Sieglitazide sodium is newly added to the national health insurance catalogue, and sales are expected to grow rapidly.
According to the notice of National Healthcare Security Administration and the Ministry of Human Resources and Social Security on issuing (National basic Medical Insurance, Industrial injury Insurance and Maternity Insurance Drug catalogue (2022)) (Medical Insurance Fa (2023) No. 5) released on January 18, 2023 on the website of National Healthcare Security Administration, the new microcore biodiabetes drug siglitartan sodium (Chiglitazar, trade name: Shuangluoping), through health insurance negotiations. It was included in the national health insurance catalogue for the first time. Siglitazide Sodium is the first PPAR agonist independently designed and developed by Microcore to treat type 2 diabetes. It was approved by China's State Drug Administration (NMPA) on October 19, 2021, and the sales revenue of the product reached 3.2587 million yuan in the same year.
In 2022, the company reached an agreement with Zhejiang Haizheng Pharmaceutical Co., Ltd. to cooperate in academic promotion across the country and establish online and offline sales channels. From January to September in 2022, the sales income of Sieglitazine was 11.27 million yuan, of which the sales income in the third quarter was 5.4218 million yuan, with a significant growth rate. Shuangluoping has been successfully included in the national health insurance catalogue and is expected to gradually increase its volume and become a new growth point for the company's performance.
Sales of cedarben, the core product, have increased steadily, and the increase in R & D costs has led to short-term pressure on net profit.
From January to September 2022, the company achieved revenue of 336 million yuan, an increase of 21.38% over the same period last year, of which 22Q3 achieved revenue of 120 million yuan in a single quarter, an increase of 28.44% over the same period last year. The sales revenue of the core product cedarben from January to September totaled 307 million yuan, and the authorized income totaled 15.0978 million yuan. The company recorded a loss of 42.2112 million yuan in net profit from January to September, which was higher than that in the same period of 2021 (loss of 24.2549 million yuan). This is mainly due to the substantial increase in R & D expenses brought about by the promotion of a number of pipeline clinical trials. The company's R & D expenditure from January to September in 2022 was 129 million yuan, an increase of about 38 million yuan compared with 91 million yuan in the same period of 2021.
The clinical progress of multi-pipeline was smooth, and cedarbamide and ciglitar sodium were included in the clinical phase of III, which are two key indications.
The company's main products are independent research and development of new molecular entities and novel mechanisms of the original new drugs. By the end of the third quarter of 2022, the company had more than 20 molecular entity projects in research and development, of which cedaben, in addition to two indications for peripheral T-cell lymphoma and breast cancer approved in 2014 and 2019, respectively, the III phase clinical trial of the combined standard therapy R-CHOP in the treatment of diffuse large B-cell lymphoma has been completed. In addition to the indication of type 2 diabetes approved in 2021, ciglitazide sodium combined with metformin in the treatment of poorly controlled type 2 diabetes III phase 2 clinical trial has also been completed. In addition, research on sioglitazine in the treatment of nonalcoholic steatohepatitis (NASH) has progressed smoothly to phase II. Another core product of the company, sioroni third-line monotherapy for non-small cell lung cancer, and phase III clinical trials of paclitaxel combined with paclitaxel for platinum-resistant or platinum-resistant recurrent ovarian cancer are under way, and multiple key phase III clinical data are expected to be read out in 2023.
Profit forecast and investment advice:
As one of the pioneers and leaders in the field of original new drugs in China, the company focuses on developing original and new molecular entity drugs with global patent protection and unique clinical effects for major diseases to meet unmet clinical needs. The sales of cedarben, a listed product, has increased steadily, and Ciglitazide sodium is expected to continue to sell after it successfully enters the national health insurance catalogue. the research pipeline is rich and many products are in the late clinical stage, and there is room for long-term development. we estimate that the company's operating income from 2022 to 2024 will be 540 million yuan, 814 million yuan and 1.184 billion yuan respectively, and the net profit will be 20 million yuan, 73 million yuan and 119 million yuan respectively. The EPS is 0.05,0.18 and 0.29 yuan respectively, and the corresponding PE is 615X, 173X and 106x respectively.
Risk Tips:
The risk of R & D falling short of expectation, the risk of product sales falling short of expectation, the risk of aggravating the pattern of market competition, the risk of policy change of innovative drugs at home and abroad, and so on.
