Yifan Pharmaceutical (002019): Performance Meets Expectations Innovative Drug R & D Enters Breakthrough Phase

Yifan Pharmaceutical (002019): Performance Meets Expectations Innovative Drug R & D Enters Breakthrough Phase

Event: e1) Jiannenglong’s innovative biological drug F-652 was granted orphan drug qualification for the treatment of acute graft-versus-host disease, indicating that the clinical data of F-625 has been initially approved by the FDA, and the probability of market approval will increase in the future.IIb Apply for clinical data for production, shorten the R & D cycle and save R & D investment. After the product is launched, it will enjoy the policy bonus; 2) Third quarterly report performance: Revenue in the first three quarters37.

9.6 billion, a 10-year growth rate of 10.

6%, net profit 7.

4.2 billion, a previous growth rate of 4.

37%, net operating cash flow 3.

810,000 yuan, of which Q3 single quarter income of 12.

78 ppm, an increase of 15 per year.

4%, net profit 2.

5.7 billion, an increase of 49 per year.

7%, R & D expenses increased by 83%, management expenses increased by 65%, and performance was in line with expectations.

Opinion: The Orphan Drugs Act was awarded multiple policy dividends for orphan drugs after approval.

Orphan drugs are also called rare drugs. In the United States, a rare disease is a disease that affects 200,000 patients with complications.

In order to encourage the development of orphan drugs, the United States introduced the orphan drug bill in 1983 and subsequently revised it. Several encouragement policies are important factors to promote the development of orphan drugs in enterprises: 1) Reduce clinical requirements and the number of clinically enrolled cases is lower than that of non-orphan drugsGroup cases; 2) Monopoly protection period, extended life cycle, 7-year exclusive rights in the US market after listing, and the protection is not affected by patent rights; 3) Special tax benefits, 50% of clinical research and development expenses can be deducted from taxAt the same time, the NDA fee for new drug applications is waived; 4) Enterprises are given a lot of independent pricing power, and the general pricing is very high.

F-652 was qualified as an orphan drug, and Jiannenglong fired the first shot of global innovation.

F-652 is a rhIL-22 (recombinant human interleukin) -Fc fusion protein. With reference to rhIL-22, F-652 has a half-life and duration of drug effect, and the bi-molecular structure is more conducive to binding to the receptor.
Currently, the clinical indications of F-652 include graft antiviral disease, acute alcoholic hepatitis, acute pneumonia, and necrotizing enterocolitis. Among them, GVHD is qualified as an orphan drug, and it is expected to report directly after completing Phase 2b clinical practice in the future;; Acute alcoholic hepatitis (IIb), acute diabetes (Phase I) have applied for breakthrough treatment drugs; preclinical studies of necrotizing enterocolitis.

Considering only the two indications of GVHD and acute alcoholic hepatitis, assuming that the annual medication costs are US $ 50,000 杭州桑拿网 and US $ 20,000, respectively, conservatively estimates that F-652 can reach more than US $ 300 million. The performance is in line with expectations, and the preparations and drug substances maintain a good trend.
Looking at the quarter, 19Q1-Q3 revenue growth rate was -9.

3%, 28.

8%, 15.

4%, net profit growth -54.

8%, 57.

8%, 49.

7%, drug volume and calcium pantothenate prices are steadily increasing, and performance has maintained a rapid growth trend; in terms of segments, 1) the preparation business maintains a high growth trend, and is expected to contribute more than 300 million net profit, with a growth rate of more than 30%, and it is expected to replace the preparation businessMaintain a high growth trend; 2) The price of calcium pantothenate is stable, and the sales volume is affected by swine fever. It is 无锡桑拿网 expected to contribute more than 400 million net profits. The price of calcium pantothenate is 350-430 yuan / kg, and the actual unit price is 350 yuan / kg. The price duration is expected.Exceeding expectations, the amount has decreased due to the impact of swine fever, and the preliminary API sector is expected to contribute 6.

Net profit of about 800 million.

In addition, the company cooperated with Amyris in the United States to develop bio-fermentation to produce vitamins, and 6 cooperation projects, 2 of which have been established. In the future, the performance of the raw material drug sector will be promoted and stabilized at about 800 million to 1 billion, providing stable cash flow for the company’s development.

Research and development progressed smoothly, and innovative drugs entered a breakthrough stage.

The research and development is progressing smoothly, F-627: The domestic clinical trial work is basically completed, and a clinical summary report is expected to be issued before the end of the year. The overseas clinical phase 3 will complete all patients enrollment in June, and it is expected to complete the group entry in the fourth quarter to enter the testing and data statistics stage.

Preliminary results show that the domestic F-627 results are better.

We believe that F-627 has a high probability of approval. It is expected to be launched globally in 2020-2021. According to neutral expectations, F-627 is expected to generate $ 5 billion in revenue; F-652: GVHD (Graft-versus-host disease, US) clinical IIa completedAnd qualified as an orphan drug.

The IIa trial of acute alcoholic hepatitis (USA) has reached its intended target, and the future market size of F-652 is expected to reach more than 300 million US dollars; F899 preclinical research.

Double antibody A-337: humanized EpCAM × CD3 diabody antibody anti-tumor clinical phase 1; double antibody A-319: CD19 × CD3 diabody, B cells and lymphoma have been approved clinically in China.

A reasonable estimate of 250 trillion over 20 years corresponds to the expected 20.

7 yuan: Estimated net profit of pharmaceuticals for 5 years 5.

800 million +, an increase of 27%, given a 20-fold PE, a reasonable estimate of 11.5 billion; the equity of the bio-innovative drug primary market (preipo valuation) is estimated to be 35 billion, and it is expected to reach 5 billion after the IPO; calcium pantothenate is sold at a price of 250 yuanThe ranking has improved in 19 years, with an estimated net profit of about 8 billion, an estimated 8 billion.

Estimated net profit for the years 19-21.

13/13.

71/15.US $ 2.2 billion, with a previous growth rate of 51% / 23% / 11%, 20-year PE 13 times, integration and aggressiveness, with both growth stock and value stock attributes. The company’s 19 years of preparations, innovative drugs and APIs have averaged upwards., 1-year 50% space, maintain “Buy” rating.

Risk Tips: Risks of clinical & marketing of innovative drugs; risk warnings such as low expected price of calcium pantothenate :.