证券研究报告 公 2024年03月29日 司 报 告 金斯瑞生物科技(01548) 行 业： 医药生物/生物制品 │ 港 投资评级： 买入（维持） 股 当前价格： 14.50港元 细胞疗法+生命科学双轮驱动的 CGT 产业链龙头 - 公 目标价格： 27.43港元 司 事件： 年 基本数据 报 点 公司发布2023年度业绩，2023全年实现营收8.40亿美元，同比+34.2%； 总股本/流通股本(百万股) 2,123.86/2,123.86 评 毛利润4.10亿美元，同比+34.7%；经调整净利润-2.98亿美元，同比收窄 流通市值(百万港元) 30,795.98 17.0%。业绩基本符合预期。 每股净资产(元) 5.01 资产负债率(%) 38.36 ➢ 生命科学等非细胞疗法业务保持稳健增长 一年内最高/最低(港元) 24.95/12.56 2023年非细胞疗法业务营收5.55亿美元，同比+8.9%；经调整净利润0.58 亿美元，同比-6.9%。其中生命科学业务营收 4.05 亿美元，同比+15.6%， 股价相对走势 受益于欧美业务量和海外营运效率提升，经调整净利润0.78亿美元，同比 金斯瑞生物科技 +1 ...

研究报告Research Report 15 Mar 2024 金斯瑞生物科技 Genscript Biotech (1548 HK) 2023 年点评：生命科学业务展现韧劲，CARVYKTI 商业化持续放量，看好前线治疗获批 23FY Review: Life science business shows resilience, and the commercialization of CARVYKTI continues to increase, and we expect frontline treatment will be approved. [观Ta点bl聚e_焦yem Inevie1s] tment Focus [Tab维le_持Inf优o] 于大市Maintain OUTPERFORM (Please see APPENDIX 1 for English summary) 事件 评级 优于大市OUTPERFORM 现价 HK$17.20 公司发布 2023 年业绩：2023 年，公司实现营业收入 8.40 亿美元 目标价 HK$30.45 （+34%），其中非细胞治疗板块，外部收入5.55亿美 ...

金斯瑞生物科技（1548.HK）公司点评 CARVYKTI用于早期治疗获ODAC推荐，加速前线扩展和产能提升 2024年03月16日 ➢ 事件：3月16日，传奇生物发布公告，CARVYKTI获得美国FDA肿瘤药物 推荐 维持评级 咨询委员会（ODAC）用于复发或难治性多发性骨髓瘤患者早期治疗的推荐，该 当前价格： 17.20港元 积极建议是委员会对 3 期研究 CARTITUDE-4 的疗效和安全性数据进行评估后 提出的。ODAC一致投票支持CARVYKTI（11票对0票），认为其对拟议适应症 [Table_Author] 的风险-获益评估结果良好。CARTITUDE-4支持的补充生物制品许可申请正在接 受FDA审查，PDUFA目标日期为2024年4月5日。 ➢ CARVYKTI 持续提高市场渗透率，前线适应症扩展和产能提升快速推进。 2023年CARVYKTI实现5亿美元的全球销售额，同比增长273%，传奇生物持 续投入研发以推进 CARVYKTI 用于多发性骨髓瘤的前线治疗，目前已获得 FDA ODAC和EMA CHMP用于前线治疗的积极意见，公司预计2024年CARVYKTI 分析师 王班 标签扩展至前 ...

