[Table_Main] 证券研究报告 | 公司点评 康方生物(09926.HK) 2024年03月21日 康方生物(9926.HK)：管线矩阵 买入（维持） 所属行业：医疗保健业/药品及生物科技 丰富，多个产品将获批，收入有 当前价格(港币)：50.70元 望继续高增 证券分析师 李霁阳 投资要点 资格编号：S0120523080003 邮箱：lijy7＠tebon.com.cn 业绩：2024年3月19日，康方生物发布2023年度，总收入为45.26亿元，同比  增长 440%。2023 年产品销售额 16.31 亿元（同比增长 48%），公司确认的年度 技术授权和技术合作收入约人民币 29.23 亿元，主要来自 Summit 支付的依沃西 (AK112, PD-1/VEGF) 授权许可首付款。由于上述原因，2023年盈利19.42亿元。 公司全年研发总投入 12.54 亿元人民币，2023年末，公司现金储备约 49亿元人 市场表现 民币。截至2023年12月31日，公司雇员数2778名，研发人员320人，临床人 员 679人，销售 788人。截至 2023年，公司已有 3个新药获批上市，6个新药 康方 ...

Investment Rating - The report maintains a "Buy" rating for 康方生物 (9926.HK) with a target price of HKD 65, indicating a potential upside of 30% from the current price of HKD 49.95 [1][2][12]. Core Insights - 康方生物's 2023 revenue and net profit are broadly in line with expectations, with a significant growth in 开坦尼, projected to continue with a revenue growth rate of over 20% in 2024. The company anticipates a moderate increase in R&D expenses for 2024 [1][2]. - Key catalysts for the company include the mid-term analysis results of the head-to-head trials of 依沃西 and K药, expected to be announced by the end of Q2 2024, with a high probability of success [1][2]. Financial Performance Summary - In 2023, 康方生物 reported a revenue of RMB 45.3 billion, a year-on-year increase of 440%, with product sales revenue rising by 48% to RMB 16.3 billion. The gross margin for product sales improved by 0.3 percentage points to 91.8% [2][8]. - The net profit attributable to shareholders for 2023 was RMB 19.4 billion, aligning with expectations. Excluding technology licensing and collaboration income, the net loss narrowed by 45% to RMB 7.9 billion [2][8]. - For 2024, the revenue forecast is RMB 3.27 billion, reflecting a decrease of 27.8% year-on-year, followed by a recovery in 2025 with a projected increase of 27.8% [8][9]. R&D and Future Prospects - R&D expenses for 2023 were RMB 1.25 billion, a decrease of 5% year-on-year, with plans for a moderate increase in 2024 while maintaining high efficiency [2][9]. - The company has several upcoming catalysts, including the expected approval of three new drugs in 2024 and important phase III clinical trial results [2][9].

交银国际研究 公司更新 医药 收盘价 目标价 潜在涨幅 2024年3月19日 港元49.95 港元70.00↑ +40.1% 康方生物 (9926 HK) 2023 年业绩强劲，即将步入催化剂多点开花的一年，上调目标价  开坦尼全年销售略超预期，扣除一次性收入后净亏损明显收窄：2023 年 个股评级 公司收入45.3 亿元，同比+440%。其中卡度尼利销售额13.6 亿元（上半 买入 年 6.1 亿，下半年 7.5 亿，环比+24% ），同比+149%，略超我们预期的 13.1亿元。公司预计2024年开坦尼销售将。全年研发费用12.5亿元，同 比-5%，占比产品收入78%（vs. 2022年 159%），费用下降主因临床团队 1年股价表现 建设降低了对 CRO 的依赖。公司于 2023 年首次实现全年盈利（19.4 亿 9926 HK 恒生指数 元），扣除一次性的技术授权即合作收入的影响后，净亏损7.9亿元，相 15% 10% 比2022 年的14.3 亿元亏损已有明显收窄。截至2023 年末，公司现金储 5% 0% 备达49.0亿元，为后续全球范围内的临床研发奠定坚实基础。 -5% -10% -15%  ...

