Financial Performance - Total revenue for 2023 reached RMB 6,206.1 million, a year-on-year increase of 36.2%, with product revenue at RMB 5,728.3 million, up 38.4%[7] - LBITDA decreased significantly by 73.0% year-on-year to RMB 600.1 million, driven by strong product sales growth and improved cost efficiency[7] - The company's cash and short-term financial assets amounted to approximately RMB 10,969.6 million (over USD 1.5 billion), ensuring a strong financial position[7] - Gross margin increased by 2.0 percentage points, while the ratio of sales and marketing expenses to total revenue decreased by 7.3 percentage points[7] - Total revenue for the year ended December 31, 2023, was RMB 6,206.1 million, a 36.2% increase compared to RMB 4,556.4 million in 2022[15] - Product revenue reached RMB 5,728.3 million in 2023, up 38.4% from RMB 4,139.1 million in 2022[15] - Gross profit margin for 2023 was 81.7%, an increase of 2.1 percentage points from 79.6% in 2022[15] - R&D expenses for 2023 were RMB 2,227.6 million, down from RMB 2,871.2 million in 2022[15] - Sales and marketing expenses for 2023 were RMB 3,100.7 million, accounting for 50.0% of total revenue, compared to 56.9% in 2022[15] - Adjusted LBITDA for 2023 was RMB 600.1 million, a 73.0% decrease from RMB 2,221.5 million in 2022[17] - Adjusted net loss for 2023 was RMB 514.5 million, a 79.1% reduction from RMB 2,461.8 million in 2022[17] - Revenue from customer contracts increased to RMB 6,206.1 million in 2023, up from RMB 4,556.4 million in 2022, driven by growth in pharmaceutical product sales, licensing fees, and R&D service income[95] - Pharmaceutical product sales reached RMB 5,728.3 million in 2023, a significant increase from RMB 4,139.1 million in 2022[95] - Licensing fee income rose to RMB 447.4 million in 2023, compared to RMB 417.1 million in 2022, with a notable one-time licensing fee of RMB 5.1 million recorded in 2023[95] - R&D service income surged to RMB 30.3 million in 2023, up from RMB 0.2 million in 2022[95] - Gross profit improved to RMB 5,069.8 million in 2023, up from RMB 3,625.4 million in 2022, reflecting higher revenue and controlled sales costs[94] - R&D expenses decreased to RMB 2,227.6 million in 2023, down from RMB 2,871.2 million in 2022, as the company optimized its R&D investments[99] - Sales and marketing expenses increased to RMB 3,100.7 million in 2023, up from RMB 2,590.8 million in 2022, as the company expanded its market presence[101] - Other income, primarily from interest and government subsidies, rose to RMB 552.4 million in 2023, up from RMB 279.7 million in 2022[97] - The company recorded a tax credit of RMB 116.5 million in 2023, compared to a tax expense of RMB 8.8 million in 2022, due to a refund of withholding tax on licensing fees[103] - Total comprehensive loss for the year improved to RMB 1,013.8 million in 2023, down from RMB 2,200.6 million in 2022, reflecting better operational performance[94] - Adjusted gross profit for 2023 was RMB 5,141,648 thousand, compared to RMB 3,682,300 thousand in 2022[104] - Adjusted R&D expenses for 2023 were RMB 1,974,933 thousand, a decrease from RMB 2,664,708 thousand in 2022[105] - Adjusted administrative and other expenses for 2023 were RMB 543,759 thousand, down from RMB 641,812 thousand in 2022[105] - Adjusted sales and marketing expenses for 2023 were RMB 3,057,482 thousand, up from RMB 2,578,373 thousand in 2022[105] - Adjusted LBITDA for 2023 was RMB 600,148 thousand, an improvement from RMB 2,221,450 thousand in 2022[107] - Adjusted net loss for 2023 was RMB 514,540 thousand, compared to RMB 2,461,834 thousand in 2022[107] - Total assets increased to RMB 20,627,360 thousand in 2023 from RMB 17,588,845 thousand in 2022[109] - Cash and cash equivalents increased to RMB 10,969.6 million in 2023 from RMB 9,166.0 million in 2022[110] - The company has unused long-term bank loan facilities of approximately RMB 2,620.0 million as of December 31, 2023[110] - The company has pledged assets totaling RMB 1,804.9 million for property, plant, and equipment, RMB 275.6 million for land use rights, and RMB 849.8 million for bank deposits as collateral for loans and bank financing[115] - The company's total revenue from the top five customers accounted for 60.8% of the total revenue in 2023, with the largest customer contributing approximately 53.1%[127] - The company's total procurement from the top five suppliers accounted for 53.2% of the total procurement in 2023, with the largest supplier contributing approximately 26.2%[128] - The company's charitable donations for the year ending December 31, 2023, amounted to approximately RMB 154.7 million, compared to RMB 247.2 million in 2022[133] - The company did not issue any bonds during the year ending December 31, 2023[134] - The Board of Directors did not recommend the distribution of a final dividend for the year ending December 31, 2023[135] - The distributable reserve from the share premium account as of December 31, 2023, was RMB 27,324,496,000, compared to RMB 24,705,638,000 in 2022[136] Product Pipeline and R&D - The product pipeline includes 