[Table_StockInfo] 买入 2024年 03月 12日 证券研究报告•2023年年报点评 当前价： 15.52港元 金斯瑞生物科技（1548.HK） 目标价： 32.55港元 Cilta-cel 持续高速放量，四位一体未来可期 投资要点 西南证券研究发展中心 [T ab事le件_S：um公m司a披ry露] 2023年年报，2023年集团实现收益 8.4亿美元（+34.2%）， [分Ta析bl师e_：Au杜th向or阳] 实现毛利4.1亿美元（+34.7%），集团亏损较2022年的约4.3亿美元收窄至约 执业证号：S1250520030002 3.6亿美元，经调整净亏损较2022年的约3.6亿美元收窄至约3亿美元。 电话：021-68416017 邮箱：duxy@swsc.com.cn  细胞疗法：Carvykti商业化持续放量，前线治疗临床试验推进顺利。2023年公 司细胞疗法外部收益约为2.9亿美元（+144.2%），CARVYKTI®（西达基奥仑赛， [相Tab对le指_Q数u表ot现eP ic] cilta-cel）2023Q4和全年净贸易销售额分别约为1.59亿美元和5亿美元。欧洲 ...

Investment Rating - The report maintains a "Buy" rating for King’s Ray Biotechnology (1548) [3][4]. Core Views - The company’s performance in 2023 met expectations, with revenue reaching $840 million, a 34.2% increase year-over-year. The adjusted net loss was $298 million, a reduction of $61 million compared to the previous year, primarily due to steady profit contributions from non-cell therapy businesses and rapid growth in CAR-T products in Europe and the U.S. [2][7]. - The company has a strong cash reserve of approximately $1.446 billion, which supports its operations and future growth [2]. - Revenue forecasts for 2024 and 2025 have been adjusted downwards to $1.251 billion and $1.792 billion, respectively, due to impacts from financing changes on the CDMO business and CAR-T production capacity. A new revenue estimate for 2026 is set at $2.756 billion [2][7]. - The non-cell therapy business showed steady growth, with external revenue of $555 million, an 8.9% increase. Life sciences services and product revenue reached $413 million, up 14.5%, although adjusted gross margins slightly declined [2][7]. - The CARVYKTI treatment for multiple myeloma (MM) is expected to receive approval in 2024, which could accelerate growth in cell therapy. The sales for CARVYKTI in 2023 were $500 million, with significant quarterly growth [2][7]. Summary by Sections Financial Performance - 2023 revenue was $840 million, a 34.2% increase from 2022. Adjusted net loss was $298 million, down from $359 million in 2022. [7] - The company forecasts revenue of $1.251 billion in 2024, $1.792 billion in 2025, and $2.756 billion in 2026, reflecting growth rates of 49%, 43%, and 54% respectively [7]. Business Segments - Non-cell therapy business revenue was $555 million, with life sciences services and products contributing $413 million. CDMO revenue was $110 million, down 12.4% due to slower financing and capacity ramp-up [2][7]. - The CAR-T therapy segment saw revenue of $285 million, a 143.7% increase, with significant contributions from milestone payments and sales sharing [2][7]. Market Outlook - The report highlights the potential for CAR-T therapies to exceed expectations in terms of market uptake, particularly with upcoming approvals in the U.S. and Europe [2][7].