Investment Rating - The report maintains a "Buy" rating for the company, indicating an expected price increase of over 15% within the next 6-12 months [3][8]. Core Insights - The company reported a revenue of 4.526 billion yuan for 2023, a significant year-on-year increase of 440%. The annual profit reached 1.942 billion yuan, a turnaround from a loss of 1.422 billion yuan in 2022 [2][3]. - The revenue growth was primarily driven by product sales, particularly the sales of Kadunili, which amounted to 1.358 billion yuan, reflecting a 149% increase compared to the previous year [2]. - The company confirmed technology licensing and cooperation income of 2.923 billion yuan, mainly from the upfront payment received from Summit Therapeutics for the licensing of Iwoshu [2]. - The company has submitted three product applications for market approval, including Iwoshu (PD-1/VEGF), Inusui (AK102, PCSK9), and Iruoqi (IL-2/IL-23), with Iwoshu's approval expected soon [2]. Financial Performance Summary - For 2023, the company achieved a revenue of 4.526 billion yuan, with a growth rate of 440% compared to 2022. The net profit for the same period was 1.942 billion yuan, a significant recovery from a net loss of 1.168 billion yuan in 2022 [6]. - The projected revenues for 2024, 2025, and 2026 are 3.008 billion yuan, 4.835 billion yuan, and 6.487 billion yuan, respectively, with corresponding net profits of -72 million yuan, 444 million yuan, and 981 million yuan [6][7]. - The company’s diluted earnings per share for 2023 was 2.41 yuan, with projections of -0.09 yuan for 2024, 0.53 yuan for 2025, and 1.17 yuan for 2026 [6][7].

研究报告Research Report 19 Mar 2024 康方生物 Akeso (9926 HK) AK104 销售 13.6 亿元，多款产品即将进入商业化阶段 AK104 Product Sales of 1358 mnRMB, Multiple Pipeline to Enter Commercial Stage [观Ta点ble聚_y焦em Ieniv1e]s tment Focus [Tab维le_持Info优] 于大市Maintain OUTPERFORM (Please see APPENDIX 1 for English summary) 事件 评级 优于大市OUTPERFORM 现价 HK$51.85 康方生物 2023 年营收 45.3 亿元（+441%）。产品销售 16.3 亿元 目标价 HK$62.80 （+48%），其中卡度尼利（AK104）销售额 13.6 亿元；技术授权 HTI ESG 2.7-1.6-3.5 和技术合作收入 29.2 亿元，主要为与 SUMMIT 合作和许可协议的 E-S-G: 0-5, (Please refer to the Appendix for E ...

Investment Rating - The report maintains a "Recommended" rating for the company [2][3]. Core Insights - The company achieved impressive performance in 2023, turning a profit with a net income of 1.942 billion RMB, a significant improvement from the previous year's loss. Revenue reached 4.526 billion RMB, marking a 440% increase year-on-year, the highest since its listing [2]. - The company has a strong innovation and research capability, with over 50 clinical innovation projects, including 19 products in clinical trials, 6 of which are potential First-In-Class or Best-In-Class bispecific antibodies. R&D investment in 2023 was 1.254 billion RMB, a 5% decrease from the previous year [2]. - Three products have been successfully commercialized, with significant sales growth. The product Katanil (PD-1/CTLA-4) achieved sales of 1.358 billion RMB, a 149% increase year-on-year. The company has also made progress in clinical trials for new indications [2]. Financial Summary - For 2024, the company is projected to achieve revenues of 2.774 billion RMB, with a net profit of -372 million RMB. The forecasts for 2025 and 2026 are revenues of 4.053 billion RMB and 5.900 billion RMB, with net profits of 205 million RMB and 483 million RMB, respectively [3][6]. - The company's cash reserves stood at 4.9 billion RMB, indicating a strong liquidity position [2]. - The report highlights a significant increase in operating cash flow to 2.468 billion RMB in 2023, with expectations of 2.109 billion RMB in 2024 [9].

