Core views

Maiwei Biotech announced that the company has submitted the Nectin-4 ADC (9MW2821) phase III clinical plan for locally advanced or metastatic urothelial carcinoma to the Drug Evaluation Center of the State Drug Administration and obtained approval, and the company will soon begin clinical research. Furthermore, the company is rapidly advancing commercialization, and the commercial progress of the two listed products is progressing smoothly; pipeline progress is in line with expectations, 9MW0321 is expected to continue to promote listing, 8MW0511 has received NDA acceptance, many products under development have made rapid progress, and Trop-2 ADC and B7-H3 ADC have also entered clinical trials. Global business is expanding rapidly. Cooperation agreements have been reached with foreign companies for various products. It is expected that milestone payments will be impressive. The company is developing rapidly and has good growth potential.

occurrences

Recently, Maiwei Biotech (688062.SH) issued an announcement. The company has submitted a plan for “a randomized, open, controlled, multi-center phase III clinical study of locally advanced or metastatic urothelial cancer that cannot be surgically resected by 9MW2821 compared with the chemotherapy treatment selected by the investigators before receiving platinum-containing chemotherapy and PD- (L) 1 inhibitors” and obtained approval. The company is about to launch a phase III clinical study of 9MW2821 for locally advanced or metastatic urothelial cancer treated with platinum chemotherapy and PD- (L) 1 inhibitors.

Future prospects

2023-2025:

(1) In terms of drug sales, 9MW0321 (MyHealth) and the new generation of long-acting G-CSF 8MW0511 have been NDA, and it is expected that they will be marketed in the future.

Considering that the company will efficiently promote the commercialization of products such as Milishu, Junmaikang, and MaiHealth, etc., and based on the pace of release of Milishu and the sales situation of MyHealth's original research drug, the company's drug release can be expected in the future.

(2) In terms of international BD, the company's agreements with companies such as DISC MEDICINAL, INC, and Searle will bring considerable milestone revenue to the company.

Among them, an exclusive license agreement was reached with DISC MEDICINAL, INC. The total amount of foreign cooperation agreements for products such as 8MW0511, 9MW1111, and 9MW3011 is RMB 3.56 billion, and sales commissions can be obtained after the product is launched. It is expected that the successor company's ADC platform will continue to be implemented and will also bring the possibility of further foreign cooperation.

(3) Many pipelines on the ADC platform, such as Nectin-4 ADC, Trop-2 ADC, and B7-H3 ADC, have all entered clinical trials, and it is expected that data will gradually be read out in the future.

7. Profit Forecast

In March 2023, the company Mileshue was approved for listing and commercial sales began. It is expected that the company's two listed products from 2023 to 2025 will enter the accelerated release stage; in the research pipeline, 9WM0321 (MyHealth) and 8WM0511 (next-generation long-term G-CSF) are expected to be listed within 2024-2025, 9MW2821 (Nectin-4 ADC) is ahead in R&D progress, and the subsequent research pipeline is rich; from 2023 to 2025, the company's product sales revenue will enter a stage of rapid growth. We It is estimated that the company's product revenue from 2023 to 2025 will be 128 million yuan, 369 million yuan, and 1,023 million yuan respectively. The company's cooperative product, Junmaikang, resumed supply in March, and production capacity will continue to increase. It is expected that from 2023 to 2025, the company will maintain continuous volume and receive revenue from promotion expenses; in the first half of 2023, the company reached cooperation with the US DISC MEDICINE company on 9WM3011 and confirmed cooperation funds; we expect the company's labor revenue from 2023 to 2025 to be 76 million yuan, 150 million yuan, and 185 million yuan respectively. Based on the above assumptions, we expect the company's total operating income from 2023 to 2025 to be 204 million yuan, 519 million yuan, and 1,208 million yuan, up 635.57%, 154.36%, and 132.88% year on year.

It is expected that the amount of the company's R&D expenses and management expenses will continue to grow steadily from 2023 to 2025. As the company's revenue increases, the R&D cost rate and management expense ratio have dropped sharply. The R&D cost rates from 2023 to 2025 are expected to be 350%, 150%, and 65%, respectively, and the management cost rates are 90%, 32%, and 20% respectively; the company will continue to launch new products from 2023 to 2025, and sales expenses are expected to rise sharply from 2023 to 2025. However, with the increase in revenue scale, the sales expense ratio is expected to gradually improve. The sales expense ratio from 2023 to 2025 was 56.48%, 49.76%, and 42.34%, respectively. Thus, the company's net profit from 2023 to 2025 is estimated to be -818 million yuan, -705 million yuan, and -399 million yuan, and the year-on-year loss narrows by 14.42%, 13.76%, and 43.35%, respectively. First coverage, giving a “buy” rating.