Investment Rating - The report maintains a "Buy" rating for the company [1] Core Insights - The company achieved a total revenue of $841.55 million in 2023, representing a year-on-year growth of 33.89%, with a narrowed net loss of $95.48 million compared to a loss of $226.85 million in the previous year, slightly exceeding expectations [2][4] - The cell therapy business has shown significant growth, with sales of CARVYKTI reaching $500 million in 2023, a 273% increase year-on-year, and further approvals expected from FDA and EMA [3] - The life sciences segment reported a revenue of $405 million, a 15.64% increase, maintaining robust growth despite a decline in biopharmaceutical investment [3] - The company has adjusted its profit forecasts for 2024 and 2025, with expected net losses of $62.05 million and a profit of $33 million respectively, projecting a net profit of $163 million by 2026 [4] Financial Summary - Total revenue projections for the upcoming years are as follows: $1,168.83 million in 2024, $1,711.65 million in 2025, and $2,581.05 million in 2026, with corresponding growth rates of 38.89%, 46.44%, and 50.79% respectively [2][10] - The company’s gross profit margin is expected to improve from 48.78% in 2023 to 57.47% by 2026 [11] - The earnings per share (EPS) is projected to improve from -0.04 in 2023 to 0.08 in 2026, indicating a positive trend towards profitability [2][10]

Investment Rating - The report maintains a "Buy" rating for the company [3]. Core Insights - The life sciences business showed robust growth with revenues of approximately $413 million in 2023, a year-over-year increase of 14.5%, and an adjusted gross margin of 54.4% [2]. - The CDMO business experienced a slight decline in revenue, achieving $109 million in 2023, down 12% year-over-year, primarily due to capacity utilization and pricing pressures [2]. - Sales of the cell therapy product Cilta-cel surged to $500 million in 2023, reflecting a 273% increase year-over-year, indicating a strong growth trajectory [2]. - The company reported total revenues of $840 million for 2023, a 34.2% increase year-over-year, with an adjusted net loss of approximately $298 million, showing a reduction in losses compared to the previous year [2]. Financial Performance Summary - Revenue projections for 2024-2026 indicate significant growth, with expected revenues of $1.188 billion in 2024 and $3.099 billion in 2026, reflecting growth rates of 41.1% and 56.3% respectively [4]. - The adjusted net profit forecast for 2024 is -$106 million, improving to $114 million in 2025 and reaching $381 million in 2026 [4]. - The earnings per share (EPS) is projected to improve from -$0.05 in 2024 to $0.18 in 2026 [4].

Investment Rating - The report assigns a "Buy" rating for the company, Kingsray Biotech (1548 HK), with a target price of HKD 27.75, indicating a potential upside of 78.8% from the current closing price of HKD 15.52 [1][10]. Core Insights - The company demonstrated resilience in its performance during 2023, with revenues reaching USD 840 million, a year-on-year increase of 34.2%, aligning closely with previous expectations [1]. - Adjusted net loss for 2023 was USD 298 million, significantly better than the anticipated loss of USD 395 million, showcasing improved operational efficiency [1]. - The overall gross margin stood at 48.8%, exceeding the forecast of 46.5%, primarily driven by the rapid improvement in the gross margin of the cell therapy segment [1]. - The report anticipates a recovery in the company's CDMO business in 2024, supported by a gradual improvement in overseas financing and accelerated market expansion [1]. Revenue Performance and Guidance - Non-cell therapy business segments showed robust growth, with life sciences services generating external revenue of USD 405 million, up 16% year-on-year, slightly exceeding expectations [2]. - The report provides guidance for 2024, projecting a revenue growth of 15-20% for life sciences services, with gross margins stabilizing around 55% [2]. - The cell therapy segment is expected to achieve peak sales of at least USD 5 billion for cilta-cel, with production capacity anticipated to double by the end of 2025 [2]. Financial Projections - The report slightly adjusts revenue forecasts for 2024 and 2025 down by 0.6% and 0.5%, respectively, but reduces the net loss forecast for 2024 by 4% and increases the net profit forecast for 2025 from USD 940 million to USD 1.48 billion [2]. - The introduction of 2026 profit forecasts estimates revenue at USD 2.16 billion, with a compound annual growth rate (CAGR) of 37% from 2023 to 2026 [2]. Valuation and Target Price - The report employs a sum-of-the-parts (SOTP) valuation method, leading to a target price of HKD 27.75, maintaining the "Buy" rating [2][8]. - The valuation breakdown indicates that the cell therapy segment contributes significantly to the overall target valuation, accounting for 69% of the total [8].