36 high-value candidates, with 10 products already approved for marketing and 3 under NMPA review[3] - Two new innovative products, Fucasso (Igeolonsa Injection) and Xinbile (Tolexizumab Injection), were approved for marketing in China[8] - Tyvyt (Sintilimab Injection) and Byvasda (Bevacizumab Injection) were approved for new indications and included in the NRDL (2023 edition)[8] - The company's product portfolio expanded to 10 commercialized products, with continued addition of new indications and NRDL coverage[8] - R&D efforts focus on oncology, cardiovascular and metabolic diseases, autoimmune disorders, and ophthalmology, with 18 new drug candidates in clinical trials[3] - Orelabrutinib tablets received approval for a second indication, benefiting more CML patients[9] - The company has 3 products under NMPA review, 5 products in Phase 3 or key clinical studies, and 18 molecules in early clinical research[9] - Fuzerex (KRAS G12C) and Taletrectinib (ROS1) are under NDA priority review, expected to be approved in 2024[9] - Sintilimab (Tyvyt®) achieved a new NSCLC indication and submitted an sNDA for EMC treatment in April 2024[9] - IBI362 (Mazdutide) reached primary and key secondary endpoints in the GLORY-1 study, with NDA submission for weight loss in February 2024[11] - IBI311 (anti-IGF-1R) achieved primary endpoints in the RESTORE-1 Phase 3 trial, with NDA submission planned for TED treatment[11] - The company plans to initiate a Phase 1 trial for Mazdutide in obese adolescents in China in 2024[11] - IBI112 (IL-23p19) demonstrated best-in-class long-term efficacy in a 58-week Phase 2 trial, with Phase 3 registration expected to support NDA submission in 2024[12] - The company’s Suzhou facility has 60,000L antibody production capacity, and the Hangzhou facility has 170,000L capacity (80,000L completed, 90,000L planned)[13] - The company's commercial product portfolio expanded to 10 products, with two new innovative products approved in China[18] - Four NDAs and sNDAs are under review by the NMPA, including IBI344, IBI351, and IBI362[18][19] - IBI362 (Mazdutide), a GLP-1R/GCGR dual agonist, is undergoing five Phase 3 clinical trials in China for overweight or obese adults (GLORY-1 and GLORY-2) and T2D patients (DREAMS-1, DREAMS-2, and DREAMS-3). The company expects to read out Phase 3 results for DREAMS-1 and DREAMS-2 in 2024 to support a second NDA submission for T2D treatment[20] - IBI112 (Piconcibart), a recombinant anti-IL-23p19 antibody, completed the first patient dosing in its Phase 3 trial (CLEAR) for moderate-to-severe plaque psoriasis in February 2023. The company expects to read out Phase 3 results in 2024 to support NDA submission[20] - IBI311, a recombinant anti-IGF-1R monoclonal antibody, achieved the primary endpoint in its Phase 3 trial (RESTORE-1) for TED in February 2024, with NDA submission expected in 2024[20] - IBI302 (Efdamrofusp alfa), an anti-VEGF/complement bispecific fusion protein, showed positive PoC results and completed the first patient dosing in its Phase 3 trial (STAR) for nAMD in October 2023[20] - IBI310, a novel anti-CTLA-4 monoclonal antibody, demonstrated positive PoC results and plans to initiate a Phase 3 trial in 2024 for neoadjuvant treatment of resectable MSI-H/dMMR colon cancer in combination with Sintilimab[20] - IBI363 (PD-1/IL-2) showed encouraging preliminary efficacy and safety in IO-resistant or non-responsive tumors, with preclinical results published in Nature Cancer[21][22] - The company advanced eight innovative molecules to the IND preparation stage in 2023, adding long-term momentum for global innovation and sustainable growth[22] - Strategic collaborations were established, including a partnership with Shengxin Biotech to develop SGB-3908, an siRNA candidate targeting AGT for hypertension treatment[22] - The company has 10 commercialized products, with 3 under NMPA review and 5 in Phase 3 or pivotal clinical studies, along with 18 molecules in early clinical research[31] - Two innovative products, Fucasso (Igeocel Injection) and Xinbile (Tolexizumab Injection), were approved in China in 2023[27] - The company expects to receive approval for two innovative products, Fuzerex (KRAS G12C) and Taletrectinib (ROS1), in 2024 for NSCLC treatment[28] - The company submitted an sNDA for Tyvyt (Sintilimab Injection) combined with Fruquintinib for 2L EMC treatment, which was accepted by NMPA with priority review status in April 2024[31] - The company initiated a Phase 3 trial for IBI310 (CTLA-4) combined with Sintilimab for colon cancer neoadjuvant therapy in March 2024[31] - IBI363 (PD-1/IL-2) and IBI389 (CLDN18.2/CD3) are advancing in early clinical studies, with early clinical data expected to be released at medical conferences in 2024[32] - IBI362 (Mazdutide) achieved primary and key secondary endpoints in the GLORY-1 study, and the company submitted the first NDA for weight loss in February 2024, with plans to submit a second NDA for T2D treatment based on DREAMS-1 and DREAMS-2 results[33] - IBI311, the first domestic anti-IGF-1R monoclonal antibody for TED, reached the primary