Bio-drug innovation enterprises, in the R & D investment period, there is no profit for the time being. Founded in 2003, Baiotai is an innovative biopharmaceutical company specializing in drug research and development in the fields of oncology, autoimmune diseases, cardiovascular diseases and other diseases. The actual control of the company is Mr. Yi Xianzhong, Ms. Guan Yu Chan and Mr. Yi Liangyu, who are immediate family members and jointly control a total of 69.3111% of the company through indirect shareholding.
At present, the company has approved an Adamu monoclonal antibody bioanalogue BAT1406 to be put on the market. among the other major products in clinical trials in the pipeline of the products under development, 3 are bioanalogues and 6 are innovative drugs. Biological analogues in the middle and late clinical stage: (1) Adamu monoclonal antibody BAT1406: the first domestic approved market, the trade name Gelele, is expected to be formally commercialized at the beginning of 2020. (2) BAT1706:NSCLC indication of bevacizumab, clinical phase Ⅲ, which is expected to be listed in 2020. (3) BAT1806: rheumatoid indication, clinical Ⅲ phase, expected to be listed in 2021. Innovative drugs in the middle and late clinical stage: (1) Batifiban BAT2094:PCI perioperative antithrombotic, has been declared for production, and is expected to be approved for market in 2020. (2) ADC of BAT8001:HER2 target, indication of advanced breast cancer, clinical stage Ⅲ, single drug is expected to be on the market in 2021. (3) the indication of BAT1306:PD-1 monoclonal antibody combined with XELOX in the first-line treatment of EBV-related gastric cancer, clinical phase Ⅱ, single drug is expected to complete phase Ⅱ clinical trial in 2022.
Deep ploughing autoimmune disease market, won the first domestic adamumab biological similar drug. Rheumatoid arthritis, ankylosing spondylitis and psoriasis have a total of about 15 million patients, the vast majority of whom have not received effective treatment. Take RA as an example, the Rheumatology Branch of the Chinese Medical Association released the results that the effective remission rate of RA patients in China is 8.6%, which is a far cry from the remission rate of more than 50% in developed countries. In the past, due to the low recognition rate of rheumatoid disease in China, non-support of payment system and low pricing of competitive products, the sales of TNF α biopharmaceuticals in China, including adamumab, were not ideal, and the overall market size in 2018 was only about 20-3 billion. In the future, with higher quality of life requirements and higher affordability, with reference to the penetration rate of half of the United States (10%) and taking into account price cuts, we expect the market to grow more than 10 times and reach more than 25 billion in the future. BAT1406 (Gloria), as the first domestic Adamumab bioanalogue approved to market, has a price of 1160 yuan per 40mg/, a decrease of about 10% compared with the original research. Extrapolating all domestic indications of Adamumab (ankylosing spondylitis, rheumatoid arthritis and psoriasis), it is expected to share the broad domestic market for autoimmune diseases. In addition, the company has entered the clinical Ⅲ phase of BAT1806, a biological analogue of tozumab, and is expected to report production in 2021, forming a product echelon in the field of autoimmune diseases.
In addition to the field of autoimmunity, the other three major clinical products focus on tumors and cardio-cerebrovascular fields. (1) BAT1706, a bioanalogue of bevacizumab: clinical phase Ⅲ, which is expected to be produced in 2020. (2) BAT8001:
The first domestic HER2-ADC to enter clinical Ⅲ phase is expected to report delivery in 2021. (3) Batifiban BAT2094: for perioperative antithrombotic PCI, production has been declared and is expected to be approved for listing in 2020.
Fund-raising projects: the company intends to issue no more than 60 million shares to the public (excluding the over-allotment portion). After deducting the issuance expenses, the raised funds will be used for drug research and development, marketing network construction and supplementary working capital.
Profit forecast: we expect the company's operating income from 2019 to 2021 to be 0.7,50 and 200 million yuan respectively, with a growth rate of NA, 7042.86% and 300.005% respectively. The net profit of the company is-10.5,9.05 and-1.126 billion yuan respectively, which is not profitable yet.
Risk hint: the risk of Adamu monoclonal antibody biological similar drug Gelele to sell less than expected, the risk that the product under development is not as expected, the risk of failure in new drug research and development, the risk of management change, the risk of loss of core technical personnel, the risk of issuance failure or delisting after listing (long-term unprofitable).