Financial Performance - For the fiscal year ending December 31, 2023, the group's revenue was approximately $839.5 million, an increase of 34.2% from approximately $625.7 million for the fiscal year ending December 31, 2022[2]. - The group's gross profit for the fiscal year ending December 31, 2023, was approximately $409.6 million, up 34.7% from approximately $304.1 million for the fiscal year ending December 31, 2022[2]. - The adjusted net loss for the fiscal year ending December 31, 2023, narrowed to approximately $298.2 million from approximately $359.4 million in the previous year[3]. - The group reported a loss attributable to equity holders of approximately $95.5 million, a decrease from approximately $226.9 million in the previous year[3]. - Total revenue for the year ended December 31, 2023, was $839,529 thousand, compared to $625,698 thousand in 2022, representing a year-over-year increase of approximately 34.2%[19]. - The company reported a net fair value gain of $2,425 thousand on financial assets measured at fair value through profit or loss for the year[20]. - The net loss for the group was approximately $355.1 million in 2023, compared to a net loss of about $428.0 million in 2022, with an adjusted net loss of approximately $298.2 million[73]. Revenue Breakdown - The external revenue from non-cell therapy business was approximately $554.5 million, a growth of 8.9% compared to approximately $509.0 million in the previous year[2]. - The external revenue from cell therapy business surged to approximately $285.0 million, marking a significant increase of 144.2% from approximately $116.7 million in the previous year[2]. - Revenue from the Life Sciences Services and Products segment was approximately $412.9 million, a 14.5% increase from $360.5 million for the year ended December 31, 2022[52]. - Revenue from biopharmaceutical development services was approximately $109.5 million, a decrease of 12.4% compared to $125.0 million for the year ended December 31, 2022[54]. - Revenue from industrial synthetic biological products increased by 11.4% to approximately $43.1 million, while adjusted gross profit remained stable at approximately $16.6 million[57]. - Cell therapy revenue surged by 143.7% to approximately $285.1 million, with adjusted gross profit increasing by 171.5% to approximately $143.9 million, primarily due to collaboration and licensing agreements with Janssen[59]. Expenses and Costs - The group's total operating expenses, including R&D, were approximately $432.8 million, compared to $390.1 million in the previous year[7]. - The cost of services and products for 2023 was $213,555 thousand, up from $139,052 thousand in 2022, reflecting an increase of about 53.6%[21]. - Employee benefits expenses, including salaries and wages, totaled $510,429 thousand, up from $439,971 thousand in 2022, reflecting an increase of approximately 16.0%[21]. - Administrative expenses increased by 16.9% to approximately $213.4 million, primarily due to investments in talent and infrastructure[67]. - Selling and distribution expenses rose by 3.6% to approximately $174.3 million, while adjusted selling and distribution expenses increased by 4.9%[66]. Assets and Liabilities - Total non-current assets increased to $1,034,191 thousand in 2023 from $781,433 thousand in 2022, representing a growth of 32.4%[10]. - Current assets rose to $2,353,111 thousand in 2023, up from $1,764,950 thousand in 2022, marking an increase of 33.3%[10]. - The total liabilities decreased from $1,183,715 thousand in 2022 to $1,342,948 thousand in 2023, a reduction of 8.5%[11]. - The company’s equity increased to $2,044,354 thousand in 2023 from $1,362,668 thousand in 2022, an increase of 50%[12]. - The total equity as of December 31, 2023, was $1,931,934,000, an increase from $1,463,216,000 in 2022, representing a growth of approximately 31.9%[47]. - The company's total liabilities decreased to $1,893,724,000 in 2023 from $1,279,713,000 in 2022, indicating a reduction of approximately 48%[38]. Cash Flow and Financing - Cash and cash equivalents increased significantly to $1,446,403 thousand in 2023 from $1,023,999 thousand in 2022, reflecting a growth of 41.3%[13]. - The net cash flow from operating activities was negative at $(286,911) thousand in 2023, compared to $(120,292) thousand in 2022, indicating a decline in operational cash flow[13]. - The investment activities resulted in a net cash outflow of $(357,728) thousand in 2023, compared to $(443,296) thousand in 2022, showing a decrease in investment spending[13]. - Financing activities generated cash inflow of approximately $1.1 billion, with net proceeds from common stock and warrants amounting to about $783.4 million[80]. - The total interest-bearing loans and borrowings as of