国际化+引进新品是后续看点。公司在8 月份发布公告，公司及控股子公司XcoveryHoldings, Inc.零缺陷（no 483）通过了美国食品药品监督管理局的临床BIMO（生物研究监测）相关PAI（批准前检查）现场核查、原料药CMC（化学、生产与控制）PAI 现场核查，本次零缺陷通过美国FDA 核查，表明公司及Xcovery 的质量体系符合美国FDA 的要求，极大的增加了恩莎替尼在美国的上市概率，值得期待；同时公司积极引进新品，根据公司公告，于今年9 月与武禾元生物签署《禾元生物药品区域经销协议》，商定禾元生物委托贝达药业在约定区域内独家经销植物源重组人血清白蛋白（商品名：奥福民），其新药上市申请（NDA）于2024 年9 月获得国家药品监督管理局受理，本次合作有利于公司丰富商业化产品组合，进一步拓展疾病治疗领域，与公司现有的肿瘤领域产品组合实现协同发展，更好满足日益增长的多元化临床需求，为公司长远发展提供持续动力。Key points of investment:
Incident: The company released its results report for the third quarter of 2024. In the first three quarters of 2024, the company achieved revenue of 2.345 billion yuan (YoY +14.73%), achieved net profit attributable to mother 0.416 billion yuan (+36.61% YoY), and realized net profit of 0.362 billion yuan (YoY +50.12%); in the third quarter of a single quarter, the company achieved revenue of 0.844 billion yuan (YoY +15.65%), and achieved net profit to mother of 0.192 billion yuan (same period) Compared to +22.95%), net profit not attributable to mother was achieved at 0.145 billion yuan (-4.88% YoY). The company's results for the 3rd quarter of '24 slightly exceeded expectations.
Driven by new products and proper management of expenses during the period were the main reasons why profits exceeded expectations. Benefiting from the release of enzatinib, befotinib, and voronib after entering medical insurance, the company's sales revenue grew steadily. The company continued to strengthen marketing efforts, actively promoted drug access in hospitals and pharmacies across the country, and increased drug market coverage. In the past two years, the company began to pay attention to input and output efficiency, and to the quality of R&D projects. Through mechanisms such as budget management, bidding management, cost assessment, and system control, the company rationally managed expenses during the period, and steadily achieved cost reduction and efficiency. According to the company's three-quarter report, the ratio of expenses to revenue for the first three quarters decreased from 73.30% to 67.54%, a decrease of 5.76 percentage points. As a result, profit growth in the first three quarters exceeded the rate of expense growth.
Internationalization+introduction of new products is a follow-up highlight. The company announced in August that the company and its holding subsidiary XcoveryHoldings, Inc. Zero Defect (no 483) have passed the US Food and Drug Administration's clinical BIMO (biological research monitoring) related PAI (pre-approval inspection) on-site inspection and the active ingredient CMC (chemical, production and control) PAI on-site inspection. This zero defect has passed the US FDA inspection, indicating that the quality system of the company and Xdiscovery meets the requirements of the US FDA, greatly increasing the probability that enzatinib will be marketed in the US and is worth it Expectations; at the same time, the company will actively introduce new products. According to the company's announcement, the “Heyuan Biopharmaceutical Regional Distribution Agreement” was signed with Wu Heyuan Biotech in September of this year, and it was agreed that Heyuan Biotech would entrust Beida Pharmaceuticals to exclusively distribute plant-derived recombinant human serum albumin (trade name: Aofumin) within the agreed area. Its new drug marketing application (NDA) was accepted by the State Drug Administration in September 2024. This cooperation will help the company to enrich its commercial product portfolio, further expand the field of disease treatment, and achieve collaborative development with the company's existing product portfolio in the field of oncology to better meet the growing Diversified clinical needs provide a continuous impetus for the company's long-term development.
Maintain a “buy” rating. The company will have many commercial growth points in the next few years, including the inclusion of first-line indications of befotinib in medical insurance, approval of enzatinib adjuvant indications after surgery, the marketing of CDK4/6 inhibitors, commercialization of enzatinib in the US, and the introduction of plant-derived recombinant human serum albumin, which will all be the driving forces for the company's growth. We keep our previous profit forecast unchanged. We expect the company's net profit to be 0.426 billion 0.563 billion and 759 million respectively in 2024-2026. The company has a rich innovation pipeline, and the internationalization process continues to advance, maintaining a “buy” rating.
Risk warning: risk of R&D failure or schedule delays, risk of sales falling short of expectations, competition risk