Financial Performance - For the fiscal year ending December 31, 2023, the total revenue of the company was RMB 4,526.3 million, a significant increase of 440% compared to RMB 837.7 million for the fiscal year ending December 31, 2022[4]. - The company reported a gross profit of RMB 4,393.0 million for the fiscal year ending December 31, 2023, up 491% from RMB 743.5 million in the previous year, primarily due to substantial growth in technology licensing and collaboration revenue[4]. - The company achieved a profit of RMB 1,942.4 million for the fiscal year ending December 31, 2023, a significant turnaround from a loss of RMB 1,422.2 million in the previous year[6]. - The total comprehensive income after deducting distribution costs for the year ended December 31, 2023, was RMB 4,526.3 million, compared to RMB 837.7 million in the previous year, reflecting a significant increase[58]. - The gross profit for the year ended December 31, 2023, was RMB 4,393.0 million, with a gross profit margin of 97.06%, up from 88.76% in the previous year[58]. - The company reported a pre-tax profit of RMB 1,942.5 million for the year ended December 31, 2023, compared to a loss of RMB 1,422.2 million in the previous year[58]. - The overall comprehensive income for the year ended December 31, 2023, was RMB 1,936.5 million, compared to a loss of RMB 1,293.6 million in the previous year[58]. - The company reported a net profit attributable to shareholders of RMB 2,028,300 thousand in 2023, a substantial increase from a loss of RMB 1,168,393 thousand in 2022[102]. - Basic earnings per share for 2023 was RMB 2.42, a recovery from a loss of RMB 1.42 per share in 2022[102]. Revenue Sources - The annual product sales amounted to approximately RMB 1,631.1 million, with the product Kantonin® (Cardinili, PD-1/CTLA-4) generating sales of RMB 1,357.8 million, reflecting a 149% increase from RMB 546.3 million in the previous year[6]. - The annual technology licensing and collaboration revenue was approximately RMB 2,922.8 million, mainly contributed by the upfront payment from Summit Therapeutics Inc for the licensing of AK112 (PD-1/VEGF)[6]. - The revenue from technology licensing and cooperation amounted to RMB 2,922,775,000 in 2023, compared to RMB 3,920,000 in 2022, indicating a substantial increase[114]. - Revenue from domestic customers in China was RMB 1,593,541,000 in 2023, up from RMB 837,656,000 in 2022, reflecting a growth of about 90%[120]. - Revenue from the United States reached RMB 2,931,509,000 in 2023, with no revenue reported in 2022, marking a new market entry[120]. Research and Development - The company has over 50 innovative projects in development, including 19 in clinical trials, with 6 being potential first-in-class or best-in-class bispecific antibodies[5]. - The company is focusing on tumor immunotherapy, with several products in clinical trials, including Cardunili and AK112, which are expected to cover a broad range of indications[20]. - The company has established multiple self-developed technology platforms, such as ADC, cell therapy, and mRNA, to explore a wide range of therapeutic areas[22]. - The company is actively advancing clinical research for other products, including AK111 (IL-17) and AK120 (IL-4R)[22]. - The company is conducting over 20 clinical trials for its core dual antibodies, Cardinili and Iwosi, covering 16 indications including gastric, liver, lung, cervical, esophageal squamous, and colorectal cancers, with 6 key Phase III trials ongoing[53]. Clinical Trials and Approvals - Cardunili achieved significant milestones in two Phase III clinical trials for gastric and cervical cancer, with the gastric cancer trial demonstrating long-term survival benefits and the submission of a new indication application expected in January 2024[10]. - The Phase III trial for AK112 (PD-1/VEGF) in NSCLC reached its primary endpoint in 2023, with the new drug