December 31, 2023, were $287,207,000, compared to $261,006,000 in 2022, reflecting an increase of about 10%[41]. Research and Development - The company continues to invest in research and development to enhance its product offerings and market position[6]. - Research and development expenses increased by 10.9% to approximately $432.8 million in 2023, up from about $390.1 million in 2022, primarily due to increased investment in talent and ongoing clinical trial activities[68]. - The company plans to invest in R&D to enhance technology and production capabilities for cell and gene therapies and other advanced therapies[53]. - The company will continue to invest in synthetic biology R&D to expand market opportunities and optimize production efficiency[110]. Strategic Initiatives - The company aims to improve global production capacity and provide localized supply chain solutions in the U.S., Singapore, and China to support long-term growth[53]. - The company plans to expand production capacity globally to meet strong customer demand, including investments in molecular biology and protein business capacity[98]. - The company has established a direct sales network covering over 100 countries, with significant revenue contributions from the U.S. ($506.0 million) and China ($162.5 million)[49]. - The company aims to enhance operational efficiency through digital transformation and lean management systems[110]. Shareholder and Governance - The company has decided not to declare any dividends for the year ended December 31, 2023, consistent with the previous year[24]. - The board of directors did not recommend a final dividend for the year ending December 31, 2023, to retain resources for business development[114]. - The company has established an audit committee consisting of three independent non-executive directors to oversee financial reporting and risk management[119]. - The annual general meeting is scheduled for May 17, 2024, with a suspension of share transfer registration from May 13 to May 17, 2024, to determine voting eligibility[121].

Company Operations and Growth - The company operates four main platforms: Life Sciences Services and Products, CDMO, Industrial Synthesis Products, and Global Cell Therapy, all of which achieved growth in R&D and commercialization by June 30, 2023[5]. - The professional team consists of approximately 6,414 members, supporting operations in over 100 countries, including China, the USA, and several European nations[5]. - The CDMO platform focused on expanding global capacity and commercialization networks during the reporting period[5]. - The company emphasizes optimizing operational processes to ensure high-quality end-to-end delivery, enhancing customer competitiveness[5]. - Legend Biotech, a subsidiary, is developing a CAR-T cell therapy for multiple myeloma in collaboration with Janssen Biotech, with cilta-cel as the lead candidate[5]. - The Life Sciences Services and Products division provides essential services such as gene synthesis and antibody development, contributing significantly to global life sciences research[5]. - The company aims to establish a healthy biotechnology ecosystem through strategic collaborations with business partners[5]. - The report period ended on June 30, 2023, indicating a focus on continuous improvement and innovation in biotechnology[5]. - The company is committed to making people and nature healthier through its proprietary gene synthesis technology[5]. Financial Performance - The group's revenue for the six months ended June 30, 2023, was approximately $391.3 million, an increase of 26.4% compared to approximately $309.6 million for the same period in 2022[11]. - The gross profit for the same period was approximately $175.0 million, up 3.9% from approximately $168.5 million in 2022[11]. - The adjusted net loss for the six months ended June 30, 2023, was approximately $162.0 million, compared to an adjusted net loss of approximately $134.8 million for the same period in 2022[11]. - The external revenue from the non-cell therapy business was approximately $281.8 million, a 13.8% increase from approximately $247.7 million in 2022, while the cell therapy business generated external revenue of approximately $109.5 million, a significant increase of 76.9% from approximately $61.9 million[11]. - The adjusted operating profit for the life sciences services and products segment was approximately $39.2 million, an increase of 16.7% from approximately $33.6 million in 2022[17]. - The revenue from the biopharmaceutical development services segment was approximately $65.1 million, a slight increase of 3.8% from approximately $62.7 million in 2022[18]. - The adjusted gross profit for the biopharmaceutical development services segment decreased