Event: the company released its 2021 annual report and 2022 quarterly report, with an income of 40.503 million yuan (- 13.1%) in 2021 and a net profit of-260 million yuan belonging to shareholders of listed companies. In the first quarter of 2022, the income was 5.67 million yuan (- 1.6%), and the net profit attributed to shareholders of listed companies was-59.242 million yuan.
Health insurance promotes the rapid growth of Aikoning sales. Aikening implemented the national health insurance price, with sales of 112000 units for the whole year, an increase of 59.8% over the same period last year. Affected by the decline in the price of health insurance, sales revenue for the whole year reached 40.503 million yuan, down 13.1% from the same period last year. In 2021, the sales revenue of Q1 and Q2 Aikening increased by 504.4% and 189.24% respectively over the same period last year. Q3 and Q4 realized sales income of 11.834 million yuan and 5.858 million yuan respectively in 2021. The decline in sales was affected by the epidemic in many infectious disease hospitals and public health centers, and the flow of personnel and logistics and transportation were blocked.
Aikening carried out the improvement of drug administration and continued to promote overseas registration. The clinical trial of increasing intravenous administration mode of Aikening has been approved by NMPA. After the clinical trial of intravenous injection is successful and approved on the market, it can significantly shorten the administration time and help to enrich the clinical application scene. In 2021, Aikoning was approved to be listed in Ecuador and Cambodia, and applications for registration were submitted to Azerbaijan, Kazakhstan and Belarus. By the end of 2021, applications for registration had been submitted to 8 countries.
FB2001, the first 3CL protease inhibitor to enter the Ⅱ / Ⅲ phase in China, is expected to meet the rigid needs of COVID-19 's inpatients. In April 2022, FB2001 was approved for phase Ⅱ / Ⅲ key clinic, which is intended to be used to treat COVID-19 's hospitalized patients. The only drug with the same mechanism approved to be listed in the world is Pfizer Inc's oral drug Paxlovid, which is used to treat COVID-19 's mild to moderate outpatients with poor prognostic risk. The global sales volume of Paxlovid in the first quarter of 2022 is about 1.47 billion US dollars. From the perspective of indications, there is no anti-novel coronavirus small molecule drug approved for the treatment of COVID-19 hospitalized patients in our country. According to the ninth edition of COVID-19 diagnosis and treatment Plan, ordinary, severe and critical COVID-19 patients need to be admitted to hospital. The development of FB2001 is of great clinical value and product scarcity. In the world, only RedSivir has been approved for COVID-19 hospitalized patients in some countries. According to Gilead Financial report, in the first quarter of 2022, RedSivir for injection achieved sales revenue of US $1.53 billion, an increase of about 5% over the same period last year and an increase of about 13% month-on-month. The first quarter of 2022 is the main period for the global epidemic of Omicron virus strains. COVID-19 inpatients around the world have a huge rigid demand for effective antiviral drugs.
Steadily promote the progress of research and development, relying on the advantages of polypeptide technology to expand the product pipeline. The company continues to increase R & D investment, with R & D investment of 170 million yuan in 2021, an increase of 24.3% over the same period last year. Three phase Ⅱ clinical trials of anti-HIV virus drug FB1002 were carried out in China and the United States respectively. FB3001, a drug for musculoskeletal joint pain, communicates with regulatory verification clinical regimens. The introduction of therapeutic long-acting hypolipidemic polypeptide vaccine FB6001 is in preclinical study. FB4001, a generic drug of peptide product teripaptide injection, plans to submit ANDA applications to FDA in the United States.
Profit forecast and investment advice. It is estimated that the EPS from 2022 to 2024 is-0.71 yuan,-0.52 yuan and-0.28 yuan respectively. Considering the continuous increase in the penetration rate of Aikening into health insurance and the great potential of COVID-19 drugs in the research pipeline market, investors are advised to pay active attention to it.
Risk hint: Aikening market promotion is not as expected; R & D progress is not as expected.
