First, the company announces that Sun Gong Si Huizheng (Shanghai) Pharmaceutical Technology Co., Ltd. has signed an "exclusive promotion service agreement" with Beijing Novartis AG Co., Ltd. and Sanders (China) Pharmaceutical Co., Ltd. for the maintenance treatment of three adult chronic obstructive pulmonary disease (chronic obstructivepulmonarydisease, COPD) drugs. Huizheng will be paid to obtain the exclusive promotion rights and interests of these three drugs in China.
Comments:
After the replacement of equity by Hillhouse Capital, the business vitality has gradually improved, and the internationalization of CSO Gene of Hanhui Pharmaceutical has gradually highlighted that Huizheng Pharmaceutical is a wholly owned subsidiary of Hanhui Pharmaceutical. Hanhui Pharmaceutical, as a pharmaceutical sales-oriented enterprise, has been in charge of its internal management since its establishment in 2012. in the past five years, it has formed a system of drug sales and academic promotion based on the "Pfizer Inc model" or the top international pharmaceutical companies. No matter from the construction of sales team, marketing system or compliance control, it is very close to the top international pharmaceutical companies, which is the most valuable "gene" of Hanhui Pharmaceutical and the sales team of other domestic pharmaceutical companies. In the early stage, due to the cooperation of shareholders and the lack of high-quality product injection, Hillhouse Capital will reposition the company's value after taking over the original Pfizer equity, make use of the company's high-quality international sales system, actively strive for the domestic agency of high-quality overseas drugs, and gradually build an international CSO company.
The acting drugs Indaterol maleate, Gelonium bromide and Indaterone bromide refer to the recommendation of LAMA+LABA compound preparation in Nanzhong to replace the current market mainstream plus hormone compound preparation in the treatment of COPD. The product agent time is 10 years, and the signing fee is 200 million yuan, which is paid in three installments.
According to IMS, the market for anti-asthma and COPD drugs in China was 11.043 billion yuan in 2017, and the market sales of long-acting bronchodilators (including hormones) were 5.8 billion yuan. The market growth of asthma and COPD is higher than that of the overall market and other chronic diseases. The core product of COPD therapy is bronchodilator, which is classified according to action time: LABA (maintained for more than 12 hours), SABA (maintained for 4-6 hours), LAMA (maintained for 1-2 days), SAMA (maintained for 4-8 hours). At present, domestic listed varieties are almost monopolized by foreign investors, and domestic enterprises are in the stage of research and development. At the present stage, the drugs for the treatment of asthma and COPD in China are mainly ICS (hormone) + bronchodilator, and the products are relatively single, and the mainstream products are all large varieties of more than 1 billion. Once the LAMA+LABA compound preparation is replaced, it has a broad market space and is expected to become a large variety of 1 billion grade. In LAMA, only tiotropium bromide is listed in China. LABA's market share is relatively small.
(1) Indaterol maleate is the first new generation of ultra-long-acting β 2 agonist (LABA) in the world. Compared with the existing products on the market, it has advantages in efficacy, safety and economy. International guidelines recommend first-line use of group B drugs. (2) Gelonium bromide is the world's second long-acting muscarinic receptor antagonist (LAMA). Compared with the first generation tiotropium bromide, it has advantages in terms of efficacy, improvement of deterioration rate and improvement of life. International guidelines recommend first-line use of BMY C group (3) Indo-terroguron bromide compound preparation is the world's first listed new long-acting β 2 agonist + long-acting muscarinic receptor antagonist (LAMA+LABA) product, the efficacy is significantly better than the existing products in the market, is a substitute for the treatment of COPD with hormone compound inhalation preparation on the market, and is currently recommended by international guidelines for group D first-line use.
According to CDE data, the three drugs are all drugs that Novartis AG has been approved to import in the past two years. At present, only Novartis sells them in China, while domestic enterprises Hesco and Hengrui are in the clinical research stage. In addition, domestic enterprises in the field of COPD bronchodilators also have Zhengda sunny and health yuan, and so on.
Company announcement: Zhejiang Haisheng Pharmaceutical Co., Ltd., a subsidiary of the company, intends to increase its capital and shares and transfer some of its old shares by introducing social capital. The capital increase and share increase and the transfer of old shares are based on Haisheng Pharmaceutical's pre-investment valuation of not less than 1.9 billion yuan, the planned capital increase is not less than 800 million yuan, and the transfer of old shares is not less than 685 million yuan. The above programs are all carried out in the form of public listing in accordance with the state-owned assets management regulations, and the listing price is 6.3333 yuan per yuan of registered capital.
