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百奥泰(688177):类似药出海进入收获期 业绩有望迎来高增

Biotech (688177): Similar drugs go overseas and enter the harvest period, and performance is expected to usher in a high increase

德邦證券 ·  Apr 2

Revenue growth was strong, and performance slightly exceeded expectations: in 2023, the company achieved operating revenue of 705 million yuan, an increase of 54.86% year on year; single Q4 revenue was 244 million yuan, an increase of 67% over the previous month. Sales of galerizumab (adalimumab) injections increased steadily over the same period last year; Schrelli (tocilizumab) injections were approved for sale in January 2023, increasing drug sales revenue; sales of Prbeshi (bevacizumab) injections increased, and drug sales commission revenue and sales milestone revenue increased. The increase in revenue was greater than the increase in expenses, and losses narrowed.

Production and research: By the end of 2023, the total production capacity of the raw solution put into use was 30,500L. The Yonghe Phase 2 expansion project has completed civil structures and construction. It is expected to be delivered for production within 2024. After Yonghe Phase 2 is put into operation, the total production capacity of the company's stock solution will reach 66,500L. By the end of 2023, the company had a total of 1,167 employees, and the company currently has 379 R&D personnel. The company's product portfolio includes more than 20 different products in the clinical stage, covering various fields such as oncology, autoimmunity, cardiovascular and ophthalmology.

Similar drugs have reached a milestone in going overseas. A number of reserve products have been approved for marketing by the US FDA. BAT1806 (tocilizumab) was approved in September 2023. It is the first tocilizumab to be approved by the FDA. BAT1706 (bevacizumab) was approved in December 2023; tocuzu and bevar have submitted marketing applications to EMA. BAT2506 (golimumab) has completed global phase III clinical research; BAT2206 (usinumab) has completed global phase III clinical research, signed commercialization agreements with Hikma in the US market, and commercialization agreements with Pharmapark in Russia and other countries. BAT2306 (scuchiumab) is currently undergoing global phase III clinical trials. We are actively developing emerging markets and reaching cooperation with companies in Brazil, Indonesia, Pakistan, Afghanistan and other regions for similar pharmaceutical products.

Innovative drug pipelines are abundant, and several ADC products are in clinical practice. BAT2094 (batifiban, beta3 integrin receptor inhibitor) is currently in the domestic marketing application stage. BAT4406F (CD20 antibody) is currently undergoing critical testing for neuromyelitis optica. Many ADC products are undergoing clinical trials. BAT8006 (FRαADC) is in phase II clinical phase, and the phase II clinical trial application has obtained FDA approval. BAT8010 (HER2 ADC) combined with BAT1006 (HER2 monoclonal antibody) has entered clinical trials to treat tumors. BAT8008 (Trop2 ADC) and BAT8007 (Nectin-4 ADC) are undergoing phase 1 clinical trials.

Profit forecast: We believe that there are high barriers to the company's similar drugs going overseas. With the commercialization of products in Europe and the US and approval for production of new products, the company's future revenue will rise high. We expect the company's 24-26 revenue to be 1,396, 25.48, 4.363 billion yuan, and net profit of -0.22, 5.71 billion yuan, and 1,329 billion yuan. Maintaining a “buy” rating

Risk warning: risk of sales falling short of expectations, risk of clinical progress falling short of expectations, risk of clinical failure

The translation is provided by third-party software.


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