Main points of investment
Recommended logic: the company's tenofovir dipyrifoxil fumarate capsule and its API have been approved by CFDA production, becoming the first generic drug with hepatitis B indication in China. This variety is a first-line anti-hepatitis B drug, which will be used rapidly in the future, and its peak sales may reach 1 billion yuan, contributing 300 million yuan to the performance.
Become the first imitation of hepatitis B indications, first-mover advantage may greatly improve the performance of the company. The company tenofovir has become the first domestic approved generic drug variety of chronic hepatitis B (HBV), leading in Chengdu Beit, Qilu Pharmaceutical, Zhengda Tianqing and other declaration enterprises. In 2008, tenofovir as an anti-HIV drug was approved and imported in China. The original research was Gilead Sciences Inc, and the indication of hepatitis B was approved in August 2013. Tenofovir and entecavir are the first-line drugs in the current guidelines for the treatment of hepatitis B. compared with entecavir, tenofovir has better clinical effects. The first imitation can bring the market first-mover advantage to the company, and it is expected that the peak sales of Tinofovir will reach 1 billion yuan after listing, contributing about 300 million yuan, which will greatly improve the company's performance.
The first-line use of hepatitis B may change the market pattern. Small molecular antiviral drugs have become the first choice for the treatment of hepatitis B, and the listing of tenofovir is expected to change the domestic market pattern of small molecule hepatitis B drugs. The domestic small molecular nucleoside drug market has grown rapidly in the past 10 years, and has achieved explosive growth driven by the listing of the effective drug entecavir. Since it was listed in 2006, the domestic entecavir market has rapidly grown to 9 billion yuan. In terms of clinical therapeutic effect, tenofovir is better than entecavir in the treatment of HBV patients, and its drug resistance is almost zero. Tenofovir is the best anti-hepatitis B small molecular nucleoside drug in the market. We believe that the listing of tenofovir may quickly change the domestic market pattern of hepatitis B drugs.
Global anti-virus heavyweight varieties, the domestic price reduction ushered in the market rapid volume. Tenofovir is still the most mainstream combination of anti-HIV drugs, with sales of its compound preparations exceeding US $9 billion. Many domestic enterprises have applied for tenofovir to be listed, but the indications are all anti-HIV, and the market capacity of anti-HIV is much lower than that of anti-hepatitis B. Tenofovir is a national drug price negotiation variety in 2016, with a drop of up to 67%. We believe that under the strong impetus of the price reduction of the original drug, the domestic market for HBV indications of tenofovir is expected to achieve rapid growth like entecavir, and market sales are expected to peak at 5 billion yuan.
Profit forecast and investment advice. It is estimated that the EPS from 2017 to 2019 is 0.61,0.82,1.21 yuan respectively, and the corresponding PE is 70 times, 52 times and 35 times respectively. The approval of the first imitation of tenofovir hepatitis B indication is expected to achieve rapid volume, which will greatly improve the company's performance. Long-term optimistic about the company's development prospects, maintain the "buy" rating.
Risk tips: drug price decline risk, new products on the market sales promotion or lower than expected.