707): Enoy Approved in the U.S. for Faster-than-Expected Injection Export Leaders
Jianyou Co., Ltd. (603707): Enoy Approved in the U.S. for Faster-than-Expected Injection Export Leaders
Event: On the evening of December 1, the company announced that it had received the USP ANDA certification notice of enoxaparin sodium injection issued by the US FDA, and a total of 7 specifications were approved.
Our Analysis and Judgment (1) Enoxaparin was listed in the US at a faster-than-expected rate. The competitive advantage of Enoxaparin Sodium Injection, which was finally approved by the US FDA in early December, was faster than expected.
We expect the company to launch in late 2020Q1 and early in 2019Q4, which may be reflected in the statements.
Enoxaparin is one of the dominant varieties in the field of anticoagulation.
Enoxaparin is the most widely used of low-molecular-weight heparin. The indications approved by the FDA include: (1) Prevention of venous thromboembolic disease (prevention of intravenous thrombosis), especially thrombosis related to orthopedics or general surgery.
(2) Treatment of deep vein thrombosis that has formed, with or without pulmonary embolism.
(3) The clinical symptoms are not serious, excluding pulmonary embolism that requires surgery or thrombolytic therapy.
(4) Treatment of unstable angina pectoris and non-Q wave myocardial infarction, combined with aspirin.
(5) Used in extracorporeal circulation of hemodialysis to prevent thrombosis.
Although more convenient direct oral anticoagulants (DOAC) have been introduced in the future, low-molecular-weight heparin has safety advantages over it: low liver and kidney toxicity, low risk of bleeding, possible reversibility, and targeting cancer patients and pregnancyPeople must use low-molecular-weight heparin, so enoxaparin still has its wide market and cannot be replaced.
According to the SHS database, in the United States in 2018, Enoxaparin brand drugs + generic drugs totaled 2 billion US dollars, and even slightly 7% in the first three quarters of 19 years.
Although the market size tends to be stable, it is expected that the market size will continue as its indication is just demand.
Enoxaparin has an excellent competition pattern in the United States. Currently, there are 4 ANDA companies in production, including high approval barriers.
Sanofi’s original Enoxaparin was initially listed in 1993. Since then, generic pharmaceutical companies that have received ANDA approval include: Sandoz (2010), Amphastar (2011), Teva (2014), Apotex (2018) and today’s Jianyou.
However, in July 2018, Sandoz notified the FDA and its customers that it will stop supplying enoxaparin generic drugs, and according to its partner analysis, the probability of restarting supply in the future is very small.
So now there are a total of 4 original pharmaceutical companies + 4 generic pharmaceutical companies in the U.S. market producing this variety.
The five suppliers belong to a very good competition pattern.
FDA’s strict approval of Enoxaparin will not worsen the future competition.
The FDA believes that the approval of enoxaparin generic drugs involves multiple challenges, including: (1) Enoxaparin has a complex chemical structure, so the FDA requires five consistency of generic drugs.
Physical and chemical properties are equal; 2.
2. Heparin raw material source and depolymerization method are the same; 3.
Disaccharide structural unit, fragment map and low melting point sequence are equal; 4.
Biological and biochemical tests are equal; 5.
Human Pharmacodynamic Equivalence Study.
(B) Enoxaparin generics are required for immunogenicity studies: Standard heparin is known to cause adverse reactions called immunogenic reactions, such as heparin-induced thrombocytopenia (HIT).
Low-molecular-weight heparin is made from standard heparin, but its hit rate is lower than standard heparin.
The FDA hopes that manufacturers of enoxaparin products will prove that their products do not pose a higher risk of these or other dangerous reactions than Lovenox.
(3) Control of the uncertainty risk of the drug substance.
The company is China’s first Enoxaparin manufacturer of ANDA approved by the US FDA. It has achieved a half-and-a-half-year exclusive agency agreement and is expected to significantly increase profits in the future.
In December 2016, the company signed an agreement with Sagent: Sagent is entitled to enjoy the exclusive sales right of Enoxaparin Sodium in designated areas within the first six months of the period.
Six months later, before the contract expires (within ten years of commercialization of the product), Sagent enjoys semi-exclusive rights.