application accepted for priority review in August 2023, marking a step towards commercialization[13]. - The company has successfully submitted NDAs for AK102 (PCSK9) and AK101 (IL-12/IL-23) in 2023, targeting hypercholesterolemia and moderate to severe plaque psoriasis, respectively[18]. - The company has received NDA acceptance for innovative products in the field of metabolic diseases, including AK102 (PCSK9) in June 2023 and AK101 (IL-12/IL-23) in August 2023[21]. - The company submitted sNDA for Pidilizumab and AK105 in China, targeting ≥3L nasopharyngeal carcinoma and 1L nasopharyngeal carcinoma, respectively[26]. Market Expansion and Strategy - The company aims to become a leading global biopharmaceutical enterprise through efficient and innovative R&D to develop first-in-class or best-in-class therapies[5]. - The company is actively promoting the hospital and commercial insurance access for Kantonin®, which is now included in 15 provinces and approximately 70 local commercial insurance products, significantly improving patient accessibility[9]. - The company has expanded the sales rights for Anikou in 11 Southeast Asian countries, enhancing its market presence[17]. - The company aims to leverage Cardunili and AK112 as cornerstone therapies to cover a wider market space through extensive combination strategies[20]. - The company is exploring market expansion opportunities, particularly in the oncology sector[149]. Financial Stability and Growth - As of December 31, 2023, the company's current assets totaled RMB 5,676.8 million, with cash and cash equivalents, time deposits, and financial products amounting to RMB 4,894.4 million, an increase of RMB 2,606.0 million from RMB 2,288.4 million as of December 31, 2022[71]. - The company's current liabilities as of December 31, 2023, were RMB 1,204.6 million, including trade payables of RMB 354.8 million and other payables of RMB 443.6 million[72]. - The group reported a current ratio of 4.39 as of December 31, 2023, compared to 2.0 in the previous year, indicating improved liquidity[78]. - The group has no significant contingent liabilities as of December 31, 2023, ensuring a stable financial position[77]. - The company plans to continue expanding its market presence and investing in new technologies to drive future growth[102]. Employee and Operational Growth - As of December 31, 2023, the total number of employees increased to 2,778, up from 2,341 in 2022, reflecting ongoing talent acquisition efforts[48]. - Total employee compensation costs for the group reached RMB 847.1 million for the year ended December 31, 2023, up from RMB 624.1 million for the year ended December 31, 2022, driven by an increase in employee numbers[82]. - The group has adopted various employee training programs to enhance staff knowledge and skills, supporting its operational growth[82]. Corporate Governance and Compliance - The board of directors does not recommend the declaration of a final dividend for the reporting period, consistent with the previous year[85]. - The company operates under the regulatory framework of the National Medical Products Administration (NMPA) in China, affecting its product approval processes[149]. - The company has established a clear revenue recognition policy based on the timing of customer acquisition of relevant technology rights, ensuring compliance with accounting standards[116].

智通财经APP讯，康方生物(09926)发布公告，于2024年2月8日(交易时段后)，该公司、买方中山康方生物医药有限公司(公司的间接全资附属公司)、卖方东瑞生物投资发展(亚洲)有限公司、东瑞制药与康融东方订立股权转让协议，据此，卖方同意出售，而买方同意按代价购买康融东方35%股权。完成收购事项后，康融东方将成为公司的间接全资附属公司。代价为人民币2.67亿元。买方须于股权转让协议日期起计第40个营业日起计120日内向卖方支付代价。预期代价将以集团内部资源拨付。公司将就买方于股权转让协议项下的付款责任提供担保。就收购事项而言，康融东方将向卖方偿还未偿还股东贷款(康融东方结欠卖方的无抵押股东贷款，其未偿还金额为人民币1.23亿元，相当于截至股权转让协议日，(i)未偿还本金总额人民币1.16亿元及(ii)贷款应计利息人民币711.27万元的总和)，有关还款责任将由买方担保。东瑞制药将就卖方履行其于股权转让协议项下的责任提供担保。 康融东方是一家集抗体药物开发、生产和销售于一体的创新生物制药公司，由买方以技术和产品注入，卖方以资金注入的形式，于2016年12月合资成立。康融东方紧跟科学发展前沿，专注心血管，肿瘤等重 ...

