Event: green Leaf Pharmaceutical released its mid-2020 report, with operating income of 2.962 billion yuan in the first half, down 5.4% from the same period last year; net profit from its mother was 539 million yuan, down 26.2% from the same period last year; and normalized EBITDA was 1.186 billion yuan, down 1.3% from the same period last year. The net cash flow generated by the company's operating activities in the first half of the year was 661 million yuan, down 12.33% from the same period last year.
In the first half of the year, all businesses affected by the epidemic must decline. Overseas business is growing against the trend. In the first half of the year, sales revenue from oncology products decreased by 5.0% to 1.334 billion yuan, while sales revenue from central nervous system products increased by 21.6% to 746 million yuan. Sales revenue from digestive and metabolic products and cardiovascular products decreased by 29.1% and 11.2% to 391 million yuan and 430 million yuan, respectively.
In the first half of the year, the company made breakthroughs in a number of businesses, with overseas sales growing by 5% against the trend. As one of the core products in the field of central nervous system, Sricon has set up its own sales teams in Singapore and the Middle East, and has reached distribution and promotion strategic cooperation with local partners in more than 10 countries and regions in the Asia-Pacific region, the Americas and Africa, making use of the partners' strong business network and resources in the local market to enhance the local accessibility of Sricon. Another core product, Lex's clear-through leather patch, has also reached new cooperation in many European countries.
Continue to increase investment in innovation and accelerate the commercialization of new drugs
The company continues to increase its investment in innovation. At present, 1 project has been approved for listing, 5 projects are in the listing application stage, and 8 projects are in the III phase or key pilot stage. In terms of the new preparation (NDDS), Lisi's Mingtuo patch has been approved in China, and the application for listing has been accepted by the European Union; risperidone injection sustained-release microspheres (LY03004) have submitted applications for listing in the United States and China; rotigotin sustained-release microspheres for injection (LY03003) have entered phase lIII in the United States and China respectively, and completed phase I clinical inclusion in Japan. Gosheriline acetate sustained-release microspheres (LY01005) for injection have entered phase III clinical practice in China, while paroperazone sustained-release suspension injection (LYO3010) is about to carry out key trials in the United States.
In terms of new molecular drug (NCE), the application for the marketing of the new antidepressant drug LYO3005 has been accepted by the FDA of the United States, which is in phase 1 clinical trial in Japan and is about to complete phase III clinical trial in China. Lurbinectedin (LY01017), an innovative anti-tumor drug cooperated with Spanish company Pharma Mar, has recently received clinical approval in China.
In terms of biomedicine, the application for marketing of bevacizumab injection (LYO1008) has been accepted by the Drug Review Center of the State Drug Administration; the bioanalogue of Prolia (LYO6006) has completed the phase III clinical trial; the bioanalogue of Xgeva (LY01011) has been enrolled in phase l; the bioanalogue of Eylea (LY09004) has completed phase I clinical entry; and the company's first overseas biological drug desumab injection (LYO6006/LY01011) has been clinically approved by the United States FDA.
Actively expand M & An and cooperation business, and continuously enhance the ability of innovation
Through strategic mergers and acquisitions and cooperative business, the company continues to inject innovative product lines and core competencies into the company's long-term development. In February this year, the company completed the acquisition of Boan Biology, accelerating the global distribution of biopharmaceuticals. Boan Biology has a number of innovative technology platforms, including whole-human antibody transgenic mouse phage display technology, nano-antibody technology, bispecific T-cell Engager technology, antibody coupling (ADC) technology, as well as a series of products under development at different clinical stages, including 8 biological analogs and more than 10 innovative biological drugs. The acquisition of Boan Biology further enriches the company's product portfolio in the field of biopharmaceuticals, and enables the company to rapidly form a complete biopharmaceutical industry chain from research and development, production to commercialization. The anti-tumor innovative drug Lurbinectedin introduced by the company from Pharma Mar has been approved by the Drug Evaluation Center of the State Drug Administration to carry out clinical practice. The drug was approved for sale in the United States in July this year and gives priority to patients in Australia and Singapore through a special access mechanism. In addition, the drug has submitted applications for new drug marketing in Switzerland, Canada and Israel, and has been granted orphan drug status for the treatment of small cell lung cancer (SCLC) in the United States, the European Union, Switzerland and Australia. In overseas clinical studies, Lurbinectedin single drug second-line treatment of sensitive and drug-resistant SCLC has shown good anti-tumor activity, this product is expected to become a potential second-line treatment of SCLC, but also inject new development momentum for the company in the anti-tumor field.
Research and development and foreign cooperation in parallel, is expected to enter a new stage of development
With the competitive advantage of innovative products, strong reserve of products under research, good R & D strength and marketing network, as well as its ability to carry out strategic acquisitions, the company has the advantage of entering a new business stage. We estimate that the company's net profit from 2020 to 2022 will be 16.44,18.27 and 2.121 billion yuan respectively, an increase of 11.9% and 11.1% respectively over the same period last year.
Risk hints: uncertainty risk of new drug research and development; risk of industry policy change and product price reduction; market competition risk of similar products