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复宏汉霖(02696) - 2024 - 中期财报
02696Shanghai Henlius(02696)2024-09-26 08:30

Financial Performance - Total revenue for the first half of 2024 reached approximately RMB 2,746.1 million, a 9.8% increase compared to RMB 2,500.5 million in the same period of 2023[9] - Net profit for the first half of 2024 was RMB 386.3 million, a significant increase from RMB 240.0 million in the same period of 2023[9] - Non-current assets increased to RMB 7,583,198,000 as of June 30, 2024, up from RMB 7,227,539,000 at the end of 2023, driven by growth in property, plant, and equipment (RMB 2,319,676,000) and intangible assets (RMB 4,819,859,000)[78] - Current assets decreased to RMB 2,396,562,000 as of June 30, 2024, compared to RMB 2,676,032,000 at the end of 2023, primarily due to a decline in cash and bank balances (RMB 649,449,000 vs. RMB 987,665,000)[78] - Net profit for the six months ended June 30, 2024, was RMB 386,301,000, contributing to a total comprehensive income of RMB 402,277,000[79] - Cash flow from operating activities for the six months ended June 30, 2024, was RMB 251,263,000, a decrease from RMB 332,460,000 in the same period of 2023[82] - The company's net asset value increased to RMB 2,578,257,000 as of June 30, 2024, up from RMB 2,192,301,000 at the end of 2023[78] - Total equity increased to RMB 2,578,257,000 as of June 30, 2024, compared to RMB 2,192,301,000 at the end of 2023, driven by retained earnings and other reserves[79] - Cash used in investing activities for the six months ended June 30, 2024, was RMB 663,655,000, primarily due to the acquisition of property, plant, and equipment (RMB 103,685,000) and intangible assets (RMB 344,798,000)[82] - The company's total liabilities decreased to RMB 7,401,503,000 as of June 30, 2024, from RMB 7,711,270,000 at the end of 2023, reflecting a reduction in both current and non-current liabilities[78] - The company's trade receivables increased to RMB 744,101,000 as of June 30, 2024, up from RMB 647,828,000 at the end of 2023, indicating higher sales on credit[78] - The company's inventory increased to RMB 783,331,000 as of June 30, 2024, compared to RMB 757,359,000 at the end of 2023, reflecting higher production or slower sales[78] - Net cash flow from financing activities was -145,815 thousand RMB, compared to 156,497 thousand RMB in the same period last year[83] - Cash and cash equivalents decreased by 558,207 thousand RMB, with a closing balance of 313,911 thousand RMB[83] - Revenue from external customers in Mainland China increased to 2,489,605 thousand RMB, up from 2,221,701 thousand RMB in 2023[90] - Total revenue for the six months ended June 30, 2024, was 2,746,109 thousand RMB, compared to 2,500,470 thousand RMB in 2023[90] - Revenue from sales of biopharmaceutical products reached 2,479,351 thousand RMB, up from 2,152,901 thousand RMB in 2023[91] - Revenue from licensing and R&D services was 14,258 thousand RMB and 251,014 thousand RMB, respectively[91] - Revenue recognized at a point in time was 2,498,899 thousand RMB, while revenue recognized over time was 245,809 thousand RMB[91] - The company's current liabilities net amount was 2,506,388 thousand RMB as of June 30, 2024[86] - Other income and gains totaled RMB 24,739 thousand, a decrease of 7.8% compared to RMB 26,837 thousand in the same period last year[92] - Interest income increased significantly to RMB 10,309 thousand, up 280% from RMB 2,712 thousand in the previous year[92] - Cost of goods sold increased to RMB 430,380 thousand, a 12.5% rise from RMB 382,617 thousand in 2023[93] - Financial costs rose to RMB 62,796 thousand, a 16.1% increase from RMB 54,084 thousand in 2023[94] - Current tax expense in Mainland China increased to RMB 9,417 thousand, up 138% from RMB 3,956 thousand in the previous year[96] - Profit attributable to ordinary equity holders of the parent for basic EPS calculation was RMB 386,301 thousand, a 61% increase from RMB 239,980 thousand in 2023[99] - Property, plant and equipment additions amounted to RMB 168,829 thousand, a decrease of 37.6% compared to RMB 270,346 thousand in the previous year[101] - Trade receivables increased to RMB 744,101 thousand, up 14.9% from RMB 647,828 thousand at the end of 2023[103] - Prepayments and other receivables decreased to RMB 174,921 thousand, down 12.9% from RMB 200,761 thousand at the end of 2023[104] - The company recovered a total of 30,640,000fromAMTDfortheyearsendedDecember31,2020,2021,and2022,andanadditional30,640,000 from AMTD for the years ended December 31, 2020, 2021, and 2022, and an additional 20,000,000 for the year ended December 31, 2023[105] - As of December 31, 2023, and June 30, 2024, the outstanding principal balance of the AMTD account investment was 66,360,000(equivalenttoRMB472,942,000)[105]ThecompanyhasfullyprovisionedforexpectedcreditlossesontheAMTDreceivable,totaling66,360,000 (equivalent to RMB 472,942,000)[105] - The company has fully provisioned for expected credit losses on the AMTD receivable, totaling 66,360,000 as of June 30, 2024, and December 31, 2023 (equivalent to RMB 472,942,000 and RMB 470,015,000, respectively)[105] - Trade