Company Overview - Akeso, Inc. has over 30 innovative projects in development, with 19 in clinical trials, including 3 commercialized products and 4 licensed products[15]. - The company aims to develop first-in-class or best-in-class therapies, focusing on oncology, autoimmune, and metabolic diseases[15]. - Akeso's TETRABODY technology addresses three major CMC challenges in developing and producing bispecific antibodies[15]. Financial Performance - Total revenue for the six months ended June 30, 2023, was RMB 3,676.9 million, a significant increase of 2,154.4% compared to RMB 163.1 million for the same period in 2022, primarily driven by product sales and licensing fees[26]. - Gross profit for the same period was RMB 3,599.7 million, up 2,566.4% from RMB 135.0 million year-over-year, mainly due to a substantial increase in licensing fee income[27]. - Profit for the six months ended June 30, 2023, was RMB 2,489.5 million, a turnaround from a loss of RMB 691.9 million in the same period of 2022, representing a year-over-year growth of 459.8%[28]. - The company recorded a profit of approximately RMB 2,489.5 million for the reporting period, marking its first half-year profit, compared to a loss of RMB 691.9 million for the same period in 2022[29]. - Product sales for the reporting period amounted to RMB 794.7 million, with the innovative drug 开坦尼® (卡度尼利) contributing RMB 605.8 million to this total[30]. - The company confirmed RMB 2,915.2 million as licensing fee income from the collaboration agreement for the dual antibody drug 依沃西 (AK112) with Summit Therapeutics, significantly boosting its cash reserves[31]. - License fee income for the six months ended June 30, 2023, was RMB 2,919.0 million, up from zero in the same period of 2022, primarily due to a collaboration agreement for the dual antibody drug[91]. - Other income and gains for the six months ended June 30, 2023, amounted to RMB 380.1 million, a 400.1% increase from RMB 76.0 million in the same period of 2022, mainly due to foreign exchange gains and government subsidies[95]. - The company’s total comprehensive income for the six months ended June 30, 2023, was RMB 2,498.2 million, compared to a loss of RMB 611.8 million in the same period of 2022[93]. Clinical Development and Product Pipeline - The company has over 30 innovative projects in development, with 19 in clinical trials, including 6 potential first-in-class or best-in-class bispecific antibodies[37]. - The clinical development of 依沃西 is being efficiently advanced in collaboration with Summit, with the first patient dosed in the U.S. for a global Phase III trial[33]. - The company is actively preparing for the commercialization of 伊努西单抗 (AK102) and 依若奇单抗 (AK101), with new drug applications accepted by the CDE[36]. - The innovative product AK102 (PCSK9) for metabolic diseases received acceptance for its new drug application in June 2023[39]. - The company has a rich pipeline in autoimmune diseases, with AK101 (IL-12/IL-23) receiving acceptance for its new drug application in August 2023[39]. - The company is focusing on expanding its market presence through the combination of its dual antibodies Katanin and AK112, aiming for broader market coverage[38]. - The company is actively pursuing clinical research for other products, including AK111 (IL-17) and AK120 (IL-4R)[39]. - The company is exploring various combination therapies for its core products, targeting multiple cancer types and stages[41]. - The company aims to leverage its innovative therapies to address a wide range of indications, including solid tumors and hematological malignancies[38]. - The company is committed to advancing its clinical research and product development to enhance its competitive position in the oncology market[41]. Collaborations and Partnerships - The company is collaborating with Rongpu Biotechnology for the development of its licensed product, Puyuheng (PD-1)[39]. - The company achieved a significant milestone in March by entering into a collaboration with Lixin Pharmaceutical to advance the development of AK112 combined with Lixin's LM-302 for related solid tumors[52]. - In March, the company partnered with Shanghai Pharmaceuticals to advance the development of Cardonili combined