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双鹭药业(002038)年报及季报点评:来那度胺获优先审批 产品储备日益丰富

招商證券 ·  May 4, 2016 00:00  · Researches

  The company announced the 2015 annual report and the first quarterly report for 2016:2015 operating income was 1,557 million yuan, net profit was 575 million yuan, down 6.95% and 17.27%, respectively, EPS was 0.84 yuan, and net profit after deduction fell 17.53% year on year. Operating income for the first quarter of '16 was 259 million yuan and net profit was 149 million yuan, down 6.66% and 16.75% respectively from the previous year. Meanwhile, the company announced that net profit for the first half of the year is expected to increase by -15% to 15%. Major products are adversely affected by industry policies. The company's revenue and profit for the first quarter of '15 and '16 showed a downward trend, mainly affected by price cuts in medical insurance fee control tenders, restrictions on adjuvant drug use in some provinces and cities, and a slowdown in the growth rate of the pharmaceutical industry. Among them, revenue for the third and fourth quarters of 2015 decreased by 8.3% and 3.6% year on year, respectively, and net profit decreased by 21.2% and 64% year on year, respectively. Sales of biological and biochemical drugs increased by 5.22%, but revenue was 976 million yuan, down 3.6% from the previous year. Revenue from Beco Energy, the main product, is expected to decline slightly. It is expected that the revenue of the main product, Pentapeptide, etc. will continue to be affected by price cuts in tenders. Sales of chemicals fell 7.96% year over year, revenue fell 19.47% year over year, and gross margin fell 12 percentage points to 64.2%. The heavy variety lenalidomide received priority review. On April 24, 2016, the National Drug Evaluation Center announced that it intends to include nalidomide APIs and capsule formulations in the priority review process in the anti-tumor drug registration application. The reasons for selection were: urgent clinical need, and the first company applied for production. Lenalidomide was developed by Celgene and is mainly used to treat myelodysplastic syndrome and multiple myeloma. It was approved by the FDA in December 05 through an expedited approval process. Indications are increasing, and in June 2006, it was approved by the FDA in combination with dexamethasone to treat patients with multiple myeloma who had received at least one type of treatment beforehand. Furthermore, the US FDA and EU EMA approved the combined use of lenalidomide and dexamethasone as first-line drugs for multiple myeloma in February 2015, further demonstrating that lenalidomide has been widely recognized by doctors and patients around the world. The average progression-free survival time of patients has been extended from 6 to 9 months to more than 2 years, greatly improving the remission time and longevity of patients with multiple myeloma. In 2015, lenalidomide sold $5.8 billion, up 16% year over year. Revenue for the first quarter of 2016 was $1,574 million, up 17% year over year. Multiple myeloma (MM) is a malignant plasmacytosis with an estimated incidence of 2 to 3 out of 100,000, the second highest incidence of all hematologic tumors. Currently, there are about 100,000 patients with multiple myeloma in China, of which more than 20,000 new cases are added every year. Domestically, Celgene's lenalidomide was approved for listing in 2013 and applied for a series of domestic patents. Multiple bone marrow is currently an area where drugs are urgently needed clinically. The cost of treatment for the original drug is about 600,000 yuan per year, and the annual treatment cost after receiving drug aid is about 180,000 yuan. Nanjing Cavendish, a subsidiary of Shuanglu Pharmaceutical, has invented a new route to synthesize lenalidomide and new crystals, and has obtained a patent license. According to the priority approval procedures for registration applications issued by the state, it is expected that the company's lenalidomide capsules will be approved for listing within the year, which will be an important driving force for the company's future performance. Product reserves are becoming more and more abundant, and a large number of potential varieties have been formed. Major products to be marketed and clinically declared include lenalidomide (declared for production), dasatinib (declared for production), and palmadomide (approved for clinical use), which have successfully challenged international patents. Product reserves are increasingly abundant in the field of anti-infective drugs and liver disease. In the field of antiviral drugs, we have the national class 1 drug adefovir ester, the new class 1.1 drug amifovir (pre-clinical), tenofovir fumarate (declared production), and macrogol recombinant human interferon alpha-2b injection (PEG-rhifnα-2b, declared clinical). In terms of drugs to protect the liver, it has adenosylmethionine (to be produced in batches) for intrahepatic cholestasis caused by cirrhosis and liver cirrhosis and intrahepatic cholestasis during pregnancy. Together with glutathione and complex coenzymes, it has established the competitive advantage of Shuanglu Pharmaceutical's series of biochemicals for liver disease. In the treatment of upper gastrointestinal bleeding caused by cirrhosis and portal hypertension, the company has also placed advantages. Octreotide and somatostatin will all become important varieties of the company in this field. In terms of drugs used to prevent and treat anaerobic infections, the company has ornidazole whose registration standards meet the standards of pharmacopoeia of developed countries (USP, EP, BP, JP, etc.). The injection has set the strictest product standards and limits for this product in the world according to ICH guidelines. It is expected that after the product is approved for marketing, it will have a driving effect on the performance of Shuanglu Pharmaceutical in the next few years. In the field of cardiovascular and cerebrovascular treatment, it has exclusive cardiovascular damage repair drugs, the proprietary cardiovascular Chinese medicine, Xingling drops, and cellular metabolism regulators. The core varieties of enoxaparin sodium, the antihypertensive drugs telmisartan and nafperdil, and the hypolipidemic agents have simvastatin. The many advantageous varieties in reserve also include the 4 patented drugs amlodipine nicotinate and amlodipine nicotate series compound varieties, selective aldosterone receptor antagonist eprilone, oral selective activity factor Inhibitor apixaban (clinically approved), oral high-selectivity factor Xa inhibitor beneficial Varoxaban. In the field of antiplatelet aggregation drugs, the company has a patented thiophene pyridine disulfide coupling mixture (antiplatelet drug, used for primary and secondary prevention of acute coronary syndrome, coronary stenting, and coronary heart disease, which can reduce the risk of heart attack, stroke, and death in patients with cardiovascular disease). Shuanglu Pharmaceutical's thiophene pyridine disulfide coupling mixture does not require liver P450s enzymolysis and is more suitable for Asian people. It highlights its advantages in all aspects, is strong, and has great potential. variety. The company has stocked a large number of advantageous products in the field of diabetes treatment, nephropathy treatment, etc., which together form the company's outstanding competitive advantage in the field of treatment of hematological diseases, cardiovascular and cerebrovascular diseases, liver disease, diabetes, nephropathy, etc. Maintain a “Prudent Recommendation - A” investment rating. The heavy-weight variety lenalidomide received priority review. After approval for marketing, it will hedge against the declining impact of existing varieties. At the same time, the company's varieties such as enoxaparin, dasatinib, adenosylmethionine sulfonate, gemcitabine, and ornidazole are also awaiting batch production, which is beneficial to the company's future performance. EPS is expected to be 0.82, 0.99, and 1.15 yuan in 16-18, and PE 35, 29, and 25 times, maintaining the “Prudent Recommendation - A” investment rating. Risk warning: Beco's sales fell short of expectations; lenalidomide registration progress fell short of expectations.

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