Comments:
The introduction of the Diabetes Line to ease the financial pressure, accelerate the listing of products in 2017, the company set up a new wholly-owned subsidiary Haisheng Pharmaceutical, and separated the diabetes macromolecular drug research and development business to Haisheng Pharmaceutical, and then operated independently as a subsidiary. Haisheng Pharmaceutical, as an important R & D platform for diabetes management of the company, is currently mainly researching products such as glargine insulin and Mendong insulin in clinical phase III. At present, the introduction of war investment is expected to share the pressure of Haizheng Pharmaceutical Industry's own R & D investment on the diabetes line. At present, the domestic enterprise layout of Ganjing and Mendong Insulin, only Zhuhai Federal and Ganli Pharmaceutical products have just been listed. The company and Tonghua Dongbao are in the first echelon of research and development.
The DCF valuation model of asparagus insulin assumes that:
1. Time to market: assume that insulin aspartate completes clinical III phase in 2019 (assuming a success probability of 85%) and goes on the market in 2022 (assuming a 90% probability of approval).
two。 According to the data of national diabetes epidemiological survey in recent years, it is assumed that the incidence of diabetes is 11600105, of which type II diabetes accounts for 90%. At present, the diagnosis and treatment rate of diabetes in China is low, the current diagnosis rate is 30%, the diagnosis rate in the United States is 73%, and the diagnosis rate in the Western Pacific is 46%. It is assumed that during the peak period of sales, the diagnosis and treatment rate can be increased to 40%.
At present, the proportion of choosing insulin drugs is about 40%, and the global proportion of insulin drugs is 60%. It is assumed that at the peak of sales, the proportion of insulin drugs in China can be as high as 60%. At present, the second generation insulin is mainly used in China, while in developed countries, the third generation insulin accounts for a large proportion. Third-generation insulin accounts for 85% of the global insulin market. Suppose that at the peak of sales, the use of third-generation insulin can reach 60%. In the third generation of insulin, the current use of asparagus insulin is about 62%, after reaching the peak of sales, the decline is decreasing. It is assumed that the penetration rate of Haizheng Pharmaceutical Co., Ltd. is as high as 33%. The winning price of insulin is 70-90 yuan (300units, 3ml/), and the average dosage is twice a day (each 30IU). It is assumed that the average annual treatment cost of insulin produced by Haizheng Pharmaceutical Co., Ltd is about 5000 yuan.
3. Discount range: assuming that the net profit margin is 0.35, and assuming that the market penetration of asparagus insulin produced by Haizheng Pharmaceutical Co., Ltd. reaches a peak of 30% in 2027, it decreases gradually from 2032 until it accounts for less than 0.1% of the market share in 2051. Suppose the discount rate is 0.1.
According to the above conditions, the free cash flow of this variety is discounted, and the risk-adjusted NPV of the indication of insulin aspartate in the clinical phase of III is about 8.136 billion yuan (about 3.98 times of peak sales).
The DCF valuation model of insulin glargine assumes that:
1. Time to market: assume that insulin glargine completes the clinical III phase in 2019 (assuming an 85% probability of success) and goes on sale in 2022 (assuming a 90% probability of approval).
two。 According to the data of the national diabetes epidemiological survey in recent years, it is assumed that the incidence of type 2 diabetes is 11600105. at present, the diagnosis and treatment rate of diabetes in China is relatively low, the current diagnosis and treatment rate is 30%, the diagnosis rate in the United States is 73%, and the diagnosis rate in the Western Pacific is 46%. It is assumed that during the peak period of sales, the diagnosis and treatment rate can be increased to 40%. At present, the proportion of choosing insulin drugs is about 40%, and the global proportion of insulin drugs is 60%. It is assumed that at the peak of sales, the proportion of insulin drugs in China can be as high as 60%. At present, the second generation insulin is mainly used in China, while in developed countries, the third generation insulin accounts for a large proportion. Third-generation insulin accounts for 85% of the global insulin market.