with SPH4336 for high-grade liposarcoma and dedifferentiated liposarcoma[46]. Clinical Trials and Approvals - The company completed enrollment for a key Phase III clinical trial of Cardonili combined with chemotherapy for unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma in March[46]. - In April, the company received CDE approval for a Phase II clinical trial of Cardonili combined with AK117 for neoadjuvant treatment of gastric or gastroesophageal junction adenocarcinoma[46]. - In June, two-year follow-up data for Cardonili combined with chemotherapy for gastric or gastroesophageal junction adenocarcinoma was presented at the 2023 ASCO annual meeting[48]. - The company received CDE approval in July for a Phase III clinical trial comparing Cardonili combined with chemotherapy against Tislelizumab combined with chemotherapy for PD-L1 negative locally advanced or metastatic NSCLC[49]. - In June, Phase II clinical data for AK112 combined with chemotherapy for EGFR/ALK negative advanced or metastatic NSCLC was presented at the 2023 ASCO annual meeting[54]. - The company initiated a Phase III clinical trial in May comparing AK112 combined with chemotherapy against Tislelizumab combined with chemotherapy for squamous NSCLC[52]. - The company completed patient enrollment for a Phase III clinical trial in August comparing AK112 monotherapy against Pembrolizumab monotherapy for PD-L1 positive NSCLC[55]. Employee and Operational Metrics - The company has a total employee count of 2,520 as of June 30, 2023, an increase from 2,289 on June 30, 2022, reflecting a growth of approximately 10.1%[81]. - The company has a total operational capacity of 54,000 liters, with ongoing expansion plans to meet future clinical and commercialization needs[82]. Shareholder Information and Corporate Governance - As of June 30, 2023, the total number of issued shares was 841,057,176, with significant shareholdings reported by various directors and entities[134]. - Dr. Xia Yu holds a total of 136,570,582 shares, representing approximately 16.24% of the issued shares, indicating substantial ownership[135]. - The company has received approval from the Stock Exchange to remove the "B" designation from its stock name effective March 28, 2023, due to the inapplicability of certain listing rules[131]. - The board of directors has undergone changes, with Mr. Tan Bo appointed as an independent non-executive director of Genting New Year Limited on January 19, 2023[132]. - The company has adopted corporate governance practices and complies with applicable codes, with the current structure allowing the same individual to serve as both Chairman and CEO[117]. Restricted Share Unit Plans - The company adopted a pre-IPO restricted share unit plan on August 29, 2019, to incentivize participants and attract talent for further development[146]. - A total of 45,270,499 shares are available for delivery under the pre-IPO restricted share unit plan[148]. - The plan allows participants to receive shares or cash equivalent to the market value of shares at the time of vesting, with a reward price set at RMB 1.00 per share[147]. - The 2021 Restricted Share Unit Plan is effective for ten years from December 6, 2021, with approximately 8 years and 3 months remaining as of the report date[186]. - The maximum number of shares involved in the rewards granted under the 2021 Restricted Share Unit Plan cannot exceed 10% of the total issued share capital during the trust period[187]. - The plan limits the maximum number of shares granted to any selected participant to 1% of the total issued share capital in any 12-month period[191]. - The plan prohibits granting rewards during specific periods, including 60 days prior to the annual results announcement and 30 days prior to the interim results announcement[191].

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容 概不負責，對其準確性或完整性亦不發表任何聲明，並明確表示，概不就 因本公告全部或任何部分內容而產生或因倚賴該等內容而引致的任何損 失承擔任何責任。 Akeso, Inc. 康 方 生 物 科 技（ 開 曼 ）有 限 公 司 （於開曼群島註冊成立的有限公司） （股份代號：9926） 截 至2023年6月30日 止 六 個 月 中 期 業 績 公 告 康方生物科技（開曼）有限公司董事會謹此公佈本集團截至2023年6月30日 止六個月的未經審核簡明綜合業績。 於本公告中，「我們」指本公司或按文義指本集團。 財務摘要 1. 收入 截至2023年6月30日止六個月，本集團總收入為人民幣3,676.9百萬元， 較 截 至2022年6月30日 止 六 個 月 為 人 民 幣163.1百 萬 元，同 比 增 長 2,154.4%。該收入主要來自藥物銷售以及許可費收入。 ...