That is, in addition to Sagent, six months after the product is launched, the issuer looks for an agent or organizes its own sales, but the sellers in this market must not exceed a part.
From the third anniversary of the completion of the first commercial sale of the product, Sagent agreed to maintain a market share of no less than 8% each year.
According to this agreement, we think that the company is 10% with the help of a supplementary 成都桑拿网 agent in a steady state?
20% of the US market share is expected, combined with the future of the US enoxaparin market 15?
About 1.8 billion US dollars, this variety can contribute to the company1.
Annual income of about $ 500 million.
Under the background of API integration, it can significantly increase profits.
(2) The effects of swine fever continued, including the price increase of heparin preparations in Enoxaparin. The pig inventory caused by African swine fever continued to decline, and the number of fertile sows remained lower, and the price of crude heparin had increased.
Since August last year, the African swine fever epidemic began to spread from north to south, resulting in a significant reduction in the number of pigs slaughtered and a tight supply of crude products.
According to data from the Ministry of Agriculture, the number of live pigs in the country in September 19 was 1.
9 billion heads, a year-on-year decrease of 41%; capable of breeding 19.24 million sows, a year-on-year decrease of 38%; and the decline of the two is still deepening.
The average hog price in 22 provinces and cities reached an absolute high in ten years in early November. It has fallen back to November (the level in October). It is considered to be the state ‘s place to put frozen meat and farmers to sell large pigs.Although the tension between supply and demand has actually been reversed.
The unit price of crude heparin is also rising, and the current price has exceeded 3.
5 million / billion units.
We believe that it takes 6-8 months for the price of pigs to rise to the price of crude heparin, and the real increase in the price of pigs since September, indicating that the price of crude products may increase and appreciate in the future.
Typical manufacturers of heparin preparations have made it clear that the rise of raw materials will swallow profits, and the critical point of price increases may come.
For example, Fresenius Kabi, an important heparin preparation manufacturer in the European and American markets, sent a letter directly to American customers for weighing in the middle of 19 years. Due to the tight supply of APIs, it began to limit the shipment of heparin products based on historical demand.
At his 19Q3 earnings call, Fresenius made it clear that although the company ‘s revenue for heparin preparations increased strongly in 19Q3, revenue growth did not increase EBIT, and profits were swallowed up by raw material costs, and future trends are expected to continue.
Therefore, we judge that the overall market for heparin preparations has a tendency to increase prices.
As an integrated drug substance and preparation company, the company holds a large amount of inventory. Whether it is segmentation, price increase or volume control, it has a great substitute for the company’s volume of preparations.
(3) The export of injectables has continued to expand, and in the future, it is expected to benefit from the consistent evaluation of the US regulatory market. The injectables industry has very high barriers. Enoxaparin and other important varieties have been approved in the EU and the United States, which illustrates the company’s strength;The formal restart of the consistency evaluation of injectables is also conducive to nurturing the domestic market. The return of US-listed products to the United States can change the time required to market and reduce research and development costs.
Investment suggestion: We are optimistic about the company’s future development prospects.
The company’s forward-looking large-scale reserve of crude heparin has a prominent value, and the right to speak will be significantly enhanced. The prosperity of the heparin API business will help to continue to improve.
At the same time, the company’s export business logic for injections continued to materialize, and performance broke out soon.
In 2018, 4 ANDAs were approved, and 10 ANDAs are expected to be approved year after year.
In addition, the company’s domestic low-molecular-weight heparin preparation business has entered an explosive growth phase.
We are optimistic that the company’s future performance will maintain rapid growth. It is estimated that the net profit attributable to mothers will be 6 in 2019-2021.
US $ 1.6 billion (considering that Enoxaparin has not started its issuance in the US, we have not adjusted the profit forecast for the time being, and readjusted after the issue scale is clear), the corresponding EPS is 0.
55 yuan, corresponding to 46/33/25 times the PE.
Maintain the “Recommended” level.
Risk reminder: The price of heparin raw materials continues to fall below expectations, the price of crude heparin rises too fast, the export business of injections falls short of expectations, and the risk of R & D falls short of expectations.