Event: on September 21, 2020, the company announced that Tiandao Pharmaceutical, a wholly-owned grandson company, had received a notice from FDA that it had approved its registration as a drug and API supplier of enoxaparin sodium preparation in the United States.
Successful entry into the US market is expected to enjoy the growth share of the standardized market. Entering the American market is expected to increase the share of the normative market. After this approval, Tiandao Pharmaceutical will supply drugs to the US listing license holder, and its partners will be responsible for all sales and distribution related costs. After entering Switzerland in June to break through the non-EU market, enoxaparin once again entered the important global market-the United States, and is expected to rely on the strength of its products to smoothly promote the global layout. The sales of enoxaparin sodium preparation in the United States in 2019 was US $460 million, accounting for about 17% of the world, and is expected to reach US $840 million in 2025 at a compound annual growth rate of 10.7%. In the first half of 2020, the company's Yinuo preparation achieved 640 million yuan in global revenue, + 37% compared with the same period last year, opening up new markets. In the future, the company is expected to rely on its subsidiary SPL to enjoy market growth and increase its market share in the United States.
Build heparin industry chain integration, biological CDMO upgrading growth. The company is a leading heparin raw drug enterprise, adhering to the integration strategy of heparin industry chain. Enoxaparin preparation has been widely recognized in the European market, accounting for about 18% of the market in 2019. At present, three brands of enoxaparin sodium preparation products of Inhixa, Neoparin and Prolongin of Tiandao Pharmaceutical have been approved in 35 countries and sold in 21 countries. In addition, the company carries out CDMO business through Saiwan Biology and SPL dual platforms, with higher professional and service barriers, with revenue of 390 million yuan in the first half of the year, an increase of 10.7% over the same period last year. Saiwan Biological has added new pDNA production facilities and expanded its business to the field of gene therapy. Thanks to the rapid growth of gene therapy research, biological CDMO is expected to become an important driving force for the company's profit growth.
Layout of global First-in-class innovative drugs, open up the company's medium-and long-term growth space. Through investment, the company has laid out a number of innovative drug research and development areas with great demand for new treatments, such as tumor immunity, II diabetic complications and drug-resistant bacteria. Oregovomab, RVX208, AR-301 and other products have entered a critical clinical stage, and the company has the right to commercialize RVX208 and Oregovomab in Greater China, which is expected to open up the company's medium-and long-term growth space in the future.
Profit forecast and investment advice. It is estimated that the net profit from 2020 to 2022 will be 1.02 billion yuan, 1.28 billion yuan and 1.54 billion yuan respectively. Considering the change of equity, the corresponding EPS is 0.70,0.87,1.05 yuan, and the corresponding PE is 33,26,22 times. With the integration of heparin APIs and preparations, macromolecular CDMO+ innovative drugs open room for growth and maintain a "buy" rating.
Risk tips: enoxaparin preparation sales may not meet expectations, innovative drug research and development failure risk.