endpoint in the RESTORE-1 Phase 3 trial in February 2024, with plans to submit an NDA and release full results at medical conferences in 2024[34] - IBI112 (Piconcibai, IL-23p19) is in Phase 3 registration clinical studies for psoriasis, expected to be completed in 2024 to support NDA submission, showing best-in-class long-term efficacy and extended dosing intervals[35] - IBI343 (CLDN18.2 ADC) demonstrated best-in-class potential in MRCT Phase 1b studies for 3L GC, with preparations underway for MRCT Phase 3 trials[36] - The company has 10 products on the market, 3 under NDA review, 5 in Phase 3 or key clinical trials, and 18 molecules in early clinical stages[37] - IBI362 (Mazdutide) is in five Phase 3 clinical trials for obesity and T2D, with GLORY-1 results to be presented at medical conferences in 2024[33] - IBI128, a potential best-in-class XOI, is undergoing overseas Phase 3 clinical studies for hyperuricemia in gout patients, with plans to initiate Phase 1 and 2 trials in China in 2024[34] - The company is advancing a diverse pipeline of innovative drugs in CVM, with plans to enter clinical stages in 2024, aiming to strengthen its strategic position in the field[34] - IBI112 (Piconcibai, IL-23p19) demonstrated superior long-term efficacy and extended dosing intervals in a 58-week Phase 2 trial, supporting its advancement in autoimmune diseases[35] - The company's commercialized product portfolio has expanded to 10 products, including Tyvyt (sintilimab injection), Bevacizumab injection, Suliximab (adalimumab injection), Rituximab injection, Pemigatinib tablets, Olverembatinib tablets, Ramucirumab injection, Selpercatinib, Igeocel injection, and Tolezumab injection[40] - Tyvyt (sintilimab injection) has been approved for seven indications in China, including lung cancer, liver cancer, gastric cancer, esophageal cancer, and classical Hodgkin lymphoma[41] - In May 2023, the NMPA approved the seventh indication for Tyvyt (sintilimab injection) for the treatment of EGFR-mutated non-squamous NSCLC patients who failed EGFR-TKI therapy[42] - In February 2024, Tyvyt (sintilimab injection) was approved for marketing in Macau by the Macau Drug Administration[42] - In April 2024, the company submitted an sNDA for Tyvyt (sintilimab injection) combined with fruquintinib for the treatment of 2L EMC, which was accepted by the NMPA[42] - In January 2023, two new indications for Tyvyt (sintilimab injection) for 1L GC and 1L ESCC were included in the 2022 NRDL, making it the first and only PD-1 inhibitor for GC included in the NRDL[43] - In December 2023, the seventh indication for Tyvyt (sintilimab injection) for EGFR-mutated non-squamous NSCLC patients who failed EGFR-TKI therapy was included in the 2023 NRDL[43] - In June 2023, the NMPA approved the eighth indication for Bevacizumab injection, combined with Tyvyt (sintilimab injection) and chemotherapy for the treatment of EGFR-mutated non-squamous NSCLC patients who failed EGFR-TKI therapy[46] - In January 2023, seven indications for Bevacizumab injection were included in the 2022 NRDL, including three new indications for epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and cervical cancer[47] - In December 2023, the eighth indication for Bevacizumab injection was included in the 2023 NRDL[47] - Dabao Hua (Rituximab Injection) had all approved indications included in the 2022 NRDL, including two new indications for maintenance therapy of previously untreated follicular lymphoma and treatment of chronic lymphocytic leukemia[48] - Sulixin (Adalimumab Injection) was approved for eight indications in China, including rheumatoid arthritis, ankylosing spondylitis, psoriasis, uveitis, polyarticular juvenile idiopathic arthritis, pediatric plaque psoriasis, Crohn's disease, and pediatric Crohn's disease[49] - Sulixin (Adalimumab Injection) had eight indications included in the 2022 NRDL, including two new indications for Crohn's disease and pediatric Crohn's disease[50] - Dabotan (Pemigatinib Tablets) was included in Taiwan's health insurance reimbursement for the treatment of adult patients with locally advanced or metastatic CCA who have received at least one systemic therapy and have confirmed FGFR2 fusion or rearrangement[51] - Olverembatinib Tablets were approved by NMPA for the treatment of CML-CP patients resistant and/or intolerant to first- and second-generation TKIs[53] - Olverembatinib Tablets were included in the 2022 NRDL for the treatment of adult patients with CML-CP and CML-AP with T315I mutation[53] - Cyramza (Ramucirumab) was approved for two indications in mainland China, including second-line treatment for advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma and treatment for hepatocellular carcinoma patients with AFP ≥400 ng/mL who have previously received sorafenib treatment[55] - Retsevmo (Selpercatinib) was conditionally approved in mainland China for the treatment of adult patients with RET gene fusion-positive locally advanced or metastatic NSCLC and adult and pediatric patients 12 years and older with advanced or metastatic MTC
信达生物(01801) - 2023 - 年度财报