by 18.4% to approximately $19.5 million, down from approximately $23.9 million in 2022[18]. - The cell therapy business reported an adjusted operating loss of approximately $205.9 million for the period[16]. - The life sciences services and products accounted for approximately 50.8% of the total revenue, while cell therapy accounted for approximately 28.0%[15]. - The loss attributable to the company's owners was approximately $93.6 million, compared to approximately $135.5 million for the same period in 2022[11]. Investments and Financial Position - As of June 30, 2023, the group's cash and bank balances were approximately $1.4 billion, an increase from about $941.9 million as of December 31, 2022[34]. - The group held significant investments valued at approximately $259.4 million as of June 30, 2023, compared to $222.5 million as of December 31, 2022[38]. - The group invested in wealth management products with expected yields ranging from 1.4% to 5.2%, with maturities from 1 day to about 1 year, all of which were non-defaulting as of June 30, 2023[39]. - The fair value of the equity portion of Probio B preferred shares was assessed at approximately $1.6 million, while the debt portion was valued at about $37.9 million, including interest of approximately $1.1 million[32]. - The group had approximately $335.3 million in available but undrawn bank credit as of June 30, 2023, compared to about $146.9 million as of December 31, 2022[34]. - The company reported a foreign exchange loss of $15,777 thousand for the period, a decrease from a loss of $24,581 thousand in the previous year, indicating an improvement of about 35.7%[127]. - The company’s total liabilities decreased to $1,298,277 thousand from $1,091,715 thousand, indicating a reduction of about 18.9%[130]. - The company's equity increased to $2,086,044 thousand as of June 30, 2023, compared to $1,362,668 thousand at the end of 2022, reflecting a growth of approximately 53.0%[130]. Research and Development - Research and development expenses increased by 16.7% to approximately $207.3 million from $177.6 million in the same period of 2022[27]. - The company aims to enhance R&D efficiency and cost-effectiveness through investments in CGT-related services and products[65]. - The company plans to continue advancing its pipeline projects in cell therapy and evaluate external collaboration opportunities[68]. - The company is focusing on optimizing pipelines and improving R&D success rates in response to the slowdown in biotech investment[65]. Employee and Management Compensation - The total employee compensation expense for the group was approximately $260.9 million, accounting for about 66.7% of total revenue[69]. - The company invests in continuous education and training programs for employees to enhance their skills and knowledge[71]. - The compensation policy for directors and senior management is based on the company's performance and market data[71]. - The adjusted annual remuneration for Dr. Zhang Fangliang is $572,000, based on individual and overall group performance[115]. - The adjusted annual remuneration for Mr. Meng Jiange is $465,139, reflecting personal and group performance adjustments[116]. - The adjusted annual remuneration for Ms. Wang Ye is $668,109, based on performance metrics[116]. Corporate Governance and Compliance - The company has a strong commitment to environmental, social, and governance (ESG) practices, as indicated by its risk management and governance committees[8]. - The company is committed to maintaining high standards of corporate governance to protect shareholder interests and enhance corporate value[111]. - The audit committee reviewed the unaudited interim results for the six months ended June 30, 2023, ensuring compliance with relevant accounting standards and regulations[113]. - The company has adopted a self-developed code for securities trading, ensuring compliance with the standards set forth in the listing rules[110]. Market Strategy and Future Outlook - The company plans to actively establish production capacity globally to meet strong future customer demand[56]. - Investment will continue in molecular biology and protein business capacity in both China and overseas markets, including expanding GMP production capacity for key reagents[56]. - The company aims to enhance CARVKI production capacity in North America and Europe to expand the treatable patient population following anticipated approval of a supplemental biologics license application[56]. - The company plans to continue expanding its market presence and investing in new technologies and product development[1]. - Future guidance indicates a focus on enhancing operational efficiency and exploring potential mergers and acquisitions to drive growth[1].