payables as of June 30, 2024, amounted to RMB 617,145,000, with RMB 606,293,000 due within one year[106] - Total interest-bearing bank and other borrowings as of June 30, 2024, were RMB 4,054,089,000, with RMB 2,837,718,000 classified as current liabilities[108] - The company's lease liabilities as of June 30, 2024, amounted to RMB 263,471,000, with RMB 98,369,000 due within one year[108] - The company's bank borrowings are secured by right-of-use assets with a net book value of RMB 190,488,000 and property, plant, and equipment with a net book value of RMB 1,033,164,000 as of June 30, 2024[109] - The company has contractual commitments for plant and machinery amounting to RMB 111,917,000 as of June 30, 2024[111] - The company has no contingent liabilities as of June 30, 2024[111] - The company has issued and fully paid-up ordinary shares totaling 543,494,853 shares as of June 30, 2024[110] - Revenue from licensing to Fosun Pharma Industrial Development increased to RMB 10,963 thousand in 2024 from RMB 10,851 thousand in 2023[114] - Services provided to Fosun Pharma Industrial Development surged to RMB 75,472 thousand in 2024 from RMB 21,774 thousand in 2023[114] - Sales of goods to Sinopharm Group reached RMB 1,062,754 thousand in 2024, up from RMB 900,069 thousand in 2023[114] - Total sales of goods to related parties amounted to RMB 1,342,731 thousand in 2024, compared to RMB 1,204,518 thousand in 2023[114] - Purchases of services/goods from related parties totaled RMB 18,426 thousand in 2024, slightly up from RMB 17,629 thousand in 2023[114] - Trade receivables from related parties stood at RMB 378,405 thousand in 2024, an increase from RMB 346,664 thousand in 2023[116] - Prepayments, other receivables, and other assets from related parties were RMB 4,702 thousand in 2024, up from RMB 4,172 thousand in 2023[116] - Trade payables to related parties were RMB 1,212 thousand in 2024, significantly higher than RMB 194 thousand in 2023[116] R&D and Product Development - R&D expenses for the first half of 2024 decreased to RMB 482.5 million, down from RMB 547.8 million in the same period of 2023[9] - HANQUYOU® (trastuzumab for injection) has benefited over 200,000 patients in China and received FDA approval in the US for breast cancer and gastric cancer treatment in April 2024[10] - HANQUYOU® received approval from Health Canada in August 2024 for early and metastatic breast cancer and metastatic gastric cancer treatment[10] - HANSIZHUANG® (serplulimab injection) received approval in Cambodia and Thailand for extensive-stage small cell lung cancer (ES-SCLC) treatment in 2024[10] - HANLIKANG® (rituximab injection) has benefited over 260,000 patients in China and received approval in Peru in May 2024[10] - Hansizhuang® (Serplulimab Injection) completed the first patient dosing in the Phase 3 portion of an international multicenter Phase 2/3 clinical trial for metastatic colorectal cancer in China in May 2024, and the Phase 3 trial was approved in Japan and Indonesia in July 2024[11] - HLX14 (Denosumab Biosimilar) achieved the primary endpoint in an international multicenter Phase 3 clinical trial for postmenopausal osteoporosis in April 2024, with MAAs submitted to EMA in May 2024 and NDSs submitted to Health Canada in September 2024[11] - HLX22 (Anti-HER2 Humanized Monoclonal Antibody) received FDA approval for a Phase 3 clinical trial in combination with trastuzumab and chemotherapy for HER2-positive advanced gastric cancer in May 2024[11] - HLX53 (Anti-TIGIT Fc Fusion Protein) in combination with Hansizhuang® and Hanbeitai® received IND approval in China for a Phase 2 clinical trial in April 2024, with the first patient dosed in August 2024[11] - HLX14 completed a Phase 1 clinical study in healthy male subjects in China in January 2024, achieving all predefined endpoints[11] - HLX42 (EGFR-Targeted Antibody-Drug Conjugate) completed the first patient dosing in a Phase 1 clinical trial for advanced/metastatic solid tumors in China in March 2024[11] - HLX6018 (Anti-GARP/TGF-β1 Humanized Monoclonal Antibody) received IND approval in China for idiopathic pulmonary fibrosis in March 2024, with the first subject dosed in April 2024[11] - HLX78 (Lasofoxifene Tablets) received IND approval in China in May 2024, following its licensing for an international multicenter Phase 3 clinical trial in January 2024[11] - HLX15 (Daratumumab Biosimilar) completed a Phase 1 clinical study in healthy male subjects in China in June 2024, achieving all predefined endpoints[11] - The company has a total of over 50 molecules and 14 R&D platforms, covering monoclonal antibodies, bispecific antibodies, ADCs, recombinant proteins, and small molecule conjugates[12] - The company's R&D activities are focused on research and development, with a reporting period ending June 30, 2024[151] Commercialization and Market Expansion - The company completed the acquisition of DDL, expanding its commercialization capabilities and business model[10] - The company signed an agreement with Fuhong Health Technology to introduce HANNAIJIA® (neratinib) for HER2-positive early breast cancer treatment in China[10] - The company's commercialization