 million yuan in 2025, 492 million yuan in 2026, and a profit of 512 million yuan in 2027, reflecting a positive outlook for the company's profitability trajectory [6] Financial Summary - Total revenue (in million yuan) is projected as follows: 2023: 1,540; 2024: 1,933; 2025: 1,690; 2026: 2,496; 2027: 4,101 [9] - The gross margin is expected to improve from 49.3% in 2023 to 82.0% by 2027, indicating enhanced operational efficiency [9] - The net profit margin is projected to turn positive by 2027, with a net profit margin of 12.5% [9] - The company's earnings per share (EPS) is expected to improve from -2.5 yuan in 2023 to 2.3 yuan in 2027 [9] Pipeline and Catalysts - The company is expected to receive approval for additional indications of Lukanosatuzumab in 2025, including 2L HR+Her2- breast cancer and other first-line indications anticipated for NDA submission in 2026 [8] - A166, another drug in the pipeline, is expected to receive approval for HER2+ breast cancer in the first half of 2025 [8]

Investment Rating - The report maintains a "Buy" rating for the company [1] Core Insights - The company's 2024 revenue is projected to be 1.933 billion RMB, representing a year-on-year growth of 25.5%. The gross profit is expected to reach 1.274 billion RMB, with a significant increase of 67.8% year-on-year. The adjusted annual loss is anticipated to narrow by 73.7% to 118 million RMB, indicating improved operational efficiency [7] - Multiple products are set to commercialize this year, which is expected to lead to rapid revenue growth. Key products include SKB264, A166, A167, and A140, with approvals anticipated to enhance profitability significantly [7] - The company has a strong cash reserve of over 3.076 billion RMB, reflecting a year-on-year growth of 21.6%, which supports its ongoing research and development efforts [7] Financial Summary - Total revenue for 2023 is reported at 1.54 billion RMB, with a projected increase to 1.933 billion RMB in 2024, followed by a decline to 1.783 billion RMB in 2025, and then a substantial rise to 3.559 billion RMB in 2026 and 5.894 billion RMB in 2027 [1][8] - The net profit attributable to the parent company is expected to improve from a loss of 574.13 million RMB in 2023 to a loss of 266.77 million RMB in 2024, with a forecasted profit of 444.17 million RMB by 2027 [1][8] - The earnings per share (EPS) is projected to improve from -2.53 RMB in 2023 to -1.17 RMB in 2024, and is expected to turn positive at 1.95 RMB by 2027 [1][8] Product Development and Market Position - SKB264, a TROP2 ADC, has received approval for multiple indications in China, with further clinical trials ongoing both domestically and internationally. This positions the company favorably in the competitive landscape [7] - The company is actively pursuing market opportunities for its innovative products, with several key approvals expected to drive future revenue growth [7]

Investment Rating - The report maintains a "Buy" rating for the company [1] Core Insights - The company's 2024 revenue is projected to be 1.933 billion RMB, representing a year-on-year growth of 25.5%. The gross profit is expected to reach 1.274 billion RMB, with a significant increase of 67.8% year-on-year. The adjusted annual loss is anticipated to narrow by 73.7% to 118 million RMB, indicating improved operational efficiency [7] - Multiple products are set to commercialize this year, which is expected to lead to rapid revenue growth. Key products include SKB264, A166, A167, and A140, with approvals anticipated to enhance profitability significantly [7] - The company has a strong cash reserve of over 3.076 billion RMB, reflecting a year-on-year growth of 21.6%, which supports its ongoing research and development efforts [7] Financial Summary - Total revenue projections for 2024, 2025, 2026, and 2027 are 1.933 billion RMB, 1.783 billion RMB, 3.559 billion RMB, and 5.894 billion RMB respectively, with growth rates of 25.5%, -7.76%, 99.61%, and 65.61% [1][8] - The net profit attributable to the parent company is forecasted to be -266.77 million RMB in 2024, -604.96 million RMB in 2025, -216.79 million RMB in 2026, and a positive 444.17 million RMB in 2027, indicating a turnaround in profitability [1][8] - The earnings per share (EPS) are projected to be -1.17 RMB in 2024, -2.66 RMB in 2025, -0.95 RMB in 2026, and 1.95 RMB in 2027, reflecting a potential recovery in earnings [1][8]

