Events:
The company announced on June 28, 2019 that its holding subsidiary Sungen Pharma, LLC (hereinafter referred to as "Shangjin") received notification from the US Food and Drug Administration (FDA) that the ANDA application for methylprednisolone tablets declared to FDA had been approved. At the same time, the company announced that it had entered into a commercial cooperation with Athenex Pharmaceuticals to obtain the right to sell bivalirudin for injection in the United States.
Comments:
Adhering to the road of industrialization of high-end specialty generic innovative drugs in line with international standards, the company has added 2 varieties of methylprednisolone tablets (4mg) and bivalirudine for injection (250mg), and the United States continues to enrich its products:
The company's holding subsidiary in the United States is still familiar with the US ANDA registration process and cGMP on-site verification process and management, which is a favorable driving force for the company's layout of the US market. At present, there are more than 10 products to complete the ANDA declaration. Following the 2018 approval of the United States near amphetamine mixed salt oral tablets and prednisone tablets or FDA, methylprednisolone (4mg) was approved to be listed on the market, and it took only 10 months from declaration to approval. Further proof of the quality and ability of the United States to declare. Methylprednisolone tablets are used in some rheumatic diseases, collagen diseases, skin diseases, allergic diseases, eye diseases, respiratory diseases, blood diseases, tumors, edema, gastrointestinal diseases, nervous system diseases, organ transplantation and so on. Combined with other anti-tuberculosis chemotherapy drugs in the treatment of tuberculous meningitis with subarachnoid obstruction or tends to block, trichinellosis involving nerves or myocardium. Adrenocortical insufficiency, congenital adrenal hyperplasia, non-suppurative thyroiditis, hypercalcemia caused by cancer. At present, the main manufacturers in the American market are Jubilant, Par, Sandoz and so on. According to IMS, 4mg had annual sales of about $93 million in the United States through the first quarter of 2019, compared with $113 million in 2018 and $124 million in 2017. The company announced that the United States is still in commercial cooperation with Athenex Pharmaceuticals to obtain the American sales right of bivalirudine (250mg) for injection, further enriching the company's product line in the United States. Bivalirudin for injection is an anticoagulant (thrombin inhibitor), which helps to prevent thrombosis. It is mainly used to prevent ischemic complications before and after angioplasty in the treatment of unstable angina pectoris. Sales of bivalirudin for injection in the United States were $81.8 million in 2018, according to IQVIA.
Profit forecast and valuation: based on the company's existing business conditions, we estimate that the company's EPS for 19-21 years is 0.23 EPS 0.25 plus 0.29 yuan, and the corresponding valuation is 22-20-17 times, maintaining a "highly recommended" rating.
Risk tips: preparation growth is not as expected; goodwill impairment risk; industry policy risk.