Suppose that at the peak of sales, the use of third-generation insulin can reach 60%. In the third generation of insulin, the current use of glargine insulin is about 42%, after reaching the peak of sales, the decline is decreasing. It is assumed that the penetration rate of Haizheng Pharmaceutical Co., Ltd. is as high as 33%. The winning price of insulin glargine is 178237 yuan (300units, 3ml/), and the average dose is once a day (each 10IU). It is assumed that the average annual treatment cost of insulin glargine produced by Haizheng Pharmaceutical Co., Ltd is 2500 yuan.
3. Discount range: assuming that the net profit margin is 0.35, and assuming that the market penetration of glargine insulin produced by Haizheng Pharmaceutical Co., Ltd. will peak at 30% in 2027, the rate of decline will decrease gradually from 2032 to less than 0.1% of the market share in 2051. Suppose the discount rate is 0.1.
According to the above conditions, if the free cash flow of this variety is discounted, the risk-adjusted NPV of insulin glargine currently in the clinical phase of III is about 5.112 billion yuan (about 4.02 times of peak sales).
III. Key points of investment
The company has gradually entered the stage of recovery and re-growth.
The company is a state-owned enterprise under the State-owned assets Supervision and Administration Commission of Taizhou City, Zhejiang Province. at present, the business segment includes chemical API, contract customization (CMO) business, chemical preparation, biological preparation, animal protection products and pharmaceutical commerce. In 2012, the company cooperated with the international pharmaceutical giant Pfizer Inc to set up a sales subsidiary, Haizheng Pfizer Inc. Haizheng Pharmaceutical was in the early stage of product development and cultivation, and the echelon of preparation products was not rich enough. therefore, the products injected by Pfizer Inc Pharmaceuticals into Haizheng Pfizer Inc became the main source of revenue and profits of Haizheng Pharmaceutical Industry at that time, but due to the differences in sales strategies between foreign-funded and state-owned pharmaceutical companies, and the supply of core products in 2015. At the same time, part of the company's API business is affected by FDA and EU ban on export, as well as the sharp increase in the company's investment in fixed assets, which leads to a rapid rise in depreciation expenses. the company has experienced a three-year trough in performance. at present, under the active coordination and promotion of the company, these problems are gradually solved and are expected to re-enter the stage of recovery and development.
With the gradual improvement of the marketing system, the preparation plate is expected to enter a high growth stage. The company's three major preparation sales platforms are Hanhui Pharmaceutical, Haikun Pharmaceutical and Baiying. After the completion of equity exchange, Hanhui Pharmaceutical is expected to give full play to its genes of international academic promotion and drug marketing, and its potential value will be gradually reflected, and its product line covers many major disease fields. it mainly includes anti-tumor, anti-bacteria, cardiovascular drugs, endocrine and so on. Haikun Pharmaceutical is mainly responsible for the marketing business of Haizheng's own products of the former Zhejiang Pharmaceutical Industry Company, and its three core products have the first market share of domestic capital. Independent operation helps to do a better job of sub-control and marketing. Shanghai Baiying is the company's macromolecular drug sales platform, and its core product Ambenol has been restricted by production bottlenecks and poor sales in recent years. In February this year, the company obtained the approval for the expansion of Ambenol GMP, which now has an annual production capacity of 1.6 million units. Ambano entered the national health insurance in 2017, capacity expansion plus health insurance assistance is expected to become a large variety of products of more than 500 million levels.
The R & D layout is leading in China, and the company is about to enter the large variety export stage from the cultivation period. The company's R & D strength is in the first echelon of domestic pharmaceutical companies. Currently, there are 8 innovative drugs in the clinical stage, 8 small molecular drugs and 12 macromolecular drugs (including biological analogues). Among them, the heavyweight hypolipidemic class 1.1 new drug, Haize Maibu, is already in the stage of declaration and production, as the first me-too drug of Yishumibu. Haize Maibu has lower reproductive toxicity and long-term toxicity, and is expected to become a class 1 billion blockbuster variety after successful marketing. in addition, Adamu McAb in the macromolecular R & D pipeline is in the declared production stage, and insulin glargine and aspartate insulin are in clinical Ⅲ trials and are expected to be on the market within 2 years. In terms of imitation pharmaceuticals, 16 varieties of the company have been included in the consistency evaluation plan, of which irbesartan and rosuvastatin have passed the consistency evaluation. at present, 9 new generic pharmaceuticals have been declared for clinical use and 7 for production.
IV. Risk hints
1. Special star supply is not as expected, Pfizer Inc preparation product sales are not as expected.
two。 Amberno's sales fell short of expectations
3. The output progress of R & D pipeline products is not as expected.