Financial Performance - The company's revenue for the year ended December 31, 2024, was RMB 1,933,045,000, representing a 25.5% increase from RMB 1,540,493,000 in 2023[4] - Gross profit for the same period was RMB 1,273,657,000, a significant increase of 67.8% compared to RMB 759,185,000 in 2023[4] - The annual loss decreased to RMB 266,766,000, a 53.5% improvement from a loss of RMB 574,134,000 in 2023[4] - Adjusted annual loss was RMB 118,481,000, down 73.7% from RMB 450,788,000 in the prior year[4] - Cash and financial assets increased to RMB 3,075,651,000, a 21.6% rise from RMB 2,528,342,000 in 2023[4] - Total equity grew to RMB 3,308,661,000, marking a 42.0% increase from RMB 2,329,497,000 in the previous year[4] - The company reported a significant reduction in operating loss to RMB 138,749 thousand in 2024 from RMB 383,383 thousand in 2023, reflecting improved operational efficiency[31] - The company reported a net loss attributable to ordinary shareholders of RMB (266,766) thousand for 2024, a significant improvement compared to a loss of RMB (574,134) thousand in 2023[55] - The company achieved significant milestones in research and development, contributing to the overall revenue growth and the commencement of drug sales in 2024[140] Research and Development - Research and development expenses rose to RMB 1,206,134,000, reflecting a 17.0% increase from RMB 1,030,966,000 in the previous year[4] - The company has 11 ADC and novel conjugate drug assets in clinical or above stages, including sac-TMT and another drug for HER2+ breast cancer that has reached NDA stage[7] - The company presented clinical data for sac-TMT at various academic conferences, including a Phase 3 study (OptiTROP-Breast01) for previously treated locally advanced or metastatic TNBC[12] - The exploratory analysis of sac-TMT in previously treated advanced TNBC patients showed significant results in the Phase 3 study[12] - The company is actively exploring sac-TMT for other solid tumors, including GC, EC, CC, OC, UC, CRPC, and HNSCC[82] - The company is conducting multiple global Phase 2 basket trials for sac-TMT as a monotherapy or in combination with other treatments for various solid tumors[125] - The company has established three core platforms focusing on ADC, macromolecule, and small molecule technologies for drug discovery and development[116] Product Approvals and Clinical Trials - The core product sac-TMT received approval from the National Medical Products Administration in November 2024 for treating adult patients with unresectable locally advanced or metastatic TNBC[6] - The NDA for the core product, A166 (HER2 ADC), was accepted by the National Medical Products Administration in January 2025, showing significant improvement in progression-free survival (PFS) compared to T-DM1[13] - Tagolizumab is the first PD-L1 monoclonal antibody approved for first-line treatment of NPC in January 2025[16] - The company received IND approval for SKB500 and SKB501 for treating advanced solid tumors in November and December 2024, respectively[16] - The NDA for sac-TMT was accepted by the NMPA in October 2024, with priority review for treating EGFR mutation-positive NSCLC patients who progressed after EGFR-TKI therapy[81] - The NDA for the HER2 ADC, A166, was accepted by the NMPA in May 2023, targeting advanced HER2+ solid tumors[87] Collaborations and Partnerships - The company has established a commercial team to implement marketing strategies for strategic products, focusing on areas with medical needs in China such as BC and NSCLC[21] - The collaboration with Merck involves the development of multiple ADC assets, with 12 ongoing global Phase 3 studies for sac-TMT in various cancer types[23] - The company has entered into a licensing and collaboration agreement with Merck to develop multiple ADC assets for cancer treatment, retaining rights for development and commercialization in Greater China[124] - The company is exploring strategic investment and acquisition opportunities to promote long-term development, with further announcements to be made as opportunities mature[181] Market and Commercialization - The company has initiated commercialization of sac-TMT and other monoclonal antibodies, with plans to launch additional products in the Chinese market by 2025[132] - The company aims to optimize patient treatment outcomes by prioritizing commercialization strategies in therapeutic areas with medical needs, such as BC, NSCLC, and GI cancers[132] - The company has received a total of $147.5 million in upfront and milestone payments from various collaboration pipelines as of 2024[129] Governance and Sustainability - The company has established a comprehensive three-tier ESG governance structure, enhancing its ESG accountability and sustainability efforts, and received the "Outstanding ESG Governance Performance Award" in June 2024[30] - The company has established a comprehensive ESG governance framework to enhance its sustainability efforts and received the "Outstanding ESG Governance Performance Award" in June 2024[136] - As of December 31, 2024, the company strictly adhered to corporate governance codes and will continue to review its governance practices[196]

