Haichen Pharmaceutical Co., Ltd. (300584): the research and development of its own varieties of NMS with abundant injection pipeline is advancing steadily.

東興證券 · Oct 24, 2019 00:00 · Researches

2019 年10 月22 日公司发布三季报报告，报告期内实现收入6.85 亿，同比增长30.24%；归母净利润0.77 亿元，同比增长24.34%。

受托拉塞米增速影响，三季度利润增速有所下降公司2019 年Q3 单季度利润0.24 亿元，同比增长14.3%，单季度增速较Q1-Q3增速（24.34%）有所下降，环比降低22.5%，主要源于公司主力品种托拉塞米注射液因南京优科停产市场份额已有较大提升，销售增速逐步下降，我们预计托拉塞米注射液Q3 销量同比增长约15%。

重磅注射剂陆续获批，后续产品储备丰厚，原料药有望贡献更多利润公司当前诸多注射剂品种销量仍然维持较高增速，如替加环素预计同比增长80%，头孢西酮预计同比增长65%，阿糖胞苷预计同比增长30%，新品种方面，公司长春西汀注射液获批生产，首仿品种兰地洛尔注射液已经完成发补，预计明年年初将获批，此外利伐沙班、非布司他及恩替卡韦等品种明年也有望获批，公司后续注射液产品储备丰厚，现有品种一致性评价工作有序进行，后续制剂板块增长潜力十足。

原料药方面，子公司镇江德瑞作为内外兼顾的原料药基地，不仅给公司供给原料药同时还有外售业务，德瑞自2019 年初投产以来稳定贡献利润，预计Q3 贡献利润~2000 万元，随着未来安庆原料药工厂的动工和新品种的陆续上马，原料药板块有望贡献更多利润。

NMS 授权品种里程碑收益预计将陆续兑现，自有品种研发稳步推进NMS 是2017 年公司收购的意大利新药研发公司，作为全球一流的抗肿瘤药物小分子研发平台，NMS 自身价值已经逐渐得到市场认可和体现。恩曲替尼2019 年8 月FDA 批准上市，预计全球峰值销售额可达20 亿美金，NMS 已经获得5200 万美元里程碑收益，目前NMS 已对外授权包括恩曲替尼在内共5 个品种，后续随着这些品种的临床推进和上市推广，NMS 将陆续获得众多里程碑收益和销售分成。

自有品种方面研发稳步推进，针对实体肿瘤的Danusertib 已经进入二期临床，针对复发性/难治性急性骨髓性白血病（ALM）的NMS P088 及新型PARP1 抑制剂NMS P293 已经进入一期临床，其中PARP1 抑制剂被誉为PD-1 之后下一个抗癌神药，公司P293 对对PARP1 选择性抑制安全性更好，产品血脑屏障透过率远超奥拉帕利，未来有望成为Best-in-class PARP 抑制剂。

公司盈利预测及投资评级：我们看好公司注射剂业务稳步增长，且创新业务整合不断深化。预计公司2019、2020、2021 年实现营收9.45、11.79 和14.21 亿，归母净利润有望分别达到1.06、1.30 和1.54 亿元，维持强烈推荐评级。

风险提示：注射剂销量不及预期、原料药贡献不及预期、创新药引进不及预期，其他风险。

The company released its quarterly report on October 22, 2019, with revenue of 685 million during the reporting period, an increase of 30.24% over the same period last year, and net profit of 77 million yuan, an increase of 24.34% over the same period last year.

Affected by the growth rate of Torasemi, the profit growth rate of Q3 in 2019 was 24 million yuan in the third quarter, an increase of 14.3% over the same period last year. The growth rate of Q3 in 2019 was lower than that of Q1-Q3 (24.34%), and decreased by 22.5% compared with the previous quarter. This is mainly due to the fact that the main product of the company, Torasemide injection, has greatly increased its market share due to the suspension of production of Nanjing Youke, and the sales growth rate has gradually declined. We expect sales of torasemide injection Q3 to increase by about 15% year-on-year.

Heavyweight injections have been approved one after another, and the subsequent product reserves are rich, and the API is expected to contribute more profits. at present, the sales of many kinds of injections in the company still maintain a high growth rate, such as tegacycline is expected to grow by 80% compared with the same period last year. Cefsidone is expected to grow by 65%, cytarabine is expected to grow by 30%. In terms of new varieties, the company has been approved for production of vinpocetine injection, and the first imitation variety of randilol injection has been completed. It is expected that it will be approved at the beginning of next year, and in addition, varieties such as Lifashaban, non-busta and entecavir are also expected to be approved next year. The company has a rich reserve of injection products, and the evaluation of the consistency of existing varieties is carried out in an orderly manner. The growth potential of the follow-up preparation sector is full.

In terms of API, the subsidiary Zhenjiang Derui, as an internal and external API base, not only supplies APIs to the company, but also has export business. Derui has steadily contributed profits since it was put into production in early 2019, and it is expected that Q3 will contribute profits of ~ 20 million yuan. with the construction of Anqing API factory and the launch of new varieties in the future, the API plate is expected to contribute more profits.

NMS authorized variety milestone benefits are expected to be realized one after another, own variety research and development steadily promote NMS is an Italian new drug research and development company acquired by the company in 2017, as a world-class anti-tumor drug research and development platform for small molecules, NMS's own value has been gradually recognized and reflected in the market. FDA approved the launch of Entretini in August 2019, and the global peak sales are expected to reach US $2 billion. NMS has achieved a milestone income of US $52 million. At present, NMS has authorized a total of 5 varieties, including Entretini. With the clinical promotion and marketing of these varieties, NMS will get many milestone earnings and sales share one after another.

The research and development of its own variety has progressed steadily. Danusertib for solid tumors has entered the second phase of clinical practice. NMS P088 and new PARP1 inhibitor NMS P293 for recurrent / refractory acute myeloid leukemia (ALM) have entered the first phase of clinical practice. PARP1 inhibitor is known as the next anticancer drug after PD-1. The company's P293 is safer for selective inhibition of PARP1, and the blood-brain barrier permeability of the product is much higher than that of orapalil. It is expected to become an inhibitor of Best-in-class PARP in the future.

Company profit forecast and investment rating: we are optimistic about the steady growth of the company's injection business and the deepening integration of innovative business. The company is expected to achieve revenue of 9.45,11.79 and 1.421 billion in 2019, 2020 and 2021, and its net profit is expected to reach 1.06,1.30 and 154 million yuan respectively.

Risk tips: injection sales are not as expected, API contributions are not as expected, innovative drug introduction is not as expected, and other risks.

The translation is provided by third-party software.

The above content is for informational or educational purposes only and does not constitute any investment advice related to Futu. Although we strive to ensure the truthfulness, accuracy, and originality of all such content, we cannot guarantee it.

海辰药业(300584)：注射液管线充沛 NMS自有品种研发稳步推进

Haichen Pharmaceutical Co., Ltd. (300584): the research and development of its own varieties of NMS with abundant injection pipeline is advancing steadily.

Risk Disclaimer

Statement