Amoy Diagnostics Co.Ltd(300685) covid-19 maintained stable growth under the disturbance of the epidemic, and the leading advantage continued to consolidate

\u3000\u30 Chongqing Baiya Sanitary Products Co.Ltd(003006) 85 Amoy Diagnostics Co.Ltd(300685) )

Event: on April 11, 2022, the company released its annual report. Results: in 2021, the company achieved an operating revenue of 917 million yuan, an increase of 25.9% year-on-year; The net profit attributable to the parent company was 240 million yuan, with a year-on-year increase of 32.86%; The net profit deducted from non parent company was 216 million yuan, with a year-on-year increase of 46.54%. On April 20, 2022, the company released the results of the first quarter of 2022: in 2022, Q1 company achieved a revenue of 206 million yuan, a year-on-year increase of 18.6%, and the net profit attributable to the parent company was 536148 million yuan, a year-on-year increase of 23.46%.

Q1 performance in 2021 and 2022 met expectations, with the gradual standardization of the diagnostic industry

The company’s performance maintained stable growth under the disturbance of covid-19 epidemic. In 2021, the company’s revenue was 917 million yuan, including 699 million yuan of testing reagent revenue, a year-on-year increase of 23.83%; The income from inspection expenses was 154 million yuan, a year-on-year increase of 33.43%; The revenue from drug clinical research services was 541774 million yuan, a year-on-year increase of 26.97%. Q1 revenue in 2022 was 206 million yuan, with a synchronous increase of 18.6%, mainly due to the spread of covid-19 epidemic in all parts of China. In March, the epidemic in Shanghai was serious, and the amount of medical diagnosis of tumor patients was affected. With the gradual consolidation of the leading position of the company, its performance maintained stable growth. In terms of products and technical platforms, the company currently has four technical platforms: PCR, ngs, IHC and fish, and has developed 24 kinds of single gene and multi gene tumor diagnosis products approved for listing. In terms of sales coverage, the company adopts the direct selling mode and focuses on the hospital market. It has covered more than 500 hospitals and more than 400 direct selling teams. With the rapid and healthy development of the diagnostic industry under the guidance of policies, in 2021, the drug audit center and device audit center of the State Food and Drug Administration issued the guiding principles for clinical trials of listed antitumor drugs and concomitant diagnostic reagents, the guiding principles for registration and review of clinical trials of originally developed concomitant diagnostic reagents developed simultaneously with antitumor drugs and other documents, and the action plan for improving the quality of cancer diagnosis and treatment was issued in 2022, Clarify the important clinical value of concomitant diagnosis of tumor drugs and further standardize the concomitant diagnosis market

Focusing on R & D and innovation, the first domestic PD-L1 concomitant diagnostic kit was approved

The company attaches importance to the building of R & D team and the investment in R & D innovation. In 2021, the company invested 156 million yuan in R & D, with a year-on-year increase of 35.63%, and 451 R & D personnel, with a year-on-year increase of 65%. At present, the company has two R & D centers in Xiamen and Shanghai, with 50 patents authorized, and the core invention patents have been authorized by China, the United States, the European Union and Japan at the same time. In terms of products, the company’s Shengxin patent algorithm breaks through the patent blockade of overseas enterprises and is based on ADX GSS ® The innovative product hrdpanel developed by the algorithm has obtained the EU IVDD certification. In March 2022, PD-L1, a tumor immune drug concomitant diagnostic product based on IHC technology platform, was approved for listing, contributing new revenue increment. In the future, the company will gradually promote the research and development of recurrence (efficacy) monitoring products such as tumor early detection, MRD and oncopro. Continue to promote cooperation between pharmaceutical enterprises and consolidate the foundation of product line. At present, the company has reached accompanying diagnosis cooperation with pharmaceutical enterprises such as AstraZeneca, Johnson & Johnson, Merck, Amgen, Lilly and Weicai. In February 2022, the company reached a strategic cooperation with the French pharmaceutical company pilfaber group to promote the registration of BRAF inhibitors in concomitant diagnostic reagents for non-small cell lung cancer and colorectal cancer; In April, the company reached a strategic cooperation with Hehuang pharmaceutical to promote the research and development of concomitant diagnostic kit for the treatment of non-small cell lung cancer.

Overseas business continued to advance, and pcr-11 gene was approved to contribute new increment in Japan

The company’s products have been sold in hospitals and scientific research institutes in more than 60 countries and regions around the world, with more than 100 international dealers. In 2021, the company’s overseas revenue was 1.05 yuan, a year-on-year decrease of 8.4%, mainly due to the sales of some covid-19 testing reagents in the company’s overseas market in 2020, and the rapid growth of tumor molecular diagnosis products excluding covid-19 business. The company’s overseas business is accelerating. At present, there are more than 50 international businesses and BD teams, with wholly-owned subsidiaries in Singapore, Hong Kong, China and Canada, and European logistics centers in the Netherlands. The company’s products have gained a firm foothold in East Asia and EU markets, and will further expand to Southeast Asia, North America and other markets in the future. At present, ros1 kit has been approved to be listed in Japan and South Korea and entered the medical insurance. In June 2021, the new product pcr-11 gene was approved to be listed in Japan and incorporated into the Japanese medical insurance in January 2022. The Japanese market may enter a period of rapid growth in 2022. Based on ADX GSS ® Hrdpanel, an independent patent algorithm, is actively promoting the registration and approval of the EU and Japan.

Profit forecast: the company is a leading enterprise accompanying the diagnosis. From March to April 2022, the covid-19 epidemic spread all over China. Considering the impact of the epidemic, the company reduced its revenue from 1.243 and 1.489 billion yuan to 1.146 and 1.490 billion yuan from 1.944 billion yuan in 2024, reduced its net profit from 334.34 million yuan to 301 and 396 million yuan from 2022 to 2023, and maintained the “buy” rating.

Risk tips: covid-19 epidemic situation is uncertain, new products are approved less than expected, industry competition intensifies, and overseas promotion is less than expected.

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