Investment Rating - The report maintains a "Buy" rating for the company [1] Core Views - The company has received approval for the first Trop2 ADC lung cancer indication globally, which aligns with previous expectations [7] - The expansion of indications is favorable for commercialization in China, with the company expected to participate in the 2025 national medical insurance negotiations [7] - The potential of the product is gradually being realized, with ongoing global phase III studies for additional lung cancer indications [7] - 2025 is projected to be a pivotal year for the company's product commercialization, with several products expected to be approved [7] Financial Summary - Revenue projections for the company are as follows: - 2023A: 1,540.5 million RMB - 2024E: 1,746.8 million RMB (growth rate: 13.4%) - 2025E: 1,836.7 million RMB (growth rate: 5.2%) - 2026E: 2,877.2 million RMB (growth rate: 56.7%) [2] - The net profit attributable to the parent company is projected to be negative, with figures as follows: - 2023A: -574.1 million RMB - 2024E: -350.1 million RMB - 2025E: -434.6 million RMB - 2026E: -286.1 million RMB [2] - Earnings per share (EPS) is expected to improve from -2.53 in 2023A to -1.26 in 2026E [2] - The company anticipates significant revenue from the product Lukanosatuzumab, with projected sales of 47 million RMB in 2024, 960 million RMB in 2025, and 1,886 million RMB in 2026 [9]

Investment Rating - The report maintains a "Buy" rating for the company [1] Core Views - The company has received approval for the first global Trop2 ADC lung cancer indication, which aligns with previous expectations [7] - The expansion of indications is favorable for commercialization in China, with the company expected to participate in the 2025 national medical insurance negotiations [7] - The potential of the product is gradually being realized, with ongoing global phase III studies for additional lung cancer indications [7] - 2025 is projected to be a pivotal year for the company's product commercialization, with several products expected to be approved [7] Financial Summary - Revenue projections for the company are as follows: - 2023A: 1,540.5 million RMB - 2024E: 1,746.8 million RMB (growth rate: 13.4%) - 2025E: 1,836.7 million RMB (growth rate: 5.2%) - 2026E: 2,877.2 million RMB (growth rate: 56.7%) [2] - The net profit attributable to the parent company is projected to be negative, with figures as follows: - 2023A: -574.1 million RMB - 2024E: -350.1 million RMB - 2025E: -434.6 million RMB - 2026E: -286.1 million RMB [2] - Earnings per share (EPS) is expected to improve from -2.53 in 2023A to -1.26 in 2026E [2] - The company anticipates significant revenue from the product Lukanosatuzumab, with projected sales of 47 million RMB in 2024, 960 million RMB in 2025, and 1,886 million RMB in 2026 [9] Key Assumptions - The company is expected to receive collaboration payments from Merck, totaling approximately 1.7 billion RMB from 2024 to 2026 [8] - The approval of Lukanosatuzumab in November 2024 is anticipated to generate substantial revenue in the following years [8]