team has grown to nearly 1,500 people, driving the commercialization of 5 products in China, including Hanquyou® and Hansizhuang®[15] - Hanquyou® has benefited over 200,000 patients in China and has been approved in 48 countries and regions, including the US, UK, and Germany[17] - Hanquyou® became the first biosimilar monoclonal antibody approved in China, Europe, and the US for breast and gastric cancer treatment[16] - Hansizhuang® has expanded its international presence, with approvals in Indonesia, Cambodia, and Thailand for extensive-stage small cell lung cancer (ES-SCLC) treatment[19] - Hansizhuang® is the first PD-1 targeted monoclonal antibody globally approved for first-line treatment of ES-SCLC, giving it a competitive edge in the PD-1 market[19] - Hanlikang® has been approved in Peru, marking the company's third self-developed product to gain overseas approval[20] - Handayuan® has received approval for all eight indications of the original adalimumab in China, including rheumatoid arthritis and Crohn's disease[20] - The company completed the acquisition of DDL, enabling the commercialization of more licensed products and expanding its business channels[15] - Hanquyou® has been approved in Brazil, the Philippines, and Uzbekistan, further expanding its global market reach[17] - The company introduced Hanlaijia® (neratinib) in China, targeting HER2-positive early breast cancer patients, and is pushing for its commercialization[15] Shareholder and Equity Information - Shareholder Zhu Jun holds 50,000 H shares, representing 0.03% of the H share class and 0.01% of the total shares[130] - Chen Qiyu holds 17,930,400 ordinary shares in Fosun International, representing 0.22% of the share class, and 18,450,000 share options, representing 0.23%[131] - Wu Yifang holds 373,000 H shares and 1,007,100 A shares in Fosun Pharma, representing 0.07% and 0.05% of the respective share classes[131] - Fosun Pharma holds 265,971,569 non-listed shares, representing 69.98% of the non-listed share class and 48.94% of the total shares[135] - Fosun International holds 291,365,387 non-listed shares, representing 76.66% of the non-listed share class and 53.61% of the total shares[135] - Fosun High-Tech holds 291,365,387 non-listed shares, representing 76.66% of the non-listed share class and 53.61% of the total shares[135] - Fosun International holds 32,331,100 H shares, representing 19.78% of the H share class and 5.95% of the total shares[135] - Wu Yifang holds a bond with a principal amount of 700,000,000dueonMay18,2026,andanotherwithaprincipalamountof700,000,000 due on May 18, 2026, and another with a principal amount of 500,000,000[132] - Wenjie Zhang holds an 8.93% stake in HenLink, which directly holds 2.92% of the company's shares[133] - Zhu Jun holds a 3.09% stake in Shanghai Guoyun, which directly holds 0.99% of the company's shares[132] Share Incentive Plans - The 2018 Share Incentive Plan involved a total of 22,750,000 shares, representing approximately 4.19% of the company's total issued shares at the time, with 11,714,650 shares held by Shanghai Guoyun and 11,035,350 shares held by HenLink[143] - The 2020 Share Incentive Plan was adopted to purchase restricted interests from resigned 2018 participants, including 360,700 non-listed shares from Shanghai Guoyun and 2,420,000 non-listed shares from HenLink, representing approximately 0.51% of the company's total issued shares[146] - The 2018 Share Incentive Plan had three categories of participants with different vesting schedules: Category 1 participants had 60% of their shares vested by April 30, 2020, Category 2 had 35%, and Category 3 had 20%[145] - The 2020 Share Incentive Plan also had three categories of participants with different vesting schedules: Category 1 participants had 60% of their shares vested by April 30, 2021, Category 2 had 20%, and Category 3 had 55% by April 30, 2023[147] - All shares under the 2018 and 2020 Share Incentive Plans were fully vested by 2023, with no unvested or unallocated shares during the reporting period[148] - The company's H shares are listed and traded on the Hong Kong Stock Exchange with a par value of RMB 1.00 per share[150] - The global offering includes 6,469,600 H shares for the Hong Kong public offering and 58,225,800 H shares initially available for subscription[150] - The company's shares are held by shareholders, with each share having a par value of RMB 1.00[151] - The company's H shares are denominated in Hong Kong dollars and traded on the Hong Kong Stock Exchange[150] - The company's global offering includes an over-allotment option for 4,366,400 H shares[150] Production and Operations - The company has a production base in Songjiang District, Shanghai, with a total planned area of 200 mu for the "Henlius Biopharmaceutical Industrialization Base (II)"[152] - The company's production base in Xuhui District, Shanghai, is located on Yishan Road[152] - The company's production base in Songjiang District, Shanghai, is under construction with a total planned area of 200 mu[152] - The company operates in a single reportable segment, focusing on biopharmaceutical R&D, services, and production[89] - The